SAMJ Vol 106, No 2 (2016) by HMPG

FEBRUARY 2016

VOL. 106 NO. 2

GUEST EDITORIAL Strengthening surgical research capacity in subSaharan Africa – collaboration is key EDITORIALS National Forum on Surgery and Anaesthesia Biological sample export from SA – bioexploitation CME Cardiology (part 2) IN PRACTICE Chronic kidney disease – transplantation the answer RESEARCH Choose your hospital for survival in emergency intraperitoneal surgery Intussusception in the developing world: The Baragwanath experience Dedicated paediatric burns units key to saving lives, but in short supply

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FEBRUARY 2016

VOL. 106 NO. 2

GUEST EDITORIAL

SAMJ

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Collaboration is key to strengthening surgical research capacity in sub-Saharan Africa R T Spence, E Panieri, S L Rayne, E M Harrison, A A Bhangu, J E Fitzgerald

EDITOR-IN-CHIEF Janet Seggie, BSc (Hons), MD (Birm), FRCP (Lond), FCP (SA)

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EDITOR’S CHOICE

DEPUTY EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB

CORRESPONDENCE

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Who will guard the guards? Medical leadership and conflict of interest in South African healthcare R P Abratt

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Difficult tracheal tube insertion: A new phraseology Z H Khan, F Tavakoli

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The UCT class of 2000 reunion P Diab, A Dramowski, N van Schaik

CEO AND PUBLISHER Hannah Kikaya | Email: hannahk@hmpg.co.za

IZINDABA

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Managing the fiscal beast – admin-to-clinician ratio now 3:1 Consciously cutting to the bone of SA’s surgical/anaesthetic delivery

MANAGING EDITOR Ingrid Nye

Editor’s choice February 2016 J Seggie

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Surgery and anaesthesia in the South African context: Looking forward N Patel, M Peffer, A Leusink, N Singh, M Smith

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Data mining and biological sample exportation from South Africa: A new wave of bioexploitation under the guise of clinical care? C Staunton, K Moodley

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Implications of direct-to-consumer whole-exome sequencing in South Africa Z Lombard, F Baine, A Krause, A Lochan, S Macaulay, C Spencer, C Aldous, J de Vries, K Fieggen, B Henderson, E Hoal, C Kinnear, N Kinsley, A September, M Urban, H Soodyall, M Pepper, M Ramsay

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Challenging the cost of clinical negligence G Howarth, E Hallinan

CME GUEST EDITORIAL

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Cardiovascular medicine in primary healthcare in sub-Saharan Africa: Minimum standards for practice (part 2)

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ARTICLES An approach to a patient with infective endocarditis J Hitzeroth, N Beckett, P Ntuli

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An approach to the patient with suspected pericardial disease C G Kyriakakis, B M Mayosi, E de Vries, A Isaacs, A F Doubell

IN PRACTICE

G Ogunbanjo, N A B Ntusi

HEALTHCARE DELIVERY

An effective approach to chronic kidney disease in South Africa

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The decolonialisation of medicine in South Africa: Threat or opportunity?

M R Moosa, A M Meyers, E Gottlich, S Naicker M de Roubaix

CASE REPORT

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TECHNICAL EDITORS Emma Buchanan Paula van der Bijl NEWS EDITOR Chris Bateman | Email: chrisb@hmpg.co.za PRODUCTION MANAGER Emma Jane Couzens DTP AND DESIGN Carl Sampson HEAD OF SALES AND MARKETING Diane Smith | Tel. 012 481 2069 Email: dianes@hmpg.co.za JOURNAL ADVERTISING Charles William Duke Benru de Jager Reneé van der Ryst Ladine van Heerden Azad Yusuf ONLINE SUPPORT Gertrude Fani FINANCE Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair), Dr M R Abbas, Dr M J Grootboom, Mrs H Kikaya, Prof. E L Mazwai, Dr M Mbokota, Dr G Wolvaardt ISSN 0256-9574 SAMA website: www.samedical.org Journal website: www.samj.org.za

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ASSOCIATE EDITORS Q Abdool Karim, A Dhai, N Khumalo, R C Pattinson, A Rothberg, A A Stulting, J Surka, B Taylor, M Blockman HMPG

EDITORIALS

EDITORS EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon) JP de V van Niekerk, MD, FRCR

Normal-pressure hydrocephalus presenting with psychiatric symptoms E Groenewald, J A Joska, S Rothemeyer

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February 2016, Vol. 106, No. 2

CONTENTS LISTED IN Index Medicus (Medline) Excerpta Medica (EMBASE) Biological Abstracts (BIOSIS) Science Citation Index (SciSearch) Current Contents/Clinical Medicine

RESEARCH

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A multicentre evaluation of emergency abdominal surgery in South Africa: Results from the GlobalSurg-1 South Africa study* R T Spence, E Panieri, S Rayne, on behalf of the GlobalSurg South Africa collaboration

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South African surgical registrar perceptions of the research project component of training: Hope for the future?* N Patel, P Naidoo, M Smith, J Loveland, T Govender, J Klopper

SAMJ SUBSCRIPTION RATES Local subscriptions ZAR 1 368.00 p.a. Foreign subscriptions ZAR 3 108.00 p.a. Single copies ZAR114.00 local, ZAR 259.00 foreign

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Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Johannesburg, South Africa* J Fabian, H Maher, A Bentley, P Gaylard, K Crymble, B Rossi, L Aucamp, E Gottlich, J Loveland, J R Botha, J Botha, R Britz

Members of the South African Medical Association receive the SAMJ only on request, as part of their membership benefit.

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Factors determining clinical outcomes in intussusception in the developing world: Experience from Johannesburg, South Africa* C Carapinha, M Truter, A Bentley, A Welthagen, J Loveland

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Are central hospitals ready for National Health Insurance? ICD coding quality from an electronic patient discharge record for clinicians* R E Dyers, J Evans, G A Ward, S du Plooy, H Mahomed

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Burn surgeons in South Africa: A rare species* N L Allorto, S Zoepke, D L Clarke, H Rode

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Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre* B Jugmohan, J Loveland, L Doedens, R L Moore, A Welthagen, C J Westgarth-Taylor

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Validating homicide rates in the Western Cape Province, South Africa: Findings from the 2009 Injury Mortality Survey* M Prinsloo, R Matzopoulos, R Laubscher, J Myers, D Bradshaw

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Empirical antimicrobial therapy for probable v. directed therapy for possible ventilator- associated pneumonia in critically injured patients* Y Ramsamy, D J J Muckart, J L Bruce, T C Hardcastle, K S S Han, K P Mlisana

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An analysis of patients transported by a private helicopter emergency medical service in South Africa* D Muhlbauer, R Naidoo, T C Hardcastle

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Treatment and outcome of unusual animal bite injuries in young children* P de Klerk, M van Dijk, A B van As

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Thrombocytopenia during pregnancy in women with HIV infection receiving no treatment* H M Sebitloane

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Which test is best for diagnosing peanut allergy in South African children with atopic dermatitis?* C L Gray, M E Levin, G du Toit

*Full article available online only.

CAREERS & CLASSIFIEDS

CPD QUESTIONS

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February 2016, Vol. 106, No. 2

Subscriptions: Tel. 012 481 2071 Email: members@samedical.org The SAMJ is published monthly by the Health and Medical Publishing Group (Pty) Ltd, Co. registration 2004/0220 32/07, a subsidiary of SAMA. HEAD OFFICE Health and Medical Publishing Group (Pty) Ltd Block F, Castle Walk Corporate Park, Nossob Street, Erasmuskloof Ext. 3, Pretoria, 0181 Tel. 012 481 2069 Email: dianes@hmpg.co.za EDITORIAL OFFICE Suites 9 & 10, Lonsdale Building, Gardener Way, Pinelands, 7405 Tel. 021 532 1281 | Cell. 072 635 9825 Email: publishing@hmpg.co.za Please submit all letters and articles for publication online at www.samj.org.za © Copyright: Health and Medical Publishing Group (Pty) Ltd, a subsidiary of the South African Medical Association Use of editorial material is subject to the Creative Commons Attribution – Non-commercial Works Licence. http://creativecommons.org/licenses/by-nc/3.0 Printed by TANDYM PRINT

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GUEST EDITORIAL

Collaboration is key to strengthening surgical research capacity in sub-Saharan Africa A call for more research in areas with the highest burden of disease

Global health research efforts are not being instigated in countries that have the highest burden of disease or the greatest clinical need.[1,2] The so-called ‘10/90 gap’ is well known, describing an estimated 10% of global health research devoted to conditions that account for 90% of the global disease burden. While much effort has addressed this disparity in the past 25 years, recent research from the Lancet Commission on Global Surgery indicates that high-income countries still account for 85% of published articles from the leading 35 countries undertaking surgical research.[3] This situation needs to change. Disease characteristics and research findings from developed countries are potentially impractical and misleading for clinicians practising in low- and middle-income countries (LMICs) that are less well resourced. Sub-Saharan Africa (SSA) is facing a quadruple burden of disease. Diseases of lifestyle, impoverishment, and HIV and trauma epidemics place massive strains on our healthcare systems. Women in Africa are developing breast cancer on average 15 years earlier than women in North America and Europe. This early onset of breast cancer in Africa suggests different risk factors and a different disease profile. [4] However, full understanding of surgical disease and best treatment practices in LMICs are restricted by an absence of local research on local areas of need.[3] Many other critically important local surgical questions have yet to be thoroughly addressed. Surgical trainees and medical officers are the workforce addressing the surgical needs of this burden. They have to cope with an extremely pressured working environment, time constraints, lack of research training and a surgical culture that leans towards service delivery over training or research. This has meant that there is a paucity of locally relevant research output from our surgical trainees, particularly in comparison with our overseas counterparts. The Health Professions Council of South Africa recently enforced a recommendation of the College of Surgeons of South Africa to make the MMed degree mandatory prior to acceptance on the specialist registry as a general surgeon. This stimulus, while commendable, will fail to encourage new research capacity if it is not accompanied by good departmental supervision and support in timely pursuit of relevant questions. It is up to the universities and surgical institutions to address the fact that lack of supervision, skills and time to pursue research still persist. Further obstacles to fostering a research-friendly culture include poor patient record keeping with the absence of good-quality clinical databases, a lack of accessible data-capturing systems in most training institutions, and little institutional memory or impetus for clinical research or audit. Lastly, there is a poor track record of collaborative research in southern African surgical departments, most having preferred insular, single-centre research.

Surgical research collaboratives provide a solution

In the UK over the past 7 years, trainee-led regional networks in general surgery have been developed to adopt a novel collaborative approach to research. Collaboration between trainees in several hospitals allows for a larger number of patients to be included in studies over a shorter time, prevents repetition, and makes the results more applicable than

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those arising from single-centre studies. Trainees are ideally placed to deliver this model; they follow a rotational pattern through several hospitals, are in regular contact with each other, are motivated, and are expected to produce evidence of research and audit. The first regionally developed general surgical research collaborative was the West Midlands Research Collaborative. Their published randomi sed controlled trial, ROSSINI (Reduction Of Surgical Site Infection using a Novel Intervention),[5] recruited 760 patients from 21 centres to use either a wound-edge protection device or standard practice. The rapid recruitment (the trial ran ahead of schedule throughout) and minimal loss to followup demonstrated the ability of trainees to plan and conduct high-quality multicentre research. Other regional and specialty-based collaboratives were subsequently established, allowing for almost complete coverage of the UK. In general surgery, these regional networks recently delivered the Multicentre Appendicectomy Audit that included 3 326 consecutive patients undergoing appendicectomy from 95 centres in just 2 months![6] Further trainee-led randomised trials and national cohort studies are ongoing, and are recruiting patients from across the UK.[7] The hands-on engagement of trainees in research and audit projects has obvious educational benefits. With this in mind, the collaborative model has now been expanded to include medical students across the UK and Ireland through the Student Audit and Research in Surgery network (STARSurg, www.starsurg.org). This is now in its third year, and the most recent cohort study saw over 1 000 collaborators collect data on over 9 200 patients across 168 hospitals. Its first cohort study, investigating the impact of postoperative non-steroidal antiinflammatory drugs on adverse events after gastrointestinal surgery, was published in the British Journal of Surgery.[8] Furthermore, these collaborations have started to publish under a group name in order to flatten the traditional hierarchies associated with academic authorship and provide academic recognition as an added incentive to participation. Ultimately, it is hoped that as these undergraduate and postgraduate collaborators progress to become consultants, a culture of research, audit and trials will be embedded in their surgical practice.

Some collaborative success to date in SSA

The South African Surgical Outcomes Study was a 7-day national, multicentre, prospective, observational cohort study of all patients older than 16 years of age undergoing inpatient non-cardiac surgery between 19 and 26 May 2014 at 50 government-funded hospitals in South Africa (SA). This collaborative effort recruited 3 927 patients from 45 hospitals located throughout the country and was recently published in the SAMJ.[9] Hospitals throughout the world providing emergency surgical care were invited to collaborate in GlobalSurg.[10] This was a multicentre, international, prospective cohort study that aimed to determine universal processes related to best outcome in emergency abdominal surgery over a 2-week period during July - November 2014.[10] Over 350 centres, including 15 from SSA, contributed to this truly international evaluation.

A way forward

The remarkable success in the UK with collaborative networks and these recent local accomplishments may suggest that a simi

February 2016, Vol. 106, No. 2

Invitation to participate on the Government Employees Medical Scheme (GEMS) Advisory Panels of Experts for: 1. Orthopaedic and Spinal Surgery 2. Psychiatry 3. Oncology and Biologics* The Government Employees Medical Scheme (GEMS) Registration Number 1598, was registered in terms of the Medical Schemes Act 131 of 1998 with effect from 1 January 2005. The Scheme reports to the Registrar of the Council of Medical Schemes and is defined as a body corporate that undertakes liability related to its members’ healthcare benefits in exchange for receiving contributions. Objective A GEMS expert advisory panel is formed with the following objectives: • Informing the Scheme’s approach to funding benefit entitlements where claims are for healthcare interventions where clinical care is not standard; • Suggesting enhancements to the Scheme’s clinical and funding protocols based on evidence that describes effective best practice; • The examination of current evidence-based data and guidelines; • Invitation of peers for review if necessary; and • Assisting the Scheme’s Ex-Gratia Committee in its decision-making process. Panels required GEMS seeks to establish the following Expert Advisory Panels: • Orthopaedic and Spinal Surgery Expert Advisory Panel • Psychiatry Expert Advisory Panel • Oncology and Biologics Expert Advisory Panel* Panel composition and structure Each expert advisory panel will consist of three members. Panels will exist and execute their duties independently from each other. Each panel will meet at least once every quarter in a year, but may meet more frequently if required. Qualification requirements and remuneration Applications are called for from suitable candidates who have the requisite qualifications, research and clinical practice experience in the relevant field. Qualification requirements are: • Appropriate academic training, qualifications and relevant clinical experience; • Proven career-related achievements in one or more of the above mentioned fields; and/or • International and/or local experience and/or recognition. GEMS will pay a competitive fee to members of the panels for participation. Travel-related subsistence costs will also be covered. The quantum of payment will comply with GEMS policies. To apply, please send your CV and covering letter to leticia@gems.gov.za. Please note that where an application is made for more than one panel, separate submissions are required. The closing date for applications is 18 March 2016. Should you not hear from us by 31 March 2016, please consider your application unsuccessful. GEMS adheres to principles of integrity and ethics in assessing responses to such invitations. *Kindly note that the Oncology and Biologics Expert Advisory Panel is already established and GEMS only seeks one candidate for this panel. Working towards a healthier you

GUEST EDITORIAL

lar model in SSA could provide the stimulus to increase research capacity, particularly in the surgical outcomes and quality improvement domains.[11] All collaboratives from the UK have found alignment with existing organised structures beneficial in providing advice and support, including professional specialty associations. In SA, for example, the Association of Surgeons of South Africa, the Surgical Research Society of Southern Africa and the South African Society of Surgeons in Training could provide the academic, structural and logistical support for us to adopt a similar model and encourage surgical trainee collaborative development in SA (Fig. 1). South African Society of Surgeons in Training

Surgical Research Society of Southern Africa National general surgical research collaborative

Regional collaborative

Local trainees

Association of Surgeons of South Africa

Local trainees

Eugenio Panieri Department of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa Sarah Louise Rayne Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

National surgical specialty research collaborative

Ewen Munro Harrison Clinical Surgery, University of Edinburgh and Royal Infirmary of Edinburgh, UK

Regional collaborative

Local trainees

Richard Trafford Spence Codman Center, Department of General Surgery, Massachusetts General Hospital, Boston, USA, and Department of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa rtspence@mgh.harvard.edu

Local trainees

Fig. 1. A proposed model for organisation and communication of national research collaboratives in SA. SA’s position as neighbours to countries in SSA with the highest disease burdens and lowest audit and research capacity potentially allows inclusion of its local surgeons into a growing collaborative network. As in the UK, surgical collaboratives in SSA can seek to establish regional, national and international ‘hub-and-spoke’ models. This will allow universities and research centres to deliver research from several local partners, increasing strength, depth and value. As clinical studies and trials disseminate best clinical practice as part of their quality control, this should have rub-off benefits for patients beyond urban centres as networks develop.

Conclusion

The paucity of research in areas of greatest clinical need must be addressed urgently. We propose a model of collaboration in an era of information systems and emerging mobile health technology that has had significant success across the UK and has shown early encouraging results in SA. We foresee that recent examples of surgical research collaboratives in SA will continue to promote regional, national and international ‘hub-and-spoke’ models and ultimately increase the South-South collaboration that is urgently needed to diffuse the skills and knowledge required to address the unmet surgical need in SSA.

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Aneel Amir Bhangu Academic Department of Surgery, University of Birmingham and Queen Elizabeth Hospital, Birmingham, UK James Edward Fitzgerald Department of General Surgery, Royal Free Hospital NHS, Barnet Hospital Campus, London, UK 1. Rottingen JA, Regmi S, Eide M, et al. Mapping of available health research and development data: What’s there, what’s missing, and what role is there for a global observatory? Lancet 2013;382(9900):12861307. [http://dx.doi.org/10.1016/S0140-6736(13)61046-6] 2. Moran M, Guzman J, Ropars AL, et al. Neglected disease research and development: How much are we really spending? PLoS Med 2009;6(2):e30. [http://dx.doi.org/10.1371/journal.pmed.1000030] 3. Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Lancet 2015;386(9993):569-624. [http://dx.doi.org/10.1016/ S0140-6736(15)60160-X] 4. Gakwaya A, Kigula-Mugambe JB, Kavuma A, et al. Cancer of the breast: 5-year survival in a tertiary hospital in Uganda. Br J Cancer 2008;99(1):63-67. [http://dx.doi.org/10.1038/sj.bjc.6604435] 5. Pinkney TD, Calvert M, Bartlett DC, et al. Impact of wound edge protection devices on surgical site infection after laparotomy: Multicentre randomised controlled trial (ROSSINI Trial). BMJ 2013;347:f4305. [http://dx.doi.org/10.1136/bmj.f4305] 6. National Surgical Research Collaborative. Multicentre observational study of performance variation in provision and outcome of emergency appendicectomy. Br J Surg 2013;100(9):1240-1252. [http:// dx.doi.org/10.1002/bjs.9201] 7. Bhangu A, Kolias AG, Pinkney T, Hall NJ, Fitzgerald JE. Surgical research collaboratives in the UK. Lancet 2013;382(9898):1091-1092. [http://dx.doi.org/10.1016/S0140-6736(13)62013-9] 8. STARSurg Collaborative. Impact of postoperative non-steroidal anti-inflammatory drugs on adverse events after gastrointestinal surgery. Br J Surg 2014;101(11):1413-1423. [http://dx.doi.org/10.1002/bjs.9614] 9. Biccard BM, Madiba TE. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J 2015;105(6):465-475. [http://dx.doi.org/10.7196/SAMJ.9435] 10. Bhangu A. Determining universal processes related to best outcome in emergency abdominal surgery: A multicentre, international, prospective cohort study. BMJ Open 2014;4(10):e006239. [http://dx.doi. org/10.1136/bmjopen-2014-006239] 11. Uthman OA, Wiysonge CS, Ota MO, et al. Increasing the value of health research in the WHO African Region beyond 2015 – reflecting on the past, celebrating the present and building the future: A bibliometric analysis. BMJ Open 2015;5(3):e006340-2014-006340. [http://dx.doi.org/10.1136/ bmjopen-2014-006340]

S Afr Med J 2016;106(2):125-126. DOI:10.7196/SAMJ.2016.v106i2.10183

February 2016, Vol. 106, No. 2

EDITOR’S CHOICE

Editor’s choice February 2016 CME: Cardiology

Cardiovascular disease (CVD) accounts for approximately 30% of deaths worldwide, with 80% of this burden in developing countries. The epidemiological transition occurring in sub-Saharan Africa (SSA) has the consequence of economic and social transformation, resulting in dramatic shifts in disease spectrum from communicable diseases and malnutrition to CVD and cancer. South Africa (SA) is faced with the challenge of four colliding epidemics: (i) poor child and maternal health; (ii) high rates of interpersonal violence; (iii) infectious diseases, including HIV/AIDS and tuberculosis; and (iv) non-communicable diseases, including CVD. This outstanding series of articles, spread across three issues of SAMJ/CME, represents the collaborative effort of primary health/family physicians and cardiologists from around the country. The authors have synthesised and presented the most current, evidence-based and practical approaches to management of common CVDs. The articles in this issue focus on infective endocarditis and suspected pericardial disease.

Towards universal access to safe and affordable surgical and anaesthetic care

In my June 2015 Editor’s Choice, I informed the SAMJ readership of the Lancet Commission on Global Surgery (LCoGS) and the key role played by Prof. Martin Smith, Academic Head of Surgery at the University of the Witwatersrand, Johannesburg, as one of the 31 Bellagio Commissioners when in February 2015 the LCoGS held a Bellagio summit, sponsored by the Rockefeller Foundation, to discuss strategies for improving access to surgery worldwide.[1] According to the LCoGS report,[2,3] five billion people in the world (and 93% in SSA) cannot obtain basic surgical care. At least 5% of the global burden of disease in low- and middle-income countries (LMICs) is potentially avoidable by scaling up a basic surgical package, and (e.g. in SA) by addressing the unequal distribution of surgical services, operating theatres and intensive care units. The South African Surgical Outcomes Study,[4] a 7-day prospective observational cohort study contributed to by surgeons from across the country, sought to investigate perioperative mortality and need for critical care admission in patients ≥16 years of age undergoing inpatient non-cardiac surgery between 19 and 26 May 2014 at 50 public sector, government-funded hospitals. While this extensive survey painted a relatively happy picture for SA, there is no room for complacency – a future scale-up to meet projected 2030 requirements is necessary. Moreover, most patients in SA’s public sector hospitals require urgent and emergency surgery, which is strongly associated with high mortality and unplanned critical care admissions. Scale-up of basic surgical services is crucial to health system strengthening, given the large burden of surgical conditions and the crosscutting nature of surgery. The LCoGS, according to modelling in 88 LMICs with a population >1 million, proposed that countries should achieve 5 000 major operations per 100 000 population per year to meet populations’ needs.[5] The extreme scarcity and unequal distribution of surgical services and operating theatres was acknowledged.[6] Four types of interventions (especially relevant to SA) are needed: competent initial surgical care for injury victims; handling of obstetric complications; timely and competent surgical management of various abdominal and extra-abdominal emergency and lifethreatening conditions; and elective care of simple surgical conditions such as hernias, clubfoot, cataract, hydroceles and otitis.

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Scale-up of basic surgical services in LMICs is an essential compo nent of health system development and the movement towards universal health coverage, towards which SA currently strives.[7] The National Forum on Surgery and Anaesthesia: an indispensa ble part of achieving universal health coverage was held at the University of the Witwatersrand under Martin Smith’s chairmanship on 7 - 8 December 2015[8,9] to host the SA launch of the LCoGS. This conference brought together surgical and anaesthetic specialists, health policy makers, public health and health system experts to discuss and debate essential surgical care and anaesthesia as part of uni versal health coverage, expanding access to safe, high-quality, affordable surgery and anaesthesia in SA, particularly in rural and under-served areas, appropriate workforce training and education, health system strengthening including infrastructure development, financing essential surgical and anaesthetic care, and building linkages across disciplines. To honour this ground-breaking conference, this issue of SAMJ features a wealth of surgical research articles, with a Guest Editorial entitled ‘Collaboration is key to strengthening surgical research capacity in Sub-Saharan Africa’[10] by Richard Spence and a number of his young surgical colleagues from around the world that amplifies their research into South African surgical registrar perceptions of the research project component of training.[11] GlobalSurg-1 was a multicentre, international, prospective cohort study conducted to address the global lack of surgical outcomes data. Six SA hospitals participated (‘A multicentre evaluation of emergency abdominal surgery in South Africa: Results from the GlobalSurg-1 South Africa study’[12]). It was hypothesised that the location of surgery was an independent risk factor for an adverse outcome following emergency intraperitoneal surgery, and the hypothesis was unfortunately confirmed: hospital 5 was associated with a 76-fold increased odds of in-hospital death and 58-fold increased odds of a major in-hospital complication, and hospital 3 was associated with a 3-fold increased odds of any in-hospital complication. The unhappy conclusion is that in SA the hospital in which emergency intraperitoneal surgery is undertaken is of itself an independent risk factor for an adverse outcome.

Intussusception in the developing world

Intussusception should not be underestimated. Even in developed countries it is associated with significant morbidity and mortality, as is highlighted by Carapinha et al.[13] Because management may be either non-operative pneumatic reduction (PR) or operative, the challenge lies in triaging patients correctly into those who will respond to PR, thus avoiding intestinal resection, and those who must be taken directly for laparotomy. The outcomes following the introduction of updated management guidelines at Johannesburg’s CHBAH in an attempt to increase the success of PR are outlined. Absolute contraindications to PR included peritonitis, free intraperitoneal air, established obstruction, haemodynamic instability or multiorgan failure, and failure of the procedure mandated open surgical exploration. Key to success of PR is a low duration of symptoms (DOS), ideally <2 days. The average DOS before presentation in the CHBAH series was 3.0 (standard deviation 2.2) days, typical of developing countries but comparing poorly with the developed world, where cases present within hours of development of symptoms. Unsurprisingly, the CHBAH intestinal resection rate was 81.5% in

February 2016, Vol. 106, No. 2

EDITOR’S CHOICE

patients undergoing exploration – high compared with other series. A good history of the exact time of onset of symptoms is key, as the longer the DOS, the more physiologically unwell the patient will be.

Paediatric burn injuries

In sub-Saharan Africa the mortality rate for burn victims under 5 years of age is 1 in 9, v. 1 in 152 in high-income countries. Burns are one of the top five causes of fatal urban injuries in SA children, according to the 2010 Bulletin of the World Health Organization,[14] with the majority of deaths occurring in children <6 years of age; approximately 1 300 of our children die annually as a result of burns. The Johnson and Johnson Paediatric Burns Unit at Chris Hani Baragwanath Academic Hospital (CHBAH) in Johannesburg opened in 1995 and admits approximately 450 patients per year. Since 2009, this dedicated burns unit has run a programme in which intensivists and a dedicated burns surgeon are part of the multidisciplinary management team. The experience of this specialised unit is described by Jugmohan et al.[15] (‘Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre’). The vast majority of admissions (76.5%) were a consequence of hot-water burns, with flame burns the second leading cause (21.8%). The steady success of the unit is depicted in Fig. 4 in the article, reproduced below. 14 Overall mortality, %

12 10

COP21

The COP21 report is at hand … while SA faces unprecedented drought and North and South America and the UK unprecedented rains and floods. While there was no enforcement of the goals and inadequate funding for developing nations to cope with the climate crisis, climate activists seem to agree that COP21 marked at least the beginning of the end of the fossil fuel era.[20] JS

8 6 4 2 0

first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Fabian et al.[18] report overall 10-year recipient and graft survival rates of 80.4% and 66.8%, respec tively, for kidney-alone transplantation. There is no shortage of potential organ donors in SA, as a visit to any busy trauma unit will testify – translating these into actual donors is where our challenge lies. Our current transplant rate of 4.7 per million population is woefully inadequate to meet needs and below the rates of other middle-income countries. The summit recommended that deceased donation be prioritised … surely requiring the introduction of a ‘deemed consent’ system, also known as the ‘opt-out’ system, to which a number of countries (e.g. Chile) already subscribe. The aim is to increase the number of organs and tissues available for transplant, reducing the number of people who die while waiting for a suitable organ to become available. In Wales, legislation for organ donation opt-out was proposed (‘if you have not registered a decision to opt-in or opt-out of organ donation, you will be treated as having no objection to being an organ donor. This is called deemed consent’) and became law on 1 December 2015,[19] with the Scottish government poised to follow.

2009 - 2010

2010 - 2011

2011 - 2012

Year

Fig. 4. Trends in mortality.

Against this background of the obviously high burden of burn injuries in SA, requiring surgeons skilled in burn care, the survey by Allorto et al.[16] (‘Burn surgeons in South Africa: A rare species’) reveals that there are few dedicated burn surgeons and few properly equipped units or centres such as that at CHBAH. The current workforce resources are inadequate, with the major deficit being lack of training and the resource-restricted environment. Fortyseven percent of survey respondents were not training registrars at the hospital or institution at which they worked. The remaining respondents (53%) trained registrars with rotations varying from 1 month (18%) to 6 months (23%). The majority opinion (72%) was that a medical officer was skilled enough to work in the field of burns and that specialist training was not necessary!

Transplantation in SA

SA nephrologists report on a summit that Moosa et al.[17] (‘An effective approach to chronic kidney disease in South Africa’) claim marks the first step in a process that, it is hoped, will ultimately culminate in universal access to renal replacement treatment for all South Africans. Transplantation is the answer … especially as the outcomes of the first 10 years of kidney and pancreas transplantation compare favourably with international survival data. In their article on the

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1. http://www.globalsurgery.info/wp-content/uploads/2015/02/Bellagio-Participant-Bios_updated_2.9.pdf (accessed 7 December 2015). 2. Lancet Commission on Global Surgery. http://www.who.int/hrh/news/2015/lancet_commission_ globsurgery/en/ (accessed 15 January 2016). 3. The Lancet Commission on Global Surgery. http://www.thelancet.com/commissions/global-surgery (accessed 7 December 2015). 4. Biccard BM, Madiba TE. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J 2015;105(6):465-475. [http://dx.doi.org/10.7196/SAMJ.9435] 5. Bickler SL, Verguet S, Alkire BC et al. Timing and cost of scaling up surgical services in lowincome and middle-income countries from 2012 to 2030: A modelling study. Lancet Glob Health 2015;3(S2):S28-S37. http://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(15)70086-0.pdf (accessed 7 December 2015). 6. Holmer H, Lantz A, Kunjumen T, et al. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health 2014;3(Apr):S9-S11. [http://dx.doi.org/10.1016/S2214109X(14)70349-3] 7. Matsoso MP, Fryatt R. National Health Insurance: The first 18 months. S Afr Med J 2013;103(3):156158. [http://dx.doi.org/10.7196/SAMJ.6601] 8. Bateman C. Consciously cutting to the bone of SA’s surgical/anaesthetic delivery. S Afr Med J 2016;106(2):132-134. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10526] 9. Patel N, Peffer M, Leusink A, Singh N, Smith M. Surgery and anaesthesia in the South African context: Looking forward. S Afr Med J 2016;106(2):135-136. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10529] 10. Spence RT, Panieri E, Rayne SL, Harrison EM, Bhangu AA, Fitzgerald JE. Collaboration is key to strengthening surgical research capacity in sub-Saharan Africa. S Afr Med J 2016;106(2):125-126. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10182] 11. Patel N, Naidoo P, Smith M, Loveland J, Govender T, Klopper J. South African surgical registrar perceptions of the research project component of training: Hope for the future? S Afr Med J 2016;106(2):169-171. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10310] 12. Spence RT, Panieri E, Rayne SL, on behalf of the GlobalSurg South Africa collaboration. A multicentre evaluation of emergency abdominal surgery in South Africa: Results from the GlobalSurg-1 South Africa study. S Afr Med J 2016;106(2):163-168. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10183] 13. Carapinha C, Truter M, Bentley A, Welthagen A, Loveland J. Factors determining clinical outcomes in intussusception in the developing world: Experience from Johannesburg, South Africa. S Afr Med J 2016;106(2):177-180. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.9672] 14. Burrows S, van Niekerk A, Laflamme L. Fatal injuries among urban children in South Africa: Risk distribution and potential for reduction. Bull World Health Organ 2010;88:267-272. [http://dx.doi. org/10.2471/BLT.09.068486] 15. Jugmohan B, Loveland J, Doedens L, Westgarth-Taylor CJ. Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre. S Afr Med J 2016;106(2):189-192. [http://dx.doi. org/10.7196/SAMJ.2016.v106i2.8942] 16. Allorto NL, Zoepke S, Clarke DL, Rode H. Burn surgeons in South Africa: A rare species. S Afr Med J 2016;106(2):186-188. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.9954] 17. Moosa MR, Meyers AM, Gottlich E, Naicker S. An effective approach to chronic kidney disease in South Africa. S Afr Med J 2016;106(2):156-159. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.9928] 18. Fabian J, Maher H, Bentley A, et al. Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Johannesburg, South Africa. S Afr Med J 2016;106(2):172-176. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10190] 19. Organ Donation Wales. http://organdonationwales.org/Organ-Donation-is-changing-in-Wales/Donation-ischanging-in-Wales/?lang=en (accessed 30 December 2015). 20. Full text of COP21 international climate pact. By Jenny Uechi in News, COP21 | December 12th 2015. http://www.nationalobserver.com/2015/12/12/news/legally-binding-climate-pact-announced-cop21paris (accessed 15 January 2015).

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Who will guard the guards? Medical leadership and conflict of interest in South African healthcare

To the Editor: Conflicts of interest (COI) arising from the interaction of the pharmaceutical industry with doctors have been described in an SAMJ editorial.[1] The common interests in patient wellbeing, shared by doctors and the pharmaceutical industry, will conflict with the pharmaceutical industry’s wish to sell their products and influence doctors’ behaviour. A number of important measures to deal with COI are described in the editorial, including disclosure of COI, creating awareness of the problem, academic discussions and fostering professionalism by practitioners. A further measure that should be included to complement the above is the use of clinical protocols (standardised care guidelines). This approach avoids negative influences on treatment rec ommendations by excluding outside sources with different agendas and avoiding financial inducements. Other potential negative influences that may arise from discrimination because of age, sex, race, sexual orientation, disease and disability may also be avoided. This approach also reinforces positive influences through trans parency and peer review and having both academic and pragmatic input. Clinical guidelines have become widely available, for good medical[2] and economic reasons A standardised approach allows for a body of experience to be reviewed individually, regionally or nationally to evaluate its effectiveness. For example, in oncology, cancer of the lung and oesophagus presents and responds differently to treatment in South Africa, Asia and Europe. Available resources will also be considered, as well as the marginal gain for new but costly treatments. Clinical guidelines reduce COI and facilitate the documentation of a body of experience on which to base patient care in the future. Raymond P Abratt

Head of Clinical Governance, Independent Clinical Oncology Network, and Professor Emeritus, University of Cape Town, South Africa raymond.abratt@cancernet.co.za

S Afr Med J 2016;106(2):129. DOI:10.7196/SAMJ.2016.v106i2.9679

To the Editor: Difficult endotracheal intubation commonly results in morbidity and mortality.[1] To overcome such complications, the airway is assessed preoperatively. An intubation is considered difficult if an appropriately trained anesthesiologist needs more than three attempts or more than 10 minutes for successful endotracheal intubation.[2] The airway is usually assessed using the modified Mallampati test (MMT),[3] head and neck extension,[4] mouth opening,[5] the upper-lip bite test,[6] Cormach-Lehane grading (CLG)[7] and a number of other preoperative tests and models. The MMT and CLG categorise difficulty on the basis of whether the glottis and epiglottis are visualised or not. In some patients, despite the fact that the structures in the oral cavity can be visualised, difficulty is encountered during the passage of the endotracheal tube (ETT) through the glottis, so smaller ETTs are used

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Zahid Hussain Khan, Farhad Tavakoli

Imam Khomeini Medical Complex, Tehran University of Medical Sciences, Iran khanzh51@yahoo.com, fahatv@yahoo.com 1. Cook TM, MacDougall-Davis SR. Complications and failure of airway management Br J Anaesth 2012;109(Suppl 1):i68-i85. [http://dx.doi.org/10.1093/bja/aes393] 2. Langenstein H, Cunitz G. Difficult intubation in adults. Anaesthesist 1996;45(4):372-383. 3. Samsoon GLT, Young JRB. Difficult tracheal intubation: A retrospective study. Anaesthesia 1987;42(5):487-490. 4. Wilson ME, Spiegelhalter D, Robertson JA, et al. Predicting difficult intubation. Br J Anaesth 1988;61(2):211-216. [http://dx.doi.org/10.1093/bja/61.2.211] 5. Saund DS, Pearson D, Dietrich T. Reliability and validity of self-assessment of mouth opening: A validation study. BMC Oral Health 2012;12:48. [http://dx.doi.org/10.1186/1472-6831-12-48] 6. Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: A prospective blinded study. Anesth Analg 2003;96(2):595-599. [http://dx.doi.org/10.1213/00000539-200302000-00053] 7. Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia 1984;39 (11):1105-1111. [http://dx.doi.org/10.1111/j.1365-2044.1984.tb08932.x] 8. Rose DK, Cohen MM: The airway: Problems and predictions in 18,500 patients. Can J Anaesth 1994;41(5):372-383. [http://dx.doi.org/10.1007/BF03009858] 9. Burkle CM, Walsh MT, Harrison BA, et al. Airway management after failure to intubate by direct laryngoscopy: Outcomes in a large teaching hospital. Can J Anaesth 2005;52(6):634-640. [http:// dx.doi.org/10.1007/]

S Afr Med J 2016;106(2):129. DOI:10.7196/SAMJ.2016.v106i2.10275

1. Parish A, Blockman M. Who will guard the guards? Medical leadership and conflict of interest in South African healthcare. S Afr Med J 2014;104(11):757-758. [http://dx.doi.org/10.7196/SAMJ.8546] 2. Grimshaw JM1, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993;342(8883):1317-1322. [http://dx.doi.org/10.1016/01406736(93)92244-N]

Difficult tracheal tube insertion: A new phraseology

to ensure an unimpeded passage. Such a difficulty arises when the diameter of the trachea is smaller than that of the ETT, i.e. the internal diameter of the ETT far exceeds the tracheal diameter. There are many definitions of different scenarios of difficult intu bation, which can be summed up as follows: difficult tracheal intu bation is defined as tracheal intubation requiring multiple attempts,[2] and occurs in 1.5 - 8.5% of patients who undergo tracheal intu bation. [8,9] Difficult direct laryngoscopy refers to inability on the part of the laryngoscopist to visualise the larynx because of anatomical abnormality or distortion of the larynx or trachea. There is, however, no mention in the literature of airways that appear to be simple during laryngoscopy and CLG, but turn out to be exceedingly difficult when actual insertion is being attempted. We consider that for such cases a new phrase, difficult tracheal tube insertion (DTTI), should be employed. Fortunately cases of DTTI can be managed successfully if smaller-size tubes are used or a malleable guide is introduced into the ETT prior to its insertion through the glottic opening.

The UCT class of 2000 reunion

To the Editor: It was with mixed emotions that we prepared for our 15-year reunion at the University of Cape Town in November 2015. Certainly the nationwide student protests and shutdowns made administration and organisation quite challenging, but they also gave us a chance to reflect on our own medical education and training. As graduates of UCT in 2000, we started our professional careers as young interns in the middle of the HIV epidemic. As medical students we joked about including HIV or TB on every differential list, but as young doctors it was no longer a joke but a grim reality. With no antiretrovirals to offer our patients, a limited supply of fluconazole and Bactrim and HIV ELISA results that took 6 weeks to return from a tertiary centre, we found ourselves signing piles of death certificates every week and standing helplessly in front of our patients despite having been trained as curative clinicians. In the 15 years since our graduation, medical education has been challenged with providing training that is socially relevant to the community served by its graduates. More recent competencybased education models are promoting additional roles for graduate doctors not only as medical experts but also as health advocates, collaborators, communicators and leaders. The outcomes are clear, but the mechanisms to teach these attitudes and skills are still debated. As part of our reunion weekend, not only did we have time for social conversations and sharing family time in the beautiful gardens

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of Kirstenbosch, but we also facilitated an ‘academic meeting’ on the Saturday morning. The purpose of this meeting was to share our experiences over the past 15 years and reflect on the varied paths we had chosen after graduation: from the prescribed internship and community service year, to working overseas, to specialising and sub-specialising, and how that journey had been different for each person, with unique challenges that moulded our decision-making and career choices. Somehow amid the chaos of being young, naive interns in comm unities devastated by HIV, our classmates had emerged as leaders, communicators, collaborators and health advocates. We heard how not even an MB ChB and an MBA degree can provide immunity against feelings of loneliness and uncertainty in one’s skills to perform the required job, that scholarship is lifelong, and that leaders are people who rise to a challenge. We were challenged to observe the world through different-coloured lenses and see the unique contribution that each individual can make, and to define ourselves as people rather than as doctors. We heard how the nightmare of the London tube bombings in 2005 would call to action years of clinical training and create leaders within minutes. We heard from advocates who not only promoted the plight of their individual patients, but are working daily to make a change and improve healthcare for their entire community. We observed the love and empathy of a small team that grew into a big team through collaboration and leadership to provide excellent healthcare for a small rural community. Many of our class had specialised, some remained in general prac tice; some were working in tertiary academic or government practice

and others in private practice. Some were working overseas, but over half of the class had returned to or remained in South Africa. Many of the class have also excelled in spheres of life outside medicine, travelled the globe, and been blessed with the joys of having a family. In reflecting on this milestone achievement of 15 years since graduation, perhaps these anecdotes provide some insight as to how change can be effected. At the time of our graduation we were eager to make a difference to healthcare in South Africa, armed with limited knowledge, skills and fledgeling critical thinking ability. It seems that even without overt exposure to a competency-based, graduate attributesdriven curriculum, the class of 2000 have emerged as ‘change agents’ in healthcare and their communities. As the first doctors of the 21st century (dubbed the ‘Millennium Medics’ by Prof. Immelman) we were going to make history anyway! Paula Diab

Discipline of Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa diabp@ukzn.ac.za

Angela Dramowski

Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa

Nienke van Schaik

Health Systems Trust, Cape Town, South Africa S Afr Med J 2016;106(2):129-130. DOI:10.7196/SAMJ.2016.v106i2.10449

Correction In the article ‘Using mobile technology to improve maternal, child and youth health and treatment of HIV patients’ by Peter et al., which appeared on pp. 3 - 4 of the January 2016 SAMJ, the USSD number was given as *150*550#, which is incorrect. The number is in fact *134*550#, and anyone dialling the *150* number to test the service will receive a message saying the service is not running. The online version of the article (http://dx.doi.org/10.7196/SAMJ.2016.v106i1.10209) was corrected on 7 January 2016.

This month in the SAMJ ... Jerome Loveland*†‡§ is Academic Head of Paediatric Surgery, University of the Witwatersrand, Clinical Head of Paediatric Surgery at Chris Hani Baragwanath Academic Hospital, and an Associate Professor in the School of Clinical Medicine, University of the Witwatersrand. He is also a senior member of the Transplant Unit at Wits Donald Gordon Medical Centre. His specific clinical interests in paediatric surgery include hepatobiliary disease, oncology and neonatal and laparoscopic surgery, as well as hepatic and renal transplantation. In addition to his clinical work, he has a keen interest in clinical research in both paediatric surgery and transplantation, and is committed to developing this field at Wits University. Outside of his career, Jerome is a committed family man, supported by his wife and children. His mental battles are fought while running … * Patel N, Naidoo P, Smith M, Loveland J, Govender T, Klopper J. South African surgical registrar perceptions of the research project component of training: Hope for the future? S Afr Med J 2016;106(2):169171. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10310] †

abian J, Maher H, Bentley A, et al. Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Johannesburg, South Africa. S Afr Med J F 2016;106(2):172-176. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10190]

‡ §

Carapinha C, Truter M, Bentley A, Welthagen A, Loveland J. Factors determining clinical outcomes in intussusception in the developing world: Experience from Johannesburg, South Africa. S Afr Med J 2016;106(2):177-180. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.9672]

Jugmohan B, Loveland J, Doedens L, Westgarth-Taylor CJ. Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre. S Afr Med J 2016;106(2):189-192. [http://dx.doi. org/10.7196/SAMJ.2016.v106i2.8942]

June Fabian* is a specialist physician and nephrologist, currently doing clinical research at Wits Donald Gordon Medical Centre. * Fabian J, Maher H, Bentley A, et al. Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Johannesburg, South Africa. S Afr Med J 2016;106(2):172-176. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10190]

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IZINDABA

Managing the fiscal beast – admin-to-clinician ratio now 3:1 The ranks of senior public healthcare administrators swelled by 12% over the past 3 years v. a 3.5% growth among all physicians, pharmacists and pathologists over the same period. This previously unpublicised skewed progression has further bolstered appeals by healthcare professional groups to stop the wide-scale, debilitating freezing of clinical posts. An Izindaba review of national public healthcare staff data also lends credence to speculation that hard-pressed provincial chief financial managers are panicking after unions (mainly the National Education and Health Workers Union, NEHAWU) won a 10% wage increase totalling ZAR69 billion over the 2015/16 financial year (part of a 3-year settlement). Bluntly put, the government’s ability to afford its own wage increases is looking increasingly shaky, especially going into a bleak 2016/17 financial year. The implications for healthcare delivery – without alternative sources of revenue or the still-distant implementation of actual national health insurance funding – are dire. The widespread freezing of critical clinical service delivery posts in December last year and this January (when most doctors and nurses were seeking them) was, according to the South African Medical Association (SAMA), ‘dangerously short-sighted’. SAMA Chairperson Dr Mzuksi Grootboom says that not only will it hurt the most vulnerable patient populations and increase existing billion-rand litigation claims, but it will aggravate work pressures as clinical staff are stretched to breaking point after colleagues leave, creating a ‘domino effect’ and leading to the potential collapse of untenably staffed district hospitals and community health centres. In spite of the overall 3.5% national increase from 18 701 clinical staff in September 2012 to 19 352 by September 2015, this clinical staff component plummeted by 327 members (–1.7 %) from March to September last year – exactly when financial austerity measures were introduced. Nursing numbers virtually flatlined from 134 153 in September 2012 to 134 453 in September 2013 to 134 811 in September 2014, before suddenly increasing by 1.2% to 136 439 in September last year.

Budget-breakers remain stubbornly in place

Says Daygan Eagar, programme manager for the Rural Health Advocacy Project and

veteran provincial healthcare financial watch dog, ‘While bringing in community service doctors made a huge difference to delivery, and although it increased costs, the glaring primary cost factors have always been higher-than-inflation salary increases and a rapidly growing administrative cadre.’ This happened regardless of how the economy was performing, with the current strain on the national fiscus hugely constricting current provincial budget allocations. Both Eagar and Izindaba Treasury sources agreed that government negotiators ‘tend to give in’ at wage negotiations with the powerful NEHAWU. Grootboom said the subsequent moratoriums on filling posts would result in lost opportunities and chronic staffing shortages this year – with multiple negative knock-on effects.

‘The glaring primary cost factors have always been higher-thaninflation salary increases and a rapidly growing administrative cadre.’ This happened regardless of how the economy was performing, with the current strain on the national fiscus hugely constricting current provincial budget allocations. ‘Although mention is made of a process whereby critical posts can be unfrozen and advertised, the reality is that this is a long bureaucratic procedure which may require approval from the premier’s office. Over the last few years we’ve seen a mushrooming of middle and senior management positions in the various provincial departments of health at district and provincial level, with a net decrease in service level posts at institution level,’ he added. (Izindaba’s 12% expansion figure depicts health directors level up to directors-general). Provinces that have frozen clinical healthcare staff posts are North West, Eastern Cape, KwaZulu-Natal, Mpumalanga and Free State. Eagar said that in his experience, even when ‘exceptional circumstances’ were proven and budgets could be freed up, it took between 6 months and a year to fill an unfrozen post. ‘Where the premier’s office is involved, it’s virtually impossible to tell whether the appointment

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is ever finalised,’ he added. Every province (with the exception of the Western Cape) was incurring debt, rendering them unable to pay many service providers who responded by refusing to continue delivering often vital services. Grootboom said that many provincial depart ments of health received qualified audits by the Auditor General, indicating ‘irregular and fruitless expenditure’ as the primary cause for failing to achieve a clean audit. Many of their financial woes were caused by dismal supply-chain management. SAMA believes that the freezing of critical posts will be damaging not only to patient care but to working conditions, and that it will increase adverse patient events. Litigation against departments of health has spiralled alarmingly over the last few years (lack of supervision and insufficiently-skilled doctors), with national health minister Dr Aaron Motsoaledi convening a summit to try and mitigate this in April last year and the biggest private sector risk underwriter, the Medical Protection Society, appealing for legal reforms at a similar seminar held in November. Grootboom said the litigation trend was set to continue unless the root causes were effectively dealt with.

Beacon-of-hope hospital flickers and fades

Eagar cited the deep-rural, well-resourced Zithulele District Hospital, 99 km from Mthatha, once regarded as a beacon of hope and a model for the country,[1,2] having recently lost a third of its staff. ‘This is not because of people wanting to leave, but because the province cannot provide nurse, doctor or comserve posts. They simply haven’t replaced anyone. Once you start losing a few staff it has a domino effect. Say you lose three of your eight doctors – the additional burden affects the others and they also leave. Madwaleni District Hospital [a few valleys across from Zithulele] is in crisis and facing collapse,’ he added. Eagar also cited several hospitals in North West (among many other provincial hospitals) having cut all elective procedures (hip and knee replacements, for example), increasing disability in the community and creating long-term, costly patient complications. Izindaba sources said provinces were also trying to cut non-core goods and services (such as travel, subsistence or venue hire), but

IZINDABA

the continual wage increases had financial managers eyeing even medicinal supplies and laboratory tests – which Motsoaledi has declared ‘non-negotiable’. A Treasury source added: ‘Massive amounts go to lower-level non-clinical staff (e.g. cleaners, groundsmen, security guards), who are employed at much higher salary levels than their private sector counterparts – you must remember their packages include medical aid and pensions – you won’t get by without paying a ZAR100 000 per annum package.’ Over the past 3 years the total public sector healthcare staff complement (clinical and nonclinical) has dropped from 314 859 people to 309 367 (–1.8%) – this after continual growth up to 2012, though Izindaba sources stressed that this figure, while illustrating a marked trend, might not be entirely accurate owing to ‘data collection issues’. With an estimated 3% staff turnover, this means the state should be able to replace 9 000 posts without increasing expenditure. Significant savings could be achieved by only filling say 7 000 posts, yet unless a pragmatic process for quickly refilling critical posts is in place, the net result could cause nearchaos, given the 400 000 annual increase in AIDS patients alone.

Trust-inducing accountability model proposed

Eagar has a ‘bottom-up’ management plan, which he has presented to the Parliamentary

Portfolio Committee on Health. It’s prem ised on giving district-level officials the responsibility for cost savings (instead of head office, where there is often little appreciation for the specific situation on the ground). ‘They can identify priorities. Province can say you need to save, say, ZAR20 million – not say where or how, but insist on your getting it done.’ Otherwise facility managers at district level did not know what to expect or how to plan. What’s been missing, Eagar believes, is communication between various levels, ‘where a facility doesn’t know what District is doing and District doesn’t know what Province is doing’. He said the Western Cape was ‘getting it right’, asking district and facility managers to submit in advance posts they’d like to fill. This was fed into a budgeted organogram that enabled everyone to ‘know what’s possible at the beginning of the year’. Eagar argues that provinces should limit themselves to guidance and support, intervening only where capacity is lacking. Saying that provinces tended to try and centralise control to save on costs, he made a heartfelt appeal for them not to be tempted to cut on low-level public health sector workers, saying that if a cleaner went, it was left to a nurse to clean an operating theatre, again impacting on proper patient care. Most lower-level workers were also not unionised, making them soft targets. National health department staff figures show that as of September last year there were 511 senior managers (directors up to directors-general) – up from 457 in Septem

ber 2012 (a 12% increase), with a gradual upward creep every year in between. In the category of ‘core administration’ (lowlevel admin posts such as financial clerks, credit controllers, material-recording and transport clerks, human resource clerks, managers and cashiers), numbers increased by 4 005 people between 2013 and 2015 (also up 12%). In September 2012 there were 34 284 core admin staff, dropping slightly to 33 331 in September 2013 and then inexorably growing to 36 136 in September 2014 and to 37 336 in September last year. Eagar said that most provinces engaged quite openly with his Rural Health Advocacy group, ‘so we know what’s going on’. However, with the hugely dysfunctional and troubled Free State, ‘it’s impossible to tell. They don’t co-operate, they close ranks and are pretty antagonistic.’ Izindaba sources said some ‘shrewd inno vative thinking’ would be necessary to create the revenue needed to make universal healthcare coverage fly – and to correct the current skewed human resource healthcare delivery model. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2016;106(2):131-132. DOI:10.7196/SAMJ.2016.v106i2.10523 1. Bateman C. Multidisciplinary teams – the rural way forward. S Afr Med J 2008;98(1):19-22. [http://dx.doi.org/10.7196/SAMJ.860] 2. Bateman C. Leadership, commitment and core values garner national award. S Afr Med J 2013;103(10):708-709.

Consciously cutting to the bone of SA’s surgical/anaesthetic delivery A critical mass of key surgeons and anaesthetists met at the University of the Witwatersrand in Dec em ber last year to start gauging the country’s paucity of access to safe, affordable surgical and anaesthetic care, guided by recently crafted global improvement templates. With South Africa (SA) at less than half of the Lancet Commission on Global Surgery’s recommended ‘norm’ for a national surgical workforce (20/100 000 population) and no change in the local ratio likely any time soon, upskilling of non-specialists and task sharing emerged as urgent priorities. A searching consensus was reached on the need to support, upskill and recognise the pivotal

From left to right: Prof. Martin Smith, Dr Emmanuel Makasa, Deputy Minister of Health Dr Joe Phaahla and Prof. John Meara.

role played by medical officers (MOs), whose retention in the district hospital system was

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‘vital’ to delivering surgery and anaesthesia. Key delegates, including Dr Terence Carter,

IZINDABA

Prof. Eckhart Buchmann.

Deputy Director-General: Hospitals Tertiary Service and Workforce Management, Prof. Mac Lukhele, Head of the School of Clinical Medicine at the University of the Witwatersrand (Wits), seminar convenor Prof. Martin Smith, Academic Head of Surgery at Wits, and Dr Richard Cooke, Acting Director of the Wits Centre for Rural Health, plus Dr Carol Marshal, recently resigned chief of the Office for Healthcare Standards Compliance (OHSC) and now heading the district specialist-led outreach teams, contributed unique perspectives on how this could be done. Delivering the keynote speech, national Deputy Minister of Health Dr Joe Paahla said that with surgical conditions accounting for 30% of the global burden of disease, increasing the pool of surgical and anaesthetic skills in SA would ‘save a lot of lives’. A veteran of deep rural hospital service, Paahla said that skills in trauma, fractures, obstetrics and gynaecology were among the basics required to handle events such as vehicle accidents, ectopic pregnancies or a ruptured appendix. In acute urinary retention, extreme pain could be relieved just by knowing how to insert a catheter: ‘If nobody knows how to do that, it can be very frustrating.’ He said it was ‘critical’ to put together a package of basic surgical skills that could be used in district and regional hospitals, and his department was committed to partner with the local and international bodies whose landmark work and pragmatic targets had sparked the local seminar. With SA’s ‘mega-challenge’ of low economic growth, creativity and innovation would be essential in prioritising use of available resources. Protection against catastrophic out-of-pocket payments for patients was a major challenge,

and Paahla appealed to delegates to pay attention to the social determinants of health that increase surgical and anaesthetic risk. He suggested encouraging specialists to leave their tertiary environments to do 6 - 12-month stints in outlying hospitals, thus ‘reversing the flow’ of district incumbents to them, while maintaining rural healthcare delivery. He said the National Health Insurance White Paper recognised the need for ‘this kind of specialist support’ (via the district clinical specialist outreach teams), ‘so this conference comes at just the right time’. Carter said universities were failing to aim specialist training at generalists, spending too much time on training subspecialists, ‘something we’ll be pushing them to change’. The package of care at district hospitals needed revision to upgrade the availability of surgical care, followed by ‘a look at the skill sets we need’. He noted that while improving access to safe surgery was vital, there was a more critical shortage of anaesthetic skills. Lukhele said the dismally low ratio of healthcare workers to population demanded a ‘complete paradigm shift’ where interprofessional healthcare education, along with upgraded skillsets, were prioritised. He said that increasing numbers of generalists while also harnessing clinical associates to do caesarean sections or circumcisions (under initial supervision) would increase patient access to care. Cooke said the widespread phenomenon of community service officers wanting to ‘escape’ into specialisation when their obligatory stint was over was driven by the lack of support they received from senior staff and the system itself during their tenure. ‘For me it’s not about the absolute numbers of MOs or comserves, it’s about attrition and vulnerability – you just haemorrhage staff very quickly.’ He suggested offering a postgraduate diploma in primary healthcare as a ‘stepping stone’. Forum delegates heard from Prof. John G Meara, Kletjian Professor of Global Health and Social Medicine in the field of Global Surgery at Harvard Medical School, that 15% of all deaths globally are due to surgically preventable conditions, with a third of the world’s population receiving just 6.3% of all surgical procedures. World Bank President Jim Kim had said that 28 - 32% of the global burden of disease was from surgical conditions, concluding that investing in surgery was hugely cost-effective, saved lives and promoted economic growth. The Wits national forum was fortuitously held a week before the release of the White Paper on National Health Insurance.

SA surgical forum ‘catching the global wave’

Smith said the seminal event was the outflow of a confluence of the Lancet Commission’s

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global surgery findings in April last year, a resolution on essential surgery by the World Health Assembly a month later, and the World Bank’s unprecedented focus on surgery in its 3rd version of Disease Control Priorities. He said the role of surgery in achieving universal access to healthcare, with vital devolution down to primary healthcare and district hospital levels, was crucial to overall integration. Meara said the Lancet Commission had ‘come up with five deceptively simple’ indicators. These were what percentage of the population lived within 2 hours of accessing essential surgery, surgical volumes (procedures done in an operating room per 100 000 population), protection against impoverishing expenditure, the surgical, anaesthetist and obstetrician (SAO) density per 100 000 population, and the postoperative mortality rate. It was estimated that globally five billion people could not access safe surgery when they needed it. ‘We need timely access, capacity, proper skills and affordability – far too many countries cannot jump through these hoops,’ he added. Several surgeons at regional and district SA hospitals said that while a process of auditing district hospital staffing levels had already begun, it was aimed at coming up with norms when a minimum staffing level was urgently required. Marshal, who resigned as founding CEO of the OHSC in June last year, only to take up leadership of the pivotal National Health Insurance’s district specialist-led outreach program in December, said that many facilities could not provide safe medical care because of staff shortages, while others were overstaffed according to workload. Prof. Ian Couper, Director of the Wits Centre

Dr Terence Carter, Deputy Director-General: Hospitals Tertiary Service and Workforce Management.

IZINDABA

for Rural Health, added that even overstaffed district hospitals were failing to provide the clinics they served with standard once-a-week visits.

No basic skills? Close the hospital down – former Bara obstetrics chief

Echoing Smith’s appeal to influence govern ment policy with hard data, Prof. Eckart Buchmann, a former senior obstetrician at Chris Hani Baragwanath Academic Hospital and now in private medicolegal practice, said that every single district hospital in the country had to be measured on its ability to perform basic caesarean sections and laparotomies: ‘If it can’t, it must be closed. That’s crucial in getting to where we want to.’ Dr Mark Blecher, Health Chief at National Treasury, urged delegates to come up with a basic surgery costing plan in order to make an unprecedented case for the discipline to his department. ‘Calling it the neglected stepchild is quite a strange term in a way; intriguing when one argues that the costing of basic surgery packages is not factored in very strongly.’ He

emphasised that SA had (financial) health packages ‘for everything, from maternal and child health, to HIV, tuberculosis and malaria – we have budgets drawn up annually by people who specialise in HIV economics’. He said that trauma surgery having recently been declared a specialty by the Colleges of Medicine had had a very positive impact on financing. ‘Surgeons seem to hate admin,’ he joked, adding that there had been a ‘great distance historically’ between surgeons and public health – something he commended the forum on trying to correct. Blecher revealed that there were no qualified surgeons in the national health department administration, adding that it would be helpful if somebody was appointed ‘who understood something about this and brought the necessary skills into financing and planning’.

