SAMJ Vol 104, No 7 (2014)

JULY 2014

VOL. 104 NO. 7

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Government expenditure on health research

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More on RWOPS Antimicrobial resistance: The South African context Smoking cessation after acute coronary syndrome Predicting outcome in traumatic brain injury CME: Paediatric palliative care

SAMF

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Strengthening Health Systems – new HMPG journal to be launched

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The ESSENTIAL MEDICAL REFERENCE for every healthcare professional!

REGISTRATION & ACCOMMODATION BOOKINGS OPEN

15th ANNUAL SA HEART CONGRESS SA Heart Congress 2014 will be held in Durban, from 16 – 19 October, with the central theme being ‘Bridging the Divide’. This is the divide that exists between current best practice – and the challenges encountered in implementing these ideals. All medical

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JULY 2014

VOL. 104 NO. 7

FROM THE EDITOR

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On mentorship J Seggie

GUEST EDITORIAL

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Health systems science can learn from medicine’s evidence revolution H Kikaya

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EDITOR’S CHOICE

EDITOR Janet Seggie, BSc (Hons), MD (Birm), FRCP (Lond), FCP (SA) EDITOR EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon) CONSULTING EDITOR JP de V van Niekerk, MD, FRCR DEPUTY EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB

CORRESPONDENCE 456

Mammography reporting at Tygerberg Hospital, Cape Town, South Africa R Pitcher, J Lotz, C Ackermann, A Bagadia, R Davis, A-M du Plessis, S Griffith-Richards, R Hattingh, G Wagener; response from J Apffelstaedt, L Dalmayer, K Baatjes

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Recommendations for the handling of fluorescent lamps in public schools in Johannesburg, South Africa W Siziba, N Naicker, A Mathee, A Swart

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A rose by any other name is an Emergency Department L N Goldstein

EDITORIAL SYSTEMS MANAGER Melissa Raemaekers, BSc (Hons), PhD SCIENTIFIC EDITOR Ingrid Nye, BSc TECHNICAL EDITORS Paula van der Bijl, BA, HDipLib Emma Buchanan, BA NEWS EDITOR Chris Bateman | Email: chrisb@hmpg.co.za HEAD OF PUBLISHING Robert Arendse

IZINDABA 459 461 463

Certificate of Need: Legal nightmare in the making?

Exchange rate hurting chronic drug suppliers – but ART pipeline safe, says govt Women doctors have a rougher time – new association born

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OBITUARIES/HULDEBLYKE Manilal Damodar Daya R B K (Ron) Tucker

PRODUCTION ASSISTANT Neesha Hassan ART DIRECTOR Brent Meder DTP & DESIGN Anelia du Plessis | Carl Sampson ONLINE MANAGER Gertrude Fani

FORUM

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MEDICINE AND THE LAW Can children aged 12 years or more refuse life-saving treatment without consent or assistance from anyone else?

D J McQuoid-Mason

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HEALTH AND FINANCE National expenditure on health research in South Africa: What is the benchmark?

F Paruk, J M Blackburn, I B Friedman, B M Mayosi

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OPINION The RWOPS debate – yes we can!

A Taylor, D Kahn

EDITORIALS

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A global call for action to combat antimicrobial resistance: Can we get it right this time?

M Mendelson, M P Matsoso

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Professional competence and professional misconduct in South Africa S Benatar

RESEARCH

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Self-reported use of evidence-based medicine and smoking cessation 6 - 9 months after acute coronary syndrome: A single-centre perspective B Griffiths, M Lesosky, M Ntsekhe

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Injury severity in relation to seatbelt use in Cape Town, South Africa: A pilot study D J van Hoving, C Hendrikse, R J Gerber, M Sinclair, L A Wallis

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Predicting outcome in severe traumatic brain injury using a simple prognostic model S Sobuwa, H B Hartzenberg, H Geduld, C Uys

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July 2014, Vol. 104, No. 7

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Assessing adherence to the 2010 antiretroviral guidelines in the antiretroviral roll-out clinic at 1 Military Hospital, South Africa: A retrospective, cross-sectional study A K Khwitshana, O B W Greeff, T Hurrell

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Childhood cancer survival rates in two South African units D K Stones, G P de Bruin, T M Esterhuizen, D C Stefan

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GUEST EDITORIAL Paediatric palliative medicine P Lück REVIEW When is the right time? Complex issues around withdrawing life-sustaining treatment in children J Ambler ARTICLES Talking to children: What to do and what not to do T Brand

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Basic counselling skills T Brand

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Managing pain in children at the end of life: What the GP should know M A Meiring

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Night-time, moonlit view of the geological formation known as the ‘Hole in the Wall’ along the Wild Coast in a region of South Africa’s Eastern Cape Province formerly known as Transkei.

Stars can be seen in the sky.

Photo and text: Eric Nathan Email: eric@ericnathan.com

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July 2014, Vol. 104, No. 7

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FIRST PUBLISHED IN 1884

On mentorship ‘… we do not choose to be a mentor, others choose us.

Your actions are being watched by others.’[1] ‘No written word, no spoken plea, Can teach youth what they should be.

Nor all the books on all the shelves It’s what the teachers are themselves.’[1] I have been fortunate to have had powerful mentors and role models throughout my career. Echoing the quotes above, none ever knew that I had chosen them! By their presence and performance in my daily working life (in and out of working hours), I judged them to be worthy mentors and my career was undoubtedly shaped by that observance.

I was reminded of this importance of mentorship while reading Adam Habib’s South Africa’s Suspended Revolution.[2] In offering a partial explanation for our country’s rash of service delivery protests, he explains that the Growth, Employment and Redistribution (GEAR) Strategy, requiring cuts in state expenditure and a reduction in the numbers of state employees, ‘circumvented the transfer of skills and capacity that demanded the two distinct processes of training and mentorship’. The skills transfer process was thus – his word – ‘sabotaged’.[2] Staff serving in public sector hospitals and clinics, linked as these are to South Africa’s medical schools, are key to mentorship of the younger under- and postgraduate members of our profession. Which brings me to the matter of remunerated work outside the public service (RWOPS), which has featured in past issues[3,4] and features again in the pages of this journal.[5] As has been and is being pointed out,[4-6] RWOPS is a dispensation for all public servants with rare skills, and is aimed within the health profession at improving remuneration for state-employed doctors.

Controversial since its inception, RWOPS, as confirmed by the leadership of the South African Medical Association,[6] ‘had a purpose nevertheless – the retention of specialist skills in the public sector’, and thus to ensure provision of services to patients and assure teaching and training of medical students and trainee specialists.

Caldwell[7] alerted us to the presence of miscreants abusing RWOPS, calling them ‘thieves of the state’ in the SAMJ’s correspondence columns; he continues to beat that drum.

There are abuses of the system, amply documented by Bateman[8] (see also Taylor and Khan[5]), by some doctors who spend unreasonable amounts of time treating private patients and neglecting their public service obligations. This led to the Minister of Health’s statement that ‘patients are dying because of specialist greed’.[8] More significantly, the absence of colleagues from the wards, clinics, operating theatres and tutorial rooms while they pursue RWOPS leads also to failure of mentorship – ‘there is no or very limited teaching from those who have a lot to share’.[8] And since, as the opening quote suggests, mentees ‘watch the teachers themselves’,[1] they will be encouraged to

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believe that they may operate with impunity in their own professional practice, as Caldwell’s colleagues allegedly do.

Moreover, as a result of abuses of RWOPS, those colleagues who are left behind to ‘hold the public fort’ become ‘overloaded, angry and resentful’.[8] It bears noting that according to the surveys reported by Taylor and Khan,[5] colleagues, including trainees, believe RWOPS to be beneficial: ensuring maintenance of skills, offering additional finan­ cial reward, and affording a spectrum of patients/diseases different from that encountered in the public sector and exposure to operations not routinely performed in public hospitals. This is resonant of claims that lack of surgical training for junior doctors at some hospitals has little to do with RWOPS. Instead the reduced number of lists, and therefore cases, has meant that trainees receive less surgical training.

As a ‘knock on’, senior registrars have to do more surgery to try to increase their exposure, further reducing training for juniors.[8] As Taylor and Khan indicate,[5] ‘A national policy is required that complies with appropriate public service regulations. The framework should set out the responsibilities of staff with regard to their public service commitments, the restrictions pertaining to private work, and how public sector and private sector duties will be monitored. This framework will require flexibility if it is to apply to all provinces and institutions, as service loads and requirements to conduct research or teach will vary between hospitals.’

The original intent of RWOPS remains valid. It is important to retain the skills of experienced staff in the public sector, and RWOPS helps to do this. However, it should be permitted to continue only if public sector work is competently dealt with and remains the primary responsibility of public sector doctors. The key to achieving this is strong management to enforce a fair RWOPS policy.

Janet Seggie

Editor janet.seggie@hmpg.co.za 1. John Wooden, UCLA Bruins’ Baseball Coach. Insights on Teaching Excellence from Coach John Wooden. http://www.paulbuyer.com/4-insights-on-teaching-excellence-from-coach-john-wooden/ (accessed 19 April 2014).

2. Habib A. South Africa’s Suspended Revolution. Johannesburg: Wits University Press, 2013:65-66.

3. Bateman C. RWOPS clampdown – a crisis in the offing. S Afr Med J 2013;103(6):354. [http://dx.doi. org/10.7196/SAMJ.7008] 4. Bateman C. RWOPS abuse ‘eroding ethical standards of juniors’. S Afr Med J 2013;106(8):505-506. [http://dx.doi.org/10.7196/SAMJ.7165] 5. Taylor A, Khan D. The RWOPS debate – yes we can! S Afr Med J 2014;104(7):475-477. [http://dx.doi. org/10.7196/SAMJ.8050] 6. Grootboom M, Sonderup M, Ramathuba P. Thieves of the state and the South African Medical Association (SAMA): The South African Medical Association responds. S Afr Med J 2013;103(6):354. [http://dx.doi.org/10.7196/SAMJ.7008] 7. Caldwell RM. Thieves of the state and the South African Medical Association (SAMA). S Afr Med J 2013;103(6):354. [http://dx.doi.org/10.7196/SAMJ.7008] 8. Bateman C. RWOPS abuse – Government’s had enough. S Afr Med J 2012;102(12):899-901. [http:// dx.doi.org/10.7196/SAMJ.6481]

S Afr Med J 2014;104(7):453. DOI:10.7196/SAMJ.8437

July 2014, Vol. 104, No. 7

GUEST EDITORIAL

Health systems science can learn from medicine’s evidence revolution Can tuberculosis be cured? Yes. Can we eradicate polio? Definitely. So why are these diseases still out there, causing suffering and hastening death? Why do proven, effective interventions stop short of achieving their potential? Because weak health systems – the combination of actors, institutions, policies and resources that strive to improve population health – prevent well-intentioned policies from being translated into population benefits.[1] The problem is that there is little useful evidence to help policy makers decide how to make their health systems stronger – or even to gauge what ‘stronger’ really means.[2] Current understanding of the complex systems that govern health is so poor that we are unable to measure, monitor or manipulate them meaningfully. Centuries of experience have somehow managed to produce little actual evidence to guide future efforts.[1,2] The reason is that while many countries have demonstrated noteworthy health systems successes – and, importantly, failures – systematic documentation of plans, implementation and outcomes is rare. As a result, lessons learned are all but lost. Without robust tailored tools such as the randomised controlled trial (RCT) to facilitate systematic investigation, the field of health reform and development is akin to what medicine was 50 years ago: an art based on expert opinion, rather than a science based on evidence.[3] By contrast, it is almost inconceivable now to think of a time when clinical medicine had no formalised system of testing or comparing treatments, or of quantifying their likely effects. A time when drug companies could manufacture and market products with no requirement that they actually worked, and when new doctors were trained on the combined experience of their predecessors to repeat old habits with blind faith.[4] In just a single generation – not more than 30 years – a thought-revolution has been fought and won.

Medicine is no longer just about providing an authoritative opinion and some sympathy, and leaving nature to take its course.[5] There is a vast and expanding body of knowledge that means that doctors’ recommendations have a basis in fact. There may be some way to go in refining the techniques,[6] but it is fair to say that, for medicine, if not its practitioners,[7] the scientific conversion is complete.

So what can health systems specialists learn from medicine? The list of useful parallels is fairly long. The revolution in medicine started with a simple idea: that every clinical decision should be considered a hypothesis to be tested. Health systems science could approach policy decisions the same way. Some key steps were pivotal in turning this idea into a movement. First, and most crucial, was the development of the RCT. The technique of randomisation minimises biases and enables investigators to isolate the treatment effect from confounders.

Application of this method to common interventions yielded many surprises, and enabled doctors to discard widely used treatments that were shown not to work.[4] There have been attempts to adapt the RCT to testing of development interventions, but so far with mixed success and much debate.[7] The second key step in medicine’s ‘scientification’ process was the broad acknowledgement that scientific investigation is an essen­tial com­plement to clinical skills.[8] A subsequent education upheaval in medical schools transformed both current and future doctors into com­ petent users of scientific literature, and motivated investi­gators.[9] On these last two steps, health systems science is far behind. The chall­enge is that systems are much more complicated than individual patients, with diagnoses and interventions that are far less well defined. What

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works in one country, region or facility may not work in another.

Useful knowledge that could help policymakers’ decision-making is scattered across several disciplines. No single cadre of workers, such as doctors, decides and administers the intervention (treatment) to a system (patient). Multiple actors with different backgrounds and competing priorities all influence health systems and service delivery in different ways.[10] Because of this complex interplay of politics, people and priorities, experimental conditions are near-impossible to create, and findings from one health system context are difficult to translate to others.

Despite these challenges, there is much to be gained if health systems specialists embrace the conventions of science, as medicine has done.[10,11] Sharing knowledge among actors and across disciplines, so that lessons can be learnt and built upon, is the first step. This is what science does best. Evidence-based medicine teaches that experiential knowledge is crucial for ‘the conscientious, explicit, and judicious use of current best evidence in making decisions’.[12] And, here, health systems science can learn once again. Combining these two types of knowledge – evidence and experience – is the key that transforms art to science.

It is with this rationale that, this month, we are proud to announce the launch of a new journal, Strengthening Health Systems (SHS), which aims to tackle the science deficit in health and development and fill evidence gaps. International, peer reviewed and open access, as journals should be, SHS intends to capture all forms of health systems knowledge – whether from academics, policy makers, donors or implementers – and, by doing so, strengthen links between research and practice. In this field where opinions so often trump facts, medicine’s enduring lesson is this: knowledge may come from many sources, but the scientific record is the foundation on which progress is built.

Hannah Kikaya

Editor, Strengthening Health Systems hannah.kikaya@hmpg.co.za

1. World Health Organization. World Health Report 2000. Health Systems: Improving Performance.

Geneva: World Health Organization, 2000.

2. Alliance for Health Policy and Systems Research. Strengthening Health Systems: The Role and Promise of Policy and Systems Research. Geneva: World Health Organization, 2004.

3. Smith R, Rennie D. Evidence based medicine – an oral history. BMJ 2014;348:g371. [http://dx.doi. org/10.1136/bmj.g371] 4. Cochrane AL. Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972.

5. Simel DL, Rennie D. The Rational Clinical Examination: Evidence-based Clinical Diagnosis. American Medical Association, 2009.

6. Every-Palmer S, Howick J. How evidence-based medicine is failing due to biased trials and selective publication. J Eval Clin Pract 2014; E-pub: 12 May. [http://dx.doi.org/10.1111/jep.12147] 7. Smith R. Doctors are not scientists. BMJ 2004;328(7454):0.9. [http://dx.doi.org/10.1136/ bmj.328.7454.0-h] 8. Pritchett L. RCTs in development: Lessons from the Hype Cycle. Center for Global Development blogs, November 2013. [http://www.cgdev.org/blog/rcts-development-lessons-hype-cycle] (accessed 8 June 2014).

9. Guyatt GH, Rennie D. Users’ guides to the medical literature. JAMA 1993;270(17):2096-2097.

10. Kim JY, Farmer P, Porter ME. Redefining global health care delivery. Lancet 2013;382(9897):10601069. [http://dx.doi.org/10.1016/S0140-6736(13)61047-8] 11. Alliance for Health Policy and Systems Research. Health Research to Practice: Make it Happen – How Decision-makers Can Use Policy and Systems Research to Strengthen Health Systems. Geneva: Global Forum for Health Research, 2005.

12. Sackett DL, Rosenberg WMC, Gray AM, et al. Evidence based medicine: What it is and what it isn’t.

BMJ 1996;312(7023):71-72.

S Afr Med J 2014;104(7):454. DOI:10.7196/SAMJ.8547

July 2014, Vol. 104, No. 7

EDITOR’S CHOICE

CME: Paediatric palliative care

July’s CME deals with the topic of paediatric palliative care and comes from Patricia Lück and a team of dedicated palliative care specialists.

Coping with death at any age is difficult, but most people find it even more difficult when it is a child who is dying. However, research shows that terminally ill children are generally aware of the severity of their illness and need to be included in clinical decisions regarding their care. A report released last year by the International Children’s Palliative Care Network and the United Nations Children’s Fund (UNICEF) estimated that more than 800 000 children in South Africa (SA) are in need of generalised palliative care and more than 300 000 in need of specialised palliative care. It is likely that only 5% of the children in need are being reached. Among the reasons for this poor reach is ‘lack of knowledge and adequate understanding among health professionals’.

Children’s palliative care is not yet a specialty in SA, and this issue of CME offers a practical approach to the ethics of end-of-life decisions, basic counselling skills and talking to children, breaking bad news, pain control, and coping with your own potential burnout.

National expenditure on health research in SA

Against the background of the Ministry of Health’s commitment to allocate at least 2% of the national health budget to research, the National Health Research Committee has performed an audit[1] to establish the extent to which SA has historically invested in health research, judged by: (i) health research expenditure as proportions of the gross expenditure on research and development and the gross domestic product; and (ii) the proportion of the national health budget and the Department of Health budget apportioned to research.

While the total investment in health research in SA from the aggregated public, private and foreign sectors has increased steadily in real terms in recent years, and represents a 2.6-fold increase in real terms since 1991/2, only 0.73% (amounting to R403 million) of the Health Vote of R114.1 billion in 2011/2012 was spent on health research in that year; data from other recent years are similar. As the authors of the audit point out, by any metric the SA government’s current allocations to health research are far below the aspirational target of 2% allocation of the national health budget to health research. They recommend that a new set of realistic, transparent, internationally accepted and clearly defined targets be adopted forthwith as a means of ensuring adequate future government investment in health research in SA, and that an efficient monitoring mechanism be developed to track the level of expenditure on health research by governmental and non-governmental funders in the national health research system, so that performance against new benchmarks can be assessed accurately.[1]

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Smoking cessation after acute coronary syndrome

Good evidence exists to support the use of key secondary prevention medications (a four-drug combination of aspirin, statins, betablockers and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) and smoking cessation in patients after acute coronary syndromes (ACSs). Little is known about adherence to medication and smoking behaviour after discharge in SA. The study by Griffiths et al.[2] provides valuable insight into pres­ cribing practices, medium-term adherence patterns after an ACS, and smoking cessation rates beyond 6 months, areas for which there are currently no published data in the SA setting. Three findings were of particular importance: prescribing of secondary prevention medication at discharge was high (70.7% for the four-drug combination), but some 20% of patients were discontinuing medication within a 6 - 9-month period (23.5% for the four-drug combination), and a large proportion (68.6%) of patients who were active smokers on admission to hospital continued to smoke. Given the importance of smoking cessation in improving short- and long-term outcomes, more focused strategies to help patients quit are required.

Traumatic brain injury

Traumatic brain injury (TBI) is the term used for any injury of the intracranial structures and cerebral parenchyma resulting from trauma to the head. Included in this definition is the cascade of pathophysiological events that lead to progressive worsening of the initial injury, such as intracranial haemorrhage and cerebral oedema.

According to the National Institute for Occupational Health, as estimated in 2009, ~89 000 (180/100 000) new cases of head injury (of any severity) are reported in SA each year. Of these, 50% are due to road traffic collisions (bicycle, vehicle or pedestrian), 25% to falls and a further 25% to violence.

TBI may result in altered brain function and present with confusion, altered consciousness, coma, convulsions and/or focal neurological signs.

It is possible to predict outcome in severe TBI, and aid clinical decision-making in the emergency setting.

Sobuwa et al.[3] show that in the prehospital setting, bilateral pupil reactivity, a Glasgow Coma Score (GCS) of 6 - 8 and oxygen saturation ≥90% predicted a positive outcome following severe TBI. The initial GCS at the scene appears to be the most sensitive of these variables … the higher the GCS, the better the outcome.

JS 1. Paruk F, Blackburn J, Friedman IB, Mayosi BM. National expenditure on health research in South Africa: What is the benchmark? S Afr Med J 2014;104(7):468-474. [http://dx.doi.org/10.7196/SAMJ.6578] 2. Griffiths B, Lesosky M, Ntsekhe M. Self-reported use of evidence-based medicine and smoking cessation 6 - 9 months after acute coronary syndrome: A single-centre perspective. S Afr Med J 2014;104(7):483-487. [http://dx.doi.org/10.7196/SAMJ.7798] 3. Sobuwa S, Hartzenberg HB, Geduld H, Uys C. Predicting outcome in severe traumatic brain injury using a simple prognostic model. S Afr Med J 2014;104(7):492-494. [http://dx.doi.org/10.7196/SAMJ.7720]

July 2014, Vol. 104, No. 7

CORRESPONDENCE

Mammography reporting at Tygerberg Hospital, Cape Town, South Africa

To the Editor: In their recent article, Apffelstaedt et al.[1] analysed 16 105 mammograms performed at Tygerberg Hospital (TBH), Cape Town, South Africa (SA), between 2003 and 2012. The summary reported that ‘mammograms were read by experienced breast surgeons’, while the discussion stated: ‘A further noteworthy fact is that this TBH series was based exclusively on mammography interpretation by surgeons with a special interest in breast health.’

The suggestion that mammograms were exclusively interpreted by breast surgeons does not reflect the mammography workflow at our institution.

Throughout the review period, same-day reporting of all TBH mammograms was done by senior radiology registrars working under the supervision of consultant radiologists; the latter were solely responsible for sign-off of the final mammography report.

All mammograms were reviewed at a weekly multidisciplinary meeting between radiologists and our colleagues in the breast clinic.

If there was consensus that a radiology report required modification, this was done by way of an addendum, written by the duty radiology registrar and attached to the original report, without changing the report itself. Addenda were required in a small minority of cases, as reflected in the TBH mammography records. Our breast clinic colleagues loaded all radiology reports onto their MS Access database during the weekly multidisciplinary meetings.

Since June 2009, when TBH converted to a digital imaging plat­ form, all mammography reporting has been on 5-megapixel diagnostic monitors, in keeping with international quality assurance require­ ments. TBH’s two 5 megapixel monitors are in the mammography unit in the Division of Radiodiagnosis. The only time breast surgeons have access to these monitors is during their weekly review of cases at the multidisciplinary meetings with radiologists.

Richard Pitcher (Head of Division of Radiodiagnosis), Jan Lotz, Christelle Ackermann, Asif Bagadia, Razaan Davis, Anne-Marie du Plessis, Stephanie Griffith-Richards, Retha Hattingh, Georg Wagener

Division of Radiodiagnosis, Department of Medical Imaging and Clinical Oncology, Faculty of Medicine and Health Sciences, Tygerberg Hospital and Stellenbosch University, Tygerberg, Cape Town, South Africa pitcher@sun.ac.za 1. Apffelstaedt JP, Dalmayer L, Baatjes K. Mammographic screening for breast cancer in a resourcerestricted environment. S Afr Med J 2014;104(4):294-296. [http://dx.doi.org/10.7196/SAMJ.7246]

Apffelstaedt et al. respond: The letter by Pitcher et al.[1] commenting on our article requires clarification that at the same time is instructive on the delivery of medical care and education in a developing country such as SA. ‘Developing country’ supposes an upward trajectory of improving services. However, changes in political circumstances often have a profound and disruptive effect on service delivery.[2] As a long-serving member of the TBH staff, JA wishes to aquaint the above esteemed colleagues with events that predate their arrival or specialisation at TBH. Political changes in SA in the mid-1990s resulted in an exodus of specialists from the public sector, leaving the Department of Radiology at TBH with only two consultant positions filled over several years; especially in mammography, there was no effective supervision by a consultant radiologist for a long period. In southern Africa the lack of educational resources, particularly in mammography, is well documented,[3] and under these conditions guidance of junior staff and reporting in mammography

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suffered even further. At the same time, mammographers delivered excellent breast imaging, and the first mammography certificate course was started at TBH in 1999. As Head of the Breast Clinic, JA was engaged in a number of multicentre international trials reliant on accurate reporting for clinical management, and had been at several international breast imaging courses. With the support of the then Head of Radiology, he instituted a reporting meeting to ensure continuing education of clinical assistants in radiology and surgery in mammography interpretation, and these meetings have been held regularly since 2001. Since 2002 each mammogram has been entered into a database after reporting by the surgical team, and reports are printed out of the database and filed in the patient folders. Clinical management is based on these reports, and the results were presented in the article[1] referred to by Pitcher et al.

The enthusiasm of radiology and surgery clinical assistants was patchy at first, but soon the educational value of the meetings was recognised and attendance was made compulsory. To this day the meetings are a vital educational resource, and many radiologist colleagues, including some of the authors of the letter above, have benefited from the expertise in interpretation of mammograms and the insights into clinical management issues that we surgeons have imparted. After a particularly rough patch from 1998 to 2005 things have improved significantly, not least as a result of the efforts of Prof. Pitcher as head of the department and regular reporting by his staff.

Cognisant that the reporting of mammograms (or any other imaging) by surgeons may be criticised, the surgical team regularly analysed the outcomes of their reporting at TBH and at another site.

These analyses are routinely subjected to peer review, which confirms that the quality of reading and reporting conforms to international best radiological practice and has resulted in several publications.[4-7] Despite an invitation to do so,[4] similar independent confirmation of high standards of mammography interpretation by our SA radiologist colleagues is lacking.

Uncritically and rigidly taking over service delivery models of well-resourced environments is counterproductive in a developing country. Services in resource-restricted environments must often be delivered by the willing and capable instead of those with the qualifications deemed necessary in wealthier settings. In a neighbouring country, for example, there is no qualified medical oncologist to treat cancer patients, and medical oncology is provided by a single general practitioner with a special interest.

By all accounts, she is delivering care matching that of specialist oncologists. Insisting that only qualified oncologists can administer chemotherapy would deprive the citizens of a vital service. Similarly, in peripheral hospitals in SA after-hours reporting by radiologists is often not available, and clinicians treat according to their interpretation of the images. Evidence that this disadvantages patients is lacking. In our own practice, KB and JA, as surgeons with a special interest in breast health, have demonstrated that insistence that a radiologist interprets images would not add anything except expense, and must therefore be viewed critically in a resourcerestricted country. While we value the input provided by our radiologist colleagues on imaging not directly related to our area of interest, and gladly share our expertise with colleagues from other specialties, it is time to accept that specialists with a particular field of interest such as vascular surgery, neurosurgery, or in our case breast health can report imaging to high standards and provide a vital educational resource of benefit to both medical practitioners in training and patients.

July 2014, Vol. 104, No. 7

CORRESPONDENCE

Justus Apffelstaedt

dyspnoea and chest tightness as well as bronchitis and bronchiolitis with interstitial pneumonitis, airway obstruction and decreased pulmonary function.[2] We recommend that the departments of Education, Health and Environmental Affairs, together with relevant non-governmental organisations, urgently draft a fluorescent lamp management policy for South African schools, and that appropriate education, awareness and monitoring programmes be undertaken to ensure the proper implementation of such policies to protect the school environment and the health of South African children.