Treasury health chief: appoint a surgical services co-ordinator

Blecher and his Treasury colleagues believed that there was a role for a surgical service co-ordinator. ‘I mean, do we know how many trauma centres are needed? It’s

Limpopo’s tragic tale of C-section deaths

An alarming example of maternal deaths due to dismal staffing, low skills levels and a total absence of supervisory support is Limpopo Province, where the National Committee for Confidential Enquiry into Maternal Deaths found that 10% of all caesarean section patients died due to anaesthesia in 2014. That’s over four times higher than the national public sector C-section (preventable) death rate from anaesthesia (2.4%). Mostly unsupervised community service doctors with no anaesthetic training were performing on average between two and three C-sections per week in the province’s 70 mainly rural district hospitals, conducting spinal blocks with no airway skills, no intubation equipment and insufficient drugs. Limpopo has a 70% vacancy rate for both general practitioners and specialists, with just four anaesthetists: one a district specialist (mainly administration), two at the local university (one about to retire) and one in a regional hospital. A 2014 audit revealed SA to have 1 300 anaesthetists, two-thirds of them in private practice with 360 in training. Nonspecialists in the discipline are estimated at 1 200, with varying degrees of commitment. Prof. Christina Lundgren, Clinical Head of Anaesthesia at Chris Hani Baragwanath Academic Hospital, and Natalie Zimmel man, CEO of the South African Society of Anaesthesiologists (SASA), told Izindaba that

Prof. Christina Lundgren.

a multistakeholder task team was immediately formed, drawing up a plan for university-led support and reaching a ‘memo of understanding’ with Limpopo. ‘I feel desperately sorry for the comserves. When we said to Province, can’t they please get 2 months of training in the tertiary hospitals, they said it was against policy – so they all had to go to district hospitals without training.’ The upshot was that nobody took responsibility for anaesthesia, with a survey among comserves and MOs revealing that even if they were doing a spinal block, they were unable to convert to a general anaesthetic or resuscitate. Low C-section volumes contributed to the overall lack of skills. ‘It was whoever’s there on the day – nobody was owning it,’ Lundgren added. At one stage, the expert duo told Izindaba, the province had even considered using dentists on overtime to provide anaesthesia – ‘but they recognised very

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difficult to answer how much money is needed for surgical services. Money seems to follow a well-costed plan – a national surgical plan would be a good idea.’ He added that the Lancet Commission report gave clear guidelines that needed tailoring to SA needs. ‘We have to ask why we are not costing surgery fully in all these basic health packages – it’s certainly cost-effective,’ he added. Marshal made the point that ‘if we miss this boat, we’ll regret it. Surgery has to be an integral part of what everybody already does.’ She said the opening of the Wits forum by the Deputy Minister of Health could be leveraged in getting government on board. Smith said a task team would be set up to work on priorities that emerged from the forum’s various workshops, incorporating all key stakeholders to help integrate surgery into the national primary healthcare model. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2016;106(2):132-134. DOI:10.7196/SAMJ.2016.v106i2.10526

quickly that was not a solution. It’s probably cheaper and quicker to train existing MOs and even comserves in an anaesthesia diploma than it would be train nurse-anaesthesiologists,’ observed Lundgren. The universities of the Witwatersrand and Pretoria had since agreed to work with the province to help train and mentor comserves and MOs, and provide equipment, workshops, guidelines and short courses. Added Lundgren: ‘There are not enough anaesthesiologists to go out and train, so they have to come to Bara – the province’s biggest worry is service delivery while we train.’ Zimmelman said what she found ‘most interesting’ was that it was actually possible to give a GP (or MO) sufficient experience and skill via an intensive and continuous 6-month diploma. Lundgren said Limpopo’s tragic story of avoidable deaths was an extreme example of the estimate that one-third of the world’s rural populations had no access to essential surgery, with more than a third having no access to anaesthesia. ‘We are the neglected stepchild, with governments reluctant to invest in anaesthesia (and surgery) – this and the lack of accessibility to theatres is a very sad reflection.’ She said that worldwide, the anaesthetic mortality rate was 1%. The ratio for anaesthesiology specialists to population in SA stood at 2:100 000, increasing to 3.5 for specialists and GPs (v. 10:100 000 in the UK, Europe and Australia, less than 0.05 in Zambia, and 0.35 for all anaesthesia providers in Zimbabwe).

EDITORIAL

Surgery and anaesthesia in the South African context: Looking forward Historically considered an expensive, inefficient and limited public healthcare initiative, the place of surgery as the ‘forgotten stepchild’ of public health now leaves almost 5 billion individuals worldwide unable to access safe, affordable surgery when needed. In his keynote address at the National Forum on Surgery and Anaesthesia, held at the University of the Witwatersrand in December 2015, Deputy Minister of Health Dr Mathume Phaala stated that the ideal of a long and healthy life for all South Africans cannot be achieved without improved access to safe surgery and anaesthesia, a goal necessitating improvements in existing infrastructure, information systems, financial management and leadership. This marked the introduction of a groundbreaking event – the launch of a sustained Global Surgery movement in South Africa (SA) aimed at stimulating discussion on and conceptualising the future of surgery in SA. Discussion focused on needs assessment, a review of the essential package of surgical and anaesthetic care offered at regional, district and tertiary levels, monitoring of policy implementation, and a movement from the ideals of the Millennium Development Goals to sustainable goals. The launch of the National Forum on Surgery and Anaesthesia coincided with the SA launch of the Lancet Commission on Global Surgery (LCoGS). The LCoGS was created 2 years ago with the purpose of generating large-scale sustainable improvement in critical, neglected areas of global health and to inform and drive policy change. It aims for surgery to be integrated into properly functioning healthcare systems by addressing current gross inequities in global delivery of safe and affordable surgery and anaesthesia. The vision of the LCoGS is simple: universal access to safe and affordable surgical and anaesthetic care when needed. This goal is a moral and economic priority in the developing world. It is estimated that failure to provide safe, accessible and effective surgical and anaesthetic services may cost low- and middle-income countries (LMICs) up to USD12.3 trillion in lost productivity, translating into 2% of gross domestic product growth annually between 2015 and 2030, if left unaddressed. Research by the LCoGS identifies six key areas that affect access to safe, effective and affordable surgery in LMICs. Access to timely surgery, specialist workforce density, surgical volume, the perioperative mortality rate, impoverishing expenditure and catastrophic expenditure represent significant barriers to surgical care. For example, specialist workforce density is a measure of the number of surgeons, anaesthetists and obstetricians (SAOs) per 100 000 population. It is estimated that approximately 72% of the world’s population live in countries with an SAO density of <40/100 000. Data analysis by the LCoGS reveals that approximately 2 million specialist healthcare providers are needed to reach the goal of an SAO density of 40/100 000 in LMICs by 2030. Using obstetrics as an example, the workforce indicator found that for each ten-unit increase in the density of SAOs, there is a 13.1% decrease in maternal mortality rate. In the SA context, it is clear that expansion of a skilled workforce capable of meeting population health needs is necessary, but will not resolve existing challenges. Human resource constraints are a well-recognised shackle preventing delivery of safe and effective healthcare. Responding to the shortage of healthcare professionals in SA, numerous training centres have undertaken the training of

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clinical associates. Although still a relatively new component of the healthcare workforce, these individuals have the potential to contribute significantly to the delivery of safe, timely surgery and anaesthesia in our context. In conjunction with an ongoing review of the current syllabus for undergraduate medical training geared towards the training of efficient generalists, these initiatives are examples of ways in which the SA medical community is already responding to public healthcare needs. As noted by representatives of the Department of Health, the concept of surgery in SA needs to change in order for the targets of the LCoGS to be met. This acknowledgement calls for support for the concept of the acute care surgeon, capable of providing specialist-level general surgical care, as well as support for the training of more generalists, possibly in the form of career medical officers, and reversing the growing trend towards narrow subspecialist training seen among newer graduates. Further, the devolution of care may necessitate the use of cross-trained and skilled medical officers to undertake to provide a broad range of surgical and anaesthetic services at regional and even primary care levels. Numerous experts at the forum raised significant concerns regarding the decentralisation of care to primary and regional centres. Maternal and anesthetic mortality rates that vary widely between provinces and between regional and tertiary centres in SA were used to argue against the decentralisation of care. Notwithstanding the merits of arguments for and against particular interventions, the LCoGS and the National Forum on Surgery and Anaesthesia provide the first objective framework with which to analyse existing policy and propose and implement change. Considering the challenges identified, developing a national road map for surgery and anaesthesia is a colossal task. Objective assessment of population needs is vital to developing any strategies aimed at addressing deficiencies in the current profile of service delivery. This assessment demands accurate and regular data collection and reporting. In spite of the existing demands on service delivery providers, an ongoing assessment of needs and the effectiveness of policy interventions provides an opportunity for innovation and to develop the relationship between tertiary, regional, peripheral and primary levels of care. As noted by the successful completion of the South African Surgical Outcomes Study, research of this nature is possible, even in our particular context. In 2015, the World Health Organization acknowledged the critical place of surgery and anaesthesia in universal healthcare through its resolution on Strengthening Emergency and Essential Surgical Care and Anaesthesia as a Component of Universal Health Coverage. This resolution guides governments that are signatories to the resolution (including SA) to actively support and engage in improving surgical care. As noted by representatives of the National Treasury, surgical care providers need greater input at policy-making level in order to develop a financial model capable of meeting our population’s surgical needs. To date, such engagement has not been realised. The National Forum on Global Surgery and Anaesthesia presents the first step towards the objective acknowledgement of the challenges of providing safe, accessible, effective and affordable surgical and anaesthetic care in the SA context. Incorporating

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A Leusink Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa

the input of local and international, surgical, anaesthetic and public health, academic and non-academic, and private and public stakeholders, the foundation to systematically discuss and tackle issues of infrastructure, workforce, service delivery, financing and information management challenges has been formed. It is now incumbent on us as the medical community to continue this momentum and effect real change.

N Singh Department of General Surgery, Faculty of Health Sciences, Sefakgo Makgathu University, Pretoria, South Africa

N Patel Department of Paediatric Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

M Smith Department of General Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

M Peffer Department of General Surgery, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa

Corresponding author: N Patel (niravpatel44@gmail.com) S Afr Med J 2016;106(2):135-136. DOI:10.7196/SAMJ.2016.v106i2.10529

Data mining and biological sample exportation from South Africa: A new wave of bioexploitation under the guise of clinical care? In September 2015, the South African (SA) health insurer Discovery announced that, in partnership with Craig Venter’s company Human Longevity Inc., it would provide genetic testing to its members for USD250 (approximately ZAR3 400) per person. On the surface, this appears to be innovative and futuristic. However, a deeper look at this announcement reveals considerable problems in the exportation of biological samples and data out of SA, and brings into sharp focus the lack of protection in place for potential donors. In return for a reduced-cost genetic test, as part of that deal the deidentified information will be exported to and stored in Venter’s company in the USA.[1] It is possible that the data will be obtained from the samples in the USA, so the samples themselves will be exported. Genetic testing is being offered under the guise of clinical care, but for the apparent purpose of building up a large database for research in another country, and in so doing exposes the deficiencies of the SA regulatory framework on the use, storage and export of biological samples. The data from these biological samples and the samples themselves are a valuable resource in medical research, helping to identify the roles that genes play in disease development and accelerating new drug development. For decades there has been a unidirectional flow of samples out of Africa to various destinations in developed countries, with no benefit to local populations or local researchers. Such ‘parachute research’ has impacted negatively on the development of local capacity, infrastructure and expertise. As genomic research is advancing in SA, every effort should be made to encourage its development and ensure that SA biological samples and data are used locally. International collaborations can further develop and improve local capacity, but this must be non-exploitative and involve a sharing of facilities, expertise and expense. A central feature of these collaborations often involves the sharing of samples and data among institutions within SA, across Africa and in the rest of the world. The H3Africa project, for example, seeks to make samples

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and data available among African collaborators for future research, necessitating the movement of samples across the H3Africa network. Central to this project is the importance of African leadership in the research, as well as strengthening control over the use of samples and data through its data and sample-sharing polices.[2,3] However, this recent development by Discovery Health under mines the strengthening of African ownership of our samples and data, and is exactly the sort of exploitative behaviour that we must guard against. Although the relatively low cost of the genetic test offered by Discovery may be enticing, this exploits consumers and is reminiscent of safari research, as the data leave the country with no SA oversight or control, for the commercial benefit of a US company and Big Pharma. In a study involving 212 participants in SA, almost 40% were not supportive of researchers or other organisations financially benefiting from the use of their biological samples, and 43% expressed a desire to share some of the profits.[4] However, the only benefit for Discovery members is the offering of a genetic test at a reduced rate that must come out of available day-to-day benefits. Discovery also promises access to genetic counselling, at a cost to be covered by the consumer.[5] This additional benefit is enticing. However, there are only 30 genetic counsellors registered on the Health Professions Council of South Africa (HPCSA) register, of whom only 18 have a master’s degree in genetic counselling. Discovery has indicated that genetic counselling will be offered by doctors, yet very few doctors have training in this field and fewer still can afford to spend time on genetic counselling and consent processes in their busy consultation rooms. Exome testing by Discovery demonstrates the need for guidelines and clarity in the export of biological data. The SA export permit system for tissues currently offers limited protection for tissue donors. The export of biological samples out of SA is governed by the National Health Act 2003, specifically the Regulations Relating to the Import and Export of Human Tissue, Blood, Blood Products,

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Cultured Cells, Stem Cells, Embryos, Zygotes and Gametes 2012. [6] A biological sample cannot be exported without a valid export permit, and only samples obtained under the terms of the Act can be exported. All applications must provide proof in writing that the biological sample will continue to be used within the terms of the Act once it is exported. The process requires that a register be established of all samples exported, thus ensuring that there is some oversight of the movement of samples out of SA. However, gaps in the regulations remain that must be addressed to protect the rights of participants as international collaborations are forged. Importantly, there is nothing in the regulations preventing Discovery from exporting the samples, unless an export permit is refused, and of concern is that there are no regulations overseeing the export of biological data from SA.

Export of biological samples: The consent concerns

Under the National Health Act 2003, informed consent is required for participation in medical research. Participants must be informed of the purpose of the research and any risks and benefit. Consent can then be given based on this information. Section 55 similarly requires the informed consent of the participant prior to the removal of any tissue. Biological samples can be reused and are a potential valuable resource for future research. Alternative consenting arrangements such as broad, tiered and dynamic consent have therefore been proposed. The 2015 Department of Health guidelines explicitly incorporate broad and tiered consent and provide guidance for research ethics committees (RECs). The Organisation for Economic Co-operation and Development (OECD) guidelines on human biobanks require that all participants be informed of access to their sample, as well as transfer abroad. [7] The guidelines recommend REC approval for all future research, but the SA health research regulations are silent on consent that is required prior to the export of biological samples. It must simply be demonstrated that the sample was obtained within the parameters of the National Health Act 2003, i.e. that consent was obtained prior to its removal, and that it is to be used within the terms of the Act. The H3Africa informed consent guidelines state that one of its goals is to make samples widely available to facilitate research. This will include transferring samples abroad to collaborators. Yet in a review of 1 305 protocols submitted under the now repealed Human Tissues Act, it was found that fewer than 50% of the informed consent documents informed research participants of their intent to export samples. [8] Sample donors do not appear to be aware of the intent or indeed the possibility of the removal of their samples from the country, and RECs do not have a formal oversight role to play. Although it appears that samples and data will be exported under Discovery’s new scheme, the extent to which people who avail themselves of the test will be aware of the storage and use of their biological data is unclear. Arguably broad consent could cover exportation of samples. Participants are consenting to the storage and reuse of their samples for future, unknown research, and this could cover research in another country. However, participants consent to the donation of their samples in accordance with the SA ethical and legal framework, and they can assume that the samples will be used in accordance with that framework. The right to withdraw samples is inherent in the process, but it may not be possible to exercise this right if samples are transferred abroad, as the sample will be used in accordance with the regulations of that country. Empirical evidence demonstrates that South Africans have clear preferences on the future use of their samples, including the exportation of the

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samples, and these preferences must be respected.[4] The possibility of exportation must therefore be raised during the informed consent process. Considering the importance of the sharing of samples in genomic biobank research, it is surprising that the revised 2015 Department of Health guidelines are silent on the export of samples. At the very least it would be expected that RECs should have some oversight function. Once a sample is exported, the SA health research regulations and RECs lose all oversight and jurisdiction over the sample. Any assurances that the participant may have received in respect of storage, future use and confidentiality can no longer be guaranteed, and the REC has no power to prevent its use in future studies that are contrary to those views. In any case, it has no way of knowing for what research the samples are to be used, and it in effect loses control of the sample once it leaves the country. Upon adoption of the broad consent model, the REC is tasked with the role of gatekeeper of the samples, so it should be satisfied that the sample will be used within the terms of the consent prior to its exportation. However, by not requiring its approval, the regulations appear to circumvent the oversight function of RECs, a role that is invested in them by the national ethics guidelines.

The absence of a material transfer agreement (MTA)

The transfer of samples raises important ownership and intellectual property (IP) rights issues flowing from the sample. To resolve these issues in advance, exchanges of biological samples are generally conducted under the auspices of an MTA. An MTA is a legally binding agreement that documents the rights of the provider and recipient of the sample and is generally seen as facilitating the sharing of samples while offering protections to local institutions. [9] MTAs should describe the purpose of the transfer as well as any restrictions on the use of the sample. It may also stipulate the terms of any publication arising from the samples, ownership of the samples or new inventions from the samples, and any potential IP rights.[10] Internationally, MTAs are a common feature of the transfer of samples endorsed by the OECD guidelines, the H3A High Level Principles on Ethics, Governance and Resource Sharing and the International Society for Biological and Environmental Repositories, among other organisations.[11] Considering the past exploitation of SA biological samples, it would be expected that an MTA be required under the SA regulatory system. However, this is surprisingly absent. The export permit system seems more concerned with tracking the movement of samples than protecting the rights of donors and research institutions in SA. The recently updated research ethics guidelines could have filled this vacuum and recommended the development of MTAs prior to transfer of samples. If not informed that their sample will be exported, donors will expect that their biological samples will be used in accordance with SA law. Health research regulations and guidelines differ across countries and may be lacking in some, so it cannot be guaranteed that the sample will be subject to the same protections. Owing to the enforceability of the MTA, the provider of the sample can continue to exercise control over the sample, as stipulated in the MTA. Importantly, MTAs can also be used to enforce donor preferences, REC decisions and the protections of SA regulations on the use of the sample in other jurisdictions. It has also been suggested that RECs should have a role to play in ensuring that the terms of the MTA are in compliance with the local and national ethical guidelines.[12] The REC would need to approve the terms of the MTA and be satisfied about the future use of the sample, in light of the

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original consent. This would also address some of the deficiencies in the consent process. Although an MTA is likely to be a requirement of transfer of biological samples in most research institutions in SA, the lack of national guidance on this point leaves institutions with the task of creating MTAs that may not consider the important role that MTAs can have in protecting the rights of the donors. MTAs are generally seen as necessary to protect the intellectual property following from the sample, but they can also be valuable tools in protecting donor rights.

Exportation of data

Genomic biobanking research not only stores large quantities of biological samples but also generates considerable data, and Discovery’s announcement demonstrates the enormous commercial value of these data. Since the birth of the Human Genome Project, the focus has been on the release of data to promote the advancement of science through the Bermuda Principles of 1996 and the Fort Lauderdale Agreement of 2003. Sharing of both samples and data is now often a condition of funding.[13] Yet the SA regulatory framework fails to address the complex issues involved in data sharing, illustrated by the Discovery development. It is primarily focused on consent, sample storage and sample reuse, requiring only that the confidentiality and privacy of donors are protected in the sharing of any data. Similar to the sharing of biological samples, the national ethics guidelines require REC approval prior to the sharing of data, but with no requirement to consult the REC in advance of exportation of the data, it is not clear whether this is taking place. The announcement from Discovery does not provide any indication of ethical approval or oversight, and this should be guarded against. Unlike the samples themselves, data are not physically exported and would therefore not form part of the export permit system. However, it is possible for the sample to remain in SA but for the data arising from that sample to be exported, as may be in the case in Discovery’s new initiative, necessitating the need for oversight on the access to data. Confidentiality and privacy of participants must be assured, and there should be oversight of data transfer. The Protection of Personal Information Act 2013 does strive to offer protection on the use of data, and it requires a binding contract (such as an MTA) and the consent of the donor prior to exportation. However, the Act only covers biometric data; this does include DNA, but it is not clear whether other types of data flowing from biological samples are covered. The HPCSA has addressed this point, and its guidelines state: ‘There must be justifiable reasons which should be provided to Research Ethics Committees for data and specimens to leave the country. This should only be done after a Material Transfer Agreement has been signed and submitted to the local Research Ethics Committee.’[14] These guidelines pertain only to healthcare professionals in SA who are registered with the Council, and not to the wider scientific community. However, the protection of data is just as important as the samples themselves. REC oversight is necessary, and the requirement of an MTA or data transfer agreement should be a feature of the SA regulatory framework.

Conclusion

To protect the genomic heritage of the country, proper national oversight on the exportation of biological samples is necessary. Medical insurance companies should not be permitted to exploit SA

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genetic heritage, yet the existing export permit system provides little in the way of ethical oversight and is more concerned with keeping a register of the movement of samples than ensuring that the system protects the rights of participants. Other than the requirement that the donor consents to the donation of the sample, it appears that there is no requirement for donor consent or REC consent for export. The export permit system fails to consider the need for legal and ethical oversight of the preferences of donors on the use of either their sample or the rights arising out of the future use of the sample. Public trust is crucial to the success of biobank research, and the removal of biological samples in the absence of any oversight as specified in the consent document may be an invasion of that trust. Equally, data should not be removed in this way. In an effort to have a public account of the movement of the samples, considerable gaps remain within the SA export permit system. Currently it offers no ethical oversight of the transfer of the samples and data, and the protection of local researchers is not required by law. International collaborative research raises specific ethical concerns, particularly when collaborators are from high-income countries. Such collaborations should be allowed to flourish and can be of considerable benefit to SA researchers, but they must not be at the expense of the local researcher, and our regulatory framework must protect the rights of both the donor and the researcher. However, a revision of the 2012 regulations is not necessary to fill the vacuums identified here. Rather they could be addressed on a national code of practice governing the use, reuse and exportation of biological samples that requires ethical approval and an MTA prior to the removal of samples, and that exportation of samples should be raised during the informed consent process. In the interim, MTAs can fill the gap left by the regulations and stipulate that the sample and data are used in accordance with national ethics guidelines and the terms of the original consent. C Staunton, K Moodley Centre for Medical Ethics and Law, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa Corresponding author: C Staunton (ciarastaunton@sun.ac.za) 1. Cassidy S. Discovery to offer genetic testing. http://www.iol.co.za/lifestyle/discovery-to-offer-genetictesting-1.1920337#.VhJuuCvd2y5 (accessed 20 October 2015). 2. H3Africa High Level Principles on Ethics, Governance and Resource Sharing. http://h3africa.org/ about/ethics-and-governance (accessed 6 January 2016). 3. Ramsay M. Growing genomic research on the African continent: The H3Africa Consortium. S Afr Med J 2015;105(12):1016-1017. [http://dx.doi.org/10.7196/SAMJ.2015.v105i12.10281] 4. Moodley K, Sibanda N, February K, Rossouw T. ‘It’s my blood’: Ethical complexities in the use, storage and export of biological samples: Perspectives from South African research participants. BMC Med Ethics 2014;15:4. [http://dx.doi.org/10.1186/1472-6939-15-4] 5. Discovery. Product enhancement in 2016. https://www.discovery.co.za/portal/individual/medical-aidnews-product-enhancements-2016 (accessed 6 January 2016). 6. http://www.sashg.org/documents/GovGazette2Mar2012.pdf (accessed 6 January 2016). 7. OECD Guidelines on Human Biobanks and Genetic Research Databases 2009. http://www.oecd.org/ sti/biotech/44054609.pdf (accessed 20 October 2015). 8. Sathar A, Dhai A, van der Linder S. Collaborative international research: Ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee. Dev World Bioeth 2014;14(3):150-157. [http://dx.doi.org/10.1111/dewb.12018] 9. Ramsay MJ, de Vries J, Soodyall H, Norris S, Sankoh O. Ethical issues in genomic research on the African continent: Experiences and challenges to ethics review committees Human Genomics 2014;8(15). [http://dx.doi.org/10.1186/s40246-014-0015-x] 10. Rodriguez V. Material transfer agreements: Open science vs. proprietary claims. Nat Biotechnol 2005;23(4):489-491. [http://dx.doi.org/10.1038/nbt0405-489] 11. International Society for Biological and Environmental Repositories. Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research. 3rd ed., 2011. Biopreserv Biobank 2012;10(2):81-161. 12. Chalmers D, Nicol D, Nicolas P, Zeps N. A role for research ethics committees in exchanges of human biospecimens through material transfer agreements. J Bioeth Inq 2014;11(3):301-306. [http://dx.doi. org/10.1007/s11673-014-9552-1] 13. Knoppers BM, Harris J, Tasse AM, et al. Towards a data sharing code of conduct for international genomic research. Genome Med 2011;3:46. [http://dx.doi.org/10.1186/gm262] 14. Health Professions Council of South Africa. Ethical Guidelines for Good Practice in the Health Care Professions: General Ethical Guidelines for Health Researchers. Book 6. http://www.hpcsa.co.za/ Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_6_gen_ ethical_guidelines_for_researchers.pdf (accessed 17 October 2014).

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February 2016, Vol. 106, No. 2

EDITORIAL

Implications of direct-to-consumer whole-exome sequencing in South Africa Next-generation sequencing (NGS) has truly trans formed human genetics and is now an integral dis covery tool in the field. Whole-exome sequencing (WES) – an NGS application focused on the proteincoding regions of the human genome – has already bridged the bench-to-bedside divide internationally and is offered as a clinical test by several accredited laboratories.[1,2] Clinical WES is not currently offered in South Africa (SA) for a number of reasons, including technological constraints, insufficient storage for the resulting large datasets, ethical considerations and limitations of our understanding of the impact of human genetic variants on health and in terms of clinical utility. The historical under-representation of individuals of black African descent in genomics research further complicates the interpretation of results obtained from WES data in black Africans.[3] Concurrently, the application of WES for preventive healthcare in seemingly healthy individuals is progressing rapidly. WES offered as a direct-to-consumer (DTC) genetic test to healthy individuals in aid of wellness and future disease risk prediction raises many critical considerations, some of which were highlighted previously in the SAMJ by the Southern African Society for Human Genetics.[4] This topic is currently back in the headlines as local health insurance company Discovery Health launched their suite of personalised medicine products, which includes WES.[5-7] This offering is presented in partnership with US-based company Human Longevity, Inc. (HLI) under the leadership of J Craig Venter.

The benefits – improved health and precision medicine

Using genome-focused information to improve health outcomes has great potential. This endeavour could benefit South Africans directly, as it is a start to wide-scale research to unravel the genetic basis of diseases in all populations. Combining NGS data with detailed electronic medical and wellness records and family history is a powerful approach towards providing improved health and wellness. Indeed, this is the course that will be taken by President Barack Obama’s Precision Medicine Initiative,[8] led by the National Institutes of Health, and the Genomics England Initiative. [9] Similar to these large public research initiatives, private enterprises such as HLI (Discovery’s partner) also strive to sequence millions of genomes in order to potentially fast-track drug discovery and improvement through partnerships with pharmaceutical companies. However, in this case it is with the stated additional purpose of commercial gain. Involving SA in this endeavour, and doing so as a DTC service to health insurance clients, raises important concerns, some of which we outline below.

Issues to consider relevant to the implementation of WES in SA

Owing to the comprehensiveness of WES data and our limited understanding of the impact of genetic variation on traits and diseases, the leading concern when dealing with WES in healthy individuals is the appropriate interpretation of results. The likelihood of identifying variants of unknown significance or disease-causing mutations linked to untreatable diseases is high. Interpreting these data in individuals from previously understudied populations (such as black African populations) further complicates interpretation. The analytical sensitivity and specificity of WES should also be considered – diagnostic laboratories offering clinical WES will validate positive findings with an alternative method before releasing diagnostic results. Owing to the uncertainty and concerns relating to the impact of results generated by WES on an individual’s health

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and wellbeing, guidelines have been established by various international professional groups, most notably the American College of Medical Genetics and Genomics.[10] Closely linked to the uncertainty of data interpretation in WES is the need for adequate pre- and post-test counselling – a service that may be negated if WES is offered direct to the consumer. The health professionals best placed to provide these services are medical geneticists and genetic counsellors. In SA, genetic counsellors and medical geneticists are health care professionals registered with the Health Professions Council of South Africa as independent practitioners, with formal tertiary training in their respective professional fields. Both have a deep and broad knowledge of genetics, communication skills to inform and educate a variable audience on the complexities of genetics, psychosocial assessment abilities and the knowledge and ability to apply professional ethics. There is currently a limited number of them in SA, raising concerns that there would be insufficient capacity to provide proper information prior to testing, during informed consent and when test results are received. The ethical implementation of WES is crucial and safeguarded by proper pre-test information sharing, counselling and informed con sent. Recommendations on what should be considered as part of this process are set out in Table 1. The Discovery/HLI WES offering will implement a broad consent model, with no option to opt out after consent is given, whereas the global trend is to move towards dynamic consent that enables greater participant engagement.[11,12] Post-test counselling for positive results must include practical guidance regarding preventive and therapeutic options, psychosocial support, and the offer of family follow-up. It is crucially important that an appropriate governance framework is in place that restricts exploitative, unapproved use of the data generated. What is important in that framework is that the interests of SA individuals and communities are appropriately considered when granting access to data. Lastly, it is strongly recommended that a local ethics committee review consent documentation and research proposals for this initiative. It would be expected that all these objectives will be in place and approved prior to any testing being offered to participants. From a legal standpoint, there are many potential pitfalls when offering direct-to-consumer WES. Confidentiality, anti-discrimination and protection of personal information are principles that are embedded in our constitution and legislation. With regard to intellectual property, patenting of DNA sequences is not allowed – however, any new diagnostics and therapeutics developed through the use of DNA sequence data are patentable. Benefit sharing, which can take several forms, should be considered, particularly since participants are paying for the service, if only in part. These details could be included in a material transfer agreement. It should also be remembered that exomes contain a great deal of information beyond disease susceptibility, such as information about ancestry, admixture and so forth. This information needs to be managed with a great deal of care because of the repercussions it might have for individuals and communities involved, including a potential for discrimination. One way of ensuring that secondary use of genomic data is not harmful or exploitative, and that it takes appropriate recognition of contextual factors important in its interpretations, is to carefully govern access to data. There is now considerable experience with regulating access to genomic data globally that should be considered in the Discovery initiative. Managed access to primary data, i.e. limiting access to suitably qualified personnel, should be encouraged.

February 2016, Vol. 106, No. 2

EDITORIAL

Table 1. Genetic counselling considerations when offering WES to healthy individuals Exclusions Healthy minors (<18 years) should be excluded. Pre-test counselling he participant should be prompted to specifically consider the T benefits, limitations and major concerns expected with WES results. Specifically, participants should be made aware: hat the analysis performed will be for disease-causing variants T in specific actionable genes f the implications of a specific positive finding for further O treatment – which may differ between individuals with a significant family history and those without f the fact that such treatment may or may not be covered by O medical aid, depending on the medical aid plan f the implications of a positive finding for future applications O for life insurance, and other possible social implications Of the implications of a positive finding for other family members hat WES will not detect all possible disease-causing variants, or all T actionable variants hat future assessment of the WES may detect significant T variants at a later stage, even if nothing is detected initially re-test counselling should be done in person, if possible. At a minimum, P the participant should have access to good-quality information, and to a genetic counsellor for important remaining queries. he cost of validation and counselling excluded from the T sequencing pricing must be declared. family history should be taken, and the participant should be A informed of particular parts of the family history in which WES may be informative (e.g. things that appear to be due to singlegene inheritance) and what parts of the family history are unlikely to provide information through WES (e.g. multifactorial disorders or those of unknown aetiology). Reporting of results and post-test counselling linically relevant results should be validated, and reported to C the participant by a health professional with appropriate genetics training (preferably a medical geneticist or genetic counsellor), especially if there is a positive finding.

A final point of consideration is the use of these data for research purposes. Exploitation of local DNA resources with a lack of significant engagement and local capacity development is a reality in the field of genomics, not only in SA but in Africa as a continent.[3,13,14] Although it has been stated that data would potentially be available to local scientists for research purposes, one has to wonder what competitive advantage African scientists will have to utilise these data fully, and whether it would ultimately lead to any kind of capacity development within the SA scientific community. If these date are simply to be used to help a US company to accumulate genome data in order to create a commercialisable private database of DNA and medical records, without any consideration for or intention of addressing urgent health and research needs of the SA population, this endeavour would raise real concern about exploitation. In conclusion, there are a number of vitally important ethical, legal and scientific concerns that have to be addressed to ensure proper and ethical implementation of this service in SA and that individuals taking part in this endeavour are fully informed of the positive and negative sequelae.

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Southern African Society for Human Genetics, Johannesburg, South Africa: Zané Lombard, Fiona Baine, Amanda Krause, Anneline Lochan, Shelley Macaulay, Careni Spencer, Division of Human Genetics, School of Pathology, Faculty of Health Sciences, National Health Laboratory Service, University of the Witwatersrand, Johannesburg, South Africa; Colleen Aldous, School of Clinical Medicine, Nelson Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa; Jantina de Vries, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa; Karen Fieggen, Division of Human Genetics, Department of Clinical Laboratory Sciences, Faculty of Health Sciences, University of Cape Town, South Africa; Bertram Henderson, Division of Human Genetics, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa; Eileen Hoal, Craig Kinnear, DST/NRF Centre of Excellence for Biomedical Tuberculosis Research/MRC Centre for Molecular and Cellular Biology, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa; Noelene Kinsley, GC Network Pty Ltd., Johannesburg, South Africa; Alison September, Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, South Africa; Michael Urban, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa Genetic Alliance South Africa, Johannesburg: Himla Soodyall, Division of Human Genetics, School of Pathology, Faculty of Health Sciences, National Health Laboratory Service, University of the Witwatersrand, Johannesburg, South Africa Southern African Human Genome Programme, Pretoria, South Africa: Michael Pepper, Institute for Cellular and Molecular Medicine, Department of Immunology, Faculty of Health Sciences, University of Pretoria, South Africa; Michele Ramsay, Sydney Brenner Institute for Molecular Bioscience, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: Zané Lombard (zane.lombard@wits.ac.za) 1. Volk A, Conboy E, Wical B, Patterson M, Kirmani S. Whole-exome sequencing in the clinic: Lessons from six consecutive cases from the clinician’s perspective. Mol Syndromol 2015;6(1):23-31. [http:// dx.doi.org/10.1159/000371598] 2. Amendola LM, Lautenbach D, Scollon S, et al. Illustrative case studies in the return of exome and genome sequencing results. Per Med 2015;12(3):283-295. [http://dx.doi.org/10.2217/pme.14.89] 3. De Vries J, Tindana P, Littler K, et al. The H3Africa policy framework: Negotiating fairness in genomics. Trends Genet 2015;31(3):117-119. [http://dx.doi.org/10.1016/j.tig.2014.11.004] 4. Dandara C, Greenberg J, Lambie L, et al. Direct-to-consumer genetic testing: To test or not to test, that is the question. S Afr Med J 2013;103(8):510-512. [http://dx.doi.org/10.7196/samj.7049] 5. Discovery to offer genetic testing to Vitality members. The Citizen, 23 September 2015. http://citizen. co.za/784172/discovery-to-offer-genetic-testing-to-vitality-members/ (accessed 6 November 2015). 6. Discovery Health. New product and benefit enhancements for 2016. https://http://www.discovery. co.za/portal/individual/medical-aid-news-product-enhancements-2016 (accessed 6 November 2015). 7. SA insurer offers cheap whole exome sequencing. Medical Brief 22 September 2015. http://www.medicalbrief. co.za/archives/sa-insurer-offers-cheap-whole-exome-sequencing/ (accessed 6 November 2015). 8. Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med 2015;372(9):793-795. [http://dx.doi.org/10.1056/NEJMp1500523] 9. Manolio TA, Abramowicz M, Al-Mulla F, et al. Global implementation of genomic medicine: We are not alone. Sci Transl Med 2015;7(290):290ps213. [http://dx.doi.org/10.1126/scitranslmed.aab0194] 10. Green RC, Berg JS, Grody WW, et al. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 2013;15(7):565-574. [http://dx.doi.org/10.1038/gim.2013.73] 11. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: A patient interface for twentyfirst century research networks. Eur J Hum Genet 2015;23(2):141-146. [http://dx.doi.org/10.1038/ejhg.2014.71] 12. Steinsbekk KS, Kare Myskja B, Solberg B. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? Eur J Hum Genet 2013;21(9):897-902. [http://dx.doi.org/10.1038/ejhg.2012.282] 13. De Vries J, Pepper M. Genomic sovereignty and the African promise: Mining the African genome for the benefit of Africa. J Med Ethics 2012;38(8):474-478. [http://dx.doi.org/10.1136/medethics-2011-100448] 14. Hoal E. Famine in the Presence of the Genomic Data Feast. Science 2011;331(6019):874. [http://dx.doi. org/10.1126/science.1203261]

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February 2016, Vol. 106, No. 2

EDITORIAL

Challenging the cost of clinical negligence Healthcare professionals in South Africa (SA) are facing challenging times. As the clinical negligence claims environment in SA deteriorates, the effect is being felt not only by healthcare professionals but also by the wider public as a result of the strain that costs place on the public purse. We look at the current claims environment, and explain why a debate about reform is so important.

The challenges

There is growing recognition of the need for legal reform in SA, not only to reduce the burden of mounting costs but also to create a system that both ensures reasonable compensation for patients and allows for a fair and robust defence where necessary. An efficient and cost-effective legal system that works for patients and their families, as well as for healthcare professionals, is crucial. In our experience at the Medical Protection Society (MPS), over the past 6 years there has been a deterioration in the overall claims environment for medical members. Our data indicate that between 2009 and 2015 the probable value of claims being brought against doctors has escalated, with claim sizes increasing by over 14% on average each year during that period. Our data also indicate that the estimation of the long-term average claim frequency for doctors in 2015 was around 27% higher than in 2009. Not-for-profit mutual organisations such as MPS have an obligation to ensure that they collect sufficient subscription income to meet the expected future costs of claims against members, so they can be in a position to defend members’ interests long into the future. If the current clinical negligence claims trend continues, it will result in higher costs for healthcare professionals. The situation is also of concern to the SA government and has been described as a ‘crisis’ by Health Minister Dr Aaron Motsoaledi. ‘The nature of the crisis is that our country is experiencing a very sharp increase – actually an explosion in medical malpractice litigation – which is not in keeping with generally known trends of negligence or malpractice,’ Motsoaledi said at a medicolegal summit in Pretoria in March 2015. ‘The cost of medical malpractice claims has skyrocketed and the number of claims increased substantially.’[1] MPS does not believe that the deteriorating claims environment in recent times reflects a deterioration in professional standards. There are potentially a multitude of complex factors, some of them positive, that are contributing to the current claims experience, including: • The lack of a patient-centred and robust complaints system is leaving many patients with litigation as the only viable avenue for redress.[2] • The lack of an efficient and predictable legal process for handling clinical negligence claims allows the size of claims to increase and makes delays endemic, with no parties benefiting. • The cost of settling a claim increases as time goes on. A protracted legal process can have a significant impact on the final costs of settling a claim, as it means that legal bills continue to mount and compensation can increase in size. • Amendments to the provisions of the Road Accident Fund Act potentially result in attorneys refocusing their area of interest towards personal injury claims, clinical negligence in particular. • Patients are increasingly aware of their rights under the Constitution and the Consumer Protection Act. • Patient expectations are increasing, with many patients now expecting greater involvement in, and understanding about, their healthcare.

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Alongside concerns about cost, there is a belief that the clinical negligence litigation system does not facilitate the efficient and fair resolution of disputes. Instead, the system is unnecessarily adversarial with frequent ‘trial by ambush’. It also lacks transparency and is time consuming and expensive. While the claims experience may not continue to deteriorate at its current pace, the experience to date merits serious consideration of legal reform.

The debate

The deterioration of the claims environment has a negative effect not only on the healthcare profession but also on wider society. Legal and procedural reforms are required to begin to tackle some of the factors that have led to this claims experience and ensure a fairer and more efficient system for all parties. Added to this, a patient-centred, standardised complaints system should be developed to ensure that patient concerns are addressed, where possible, before they become a claim. Any proposals to tackle the rising cost of clinical negligence need to be debated and explored at a public policy level because of the current effect of clinical negligence on the public purse. Dr Motsoaledi initiated the debate about reforms, and MPS has contributed to the debate by launching its policy paper ‘Challenging the costs of clinical negligence: The case for reform’ in Johannesburg on 10 November 2015. We are only one voice, however, and our reform proposals are not exhaustive.[3] The lively and informative debate at the launch event highlighted some of the many interesting ideas for reform that should be considered. These include further thoughts on alternative dispute resolution, and how risk management can be used to prevent claims arising in the first place. Prevention is an important theme, and defence organisations must continue to play their part to promote safe practice in medicine, with open disclosure being a crucial element. When organisations embrace open disclosure, it benefits all involved. Above all, it is the ethical thing to do.

Our proposals

1. Complaints process • The development of a consistent, efficient, aligned and patientcentred complaints process that allows for local resolution. 2. Frequency of claims • A Certificate of Merit be introduced. • Further consideration of ways to encourage alternative dispute resolution. 3. Pre-litigation resolution framework • The introduction of a pre-litigation resolution framework. 4. Procedural changes • Procedural change to ensure: • the exchange of factual witness statements • early exchange of expert notices and summaries • mandatory early experts meetings. 5. Limiting damages awards (general and special) • A tariff of general damages is created in statute • A limit on general damages

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EDITORIAL

• A limit on future care costs • A limit on claims for loss on future earnings. The importance of the debate, and engagement therewith, cannot be over-emphasised.[4] Conflict of interest. Both authors are full-time employees of the Medical Protection Society (MPS). MPS is not an insurance company but a nonprofit mutual organisation.

Graham Howarth Head of Medical Services: Africa, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK

Emma Hallinan Director of Claims and Litigation, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK Corresponding author: G Howarth (graham.howarth@medicalprotection.org) 1. SA’s shocking medical malpractice crisis. http://www.health24.com/News/Public-Health/SAsshocking-medical-malpractice-crisis-20150309 (accessed 29 December 2015). 2. Howarth GR, Tiernan J, Carstens P, Gillespie G. A good complaints system. S Afr Med J 2015:105(6):425-426. [http://dx.doi.org/10.7196/SAMJ.9358] 3. Challenging the cost of clinical negligence: The case for reform. http://www.medicalprotection.org/ southafrica/about-mps/our-policy-work (accessed 29 December 2015). 4. Howarth GR, Goolab B, Dunn RN, Fieggen AG. Public somnambulism: A general lack of awareness of the consequences of increasing medical negligence litigation. S Afr Med J 2014;104(11):752-753. [http://dx.doi.org/10.7196/SAMJ.8568]

S Afr Med J 2016;106(2):141-142. DOI:10.7196/SAMJ.2016.v106i2.10408

This month in the SAMJ ... Dagmar Muhlbauer* is a lecturer in the Department of Emergency Medical Care and Rescue at the Durban University of Technology, KwaZulu-Natal. She holds a master’s degree in emergency medical care, is serving a second term on the Professional Board for Emergency Care, and is the current chairperson of the Education Committee. She has directed her research efforts towards helicopter emergency medical services, as she has 16 years of experience in this field of prehospital emergency medicine. She believes that it is a very valuable resource, but that it needs to be utilised effectively in order to benefit patients in the South African context. * Muhlbauer D, Naidoo R, Hardcastle TC. An analysis of patients transported by a private helicopter emergency medical service in South Africa. S Afr Med J 2016;106(2):201205. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.9919]

The Lancet Commission Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Lancet 2015;386(9993):569624. [http://dx.doi.org/10.1016/S0140-6736(15)60160-X]

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February 2016, Vol. 106, No. 2

CME

GUEST EDITORIAL

Cardiovascular medicine in primary healthcare in sub-Saharan Africa: Minimum standards for practice (part 2) In the past decades sub-Saharan Africa (SSA) has witnessed urbanisation at unparalleled rates of increase, together with changing lifestyles. The consequence of this epidemiological transition has been a dramatic increase in the incidence of non-communicable diseases (NCDs), in particular cardiovascular disease (CVD). At the same time social disintegration and inequality, compounded by the dwindling economy in many countries in SSA, have seriously hindered a cohesive response to NCDs.[1] Moreover, infections remain rife and many societies in SSA have to contend with the twin epidemics of both communicable diseases and NCDs.[2] The World Health Organization noted that the number of disabilityadjusted life-years lost to CVD in SSA rose from 5.3 million for men and 6.3 million for women in 1990 to 6.5 million and 6.9 million, respectively, in 2000, and that these could rise above 8.1 million and 7.9 million, respectively, in 2010.[3] In SSA, CVD mortality is much higher than in developed countries[4] and affects younger people and women disproportionately.[2,4] The prevalence and management status of common CVDs, such as hypertension, heart failure (HF), cardiomyopathy, stroke, ischaemic heart disease, rheumatic heart disease and pericardial disease, remain largely unknown in South Africa (SA), much as in the rest of SSA. However, the available data suggest that these conditions are very poorly managed.[5,6] Furthermore, there are significant systemic barriers to planning and providing care for people with CVD, which compound the problem. For instance, in SA inadequate classification of deaths from CVD and differences in patterns of risk and disease among ethnic groups hampered effective planning.[7] This issue of CME focuses on the clinical approaches to these common cardiovascular challenges, and forms the second part of a series of articles jointly produced by SA cardiologists and family physicians with the dual objectives of empowering doctors who manage these conditions in primary care settings in SA and improving the care of CVD patients in such settings and emergency departments. In the previous issue, HF,[8] dyspnoea,[9] hypertension in the young[10] and valvular heart disease[11] were reviewed. The current edition provides an evidence-based and pragmatic approach to the important clinical problems of infective endocarditis[12] and pericardial disease.[13] A review of infective endocarditis is included in this series owing to its high in-hospital and 1-year mortality. Viridans streptococci cause most cases, although Staphylococcus aureus is also an important cause that often requires early surgery for successful eradication. Paucity of data, particularly in SSA where rheumatic valvular heart disease is still highly prevalent, makes decisions with regard to the optimal treatment of this disease very difficult. In this timely review, Hitzeroth et al.[12] emphasise that the diagnosis of infective endocarditis is primarily clinical, while laboratory findings play a confirmatory role. The clinical presentation can vary. Patients may present with a nonspecific constitutional illness, features of valve dysfunction and HF (fulminant or subacute) or signs and symptoms due to peri

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pheral embolisation. A growing problem is the entity of healthcareassociated infective endocarditis, particularly due to the introduction of bacteria after peripheral or central vein cannulation. The diagnosis is traditionally based on the modified Duke criteria, which provide a useful framework for the investigation of patients suspected of having infective endocarditis. The diagnosis rests on clinical features, to a lesser extent certain laboratory findings, microbiological assessment (blood cultures in the majority of cases) and imaging to detect evidence of endocardial infection (by means of echocardiography or scintigraphy) or septic emboli (often with the assistance of a computed tomography scan). A high proportion of the microbiological cultures are negative owing to prior antibiotic administration to patients. If infective endocarditis is not treated – or poorly treated – sequelae include HF, local intracardiac extension of infection, stroke and intracranial haemorrhage. When indicated, surgery to remove the infective tissue and replace the diseased valve should always be considered. The role of prophylactic antibiotics is discussed. The European Society of Cardiology has recently updated its guidelines on the diagnosis and management of infective endocarditis.[14] Kyriakakis et al.[13] review the approach to a patient with suspected pericardial disease. The spectrum of pericardial diseases includes pericarditis, pericardial effusions, pericardial tamponade and peri cardial constriction. In industrialised countries, the aetiology of acute pericarditis is either viral or idiopathic, whereas in SSA tuberculosis (TB) features prominently, especially in the context of the high HIV/AIDS prevalence. Recurrent pericarditis may occur in up to 50% of patients with acute idiopathic pericarditis who have not been prescribed colchicine as part of their initial management. The most common complications are pericardial effusions and cardiac tamponade. Pericardial effusions complicated by pericardial tamponade are commonly encountered in SSA owing to the high prevalence of TB pericarditis. Tamponade is a life-threatening condition that remains a clinical and not an echocardiographic diagnosis. Central to establishing a diagnosis of cardiac tamponade is the presence of a pulsus paradoxus >10 mmHg in a patient with a pericardial effusion; this sign may, however, be difficult to elicit in a hypotensive patient. Echocardiography confirms the presence of an effusion when tamponade is suspected and assists in identifying the best approach to safe pericardiocentesis. Constrictive pericarditis is a rare cause of HF and is potentially curable. It is a particularly challenging clinical diagnosis and many patients are only identified late in the course of their disease when their peri-operative mortality risk is at its highest. Prior cardiac surgery is the most common cause of constriction in the developed world, while TB remains the culprit in the developing world. A limited anterior surgical pericardiectomy has been shown to result in a higher recurrence of constriction than a radical and complete pericardial resection. The latter is more effectively accomplished earlier on in the disease before pericardial calcium has infiltrated the myocardium, emphasising the need for early detection of the disease.

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It is our sincere hope that this series of articles on common cardiovascular conditions often encountered in primary care settings in SA and SSA will improve the care of patients with CVD. Furthermore, it is our wish that the articles clearly emphasise the minimum standards for management of these common cardiovascular disorders.

Gboyega Ogunbanjo Guest editor Department of Family Medicine and Primary Health Care, Sefako Makgatho Health Sciences University, Pretoria, South Africa profbanjo@gmail.com

Ntobeko A B Ntusi Guest editor Division of Cardiology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa ntobeko.ntusi@gmail.com

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1. Kadiri S. Tackling cardiovascular disease in Africa. BMJ 2005;331:711. [http://dx.doi.org/10.1136/ bmj.331.7519.711] 2. Gersh BJ, Sliwa K, Mayosi BM, Yusuf S. The epidemic of cardiovascular disease in the developing world: Global implications. Eur Heart J 2010;31:642-648. [http://dx.doi.org/10.1093/ eurheartjehq030] 3. World Health Organization (WHO). Reducing risks, promoting healthy life. World Health Report 2002. Geneva: WHO, 2002. http://www.who.int/whr/2002/en/index.html (accessed 6 December 2015). 4. Ntusi NAB, Mayosi BM. Epidemiology of heart failure in sub-Saharan Africa. Expert Rev Cardiovasc Ther 2009;7:169-180. [http://dx.doi.org/10.1586/14779072.7.2.169] 5. Steyn K. Heart disease in South Africa. The Heart and Stroke Foundation of South Africa. Media Data Document. Medical Research Council of South Africa. http://www.mrc.ac.za/chronic/heartandstroke. pdf (accessed 6 December 2015). 6. Ntusi NAB. Dismal management of hypertension at primary level: Does it reflect a failure of patients, a failure of the system or a failure of doctors? Cardiovasc J Afr 2011;22(4):172-174. 7. Bradshaw D. What do we know about the burden of cardiovascular disease in South Africa? Cardiovasc J S Afr 2005;16:140-141. 8. Kraus S, Ogunbanjo G, Sliwa K, Ntusi NAB. Heart failure in sub-Saharan Africa: A clinical approach. S Afr Med J 2016;106(1):23-31. [http://dx.doi.org/10.7196/SAMJ.2016.v106i1.10325] 9. Coccia CBI, Palkowski GH, Schweitzer B, Motsohi T, Ntusi NAB. Dyspnoea: Pathophysiology and a clinical approach. S Afr Med J 2016;106(1):32-36. [http://dx.doi.org/10.7196/SAMJ.2016. v106i1.10324] 10. Mangena P, Saban S, Hlabyago KE, Rayner B. An approach to the young hypertensive patient. S Afr Med J 2016;106(1):36-38. [http://dx.doi.org/10.7196/SAMJ.2016.v106i1.10329] 11. Cupido BJ, Peters F, Ntusi NAB. An approach to the diagnosis and management of valvular heart disease. S Afr Med J 2016;106(1):39-42. [http://dx.doi.org/10.7196/SAMJ.2016.v106i1.10326] 12. Hitzeroth J, Beckett N, Ntuli P. An approach to a patient with infective endocarditis. S Afr Med J 2016;106(2):145-150. [http://dx.doi.org/10.7196/SAMJ.2016.v106i2.10327] 13. Kyriakakis CG, Mayosi BM, de Vries E, Isaacs A, Doubell AF. An approach to the patient with suspected pericardial disease. S Afr Med J 2016;106(2):151-155. [http://dx.doi.org/10.7196/ SAMJ.2016.v106i2.10328] 14. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC) endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J 2015;36:30753128.

S Afr Med J 2016;106(2):143-144. DOI:10.7196/SAMJ.2016.v106i2.10454

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An approach to a patient with infective endocarditis J Hitzeroth,1 MB ChB, DA (SA), FCP (SA), Cert Cardiology (SA); N Beckett,2 MB ChB, PG Dip FM (SA); P Ntuli,3 MB ChB, FCP (SA), Cert Cardiology (SA) Private Practice, Vincent Pallotti Hospital, Cape Town, South Africa Division of Family Medicine, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 3 Division of Cardiology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, and Groote Schuur Hospital, Cape Town, South Africa 1 2

Corresponding author: J Hitzeroth (jens314@gmail.com)

Although infective endocarditis (IE) is relatively uncommon, it remains an important clinical entity with a high in-hospital and 1-year mortality. It is most commonly caused by viridans streptococci. Staphylococcus aureus is responsible for a malignant course of IE and often requires early surgery to eradicate. Other rarer causes are various bacilli, including the HACEK (Haemophilus, Actinobacillus, Cardiobacterium, Eikenella and Kingella spp.) group of organisms and fungi. The clinical presentation varies. Patients may present with a nonspecific illness, valve dysfunction, heart failure (HF) and symptoms due to peripheral embolisation. The diagnosis is traditionally based on the modified Duke criteria and rests mainly on clinical features and to a lesser extent on certain laboratory findings, microbiological assessment and cardiovascular imaging. Identification of the offending micro-organism is not only important from a diagnostic point of view, but also makes targeted antibiotic treatment possible and provides useful prognostic information. A significant proportion of microbiological cultures are negative, frequently owing to the administration of antibiotics prior to appropriate culture. Blood-culture-negative IE poses significant diagnostic and treatment challenges. The course of the disease is frequently complicated, and sequelae include HF, local intracardiac extension of infection (abscess, fistula, pseudoaneurysm), stroke and intracranial haemorrhage due to septic emboli or mycotic aneurysm formation as well as renal injury. Management includes prolonged intravenous antibiotics and consideration for early surgery with removal of infective tissue and valve replacement in patients who have poor prognostic features or complications. Antibiotic administration for at-risk patients to prevent bacteraemia during specific procedures (particularly dental) is recommended to prevent IE. The patient population who would benefit from antibiotic prophylaxis has become increasingly restricted, and guidelines recommend prophylaxis only for patients with cyanotic congenital heart disease, prosthetic heart valves and a previous episode of IE. The management of a patient with IE is challenging and often requires multidisciplinary input from an IE heart team, which includes cardiologists. S Afr Med J 2016;106(2):145-150. DOI:10.7196/SAMJ.2016.v106i2.10327

Infective endocarditis (IE) remains a challenging clinical entity.[1] It has a relatively low incidence, the clinical presentation varies widely and the offending organisms cover a large spectrum of microbiological species. It is therefore not uncommon that the diagnosis is delayed. Despite advances in its management, it remains a condition with a high mortality and significant morbidity. Paucity of data, particularly in Africa where rheumatic valvular heart disease is still highly prevalent, makes decisions regarding the optimal treatment of this disease very difficult. To complicate matters, there has been considerable controversy surrounding prevention of the disease. The objective of this article is to inform the clinician on the current state of knowledge of IE in order to provide a practical approach to the patient with suspected IE.

Bacteriology

Viridans streptococci account for 50 - 70% of native valve IE. Staphylococcus aureus is responsible for a further 25%. Various bacilli, the HACEK group of organisms (Haemophilus, Actinobacillus, Cardiobacterium, Eikenella and Kingella spp.) and fungi are rare. The offending organisms in prosthetic valve endocarditis are frequently Staphylococcus epidermidis or S. aureus.

Prevention

Previously, antibiotic prophylaxis was administered widely to patients with various predisposing cardiac conditions. In 2002 the indications

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for antibiotic prophylaxis were restricted to a much smaller population of patients with cardiac pathology,[2] for various reasons: • Bacteraemia occurs more frequently during routine activities (e.g. toothbrushing) and the risk of endocarditis may be related to generally poor dental health rather than occasional high-grade bacteraemia following a dental procedure. • There is poor correlation between invasive dental procedures and IE. • The estimated risk of IE following a dental procedure is very low. • Antibiotic prophylaxis carries a small but definite risk of anaphy laxis/severe allergic reaction. • Prophylactic antibiotic use may contribute to increased resistant bacteria. • There are no randomised controlled trials that have investigated whether antibiotic prophylaxis does in fact reduce the incidence of IE. In a recent analysis in the UK, the incidence of IE increased significantly after introduction of the restricted antibiotic prophylaxis guidelines. It is not entirely certain what conclusions can be drawn from this observational data, where confounding factors cannot be excluded. The finding has not been confirmed in various observational studies in other countries. The current European Society of Cardiology (ESC) guidelines still recommend that antibiotic prophylaxis should be considered for: • Patients with a prosthetic valve or where prosthetic material was used for surgical repair of a valve.

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• Patients with a previous episode of IE. • Any type of cyanotic congenital heart disease. • Any coronary heart disease repaired with prosthetic material up to 6 months after the procedure or lifelong if there is residual shunt/ valvular regurgitation.[3] Furthermore, the use of antibiotic prophylaxis is limited to dental procedures requiring manipulation of the gingival/periapical tooth region or perforation of the oral mucosa. Antibiotic prophylaxis is not recommended for less-invasive procedures such as bronchoscopy, gastroscopy, colonoscopy, cystoscopy or skin/soft-tissue procedures. This also includes caesarean sections and vaginal delivery. Respiratory, gastrointestinal tract or genitourinary procedures where antibiotic prophylaxis is given to prevent wound infection or sepsis should receive the appropriate antibiotic. The recommended regimen for patients in whom antibiotic prophylaxis is indicated is amoxicillin 2 g orally or intravenously (IV) 30 - 60 minutes prior to the procedure. Patients with a penicillin allergy should receive clindamycin 600 mg orally or IV. Lastly, the following general measures to reduce bacteraemia are felt to be very important: • Strict dental and cutaneous hygiene. • Disinfection of any wounds. • Eradication of chronic bacterial carriage: skin/nasal/urine. • Aggressive therapy of any bacterial infection. • Strict infection control measures for any procedure. There have been case reports of IE after body piercing or tattooing; therefore, these should be strongly discouraged in at-risk individuals. A final comment must be made surrounding so-called healthcareassociated IE. This accounts for up to 30% of all cases of IE. To prevent this, the following points are important: • The often unnecessary use of IV catheters should be limited. • A strict aseptic technique should be followed, particularly when placing central catheters. • Catheters should be changed routinely every 3 - 4 days. Table 1. Definition of IE according to modified Duke criteria Definite IE Pathological criteria Micro-organism demonstrated by culture or histological examination of a vegetation, a vegetation that has embolised, or an intracardiac abscess specimen, or Pathological lesions vegetation or intracardiac abscess confirmed by histological examination showing active endocarditis Clinical criteria 2 major criteria, or 1 major criterion and 3 minor criteria, or 5 minor criteria Possible IE 1 major criterion and 1 minor criterion, or 3 minor criteria Rejected IE Firm alternative diagnosis, or Resolution of symptoms suggesting IE after antibiotic therapy for <4 days, or No pathological evidence of IE at surgery or autopsy, with antibiotic therapy for <4 days, or Does not meet criteria for possible IE, as above

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Diagnosis

The modified Duke criteria provide a formal framework for the diagnosis of IE and are shown in Tables 1 and 2.[4] An important caveat is that the Duke criteria have a sensitivity of 80% for the diagnosis of IE.[5] It is therefore possible to miss IE if one applies the Duke criteria too strictly. The diagnosis is based on four distinct legs: • Clinical features. • Laboratory findings. • Imaging. • Microbiological tests. Table 2. Definition of terms used in the Duke criteria Major criteria Blood culture positive for IE ypical micro-organism consistent with IE from two separate T blood cultures Viridians streptococci, Streptococcus gallolyticus, HACEK group, S. aureus, or Community-acquired enterococci, in the absence of a primary focus, or Micro-organisms consistent with IE from persistently positive blood cultures defined as follows: >2 positive blood cultures of blood samples drawn >12 hours apart, or All of 3 or a majority of >4 separate blood cultures (with first and last sample drawn >1 hour apart), or Single positive blood culture for Coxiella burnetti or IgG titre >1:800 Imaging positive for IE Echocardiogram positive for IE Vegetation, or Abscess, pseudoaneurysm, intracardiac fistula, or Valvular perforation or aneurysm, or New partial dehiscence of prosthetic valve Definite paravalvular lesions on cardiac CT Abnormal activity around the site of prosthetic valve implantation detected by 18F-FDG PET/CT (only if prosthesis was implanted for >3 months) or radio-labelled leukocytes SPECT Minor criteria Predisposition, such as predisposing heart condition or IV drug use Fever defined as temperature >38°C Vascular phenomena (including those detected by imaging only) Major arterial emboli Septic pulmonary infarcts Infectious aneurysm Intracranial haemorrhage Conjunctival haemorrhages Janeway’s lesions Immunological phenomena Glomerulonephritis Osler’s nodes Roth’s spots Rheumatoid factor Microbiological evidence Positive blood culture but does not meet major criteria for blood cultures as noted above, or Serological evidence of active infection with organism consistent with IE 18

F-FDG PET/CT = fluorine-18 fluorodeoxyglucose positron emission tomography/ computed tomography; SPECT = single-photon emission computed tomography.

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Clinical features

IE usually has an acute onset, and it often causes multisystem disease with skin manifestations that can imitate a number of diseases.[6] In a primary care setting it is important to have a high index of suspicion, and the clinical history of a patient with unexplained high fever should always include asking about possible risk factors such as previous cardiac valvular disease, IV drug use, the presence of prosthetic devices (prosthetic valves, orthopaedic hardware), as well as cardiac implantable electronic devices such as pacemakers, which can be possible sources of infection. The clinical picture of IE varies from nonspecific symptoms to symptoms sugges tive of pre-existing cardiac valvular disease, as well as embolic phenomena. Nonspecific symptoms include a high fever (in about 80 - 90% of cases), headache, anorexia, myalgia, night sweats and joint pains.[7,8] The patient often presents acutely, with no prior history of valvular disease or existing cardiac murmurs. Patients with pre-existing valve lesions and congenital heart disease usually present with the subacute form of the disease. There is an overlap of symptoms with those found in acute cases, because the clinical picture is influenced by the source or site of the infection, as well as the organism involved. About 99% of these patients will have a cardiac murmur but only 10% of these patients have a change in the characteristics of the murmur.[9] Patients who have leftsided valvular insufficiency may present with an acute onset of congestive cardiac failure. Splenomegaly is found in about 11% of patients with long-standing disease, but clubbing of fingers and toes is rare. The classic signs of IE are summarised in Table 3. Patients who have embolic complications can present with neurological outcomes (40% of cases), which include hemiparesis, paralysis and aphasia. In 50% of patients who present with cerebral emboli as the first manifestation of IE, there is a 2 4 times increased mortality rate. It is therefore impor t ant to enquire about the previously mentioned risk factors as possible sources of infection, especially in a young person who presents with stroke symptoms. Other manifestations include glomerulonephritis and renal failure. Systemic septic emboli (S. aureus infection) can result in abscess formation in almost any organ, including the heart, brain and kidneys. IV drug users (IVDUs) are susceptible to tricuspid IE. These patients have pulmonary symptoms, in addition to symptoms such

as high fever and petechiae. IVDUs with concurrent HIV infection are at increased risk of tricuspid valve endocarditis. Patients with advanced stages of HIV disease have a greater mortality risk of IE.[10]

Laboratory findings

None of the various laboratory investigations that are performed are diagnostic, and generally have poor positive predictive values. The tests are at most supportive in the diagnosis of IE. A raised white cell count or other marker of sepsis such as a raised erythrocyte sedimentation rate, C-reactive protein or procalcitonin may be found. Anaemia of chronic disease can be present. Patients may have low complement levels or elevated rheumatoid factor. An ele vated creatinine may be due to acute tubular necrosis, immune-complex mediated nephritis or renal emboli.

Imaging

Echocardiography Echocardiography remains one of the most useful investigations in the evaluation of some one with suspected IE.[11] If the transthoracic echo cardiogram is negative, one should proceed to trans oesophageal echocardiography to obtain the necessary image quality to look for small vegetations or early intracardiac complications (e.g. perivalvular abscesses).[12] Transoesophageal

echocardiography must also be performed in patients with suspected prosthetic valve endo carditis. The resolution of a transthoracic echo cardiogram is not adequate in this setting. Patients with S. aureus bacteraemia often have underlying IE with a very poor prognosis, and an echocardiogram is recommended in this setting to look for IE.[13] It needs to be emphasised that a normal echocardiogram does not rule out IE and if the clinical suspicion remains high, the study should be repeated 5 days later. Computed tomography scanning Multislice computed tomography (CT) may be helpful to detect the following: • CT coronary angiography is helpful in patients in whom a preoperative angiogram is indicated. The risks of invasive angiography including potential dislodgement of vege tation are thus avoided. • Multislice CT of the lungs, spleen or brain can detect embolic lesions, which can help to confirm the diagnosis of IE. • Cardiac CT can detect intracardiac/peri valvular abscesses and fistulae. Magnetic resonance imaging This may help in detecting cerebral lesions. Cardiovascular magnetic resonance may be helpful in identifying vegetations, myo cardial abscesses and other associated complications.

Table 3. Clinical signs of IE Clinical sign

Occurrence, %

Description

Petechiae

Common, nonspecific

Common, nonspecific and found on extremities, mucosa and palate

Splinter haemorrhages

Dark, linear lesions in nail beds

Osler’s nodes

Tender, papulopustules on distal pads of digits

Roth’s spots

Retinal haemorrhages with small, clear centres

Janeway’s lesions

Painless erythematous macules on palms of hands and soles of feet

Conjunctival haemorrhages

Bright red/dark red patch on the sclera

Haematuria

Blood in the urine

Table 4. Empirical therapy of IE Condition Native valve IE Prosthetic valve IE

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Antibiotics

Dose

Duration (weeks)

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

Rifampicin

15 mg/kg/day given 12-hourly po

Gentamicin

3 mg/kg/day given 12-hourly IV

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Nuclear imaging In centres with the necessary expertise and equipment, fluorine-18 fluoro deoxyglucose positron emission tomography/CT (18F-FDG PET/CT) can diagnose septic foci.

Microbiological tests

Blood cultures are critical in the diagnosis of IE. It is recommended that three sets are taken at least 30 minutes apart. Peripheral samples are preferred. Blood cultures do not need to be timed with fever spikes, as bacteraemia in IE is very constant. Similarly, a single positive blood culture should be interpreted carefully, as usually in IE all blood cultures will be positive. Positive blood cultures allow for identification of the causative organism as well as antibiotic susceptibility testing. Unfortunately, in about one-third of cases blood cultures are negative. This frequently results in diagnostic dilemmas and considerable challenge in terms of therapy. By far the most common cause is prior antibiotic administration without appropriate blood cultures being taken at the time. In these cases it may be useful (if the clinical status of the patient allows) to stop the antibiotics and repeat blood cultures. Another cause of blood-culture-negative IE is unusual organisms such as fungi and certain intracellular bacteria, which require specific growth media. Serology and polymerase chain reaction (PCR) for specific organisms (Coxiella, Bartonella and Brucella) may be helpful in these cases.[14] Lastly, microbiological examination of resected tissue during surgery can be extre mely helpful. All tissue excised during surgery should be sent for appropriate microbiological and histological investigation.

Complications

Not all the potential complications of IE are discussed here, but some of the more commonly occurring problems deserve special mention. Apart from heart failure, IE can manifest comp lications affecting the central nervous system, spleen, kidneys as well as blood vessels with the formation of mycotic aneurysms. Neurological About 20% of patients develop symptomatic neurological complications. These are usual ly due to septic emboli and may be the first manifestation of IE. The usual clinical presentation is with focal neurological signs due to an ischaemic stroke but more severe complications such as haemorrhage, meningitis and abscess formation can occur. Cardiac surgery to prevent further embolism should be considered early in patients with neurological complications.

Spleen Splenic abscesses or rupture present with abdominal pain and often a failure of anti biotic therapy. Although this complication is rare, it is important to recognise as these patients may require splenectomy to cure their infection; however, small abscesses may still respond to antibiotics alone. Heart block This is a rare complication but usually indi cates perivalvular spread of the infection and is therefore often an indication for surgery. Kidney Up to 30% of patients can develop acute renal failure. The following aetiologies should be considered: • Acute tubular necrosis due to sepsis or haemodynamic compromise. • Immune complex-mediated glomerulo nephritis. • Renal infarction due to emboli. • Drug toxicity or drug-induced nephritis.

Treatment

The therapy of IE comprises appropriate antibiotic therapy, cardiac surgery to resect

infected cardiac tissue (usually with valve replacement) and the treatment of compli cations. Antibiotic therapy Specific antibiotic therapy should be guided by the identification of the organism and results of antibiotic susceptibility testing. Tables 4 - 9 outline the empirical treatment of patients with IE (before blood culture results are available) as well as the antibiotic regimen for the most common organisms once they have been identified by cultures.[15] It is strongly recommended to discuss the specific treatment regimen with a microbiologist/ infectious disease specialist. Surgery Surgery is indicated broadly for three reasons: the development of heart failure, inadequate response to antibiotic therapy and a reduction in the risk of septic embolism. • Heart failure Heart failure is usually on the basis of severe mitral or aortic regurgitation. Patients who do not respond to medical heart failure therapy should undergo surgery within 24 hours.

Table 5. Therapy for streptococcal IE (native valve) Condition

Antibiotics

Dose

Duration (weeks)

Viridans streptococci susceptible to penicillin

Penicillin

6 mU given 6-hourly IV

Viridans streptococci moderately susceptible to penicillin

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Viridans streptococci moderately resistant to penicillin

Enterococci susceptible to penicillin

Abiotrophia/Granulicatella

Viridans streptococci fully resistant to penicillin

Enterococci resistant to penicillin

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Patients who respond to heart failure therapy should undergo surgery within 7 days. Patients who are left with valve lesions with no evidence of heart failure should be followed up and then operated on electively. â&#x20AC;˘ Inadequate response to antibiotic therapy This usually manifests as either persisting fever or persistently positive blood cultures for >7 days after initiation of appropriate antibiotic therapy. Another manifestation of uncontrolled infection is the development of local cardiac complications such as abscesses, false aneurysm, fistulae and vegetations that are enlarging. In these cases surgery within 7 days is advised to remove infective tissue and treat local complications. Some infections are caused by organisms (e.g. fungi or resistant organisms) that have a high likelihood of not being adequately treated with antibiotic therapy alone. In these patients, early surgery with removal of infective tissue should strongly be considered. â&#x20AC;˘ Reduction in embolism risk Patients who have vegetations >10 mm, in particular if they have had a previous embolic episode or other poor prognostic factors (e.g. heart failure), should be considered for early surgery.[16]

Cardiac device-related IE

Patients who develop IE with involvement of a pacemaker or ICD deserve a special mention because mortality in this setting is

particularly high and treatment is often very difficult. Apart from following the principles outlined above to make the diagnosis, it needs to be emphasised that the treatment of IE in this setting should not involve prolonged antibiotic therapy only, but also complete removal of all device-associated hardware (pacemaker and leads). If this is not performed, recurrence frequently occurs.

Prognosis

Between 15% and 30% of patients will die from IE in hospital. Table 10 outlines the predictors of a poor outcome for these patients. Patients with heart failure, periannular complications or S. aureus infections are at highest risk of in-hospital death or need for surgery. The risk is cumulative and is 79% if a patient has all three of the aforementioned risk factors.[17,18]

Conclusion

IE is a serious condition with a high mortality. It is difficult to diagnose and treat, and optimal management often requires input from multiple medical as well as surgical disciplines. Early surgery is frequently beneficial in patients with IE, and access to a good cardiac surgery service is therefore of paramount importance. As a final point we recommend that all patients with suspected IE are referred to a specialist centre for investigation and management.

Table 6. Therapy for streptococcal IE (prosthetic valve) Condition

Antibiotics

Dose

Duration (weeks)

Viridans streptococci susceptible to penicillin

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Viridans streptococci moderately susceptible to penicillin Viridans streptococci moderately resistant to penicillin Enterococci susceptible to penicillin Abiotrophia/Granulicatella Viridans streptococci fully resistant to penicillin Enterococci resistant to penicillin

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Penicillin

6 mU given 6-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

Gentamicin

3 mg/kg/day given 12-hourly IV

Table 7. Therapy for staphylococcal IE Condition

Antibiotics

Dose

Duration (weeks)

Native valve: cloxacillin/methicillin sensitive

Cloxacillin

2 g given 6-hourly IV

4-6

Native valve: cloxacillin/methicillin resistant

Vancomycin

30 mg/kg/day given 12-hourly IV

4-6

Rifampicin

15 mg/kg/day given 12-hourly po

4-6

Cloxacillin

2 g given 6-hourly IV

6-8

Rifampicin

15 mg/kg/day given 12-hourly po

6-8

Gentamicin

3 mg/kg/day given 12-hourly IV

Vancomycin

30 mg/kg/day given 12-hourly IV

6-8

Rifampicin

15 mg/kg/day given 12-hourly po

6-8

Gentamicin

3 mg/kg/day given 12-hourly IV

Prosthetic valve: cloxacillin/methicillin sensitive

Prosthetic valve: cloxacillin/methicillin resistant

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References

Table 8. Therapy for blood culture negative IE Pathogen

Antibiotics

Brucella

Bartonella Coxiella burnetti (Q fever)

Dose

Duration (weeks)

Doxycycline

200 mg daily po

Cotrimoxazole

960 mg 12-hourly po

Rifampicin

300 - 600 mg daily po

Doxycycline

200 mg daily po

Gentamicin

1 mg/kg 8-hourly IV

Doxycycline

100 mg 12-hourly po

Ciprofloxacin

250 mg 12-hourly po

>18

Table 9. Therapy for HACEK group IE Condition

Antibiotic

Dose

Duration (weeks)

HACEK organisms

Ceftriaxone

1 g daily IV/IM

Table 10. Predictors of poor outcome in patients with IE[3] Patient factors Older age Prosthetic valve IE Diabetes mellitus Comorbidity (e.g. frailty, immunosuppression, renal/pulmonary disease) Complications Heart failure Renal failure Greater than moderate area of ischaemic stroke Brain haemorrhage Septic shock Micro-organism S. aureus Fungi Non-HACEK Gram-negative bacilli Echocardiographic findings Periannular complications Severe left-sided valve regurgitation Low left-ventricular ejection fraction Pulmonary hypertension Large vegetations Severe prosthetic valve dysfunction Premature mitral valve closure and other signs of elevated diastolic pressures

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1. Thuny F, Grisoli D, Collart F, Habib G, Raoult D. Management of infective endocarditis: Challenges and perspectives. Lancet 2012;379(9819):965-975. [http://dx.doi.org/10.1016/S01406736(11)60755-1] 2. Duval X, Leport C. Prophylaxis of infective endocarditis: Current tendencies, continuing controversies. Lancet Infect Dis 2008;8(4):225-232. [http://dx.doi.org/10.1016/S14733099(08)70064-1] 3. Habib G, Lancellotti P, Antunes MJ. ESC guidelines for the management of infective endocarditis. Eur Heart J 2015;36:3075-3128. [http://dx.doi.org/10.1093/eurheartj/ ehv319] 4. Li J, Sexton DJ, Mick N, et al. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis 2000;30(4):633-638. [http://dx.doi. org/10.1086/313753] 5. Habib G, Derumeaux G, Avierinos JF. Value and limitations of the Duke criteria for the diagnosis of infective endocarditis. J Am Coll Cardiol 1999;33(7):2023-2029. 6. Baggett M, Turbett SE, Schwartzenberg SS, Stone JR. Case records of the Massachusetts General Hospital: Case 5: A 59-year-old man with fever, confusion, thrombocytopenia, rash, and renal failure. N Engl J Med 2014;370(7):651-660. [http:// dx.doi.org/10.1056/NEJMcpc1310004] 7. Sexton DJ, Fowler VG. Clinical manifestations and diagnosis of infective endocarditis. UpToDate 2015. http://www.uptodate. com (accessed 1 July 2015). 8. Hoen B, Duval X. Clinical practice. Infective endocarditis. N Engl J Med 2013;368(15):1425-1433. [http://dx.doi.org/10.1056/ NEJMcp1206782] 9. Brusch JL. Infective Endocarditis: Clinical Presentation. http:// emedicine.medscape.com/article/216650-216650 (accessed 13 August 2015). 10. Yasar KK, Pelivanoglu F, Gursoy S, Sengoz G. Tricuspid endocarditis and septic pulmonary embolism in an intravenous drug user with advanced HIV infection. Oman Med J 2011;26(5):365-367. 11. Habib G, Badano L, Tribouilloy C, et al. Recommendations for the practice of echocardiography in infective endocarditis. Eur J Echocardiogr 2010;11(2):202-219. [http://dx.doi.org/10.1093/ ejechocard/jeq004] 12. Mügge A, Daniel WG, Frank G, Lichtlen PR. Echocardiography in infective endocarditis: Reassessment of prognostic implications of vegetation size determined by the transthoracic and the transesophageal approach. J Am Coll Cardiol 1989;14(3):631-638. 13. Rasmussen RV, Høst U, Arpi M, et al. Prevalence of infective endocarditis in patients with Staphylococcus aureus bacteraemia: The value of screening with echocardiography. Eur J Echocardiogr 2011;12(6):414-420. [http://dx.doi.org/10.1093/ ejechocard/jer023] 14. Fournier PE, Thuny F, Richet H, et al. Comprehensive diagnostic strategy for blood culture-negative endocarditis: A prospective study of 819 new cases. Clin Infect Dis 2010;51(2):131-140. [http://dx.doi.org/10.1086/653675] 15. Oliver S, Whitelaw A, Bamford C. Western Cape Academic Hospitals Antimicrobial Recommendations 2013. Cape Town: National Health Laboratory Service, 2013. 16. Thuny F, Beurtheret S, Mancini J, et al. The timing of surgery influences mortality and morbidity in adults with severe complicated infective endocarditis: A propensity analysis. Eur Heart J 2011;32(16):2027-2033. [http://dx.doi.org/10.1093/ eurheartj/ehp089] 17. Chu V, Cabell CH, Benjamin DK Jr, et al. Early predictors of in-hos pital death in infective endocarditis. Circulation 2004;109(14):17451749. [http://dx.doi.org/10.1161/01.CIR.0000124719.61827.7F]  18. San Román JA, López J, Vilacosta I, et al. Prognostic stratification of patients with left-sided endocarditis determined at admission. Am J Med 2007;120(4):369-377. [http://dx.doi.org/10.1016/j. amjmed.2006.05.071]

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An approach to the patient with suspected pericardial disease C G Kyriakakis,1 MB ChB, FCP (SA), MMed (Int), Cert Cardiology (SA); B M Mayosi,2 MB ChB, FCP (SA), DPhil; E de Vries,3 MB ChB, MFamMed, FCFP (SA); A Isaacs,4 MB ChB, MFamMed; A F Doubell,1 MB ChB, MMed (Int), FCP (SA), BSc Hons, PhD Division of Cardiology, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Academic Hospital, Cape Town, South Africa 2 Department of Medicine, Faculty of Health Sciences, Groote Schuur Hospital and University of Cape Town, South Africa 3 Department of Family Medicine, Mitchell’s Plain Hospital, Cape Town, South Africa 4 Division of Family Medicine, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 1

Corresponding author: C G Kyriakakis (cgk@sun.ac.za)

Diseases of the pericardium commonly manifest in one of three ways: acute pericarditis, pericardial effusion and constrictive pericarditis. In the developed world, the most common cause of acute pericarditis is viral or idiopathic disease, while in the developing world tuberculous aetiology, particularly in sub-Saharan Africa, is commonplace owing to the high prevalence of HIV. This article provides an approach to the diagnosis, investigation and management of these patients. S Afr Med J 2016;106(2):151-155. DOI:10.7196/SAMJ.2016.v106i2.10328

Pericardial diseases are rela tively common in clinical practice, presenting in one of three ways: pericarditis (which may recur or become chronic), pericardial effusion with or without cardial tamponade and constrictive peri peri carditis. Less common manifestations include pericardial cysts and neoplasms. A variety of aetiologies (Table 1) are implicated in peri cardial disease, and establishing a definitive diagnosis is challenging, as the yield of diagnostic tests is relatively low.[1] The incidence of acute pericarditis is 27.7/100 000 cases in the developed world and accounts for 5% of emergency room admissions for chest pain.[2,3] Viral infection is responsible for the majority of cases in the developed world, while in the developing world Myco bacterium tuberculosis, particularly with HIV co-infection in sub-Saharan Africa, remains prevalent.[4,5] A paucity of randomised data exists in the field of pericardial disease; however, more recently multicentre randomised trials have defined the role of colchicine in acute and recurrent pericarditis and that of steroid therapy in tuberculous pericarditis.[6-8] This review focuses predominantly on an approach to acute pericarditis commonly encountered at primary care level, and offers brief insights into effusive disease and constriction.

An approach to pericarditis

The following is a stepwise approach to acute pericarditis: • Presenting symptoms and signs. • Appropriate special investigations.

Table 1. Aetiology of pericardial disease Infectious causes Viral: coxsackieviruses, echoviruses, Epstein Barr virus, cytomegalovirus, parvovirus B19 Bacterial: TB, other bacterial causes are rare, e.g. Staphylococcus Fungal: very rare, e.g. Candida species in immunocompromised patients Parasitic: very rare, e.g. Echinococcus Non-infectious causes utoimmune: systemic lupus erythematosus, scleroderma, rheumatoid arthritis, A Sjögren syndrome, acute rheumatic fever Neoplastic: primary tumours are rare; metastases from lung, breast and lymphoma are more common Metabolic: renal failure, hypothyroidism Traumatic: early – penetrating or non-penetrating traumatic injury; delayed – postmyocardial infarction, post-cardiac surgery Drug-induced: rare, e.g. hydralazine, all-trans retinoic acid Other: sarcoidosis, aortic dissection (the pericardium includes the proximal 2 - 3 cm of the great vessels)

• When to consider hospital admission. • Evidence-based medical therapy and assesss ing for a response. • Prognosis. • Recurrent pericarditis.

Presenting symptoms and signs

Positional pleuritic chest pain, improved by sitting forward and exacerbated by deep inspiration, is present in >85 - 90% of cases.[3] Radiation of pain to the trapezius ridge is virtually pathognomonic of pericarditis, as the phrenic nerve that innervates these muscles traverses the pericardium. [9] Prodromal symptoms of a viral illness may be present and constitutional symptoms of tuberculosis (TB) should be sought. Sinus tachycardia and low-grade fever

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are common, while a temperature >38oC suggests a specific cause of pericarditis. A triphasic pericardial friction rub is audible in approximately one-third of cases, best heard with the diaphragm of the stethoscope over the left lateral sternal border with the patient leaning forward (Audio 1).[3] This can be transient and frequent evaluation for its presence is useful as it is highly specific for the disease. Signs of an underlying systemic inflammatory disease may point to a specific cause, e.g. systemic lupus erythematosus with a pericardial serositis. A clinical diagnosis of pericarditis can be established when two of the following cri teria are present:[3] • Pericarditic chest pain. • Pericardial friction rub.

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• Characteristic electrocardiogram (ECG) changes. • Pericardial effusion.

Appropriate special investigations

The following are recommended in all patients with suspected pericarditis: a 12-lead ECG, a chest radiograph, inflammatory markers and a transthoracic echocardiogram.[10] A 12-lead ECG is the first-line investigation • Typical ECG findings are found in up to 60% of patients, are highly variable between different patients and are influenced by therapy.[11] • They include (Fig. 1): • Widespread saddle-shaped (concave t ion not upward) ST-segment eleva confined to a single coronary territory with reciprocal ST depression in aVR. • Inferior and precordial PR-segment depression with PR-segment elevation in aVR – the discordant ST-PR segment sign. This is more specific for pericarditis than diffuse ST elevation alone.[12] • Sinus tachycardia. • Q waves may be present in post-myocardial infarction (MI) pericarditis. Both early and late (Dressler’s syndrome) manifestations are rare in the era of reperfusion therapy; they may however occur after a silent MI or a missed infarct. • Ultimately the ST and PR segments normalise, which may be followed by widespread T-wave inversion. • The most important differential diagnosis is that of an ST-elevation acute coronary syndrome. This necessitates a thorough evaluation of the nature of the chest pain and the morphology and distribution of ST elevation on ECG.

Chest radiograph • Features of pleuropulmonary disease may point to a specific aetiology, e.g. TB.[13] • The cardiac silhouette only increases when >300 mL of pericardial fluid has collected and is therefore commonly normal in acute pericarditis.[14] Laboratory tests • Inflammatory markers: C-reactive protein (CRP), or erythrocyte sedimentation rate (ESR) where CRP is not available, and a white cell count should be undertaken in all cases. Elevations are supportive of a diagnosis of acute pericarditis and are valuable for monitoring disease activity and response to therapy.[15] • Troponins may be elevated in patients with associated myocarditis.[16] • Given its high prevalence in sub-Saharan Africa, TB should always be considered as a possible cause. Constitutional symp toms of TB and/or radiological evidence of the disease mandate further work-up. A high index of suspicion for TB must be maintained in patients from a disadvantaged socioeconomic setting.[17] • Retroviral serology and serum creatinine level determination should be undertaken routinely. • Routine serological markers for connective tissue disease are not indicated in low-risk cases; neither is routine viral serology as it has a low yield and does not alter management.[1] • A more detailed search for a specific cause is undertaken in patients requiring hospital admission or who fail a trial of medical therapy. Transthoracic echocardiogram (TTE) • An associated pericardial effusion, its haemodynamic effects and possible myo carditis can be evaluated via TTE.

• TTE is recommended in all patients.[10] However, in under-resourced areas it would not be unreasonable to limit it to patients requiring hospital admission or in whom a specific aetiology is suspected. Cardiac magnetic resonance and cardiac computed tomography CMR can more accurately delineate pericardial inflammation by means of pericardial late gadolinium enhancement.[13] Cardiac CT also offers a more accurate assessment of peri cardial thickness than TTE, at the expense of exposure to ionising radiation. Neither of these adjunctive imaging modalities take preference over TTE as a first-line investigation. Their value is in the rare setting where a high clinical suspicion of pericarditis exists, yet the clinical diagnostic criteria remain unmet.[13]

When to consider hospital admission

High-risk cases[18] Hospital admission is required when a specific aetiology is suspected or when ≥1 of the following poor prognostic features are present: • Temperature >38°C. • Subacute onset. • Large pericardial effusion (diastolic echofree space >20 mm) with or without cardiac tamponade. • Myopericarditis. • Traumatic pericarditis. • Chronic oral anticoagulant or immuno suppressive therapy. • Failure to respond to at least 1 week of aspirin or non-steroidal anti-inflammatory drug (NSAID) therapy. A more detailed work-up, including evalua tion for TB, connective tissue disease and metabolic diseases, is required. When a specific cause is identified, therapy aimed at the underlying cause is indicated.

Evidence-based medical therapy and assessing for a response

Fig. 1. A 12-lead ECG of a 29-year-old man with acute pericarditis. Sinus tachycardia, widespread saddle-shaped ST-segment elevation with PR-segment elevation in aVR and depression in the inferior and precordial leads V2 - V6 (the discordant ST-PR segment sign) are present.

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• Low-risk patients, in whom no specific cause is suspected and who do not have predictors of a poor prognosis, can be managed as outpatients.[10] It would not be unreasonable to limit TTE in this group to those who fail to respond to 1 week of antiinflammatory therapy, particularly when managed at primary healthcare level. • Restriction of physical activity is recommended until symptoms resolve and the CRP normalises. In athletes, a restrict ion of athletic activity for at least 3 months is advised, provided the CRP, ECG and TTE have returned to normal at the end of this period.[10] In suspected myopericarditis

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•

• •

•

(elevated troponin level) athletic activity should be avoided for 6 months.[10] First-line medical therapy includes aspirin or NSAIDs and colchicine.[6,7] Gastro protection, preferably proton pump inhi bitors, should be provided (Table 2). Anti-inflammatory therapy commonly provides abrupt symptomatic relief. Colchicine, added to aspirin or NSAID therapy, has been evaluated in two wellconducted, placebo-controlled, randomised clinical trials, where it has been shown to improve the response to medical therapy and prevent recurrences.[6,7] Corticosteroids are associated with the evolution of acute pericarditis into a chronic, recurrent disease and are therefore not indicated as first-line therapy.[10] They are considered when NSAIDs or aspirin are contraindicated or have failed to provide a response, and an infective aetiology has been excluded. Alternatively, they are indicated when a specific cause mandates their use, such as connective tissue disease. When indicated for idiopathic disease, they should be used at a low-to-moderate dose together with colchicine and tapered once the CRP has normalised (Table 2).[10] Low-risk patients should be re-evaluated after 1 week for a response. Those who fail to respond (persistent symptoms and/or elevated CRP) are considered to be moderate risk and require hospital admission and an aetiology search. Those who respond infrequently require >2 weeks of NSAID or aspirin therapy, while colchicine should be continued for 3 months (Table 2).[10]

Prognosis

• Acute idiopathic or viral pericarditis has a good prognosis with a low complication rate.[19] • Cardiac tamponade and constrictive pericarditis are more commonly asso ciated with specific underlying aetio lo gies, particularly TB and purulent peri carditis.[19] • Up to 30% of idiopathic cases can develop recurrent pericarditis, associated with considerable morbidity.[20] This risk can be halved by the administration of colchicine at the outset.[20]

• The most common cause for recurrent pericarditis is the inadequate treatment of an initial episode.[20] • A search for a potential underlying cause is required and referral for tertiary evaluation is recommended. • In cases of idiopathic disease, treatment is similar to that for a first attack, except for an extended duration of therapy with both NSAIDs (weeks - months) and weight-ad justed colchicine (≥6 months’ duration).[20] • Corticosteroids remain second-line thera py owing to their risk for precipitating a chronic form of the disease. • In patients who do not respond to antiinflammatory therapy or who require high maintenance doses of prednisone, azathio prine, intravenous immunoglobulin and anakinra (a recombinant inter leukin 1β receptor antagonist) have been attempted.[10] • As a last resort, after failed medical therapy, pericardiectomy may be required.[10] • Overall, the prognosis is good in that a case of constrictive pericarditis has never been attributed to idiopathic recurrent pericarditis. However, morbidity is high owing to persistent symptoms.

•

An approach to pericardial effusions

• In sub-Saharan Africa TB is responsible in >90% of HIV-positive and 50 - 70% of

HIV-negative patients who present with a large pericardial effusion. Emphasis must therefore be placed on excluding TB.[21] The development of cardiac tamponade, a life-threatening condition, is determined by the rate of fluid accumulation, pericardial compliance and position of a loculated collection. The rapid accumulation of 200 mL of fluid can lead to acute tamponade, whereas slow accumulation can be well tolerated owing to pericardial distensibility. Loculated collections situated over lowpressure chambers, e.g. the right ventricle, can result in early haemodynamic compromise. The 12-lead ECG may reveal small-voltage QRS complexes with electrical alternans due to swinging of the heart within a large collection (Fig. 2 and Video 1). Cardiac tamponade remains a clinical diagnosis. Clinical signs include: • Tachycardia and elevated jugular venous pressure (JVP). • Muffled heart sounds. • Pulsus paradoxus (>10 mmHg inspira tory drop in systolic blood pressure). A TTE confirms the presence of an effusion, identifies the safest approach for needle aspiration and provides supportive evidence of associated haemodynamic compromise. Pericardiocentesis has a complication rate of 4 - 10%, depending on operator experience and procedural urgency.[22]

Table 2. Recommended drug doses and durations for acute idiopathic pericarditis* Drug

Dosing

Duration

Tapering

Aspirin

750 - 1 000 mg tds

1 - 2 weeks

Decrease by 250 - 500 mg every 1 - 2 weeks

Ibuprofen

600 mg tds

1 - 2 weeks

Decrease by 200 - 400 mg every 1 - 2 weeks

Colchicine

<70 kg: 0.5 mg daily ≥70 kg: 0.5 mg bd

3 months

Not mandatory

Prednisone

0.2 - 0.5 mg/kg daily

Tapered

Slow taper, provided asymptomatic and CRP normal

*Combination therapy of colchicine with either aspirin or ibuprofen as initial therapy; steroids are second-line agents.

Recurrent pericarditis

• This is defined as a recurrence of pericarditis after a symptom-free period of 4 - 6 weeks after the initial illness. While up to 30% of patients may experience a recurrence after the index episode, the risk of a second recurrence may be as high as 50% in those not treated with colchicine, and even higher after corticosteroid administration.[20]

Fig. 2. A 12-lead ECG in a patient with a large pericardial effusion. Note the prominent electrical alternans.

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‘Blind’ pericardiocentesis is discouraged and TTE or ultrasonographic guidance to determine the site and angle of puncture is recommended.[22] In under-resourced areas, emergency pericardiocentesis in a haemodynamically unstable patient may be necessary without ultrasound guidance, provided the diagnosis of pericardial tampo nade is established as accurately as clinically possible. Ultrasound or TTE availability is also useful for confirming a puncture that is within the pericardial space and not a cardiac chamber or pleural cavity by the injection of agitated contrast saline bubbles (Video 2).[23] All effusions should be evaluated for a specific underlying aetiology. If safely accessible, pericardiocentesis should be undertaken in a controlled environment by a skilled operator. A pericardial fluid adenosine deaminase level ≥35 U/L has a sensitivity and speci ficity of 89% and 74%, respectively, for the diagnosis of TB pericarditis.[24] Traditional diagnostic tests for pericardial TB are insensitive and require long culture periods. The organism is not identified in the pericardial fluid of 27 - 48% of cases and adenosine deaminase therefore remains an important biochemical diagnostic aid.[24,25] In our local experience complete percuta neous drainage of a tuberculous effusion, in combination with antituber culous therapy, is associated with an extremely low risk for constriction and cardiac death.[25] One small trial has shown that the addition of intrapericardial uro kinase may facilitate this approach.[26] The administration of intrapericardial steroids did not influence the risk of developing constriction in an underpowered trial of 57 patients.[27] However, more recently adjunc tive oral steroid therapy has been shown to reduce the risk of constriction in both HIV-positive and -negative patients.[8] In this trial a definite diagnosis of TB pericarditis was established in 16.7% of participants. Highdose oral prednisone did not translate into a mortality benefit and was unfortunately associated with an increase in HIV-related cancers in the HIV-positive group.[8]

An approach to constrictive pericarditis

• Constriction is a form of diastolic heart failure that is potentially curable. • The heart becomes encased in a rigid shell of pericardium, isolating it from the rest of the thoracic cavity. • Respiratory changes in intrathoracic pres sure can therefore not be transmitted to

Fig. 3. (A) The pulmonary veins lie extrapericardial. In health, changes in intrathoracic pressure are conveyed to both the pulmonary veins and the cardiac chambers (due to the compliant pericardium). On inspiration, negative intrathoracic pressure is exerted on both the pulmonary veins and the left ventricular (LV) cavity; this maintains the forward driving gradient over the mitral valve responsible for LV filling. In constriction, the heart is isolated from changes in intrathoracic pressure and therefore the transmitral forward driving gradient is degraded, with resultant slower filling of the LV compared with the right ventricle (RV) during inspiration.This image was taken during a left and right heart haemodynamic study of a patient with constrictive pericarditis. The light-blue line represents pulmonary capillary wedge pressure (a reflection of pulmonary venous pressure that varies with respiration), the red tracing represents intracavitary LV pressure (which does not vary with respiration in this isolated heart). Notice how the gradient (grey-shaded area) between the two is diminished during inspiration (white arrow), resulting in diminished inspiratory forward flow over the mitral valve. This represents the dissociation of intrathoracic and intracardiac pressures in constriction.

Fig. 3. (B) This image is from the same patient as in Fig. 3 (A). The light-blue trace represents RV pressure and the red trace LV pressure during tidal volume respiration. Notice how on inspiration (white arrow) the LV pressure falls (owing to relatively slower LV filling as a result of the dissociation of intrathoracic and intracardiac pressures) and the RV pressure consequently rises (in health the two should follow each other during respiration). This demonstrates the second physiological hallmark of constriction, i.e. enhanced ventricular interdependence.

the heart, leading to the two hallmark physiological features of constriction: • dissociation of intrathoracic and intra cardiac pressures; and • enhanced ventricular interdependence (Fig. 3 A and B, and Video 3).

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• Establishing a clinical diagnosis is challen ging and the disease therefore often goes unrecognised until late in its course, when overt right heart failure develops. • A high index of suspicion is required in patients who have had prior TB, cardiac

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Fig. 4. Lateral chest radiograph. Calcification commonly occurs over the RV, diaphragmatic surface and apex (the latter two are visible on this film). The chest radiograph, often forgotten, is an inexpensive adjunct to establishing the diagnosis of constrictive pericarditis.

• •

•

surgery, thoracic irradiation or pericarditis. TB remains the most important cause in South Africa.[8] Symptoms range from a change in effort tolerance to those of predominant right heart failure. Clinical signs may be subtle and careful evaluation for their presence is required: • A raised JVP with rapid y-descents (Video 4). The JVP may be raised to a point within the cranium at a recumbent level of 45° and may therefore not be visible. The level of elevation often only becomes apparent in the upright position. • Kussmaul’s sign – paradoxical inspiratory elevation of the JVP. • Diastolic apex beat. • A right ventricular pericardial knock (Audio 2). • Ascites that is more prominent than the degree of peripheral oedema. A lateral chest radiograph can reveal pericardial calcification in up to 50% of patients with tuberculous constriction (Fig. 4). The clinical diagnosis can be confirmed by TTE, with tissue Doppler imaging aiding in both establishing the diagnosis and differentiating constriction from restrictive cardiomyopathy. An invasive left and right heart study is infrequently required, but is most useful to distinguish constriction from restrictive cardiomyopathy if doubt exists despite a detailed TTE. Early diagnosis leads to timelier referral for surgical pericardiectomy, thereby reducing perioperative mortality. This risk is as high as 15% in patients who already have a New York Heart Association class IV effort tolerance and/or hyponatraemia at the time of surgery.[28]

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2. Imazio M, Cecchi E, Demichelis B, et al. Myopericarditis versus viral or idiopathic acute pericarditis. Heart 2008;94:498-501. [http://dx.doi.org/10.1136/hrt.2006.104067] 3. Imazio M. Contemporary management of pericardial diseases. Curr Opin Cardiol 2012;27:308-317. [http://dx.doi.org/10.1097/HCO.0b013e3283524fbe] 4. Imazio M, Spodick DH, Brucato A, et al. Controversial issues in the management of pericardial diseases. Circulation 2010;121:916-928. [http://dx.doi.org/10.1161/CIRCULATIONAHA.108.844753] 5. Sliwa K, Mocumbi AO. Forgotten cardiovascular diseases in Africa. Clin Res Cardiol 2010;99:65-74. [http://dx.doi.org/10.1007/s00392-009-0094-1] 6. Imazio M, Bobbio M, Cecchi E, et al. Colchicine in addition to conventional therapy for acute pericarditis: Results of the COlchicine for acute PEricarditis (COPE) trial. Circulation 2005;112:20122016. [http://dx.doi.org/10.1161/CIRCULATIONAHA.105.542738] 7. Imazio M, Brucato A, Cemin R, et al. A randomised trial of colchicine for acute pericarditis. N Engl J Med 2013;369:1522-1528. [http://dx.doi.org/10.1056/NEJMoa1208536] 8. Mayosi BM, Ntsekhe M, Bosch J, et al. Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis. N Engl J Med 2014;371:1121-1130. [http://dx.doi.org/10.1056/NEJMoa1407380] 9. Shabetai R. The Pericardium. Norwell, MA: Kluwer, 2003. [http://dx.doi.org/10.1007/978-1-44199137-9] 10. The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the diagnosis and management of pericardial diseases. Eur Heart J 2015;36(42):2921-1264. [http://dx.doi.org/10.1093/eurheartj/ehv318] 11. Imazio M, Demichelis B, Parrini I, et al. Day-hospital treatment of acute pericarditis: A management program for outpatient therapy. J Am Coll Cardiol 2004;43(6):1042-1046. [http://dx.doi.org/10.1016/j. jacc.2003.09.055] 12. Alraies MC, Klein AL. Should we still use electrocardiography to diagnose pericardial disease? Cleveland Clinic J Med 2013;80(2):97-100. [http://dx.doi.org/10.3949/ccjm.80a.11144] 13. Klein AL, Abbara S, Agler DA, et al. American Society of Echocardiography clinical recommendations for multimodality cardiovascular imaging of patients with pericardial disease: Endorsed by the Society for Cardiovascular Magnetic Resonance and Society of Cardiovascular Computed Tomography. J Am Soc Echocardiogr 2013;26:965-1012.e15. http://dx.doi.org/10.1016/j.echo.2013.06.023] 14. Imazio M, Adler Y. Management of pericardial effusion. Eur Heart J 2013;34:1186-1197. [http://dx.doi. org/10.1093/eurheartj/ehs372] 15. Imazio M, Brucato A, Maestroni S, et al. Prevalence of C-reactive protein elevation and time course of normailzation in acute pericarditis: Implications for the diagnosis, therapy and prognosis of pericarditis. Circulation 2011;123:1092-1097. [http://dx.doi.org/10.1161/ CIRCULATIONAHA.110.986372] 16. Imazio M, Cecchi E, Demichelis B, et al. Myopericarditis versus viral or idiopathic acute pericarditis. Heart 2008;94:498-501. [http://dx.doi.org/10.1136/hrt.2006.104067] 17. Mayosi BM. Contemporary trends in the epidemiology and management of cardiomyopathy and pericarditis in sub-Saharan Africa. Heart 2007;93:1176-1183. [http://dx.doi.org/10.1136/ hrt.2007.127746] 18. Imazio M, Cecchi E, Demichelis B, et al. Indicators of poor prognosis of acute pericarditis. Circulation 2007;115:2739-2744. [http://dx.doi.org/10.1161/CIRCULATIONAHA.106.662114] 19. Imazio M, Brucato A, Maestroni S, et al. Risk of constrictive pericarditis after acute pericarditis. Circulation 2011;124:1270-1275. [http://dx.doi.org/10.1161/CIRCULATIONAHA.111.018580] 20. Imazio M, Brucato A, Cemin R, et al. Colchicine for recurrent pericarditis (CORP): A randomised trial. Ann Intern Med 2011;155:409-414. [http://dx.doi.org/10.7326/0003-4819-155-7-20111004000359] 21. Reuter H, Burgess LJ, Doubell AF. Epidemiology of pericardial effusions at a large academic hospital in South Africa. Epidemiol Infect 2005;133:393-399. [http://dx.doi.org/10.1017/ S0950268804003577] 22. Maisch B, Ristic AD, Seferovic PM, et al. Interventional Pericardiology: Pericardiocentesis, Pericardioscopy, Pericardial Biopsy, Balloon Pericardiotomy and Intrapericardial Therapy. Heidelberg: Springer, 2011. [http://dx.doi.org/10.1007/978-3-642-11335-2] 23. Ainsworth CD, Salehian O. Echo-guided Pericardiocentesis: Let the bubbles show the way. Circulation 2011;123:e210-e211. [http://dx.doi.org/10.1161/CIRCULATIONAHA.110.005512] 24. Burgess LJ, Reuter H, Carstens ME, et al. The use of adenosine deaminase and interferon-ϒ as diagnostic tools for tuberculous pericarditis. Chest 2002;122:900-905. [http://dx.doi.org/10.1378/chest.122.3.900] 25. Reuter H, Burgess LJ, Louw VJ, Doubell AF. The management of tuberculous pericardial effusion: Experience in 233 consecutive patients. Cardiovasc J S Afr 2007;18(1):20-25. 26. Cui HB, Chen XY, Cui CC, et al. Prevention of pericardial constriction by transcatheter intrapericardial fibrinolysis with urokinase. Chin Med Sci J 2005;20:5-10. 27. Reuter H, Burgess LJ, Louw VJ, Doubell AF. Experience with adjunctive corticosteroids in managing tuberculous pericarditis. Cardiovasc J S Afr 2006;17:233-238. 28. Mutyaba AK, Balkaran S, Cloete R, et al. Constrictive pericarditis requiring pericardiectomy at Groote Schuur Hospital, Cape Town, South Africa: Causes and perioperative outcome in the HIV era (1990-2012). J Thorac Cardiovasc Surg 2014;148:3058-3065. [http://dx.doi.org/10.1016/j. jtcvs.2014.07.065]

Audiofiles (headphones are required) and videoclips Audio 1. Typical triphasic pericardial rub recorded in a patient with acute pericarditis. Audio 2. Recording of a pericardial knock in a patient with constrictive pericarditis. The early diastolic knock is heard just after the second heart sound over the left sternal border, occurring earlier in diastole than an S3. Video 1. Apical 4chamber TTE image of a patient with a large pericardial effusion. Note the electrical alternans on the recorded ECG strip. As the heart swings to and fro within the fluid, the direction of the main vector of depolarisation changes from beat to beat, producing the ECG finding of electrical alternans. Video 2. Pericardiocentesis in the emergency room. Before a 6French sheath or central venous pressure line is inserted, the puncture needle is held in place and agitated saline bubble contrast injected to confirm one’s position. Note the echobright saline bubbles within the pericardial space, which confirms that the operator has punctured the pericardial space and can safely proceed with the aspiration procedure. Video 3. Apical 4chamber TTE image (RV on left of image, LV on the right) in the same patient as in Fig. 3A and B. Note the simultaneous respirometer trace and biatrial dilatation. During inspiration the RV fills relatively more quickly than the LV owing to the degraded transmitral forward driving gradient. The result is respiratophasic septal shift into the LV. Video 4. Rapid ydescents seen in the JVP of a patient with constrictive pericarditis. These are generally appreciated as rapid inward ‘flicking’ movements in the presence of an elevated JVP (courtesy Dr Annari van Rensburg).

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An effective approach to chronic kidney disease in South Africa M R Moosa, A M Meyers, E Gottlich, S Naicker Rafique Moosa, MB ChB, FCP (SA), MD, FRCP (Lond), is a member of the Ministerial Advisory Committee on Transplantation, Executive Head of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa, and a specialist nephrologist at Tygerberg Academic Hospital, Cape Town. Tony Meyers, MB BCh, FCP (SA), FRCP (Lond), is Emeritus Professor of Medicine in the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, and Chairman of the National Kidney Foundation. Errol Gottlich, MB BCh, DCH, FCP Paeds (SA), Cert Nephrol (Paeds) (SA), is a paediatric nephrologist at Morningside Mediclinic, Johannesburg. Sarala Naicker, MB ChB, MRCP (UK), FRCP (Lond), PhD, is a member of the Ministerial Advisory Committee on Transplantation and Emeritus Professor of Medicine in the Faculty of Health Sciences, University of the Witwatersrand. Corresponding author: M R Moosa (rmm@sun.ac.za)

Very few patients with end-stage kidney disease in South Africa receive renal replacement treatment (RRT), despite the rapidly growing demand, because of resource constraints. Nephrologists who agonise daily about who to treat and who not to, and have been doing so since the inception of dialysis in this country, welcomed the opportunity to interact with the National Department of Health at a recent summit of stakeholders. The major challenges were identified and recommendations for short- to long-term solutions were made. While the renal community can still improve efficiencies, it is clear that much of the responsibility for improving access to RRT and reducing inequities must be borne by the national government. The summit marks the first step in a process that we hope will ultimately culminate in universal access to RRT for all South Africans. S Afr Med J 2016;106(2):156-159. DOI:10.7196/SAMJ.2016.v106i2.9928

Fewer than 5% of all patients with end-stage kidney disease (ESKD) in sub-Saharan Africa receive dial ysis, with patients in several countries having no access at all.[1] While the situation is somewhat less dire in South Africa (SA), we compare very poorly with countries that are our economic peers (Fig. 1). The recent release of the South African Renal Registry by the South African Renal Society[2] produced data that were so alarming that the National Department of Health (NDoH) convened a national summit to discuss the challenges faced in SA. Delegates to the summit included relevant stakeholders: public and private sector clinicians, healthcare funders, representatives of the pharmaceutical industry and the NDoH, a representative of the World Health Organization (WHO) and representatives of the National Kidney Foundation. The meeting was held in Johannesburg over 2 days in March 2015 and produced recommendations to provide short-, medium- and longterm solutions. Discussions revolved around a few key issues in an attempt to find workable solutions.

Human resources

Chronic kidney disease (CKD) affects 14% of the adult population in sub-Saharan Africa.[1] The vast majority of South Africans who have ESKD die because of lack of access to definitive lifesaving treat ment.[3] The major challenge faced by the country is lack of sufficient resources – capital and human – to provide universal access. The reason why SA has lagged so severely behind in the provision of renal replacement treatment (RRT) compared with similar middleincome countries is probably the HIV/AIDS epidemic, which has demanded a disproportionate quantum of the health budget.[4] In addition, there are inequities in the provision of renal services at several levels. Poorer patients and patients in rural areas are underserved as a result of the lack of facilities. In response to RRT being

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made a minimum prescribed benefit, the private sector facilities have grown by over 3 000% over two decades, but in contrast there has been no significant growth in renal services in the public sector that serves over 80% of the country’s population.[2] The renal community faces a major shortage of skilled personnel and reflects the national skills challenges.[5] The lack of appropriate and adequate skilled personnel has hampered the development of renal care in SA. Insufficient numbers of personnel are being trained and effective retention strategies are lacking. To address the situation, the summit proposed medium- and long-term strategies. In order to ensure high-quality renal care it was agreed that a nephrologist (or a specialist physician where no nephrologist is available) should be attached to every dialysis unit. SA currently has 1.1 nephrologists per million population (pmp), compared with 6.5 and 4.5 in Egypt and Morocco, respectively – not even comparing ourselves with high-income countries.[6] Additional posts to train more specialist nephrologists were strongly recommended. This would also require an increase in the number of permanent academic hospital posts and a clear retention strategy. A mid-level worker, provisionally identified as a ‘clinical associate’ working under the supervision of a nephrologist, was proposed as an option. The clinical associate would be trained to perform procedures that would obviate the need to transfer patients to the care of a nephrologist, including insertion of dialysis catheters and performing renal biopsies. The role of this associate will need further discussion to ensure that the level of training is matched to the requisite skills level. Renal nurses form the backbone of any renal replacement pro gramme, but are in short supply. An important approach is to create more training centres and programmes for renal nurses around the country. A way of optimising the use of the limited numbers of renal nurses is to reduce the recommended dialysis staff-topatient ratio from the current 1:4 to 1:6, as a strategy that would

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Qatar Kuwait Singapore Norway USA Saudi Arabia Hong Kong, China Swedan Austria Netherlands Denmark Canada Oman Australia Belgium Finland France Japan UK Iceland New Zealand Bahrain Spain Korea (Republic of ) Israel Slovenia Greece Portugal Russian Federation Taiwan Malaysia Hungary Chile Croatia Turkey Uruguay Romania Argentina Lebanon Mexico Brazil Iran (Islamic Republic of ) Thailand SA Colombia Serbia Bosnia and Herzegovina Philippines

275 374 1 374 248 1 435 483 708 403 507 384 461 683 364 505 1 423 325 618 2 365

840 243 557 238 478 1 081 730 685 904 1 068 168

2 902 992 633 1 060 652 710 757 679 668 665 883 504 322 817

Dialysis

133 479 646 666

185 500

1 000

1 500

2 000

2 500

3 000

Dialysis rate, pmp

Fig. 1. Prevalence rates of dialysis in various countries (pmp) in 2012. The countries are listed in order of increasing gross national income per capita (GNI-PC) in 2012. All countries listed above SA are categorised as high income by the World Bank. SA and those below are upper-middle countries (lighter shade). South Africa’s GNI-PC was USD11 726, compared with USD123 365 and USD6 060 for Qatar and the Philippines, respectively. SA has the lowest reported dialysis rate and with few exceptions fares considerably poorly compared with countries with comparable GNI-PC. The dialysis rates are from the US National Institutes of Health and the US Renal Data System,[21] and GPI-PC data are from the Human Development Reports of the United Nations Development Programme.[22]

be easily and rapidly implemented. While this may raise some concerns, these ratios do prevail in dialysis units in high-income countries.[7] The risks are those of greater burnout and reducing the quality of care, although there are limited data to support

this as yet.[8] However, with the current gene ration of dialysis machines equipped with vastly improved technology and safety features, a different level of nursing oversight is required. Reducing the staffing ratio may allow additional dialysis sessions to be acti

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vated without additional infrastructure. However, the summit made the crucial sugges tion that a completely different staffing model be considered: dialysis units should be staffed with registered nurses who take responsibility for up to 16 patients with the development of a team of midlevel workers specifically trained to provide dialysis-related services who would work under the supervision of the registered nurse.[9] In this way, staff-to-patient ratios of 1:4 could be retained but costs contained, as fewer registered nurses would be required. The summit recommended a staff-to-patient ratio for peritoneal dialysis of 1:25. The summit also recognised that a successful renal programme required the services of other skilled personnel, including surgeons (trained in fashioning vascular access and placement of peritoneal dialysis catheters) and dialysis technicians (whose scope of practice must be broadened to assist the registered nurses), alongside social workers, dieticians and transplant co- ordinators, among other support staff. Several of these staff could be shared between units in the same region. The shor tage of surgeons and limited theatre times to perform the relevant procedures is a major factor compromising patient care; delays in fashioning vascular fistulas mean that prolonged temporary vascular access is required, resulting in severe morbidity and, not infrequently, in preventable deaths.

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Dialysis is expensive, and is conservatively estimated to cost approximately ZAR200 000 per annum per patient. Despite the fact that haemodialysis requires considerably more infrastructure and staff, the cost differ ential between haemodialysis and peritoneal dialysis is minimal and favours haemo dialysis as the cheaper option.[10] The high costs of peritoneal dialysis fluid needs to be interrogated, considering that such fluids are locally produced and are less expensive in countries that use locally sourced prod ucts.[10] The summit proposed short- and longterm solutions to improve costs. Developing the new staffing model alluded to above could be an important long-term solution. Other measures that could be instituted almost immediately include tendering for items at a national level to benefit from economies of scale, minimising hospital admissions and stay, ensuring quality dialysis and patient care, and the appropriate use of pharmaceuticals. The summit was cognisant of the fact that a large proportion of our patients are based in rural areas, making

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ambulatory care difficult. The summit also recommended a ‘peritoneal dialysis first’ strategy and infrastructure to support this approach. Several countries have instituted incentives to promote peritoneal dialysis, including reducing import duties.[10] Greater use of existing dialysis facilities, which are generally adequate, was also recommended to allow greater numbers of patients access to treatment; this could be achieved in an incremental fashion. Since dialysis machines can be used as often as required, the cost of disposables and lack of personnel are the main limitations to increasing the use of facilities in the public sector. Negotiations with the private sector may allow patients access to dialysis in regions where state facilities are lacking, without a major outlay by government. Timely referrals of patients with CKD will improve assessment of patients, improve preparation for RRT and obviate the need for acute dialysis (which, in SA, is arguably how the majority of patients present, only to have the diagnosis of CKD confirmed subsequently). Late presentations add to costs in several ways: prolonged hospitalisation, need for temporary vascular access and more intensive dialysis. Besides the significant economic impact, late and ultra-late presentations are associated with poorer patient outcomes, and are potentially avoidable.[11] The ideal of pre-emptive kidney transplantation would reduce costs and improve patient outcomes, but remains an elusive goal; globally only 5% of CKD patients receive transplants without prior dialysis.[12] Although the summit recognised that while healthcare funders bear the brunt of the treatment costs, the economic and psychosocial costs to the patient and his/her family are not insubstantial. The impact of the disease on the patient’s lifestyle and ability to seek employment and earn has a direct influence on treatment choices and compliance.

Transplantation

There is no shortage of potential organ donors in SA, as a visit to any busy trauma unit will confirm – translating these into actual donors is where our challenge lies. The current transplant rate of 4.7 pmp in SA is woefully inadequate to meet needs and below the transplant rate of other middle-income countries.[2] The declining number of kidney transplants is the result of declining numbers of donations from deceased donors. The summit has recommended that deceased donation be prioritised. There are several models of organ donation, of which the Spanish and Croatian models are the most effective at increasing deceased donor transplantation; the former has been successfully employed across a diverse range of countries. The successful models have in common an integrated approach including legislative changes, centralisation of authority, employment of transplant co-ordinators responsible for organ recovery, reimbursement of donor hospitals and public awareness campaigns.[13,14] Although countries with an opt-out system have 25 30% more donations than countries with required consent, in the integrated models – that incorporate opt-out systems – the benefits are of lesser importance. The yield of organs with the integrated models reduces, or may obviate, the need for non-heart-beating and extended criteria donors.[13] The current reliance on living donor transplants is of some concern, as there is recent evidence that in the long term, altruistic kidney donors may suffer some ill health. [15] New deceased donor concepts that bear consideration include those of reciprocity and prioritisation, where persons who previously registered as donors are prioritised should they require a kidney. This has led to a dramatically significant increase in donors and transplants in Israel.[16] The introduction of the Spanish model in Latin America was less successful, with failure ascribed to scarcity of resources and, more importantly, the lack of political will.[17] The importance

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of the involvement of our NDoH in ensuring the success of such a programme therefore cannot be over-emphasised. Controversy surrounds the use of incentives for organ donation. Notably, the World Medical Association, the WHO and the Convention on Human Rights and Biomedicine all support compensation for expenses the living donor may have incurred.[18] The effect of other measures that have been suggested to increase organ donation appears to be limited. There is an urgent need to improve access to RRT for patients using the public health service in a fair and equitable fashion, and the summit’s call for ‘250 and 25 by 2025!’, which alludes to the plan to increase dialysis to 250 pmp and kidney transplantation to 25 pmp by 2025 (from 164 and 4, respectively), needs to become a clarion call!

Reducing the burden of kidney disease

The SA government’s National Development Plan – 2030 emphasises prevention of disease, but to a large extent CKD is the end result of a much larger health challenge facing our country. Diseases such as hypertension, diabetes mellitus, and to a lesser extent infections and acute kidney injury lead to CKD. These diseases need to be appropriately managed to reduce the risk of the development of CKD. Diabetes mellitus will increase by 88% between 2012 and 2030 in sub-Saharan Africa, and hypertension by 70% between 2008 and 2025.[19] The diabetes mellitus epidemic is driven by our sedentary lifestyle and poor nutritional choices that contribute to one of the largest health challenges facing our society – obesity. Almost 70% of SA women are overweight or obese; of even greater concern is that over 25% of girls are also overweight or obese.[20] Managing the lifestyle diseases will ultimately have a beneficial effect on CKD. Community-based screening for CKD is not cost-effective, but highrisk patients – mainly those with diabetes and hypertension – would benefit from strategies that reduce the risk of developing, and retard progression to, ESKD. Such an initiative could be driven by health workers in primary care.

In closing

Each week, the equivalent of two planeloads of SA lives are lost because of lack of access to RRT. This appalling situation is steadily getting worse. Appeals from clinicians to health authorities for greater access to treatment have been met with the usual refrain that resources are insufficient – an explanation that is particularly disappointing in face of funds being diverted from the national fiscus to a range of expenditures that benefit the citizenry not at all. We are presenting the NDoH with a well-considered and workable blueprint for addressing the crisis of CKD and its treatment. As patient advocates who have to manage the crisis, we challenge the government to work with us to improve care for patients with CKD. Every time one of our patients dies, it is an indictment on us all. Acknowledgements. We gratefully acknowledge the valuable contributions made by all the participants of the Ministerial NDoH Summit, as well as those of Prof. Melvyn Freeman and his team (for organising the event), Prof. Yosuf Veriava for his leadership in the process, and Prof. Charles Swanepoel for his critical review of this article. 1. Stanifer JW, Jing B, Tolan S, et al. The epidemiology of chronic kidney disease in sub-Saharan Africa: A systematic review and meta-analysis. Lancet Global Health 2014;2(3):174-181.[http://dx.doi. org/10.1016/S2214-109X(14)70002-6] 2. Davids MR, Marais N, Jacobs JC. South African Renal Registry Report 2012. Cape Town: South African Renal Society, 2014. 3. Moosa MR, Kidd M. The dangers of rationing dialysis treatment: The dilemma facing a developing country. Kidney Int 2006;70(6):1107-1114. [http://dx.doi.org/10.1038/sj.ki.5001750] 4. Kevany S, Benatar SR, Fleischer T. Improving resource allocation decisions for health and HIV programmes in South Africa: Bioethical, cost-effectiveness and health diplomacy considerations. Global Public Health 2013;8(5):570-587. [http://dx.doi.org/10.1080/17441692.2013.790461]

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5. Crisp N, Chen L. Global supply of health professionals. N Engl J Med 2014;370(10):950-957. [http:// dx.doi.org/10.1056/NEJMra1111610] 6. Naicker S. Burden of end-stage renal disease in sub-Saharan Africa. Clin Nephrol 2010;74(Suppl 1):S13-S16. [http://dx.doi.org/10.5414/CNP74S013] 7. Yoder LA, Xin W, Norris KC, Yan G. Patient care staffing levels and facility characteristics in U.S. hemodialysis facilities. Am J Kidney Dis 2013;62(6):1130-1140. [http://dx.doi.org/10.1053/j. ajkd.2013.05.007] 8. Thomas-Hawkins C, Flynn L, Clarke SP. Relationships between registered nurse staffing, processes of nursing care, and nurse-reported patient outcomes in chronic hemodialysis units. Nephrol Nurs J 2008;35(2):123-131. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845981] 9. Outpatient renal dialysis facilities: Fact Sheet. https://public health oregon gov/ProviderPartnerResources/ HealthcareProvidersFacilities/HealthcareHealthCareRegulationQualityImprovement/Documents/ ESRD_RulesFactSheet_2012 (accessed 15 July 2015). 10. Karopadi AN, Mason G, Rettore E, Ronco C. Cost of peritoneal dialysis and haemodialysis across the world. Nephrol Dial Transplant 2013;28(10):2553-2569. [http://dx.doi.org/10.1093/ndt/gft214] 11. Udayaraj UP, Haynes R, Winearls CG. Late presentation of patients with end-stage renal disease for renal replacement therapy – is it always avoidable? Nephrol Dial Transplant 2011;26(11):3646-3651. [http://dx.doi.org/10.1093/ndt/gfr164] 12. Huang Y, Samaniego M. Preemptive kidney transplantation: Has it come of age? Nephrol Ther 2012;8(6):428-432. [http://dx.doi.org/10.1016/j.nephro.2012.06.004] 13. Zivcic-Cosic S, Busic M, Zupan Z, et al. Development of the Croatian model of organ donation and transplantation. Croat Med J 2013;54(1):65-70. [http://dx.doi.org/10.3325/cmj.2013.54.65]

14. Matesanz R, Miranda B. A decade of continuous improvement in cadaveric organ donation: The Spanish model. J Nephrol 2002;15(1):22-28. 15. Mjoen G, Hallan S, Hartmann A, et al. Long-term risks for kidney donors. Kidney Int 2014;86(1):162167. [http://dx.doi.org/10.1038/ki.2013.460] 16. Cronin AJ. Points mean prizes: Priority points, preferential status and directed organ donation in Israel. Isr J Health Policy Res 2014;3(1):8. [http://dx.doi.org/10.1186/2045-4015-3-8] 17. Matesanz R. Factors influencing the adaptation of the Spanish model of organ donation. Transplant International 2003;16(10):736-741. [http://dx.doi.org/10.1111/j.1432-2277.2003.tb00233.x] 18. Dalal AR. Philosophy of organ donation: Review of ethical facets. World J Transplant 2015;5(2):44-51. [http://dx.doi.org/ 10.5500/wjt.v5.i2.44] 19. International Diabetes Federation. IDF Diabetes Atlas. 6th ed. Brussels, Belgium: International Diabetes Federation, 2013. 20. Baleta A, Mitchell F. Country in Focus: Diabetes and obesity in South Africa. Lancet Diabetes Endocrinol 2014;2(9):687-688. [http://dx.doi.org/10.1016/S2213-8587(14)70091-9] 21. US Renal Data System. USRDS 2014 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases, 2014. 22. United Nations Development Programme, Human Development Reports. GNI per capita in PPP terms (constant 2011 PPP$). http://hdr.undp.org/en/content/gni-capita-ppp-terms-constant-2011ppp (accessed 29 July 2015).

Accepted 28 September 2015.

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The decolonialisation of medicine in South Africa: Threat or opportunity? M de Roubaix Malcolm de Roubaix is a trained anaesthesiologist who holds a doctorate in Applied Ethics (Bioethics). He is affiliated to the Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa, and is a Fellow of the Centre for Applied Ethics in the Department of Philosophy at the same university. He has a wide interest in bioethics and the ethics of traditional medicine, is passionate about the development of medical ethics and the capacity for ethical argument among medical students and practising medical professionals, and is currently managing the local arm of an international project investigating the social and ethical implications of HIV cure research and cure. Corresponding author: M de Roubaix (malcolmderoubaix@gmail.com)

The South African Traditional Health Practitioners Act 22 of 2007 is now fait accompli. The Act has been promulgated and the Department of Health (DoH) is proceeding with its implementation. An Interim Traditional Health Practitioners Council and a dedicated DoH deputy director have been appointed, the appointment of a registrar is being finalised, and the DoH has conducted a roadshow to introduce the Act and its implications to groups of traditional health practitioners (THPs) countrywide. The objective is eventual formalisation and professionalisation of THP practice to provide appropriate primary healthcare services through co-operation with biomedical service providers. Biomedical practitioners should understand the provisions of Act 22, and how this may affect their own practices. S Afr Med J 2016;106(2):159-161. DOI:10.7196/SAMJ.2016.v106i2.10371

Many aspects of societal and public life are being transformed to an alternative way of believing, thinking and doing; in short, being ‘decolonialised’. The ‘hashtag revolution’ has invaded the South African (SA) public space, with political and university terroir in turmoil, and radical change is upon us. Medicine and healthcare delivery will not be spared, although the ‘revolution’ has remained under the public radar with few reports and commentaries. It is driven not by public outcry, but by an Act of Parliament. This article is a provocative reflection on the implications this has for biomedical practice, though it makes no judgement on the ‘legitimacy’ of traditional healing. We, as advocates of biomedicine, have been steeped in a tradition of sound, scientific, evidence-based medicine, believing this to be the only responsible approach to attaining the objectives of medicine – to diagnose, treat and cure if possible, or at least alleviate and console, with compassion and respect. Our belief system conflicts with traditional African cosmology comprising confluent explanations of existence and

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natural occurrences, of life, religion, health, disease, healing and death. Descriptions or generalisations of African culture and cosmology are bound to be idealised, since Africa is a vast continent with a population of nigh on one billion, more than 50 countries, countless tribes and thousands of languages,[1] and the original descriptions upon which our conceptions of traditional African beliefs emanated from small communities scattered throughout the continent. Yet these descriptions were remarkably similar.