Head, Breast Clinic, Tygerberg Hospital, Tygerberg, Cape Town, South Africa, and Department of Surgery, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg jpa@sun.ac.za

Lisa Dalmayer

Department of Radiation Oncology, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa

Karin Baatjes

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

Wellington Siziba

1. Apffelstaedt JP, Dalmayer L, Baatjes K. Mammographic screening for breast cancer in a resourcerestricted environment. S Afr Med J 2014;104(4):294-296. [http://dx.doi.org/10.7196/samj.7246] 2. Murray EM. Medical and radiation oncology for breast cancer in developing countries with particular reference to locally advanced breast cancer. World J Surg 2003;27(8):924-927. [http://dx.doi. org/10.1007/s00268-003-6977-9] 3. Rabinowitz DA, Pretorius ES. Postgraduate radiology training in sub-Saharan Africa: A review of current educational resources. Acad Radiol 2005;12(2):224-231. [http://dx.doi.org/10.1016/j. acra.2004.11.014] 4. Apffelstaedt JP, Steenkamp V, Baatjes K. Performance data of screening mammography at a dedicated breast health centre. S Afr Med J 2008;98(12):950-953.

5. Apffelstaedt JP, Steenkamp V, Baatjes KJ. Surgeon-read screening mammography: An analysis of 11,948 examinations. Ann Surg Oncol 2010;17(Suppl 3):249-254. [http://dx.doi.org/10.1245/s10434010-1241-7] 6. Mouton JP, Apffelstaedt J, Baatjes K. Surgical mammography reporting in a limited resource environment. World J Surg 2010;34(11):2530-2536. [http://dx.doi.org/10.1007/s00268-010-0530-4] 7. Taylor L, Basro S, Apffelstaedt JP, Baatjes K. Time for a re-evaluation of mammography in the young?

Results of an audit of mammography in women younger than 40 in a resource restricted environment.

Breast Cancer Res Treat 2011;129(1):99-106. [http://dx.doi.org/10.1007/s10549-011-1630-z]

S Afr Med J 2014;104(7):456-457. DOI:10.7196/SAMJ.8455

Recommendations for the handling of fluorescent lamps in public schools in Johannesburg, South Africa

To the Editor: Fluorescent lamps are regarded as hazardous waste because of their mercury content.[1] Mercury has toxic properties that may have acute or chronic detrimental impacts on human health and the environment.[2-4] A study was recently undertaken with the objective of determining the availability of guidelines for the handling of fluorescent lamps in selected public schools in Johannesburg, South Africa. The study was undertaken under the umbrella of the World Health Organization Collaborating Centre for Urban Health’s Health, Environment and Development (HEAD) study.[5] The sample included 22 public schools from within and in the immediate vicinity of the five HEAD study sites, Hillbrow, Bertrams, Riverlea, Braamfischerville and Hospital Hill. A structured questionnaire and observation checklist was administered, typically to the school principal.

Of the study schools, 18% had informal guidelines regarding storage of fluorescent lamps before use (64% had none and 18% were ‘not sure’), 9% had informal guidelines for cleaning of spillage from broken lamps (82% none, 9% ‘not sure’), and 9% and 14% had informal guidelines for storage and disposal, respectively, of lamps after use (82% and 77% none, 9% ‘not sure’ for both). No school had formal (i.e. written) guidelines.

There appear to be no official recommendations on fluorescent lamp management in Gauteng public schools. Instead, a general policy on risks in schools makes brief reference to light bulbs. In countries such as the USA, the hazard of mercury in schools has been seriously considered and dealt with by the Environmental Protection Agency.[6] Childhood exposures to elemental mercury often result from inap­ propriate handling or clean-up of spilled mercury, so primary prevention measures such as health education and policy initiatives are important.[7] Acute exposure to mercury vapour (>0.1 mg mercury/m3) causes respiratory effects such as cough,

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Environment and Health Research Unit, Medical Research Council, and Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa wellington.siziba@mrc.ac.za

Nisha Naicker

Environment and Health Research Unit, Medical Research Council, Johannesburg, South Africa

Angela Mathee

Environment and Health Research Unit, Medical Research Council, and Faculty of Health Sciences, University of Johannesburg, South Africa

André Swart

Faculty of Health Sciences, University of Johannesburg, South Africa 1. Lombard JE, Webb PS. What Happens When The Lights Go Out? The 9th Waste Management Conference of the Institute of Waste Management of Southern Africa (IWMSA), 6-10 October 2008, Durban, pp. 439-449. http://ewasteguide.info/files/Lombard_2008_WasteCon.pdf (accessed 22 October 2009).

2. World Health Organization. Guidance for identifying populations on risk from mercury exposure, pp. 2-4.

2008. http://www.chem.unep.ch/mercury/IdentifyingPopnatRiskExposuretoMercuryFinalAugust08. pdf (accessed 22 October 2009).

3. North Carolina Division of Pollution Prevention and Environmental Assistance. Fluorescent Lamps and Mercury. 2009. http://www.p2pays.org/mercury/lights.asp (accessed 25 August 2009).

4. Reclite. E-waste in South Africa. Lighting lamps. 2008. http://www.ita.org.za/.../EWASTE/IN/SOUTH/ AFRICA/Pres.pdf (accessed 25 August 2009).

5. World Health Organization Collaborating Centre for Urban Health. WHOCCUH Annual Report, pp.

4-7. 2007. http://www.mrc.ac.za/healthdevelop/ar07_who_part3.pdf. (accessed 12 December 2013).

6. United States Environmental Protection Agency. Compact fluorescent light bulbs (CFLs). Last updated 9 July 2013. http://www.epa.gov/mercury/schools.htm (accessed 12 December 2013).

7. Lee R, Middleton D, Caldwell K, et al. A review of events that expose children to elemental mercury in the United States. Environ Health Perspect 2009;117(6):871-877. [http://dx.doi.org/10.1289/ ehp.0800337]

S Afr Med J 2014;104(7):457. DOI:10.7196/SAMJ.8052

A rose by any other name is an Emergency Department

To the Editor: In William Shakespeare’s Romeo and Juliet, Juliet says: ‘What’s in a name? that which we call a rose By any other name would smell as sweet.’

She is arguing that the name of something does not matter, only the thing itself matters. This is not always true. A name can deter­ mine destiny. Misnaming something can have negative implications.

This is why it is so crucial that leaders in the specialty of emergency medicine unite in choosing the name of the department in which we work – the Emergency Department. We are still fighting the demons of ‘Casualty’, and now another misnomer has arisen: that of ‘Emergency Centre’.

Where does the term ‘Casualty’ come from? According to the Concise Oxford English Dictionary,[1] ‘casualty’ means ‘A person killed or injured in war or accident; an accident, mishap or disaster’, ‘accident’ means ‘An unfortunate incident that happens unexpectedly or unintentionally’, and ‘emergency’ means ‘A serious unexpected and potentially dangerous situation requiring immediate action’.

‘Casualty’ was traditionally the area where emergency cases were first seen in the frontlines of a hospital. Patients were briefly assessed

July 2014, Vol. 104, No. 7

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CORRESPONDENCE

(not necessarily by qualified medical staff) and referred for further management. From as early as the 1950s, people started to question why the sickest patients were being attended to by the least qualified doctors. What US trauma surgeon Dr Robert H Kennedy called ‘the weakest link’[2] progressed over the next 20 years into the specialty of emergency medicine in the UK in 1976, in the USA in 1979, in Australia in 1981 and in South Africa (SA) in 2004.

Then where does the term ‘Emergency Centre’ come from?

According to Pubmed, the term ‘Emergency Centre’ does not exist in the medical literature. It is a term commonly used in the Western Cape, but it was not coined by an emergency physician. Emergency medicine is an up-and-coming specialty in SA that is starting to make its presence known among the other more established specialties. As more and more specialist emergency physicians graduate and take over the emergency areas of hospitals, so the historic term ‘Casualty’, with its associated negative connotations, will be replaced – but surely not by ‘Emergency Centre’, which is not universally recognised.

Since the 1990s, the more accurate term ‘Emergency Department’ has been in use in Australia, New Zealand and the USA. In the UK, emergency physicians are struggling to get rid of the term ‘Accident and Emergency Department’ and have it become ‘Emergency Department’ alone – but at least these colleagues work in a department!

Sakr and Wardrope’s article ‘Casualty, accident and emergency, or emergency medicine, the evolution’,[3] published in the Journal of

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Accident and Emergency Medicine, is now 14 years out of date. Even that journal changed its title just a year later in 2001 to the Emergency Medicine Journal in order to remain current.

If international best-standard emergency medicine is to be practised in SA, then international nomenclature should be adhered to and we should use the term ‘Emergency Department’ to describe the area in the hospital in which we save lives.

William Shakespeare said, ‘There is no sound so sweet as the sound of one’s own name’ – and the internationally recognised name ‘Emergency Department’ should be made our own and be the name used throughout South Africa.

Lara Nicole Goldstein

Helen Joseph Hospital and Division of Emergency Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa drg666@gmail.com

1. Soanes C, Stevenson A. Concise Oxford English Dictionary. 11th ed. New York: Oxford University Press, 2004.

2. American College of Emergency Physicians. http://www.acep.org/About-Us/1965-Report-Calls-forIncreased-Emphasis-on-Emergency-Care/ (accessed 5 May 2014).

3. Sakr M, Wardrope J. Casualty, accident and emergency, or emergency medicine, the evolution. J Accid Emerg Med 2000;17:314-319. [http://dx.doi.org/10.1136/emj.17.5.314]

S Afr Med J 2014;104(7):457-458. DOI:10.7196/SAMJ.8097

July 2014, Vol. 104, No. 7

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IZINDABA

Certificate of Need: Legal nightmare in the making?

Telling healthcare providers where they may or may not practice, based purely on creating an equitable spread of healthcare services across the country (i.e. the newly promulgated Certificate of Need (CoN) law), may prove a legal nightmare, ultimately undermining healthcare delivery.

In spite – or perhaps because – of this, three of the country’s top doctor bodies have adopted a conciliatory approach, appealing to government to embrace their expertise and coalface experience in helping more South Africans access quality healthcare after the sudden promulgation of the long-dormant law. Regulations have yet to be drawn up.

The CoN, if passed in its current form, will have far-reaching unintended consequences for the private sector, and the doctor bodies are convinced that this could undermine its commendable intentions. While fully behind the government’s aim to improve access to healthcare, particularly in underserved areas, they believe that as it currently stands it is a clumsy legal instrument that could so disadvantage healthcare providers and patients as to worsen rather than improve access to services. The South African Medical Association (SAMA), the country’s largest representative doctor body, the South African Dental Association (SADA), its equivalent for dentists, and the South African Private Practitioners Forum (SAPPF), the largest private specialist body, have banded together to form a united front, urgently engaging government to help create a more universally beneficial outcome. Other major players such as the Hospital Association of South Africa (HASA) are opting for an even more cautious approach, conducting rapid research in all relevant fields before deciding whether to join the ‘diplomatic doctor’ initiative. Top Izindaba sources confided that the sudden promulgation of the law, put on ice in the Mbeki era after it ran into a firestorm of controversy, has caught most in the private sector by total surprise.

Several of the relevant sections of the National Health Act, first drafted in 2003 when relations between most nongovernment healthcare bodies and the Thabo Mbeki government were at an alltime low (over HIV/AIDS), remain unclear.

The entire law gives unfettered power to

(including existing public and private facilities in an area), and correcting racial, gender, economic and geographical imbalances, to taking into account the demographic and epidemiological characteristics of the population to be served, plus furthering the Employment Equity Act in emerging small, medium and micro-enterprises.

Road to final enactment full of potholes

Malebona Precious Matsoso, National DirectorGeneral of Health. Picture: Chris Bateman.

the Director-General of Health, currently Malebona Precious Matsoso, and her provincial counterparts effectively to decide where all healthcare providers, facilities and medical equipment (undefined) may or may not operate or practise. The instrument for this is the CoN – and all healthcare providers have until 1 April 2016 to apply for it. The regulations, which the doctor bodies want to be intimately involved in drawing up to prevent alarming prohibitive constraints on them and their patients, are to be drafted as part of a ‘consultative’ process before then.

However, the regulations may not conflict with the provisions of the Act, making it unlikely that they will remedy the doctor groupings’ fundamental concerns.

What the law says

According to the law, a CoN will be required for anyone: (i) establishing, constructing, modifying or acquiring a health establishment or agency; (ii) increasing the number of beds in, or acquiring prescribed health technology at, a health establishment or health agency; (iii) providing ‘prescribed’ health services; or (iv) continuing to operate a health establishment or health agency after the expiration of 24 months from the date at which the relevant addition to the Act took effect (1 April 2014). The Act also requires the Director-General of Health (or their designate) to apply their minds to a host of requirements before issuing a certificate. These range from consistency of health services development in terms of planning, equitable distribution and rationalisation of services and resources

459

Examination of the resuscitated law by the three doctor bodies – and the entire medical fraternity, which is abuzz with anxious debate – reveals that it severely limits not only the rights of healthcare providers but also those of patients in accessing care and medical information; that it could render existing medical businesses worthless; and that it will create a mountain of red tape, with a huge and expensive bureaucracy.

Practical administrative issues such as ensuring that locums possess a CoN, selling a practice or taking on partners, and the clashing of the CoN with at least six other existing laws (the Consumer Protection Act, the Promotion of Access to Information Act, the Promotion of Equality and Prevention of Unfair Discrimination Act, the Health Care Professions Act and the Protection of Personal Information Act), pose major problems. Besides this, the CoN conflicts with constitutional provisions protecting freedom of movement and association, which is likely to render the consultative process tricky and longer than the actual law permits.

SAMA’s perspective

Dr Mzukisi Grootboom, Chairperson of SAMA, said that besides the lack of consultation after the nine-year dormancy and its sudden enactment by President Jacob Zuma this April, the CoN could create several perverse outcomes. ‘One immediately asks, will it affect only newcomers to the system (as similar laws are widely applied internationally), or those already practising?

It’s quite clear from the way it’s written that everybody practising will have to get a CoN just to justify your existence and where you practice.’ (Failure to comply will result in a fine or five years’ imprisonment, or both.) Grootboom said that among the potential unintended consequences are the

July 2014, Vol. 104, No. 7

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closing down of practices and the denial of healthcare to existing populations.

An examination of the equivalent law introduced in the USA showed that it was used to adjudicate on aspirant healthcare facilities in order to avoid over-concentration of services and expensive equipment in one area. SAMA was ‘totally behind’ improving access to healthcare in underserviced areas in South Africa (SA), but did not believe the CoN was the only instrument to use.

Asked Grootboom: ‘Can the CoN be one of the instruments? The answer is theoretically maybe, based purely on whether it’s practical.

But what remedies are in place to address the host of unintended consequences?’ He said that besides anecdotal evidence, there was ample research to show that simple remuneration did not keep healthcare providers in place (government has implemented the Occupation-Specific Dispensation (OSD) and rural allowance incentives).

This had emerged from the national health department’s own White Paper on Human Resources for Healthcare. The experience of SAMA’s public sector members was that ‘the terrain out there is extremely unsupportive to doctors’. Besides drug stock-outs, lack of instruments and supervision, and the scarcity of subsidised accommodation, most hospitals were run by ‘people with no idea about medicine and healthcare delivery.

They’re only interested in keeping within a budget; service delivery is neither here nor there to them.’ Grootboom pleaded with government ‘for all of us to sit down and work out what instruments to use to ensure we become responsible to the needs of the population. Things like creating more viable campuses in the more rural provinces and retaining high-level teaching staff … We need to make sure people have a reason to stay there.’ He cited the Thai model, where most training centres are now in underserviced, outlying areas, attracting high-level expertise. He said that government had an unfortunate track record in partnering with doctors to find solutions.

‘A lot of us are sensitive to what the ANC and the government are trying to achieve in addressing disparities – and they’re bound to make mistakes. So we need to rise above petty squabbles and let them know they have our support – but please involve those of us who deal with patients on a daily basis instead of controlling us from the outside.’

Grootboom said he had spoken to Matsoso, who said the CoN was needed to empower the new Office of Healthcare Standards, a core component of the incoming National Health Insurance dispensation (i.e.

Dr Mzukisi Grootboom, SAMA Chairperson.

Picture: Chris Bateman.

universal healthcare access). ‘She said that when they [healthcare standards officers] go around checking facilities, they also need to check if they have a certificate to run that particular healthcare facility.’

Matsoso had conceded to him that there ‘might be constitutional problems which need addressing’, but whatever reassurances she made, ‘what’s written [in the new law] is what’s written’. Top constitutional lawyer in healthcare, Elsabe Klinck, said no standards have been issued for various types of practices in the private sector yet, and the health department must first climb a mountain of administration before these can be promulgated, let alone have the Office of Health Standards Compliance conduct inspections and then go through CoN applications for thousands of establishments.

National health department spokesman Joe Maila reflected Matsoso, saying ‘nothing is going to be unilateral’ and adding that it would be unconstitutional to force doctors to work in places where they did not want to. He promised that ‘nothing will be done without full consultation’. Klinck said that a CoN would be linked to the building in which the professional worked, but Maila could not explain what would happen if a certificate was denied, or how the process would work for specialists who work at three different private hospitals, as is common.

The dentists’ view

Maretha Smit, CEO of SADA, said doctors and dentists cared about South Africans and wanted to partner with government in addressing the principle of universal access to healthcare. However, ‘we’d like to ask that this be consistent, constructive and solutionsdriven and to include engagement with

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July 2014, Vol. 104, No. 7

the professions. To alienate the professions simply means that government won’t be able to reach their target.’ She said that on a ‘cold reading of the Act we are fundamentally affected – but when you speak to health department representatives they take a much more pragmatic and conciliatory approach, even admitting they don’t have the resources to look at every individual practice’.

Smit said the professions were ‘crying out for a carrot approach – we’re talking about people who went into a certain profession because they care. I get the sense from my members that they really want to make an impact on providing health for as many people as possible.’ There appeared to be an official lack of understanding of the difficulties inherent in the practice environment. The over-riding focus for practitioners had become ‘how do I survive?’ instead of ‘how do I care?’. ‘If we take the “how do I survive” out of the equation, you’ll get a lot more people saying “how do I care?”!’ she stressed.

SA’s healthcare problems seemed not so much about ideology but execution. ‘I’m constantly amazed at the decisions taken without an understanding of the risks attached and a comprehensive analysis of the downstream impact and potential of where things could go wrong.’ Smit warned that this could result in a dramatic downturn in people wanting to enter the healthcare professions, with dire national implications.

Maretha Smit, CEO of the SADA.

Private doctors’ body speaks

Dr Chris Archer, CEO of the SAPPF, echoed Grootboom, saying that ‘we have to look at the Act itself, not the interpretation of the Act by the Director-General’. He also emphasised that the SAPPF was not in opposition to

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IZINDABA

Stop Press: Motsoaledi’s impromptu response on CoN

National Minister of Health Dr Aaron Motsoaledi, button-holed briefly by Izindaba as he was leaving a press conference after delivering the closing speech at the 4th SA TB Conference in Durban on 13 June, had this to say about private doctor alarm at the Certificate of Need.

‘They’re looking at [i.e. the law speaks of] health facilities. When it comes to individuals it will be very difficult to force any doctor to move. There will be a big discussion on this issue; it’s not something we’re going to apply inhumanely and mechanically. We’ll meet doctors to discuss the parameters.

I don’t understand all the objections – I mean [Netcare] Park Lane Clinic [in Parktown, Johannesburg] has more gynaes than Limpopo and Mpumalanga provinces put together! It will be difficult to force them to move – but should we allow more gynaes to move into that small space called Park Lane? I don’t think so!’

the government’s ultimate objective, but to the methodology used in getting there. As the law stood, it was ‘an experiment in social engineering’ that seemed doomed to failure with huge potential for bribery and corruption. Unless there was a pragmatic accommodation of healthcare providers’ concerns in the regulations, doctors could end up ‘voting with their feet’.

Archer said that in terms of the Act, the CoN definition of a health establishment included established practices. While there was some talk of a grandfather clause, ‘what about when I want to retire and sell my practice? If the DG decides there are too many gynaes in my hospital and wants to spread elsewhere, she won’t issue a certificate for my practice and I’ll have nothing to sell.

The same applies to father and son, mother and daughter, coming into a practice.’ The concept of a third party determining one’s fate ‘because they have the power to do so’ was ‘complete anathema’ to the SAPPF. ‘Even if they are magnanimous, they still have the power … and what happens when the DG or the Minister of Health changes?’ he asked. He wants the law to be changed to exclude established practitioners, enabling professionals working in a well-served area to sell their practice to a new entrant, who would then have to apply. He also suggested setting a

maximum price ceiling on equipment affected by the Act to enable the upgrading of less costly equipment such as ultrasound scanners.

Archer described the CoN promulgation as ‘very worrying indeed’, but said he took some comfort in the vastly increased accessibility of the Minister of Health and his DG, compared with when the law was first mooted.

Casper Venter, Director of the Healthman Consultancy, said the certificates would be an ‘administrative nightmare’. ‘There are about 70 000 dieti­ cians, specialists, GPs, physiotherapists and occupational therapists who would all need certificates to open a new practice in private. The Department is not geared for this kind of [action]. If a doctor is prevented from opening a practice in Sandton, it is not clear if he or she will then work in nearby Alexandra.’ Klinck appealed to healthcare professionals not to panic or act prematurely. ‘One of the criteria in the Act is the financial viability of a practice, which would mean no one could force a practitioner to start a practice in an area where it would not be financially viable,’ she said.

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(7):459-461.

DOI:10.7196/SAMJ.8550

Exchange rate hurting chronic drug suppliers – but ARV pipeline safe, says govt The government has cate­ gorically denied that there is any danger of antiretro­ viral (ARV) drug supp­ lies running short or drying up following a claim from one of their three supp­liers, Aspen Pharma­­ceuti­cals, that insuffi­cient relief on the dismal rand exchange rate and single exit price (SEP) is creating a net loss.

The claim, originally floated by Aspen’s group CEO Stephen Saad when releasing his company’s financial results in March, was elaborated upon by his Senior Executive, Strategic Trade Development, Stavros Nicolaou, at a pioneering Medicines Summit held by Discovery Health on 15 May in Gauteng. Nicolaou said that the ARV fixeddose combinations (FDCs) were among the

most expensive chronic medication drugs to produce and would be hit hardest by the ongoing dismal performance of the rand (25% depreciation), with the situation reaching crisis levels by the end of this year if the devaluation continues. He said the dilemma was affecting all chronic medications and claimed that one company, Fresenius Kabi, recently stopped supplying one drug line to South Africa (SA) because of it.

‘What I’m saying is that if the rand depreciated 25% on a trade-weighted basis and you’re only getting 5.8% (SEP adjustment), there’s obviously a shortfall which is not caught up – and it lands up compounding over a period of time, to the extent that manufacturers will say it’s no longer viable and withdraw from the market – that’s what happened with Fresenius Kabi,’ he added.

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Aspen’s Stavros Nicolaou.

July 2014, Vol. 104, No. 7

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averaging the exchange rate – which he conceded was ‘bad news for pharma’ if the rand progressively weakened. While expecting that companies would take that risk into consideration when pricing their products, government had not planned for such a dramatic weakening of the rand.

‘There was nothing malicious in it, we agreed that they didn’t anticipate it and we didn’t plan for it to happen, so we settled in the end by funding half the difference, in spite of this not being in the contract. It would cost us millions to fund the entire difference in the exchange rate, which is what Aspen wants us to do,’ he said.

Government sources said the formula pro­ posed by the industry, including Aspen, would have produced an increase of 9%, so this would also have fallen short of the 25% deterioration in the rand.

‘Costing not a factor in our drug withdrawal’ – Fresenius Kabi

Wilna Stapelberg, MD of Fresenius Kabi, a critical care medications company based in Germany with a factory in Port Elizabeth, said costing had nothing to do with their artificial colloid Voluven (a plasma volume expander) being taken off the local market for six months from August last year. ‘While I agree with Stavros that pricing is a huge issue that’s becoming more and more diffi­ cult in SA, the issue with Voluven was a European Union (EU) one involving risks and bene­fits, and the UK and SA’s Medicines Control Council followed suit.’ She said that after re­assessment of the drug’s sideeffects, and ‘due to doctor demand’, it was reinstated in the market. The episode had ‘nothing to do with the health department only giving us 5.8% on the SEP, or the exchange rate – I think Stavros got it a little bit wrong’. Stapelberg warned that it was easy for bulk buyers (read governments) to say that if one company didn’t provide, another would: ‘there are always lead times to manufacture and patients sit without products in that time’. She added that she’d ‘never understand why government wants to control the private sector’.

Elaborating on the introduction of FDCs into the SA ARV supply chain and its effects on costs, Nicolaou said if government was ordering, for example, four million packs a month and patients were not converting from the single-component drug regimen, now being phased out, ‘you end up vastly overstocked on FDCs’. ‘If uptake on the ground and depot level is not consistent with production, then you tie up massive amounts of working capital,’ he told the Medicines Summit delegates. Making a point in the presence of the national drug committee chairperson, Professor Fatima Suleman, Head of the School of Pharmacy Practice at the University of KwaZulu-Natal, he said the ARV companies’ experience of the regulatory relief allowed by Regulation 9 of the Medicines and Controlled Substances Act (the so-called ‘extraordinary increase’ provision) was that it was ‘so laden with red tape’ as to be wholly ineffective. ‘It’s fine when the rand is strong – but when there is sustained weakness and no price relief through the SEP method, we’ll see

‘Aspen wanted twice the price adjustment of other suppliers’ – government

Dr Anban Pillay, Deputy Director-General of Health for Regulation and Compliance Manage­ ment.

more and more distressed assets with them discontinued or sold off,’ he predicted.

Fresenius Kabi had tried ‘for many years’ to secure a Regulation 9 ruling, but eventually gave up, he claimed. The industry’s experience was that the regulator ‘hardly ever’ allowed an application, and ‘you end up with forms just being sent back and forth’.

Anban Pillay, Deputy Director-General of Health for Regulation and Compliance Management, countered that the procedure for a regulation 9 application was clearly defined and all the information available and based on an applicant proving exceptional circumstances with evidence. ‘If the evidence does not prove the case we cannot approve it.

This is not called red tape but an evidencebased process,’ he added.

Pillay said the ARV tender contracts included a defined formula to adjust for exchange rate variation averaging the exchange rate – which he conceded was ‘bad news for pharma’ if the rand progressively weakened.

National Health Minister Aaron Motsoaledi’s ‘coup’ in securing a 53% drop in ARV drug prices – and the introduction of FDCs – were globally hailed as a moral, economic and adherence-enhancing victory. Pillay said the ARV tender contracts included a defined formula to adjust for exchange rate variation

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Mylan and Cipla had accepted the amen­ded deal, but Aspen wanted a 100% adjustment.

Aspen and Mylan each supply SA with about a million FDC packs per patient-month and Cipla about 500 000. Pillay said the original price from Aspen was about R96 per pack, with Cipla slightly lower and Mylan, slightly higher. ‘Those are the prices they came in with – the agreed currency adjustment moves the prices higher.’

Aspen needed to be ‘fully transparent’ about its costs and take full responsibility for having signed a contract that put them at major risk. ‘They’re sitting with lots of stock, but we also have Adcock who have lots of stock – Adcock will give it to us at a lower price than Aspen are currently supplying.’ He said that Aspen raising the danger of stock-outs was ‘the most powerful weapon they have’.

‘I’ve called Myland and Cipla and they don’t know what he’s talking about – they want to supply even more. If Aspen want to step down, Mylan will increase production and so will the others.’ Pillay flatly denied Nicolaou’s contention that government had asked Cipla to provide 700 000 FDC packs, but that Cipla had insisted on capping production at 500 000. ‘They never agreed to supply more than 500 000, because that was their capacity – it had nothing to do with the exchange rate,’ he said. Pillay admitted there was a problem with FDC patient uptake ‘at facility level’, with this currently standing at about 60%. ‘Some patients believe three drugs (the former official ARV regimen) are stronger than the single FDC drug, and some doctors are reluctant to change to FDC because their patients are doing well on the three separate pills.’ This ‘lack of conversion’ resulted in a problem for all three drug suppliers, with orders from the nine provinces out of kilter

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with the FDC uptake they wanted. The national health department had wanted to convert all eligible patients (about 90% of adults) much sooner than had been the case.