Traditional African cosmology and the role of traditional health practitioners (THPs)

Traditional African societal structure is summarised in John Mbiti’s famous aphorism: ‘I am because we are, and because we are, therefore I am’,[2] or ‘ubuntu’, made famous by Archbishop Emeritus Desmond Tutu,[3] a unique way of reiterating that no man is an island entirely of itself; when the bell tolls, it tolls collectively for

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humanity.[4] In traditional African thinking, disease may have more direct immediate causes, but often has an ultimate cause, e.g. to be found in some relational disharmony (between individuals in a community, between the patient and some animate or inanimate entity, nature or the ancestors). The diviner (sangoma) determines the nature of disharmony and prescribes corrective measures. But many consultations take place with herbalists who treat a variety of ordinary diseases with natural products. THPs are numerous, ranging from 1:110 of the population (Benin City, Nigeria) to 1:700 1 200 (Venda, SA),[5] with a suggested overall sub-Saharan ratio of 1:500.[6] The number of THPs in SA is estimated at ~300 000,[7] a ratio of more than 1:170. THPs are trusted and respected in their communities, culturally embedded, readily available when transport is lacking, and usually less expensive than biomedicine. Peer and family pressure promote their utilisation. Up to 80% of black South Africans may rely on THPs, even if this is through necessity and they do not utilise THPs preferentially.[8] The 2007 SA traditional medicine (TM) trade was estimated at ZAR2.9 billion.[9] An estimated 5 100 full-time THPs practise in the townships of Cape Town and trade about 1 300 tons of plant products annually[10] – with a decided environmental impact!

The root of the dilemma

Whereas biomedical practitioners are steeped in the discourse of evidence-based medicine based on formal studies, the THP exists in a cosmology in which the physical and metaphysical coexist harmoniously. And while the worlds of science and biomedicine have to an extent been opened to the THP, the reverse has not taken place. THPs often combine elements of the biomedical with the traditional. It is difficult for the scientifically trained mind to appreciate the non-standardised and untested, thus unscientific, nature of THP treatments and of the profession. There is evidence that some (Tanzanian) THPs embrace ‘modern’ approaches, e.g. testing treatments for efficacy and dosage, manufacturing powders and tablets to make medicines last longer than fresh plant products do, and large-scale manufacturing and packaging [11] Reconciling (‘proven’, in some way or another) herbal treatments with biomedicine may be possible, but ‘any approach involving divination and mysticism poses a far greater challenge to the bureaucratic mindset’.[7] The two clashing worldviews are characterised respectively by a high level of regulation and formalisation of the biomedical (read: legitimacy) and non-existent regulation and formalisation of the traditional. However, developments aimed at institutionalising and professionalising THPs may help in bridging this divide.

WHO/AU initiatives

Political advocates of biomedicine have believed that the answer to Africa’s medical needs lies in bringing medicine to the people. But globally, in Africa and lately in SA, an alternative approach has deve loped in recent decades: a return to traditional ways of healing, or, in current terminology, ‘decolonialisation’ of medicine. The World Health Organization has recognised the legitimacy of traditional approaches to medicine and has proposed measures to promote traditional healing as a profession.[12,13] The African Union (AU) responded by declaring 2001 2010 the Decade of African Traditional Medicine (extended to 2020),[13] and their 2003 action plan promotes this strategy. There has been some progress, e.g. the declaration of 31 August as African Traditional Medicine Day; collaborations and partnerships; and adoption of TM policies, strategic plans and regulatory frameworks by many African countries. AU promotes research on TMs, and training tools have been created. Drawbacks include inadequate funding, human capital and regulatory capacity, lack of evidence of safety and efficacy, and inability to mass-produce medications.[13,14]

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Local initiatives

The SA National Department of Health (DoH) has developed strate gies to institutionalise and regulate THPs. The Witchcraft Suppression Act 3 of 1957 (amended 1970) declared TM unlawful. The Traditional Health Practitioners Act 22 of 2007 recognises four THP groupings: diviners, herbalists, traditional birth attendants, and traditional surgeons. [7] In accordance with the Act, an Interim Traditional Health Practitioners Council of SA has been appointed. The Council is directed to advance TM as an acknowledged and esteemed healthcare delivery partner responding to SA’s needs. This Council has yet to formalise and operationalise its own structures and will look to the structure/ organisation of the SA Health Professions Council, for example. A registrar should be appointed in 2016, and compulsory registration of THPs (an eventual requisite to practise) will follow. The Act has been much criticised, e.g. for its vagueness on training requirements and regarding the non-scientific approach to disease, research and treatment that it effectively legitimises.[14] Council should eventually be self-funding. The DoH recently conducted a national roadshow to explain Act 22 locally to groups of THPs, and according to the Deputy Director, Traditional Healthcare, DoH (personal communication), found broad and general acceptance of its implications. I was fortunate to attend one of these closed meetings as an observer. Traditional healing comprises widely divergent practices, treatments and training, so regulating it will be difficult. Current training and licensing of THPs are conducted by approximately 100 THP organisations. The largest umbrella organisation is the cross-border Traditional Healers Organisation (THO), with 25 000 SA members.[15]

Current initiatives: Lessons from HIV and AIDS care

Taking HIV and AIDS care as an example, many patients regard bio medicine and TM as equally important, and visit both THPs and clinics before starting on ARVs and even while on ARVs.[16-19] THPs form a ‘comprehensive network potentially capable of expanding and simplifying access to comprehensive HIV care through various entry points’.[20] Many biomedicine-THP collaborative HIV and AIDS prevention/care programmes are current in Africa (e.g. Swaziland Traditional Healers New Partners Against HIV/AIDS (online: http://www.irinnews.org/ report/32780/swaziland-traditional-healers-new-partners-against-hivaids), Uganda’s Traditional and Modern Health Practitioners Together Against AIDS programme, Tanzania’s Tanga AIDS Working Group and SA THO programmes[7]). In SA, THPs have successfully been integrated into biomedical programmes after undergoing training in HIV prevention strategies, and used to train other THPs;[21] and THPs have been trained/accredited as voluntary counselling and testing counsellors, with positive outcomes.[22] Clinical THP-biomedical co-operation is therefore practicable.

The road forward

Even if all stakeholders stand to gain by the promotion of the insti tutionalisation of THPs,[23] it is unclear how this is to be done. A model for integrating THPs into the SA national healthcare delivery system was developed around ‘effective communication, mutual respect and trust, reciprocal education and training, two-way referral, scientific testing of TMs’.[24] The THP should eventually be recognised as a fellow professional, and appropriate modules contemplated in undergraduate medical studies. Space would need to be created for THPs within current healthcare structures. Patients should always be provided quality and affordable care, be that by biomedical practitioners or THPs. The DoH aims to promote collaboration, inclusivity (THPs and biomedical practitioners), and broad institutionalisation of THPs, which are the stated aims of Act 22.

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IN PRACTICE

The professionalisation and institutionalisation of THPs will proceed in accordance with the aims of Act 22. At present, biomedicine is sceptical about co-operating with THPs, who are unhappy about the present state of affairs; when compromise is required, it is expected that they perform – never their biomedical counterparts. Perhaps we will also have to learn to compromise; after all, we control both medical discourse and medicine’s considerable purse strings. Experience in HIV and AIDS care has shown that co-operation between THPs and biomedicine is possible. Extrapolating this to everyday encounters will be a mammoth task, but there may be no other option. My hope is that this article will stimulate a proactive debate and co-operation with the THP fraternity to provide the type of healthcare delivery system South Africans deserve, and seem to want. Besides, I doubt that we will be able to barricade ourselves in our ivory towers. 1. Fearon JD. Ethnic and cultural diversity by country. J Econ Growth 2003;8(2):195-222. 2. Mbiti J. African Religions and Philosophies. New York, USA: Doubleday & Co, 1970:141. 3. Battle M. Reconciliation: The Ubuntu Theology of Desmond Tutu. 2nd ed. Cleveland, Ohio: Pilgrim Press, 2009. 4. Donne J. Meditation XVII. In: Literature Network. http://www.online-literature.co./donne/409/ (accessed 10 November 2015). 5. Chatora R. An overview of the traditional medicine situation in the African region. Afr Health Monit 2003;4(1):4-7. 6. Richter ML. Traditional healing and human rights in South Africa. Poster Exhibition: The XV International AIDS Conference, Bangkok, 11 - 16 July 2004. (Abstract no.: MoPeE4200). https://www.aids2014.org/Abstracts/ A2168031.aspx (accessed 10 November 2015). 7. Flint A, Payne J. Reconciling the irreconcilable? HIV/AIDS and the potential for middle ground between the traditional and biomedical healthcare sectors in South Africa. Forum Dev Stud 2013;40(1):47-68. [http://dx.doi. org/10.1080/08039410,2012.702681] 8. Wilkinson K. Do 80% of South Africans regularly consult traditional healers? The claim is false. Africa Check, 31 July 2013. http://shar.es/1ou3U5 (accessed 4 February 2015). 9. Mander M, Ntuli L, Diederichs N, Mavundla K. Economics of the traditional medicine trade in South Africa. S Afr Health Rev 2007;Chap 13:189-196. Health Systems Trust. http://www.hst.org.za/sites/default/files/chap13_07. pdf (accessed 20 March 2015).

ffer o l a eci Sp

10. Petersen L. Cape Town’s trade in wild medicines: Ecological threat or essential livelihood resource? Sustainable Livelihoods Foundation, REDI/Econ3x3. January 2014. http://www.econ3x3.org/article/cape-town%E2%80%99strade-wild-medicines-ecological-threat-or-essential-livelihood-resource (accessed 31 July 2015). 11. Marsland R. The modern traditional healer: Locating ‘hybridity’ in modern traditional medicine, Southern Tanzania. J S Afr Stud 2007;33(4):751-765. http://dx.doi.org/10.1080/03057070701646845. 12. World Health Organization. WHO Regional Committee for Africa’s Resolution AF/RC50/R3. 56th World Health Assembly, 2003. Report by Secretariat: Traditional Medicine. http://apps.who.int/gb/archive/pdf_files/WHA56/ ea5618.pdf (accessed 10 March 2015). 13. World Health Organization. WHO Regional Office for Africa 61st Session, September 2011. AFR/RC61/PR/2, 5 July 2011. Progress Report on Decade of Traditional Medicine in the African Region. www.afro.who.int/index. php?option=com_docman&task=doc_download&gid=6665 (accessed 10 March 2015). 14. Van Niekerk JP. Traditional healers formalised? S Afr Med J 2012;102(8):105-106. 15. Summerton JV. The organisation and infrastructure of the African traditional healing system: Reflections from a sub-district of South Africa. Afr Stud 2006;65(2):297-319. [http://dx.doi.org/10.1080/00020180601035708] 16. Mall S. Attitudes of HIV positive patients in SA to African traditional healers and their practices. Cape Town: University of Cape Town Centre for Social Science Research: AIDS and Society Research Unit, CSSR Working Paper 215, May 2008. 17. Babb DA, Pemba L, Seatlanyane S, Charalambous S, Churchyard GJ, Grant AD. Use of traditional medicine by HIVinfected individuals. Psychol Health Med 2007;12(3):314-320. [http://dx.doi.org/10.1080/13548500600621511] 18. Langlois-Klassen D, Kipp W, Jhangri GS, Rubaale T. Use of traditional herbal medicine by AIDS patients in Kabarole district, Western Uganda. Am J Trop Med Hyg 2007;77(4):757-756. 19. Peltzer K, Friend-du Preez, Ramlagen S, Fomundam H. Use of traditional complementary and alternative medicine for HIV in KwaZulu-Natal, South Africa. BMC Public Health 2008;8:255. [http://dx.doi. org/10.1186/1471-2458-8-255] 20. Homsy J, King R, Balaba D, Kabatesi D. Editorial. Traditional health practitioners are key to scaling up comprehensive care for HIV/AIDS in Sub-Saharan Africa. AIDS 2004;18(12):1723-1725. [http://dx.doi. org/10.1097/01.aids.0000131380.30479.16] 21. Green EC, Zokwe B, Dupree JD. The experience of an AIDS prevention program focused on South African traditional healers. Soc Sci Med 1995;40(4):503-515. 22. Wreford J, Esser M, Hippler S. Involving traditional health practitioners in HIV/AIDS interventions: Lessons from the Western Cape Province. In: CSSR Working Paper No. 210. Cape Town: University of Cape Town Centre for Social Science Research, January 2008:6-7. 23. Kofi-Tsekpo M. Institutionalization of African traditional medicine in health care systems in Africa. Afr J Health Sci 2004:11(1-2):i-ii. http://www.ncbi.nlm.nih.gov/pubmed/17298111 (accessed 16 August 2015). 24. Pinkoane MG, Greeff M, Koen MP. A model for the incorporation of the traditional healers into the national healthcare delivery system of South Africa. Afr J Complement Alt Med 2012;9(Suppl 3):12-18. [http://dx.doi. org/10.4314/ajtcam.v9i3s.2]

Accepted 2 December 2015.

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Sony Professional Solutions Specialist 161 February 2016, Vol. 106, No. 2

IN PRACTICE

CASE REPORT

Normal-pressure hydrocephalus presenting with psychiatric symptoms E Groenewald, J A Joska, S Rothemeyer Engelina Groenewald is a psychiatrist subspecialising in neuropsychiatry in the Department of Psychiatry, Faculty of Health Sciences, University of Cape Town (UCT) and Groote Schuur Hospital, Cape Town, South Africa. John Joska heads the Division of Neuropsychiatry at UCT and the Clinical Unit of Psychiatry at Groote Schuur Hospital. Sally Rothemeyer is a neurosurgeon with a special interest in functional neurosurgery working as a consultant in the Division of Neurosurgery at UCT and Groote Schuur Hospital. Corresponding author: E Groenewald (lina.groenewald@uct.ac.za)

A 62-year-old man presented with a 2-month history of psychiatric symptoms. These were preceded by cognitive deterioration, urinary incontinence and an abnormal gait. A diagnosis of normal-pressure hydrocephalus (NPH) was made, and the patient improved after surgery. S Afr Med J 2016;106(2):162. DOI:10.7196/SAMJ.2016.v106i2.10512

Case report

A 62-year-old man with a history of schizophrenia but stable for many years presented with a 2-month history of aggressive behaviour, persecutory delu sions and depression subsequent to defaulting his psychiatric treatment. His daughter reported that his current symptoms had been preceded by forgetfulness, a gait disturbance and urinary incontinence of 1 year’s duration. On mental state examination, he had psychomotor slowing, appeared depressed and had a blunted affect. He scored 17/30 on the mini-mental state examination. He had scars on his body (which he attributed to falling) and a broad-based magnetic-type gait. A cerebrospinal fluid tap test was positive. His mental state improved after each lumbar puncture but declined approximately 5 days later. All blood investigations were normal. A computed tomography scan of the brain showed enlarged ventricles but no significant cortical atrophy (Fig. 1). The fourth ventricle and aqueduct were relatively small on magnetic resonance imaging, and late-onset aqueductal stenosis was suspected. An endoscopic third ventriculostomy was performed and the patient’s psychiatric symptoms, cognition and functioning improved significantly after surgery.

Discussion

The patient’s non-adherence to treatment was probably caused by cognitive impairment, which is a cardinal symptom of normalpressure hydrocephalus (NPH).[1] Collateral history revealed the chronology of symptoms that led us to consider this diagnosis. It was critical not to attribute the psychiatric symptoms to the chronic disorder alone without carefully reviewing the full clinical picture. Patients with NPH often present with psychiatric symptoms, of which apathy, depression and anxiety are the most common.[2,3] NPH is one of the reversible causes of dementia[4] and is mis diagnosed in approximately 80% of cases.[4] This case illustrates the

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Fig. 1. Computed tomography scan of the brain, showing enlarged ventricles but no significant cortical atrophy.

importance of considering a diagnosis of NPH in any elderly patient who presents with psychiatric symptoms. 1. Graff-Radford NR. Normal pressure hydrocephalus. Neurol Clin 2007;25(3):809-832. [http://dx.doi. org/10.1016/j.ncl.2007.03.004] 2. Oliviera MF, Oliviera JR, Rotta JM, Pinto FCG. Psychiatric symptoms are present in most of the patients with idiopathic normal pressure hydrocephalus. Arq Neuropsiquiatr 2014;72(6):435-438. [http://dx.doi.org/10.1590/0004-282X20140047] 3. Kito Y, Kazui H, Kubo Y, Yoshida T. Neuropsychiatric symptoms in patients with ideopathic normal pressure hydrocephalus. Behav Neurol 2009;21(3-4):165-174. [http://dx.doi.org/10.3233/BEN-20090233] 4. Kiefer M, Unterberg A. The differential diagnosis and treatment of normal-pressure hydrocephalus. Deutches Arzteblatt International 2012;109(1-2):15-25. [http://dx.doi.org/10.3238/arztebl.2012.0015]

Accepted 4 January 2016.

February 2016, Vol. 106, No. 2

RESEARCH

A multicentre evaluation of emergency abdominal surgery in South Africa: Results from the GlobalSurg-1 South Africa study R T Spence,1,2 MB ChB, MPhil; E Panieri,2 MB ChB, FCS (SA); S L Rayne,3 MB ChB, FCS (SA); on behalf of the GlobalSurg South Africa collaboration odman Center, Department of General Surgery, Massachusetts General Hospital, Boston, USA C Department of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa 3 Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1 2

Corresponding author: R T Spence (rtspence@mgh.harvard.edu)

Background. GlobalSurg-1 was a multicentre, international, prospective cohort study conducted to address the global lack of surgical outcomes data. Six South African (SA) hospitals participated in the landmark surgical outcomes study. In this subsequent study, we collated the data from these six local participants and hypothesised that the location of surgery was an independent risk factor for an adverse outcome following emergency intraperitoneal surgery. Methods. Participating hospitals contributed 30-day outcomes data of consecutive emergency intraperitoneal surgical operations performed during a 2-week period between July and November 2014. The six heterogeneous hospital cohorts were compared by categorical confounders. The primary outcome measure was in-hospital mortality; secondary outcome measures were in-hospital morbidity and length of stay of >14 days. The unadjusted association between hospital and adverse outcome and the univariate association between categorical confounders and adverse outcome were tested. Significant associations were further tested by a multivariate stepwise forward logistic regression model built for each outcome of interest. Results. Six hospitals (designated 1 - 6) contributed outcomes data for 169 operations. The mean age of the patients was 34.9 years (range 9 - 82), 116 (68.6%) were male, and the majority (37.2%) presented as a result of trauma. Hospital 5 was associated with 76-fold increased odds of in-hospital death and 58-fold increased odds of a major in-hospital complication, and hospital 3 was associated with 3-fold increased odds of any in-hospital complication. The final model predicting in-hospital death had a receiver operating characteristic curve statistic of 0.8892. Conclusion. The hospital is an independent risk factor for risk-adjusted adverse outcomes following emergency intraperitoneal surgery in SA. S Afr Med J 2016;106(2):163-168. DOI:10.7196/SAMJ.2016.v106i2.10183

Two hundred and fifty million surgical operations are performed annually worldwide, and approximately 28 32% of the global burden of disease is due to surgical reversible disease. Only 3.5% of these operations will be performed on the poorest third of the world’s popula tion. [1] Global surgery is increasingly being recognised as a new priority in reducing global mortality. In high-income countries such as the UK, about 10% of patients undergoing surgery are at high risk of complications, and they account for 80% of postoperative deaths.[2] This burden is likely to be much higher in low- and middle-income countries (LMICs), but clinical outcomes following major surgery are poorly described at national and even at institutional level in most countries, including South Africa (SA).[3] The GlobalSurg collaborative has been a pioneering attempt to address this lack of surgical outcomes data through multicentre international prospective data collection. The investigators hypothesised that emergency abdominal surgery, including laparotomy, appendicectomy and hernia repair, is performed in surgical units throughout the world and is likely to be subject to performance variation.[4] With no national database on non-cardiac The GlobalSurg-1 South Africa collaboration: J-A Carreira, K Connor, V Jennings, H Kretzmann, D Nel, N Ngayu, A M Mphatsoe, R Moore, C Sampson, N Sishuba, E Teasdale, M Tun, M Wagener, E Harrison, J Fitzgerald, A Bhangu.

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surgical outcomes in the public or private sector in SA, the degree to which this variation exists here is not currently known.

Objectives

The primary objective of this study was to use data from SA hospitals that contributed to GlobalSurg-1 to compare risk-adjusted adverse outcomes among participating hospitals. We hypothesised that the location of surgery was an independent risk factor for an adverse outcome following emergency intraperitoneal surgery. The secondary objective was to contribute to the growing evidence that national benchmarking of surgical outcomes is both feasible and important, even in a resource-limited country.

Methods

Patient population

GlobalSurg-1 was a multicentre, prospective observational study of consecutive patients undergoing emergency intraperitoneal surgery. Any hospital in the world was eligible to enter, and the study was carried out during 14-day consecutive time periods of the individual participants’ choice during a 5-month study period window between July and November 2014. Patients (adult and paediatric) of all ages undergoing emergency intraperitoneal surgery during the chosen period were eligible for inclusion. Emergency procedures were defined as unplanned, non-elective operations and included reoperations after previous procedures. Intraperitoneal surgery included laparoscopic,

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RESEARCH

laparoscopic converted and open cases. This could have included gastrointestinal, vascular, urological and gynaecological surgery. Elective (planned) or semi-elective (where the patient is initially admitted as an emergency, then discharged from hospital and readmitted at a later time for surgery) procedures were excluded, along with caesarean sections. Centres had to ensure that they included consecutive patients and provided >95% data completeness (centres with >5% missing data were excluded from analysis). There was no minimum number of patients per centre. Six SA hospitals that contributed to GlobalSurg-1 were included in the final analysis and made up the study population for this study. Three hospitals were academic teaching hospitals and three were secondarylevel institutions. All participating hospitals were in the public sector.

Data collection

In the original GlobalSurg-1 study, data points related to the patient, surgeon, operation, hospital, operative method and postoperative period were collected. The original data sheet can be accessed online (http://bmjopen.bmj.com/content/4/10/ e006239/T1.expansion.html). For this SA study, variables were categorised according to our new model for surgical outcomes research, where factors are separated into the domains of patient, presenting problem, provider, process of care and postoperative course. In this manner, the ‘5P’ of surgical outcomes research has been piloted. Local investigators entered data via a secure online web page, provided using the Research Electronic Data Capture (REDCap) system hosted at the University of Edinburgh, Scotland.[5] All patient data were transmitted and held anonymously. The data for GlobalSurg-1 were not analysed at identifiable hospital or surgeon level. In this study, the hospitals were anonymised before local data analysis.

that led to an unplanned 30-day critical care (intensive care unit) admission. Minor in-hospital complications were defined as an intraoperative or postoperative complication that did not lead to critical care admission. Any in-hospital complication represented the presence or absence of either an in-hospital death or a major or minor complication. LOS>14 was generated by dichotomising the length of stay into >14 days or ≤14 days from the day of surgery.

Analysis

To explore the association between hospital site and the defined endpoints, the six partici pating hospitals were first compared by the spread of the categorical confounder variables included in our 5P framework. The unadjusted association between hospital and outcome was then tested. A univariate screen between all other categorical confounders and outcome was also performed. Pearson’s χ2 test or Fisher’s exact test where appropriate was used for both these steps. Any confounder that was statistically associated with the outcome at the 0.1 level was then entered into a stepwise forward entry logistic regression algorithm predicting the outcome of interest. The significance level for entry into the final logistic regression model was 0.05. The final models predicting all five outcomes of interest are presented. The model’s discriminatory ability to predict the primary binary outcome of in-hospital mortality was assessed by constructing the receiver operating characteristic (ROC) curve. ROC statistics range from 0 to 1, 0 indicating no discriminatory ability and 1 perfect discri minatory ability.

Ethical considerations

Ethics approval was received from the appro priate SA university human research ethics committees for each participating hospital.

Patient characteristics

The six SA hospitals participating in GlobalSurg-1 contributed 169 patients to the multicentre international evaluation and vividly represented the significant trauma burden our country faces relative to other participating countries (Fig. 1). Patient characteristics in each hospital are presented in Table 1, compared by categorical characteristics of the patients, providers, presenting problems and process of care received. The mean age of the patients undergoing surgery was 34.9 years (range 9 82); 116 were male (68.6%) and 53 female (31.4). The greatest proportion of patients presented as a result of trauma (n=61, 37.2%), followed by acute appendicitis (n=41, 24.4%), symptomatic ventral hernia (n=12, 7.1%) and perforated peptic ulcer (n=10, 6.0%). There was significant variation in hospital cohorts. Patient characteristics differed by gender (p=0.016), American Association of Anesthesiologists (ASA) score (p<0.001), prevalence of diabetes (p=0.027) and prevalence of current smoking (p=0.031). The presenting problem also differed markedly, with hospital 2 treat ing the greatest proportion of trauma (48.7%) and hospital 6 treating the greatest proportion of acute appendicitis (59.1%; p<0.0001). The presence of specialist medical practi tioners varied significantly among the hospitals (p<0.0001). Specialist surgeons were present in only 10.8% of operations in hospital 2 but in 86.4% in hospital 6, while specialist anaesthetists were present in 5.6% in hospital 4 and 100% in hospital 2. The process of care differed among the hospitals with reference to the preoperative delay to theatre (p=0.003), use of preoperative computed tomo graphy (CT) scanning (p<0.0001), fashioning of any form of stoma (p=0.038) and the operation

0 - 2%

Classification of endpoints

The primary endpoint for this study was in-hospital mortality. This was generated by combining the ‘intraoperative mortality’ and ‘died as inpatient after surgery’ variables collected in GlobalSurg-1. In-hospital mortality was chosen because it is a clear endpoint with a small chance of misclassification bias. Thirtyday mortality was reported inconsistently in the original study. Secondary endpoints included in-hospital complications (major, minor and any) and length of stay (LOS) greater than 14 days (LOS>14). A major in-hospital complication was defined as an intraoperative or postoperative complication

Results

>2 - 5% >5 - 10% >10 - 20% >20%

Fig. 1. Proportion of trauma as the presenting problem in GlobalSurg-1. (Reproduced with permission from the GlobalSurg-1 collaborators.)

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RESEARCH

Table 1. Comparison of patient characteristics (N=169) by participating hospital Hospital Patient characteristics

35 (20.7)

37 (21.9)

47 27.8)

18 (10.7)

10 (5.9)

22 (13.0)

p-value

Patient Total patients, n (%) Age category, n (%)

0.226

Paediatric

4 (11.4)

3 (8.1)

1 (2.1)

2 (11.1)

1 (10.0)

5 (22.7)

Adult

29 (82.9)

33 (89.2)

43 (91.5)

13 (72.2)

9 (90.0)

16 (72.7)

Elderly

2 (5.7)

1 (2.7)

3 (6.4)

0 (0.0)

1 (4.6)

Gender, n (%)

0.016

Male

27 (77.1)

23 (62.2)

30 (63.8)

8 (44.4)

10 (100.0)

18 (81.8)

Female

8 (22.9)

14 (37.8)

17 (36.2)

10 (55.6)

0 (0.0)

4 (18.2)

26 (74.2)

12 (32.1)

19 (45.2)

9 (50.0)

10 (100.0)

18 (81.8)

6 (17.1)

12 (32.1)

8 (19.1)

3 (16.7)

0 (0.0)

2 (9.1)

1 (2.9)

8 (21.6)

9 (21.4)

4 (22.2)

0 (0.0)

2 (9.1)

2 (5.7)

3 (8.1)

6 (14.3)

1 (5.6)

0 (0.0)

2 (5.4)

0 (0.0)

1 (5.6)

0 (0.0)

ASA score

0.0007

Diabetes, n (%)

0.027

Present

35 (100.0)

34 (91.9)

45 (95.7)

15 (83.3)

8 (80.0)

22 (100.0)

Absent

0 (0.0)

3 (8.1)

2 (4.3)

3 (16.7)

2 (20.0)

0 (0.0)

Current

16 (45.7)

9 (24.3)

20 (42.6)

4 (22.2)

6 (60.0)

16 (72.7)

Never/stopped

18 (51.4)

26 (70.3)

18 (38.3)

12 (66.7)

1 (10.0)

3 (13.6)

Missing data

1 (2.9)

2 (5.4)

9 (19.2)

2 (11.1)

3 (30.0)

3 (13.6)

Cancer

1 (1.9)

1 (2.7)

5 (10.9)

2 (11.8)

2 (20.0)

0 (0.0)

O&G

0 (0.0)

5 (10.9)

6 (35.3)

0 (0.0)

Trauma

16 (47.1)

18 (48.7)

16 (34.8)

3 (17.7)

3 (30.0)

5 (22.7)

Appendicitis

10 (29.4)

9 (24.3)

1 (2.2)

2 (11.8)

2 (20.0)

13 (59.1)

Perforated peptic ulcer

5 (14.7)

2 (5.4)

1 (2.2)

1 (5.9)

2 (20.0)

1 (4.6)

Other

2 (5.9)

7 (18.9)

28 (59.6)

4 (22.2)

0 (0.0)

3 (13.6)

Missing data

1 (1.9)

0 (0.0)

1 (2.2)

0 (0.0)

1 (10.0)

0 (0.0)

Present

12 (34.3)

4 (10.8)

33 (71.7)

15 (83.3)

6 (60.0)

19 (86.4)

Absent

23 (65.7)

33 (89.2)

13 (28.3)

3 (16.7)

4 (40.0)

3 (13.6)

Present

28 (80.0)

37 (100.0)

11 (23.4)

1 (5.6)

3 (30.0)

5 (22.7)

Absent

7 (20.0)

0 (0.0)

36 (76.6)

17 (94.4)

7 (70.0)

17 (77.3)

17 (48.6)

16 (43.2)

12 (25.5)

6 (33.3)

3 (30.0)

12 (54.6)

6 - 11

6 (17.1)

4 (10.8)

7 (14.9)

2 (11.1)

4 (40.0)

7 (31.8)

13 - 23

8 (22.9)

11 (29.7)

12 (25.5)

2 (11.1)

1 (10.0)

2 (9.1)

24 - 47

2 (5.7)

3 (8.1)

7 (14.9)

4 (22.2)

0 (0.0)

1 (4.6)

>47

2 (5.7)

3 (8.1)

9 (19.2)

4 (22.2)

2 (20.0)

0 (0.0)

Smoking, n (%)

0.031

Presenting problem, n (%)

<0.0001

Provider, n (%) Qualified surgeon

<0.0001

Qualified anaesthetist

<0.0001

Process, n (%) Delay to theatre (h)

0.003

continued ...

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Table 1. (continued) Comparison of patient characteristics (N=169) by participating hospital Hospital Patient characteristics

CT performed preoperatively

p-value <0.0001

Yes

3 (8.6)

0 (0.0)

21 (44.7)

6 (33.3)

2 (20.0)

20 (90.9)

32 (91.5)

37 (100.0)

26 (55.3)

12 (66.7)

8 (80.0)

2 (9.1)

Blood transfusion

0.789

Yes

7 (20.0)

9 (24.3)

13 (27.7)

4 (22.2)

4 (40.0)

4 (18.2)

28 (80.0)

28 (75.7)

34 (72.3)

14 (77.8)

6 (60.0)

18 (81.8)

Yes

6 (17.1)

8 (21.6)

7 (14.9)

2 (11.1)

1 (10.0)

3 (13.6)

29 (82.9)

29 (78.4)

40 (85.1)

16 (88.9)

9 (90.0)

19 (86.4)

Resection performed

0.941

Stoma sited

0.038

Yes

3 (8.6)

1 (2.7)

10 (21.3)

3 (16.7)

2 (20.0)

0 (0.0)

32 (91.5)

36 (97.3)

37 (78.7)

15 (83.3)

8 (80.0)

22 (100.0)

Negative

1 (2.9)

4 (10.8)

8 (19.1)

1 (5.6)

1 (10.0)

0 (0.0)

Foregut

11 (31.4)

6 (16.2)

3 (6.4)

3 (16.7)

3 (30.0)

2 (9.1)

Midgut

14 (40.0)

16 (43.2)

5 (10.7)

8 (44.4)

2 (20.0)

16 (72.7)

Hindgut

4 (11.4)

6 (16.2)

7 (14.9)

3 (16.7)

2 (20.0)

2 (9.1)

Other

5 (14.7)

5 (13.5)

24 (51.1)

3 (16.7)

2 (20.0)

2 (9.1)

Operation

<0.0001

O&G = obstetrics and gynaecology.

performed (p<0.0001). No patient received a CT scan preoperatively in hospital 2, whereas 90.9% in hospital 6 received one. The negative laparotomy rate was as low as 0% in hospital 6 and as high as 19.1% in hospital 3. Completion rates for the information included in Table 1 were very high. Data were missing only for current smoking status in 20/169 (11.8%) and presenting problem in 3/169 (1.8%).

Occurrence of endpoints

The overall in-hospital mortality rate was 13.4% (95% confidence interval (CI) 8.78 19.98), the rate of major complications 17.5% (95% CI 12.11 - 24.49), the rate of any complications 33.6% (95% CI 26.36 - 41.61), the rate of minor complications 15.4% (95% CI 10.43 - 22.25) and the LOS>14 rate 16.8% (95% CI 11.55 - 23.75). Unadjusted outcomes differed among the participating hospitals, as presented in Table 2. The unadjusted in-hospital mortality rate ranged from 6.4% to 40.0% (p=0.043), the major in-hospital mortality rate from 5.4% to 40.0% (p=0.002), the minor in-hospital complication rate from 0% to 27.7% (p=0.018) and the any in-hospital complication rate from 16.7% to 70.0% (p=0.002). The unadjusted LOS>14 rate did not differ by hospital (p=0.572). Completion rates for outcomes of interest in this study were adequate. Data on in-hospital mortality were missing in 4 cases (2.4%), on in-hospital morbidity in 12 (7.1%) and on LOS

in 14 (8.3%). The majority of these missing data came from the hospital 4 cohort, which had the most scanty follow-up of patients, only reporting complications on 11 cases (61.1%) and LOS data on 15 (83.3%). The results of the multivariate analysis show that hospital location of surgery was an independent risk factor for in-hospital mortality, minor complications and major complications after controlling for all the 5P (patient, provider, presenting problem and process) variables considered in Table 1. The final logistic regression models predicting an adverse outcome of interest following emerg ency abdominal surgery are shown in Table 3. A patient undergoing emergency abdominal surgery at hospital 5 had a 76-fold increased odds of in-hospital death (95% CI 8.94 646.93) and a 58-fold increased odds of a major in-hospital complication (95% CI 7.09 - 478.7) requiring critical care admission compared with the reference hospital, after controlling for the abovementioned confounders. Surgery at hospital 3 was associated with a 3-fold increased odds of any in-hospital complication (95% CI 5.01 - 458.85). Although a minor in-hospital complication was associated with a 10-fold increased odds of LOS>14, the hospital site was not an independent risk factor for prolonged LOS. The logistic regression model developed for predicting in-hospital mortality following emergency abdominal surgery in the SA hospitals contributing to GlobalSurg-1 has an

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ROC value of 0.8892 (95% CI 0.789 - 0.9234) (Fig. 2).

Discussion

In comparing outcomes in emergency abdo minal surgery in SA hospitals using the 5P framework, this study found that hospital site was an independent predictor of in-hospital mortality and morbidity. Overall trauma was the most common presenting problem in the study, although this varied between hospitals, as did the demographic characteristics of the patients and the characteristics of the treating surgeons and anesthetists. Hospital cohorts were quite different, particularly with regard to the process of care variables, where the variation in presence of qualified specialists and the use of CT scans was most striking. Interestingly, but perhaps unsurprisingly, the hospital with the most liberal use of CT scanning reported no negative laparotomies. These findings are consistent with and extend those from the limited number of previous reports looking at variation in surgical outcomes from noncardiac procedures performed in SA and internationally. The European Surgical Outcomes Study (EuSOS) was conducted in 2011 with the primary objective of describing mortality rates and patterns of critical care resource use for patients undergoing non-cardiac surgery across 28 European nations.[2] The results

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Table 2. Unadjusted outcome measures by participating hospital Hospital Outcome

In-hospital mortality, n (%)

0.043

Yes

3 (8.6)

6 (16.2)

3 (6.4)

2 (11.1)

4 (40.0)

2 (9.1)

32 (91.4)

30 (81.1)

43 (91.5)

15 (83.3)

5 (50.0)

20 (90.9)

Missing data

0 (0.0)

1 (2.7)

1 (2.1)

1 (5.6)

1 (10.0)

0 (0.0)

2 (5.7)

2 (5.4)

14 (29.8)

3 (16.7)

4 (40.0)

2 (9.1)

33 (94.3)

32 (86.5)

32 (68.1)

8 (44.4

5 (50.0)

20 (90.9)

Missing data

0 (0.0)

3 (8.1)

1 (2.1)

7 (38.9)

1 (10.0)

0 (0.0)

5 (14.3)

1 (2.7)

13 (27.7)

0 (0.0)

2 (20.0.0)

2 (9.1)

Major complication, n (%) Yes

0.002

Minor complication, n (%) Yes

0.018

30 (85.7)

33 (89.2)

33 (70.2)

11 (61.1)

7 (70.0)

20 (90.9)

Missing data

0 (0.0)

3 (8.1)

1 (2.1)

7 (38.9)

1 (10.0)

0 (0.0

Yes

8 (22.9)

7 (18.9)

22 (46.8)

3 (16.7)

7 (70.0)

4 (18.2)

27 (77.)

28 (75.7)

24 (51.1)

8 (44.4)

2 (20.0)

18 (18.8)

Missing data

0 (0.0)

2 (5.4)

1 (2.1)

7 (38.9)

1 (10.0)

0 (0.0)

Any complication, n (%)

0.002

LOS>14, n (%)

0.572

Yes

4 (11.4)

3 (8.1)

10 (21.3)

3 (16.7)

3 (30.0)

3 (13.6)

30 (85.7)

26 (70.3)

36 (76.6)

12 (66.7)

7 (70.0)

18 (18.8)

Missing data

1 (2.9)

8 (21.6)

1 (2.1)

3 (16.7)

0 (0.0)

1 (4.6)

1.00

0.75

Sensitivity

showed that mortality rates varied 20-fold between countries (from 1.2% for Iceland to 21.5% for Latvia), despite adjustment for confounding variables. This meant that, after adjustment for variations in perioperative factors, a patient was up to seven times more likely to die postoperatively simply because of the hospital or country location of the surgery. Following the findings of this landmark study in the emerging field of surgical outcomes research, EuSOS provided the rationale for Biccard et al.[6] to conduct a similar 7-day cohort study known as the South African Surgical Outcomes Study (SASOS) during 2014 in SA. The primary outcome was in-hospital mortality. In SASOS, crude in-hospital mortality rates were 123/3 927 (3.1%, 95% CI 2.6 - 3.7). Urgent or emergency surgery occurred in 2 120/3 915 (54.2%), with a population-attributable risk for mortality of 25.5% (95% CI 5.1 - 55.8). SASOS concluded that most patients in SA undergo urgent and emergency surgery, which is strongly associated with mortality and unplanned critical care admissions. Based on the estimates of surgical volumes in SA by Weiser et al.,[7] the population statistics of SA for 2013[8] and the SASOS data,[6] the estimated mortality rate for adults (≥20 years of age) undergoing surgery in SA is between 76 and 128/100 000, which is equivalent to 7.2% and 12.1%, respectively,

p-value

0.50

0.25

0.00 0.00

0.25

0.50 1–specificity

0.75

1.00

Area under ROC curve = 0.8892

Fig. 2. Area under the ROC for the model predicting in-hospital mortality following emergency intraperitoneal surgery in GlobalSurg SA.

of all deaths in SA. These estimates provide substantial support for more in-depth analyses of the quality of surgical care provided in SA. With no current national dataset collating surgical outcomes of non-cardiac surgery in SA, targeting emergency laparotomies is

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a logical starting point. Resource-intensive national quality improvement (QI) pro grammes such as the American College of Surgeons National Surgical QI Essentials Program that only report specialty-specific outcomes (general surgery, orthopaedic

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Table 3. Logistic regression models built to predict in-hospital complications following emergency intraperitoneal surgery in GlobalSurg SA

outcomes data in the public sector of SA are not routinely measured, and any findings in this field are exploratory and preliminary. The effective sample size of 169 shared by six hospitals is particularly small considering that the primary out come occurred relatively infrequently. Our estimates are therefore not precise, as reflected by the very large CIs. However, despite these imprecise estimates, there is consistency in this emerging field in the literature, and this makes us confident about the following closing comments: • Non-cardiac surgery performed in hospitals across the world is subject to performance variation. • Emerging web-based mobile-health tech nologies, such as REDCap, make rapid prospective database development and risk-adjusted benchmarking feasible, even in a resource-limited environment. • Complications following major non-cardiac surgery, and particularly emergency surgery, are a common cause of death in SA and further work in this field is encouraged. • The emergency exploratory laparotomy is a sensible procedure to target for a surgical QI initiative. • Collaboration is key.[11]

Odds ratio

95% CI

p-value

Hospital 5

76.05

8.94 - 646.93

<0.0001

Age category elderly

30.98

3.18 - 302.04

0.003

ASA category 3

9.79

1.69 - 56.79

0.011

ASA category 4

23.64

3.09 - 180.84

0.002

Any resection

4.46

0.99 - 20.02

0.051

Hospital 5

58.24

7.09 - 478.7

<0.001

Age category elderly

33.32

4.95 - 224.16

<0.001

ASA category 3

8.25

1.98 - 34.33

0.004

ASA category 4

12.95

1.97 - 85.01

0.008

Diagnosis of perforated peptic ulcer

5.55

1.71 - 26.31

0.031

CT scan not performed

4.28

1.02 - 17.89

0.047

3.3

1.27 - 8.59

0.015

Hospital 5

47.92

5.01 - 458.85

0.001

Hospital 3

3.08

1.27 - 7.49

0.013

Age category elderly

7.41

1.46 - 37.67

0.016

ASA 3

3.13

1.09 - 9.02

0.035

ASA 4

3.46

0.81 - 14.72

0.043

Delay >47 h

2.84

0.96 - 8.39

0.059

Presence of minor complication

10.36

2.71 - 39.54

0.001

The hospital is an independent risk factor for risk-adjusted adverse outcomes following emergency intraperitoneal surgery in SA.

Blood transfusion

7.03

1.99 - 24.75

0.002

References

Diagnosis of cancer

19.91

2.28 - 173.43

0.007

Diagnosis of perforated peptic ulcer

8.64

0.69 - 108.11

0.04

Delay 24 - 47 h

4.19

1.04 - 16.85

0.043

In-hospital mortality

Major in-hospital complication

Minor complication Hospital 3 Any complication

LOS>14

surgery, etc.) may not be sufficiently granular for targeting specific procedures or subspecialty areas for improvement. They may even be falsely reassuring and result in missed opportunities for improvement.[9] For example, a hospital’s poor performance in colorectal surgery may be masked by better-than-average outcomes in trauma surgery, or vice versa. Procedure-specific performance measures would alleviate such problems. Focusing on procedure-specific outcomes assessment in a resource-limited setting would also reduce the amount of information needed for risk adjustment.[10] In LMICs, effort needs to be focused on receiving the greatest return on investment of time and resources. Emergency exploratory laparotomy is both common and high risk. It has the added benefit that various general surgery subspecialties and general surgeons, as well as gynaecologists, perform it.

The published protocol for GlobalSurg-1 specifically excluded analyses on individual hospitals and surgeons. Although we have focused analyses on individual hospitals as comparators, this work is still in keeping with Donabedian’s philosophies of ‘system’ measures and not ‘human’ measures.[11] Hospitals function as complex systems, and pursuing further work in this field under the novel structure, process and outcomes model will continue to destigmatise the individual as a target of ‘blame’ for unfavourable outcomes and emphasise a broader understanding, in that QI requires awareness that the system is ultimately what contributes to most of the variation seen in outcomes.[12] This will hold true particularly in the SA public sector, and we should pursue further research in this area without hesitation. These data must be interpreted in the context of the study design. Reliable surgical

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Conclusion

1. Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Lancet 2015;386(9993):569-624. [http://dx.doi.org/10.1016/S0140-6736(15)60160-X] 2. Pearse RM, Rhodes A, Moreno R, et al. EuSOS: European Surgical Outcomes Study. Eur J Anaesthesiol 2011;28(6):454456. [http://dx.doi.org/10.1097/EJA.0b013e328344907b] 3. Haynes AB, Regenbogen SE, Weiser TG, et al. Surgical outcome measurement for a global patient population: Validation of the Surgical Apgar Score in 8 countries. Surgery 2011;149(4):519524. [http://dx.doi.org/10.1016/j.surg.2010.10.019] 4. Bhangu A. Determining universal processes related to best outcome in emergency abdominal surgery: A multicentre, international, prospective cohort study. BMJ 2014;4(10):e006239. [http://dx.doi.org/10.1136/bmjopen-2014-006239] 5. Project REDCap. 2015. http://www.project-redcap.org/ (accessed 24 June 2015). 6. Biccard BM, Madiba TE. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J 2015;105(6):465-475. [http://dx.doi.org/10.7196/SAMJ.9435] 7. Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: A modelling strategy based on available data. Lancet 2008;372(9633):139-144. [http://dx.doi. org/10.1016/S0140-6736(08)60878-8] 8. Statistics South Africa. 2013. http://www.statssa.gov.za/ (accessed 24 June 2015). 9. Birkmeyer JD, Shahian DM, Dimick JB, et al. Blueprint for a new American College of Surgeons: National Surgical Quality Improvement Program. J Am Coll Surg 2008;207(5):777-782. [http://dx.doi.org/10.1016/j.jamcollsurg.2008.07.018] 10. Anderson JE, Rose J, Noorbakhsh A, et al. An efficient risk adjustment model to predict inpatient adverse events after surgery. World J Surg 2014;38(8):1954-1960. [http://dx.doi.org/10.1007/s00268-014-2490-6] 11. Donabedian A. Evaluating the quality of medical care. Milbank Q 2005;83(4):691-729. [http://dx.doi.org/10.1111/j.1468-0009.2005.00397.x] 12. Spence RT, Panieri E, Rayne SL, et al. Strengthening surgical research capacity in sub-Saharan Africa: Collaboration is key. S Afr Med J 2016;106(2):xxxx. [http://dx.doi.org/10.7196/ SAMJ.2016.v106i2.10182]

Accepted 25 October 2015.

RESEARCH

South African surgical registrar perceptions of the research project component of training: Hope for the future? N Patel,1 BA Hons, MA, MB BCh; P Naidoo,2 BSc (Pharm Hons), MB BCh, MMedSc; M Smith,1 MB BCh, FCS (SA); J Loveland,3 MB BCh, FCS (SA), Cert Paed Surg; T Govender,1 MB BCh; J Klopper,4 MB BCh, FCS (SA epartment of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa D Department of Internal Medicine, RK Khan Regional Hospital and School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 3 Department of Paediatric Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 4 Department of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa 1 2

Corresponding author: P Naidoo (poobalan1naidoo@yahoo.com)

Background. The Health Professions Council of South Africa requires that a research project be submitted and passed before registration as a specialist. Objective. To describe surgical registrars’ perceptions of the compulsory research project. Method. Ethics clearance was received before commencing the study. A questionnaire was developed to collect feedback from surgical registrars throughout South Africa (SA). Completed questionnaires underwent descriptive analysis using MS Excel. Fisher’s exact test and the χ2 test were used to compare perceptions of the research-experienced and research-naive groups. Results. All medical schools in SA were sampled, and 51.5% (124/241) of surgical registrars completed the questionnaire. Challenges facing registrars included insufficient time (109/124), inadequate training in the research process (40/124), inadequate supervision (31/124), inadequate financial resources (25/124) and lack of research continuity (11/124). Of the registrars sampled, 67.7% (84/124) believed research to be a valuable component of training. An overwhelming percentage (93.5%, 116/124) proposed a dedicated research block of time as a potential solution to overcoming the challenges encountered. Further proposals included attending a course in research methodology (79/124), supervision by a faculty member with an MMed or higher postgraduate degree (73/124), and greater research exposure as an undergraduate (56/124). No statistically significant differences were found between the perceptions of the researchexperienced and research-naive groups. Conclusions. Challenges facing surgical registrars in their efforts to complete their research projects were identified and solutions to these problems proposed. It is heartening that respondents have suggested solutions to the problems they encounter, and view research as an important component of their careers. S Afr Med J 2016;106(2):169-171. DOI:10.7196/SAMJ.2016.v106i2.10310

means of an anonymous questionnaire. The questionnaire focused on demographic data, previous research experience, current involve ment in research and views on the value of research, obstacles to research, and proposed solutions to barriers to research. A total of 124 questionnaires were completed. To ensure fairness and minimise real or imagined repercussions for respondents, findings were not reported by training institution. Descriptive statistics were performed using MS Excel.

Results

Results are presented in Fig. 1 and Table 1.

40 Respondents, %

Postgraduate surgical training in South Africa (SA) consists of rotation as a registrar through various surgical disciplines, typically over a 4-year period. Historically, subsequent to passing written and oral examinations and after completion of training rotation, the registrar has been registered as a specialist surgeon. In 2010, the Health Professions Council of South Africa made it compulsory that a research project be submitted and passed before registration as a specialist.[1] The research component of training, formalised in the research project, is viewed as a means of ensuring that future specialists are equipped with the basic analytical skills required to stay abreast with evidence-based advances in medicine.[2,3] Published research gives universities opportunities to increase universities’ research output, since all trainees are formally registered as postgraduate students, and also to receive state subsidy. There is a paucity of local literature on the views of registrars regarding their completion of a research project. This study serves as an initial step in assessment of the needs of surgical registrars with regard to their conducting research.

30 20 10 0

Methods

Ethics clearance was obtained from the University of the Wit watersrand Research Ethics Committee. Data were collected by

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3 Year of training

Fig. 1. Distribution of respondents.

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Table 1. Descriptive statistics University medical schools sampled, N

Registrars currently enrolled, N

241

Completed questionnaires, n

124

Registrars with no research experience, n/N (%)

87/124 (70.2)

Registrars with research experience, n/N (%)

37/124 (29.8)

Undergraduate level, n

Postgraduate level, n

Registrars strongly agreeing or agreeing with the statements below, n/N (%) Their institution adequately prepared them for research

41/124 (33.1)

They received formal research training

52/124 (41.9) (22 - 100†)

They were aware of ongoing research in their department

98/124 (79.0)

They were currently involved in research (other than MMed)

54/124 (43.5) (0 - 79†)

hey recognised the value of undertaking research, apart T from requirement for registration

84/124 (67.7) (44 - 89†)

Agreed reasons for performing research*, n/N (%) Advancement of knowledge

52/124 (41.9)

Requirement for registration

45/124 (36.3)

Academic promotion

9/124 (7.3)

Fame

5/124 (4.0)

Wealth

5/124 (4.0)

Identified obstacles to research*, n/N (%) Insufficient time

109/124 (87.9)

Inadequate of training in the research process

40/124 (32.3)

Lack of supervisors

31/124 (25.0)

Insufficient funding

25/124 (20.2)

Lack of ongoing research within the department

11/124 (8.9)

Other

6/124 (4.8)

Proposed solutions*, n/N (%) Dedicated research block

116/124 (93.5) (84 - 100†)

Research methods course

79/124 (63.7) (27 - 100†)

S upervision by faculty with MMed or higher postgraduate degree

73/124 (58.9) (0 - 70†)

More research exposure as undergraduates

56/124 (45.2) (0 - 68†)

Other

4/124 (3.2)

Registrars with plans to undertake future research, n/N (%)

81/124 (65.3) (33 - 78†)

Some respondents identified >1 obstacle and/or solution. Range of responses (%) from different institutions.

†

Discussion

Respondents identified lack of time, lack of supervisors and lack of training in research methodology as significant obstacles to research. They proposed a dedicated research block, formal training in research methodology, supervision of research by faculty with an MMed degree or higher, and greater undergraduate research exposure as solutions to the obstacles identified. Owing to the high burden of disease, the relative shortage of trained surgeons and a

‘Halstedian’ approach to surgical training (in place for over a century, and encompassing exposure to graduated clinical experience in the operating room during several years of registrar training under the close tutelage of dedicated senior consultant surgeons), the surgical registrar in SA is arguably heavily overworked. Against this background, it is therefore not surprising that most of the respondents view lack of time as the major obstacle to completing their research projects.

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Since consultant surgeons fluent in the nuances of research are most likely to ensure that the time registrars invest in research is productive, we suggest a supervisor’s course in research methodology as a minimum requirement for all consultants responsible for supervising registrar research. Training institutions should provide consultants with incentives to upskill, obtain research degrees and increase their research output. Furthermore, there is a need to improve communication between registrars and departments on planned and ongoing research, to identify possibilities for registrar involvement. Only a minority of the respondents agreed that their institution adequately pre pared them for research. This finding mirrors those of the American Surgical Association’s Blue Ribbon Committee on surgical education, which found that research training in the USA is thought to lack the structure, organisation and strict oversight that are well developed in clinical training.[2] In order to improve the research capability of registrars, we suggest mandating the completion of a validated formal research methodology course for all surgical registrars within the first year of their registrar training, or as a requirement for qualification for the surgical intermediate examination. In addition, we suggest provi sion of time to be dedicated solely to research and the completion of a research project within the framework of existing surgical training programmes. The decrease in registrars’ clinical responsibility during this time would necessitate the employment of additional registrars or medical officers in order to mitigate deficiencies in clinical service. We found that research exposure varied widely between training institutions, indicating a need to strengthen research training and output at certain institutions. A minority of surgical registrars have previous research experience, although no significant differences in perceptions of research existed between the researchexperienced and research-naive groups. This similarity between the two groups is counterintuitive and, owing to the low number of respondents with previous research experience, may be a type II error. Furthermore, the finding is limited by the subjective perception of previous research experience. A limitation of this study that may also contribute to this finding is the failure to distinguish between respondents with previous research exposure as undergraduate medical students and those with previous research exposure as undergraduates in other fields.

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The majority of surgical registrars value completing a research project and plan to continue to undertake research in the future. This finding mirrors a study conducted among general surgeons in the UK, which found that general surgeons believed research training and undertaking research to be critical to surgical training and practice.[4] Given the decrease in funding for academic hospitals over the past 20 years and the consequent drop in research output of SA medical institutions,[5] the recently instituted research component of specialist training presents the opportunity to revive research and has substantially changed the training requirements of surgical registrars in SA. Training in research needs to be balanced with the provision of services in a resource-limited environment and the training of surgical specialists in the required core clinical competencies.[6]

Conclusions

Many challenges face surgical registrars and their efforts to undertake research. It is reassuring that registrars view research as an important component of their careers and are willing to propose solutions to the problems they encounter. Future enquiry may seek to capture the perceptions of academic surgical consultants with regard to research and their role in the training of registrars. SA has a

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history of producing medical breakthroughs.[7,8] The now compulsory research project may reinvigorate the culture of surgical research and innovation, provided that the conditions suggested to facilitate this are implemented. References 1. Health Professions Council of South Africa Subcommittee for Postgraduate Education and Training (Medical). New Requirements for the Registration of Specialists in South Africa. http://www.hpcsa. org.za/downloads/medical_dental/new_requirements_forregistration_of_specialists_in_sa.pdf (accessed 12 June 2015). 2. Debas HT, Bass BL, Brennan MF, et al. American Surgical Association Blue Ribbon Committee Report on Surgical Education 2004. Ann Surg 2005;241(1):1-8. [http://dx.doi.org/10.1097/01. sla.0000150066.83563.52] 3. Reid K, Montgomery BD, Stocks NP, Farmer, EA. General practice research training: Impact of the Australian Registrar Research Workshop on research skills, confidence, interest and involvement of participants, 2002-2006. Fam Pract 2008;25(2):119-126. [http://dx.doi.org/10.1093/fampra/cmn010] 4. Dawson J, Harrison E, Taylor I. Research in the training of general surgeons: Results of a survey. Ann R Coll Surg Engl 1996;78(3):188-191. 5. Benatar SR. Health care reform in the new South Africa. N Engl J Med 1997;336(12):891-895. [http:// dx.doi.org/10.1056/NEJM199703203361224] 6. Krige JE. Departments of surgery in South Africa â&#x20AC;&#x201C; legacies of the past, challenges for the future. S Afr J Surg 2004;42(3):76-77. 7. Barnard CN. The operation. A human cardiac transplant: An interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J 1967;41(48):1271-1274. 8. Brenner S. Worms and science: An interview with Sydney Brenner, distinguished research professor at The Salk Institute, La Jolla, USA, and one of the winners of the 2002 Nobel Prize for Physiology and Medicine. EMBO Rep 2003;4(3):224-226. [http://dx.doi.org/10.1126/science.1088539, http://dx.doi. org/10.1126/science.302.5645.533, http://dx.doi.org/10.1126/science.301.5630.167c]

Accepted 20 November 2015.

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Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre, Johannesburg, South Africa J Fabian,1,2 MB ChB, FCP (SA), Cert Neph (SA); H Maher,1 Registered Nurse; A Bentley,1,3 PhD; P Gaylard,4 PhD; K Crymble,1 Registered Nurse; B Rossi,1 MBA, Registered Nurse; L Aucamp,1 Registered Nurse; E Gottlich,1,5 MB ChB, DCH, FCP Paed (SA); Cert Neph Paed (SA); J Loveland,1,6 MB ChB, FCS (SA), Cert Paed Surg (SA); J R Botha,1 MB ChB, FCS (SA); J Botha,1 MB ChB, FCS (SA); R Britz,1 MB ChB, FCS (SA) Wits Donald Gordon Medical Centre, Johannesburg, South Africa Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 3 Department of Family Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 4 DMSA (Data Management and Statistical Analysis), Johannesburg, South Africa 5 Morningside Mediclinic, Johannesburg, South Africa 6 Department of Paediatric Surgery, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1 2

Corresponding author: J Fabian (june.fabian@mweb.co.za)

Background. It is important for centres participating in transplantation in South Africa (SA) to audit their outcomes. Wits Donald Gordon Medical Centre (WDGMC), Johannesburg, SA, opened a transplant unit in 2004. The first 10 years of kidney and pancreas transplantation were reviewed to determine outcomes in respect of recipient and graft survival. Methods. A retrospective review was conducted of all kidney-alone and simultaneous kidney-pancreas (SKP) transplants performed at WDGMC from 1 January 2004 to 31 December 2013, with follow-up to 31 December 2014 to ensure at least 1 year of survival data. Information was accessed using the transplant registers and clinical records in the transplant clinic at WDGMC. The Kaplan-Meier method was used to estimate 1-, 5- and 10-year recipient and graft survival rates for primary (first graft) kidney-alone and SKP transplants. Results. The overall 10-year recipient and graft survival rates were 80.4% and 66.8%, respectively, for kidney-alone transplantation. In the kidney-alone group, children tended towards better recipient and graft survival compared with adults, but this was not statistically significant. In adults, recipient survival was significantly better for living than deceased donor type. Recipient and graft survival were significantly lower in black Africans than in the white (largest proportion in the sample) reference group. For SKP transplants, the 10-year recipient survival rate was 84.7%, while kidney and pancreas graft survival rates were 73.1% and 43.2%, respectively. Conclusion. Outcomes of the first 10 years of kidney and pancreas transplantation at WDGMC compare favourably with local and international survival data. S Afr Med J 2016;106(2):172-176. DOI:10.7196/SAMJ.2016.v106i2.10190

Solid-organ transplantation began in South Africa (SA) when the first kidney transplant was performed at the old Johannesburg Hospital on 25 August 1966.[1] In 1973, the only centres offering transplantation were in the public sector, namely Johannesburg General, Baragwanath, Addington, HF Verwoerd and Groote Schuur hospitals. By 1982, Universitas and Tygerberg hospitals had commenced transplantation.[2,3] There are now 18 transplant centres throughout SA, eight in the public sector and ten in the private sector. It is noteworthy that all these centres are clustered in large urban settings and are located in only four of the nine provinces in SA, making access to transplantation relatively inequitable.[4] Wits Donald Gordon Medical Centre (WDGMC), University of the Witwatersrand, Johannesburg, SA, is a private academic teaching hospital. In 2004, a solid-organ transplant unit was established that now offers adult and paediatric kidney, simultaneous kidney-pancreas (SKP), pancreas alone (PA), pancreas after kidney (PAK), liver and combined liver-kidney (CLK) transplantation. Liver, kidney and SKP transplants have been performed since 2004, CLK transplantation began in 2007, a hand-assisted laparoscopic live donor nephrectomy (HALLDN) programme was introduced in 2008, and pancreas-

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only transplantation (PA/PAK) has been performed since 2012. A paediatric living-donor liver transplant programme was started in 2013 and is currently the only such programme in southern Africa. Many international centres that participate in transplantation programmes are obliged to report outcomes annually to a national registry. Unfortunately, the South African Dialysis and Transplant Registry last published national transplant survival data in 1994. The Organ Donor Foundation (ODF) collects annual transplant statistics for SA, but this reporting is voluntary and does not include survival. Outcomes for paediatric liver transplantation in the Johannesburg region have recently been published.[5] An audit of the adult liver transplantation programme in Johannesburg will be published separately. The focus of this article is on reporting recipient and graft survival from kidney and pancreas transplantation at WDGMC during the first 10 years.

Methods

A retrospective review was conducted of all kidney and pancreas transplants performed at WDGMC from 1 January 2004 to 31 Decem足 ber 2013. Permission to conduct the review was granted by the University of the Witwatersrand Human Research Ethics Committee

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(Medical) (M140647). Data were extracted from regu latory registers and patient records in the transplant clinic, from on-site pathology laboratories for blood results, and from patient records from participating doctors at WDGMC and in clinical practice outside the hospital, all of whom were involved in the long-term care of recipients after transplantation. All the patients who underwent transplants were funded by private medical insurance. Where necessary, clinicians were contacted regarding survival of their patients and the most recent laboratory test results were obtained for the survival analyses. Data comprised the total number of transplants, repeat transplants, solid organs transplanted, recipient age (adults were defined as ≥18 years), gender, ethnicity, date of transplant, donor type (deceased v. living) and duration of post-transplant follow-up. In the case of deceased donation, all donors were heart-beating and braindead; there was no donation after cardiac death. SKP transplantation was only offered to patients with type 1 diabetes who had been rigorously screened to exclude vascular disease before transplantation. Kaplan-Meier recipient and graft survival analyses were conducted for transplants carried out during the study period, with at least 1 year of follow-up of all recipients. Those who had died or were lost to follow-up were censored in the graft survival analyses. Data were not censored for death with a functioning graft. Kidney graft survival, for the primary (first) graft only, was determined by the latest available serum creatinine level, and graft loss was defined by the date of commencement of post-transplant chronic dialysis, graft removal, retransplantation or death. Pancreas graft loss was defined by the date of surgical removal of the organ, commencement of insulin therapy if the graft was in situ, or death. Survival analysis for pancreas recipients only included adult SKP transplants, as the numbers of pancreas-only and paediatric pancreas recipients were very small. Cox proportional hazards regression was used for between-group comparisons for adult v. paediatric recipients, living v. deceased donors, gender and ethnicity. Selfreported ethnicity was categorised as Asian, black African, mixed or white. Because numbers of recipients of mixed ethnicity were small and none of them had reached 10 years of follow-up, these patients were excluded from the between-group ethnicity survival analysis. The 5% significance level was used throughout and analysis was carried out using SAS version 9.4 (SAS Institute Inc., USA). National statistics were obtained from the ODF annual reports.