Turning to the SEP, Pillay emphasised that this legislation only affected the private sector (about 10% of all patients on ARV therapy). With this system, government applied an industry-proposed formula of 70% of the consumer price index (CPI), 15% on the rand/dollar exchange rate and 15% on the rand/euro exchange rate.

Manufacturers had argued that this was the basis of their cost structure. However, over time government had done its research and ‘realised that this is not true’.

‘If you look at the originator medicines you see the research and development component built into the price. The question then becomes, does the R&D component fluctu­ ate with CPI or the rand/dollar exchange rate? The answer is no. So therefore giving the manufacturer that formula at the quoted price is not a fair adjustment. It has to be on what their true costs are’.

Latest meeting fails government transparency demands

Pillay revealed that his team met with the three drug companies as recently as 26 May

and told them it was prepared to make a SEP formula adjustment – provided they were transparent on their true costs. ‘They said originator head offices would never reveal that,’ he said. Asked to summarise his position, Pillay responded: ‘My responsibility is to make sure public funds are appropriately spent. I believe the money spent on ARVs must be appropriately used so we can treat as many patients as possible.’

Responding to the suggestion that the exchange control situation might result in supplies being cut, he said: ‘We have a very good surveillance system in place and we’d detect any decreases in supply – we have other options available at affordable prices for South Africans.’ Pillay emphasised that SA now had the lowest ARV prices in the world and together with other big procurement agencies, the Global Fund (on behalf of developing countries) and Pepfar, purchased 90% of the globe’s supplies. ‘So we know exactly what suppliers are capable of and their constraints. If there are any risks, the signals would quickly come from our fellow buyers. We’re very sensitive to interrupted supplies. If there’s a drug plant fire or strike, we get to know about it very quickly and work out whether to shift orders somewhere else – or whatever the situation demands.’

‘We’ll never stop supplies in favour of profits’ – Cipla

Paul Miller, CEO of Cipla SA, confirmed that the depreciation of the rand had affec­ted ARV margins and that the price of chronic medication was an issue. However, the key challenge in helping people living with HIV was continuity of supply ‘of these life-saving medicines, along with ensuring all those on single therapies are converted onto fixeddose combinations’. Cipla had a duty, both to government and to the SA public, to ensure that chronic medication reached the endconsumer. At no stage would Cipla not supply the country with key medication because of profit motives. ‘We remain committed to honouring the tender obligation to government to supply ARVs, despite pricing pressures. In addition, if the industry can collectively work together with government in limiting the effect of profit margins on supply, then government will be able to deliver on its mandate to ensure that ARV (and other chronic medication) supply is not affected,’ he added.

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(7):461-463.

DOI:10.7196/SAMJ.8540

Women doctors have a rougher time – new association born Medicine in South Africa (SA) is replete with women doctors at an advanced stage of their careers who were actively dissuaded from speciali­ sing or baulked at the demands of registrar­ship combined with potential mother­ hood, while hundreds of their younger colleagues daily brave security threats and discrimination.

These are among several reasons why a core group of some 50 women doctors, led by deputy health minister Gwen Ramakgopa, are in the final throes of forming a local Medical Women’s Association to tackle such issues – and collectively help advance caring, effective healthcare delivery. Born of a query to Ramakgopa by a Nigerian colleague at the World Health Assembly

in Geneva early last year, the association will be formally launched in Pretoria on 9 August, National Women’s Day. Dr Nono Simelela, who staunchly steered the national HIV/AIDS directorate through the dark political waters of AIDS denialism, is now Ramakgoba’s ‘right-hand woman’. She says the association’s aim is to be all-inclusive, embracing, for example, women doctors in the construction and medical device industries, academics, non-practising doctors, and most vitally young interns and community service conscripts: ‘We think everyone has some value to add.’

She said that after four meetings, which began in March and were facilitated by the Foundation for Professional Development (FPD), a South African Medical Association (SAMA) body, concern emerged around

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‘what we can do to add value and improve/ contribute to the bigger social agenda of community, government, poverty and vio­ lence’. Five key areas were identified.

Challenging and/or supporting health policy

Says Simelela: ‘We can promote policy – and challenge it – and be accountable, not just to medical women, but to women overall.

The human capital and network we can bring is significant.’ The key areas, with provincial branches established using SAMA and FPD databases, will be Governance and Institutional Arrangements, Resource Mobilisation (including fund raising), a Prog­ ramme of Action (including prof­ essional development, social issues and a mentorship programme, and involving all

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eight (soon to be nine) medical schools), and Communication and Marketing Strategy.

The new SA body will join six other African countries already affiliated to the Inter­national Women’s Medical Association (IWMA, founded in 1919 and one of the oldest professional bodies in the world), a non-political, non-sectarian and nonprofit-making NGO representing women doctors from six continents. Besides actively working for gender equality and improving career and economic prospects for women, the IWMA, on which the prospective local body is modelled, promotes communication and co-operation between medical women, regardless of race, religion or political views.

A corporate aim of the local body will be to ‘mend fences’ between the public and private sectors, where attitudes, perceptions and incomes are so often alienating and disparate. Asked to give examples of gender disparities during her own career, Simelela recalled helping perform a caesarean section on a patient 25 years ago, while she herself was pregnant, near the end of a 36-hour shift. ‘I noticed blood on the floor and wondered how it got there … then I realised my membranes had just ruptured and that I was in premature labour (at 30 weeks).

Dr Nono Simelela says the association’s aim is to be allinclusive, embracing, for example, women doctors in the construction and medical device industries, academics, non-practising doctors, and most vitally young interns and community service conscripts.

‘I delivered the patient’s baby and left. In the change-rooms I realised I was in trouble. So I promptly switched roles from doctor to patient, and the next baby was mine – luckily Prof. Ephraim Mokgokong (now 80 and former head of the Nelson Mandela Medical School and former Medunsa Deputy Dean), was the senior on duty. He helped with the birth.’ Today Rudzani is a top dancer with the Cape Academy of Performing Arts, and none the worse for her dramatic arrival.

Following in the steps of business

Dr Nomonde Mabuya, a GP in private practice and veteran of the Businesswomen’s Association of South Africa, a chapter of the International Women’s Forum, singled out safety and security for women doctors in various institutions as her top issue.

‘Women are getting raped and mugged – while it’s not the fault of the institutions generally, they don’t take responsibility and there’s no real support.’ She said her second priority was women ‘making it’ into certain specialties such as obstetrics and gynaecology, and surgery. ‘During my time this was a very serious issue. I wanted to be an ophthalmologist. I couldn’t get in because they asked how I’d handle giving birth while a registrar. We need to help women into all specialties. Check out gynaecology – you’ll see that there are not that many women.

It cannot be because they didn’t want to study!’ While she underwent six years of training, her modern-day equivalents did nine, ‘and they’re sent to rural areas without supervision – our younger girls badly need mentorship and coaching’. Mabuya said leadership was vital. On the international political stage only the Scandinavian countries had achieved true gender parity.

‘We shouldn’t have to explain why women have to be there. If leadership sets the tone, then everything cascades down to society’ (15 of South Africa’s 35 cabinet ministers and 17 of the 33 deputy ministers are women). Data supplied to Izindaba by the Health Professions Council of South Africa (HPCSA) showing gender trends among registered medical practitioners over the past nine years (December 2004 - December 2013) are interesting to read.

More young women doctors, but overall progress slow

In their Community Service stint last year, women outnumbered men by nearly 8% (compared with 1.7% in 2004) and by 10.6% in their medical internship year (1.4% in 2004).

Just how slow the overall gender rebalancing act has been is evident from the total pool of medical practitioners registered with the HPCSA last year (34 961) – men outnumber women by 30%, compared with 45% in 2004.

Just how slow the overall gender rebalancing act has been is evident from the total pool of medical practitioners registered with the HPCSA last year – men outnumber women by 30%, compared with 45% in 2004.

One gender-unrelated pattern to emerge over the nine-year period is a consistently equal but dramatic 24% drop between the numbers of men and women registering for

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their community service, and subsequently registering to enter full-time medical practice.

Women make up 52.0% of the population in SA, with 43.9% of working South Africans being women. They constitute 21.4% of all executive managers in the country, tallying as low as 17.1% of all directors. The 9.1% of women collectively working as CEOs (3.6%) and chairpersons (5.5%) in SA remain ‘a minority within a minority’.

‘We can promote policy – and challenge it – and be accountable, not just to medical women but to women overall. The human capital and network we can bring is significant.’ – Simelela Globally, SA leads Australia and Canada in terms of women directorships and is at comparable levels to Israel and the USA. Data extracted from the 2011 census report show that SA continues to have one of the highest numbers of women executive managers compared with its international counterparts. But if one looks at a breakdown of JSE-listed companies and state-owned enterprises, only half of the industries reflect increased percentages of women executive managers. Healthcare showed a significant increase at 16.6%, but all percentages are still below 30% (2009 census). Attempts by Izindaba to extract gender breakdowns for specific medical disciplines from the HPCSA proved unsuccessful.

Mabuya said that in her own experience discrimination was a ‘big issue’, adding ‘we’ve learnt to be civil’. Career interruption in order to have a family was a thorny problem, ‘because you get isolated from your family and career path’. She also appealed for more work to be done on ‘closing the intergenerational gap between doctors – we need to understand the new challenges and bring more young medical students on board’.

Dr Gustaaf Wolfaardt, CEO of the FPD, said that with well over half of all medical school graduates now female, ‘there is a serious need to rethink, especially in the public sector, how the healthcare system is geared to embrace this changing reality. We need to look at issues like good security, crèche facilities and jobsharing appointments.’

Chris Bateman chrisb@hmpg.co.za S Afr Med J 2014;104(7):463-464.

DOI:10.7196/SAMJ.8539

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OBITUARIES Manilal Damodar Daya (1941 ­ 2013)

Manilal Damodar Daya was born in South End, Port Elizabeth, in June 1941 of parents who had immigrated to South Africa from Gujarat State in India. He did his schooling in Port Elizabeth, matriculating at South End High School, and completed his MB ChB at the University of Cape Town in 1967. After doing his internship at Somerset Hospital he started work as a medical officer at Livingstone Hospital, Port Elizabeth, in 1969. He married his wife Hemkala in 1971 and they had four boys, two of whom followed in their father’s footsteps to become medical doctors.

Mani developed a passion for surgery, and was motivated and encouraged by other specialists to pursue postgraduate studies. He started work as a medical officer in general surgery at Livingstone Hospital in 1978 under one of his mentors, Mr John McQuaide, and obtained the FRCS (Edin) and FRCS (Glasg) in 1978. This was a major achievement, as Livingstone Hospital was not a recognised teaching hospital and Mani had to spend time at Groote Schuur Hospital in Cape Town before being allowed to register as a specialist. He returned to work as a consultant at Livingstone Hospital and went into private practice in 1984.

I met Mani in 1979 at Livingstone Hospital and was impressed by this unassuming, confident surgeon. He never hesitated to ask colleagues for an opinion and was always prepared to listen and entertain an alternative – a true role model and inspiration during the heady days of apartheid.

Mani was always busy, but always had time for a patient or a friend. His intently calculating and deliberate surgical decision-making was an example to his young colleagues. Our relationship grew from his being my boss to my

consultant, my friend, my partner, and finally my brother, mentor and peer. We had a very special relationship, and I always derived solace and strength from his reassuring presence during surgery.

Mani’s unhesitating willingness to help whenever he was asked, be it to do clinics and emergency calls at state hospitals, or become an ATLS and basic surgical skills instructor or a journal club presenter, represented the most admirable example of altruism, selflessness and goodness.

Mani remained an ardent supporter and member of the Association of Surgeons of South Africa, SURGICOM and the South African Medical Association throughout his career. He was SAMA Eastern Cape President in 2010, and was honoured with the SAMA Life Membership award in 2011.

Rest in peace, Mani – the surgical fraternity of South Africa will miss a truly exemplary surgeon, peer and role model.

Hambe kahle mhlobo wam. Slaap rustig, die Baai se kind en Afrika se seun.

Sats S Pillay Head, Department of Surgery, University of Limpopo (Polokwane Campus), Limpopo, South Africa Past Head, Department of Surgery, Port Elizabeth Metropole Hospitals, Eastern Cape, South Africa livsurg@global.co.za

R B K (Ron) Tucker (1929 ­ 2014)

With Ron Tucker’s passing, South Africa has lost one of her most distinguished physicians.

Ron matriculated at Germiston High School in 1946 and, passionate about medicine but lacking the means to go straight to medical

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school, trained as a medical technologist at the South African Institute for Medical Research. He went to work on the Copperbelt in what was then Northern Rhodesia, and after four years had saved enough to enrol at the University of the Witwatersrand, where he graduated in 1959. He stood out as a student, serving on the Students’ Medical Council and the Rag Committee, playing both tennis and squash for the University, and being awarded the Cottrill Prize for academic achievement and service to the student body. Ron and I played tennis and squash together, and were in the same group throughout our clinical years. I realised that, whether on the courts or at the bedside, he had an extraordinary ability to be in the right place and to make the right decisions. One great decision was to woo and win Barbara Louw. They married in 1957 and were blessed with three sons and a daughter – all professionals now.

Ron specialised in internal medicine and quickly achieved the Fellowship of the College of Physicians, after which he super-specialised in cardiology. He remained in the Cardiac Unit at Johannesburg General Hospital until 1968, becoming increasingly involved in both the Johannesburg and national cardiac societies.

He was one of the pioneers of coronary angiography in South Africa.

In 1968 Ron started a private practice, and soon attracted the ‘who’s who’ of Johannesburg as patients. I knew some of them, all of whom attested to the thoroughness of his clinical approach and his unfailingly caring attitude.

In addition to his busy practice, he advised life insurance companies and was Chairman of the International Medical Advisory Panel of the Asbestos International Association for 12 years.

Ron was soon co-opted to the Council of the College of Medicine, which he served faithfully for 34 years. He was active on many of its committees and as an examiner, was Mace Bearer, served as Vice-President for two terms, and was elected President in 1992. He received honorary fellowships from colleges and associations in America, Australia, Malaysia, Singapore, London and Ireland. In 1997 he was awarded the Gold Medal of the University of the Witwatersrand on the occasion of the 75th Anniversary of the Medical School.

If a person’s life is to be measured by his contributions to society and the positive effects he had on the people with whom he came into contact, Ron’s was a life supremely well lived.

Olliver Ransome Ramsgate, KwaZulu-Natal, South Africa oransome@telkomsa.net

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MEDICINE AND THE LAW

Can children aged 12 years or more refuse life-saving treatment without consent or assistance from anyone else?

D J McQuoid-Mason David McQuoid-Mason is Professor of Law at the Centre for Socio-Legal Studies, University of KwaZulu-Natal, Durban, and publishes and teaches in medical law.

Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

The question of whether a child aged 12 years or more who is sufficiently mature and has the necessary mental capacity may refuse to consent to life-saving treatment without consent from a parent, guardian or caregiver or without the assistance of a parent or guardian is governed by the Constitution, the Children’s Act, the National Health Act and the common law. The best interests of the child are paramount, and should the child unreasonably refuse to consent to life-saving treatment, the Minister of Social Development may give consent for such treatment in terms of the Children’s Act. Otherwise, should a parent, guardian, caregiver or healthcare provider believe that such a refusal is not in the best interests of the child, he or she may approach the High Court for an order to provide such treatment.

S Afr Med J 2014;104(7):466-467. DOI:10.7196/SAMJ.8417

The Children’s Act[1] provides that a child who: (i) is 12 years of age or older; (ii) is of sufficient maturity; and (iii) has the mental capacity to understand the benefits, risks, social and other implications of the treatment may consent to medical treatment without consent from a parent, guardian or caregiver or the assistance of a parent or guardian (section 129(2)). However, the question arises whether a child may refuse to consent to life-saving medical treatment without such consent or assistance. In order to answer this question, it is necessary to consider the provisions of the Constitution[2] (chapter 2), the Children’s Act[1] (section 129(2)), the National Health Act[3] (section 6(1)(d)) and the common law.

Constitutional provisions regarding children

The Constitution[2] defines a child as a person under 18 years of age (section 28(3)) and lists the rights that are specially given to children (section 28(1)), apart from the other rights that also apply to them, such as the right to dignity (section 10), the right to life (section 11), the right to bodily and psychological integrity (section 12(2)) and the right to privacy (section 14). However, the most important provision in the Bill of Rights that affects children states: ‘A child’s best interests are of paramount importance in every matter concerning the child’ (section 28(2)). What is a ‘child’s best interests’ is not defined in the Constitution, but may be interpreted by reference to the Children’s Act and the common law.

The Children’s Act and the ‘best interests of the child’

The relevant provisions of the Children’s Act[1] state that a child’s best interests are ‘of paramount importance’ (section 9), and set out the ‘best interests of the child standard’, which requires, among other things, that the following be taken into account: (i) the child’s age, maturity and stage of development, gender, background, and any

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other relevant characteristics; (ii) the child’s physical and emotional security and his or her intellectual, emotional, social and cultural development; (iii) any disability that the child may have; and (iv) any chronic illness from which the child may suffer (section 7(1)).

The Act goes on to say that a child with a disability or chronic illness has the right not to be subjected to medical, social, cultural or religious practices that are detrimental to his or her health, wellbeing or dignity (section 11(3)). The relevant factors listed in the Act for assessing the best interests of the child standard may assist a healthcare provider in deciding whether a child of 12 years of age or more is ‘of sufficient maturity’ and has the necessary ‘mental capacity’ to give informed consent. The provision regarding disability and chronic illness implies that such a child may refuse to be subjected to medical treatment that is detrimental to his or her dignity – which is also a constitutional imperative[2] (section 10).

The Children’s Act and consent to medical treatment by children

As previously mentioned, the Children’s Act[1] provides that a child over the age of 12 years who is sufficiently mature and who has the mental capacity to understand the benefits, risks and social and other implications of the treatment, may consent to medical treatment on their own (section 129(2)). There is no need for consent by a parent, guardian or caregiver or for assistance from a parent or guardian, unlike in the case of surgical operations, where the assistance of a parent or guardian is required (section 129(3)). The consent of a parent, guardian or caregiver is required in the case of persons who are under 12 years of age, or who are 12 years of age but do not have the necessary maturity or mental capacity (section 129(4)).

The Children’s Act[1] does not mention refusal of consent by children, apart from the implication regarding children who suffer from a disability or chronic illness (section 11(3)). The Act provides, however, that the Minister of Social Development may consent to medical treatment of a child ‘if the child unreasonably refuses to

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give consent’ (section 129(8)). When deciding the reasonableness or otherwise of the child’s refusal, the Minister should judge it against the best interests of the child standard. In any event, the Act does not exclude the inherent jurisdiction of the High Court as the upper guardian of all children (section 45(4)), and the Court can always be approached as a last resort to ensure that decisions are made in the best interests of the child.

The other legal principles relevant to refusal of life-saving medical treatment by children are to be found in the National Health Act[3] (section 6(1)(d)) and the common law.

National Health Act provisions dealing with refusal of consent to medical treatment

The National Health Act[3] (section 6(1)(d)) requires health providers to inform users (patients) about their right to refuse health services, and also requires them to explain the implications, risks and obligations of such refusal. These requirements are not very different from what is contained in the ‘mental capacity’ necessary for 12-yearold children to consent to treatment, as they need to ‘understand the benefits, risks, social and other implications of the treatment’[1] (section 129(2)). Therefore, if the child is able to understand these implications, the refusal to consent will have to be given by a parent, guardian or caregiver[1] (section 129(4)).

Health providers can test the child’s ability to understand the consequences of refusal of consent by explaining the implications to the child in simple language and then getting the child to paraphrase what has been explained. It may be necessary to explain the implications more than once before testing the child’s understanding in order to avoid making a hasty determination of the child’s ability to give an informed refusal of consent.

The common law and refusal of consent to medical treatment

The common law has to be developed in line with ‘the spirit, purport and objects of the Bill of Rights’[2] (section 39(2)). The common law principle that patients may refuse life-saving medical treatment is echoed in the provisions of the National Health Act[3] (section 6(1)(d)) and should be developed in line with the constitutional provisions[2] regarding the rights to dignity (section 10), life (section 11), bodily and psychological integrity (section 12(2)) and privacy (section 14). In the case of children, the common law also has to ensure that the best interests of the child are paramount (section 14).

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The right to dignity means that patients have the right to have their dignity respected and protected if they feel that medical treatment will subject them to infringements of their dignity[2] (section 10). This may occur when invasive medical treatment that subjects the patient to indignity is used to preserve the patient’s life in situations where the prognosis is hopeless and has been continued despite a request by the patient that it be stopped. Such conduct would likewise violate the patient’s rights to bodily and psychological integrity (section 12(2)) and privacy (section 14), and the health providers concerned would be acting unethically and illegally as their conduct would amount to an assault on the patient.[4] The right to life implies that a person may end his or her own life – although the common law does not allow a third person to take active steps to end another person’s life.[5] The common law does, however, recognise that it is not unlawful to withhold or withdraw medical treatment where a patient of sound mind has made that request or has made an advance directive (e.g. a living will).[6]

Conclusion

In the light of the above discussion about the effect of the Constitution, the Children’s Act, the National Health Act and the common law, provided s/he is sufficiently mature and has the necessary mental capacity[1] (section 129(2)), a child aged 12 years or more may refuse to consent to life-saving treatment without consent from a parent, guardian or caregiver and without the assistance of a parent or guardian.

Should the child ‘unreasonably refuse’ to consent to life-saving treatment, the Minister of Social Development may give consent for such treatment in terms of the Children’s Act[1] (section 129(8)).

Alternatively, should a parent, guardian or caregiver – or indeed a healthcare provider – believe that such a refusal is not in the best interests of the child, he or she may approach the High Court for an order to provide such treatment.

1. South African Government. The Children’s Act No. 38 of 2005. Pretoria: Government Printer, 2005. http://www.justice.gov.za/legislation/acts/2005-038%20childrensact.pdf (accessed 15 April 2014).

2. South African Government. The Constitution of the Republic of South Africa 1996. Pretoria: Government Printer, 1996. www.thehda.co.za/uploads/images/unpan005172.pdf (accessed 15 April 2014).

3. South African Government. The National Health Act No. 61 of 2003. Pretoria: Government Printer, 2005. http://www.saflii.org/za/legis/consol_act/nha-2003147/pdf (accessed 15 April 2014).

4. Cf. Esterhuizen v Administrator, Transvaal 1957 (3) SA 710 (T).

5. S v Hartmann 1975 (3) SA 532 (C).

6. Currie I, de Waal J. The Bill of Rights Handbook. 5th ed. Cape Town: Juta & Co, 2006:289.

Accepted 12 May 2014.

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HEALTH AND FINANCE

National expenditure on health research in South Africa: What is the benchmark?

F Paruk, J M Blackburn, I B Friedman, B M Mayosi Fathima Paruk, PhD, FCOG (SA), Cert Crit Care (SA), is Director of the Cardiothoracic Intensive Care Unit in the Department of Anaesthesiology and Division of Critical Care, Charlotte Maxeke Johannesburg Academic Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (SA), and a member of the Human Research Ethics Committee at the University of Witwatersrand and of the National Health Research Committee (NHRC), Department of Health (DoH), SA. Jonathan Blackburn, DPhil (Oxon), holds the National Research Foundation SA Research Chair in Applied and Chemical Proteomics in the Institute of Infectious Disease and Molecular Medicine and Division of Medical Biochemistry, Faculty of Health Sciences, University of Cape Town, SA, and is a member of the NHRC. Irwin Friedman, MB BCh, FFPH (UK), is Public Health Physician in the Health Programme, SEED Trust, Durban, SA, a member of the Technical Task Team of the SA Health Products Regulatory Authority, which is linked to the SA DoH, and a former member of the NHRC. Bongani Mayosi, DPhil, FCP (SA), is Professor of Medicine and Head of the Department of Medicine, Groote Schuur Hospital and University of Cape Town, and Chair of the NHRC. Fathima Paruk and Jonathan Blackburn contributed equally to this work.

Corresponding authors: F Paruk (Fathima.Paruk@wits.ac.za), J M Blackburn (Jonathan.Blackburn@uct.ac.za)

The Mexico (2004), Bamako (2008) and Algiers (2008) declarations committed the South African (SA) Ministry of Health to allocate 2% of the national health budget to research, while the National Health Research Policy (2001) proposed that the country budget for health research should be 2% of total public sector health expenditure. The National Health Research Committee has performed an audit to determine whether these goals have been met, judged by: (i) health research expenditure as proportions of gross expenditure on research and development (GERD) and the gross domestic product (GDP); and (ii) the proportion of the national health and Department of Health budgets apportioned to research. We found that total expenditure on health research in SA, aggregated across the public and private sectors, was R3.5 billion in 2009/10, equating to 16.7% of GERD. However, the total government plus science council spend on health research that year was only R729 million, equating to 3.5% of GERD (0.03% of the GDP) or 0.80% of the R91.4 billion consolidated government expenditure on health. We further found that R418 million was spent through the 2009/2010 Health Vote on health research, equating to 0.46% of the consolidated government expenditure on health or 0.9% of the R45.2 billion Health Vote. Data from other recent years were similar. Current SA public sector health research allocations therefore remain well below the aspirational goal of 2% of the national health budget. We recommend that new, realistic, clearly defined targets be adopted and an efficient monitoring mechanism be developed to track future health research expenditure.

S Afr Med J 2014;104(7):468-474. DOI:10.7196/SAMJ.6578

High-quality research is essential for identifying the health needs and improving the health outcomes of a population.[1] Health research drives development, as it generates the knowledge needed to improve health systems performance and, ultimately, health and health equity.[2] Remarkable medical advances have taken place in South Africa (SA), such as the invention of computed tomography[3] and the first human heart transplant,[4] through investment in health research by government and industry. There has, however, been a perceived reduction in state expenditure on health research in real terms from the beginning of the 1980s,[5] characterised by a redistribution of state expenditure in the healthcare system towards primary healthcare and an apparent stagnation in real terms in the level of government-funded health research expenditure between 1996 and 2006.[6] The Consensus Report on Revitalising Clinical Research in South Africa of the Academy of Science of South Africa (ASSAf)[5] has identified the low level of investment in clinical research as a major factor in SA’s declining clinical research performance. This report recommended inter alia that developing countries should invest at least 2% of their gross domestic product (GDP) in research and development (R&D), and that 20% of gross expenditure on R&D (GERD) (i.e. 0.4% of the GDP) should be allocated to health

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research.[5] Against this background, the SA Ministry of Health, the Department of Health (DoH) and the National Health Research Committee (NHRC) have made a series of commitments to increase investment in health research through the country budget and the national health budget. For example, the National Health Research Policy of 2001[7] proposed that the country budget for health research should be raised to at least 2% of total public sector health expenditure. Subsequently, the Ministry of Health committed itself through the Mexico, Bamako and Algiers declarations to allocate at least 2% of the national health budget to research.[8-10] In addition, the 2011 National Health Research Summit report[11] recommended that the national DoH increase its funding for health research to achieve the 2% target of the national health budget.