Table 1. Demographics and 1-, 5- and 10-year patient and graft survival for primary kidney-alone transplants performed at WDGMC, 2004 - 2013 Variable

Overall

0 - 17 years

≥18 years

Recipients, N

355

305

10.3 (4.1)

42.3 (12.3)

2 (4.0)

29 (9.5)

Age (years), mean (SD) Donor type, n (%) NRLD

31 (8.7)

RLD

123 (34.6)

30 (60.0)

93 (30.5)

Deceased

201 (56.7)

18 (36.0)

183 (60.0)

130 (36.6)

19 (38.0)

111 (36.4)

Gender, n (%) Female Male

224 (63.1)

30 (60.0)

194 (63.6)

Unknown

1 (0.3)

1 (2.0)

0 (0.0)

40 (11.3)

6 (12.0)

34 (11.1)

Ethnicity, n (%) Asian Black African

123 (34.6)

16 (32.0)

107 (35.1)

Mixed

19 (5.4)

3 (6.0)

16 (5.3)

White

156 (43.9)

22 (44.0)

134 (43.9)

Unknown

17 (4.8)

3 (6.0)

14 (4.6)

1-year survival, % (95% CI) Patient

94.2 (91.3 - 96.3)

98.0 (86.6 - 99.7)

93.7 (90.3 - 95.9)

Kidney

91.7 (88.3 - 94.1)

93.8 (82.0 - 98.0)

91.3 (87.5 - 94.0)

Patient

87.8 (83.4 - 91.1)

98.0 (86.6 - 99.7)

86.1 (81.1 - 89.9)

Kidney

80.3 (74.9 - 84.7)

87.7 (72.0 - 94.9)

79.1 (73.1 - 83.9)

5-year survival, % (95% CI)

10-year survival, % (95% CI) Patient

80.4 (70.5 - 87.2)

98.0 (86.6 - 99.7)

77.9 (67.0 - 85.5)

Kidney

66.8 (55.0 - 76.1)

87.7 (72.0 - 94.9)

64.6 (52.1 - 74.6)

NRLD = non-related living donor; RLD = related living donor.

Results

During the study period, WDGMC per formed 15.2% (368/2 424) of all kidney transplants and 79.1% (72/91) of all pancreas (PA, PAK, SKP) transplants in SA. Of the kidney-alone recipients, 96.5% (355/368) received a primary graft and 3.0% (11/368) a second graft, two recipients (0.5%) receiving a third graft. The total number of paediatric kidney-alone recipients comprised 51/368 (13.9%), and all except one received primary grafts. After introduction of the HALLDN programme in 2008, 73.4% (94/128) of all livingdonor nephrectomies were performed using this technique. Of all the pancreas transplants performed, 93.1% (67/72) were SKP transplants, 5.5% (4/72) were PAK transplants and one (1.4%) was a PA transplant. Only one paediatric SKP transplant occurred during this period. The demographics and recipient and graft survival rates for all primary kidneyalone transplants are shown in Table 1.

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For primary kidney-alone transplantation, the male/female ratios were 1.6 and 1.8 for children and adults, respectively. In the paediatric group the most common source of the organ was a live donor (64.0%), while deceased donation predominated in adults (60.0%). Overall, the 1-year primary kidneyalone survival rate was 94.2% for recipients and 91.7% for grafts. After 10 years, 80.4% of recipients had survived with a corresponding 66.8% survival of their grafts. When looking at Kaplan-Meier survival of subgroups within the primary kidney-alone transplants, the paediatric group tended towards better recipient and graft survival compared with adults, but this was not statistically significant. Among the adults, there were no significant gender differences for recipient (p=0.69) or graft (p=0.40) survival. Survival of adult living-donor recipients was significantly better than that of deceased-donor recipients (p=0.047; hazard ratio (HR) 0.48; 95% confidence

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Discussion

1.0

Estimated survival probabilty

0.8

0.6

0.4

0.2

0.0

Survival time (years) Donor type

Graft survival: deceased Patient survival: deceased

Graft survival: living Patient survival: living

Fig. 1. Kaplan-Meier recipient and graft survival for adult primary kidney-alone transplants at WDGMC, 2004 - 2013 (living v. deceased donor type). 1.0

Estimated survival probabilty

0.8

0.6

0.4

0.2

0.0

Ethnicity

4 5 6 7 Survival time (years) Black African Asian

White

Fig. 2. Kaplan-Meier recipient survival for adult primary kidney-alone transplants at WDGMC, 2004 - 2013 (by ethnicity).

interval (CI) 0.24 - 0.99) (Fig. 1). There was no difference in graft survival when comparing living v. deceased donor type (p=0.11). Survival of adult black recipients was significantly worse than the reference group of white recipients (p=0.038; HR 2.05; 95% CI 1.04 - 4.03) (Fig. 2). Similarly, kidney graft survival was significantly worse in adult black recipients (p=0.042; HR 1.78; 95% CI 1.02 - 3.09) and significantly better in Asian recipients (p=0.035; HR 0.12; 95%

CI 0.02 - 0.86) compared with the reference group of white recipients (Fig. 3). The demographics and recipient and graft survival rates for all adult SKP transplants are shown in Table 2. In the adult SKP group (n=66), the male/female ratio was 0.69. Overall, for adult SKP transplants the 10-year recipient, kidney and pancreas survival rates were 84.7%, 73.1% and 43.2%, respectively. The Kaplan-Meier survival curves are depicted in Fig. 4.

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Overall, both 1-year recipient and graft survival rates for kidney-alone trans plantation at WDGMC were >90%. The 10-year survival rate for kidney-alone trans plantation was 80.4% for recipients and 66.8% for grafts. In the adults, recipient survival was better for living-donor recipients, and both recipient and graft survival were worse in the black population. The 10-year survival rates for adult SKP transplantation at WDGMC for recipient, kidney and pancreas were 84.7%, 73.1% and 43.2%, respectively. Outcomes for adult kidney-alone trans plantation at WDGMC compare favourably with international transplant centres. The adult 10-year graft survival rate (64.6%) was similar to that reported for Spain (71.3%) in a recent review that compared outcomes in the USA with those in Spain,[6] and better than that reported for the USA (53.4%). Similarly, 10-year recipient survival (77.9%) was comparable to that in Spain (86.2%) and superior to that in the USA (67.4%).[6] In the adult primary kidney transplant group, the significantly worse outcomes for black recipients and their grafts paralleled outcomes seen in African Americans. Deceased donor graft survival in African Americans has been shown to be significantly worse than that observed for other ethnic groups (Europeans, Hispanics and white Americans), and this difference was accentuated 5 and 10 years after transplantation.[7] Our results, although similar to those for African Americans at 5 and 10 years after transplantation, contradict findings from a study at Tygerberg Hospital in Cape Town, where no significant difference in graft survival based upon ethnicity was found. However, the period under review at Tygerberg was earlier than in this study and there were far fewer black recipients (n=56/542 (10.3%).[8] A host of factors have been proven to pre dispose African Americans to poorer graft outcomes. For example, Medicare health funder policy only finances immuno suppressant medication for the first 3 years after transplantation, which forces patients to buy their own expensive medication thereafter. Consequently com pliance falls, contributing to graft loss. African Americans have lower rates of living-related donation, and higher rates of immunological rejection and HLA mismatching, and persistent hyper tension after the transplant.[9,10] Recently identified genetic mutations in the APOL1 gene in African American living donors may also impact adversely on graft function after donation.[11,12] Our preliminary findings

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1.0

Table 2. Demographics and 1-, 5- and 10-year patient and graft survival for SKP transplants performed at WDGMC in adults, 2004 - 2013

Estimated survival probabilty

0.8

Variable Gender, n (%) 0.6

0.2

Survival time (years) Black African Asian

White

Fig. 3. Kaplan-Meier graft survival for adult primary kidney-alone transplants at WDGMC, 2004 2013 (by ethnicity).

Asian

3 (4.6)

Black African

7 (10.6)

Mixed

2 (3.0)

White

48 (72.7)

Unknown

6 (9.1) 34.6 (6.1)

1-year survival, % (95% CI) Patient

97.0 (88.4 - 99.2)

Kidney

97.0 (88.4 - 99.2)

Pancreas

86.1 (75.0 - 92.5)

5-year survival, % (95% CI)

1.0

0.8 Estimated survival probabilty

27 (40.9)

Age (years) mean (SD) 0

Ethnicity

Patient

84.7 (72.5 - 91.8)

Kidney

73.1 (58.2 - 83.5)

Pancreas

62.6 (48.5 - 73.8)

10-year survival, % (95% CI)

0.6

0.4

0.2

0.0

39 (59.1)

Male Ethnicity, n (%)

0.4

0.0

Female

Survival time (years) Patient survival

Kidney graft survival

Pancreas graft survival

Fig. 4. Kaplan-Meier recipient and graft survival for SKP transplants at WDGMC, 2004 - 2013.

highlight the need for rigorous research into the SA kidney transplant donor and recipient community in order to determine population-specific factors that influence outcomes. The paediatric primary kidney recipient and graft survival in this cohort was excellent, with >90% recipient and >85% graft survival at 10 years. However, the estimates are not very precise because of the small number of children who have had transplants so far. Charlotte Maxeke

Johannesburg Academic Hospital (CMJAH) reviewed 282 paediatric transplants from 1984 to 2003.[13] Ten-year recipient and graft survival rates were 68% and 23%, respectively. Red Cross War Memorial Children’s Hospital (RCWMCH) in Cape Town reviewed 89 transplants from 1995 to 2005 and found the 7-year graft survival rate to be 72%.[14] In a recent publication from the USA that reviewed 17 000 paediatric kidney transplants, outcomes were significantly better after 2001, which may be related

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Patient

84.7 (72.5 - 91.8)

Kidney

73.1 (58.2 - 83.5)

Pancreas

43.2 (24.5 - 60.6)

to better immunosuppression, with 10-year recipient and graft survival rates of 90.5% and 60.2%, respectively.[15] Explanations for the relatively good survival in our cohort, given that it is still a small sample, may reflect the more ‘recent’ time frame of analysis; higher living donor rates (64%) compared with 24% at RCWMCH and 21% at CMJAH; fewer black children, who have been shown to have poorer graft survival; fewer repeat transplants; and the assumption that socioeconomic circumstances are better in patients accessing a funded healthcare environment.[16] SKP transplantation is considered the treatment of choice for type 1 diabetics with end-stage kidney disease who are <50 years of age. [17,18] There is, however, a debate around this in the literature, because some centres have shown inferior survival for SKP transplantation when compared with living donor kidney-alone transplantation in type 1 diabetics with end-stage kidney disease.[19] Unfortunately

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we do not have sufficient numbers of type 1 diabetics who received a kidney-alone transplant to compare their outcomes with the SKP group, but adult recipient and kidney graft survival rates in the SKP group were comparable to those in the kidney-alone group (Table 2). Pancreas survival at 5 years is commonly >60%, and this was also observed in this series.[20] Ten-year survival data, although more scarce, are generally >50%, which is in line with this cohort at 43.2% (95% CI 24.5 - 60.6).

Study limitations

There are limitations to this study. Firstly, the annual national statistics from the ODF rely on voluntary reporting of transplant activity from individual transplant units. Although the ODF is the only available source of national transplant statistics, these may not accurately reflect transplant activity if units do not submit data, or submit incomplete or inaccurate data. Annual reports are compiled and returned to participating units after data submission. There were some minor discrepancies when comparing data from the WDGMC registers with ODF national statistics. The transplant statistics in this article were from the WDGMC registers/recipient records in preference to ODF statistics, as the former have been accurately verified. Secondly, the numbers of patients who underwent transplants in this series were relatively small and this prevented us from doing further analyses to understand some of the findings, for example exploring the observed differences in outcomes for black v. white recipients and their grafts. Unfortunately no further analysis of deceased v. living donor graft survival in black recipients was possible owing to the small numbers of patients at 5 and 10 years after the transplant. This also limited comparisons with larger cohorts internationally.

Conclusion

Outcomes of kidney and pancreas transplantation for the first 10 years at WDGMC compare favourably with local and international data. Further research is required into the SA donor and recipient pool to identify specific risk factors that could be addressed to improve recipient and graft survival.

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Acknowledgements. We thank the dedicated team in the transplant clinic at WDGMC, the doctors and their staff who willingly volunteered clinical information regarding the long-term survival of their patients after transplantation, the patients who have undergone transplantation at WDGMC, the donors and families who generously donated organs for transplantation, and Mr Masupha Adoro for data capture. References 1. Schreiber L, Gillwald J. Johannesburg Hospital/Hospitaal 1890-1990: History of the Hospital. Johannesburg: Johannesburg Hospital Board, 1990. 2. Furman K. Maintenance haemodialysis and renal transplantation facilities in South Africa July 1974. S Afr Med J 1975;49(11):394-396. 3. Furman K, du Toit E. Facilities for treatment and patients on renal replacement therapy in South Africa: A report on the 1982 registration. S Afr Med J 1983;63(11):407-408. 4. Organ Donor Foundation of South Africa. 2014. https://www.odf.org.za/ (accessed 6 November 2014). 5. Loveland J, Britz R, Joseph C, et al. Paediatric liver transplantation in Johannesburg revisited: 59 transplants and challenges met. S Afr Med J 2014;104(11):799-802. [http://dx.doi.org/10.7196/SAMJ.8627] 6. Ojo AO, Morales JM, Gonzalez-Molina M, et al. Comparison of the long-term outcomes of kidney transplant ation: USA versus Spain. Nephrol Dial Transplant 2013;28(1):213-220. [http://dx.doi.org/10.1093/ndt/gfs287] 7. Gondos A, Döhler B, Brenner H, Opelz G. Kidney graft survival in Europe and the United States: Strikingly different long-term outcomes. Transplantation 2013;95(2):267-274. [http://dx.doi. org/10.1097/TP.0b013e3182708ea8] 8. Moosa MR. Impact of age, gender and race on patient and graft survival following renal transplant ation – developing country experience. S Afr Med J 2003;93(9):689-695. 9. Katznelson S, Gjertson D, Cecka J. The effect of race and ethnicity on kidney allograft outcome. Clin Transpl 1995:379-394. 10. Cosio FG, Dillon JJ, Falkenhain ME, et al. Racial differences in renal allograft survival: The role of systemic hypertension. Kidney Int 1995;47(4):1136-1141. [http://dx.doi.org/10.1038/ki.1995.162] 11. Cohen DM, Mittalhenkle A, Scott DL, Young CJ, Norman DJ. African American living-kidney donors should be screened for APOL1 risk alleles. Transplantation 2011;92(7):722-725. [http://dx.doi. org/10.1097/TP.0b013e31822] 12. Reeves‐Daniel AM, DePalma JA, Bleyer AJ, et al. The APOL1 gene and allograft survival after kidney transplantation. Am J Transplant 2011;11(5):1025-1030. [http://dx.doi.org/10.1111/j.1600-6143.2011.03513.x] 13. Pitcher GJ, Beale PG, Bowley DM, Hahn D, Thomson PD. Pediatric renal transplantation in a South African teaching hospital: A 20-year perspective. Pediatr Transplant 2006;10(4):441-418. [http:// dx.doi.org/10.1111/j.1399-3046.2006.00489.x]. 14. McCulloch M, Gajjar P, Spearman C, et al. Overview of a paediatric renal transplant programme. S Afr Med J 2008;96(9):955-959. 15. Van Arendonk KJ, Boyarsky BJ, Orandi BJ, et al. National trends over 25 years in pediatric kidney transplant outcomes. Pediatrics 2014;133(4):594-601. [http://dx.doi.org/10.1542/peds.2013-2775] 16. Patzer RE, Mohan S, Kutner N, McClellan WM, Amaral S. Racial and ethnic disparities in pediatric renal allograft survival in the United States. Kidney Int 2015;87(3):584-592. [http://dx.doi.org/10.1038/ki.2014.345] 17. Waki K, Terasaki PI, Kadowaki T. Long-term pancreas allograft survival in simultaneous pancreaskidney transplantation by era: UNOS registry analysis. Diabetes Care 2010;33(8):1789-1791. [http:// dx.doi.org/10.2337/dc09-2276] 18. Ojo AO, Meier-Kriesche H-U, Hanson JA, et al. The impact of simultaneous pancreas-kidney transplantation on long-term patient survival. Transplantation 2001;71(1):82-89. 19. Morath C, Zeier M, Döhler B, et al. Transplantation of the type 1 diabetic patient: The long-term benefit of a functioning pancreas allograft. Clin J Am Soc Nephrol 2010;5(3):549-552. [http://dx.doi. org/10.2215/CJN.03720609] 20. Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nature Reviews Endocrinology 2013;9(9):555-562. [http://dx.doi.org/10.1038/nrendo.2013.138]

Accepted 19 October 2015.

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Factors determining clinical outcomes in intussusception in the developing world: Experience from Johannesburg, South Africa C Carapinha,1 MB ChB, FC Paed Surg; M Truter,1 MB BCh; A Bentley,2 PhD; A Welthagen;1 J Loveland,1 MB ChB, FCS (SA), Cert Paed Surg (SA) Department of Paediatric Surgery, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 2 Department of Family Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: J Loveland (loveland@wol.co.za)

Background. Rates of open reduction of intussusception were noted to be unacceptably high during an institutional internal audit. Objectives. To determine the impact of revised protocols to better select patients for pneumatic reduction (PR), and document associated morbidity and mortality, and the factors that affect the above. Methods. Medical records of patients between 3 months and 3 years of age presenting to the Department of Paediatric Surgery at Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa, from 2007 to 2010 were reviewed. Determining factors, including duration of symptoms, admission C-reactive protein (CRP) level and weight, were analysed against clinical outcomes, notably PR, bowel resection, relook laparotomy and death. Results. A total of 97 cases were suitable for inclusion. In 62 of these (63.9%), PR was attempted; this was successful in 32 cases (51.6%), giving an overall successful PR rate of 33.0%. In 7 of the 62 patients, a pneumoperitoneum was documented during the reduction attempt. Of the 65 patients who underwent surgery, 53 required intestinal resection and 12 had spontaneous or manual reduction. Ileostomy was necessary in 9 patients, and 7 required relook laparotomy. The overall mortality rate was 9.1%. Averages of ‘determining factors’ assessed against clinical outcome were as follows: mean weight (standard deviation (SD)) 7.4 (4.3) kg, mean duration of symptoms (DOS) 3.0 (SD 2.2) days, and admission CRP level 50.9 mg/L (range 1 - 249.3). Prolonged DOS and a raised CRP level predicted a poor outcome. Conclusions. Despite marked improvements in management and PR outcomes, intussusception remains associated with significant morbidity and mortality. Prolonged DOS and an elevated CRP predict worse outcomes. The use of these markers in association with clinical factors may assist management decisions, specifically with regard to operative or non-operative management. Awareness and education are key to prompt presentation and early diagnosis. Well-defined protocols introduced at all points of contact ensure early recognition and resuscitation as well as prompt referral for definitive management. S Afr Med J 2016;106(2):177-180. DOI:10.7196/SAMJ.2016.v106i2.9672

Intussusception is classically divided into idio pathic and pathological causes, with idiopathic intussusception typically occuring between the ages of 6 months and 3 years.[1] Over the age of 3 years, pathological causes predominate, with Meckel’s di verti culum, intestinal duplication cysts, polyps and intestinal malignancy the most commonly occurring lead points.[2,3] If intuss usception is not rapidly reduced, congestion and subsequent ischaemia of the bowel wall will result, with necrosis, perforation and death as possible outcomes. Management may be either non-operative or operative. The challenge is in triaging patients correctly into the two management groups, and this is dependent on epidemiological, clinical and radiological factors. Before 2006, an unpublished audit at our insti tution (Chris Hani Baragwanath Academic Hospital (CHBAH), Johannesburg, South Africa (SA)) demonstrated a subjective reluctance to attempt pneumatic reduction (PR), with the result that the vast majority (>90%) of patients were taken directly for laparotomy. Intestinal resection rates were perceived to be high. In 2006, with the employment of new paediatric surgeons and in co-operation with the Department of Radiology, updated manage ment guidelines were instituted in an attempt to increase the success of PR. These included the introduction of a standardised PR protocol,

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where both the radiology consultant and the senior paediatric surgery registrar are present during the PR procedure, which is initiated at an inflation pressure of 80 mmHg, maintained for 3 minutes, then increased by 20 mmHg every 3 minutes to a maximum of 120 mmHg. The PR procedure is performed in the radiology suite without sedation. Failure of PR after this protocol mandated open surgical exploration, and the cohort of patients in this series were not offered a second PR attempt. Absolute contraindications to PR included peritonitis, free intraperitoneal air, established obstruction, haemodynamic instability and multiorgan failure. We simultaneously instituted a prospective observational study to assess our cohort of patients presenting with intussusception and document the impact of our updated guidelines. A further aim was to assess which local epidemiological and clinical factors affected morbidity and mortality, expressed as defined clinical outcomes.

Methods

After approval by the Human Research Ethics Commitee of the University of the Witwatersrand, Johannesburg (Protocol No. M080206), a prospective observational study of paediatric patients presenting with intussusception to CHBAH and Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) from January 2007 to April 2010 was undertaken. CHBAH and CMJAH are tertiary/

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quaternary hospitals affiliated to the Uni versity of the Witwatersrand, each having a dedicated paediatric surgical unit. Only data on patients between 3 months and 3 years of age were used. Proven cases of colocolic intussusception were excluded from this study, as these are traditionally thought to occur secondary to a pathological lead point, mandating resection in our unit. Two further cases of suspected intussusception were excluded, as these children died on arrival in the emergency department and did not come to either arm of intervention. Once suitable study candidates had been identified and appropriate consent obtained from their caregiver, a blood sample for C-reactive protein (CRP) was drawn, this being the only extra variable added to the study. CRP was measured by latex immunoassay. Thereafter routine clinical management was instituted as per protocol. At the end of the study period, records of documented cases were reviewed for age, gender, weight, duration of symptoms (DOS), CRP levels, presence of palpable intussusceptum on rectal examination, serology results, radiological investigations including PR, surgical procedure and findings, and histological reports. The following ‘determining factors’ were assessed against clinical outcome: DOS, admission CRP level, weight, and presence of palpable intussusceptum per rectum. All pathology specimens from patients who underwent resection were histo logically assessed for the presence of transmural necrosis of the intestinal wall. Subgroup analysis was undertaken on patients presenting primarily to CMJAH and CHBAH (referred to as ‘in-house’ patients) and those transferred from peripheral referral hospitals. Groups were compared with the MannWhitney U-test and independent samples t-test for numerical variables, and the χ2/ Fisher’s exact tests for categorical variables. Correlation between CRP levels and DOS was assessed using the Pearson’s productmoment correlation coefficient. Univariate logistic regression was used to quantify the association between determining factors and clinical outcomes. The 5% significance level was used. Statistica (Statsoft Inc., USA) software was employed for statistical analysis.

an unknown cause of intestinal obstruction where a jejunojejunal intussusception was discovered. Two children with presumed ileocolic intussusception died on arrival before intervention, and were also excluded. A total of 97 cases of presumed ileocolic intussusception were therefore included in the study. PR was attempted in 62 patients (63.9%); it was successful in 32 (51.6%), equating to an overall success rate of 33.0% (32/97). In 7 cases a pneumoperitoneum was docu mented during PR. At operation all of these patients were found to have transmural necrosis at the site of perforation, confirming that the perforations were pre-existing and secondary to the advanced state of pathology, as opposed to over-enthusiastic reduction techniques. A total of 65 patients underwent surgical management, 35 primarily and 30 after failed PR. The indication for primary surgery in the 35 cases was established intes tinal obstruction with significant abdominal distension, where additional distention of the gastrointestinal tract would cause further respiratory distress. None of the patients who were treated surgically presented with peritonitis. Fifty-three (81.5%) required intestinal resection. No lead-point pathology was documented histologically. Of the remaining 12 intussusceptions (18.5%), 7 were found to have reduced spontaneously,

N=97 Total cases

n=62 Attempted PR

n=32 Successful PR

n=35 Primary surgery

n=30 Failed PR

n=53 Surgical resection

Results

A total of 108 cases of pediatric intuss usception were documented, of which 11 were excluded. Eight patients were aged >3 years and underwent primary surgical intervention as per local protocol, and one infant had an exploratory laparotomy for

all in the PR group. Manual reduction was required in the remaining 5. Diversion of the gastrointestinal tract by means of ileostomy was necessary in 9 of the 65 patients who required exploration (13.8%), all in the group that needed resection (Fig. 1). Averages of the determining factors were as follows: mean (standard deviation (SD)) weight 7.4 (SD 4.3) kg, mean DOS 3.0 (SD 2.2) days, palpable rectal intussusceptum 22% (21/97), and admission CRP level 50.9 mg/L (range 1 - 249.3). In the subgroup analysis comparing patients admitted directly to CMJAH and CHBAH with those referred from peripheral hospitals, no significant differences were noted in DOS, admission CRP or weight. There was also no significant difference between the referred group and the in-house group with regard to the rate of successful PR (13/32 (40.6%) and 18/30 (60.0%), respectively) (p=0.16). The mortality rate was nearly three times higher in the referred group (7/55 (12.7%) v. 2/42 (4.7%) in the in-house group), but the difference was not statistically significant (p=0.18). In the subgroup analysis of patients who underwent intestinal resection, CRP levels were compared between two groups: cases in which histological examination confirmed the presence of transmural necrosis (mean CRP 108 mg/L, range 11.8 - 229.9), and those in which

n=65 Total surgical

n=7 Spontaneous reduction

n=20 ICU admission

n=5 Manual reduction

n=9 Ileostomy

Fig. 1. Flow diagram of intussusception management outcomes. (ICU = intensive care unit.)

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Table 1. Univariate logistic regression per clinical outcome* Clinical outcomes

Variables

p-value

OR (95% CI)

Failed pneumatic reduction

DOS (days)

0.013

2.0 (1.2 - 3.5)

CRP (mg/L)

0.043

1.01 (1.001 - 1.03)

Relook

DOS (days)

0.005

2.5 (1.3 - 4.7)

CRP (mg/L)

0.025

1.01 (1.001 - 1.03)

Mortality

DOS (days)

0.020

1.4 (1.06 - 1.85)

OR = odds ratio; CI = confidence interval. *Only the determining factors with significant ORs are tabulated.

transmural necrosis was not found (mean CRP 39.2 mg/L, range 6 - 245.4). The difference was not statistically significant (p=0.057). The relationships between the outcomes and DOS and CRP levels are presented in Table 1. The DOS positively predicted a poorer outcome. The positive correlation between CRP levels and DOS was significant. Seven patients required a relook laparotomy after their initial procedure, the most common indication being abdominal compartment syndrome (ACS) (n=3). Sheath dehiscence occurred in 2 cases and an anastomotic leak after right hemicolectomy and ileocolic anastomosis in 1 case. This last patient required repair after developing a jejunal perforation arising from a serosal tear sustained at initial laparotomy. The mortality rate was 7.2% (7/97) in the study group, but including the 2 patients who were excluded from the study because they died prior to intervention, this increased to 9.1%. The first of these, a 4-monthold infant with AIDS, died of systemic sepsis secondary to Pneumocystis jirvoveci pneumonia, and the second, a 3-monthold with acute lymphoblastic leukaemia, developed tumour lysis syndrome and acute renal failure. We considered it pertinent to include these in our mortality statistics, as they reflect the overall mortality in patients with intussusception presenting to our unit. Five patients died postoperatively secondary to nosocomial sepsis and multiple organ dysfunction, one infant died from severe gastroenteritis and septic shock a week after hospital discharge, and another developed seizures of unknown aetiology and presented to the emergency department dead on arrival, also in the week following discharge. Univariate logistic regression per clinical outcome is shown in Table 1.

Discussion

Idiopathic intussusception is common in children, with described rates of successful non-operative reduction of >90% and overall mortality approaching zero.[4,5] The present series, as well as others from

developing countries, reports associations with significant morbidity and mortality, and emphasises that intussusception should not be underestimated. The last reported experience from CMJAH, by Rogers et al.[6] in 2007, documented a 25% success rate of PR in comparison with the current rate of 33%.[6] At the time of the previous study, standardised PR techniques were not in place and treatment was primarily surgical, with a low threshold for opting for resection. The improvement can be explained by the introduction and implementation of standardised protocols in 2006, including guidelines for resuscitation as well as selection for, and performance of, PR. Greater experience in both paediatric surgery and radiology have also had a positive effect. Our intestinal resection rate of 81.5% in patients undergoing exploration is high compared with other series. Mayell[7] reported a 22.7% resection rate, with the rest of the operative cases undergoing spontaneous or manual reduction, possibly demonstrating poor selection for operation in their series. There has been a steady decrease in the number of manual reductions over the years, with our experience demonstrating the lowest manual reduction rate in SA,[6-11] suggesting that institutional protocols for PR are stringent and reliable. The average DOS before presentation was 3.0 (SD 2.2) days in our series, which is similar to other series from developing countries. However, this compares poorly with data from the developed world, where the majority of patients have had mere hours of symptoms before presentation. The average DOS for a successful pneumatic reduction in our series is 1.9 (SD 1.3) days, which suggests that stringent protocols excluding attempts at PR in cases with symptoms longer than 24 hours are not well founded. A good history of the exact time of onset of symptoms is important, however, as the longer the DOS, the more physiologically unwell the patient will be. This is confirmed by the predictive nature of DOS for relook laparotomy and mortality, with odds ratios (ORs) of 2.4

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and 1.4, respectively. It is not clear why the DOS does not have any influence on the resection rate in our series, as it would be expected that the longer the duration of a non-reduced intussusception, the greater the chance that ischaemia and necrosis would develop, necessitating bowel resection at laparotomy. It could be postulated that although DOS does not impact on the development of ischaemia and necrosis, it does provide a prolonged opportunity for stasis and bacterial translocation, resulting in the systemic inflammatory response syndrome and multiple organ dysfunction syndrome. Prolonged DOS and intestinal obstruction would also cause excessive fluid losses, causing significant metabolic and electrolyte abnormalities. While intussusception may result in localised intra-abdominal complications, specifically bowel necrosis and perforation, it is the systemic effects, particularly intravascular depletion and metabolic acidosis, that are most concerning and need to be rapidly and aggressively addressed before definitive management. It is of interest that the DOS and CRP predict for similar clinical outcomes and a positive correlation exists between DOS and CRP, with a Pearson correlation coefficient of 0.4. Although not linear, CRP values increase incrementally the longer the DOS. The exact relationship between these two factors cannot be concluded from this study. However, it is important to clarify that prolonged DOS results in a poor outcome, while a raised CRP level is a marker of, but not contributory to, poor outcome. A raised CRP is predictive of failure of PR and relook laparotomy, with ORs of 1.01 (p=0.043) and 1.01 (p=0.025), respectively. This discrepancy between OR and p-value is attributed to the fact that a wide range in CRP values (1 - 243.2) was analysed. Our results concur with previous studies indicating an association of failed PR with a raised CRP. This study did not evaluate at what level a raised CRP would positively predict failure. However, the converse should hold true: PR in a patient with a normal CRP value on presentation should prove successful in the majority of cases. As positive predictors of outcome, these two factors in combination with other clinical and radiological findings can assist the clinician in stratifying patients for operative and non-operative management. Relook laparotomies are a described but rare procedure in paediatric surgery. However, in this series a relook laparotomy was required in 10.8% of all the operative cases, for the reasons listed above. Relook

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laparotomy predicts for mortality with an OR of 44. On closer analysis of the cases in which relook procedures were done, we suspect a common denominator: perioperative fluid resuscitation, particularly in the face of multiorgan dysfunction and postoperative sepsis, may contribute to a significantly positive overall fluid balance, which consequently results in increased third-space fluid, generalised oedema, poor pulmonary compliance, secondary ACS, and poor anastomotic healing. ACS is an under-recognised phenomenon in infants and children. When comparing in-house patients with those referred from district-level hospitals, CRP levels and DOS were similar. Although no statistical significance was reached, the mortality rate for the referred group was three times higher than that for the in-house group. We attribute this to delayed diagnosis and under-resuscitation at the referring facilities, as well as prolonged transportation times with under-resuscitation during transfer. While this is purely speculative, it does highlight the importance of resuscitation at the point of first contact. Our mortality rate was high, and comparison of mortality rates can be misleading, with many unaccounted-for factors contributing to death. If we exclude the two patients who died after discharge, our mortality rate would be 7%, comparable to other SA case series. However, our results are not favourable when compared with international series, which document success rates of non-operative reduction in excess of 90% and mortality rates approaching zero.[3,4] A betterdeveloped health infrastructure, well-informed patient population, better socioeconomic status, an increased ratio of specialists (paediatric surgeons and radiologists) to population and easier access to healthcare all contribute to this significant difference in outcome.

Conclusions

Intussusception is not a benign condition; on the contrary, it is associated with significant morbidity and mortality. A prolonged

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DOS, invariably due to socioeconomic, infrastructural and health management factors, and a raised CRP level are predictors for outcomes in intussusception. The use of DOS and CRP in assoÂ ciation with other clinical factors may assist clinicians in making management decisions, specifically regarding operative or nonoperative management. Introduction of PR guidelines has improved our use of this modality, directly contributing to an increase of successful PR from 25% to 33%. Public awareness and education would result in more prompt presentation to healthcare facilities. Well-defined protocols introduced at all points of contact in the healthcare delivery system would ensure early recognition of intussuception and aggressive resuscitation, followed by appropriate referral for definitive management. References 1. Romeo C, Ignacio JR. Intussusception. In: Holcomb GW, Murphy JP, eds. Ashcrafts Pediatric Surgery. 5th ed. Philadelphia: Saunders, 2010:508-516. 2. Maazoun K, Mekki M, Sahnoun L, et al. Intussusception owing to pathologic lead points in children: Report of 27 cases. Arch Pediatr 2007;14(1):4-9. [http://dx.doi.org/10.1016/j.arcped.2006.09.027] 3. Lai WP, Yang YJ, Cheng CN, et al. Clinico-pathological features of intussusceptions in children beyond five years old. Acta Paediatr Taiwan 2007;48(5):267-271. 4. Parashar UM, Holman RC, Cummings KC, et al. Trends in intussusception-associated hospitalizations and deaths among US infants. Pediatrics 2000;106(6):1413-1421. [http://dx.doi.org/10.1542/ peds.106.6.1413] 5. Jenke AC, Klaassen-Mielke R, Zilbauer M, et al. Intussusception: Incidence and treatment â&#x20AC;&#x201C; insights from the Nationwide German Surveillance. J Pediatr Gastroenterol Nutr 2011;52(4):446-451. [http:// dx.doi.org/10.1097/MPG.0b013e31820e1bec] 6. Rogers TN, Eastman L, Brauer B, et al. Intussusception: Still a surgical disease in Africa. Trop Doct 2007;37(4):254-256. [http://dx.doi.org/10.1258/004947507782333035] 7. Mayell MJ. Intussusception in infancy and childhood in southern Africa: A review of 223 cases. Arch Dis Child 1972;47(251):20-25. [http://dx.doi.org/10.1136/adc.47.251.20] 8. Grant HW, Buccimazza I, Hadley GP. A comparison of colo-colic and ileo-colic intussusception. J Pediatr Surg 1996;31(12):1607-1610. [http://dx.doi.org/10.1016/S0022-3468(96)90031-7] 9. Isdale JM, Saunders WC. Intussusception in Johannesburg: A review of 81 cases. S Afr Med J 1986;69(10):610-611. 10. Postma MH, Hadley GP. Intussusception in black children. S Afr Med J 1985;68(6):405-406. 11. Wiersma R, Hadley GP. Minimizing surgery in complicated intussusception in the Third World. Pediatr Surg Int 2004;20(3):215-217. [http://dx.doi.org/10.1007/s00383-003-1099-x]

Accepted 16 November 2015.

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Are central hospitals ready for National Health Insurance? ICD coding quality from an electronic patient discharge record for clinicians R E Dyers,1,2 MB ChB, FCPHM (SA); J Evans,2 BSc (Med), PhD; G A Ward,2,3 MB ChB; S du Plooy;2 H Mahomed,1,2 MB ChB, MMed, PhD ivision of Community Health, Department of Interdisciplinary Health Sciences, Faculty of Medicine and Health Sciences, D Stellenbosch University, Tygerberg, Cape Town, South Africa 2 Western Cape Government Department of Health, Cape Town, South Africa 3 School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 1

Corresponding author: R E Dyers (robindyers@me.com)

Background. South Africa (SA)’s planned National Health Insurance reforms require the use of International Statistical Classification of Diseases (ICD) codes for hospitals to purchase services from the proposed National Health Authority. However, compliance with coding at public hospitals in the Western Cape Province has been challenging. A computer application was developed to aid clinicians in integrating ICD coding into the patient hospital discharge process. Objectives. To evaluate the quality of ICD codes captured using the application and predictors thereof in a single hospital department. Methods. After 6 months, the quality of ICD codes was determined by comparing ICD code descriptors with medical concepts in a random sample of original patient records selected over a 6-week period. Patient and personnel characteristics influencing quality of coding, derived from a theoretical framework, were collected. Results. Of 223 patient records, 45.3% (95% confidence interval (CI) 38.8 - 51.9) had complete ICD codes. Primary ICD code accuracy was 74.0% (95% CI 67.8 - 79.5). Patient characteristics such as female gender, younger age group and fewer comorbidities, as well as seniority of clinician rank, were significantly associated with ICD coding being complete on adjusted analysis. Conclusions. The results of this study describe ICD coding quality at a central hospital in SA supported by a computer application and the factors influencing this. More interventions are required to achieve reliable coding data, such as additional ICD coding validation tools, training and oversight of junior clinicians. S Afr Med J 2016;106(2):181-185. DOI:10.7196/SAMJ.2016.v106i2.10079

More than 100 countries, including South Africa (SA), use the 10th revision of the International Statistical Classification of Diseases and Related Health Problems of the World Health Organization (ICD-10) codes to promote international comparability in the collection, classification, processing and presentation of morbidity and mortality statistics. Healthcare facilities generally use ICD codes for determining the acuity and severity of cases as well as to assess quality of care. In SA, ICD codes are primarily used by the public sector for patient billing and morbidity and mortality surveillance. Reliable hospital morbidity profiles are necessary to prioritise and fund appropriate public health interventions. Despite policy requiring clinicians to use ICD codes for all patients in the public sector, the implementation of ICD coding has not been systematically monitored for coverage and quality. Unlike the private sector, which relies on dedicated coders, public sector clinicians are expected to code diagnoses of all inpatients themselves. There is evidence to support the need to improve ICD coding quality for mortality surveillance in SA.[1] However, little has been published on the quality of ICD coding for morbidity surveillance in SA. Purchasing by means of diagnosis-related groups (DRGs) is mentioned in the National Health Insurance (NHI) policy, for which ICD coding will be essential.[2] In a review of NHI pilot site performance 18 months after the start of the pilot, it was noted that the ICD system was not yet operating satisfactorily and would need to be strengthened.[2] Support processes such as initial orientation and training, ongoing coder training programmes, coder accreditation, communication

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between health professionals, peer review and review by superiors are key to improving ICD coding quality.[3] It has also been recomm ended that appropriate assistive tools such as coding software and guidelines should be available to coders as well.[4] Although training programmes have been shown to have a positive impact on the quality of ICD codes by professional coders,[5] clinicians find it difficult to commit to costly, time-consuming accredited ICD coding courses. Concurrent implementation of all the abovementioned recomm endations would be difficult within the current capacity of the Western Cape Government Department of Health. As a compromise, a process was initiated to improve the quality of ICD coding by commissioning a software application for discharge summaries, the electronic Continuity of Care Record (eCCR). It was designed to assist clinicians in preparing discharge summaries by integrating it with ICD code lookup functionality.

Objectives

The primary objective of this study was to evaluate the completeness and accuracy of ICD codes captured using the eCCR tool at a central hospital in the Western Cape Province of SA. The study also explored patient and clinician characteristics that may be associated with ICD coding accuracy and completeness.

Methods

Study design

This was a cross-sectional study in which the quality of eCCR data was assessed in relation to patient records.

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Study setting and population

The study was conducted in the internal medicine wards of a central hospital in the Western Cape. Hard-copy patient records and the eCCR were reviewed for patients who were discharged over the 6-week period 22 July 2013 - 30 August 2013. During this period it was required that all patients admitted to general internal medicine wards receive discharge summaries prepared using the eCCR.

Sample size

A total of 477 patients were discharged from the general internal medicine department during the 6-week study period. Owing to the relatively small size of this population (<5 000), the normal approximation to the hypergeometric distribution was used to estimate the sample size. With an estimated expectation of 50% completeness and accu racy, a level of confidence of 95% and a significance level of 5%, a required sample size of 214 was obtained. This was inflated by 10 to address the possibility that original patient records might be missing. Two hun dred and twenty-four records were randomly selected from the eCCR database.

Data collection

Data were collected from original patient records, the human resource management information system and the eCCR. The ICD codes from the eCCR were checked against discharge summary narra tives and original patient records by the principal investigator and an ICD coding expert. Similar to a method used by Chute et al.,[6] primary ICD codes for each patient record were reviewed and classified as: • Match. The primary diagnosis in the patient record was coded to the highest level of detail available in the ICD-10 Master Industry Table, SA version – June 2013 (SA MIT). • Partial match. The primary diagnosis in the patient record was within the scope of the medical concept of the chosen primary ICD code descriptor, but not to the highest level of detail available in the ICD-10 SA MIT. • No match. The primary diagnosis in the patient record was not within the scope of the medical concept of the chosen primary ICD code. For this study, discharge summary clini cal narratives in the original patient rec ord were regarded as the source for the ‘relevant clinical concepts’ of the clinical encounter, based on the assumption that the clinician had diligently abstracted the most

relevant clinical information of the patient episode. The eCCR discharge summary narratives were reviewed for any free-text relevant clinical concepts that should have been coded by the clinician as secondary diagnostic codes. The number of free-text clinical concepts that were not coded was recorded. The definitions of terms used in this report are set out in Table 1. Data from the patient records and eCCR were entered onto predesigned data collection forms and then entered directly into a piloted, preformatted and locked Microsoft Excel 2011 spreadsheet by the principal investigator and checked by an expert in ICD coding.

Inclusion criteria

• Records of inpatients who were dis charged using the eCCR in the internal medicine department at a central hospital between 22 July 2013 and 30 August 2013.

Exclusion criteria

• Where there were records of repeat admissions within the study period, only the first admission was selected.

• Records of patients who died in hospital before discharge were excluded. • Patient records where the original paper patient record could not be found after three requests on separate dates were excluded. • ICD-9 codes, used for coding procedures, were excluded.

Measurement tools

The ICD-10 (SA version, June 2013) was used as a reference for checking the accuracy and completeness of ICD codes. Instructional notes from the Centers for Disease Control, Atlanta, USA, were used to assist in appraising the ICD coding. These two resources were available to clinicians utilising the eCCR during the study period. Patient data were collected from folders and clinician charac teristics from human resources records.

Statistical analysis

Primary ICD codes were regarded as accurate if they were classified as a ‘match’, as described above. ICD coding of a record was regarded as complete if all the relevant clinical concepts were represented by at least a ‘partial match’.

Table 1. Definitions of common terms used by clinicians and ICD coders Term

Definition for this study

Primary diagnosis

The main condition is defined as the condition, diagnosed at the end of the episode of healthcare, primarily responsible for the patient’s need for treatment or investigation. It is the ‘main condition treated’. If there is more than one ‘main condition treated’, then the most clinically severe or life-threatening condition should be selected. There can only be one primary discharge diagnosis per patient admission.

Secondary diagnosis

Additional conditions that affect patient care may coexist with the primary diagnosis in terms of requiring clinical evaluation, therapeutic treatment, diagnostic procedures, extended length of hospital stay, or increased nursing care and/or monitoring. This includes any comorbidity that the patient may have. There may be multiple secondary diagnoses per patient.

Procedure

Any surgery, diagnostic and therapeutic procedures carried out on the patient. These include surgical procedures (operations), e.g. appendectomy, cholecystectomy and amputations, diagnostic procedures, e.g. lumbar puncture, angiogram, gastroscopy and contrasted computed tomography, and therapeutic procedures, e.g. blood transfusion and central venous pressure monitoring.

Clinical concept

A clinical concept is any diagnosis, procedure, risk factor, modifier, morphological reference or contextual circumstance that can be represented as an ICD code. ICD codes are therefore not restricted to diagnoses.

Diagnostic codes

All coded clinical concepts that were coded as primary, secondary and complication ICD codes.

Paying patients

Patients who earn more than ZAR36 000 per annum if they are single, earn more than ZAR49 999 per annum as a family unit, or have private medical insurance are required to ensure payment of applicable hospital fees for admission to hospital. This was based on hospital policy applicable during the study period.

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Data were exported from Excel to and ana lysed in Stata, version 13.1, with p-values of <0.05 regarded as statistically significant. Means and 95% confidence intervals (CIs) and medians and interquartile ranges (IQRs) were calculated for continuous and count variables. Categorical variables were described with proportions and 95% CIs. Multiple logistic regression was used to determine the associations between ICD coding completeness and patient as well as clinician characteristics. Similarly, associations between ICD coding accuracy and patient as well as clinician characteristics were explored. We reported on crude and adjusted odds ratios (ORs) with 95% CIs and p-values. Based on the assumption that these were the most likely factors that would modify ICD code quality, the adjusted regression model included patient age, gender, fee paying, comorbidity and the clinician’s position. The number of summaries prepared per clinician varied, introducing a cluster design effect, which was adjusted for the analysis.

Ethics approval

The study was approved by the Stellenbosch University Health Research Ethics Comm ittee, and was conducted according to accepted and applicable national and international ethical guidelines and principles, including those of the Declaration of Helsinki, October 2008. Permission was obtained from the Prov incial Health Research Committee to conduct the research and to access the routine data required. Patient identifiers were removed prior to analysis and reporting.

Results

Included records

Of the 224 electronic and paper records that were requested, one was excluded on the basis that the patient died before discharge. There were no missing folders, and 223 records were included in the analysis.

Patient and clinician characteristics

Descriptive characteristics of patients and clinicians are shown in Table 2. There was no statistically significant difference in the number of comorbid conditions between male and female patients (p=0.84). Patients aged ≥40 years accounted for about twothirds of the sample, paying patients accounted for 62.8% of the sample, and interns accounted for just over half of the 33 clinicians.

ICD-10 coding completeness and accuracy

While 165 (74.0%) of the 223 patient dis charge records’ primary ICD codes were

female patients had twice the odds of having a complete set of diagnostic codes compared with males. Patients aged ≥40 years were 50% less likely to have a complete set of codes compared with those aged <40 years. The odds of the ICD codes being complete in the patient record decreased by 40% each time an additional comorbid condition required encoding. There was a significant increase in the odds of ICD coding completeness with an increase in clinician age in the bivariate analysis. However, this relationship was no longer significant in the adjusted analysis. Compared with interns, registrars were more likely to have produced a complete set of ICD codes for a patient record in both the

accurate (i.e. had a complete match), only 101 records (45.3%) had complete sets of codes for the admission. There were 192 patient discharge records (86.1%) with at least a partial match of the primary ICD code to the primary discharge diagnosis. Six hundred and sixty (75.4%) of the 875 diagnostic clinical concepts in all the discharge summaries were coded.

Factors associated with ICD-10 coding completeness and accuracy

Patient characteristics of female gender, age <40 years and fewer comorbid conditions were significantly associated with the completeness of ICD coding in the bivariate and multivariate analyses. The records of

Table 2. Characteristics of patients and clinicians in a central hospital Patient characteristics (N=223) Female patient, n (%) (95% CI)

122 (54.7) (48.1 - 61.2)

Age ≥40 years, n (%) (95% CI)

155 (69.5) (63.1 - 75.2)

Paying, n (%) (95% CI)

140 (62.8) (56.4 - 69.2)

Age (years), median (IQR)

54 (35 - 68)

Length of stay (days), median (IQR)

6 (4 - 11)

Comorbidity (n conditions), median (IQR)

4 (2 - 5)

Clinician characteristics (N=33), n (%) (95% CI) Female clinician

18 (54.4) (28.8 - 63.2)

Intern

18 (54.6) (36.8 - 71.2)

Medical officer

5 (15.2) (6.1 - 32.8)

Registrar

10 (30.3) (16.6 - 48.8)

Home language English

20 (60.6) (42.4 - 76.3)

Table 3. Crude and adjusted ORs (also adjusted for clustering) between patient/ clinician characteristics and completeness of ICD coding Crude OR

95% CI

p-value

Adjusted OR

95% CI

p-value

Female

2.1

1.2 - 3.5

0.01

2.9

1.4 - 6.3

0.01

Age ≥40 years

0.5

0.3 - 0.9

0.02

0.5

0.3 - 0.9

0.01

Paying

1.3

0.8 - 2.3

0.32

1.4

0.7 - 2.7

0.30

Length of stay

1.0

1.0 - 1.0

0.28

1.0

1.0 - 1.0

0.27

Comorbidity

0.6

0.5 - 0.7

<0.01

0.6

0.5 - 0.7

<0.01

Female

0.8

0.5 - 1.4

0.48

0.6

0.2 - 1.3

0.21

Age

1.1

1.0 - 1.2

0.01

0.9

0.8 - 1.1

0.27

Medical officer (relative to interns)

1.6

0.6 - 3.9

0.31

1.7

0.5 - 5.7

0.37

Registrar (relative to interns)

3.9

1.8 - 8.4

<0.01

9.2

1.6 52.2

0.01

Patient characteristics

Clinician characteristics

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Table 4. Crude and adjusted ORs between patient/clinician characteristics and accuracy of primary ICD codes Crude OR

95% CI

p-value

Adjusted OR

95% CI

p-value

Female

0.8

0.4 - 1.5

0.49

0.8

0.4 - 1.5

0.43

Age ≥40 years

0.5

0.2 - 1.0

0.06

0.4

0.1 - 1.1

0.07

Paying

0.6

0.3 - 1.2

0.15

0.4

0.2 - 0.9

0.03

Length of stay

1.0

1.0 - 1.0

0.68

1.0

1.0 - 1.0

0.33

0.9

0.8 - 1.0

0.06

Patient characteristics

Comorbidity

0.9

0.8 - 1.0

0.20

Female

0.7

0.4 - 1.3

0.28

0.7

0.3 - 1.5

0.38

Age

1.0

1.0 - 1.1

0.27

1.0

0.8 - 1.1

0.48

Medical officer (relative to interns)

1.1

0.4 - 2.9

0.88

1.0

0.3 - 2.9

0.98

Registrar (relative to interns)

2.7

1.8 - 3.5

<0.01

3.2

0.8 - 12.4

0.09

Clinician characteristics

crude and adjusted analyses. Registrars had nearly three times the odds of correctly coding the patient’s primary diagnosis compared with interns in the bivariate analysis, but this was no longer significant in the adjusted multivariate analysis. Details of the associations and CIs are summarised in Tables 3 and 4.

Discussion

The results of this study describe the completeness and accuracy of discharge ICD coding using an electronic discharge summary application and the factors influencing these. About three-quarters of patients included in the analysis were assigned an accurate primary diagnosis code on discharge using the eCCR tool, with just under half receiving complete sets of discharge diagnosis codes. The 86.1% at least partial match of primary ICD codes in the complex setting of internal medicine suggests that the data from the eCCR may be acceptable for high-level description of morbidity of hospital patients. However, this may not be an acceptable standard for the purposes of revenue retrieval and compliance with financial prescripts. Having a quarter of inaccurately coded patient records may have negative consequences on DRG formulation and purchases by regional and central hospitals from the National Health Authority as proposed in the NHI policy. Both patient and clinician factors were found to affect ICD-10 coding quality.

Increasing comorbidity had a negative association with the quality of ICD codes, possibly because the clinician was faced with the technical challenges of finding the correct ICD code for each additional clinical concept, while working in a timeconstrained environment. A study of the acute hospitalisation needs of adults admitted to public facilities in Cape Town found that comorbid disease was present in 78.1% of all medical admissions.[7] This is an indication of the proportion of patients who would have an increased chance of having their admission episodes incompletely coded, and therefore a highly relevant finding. The statistically significant relationship between ICD coding completeness and age ≥40 years is probably linked to age 40 being a recognised age of onset of comorbid diseases of lifestyle such as diabetes and hypertension.[8] This finding therefore reflects the higher number of a patient’s comorbid conditions, rather than his/her increased age, as an independent predictor of coding incompleteness. The statistically significant finding that records of female patients were twice as likely to have a complete set of ICD codes as those of male patients may relate to clinicians experiencing difficulty in encoding medical conditions that were more prevalent among males than females in this study population. This requires further investigation into the morbidity profiles of the patients. Although the statistically significant inverse relationship between primary ICD

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coding accuracy and the patients’ paying status in the adjusted results may raise concerns about clinician-generated data quality for revenue retrieval, it may, on the other hand, justify targeted support for coding paying patients’ medical records. Perhaps clinicians assumed that case managers would provide more comprehensive codes and that free-text narrative was adequate. The clinicians’ experience in clinical practice, particularly in the skill of summarising inpatient episodes, may account for the statistically significant relationships between clinician age and clinician rank with ICD coding quality. It may be worthwhile for clinical departments to explore processes whereby more experienced clinicians check the ICD codes in the discharge summaries prepared by their junior colleagues. The conflict between everyday clinical terminology and the descriptors of the ICD coding system may have contributed to inaccurate and incomplete coding.[9,10] Hohnloser and Purner[11] noted that imposing too many restrictions and non-editable lists, especially mandatory ICD coding, drove users away from their discharge summary application back to manual documentation. They therefore allowed substantial parts of the discharge summary to be entered as free text. Unlike Hohnloser’s Patient Archiving and Documentation System (PADS), the eCCR did not allow users to print a discharge summary unless a primary ICD code and description was selected from a non-editable list.[11] While Hohnloser et al.[12] noted that as many as 84% of relevant clinical concepts may be shifted to the free-text section of the discharge summary when clinicians are forced to code manually, only 24.6% of these were represented as free text in the eCCR. In our SA context, clinicians were more willing to accept some restrictions, the reasons for which require further exploration. The quality of ICD coding in this study should be interpreted together with previous research findings that, because of the limitations in the design of the ICD system, it may not be possible ever to achieve perfect results.[9,13,14] Chute and co-workers[6,14] noted that none of the classification systems was able to capture all clinical concepts that were of interest to clinicians. However, there are key lessons about some of the enablers of, and barriers to, ICD coding in this study, particularly if these are viewed as part of a quality improvement cycle. There may be benefits to looking beyond ICD coding and rather seeking overall improvement in the entire discharge process with ‘the use of checklists, alerts, and predictive tools;

RESEARCH

embedded clinical guidelines that promote standardized, evidencebased practices; electronic prescribing and test-ordering that reduces errors and redundancy; and discrete data fields that foster use of performance dashboards and compliance reports’.[15] All these benefits would not only free up clinicians’ time to apply their minds to ICD coding, but also provide practical ways of managing competing demands during the discharge process.

Study limitations

The issue of temporality is an important limitation of this crosssectional study. Causality between the independent and dependent variables cannot be assumed. Furthermore, the relationship between these variables may be confounded by a number of factors that were not investigated in this study. The study did not include the ordering of ICD codes as a measure of ICD coding quality. The use of only one clinical discipline at only one hospital limits the generalisability of the results. However, given the complexity of a central hospital, it may be reasonable to assume that coding accuracy may be better in a less complex environment, recognising that there are likely to be differences in the clinical practice and administrative processes between different hospitals and between clinical disciplines. The significant findings of associations between patient or clinician characteristics and ICD coding quality may reflect the fact that particular types of patients are assigned to particular types of clinicians, and these types of clinicians may have a tendency to get the ICD codes either right or wrong. The investigators sought to compensate for this with cluster analysis. Addressing this potential bias by randomising patient or clinician assignment and balancing the number of discharges per clinician would have created an artificial scenario that did not exist on the service delivery platform. The investigators used a more pragmatic approach to research this subject in order to retain the complexity of the actual healthcare delivery setting, thereby making the results more meaningful for translation into policy. The study findings suggest that the use of a tool such as the eCCR has the potential to improve ICD coding quality, thereby aiding in the implementation of NHI policy in central hospitals. The eCCR was developed not only to help clinicians with ICD coding, but also to help them manage competing clinical processes in a comprehensive and structured manner. This study was, however, not designed to measure the impact of the eCCR as an intervention, or to gauge clinicians’ experience with the tool. These aspects will be described in future publications where more appropriate study designs will have been used.

Conclusions

These cross-sectional study results describe the baseline of ICD coding quality in a central hospital setting in SA. More work is

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required to improve morbidity surveillance data to a standard that can inform public health policy. The integration of clinical concept coding into the discharge summary may aid clinicians in producing ICD codes of fair quality. Further experimental research of the eCCR or similar software should be considered in additional hospital settings, with a view to integrating it within the routine hospital information system. Additional ICD coding validation tools, training, oversight of junior clinicians and co-ordination of competing processes are also recommended. Acknowledgments. We thank the following people in the Western Cape Government Department of Health for providing us with data for this research: Krish Vallabhjee, Ian de Vega, Lesley Shand, Wendy Bryant, Rashida Adam, Nadine Ross and Adam Loff. We also thank Peter Raubenheimer, Tracey Naledi, David Coetzee, Lilian Dudley, Stephan Fourie, Lyn Hanmer and Suzette Munro for providing technical support, and Justin Harvey, Roderick Machekano and Nesbert Zinyakatira for statistical support. References 1. Nojilana B, Groenewald P, Bradshaw D, Reagon G. Quality of cause of death certification at an academic hospital in Cape Town, South Africa. S Afr Med J 2009;99(9):648-652. 2. Matsoso MP, Fryatt R. National Health Insurance: The first 18 months. S Afr Med J 2013;103(3):156158. [http://dx.doi.org/10.7196/SAMJ.6601] 3. Groom A. Congratulations! You’ve passed the coding course. Paper presented at the International Federation of Health Records Organizations Congress, Melbourne, Victoria, October 2000. Reprinted in ICD Coding Newsletter (November 2000). Melbourne: Victorian ICD Coding Committee and Victorian Department of Human Services, 2000:97-100. 4. Hohnloser JH, Purner F, Kadlec P. Coding medical concepts: A controlled experiment with a computerized coding tool. Med Inform (Lond) 1996;21(3):199-206. [http://dx.doi. org/10.3109/14639239609025357] 5. Lorenzoni L, Da Cas R, Aparo UL. The quality of abstracting medical information from the medical record: The impact of training programmes. Int J Qual Health Care 1999;11(3):209-213. [http://dx.doi. org/10.1093/intqhc/11.3.209] 6. Chute CG, Cohn SP, Campbell KE, Oliver DE, Campbell JR. The content coverage of clinical classifications. J Am Med Inform Assoc 1996;3(3):224-233. [http://dx.doi.org/10.1136/ jamia.1996.96310636] 7. De Vries E, Raubenheimer P, Kies B, Burch VC. Acute hospitalisation needs of adults admitted to public facilities in the Cape Town Metro district. S Afr Med J 2011;101(10):760-764. 8. Garcia-Olmos L, Salvador CH, Alberquilla A, et al. Comorbidity patterns in patients with chronic diseases in general practice. PLoS One 2012;7(2):e32141. [http://dx.doi.org/10.1371/journal. pone.0032141] 9. Chute CG, Huff SM, Ferguson JA, Walker JM, Halamka JD. There are important reasons for delaying implementation of the new ICD-10 coding system. Health Aff (Millwood) 2012;31(4):836-842. [http:// dx.doi.org/10.1377/hlthaff.2011.1258] 10. Jiang G, Pathak J, Chute CG. Formalizing ICD coding rules using Formal Concept Analysis. J Biomed Inform 2009;42(3):504-517. [http://dx.doi.org/10.1016/j.jbi.2009.02.005] 11. Hohnloser JH, Purner F. PADS (Patient Archiving and Documentation System): A computerized patient record with educational aspects. Int J Clin Monit Comput 1992;9(2):71-84. [http://dx.doi. org/10.1007/bf01142184] 12. Hohnloser JH, Puerner F, Soltanian H. Improving clinician’s coded data entry through the use of an electronic patient record system: 3.5 years experience with a semiautomatic browsing and encoding tool in clinical routine. Comput Biomed Res 1996;29(1):41-47. [http://dx.doi.org/10.1006/ cbmr.1996.0004] 13. Watzlaf VJ, Garvin JH, Moeini S, Anania-Firouzan P. The effectiveness of ICD-10-CM in capturing public health diseases. Perspect Health Inf Manag 2007;4:6. 14. Chute CG. Clinical classification and terminology: Some history and current observations. J Am Med Inform Assoc 2000;7(3):298-303. [http://dx.doi.org/10.1136/jamia.2000.0070298] 15. Silow-Carroll S, Edwards JN, Rodin D. Using electronic health records to improve quality and efficiency: The experiences of leading hospitals. Issue Brief (Commonw Fund) 2012;17:1-40.

Accepted 28 September 2015.

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RESEARCH

Burn surgeons in South Africa: A rare species N L Allorto,1 MMed, FCS (SA); S Zoepke,2 Medical Student; D L Clarke,1 MMedSci, FCS (SA), MPhil, MBA, PhD; H Rode,3 MMed, FRCS (Edin), FCS (SA) epartment of Surgery, Pietermaritzburg Metropolitan Hospital Complex and School of Clinical Medicine, College of Health Sciences, D Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 2 School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa 3 Department of Paediatric Surgery, Red Cross War Memorial Children’s Hospital and Faculty of Health Sciences, University of Cape Town, South Africa 1

Corresponding author: N L Allorto (nikkiallorto@gmail.com)

Background. The high burden of burn injuries in South Africa (SA) requires surgeons skilled in burn care. However, there are few dedicated burn surgeons and properly equipped units or centres. Objectives. To quantify the involvement of surgeons in burn care in SA hospitals, identify factors that attract surgeons to pursue burn care as a career and deter them from doing so, and understand the challenges of hospitals treating burn patients around the country. Methods. This was a prospective, qualitative study. Questionnaires were handed out at the South African Burn Society Congress in September 2013 and a trade symposium in March 2014. Results. One hundred questionnaires were handed out, and there was a 70% response rate. Twenty-six (39%) of the respondents had a specialist surgical qualification. Only half the units had registrars (48%) and interns (51%) on their staff. Only 30% of the respondents were dedicated to burn care alone, the majority being involved on a part-time basis. The most common factor respondents suggested was needed to recruit future burn care providers, cited by 76%, was better facilities and resources. Other factors included training and skills development (59%), subspecialist training (55%), development of a diploma in burn care (52%), development of research (52%) and healthcare worker psychological support (45%). Conclusion. We have demonstrated that current workforce resources for burn care are inadequate, the major deficit being lack of training and the resource-restricted environment. This survey provides basic information towards workforce planning, which can be used to inform the necessary strategic decisions. S Afr Med J 2016;106(2):186-188. DOI:10.7196/SAMJ.2016.v106i2.9954

Access to quality burn care in Africa is limited, and systems that do exist struggle with financial restraints, large numbers of patients and acute shortages of ade quately trained staff and facilities to render burn services.[1,2] An acceptable standard of care can only be achieved with a fundamental investment in burn facilities and adequately trained staff. It is estimated that in South Africa (SA), which has the second largest economy in Africa, 3.2% of the population sustain a burn injury each year. The majority of these burns are minor and moderate (1.6 million injuries), <10% being severe (3 200 injuries) and needing specialised care. However, admission numbers collected from burn units around the country show that there are in fact 8 800 admissions per year. Poorly managed burns result in high morbidity and an increased number of burn-related deaths. Currently there are 23 burn ‘units’ in SA, with a large variation in leadership, capacity and functioning. All can generally render acute emergency care, with a limited number rendering comprehensive care. The shortage of burn and trauma specialists is not unique to SA, shortages in general and specialist staff being reported in both high- and low-income countries.[3-6] In order to align with the South African Burn Society’s goal of improving burn care across the country, the workforce deficit needs to be addressed. Workforce planning is an essential part of capacity building and is the systematic process that identifies the current deficits and enables implementation of gap reduction strategies in order to overcome the barriers to achieving the defined goals. The purpose of this study was to investigate and quantify the involvement of medical personnel/surgeons in burn care in SA hospitals and to

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identify factors that attract or deter colleagues from entering the field of burn care as a career. This information is crucial to strategic planning for the future.

Methods

This was a prospective, qualitative study. Questionnaires were distributed at the SA Burn Society Congress in September 2013 and at a burn symposium in March 2014. Questions included information concerning the respondents’ training, working environment, experience of staffing and time allocated to burn care, and their personal opinions regarding motivation to become involved, or not, in burn care. Doctors were asked to answer these questions anonymously and voluntarily. The data were collated into a Microsoft Excel spreadsheet for descriptive statistical analysis. The questionnaire is attached as Appendix 1.

Results

Demographics

One hundred questionnaires were handed out, and there was a 70% response rate. Fifty (71%) of the respondents were male, and the majority (69%) were between 30 and 49 years of age. Fig. 1 illustrates the age distribution of respondents. The majority had been involved in burn care for 5 - 10 years (36%) and 11 - 20 years (31%), with 16% involved for <5 years, 14% for 21 - 30 years and 3% for >30 years.

Training

Twenty-six respondents (37%) had a specialist surgical qualification. This study did not distinguish between specialists in training

February 2016, Vol. 106, No. 2

Age (years)

<30

21%

30 - 39

60 50 40 30 20 10

40 - 49

33%

0 Ea rly Pr ev ex io po us su po re st gr ad ro ta tio M n en to ri nfl ue nc e Po ss ib le ca As re er so cia te Ac d lif ad es em ty le ic op po r tu ni tie Re s w ar di ng fie ld

Respondents, %

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50 - 59 ≥60

36%

Fig. 2. Attractions to a career in burn care.

Attractions to a career in burn care

Asked why they had become involved in burn care in SA, 54% cited early exposure (as a student, intern or medical officer) to burn care and 39% exposure at a postgraduate level. Mentor influence during training was cited by 37%, 31% seeing burn care as a possible career path and 56% believing it to be a rewarding field (Fig. 2).

Deterrents to a career in burn care

Respondents cited emotional difficulties (75%), a difficult working environment (70%), lack of support (55%) and the nature of the surgery (51%) as key deterrents to working in the burn field. Poor prognosis (46%), lack of training and skills development (35%), poor remuneration (30%) and lack of associated academic prestige (27%) were other deterrents. Lack of teamwork and interest, longterm morbidity caused by burns and lack of recognition by hospital

187

e tig

en t

pr es

ay m

cia te d

sk d an

in La

in tra of La

Po o

op ve l

ills

ck La

en t

kin

w or lt

cu ffi

sis

ry Po o

ro gn o

lt fs re o

na io ot Em

The majority of units (85%) had access to consultants. Only half the units had registrars (48%) and interns (51%) as part of the staff complement. Thirty percent of the respondents were dedicated to burn care, the majority being involved in burn care part time, being otherwise in trauma (42%), plastic surgery (44%) or general surgery (48%). Involvement in duties other than clinical work included research (52%) and education of doctors (60%), nurses (44%), physiotherapists (3%) and medical students (39%). Only 30% were involved in community outreach. Burn care was provided in a dedicated burn ward in 52% of respondents’ hospitals. Working hours in burn care per week were on average 14 hours per week (range 0 - 120) in the ward, 7 hours (range 0 - 25) in theatre, 2.3 hours (range 0 - 20) in the clinic and 2.9 hours (range 0 - 28) in teaching. There was an expressed need for more staff on all levels, 58% needing registrars, 62% medical officers, 68% nurses and 58% allied health professionals. Forty-seven percent of respondents were not training registrars at the hospital or institution at which they worked. The remaining respondents (53%) trained registrars with rotations varying from 1 month (18%) to 6 months (23%). The majority opinion (72%) was that a medical officer was skilled enough to work in the field of burns and that specialist training was not necessary.

Na tu

lly

Burn unit resources and activities

ur ge

ffi

(registrars) and medical officers. Forty-four (62%) had received postgraduate training in burn care, whereas 55 (79%) had learnt through practical hospital experience. Twenty-one respondents (30%) had completed a burn care rotation during internship, and 43 (61%) had completed a 3 - 6-month rotation at postgraduate level.

80 70 60 50 40 30 20 10 0

Respondents, %

Fig. 1. Age distribution of the respondents.

Fig. 3. Deterrents to a career in burn care.

management were further deterrents to entering the field of burn care as a profession (Fig. 3).

Issues for workforce planning

Better facilities and resources (76%) was by far the most common factor that respondents suggested was needed to recruit future burn care providers (Fig. 4). Others included training and skills development (59%), subspecialist training (55%), a diploma in burn care (52%), development of research (52%), healthcare worker psychological support (45%), better payment (44%) and flexible working hours (39%). Encouragement and adequate learning opportunities including seminars and courses, a change in mindset regarding burn care, better integration between departments at healthcare institutions, publicity of success stories to improve the image of burn care and clearer guidelines on management of burns were other strategies suggested.

Discussion

Burn care, encompassing an integrated and functional infrastructure staffed with appropriately trained personnel to provide adequate care for a patient with highly complex injuries, is associated with improved survival, decreased length of hospital stay and a reduction in costs.[7,8] Burn care is viewed as a Cinderella-type, non-accredited specialty. There is a shortage of burn units, as defined by the American Burn Association, for large numbers of patients, and inadequate num bers of surgeons/medical officers to provide the services needed for prehospital care, acute care and post-burn rehabilitation. The deficit is even greater among professions allied to medicine. The

February 2016, Vol. 106, No. 2

80 70 60 50 40 30 20 10 0

Su bs

pe cia

Di pl om ai lis n tt BC r ain Re se in ar g ch in Be BC tte de rf ve ac lo ilit pm HC ie en sa W t nd ps Tr re yc ain so ho ur in lo g ce gi an s ca d l s sk u pp ills or de t Fle ve xib lo p le m w en or t kin g ho Be ur tte s rp ay m en t

Respondents, %

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Fig. 4. Potential attractions to burn care. (BC = burn care; HCW = healthÂ care worker.)

skills needed to care for burn patients are diverse and include skills from general and plastic surgery as well as from critical care. This means that very often no single specialty will or can accept overall responsibility for the management of these complex cases, further compounding an already critical situation. This survey has provided basic information towards workforce planning, which can be used to inform strategic decisions. The majority of doctors engaging in burn care are young, are not specialist surgeons, and are involved part time (with an average of only 16 hours per week). It was not clear from the survey whether the additional clinical workload of trauma, general and plastic surgery diluted time allocated to burn care. It may be that doctors prefer to have diverse interests or that the department they work in dictates additional responsibilities. This survey emphasised the unattractiveness of a career in burn care. Many factors have been identified: burn surgery is not accredited as a specialty, there are no specific training programmes, experienced supervision is often deficient, there is a lack of career path development, facilities are often inadequate, fiscal restraints hamper progress, and academic standing is lacking. Burn surgery is not part of mainstream trauma management and is often seen as a separate and mainly unrelated, albeit essential, service. There is also the belief among surgeons and administrators that non-surgeons can treat major complex burns. While burn care is a labour-intensive field with specific needs, less than half the respondents were managing their patients in a dedicated ward. Burn care facilities were often short-staffed, 60% of respondents expressing the need for more doctors, nurses and allied health professionals. Poor resource allocation and infrastructure, common in low- to middle-income countries,[6,9] was the second most common deterrent to working in this field. Nevertheless, remedial factors were identified that made working under these circumstances tolerable. Three-quarters of the respondents said that what encouraged them to carry on working in burn care was the alleviation of suffering, restoration of function, patient resilience, and the personal reward of observing long-term recovery and reintegration into society of patients after being severely burned. Additional factors were working with children, the need for burns specialists in the public sector, the challenging nature of burn care, a team ethos and the encouragement and inspiration provided by mentors. The emotional wellbeing of caregivers was conversely

188

sadly neglected, it being imperative to ensure psychological support for healthcare professionals in burn care. Can factors be identified and implemented from this survey to make burn care as a specialty more attractive? We have demonstrated that current workforce resources are inadequate, with the major deficit being lack of training and the resource-restricted, shortstaffed environment. As career choices are influenced by early clinical exposure, education (the theory and practice of burn care) and training should start at under- and postgraduate level with a compulsory rotation in burns for both interns and registrars.[3] Skills development focusing on core knowledge and practical competencies should be the primary goals. Current burn surgeons are in a unique situation to act as mentors to their younger colleagues and could act as a catalyst to consideration of burn surgery as a career.[3,10] With the small number of specialists in the field, sustainability of education and training would be a challenge. The use of modalities such as e-learning, career pathway development, fellowships and research and academic support are essential components. International collaboration with high-income countries providing support and expertise to address the surgical workforce crisis, as demonstrated in Malawi,[11] could be an effective model in enhancing burn care locally. Regular psychological support and team development are also needed to prevent compassion fatigue among staff working day after day with challenging cases. This would strengthen the pull factors towards working in and staying in burn care. National programmes need to be established. The creation of more training and consultant posts and improvement of infrastructure requires resource allocation and political will.

Conclusion

We have provided an overview of the current workforce resources and gaps in the field of burn care in SA. Key areas have been identified to achieve development of an action plan to close the gaps. Implementation of the plan, monitoring, evaluation and revision over time are steps toward capacity building in burn care. References 1. Rode H, Rogers A, Adams S, et al. The dilemma of treating major burns in South Africa. S Afr Med J 2013;103(9):608-609. [http://dx.doi.org/10.7196/SAMJ.7361] 2. Rode H, Cox SG, Numanoglu A, Berg AM. Burn care in South Africa: A micro cosmos of Africa. Pediatr Surg Int 2014;30(7):699-706. [http://dx.doi.org/10.1007/s00383-014-3519-5] 3. Kahn SA, Goldman M, Daul, M, Lentz CW. The burn surgeon: An endangered species. Can exposure in medical school increase interest in burn surgery? J Burn Care Res 2011;32(1):39-45. [http://dx.doi. org/10.1097/BCR.0b013e318204b318] 4. Ortiz-Pujols SM, Thompson K, Sheldon GF, Fraher E, Ricketts T, Cairns BA. Burn care: Are there sufficient providers and facilities? Bull Am Coll Surg 2011;96(11):33-37. 5. Kelly E, Rogers SO Jr. Graduate medical education in trauma/critical care and acute care surgery: Defining goals for a new workforce. Surg Clin North Am 2012;92(4):1055-1064. [http://dx.doi. org/10.1016/j.suc.2012.04.006] 6. Gupta S, Wong EG, Mahmood U, Charles AG, Nwomeh BC, Kushner AL. Burn management capacity in low and middle-income countries: A systematic review of 458 hospitals across 14 countries. Int J Surg 2014;12(10):1070-1073. [http://dx.doi.org/10.1016/j.ijsu.2014.08.353] 7. American Burn Association. Burn Incidence and Treatment in the United States: 2011 Fact Sheet. http://www.ameriburn.org/resources_factsheet.php (accessed 11 August 2015). 8. Sheridan RL. Burn care: Results of technical and organizational process. JAMA 2003;290(6):719-722. [http://dx.doi.org/10.1001/jama.290.6.719] 9. Calland JF, Holland MC, Mwizerwa O, et al. Burn management in sub-Saharan Africa: Opportunities for implementation of dedicated training and development of specialty centers. Burns 2014;40(1):157163. [http://dx.doi.org/10.1016/j.burns.2013.05.015] 10. Ellsbury KE, Carline ID, Irby DM, Stritter FT. Influence of third-year clerkships on medical student specialty preferences. Adv Health Sci Educ Theory Pract 1998;3(3):177-186. 11. Qureshi JS, Young S, Muyco AP, et al. Addressing Malawiâ&#x20AC;&#x2122;s surgical workforce crisis: A sustainable paradigm for training and collaboration in Africa. Surgery 2013;153(2):272-281. [http://dx.doi. org/10.1016/j.surg.2012.08.004]

Accepted 14 October 2015.

February 2016, Vol. 106, No. 2

RESEARCH 1

Appendix 1

South African Burn Care Provider Survey We are conducting a survey to determine the future of burn care in South Africa and we would like to invite you to participate in our survey by answering the following questions.

Respondent gender:

Respondent

Male/Female

Hospital, province currently employed at:

MB CHB

FCS

MMed Surgery

Other: Please indicate

Respondent age:

<30

30 -‐ 39

40 -‐ 49

50 -‐ 59

>60

Number of years

5 -‐ 10

11 -‐ 20

21 -‐ 30

>30

qualifications:

involved in burn care:

Type of training receive to

Received formal

Trained by in-‐hospital

provide burn care:

postgraduate training

experience

Yes/No

Burn care at your hospital is provided

Dedicated burns unit

Medical or surgical ward

in:

Indicate staff structure available

Consultant Medical

for burn care in your hospital:

Registrar

officer

Indicate the number of burn patients admitted

officer

Number of adults

Number of children <12 years

to your hospital annually:

Describe your current involvement in Dedicated to burn care burn care at your hospital or institution:

Intern/House

only:

Yes/No

February 2016, Vol. 106, No. 2

Partially involved in the following (please indicate): Trauma

General

Plastic

surgery

RESEARCH

2 Education – Community please

Are you currently involved in:

Research

outreach

Medical students Doctors

indicate which

programme of the

Nurses Other – please indicate

following:

Early exposure to burn surgery Completed a burn rotation during postgraduate training Why did you become

Influenced by a mentor during training

involved in burn care –

Interested in burn care as a possible career

please indicate:

Lifestyle associated with burn care Academic opportunities within burn care Rewarding field to work in

How many hours do you

Hours in the ward

Hours in theatre

Outpatient

Hours teaching

clinics

spend on burn care per week:

Do you have to be a surgeon, or can a medical

Must be a surgeon

Can be a medical officer

officer also do the work:

Have you been training registrars in burn care: If yes, indicate time devoted to

Yes/No

1 -‐ 3 months

3 -‐ 6 months

More than 6

registrar training:

months

Have you completed a burn rotation during your internship?

Yes /No

Have you completed a burn rotation during your post-‐graduation

Yes/No

training?

What would your future staffing

Registrars

Medical officer Nurses

Allied health workers

needs be (you can indicate more than one option):

February 2016, Vol. 106, No. 2

RESEARCH

The nature of burn care at times makes it difficult to maintain momentum – what motivates you?

Emotionally difficult Nature of the surgery Reasons why

Poor prognosis of the patients

people do not

Difficult working environment – poor infrastructure, lack of resources

work in

Lack of support

burns:

Lack of training and skills development Poor remuneration Lack of associated academic prestige OTHER: please specify

Diploma in burns care Sub-‐specialist training in burns care Factors that

Research development

you believe

Better facilities and resource allocation to burns

will attract

Better healthcare worker pyschological/emotional support

people to

Training and skills development

burns as a career choice

Flexible/part-‐time working hours Better remuneration OTHER: please specify

February 2016, Vol. 106, No. 2

RESEARCH

Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre B Jugmohan,1 MB ChB; J Loveland,1 MB ChB, FCS (SA), Cert Paed Surg (SA); L Doedens,2 MB ChB, FC Paed (SA), Cert Crit Care (SA); R L Moore,1 MB ChB, FCS (SA); A Welthagen;1 C J Westgarth-Taylor,1 MB ChB, FC Paed Surg (SA) epartment of Paediatric Surgery, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the D Witwatersrand, Johannesburg, South Africa 2 Department of Paediatric Critical Care, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: B Jugmohan (benjugmohan@gmail.com)

Background. Childhood mortality is high in low- and middle-income countries. Burns are one of the five leading causes of childhood injury mortality in South Africa (SA). While there is an abundance of literature on burns in the developed world, there are far fewer publications dealing with childhood mortality related to burns in Africa and SA. Objective. To describe the mortality of children admitted to a dedicated paediatric burns unit, and investigate factors contributing to reducing mortality. Methods. A retrospective review was performed of patients admitted to the Johnson & Johnson Paediatric Burns Unit, Chris Hani Baragwanath Academic Hospital, Johannesburg, SA, between May 2009 and April 2012. Results. During the study period, 1 372 patients aged ≤10 years were admitted to the unit. There were 1 089 admissions to the general ward and 283 admissions to the paediatric burns intensive care unit (PBICU). The overall mortality rate was 7.9% and the rate for children admitted to the PBICU 29.3%; 90.8% of deaths occurred in children aged ≤5 years. Of children admitted with an inhalational injury, 89.5% died. No child with a burn injury >60% of total body surface area (TBSA) survived. Conclusions. Our overall mortality rate was 7.9%, and the rate declined significantly over the 3-year study period from 11.7% to 5.1%. Age ≤5 years, the presence of inhalational injury, burn injury >30% of TBSA and admission to the PBICU were significant risk factors for mortality. S Afr Med J 2016;106(2):189-192. DOI:10.7196/SAMJ.2016.v106i2.8942

In high-income countries, the mortality rate for children <5 years of age is 1 in 152.[1] In sub-Saharan Africa (SSA) the rate is 1 in 9.[1] In 2011, SSA and Southern Asia shared 83% of global deaths in children <5 years of age.[1] In 2007, the childhood mortality rate was 1 in 21 in South Africa (SA).[2] The 2010 Bulletin of the World Health Organization lists burns as one of the top five causes of fatal urban injuries in SA children.[3] Globally, burn-related deaths account for approximately 100 000 deaths per annum.[4] In SA, approximately 1 300 children die annually as a result of burns.[4] The Johnson & Johnson Paediatric Burns Unit at Chris Hani Baragwanath Academic Hospital (CHBAH), Johannesburg, SA, opened in 1995. The unit admits approximately 450 patients per year. Before 2009, the unit, including the paediatric burns intensive care unit (PBICU), was run solely by the Department of Paediatric Surgery. For the surgeons managing the unit, burns were just one of several key areas that they were expected to take responsibility for, the others broadly divided into neonatal and general paediatric surgery. Recordkeeping before 2009 was imperfect, but there was a perception that the mortality due to burns, particularly those involving a total body surface area (TBSA) of 10 - 20%, was unacceptably high. An internal audit at this point revealed an overall mortality rate approximating 20%, which was deemed unacceptably high, particularly when compared with major burn centres such as the Shriners Hospital for Children in Texas, USA (mortality rate 2.7%) and SB Ankara Diskapi Paediatric Education and Research Hospital in Ankara, Turkey (5.8%).[5,6] This finding prompted negotiations with the paediatric intensive care unit with a view to the intensivists taking over the

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intensive care management of all patients admitted to the PBICU. This programme in which intensivists became an inclusive part of the multidisciplinary team managing burns patients began in 2009. In addition, a dedicated burns surgeon was employed, and advances in wound care were adopted during the study period. The use of a database enabled improved record keeping.

Objective

To investigate the mortality among children admitted to a dedicated paediatric burns unit at CHBAH.

Methods

After ethical approval had been obtained, the records of patients admitted to the Johnson & Johnson Paediatric Burns Unit, CHBAH, were retrospectively reviewed for May 2009 to April 2012. After excluding elective readmissions for skin grafts and other reconstructive procedures as well as cases with incomplete records, 1 372 patients were included in the study. Age, gender, mechanism of injury and TBSA burned were recorded. The presence of inhalational injury was recorded. Autopsy findings and results were unavailable, and only the suspected cause of death was recorded. Admission to the PBICU, either initially or during the course of the hospital stay, was noted. The mortality rate for each year was determined. Mortality in the paediatric burns general ward and the PBICU was calculated separately. The overall mortality was then determined. Median ages of children admitted to the general ward and the PBICU and of those who died were calculated. Age groups (years) were categorised

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RESEARCH

Table 1. Admissions Year

Admissions, n Deaths, n Mortality, %

May 2009 - April 2010

May 2010 - April 2011

May 2011 - April 2012

Total

318

414

449

116

565

1 089

283

1 372

109

1.3

20.8

8.2

0.7

22.4

5.1

1.5

29.3

7.9

322

393

2.8

52.1

11.7

W = paediatric burns general ward; I = PBICU; P = paediatric burns unit (W + I).

as follows: 0 - 1, 1 - 3, 3 - 5 and 5 - 10. The cause of the burn injury was classified as hot water, flame or other, the latter including electrical burns, surface contact burns and various other liquid burns (e.g. tea, coffee and oil). The TBSA burned was determined using a Lund-Browder chart. In this regard, there were often discrepancies between the assessment of the admitting doctor in casualty and the treating team in the unit. The assessment in the unit was taken to be correct, as this was a consensus decision by several staff including surgeons, intensivists and nurses. Simple erythema was not included as part of the TBSA. The TBSA was categorised as follows: 0 - 10%, 11 - 20%, 21 - 30%, 31 - 40%, 41 - 60% and >60%. Specific mortality rates for gender and the subgroups of age and TBSA were also determined for each year of the study period. The Cochran-Armitage test for trends was used to determine the significance of the trends over the 3-year period. The z-test for proportions was used to determine the significance of the difference in mortality between male and female patients admitted to the unit. A statistician assisted with the statistical analysis of the data.

Results

Including all children ≤10 years of age, 1 372 patients, of whom 754 (55.0%) were male, were admitted to the unit during the study period, 283 having been managed in the PBICU. Table 1 shows the admissions to and deaths in the unit, further subdivided into the general ward and the PBICU, for the 3-year study period. The median age of all patients admitted to the unit was 4.1 years, while the median age of those admitted to the PBICU was 3.0 years. Children aged ≤5 years comprised 63.0% of the total admissions. The median age of the patients who died was 3.0 years. The vast majority of admissions were of children with hot-water burns (n=1 049, 76.5%). Flame burns were the second leading cause of burn injuries (n=299, 21.8%). Electrical burns, contact burns and burns

Table 2. Mechanisms of burn injury Mechanism

Admissions, n

Deaths, n

Standardised mortality, %

Hot water

1 049

7.5

Flame

299

9.4

Other

8.3

Table 3. Inhalational injury

Table 4. Percentage of overall deaths that occurred in the PBICU

Year 1

Total

Inhalation injury, n

Alive

Dead

Inhalation mortality, %

100.0 90.0 50.0

89.5

from liquids other than water together accounted for 1.8% of all admissions to the unit. The standardised mortality for the respective mechanisms of injury for the study period is shown in Table 2. Nineteen patients were admitted with inhalational injury, all to the PBICU. Of these, 17 died (Table 3). There were 109 deaths during the 3-year period, giving an overall mortality rate of 7.9%. Of these deaths, 85.3% occurred in the PBICU (Table 4), the remaining 14.7% occurring in the ward. The majority of deaths occurred in younger children. There was an inverse relationship between age and mortality (Fig. 1). Of the deaths, 50.4% were in children ≤3 years of age, while 90.8% of deaths were in children ≤5 years of age (Fig. 2). The standardised mortality according to TBSA is shown in Fig. 3. During the study period, no child with a burn injury ≥60% TBSA survived. The mortality rates since 2009 are shown in Fig. 4.

Discussion

Reported rates of burn mortality are highest in the first 3 years of life, decreasing and reaching a nadir in adolescence, after

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February 2016, Vol. 106, No. 2

Year 1 % of total deaths that occurred in PBICU

80.4 88.2

Total

89.7

85.3

which they start to increase again. This concentration of burn injury and mortality among infants and toddlers occurs across SA’s population groups. Mortality as well as injury rates are higher in males than in females.[4] This male preponderance is not limited to SA and other low- and middleincome countries (LMICs). A large Euro pean systematic review published in 2010 found a 60% male predominance among burn victims aged <16 years.[7] According to the National Injury Mortality Surveillance System, the childhood mortality rate for burns in SA in 2001 was 14.1%, with the majority of deaths occurring in children <6 years of age.[4] Several decades ago, TBSA burns of >80% were considered uniformly fatal, particularly in the elderly and in very young children. With improvements in resuscitation, inten sive care and understanding of the patho physiology of burns, the mortality has significantly improved. In 1998, the Shriners Institute showed a mortality rate of 33% for massive burns (TBSA >80%) in patients aged 6 months - 17 years. They cited lower age, larger burn size, the presence of inhalation injury, delayed intravenous access, lower admission haematocrit, lower base deficit on

RESEARCH

% of deaths (standardised) (n=109)

14 12 Patients, %

10 8 6 4 2 0

0-1

1-3

3-5

Age category, years

100 90 80 70 60 50 40 30 20 10 0

≤10

11 - 20

21 - 30

31 - 40

41 - 60

>60

TBSA burned, %

Fig. 3. Standardised mortality according to TBSA.

Overall mortality, %

% of deaths (n=109)

Fig. 1. Standardised mortality by age group.

30 25 20 15 10 5 0

10 8 6 4 2

0-1

1-3

3-5

2009 - 2010

Age category, years

2010 - 2011

2011 - 2012

Year

Fig. 2. Mortality by age group as a percentage of overall mortality.

Fig. 4. Trends in mortality.

admission, higher serum osmolarity at arrival, sepsis, requirement for inotropic support, platelet count <20 × 109/L and ventilator dependency as significant predictors of mortality.[8] In 2001, the same institute showed that children aged <3 years have an increased mortality risk, whether or not they have an additional inhalational burn injury.[9] The hypothesis that very young children are at increased risk was further backed up by a large multicentre study in 2006 that reviewed 12 000 children from 43 burn centres across the USA. The authors concluded that there is strong evidence that, when comparing children based on burn injuries of similar size and aetiology, children aged <4 years are at substantial risk for death compared with their older counterparts.[10] We compared our overall mortality rate with rates for various institutions around the world (Table 5). Our overall burn mortality is lower than that in institutions from other LMICs, but higher than that in the SB Ankara Diskapi Paediatric Education and Research Hospital in Turkey, an upper middle-income country, and the Shriners Hospital for Children in the USA, a high-income country. While we believe that this comparison is useful to see where we feature in the global picture, we understand that the various overall mortality rates may be influenced by many factors, including resources and admission criteria. The majority of our patients had thermal injuries caused by hot water (76.5%). The problems associated with low socioeconomic status, poor living conditions and their correlation with thermal injuries in the SA setting have been well documented.[13] The next most common burns were due to flame injuries (21.8%). Electrical injuries and contact burns made up a very small percentage of our admissions. There was no significant difference in the standardised mortality for the different mechanisms of burn injury (z-test for proportions) (Table 2).

Fifty-five percent of patients admitted during the study period were male. While the mortality in female patients was higher than that in their male counterparts (8.7% v. 7.3%), this difference was not significant (p=0.31; z-test for proportions). This is in contrast to the national population injury mortality in the SA setting, where the mortality rate for male children was found to be significantly higher than that for female children.[4] Inhalational injury was a significant risk factor for mortality, 17 of 19 patients admitted with an inhalational injury having died. Although our overall mortality decreased significantly during the 3-year study period (p=0.0002; Cochran-Armitage test for trend), there was no significant decrease during this time in the trend of mortality of patients who sustained inhalational injuries (p=0.07; Cochran-Armitage test for trend). Another vulnerable subgroup was children aged ≤5 years. We observed a decreasing trend in mortality with increasing age (Fig. 1), also noted in the literature.[4] Children aged ≤5 years comprised 63.0% of total admissions and 90.8% of total deaths (Fig. 2). Patients requiring admission to the PBICU have a greatly increased mortality compared with those admitted to the ward (29.3% v. 1.5% chance of dying), with 85.3% of deaths occurring in the PBICU setting. The change in this trend over the 3-year study period was not significant (p=0.24; Cochran-Armitage test for trend). The fact that more severely injured patients are being admitted to the PBICU accounts for the significantly higher mortality in this environment. However, it is concerning that 16 patients (mortality 1.5%) died during their admission to the ward. These deaths were either truly unexpected or the patients were inadequately assessed and incorrectly admitted to the general ward instead of the PBICU. While we have seen a decreasing trend in the number of ward deaths over the 3-year study period, this decline was not significant. This potentially incorrect assessment

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RESEARCH

Table 5. Comparison of overall mortality with that published by other institutions Institution

Mortality, %

Chris Hani Baragwanath Academic Hospital Paediatric Burns Unit, May 2009 - April 2012 (the present study)

7.9

University of Lagos State University Teaching Hospital, Lagos, Nigeria, 2004 - 2008[11]

29.9

Department of Plastic and Reconstructive Surgery, Motahari Burn Hospital, Tehran University of Medical Sciences, Tehran, Iran, 2005 - 2009[12]

10.6

Shriners Hospital for Children, Texas, USA, 1989 - 2009[5]

2.7

SB Ankara Diskapi Paediatric Education and Research Hospital, Ankara, Turkey, 1998 - 2006[6]

5.8

or underassessment of burn injuries is an area that we should improve on. The mortality of patients admitted to our unit increased steeply once the TBSA burned rose to >30%. While massive burns (TBSA >60%) were uniformly fatal during the study period, we have had two survivors subsequently. Numerous major changes have taken place in the unit since the commencement of the study. These have included improvement in human resources with the introduction of paediatric intensivists, a dedicated burn surgeon, and increased numbers of junior and mid-level trainees. Since their introduction, the paediatric intensivists manage all patients admitted to the PBICU. All outside referrals to the PBICU are discussed with the paediatric intensivist, as are patients admitted to the PBICU from casualty after they have initially been assessed and resuscitated by the surgical registrar. The intensivist sees all patients admitted to the PBICU at least twice a day, and also assists with the management of certain patients admitted to the paediatric burns general ward. This includes patients awaiting intensive care unit beds, assistance with antimicrobial coverage and fluid management, and any patient the surgical team may be concerned about. Improved availability and usage of dressings and a perceived general trend towards earlier skin coverage have occurred. Since 2009, there has been a significant decline in the overall mortality rate (Fig. 4) (p=0.0002; CochranArmitage test for trend), with mortality during the final year of the study period being similar to those in high-income countries. It is our opinion that this significant decline is largely due to the above changes. Unfortunately we did not document time taken from admission to achieving skin coverage in this data set, but this will be documented in the future. Clean burn wounds with a TBSA >10% up to a depth of superficial partial thickness have

increasingly been covered with Biobrane and Acticoat dressings within the first 24 hours after burn injury. We have also tended towards earlier skin coverage for wounds that would take >2 weeks to heal. Where there was sufficient donor skin on the patient, early split-thickness skin grafting was used. If necessary, the skin was meshed up to a ratio of 3:1. If meshing the skin did not give sufficient skin coverage, attempts were made to procure cadaver donor skin. We have found cadaver donor skin to be very useful. In the majority of our patients, the cadaver skin sloughs between days 10 and 14. The underlying wound can then be skin grafted using healed donor skin sites. Occasionally the underlying wound had begun to epithelialise, negating the need for further skin grafting. More rarely, the cadaver skin had taken completely. Our challenges in managing massive burns (TBSA >60%) and paying special attention to children aged <5 years are clear. Significant improvement in the management and out come of children admitted with TBSA burns of 30 - 60% is also required. There are currently two ongoing studies in our unit directly addressing: (i) the impact of paediatric intensivists on our unit; and (ii) the impact of specific dressings on specific populations.

Conclusion

The mortality rate in the Johnson & Johnson Paediatric Burns Unit at CHBAH is 7.9%, having declined significantly over the 3-year study period, and is lower than that quoted in institutions from other LMICs. Age ≤5 years, the presence of inhalational injury, TBSA >30% and admission to the PBICU were significant risk factors for mortality. We believe that other burn centres in SA should pay special attention to these at-risk populations. In particular, a lower threshold for admission to the PBICU and the early involvement of a paediatric intensivist is recommended. The importance of the multidisciplinary team in the management of burns is widely

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known.[14] Advances in wound care and skin coverage continue. Our challenges lie in understanding how best to implement these advances in a resource-constrained environment, and more importantly to ensure that the changes implemented translate into improvements in patient care. If these challenges are successfully met, our long-term goal of achieving and sustaining the standards achieved by major international paediatric burn centres may be realised. Acknowledgements. We acknowledge and thank Petra Gaylard and the Wits Donald Gordon Medical Centre for their assistance with our statistical analyses, as well as all members of the paediatric surgical, intensive care and allied medical staff that have had such a positive impact on the outcomes of these children. References 1. You D, New JR, Wardlaw T. Levels and Trends in Child Mortality Report 2012. New York: United Nations Children’s Fund, 2012. 2. Nannan N, Dorrington R, Laubscher R, et al. Under-5 Mortality Statistics in South Africa: Shedding Some Light on the Trend and Causes 1997-2007. Cape Town: South African Medical Research Council, 2012. 3. Burrows S, van Niekerk A, Laflamme L. Fatal injuries among urban children in South Africa: Risk distribution and potential for reduction Bull World Health Organ 2010;88:267-272. [http:// dx.doi.org/10.2471/BLT.09.068486] 4. Van Niekerk A, Titi N, Lau U, Arendse N. Flame and scalding burns in children. In: Van Niekerk A, Suffla S, Seedat M, Ratele K, eds. Crime, Violence and Injury in South Africa: Enabling Child Safety, 01/2011: chapter; Cape Town: South African Medical Research Council, 2011. 5. Williams FN, Herndon DN, Hawkins HK, et al. The leading causes of death after burn injury in a single pediatric burn center. Crit Care 2009;13(6):R183. [http://dx.doi.org/10.1186/ cc8170.] 6. Senel E, Yasti AC, Reis E, Doganay M, Karacan CD, Kama NA. Effects on mortality of changing trends in the management of burned children in Turkey: Eight years’ experience. Burns 2009;35(3):372-377. [http://dx.doi.org/10.1016/j. burns.2008.07.020] 7. Brusselaers N, Monstrey S, Vogelaers D, Hoste E, Blot S. Severe burn injury in Europe: A systematic review of the incidence, etiology, morbidity, and mortality. Crit Care 2010;14(5):R188. [http://dx.doi.org/10.1186/cc9300/ccforum.com/content/14/5/ R188] 8. Wolf SE, Rose JK, Desai H, et al. Mortality determinants in massive pediatric burns: An analysis of 103 children with 7080% (full-thickness) TBSA burns. Ann Surg 1997;225(5):554569. 9. Barrow RE, Spies M, Barrow LN, Herndon DN. Influence of demographics and inhalation injury on burn mortality in children. Burns 2004;30(1):72-77. [http://dx.doi.org/10.1016/j. burns.2003.07.003]. 10. Thombs BD, Singh VA, Milner SM. Children under 4 years are at greater risk of mortality following acute burn injury: Evidence from a national sample of 12902 pediatric admissions. Shock 2006;26(4):348-352. [http://dx.doi.org/10.1097/01. shk.0000228170.94468.e1] 11. Fadeyibi IO, Mustapha IA, Ibrahim NA, et al. Characteristics of paediatric burns seen at a tertiary centre in a low income country: A five year (2004-2008) study. Burns 2011;37(3):528534. [http://dx.doi.org/10.1016/j.burns.2010.09.015.] 12. Karimi H, Motevalian S-A, Rabbani A, et al. Prediction of mortality in pediatric burn injuries: R-Baux score to be applied in children (Pediatrics-Baux Score). Iran J Pediatr 2013;23(2):165-170. http://ijp.tums.pub/en/articles/1911.html (accessed 6 January 2016). 13. Blom L, van Niekerk A, Laflamme L. Epidemiology of fatal burns in rural South Africa: A mortuary register-based study from Mpumalanga Province. Burns 2011;37(8):1394-1402. [http://dx.doi.org/10.1016/j.burns.2011.07.014] 14. Rode H, Rogers AD, Numanoglu A, et al. A review of primary and secondary burn services in the Western Cape, South Africa. S Afr Med J 2015;105(10):852-857. [http://dx.doi. org/10.7196%2FSAMJnew.8187]

Accepted 20 October 2015.

RESEARCH

Validating homicide rates in the Western Cape Province, South Africa: Findings from the 2009 Injury Mortality Survey M Prinsloo,1 MPH; R Matzopoulos,1,2 PhD; R Laubscher,3 BComm (Maths); J Myers,2 PhD; D Bradshaw,1 DPhil urden of Disease Research Unit, South African Medical Research Council, Cape Town, South Africa B School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa 3 Biostatistics Unit, South African Medical Research Council, Cape Town, South Africa 1 2

Corresponding author: M Prinsloo (megan.prinsloo@mrc.ac.za)

Background. The Western Cape Province had the highest homicide rates in South Africa during the early 2000s. South African Police Service (SAPS) data suggested a significant decline in homicide rates in the Western Cape since 2007. It ranked second highest to the Eastern Cape Province until 2013 and ranked highest again at 52.1/100 000 in 2015. A recent national injury mortality survey offers an alternative data source to assess whether the decline in homicide rates in the Western Cape was real. Methods. A retrospective record review of autopsies was conducted from 45 state mortuaries in eight provinces for 2009. In addition, mortality data for the Western Cape were sourced from the Provincial Injury Mortality Surveillance System. Age-standardised mortality rates and crude homicide rates per 100 000 population were calculated to compare with the SAPS crude rates. Results. Our study found that the Western Cape had a provincial age-standardised homicide rate of 40.1/100 000 in 2009 and ranked fourth highest among the nine provinces. The crude homicide rate of 43/100 000 for the Western Cape was similar to the SAPS provincial homicide rate of 42.4/100 000. The Northern Cape Province was the only notable exception to our provincial homicide rate ranking comparison with the SAPS for 2009. Conclusions. The Western Cape is fortunate to have alternative data sources to monitor trends in homicides over time. The latest release of the 2014/2015 SAPS crime statistics should be assessed in a similar manner, with a more recent data source, to validate accuracy of the provincial rates on a regular basis. S Afr Med J 2016;106(2):193-195. DOI:10.7196/SAMJ.2016.v106i2.10211

More than a decade ago, the Western Cape Province of South Africa (SA) was considered to have the highest homicide rate in the country. The first National Burden of Disease study for 2000[1] estimated that the age-standardised homicide rate in the Western Cape was highest at 74/100 000 population, compared with a national average of 67/100 000. High homicide rates in the Western Cape were also noted in the five-city trend analysis from 2001 to 2005,[2] which indicated that Cape Town had the highest average homicide rate compared with selected cities in other provinces. Analysis of South African Police Service (SAPS) data for 2002/2003 indicated that the homicide rate of 85/100 000 in the province was approximately 1.8 times the national average,[3] albeit based on crude rates that did not account for provincial differences in the age profile. SAPS data suggest that there has been a significant decline in homicide rates in the Western Cape relative to other provinces since 2007 (Fig. 1). A 5-year period of relatively constant rates followed, during which it ranked second to the Eastern Cape Province, although it started to increase from 2013 and ranked highest once again at 52.1/100 000 for the 2014/2015 financial year.[4,5] The importance of the decline in 2007 may have been missed amid the annual media maelstrom that follows the release of police crime statistics, or perhaps because crime statistics in SA – even homicide statistics, which in the rest of the world are the most widely used measure to compare the extent of interpersonal violence across countries, cities and regions[6] – are considered inaccurate.[7] A recent study of injury mortality, undertaken as part of the second National Burden of Disease study, recorded 13% more homicides than

193

the police in 2009[8] and offers an alternative data source to assess whether the decline in the homicide rates in the Western Cape was real. It also provides information about homicide rates in metropolitan (metro) areas compared with non-metropolitan (non-metro) areas.

Methods

We conducted a retrospective record review of autopsies from 45 state mortuaries in eight provinces for 2009. Mortuaries were selected by multistage cluster sampling and stratified by metro (comprising the metropolitan municipalities of the City of Cape Town, the City of Johannesburg, the City of Tshwane, Ekurhuleni, eThekwini and Nelson Mandela Bay) and non-metro area, as well as mortuary size, which varied from small (up to 500 bodies) to large mortuaries (>1 500 bodies). Full details of the sampling strategy and methodology are available in Matzopoulos et al.[8] Mortality data were sourced from the Western Cape’s Provincial Injury Mortality Surveillance System[9] to complete the national sample. Fieldworkers were trained to review postmortem folders and to capture the required information on a mobile phone loaded with custom-designed software.[10] Death records were first assessed for natural, non-natural or undetermined causes, after which information on age, gender, population group, date of death, apparent manner of death and external cause of death, consistent with the 10th revision of the International Statistical Classification of Diseases and Related Health Problems,[11] was captured. Age-standardised mortality rates per 100 000 population were calculated for homicide, suicide, unintentional injuries, transport and deaths where the intent was undetermined.[8]

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The Western Cape had a provincial agestandardised homicide rate of 40.1/100 000 population in 2009, ranking fourth highest among the nine provinces and close to the national average of 38.4/100 000 (Table 1). There was a marginal difference between the metro and non-metro areas in the Western Cape. The Eastern Cape had the highest homicide rate at 57.9/100 000, which was 1.5 times the national average. KwaZulu-Natal Province (KZN) had the highest metro homicide rate (72.3/100 000), considerably higher than the rate for the province’s non-metro area of 37.9/100 000. There was not much difference between the age-standardised rates and crude rates in our study. The crude homicide rate of 43/100 000 for the Western Cape was similar to the SAPS provincial homicide rate of 42.4/100 000 for the 2009/2010 financial years (Fig. 1). Our analysis also confirms the SAPS finding that the Eastern Cape had the highest homicide rate. However, there are two exceptions in the top four ranking comparison of our study with the SAPS for 2009 – KZN ranked third highest for the SAPS, while the Northern Cape Province was the least consistent with our findings, our study’s homicide rate being 1.6 times higher than that of the SAPS.

The reasons for this decrease are unclear. The province’s holistic approach to violence prevention, which supports evidence-based approaches for violence prevention and a review and consultation process aimed at aligning existing performance priorities and deliverables across departments, has received some international recognition, but was only formally adopted in 2013. [12] Nationally, the significant decrease in homi cides from 2000 has been attributed to the decline in firearm homicide corresponding with the implementation of the Firearms Control Act (No. 60 of 2000). Matzopoulos et al.[2] reported a consistent year-on-year decline in firearm homicide rates in five major cities from 2001 to 2005. Cape Town’s decline in firearm homicide rates from 34.4

60 50 40 30 20 10

Discussion

The ranking of provincial homicide rates in our study was very similar to the SAPS crime statistics for 2009, with the notable exception of the Northern Cape. This finding is consistent with the reported decrease in Western Cape homicide rates.

to 20.9/100 000 from 2001 to 2005 was sharper than Durban’s decline of 38.2 - 28.3 for the same period.[13] The 2009 Injury Mortality Survey found that this decline was sustained for the Western Cape, with firearms accounting for 22% of homicides compared with 42% in KZN.[14] A study conducted in rural areas of KZN reported firearms to account for an average of 65% of homicides from 2000 to 2008.[15] Globally, much of the variance in homicide rates has been explained by changes in firearm homicide,[16] and it is conceivable that the Western Cape fared better in terms of enforcement of firearms legislation until 2009. According to the SAPS, the Western Cape homicide rate remained constant since the

Deaths/100 000 population

Results

2004/2005 2005/2006 2006/2007 2007/2008 2008/2009 2009/2010 2010/2011 2011/2012 2012/2013 2013/2014 2014/2015

Eastern Cape

Free State

Gauteng

KwaZulu-Natal

Limpopo

Mpumalanga

North West

Northern Cape

Western Cape

Fig. 1. SAPS crude homicide rates by province, 2004/2005 - 2014/2015. (Source: South African Police Service, 2004 - 2014,[4] and 2014/2015 rates from the Institute for Security Studies.[5])

Table 1. Age-standardised homicide rate (ASR) and crude homicide rate (CR) (/100 000) by province and area based on the Injury Mortality Survey (IMS), SA 2009 (N=19 028) Provincial ranking

IMS metro ASR (95% CI)

IMS non-metro ASR (95% CI)

IMS homicide ASR (95% CI)

IMS homicide CR (95% CI)

1. Eastern Cape

62.2 (9.4 - 115.5)

55.4 (8.4 - 102.8)

57.9 (20.9 - 94.9)

53.5 (20.2 - 86.8)

2. Northern Cape

53.6 (4.2 - 104.6)

51.5 (3.6 - 99.3)

3. KZN

72.3 (30.6 - 114.0)

37.9 (19.3 - 56.5)

50.8 (31.1 - 70.4)

47.3 (29.6 - 65.0)

4. Western Cape†

41.8

37.0

40.1

43.0

5. Gauteng

36.2 (19.2 - 53.2)

‡

36.2 (19.2-53.2)

38.5 (21.1-55.9)

6. Free State

35.3 (10.0 - 60.7)

35.3 (10.4 - 60.1)

7. North West

25.1 (7.6 - 42.5)

25.0 (8.0 - 41.9)

8. Limpopo

18.8 (3.8 - 34.1)

16.8 (3.7 - 29.9)

9. Mpumalanga

17.5 (4.0 - 31.1)

16.5 (4.1 - 28.9)

South Africa

45.1 (37.3 - 52.9)

33.2 (25.0 - 41.4)

38.4 (33.6 - 43.3)

37.9 (33.6 - 42.3)

CI = confidence interval. *These provinces have no metropolitan municipalities. † The Western Cape data include the full sample of 18 mortuaries and hence have no CIs. ‡ This province has no designated non-metropolitan area.

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decline but has shown an increase in 2013/2014 and currently ranks highest. However, in this regard it is possible that certain other SAPS provincial rates are under-reported. The SAPS statistics for 2009 showed that the Northern Cape’s rate for attempted murder was nearly double the rate for the Western Cape and has been highest of all the provinces from 2004 to 2011.[4] This could be the result of statistics not being updated to homicide in the event of death, but there has been past speculation regarding findings that are particular to attempted murder rates and the fact that these are easier to manipulate than homicide statistics.[7,17] This should be investigated. Reports of police corruption, with the most recent implicating a senior policeman for illegally supplying confiscated weapons to Cape Town gangs,[18,19] provide further impetus to the understanding that the number of firearms in circulation, and illegally obtained firearms in particular, may explain the latest increase in Western Cape homicide rates. There are limitations in comparing the 2009 Injury Mortality Survey with the SAPS figures. Our study represented a calendar year, whereas the SAPS reports on financial years. The sampling strategy for our study was based on attaining metro/non-metro rather than provincial representivity. This explained the wide confidence intervals and possibly also the anomalous results for the Northern Cape. The Western Cape is fortunate to have alternative data sources to monitor trends in homicides over time. A similar source of data is needed to investigate the decrease in the reported SAPS homicide rates for KZN between 2009 and 2011, given the high levels of firearm homicide reported in earlier studies and the contention surrounding the accuracy of KZN crime statistics.[20] The latest release of the 2014/2015 SAPS crime statistics should be assessed in a similar manner, with a more recent data source, to validate its accuracy on a regular basis.

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References 1. Bradshaw D, Nannan N, Laubscher R, et al. South African National Burden of Disease Study 2000: Estimates of Provincial Mortality. Cape Town: South African Medical Research Council, 2004. 2. Matzopoulos RG, Thompson ML, Myers JE. Firearm and nonfirearm homicide in 5 South African cities: A retrospective population-based study. Am J Public Health 2014;104(3):455-460. [http://dx.doi. org/10.2105/AJPH.2013.310650] 3. Leggett T. What’s up in the Cape? Crime rates in Western and Northern Cape provinces. SA Crime Quarterly 2004;No.7:15-20. 4. South African Police Service. RSA: April to March 2004 - 2014: Crime Categories Figures and Ratios 2014. http://www.saps.gov.za/resource_centre/publications/statistics/crimestats/2014/crime_stats.php (accessed 27 July 2015). 5. Institute for Security Studies. Murder and robbery – overview of the official statistics: 2014/2015. Fact sheet, September 2015. https://www.issafrica.org/crimehub/uploads/SA-CrimeStats%E2%80%932015-Murder-and-robbery-fact-sheetV2.pdf (accessed 9 October 2015). 6. Matzopoulos R, Bhalla K, Harrison J. Homicide. In: Donnelly PD, Ward CL, eds. Oxford Textbook of Violence Prevention: Epidemiology, Evidence and Policy. Oxford: Oxford University Press, 2015:11-77. 7. Bruce D. ‘The ones in the pile were the ones going down’: The reliability of violent crime statistics. SA Crime Quarterly 2010;No.31:1-17. 8. Matzopoulos R, Prinsloo M, Pillay-van Wyk V, et al. Injury-related mortality in South Africa: A retrospective descriptive study of post-mortem investigations. Bull World Health Organ 2015;93:303313. [http://dx.doi.org/10.2471/BLT.14.145771] 9. Matzopoulos R, Martin LJ, Wadee S, et al. The Provincial Injury Mortality Surveillance System (PIMSS): A surveillance tool for the Western Cape. Inj Prev 2010;16(Suppl 1):A47-A48. [http://dx.doi. org/10.1136/ip.2010.029215.172] 10. Mobenzi Researcher. Mobenzi Home Page 2011. http://www.mobenzi.com/researcher (accessed 22 April 2013). 11. World Health Organization. International Statistical Classification of Diseases and Related Health Problems – Tenth Revision. Vol. 2. Geneva: WHO, 2008. http://www.who.int/classifications/apps/icd/ icd10online/ (accessed 15 November 2014). 12. Matzopoulos R, Myers JE. The Western Cape Government’s new Integrated Provincial Violence Prevention Policy Framework: Successes and challenges. Aggress Violent Behav 2014;19(6):649-646. [http://dx.doi.org/10.1016/j.avb.2014.09.009] 13. Prinsloo M, ed. A Profile of Fatal Injuries in South Africa, 2005. Seventh Annual Report of the National Injury Mortality Surveillance System. Cape Town: MRC-UNISA Crime, Violence and Injury Lead Programme, 2007. 14. Matzopoulos R, Prinsloo M, Bradshaw D, et al. The Injury Mortality Survey: A National Study of Injury Mortality Levels and Causes in South Africa in 2009. Cape Town: Medical Research Council, 2013. 15. Otieno G, Marinda E, Bärnighausen T, Tanser F. High rates of homicide in a rural South African population (2000-2008): Findings from a population-based cohort study. Popul Health Metr 2015;13:20. [http://dx.doi.org/10.1186/s12963-015-0054-0] 16. Bhalla K, Matzopoulos R, Harrison J, et al. Tracking national homicide rates: Generating estimates using vital registration data. Small Arms Survey: Issue Brief No.1 2012:1-12. 17. Gould C, Burger J, Newham G. The SAPS crime statistics: What they tell us – and what they don’t. SA Crime Quarterly 2012;No.42:3-12. 18. Baadjies M. ‘Dirty cop sold us 200 guns’. Daily Voice 15 July 2015. 19. Dolley C. Police ‘gave guns to gangs’. Weekend Argus 28 September 2014. 20. Dawood Z, Dzanibe S. New KZN crime stats show massive spikes. Daily News 25 September 2014.

Accepted 23 October 2015.

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Empirical antimicrobial therapy for probable v. directed therapy for possible ventilator-associated pneumonia in critically injured patients Y Ramsamy,1,2,6 MB ChB, FCPath (Micro), MMed (Micro); D J J Muckart,3 MB ChB, FRCS, MMSc Crit Care (SA); J L Bruce,4,5 MB ChB, FCS (SA); T C Hardcastle,3 MB ChB, MMed (Chir), FCS (SA), PhD; K S S Han,2,6 MB BS, FCPath (Micro), MMed (Micro), DTMH, PDIC; K P Mlisana,2,6 MB ChB, MMed (Micro), PhD epartment of Medical Microbiology, Prince Mshiyeni Memorial Hospital, Durban, South Africa D Department of Medical Microbiology, School of Laboratory Medicine and Medical Sciences, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 3 Department of Surgery, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 4 Trauma Fellow, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 5 Pietermaritzburg Trauma Service, South Africa 6 National Health Laboratory Service (KZN Academic Complex), Durban, South Africa 1 2

Corresponding author: Y Ramsamy (yogandree@gmail.com)

Background. Ventilator-associated pneumonia (VAP) has recently been classified as possible or probable. Although direct attributable mortality has been difficult to prove, delay in instituting appropriate therapy has been reported to increase morbidity and mortality. Recent literature suggests that in possible VAP, instituting directed therapy while awaiting microbiological culture does not prejudice outcome compared with best-guess empirical therapy. Objectives. To ascertain outcomes of directed v. empirical therapy in possible and probable VAP, respectively. Methods. Endotracheal aspirates were obtained from patients with suspected VAP. Those considered to have possible VAP were given directed therapy following culture results, whereas patients with more convincing evidence of VAP were classed as having probable VAP and commenced on empirical antimicrobials based on microbiological surveillance. Results. Pneumonia was suspected in 106 (36.8%) of 288 patients admitted during January - December 2014. Of these, 13 did not fulfil the criteria for VAP. Of the remaining 93 (32.2%), 31 (33.3%) were considered to have probable and 62 (66.7%) possible VAP. The former were commenced on empirical antimicrobials, with 28 (90.3%) receiving appropriate therapy. Of those with possible VAP, 34 (54.8%) were given directed therapy and in 28 (45.2%) no antimicrobials were prescribed. Of the latter, 24 recovered without antimicrobials and 4 died, 3 from severe traumatic brain injury and 1 due to overwhelming intra-abdominal sepsis. No death was directly attributable to failure to treat VAP. No significant difference in mortality was found between the 34 patients with possible VAP who were commenced on directed therapy and the 31 with probable VAP who were commenced on empirical antimicrobials (p=0.75). Conclusions. Delaying antimicrobial therapy for VAP where clinical doubt exists does not adversely affect outcome. Furthermore, this policy limits the use of antimicrobials in patients with possible VAP following improvement in their clinical condition despite no therapy. S Afr Med J 2016;106(2):196-200. DOI:10.7196/SAMJ.2016.v106i2.9870

Ventilator-associated pneumonia (VAP) remains a diagnostic dilemma.[1] New-onset fever, leucocytosis, changes in chest auscultation, radiology and lung function and a positive bacterial culture suggest VAP, but do not necessarily confirm it. Overdiagnosis of VAP on clinical and radiological grounds may occur in up to 50% of patients, leading to inappropriate overuse of broad-spectrum antimicrobials, which is a major determinant of bacterial resistance, whereas failure to treat established VAP is reported to increase morbidity and mortality.[1] Guidelines continue to evolve as the definitions for VAP change in an effort to clarify a complex clinical condition and identify those patients who require therapy.[2] Recent Centers for Disease Control (CDC) guidelines[3] propose a tiered approach to VAP and the division of infection-related ventilatorassociated complications into possible and probable VAP. A change in temperature and white blood cell count, worsening oxygenation, purulent secretions and the empirical prescription of antimicrobials are prerequisites for both categories. In addition, a diagnosis of possible VAP requires either purulent secretions or a positive

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bacterial culture of sputum, whereas a diagnosis of probable VAP requires purulent secretions and specific quantitative analysis of either an endotracheal aspirate (ETA) or more invasive specimens from bronchoalveolar lavage, a protected specimen brush, pleural fluid or lung tissue. In the absence of purulent secretions, diagnostic tests for Legionella or a number of viruses are recommended. In both possible and probable VAP, specimens containing normal respiratory or oral flora, Candida, coagulase-negative staphylococci or enterococci are excluded. Given the absolute criterion that antimicrobials need to be administered in both categories, these divisions do not reduce unnecessary prescriptions and will have little impact on curbing bacterial resistance. Whether possible or probable, VAP is defined as pneumonia occurring after 48 hours of endotracheal intubation and mechanical ventilation. The American Thoracic Society guidelines[4] divide VAP into early (starting on days 3 and 4) and late (starting on day 5 or thereafter). Regardless of the time of onset of suspected VAP, initial antimicrobial therapy will of necessity be empirical until microbiology results become available. The recommendation

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is to use broad-spectrum drugs and de- [5] escalate when sensitivities are reported. Delays in microbiology results or marked improvement in the patient’s clinical condition may perpetuate use of the initial choice of antimicrobial, a potent stimulus for multidrug bacterial resistance. Recent work suggests that where there is diagnostic doubt, delaying antimicrobials until culture results are available does not increase mortality and in fact may improve survival.[6] The antimicrobial policy in the Trauma Intensive Care Unit (TICU) at Inkosi Albert Luthuli Central Hospital (IALCH), Durban, South Africa, is to treat probable VAP empirically but to await microbiological results before treating possible VAP. We embarked on a prospective observational study in the TICU with a view to deter mining whether delaying antimicrobial prescriptions in patients with possible VAP until microbiology results became available made any difference to outcome.

Methods

The study was approved by the Bioethics Committee of the University of KwaZuluNatal, Durban (BE 207/09), as part of the class approval covering the unit data. All patients admitted to the TICU at IALCH who required mechanical ventilation for >48 hours were considered for inclusion in the study, which was conducted pro spectively for the 12-month period January December 2014. Patients in whom aspiration was suspected before or during endotracheal intubation, those in whom a positive culture was obtained within the first 48 hours, and those who did not conform to the CDC criteria were excluded. The diagnostic criteria for probable VAP were the combination of new-onset fever of ≥38.4oC, purulent secretions in an ETA, changes in chest auscultation or radiographs, a rise in the white cell count, a deterioration in lung function manifested by a reduction in the partial pressure of arterial oxygen/fraction of inspired oxygen ratio, reduced compliance and an elevated procalcitonin level. Possible VAP was defined similarly, but without marked changes in chest auscultation, radiology or pulmonary function. Early VAP was defined as occurring on the 3rd or 4th days of mechanical ventilation and late VAP as starting on or beyond day 5. All microbiology specimens were submitted as ETAs, and more invasive diagnostic tests were not undertaken. Specimens were processed by the National Health Laboratory Service (NHLS), where processing, identification of pathogens and susceptibility testing were conducted

according to standard NHLS operating procedures.[7] Patients who fulfilled the criteria for probable VAP were commenced on empirical antimicrobial therapy as per the antimicrobial protocol in the TICU at IALCH, which is based on microbiological surveillance. The antimicrobial of choice for early-onset VAP is amoxicillin/clavulanic acid and that for late-onset VAP piperacillin/ tazobactam. Combination therapy is not used. Antimicrobial therapy for patients with possible VAP was delayed until microbiology results were available. Patients with Acinetobacter isolates were not treated unless this was the sole pathogen in a case of possible VAP, when nebulised amikacin was the treatment of choice. Data were analysed according to the first episode of suspected VAP with the hypothesis that delays in initiating antimicrobials at this time would affect outcome. Endpoints of the study were duration of mechanical ventilation, length of stay in the TICU and mortality rate. Categorical data

were analysed using the χ2 or Fisher’s exact tests and continuous data using Student’s t-test. Differences in outcome between patients with possible and probable VAP were considered significant at p<0.05.

Results

A total of 288 patients were admitted to the TICU at IALCH during the study period, of whom 106 (36.8%) were suspected to be developing pneumonia. There were 84 (79.2%) males and 22 (20.8%) females, with a median age of 29 years (interquartile range (IQR) 21 - 37) and a median injury severity score (ISS) of 31 (IQR 24 - 38). The mechanism of injury was predominantly blunt, with 77 (72.6%) having been injured in motor vehicle collisions, 17 (16.1%) having sustained non-vehicular blunt trauma, and 8 (7.5%) having gunshot wounds, 3 (2.8%) stab wounds and 1 (0.9%) a snakebite. A total of 247 positive cultures were obtained, of which 168 (68.0%) were Gram-negative, 58 (23.4%) Gram-positive and 21(8.5%) fungal. Eleven

Table 1. Distribution of early and late VAP, ISS, duration of mechanical ventilation, length of TICU stay and mortality in patients with possible and probable VAP Possible VAP

Probable VAP

Early v. late VAP, n (%)

p-value 0.82

Early

22 (35.5)

12 (38.7)

Late

40 (64.5)

19 (61.3)

ISS, median (IQR)

34 (25 - 41)

34 (25 - 43)

0.79

Ventilation (days), median (IQR)

11 (8 - 16)

10 (8 - 15)

0.32

LOS (days), median (IQR)

16 (12 - 21)

13 (11 - 19)

0.45

Mortality, n (%)

8 (12.9)

5 (16.1)

0.75

LOS = length of stay.