This multiplicity of commitments, compounded by the lack of a detailed information system, renders interpretation of these commitments a complex process. The NHRC, which is a statutory body tasked with setting priorities for health research in SA, has therefore conducted an audit to determine the proportion of gross expenditure on R&D that has been spent on health research (as a proxy for the proportion of country budget spent on health research) in the past decade, as well as the proportion of the budget of the DoH that was spent on research in the period 2009/10 - 2012/13. We have compared these data with internationally accepted benchmarks as a

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Table 1. Recommendations for the minimum level of investment in health research using different measures Organisation

Metric

DoH, SA: 2001 Health Research Policy in South Africa[7]

The health research budget be raised to at least 2% of total public health expenditure. In this analysis, we have used GERD as a proxy for estimating the proportion of national expenditure that is spent on health research

WHO: Ministerial Summit on Health Research and Development: The Bamako Call to Action[9]

At least 2% of national health budgets be apportioned to research. In this analysis, we have used the consolidated government expenditure on health as the national health budget

ASSAf: Consensus Report on Revitalising Clinical Research in South Africa[5]

2% of the GDP be invested in indigenous science and technology development, with health research receiving at least 20% of this amount

COHRED[20]

2% of a developing nation’s GDP be allocated to R&D

Third World of Academy of Sciences[20]

2% of the GNP of developing countries be a minimum investment in indigenous science and technology development, with health research receiving 10% of this amount

DoH = Department of Health; SA = South Africa; GERD = gross expenditure on research and development; WHO = World Health Organization; ASSAf = Academy of Science of South Africa; GDP = gross domestic product; COHRED = Council on Health Research and Development; R&D = research and development; GNP = gross national product.

way to judge historical trends and to provide a benchmark for future aspirations.

Sources of information

We used several sources of information on public and private expenditure on health research in SA, including the national surveys of research and experimental development of the Department of Science and Technology (1991/2 and 2009/10);[12-14] the Global Forum for Health Research (GFHR) reports Financing Research and Development for Health[15] and Monitoring Financial Flows for Health Research;[16] the National Treasury’s 2013 Estimates of National Expenditure;[17] the ASSAf report Revitalising Clinical Research in South Africa;[5] the National Treasury’s medium-term budget policy statements (2010 and 2012);[18,19] the 2001 Health Research Policy in South Africa document;[7] and the 2011 National Health Research Summit report Strengthening Research for Health, Innovation and Development in South Africa.[11]

Findings

Various recommendations for the minimum level of investment in health research, based on different metrics, are outlined in Table 1.[5,7,9,20] The 2001 Health Research Policy in SA was developed through consultation of relevant stakeholders by the Essential National Health Research Committee, the forerunner of the NHRC. This policy was adopted by the national DoH, but it was not presented to Cabinet or gazetted by Parliament.

In SA, health research is funded from multiple sources including local (public and private sectors) and foreign agencies.

Moreover, in the public sector, health research funding is not exclusively provided by the DoH but also by the departments of Science and Technology and of Higher Education and Training. In view of the complexities of the SA health research funding model, we have used GERD – both as a proportion of

Cyprus Mexico Greece India South Africa Portugal Brazil Russia New Zealand China Czech Republic UK Canada Belgium Australia France Germany Austria Denmark USA Korea Japan Finland Sweden Israel

0.4 0.46 0.6 0.71 0.9 1 1.02 1.07 1.16 1.49 1.6 1.8 1.94 1.9 2.01 2.1 2.5 2.5 2.5 2.66 3.22 3.39 3.5 3.7 1

2 3 GERD, % of GDP

4

4.53 5

Fig. 1. Gross expenditure on research and development as a percentage of the gross domestic product.

Data are for 2006 in general, except for India (2004), New Zealand and Mexico (2005), and China (2007). (GERD = gross expenditure on research and development; GDP = gross domestic product.)

the GDP and in absolute terms – together with the proportion of GERD (both in absolute and percentage terms) allocated to health research as surrogate indicators of total health expenditure on research in this country. Furthermore, we have established the total government sector expenditure on health research, as well as the specific DoH expenditure on health research, as proportions of the consolidated government expenditure on health. In the absence of accurate definitions of the ‘health research budget’ and ‘total public health expenditure’ in the National Health Research Policy of 2001, we used the consolidated government expenditure outcome on health as a proxy

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for the national health budget and the Health Vote as a proxy for the DoH’s budget.

In this audit, we assessed performance against two metrics: (i) health research expenditure (government sector and total) as proportions of the GDP and GERD; and (ii) the proportion of national health budget and DoH budget apportioned to research.

Gross expenditure on R&D

Fig. 1 illustrates GERD for a basket of highand low-middle-income countries (HICs and LMICs, respectively) for the year 2006, as well as for India (2004), New Zealand and Mexico (2005) and China (2007).[15,16] The SA data relate to aggregated public and

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GERD spent on health research

Fig. 4 illustrates the investment in health research as a proportion of GERD for various HICs and LMICs made in 2005,[15,16] and reveals that for SA this figure was 14.8%.

Furthermore, Fig. 5 shows that over the period 2001 - 2009, the percentage of GERD spent on health research has never exceeded 17%.

The total R&D spend on health research in SA in 2009/10 has been reported at R3.5 billion, equating to 16.7% of GERD, which is close to the ASSAf recommendation of 20% of GERD to be spent on health research.[5] However, the aggregated SA government plus science council spend on health research in 2009/10 was only R729 million out of the total R&D spend on health research of R3.5 billion.

According to the Department of Science and Technology’s National Survey of Research and Experimental Development (2009/10),[14] the government sector expen­diture on health research in that year was made up of ~R288 million government spend and ~R441

GERD, million ZAR

25 000 20 000 15 000 10 000 5 000 0

1991 1993 1997 2001 2003 2004 2005 2006 2007 2008 2009 Year

Fig. 2. Gross expenditure on research and development for South Africa from 1991 to 2009.

1 0.9

0.84

0.81

0.8 GERD, % of GDP

private sector funding sources and reveal that ~0.9% of the GDP was spent on R&D in 2006, which was well below the ASSAf target of 2% for a middle-income country.

Countries that invested less than 0.9% of their GDP on R&D include India, Mexico and Greece, while China spent 1.49% of its GDP on R&D and established market economies spent 1.8 - 4.3%.

Analysis of GERD in SA for the period 1991 - 2009 reveals that it declined between 1991 and 1994 (Fig. 2). Since 1994 there has been a steady increase in the nominal value of GERD from under R4 billion to R20.9 billion in 2009/10, equating to an average increase of 11.7% per year during this period, which is well above the average inflation rate of ~6.5% for the same period (based on consumer price index (CPI) data from Statistics South Africa[21]). GERD in SA therefore increased ~2-fold in real terms over the period 1994 - 2009. Interestingly, although there was a R1.1 billion increase in public research expenditure in 2009/10 aggregated across government departments, science councils and higher education, the 9.7% reduction in research expenditure in the private sector in that year resulted in an overall decline in GERD from R21.04 billion in 2008/9 to R20.9 billion in 2009/10, probably reflecting the 2008/2009 global financial crisis. Notably, the percentage of the GDP spent on R&D has never exceeded 1% (Fig. 3), despite the annual growth in the economy exceeding 5% between 2006 and 2008. It declined from 0.92% in 2008/9 to 0.87% in 2009/10, and remains persistently below the ASSAf target of 2%.[5]

0.7 0.6

0.87

0.92

0.95

0.93 0.92

0.87

0.73 0.61

0.6

0.5 0.4 0.3 0.2 0.1 0

1991 1993 1997 2001 2003 2004 2005 2006 2007 2008 2009 Year

Fig. 3. Gross expenditure on research and development as a percentage of the gross domestic product in South Africa.

million science council spend; this represents an approximately 4-fold rise in government sector health research expenditure in real terms since 1991/2 from a nominal base of ~R54 million (equivalent to R187 million in 2009, adjusted by the CPI). Government sector spend on health research has therefore risen from ~1.9% of GERD in 1991/2 to 3.5% in 2009/10.

Proportion of national health budget spent on health research

The absence of adequate information systems makes it difficult to track trends of the DoH’s investment in health R&D activities accurately. Blecher and McIntyre[22] reported that 1.1% of the total expenditure on health in SA in 1991/92 was spent on research. Fig. 6 illustrates the proportion of the national health budget of HICs and LMICs that was spent on health R&D for the year 2005. According to the GFHR, SA spent 1.6% of the national health budget on R&D in that year.[15,16] The National Treasury medium-term bud­­ get policy statements (2010 and 2012)[18,19] record the consolidated government expend­

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iture outcome on health as R91.4 billion in 2009/10 and R114.1 billion in 2011/12, while the 2013 National Treasury Estimates of National Expenditure[17] records the audited Health Vote at R45.2 billion in 2009/10 and R55.3 billion in 2011/12. According to the audited figures contained in the 2013 Estimates of National Expenditure and the 2013 Health Vote documents, the major recipients of national DoH research funding in SA in 2011/12 were: (i) the Health Systems Trust to support health systems research activities, including the annual South African Health Review and the District Health Barometer; (ii) the Health Information Management, Monitoring and Evaluation Unit in the DoH, to develop and maintain a national health information system, and commission and co-ordinate research; (iii) the Human Resources Policy Research and Planning Unit, which is responsible for medium- to long-range human resources planning in the national health system and public entities; and other agencies such as (iv) the National Health Laboratory Service and (v) the South African Medical Research Council (MRC). The figures for 2009/10

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Russia China Korea India Brazil Israel Trinidad New Zealand Mexico Greece Finland Japan Portugal Germany Poland South Africa Argentina France Ireland Norway Italy Singapore Spain Netherlands Cuba Sweden Canada USA Belgium Denmark UK Switzerland Iceland Panama 5

10

25 15 20 Health R&D, % of GERD

30

35

40

Fig. 4. Investment in health research as a proportion of gross expenditure on health and development in 2005. (R&D = research and development; GERD = gross expenditure on research and development.)

through to 2012/13 are shown in Table 2, although it should be emphasised that the cumulative figures in this table are estimates, since not all allocations may be accounted for precisely in the 2013 Budget and Health Vote documents.

Collectively, the five major recipients of DoH funding for research constitute 0.46% (R417.9 million) and 0.35% (R403 million) of the consolidated government expenditure on health in 2009/10 and 2011/12, respectively (Table 2); these figures suggest that the DoH’s expenditure on health research has fallen well below the 1.6% cited by the GFHR for 2005.[13,14] These estimates for 2009/10 and 2011/12 are limited by the fact that they are derived from the Health Vote documents, which

only identify five recipients of national DoH funding; we are aware that the DoH may fund other research-related activities, but these funding streams are not tracked and are therefore not reflected in the above calculation.

The lack of complete health research funding records clearly highlights the need for adequate information systems to track financial flows and thereby accurately gauge health research financing streams in SA. Despite the caveats set out above, these various figures imply that in recent years an inadequate proportion of the national DoH budget has been spent on health research, perhaps reflecting in part the consequences of the Mbeki-Dlamini-Msimang denialism and its impact on government funding for medical research. This inadequate expen-

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diture by the national DoH on health research is in sharp contrast to the fact that total health research expenditure in SA has increased from R384 million in 1991/2 to R3.5 billion in 2009/10;[12-14] taking into account the CPI, this means that there has been a 2.6-fold increase in total health research expenditure in real terms over the past 19 years, reflecting the new role of business and foreign governments as major funders of health R&D in SA. The MRC is the DoH’s primary research funding instrument; it is therefore of particular note that the MRC’s audited baseline funding from the DoH increased from R221 million in 2007/8 to only R238 million in 2011/12,[23] equating to an average increase of ~1.9% per annum over this period. However, during the same period the CPI increased by 6.8% per annum,[21] meaning that the MRC’s baseline funding declined by 17.4% (~R50 million) in real terms between 2007 and 2011. The SA National Treasury’s mediumterm expenditure forecast (2013)[17] then estimates an increase in the MRC’s baseline funding from R297 million in 2012/13 to R616 million in 2015/16, equating to an annual increase of 26.8% in nominal terms over the period 2011/12 - 2015/16.

We note that at present there is no direct public health sector research funding stream that flows to universities or provincial DoHs. For example, the conditional grant for health R&D of the mid-1990s has been replaced by the health professions training and development grant, which may not be used for research purposes. The policy framework of the professional education- and trainingfunding streams provided to the provincial health departments should therefore be clarified to enhance their contribution to health research.

Non-governmental funding for health research

Major contributors to health research funding in SA include pharmaceutical organisations and foreign not-for-profit entities such as the US National Institutes of Health (NIH) (which invests over $80 million per year in SA in the form of more than 400 research and research training awards; source NIH), the Bill and Melinda Gates Foundation and the Wellcome Trust.

Precise details pertaining to funding from some of these sources are not readily available, but it is estimated, for example, that pharmaceutical companies spent R822 million on R&D (primarily including clinical trials) in SA in 2005/6.[24]

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Discussion

The origin of the various commitments and recommendations made by the SA Ministry of Health, the DoH and the NHRC to allocate at least 2% of the national health budget to research can seemingly be traced back to the Commission on Health

Research for Development (COHRED) report of 1990, entitled Health Research: Essential Link to Equity in Development,[20] which recommended: ‘All countries should vigorously undertake essential national health research (ENHR) to accelerate health action in diverse national and community

18

16.7

16

14.8

Health R&D, % of GERD

10

14.8

14

13.5

14 12

15.1

10.2

8 6 4

2009/2010

2008/2009

2007/2008

2006/2007

2004/2005

2003/2004

0

2001/2002

2

Year Fig. 5. Percentage of gross expenditure on research and development spent on health research in South Africa. (R&D = research and development; GERD = gross expenditure on research and development.)

settings ... Countries should invest at least 2% of national health expenditures to support ENHR studies …’; this recommendation was further clarified in the report as ‘We recommend that all governments commit 2% of their health budgets for ENHR.’ As such, it seems clear that the COHRED report referred to government sector expenditure on health research, not total expenditure, and we therefore suggest that the various SA government commitments should hence­ forth be interpreted in that light.

Against this background, the analysis presented here shows that the expenditure on health research by the DoH of R403 million in 20011/12 equated to only 0.35% of the consolidated government expenditure on health (i.e. the national health budget) and only 0.73% of the Health Vote (i.e. the DoH’s budget). If we relax the criteria to include total government sector spend on health research, the R729 million expenditure recorded for 2009/10 (the latest year for which data are available) equated to only 0.80% of the national health budget for that year. Therefore, by any logical metric – for example ‘DoH research expenditure as a proportion of its own budget’ or ‘total government sector health research expenditure as a proportion of the national health budget’ – the SA government’s curr­ ent allocations to health research are far below the aspirational target of 2% allocation of the national health budget to health

Table 2. Estimate of expenditure on health research by the South African government during the period 2009 - 2013 Government budget 2009/10

2010/11

2011/12

2012/13

Total

R832.5bn*

R885.8bn*

R964.4bn*

R1 042.9bn*

Consolidated government expenditure on health

R91.4bn*

R100.2bn*

R114.1bn*

R126.0bn*

Health Vote

R45.2bn*

R27.2bn*

R55.3bn*

R33.1bn†

Health research expenditure through the Health Vote

R417.9m

R368.7m

R403.0m

R448.3m

Health research expenditure through the Health Vote, as % of total government health expenditure

0.46%

0.37%

0.35%

0.36%

Health research expenditure through the Health Vote, as % of total Health Vote

0.92%

1.36%

0.73%

1.35%

HST

R2.8m*

R4.9m*

R6.1m*

R8.3m†

HIMME

R39.1m*

R21.6m*

R51.9m*

R43.2m†

HRPRP

R17.2m*

R8.5m

R9.6m

Not known

NHLS

R136.1m*

R96.4m*

R97.5m*

R100m†

MRC

R222.7m*

R237.3m*

R237.9m*

R296.8m†

Total

R417.9m

R368.7m

R403.0m

R448.3m

Research recipients

†

†

bn = billion; m = million; HST = Health Systems Trust; HIMME = Health Information Management, Monitoring and Evaluation; HRPRP = Human Resources Policy Research and Planning; NHLS = National Health Laboratory Service; MRC = Medical Research Council. *Actual expenditure outcome. † Forecast budget.

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Ecuador Guatemala Uruguay Tobago Russia Greece Brazil China India Romania Portugal Poland South Africa Italy Ireland Spain Germany Norway Israel France Australia Austria Turkey Netherlands USA Canada Finland Japan Belgium UK Denmark Switzerland Sweden Iceland Singapore 2

4 10 6 8 12 Health R&D, % of national health budget

14

Fig. 6. Health research and development expenditure as a proportion of the national health expenditure in 2005. (R&D = research and development.)

research. These data suggest that health research expenditure by the government would need to at least double in order to provide appropriate levels of investment in health research and to approach the levels to which it has previously committed itself.

The data presented here demonstrate, however, that in contrast to general perception, total SA investment in health research from the aggregated public, private and foreign sectors has increased steadily in real terms during recent years judged by several metrics, a trend that seems set to continue in the short term at least. For example, the percentage of the GDP spent on R&D was 0.87% in 2009/10, GERD

increased 2-fold in real terms from 1994 to 2009/2010, the percentage of GERD spent on health research was 16.7% in 2009/10, the government sector expenditure on R&D increased 4-fold in real terms from 1991/2 to 2009/10, and the total health research expenditure increased 2.6-fold in real terms from 1994 to 2009/10. However, we note that this total investment in health research in 2009/10 equated to only 0.15% of the GDP (GERD being 0.87% of the GDP and 16.7% of GERD being spent on health research), meaning that total investment in health research would need to at least double in order to approach the ASSAf target of 0.4% of the GDP and thereby

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provide appropriate levels of investment in health research in SA. The global disparity in the distribution of funds for health R&D has resulted in many developing countries spending lower proportions of their GDP on health research, despite a high proportion of disease burden. It is therefore not surprising that in developing countries there is a perceived lack of capacity to develop innovative technologies to meet the health needs of the population. There is a concerted effort driven by the World Health Organization to redress these inequities.

The Consultative Expert Working Group on Research and Development: Finance and Co-ordination (CEWG) has proposed novel strategies to incentivise, co-ordinate and sustain heath research in developing countries.[25] The CEWG proposes that all countries commit to contributing at least 0.01% (0.15 - 0.2% for developed countries) of the GDP on government-funded health R&D. They additionally recommend that the funds be pooled and managed centrally so that developing countries receive 20 50% of the pooled funds. We suggest that these CEWG recommendations provide a more tangible and transparent aspiration and means to enable properly funded health research in SA than the current confused ‘2% of national health budgets to research’ commitments. We therefore recommend that the CEWG proposals should be adopted by the SA government without delay.

The data presented here show that in 2009/10 the proportion of the R3.5 billion total health expenditure in 2009/10 attributable to SA government funding was only R729 million, meaning that governmentfunded health R&D constituted only 0.03% of the GDP in that year, close to the bottom of the CEWG-recommended range. Once again, these data suggest that there is considerable scope to increase government sector investment in health research immediately.

Among others, the data presented here illustrate the need to develop an efficient monitoring mechanism to track the level of expenditure on health research by governmental and non-governmental funders in the national health research system so that performance against international benchmarks can be assessed accurately. Such a national information system for health research expenditure will also be invaluable in enabling accurate assessment of whether health research funding is being effectively utilised to address SA healthcare priorities, and in addition will provide a means to better co-ordinate the activities of different

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government departments in the health research arena. As such, it should form a cornerstone of plans for the new National Health Research Observatory in SA now being developed by the NHRC. A new consensus is emerging on the fundamental importance of a national health research system as an integral component in strength­ ening the public sector delivery system in preparation for the new National Health Insurance (NHI) system, the aim of which is to achieve a long and healthy life for all SA citizens.[26] The procurement and allocation of funds for research is one of the central functions of a health research system,[2] and the need for increased investment in R&D has been recognised. It is therefore of concern that, using the annual baseline allocations to the MRC in the period 2007/8 - 2011/12 as a barometer, the proportion of the budget of the national DoH that has been allocated to health research has been in decline in real terms in recent years, despite the fact that SA faces an unprecedented burden of infectious and non-communicable diseases. One step in the right direction will therefore be for the national DoH to progressively increase the percentage of the Health Vote allocated to health research, and we note encouraging signs of this in the 2013 Estimates of National Expenditure,[17] which forecast an increase in the MRC’s baseline funding to R616 million in 2015/16, constituting a 26.8% average growth rate in nominal terms in the period 2011/12 - 2015/16. In addition, we note the recent launch of the new National Health Scholars Programme and the Strategic Health Innovation Partnership – both of which are partially supported by new budgets from the national DoH – as further evidence of progress towards developing new funding streams for expenditures on health research under the national DoH and its entities.

In conclusion, it seems clear from our analysis that neither the aspirational public commitments made by the the SA Ministry of Health to specific levels of funding of health research, nor the goals for funding of health research set out in the National Health Research Policy (2011), have been met and indeed that they may not be achievable in full in the short term. We therefore recommend that a new set of realistic, transparent, internationally accepted and more clearly defined targets be adopted forthwith as a means to ensure adequate future government investment in health research in SA. Acknowledgements. This report is based on the work of the NHRC. We gratefully acknowledge the helpful comments of the following members of the Committee during the development of this manuscript: Prof.

Nobelungu J Mekwa (Deputy Chair), Prof. Hoosen Coovadia, Prof.

Mohamed Jeenah, Dr Edith N Madela-Mntla, Prof. Adelaide S Magwaza, Dr Zinhle Makatini, Prof. Dan L Mkize, Ms Catherine MokgatleMakwakwa, Dr Kebogile Mokwena and Ms Khanyisa Nevhutalu. We are grateful to Dr Mark Blecher (Treasury) for assistance with sources

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of information and to Mr Mpho Kgasi for secretarial support. We wish to express our gratitude to Dr Andrew Kanyegirire (COHRED) for permission to use published COHRED data to generate Figs 1, 4 and 6.

We are particularly grateful to Prof. Wieland Gevers, Executive Director, ASSAf, for his insight and helpful discussions during the preparation of this manuscript.

1. IJsselmuiden C, Marais DL, Becerra-Posada F, Ghannem H. Africa’s neglected area of human resources for health research – the way forward. S Afr Med J 2012;102(4):228-233.

2. Pang T, Sadana R, Hanney S, Bhutta ZA, Hyder AA, Simon J. Knowledge for better health: A conceptual framework and foundation for health research systems. Bull World Health Organ 2003;81(11):815-820.

3. Vaughan CL, Mayosi BM. Origins of computed tomography. Lancet 2007;369(9568):1168. [http:// dx.doi.org/10.1016/S0140-6736(07)60562-5] 4. 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(12):1271-1274.

5. Mayosi BM, Dhai A, Folb P, et al. Revitalising Clinical Research in South Africa: A Study on Clinical Research and Related Training. Pretoria: Academy of Science of South Africa, 2009.

6. Coovadia H, Jewkes R, Barron P, Sanders D, McIntyre D. The health and health system of South Africa: Historical roots of current public health challenges. Lancet 2009;374(9692):817-834. [http://dx.doi. org/10.1016/S0140-6736(09)60951-X] 7. Department of Health. Health Research Policy in South Africa. Pretoria: DoH, 2001.

8. Mexico Statement on Health Research. Knowledge for Better Health: Strengthening Health Systems.

From the Ministerial Summit on Health Research, Mexico City, 16-20 November 2004. http://www. who.int/rpc/summit/agenda/en/mexico_statement_on_health_research.pdf (accessed 24 March 2014).

9. The Bamako call to action: Research for health. Lancet 2008;372(9653):1855. [http://dx.doi. org/10.1016/S0140-6736(08)61789-4] 10. The Algiers Declaration: Ministerial Conference on Research for Health in the African Region – Narrowing the Knowledge Gap to Improve Africa’s Health. Brazzaville, Congo: World Health Organization: Africa, 2008.

11. Mayosi BM, Mekwa JN, Blackburn J, et al. Strengthening Research for Health, Innovation and Development in South Africa: Proceedings and Recommendations of the 2011 National Health Research Summit. Pretoria: National Health Research Committee, South Africa, 2012.

12. Department of National Education. Resources for R&D in the Republic of South Africa 1991/1992.

Results of Survey Programme No. 17. Pretoria: Department of National Education, 1993.

13. Department of Science and Technology. National Survey of Research and Experimental Development (2008/09 Fiscal Year). Pretoria: Department of Science and Technology, 2010.

14. Department of Science and Technology. National Survey of Research and Experimental Development (2009/10 Fiscal Year). Pretoria: Department of Science and Technology, 2012.

15. Landriault E, Matlin SA. The 2008 Report Card on Financing Research and Development for Health.

Geneva: Global Forum for Health Research, 2009.

16. Burke MA, Matlin SA. Monitoring Financial Flows for Health Research 2008. Geneva: Global Forum for Health Research, 2008.

17. National Treasury, Republic of South Africa. Estimates of National Expenditure 2013. http://www. treasury.gov.za/documents/national%20budget/2013/ene/FullENE.pdf (accessed 24 March 2014).

18. National Treasury, Republic of South Africa. Medium Term Budget Policy Statement 2010. http://www. treasury.gov.za/documents/mtbps/2010 (accessed 24 March 2014).

19. National Treasury, Republic of South Africa. Medium Term Budget Policy Statement 2012. http://www. treasury.gov.za/documents/mtbps/2012 (accessed 24 March 2014).

20. Commission on Health Research for Development (COHRED) report of 1990: Health Research: Essential Link to Equity in Development. Cambridge, Mass: Oxford University Press, 1990.

21. Statistics South Africa. Consumer Price Index History. February 2014. http://beta2. statssa.gov.za/ publications/P0141/CPIHistory.pdf (accessed 24 March 2014).

22. Blecher MS, McIntyre D. Expenditure on health in South Africa, 1991/1992. S Afr Med J 1995;85(5):365-370.

23. National Treasury, Republic of South Africa. Estimates of National Expenditure 2011. http://www. treasury.gov.za/documents/national%20budget/2011/ene/FullENE.pdf (accessed 24 March 2014).

24. Kahn M, Gastrow M. Pharmacologically active: Clinical trials and the pharmaceutical industry. S Afr Med J 2008;98(2):114-116.

25. Rottingen JA, Chamas C, Goyal LC, Harb H, Lagrada L, Mayosi BM. Securing the public good of health research and development for developing countries. Bull World Health Organ 2012;90(5):398-400. [http://dx.doi.org/10.2471/BLT.12.105460] 26. Mayosi BM, Lawn JE, van Niekerk A, Bradshaw D, Abdool Karim SS, Coovadia HM. Health in South Africa: Changes and challenges since 2009. Lancet 2012;380(9858):2029-2043. [http://dx.doi. org/10.1016/S0140-6736(12)61814-5]

Accepted 6 April 2014.

July 2014, Vol. 104, No. 7

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OPINION

The RWOPS debate – yes we can!

A Taylor, D Kahn Allan Taylor is a neurosurgeon working at Groote Schuur Hospital, Cape Town, South Africa, and Delawir Kahn is Head of the Department of Surgery at the University of Cape Town, South Africa.

Corresponding author: A Taylor (allan.taylor@uct.ac.za)

Remunerated work outside of public service (RWOPS) has largely been seen in a negative light. This is partly a result of the Public Service Commission review undertaken in 2004, but attitudes are also shaped by unsubstantiated reports of abuse. There are, however, potential advantages for both patients and doctors if RWOPS is done without neglecting public sector service and academic commitments. We explore some of the issues around controlling RWOPS, and the experience with this in the Department of Surgery at the University of Cape Town, South Africa.

S Afr Med J 2014;104(7):475-477. DOI:10.7196/SAMJ.8050

Remunerated work outside of public service (RWOPS) for doctors has been controversial since its inception.

It was introduced to improve remuneration for stateemployed doctors, and thereby retain doctors in the public sector. There are, however, other benefits of RWOPS, which are outlined below.

Recently the focus has been on abuse of the system by some doctors who spend unreasonable amounts of time treating private patients and neglecting their public service obligations.[1,2] Evidence for this abuse is almost all anecdotal. The Public Service Commission (PSC) conducted an enquiry into RWOPS in Gauteng Province, South Africa, in 2004.[3] This report was largely negative and stated that, among other abuses, more than 50% of state-employed specialists owned private clinics and that ‘sick leave’ was taken in order to conduct private work. It should be noted that this report was based on questionnaires completed by only 20 of a total of over 700 doctors employed at the institutions under review. A more recent review (unpublished) of RWOPS in Mthatha, Eastern Cape Province, was similarly negative and showed that one in four specialists employed at the Nelson Mandela academic complex of Walter Sisulu University earned R6 500 - R126 000 over a 6-month period by doing private work. This was felt to be excessive and added to perceptions of abuse, prompting the Minister of Health’s statement that ‘patients are dying because of specialist greed’.[4]

system because of inadequate salaries and frustration with budget cuts, inadequate equipment and service restrictions. The intention was to allow doctors to supplement their income, and to have access to modern equipment and resources so that their skills could continue to be improved, all of which would allow them to remain in the public system. Potentially, RWOPS stood to increase practitioners’ exposure to a broader spectrum of disease and/or a greater number of focused cases, and to open up research opportunities and broaden the teaching platform for undergraduate and postgraduate students.