Table 2. Distribution of the commonest Gram-negative pathogens between early and late VAP Early VAP n (%)

Late VAP n (%)

Acinetobacter baumannii (N=46)

8 (17.4)

38 (82.6)

Klebsiella pneumoniae (N=32)

5 (15.6)

27 (84.4)

Haemophilus influenzae (N=25)

17 (68.0)

8 (32.0)

Pseudomonas aeruginosa (N=17)

1 (5.9)

16 (94.1)

Proteus mirabilis (N=15)

1 (6.7)

14 (93.3)

Enterobacter spp. (N=10)

1 (10.0)

9 (90.0)

Escherichia coli (N=9)

3 (33.3)

6 (66.7)

Moraxella catarrhalis (N=8)

5 (62.5)

3 (37.5)

Staphylococcus aureus (N=43)

17 (39.5)

26 (60.5)

Streptococcus pneumoniae (N=9)

6 (66.7)

3 (33.3)

Other streptococci and enterococci (N=6)

3 (50.0)

Pathogen Gram-negative

Gram-positive

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Table 3. Antimicrobial susceptibility of the commonest Gram-negative pathogens Gram-negative pathogens

Co-amox n (%)

Pip/taz n (%)

Cipro n (%)

Amik n (%)

Merop n (%)

Colistin n (%)

A. baumannii (N=46)

3 (6.5)

44 (95.7)

3 (6.5)

46 (100.0)

K. pneumoniae (N=32)

28 (87.5)

31 (96.9)

32 (100.0)

H. influenzae (N=25)

25 (100.0)

Not drug of choice

P. aeruginosa (N=17)

Not drug of choice

17 (100.0)

P. mirabilis (N=15)

11 (73.3)

15 (100.0)

Intrinsic resistance

Enterobacter spp. (N=10)

Not drug of choice

10 (100.0)

Not drug of choice

10 (100.0)

E. coli (N=9)

7 (77.8)

9 (100.0)

M. catarrhalis (N=8)

8 (100.0)

Not drug of choice

Co-amox = amoxicillin/clavulanate; Pip/taz = piperacillin/tazobactam; Cipro = ciprofloxacin; Amik = amikacin; Merop = meropenem.

different species of Gram-negative and 7 of Gram-positive organisms were cultured. Of the 106 patients, 13 did not fulfil the criteria for VAP (in 8 VAP was suspected <48 hours after intubation and mechanical ventilation, in 3 respiratory flora were isolated after suspected aspiration, and in 2 Candida was the sole isolate). These were excluded from analysis, leaving a total of 93 patients. Of these 93, 57 (61.3%) had a single episode of suspected VAP, 22 (23.6%) two episodes and the remaining 14 (15.1%) three or more episodes, with a maximum of five in a patient ventilated for 72 days. Based on the first episode of VAP, 62 patients (66.7%) were diagnosed as having possible and 31 (33.3%) probable VAP. The distribution and outcomes of possible and probable and early and late VAP are shown in Table 1. The commonest Gram-positive and Gram-negative pathogens in early and late VAP are documented in Table 2, and their susceptibilities in Tables 3 and 4. The most prevalent Gram-negative organ ism in early VAP was Haemophilus influenzae (38%). All isolates were suscep tible to amoxicillin/clavulanate. In addition to being the most common isolate in late VAP, A. baumannii was the most prevalent Gram-negative isolate overall and almost five times more common in late as opposed to early VAP. Forty-three (93.4%) of the 46 isolates of A. baumannii were multidrug resistant, susceptible only to colistin (100%) and amikacin (96%). Of the 43 patients in whom multidrug-resistant (MDR) A. baumannii was cultured, 6 (14%) were offered therapy, 5 with nebulised amikacin and 1 with intravenous colistin. All but 1 patient with MDR A. baumannii survived,

Table 4. Antimicrobial susceptibility of the commonest Gram-positive pathogens Gram-positive pathogens

Penicillin n (%)

Cloxacillin n (%)

Vancomycin n (%)

S. aureus (N=43)

N/A

39 (90.7)

43 (100.0)

S. pneumoniae (N=6)

6 (100.0)

Not drug of choice

6 (100.0)

the sole death occurring in a patient with overwhelming uncontrolled abdominal sep sis, retroperitoneal necrotising fasciitis and multiple organ failure. Of the 32 K. pneumoniae isolates, 28 (87.5%) were susceptible to amoxicillin/ clavu lanate, 3 (9.3%) were extendedspectrum beta-lactamase (ESBL)-positive and susceptible to ciprofloxacin, and one was susceptible only to meropenem. There were 9 E. coli isolates, of which 2 were ESBL-positive and 7 were susceptible to amoxicillin/clavulanate. Of the 15 isolates of P. mirabilis, 4 (26.7%) were ESBLpositive and 11 (73.3%) were susceptible to amoxicillin/clavulanate. There were no MDR P. aeruginosa isolates; all were susceptible to piperacillin/tazobactam, ciprofloxacin and meropenem. All 10 Enterobacter spp. were susceptible to ciprofloxacin and meropenem. Serratia spp., Aeromonas spp. and Citrobacter spp. were rare isolates. Among the Gram-positive organisms there were 43 isolates of S. aureus, of which 4 were vancomycin-sensitive methicillinresistant S. aureus (MRSA) and arose during episodes of late VAP. All 6 isolates of S. pneumoniae were susceptible to penicillin. Thirty-one patients were treated empiri cally for probable VAP, prescriptions being correct in 28 cases (90.3%). Among the 3

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patients with incorrect prescriptions, ESBL K. pneumoniae resistant to amoxicillin/ clavulanate was isolated in 1 patient with early VAP, and E. aerogenes resistant to piperacillin/tazobactam was cultured in 2 patients with late VAP. In this group, 1 death occurred in an elderly man with severe traumatic brain injury and major blunt thoracic and abdominal trauma. Although inappropriate therapy may have contributed to his death, age and the extent of injury placed him in the probable non-survivor category. In the probable VAP cohort, no deaths were attributable to withdrawal of non-beneficial therapy due to futility. Antimicrobials were commenced in 34 (54.8%) of the 62 patients with possible VAP, and not prescribed in the remaining 28 (45.2%). Of the latter, 24 recovered without antimicrobials and 4 died, no deaths being directly attributable to failure to treat nosocomial pneumonia. Death was due to withdrawal of non-beneficial therapy in 3 patients with severe traumatic brain injury and to retroperitoneal fasciitis in the remaining patient following the breakdown of a colonic anastomosis. There was no significant difference in mortality between the 34 patients with possible VAP who were commenced on directed therapy and the 31 with probable

RESEARCH

VAP who were commenced on empirical antimicrobials (11.7% v. 16.1%; p=0.79). Excluding the 4 deaths due to withdrawal of nonbeneficial therapy and uncontrolled abdominal sepsis, the overall mortality rate in patients with possible VAP, including those who were not offered antimicrobials, was 6.4% v. 16.1% in the probable group (p=0.29).

Discussion

Antimicrobials are an integral component of the management of sepsis,[5] and virtually all agree that the sooner appropriate antimicrobials are given, the better the outcome is. In addition to a delay in antimicrobial therapy, inappropriate prescriptions to which the pathogen is resistant are associated with decreased survival.[8] The recommendation is therefore to commence early broad-spectrum empirical therapy while awaiting microbiological confirmation, and then de-escalate as necessary.[9] Although minimising inappropriate prescriptions, this policy risks creating collateral damage and inducing bacterial resistance. Based on data showing that early appropriate administration of antimicrobials improves outcome in severe sepsis and septic shock, the same premise has been extrapolated to less-severe infections without proof of benefit. In patients with uncomplicated sepsis, the evidence for the timing of antimicrobial administration is contentious[10] and there are no studies substantiating the need for the same approach as is used in severe sepsis or septic shock. In fact, evidence to the contrary has been presented.[11] In the absence of haemodynamic instability or worsening organ function, there is no reported relationship between the timing of treatment and outcome. Moreover, the unwarranted use of broad-spectrum empirical antimicrobials in sepsis without organ dysfunction or hypotension may potentiate bacterial resistance without conferring benefit. Awaiting microbiological confirmation of the inciting pathogen and using directed therapy appears to be acceptable practice. The pathogens isolated in our study were similar to those previously reported for VAP in the critically injured,[12] where Gram-negative organisms of the Enterobacteriaceae family predominated, especially in late VAP. Gram-positive species were less common, S. aureus being isolated most frequently. Among the pathogens we encountered few ESBL-producing organisms or MRSA, for which there are a number of explanations. Firstly, we have a strict infection control policy. Secondly, we have adopted a policy of antimicrobial stewardship and prescriptions based on microbiological surveillance. Thirdly, our patient population is young and antimicrobial naive; at the time of the first episode of VAP, only 40% had received prior antimicrobials. Patients treated in the TICU are a unique population compared with those admitted to general medical and surgical intensive care units (ICUs). The TICU is exclusively for critically injured patients who require mechanical ventilation and are generally an otherwise well population free from chronic medical conditions and with no previous hospital visits or use of antimicrobials. Owing to ethical constraints regarding informed consent, and the knowledge that it does not impact on the immediate management or outcome of lifethreatening injuries,[13] routine HIV testing is not undertaken.[14] Although the isolated flora may be similar in ICUs, reasons for bacterial resistance to antimicrobials vary, the commonest being previous antimicrobial exposure, the overuse of broadspectrum agents and selective pressure. Despite suggestions that the differentiation between early and late VAP is irrelevant and that all patients should be treated with broad-spectrum agents,[15] our data confirm that this distinction remains useful when deciding on empirical therapy. The vast majority of pathogens in early VAP in our

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patients were community-acquired flora susceptible to amoxicillin/ clavulanate, and indiscriminate use of broad-spectrum antimicrobials would encourage development of resistant strains. MDR A. baumannii was the most common organism isolated in late VAP. Owing to its natural multidrug resistance and low virulence and pathogenicity, the unit policy is not to treat MDR Acinetobacter unless it is the sole pathogen in possible VAP that fails to improve. Of the 43 patients in whom MDR A. baumannii was cultured, only 6 were offered therapy, mainly in the form of inhaled/nebulised amikacin. There was 1 fatality due to uncontrolled retroperitoneal fasciitis following a faecal leak. Based on these data, we suggest that treating all Acinetobacter isolates is unnecessary and will promote bacterial resistance. The high incidence of possible pneumonia in our cohort reflects the difficulties in confirming the diagnosis of VAP. This is especially problematic in patients with blunt thoracic trauma and the systemic inflammatory response syndrome. Fever, progressive changes in chest auscultation and radiographs and a positive sputum culture are common before resolution of the underlying lung injury. That said, if there is diagnostic doubt and no immediate need for therapy, our results confirm that in patients with possible VAP, awaiting definitive microbiologal results before commencing antimicrobials does not compromise outcome. Furthermore, due to an improvement in clinical signs in almost 50% of patients with possible VAP, antimicrobials were not prescribed. However, this policy may only be implemented in association with an effective microbiology service employing urgent Gram staining and rapid susceptibility testing. In addition, although the incidence of VAP is reported to be significantly higher in the critically injured, the outcome is better than for non-trauma patients.[16] The most likely explanation is that young, previously healthy males comprise the vast majority of the trauma population, whereas non-trauma patients are an older population, often with comorbidities. In that light, our findings may not be universally applicable to all critically ill populations. A number of myths concerning antimicrobials perpetuate the prescription of broad-spectrum drugs. It is a misconception that sicker patients require what are erroneously termed â&#x20AC;&#x2DC;stronger antibioticsâ&#x20AC;&#x2122;. Firstly, regardless of the severity of the underlying disease, the susceptibility of pathogens remains identical for that pathology. For example, the organisms involved in appendicitis are the same whether the disease is localised or causing generalised peritonitis, and as such there is no need initially to use a broader-spectrum agent. The same premise holds true for early VAP, where H. influenzae is almost universally susceptible to amoxicillin/clavulanate. Secondly, with the exception of bacteriostatic v. bactericidal antibiotics, there is no such entity as a stronger antibiotic, only antibiotics with a broader spectrum of action. To minimise the development of antimicrobial resistance, the principle should be to use a drug with the narrowest spectrum against the most likely pathogens. This requires a working knowledge of local flora and of their antibiotic sensitivities, achieved through bacteriological surveillance. Thirdly, there is no proof that empirical combination therapy has any advantage over monotherapy if an appropriate single antimicrobial is selected.[17] The only patients in whom combination therapy appears to be beneficial are those in septic shock.[9] In the presence of effective microbiological surveillance, it is possible to achieve adequate empirical antimicrobial therapy over 90% of the time with the initial empirical choice of a single agent.[18] The TICU at IALCH subscribes to stewardship and employs an empirical antimicrobial policy based on surveillance. Lastly, there is a mistaken belief that newer drugs are superior to their elderly counterparts. This is untrue â&#x20AC;&#x201C; the drug of choice for a penicillin-sensitive organism is penicillin.

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Combating the problem of drug resistance requires a ‘multipronged’ approach. In addition to antibiotic stewardship and surveillance, early convincing diagnosis of infection would greatly improve use of antibiotics and in turn address the problem of antibiotic resistance. Conventional microbiological culture, performed by most laboratories worldwide, requires several days for isolation, identification and antimicrobial susceptibility testing of the pathogen. As a result there is a delay in the identification of resistant bacteria, which results in the inappropriate use of antimicrobials. Rapid diagnostic methods must therefore have the capability of influencing early antibiotic decision-making to allow for more appropriate treatment of antibiotic-resistant bacterial infection, as well as minimisation of unnecessary use of broad-spectrum agents.[19] May et al.[20] described a novel strategy for the rapid diagnosis of VAP, using exhaled breath condensate fluid obtained from heat-moisture exchangers to provide a substrate for testing with the polymerase chain reaction to identify bacterial DNA. The advantage of molecular diagnostic platforms lies in the ability to diagnose pathogens and their accompanying resistance genes rapidly. The challenge to ICU clinicians is how to use antimicrobials most effectively to maximise patient benefits while minimising the emergence of resistance. In this, the use of rapid diagnostics may hold the key.[19] Despite numerous warnings in the medical literature about the threat of bacterial resistance, indiscriminate antimicrobial prescribing continues unabated, with as many as 64% of prescriptions being deemed either unnecessary or an inappropriate choice.[21] Our data confirm that delaying antimicrobial prescriptions in situations of doubtful sepsis, or omitting therapy altogether, does not adversely affect outcome. The real possibility of a post-antibiotic era in the 21st century has been highlighted by the World Health Organization (WHO) report on antimicrobial resistance,[22] and concern has now reached political level[23,24] with proposals to provide incentives to the pharmaceutical industry to develop new antimicrobials. This approach is short sighted and ineffective for a number of reasons. History will undoubtedly repeat itself: the development of each new antimicrobial has been followed by resistance, the normal evolutionary process of mutation and natural selection conferring a survival benefit. In the modern pharmaceutical market, antimicrobials are not a cost-effective investment for research and development and, ironically, pressure from the pharmaceutical industry to use their broad-spectrum products has contributed to the current situation. The most logical and practical short- and long-term solutions to preserve what drugs we currently possess are education, bacteriological surveillance and antimicrobial stewardship.[18] Antimicrobial stewardship is of paramount importance, especially in areas with frequent antimicrobial use. Pivotal to success are interested clinicians and microbiologists, knowledge of local resistance patterns, and an antimicrobial policy that optimises the choice, dose and duration of therapy.[18] The particular patient population, local epidemiology, and prior antimicrobial exposure in each specific ICU

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need to be considered when considering empirical antimicrobial therapy. The WHO has warned that bacterial resistance has become a global health emergency, and in the not-too-distant future there is the very real possibility that previously treatable common infections and minor injuries may become fatal. Unless urgent action is taken, a bacterial apocalyptic fantasy may become reality.[22] References 1. Kollef MH. Ventilator-associated complications, including infection-related complications. Crit Care Clin 2013;29(1):33-50. [http://dx.doi.org/10.1016/j.ccc.2012.10.004] 2. Munro N, Ruggiero M. Ventilator-associated pneumonia bundle reconstruction for best care. AACN Advanced Critical Care 2014;25(2):163-175. [http://dx.doi.org/10.1097/NCI.0000000000000019] 3. Magill SS, Klompas M, Balk R, et al. Developing a new national approach to surveillance for ventilatorassociated events. Am J Crit Care 2013;22(6):469-473. [http://dx.doi.org/10.4037/ajcc2013893] 4. American Thoracic Society. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Care Med 2005;171(4):388416. [http://dx.doi.org/10.1164/rccm.200405-644ST] 5. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock. Crit Care Med 2013;41(2):580-563. [http://dx.doi.org/10.1097/CCM.0b013e31827e83af] 6. Hranjec T, Sawyer RG. Conservative initiation of antimicrobial treatment in ICU patients with suspected ICU-acquired infections: More haste less speed. Curr Opin Crit Care 2013;19(5):461-464. [http://dx.doi.org/10.1097/MCC.0b013e328364d525] 7. National Health Laboratory Service. Q-pulse Standard Operating Procedures Q-pulse 5/docs/active/ MIC 1569v1, MIC 1587v1, MIC 1840v1, MIC 1849v1. Johannesburg: NHLS, 2010. 8. Swanson JM, Wells DL. Empirical antibiotic therapy for ventilator-associated pneumonia. Antibiotics 2013;2(3):339-351. [http://dx.doi.org/10.3390/antibiotics2030339] 9. Borgatta B, Rello J. How to approach and treat VAP in ICU patients. BMC Infect Dis 2014;14:211. [http://dx.doi.org/10.1186/1471-2334-14-211] 10. Simonetti A, Viasus D, Garcia-Vidal C, et al. Timing of antibiotic administration and outcome of hospitalized patients with community-acquired and healthcare-associated pneumonia. Clin Microbiol Infect 2012;18(11):1149-1155. [http://dx.doi.org/10.1111/j.1469-0691.2011.03709.x] 11. De Groot B, Ansems A, Gerling DH, et al. The association between time to antibiotics and relevant clinical outcomes in emergency department patients with various stages of sepsis: A prospective multicenter study. Crit Care 2015;19:194 [http://dx.doi.org/10.1186/s13054-015-0936-3] 12. McMillian WD, Bednarik JL, Aloi JJ, et al. Utility of ampicillin-sulbactam for empiric treatment of ventilator-associated pneumonia in a trauma population. J Trauma 2010;69(4):861-865. [http://dx.doi. org/10.1097/TA.0b013e3181e83f8b] 13. Bhagwanjee S, Muckart DJJ, Jeena PM, et al. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? BMJ 1997;314:1077-1081. [http://dx.doi.org/10.1136/ bmj.314.7087.1077a] 14. Kale R. Commentary: Failing to seek patients’ consent to research is always wrong. BMJ 1997;314:1081. [http://dx.doi.org/10.1136/bmj.314.7087.1081] 15. Gastmeier P, Sohr D, Geffers C, et al. Early- and late-onset pneumonia: Is this still a useful classification? Antimicrob Agents Chemother 2009;53(7):2714-2718. [http://dx.doi.org/10.1128/AAC.01070-80] 16. Cook A, Norwood S, Berne J. Ventilator associated pneumonia is more common and of less consequence in trauma patients compared with other critically ill patients. J Trauma 2010;69(5):10831091. [http://dx.doi.org/10.1097/TA.0b013e3181f9fb51] 17. Kumar A. An alternate physiological paradigm of sepsis and septic shock. Virulence 2014;5(1):80-97. [http://dx.doi.org/10.4161/viru.26913] 18. Ramsamy Y, Muckart DJJ, Han KSS. Microbiological surveillance and antimicrobial stewardship minimise the need for ultrabroad-spectrum combination therapy for treatment of nosocomial infections in a trauma intensive care unit: An audit of an evidence-based empiric antimicrobial policy. S Afr Med J 2013;103(6):371-376. [http://dx.doi.org/10.7196/SAMJ.6459] 19. Kollef MH. Ventilator-associated pneumonia: The role of emerging therapies and diagnostics. Chest 2015;147(6):1448-1450. [http://dx.doi.org/10.1378/chest.14-2745] 20. May AK, Brady JS, Romano-Keeler J, et al. A pilot study of noninvasive assessment of the lung microbiota as a potential tool for the early diagnosis of ventilator-associated pneumonia. Chest 2015;147(6):1494-1502. [http://dx.doi.org/10.1378/chest.14-1687] 21. Cusini A, Rampini SK, Bansal V, et al. Different patterns of inappropriate antimicrobial use in surgical and medical units at a tertiary care hospital in Switzerland: A prevalence survey. PLoS One 2010;5(11):e14011. [http://dx.doi.org/10.1371/journal.pone.0014011] 22. World Health Organization. Antibiotic Resistance Global Report on Surveillance. Geneva: WHO, 2014. 23. Report to the President on Combating Antibiotic Resistance. President’s Council of Advisors on Science and Technology (PCAST). 2014. www.whitehouse.gov/ostp/pcast (accessed 18 September 2014). 24. BBC News Health. Antibiotic resistance: Cameron warns of medical ‘Dark Ages’. http://www.bbc.com/ news/health/-28098838 (accessed 2 July 2014).

Accepted 29 October 2015.

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RESEARCH

An analysis of patients transported by a private helicopter emergency medical service in South Africa D Muhlbauer,1 MTech Emergency Medical Care; R Naidoo,1 MSc (Cardiol), MSc (Med); T C Hardcastle,2 MB ChB, MMed (Chir), FCS (SA), PhD 1 2

epartment of Emergency Medical Care and Rescue, Durban University of Technology, South Africa D Department of Surgery, Inkosi Albert Luthuli Central Hospital and College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, South Africa

Corresponding author: D Muhlbauer (dagmarm@dut.ac.za)

Background. A helicopter emergency medical service (HEMS) is a specialist flying emergency service where on-board medical personnel have both the knowledge and equipment to perform complicated medical procedures. The paucity of literature describing the types of patients flown by HEMS in South Africa (SA) and their clinical outcome poses a challenge for current aeromedical services, as there is no baseline information on which to base flight criteria, staffing and policy documents. This has the potential to hamper the advancement of HEMS in SA. Objectives. To undertake a descriptive analysis of patients flown by the Netcare 911 HEMS over a 12-month period in Gauteng and KwaZulu-Natal (KZN) provinces, SA, and to assess patient outcomes. The clinical demographics ofÂ patients transported by the HEMS were analysed, time frames from dispatch of the helicopter to delivery of the patient to the receiving hospital determined, and patient outcomesÂ at 24 hours and 72 hours analysed. Methods. The study utilised a retrospective quantitative, descriptive design to analyse patients transported by a private HEMS in SA. All complete records of patients transported by the Netcare 911 HEMS between 1 January and 31 December 2011 were included. Results. The final study population comprised 537 cases, as 10 cases had to be excluded owing to incomplete documentation. Of the 537 cases, 82 (15.3%) were managed by the KZN HEMS and 455 (84.7%) by the Gauteng HEMS. Adult males were the patients most commonly flown in both Gauteng and KZN (350/455 patients (76.9%) in Gauteng and 48/82 (58.5%) in KZN were males, and 364/455 patients (80.0%) in Gauteng and 73/82 (89.0%) in KZN were adults). Motor vehicle collisions were the most common incidents necessitating transport by HEMS in both operations (n=193, 35.9%). At the 24-hour follow-up, 339 patients (63.1%) were alive and stable, and at the 72-hour followup, 404 (75.3%) were alive and stable. Conclusions. The study findings provided valuable information that may have an impact on the current staffing and authorisation criteria of SA HEMS operations. S Afr Med J 2016;106(2):201-205. DOI:10.7196/SAMJ.2016.v106i2.9919

A helicopter emergency medical service (HEMS) is a specialist flying emergency service where on-board medical personnel have both the knowledge and equipment to perform complicated medical procedures. This scarce resource may be called upon in circumstances where either a traditional ground ambulance cannot reach the incident in an appropriate response time or the patient needs to be transported to an appropriate facility over a long distance or over inhospitable terrain. Air transportation has the advantages of being able to deliver a highly skilled medical team to an incident speedily, as well as transport a patient to the most appropriate hospital instead of the closest hospital.[1] HEMS originated in military operations and inspired the idea of dedicated civilian air ambulances.[2,3] The use of civilian helicopters for the transport of ill or injured patients has become an important part of modern emergency care systems.[4] Since the 1970s, there have been a number of different HEMS operations across South Africa (SA) in both the private and public sectors. The HEMS in SA currently comprises three major service providers: Netcare 911, ER24 and the Red Cross Air Mercy Service. This study examined the Netcare 911 HEMS operations, staffed by a medical doctor and an Advanced Life Support paramedic. Medical evacuations can be broadly categorised into primary flights (removal of a patient from the initial scene of the incident) and interfacility patient transfers. Each individual flight is authorised by

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a medical doctor based on predetermined flight criteria (NTC911HEMS-007-HEMS Flight Crew Requirements). However, as HEMS operations represent one of the most expensive prehospital treatment modalities, it is essential that the benefits are taken into consideration when determining procedures and policies for their use[5] and that a developing country such as SA utilises this expensive and scarce resource cautiously. The paucity of literature on this topic poses a challenge for current aeromedical services, as there is no baseline information on which to base flight criteria, staffing and policy documents.

Objectives

To undertake a descriptive analysis of the use of a private HEMS operation over a 12-month period.

Methods

Netcare 911 helicopters were based in Midrand, Gauteng Province, and Durban North, KwaZulu-Natal Province (KZN), SA. The Gauteng and KZN HEMS operations serviced primary call-outs and interfacility transfers and were configured to transport one patient at a time. The service operated 365 days a year, with the Gauteng operation available 24 hours a day and the KZN operation during daylight hours only. The crew consisted of a pilot, a medical doctor and an Advanced Life Support paramedic. Both the doctor and the paramedic needed to meet specific criteria (NTC911-HEMS007) in

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Results

A total of 547 cases were serviced by the Netcare 911 HEMS operations during the 12-month study period. Of these, 10 had to be excluded owing to missing variables in the documentation. The Gauteng HEMS operation serviced 455 cases (84.7%) and the KZN operation 82 (15.3%). Chi-square tests showed a statistical significance in the call volume split between the two operations (p<0.05: confidence interval 99%). Both the HEMS operations were most frequently dispatched to primary transfers, which totalled 357 (66.5%) of all the cases. The remaining cases were interfacility transfers (n=180, 33.5%). SA is divided into 52 health districts. Analysis of the records showed that the two HEMS operations generally retrieved patients from within their own provinces. How ever, in certain instances both the helicopters retrieved patients from outside their respective provinces. The most com mon districts from which cases managed by the Gauteng HEMS operation originated were the City of Johannesburg metropolitan municipality (n=110, 24.2% of total cases),

cipality. These flights were from local medi cal centres in Bizana and Matatiele, and both were interfacility transfers. Of the 455 patients transported by the Gauteng HEMS operation, 350 (76.9%) were males and 105 (23.1%) females, and of the 82 cases transported by the KZN HEMS operation, 48 (58.5%) were males and 34 (41.5%) females (Fisher’s exact test p=0.001). The ratio of females to males in Gauteng was 1:3, while for KZN it was 1:1.5 (Fig. 1). Adult patients were transported most frequently by both HEMS operations, the percentages of adult patients flown (Gauteng

Ekurhuleni metropolitan municipality (n=101, 22.2%), and the City of Tshwane metropolitan municipality (n=78, 17.1%). The Gauteng HEMS operation also collected 2 patients (0.4%) from the Amajuba district municipality, which falls in KZN. The KZN HEMS operation most frequently collected patients from the eThekwini metropolitan municipality (n=22, 26.8%), followed by the Ugu district municipality (n=17, 20.7%) and the uMgungundlovu district municipality (n=16, 19.5%). It also crossed over into the Eastern Cape Province to collect 2 patients (2.4%) from the Alfred Nzo district muni 90 80

Gauteng HEMS operation n=350

KZN HEMS operation

n=398

Combined n=48

Patients, %

60 50

n=34

40 30

n=139

n=105

20 10 0 Male

Female

Fig. 1. Gender of patients transported by the Gauteng and KZN HEMS operations. 100

Gauteng HEMS operation n=73

KZN HEMS operation

n=437

n=364

Combined

80 70 60 Patients, %

order to be part of the HEMS crew. These criteria included Health Professions Council of South Africa registration, a minimum of 2 years’ post-graduation clinical experience, currency in the American Heart Association courses, annual completion of a CAT138, and a current class II flight medical certi ficate.[6] Ethical approval was obtained from the Durban University of Technology Insti tutional Research Ethics Committee (ref. REC36/2), and permission was also obtained from the Netcare 911 Research Committee. A retrospective quantitative, descriptive chart review design was utilised to analyse patients transported by the Netcare 911 HEMS in SA between 1 January and 31 Decem ber 2011. Cases with incomplete docu mentation were excluded. Data were collected from the Clinical Audit and Reporting System (CARS) database. The documentation accessed included an electronic patient care record, flight assess ment form, flight follow-up sheet and flight log. The relevant data were extracted from the CARS database by the researcher and entered onto an electronic data collection tool. The data were analysed using SPSS version 21.0 (IBM, USA), with descriptive statistics. Student’s t-test was utilised for data with a normal distribution and the χ2 test or Fisher’s exact test for categorical variables. The p-value was set at <0.05.

50 40 30 20

n=69

n=75 n=6 n=14 n=2

n=16

n=8

0 Adult

Paediatric

Infant

Fig. 2. Ages of patients transported by the Gauteng and KZN HEMS operations.

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n=1

n=9

Newborn

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Discussion

The Netcare 911 HEMS operation in Gau teng was a 24-hour operation, while the KZN operation was a daylight-only service. The cases managed required authorisation through one of four different methods: (i) medical aid; (ii) provincial; (iii) the Road Accident Fund; and (iv) Workmen’s Compensation. The provincial authorisation process is tendered for in each provincial area, and only the Gauteng operation was able to fly patients through the provincial authorisation process. Although a number of international studies have been conducted describing types of patients flown, the time frames associated with HEMS transfers, the aeromedical crew and patient outcome, only two local studies have been performed.[7,8]

Table 1. Mean time frames Mean

0:21:00.66

0:18:35.52

Median

IQR

0:12:00.00

0:10:00.00

0:13:00.00

0:12:00.00

Gauteng HEMS Flying time to scene incident On-scene time

0:30:46.68

0:26:57.95

Flying time to hospital

0:14:37.85

0:53:19.37

Total mission time

1:55:49.05

0:59:44.01

Flying time to scene incident

0:42:10.24

0:29:46.46

KZN HEMS On-scene time

0:32:20.00

0:21:47.67

Flying time to hospital

0:33:30.37

0:27:12.84

Total mission time

2:34:40.98

1:10:19.76

Combined Flying time to scene incident

0:24:14.53

0:22:01.08

On-scene time

0:31:00.78

0:26:14.25

Flying time to hospital

0:17:28.99

0:50:41.34

Total mission time

2:01:45.14

1:02:58.33

SD = standard deviation; IQR = interquartile range.

Table 2. Mean on-scene time frames for different transfer types On-scene time Type of transfer

Mean

Primary transfers

357

0:30:37.42

0:26:29.05

Interfacility transfers

180

0:31:46.99

0:25:47.92

SD = standard deviation.

Gauteng HEMS operation KZN HEMS operation

n=59 70

Combined n=280

n=339

50 Patients, %

n=364, 80.0%; KZN n=73, 89.0%) being significantly higher than the percentages of paediatric patients (Gauteng n=69, 15.2%; KZN n=6, 7.3%), infants (Gauteng n=14, 3.1%; KZN n=2, 2.4%) and neonatal patients (Gauteng n=8, 1.8%; KZN n=1, 1.2%) (Fig. 2). The difference in the age groups transported by both the HEMS operations was statistically significant (p<0.001, Fisher’s exact test). The main type of incident resulting in patients needing HEMS transport was motor vehicle collisions, with 168 cases for Gauteng (36.9%) and 25 for KZN (30.5%) (193/537 (35.9%) combined). Pedestrianmotor vehicle collisions were also common, with 67 for Gauteng (14.7%) and 2 for KZN (2.4%) (n=69 (12.9%) combined). Of nontrauma-related incident types, cardiac cases were most frequent (Gauteng n=21 (4.6%); KZN n=16 (19.5%); combined n=37 (6.9%)). The mean flying time to the scene (Gauteng 0:21:00.66 (i.e. 21 minutes and 0.66 seconds); KZN 0:42:10.24) and the mean flying time from the scene to hospital (Gauteng 0:14:37.85; KZN 0:33:30.37) were longer in the KZN HEMS operation missions than in the Gauteng operation (Table 1). The mean on-scene time was very similar for both operations (Gauteng 0:30:46.68; KZN 0:32:20.00). No statistical significance was identified when comparing the mean on-scene times for primary and interfacility transfers (primary transfers 0:30:37.42; interfacility transfers 0:31:46.99) (Table 2). At the 24-hour follow-up (Fig. 3), 339 patients who had been transported by both services (63.1%) were alive and stable, 66 (12.3%) were dead and 10 (1.9%) had been discharged (p=0.049). At the 72-hour followup (Fig. 4), 404 patients (75.3%) were alive and stable, 26 (4.8%) were dead and 37 (6.9%) had been discharged.

30 n=110

n=122

20 n=12

n=58

n=66 n=8

n=7

n=3

n=10

0 Alive and stable

Alive and unstable

Fig. 3. Patient outcomes after 24 hours.

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Deceased

Discharged

RESEARCH

n=345

Gauteng HEMS operation

n=404 n=59

KZN HEMS operation

Combined 60

Patients, %

20 n=63

n=70

n=10

n=7

n=20 0

Alive and stable

Alive and unstable

n=6

n=26

Deceased

n=27

n=37

Discharged

Fig. 4. Patient outcomes after 72 hours.

Our results demonstrated that certain districts in Gauteng and KZN were consi derably busier than other districts. Interes tingly, the busier districts were more centrally located in the urban areas for both the operations. Although HEMS operations are very expensive to implement and operate, there are certain situations in which helicopters are seen as an acceptable transport resource.[9] This is specifically true for isolated rural areas, and for areas prone to traffic congestion.[10] The Netcare 911 HEMS operations appear to have transported most of their patients from urban areas that are in close proximity to major hospital facilities. While this could possibly reflect traffic congestion, it could not be confirmed, as the time of day of the flights was not routinely recorded for this study. Certain logistical and geographical situations, such as severe traffic congestion, may support HEMS transportation in an urban setting, but it is unwarranted in most cases.[11] Furthermore, a number of studies have determined that transporting a patient by helicopter is not always faster than ground-based transport. A HEMS operation is usually only faster over distances >45 km, in poor road conditions and when traffic conditions are congested.[12] The majority of the patients transported were adult males. This appears to be in line with international trends, although many studies have only included patients aged >15 years.[13,14] Various other studies have had similar findings. In a study conducted in KZN in 1997 on another aeromedical service, of the 398 patients who were trans

ported during the 12-month study period, males comprised 63% and females 33%. While the age distribution included patients of all ages, the majority were <50 years of age with a mild peak between 21 and 40 years.[15] A more recent study was done on a HEMS operation in Richards Bay, KZN. This included patients of all ages and showed that 797 adult patients (61.9%) were flown during the 5-year study period, with only 194 paediatric (15.1%) and 278 neonatal (21.6%) patients.[7] The Netcare 911 HEMS operations attended to 357 primary responses (66.5%) and 180 interfacility transfers (33.5%) during the study period, with primary responses being the most common type of transfer in both provinces (Gauteng n=306 (67.3%); KZN n= 51 (62.2%)). The Gauteng operation had 149 interfacility transfers (32.7%) and the KZN operation 31 (37.8%). In the study focusing on the HEMS operation in Richards Bay, the reverse was found, interfacility transfers making up the majority of the cases attended to: of a total of 1 418 flights, 1 253 (88.4%) were interfacility transfers and only 165 (11.6%) primary responses. [7] Many international studies have focused on either primary transfers or interfacility transfers, and there have been few studies that included both. Opinions on the potential benefits of HEMS operations for interfacility transfers have differed. One study determined that insufficient evidence is available at this stage to determine the immediate benefits of HEMS over groundbased transport for interfacility transfers,[16]

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while another determined that the use of HEMS to transport patients for interfacility transfers appeared to provide a time benefit as it reduces transport time.[11] These studies were from high-income countries where the staffing of ground v. air components was identical, which is different to the HEMS staffing in SA. The most common type of incident to which a helicopter was dispatched was motor vehicle collisions (n=193, 36.0%). This finding is in line with a number of international studies.[5,17,18] Patients involved in motor vehicle collisions may present with time-sensitive pathologies such as traumatic haemorrhage, polytrauma and traumatic brain injury. Cardiac cases (n=37, 6.9%) were the most common non-traumatic incident for both the Netcare 911 HEMS operations. Since speed is seen as one of the major advantages of HEMS operations, it is essential that the incident types attended to would potentially benefit from the faster services. Some of the time-sensitive pathologies identified in previous studies were traumatic haemorrhage, ST-elevation myocardial infarction, polytrauma, traumatic brain injury, burns, stroke and paediatric emergencies.[2,19] Polytrauma patients and patients with neurological injuries also appear to derive considerable benefit from doctor-based prehospital care.[14] There can be no doubt that a helicopter is an effective option for patients who have time-sensitive pathologies and are situated in remote areas some distance away from definitive care, as the speed of the operation allows for optimal patient outcome. In such cases, the use of helicopters has many benefits, reducing not only the time to reach the patient, so that critical patient care can be initiated more speedily, but also the time to transport the patient to the most appropriate hospital for further care while administering a high level of care in transit. A helicopter must shorten the time to delivery of care (whether on the scene by skilled aeromedical crew or in hospital) in order to provide any form of benefit to the patient.[2] When comparing the mean on-scene times of both the Netcare 911 HEMS operations with other similarly staffed operations, the mean on-scene times for the Netcare operations were often shorter.[7,20,21] An interesting finding was the similarity between the interfacility transfer and primary transfer on-scene times. The transfer times from scene to hospital for both the Netcare 911 HEMS operations were similar to another SA study.[7] Comparing HEMS transfer times with ground transfer times was not an objective of this study.

RESEARCH

However, HEMS transfer times that are longer than ground transfer times can be justified as the HEMS operation may elect to bypass some of the district hospitals and community clinics in an attempt to source a regional hospital capable of managing a potential surgical emergency as part of definitive care, while ground operations tend to transport patients to the nearest facility.[22] Even though the evidence indicates that HEMS operations can lead to improved outcomes in trauma patients, it would appear that these operations are over-utilised. Adult patients have an over-triage rate of 60% and paediatric patients an over-triage rate of 85% in trauma incidents. A meta-analysis of 22 studies determined that one in four HEMS-transported patients were discharged within 24 hours of arrival at a trauma centre, and up to 70% had non-lifethreatening injuries.[13,23] Analysis of the results of the Netcare 911 HEMS operations shows that there may be a potential for over-triage, as at the 24-hour follow-up point, 339 patients (63.1%) were alive and stable and 10 (1.9%) had already been discharged. These findings were statistically significant (p=0.049). At the 72-hour follow-up, 404 (75.3%) were alive and stable and 37 (6.9%) had been discharged. A number of studies also reflect the fact that patients with an Injury Severity Score (ISS) of >15 require a higher level of specialised care, and this is supported by the finding that HEMS transportation results in a reduction in mortality in these patients.[5,24] In Cudnik et al.’s[13] study, up to 72% of patients had minor injuries with an ISS of ≤15, suggesting that HEMS operations were being over-utilised.[13] Analysis of our patient outcome statistics indicates that this may also be true for the patients transported by the Netcare 911 HEMS operations. Although there are some perceived benefits of HEMS operations, the annual costs are very high, ranging in one study from USD115 777 to USD5 571 578 per annum.[9] In the SA context, the cost of operating a twin-engine aeromedical helicopter is approximately ZAR30 000 per flying hour. Owing to these significant cost implications, it is crucial that patients are airlifted from locations that would result in some definite benefit to the patient.

Study limitations

The main limitation of this study was that it included only patients transported by the Netcare 911 HEMS operations in Gauteng and KZN. The other private and provincial HEMS operations across SA were not included. A further limitation was that the cost implications of utilising a HEMS operation instead of a ground operation to transport patients were not a focus area of this study.

Conclusions

A HEMS operation provides on-board medical personnel with the knowledge, skills and equipment to perform complicated medical procedures and assist in the transfer of ill and/or injured patients to the most appropriate facility. Since HEMS is a very costly resource, it is essential that it be utilised in situations that would offer the most benefit to the patient. While a number of findings were in line with several international and local studies, certain results were concerning, such as potential over-triage and over-use of the HEMS

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service in the urban environment. Future studies should focus on which specific patients may benefit from HEMS transportation, and the impact of placing the HEMS operation in a rural region. Acknowledgement. We thank Prof. J K Adam of the Durban University of Technology for her wise input and advice on the developmental phases of this research project and assistance in collating the first author’s MTech Emergency Medical Care thesis document (on part of which this article is based) for examination. References 1. Farlex. Air ambulance definition 2013. http://www.thefreedictionary.com (accessed 15 September 2011). 2. Floccare DJ, Stuhlmiller DFE, Braithwaite SA, et al. Appropriate and safe utilization of helicopter emergency medical services: A joint position statement with resource document. Prehosp Emerg Care 2013;17(4):521-525. [http://dx.doi.org/10.3109/10903127.2013.804139] 3. Martin T. Aeromedical Transportation: A Clinical Guide. 2nd ed. UK: Ashgate, 2006. 4. Bledsoe BE. EMS myth # 6: Air medical helicopters save lives and are cost effective. 2003. http://www. emsworld.com (accessed 15 September 2011). 5. Galvagno SM, Haut ER, Nabeel Zafar S, et al. Association between helicopter vs ground emergency medical services and survival for adults with major trauma. JAMA 2012;307(15):1602-1610. [http:// dx.doi.org/10.1001/jama.2012.467] 6. Netcare 911. Netcare 911. 2013. http://netcare911.co.za (accessed 15 September 2013). 7. D’Andrea PA, van Hoving DJ, Smith WP. A 5-year analysis of the helicopter air mercy service in Richards Bay, South Africa. S Afr Med J 2014;104(2):124-126. [http://dx.doi.org/10.7196/SAMJ.7310] 8. Van Hoving DJ, Smith WP, Wallis LA. Comparison of mean on-scene times: Road versus air transportation of critically ill patients in the Western Cape of South Africa. Emerg Med J 2008;25(3):136-139. [http://dx.doi.org/10.1136/emj.2007.051540] 9. Taylor CB, Stevenson M, Jan S, Middleton PM, Fitzharris M, Myburgh JA. A systematic review of the costs and benefits of helicopter emergency medical services. Injury 2010;41(1):10-20. [http://dx.doi. org/10.1016/j.injury.2009.09.030] 10. Stratton SJ. Should helicopters dispatched for EMS trauma response be grounded? Ann Emerg Med 2013;62(4):365-366. [http://dx.doi.org/10.1016/j.annemergmed.2013.04.003] 11. Brown JB, Gestring ML. Does helicopter transport impact outcome following trauma? Trauma 2013;15(4):279-388. [http://dx.doi.org/10.1177/1460408613497153] 12. Melton JT, Jain S, Kendrick B, Deo SD. Helicopter emergency ambulance service (HEAS) transfer: An analysis of trauma patient case-mix, injury severity and outcome. Ann R Coll Surg Engl 2007;89(5):513-516. [http://dx.doi.org/10.1308/003588407X202074] 13. Cudnik MT, Werman HA, White LJ, Opalek JM. Prehospital factors associated with mortality in injured air medical patients. Prehosp Emerg Care 2012;16(1):121-127. [http://dx.doi.org/10.3109/10 903127.2011.615011] 14. Giannakopoulos GF, Kolodzinskyi MN, Christiaans HMT, et al. Helicopter emergency medical services save lives: Outcome in a cohort of 1073 polytrauma patients. Eur J Emerg Med 2013;20(2):7985. [http://dx.doi.org/10.1097/MEJ.0b013e328352ac9b] 15. Johnson B, Dimopoulos GE. An analysis of aeromedical transportation of patients in KwaZulu-Natal. Trauma and Emergency Medicine 1998;August/September:6-8. 16. Schwartz RJ, Jacobs LM, Yaezel D. Impact of pre-trauma center care on length of stay and hospital charges. J Trauma 989;29(12):1611-1615. [http://dx.doi.org/10.1097/00005373-198912000-00002] 17. Hassani SA, Moharari RS, Sarvar M, Nejati A, Khashayar P. Helicopter emergency medical service in Tehran, Iran: A descriptive study. Air Med J 2012;31(6):294-297. [http://dx.doi.org/10.1016/j. amj.2012.05.001] 18. McQueen C, Crombie N, Perkins GD, Wheaton S. Impact of introducing a major trauma network on a regional helicopter emergency medicine service in the UK. Emerg Med J 2013;30(7):1-7. [http://dx.doi. org/10.1136/emermed-2013-202756] 19. Mommsen P, Bradt N, Zeckey C, et al. Comparison of helicopter and ground emergency medical service: A retrospective analysis of a German rescue helicopter base. Technol Health Care 2012;20(1):49-56. 20. Ringburg AN, Spanjersberg WR, Frankema SPG, Steyerberg EW, Patka P, Schipper IB. Helicopter emergency medical services (HEMS): Impact on scene times. Journal of Trauma, Injury, Infection and Critical Care 2007;63(2):258-262. [http://dx.doi.org/10.1097/01.ta.0000240449.23201.57] 21. Butler DP, Anwar I, Willett K. Is it the H or the EMS in HEMS that has an impact on trauma patient mortality? A systematic review of the evidence. Emerg Med J 2010;27(9):692-701. [http://dx.doi. org/10.1136/emj.2009.087486] 22. Hardcastle T. The 11 P’s of an Afrocentric trauma system for South Africa – time for action! S Afr Med J 2011;101(3):160-161. 23. Bledsoe BE, Wesley AK, Eckstein M, Dunn TM, O’Keefe MF. Helicopter scene transport of trauma patients with nonlife-threatening injuries: A meta-analysis. J Trauma 2006;60(6):1257-1265. [http:// dx.doi.org/10.1097/01.ta.0000196489.19928.c0] 24. Nicholl JP, Brazier JE, Snooks HA. Effects of London helicopter emergency medical service on survival after trauma. BMJ 1995;311(6999):217-222. [http://dx.doi.org/10.1136/bmj.311.6999.217]

Accepted 14 October 2015.

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RESEARCH

Treatment and outcome of unusual animal bite injuries in young children P de Klerk,1 BSc; M van Dijk,2 PhD; A B van As,3 PhD epartment of Pediatric Surgery, Erasmus University, Rotterdam, Netherlands D Department of Pediatric Surgery and Paediatrics, Erasmus MC-Sophia Children’s Hospital, Rotterdam, Netherlands 3 Department of Paediatric Surgery, University of Cape Town, Red Cross War Memorial Children’s Hospital, Cape Town, South Africa 1 2

Corresponding author: P de Klerk (peterdeklerk@live.nl)

Background. Animal bites are a major cause of preventable traumatic injuries. Objectives. To provide more epidemiological information on animal bites, and assist in increasing awareness of the problem. Methods. A retrospective chart review was performed including children aged >13 years presenting with bite injuries (excluding dog and human bites) to the trauma unit at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa, over a 25-year period. Results. Two hundred and thirteen children were eligible to be entered into the study. The median age was 2.9 years (range 1.2 - 6.5), with boys slightly predominating (54.9%). Most (74.6%) of the bite injuries were inflicted by mammals, the majority (64.8) of mammalian bites being rat bites. The proportions of boys and girls in the age group 0 - 4 years bitten by rats significantly differed from the proportions in the age group >4 years (p=0.039). In the age group 0 - 4 years more girls suffered rat bites, while more boys were bitten in the age group >4 years. Of 91 rat bites, 81 (89.0%) occurred inside the house. The hands (43.9%) and the head/face/neck region (39.0%) were most affected. The underdeveloped suburbs of Philippi, Gugulethu and Khayelitsha in Cape Town represented a disproportionate number (41.6%) of rat bites. Conclusions. There is a relationship between poverty, unemployment, poor housing, informal settlements and rodent infestation. These high-risk populations need to be the target for government rat eradication programmes. S Afr Med J 2016;106(2):206-209. DOI:10.7196/SAMJ.2016.v106i2.10106

Animal bites are a major cause of preventable traumatic injuries, and most reported cases involve children.[1] There is no accurate epidemiological information, as not all people who are bitten seek medical care.[2] Previously reported studies have focused mainly on dog bites.[2-5] Rat bites have, however, become an increasing problem in informal settlements.[6] Not only do these bites cause severe trauma, but rats are important vectors of a variety of diseases, including leptospirosis, lassa fever, rat-bite fever, viral haemorrhagic fevers, bartonelosis, plague, murine typhus and salmonellosis.[7,8] Younger children (<5 years) in particular tend to be the victims of rat bites, typically in their beds as they sleep during the night. There is a strong association between the incidence of rat bites and poverty in urban areas. In Philadelphia and New York City, USA, the highest incidences were found in areas with high unemployment, low family income and old housing structures.[9,10] Poor sanitation and drainage, open drains and improper storage of food and garbage make food and water available for rats, while their nesting and breeding is promoted by the poor conditions of the houses.[6,7,11] Poor living conditions such as those in the informal settlements in South Africa (SA) are conducive to rodent infestation. SA therefore represents a high-risk area requiring implementation of prevention programmes. The current study was designed to provide insight into and epidemiological information on unusual animal bites, rat bites in particular. We believe that publication of these results will enhance awareness of the problem.

Methods

This retrospective chart review included children <13 years of age presenting with bite injuries to the trauma unit at Red Cross War

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Memorial Children’s Hospital (RCWMH), Cape Town, SA, during the 25-year period 4 January 1991 - 14 March 2015. Exclusion criteria were dog bites, human bites, bites associated with falls, tongue bites, unknown types of bite, and trauma causes other than bites.

Research procedure and data collection

Patient details were retrieved from the Child Accident Prevention Foundation of South Africa (CAPFSA) database, in which the entry ‘other bites’ was used to identify our study population. From this database the following variables were extracted: gender, age at the time of the bite incident, date of the incident, the child’s first language, demographic characteristics, type of bite wound, description of the bite incident (e.g. (indoor/outdoor) and time, anatomical site of the bite injury, pathology, severity assessed with the Abbreviated Injury Score (AIS) (minor, moderate, severe, mortal), treatment (medication, immunisation, analgesic, wound dressing, sutures, stitches, debridement, amputation, skin graft, etc.), follow-up (returned for check-up), socioeconomic background, family income and parental employment. Statistical information on the different regions in Cape Town was extracted from a report published by the City of Cape Town in 2011.[12]

Data analysis

Normally distributed variables were presented as means (standard deviation) and non-normally distributed variables as medians (interquartile range (IQR)). Numbers of rat bites were compared between gender and age groups using Fisher’s exact test. The data analyses were performed using SPSS Statistics 23.0 (IBM, USA). A p-value of <0.05 was considered statistically significant.

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RESEARCH

Results

In the CAPFSA database, 450 patients were identified with the entry ‘other bite’, 237 of whom were excluded because they did not meet the inclusion criteria or there was an exclusion criterion. Table 1 presents the background characteristics of the 213 patients included in the study. The median age was 2.9 years (IQR 1.2 - 6.5), and 117 (54.9%) were boys. In 107 cases the patient’s racial category was identified: 20 children (18.7%) were categorised as black, 21 (29.6%) as white and 66 (61.7%) as coloured (of mixed race). Mammals inflicted most of the bite injuries (159/213, 74.6%). Thirty-nine chil dren (18.3%) were bitten by insects, 8 (3.8%) by species of birds (e.g. chickens), and 7 (3.3%) by snakes. Fig. 1 is a pie chart of all the mammalian bite injuries, divided into the different species. It is clear that most bite injuries were inflicted by rats. The boxplot in Fig. 2 presents the ages of the children at the time of the bite incident, categorised by type of animal. The children bitten by rats had the lowest median age (1.5 years, IQR 1.5 - 3.3).

Of the 103 children who were bitten by a rat, 57 (55.3%) were girls and 46 (44.7%) were boys. Of these, 51 girls (49.5%) and 33 boys (32.0%) fell into the age category 0 - 4 years, while 13 boys (12.6%) and 6 girls (5.8%) were aged >4 years. Fisher’s exact test showed a significant difference between the proportions of boys and girls aged ≤4 years and those aged >4 years (p=0.039). In 198 cases, the geographical place where the bite occurred was documented. Of all

3.8%

animal bites, the largest proportion (61.6%) occurred inside the house. Bites inflicted by birds occurred most frequently outdoors (62.5%), whereas bites by mammals occurred more frequently inside the house (69.2%) (Table 2). The place of occurrence could be identified for 91 out of the 103 rat bites; of these, 81 (89.0%) occurred inside the house. Of all the 213 patients, 180 (84.5%) presented to hospital between 07h00 and 22h00.

3.1% 1.3%

8.2%

8.8% 64.8% 10.1%

Rat Cat Horse or donkey Rabbit or squirrel Mouse Other Monkey

Table 1. Background characteristics of the patients Patients

n (%)

Age at incident (years) 0-2

80 (37.6)

2-4

44 (20.7)

4-6

26 (12.2)

6-8

27 (12.7)

8 - 10

19 (8.9)

>10

17 (8.0)

Total

213 (100.0)

Fig. 1. Mammalian bite wounds by animal species.

14 12 10

Male

117 (54.9)

Female

96 (45.1)

Total

213 (100.0)

Race

Age, years

Gender

8 6

Black

20 (18.7)

White

21 (19.6)

Coloured

66 (61.7)

Total

107 (100.0)

Xhosa

32 (38.6)

Afrikaans

20 (24.1)

English

30 (36.1)

French

1 (1.2)

Total

83 (100.0)

First language

Rat Bird, e.g. Other Rabbit Horse Cat chicken or or squirrel donkey Type of bite

Fig. 2. Ages of the children at time of the bite incident.

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Insect Monkey Mouse Snake

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Some patients had more than one bite, and there were 223 bites in total. We categorised the bite injuries into seven anatomical sites. Fig. 3 shows that the most commonly injured anatomical sites were the hands (43.9%) and the head/face/neck (39.0%). Information concerning treatment, medi cation and analgesics was documented in 91 cases. Forty-five patients (49.4%) received tetanus immunisation (in 10 cases (11.0%) this immunisation was already up to date). Rabies vaccination was reportedly given to only 8 children (8.8%). Thirteen patients (14.3%) received antibiotics, and 1 patient was treated with prednisone and 1 with ibuprofen. Analgesics were administered to 28 patients (30.8%) (paracetamol n=21, pilidine n=5, diclofenac n=2). Of all the 213 patients, 180 (84.5%) were classified as having AIS minor injuries, 28 as having moderate injuries and 5 as having severe injuries. Surgery was reported in 3 of the 5 severe cases and 8 of the 28 moderate cases. Six surgical procedures encompassed wound debridement, 1 patient needed a fasciotomy and 4 patients required skin grafting. Two rat bites classified as moderate/ severe injuries and described as a ‘deep bite in lower end of finger’ necessitated amputation of a fingertip. One child with a snakebite to the leg had clinical signs of a compartment syndrome (extensively swollen, tender and tense calf, decreased sensation to touch and calf pain on dorsiflexion of the foot) and fasciotomy was required to release the pressure in the compartment, with subsequent skin transplantation.

Table 2. Geographical place of occurrence in relation to type of bite (N=198) Type of bite

Home, indoors n (%)

Outdoors n (%)

School/public place n (%)

Mammal

101 (69.2)

34 (23.3)

11 (7.5)

Insect

16 (42.1)

14 (36.8)

8 (21.1)

Bird

2 (25.0)

5 (62.5)

1 (12.5)

Snake

3 (50.0)

0 (0.0)

Total

122 (61.6)

56 (28.3)

20 (10.1)

Head/face/neck n=87 (39.0%) 39%

Shoulder/arm n=23 (5.4%)

5% 1%

Thorax/trunk n=3 (1.3%)

Pelvic region n=3 (1.3%)

Hand n=98 (43.9%)

44%

Area statistics for rat bites

The area code was recorded for 101 rat bites (98.1%). Forty-two rat bites (41.6%) occurred in the suburbs of Philippi (n=20), Gugulethu (n=12) and Khayelitsha (n=10). The other rat bites occurred in 23 other areas throughout Cape Town. The population size, demographic profiles, economic profiles and dwelling profile of Philippi, Gugulethu and Khayelitsha are set out in Table 3.

Leg n=9 (4.0%)

Follow-up

In 28 cases, information concerning followup was documented. Twenty children were followed up by social workers, who reported that the children bitten by rats lived in informal settlements under poor socioeconomic circumstances, their families living in shacks or ‘Wendy houses’, with children frequently sleeping on a dilapidated wooden floor. Some families’ dwellings were close to drains or on farms adjacent to open fields. It was confirmed that there were rat problems in these areas: ‘huge rat problem in the area’;

Foot n=11 (4.9%) Total N=223 (100.0%) Fig. 3. Anatomical sites of the bites.

‘similar problems in the past’; ‘big rats come out during the night time and bite children’. Social workers sometimes reported that more than one family member had been bitten: ‘brother was bitten previously by a

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rat’; ‘all four children have been bitten by rats previously’. There were also reports, albeit rare, that the mother was intoxicated with alcohol and therefore failed to respond to the child’s crying.

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Table 3. Demographic data on the suburbs of Philippi, Gugulethu and Khayelitsha Suburb

Population size, N

Income <ZAR3 200, %

Black Africans, %

Informal dwellings, %

Philippi

191 025

78.2

55.6

Gugulethu

391 749

73.7

54.5

Khayelitsha

98 468

71.4

47.1

Discussion

A disproportionate number of the rat bite victims lived in Philippi, Gugulethu and Khayelitsha, which are disadvantaged areas. Our findings indicated that around 50 55% of the households lived in informal dwellings and 70 - 80% lived in poverty (surviving on <ZAR3 200 per month). Several studies have reported that poor socio economic circumstances, unemployment, living below the poverty line, poor sanitation and drainage, open drains, overcrowding of homes, poor/informal housing and environmental conditions that provide food, water and shelter for rodents are linked to rodent infestation.[6-11,13,14] Previous reports have documented that rodent bites occur most frequently in areas with high rates of poverty and unemployment.[6,10] Rodents are a significant problem in urban settlements in Johannesburg, especially in the poor areas.[6] These findings are consistent with our results. RCWMH is a tertiary-level referral hospital that treats only severe and referred cases. Since not all victims of bite injuries are referred to a healthcare institution for medical treatment,[15] it is probable that the cases seen at RCWMH represent the tip of an iceberg. In this study, 54.9% of the children presenting after animal bite injuries were boys. This is consistent with the literature, most studies on animal bite injuries reporting a male predominance.[15-18] In contrast to this finding, we found that in the age group 0 - 4 years, girls were more likely to be bitten by rats. Furthermore, most of the rat bites occurred in the youngest age group. This may be explained by the fact that children in this age category, perhaps girls in particular, are not capable of protecting themselves from rats. Parents or other caregivers must therefore take adequate precautions to prevent these injuries to young children. The head (face) and hands were the ana tomical locations most affected by animal bite injuries. This is in agreement with other

studies.[9,10,17] According to Jaindl et al.,[17] young children may be vulnerable because they do not yet understand the behaviour of animals, while their short stature exposes their faces and hands and makes them easier targets. Hirschhorn and Hodge’s[10] observation that most bite injuries occur in sleeping children would also offer an explanation why the face and hands were most affected, these body parts being more exposed during sleep. The finding that most mammalian bites occurred inside the house is explained by the predominance of rat bites, of which 84% are known to occur indoors.[10] This in turn is explained by the fact that families of victims of rat bites typically live in informal settlements, in shacks with dilapidated floors. In the present study, almost 50% of the children received a tetanus vaccination. The guideline for tetanus immunisation is the same for animal bites as for any other inj [1] ury that penetrates the epidermis. We found that just over 14% of the animal bites were treated with antibiotics, in line with a previous study. [17] While there is no scientific evidence for the benefits of anti biotic prophylactic therapy in animal bites,[1,9,19] antibiotics tend to be prescribed to patients with deep puncture wounds and high-risk immunocompromised patients. [1,19] A deep wound generally also requires extensive cleaning, debridement and suturing, and in some cases skin grafting.[1] Dealing with the public health issue of rodent bite injuries in children requires development of preventive strategies that target the population at risk. Rodent control programmes are often understaffed and fail to address the fundamental underlying problems.[6] While education of families will create awareness of this community health problem, and rodent eradication programmes are important, they are unlikely to be sufficient. What needs to be achieved is an improvement in housing quality, prevention of overcrowding and installation

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of proper sanitation and drains, while at the same time addressing the scourges of poverty and unemployment. This can only be achieved over the long term.

Conclusions

There is a relationship between poverty, unemployment, poor housing, informal settlements and rodent infestation. Recogni sable high-risk populations need to be targeted for public health rat eradication programmes that should include improved domestic hygiene, the safe storage of garbage, and sanitation control. References 1. Kannikeswaran N, Kamat D. Mammalian bites. Clin Pediatr 2009;48(2):145-148. [http://dx.doi.org/10.1177/0009922808324494] 2. Schalamon J, Ainoedhofer H, Singer G, et al. Analysis of dog bites in children who are younger than 17 years. Pediatrics 2006;117(3):e374-e119. [http://dx.doi.org/10.1542/peds.2005-1451] 3. Dwyer JP, Douglas TS, van As AB. Dog bite injuries in children – a review of data from a South African paediatric trauma unit. S Afr Med J 2007;97(8):597-600. 4. Griego RD, Rosen T, Orengo IF, Wolf JE. Dog, cat, and human bites: A review. J Am Acad Dermatol 1995;33(6):1019-1029. [http://dx.doi.org/10.1016/0190-9622(95)90296-1] 5. Sacks JJ, Lockwood R, Hornreich J, Sattin RW. Fatal dog attacks 1989-1994. Pediatrics 1996;97(6):891-895. 6. Jassat W, Naicker N, Naidoo S, Mathee A. Rodent control in urban communities in Johannesburg, South Africa: From research to action. Int J Environ Health Res 2013;23(6):474-483. [http://dx.doi.org/10.1080/09603123.2012.755156] 7. Roomaney R, Ehrlich R, Rother HA. The acceptability of rat trap use over pesticides for rodent control in two poor urban communities in South Africa. Environ Health 2012;11:32. [http://dx.doi.org/10.1186/1476-069X-11-32] 8. Kajdacsi B, Costa F, Hyseni C, et al. Urban population genetics of slum-dwelling rats (Rattus norvegicus) in Salvador, Brazil. Mol Ecol 2013;22(20):5056-5070. [http://dx.doi.org/10.1111/mec.12455] 9. Childs JE, McLafferty SL, Sadek R, et al. Epidemiology of rodent bites and prediction of rat infestation in New York City. Am J Epidemiol 1998;148(1):78-87. [http://dx.doi.org/10.1093/ oxfordjournals.aje.a009563] 10. Hirschhorn RB, Hodge RR. Identification of risk factors in rat bite incidents involving humans. Pediatrics 1999;104(3):e35. [http://dx.doi.org/10.1542/peds.104.3.e35] 11. Bonner PC, Schmidt WP, Belmain SR, Oshin B, Baglole D, Borchert M. Poor housing quality increases risk of rodent infestation and Lassa fever in refugee camps of Sierra Leone. Am J Trop Med Hyg 2007;77(1):169-175. 12. City of Cape Town – 2011 Census Suburb: City of Cape Town. 2011. https://www.capetown.gov.za/en/stats/Pages/2011-CensusSuburb-Profiles-land.aspx (accessed 8 July 2015). 13. Mehndiratta S. Animal bites in children: Burden in urban Delhi. Trop Doct 2012;42(2):114-115. [http://dx.doi.org/10.1258/ td.2011.110444] 14. De Masi E, Vilaca P, Razzolini MT. Environmental conditions and rodent infestation in Campo Limpo district, Sao Paulo municipality, Brazil. Int J Environ Health Res 2009;19(1):1-16. [http://dx.doi.org/10.1080/09603120802126670] 15. Dendle C, Looke D. Animal bites: An update for management with a focus on infections. Emerg Med Australas 2008;20(6):458467. [http://dx.doi.org/10.1111/j.1742-6723.2008.01130.x] 16. Fleisher GR. The management of bite wounds. N Engl J Med 1999;340(2):138-140. [http://dx.doi.org/10.1056/ NEJM199901143400210] 17. Jaindl M, Grunauer J, Platzer P, et al. The management of bite wounds in children – a retrospective analysis at a level I trauma centre. Injury 2012;43(12):2117-2121. [http://dx.doi. org/10.1016/j.injury.2012.04.016] 18. Goldstein EJ. Management of human and animal bite wounds. J Am Acad Dermatol 1989;21(6):1275-1279. [http://dx.doi. org/10.1016/S0190-9622(89)70343-1] 19. Morgan M. Hospital management of animal and human bites. J Hosp Infect 2005;61(1):1-10. [http://dx.doi.org/10.1016/j. jhin.2005.02.007]

Accepted 14 October 2015.

RESEARCH

Thrombocytopenia during pregnancy in women with HIV infection receiving no treatment H M Sebitloane, MB ChB, FCOG (SA), MMed Department of Obstetrics and Gynaecology, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa Corresponding author: H M Sebitloane (sebitloanem@ukzn.ac.za)

Background. Thrombocytopenia (TCP) complicates 5 - 8% of pregnancies. Most cases of TCP are gestational, and the condition is usually mild and occurs in the latter part of pregnancy. Apart from pregnancy-associated medical complications such as pre-eclampsia, HIV infection is a recognised cause of TCP, and a relatively high prevalence of TCP during pregnancy would be expected in a setting with a high antenatal seroprevalence of HIV. Methods. This was a sub-analysis of the data from a prospective trial in which the incidence of postpartum sepsis in HIV-infected women was compared with that in HIV-uninfected women. Women who were considered at low risk and eligible for vaginal delivery were recruited at 36 weeks’ gestation, and followed up for 6 weeks after delivery. Full blood counts and CD4 counts of HIV-infected women were obtained at baseline and repeated 6 weeks after delivery. Results. The prevalence of TCP was 5.3% during pregnancy and 1.2% 6 weeks after delivery. The prevalence was similar among HIVinfected (6.0%) and HIV-uninfected women (4.7%) (p=0.292). Among the HIV-infected women, who were not receiving antiretroviral therapy (mean CD4 cell count of 453 cells/µL), there was no significant association between immunosuppression and the severity of TCP. Conclusions. Most of the TCP seen during pregnancy is of the gestational variety, and in this study HIV infection did not increase its prevalence or its severity. S Afr Med J 2016;106(2):210-213. DOI:10.7196/SAMJ.2016.v106i2.9903

Thrombocytopenia (TCP) (platelet count <150 × 109/L) during pregnancy often causes anxiety among both patients and healthcare practitioners. It occurs in 5 - 8% of pregnancies, the prevalence depending on whether it is associated with medical disorders or not.[1,2] Gestational TCP (gTCP), also known as incidental or benign TCP of pregnancy, accounts for approximately 80% of all cases of TCP occurring in pregnancy[1] and typically develops in the late second or third trimester when physiological haemodilution leads to an increased mean platelet volume and subsequent accelerated consumption. Women with gTCP are usually asymptomatic, their low platelet count being detected as part of routine antenatal screening. Fetal TCP is usually mild and transient, requiring no intervention. [3] A history of gTCP is sometimes obtained, as there is the potential for it to recur. A recurrence rate of 13.6% was noted in a series of 22 cases,[4] while among 37 patients with gTCP, Ruggeri et al.[3] reported 100% recurrence in 4 women who had repeat pregnancies.[3] gTCP is usually mild (platelet count 100 - 150 × 109/L), and although the minimum threshold has never been established, counts of ≤70 × 109/L are uncommon.[5] Severe TCP (≤50 × 109/L) is rare, occurring in ≤0.1% of pregnancies.[6] In these cases, pathological causes of increased destruction or utilisation of platelets such as preeclampsia/eclampsia, the HELLP syndrome (haemolysis, elevated liver enzymes and low platelet count), and microangiopathies such as thrombotic thrombocytopenic purpura, (auto)immune thrombocytopenic purpura, haemolytic uraemic syndrome and haemolysis are likely. Viral infections such as viral hepatitis and infection with cytomegalovirus and HIV may also cause TCP. In the era of HIV, particularly in South Africa (SA), where the seroprevalence in the antenatal population exceeds 25%, clinicians may not be able to differentiate gTCP from that associated with HIV. TCP has been reported to be present in 5 - 9% of patients who have

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HIV infection but are asymptomatic, and in 21 - 40% of those with AIDS.[6,7] Although TCP was initially thought to occur early in the course of HIV infection, reports have shown a correlation between TCP and low CD4 counts.[6,7] Moreover, TCP has been shown to correlate with a poorer prognosis and rapid progression to AIDS. [7,8] Transient TCP is a feature of the acute retroviral syndrome seen in primary HIV infection.[9] The two mechanisms involved in HIVassociated TCP are thought to be immune-mediated destruction of platelets (in early infection) and a defect in platelet production (in advanced disease).[8] HIV also directly infects megakaryocytes, causing apoptosis and dysmegakaryopoiesis.[8] Individuals with HIVassociated TCP have a clinical presentation and response to therapy similar to that of idiopathic (immune) thrombocytopenic purpura (ITP).[10] Apart from the severity and the time of onset of TCP in pregnant women with ITP (being more severe and occurring in earlier gestation), there is as yet no diagnostic test to differentiate gTCP from ITP, as circulating antibodies may be found in both conditions.[11] There are limited data on the prevalence of gTCP in HIV-infected women. In a clinical setting where patients may arrive unbooked and in labour, or without a previous platelet count, it becomes important to establish the role of HIV in TCP.

Methods

This was a sub-analysis of data from a prospective longitudinal study aimed at determining the effect of HIV on postpartum infectious morbidity. The cohort comprised HIV-infected (n=675) and HIV-uninfected (n=648) women attending King Edward VIII Hospital, Durban, SA, between 2005 and 2007. Participants were recruited at ≥36 weeks’ gestation. They had to be at low risk with no obstetric morbidities, and eligible for a vaginal delivery. Ethical approval for the parent study was obtained from the University of

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KwaZulu-Natal BioMedical Research Ethics Committee (Ref. H031/01). At baseline all women had full blood counts (FBCs), and CD4 counts if HIVinfected. They were reviewed on three occasions in the post-delivery period, and tests were repeated 6 weeks after delivery. TCP was defined as a platelet count of ≤150 × 109/L. It was regarded as severe if the platelet count was ≤50 × 109/L.

Results

Results were available for 1 311 women (669 HIV-infected and 642 HIV-uninfected) at baseline, and for 897 (461 (68.9%) of the HIV-infected and 436 (67.9%) of the HIV-uninfected) women at 6 weeks. None of the HIV-infected participants received combination antiretroviral therapy (ART), as the standard of care at the time was only single-dose nevirapine. The HIVinfected and HIV-uninfected groups were comparable in terms of age, parity and body mass index (Table 1). The baseline FBC results are also shown in Table 1. HIVinfected women had significantly lower baseline haemoglobin (Hb) concentrations and total white cell counts (WCCs) than HIV-uninfected women. The mean Hb at baseline was 11.1 g/dL for HIV-infected women and 11.7 g/dL for HIV-uninfected women (p<0.001). Twenty-three percent of the women had an Hb of ≤10.5 g/dL; these comprised 30.1% of the HIV-infected group compared with 16.4% of the HIV-uninfected group (p<0.001). The mean CD4 count of the HIV-infected women was 453 cells/µL at enrolment, increasing by 22% to a mean of 552 cells/µL at 6 weeks postpartum. Women with CD4 counts of <200 cells/µL (11.1% of the HIV-infected population) had a mean CD4 count at enrolment of 129 cells/µL and a mean count of 131 cells/µL 6 weeks after delivery. The mean platelet count was 243.2 × 109/L in the HIV-infected group (range 84 - 533) and 247.4 × 109/L in the HIV-uninfected group (range 26 - 597) (p=0.354) (Table 1). The incidence of gTCP was 40/669 (5.9%) in the HIV-infected and 30/642 (4.7%) in the HIV-uninfected women at baseline (relative risk (RR) 1.28; 95% confidence interval (CI) 0.81 - 2.03; p=0.292) (Table 2). The TCP was mild in both groups, with only 3 HIV-uninfected and 4 HIV-infected women in each group having platelet counts of ≤100 × 109/L. Among the HIV-infected women, TCP occurred at all ranges of CD4 counts and was not associated with immunosuppression (CD4 count <200 cells/µL). On the contrary, TCP occurred with increasing frequency

Table 1. Demographic data (means) HIV-infected (N=669)

HIV-uninfected (N=642)

p-value

Age (years)

26.7

0.048

Weight (kg)

80.7

79.8

0.774

Parity

1.0

0.667

Height (m)

1.7

1.8

0.272

Gestational age (wks)

36.8

0.051

Hb (g/dL)

11.1

11.7

<0.001 <0.001

WCC (× 10 /L)

7.8

8.7

Lymphocytes (× 109/L)

2.1

2.2

0.907

Platelets (× 109/L)

243.2

247.4

0.354

Table 2. Thrombocytopenia at baseline HIV-positive according to CD4 count (cells/µL) (N=669) Platelets (× 109/L)

<200

200 - 350

351 - 500

>500

HIV-negative (N=642)

<100, n

100 - 150, n

15.0

25.0

27.5

32.5

Total, n (%)

40 (6.0)†

30 (4.7)†

*% of HIV-positive and HIV-negative women with TCP. † RR 1.28 (CI 0.81 - 2.03); p=0.292.

with increasing CD4 counts (Table 2). The non-parametric test showed a low corre lation of 0.062. Three participants (all HIVinfected) were found to have puerperal sepsis (endometritis), their infection resolving on first-line antibiotics. For 461 HIV-infected women and 436 HIV-uninfected women, both the base line and 6 weeks post-delivery platelet measurements were available. Eleven women had TCP at the 6-week assessment (6 HIVinfected women (1.3%) and 5 HIV-uninfected women (1.2%)) (p=0.881) (Table 3). TCP had persisted from the antenatal period in 3 women in each HIV group (total 6); the remainder (3 HIV-infected and 2 HIVuninfected women) were new cases of TCP. The correlation between platelet counts and CD4 counts at baseline and 6 weeks for the 11 women with TCP in the postpartum period is shown in Table 4. Of the 3 HIVinfected women with persistent TCP after the first assessment, only 1 (patient 3) was immunosuppressed according to the CD4 count. Of the 3 who had developed TCP for the first time in the postnatal period, only 1 (patient 4) was immunosuppressed.

Discussion

gTCP develops in up to 5% of all preg nancies in the third trimester.[1] In the

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present study the overall prevalence of TCP during pregnancy was 5.3%, and there was no statistical difference in the preva lence between women with and without HIV infection. Mandelbrot et al.[11] found a comparable prevalence of TCP among HIVinfected pregnant women of 3.2%; however, these authors associated >80% of cases of TCP with HIV-positive status despite the study having no HIV-uninfected controls. In the present study, the prevalence of severe TCP (<50 × 109/L) was very low despite half of the patients being HIVinfected. In a study of patients of unknown HIV status, with a sample size comparable to the present study, Dwivedi et al.[12] reported an overall prevalence of TCP of 8%, 4% of cases being severe, and attributed this to the high prevalence of anaemia in their patients.[12] There are several reasons why the TCP in the women in the present study was probably gestational: (i) the prevalence rates are comparable to those reported in other series;[1,2] (ii) in most of the women with TCP who had two readings (22/26 HIV-infected women and 18/21 HIV-uninfected women), the platelet counts returned to normal in the postpartum period; and (iii) most of the women had mild TCP, in keeping with previous reports on gTCP.[1,2] Of the women

RESEARCH

with TCP at 6 weeks, low platelet counts had been detected in the antenatal period in 3 in each HIV group, and their TCP was mild (>100 × 109/L), a feature not in keeping with ITP. One woman (patient 7 in Table 4) who had antenatal and post-delivery platelet counts of 81 × 109/L and 92 × 109/L, respectively, may in fact have had ITP, although it has been reported that it may take as long as 12 weeks after delivery for platelet counts to recover,[13] and followup in the present study did not extend beyond 6 weeks. ITP could also have been responsible for the new development of TCP in 2 HIV-uninfected participants, as no other explanation could be found. Classic ITP occurs in the second or third decade of life,[3] and complicates 1/1 000 - 10 000 pregnancies.[12] In a report of 117 patients with TCP at term, Subbiah et al.[14] found 41% of cases to be gestational and 26% to be due to ITP. However, this was a selected high-risk group and does not represent the general obstetric population. The development of new-onset TCP in 3 HIV-infected women could have been related to their HIV status. In the first case (patient 4 in Table 4), TCP was probably due to defective production of platelets. This woman was severely immunocompromised and had a low Hb and total WCC both at baseline and 6 weeks after delivery. She was not receiving any ART, in the context of Dominguez et al.’s[10] finding that untreated HIV-infected thrombocytopenic individuals had lower platelet turnover than those treated with zidovudine. The TCP in the other 2 women was probably immune-

Table 3. Baseline and 6-week platelet counts according to HIV status 6-week platelets (× 109/L)

Baseline platelets (× 109/L)

<150

>150

Total

<150

3 (11.5)

23 (88.5)

>150

3 (0.7)

432 (99.3)

435

HIV-infected, n (%)

HIV-uninfected, n (%) <150

3 (15.0)

18 (85.7)

>150

2 (7.2)

413 (92.8)

415

mediated HIV-associated TCP, since both had relatively high CD4 counts. Immunologically competent HIV-infected individuals (as opposed to those who are immunosuppressed) would be expected to produce more antiplatelet antibodies, leading to increased platelet destruction; among 41 HIV-infected individuals with TCP, platelet destruction was more prominent in patients with high CD4 counts.[10] It could be argued that the TCP in the HIV-infected participants (patients 1 - 3 in Table 4) that was detected both in the antenatal period and at 6 weeks was also immunologically induced. If that is so, the prevalence of HIVrelated TCP during pregnancy in the present study would be 0.9%, and while low platelet counts occurred mainly among women with CD counts of >200 cells/µL, the TCP was mild. While other studies have reported a relationship between the severity of the HIV infection and the occurrence or severity of TCP,[7] this was not confirmed in the present study. Ambler et al.[15] documented similar findings in a population of highly active antiretroviral therapy (HAART) recipients. As this was a retrospective analysis, maternal TCP could not be correlated with neonatal platelet counts. However, the findings are relevant to inform clinical practice, serving as a baseline. In the current era of universal HAART for all pregnant HIV-infected women, it can be expected that HIV-related TCP will be less frequent. While it is recommended that all efforts be made to acquire a baseline Hb and platelet count for all patients who are about to give birth, a fresh sample is not always indicated, as some clinicians have insisted for fear of HIV-related TCP. This causes delay in management and may potentially lead to poor perinatal outcomes.

Conclusion

This analysis establishes that TCP in HIV-infected pregnant women is mainly a result of the pregnancy itself, and that HIV-related TCP is rare, even in women not receiving ART. This is reassuring for practitioners managing women who present ‘unbooked’ in labour and perhaps require emergency caesarean section, but for whom a previous platelet count is unavailable. A baseline FBC, including Hb and platelets, should ideally be obtained as part of antenatal care during the course of pregnancy, but needs to be repeated during labour only in women with pre-eclampsia or obstetric haemorrhage.

Table 4. Details of women with thrombocytopenia at 6 weeks Patient No.

Platelets at baseline, × 109/L

CD4 at baseline, cells/µL

Platelets at 6 weeks, × 109/L

CD4 at 6 weeks, cells/µL

Probable cause

101

235

114

253

?gTCP, ?HIV-TCP

110

383

101

261

?gTCP, ?HIV-TCP

133

116

113

170

?gTCP, ?HIV-TCP

158

HIV-TCP

205

703

124

792

HIV-TCP

164

314

148

510

HIV-TCP

ITP

126

109

?gTCP

119

?gTCP

278

?ITP

197

129

?ITP

HIV-infected CP at both T assessments CP only at 6 T weeks HIV-uninfected CP at both T assessments CP only at 6 T weeks

HIV-TCP = HIV-associated thrombocytopenia.

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References 1. Levy AJ, Murphy LD. Thrombocytopenia in pregnancy. J Am Board Fam Pract 2002;15(4):290-297. 2. Sullivan CA, Martin JN Jr. Management of the obstetric patient with thrombocytopenia. Clin Obstet Gynecol 1995;38(3):521-534. [http://dx.doi.org/10.1097/00003081-199509000-00011] 3. Ruggeri M, Schiavotto C, Castaman G, et al. Gestational thrombocytopenia: A prospective study. Haematologica 1997;82(3):341-342. 4. Karim R, Sacher RA. Thrombocytopenia in pregnancy. Curr Hematol Rep 2004;3(2):128-133. 5. Anteby E, Shalev O. Clinical relevance of gestational thrombocytopenia of <100,000/microliters. Am J Hematol 1994;47(2):118-122. [http://dx.doi.org/10.1002/ajh.2830470210] 6. Sloand EM, Klein HG, Banks SM, et al. Epidemiology of thrombocytopenia in HIV infection. Eur J Haematol 1992;48(3):168-172. [http://dx.doi.org/10.1111/j.1600-0609.1992.tb00591.x] 7. Volberding PA, Baker KR, Levine AM. Human immunodeficiency virus hematology. ASH Education Book 2003;2003(1):294-313. [http://dx.doi.org/10.1182/asheducation-2003.1.294] 8. Litttleton N. Thrombocytopenia in HIV. CME 2007:25(6):272-275. 9. Lescale KB, Eddleman KA, Cines DB, et al. Antiplatelet antibody testing in thrombocytopenic pregnant women. Am J Obstet Gynecol 1996;74(3):1014-1018. [http://dx.doi.org/10.1016/S00029378(96)70342-3]

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10. Dominguez A, Gamallo G, Gaercia R, et al. Pathophysiology of HIV related thrombocytopenia: An analysis of 41 patients. J Clin Pathol 1994;47(11):999-1003. [http://dx.doi.org/10.1136/jcp.47.11.999] 11. Mandelbrot L, Schlienger I, Bocigain A, et al. Thrombocytopenia in pregnant women infected with human immunodeficiency virus: Maternal and neonatal outcomes. Am J Obstet Gynecol 1994;171(1):252-257. [http://dx.doi.org/10.1016/0002-9378(94)90478-2] 12. Dwivedi P, Puri M, Nigam A, Agarwal K. Fetomaternal outcome in pregnancy with severe thrombocytopenia. Eur Rev Med Pharmacol Sci 2012;16(11):1563-1566. 13. ACOG practice bulletin: Thrombocytopenia in pregnancy. Number 6, September 1999. Int J Gynaecol Obstet 1999;67(2):117-128. 14. Subbiah M, Kumar S, Kallol KR, Sharma JB, Singh N. Pregnancy outcome in patients with idiopathic thrombocytopenic purpura. Arch Gynecol Obstet 2014;289(2):269-273. [http://dx.doi.org/10.1007/ s00404-013-2958-x] 15. Ambler KL, Vickars LM, Leger CS, et al. Immune thrombocytopenia in the HAART era. Adv Hematol 2012(2012), Article IDÂ 910954. [http://dx.doi.org/10.1155/2012/910954]

Accepted 14 October 2015.

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Which test is best for diagnosing peanut allergy in South African children with atopic dermatitis? C L Gray,1 MB ChB, FRCPCH, MSc, PhD; M E Levin,1 MB ChB, FCPaeds, PhD; G du Toit,2 MB ChB, FRCPCH 1 2

ivision of Allergology, Red Cross War Memorial Children’s Hospital, Cape Town, South Africa D King’s College London, King’s Health Partners, MRM & Asthma UK Centre in Allergic Mechanisms of Asthma, and Department of Paediatric Allergy, Guy’s and St Thomas’ NHS Foundation Trust, London, UK

Corresponding author: C Gray (claudiagray.paediatrics@gmail.com)

Background. Diagnosing peanut allergy based on sensitisation alone leads to an unacceptable rate of overdiagnosis. Objective. To define parameters that may help differentiate peanut allergy from asymptomatic sensitisation in a cohort of South African (SA) children with atopic dermatitis (AD). It is the first study in SA to utilise oral food challenge tests and analyse peanut component patterns. Methods. This was a prospective, observational study at a paediatric university hospital in Cape Town, SA. Children with AD, aged 6 months - 10 years, were recruited randomly. They were assessed for sensitisation and allergy to peanut by questionnaire, skin-prick tests (SPTs), immuno solid-phase allergen chip (ISAC) tests, ImmunoCAP component tests to Ara h 1, 2, 3, 8 and 9, and incremental food challenges. Results. One hundred participants (59 Xhosa (black Africans) and 41 of mixed race, median age 42 months) were enrolled. Overall, 44% of patients were peanut sensitised and 25% had a true peanut allergy. SPTs and ImmunoCAP Ara h 2 produced the highest areas under the receiver operating characteristic curve for predicting peanut allergy in peanut-sensitised patients. The ISAC test was less sensitive, more specific and produced significantly lower median values than ImmunoCAP tests. Ara h 2 was the most useful component in differentiating allergy from tolerance in both ethnic groups, being positive in 92% of allergic and 40% of sensitised but tolerant children (p<0.001). There was little additional contribution from Ara h 1 and 3. Ara h 8 and 9 were associated with tolerance. Commonly used 95% positive predictive values (PPVs) for SPTs, peanut-specific IgE and Ara h 2 levels fared suboptimally in our population. Maximum PPVs for this study population were found at SPT 11 mm, peanut IgE 15 kU/L and ImmunoCAP Ara h 2 of 8 kU/L, but these adjusted levels still had suboptimal PPVs in Xhosa subjects. Severe peanut allergy was associated with increased median peanut IgE and Ara h 2. Conclusions. The component Ara h 2 was useful for differentiating allergy from tolerance in both ethnic groups in this SA cohort. Ninetyfive percent PPVs for peanut allergy tests may need to be revised, especially in Xhosa patients. An SPT result ≥11 mm as well as Ara h 2 ≥8 kU/L had the best predictive value for peanut allergy. S Afr Med J 2016;106(2):214-220. DOI:10.7196/SAMJ.2016.v106i2.10125

The increase in allergy to peanut in westernised countries[1] has sparked widespread interest in peanut allergy. Recent progress has been made in identifying risk factors for peanut allergy, such as epithelial barrier defects leading to epicutaneous sensitisation by peanut protein.[2] Further research into possible strategies to prevent peanut allergy in high-risk patients has favoured early introduction of peanut protein, which may promote tolerance in selected patients.[3] Screening for peanut allergy is an important part of the management of the patient at risk of peanut allergy. However, sensitisation does not equate to allergy in peanut-sensitised patients, and further specialised tests such as food challenges may be required to differentiate between asymptomatically sensitised and truly allergic patients. Ninety-five percent positive predictive values (PPVs) have been established to predict food allergies more reliably and reduce the number of labour-intensive and potentially hazardous food challenges. However, these PPVs may be population and age specific.[4] The use of molecular allergology using component-resolved diagnostics has become commonplace in peanut allergy diagnosis in the past decade. Peanut components are prefixed ‘Ara’ after the name for peanut, Arachis hypogaea. Component testing for peanut proteins helps differentiate between nonspecific crossreactive components such as Ara h 5, 8 and 9 and specific peanut

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components such as Ara h 1, 2, 3 and 6, which are heat-resistant storage proteins. Ara h 2 (2S albumin storage protein) has been shown to be the most important component in prediction of food allergy in several countries, including the UK,[5] France,[6] Japan[7] and the USA,[8] with a positive result (>0.35 kU/L) to Ara h 2 having a high predictive value for peanut allergy. In Mediterranean countries, the lipid transfer factor Ara h 9 is an important peanut allergen.[9] Ara h 8, in the PR10 protein group of labile food allergens, is more prominent in those exposed to certain pollens such as birch and alder.[10] The pattern and relevance of peanut components may therefore vary between geographical areas and possibly between ethnic groups. Currently there are no reliable data on peanut allergy prevalence in South Africa (SA), but prevalence studies are underway. A recent study on food allergy prevalence in patients with atopic dermatitis (AD) suggests a high rate of peanut allergy of 25% in this high-risk population.[11] However, the rate of asymptomatic sensitisation was also high: a further 19% of patients were peanut sensitised but not allergic. The objective of this study was to determine parameters that may help in differentiating between peanut allergy and asymptomatic sensitisation in our cohort of children with AD. It is the first study in SA to utilise oral food challenge tests in equivocal cases, and also the first to analyse peanut component patterns. Patterns of peanut component sensitisation (Ara h 1, 2, 3, 8 and

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9) and the value of internationally derived 95% PPVs for peanut allergy were explored.

Methods

The methods have been described in detail in a previous article.[11] In brief, 100 children (aged 6 months - 10 years) with moderate to severe AD were randomly selected from a dermatology clinic at Red Cross War Memorial Children’s Hospital (RCWMCH), Cape Town, SA. They completed an allergy questionnaire and underwent eczema scoring by SCORAD (SCORing Atopic Dermatitis) assessment, and a panel of skin-prick tests (SPTs) including peanut extract (Alk Abello, Spain). They all underwent an ImmunoCAP immuno solid-phase allergen chip (ISAC) 103 microarray test that tested for peanut components Ara h 1, 2, 3 and 8. The patients who were sensitised to peanut by the SPT or ISAC test (n=44) further underwent ImmunoCAP testing to whole-peanut extract and components, Ara h 1, 2, 3, 8 and 9 (Phadia, Sweden). In all patients in whom there was uncertainty regarding peanut allergy, an incremental open food challenge was performed as a day case at RCWMCH. The challenge food was given in the form of peanut butter, starting with a lip challenge then moving from 0.3 g to 17 g of peanut butter over 2 hours with dose increments every 15 - 20 minutes.

Overall, 57% of peanut-sensitised patients were peanut-allergic; this ratio was 75% in children of mixed race and 38% in Xhosas, and was significantly different at p<0.001.

Value of history of past reaction to peanut allergy in the diagnosis of peanut allergy

Overall, 23% of the patients (n=23) reported a reaction to peanut, of whom 16 were found to be allergic; 70% (16/23) with a perceived peanut allergy therefore had a true peanut allergy. Eight patients who were subsequently found to be allergic had never eaten peanut before. Symptoms of a severe reaction such as wheeze, tight throat and circulatory compromise were 100% accurate in predicting peanut allergy, as was an itchy mouth. However, symptoms such as perceived angio-oedema and eczema exacerbation had a poor predictive value (Table 1).

Sensitivity and specificity of positive SPTs, ISAC tests and ImmunoCAP tests in differentiating peanut allergy from tolerance in peanut-sensitised patients (n=44)

Patients who were found to be sensitised to peanut by the screening SPTs/ISAC tests underwent ImmunoCAP tests to whole peanut and components Ara h 1, 2, 3, 8 and 9 (n=44). A positive test result was

Study definitions

60 50 Patients, %

IgE-mediated peanut sensitisation was defined as a positive SPT (≥3 mm above the negative control) and/ or positive food-specific IgE by ISAC (≥0.3 ISAC units). IgE-mediated peanut allergy was defined as either a positive food challenge or a convincing clinical history of significant type I allergic reactions after isolated ingestion of peanut-containing food in the preceding 6 months, with significantly positive SPT/specific IgE above the 95% PPV for peanut of 8 mm for SPT and 14 kU/L for ImmunoCAP.[12,13]

50%

44%

41%

40 30

24%

15%

10 0

Overall

The study was approved by the University of Cape Town’s Faculty of Science Human Ethics committee (reference 426/2009). Informed consent was obtained from a parent/legal guardian for study participation, food challenges and blood testing.

Data entry and statistics

Data were entered onto a computerised database using STATA version 11.1 (Stata Corp, USA). Statistical tests were performed according to parametric or non-parametric distribution of data for comparisons between continuous parameters and categorical variables. The χ2 test or the two-sample test of proportion was used to test for statistical differences between proportions. A p-value of <0.05 was considered statistically significant. Receiver operating characteristic (ROC) curves were used to assess the capacity of a variable or component to diagnose food allergy. Specificity, sensitivity and PPVs were calculated at various cut-off levels.

Results

Peanut sensitisation and allergy patterns

Overall, 44% of the patients (n=44) were sensitised to peanut (40% (24/59) of Xhosa (black African) patients and 50% (20/40) of mixedrace patients (p=0.1)). Overall, 24% (n=24) of the patients were peanut allergic (15% (9/59) of Xhosa patients and 38% (15/40) of mixed-race patients). The inter-ethnic difference was significant (p=0.01) (Fig. 1).

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Mixed race

Xhosa Sentitised

Ethical considerations

38%

Allergic

Fig. 1. Proportions of patients with peanut sensitisation and allergy, by ethnic group.

Table 1. Reported symptoms caused by peanut and their predictive values

Symptom

Patients with history of reaction to peanut n/N (%)

Proportion of patients with this symptom who were found to have peanut allergy n/N (%)

Itchy rash

15/23 (65)

10/15 (67)

Angio-oedema

9/23 (39)

5/9 (56)

Exacerbation of eczema

9/23 (39)

5/9 (56)

‘Doesn’t like’ the food

7/23 (30)

5/7 (71)

Flushing

5/23 (22)

4/5 (80)

Wheeze

5/23 (22)

5/5 (100)

Vomiting

4/23 (17)

3/4 (75)

Itchy mouth

3/23 (13)

3/3 (100)

Tight throat

3/23 (13)

3/3 (100)

Circulatory compromise (blue lips, shock)

1/23 (4)

1/1 (100)

Diarrhoea

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considered to be ≥3 mm for SPT, ≥0.35 kU/L for ImmunoCAP tests and ≥0.3 ISAC units/L for ISAC tests. In the 44 peanut-sensitised patients, the highest sensitivity for diagnosis of peanut allergy was achieved by both the SPT and the ImmunoCAP test to whole peanut, at 100% in both ethnic groups. However, the specificity of these tests and the PPV was poor: for SPT ≥3 mm the specificity was 73% and the PPV 55%, and for ImmunoCAP Peanut ≥0.35 kU/L the specificity was 40% and the PPV 67%. Component testing for Ara h 2 by both ISAC test and the ImmunoCAP test produced lower sensitivities than the SPT but higher specificities and PPVs: for ISAC Ara h 2 ≥0.3 ISAC units, sensitivity for peanut allergy diagnosis was 83%, specificity 75% and PPV 80%, and for ImmunoCAP to Ara h 2 sensitivity was 92%, specificity 60% and PPV 73%. Sensitivities, specificities and PPVs for peanut-sensitised patients are set out in Table 2. The trend for all the above screening tests was towards a lower specificity and PPV in the Xhosa patients, as depicted in Table 2.

ROC curves for diagnosis of peanut allergy in peanut-sensitised patients

ROC curves were performed to assess the capacity of variables to diagnose peanut allergy in peanut-sensitised patients. The highest area under the ROC curve (AUC) was attained for SPT to peanut (0.94), followed by ImmunoCAP Ara h 2 and ISAC Ara h 2 (both 0.86), then ImmunoCAP to whole peanut (0.80). The ROC AUC was significantly lower for Ara h 1, both by ISAC (AUC 0.62) and ImmunoCAP

(AUC 0.68), and for Ara h 3 for ISAC (AUC 0.62) and ImmunoCAP (AUC 0.64). Performance in the prediction of peanut allergy was poor for ImmunoCAP Ara h 8

(AUC 0.56) and Ara h 9 (AUC 0.51). The ROC AUC results and ethnic comparisons for peanut-sensitised patients are depicted in Table 3 and Fig. 2.

Table 2. Sensitivities and specificities of SPTs, ISAC tests and ImmunoCAP tests for predicting peanut allergy in peanut-sensitised patients Overall (N=44), %

Xhosa (n=24), %

Mixed race (n=20), %

Difference between ethnic groups (p-value by χ2 test)

Sensitivity

100

1.0

Specificity

0.45

PPV

0.01

NPV

100

1.0

Sensitivity

100

1.0

Specificity

0.07

PPV

0.004

NPV

100

1.0

Sensitivity

0.44

Specificity

100

0.005

PPV

100

0.001

NPV

0.34

Sensitivity

0.65

Specificity

0.06

PPV

0.004

NPV

0.41

SPT peanut ≥3 mm

ImmunoCAP Peanut ≥0.35 kU/L

ISAC Ara h 2 ≥0.3 ISAC units

ImmunoCAP Ara h 2 ≥0.35 kU/L

NPV = negative predictive value.

Table 3. ROC graphs for SPT, peanut ImmunoCAP and peanut components as predictors of peanut allergy in peanut-sensitised patients

SPT peanut

ROC overall (N=44) AUC (95% CI)

ROC Xhosa (n=24) AUC (95% CI)

ROC mixed race (n=20) AUC (95% CI)

Difference in AUC between ethnic groups (p-value)

0.94 (0.87 - 1)

0.91 (0.78 - 1)

1 (1 - 1)

0.15

ImmunoCAP Peanut

0.80 (0.66 - 0.94)

0.76 (0.55 - 0.96)

0.87 (0.69 - 1)

0.40

ISAC Ara h 1

0.62 (0.47 - 0.77)

0.50 (0.29 - 0.72)

0.8 (0.67 - 0.93)

0.02* 0.18

ISAC Ara h 2

0.86 (0.76 - 0.97)

0.79 (0.59 - 0.98)

0.93 (0.84 - 1)

ISAC Ara h 3

0.62 (0.49 - 0.75)

0.48 (0.34 - 0.62)

0.77 (0.64 - 0.89)

0.003*

ImmunoCAP Ara h 1

0.68 (0.48 - 0.89)

0.64 (0.37 - 0.91)

0.77 (0.55 - 0.99)

0.48

ImmunoCAP Ara h 2

0.86 (0.74 - 0.98)

0.85 (0.69 - 1)

0.91 (0.76 - 1)

0.60

ImmunoCAP Ara h 3

0.64 (0.44 - 0.84)

0.53 (0.27 - 0.8)

0.8 (0.49 - 1)

0.26

ImmunoCAP Ara h 8

0.56 (0.37 - 0.76)

0.43 (0.37 - 0.89)

0.63 (0.37 - 0.89)

0.31

ImmunoCAP Ara h 9

0.51 (0.31 - 0.71)

0.35 (0.08 - 0.61)

0.7 (0.19 - 1)

0.22

CI = confidence interval. 2

*Statistically significant by χ test.

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0.00

0.25

Sensitivity 0.50 0.75

1.00

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0.00

0.25

0.50 1– specificity

Peanut: ROC area 0.72 Ara h 2: ROC area 0.82 SPT: ROC area 0.92

0.75

1.00

Ara h 1: ROC area 0.69 Ara h 3: ROC area 0.65

Fig. 2. ROC curves for ImmunoCAP tests and SPTs in all peanut-sensitised patients (N=44).

Patients, %

100 80

83%* 50%*

60 40 20 0

38%* 7%

7% ISAC Ara h 1

ISAC Ara h 2 Sentitised

ISAC Ara h 3

Allergic

Fig. 3. ISAC components in peanut-allergic v. tolerant patients in the overall study population (N=99). (*Statistically significant.)

Patients, %

Value of internationally derived 95% PPVs

p<0.001

100 80 60 40 20 0

Peanut

Any of Ara h 1 Ara h 1, 2 or 3

Ara h 2

Overall allergic

were Ara h 2-positive (p=0.001). The components ImmunoCAP Ara h 1 and ImmunoCAP Ara h 3 were not significantly different between allergic and tolerant patients in this peanut-sensitised group, both overall and in each ethnic group (Fig. 4). In all cases of peanut allergy with Ara h 1 and/or 3 positivity, Ara h 2 was also positive. Ara h 8 and 9 were higher in tolerant than allergic patients in both ethnic groups, and this reached statistical significance in the Xhosa group for Ara h 9, and was significantly more frequent in non-allergic patients (p=0.04). In all but one case of Ara h 8 positivity, Ara h 9 was also positive. In the Xhosa population, Ara h 9 therefore seems to be the most useful test in assessing tolerance by cross-reactivity. When analysing the best predictive combination of components for predicting peanut allergy, Ara h 2 positivity was 73% predictive of true peanut allergy in the overall population. If Ara h 1 and 2 were positive (n=16) this increased to 80%, and if Ara h 1 and 2 were positive and Ara h 9 was negative (n=9) the predictive value became 100% for peanut allergy in both ethnic groups. By ISAC components, the proportion of patients with sensitisation to Ara h 2 and Ara h 3, as well as Ara h 1 in mixed-race patients only, was significantly higher in allergic patients. Peanut component distribution in allergic and tolerant patients is set out in Table 4. Despite the overall superiority of Ara h 2 in differentiating allergy from tolerance in both ethnic groups, the Xhosa patients had a significantly higher false-positive rate. The likelihood of being peanut allergic given a positive ImmunoCAP Ara h 2 was significantly lower wSimilarly, for a positive ISAC Ara h 2 test, the chance of peanut allergy was 58% for Xhosa patients v. 100% for mixed-race patients (p=0.009).

Ara h 3

Ara h 8

Ara h 9

Overall tolerant

Fig. 4. Proportion of patients with sensitisation (≥0.35 kU/L) to peanut components by ImmunoCAP (N=44).

Peanut component patterns

Peanut component testing in the overall study population (n=99) Of the 100 patients, 99 completed their peanut allergy investigations. In this group, the proportion of patients who tested positive was significantly higher for all three ISAC components in peanut-allergic v. tolerant patients (p<0.001 for all components Ara h 1, 2 and 3), as depicted in Fig. 3. Peanut component testing in peanut-sensitised patients (n=44) Overall, in the 44 peanut-sensitised patients, the most common peanut components by ImmunoCAP were Ara h 2 (69%), Ara h 1 (62%), Ara h 3 (58%), Ara h 9 (49%) and Ara h 8 (33%). ImmunoCAP Ara h 2 was 92% positive in peanut-allergic patients v. 40% positive in peanut-tolerant patients (p<0.001.) The significant trend in Ara h 2 positivity in allergic patients was followed in both ethnic groups: in Xhosa patients, 89% of allergic v. 47% of tolerant patients were Ara h 2-positive (p=0.04), and in mixedrace patients 93% of peanut-allergic and 20% of tolerant patients

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The sensitivities, specificities and PPVs in diagnosing peanut allergy were analysed at the internationally derived levels of SPT and specific IgE widely used as 95% predictive for peanut allergy: these levels were 8 mm for SPT to peanut extract,[12] 14 kU/L for ImmunoCAP to peanut,[13] and 0.35 kU/L for ImmunoCap Ara h 2.[5] In the study population overall, these cut-off values produced PPVs of 85%, 77% and 73%, respectively, for SPT 8 mm, ImmunoCAP Peanut 14 kU/L and Ara h 2 0.35 kU/L (Table 5). These cut-off values proved useful in the mixed-race population (PPV 88%, 93% and 100%, respectively), but were of significantly less predictive value in the Xhosa population (80%, 57% and 53%, respectively). In analysing the cut-off points producing the highest PPV for allergies, at an SPT of 11 mm, the PPV was 95% overall (100% for mixed-race and 88% for Xhosa patients). For peanut-specific IgE, a maximum PPV of 80% was attained at a level of 15 kU/L (100% for mixed-race and 57% for Xhosa patients). For Xhosas, a maximum PPV of only 66% was attained at a level of 65 kU/L. For ImmunoCAP Ara h 2, a PPV of 93% was attained at a level of 8 kU/L for the study population overall, at which level the PPV was 100% in the mixed-race group and 80% in Xhosas. For ISAC Ara h 2, a 93% PPV was attained at a level of 1.8 ISAC units/L, at which level the mixed-race subgroup had a PPV of 100% and the Xhosas a PPV of 83%.

Severe peanut allergy

Five patients (4 of mixed race, 1 Xhosa) had symptoms of severe peanut allergy. All 5 were ImmunoCAP Ara h 2- and ISAC Ara h 2-positive, as well as ISAC Ara h 1-positive; 80% (4/5) were also ImmunoCAP Ara h 1- and Ara h 3-positive, and 80% (4/5) were ISAC Ara h 3-positive. The presence of ISAC Ara h 1 and ISAC

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Table 4. Peanut component sensitisation in peanut-sensitised patients (N=44) Patients with positive component test (>0.3 ISAC units for ISAC or >0.35 kU/L for ImmunoCAP), % Overall allergic (n=24)

Overall tolerant (n=20)

Difference between allergic and tolerant patients (p-value)

ISAC Ara h 1

0.09

ImmunoCAP Ara h 1

0.16

ISAC Ara h 2

<0.001*

ImmunoCAP Ara h 2

<0.001*

ISAC Ara h 3

0.04*

ImmunoCAP Ara h 3

0.7

ImmunoCAP Ara h 8

0.45

ImmunoCAP Ara h 1+2-positive

0.002*

ImmunoCAP Ara h 1+2-positive, Ara h 9-negative

0.002*

ImmunoCAP Ara h 1+2-negative, Ara h 9-positive

<0.001* (in favour of tolerance)

*Statistically significant by χ test.

Table 5. Value of commonly used 95% PPVs in the study population Overall PPV, %

Xhosa PPV, %

Mixed race PPV, %

Commonly used 95% PPVs SPT to peanut ≥8 mm

Immunocap Peanut ≥14 kU/L

I mmunoCAP Ara h 2 ≥0.35 kU/L

ISAC Ara h 2 ≥0.3 ISAC units/L

100

Levels producing maximum PPV for the study population SPT to peanut ≥11 mm

100

ImmunoCAP Peanut ≥ 15 kU/L

100

I mmunoCAP Ara h 2 ≥8.0 kU/L

100

ISAC Ara h 2 ≥1.8 ISAC units/L

100

Ara h 3 in addition to a positive ISAC Ara h 2 significantly increased the likelihood of the allergy being severe, as depicted in Table 6. The median value for ImmunoCAP to whole peanut was significantly higher in children with severe peanut allergy than in those with an allergy but no anaphylactic symptoms (88 kU/L v. 12.1 kU/L; p=0.04). Similarly, the median value for ImmunoCAP Ara h 2 (64.5 kU/L v. 8.98 kU/L; p=0.01) and

the median ISAC to Ara h 2 (11.0 ISAC units v. 2.2 ISAC units; p=0.009) were significantly higher in the patients with severe peanut allergy.

Comparing ISAC with ImmunoCAP tests for peanut allergy

In the peanut-sensitised subgroup (n=44), in which both ISAC and ImmunoCAP tests were performed, these two tests could

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be compared. The ISAC test proved less sensitive but more specific for peanut allergy than the ImmunoCAP tests. Of peanut-allergic patients, 88% tested posi tive to at least one ISAC component, and 83% to ISAC Ara h 2, while 96% tested positive to any ImmunoCAP component, and 92% to ImmunoCAP Ara h 2 (p=0.35). Testing by ISAC components alone would have missed 3 cases of peanut allergy (12.5%). Median values for ImmunoCAP com ponent levels were significantly higher than ISAC values for both allergic and tolerant patients. The median Ara h 2 by ImmunoCAP in peanut-allergic patients was 15.25 kU/L, v. 3.6 ISAC units (p<0.001). In tolerant patients, the median value for Ara h 2 by ImmunoCAP was 0.21 kU/L, v. 0 ISAC units (p<0.001).

Discussion

This is the first study in SA to explore challenge-proven peanut allergy, as well as component patterns, and therefore provides an opportunity to explore clinical and laboratory parameters that most accu rately predict peanut allergy. The study was performed in children with moderate to severe AD, a population known to be at significantly higher risk of peanut allergy than the general population. Peanut sensitisation (44%) and allergy rates (24%) were high in our study population, yet the rate of asymptomatic sensitisation in our study was also significant (43% of sensitised patients were found to tolerate peanut). Diagnosing peanut allergy based on sensitisation alone leads to an unacceptable rate of overdiagnosis, unnecessary food elimination and anxiety. Moreover, avoiding foods unnecessarily in a child’s diet may actually abrogate tolerance induction and conversely lead to higher eventual allergy rates. This has been demonstrated recently in the LEAP (Learning Early About Peanut Allergy) study, in which children at risk of peanut allergy, who were not yet signi ficantly sensitised, had lower peanut allergy rates at 5 years of age if peanut had been introduced into their diet early and regularly.[3] It is therefore important to identify clinical and laboratory parameters that may help differentiate true allergy from asymptomatic sensitisation, and allow patients to be selected more prudently for food challenges/ food introduction. Our study showed that a history of per ceived reaction to peanut carried only a 70% likelihood of a true allergy. Positive SPTs and ImmunoCAP Peanut were highly

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Table 6. Component patterns and median values in patients with severe peanut allergy Severe peanut allergy

Peanut allergy, no severe reaction

Difference (p- value)

ISAC Ara h 2-positive, n/N (%)

5/5 (100)

15/19 (78)

0.26

ISAC Ar h 1-positive, n/N (%)

5/5 (100)

7/19 (36)

0.012*

ISAC Ara h 3-positive, n/N (%)

4/5 (100)

5/19 (26)

0.027*

ImmunoCAP Ara h 1-positive, n/N (%)

4/5 (80)

13/19 (68)

0.61

ImmunoCAP Ara h 2-positive, n/N (%)

5/5 (100)

18/19 (94)

0.6

ImmunoCAP Ara h 3-positive, n/N (%)

4/5 (80)

9/19 (47)

0.19

ImmunoCAP Ara h 1- and 2-positive, n/N (%)

4/5 (80)

13/19 (68)

0.61

ImmunoCAP Ara h 1-, 2- and 3-positive, n/N (%)

4/5 (80)

9/19 (47)

0.19

ImmunoCAP to peanut (kU/L), median (IQR)

88 (19 - 99)

12.1 (3.3 - 53)

0.04†

ImmunoCAP Ara h 2 (kU/L), median (IQR)

64.5 (41.7 - 68.8)

8.98 (1.66 - 17.1)

0.01†

ISAC Ara h 2 (ISAC units), median (IQR)

11.0 (7.4 - 15)

2.2 (0.6 - 5.7)

0.008†

SPT size (mm), median

0.45

IQR = interquartile range. 2 *Statistically significant by χ test. † Statistically significantly by Mann-Whitney test.

sensitive but not specific for peanut allergy. ROC curves in patients sensitised to peanut showed SPT size and Ara h 2 to be most valuable parameters in differentiating allergy from tolerance. However, the cut-off levels above which allergy is likely for these parameters were higher in our study than previously described.[12,13] In this study, the pattern of component reactivity between the two ethnic groups was similar, with Ara h 2 being the superior component for differentiating true allergy from tolerance. Our study concurs with previous studies that Ara h 2 seems to be the most important peanut allergen.[5-8] Ara h 2 by ImmunoCAP as well as the ISAC test were significantly more frequently positive in peanut-allergic than in asymptomatically sensitised patients. ImmunoCAP Ara h 2 was positive in 92% of peanut-allergic patients, similar to recent studies in China[14] (87% positivity) and Japan[7] (88% Ara h 2-positive). However, the component reac tivity among asymptomatically sensitised patients was significantly higher in the Xhosa population than in the mixed-race patients. In Xhosa patients shown to be sensitised to Ara h 2 by the ImmunoCAP test, the chance of having a peanut allergy was significantly lower (53%) than in the mixed-race group (93%). Food challenges

may therefore be of particular importance in Xhosa patients with sensitisation to peanut. Ethnic differences in peanut sensitisation/ allergy patterns have been described in more detail in a previous article.[15] Little additional benefit was shown from ImmunoCAP Ara h 1 and Ara h 3, which were not significantly higher in allergic patients than in tolerant patients in either ethnic group. ImmunoCAP Ara h 8 or 9 reactivity in the absence of Ara h 2 reactivity was highly suggestive of tolerance despite a positive SPT or ImmunoCAP to peanut. A cost-effective approach to component testing in this population would therefore be to test Ara h 2 and Ara h 9. Ninety-five percent PPVs have been deve loped as a surrogate to oral food challenges, and also to minimise the overdiagnosis of food allergy based on laboratory results alone. Although there is some variation of PPVs for peanut allergy in the international literature, a specific IgE level of ≥14 kU/L is commonly used,[13] as is an SPT value of >8 mm.[12] In a recent British study, an excellent performance of Ara h 2 Immuno CAP was attained, with 97.5% of patients correctly classified as peanut allergic v. tolerant at a cut-off of 0.35 kU/L.[5] However, 95% PPVs may be age and population specific. The HealthNuts study,

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performed in infants in Australia, recently showed that an SPT of 8 mm had a PPV of 95% in this population, similar to previous studies; however, the serum IgE with a 95% PPV for peanut allergy was higher than previously quoted, at 34 kU/L.[4] A recent Japanese study has suggested an Ara h 2 cutoff of 4 kU/L to have a 91% PPV for peanut allergy,[16] and in a German study a 90% probability for positive peanut challenge for Ara h 2 was estimated at 14.4 kU/L.[17] In our population, commonly used PPVs for SPT, ImmunoCAP Peanut and Ara h 2 performed suboptimally at 85%, 77% and 73%, respectively. Furthermore, there were significant ethnic differences, with the Xhosa patients faring even more poorly using these cut-offs. A high SPT value of ≥11 mm and ImmunoCAP Ara h 2 of ≥8 kU/L carried the best predictive value for peanut allergy. These findings suggest that 95% PPVs may have to be tailored to our local population as well as to the ethnicity of the patients, and larger studies in unselected population are needed in order to do this. The 5 patients with severe peanut allergy tended to be sensitised to multiple storage proteins (Ara h 1, 2 or 3) and had higher median values for specific IgE to whole peanut and Ara h 2, but not for SPT size. The use of ISAC technology offers a wider sensitisation profile for each patient and enhances diagnosis of cross-reactivity. ISAC and ImmunoCAP technologies have in the past shown high concordance in the measurement of IgE to peanut allergens. [18] Our results show that the ISAC test has lower sensitivity, higher specificity and generally lower values than the ImmunoCAP test, and missed 12.5% cases of peanut allergy. We therefore suggest that ISAC and ImmunoCAP tests are not equivalent or interchangeable.

Conclusion

Peanut allergy may be increasing in SA children. However, asymptomatic sensi tisation is also common and we need tools to help differentiate true allergy from possible asymptomatic sensitisation. Widely used 95% PPVs for peanut allergy performed suboptimally in this study population of children with AD, particularly in Xhosa patients, and will need revision. A high SPT to peanut of ≥11 mm is valuable in diagnosing peanut allergy. Ara h 2 is the most valuable component for differentiating sensitisation from allergy in both Xhosa and mixed-race groups, little added benefit is derived from measuring Ara h 1 and 3, and Ara h 9 is the component most often associated with tolerance.

RESEARCH

Acknowledgements. We would like to thank Thermo Fisher Scientific for sponsoring the specific IgE as well as ISAC reagents for the study, Prof. Heather Zar, Prof. Paul Potter, Prof. Nonhlanhla Khumalo and Sister Lucia Volkwyn for their input into the study, Bartha Fenemore for the laboratory work and Henri Carrera for assistance with statistics. References 1. Venter C, Hasan AS, Grundy J, et al. Time trends in the prevalence of peanut allergy: Three cohorts of children from the same geographical location in the UK. Allergy 2010;65(1):103-108. [http://dx.doi. org/10.1111/j.1398-9995.2009.02176.x] 2. Brough HA, Liu AH, Sicherer SH, et al. Atopic dermatitis increases the effect of peanut exposure to peanut antigen in dust on peanut sensitization and likely peanut allergy. J Allergy Clin Immunol 2015;135(1):164-170. [http://dx.doi.org/10.1016/j.jaci.2014.10.007] 3. Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of peanut consumption in infants at high risk for peanut allergy. N Engl J Med 2015;372(9):803-813. [http://dx.doi.org/10.1056/NEJMoa1414850] 4. Peters RL, Allen KJ, Dharmage SC, et al. Skin prick test responses and allergen-specific IgE levels as predictors of peanut, egg and sesame allergy in infants. J Allergy Clin Immunol 2013;132(4):874-880. [http://dx.doi.org/10.1016/j.jaci.2013.05.038.] 5. Nicolaou N, Murray C, Belgrave D, et al. Quantification of specific IgE to whole peanut extract and peanut components in prediction of peanut allergy. J Allergy Clin Immunol 2011;127(3):684-685. [http://dx.doi.org/10.1016/j.jaci.2010.12.012] 6. Codreanu F, Collignon O, Roitel O, et al. A novel immunoassay using recombinant allergens simplifies peanut allergy diagnosis. Int Arch Allergy Immunol 2011;154(3):216-226. [http://dx.doi. org/10.1159/000321108] 7. Ebisawa M, Moverare R, Sato S, et al. Measurement of Ara h 1-, 2-, and 3-specific antibodies is useful in diagnosis of peanut allergy in Japanese children. Pediatr Allergy Immunol 2012;23(6):573-581. [http:// dx.doi.org/10.1111/j.1399-3038.2012.01332.x]

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8. Hong X, Caruso D, Kumar R, et al. IgE, but not IgG4, antibodies to Ara h 2 distinguish peanut allergy from asymptomatic peanut sensitization. Allergy 2012;67(12):1538-1546. [http://dx.doi.org/10.1111/all.12047] 9. Krause S, Reese G, Randow S, et al. Lipid transfer protein (Ara h 9) as a new peanut allergen relevant for a Mediterranean allergic population. J Allergy Clin Immunol 2009;124(4):771-778. [http://dx.doi. org/10.1016/j.jaci.2009.06.008] 10. Maeda Y, Ono E, Fukutomi Y, et al. Correlations between alder specific IgE and alder-related tree pollen specific IgE by RAST method. Allergol Int 2008;57(1):79-81. [http://dx.doi.org/10.2332/ allergolint.o-07-496] 11. Gray CL, Levin ME, Zar H, et al. Food sensitization and allergy in South African children with atopic dermatitis. Paediatr Allergy Immunol 2014;25(6):572-579. [http://dx.doi.org/10.1111/pai.12270] 12. Sporik R, Hill DJ, Hosking CS. Specificity of allergen skin testing in predicting positive open food challenges to milk, egg and peanut in children. Clin Exp Allergy 2000;30(11):1540-1546. [http://dx.doi. org/10.1046/j.1365-2222.2000.00928.x] 13. Sampson HA. Utility of food-specific IgE concentrations in predicting symptomatic food allergy. J Allergy Clin Immunol 2001;107(5):891-896. [http://dx.doi.org/10.1067/mai.2001.114708] 14. Chiang WC, Pons L, Kidon MI, et al. Serological and clinical characteristics of children with peanut sensitization in an Asian community. Pediatr Allergy Immunol 2010;21(2):e429-e438. [http://dx.doi. org/10.1111/j.1399-3038.2009.00930.x] 15. Gray CL, Levin ME, du Toit G. Ethnic differences in peanut allergy patterns in South African children with atopic dermatitis. Pediatr Allergy Immunol 2015;26(8):721-730. [http://dx.doi.org/10.1111/pai.12459] 16. Ebisawa M, Moverare R, Sato S, et al. The predictive relationship between peanut- and Ara h 2-specific serum IgE concentrations and peanut allergy. J Allergy Clin Immunol Pract 2015;3(1):131-132. [http:// dx.doi.org/10.1016/j.jaip.2014.10.014] 17. Beyer K, Grabenhenrich L, Hartl M, et al. Predictive values of component-specific IgE for the outcome of peanut and hazelnut food challenges in children. Allergy 2015;70(1):90-98. [http://dx.doi.org/10.1111/ all.12530] 18. Gadisseur R, Chapelle JP, Cavalier E. A new tool in the field of in-vitro diagnosis of allergy: Preliminary results in the comparison of ImmunoCAPÂŠ 250 and ImmunoCAPÂŠ ISAC. Clin Chem Lab Med 2011;49(2):277-280. [http://dx.doi.org/10.1515/CCLM.2011.052.]

Accepted 29 September 2015.

February 2016, Vol. 106, No. 2

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THE SOUTH AFRICAN MEDICAL ASSOCIATION Medical Coding Consultant Job Responsibilities Coding Enquiries Correspondence on Coding Interpretation and Private Practice Information: • Provide prompt and factually correct telephonic support on coding matters timely manner using all communication media (eg. email, telephone) procedural coding (for example MDCM, COID, HPCSA, RAF, RPL, CPT and CCSA) and diagnostic coding (ICD-10) in a manner that is easily understood. Responsible for all email and telephone enquiries on coding and private practice matters. • Create and accurately log all relevant queries from and replies to members and 3rd parties and ensure that trends are identified and communicated to the Head of the Department • Refer queries to the relevant departments where the Private Practice Department is not able to assist and effectively follow up to ensure that the queries have been dealt with timeously. • Liaise with colleagues on more difficult queries before replying to enquiries. • Educate staff members of doctors and medical scheme staff regarding medical coding and related issues in order for them to do accurate coding. Assist with Updating of Coding Structures: • Assist in the preparation of the Medical Doctors’ Coding Manual (MDCM), Complete CPT for South Africa (CCSA) and ICD-10 coding system. • Update crosswalk between the Medical Doctors’ Coding Manual (MDM) and Complete CPT for SA (CCSA) on a regular basis. • Compare MDCM with RAF, HPCSA, COID etc and compiling a document with the differences. Administrative Function for Private Practice Department: • Assist in the production of departmental products through typing, presentation layout, etc. • Assist with distributing coding orders and hand-outs. • Ensure that the filing of correspondence and documentation is done in a way that is easily accessible to the rest of the department’s staff. Convert and Recruit New Members: • Handle all non-members referred or phoning in with enquiries to convert them to members. • Be well informed and able to professionally convey the benefits, options and procedures to follow. • Transfer potential members accurately and timely to correct department for processing. Job Requirements • Medical related diploma/degree • Registration with HPCSA / Nursing Council/ Pharmaceutical Council • 3-5 Years Medical Coding experience • Anatomy terminology • Physiology terminology • Medical terminology • Health care industry • Term: Permanent To apply: Send CV to careers@samedical.org or phone 012 481 2029 Closing date: 25 Feb 2016 For more information on this post, visit the website: www.professionalads.co.za

THE SOUTH AFRICAN MEDICAL ASSOCIATION Public Health Medicine Specialist/ Senior Health Policy Analyst Job Responsibilities Health Policy Review: • Analyses and develop health policy proposals, produce statements, guidance and other practical support materials Research to inform evidencebased and ethical health policy and legislation development in South Africa and internationally. • Policy analysis to inform SAMA health policy position • Identification and collation of information to support evidence-based health care Treatment Guidelines • Development of Clinical Guidelines • Identify gaps in local treatment guidelines • Interact with all the specialist societies, interest groups and government to facilitate development of a standardized clinical guideline Relationship Management: • Participate relevant Health Policy events, meetings etc. and report applicable information back to the interested parties for publication, potential research, policy or media work ensuring that SAMA’s branding is always upheld. Knowledge Management • Support information and knowledge management activities within SAMA Job Requirements: • Masters in Medicine Degree in Public Health/FCPHM preferred or • Master’s in Public Health or similar with minimum of 5 years’ experience in Public Health or similar • MBChB To apply: Send CV to careers@samedical.org or phone 012 481 2029 Closing date: 25 Feb 2016 For more information on this post, please visit the website: www.professionalads.co.za

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True (A) or false (B): SAMJ A multicentre evaluation of emergency abdominal surgery in South Africa (SA): Results from GlobalSurg-1 1. Among six SA participating hospitals, the location of surgery was an independent risk factor for an adverse outcome following emergency intraperitoneal surgery (one hospital having a 76-fold increased odds of in-hospital death and a 58-fold increased odds of a major in-hospital complication). Favourable outcomes for the first 10 years of kidney and pancreas transplantation at Wits Donald Gordon Medical Centre (WDGMC) 2. The outcomes of the first 10 years of kidney and pancreas trans plantation at WDGMC compare favourably with international survival data. Factors determining clinical outcomes in intussusception in the developing world: Experience from Johannesburg 3. Intussusception typically occurs between the ages of 6 months and 3 years and is a result of underlying pathology such as Meckel’s diverticulum, intestinal duplication cysts, polyps and intestinal malignancy. 4. If intussusception is not rapidly reduced, ischaemia of the bowel wall potentially results, with risk of necrosis, perforation and death. Mortality in paediatric burn victims: A retrospective review from 2009 to 2012 in a single centre 5. I n the 2010 Bulletin of the World Health Organization, burns are listed as one of the top five causes of fatal injuries in urban SA children. 6. The vast majority of burns are hot-water burns. 7. Significant risk factors for mortality were age <5 years, presence of inhalational injury, and total burn surface area >30%. Empirical antimicrobial therapy for probable v. directed therapy for possible ventilator-associated pneumonia (VAP) in critically injured patients 8. The diagnostic criteria for probable VAP include new-onset fever of ≥38.4oC, purulent pulmonary secretions, chest auscultatory changes, changes on the chest radiograph and a rise in white cell count.

Treatment and outcome of unusual animal bite injuries in young children 9. Most of the bite injuries in the study were inflicted by dogs. Thrombocytopenia (TCP) in pregnant women with HIV infection 10. TCP, which complicates 5 - 8% of pregnancies, is usually of mild degree and typically occurs in the latter part of pregnancy. CME An approach to a patient with infective endocarditis 11. Infective endocarditis is rarely caused by viridans streptococci. 12. Healthcare-associated infective endocarditis is a growing problem. 13. Current guidelines for antibiotic prophylaxis recommend pro phylaxis only for patients with cyanotic congenital heart disease, patients with prosthetic heart valves and patients who have had a previous episode of infective endocarditis. 14. The main indications for surgery in infective endocarditis are the development of heart failure, inadequate response to antibiotic therapy and a reduction in embolism risk. 15. There is a poor correlation between invasive dental procedures and infective endocarditis. An approach to the patient with suspected pericardial disease 16. Positional pleuritic chest pain, improved by sitting forward and exacerbated by deep inspiration, is present in >85 - 90% of cases. 17. In pericardial disease, troponins may be elevated in patients with associated myocarditis. 18. A transthoracic echocardiogram is recommended in all patients with suspected pericarditis. 19. Hospital admission is required when a specific aetiology is suspected. 20. The most important differential diagnosis of pericardial disease is ST-elevation acute coronary syndrome.

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February 2016, Vol. 106, No. 2

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