These are, of course, mostly advantageous to practitioners and not necessarily to patients. However, there are advantages to both public and private patients in allowing this crossover practice.

Private patients benefit from the evidence-based practice that is part of academic medical practice and from accessing super-specialist services, available only in large academic hospitals. The advantage for public patients is improved care through retention of experienced staff who are not lost to the private sector. The PSC report hints at a more subtle advantage by suggesting that staff should be directed towards serving their communities. How much better could our public healthcare facilities be if service levels approached those of private facilities? Perhaps exposure to the private culture of efficient, professional and polite service could diffuse into our public hospitals by staff crossing between institutions.

Abuse of RWOPS

A national policy that complies with appropriate public service regulations is required. The framework should set out the responsibilities of staff with regard to their public service commitments, the restrictions pertaining to private work, and how public sector and private sector duties will be monitored. This framework will require flexibility if it is to apply to all provinces and institutions, as service loads and requirements to conduct research or teach will vary between hospitals.

There are currently four major issues in respect of how RWOPS is performed: • How many hours of RWOPS? Most doctors in medical officer or specialist posts are contracted to work 56 hours per week. Forty hours are considered to be for normal duties and 16 hours are for overtime work. In the Western Cape Province, 16 hours per week of private work is currently allowed, although in the Department

Abuse of RWOPS by some doctors who spend unreasonable amounts of time treating private patients and neglect their public service obligations needs to be taken seriously. The PSC report made a number of recommendations aimed at improving the RWOPS policy framework with tighter management control. It concluded that attitudes of staff should be directed towards serving their communities, and also stated that ‘constant improvement of an ethical culture requires that appraisal systems be utilised in order to recognise and reward ethical behaviour, while unethical behaviour continues to be swiftly and visibly punished’.[3]

Potential advantages of RWOPS

RWOPS was introduced at a time when many staff, particularly young, newly qualified specialists, were leaving the public healthcare

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Improving RWOPS control

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A framework will need to deal with all of these issues, and ideally should move towards an output-based monitoring system rather than a purely restrictive system.

RWOPS in the Department of Surgery at UCT

The Department of Surgery at UCT established a RWOPS Committee (Profs D Kahn, J Brink, E Panieri and A Taylor) to monitor RWOPS activities in the Department.

Each staff member has to apply annually for the privilege of performing RWOPS. In the application process the practitioner has to produce a detailed work plan that outlines all activities in both the state and private sectors, i.e. ward rounds, outpatient clinics, theatre, teaching, administration, etc.

The application has to be signed off by the practitioner’s supervisor, the Head of the Division and the Head of the Department before being sent to the CEO of the hospital for approval.

In principle, RWOPS is encouraged but should be limited to 8 hours per week.

Furthermore, doctors are encouraged to perform RWOPS in the UCT Private Academic Hospital, which is on site, while off-site practices are discouraged. Practitioners are allowed to perform RWOPS during normal working hours, but outside of the 40 hours of normal duty.

The 2012 RWOPS audit

Aware of the criticism of RWOPS abuses, directed mostly at surgeons, the Department of Surgery RWOPS Committee undertook a review of RWOPS practice in the Department in 2012.

Method

All full-time staff, including division heads, and a registrar and student sample were interviewed by the RWOPS Committee and asked to comment on the following issues:

9

UCT

8

• perception that the Department abuses RWOPS • perception that some divisions abuse RWOPS • impact on full-time commitments • own RWOPS practice.

Of 57 full-time staff members, five were excluded from the process because they were retiring or not available; 52 were interviewed, including four surgeons who had voluntarily taken part-time positions, or had given up their overtime work and pay because they wished to spend more than 8 hours per week doing private work.

Results

Of the 48 interviewed who were in full-time positions, 14 (29.2%) performed no private work.

While a few practitioners felt that RWOPS was not beneficial, the majority believed that it was, citing maintenance of skills, financial reward, exposure to a different spectrum of patients/disease, and opportunity for registrar training as reasons.

Of specialists who performed private work, 13 practised only at the UCT Private Academic Hospital and 21 worked at another private hospital (Fig. 1). Of the 34 fulltime staff performing RWOPS, 26 (76.5%) performed 8 hours or less of private work per week, with eight undertaking more than this (Fig. 2). More than 83% of the 48 fulltime staff members interviewed were not performing RWOPS or spent 1 day or less doing private work.

The registrars who were interviewed did not have negative comments about consultants doing private work, and many felt that they had benefited through exposure to

Off-site

7 Doctors, n

of Surgery at the University of Cape Town (UCT) this is further restricted to 8 hours.

Eight hours per week was considered by colleagues in the Department to be reasonable.

• When can RWOPS be performed?

When private work can be performed is a more thorny issue, with some feeling that it should only be done after normal working hours or over weekends. The assumption underlying this is that doctors’ hours are regular. Although true for some specialties, this is not so for many others, where working hours are determined by service demands and as patients present, often acutely. In the Western Cape this has been dealt with through a ‘work plan’, which requires that 40 hours per week be worked in public service between 06h00 and 19h00. As long as this requirement is met, doctors may undertake their private work at any time. Overtime commitments must also be detailed in the work plan.

• Where may RWOPS be performed?

Currently private work is not allowed to be performed in any state hospital or involve use of any state equipment. Some institutions (UCT, the University of the Free State and the University of the Witwatersrand) are fortunate in having associated private hospitals where RWOPS can be done. Many doctors, however, have no alternative but to work in other private hospitals. Splitting working time between remote hospitals is not ideal, because it affords little chance for managers to oversee and control staff. A solution might be public-private partnerships where public hospital managers or universities have some oversight of doctors working in private institutions.

• Should income from RWOPS be limited? Income is a complex issue, as there are currently no ethical tariffs and disparities in practice costs are wide. For instance, malpractice cover currently runs at around R330 000 per annum for highrisk practice and only R16 080 for lowrisk practice. It is unfair to judge doctors as greedy based on a gross income. It is also unreasonable to assume that all RWOPS-generated funding is used for cars, expensive homes and holidays.

Many doctors use this money to support research efforts and departmental funds, and to pay for attendance at congresses.

6 5 4 3 2 1 0

Card

Urol

ENT

Neur

Plas

Oph

Orth

Gen

Fig. 1. Sites of remunerated work outside of public service of the responding doctors. (Card = cardiac surgery; Urol = urology; ENT = ear, nose and throat; Neur = neurosurgery; Plas = plastic surgery; Oph = ophthalmology; Orth = orthopaedics; Gen = general surgery.)

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operations not routinely performed in pub­ lic hospitals.

15

Conclusion

10 Doctors, n

Following this audit, the Department deci­ ded to continue with an annual review of RWOPS activities and to limit private practice to two half-day sessions a week.

No new consultations or procedures could be undertaken beyond this limit, although urgent problems arising with inpatients could be attended to. Doctors were also encouraged to undertake their RWOPS at the UCT Private Academic Hospital.

2013 RWOPS audit

As part of the ongoing monitoring process, the RWOPS Committee repeated their audit of RWOPS activities of all members of the Department.

Method

5

0

<1

1

2

3

5

>5

Sessions, n Fig. 2. Sessions of remunerated work outside of public service (n/week) worked by the responding doctors. (1 session = half day (4 hours).)

An online survey of RWOPS practice of all specialists in the Department was under­ taken. They were asked to populate an Excel spreadsheet detailing fixed full-time commit­ments and fixed times allocated to RWOPS. They also had to submit a list of all private activities, including dates and times of consultations and procedures, during a 2-week period in September.

Two consultants each performed 1 hour per week of private work outside of their agreed work plan when they had to treat emergency cases. Six doctors scheduled some of their RWOPS work after 19h00 on weekdays, or over weekends, in order not to conflict with full-time commitments. Thirteen doctors (40.6%) did no overtime work during the period under review.

Results

Conclusion

Thirty-two replies were received. Almost all staff had com­plied with their agreed work plans, performing less than 8 hours of private work per week. Only two doctors did more than 8 hours of private work per week bet­ ween the hours of 07h00 and 19h00, one of whom had given up overtime pay in an agreed contract allowing more RWOPS work.

4

RWOPS is responsibly performed in the Department, with very few deviations from submitted work plans. Outstanding replies are being followed up and random audits are still to be done on submitted data.

The original intent of RWOPS remains valid. It is important to retain the skills of

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experienced staff in the public sector, and RWOPS helps to achieve this end. However, RWOPS can only continue if public sector work is competently dealt with and remains the primary responsibility of public sector doctors. The key to achieving this is strong management to ensure and enforce a fair RWOPS dispensation.

1. Goldstein L. Thieves of the state. S Afr Med J 2012;102(9):719. [http://dx.doi.org/10.7196/SAMJ.6165] 2. Caldwell R. Thieves of the state – a response. S Afr Med J 2012;102(10):775. [http://dx.doi.org/10.7196/SAMJ.6301] 3. Public Service Commission. Remunerative work outside of Public Service. 2004 report. http://www.psc.gov.za/ documents/2004/remunerati ve_woroutside_psc.pdf (accessed 30 November 2013).

4. Bateman C. RWOPS abuse – Government’s had enough. S Afr Med J 2012;102(12):899-901. [http://dx.doi.org/10.7196/ SAMJ.6481]

Accepted 4 April 2014.

EDITORIAL

A global call for action to combat antimicrobial resistance: Can we get it right this time?

On 17 May 2014, the World Health Assembly adopted World Health Organization (WHO) reso­ lution WHA67.25 ‘Combating antimicrobial resis­ tance including antibiotic resistance’.[1] Among other directives, the nine-point call to action urges member states ‘to develop or strengthen national plans, strategies and international collaboration for the containment of antimicrobial resistance’. Such calls have been heard before.[2-3] So what is different this time, how do we break the mould to ensure that significant international change occurs, and how is South Africa (SA) positioning itself to respond to the call?

Commonly, a crisis only becomes a crisis when high-income countries become threatened and a tipping point is reached where a commodity becomes scarce. Bugs travel, and with them come antimicrobial resistance (AMR) genes. The global dissemination of New Delhi metallo-beta-lactamase-1 (NDM-1)-containing Gram-negative bacteria from India,[4] and Klebsiella pneumoniae carbapenemase (KPC) from the USA,[5] testifies to the fact that we are facing an international problem, capable of affecting all countries irrespective of how good their antimicrobial policies to prevent resistance are. As such, an international, collaborative approach is needed where all nations are involved. To cement this, a sea-change in perception is required. The WHO resolution recognises the efficacy of an antimicrobial as a global public good, i.e. one that is both non-excludable (universal access) and non-rival in consumption (will not deplete the efficacy of the drug). The non-rival nature of antimicrobial efficacy can only be preserved if we stop perceiving antimicrobials as our own private goods, and attend to the main drivers of resistance. This is not only relevant to antimicrobials for human use, but applies equally to the far greater volume used for animal health, agriculture and aquaculture.

While antibacterial resistance is a Darwinian response by bacteria to selective pressure exerted by an antibacterial, its main driver is inappropriate overuse. This practice spans resource settings, rural and urban communities, public and private healthcare, and all types of prescribers. Empiric antibacterial prescribing for undifferentiated fever commonly lies at the heart of inappropriate use, whether it is the child in a rural low- or middle-income country attending a local clinic with what is actually malaria, adults throughout the world requesting antibacterials for themselves or their children for viral upper respiratory tract infection, or the elderly patient who is admitted to hospital with fever and confusion labelled ‘sepsis, unknown cause’. Improved diagnostics, preferably at point of care and ideally those that identify not only the microbe but its resistance profile too, in addition to development of laboratory infrastructure and services to strengthen surveillance, would enable appropriate prescribing. Education, evidence-based guidelines and task shifting to allow safe, appropriate non-physician-based prescribing would improve access to appropriately prescribed antimicrobials to all in need, and removal of perverse incentives to over-prescribe, such as remuneration linked to prescription, would disincentivise inappropriate prescribing.

The lack of new drugs to treat bacteria containing NDM-1, KPC and other multidrug-resistant mutations is having significant effects on patient morbidity and mortality.[6-7] For many such infections we

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now rely on colistin, a drug developed in the 1960s with significant renal toxicity, as the last line of defence. The increasing reports of colistin resistance, including in our own country, herald our entry into the post-antibiotic era.[8,9] With no new antibacterials expected for multidrug-resistant Gram-negative bacteria in the next 10 - 15 years based on current models, we need to preserve what we have, and reinvigorate the antibacterial drug pipeline. To enable this, new models of antimicrobial research and development (R&D), and pricing that de-links profit from volume of sales, are required, and a combination of push-and-pull mechanisms, private-public partnerships and other innovative models that can serve as incentives for R&D should be explored.

AMR in the SA context needs to take into account a range of infections. Extensively and totally drug-resistant tuberculosis (TB) is spreading in the country;[10] approximately half of all non-albicans candida infections are resistant to fluconazole;[11] current rates of transmitted resistance to first-line antiretrovirals in HIV are ~5%, yet as antiretroviral roll-out continues, resistance rates are set to rise to 10 - 17%;[12] and hopes for the elimination of falciparum malaria are threatened by the risk of spread of artemesinin resistance from SouthEast Asia.[13] A number of strategies are already in place for HIV, TB and malaria through established national working groups. In terms of antibacterial resistance, the national response has gathered pace since the publication of a situational analysis in 2011 by the Global Antibiotic Resistance Partnership-South Africa (GARP-SA).[14] The South African Antibiotic Stewardship Programme (SAASP)[15] has led the introduction of stewardship to promote appropriate antimicrobial prescribing across public and private health sectors, with positive results.[16] AMR working groups with co-ordinated activities have begun work in some provinces, and following meetings between the SAASP and the National Department of Health, work began on a national AMR strategy with widespread stakeholder involvement.

This work has accelerated since the WHO resolution was proposed in January 2014. The strategy rests on strengthening four pillars: governance, surveillance and reporting, antimicrobial stewardship (AMS), and infection prevention and control.

Recognising that AMR involves human and animal health, and requires co-ordinated collaboration with other key areas, an intersectoral Ministerial Advisory Committee is to be formed to advise the Minster of Health. The committee will include representation from the departments of Health, Agriculture, Forestry and Fisheries, Science and Technology, Trade and Industry, and Education, in addition to public and private health providers, academia, infection societies and other relevant stakeholders. National core standards for AMS and infection prevention control (IPC) are under consideration, which will direct governance at institutional and district levels.

Strengthening of surveillance and reporting go beyond patterns of AMR to include antimicrobial use, drug quality and medication errors, all of which are important factors to optimise prescribing.

A central, national body is needed to co-ordinate and warehouse all laboratory surveillance data, and both statutory and sentinel reporting notification systems are required to inform appropriate prescribing.

To strengthen AMS, we need to build expertise by integrating it into curricula for all healthcare professionals in training and making

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EDITORIAL

it part of continuing professional development programmes. We need to institutionalise AMS so that it is incorporated into job descriptions and performance appraisals, and develop ‘champions’ in facilities and districts. At the coalface, the strategy is to integrate information technology systems so that pharmacy, microbiology and clinical information can be collated and drive appropriate prescribing.

Adopting national core standards that require each institution and district to have an AMS committee and AMS team(s) will promote appropriate prescribing, as will a set of national guidelines, in line with the Essential Drugs List and structured treatment guidelines.

For animal health, we need to phase out the use of antimicrobials where evidence exists that they select out for cross-resistance in humans. In addition, a co-ordinated programme of research and audit is required towards phasing out of antimicrobials used for animal growth promotion.

The strategy to strengthen IPC mirrors much of that for AMS in terms of education, clear governance structures, and integration with AMS team activities. Supporting the Expanded Program on Immunization to ensure that our children, high-risk adolescents and adults are vaccinated against bacterial and viral infections can reduce the need for antimicrobials in the first place. Creating the infrastructure and support systems to ensure proper airborne precautions to prevent Mycobacterium tuberculosis transmission, and contact precautions for bacterial infections other than TB, focusing on identification and isolation of patients, personal protective equipment and above all excellent hand hygiene practice, lie at the heart of the IPC strategy. Involving our patients by empowering them to remind health professionals to comply with hand hygiene and protective equipment is another valuable piece in the jigsaw.[17] AMR is no longer someone else’s problem. It’s personal, it’s here to stay, and if we don’t do something about it now, our patients’ morbidity and mortality will increase substantially. It would be good not to hear anyone say ‘Nice resolution, shame about the action.’

Marc Mendelson Division of Infectious Diseases and HIV Medicine, Department of Medicine, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa Malebona Precious Matsoso National Department of Health, Pretoria, South Africa Corresponding author: M Mendelson (marc.mendelson@uct.ac.za) 1. World Health Assembly Resolution WHO 134.R13. Combating antimicrobial resistance including antibiotic resistance. http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_R13-en.pdf (accessed 2 June 2014).

2. World Health Assembly Resolution WHA51.17. Emerging and other communicable diseases: antimicrobial resistance. http://apps.who.int/medicinedocs/documents/s16334e/s16334e.pdf (accessed 2 June 2014).

3. World Health Assembly Resolution WHA58.27. Improving the containment of antimicrobial resistance. http://www.searo.who.int/entity/medicines/topics/wha_58_27.pdf (accessed 2 June 2014).

4. Kumarasamy KK, Toleman MA, Walsh TR, et al. Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: A molecular, biological, and epidemiological study. Lancet Infect Dis 2010;10(9):597602. [http://dx.doi.org/10.1016/S1473-3099(10)70143-2] 5. Nordmann P, Cuzon G, Naas T. The real threat of Klebsiella pneumoniae carbapenemase-producing bacteria.

Lancet Infect Dis 2003;9(4):228-236. [http://dx.doi.org/10.1016/S1473-3099(09)70054-4] 6. Centers for Disease Control and Prevention, US Department of Health and Human Services. Antibiotic Resistance Threats in the United States, 2013. Atlanta, Ga: CDC, 2013. http://www.cdc.gov/drugresistance/ threat-report-2013/ (accessed 2 June 2014).

7. European Commission. Action plan against the rising threats from antimicrobial resistance. Brussels, 2011. http://ec.europa.eu/dgs/health_consumer/docs/communication_amr_2011_748_en.pdf (accessed 2 June 2014).

8. Cai Y, Chai D, Wang R, Liang B, Bai N. Colistin resistance of Acinetobacter baumannii: Clinical reports, mechanisms and antimicrobial strategies. J Antimicrob Chemother 2012;67(7):1607-1615. [http://dx.doi. org/10.1093/jac/dks084] 9. Brink AJ, Coetzee J, Corcoran C, et al. Emergence of OXA-48 and OXA-181 carbapenemases among Enterobacteriaceae in South Africa and evidence of in vivo selection of colistin resistance as a consequence of selective decontamination of the gastrointestinal tract. J Clin Microbiol 2013;51(1):369-372. [http://dx.doi. org/10.1128/JCM.02234-12] 10. Klopper M, Warren RM, Hayes C, et al. Emergence and spread of extensively and totally drug-resistant tuberculosis, South Africa. Emerg Infect Dis 2013;19(3):449-455. [http://dx.doi.org/10.320/EID1903.120246] 11. World Health Organization. Antimicrobial Resistance: Global Report on Surveillance. Geneva: WHO, 2014.

12. World Health Organization. WHO Drug Resistance Report 2012. Geneva: WHO, 2012.

13. Dondorp AM, Yeung S, White L, et al. Artemisinin resistance: Current status and scenarios for containment.

Nat Rev Microbiol 2010;8(4):272-280. [http://dx.doi.org/10.1038/nrmicro2331] 14. Duse A. The Global Antibiotic Resistance Partnership. S Afr Med J 2011;101(8):551.

15. Mendelson M, Whitelaw A, Nicol M, Brink A. Wake up South Africa! The antibiotic ‘horse’ has bolted. S Afr Med J 2012;102(7):607-608.

16. Boyles TH, Whitelaw A, Bamford C, et al. Antibiotic stewardship ward rounds and a dedicated prescription chart reduce antibiotic consumption and pharmacy costs without affecting inpatient mortality or re-admission rates. PLoS One 2013;8(12):e79747. [http://dx.doi.org/10.1371/journal.pone.0079747] 17. Mendelson M. Patient empowerment as a driver of hand hygiene practice: Time for patients in South Africa to have their say. Southern African Journal of Infectious Diseases 2014;29(1):3-4.

S Afr Med J 2014;104(7):478-479. DOI:10.7196/SAMJ.8534

Izindaba News Editor wins award

Izindaba News Editor Chris Bateman has won the ‘Best Analysis and Commentary’ category in the annual Discovery Health Journalism Awards, bringing to five the number of times he has won a category since the competition began in 2008. The judges’ citation for the award, made late last month, reads: ‘In his article, “Doctor shortages: Unpacking the Cuban solution”,* Bateman provides an excellent analysis of the government’s attempt to address the need for more doctors by sending trainees to Cuba. He does an impressive job of bringing together the different views of experts and academics in medical training to demonstrate how the solution might not necessarily address the problem and might even create new problems. In this regard, Bateman demonstrates a depth of understanding of the issue in ways that are illuminating and can inform decisions on medical training in our society in the future.’

Bateman is the only journalist to have won two categories twice in different years, twice bringing the honour of ‘Best Trade Journal’ to the SAMJ. *Bateman C. Doctor shortages: Unpacking the ‘Cuban solution’. S Afr Med J 2013;103(9):603-605. [http://dx.doi.org/10.7196/SAMJ.7323]

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July 2014, Vol. 104, No. 7

EDITORIAL

Professional competence and professional misconduct in South Africa Professional life has long been fraught with many difficulties, and the literature is replete with valid criticisms of individuals and the professions (see, for example, Freidson[1] and Kronman[2]). With advancing complexity in medical knowledge and skills and in providing healthcare, maintaining high professional standards is an increasingly recognised challenge in all societies.

Enhanced educational efforts to sustain professionalism, improved methods of vigilance, and robust methods of reporting complaints and dealing with offenders are essential.[3-7] In addition to the usual complaints regarding professional competence and misconduct, some serious and deeply worrying problems about medical professionals in South Africa (SA) are currently being exposed. These include reports of poorly qualified cardiothoracic surgeons being allowed to enter practice, and the lack of robust mechanisms to prevent those who may be incompetent from continuing to practise.[8,9] At the same time, some highly competent surgeons have lost their jobs in the public sector despite lack of appropriate procedures to endorse such action.[10,11] Also of great concern are complaints about full-time health professionals in the public sector fraudulently short-changing their patients, junior colleagues and the state in their public appointment capacities by working unduly long hours in their private practices.[12-14] Both of these concerns strike at the heart of what health professionalism is about, in particular as health professionals are granted the social privilege of self-governance and internal maintenance of high professional standards, and because trust in professionals by the public is a central factor in healthcare. The background to both these issues is complex. How they could and should be addressed, and what remedial or punitive approaches are appropriate for institutions and individuals when problems are confirmed, are also important questions.

While highlighting and investigating such problems, we should not lose sight of the range of competencies in all professions (from acceptably skilled to highly skilled), and the fact that many health practitioners (it is to be hoped a majority) undertake their work with integrity, dedication and commitment. As with so much in society, the bad behaviour of a few can harm the reputation of whole groups of professionals who conduct themselves honourably and apply their skills for the benefit of many individuals and for society as a whole.

In healthcare it is very common to hear complaints of poor treatment and adverse outcomes, but these are seldom placed in the context of the many positive achievements within institutions and practices. As examples of the best that medicine can offer, such services have long been widely appreciated and acknowledged, and SA graduates enjoy excellent reputations locally and abroad. However, these successes should not prevent the investigation of valid complaints, and an understanding of the corrosive effects of unprofessional behaviour on the lives and wellbeing of others.

Inadequate training of specialists

The extent to which local postgraduate training facilities may not be producing specialists with the skills and attitudes required to practise effectively and safely is currently being raised following complaints of inadequate training of cardiothoracic surgeons.[9,15-17] The debate about such issues is heated and there is a paucity of facts about the adequacy of postgraduate training facilities, the extent

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to which experienced clinician teachers/mentors are avail­ able, and whether adequate numbers of relevant cases are available for learning purposes. Although such concerns have been focused on cardiothoracic surgery, they are relevant to all specialties, especially those with surgical and other interventional responsibilities. In addition to the adequacy of training facilities, there is a need to review methods of supervision and certification of hours of training and practical experience.

Relevant questions include how many operations specific to the specialty in question newly qualified surgeons are required to have performed; how many such operations they have indeed performed before they are allowed to go into practice; and what attempts are being made to enable new graduates in such specialties to work for a few years under the supervision of experienced colleagues before they go into solo practice. While full answers to such questions and associated concerns are not available, it would seem that, in part, lack of due diligence along the training and certification chain may be contributing to delays in finding solutions.

Training facilities

The first issue on which to focus is the ability to train new genera­ tions of specialists with necessary skills. All postgraduate training requires the development of practical skills under supervision, as well as certification of competence. Against the background of many decades of widely acknowledged, high-quality medical education and training in our medical schools, it was pointed out in the late 1990s and early 2000s that reductions in tertiary beds and freezing of posts in academic hospitals were impairing the ability to sustain specialised services in the public sector and reducing the capacity to train new generations of specialised practitioners.[18] For example, in 2004 it was reported that at Groote Schuur Hospital (GSH), Cape Town, cardiac surgical operations on adults had been reduced from 700 per year to fewer than 250 per year. In orthopaedics, budgetary reductions had resulted in the limitation of joint replacements to 60 procedures per year in 2003, compared with 350 in 1993. Although the majority of orthopaedic surgery is for traumatic injuries, joint replacement surgery is a critical skill that needs to be sustained. In ophthalmology, there had been a 60% reduction in experienced staff and a 50% reduction in beds over the previous decade. In general surgery, the waiting time for surgery for breast cancer had increased to 8 weeks (compared with 2 weeks in the early 1990s). The only information I was able to obtain about cutbacks at other medical schools at the time was that in November 2003 elective surgery was put on hold for 6 months at the University of the Witwatersrand’s major academic hospitals.[18] Acknowledgement that cutbacks to tertiary medicine in the public sector were unacceptable has led to some reversal of these adverse trends over recent years. For example, by 2013 cardiac surgical operations at GSH had been increased to 320 per year. In ophthalmology, consultant staffing had returned to pre-1994 levels, with one additional full-time consultant at Red Cross War Memorial Children’s Hospital, and there has been a drive to improve cataract surgery services.[19] In orthopaedics at GSH, 10 - 12 large-joint (hip, knee and shoulder) replacements are done each week. Yet 314 patients are currently on the waiting list for hip replacement. With six hip replacements per week this amounts to a 12 - 14-month waiting period, adjusting for public holidays, etc. The waiting list

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EDITORIAL

for 623 patients to have knee replacements (four knee replacements per week) is close to 3 years. In general surgery, the waiting time for breast surgery has been reduced to 4 weeks. The time has surely come to acquire and examine more such information from all our local academic institutions.

Assessing professional competence

All the fellowship examinations at the Colleges of Medicine of South Africa (CMSA) are exit examinations. Success in these examinations, taken towards the end of training, together with completion of required training time in appropriate facilities, enables registration with the Health Professions Council of South Africa (HPCSA) and entry into a career as a specialist. The CMSA surgical fellowships have rules stating that a portfolio of surgical experience must be submitted at the time of applying for the final fellowship examination. No mention is made in the rules of the number of operations that should have been done or assisted with, or whether the examiners themselves evaluate the portfolios.

It would seem timely to instigate an open investigation of the patient loads, surgical facilities and staffing levels of all training institutions, as well as of the thoroughness and accountability of the evaluation of practical experience, including scrutiny of wellprepared, validated case portfolios, before qualifying surgeons to enter practice as specialists.

Abuses of limited private practice

Limited private practice, introduced some years ago in order to retain within the public sector those clinicians whose skills were not being adequately used or remunerated, has not been unanimously supported and has had both advantages and disadvantages that vary across the country. In the Western Cape (and presumably throughout the public health sector), practitioners who are paid for overtime (16 hours per week in addition to a salary for a 40-hour working week) are permitted to do a maximum of 16 hours of remunerated work outside of public service (RWOPS) (however, not between 07h00 and 17h00).

Practitioners applying for this privilege are required to sign a contract agreeing to remain accountable to the head of component/department tasked with the performance management assessment including the control, supervision and monitoring of RWOPS. An article in this issue describes how RWOPS is managed in the University of Cape Town (UCT)/GSH Department of Surgery, where 8 hours of private practice is the limit allowed by internal agreement.[20] Although abuses have been recognised in the past, there is now renewed concern and growing evidence that the privilege of RWOPS has been considerably abused by some (perhaps many) healthcare professionals.[12-14] Inadequate opportunities to sustain surgical and other skills, inadequate working conditions in poorly organised and maintained health facilities, and perceptions of inadequate remuneration are causes of frustration for professionals in the public sector.[21] However, it should be acknowledged that greed, dishonesty and lack of professional integrity are, at least to a certain extent, also significant factors for some.

Erosive adverse effects of dereliction of public duties (for which full-time remuneration packages are provided) are wide-ranging.

They extend from harm to individual patients in the public sector who are deprived of the time and attention they should receive from experienced clinicians, through inadequate supervision of junior staff, to overloading and frustrating those practitioners who do not abuse this privilege and who struggle to maintain high-quality services and student mentorship in a crumbling public sector.[22,23]

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Taking action against professional incompetence/misconduct

In general, when concerns about professional competence or integrity arise in practice, the first step should be for a colleague or a group of colleagues to personally approach the person whom they consider is not meeting required standards of practice. While this is not easy to do, it is the most collegial and respectful way to follow up on professional responsibility to society and the profession. A skilled ombudsman could facilitate such inquiries. If discussion and good advice are not successful in identifying correctable problems and modifying behaviour, then complaints need to be made formally upstream – first to institutions such as the facilities within which the work takes place, for example hospitals and medical faculties. The Professional Standards Committee in the UCT Faculty of Health Sciences (FHS) provides an example of a formal structure and process to address issues of professional misconduct in that faculty.[24] Failure to achieve a satisfactory solution at this level should be followed by reporting to such higher levels as South African Medical Association committees or the HPCSA.[25] The HPCSA’s Annual Report for 2012/2013[26] noted that the Council’s legal department had received a total of 2 997 complaints of professional misconduct for all the health professions (310 more cases than in the previous year). Of these, 403 were referred to the office of the ombudsman, and 117 police files were opened regarding unregistered individuals. Most cases were settled at the disciplinary level with admission of guilt fines, while 51 practitioners were suspended from practising.

With regard to serious allegations against the Port Elizabeth cardiothoracic surgeons, it seems that both the HPCSA and local employing authorities may not have paid sufficient attention to the College portfolio rules for qualification to practise, and therefore allowed allegedly incompetent cardiothoracic surgeons to continue to operate despite a litany of operative disasters attributed to them.[8,15] In 2012 a prominent and highly skilled thoracic surgeon at GSH/ UCT wrote to the Dean of the FHS at UCT and the CEO of GSH criticising training in the Department of Cardiothoracic Surgery.

This letter was not answered and he was subsequently fired from his position. An investigation is now in progress under the new Dean. However, delays by UCT’s FHS in making a decision on professional grounds, despite the findings of the arbitrator in the surgeon’s favour[10] (Arbitration Award, Public Health and Social Development Sectoral Bargaining Council – case no. PSHS 14313/14, 6 October 2013), have resulted in public sector patients and thoracic surgical trainees being deprived of access to the skills of the most highly competent thoracic surgeon on the GSH/UCT staff.

Additional delays have been imposed by pursuit of an appeal by the Western Cape Province Department of Health (DoH) against the arbitrator’s decision. By resorting to legal solutions, both the University and the DoH are regrettably failing to make a decision on professional/ethical grounds regarding the surgeon’s concerns about standards of training.

The sacking of the Head of the Department of Cardiothoracic Surgery at the University of KwaZulu-Natal, one of SA’s most experienced cardiothoracic surgeons, is also worrying. Allegations of his racism, blasphemy, bigotry and unprofessional conduct were evaluated, but while the hearing was still in progress an executive decision was taken to terminate his employment.[11] To the best of my knowledge the proceedings of these hearings and the reasons for the decision taken are not publicly accessible. Such lack of accountability could be interpreted as a sign of institutional arrogance.

July 2014, Vol. 104, No. 7

EDITORIAL

The juxtaposition of incompetent surgeons being allowed to continue operating while highly skilled surgeons have been removed from the public service to which they have given high-quality and devoted service is bizarre, to say the least.

In the pursuit of complaints about excessive time taken for RWOPS, as much evidence as possible should be obtained about individual practitioners who are thought to be fraudulently exceeding their limits. The first step would be to establish mechanisms to ensure that each full-time member of staff is meeting all his/her designated responsibilities. Such evidence could include careful documentation of: (i) the extent to which their public duties are being met; (ii) the amount of time they are away from their workplace; and (iii) income as self-reported or based on other evidence. One would hope that in academic hospitals some formal tracking of private practice earnings could be possible, as described at the UCT/GSH Department of Surgery.[20] Tracking time spent at formal places of work is not easy, but such data are needed to allow hospitals, provincial employing authorities or the HPCSA to take action within the realms of their regulatory standards. It would seem that some such investigations are under way,[22] but these should be intensified and made transparent, if necessary with the assistance of an organisation such as EthicsSA.[27] When all the methods described above to assess and address professional incompetence or misconduct are unsuccessful, a complementary approach would be to establish a public commission of inquiry (with sufficient resources, skills and person-power) to investigate a hospital or a provincial health service. The Bristol affair in the UK[28] and the more recent investigations into the MidStaffordshire NHS Foundation Trust[29] are examples of responsible and accountable inquiries, although such undertakings are not without controversy.[30,31]

Conclusions

As in all other countries, both high and low income, many aspects of healthcare services in SA are problematic. In addition to health funding that is currently being reconsidered, the adequacy of facilities and the extent of support for postgraduate education/training in complex specialties need to be addressed and augmented if found wanting. If this cannot be achieved adequately within the public sector, the development of mutually agreeable strategic alliances with the private sector for training purposes should be considered, with the proviso that achievement of public benefit can be assured as the major goal. Constant vigilance and willingness of the professions to critically examine themselves and to review methods of supervision and certification of training and practical experience are essential aspects

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of professionalism required to sustain high-quality clinical services in the best interests of patients, the public at large and the profession.

Solly Benatar Bioethics Centre, University of Cape Town, South Africa, and Joint Centre for Bioethics, University of Toronto, Canada Corresponding author: S Benatar (solomon.benatar@uct.ac.za) 1. Freidson E. Professional Dominance: The Social Structure of Medical Care. Chicago: University of Chicago Press, 1970.

2. Kronman AT. The Lost Lawyer: Failing Ideals of the Legal Profession. Cambridge, Mass: Harvard University Press, 1993.

3. Royal College of Physicians of London. Doctors in Society: Medical Professionalism in a Changing World.

Report of a Working Party. December 2005. http://www.rcplondon.ac.uk/sites/default/files/documents/ doctors_in_society_reportweb.pdf (accessed 28 May 2014).

4. American Medical Association. Code of Ethics. http://www.ama-assn.org/ama/pub/physician-resources/ medical-ethics/code-medical-ethics.page (accessed 28 May 2014).

5. Medical Protection Society. Guide to Ethics. A map for the moral maze. http://www.medicalprotection.org/ southafrica/booklets/MPS-guide-to-ethics (accessed 28 May 2014).

6. Ethics: World Medical Association. http://www.wma.net/en/20activities/10ethics/ (accessed 28 May 2014).

7. Hsiao WC. Correcting past health policy mistakes (in China). Daedalus 2014;143(2):53-68.

8. Surgeons accused of terrifying incompetence. Noseweek 2013; November, 170:10-11.

9. Beware of ill-trained surgeons. Noseweek 2014; February, 172:16-18.

10. De Groot vs UCT: The arbitrator’s findings. Noseweek 2014; February, 172:19.

11. Jansen L. Surgeon sacked in racism dispute. IoL News 2013, 18 June, 11:25 am. http://www.iol.co.za/news/ crime-courts/surgeon-sacked-in-racism-dispute-1.1533573#.U5adTy_di2w (accessed 10 June 2014).

12. Goldstein L. Thieves of the state. S Afr Med J 2012;102(9):719. [http://dx.doi.org/10.7196/SAMJ.6165] 13. Caldwell RI. Thieves of the state: A response. S Afr Med J 2012;102(10):775. [http://dx.doi.org/10.7196/ SAMJ.6301] 14. Grootboom M, Sonderup M, Ramathuba P. Thieves of the state and the South African Medical Association (SAMA): The South African Medical Association responds. S Afr Med J 2013;103(6):354. [http://dx.doi. org/10.7196/SAMJ.7008] 15. A tale of two doctors. Noseweek 2014; February, 172:20-21.

16. Noseweek guilty of a serious lapse of ethics. Statement issued by Patricia Lucas, UCT Communication & Marketing Department, 31 January 2014. http://www.politicsweb.co.za/politicsweb/view/politicsweb/en/pa ge71619?oid=528316&sn=Marketingweb+detail (accessed 28 May 2014).

17. UPDATE: The heart of the matter. Noseweek 2014; March, 173:14-15.

18. Benatar SR. Health care reform and the crisis of HIV and AIDS in South Africa. N Engl J Med 2004;351(1):81-92. [http://dx.doi.org/10.1056/NEJMhpr033471] 19. Lecuona K, Cook C. South Africa’s cataract surgery rates – why are we not meeting our targets? S Afr Med J 2011;101(8):510-512.

20. Taylor A, Kahn D. The RWOPS debate – yes we can! S Afr Med J 2014;104(7):475-477. [http://dx.doi. org/10.7196/SAMJ.8050] 21. Erasmus N. Slaves of the state: Medical internship and community service in South Africa. S Afr Med J 2012;102(8):655-658. [http://dx.doi.org/10.7196/SAMJ.5987] 22. Bateman C. RWOPS abuse: Government’s had enough. S Afr Med J 2012;102(12):899-901. [http://dx.doi. org/10.7196/SAMJ.6481] 23. Treatment Action Campaign. Death and dying in the Eastern Cape: Redacted report. http://www.section27. org.za/wp-content/uploads/2013/09/SECTION27-report-redacted.pdf (accessed 28 May 2014).

24. Professional Standards Committee, Faculty of Health Sciences, University of Cape Town. http://www.health. uct.ac.za/fhs/about/governance/committees/standards/ (accessed 28 May 2014).

25. Benatar SR. The impaired doctor. S Afr Med J 1994;84(10):651-652.

26. Health Professions Council of South Africa. Annual Report 2012/2013. http://www.hpcsa.co.za/downloads/ press_releases/annual_reports/hpcsa_annual_report_2012_2013.pdf (accessed 28 May 2014).

27. Ethics Institute of South Africa. http://www.ethicsa.org/ (accessed 28 May 2014).

28. Learning from Bristol. UK Government Report. https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/273320/5363.pdf (accessed 28 May 2014).

29. Mid-Staffordshire Inquiry. Several articles in the BMJ. http://www.bmj.com/search/mid%2520staffordshire %2520inquiry (accessed 28 May 2014).

30. Savulescu J. Beyond Bristol: Taking responsibility. J Med Ethics 2002;28(5):281-282. [http://dx.doi. org/10.1136/jme.28.5.281] 31. Dunn PM. The Bristol affair. BMJ 1998;317:1659.2. [http://dx.doi.org/10.1136/bmj.317.7173.1659a]

S Afr Med J 2014;104(7):480-482. DOI:10.7196/SAMJ.8492

July 2014, Vol. 104, No. 7

RESEARCH

Self-reported use of evidence-based medicine and smoking cessation 6 - 9 months after acute coronary syndrome: A single-centre perspective B Griffiths,1 MB ChB; M Lesosky,1 PhD; M Ntsekhe,2 MD, PhD 1

Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa Division of Cardiology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa

2

Corresponding author: B Griffiths (bpgriffiths@gmail.com) Background. Good evidence exists to support the use of secondary prevention medications (aspirin, statins, beta-blockers and angiotensinconverting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs)) and smoking cessation in patients after acute coronary syndromes (ACSs). Little is currently known about adherence to medication and smoking behaviour after discharge in South Africa.

Methods. We conducted a cross-sectional analysis of all patients with a diagnosis of ACS discharged from the Coronary Care Unit at Groote Schuur Hospital, Cape Town, between 15 November 2011 and 15 April 2012. Patients were telephoned 6 - 9 months after discharge and completed a standardised questionnaire detailing current medication use, reasons for non-adherence and smoking status.

Results. Prescribing of secondary prevention medications at discharge was high (aspirin 94.5%, statins 95.7%, beta-blockers 85.4%, ACEIs/ ARBs 85.9%), and 70.7% of patients were discharged on a combination of all four drugs. At 6 - 9-month follow-up, the pro­portion using these medications had dropped by 8.9% for aspirin, 10.1% for statins, 6.2% for beta-blockers and 17.9% for ACEIs/ARBs. Only 47.2% remained on all four drugs, a reduction of 23.5%. Of the 56.0% of patients who were smokers, 31.4% had stopped smoking.

Conclusions. A significant decline in adherence to recommended therapy 6 - 9 months after discharge and a poor rate of smoking cessation suggest that efforts to educate patients about the importance of long-term adherence need to be improved. Furthermore, more effective interventions than in-hospital reminders about the hazards of smoking are needed to improve smoking cessation.

S Afr Med J 2014;104(7):483-487. DOI:10.7196/SAMJ.7798

The incidence of ischaemic heart disease (IHD) is on the rise in Africa. Recent projections suggest that by 2030 IHD will become a leading cause of death on the continent, surpassing HIV/AIDS.[1] In the South African National Burden of Disease Study in 2000,[2] IHD was found to be the largest single cause of death in the Western Cape Province (12%), followed by stroke (8.8%) and HIV/AIDS (8.4%), and non-communicable diseases accounted for a larger prop­ortion of deaths in the Western Cape (58%) than in the rest of South Africa (SA) (38%). In a subsequent study,[3] mortality from IHD in Cape Town was found to be very similar to HIV/ AIDS (76 v. 83 deaths/100 000 population, respectively), and IHD featured as the leading cause of death from non-communicable diseases. The Second National Burden of Disease Study is nearing completion and will give us more current data on mortality trends.

The epidemiological transition of cardiovascular disease described

by Yusuf et al.[4] suggests that with progression from underdevelopment to industrialisation we can expect an increasing burden of degenerative disease, particularly IHD and stroke.

The use of evidence-based optimal medical therapy (dual antiplatelet therapy, statins, beta-blockers and angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs)) after acute coronary syndrome (ACS) is known to reduce 6-month mortality by up to 87%.[5] Patients who continue to smoke after an ACS have a significantly increased risk of a future acute myocardial infarction (MI)

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compared with those who quit.[6] Furthermore, smoking in the presence of established IHD is associated with a significantly increased risk of death, including sudden cardiac death. Over an 8-year period, smoking cessation reduces this risk to levels comparable to that for people who have never smoked.[7] Despite this, medication adherence and smoking cessation in patients after discharge are often disappointing.[6-9] Results from the Prospective Urban Rural Epidemiology (PURE) study[10] suggest that in SA, and in countries with similar income profiles, use of these medicines in patients with coronary heart disease at a median follow-up period of 4 years varies between 21.1% and 31%, compared with 46.5% and 70.9% for upper-income countries. These figures are even lower when Africa as a whole is compared with other areas.[10] The reasons for discontinuation of medication are diverse, and include the high cost of obtaining medicine, high pill burden and lower level of education.[11] To date there are no published SA data on the medium- to longterm (>6 months) use of secondary prevention medication and smoking cessation among patients discharged from hospital after an ACS. We designed this cross-sectional study to assess the continued use of four selected drug classes and rates of smoking cessation at a follow-up period of 6 - 9 months post discharge after an ACS.

Methods

Study design

Cross-sectional analysis with retrospective subject identification.

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RESEARCH

Study population

Groote Schuur Hospital is an 893-bed state-funded tertiary hospital in Cape Town, SA. It has a six-bed coronary care unit (CCU) and a cardiac catheterisation laboratory. Patients who are admitted to the CCU either present directly to the emergency unit or are referred from secondary-level institutions. Those who survive their acute cardiac insult are discharged home on optimal medical therapy and advised about smoking cessation. Clopidogrel, the only P2Y12 receptor antagonist available in our setting and now widely available, was only offered to those patients who underwent percutaneous coronary intervention during the study period, owing to funderinduced prescribing limitations at the time. Apart from a limited discussion about the hazards of smoking and its adverse effects on coronary artery disease, no specific smoking cessation guidance is offered. Long-term care and follow-up take place at the community health centre closest to the patient’s home. Medication is supplied free of charge to patients who are pensioners, unemployed, or earn less than R36 000 per annum, which includes the vast majority of patients admitted to our unit.

We retrospectively enrolled all patients discharged alive from the CCU with a final diagnosis of unstable angina pectoris, non-ST elevation MI or ST-elevation MI during the 5-month period between 15 November 2011 and 15 April 2012. In each case the consultant cardiologist in charge of the patient’s care made the diagnosis.

Approval to conduct the study was obtained from the Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town.

significance level of p<0.05 was used. All statistical analysis was done using R 3.0.

Results

Patient characteristics

A total of 164 patients with a diagnosis of ACS were discharged alive from the CCU and were therefore eligible for enrolment into the study. Their mean age was 58.6 years, and 97 (59.1%) were male. The baseline demographic variables, type of ACS and inpatient treatment strategy are summarised in Table 1.

Of the 164 patients enrolled in the study, 125 (76.2%) completed follow-up interviews. Two patients (1.6%) fell outside the planned follow-up range of 6 - 9 months (9.5 and 10.75 months), but were included for the sake of completeness and the low likelihood of two individuals making a difference to the results. Of the remaining patients, 19 (11.6%) had died, 19 (11.6%) were not contactable, and one (0.6%) declined participation (Fig. 1). The patients who died or were lost to follow-up were more likely to have received medical treatment only (p=0.01) and were significantly older (p<0.0001).

Medication use at discharge and at 6 - 9 months’ follow-up

A medical record review was performed and a standardised data capture form completed for each eligible patient. Information gathered included demographic characteristics, income group, comorbid conditions, medication use on admission, smoking status, ACS diagnosis, ACS in-hospital treatment, length of stay and discharge medication.

The principal author performed follow-up via a telephone call with the patient or primary caregiver at a time period between 6 and 9 months after discharge. A Xhosa-speaking interpreter performed three of the interviews under the guidance of the principal author, and a single patient was contacted by email. Verbal informed consent for enrolment into the study was obtained at this time from the patient or caregiver, and it was made clear that the telephone call was for study purposes only.

Patients were encouraged to fetch their current medications and actively list them over the telephone. Where a medication of interest was not listed, the patient was asked why this was the case. They were then asked a standardised smoking question: ‘Do you smoke every day, only some days, or never?’ Any reported smoking classified the patient as an ongoing smoker.

Interviews were conducted primarily in English, Afrikaans or Xhosa only being used if the patient was unable to communicate in English or requested otherwise, and the interviewer did not identify himself as a doctor unless specifically asked. Where behaviour hazardous to health was identified during the interview, such as ongoing smoking or non-adherence to medication, this was addressed prior to completing the interview.

Of the 164 patients enrolled in the study, 155 (94.5%) were discharged on aspirin. Of the patients followed up (n=125), 85.6% (n=107) remained on this medication, a reduction of 8.9% (p=0.01). Factors associated with ongoing aspirin use, by univariate analysis, were a previous diagnosis of IHD (p=0.01) and having undergone coronary angiography (p=0.0002). Reasons given for aspirin non-adherence were dyspepsia, iron deficiency anaemia, introduction of warfarin therapy, and not realising the importance of continued use.

Statins were prescribed to 157 patients (95.7%) at discharge. At follow-up 85.6% (107/125) remained on this medication, a reduction of 10.1% (p=0.0008). The only factor associated with continued use was a diagnosis of hypercholesterolaemia (p=0.02). Reasons given for discontinuation of statins were nausea, and not realising the importance of continued use.

Beta-blockers were prescribed for 140 patients (85.4%) at discharge. At follow-up 79.2% (99/125) remained on this medication, a reduction of 6.2% (p<0.0001). Factors associated with adherence were hypercholesterolaemia (p=0.005), a previous diagnosis of IHD (p=0.005), and female gender (p=0.02). Reasons given for discontinuation were doctor-initiated cessation due to a reduced heart rate, and not realising the importance of continued use.

ACEIs/ARBs were prescribed for 141 patients (85.9%) at discharge.

At follow-up, 68.0% (85/125) were still using this medication, the largest reduction in use for any of the four drug classes at 17.9% (p<0.0001). Ongoing use was associated with a previous diagnosis of IHD (p=0.04). Reasons given for discontinuation were angiooedema, cough, doctor-initiated cessation due to low blood pressure, and not realising the importance of continued use.

The number of patients discharged on a combination of all four drug classes was 116 (70.7%). Of the 125 patients followed up, only 47.2% (n=59) remained on all four drugs, a reduction of 23.5% (p=0.001). A total of five patients (4.0%) had stopped all medications because they did not realise the importance of ongoing use. Results are summarised in Table 2.

Statistical analysis

Smoking on admission and at 6 - 9 months’ follow-up

Data collection

Means and standard deviations were calculated for the full data and various data subsets. Comparisons of differences between groups were calculated using Fisher’s exact test or the Wilcoxon rank-sum test (for categorical and continuous variables), as appropriate. A

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Of the 125 patients who were followed up, 70 (56.0%) had been active smokers on admission to hospital, and 22 of these had had stopped smoking by the time of the interview, representing a smoking cessation rate of 31.4%. One patient had taken up

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Table 1. Demographic characteristics of patients enrolled, completing interviews and lost to follow-up Variable

Enrolled (N=164)

Completed interview (N=125)

Lost to follow-up (N=39)

Age (yrs), mean (SD)

58.6 (11.2)

57.0 (10.9)

63.8 (11.0)

Male, n (%)

97 (59.1)

71 (56.8)

26 (66.7)

Unemployed/pensioner

47 (28.6)

31 (24.8)

16 (41.0)

Income <R36 000 p.a.

85 (51.8)

66 (52.8)

19 (48.7)

Income <R72 000 p.a.

14 (8.5)

14 (11.2)

-

Income >R72 000 p.a.

13 (7.9)

9 (7.2)

4 (10.3)

Private medical aid/foreigner

4 (2.4)

4 (3.2)

-

Unknown

1 (0.6)

1 (0.8)

-

Hypertension

99 (60.3)

71 (56.8)

28 (71.8)

Diabetes mellitus

51 (31.0)

36 (28.8)

15 (38.5)

Hypercholesterolaemia

73 (44.5)

57 (45.6)

16 (41.0)

IHD

83 (50.6)

61 (48.8)

22 (56.4)

90 (54.8)

70 (56.0)

20 (51.3)

ST-elevation MI

59 (35.9)

44 (35.2)

15 (38.5)

Non ST-elevation MI

77 (46.9)

57 (45.6)

20 (51.3)

Unstable angina pectoris

28 (17.0)

24 (19.2)

4 (10.3)

Medical only

95 (57.9)

65 (52.0)

30 (76.9)

PCI

59 (35.9)

50 (40.0)

9 (23.1)

Coronary artery bypass graft

10 (6.09)

10 (8.0)

-

Angiogram (including PCI), n (%)

112 (68.2)

92 (73.6)

20 (51.3)

3.018 (1.9)

2.98 (2.0)

3.13 (1.7)

Income category, n (%)

Medical history, n (%)

Current smoker, n (%) Diagnosis, n (%)

Treatment, n (%)

Length of stay (days), mean (SD)

SD = standard deviation; p.a. = per annum; IHD = ischaemic heart disease (previous myocardial infarction or unstable angina pectoris); MI = myocardial infarction; PCI = percutaneous coronary intervention.

smoking for the first time after discharge.

The only factor independently associated with an increased rate of smoking cessation, by univariate analysis, was a longer length of hospital stay (p=0.006). We could find no relationship between smoking cessation rate and age, gender, income category, comorbid conditions, admission diagnosis or treatment received.

Discussion

There was good early initiation of secondary prevention medication after ACS in our cohort of patients. It has been shown that patients who do not start medication shortly after the acute event are unlikely to ever have medication added, and a focused effort to start treatment in the immediate postinfarction period is likely to provide longterm benefit.[12] When we compare these findings with those of the Clinical Pathways for Acute Coronary Syndromes in China

(CPACS)[8] and the Global Registry of Acute Coronary Events (GRACE)[9] studies, our prescribing rates for the four selected drugs at discharge after ACS are higher for all drug classes (Table 3 and Fig. 2). Since both the above studies used the same method of follow-up as we did, namely telephone calls and active listing of medications, they provide a reasonable comparison. The CPACS investigators felt that there was a significant gap between evidence and practice in medication prescribing after ACS, which was not found in our study. It should be noted that the low rates of prescribing of secondary prevention medication found in the GRACE study may in part be because the data were collected from 1999 to 2003, when less emphasis was placed on these medications.

Our finding of a high early initiation rate of all four recommended drugs is important and demonstrates that adherence to best-practice guidelines in our setting is feasible.

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Discharged alive with a diagnosis of ACS (N=164) Not contactable (n=19)

Declined participation (n=1)

Died (n=19)

Completed interviews (n=125) Fig. 1. Flow diagram demonstrating followup of enrolled patients. (ACS = acute coronary syndrome.)

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Table 2. Medication use at discharge and follow-up Discharge (N=164), n (%)

Follow-up (N=125), n (%)

Reduction in use (%)

p-value

Aspirin

155 (94.5)

107 (85.6)

8.9

0.01

Statin

157 (95.7)

107 (85.6)

10.1

0.0008

Beta-blocker

140 (85.4)

99 (79.2)

6.2

<0.0001

ACEI/ARB

141 (85.9)

85 (68.0)

17.9

<0.0001

Four-drug comb.

116 (70.7)

59 (47.2)

23.5

0.001

ACEI/ARB = angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.

Table 3. Comparison between medication use at discharge and follow-up in the present study and two similar studies Griffiths et al. (SA, present study)

Bi et al.[8] (CPACS China)

DC (N=164) n (%)

FU (N=125) n (%)

DC (N=2 901) n (%)

FU (N=2 521) n (%)

Diff., %

Aspirin

155 (94.5)

107 (85.6)

-8.9

2 687 (92.7)

2 211 (88.2)

Lipid-lowering agent

157 (95.7)

107 (85.6)

-10.1

2 332 (80.4)

Beta-blocker

140 (85.4)

99 (79.2)

-6.2

ACEI/ARB

141 (85.9)

85 (68.0)

Four-drug comb.

116 (70.7)

59 (47.2)

Eagle et al.[9] (GRACE multi-country) DC (N=13 830) n (%)

FU (N=13 830) n (%)

-4.5

12 463 (90.1)

11 465 (82.9)

-7.2

1 654 (65.8)

-14.6

6 320 (45.7)

5 522 (39.9)

-6.1

2 031 (70.0)

1 798 (71.8)

+1.8

7 738 (56.0)

6 796 (49.1)

-6.9

-17.9

2 194 (75.6)

1 694 (67.2)

-8.4

2 379 (17.2)

1 906 (13.8)

-3.4

-23.5

1 384 (47.7)

1 088 (43.6)

-4.1

NA

NA

NA

Diff., %

Diff., %

SA = South Africa; DC = medication prescribed at discharge; FU = medication use reported at follow-up; Diff. = difference between DC and FU; ACEI/ARB = angiotensin-converting enzyme inhibitor or angiotensin receptor blocker; CPACS = Clinical Pathways for Acute Coronary Syndromes in China study; GRACE = Global Registry of Acute Coronary Events study; NA = not applicable.

Source Eagle et al.[9] 100

Medication use, %

Griffiths et al. (present study)

4 drugs

ACEI

Aspirin

Bi et al.[8]

BB

LLA

75

50

25

Follow-up

Discharge

Follow-up

Discharge

Follow-up

Discharge

Follow-up

Discharge

Follow-up

0 Discharge

We found a significant increase in the rate of non-adherence to the selected medications in our group of patients beyond 6 months.

Medication cessation for appropriate reasons, such as ACEI-induced angio-oedema or betablocker-induced symptomatic bradycardia, is unavoidable and expected for a minority of patients. What is more concerning is that patients stopped medication because they did not realise the importance of ongoing use, which was found to be a reason for nonadherence for each of the four drug classes, and for the five patients who stopped all four drugs completely. Rates of discontinuation of medication were higher for most of the drug classes when compared with the CPACS and GRACE studies (Table 3 and Fig. 2), the exceptions being lipid-lowering agents when compared with CPACS (a 10.1% drop-off in adherence v. 14.6%) and beta-blockers when compared with GRACE (6.2% v. 6.9%). It is not clear from our data why the rates of non-adherence are higher. There is no clear link to a language barrier, as all but three of the patients could speak English or Afrikaans, both of which are spoken in the CCU by doctors and nursing staff. There was also no demonstrable link between income

Fig. 2. Graphic representation of the comparison between medication use at discharge and follow-up in the present study and two similar studies. (ACEI = angiotensin-converting enzyme inhibitor; BB = beta-blocker; LLA = lipid-lowering agent.)

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category and adherence, and SA and China are both rated as upper middle-income countries by the World Bank Country Classification, so adherence rates based purely on income would be expected to be similar. It is possible that level of education and insight into disease could play a role, but these were not included in our questionnaire. No patient mentioned a shortage of medication at a local clinic as a reason for discontinuation. The frequent reporting of non-adherence to medication as a result of not understanding the importance of ongoing use implies that good communication with the patient during the index hospital admission, with a focus on education about the disease and future treatment, is essential.

Enhanced communication between treating doctor and patient, as well as involving ancillary healthcare providers such as nursing staff and pharmacists, have both been shown to improve adherence, both during admission and through community-based cardiac rehabilitation programmes. Innovative measures such as the use of short message service (SMS) reminder technology for mobile phones, which has been demonstrated to improve adherence to antiretroviral medication in SA and to other chronic medications elsewhere, should be looked at to improve adherence in our setting.

More of our patients continued to smoke after an ACS than has been found in similar studies. Evidence from the PURE study shows a clear link between smoking cessation after a coronary heart disease or stroke event and country income category, with cessation rates highest in upper-income countries, and decreasing with declining income category of the country.[13] The smoking cessation rate in upper middle-income countries such as SA was found to be 54.6%,[13] which is still higher than the 31% rate in our group. We did not ask patients whether they had tried to stop smoking, or indeed whether they wanted to try to stop, so the rate of failed attempts at smoking cessation is unknown. The Western Cape is known to have the highest smoking rate of all the SA provinces, at 44.7% of men and 27% of women.[14] A recent Cochrane review found that intensive behavioural interventions in hospitalised patients, followed by at least a month of outpatient supportive contact, was effective at significantly improving smoking cessation rates, and it should be considered as an option in this group of patients. The addition of nicotine replacement therapy in gum or patch form further improves smoking cessation. At present there is not sufficient evidence to prove that bupropion or varenicline in addition to intensive counselling in hospitalised patients increases cessation rates over intensive counselling alone.[15] The smoking cessation rates in our cohort suggest that adoption of these and other evidence-based methods of influencing smoking behaviour should be made an urgent priority.

Study limitations

Our study has a number of limitations. We measured adherence by self-report, with no electronic or pill count data to back up our findings. Although this method of active listing of medications over the telephone tends to overestimate adherence, it has been used successfully in similar studies[8,9,11] and is highly specific. While measurement of smoking by self-report can lead to an overestimation of smoking cessation, this method has been shown to correlate well with cotinine testing in most studies. Other limitations include enrolling patients from only a single urban tertiary centre, having a relatively small sample size, and borderline significance of univariate analyses. Not knowing the medication adherence and smoking cessation rates of those patients who died is another limitation, as this information may have improved insight into mortality in this group of patients. These factors raise the concern that our findings

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may not be representative of the population as a whole. In order to avoid selection bias at enrolment, we included every patient with ACS discharged alive from the CCU over the selected 5-month period, and did not limit inclusion to those patients who were followed up at our institution. SA is a diverse country with broad variations in culture, income and access to healthcare, and a similar multicentre, prospective study in future could improve our understanding of the challenges posed by medication adherence and smoking cessation after ACS.

Conclusion

This study has provided valuable insight into prescribing practices, medium-term adherence patterns after ACS, and smoking cessation rates beyond 6 months, areas for which there are currently no published data in our setting. Three findings were of particular importance: (i) we found that our prescribing of secondary prevention medication at discharge is high (70.7% for the four-drug combination); (ii) we noted that a fairly large proportion of our patients are discontinuing medication within a 6 - 9-month period (23.5% for the four-drug combination); and (iii) we demonstrated that a large proportion (68.6%) of patients who were active smokers on admission to hospital continued to smoke, giving a cessation rate of 31.4%. Given the importance of smoking cessation in improving short- and long-term outcomes, more focused strategies to improve this adverse behaviour, particularly in this high risk population, are required.

References 1. Ntsekhe M, Damasceno A. Recent advances in the epidemiology, outcome, and prevention of myocardial infarction and stroke in sub-Saharan Africa. Heart 2013;99(17):1230-1235. [http://dx.doi. org/10.1136/heartjnl-2012-303585] 2. Bradshaw D, Nannan N, Laubscher R, et al. South African National Burden of Disease Study 2000.

Estimates of Provincial Mortality: Western Cape Province. Cape Town: South African Medical Research Council, 2003. http://www.mrc.ac.za/bod/westerncape.pdf (accessed 26 November 2013).

3. Groenewald P, Bradshaw D, Daniels J, et al. Cause of Death and Premature Mortality in Cape Town, 2001-2004. Cape Town: South African Medical Research Council, 2007. http://www.mrc.ac.za/bod/ capetownreport.pdf (accessed 26 November 2013).

4. Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases. Part I: General considerations, the epidemiologic transition, risk factors, and impact of urbanisation. Circulation 2001;104(22):2746-2753. [http://dx.doi.org/10.1161/hc4601.099487] 5. Mukherjee D, Fang J, Chetcuti S, Moscucci M, Kline-Rogers E, Eagle KA. Impact of combination evidence-based medical therapy on mortality in patients with acute coronary syndromes. Circulation 2004;109(6):745-749. [http://dx.doi.org/10.1161/01.CIR.0000112577.69066.CB] 6. Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes.

Circulation 2010;121(6):750-758. [http://dx.doi.org/10.1161/circulationaha.109.891523] 7. Goldenberg I, Jonas M, Tenenbaum A, et al. Current smoking, smoking cessation, and the risk of sudden cardiac death in patients with coronary artery disease. Arch Intern Med 2003;163(19):23012305. [http://dx.doi.org/10.1001/archinte.163.19.2301] 8. Bi Y, Gao R, Patel A, et al. Evidence-based medication use among Chinese patients with acute coronary syndromes at the time of hospital discharge and 1 year after hospitalization: Results from the Clinical Pathways for Acute Coronary Syndromes in China (CPACS) study. Am Heart J 2009;157(3):509-516. [http://dx.doi.org/10.1016/j.ahj.2008.09.026] 9. Eagle KA, Kline-Rogers E, Goodman SG, et al. Adherence to evidence-based therapies after discharge for acute coronary syndromes: An ongoing prospective, observational Study. Am J Med 2004;117(2):73-81. [http://dx.doi.org/10.1016/j.amjmed.2003.12.041] 10. Yusuf S, Islam S, Chow CK, et al. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE study): A prospective epidemiological survey. Lancet 2011;378(9798):1231-1243. [http://dx.doi.org/10.1016/ S0140-6736(11)61215-4] 11. Melloni C, Alexander KP, Ou FS, et al. Predictors of early discontinuation of evidence-based medicine after acute coronary syndrome. Am J Cardiol 2009;104(2):175-181. [http://dx.doi.org/10.1016/j. amjcard.2009.03.013] 12. Gislason GH, Rasmussen JN, Abildstom SZ, et al. Long-term compliance with beta-blockers, angiotensin-converting enzyme inhibitors, and statins after acute myocardial infarction. Eur Heart J 2006;27(10):1153-1158. [http://dx.doi.org/10.1093/eurheartj/ehi705] 13. Teo K, Lear S, Islam S, et al. Prevalence of healthy lifestyle among individuals with cardiovascular disease in high-, middle- and low-income countries: The Prospective Urban Rural Epidemiology (PURE) study. JAMA 2013;309(15):1613-1621. [http://dx.doi.org/10.1001/jama.2013.3519] 14. Chopra M, Steyn N, Lambert V. Western Cape Burden of Disease Reduction Project: Decreasing the burden of cardiovascular disease. Final report 2007. http://www.westerncape.gov.za/text/2007/6/ cd_volume_6_cardiovascular_diseases.pdf (accessed 26 November 2013).

15. Rigotti NA, Clair C, Munafò MR, Stead LF. Interventions for smoking cessation in hospitalised patients.

Cochrane Database Syst Rev 2012; Issue 5. Art. No.: CD001837. [http://dx.doi.org/10.1002/14651858.

CD001837.pub3]

Accepted 17 March 2014.

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Injury severity in relation to seatbelt use in Cape Town, South Africa: A pilot study D J van Hoving,1 MB ChB, DipPec (SA), MMed (Emerg Med), MScMedSci (Clin Epi); C Hendrikse,1 MB ChB; R J Gerber,1 MB ChB, DipPec (SA); M Sinclair,2 BSc, M Urban Design, PhD; L A Wallis,1 MB ChB, MD, DIMCRSCEd, Dip Sports Med, FRSCEd (A&E), FCEM, FCEM (SA) 1 2

ivision of Emergency Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa D Department of Civil Engineering, Stellenbosch University, Stellenbosch, Western Cape, South Africa

Corresponding author: D J van Hoving (nvhoving@sun.ac.za) Background. Injuries and deaths from road traffic collisions present an enormous challenge to the South African (SA) healthcare system.

The use of restraining devices is an important preventive measure.

Objective. To determine the relationship between seatbelt use and injury severity in vehicle occupants involved in road traffic collisions in Cape Town, SA. Methods. A prospective cohort design was used. Occupants of vehicles involved in road traffic collisions attended to by EMS METRO Rescue were included during the 3-month data collection period. Triage categories of prehospital patients were compared between restrained and unrestrained groups. Patients transferred to hospital were followed up and injury severity scores were calculated. Disposition from the emergency centre and follow-up after 1 week were also documented and compared.

Results. A total of 107 patients were included in the prehospital phase. The prevalence of seatbelt use was 25.2%. Unrestrained vehicle occupants were five times more likely to have a high triage score (odds ratio (OR) 5.4; 95% confidence interval (CI) 1.5 - 19.5). Fifty patients were transferred to study hospitals. Although seatbelt non-users were more likely to be admitted to hospital (p=0.002), they did not sustain more serious injuries (OR 0.44; 95% CI 0.02 - 8.8).

Conclusion. The prevalence of seatbelt use in vehicle occupants involved in road traffic collisions was very low. The association between seatbelt non-use and injury severity calls for stricter enforcement of current seatbelt laws, together with the development and implementation of road safety interventions specifically focused on high-risk groups.

S Afr Med J 2014;104(7):488-492. DOI:10.7196/SAMJ.7933

The contribution of road traffic injuries to the burden of injury is an emerging priority worldwide. The latest global road traffic mortality rate is 18/100Â 000 persons, and about 14 000 deaths a year result from accidents on South African (SA) roads.[1] Many road traffic injuries are preventable. Although it is unrealistic to expect that all collisions can be prevented, it is certainly possible to implement measures to reduce the impact of a collision and hence decrease serious injuries or death. Risk factors that contribute to serious road traffic injuries can be categorised into five groups: (i) driver attributes (e.g. young age, substance abuse, seatbelt use); (ii) vehicle characteristics (e.g. type and weight of vehicle); (iii) road design (e.g. presence of shoulders, speed limits); (iv) environmental factors (weather, time of day, etc.); and (v) crash characteristics (e.g. roll-over, ejection of occupants).[2] SA has numerous road safety strategies in place, but it is unclear how effective they have been in reducing this burden of disease.

The fact that nationally fatal injury levels remain largely unchanged year after year suggests that current strategies are falling short of addressing the problem effectively.[2] One of the main problems is the data on traffic injuries. Data collection is commonly recognised to be undermined by problems of under-reporting, poor quality of reporting and disorganised record storage. It further concentrates on recording only the broadest details around the physical circumstances of the incident, e.g. the location, date, time, type of vehicle, etc. In the process, very little effort is spent on detailing the nature of the injuries sustained by the victims and

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the circumstances influencing those injuries, e.g. their position in the vehicle, evidence of seatbelt use, etc.

SA has one of the lowest rates of seatbelt use (Âą60%) in the world, despite international research confirming that use of seatbelts is the most important factor affecting the risk of death in the event of a serious collision.[1] Unfortunately this information is not routinely collected in standard collision reporting forms in SA, and the relationship between these rates and injury severity has not been quantified.

Determining patterns in road behaviour has the potential to allow an evidence-based approach to preventing road traffic collisions in the future; by understanding the specific dimensions of and factors affecting injury severity, we will be better placed to develop and implement strategies that show promise in terms of reducing injury severity. Furthermore, the addition of hospital data to mortuary and police reports would increase the knowledge base regarding the effect of seatbelt non-use on the occupants of vehicles involved in road traffic collisions. The aim of this pilot study was to determine the relationship between seatbelt use and injury severity in patients involved in road traffic collisions in Cape Town, Western Cape Province, SA.

Methods

Study design

A prospective cohort design was used. The study had two phases, a prehospital phase in which persons involved in road traffic collisions were identified and evaluated, and a second in-hospital phase assessing all patients transported to study hospitals.

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Study setting

The study was done in the City of Cape Town, a metropolitan municipality of SA covering an area of 2 461 km2, with an estimated population of 3.7 million.[3] The Western Cape Department of Health: Emergency Medical Services (EMS) provides medical response and prehospital services to the public. This 24-hour service is the first medical contact point for ill or injured patients. After the necessary medical stabilisation, patients are transferred to the nearest hospital deemed appropriate to handle their condition. EMS also provides various technical rescue services, including aquatic rescue, aviation rescue and extricating the occupants of wrecked vehicles. Although the standard operating procedure stipulates that rescue technicians can be dispatched to any road traffic collision, they are typically called out to severe collisions (e.g. multi-vehicle involvement, rollovers, entrapped vehicle occupants). The rescue technicians’ primary responsibility is patient extrication, and they are only involved in patient care when other emergency services are unavailable.

This study was approved by the Stellenbosch University Health Research Ethics Committee (N11/03/080).

Study population

Occupants of vehicles involved in road traffic collisions in the Cape Town metropole attended to by EMS METRO Rescue during the 3-month data collection period (1 June 2012 - 31 August 2013) were eligible for inclusion in the prehospital phase. Occupants of buses, taxis, non-motorised vehicles, heavy goods vehicles, emergency vehicles and two-wheel motorised vehicles were excluded. Patients were included in the in-hospital phase of the study if they were transferred to one of six hospitals (Groote Schuur Hospital, Tygerberg Hospital, G F Jooste Hospital, New Somerset Hospital, Victoria Hospital and Red Cross War Memorial Children’s Hospital).

Data collection and management

The METRO Rescue team is based in Pinelands, Cape Town, and serves the entire Cape Town metropole. This team assisted with prehospital data collection, completing a standardised data collection sheet for each vehicle occupant involved in a road traffic collision.

The South African Triage Scale (SATS) was used to prioritise patients (red = emergency; orange = very urgent; yellow = urgent; green = non-urgent; blue = dead).[4] The data were collected in such a way as to protect patient confidentiality, and no personal or identifying information was collected for patients who were uninjured or discharged directly from the scene. However, identifying information for patients transferred to hospital was captured on the prehospital data collection sheets. This was necessary to enable the hospital data collector to locate the patient in the relevant hospital. A research assistant collected the data sheets on a weekly basis from the METRO Rescue base.

The patient report form (PRF) or incident number, together with the patient’s name, was used to link the prehospital and in-hospital data. Patients were identified in the various trauma admissions books, using the date, time and type of accident or injury. Correlating folder numbers were obtained and data were retrieved from folders. The hospital data were linked to a specific study code. Only the hospital folder number of the patient, and no further personal or identifying information, was collected. Patients admitted to study hospitals were followed up 1 week after the admission date. Data were recorded on a standardised data collection sheet. The Injury Severity Score (ISS) was used to determine injury severity. The hospital data collector was blinded to whether patients had been using seatbelts or not.

The collected data were entered onto an electronic spreadsheet (Microsoft Excel). The spreadsheet contained only the study code. A

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separate data file containing the identifying names, folder numbers and PRF or incident numbers was kept securely in the offices of the Division of Emergency Medicine at Stellenbosch University. Access to this information was restricted to the principal investigator only.

All data capture sheets were destroyed after data extraction – a paper shredder was used for this purpose. All electronic spreadsheets were password protected.

Statistical analysis

Data were analysed by the Centre for Statistical Consultation at Stellenbosch University using Statistica version 10 (2012). Variables were described using summary statistics. The prevalence of seatbelt use was calculated and compared between different variables. The relationship between two nominal variables was investigated using Pearson’s χ2 test. The relationships between continuous response variables and nominal input variables were analysed using appropriate analysis of variance. Non-parametrics were used when ordinal response variables were compared with nominal input variables. For completely randomised designs, the Mann-Whitney U test was used.

The significance level was set as p<0.05.

Results

Prehospital phase

METRO Rescue responded to 367 road traffic collisions during the 3-month study period. Data were collected on 205 patients from 55 collisions; 98 patients were excluded (Fig. 1). A total of 107 patients were therefore included in the prehospital phase (55 drivers, 28 front seat passengers and 24 rear seat passengers). The mean age of the vehicle occupants was 34.6 years (drivers 36.6, front seat passengers 33.8, rear seat passengers 30.6). Three occupants were younger than 13 years of age.

The prevalence of seatbelt use was 25.2% overall (n=27) (drivers 34.5% (n=19), front seat passengers 21.4% (n=6), rear seat passengers 8.3% (n=2)). The mean ages of patients who had and had not been using a seatbelt were 36.9 years (n=74) and 33.4 years (n=23), respectively (p=0.23) (incomplete data n=10). Gender did not appear to influence seatbelt use significantly (p=0.49; males n=14, 22.9%; females n=13, 28.9%).

With regard to time of seatbelt use, the rate of use was highest during the middle of the day (12h00 - 16h00), with very low use during the early morning and late at night (Fig. 2). This association was not statistically significant (p=0.13). Eighteen vehicle occupants had incomplete data.

A statistically significant association between not wearing a seatbelt when involved in a road traffic collision and triage category was demonstrated (p=0.02) (Table 1). Dead or seriously injured Assessed for eligibility (n=205) Excluded (n=98) · Accidents with taxis (n=94) · Accidents with heavy goods vehicles (n=2) · Sustained gunshot wound prior to collision (n=2) Included in prehospital phase (n=107) Excluded (n=57) · Discharged from scene (n=13) · Transferred to non-study hospitals (n=33) · Missing data (n=11) Included in hospital phase (n=50)

Fig. 1. Flow diagram of the study population.

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80

Table 2. Association of seatbelt use and possible confounders No seatbelt n (%)

60 50

Wearing seatbelt n (%) p-value

Position in car (n=107)

40

0.12

Driver

36 (65.5)

19 (34.5)

20

Front seat passenger

22 (78.6)

6 (21.4)

10

Rear seat behind driver

8 (100)

0 (0)

Rear seat middle

5 (100)

0 (0)

22h00 - 23h59

20h00 - 21h59

18h00 - 19h59

16h00 - 17h59

14h00 - 15h59

12h00 - 13h59

10h00 - 11h59

08h00 - 09h59

06h00 - 07h59

04h00 - 05h59

0

02h00 - 03h59

30

00h00 - 01h59

Prevalence, %

70

Time of day

Rear seat behind front passenger 9 (81.8)

2 (18.2)

Roll-over (n=98)

Fig. 2. Influence of time of day on the prevalence of seatbelt use.

0.38

Yes

26 (83.9)

5 (16.1)

No

51 (76.1)

16 (23.9)

Driver side

23 (79.3)

6 (20.7)

Site of impact (n=105)

Table 1. Influence of seatbelt use on prehospital injury acuity

0.54

Triage category

No seatbelt n (%)

Wearing seatbelt n (%) Total*

Passenger side

14 (70.0)

6 (30.0)

Green (non-urgent)

15 (57.7)

11 (42.3)

26

Front

28 (70.0)

12 (30.0)

Yellow (urgent)

31 (70.5)

13 (29.5)

44

Rear

7 (70.0)

3 (30.0)

Orange (very urgent)

10 (76.9)

3 (23.1)

13

All four sides

6 (100)

0 (0)

Red (emergency)

10 (100.0)

0 (0.0)

10

Blue (dead)

11 (100.0)

0 (0.0)

11

Yes

14 (82.4)

3 (17.6)

No

66 (73.3)

24 (26.7)

Entrapped (n=107)

*Incomplete data n=3.

patients (triaged blue, red and orange) were five times less likely to have worn a seatbelt than those with less severe injuries (odds ratio (OR) 5.4; 95% confidence interval (CI) 1.49 - 19.47). None of the 11 patients who died had been restrained (p=0.03).

Eighty-three patients were transferred to hospitals (seatbelt n=19, 22.9%), while 13 were discharged directly from the scene (seatbelt n=8, 61.5%) (11 had incomplete data). Vehicle occupants who had not been wearing seatbelts were significantly more likely to be transferred to hospital (p=0.002).

There were no significant associations between seatbelt use and position in the vehicle, roll-over of the vehicle, site of impact or entrapment of occupants (Table 2).

In-hospital phase

After excluding 33 patients who were transported to non-study hospitals, 50 patients were followed through to the various study hospitals (Fig. 1). Only six patients (12.0%) had been restrained.

The median ISS for all hospitalised patients was 6.0 (interquartile range (IQR) 2.3 - 11.0), for restrained patients 7.5 (IQR 2.25 - 9.0), and for unrestrained patients 5.5 (IQR 2.75 - 11) (p=0.67). The highest ISS in the seatbelt group was 11 v. a maximum of 75 in the no-seatbelt group (Table 3). Patients were then divided into those with serious injuries (ISS â&#x2030;Ľ15) and less serious injuries (ISS <15). Although none of the seven patients who sustained serious injuries had been using a seatbelt, there was no statistically significant difference between use of seatbelts and being seriously injured (OR 0.44; 95% CI 0.02 - 8.8).

Patients sustained a total of 134 injuries, of which only 13 (9.7%) occurred in the seatbelt group. The majority of injuries were to the extremities (n=38, 28.4%), the neck (n=27, 20.1%) and the chest (n=24, 17.9%) (Fig. 3).

490

0.43

Table 3. ISSs for hospitalised patients ISS

Wearing seatbelt

No seatbelt

All

1

2

4

6

2

0

7

7

3

0

4

4

4

0

4

4

5

0

3

3

6

1

3

4

9

1

4

5

10

1

2

3

11

1

3

4

13

0

1

1

14

0

2

2

17

0

1

1

22

0

1

1

24

0

1

1

25

0

1

1

27

0

1

1

50

0

1

1

75

0

1

1

Total

6

44

50

Mean (SD)

6.3 (4.46)

10.2 (13.65)

9.74 (12.93)

ISS = Injury Severity Score; SD = standard deviation.

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30

Wearing seatbelt

n=35

RESEARCH

No seatbelt

n=22

n=15

15

n=16

Injuries, %

20

n=22

25

n=1 n=3 External

n=3 Extremities

n=1 Abdomen

Chest

Face

Neck

0

Head

n=1

5

n=2

n=5

n=8

10

Fig. 3. Injured body regions stratified according to seatbelt use. (External: lacerations, contusions, abrasions and burns, independent of their location on the body surface.)

Disposition from the emergency centre or trauma unit did not differ according to seatbelt use (p=0.92). Twenty-six patients (52%; wearing seatbelt n=3, 11.5%) were directly discharged, whereas 24 were admitted, only three (12.5%) of whom had worn seatbelts. At the 1-week follow-up, only eight patients (16.0%) remained in hospital (not wearing seatbelt n=7) and one patient had died. The association between not wearing a seatbelt and increased hospital stay was not significant (p=0.44).

Twelve patients died during the study period (11 in the prehospital phase and one in hospital). None of them had been wearing a seatbelt.

Discussion

The low prevalence of seatbelt use (25%) is a concern, and this figure is considerably lower than the 59% published by the World Health Organization.[1] The prevalence in patients involved in road traffic collisions in KwaZulu-Natal was only 17%, indicating that the actual seatbelt wearing rate is vastly over-estimated.[5] People have many excuses for not wearing seatbelts (e.g. ‘it’s uncomfortable’, ‘my car has airbags’, ‘I’m a good driver’), but there may in fact be a relationship between seatbelt compliance and safe driving. International research has shown that people involved in road traffic accidents comply with seatbelt regulations less often than the rest of the general public.[6] Vehicle occupants not wearing seatbelts are generally young, male, and have poor driving habits (driving under the influence of alcohol, speeding, previous road traffic collisions and driving offences).[6–9] We also found that seatbelt use decreased dramatically during night-time driving (Fig. 2), but this trend is also not unique to Cape Town.[6,9,10] Road traffic collisions at night are often not a result of poor vision in the dark, but rather a consequence of driver-associated factors (e.g. increased rates of intoxication).[9] The abovementioned studies[6–9] suggest that a subgroup of drivers exists who may place themselves, their passengers and other road users at risk for crash-related injuries and fatalities by intentionally engaging in multiple risky behaviours.[6–9] Whether SA seatbelt behaviour is comparable to these international examples is as yet unclear. What we do know is that rates of seatbelt use are significantly lower than the international standard for all vehicle occupant classes, which indicates that not wearing seatbelts

491

may be less intentional than simply habitual. In either case, a great deal can and should be done to influence seatbelt wearing rates.

Injury prevention programmes should be designed to selectively target these high-risk drivers in order to improve seatbelt compliance.

A strong association between seatbelt use and prehospital triage assessment was demonstrated (OR 5.4). This is similar to a prehospital study in Qatar, where unbelted vehicle occupants were nearly twice as likely as those who used seatbelts to suffer severe injury or death.[11] It has also been suggested that several mechanical factors, including seatbelt use, be included in prehospital triage to reduce under-triage and help anticipate the need for high-level care.[12] Multiple studies have highlighted the association between seatbelt non-compliance and injury severity, mortality, and disposition from the emergency centre or trauma unit.[6,8,13,14] In a prospective study (N=766) in the United Arab Emirates, belted occupants had a lower mean ISS (6.1 v. 9.4; p=0.001), a shorter hospital stay (5.3 v. 9.6 days; p=0.005) and a lower mortality rate (1.5% v. 2.4%; p=0.075).[8] A study in the USA (N=23 920) evaluated the Wisconsin Crash Outcome Data Evaluation System (CODES) database and found that admission rates were twice as high and mortality rates three times higher in the unbelted group.[14] The percentage of vehicle occupants without seatbelts also increased with increased injury severity.[14] Cummins et al.[13] evaluated 184 992 patients and demonstrated a reduction in both mortality (adjusted OR 0.49; 99% CI 0.45 - 0.52) and serious injuries (adjusted OR 0.509; 99% CI 0.49 - 0.53). The fact that these associations were not very apparent during the hospital phase of our study can be attributed to a number of limitations of this pilot study (see below): further, the small sample size (n=50) and the low seatbelt compliance rate (n=6, 12.0%) in the hospital cohort could have masked a true effect, and the majority of the patients (n=43, 86.0%) were also not seriously injured (ISS <15), seeming to eliminate the safety effect of seatbelts. On the other hand, the breakdown of injured body regions (Fig. 2) and the fact that all the patients who died (n=12) were unbelted emphasise the protective value of seatbelts.

Study limitations

This was a pilot study, and data collection was only done for a 3-month period and not until a specified sample size was reached.

This resulted in a small sample size with limited statistical inference.

Data were only collected on patients involved in collisions that were considered to be serious, to which METRO Rescue responded and where patients were transferred to certain study hospitals. We acknowledge that this study under-represents road traffic collisions in Cape Town, but still see the data as useful. Second, the study does not specify whether seatbelts were in working condition, whether they were fitted correctly, whether they were used appropriately, or indeed whether they were fitted to all the vehicles (some vehicles on SA roads are very old). Third, ethanol inebriation is an important factor in road traffic collisions, but was not measured. The international literature is contradictory, with studies indicating both a negative and a positive correlation between blood alcohol values and injury severity.[7,15] It is therefore unlikely that ethanol inebriation could have had a massive influence on the results. Fourth, the in-hospital follow-up was mainly completed from hospital records, which had various missing variables. However, the likelihood of loss to followup was similar in the belted and unbelted groups, minimising any effect on the estimate of association. Finally, miscalculation of the ISS could have resulted in either under- or overestimation of the severity of injuries. This potential error was overcome through adequate training of the data collector, periodic monitoring and cross-checking of the results by the principal investigator.

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Conclusion

This study demonstrated a reduction in injury severity, hospital admission rate, duration of hospital stay and mortality rate when seatbelts were used by occupants of vehicles involved in road traffic collisions. Consistent with previous research, these results illustrate the significance of this modifiable health risk and should motivate policy makers and government officials to enforce seatbelt laws more strictly.

Conflicts of interest. This study received a research grant from the Harry Crossley Foundation.

Acknowledgements. We acknowledge the assistance of Mr K Moodley, the EMS METRO Rescue paramedics, Ms Z Houlie and the administrative staff of the relevant hospitals.

References 1. World Health Organization. Global Status Report on Road Safety 2013: Supporting a Decade of Action. Geneva: World Health Organization, 2013. http://www.who.int/violence_injury_prevention/ road_safety_status/2013/report/en/index.html (accessed 22 March 2013).

2. Road Traffic Management Corporation. Road Traffic Report 31 March 2011. Pretoria: Road Traffic Management Corporation. http://www.arrivealive.co.za/documents/March%202011%20Road%20 Traffic%20Report.pdf (accessed 22 March 2013).

3. City of Cape Town. Statistics for the City of Cape Town – 2012. http://www.capetown.gov.za/en/stats/ Documents/City_Statistics_2012.pdf (accessed 23 October 2013).

4. South African Triage Group. The South African Triage Scale (SATS). http://emssa.org.za/sats/2012 (accessed 7 March 2014).

5. Parkinson F, Kent S, Aldous C, Oosthuizen G, Clarke D. Road traffic crashes in South Africa: The burden of injury to a regional trauma centre. S Afr Med J 2013;103(11):850-852. [http://dx.doi. org/10.7196/samj.6914] 6. Ball CG, Kirkpatrick AW, Brenneman FD. Noncompliance with seat-belt use in patients involved in motor vehicle collisions. Can J Surg 2005;48(5):367-372.

7. Mann B, Desapriya E, Fujiwara T, Pike I. Is blood alcohol level a good predictor for injury severity outcomes in motor vehicle crash victims? Emerg Med Int 2011;2011:616323. [http://dx.doi.org/ 10.1155/2011/616323] 8. Abu-Zidan FM, Abbas AK, Hefny AF, Eid HO, Grivna M. Effects of seat belt usage on injury pattern and outcome of vehicle occupants after road traffic collisions: Prospective study. World J Surg 2012;36(2):255-259. [http://dx.doi.org/10.1007/s00268-011-1386-y] 9. Mohammadi G. The pattern of fatalities by age, seat belt usage and time of day on road accidents. Int J Inj Contr Saf Promot 2009;16(1):27-33. [http://dx.doi.org/10.1080/17457300802406963] 10. Carpenter D, Pressley JC. Graduated driver license nighttime compliance in U.S. teen drivers involved in fatal motor vehicle crashes. Accid Anal Prev 2011;56(2013):110-117. [http://dx.doi.org/10.1016/j. aap.2011.12.014] 11. Munk M-D, Carboneau DM, Hardan M, Ali FM. Seatbelt use in Qatar in association with severe injuries and death in the prehospital setting. Prehosp Disaster Med 2008;23(6):547-552.

12. Staff T, Eken T, Wik L, Røislien J, Søvik S. Physiologic, demographic and mechanistic factors predicting New Injury Severity Score (NISS) in motor vehicle accident victims. Injury 2014;45(1):9-15. [http:// dx.doi.org/10.1016/j.injury.2012.11.010] 13. Cummins JS, Koval KJ, Cantu RV, Spratt KF. Do seat belts and air bags reduce mortality and injury severity after car accidents? Am J Orthop (Belle Mead NJ) 2011;40(3):E26-29.

14. Allen S, Zhu S, Sauter C, Layde P, Hargarten S. A comprehensive statewide analysis of seatbelt non-use with injury and hospital admissions: New data, old problem. Acad Emerg Med 2006;13(4):427-434. [http://dx.doi.org/10.1197/j.aem.2005.11.003] 15. Tulloh BR, Collopy BT. Positive correlation between blood alcohol level and ISS in road trauma. Injury 1994;25(8):539-543. [http://dx.doi.org/10.1016/0020-1383(94)90097-3]

Accepted 2 April 2014.

Predicting outcome in severe traumatic brain injury using a simple prognostic model S Sobuwa,1 MSc (Med) (Emerg Med); H B Hartzenberg,2 MMed (Neurosurg); H Geduld,3 MMed (Emerg Med); C Uys,4 MSc (Stats) epartment of Emergency Medical Sciences, Faculty of Health and Wellness Sciences, Cape Peninsula University of Technology, D Cape Town, South Africa 2 Division of Neurosurgery, Stellenbosch University, Parow, South Africa 3 Division of Emergency Medicine, University of Cape Town, South Africa 4 Centre for Postgraduate Studies, Cape Peninsula University of Technology, Cape Town, South Africa 1

Corresponding author: S Sobuwa (simpiwesobuwa@gmail.com)

Background. Several studies have made it possible to predict outcome in severe traumatic brain injury (TBI) making it beneficial as an aid for clinical decision-making in the emergency setting. However, reliable predictive models are lacking for resource-limited prehospital settings such as those in developing countries like South Africa.

Objective. To develop a simple predictive model for severe TBI using clinical variables in a South African prehospital setting.

Methods. All consecutive patients admitted at two level-one centres in Cape Town, South Africa, for severe TBI were included. A binary logistic regression model was used, which included three predictor variables: oxygen saturation (SpO2), Glasgow Coma Scale (GCS) and pupil reactivity. The Glasgow Outcome Scale was used to assess outcome on hospital discharge.

Results. A total of 74.4% of the outcomes were correctly predicted by the logistic regression model. The model demonstrated SpO2 (p=0.019), GCS (p=0.001) and pupil reactivity (p=0.002) as independently significant predictors of outcome in severe TBI. Odds ratios of a good outcome were 3.148 (SpO2 ≥90%), 5.108 (GCS 6 - 8) and 4.405 (pupils bilaterally reactive).

Conclusion. This model is potentially useful for effective predictions of outcome in severe TBI. S Afr Med J 2014;104(7):492-494. DOI:10.7196/SAMJ.7720

Several studies[1-4] have made it possible to predict out­ come in severe traumatic brain injury (TBI) making it beneficial as an aid for clinical decision-making in the emergency setting. Accurate assessment of prognosis is crucial in multi-casualty incidents

492

so that prehospital emergency care practitioners can focus their attention on patients predicted to have a good outcome. No single prognostic model is practised broadly despite many models being described in the literature. Most models are derived from developed nations, which potentially offer superior intensive healthcare services

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owing to their better resources, resulting in outcomes of TBI that are different to those of developing countries.[5] A model that will be used in the prehospital setting should include variables that can be measured instantly and easily with resources available to prehospital emergency care providers.

We aimed to develop a simple predictive model for severe TBI using clinical variables.

Methods

All consecutive patients with severe TBI in the Cape Town Metropole from 1 January 2009 to 31 August 2011 admitted to Groote Schuur Hospital (GSH) or Tygerberg Hospital (TBH) were enrolled in the study. The patients were enrolled if they were ≥16 years of age.

Patients who were transferred to TBH and GSH from another facility were excluded from the study, as were those who had sustained penetrating head trauma. Patients who were declared dead on scene were not eligible for the study.

The Glasgow Outcome Scale (GOS) (Table 1) was used to assess outcome. For the purposes of this study, outcome was divided into good (good recovery or moderate disability) and poor (dead, vegetative state or severe disability). Initially the model included five predictor variables for the two outcomes: (i) oxygen saturation (SpO2) (≥90% and <90%); (ii) Glasgow Coma Scale (GCS) (3 - 5 and 6 - 8) measured on arrival at the scene; (iii) pupil reactivity (pupils bilaterally reactive and all other findings); (iv) systolic blood pressure (SBP) (>90 mmHg and <90 mmHg); and (v) presence of a concomitant injury or not. Presence of a concomitant injury and SBP did not have a significant impact on the model and were omitted, leaving three variables – SpO2, GCS and pupil reactivity.

The predictor variables were therefore reclassified into binary variables. A binary logistic regression model was fitted using the three predictor variables as categorical independent binary predictors and the GOS as the dependent binary variable. Binary logistic regression predicts binary outcomes (i.e. poor or good in the case of this study) of the dependent variable using a number of independent predictor variables. The goodness-of-fit of this model is measured by the Hosmer-Lemeshow χ2 statistic, which gives a non-significant result (χ2=2.986; degrees of freedom 7; p=0.622). The Hosmer-Lemeshow statistic tests the null hypothesis that there is a linear relationship between the independent predictors and the logarithmic odds of the dependent binary variable. The hypothesis is tested using a χ2 distribution and a non-significant result is an indication of a good fit.

Estimated β-values were coefficients in the logistic regression model used to calculate the odds ratio (OR) and the subsequent probability of a good outcome as follows: OR (good outcome) = e-2.717 + 1.673 × GCS + 1.187 × SpO2 + 1.564 × pupil reactivity Probability (good outcome) = OR 1 + OR

Results

A total of 124 patients were enrolled during the period 1 January 2009 - 31 August 2011. There was an equal split of patients (n=62) from GSH and from TBH. There was no significant difference in outcome between the two hospitals (p=0.583). Males comprised 89% of the sample population, with road traffic accidents being the leading cause of injury. The mortality rate for the study population was 39%, with 60% having a good outcome.

The binary logistic regression model correctly predicted 74.4% of the patients to be in one of the two outcome groups (Table 2).

With our model, bilateral pupil reactivity, GCS of 6 - 8 and SpO2 ≥90% were shown to predict a positive outcome following severe TBI. The higher the GCS score, the better the outcome. Increasing age was not associated with poor outcome in this analysis. Having bilateral reactive pupils increased the odds of a good outcome by 340.5%.

The odds of a good outcome increased by 214.8% in patients with SpO2 ≥90%. The presence of hypotension did not have a significant effect on the model.

ORs and probabilities for different scenarios are summarised in Table 3. The odds of the patient having a good outcome on the GOS was 5.5124:1 and the probability of a good outcome was 0.8464 if the patient had a GCS of 6 - 8, SpO2 of >90% with bilateral reactive pupils. It was evident that when there were ≥2 negative predictor values for a patient, the OR dropped significantly to <1 (Table 3, scenario 5).

Discussion

Using our logistic regression model, bilateral pupil reactivity, GCS of 6 - 8 and SpO2 ≥90% were shown to predict a positive outcome following severe TBI. These variables have been previously reported to predict prognosis in TBI.[1-4,6] The initial GCS on scene appears to be the most sensitive of these variables as seen in the model. Our analysis suggests that the higher the GCS score, the better the outcome. In fact, the OR suggests that having a GCS score of 6 - 8 in the case of severe TBI increases the odds of a good outcome by 410.8%. Contrary to other studies that found increasing age to be associated with adverse outcome,[3,7] increasing age was not associated with poor outcome in this analysis. This could be due to the fact that patients <16 years of age were not included in the study. In the CRASH trial, a poorer outcome Table 1. Glasgow Outcome Scale Level

Term

1

Dead

2

Persistent vegetative state

3

Severe disability

4

Moderate disability

5

Good recovery

Table 2. Logistic regression analysis* β-value

SE

Wald χ2

df

p-value

OR

GCS (6 - 8)

1.673

±0.446

14.032

1

0.000

5.108

SpO2 (>90%)

1.187

±0.506

5.515

1

0.019

3.148

Pupil reactivity (bilateral)

1.564

±0.513

9.303

1

0.002

4.405

Constant

-2.717

±0.560

23.574

1

0.000

15.133

SE = standard error; GCS = Glasgow Coma Scale; SpO2 = oxygen saturation; df = degrees of freedom; OR = odds ratio. *Glasgow Outcome Scale classified into two binary categories as the dependent variable.

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Table 3. Odds ratios and probability of good outcome for various situations Scenario

GCS

SpO2 (%)

Pupil reactivity

OR

Probability

Clinical PPV, n

8

6-8

≥90

Bilaterally reactive

5.5124

0.8464

3

6

6-8

<90

Bilaterally reactive

1.6820

0.6271

2

7

6-8

≥90

All other findings

1.1537

0.5357

2

4

3-5

≥90

Bilaterally reactive

1.0346

0.5085

2

5

6-8

<90

All other findings

0.3520

0.2604

1

2

3-5

<90

Bilaterally reactive

0.3157

0.2399

1

3

3-5

≥90

All other findings

0.2165

0.1780

1

1

3-5

<90

All other findings

0.0661

0.0620

0

GCS = Glasgow Coma Scale; SpO2 = oxygen saturation; OR = odds ratio; PPV = positive predictive value.

was present after the age of 40 years,[3] suggesting that there is a major difference between patients >40 years and those <40 years.

There is no published literature in the prehospital setting investigating the association between pupillary findings and outcome following severe TBI. However, some authors have suggested a strong relationship between pupillary findings and outcome in the in-hospital setting.[1,8,9] The pupillary light reflex is an indirect measure of brain stem injury and herniation as compression of the third cranial nerve results in a fixed and dilated pupil. Jiang et al.[10] and Signorini et al.[4] discovered a strong relationship between fixed, dilated pupils and ultimate mortality.

Normally, an ipsilateral fixed and dilated pupil suggests lateral transtentorial herniation, while bilaterally fixed and dilated pupils are consistent with central transtentorial herniation in a fully resuscitated patient. In our analysis, having bilateral reactive pupils increased the odds of a good outcome by 340.5%.

The increased odds of a good outcome (214.8%) in patients with SpO2 ≥90% emphasises the importance of airway maintenance, oxygenation and ventilation in the prehospital setting to optimise outcome for the obtunded patient with severe TBI. However, the Brain Trauma Foundation does not recommend intubation of ground transport patients where the SpO2 is ≥90%.[11] In our previous work, prehospital intubation did not demonstrate improved outcomes over basic airway management.[12] Although it might be assumed that patients who suffer concomitant injuries would have worse outcomes, this was not shown in our analysis. The presence of hypotension did not have a significant effect on the model despite being widely reported as one the most serious influences in the TBI patient.[6] This could be attributed to the few patients (n=7) who were hypotensive in our sample population. Significant decreases in the cerebral perfusion pressure result in brain tissue ischaemia and failure of auto-regulation. The brain then becomes dependent on the mean arterial pressure for perfusion, making maintenance of cerebral perfusion and oxygenation crucial in the setting of TBI as the brain is so vulnerable to ischaemic injury.

494

Conclusion

This was the first simple model developed with the aim of predicting outcome in severe TBI in the South African prehospital setting. Our model was reasonably precise in correctly predicting 74.4% of the patient outcomes. It is, however, unclear what the long-term survival would have been since patients were followed up to discharge from hospital only.

Future research is needed to determine how this model would impact management and outcome of severe TBI in the prehospital setting.

Author contributions. SS and CU wrote the manuscript while HBH and HG were responsible for the study design and critical revision of the manuscript. CU was also responsible for the statistical input.

References

1. Narayan RK, Greenberg RP, Miller JD, et al. Improved confidence of outcome prediction in severe head injury. J Neurosurg 1981;54(6):751-762. [http://dx.doi.org/10.3171/jns.1981.54.6.0751] 2. Mamelak AN, Pitts LH, Damron S. Predicting survival from head trauma 24 hours after injury: A practical method with therapeutic implications. J Trauma 1996;41(1):91-99. [http://dx.doi.org/10.1097/00005373199607000-00014] 3. MRC Crash Trial Collaborators. Predicting outcome after traumatic brain injury: Practical prognostic models based on large cohort of international patients. BMJ 2008;336:425. [http://dx.doi.org/10.1136/ bmj.39461.643438.25] 4. Signorini DF, Andrews PJD, Jones PA, Wardlaw JM, Miller JD. Predicting survival using simple clinical variables: A case study in traumatic brain injury. J Neurol Neurosurg Psychiatry 1999;66:20-25. [http:// dx.doi.org/10.1136/jnnp.66.1.20] 5. De Silva MJ, Roberts I, Perel P, Edwards P, et al, on behalf of the CRASH Trial Collaborators. Patient outcome after traumatic brain injury in high-, middle- and low-income countries: Analysis of data on 8927 patients in 46 countries. Int J Epid 2009;38(2):452-458. [http://dx.doi.org/10.1093/ije/dyn189] 6. Chesnut RM, Marshall LF, Klauber MR, et al. The role of secondary brain injury in determining outcome from severe head injury. J Trauma 1993;34(2):216-222. [http://dx.doi.org/10.1097/00005373-19930200000006] 7. Chesnut RM, Ghajar J, Maas AI, et al. Early indicators of prognosis in severe traumatic brain injury. J Neurotrauma 2000;17:557-627.

8. Rivas JJ, Lobato RD, Sarabia R, et al. Extradural haematoma: Analysis of factors influencing the courses of 161 patients. J Neurosurg 1988;23(1):44-51. [http://dx.doi.org/10.1227/00006123-198807000-00010] 9. Braakman R, Gelpke G, Habbema J, Maas AIR, Minderhoud JM. Systemic selection of prognostic features in patients with severe head injury. J Neurosurg 1980;6(4):362-370. [http://dx.doi.org/10.1097/00006123198004000-00002] 10. Jiang J-Y, Gao G-Y, Li W-P, Yu M-K, Zhu C. Early indicators of prognosis in 846 cases of severe traumatic brain injury. J Neurotrauma 2002;19(7):869-874. [http://dx.doi.org/10.1089/08977150260190456] 11. Badjatia N, Carney N, Crocco TJ, et al. Guidelines for prehospital management of traumatic brain injury 2nd edition. Prehosp Emerg Care 2008;12(Suppl 1):S1-S52. [http://dx.doi.org/10.1080/10903120701732052] 12. Sobuwa S, Hartzenberg HB, Geduld H, Uys C. Outcomes following prehospital airway management in severe traumatic brain injury. S Afr Med J 2013;103(9):644-646. [http://dx.doi.org/10.7196/SAMJ.7035]

Accepted 10 February 2014.

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Assessing adherence to the 2010 antiretroviral guidelines in the antiretroviral roll-out clinic at 1 Military Hospital, South Africa: A retrospective, cross-sectional study A K Khwitshana,1 MB ChB, Dip HIV, MPharmMed; O B W Greeff,2 MB ChB, FCFP (SA), MPharmMed, FFPM (RCP), MD; T Hurrell,2 MSc (Pharm) 1 2

I nfectious Disease Clinic,1 Military Hospital, Pretoria, South Africa Department of Pharmacology, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa

Corresponding author: T Hurrell (tracey.hurrell@up.ac.za) Background. HIV research is a therapeutic area for which well-defined population-specific treatment and prophylaxis guidelines exist.

However, there are limited objective, evidence-based data for assessing adherence to these guidelines.

Objective. To conduct a retrospective, cross-sectional study of adult HIV-infected patients receiving treatment at the antiretroviral (ARV) roll-out clinic of the Infectious Diseases Clinic Pharmacy at 1 Military Hospital (1MH) over a period of 3 years to assess clinicians’ adherence to the 2010 ARV guidelines.

Methods. Pharmacy files from the pool of adult patients receiving treatment at the ARV roll-out clinic between 1 April 2009 and 31 March 2012 were selected. Variables used to establish adherence were assessed through evaluation of pharmacy scripts and laboratory tests.

Results. In accordance with the ARV guidelines, we found a switch in the first-line regimen from stavudine to tenofovir during the period following implementation. There was no difference in baseline blood tests conducted, suggesting that clinicians were recommending a standardised test panel. Notably, similar blood tests were routinely done during follow-up visits, despite no indication for doing so. While the number of blood tests was found to decrease over time, the type of blood tests requested for specific treatment regimens was not in accordance with the ARV guidelines.

Conclusion. We used an evidence-based approach to critically assess variations from the delineated ARV guidelines. Adherence to clinical guidelines at 1MH, while demonstrating improvement in patient outcomes, highlighted the need for increased vigilance in monitoring failure of prescribers to comply with ARV guidelines.

S Afr Med J 2014;104(7):495-500. DOI:10.7196/SAMJ.7926

Advances in management and treatment of HIV/ AIDS have transformed HIV into a chronic condition rather than a debilitating terminal illness. Data on patient adherence suggest positive outcomes provi­ ded there is >95% compliance with therapy.[1] Well-defined, population-specific treatment and prophylaxis guidelines for treatment of HIV exist,[1] which integrate scientific evidence and clinical expertise to produce clinically valid, operational recommendations with the aim of improving various health outcomes. These clinical practice guidelines can be defined as systematically developed statements for both practitioners and patients, to assist with appropriate healthcare decisions for specific clinical circumstances.[2] Their intention is to improve healthcare processes, decrease practice variation and optimise use of resources to improve health outcomes.

However, studies reveal widespread variability among practit­ ioners, notably in specialised domains with respect to adher­ence to the core recommendations of various practice guidelines.[3] Antiretroviral treatment (ART), in the form of highly active anti­retroviral therapy, consists of a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-NRTI or a protease inhibitor. The South African (SA) 2004 antiretroviral (ARV) guidelines recommended a combination of stavudine (d4T) and lamivudine (3TC) as the NRTI backbone in the first-line regimen and a combination of zidovudine (AZT) and didanosine (DDI) as the backbone in the second-line regimen.[4] Unfortunately, both d4T

495

and DDI were found to be major culprits in the onset of metabolic toxicities and became further implicated in development of fatal complications such as lactic acidosis.[5,6] Currently SA has the largest HIV treatment programme in the world, with ~1.3 million people receiving ART by the end of 2010.[7] However, burdensome adverse effects, although varying in their impact, have concerned government, healthcare providers and patients alike. As a result, the 2010 ARV guidelines focused on curbing morbidity and mortality associated with d4T and DDI. These and subsequent guidelines suggested replacing d4T and DDI with less toxic alternatives such as tenofovir (TDF) as the first-line regimen and 3TC as the second-line regimen.

The 2010 ARV treatment guidelines advised: • when to initiate therapy • what drugs to use in the first-line regimen • when to modify therapy • what combinations of drugs to use when a change was indicated • what laboratory tests to do prior to treatment initiation • how often to monitor treatment • what laboratory tests to repeat during follow up visits.[8] Ordinarily, subjective approaches such as interviews and self-report questionnaires by clinicians themselves are used to determine adherence to guidelines and success of therapeutic endeavours.

There are limited published data, both locally and internationally, for assessing adherence to these guidelines using objective evidence-

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based approaches such as assessing prescrip­ tions and the choice of laboratory tests associated with specific drug regimens, as delineated in the guidelines.[1] The aim of this study was to assess com­ pliance with the 2010 ARV guidelines to determine the degree of guideline imple­ mentation and provide insight into changes required to strengthen subsequent guideline implementation.

Methods

Ethical approval

Ethical clearance to review patient records was obtained from the Faculty of Health Sciences Research Ethics Committee of the University of Pretoria (reference no. 27/2013) and 1 Military Hospital (1MH) Ethics Comm­ ittee (reference no. 1MH/302/6). Patient tained with confidentiality was strictly main­ no identifying file numbers being presented on datasheets, compiled results or manuscripts.

Study design

A retrospective, cross-sectional study of adult HIV-infected patients receiving treatment prescriptions and management at the ARV roll-out clinic of the Infectious Diseases Clinic Pharmacy at 1MH over a period of 3 years, to assess clinicians’ adherence to the 2010 ARV guidelines through the evaluation of pharmacy scripts and laboratory tests ordered.

Data collection

Approximately 300 pharmacy files from the pool of adult patients receiving ART between 1 April 2009 and 31 March 2012 were selected using a predetermined randomisation system. From the 300 randomised adult patient files selected, 252 met the inclusion criteria (>18 years of age and continuing to receive ART).

The files were subsequently divided into three patient categories: • Group 1: adult patients who were dispensed ART between 1 April 2009 and 31 March 2010 (1 year prior to implementation of the 2010 ART guideline) (n=77).

• Group 2: adult patients who received ART between 1 April 2010 and 31 March 2011 (year 1 of implementation of the 2010 ART guideline) (n=83).

• Group 3: adult patients who were dispensed ART between 1 April 2011 and 31 March 2012 (2 years after implementation of the 2010 ART guideline) (n=92).

Patient files were audited for demographic characteristics; drugs dispensed in both first- and second-line regimens; CD4+ counts for patient cohorts initiating

Table 1. Sample demographics Sample size, n

Group 1

Group 2

Group 3

77

83

92

Gender, n (%) Female

28 (36.36)

26 (31.33)

35 (38.04)

Male

49 (63.64)

57 (68.67)

57 (61.06)

42.49 (5.49)

41.75 (4.89)

42.07 (7.30)

Age (years) Mean (SD) Median

41

41

42

Lower quartile

39

39

38

Upper quartile

46

45

45

SD = standard deviation.

Table 2. Prescriptions per month for drugs in each group before and after the new guidelines (mean n) Drug

Group 1, pre-2010

Group 1, post-2010

Group 2, post-2010

Group 3, post-2010

Post-2010, combined mean

Abacavir

1.00

0.92

0.00

3.08

1.33

Aluvia

6.00

11.04

16.29

10.00

12.44

Combivir

2.17

2.63

0.46

0.17

1.09

DDI

1.42

2.63

2.42

0.00

1.68

EFV

57.67

60.79

61.88

64.25

62.31

3TC

61.17

63.38

68.58

64.42

65.46

NVP

3.50

2.67

0.78

0.92

1.46

Reyataz

0.00

0.75

1.46

1.00

1.07

D4T

49.50

35.42

32.96

17.00

28.46

TDF

4.17

20.75

30.21

38.83

29.93

Truvada

2.50

6.46

8.00

13.17

9.21

AZT

7.92

8.71

8.50

6.00

7.74

DDI = didanosine; EFV = efavirenz; 3TC = lamivudine; NVP = nevirapine; D4T = stavudine; TDF = tenofovir; AZT = zidovudine.

Table 3. Monthly prescriptions for each group pre- and post-2010 (differences in means)

Drug

Group 1, pre-2010

Group 1, post-2010

Group 2, post-2010

Group 3, post-2010

Post-2010, mean difference

Abacavir

1.00

-0.08

-1.00

2.08

0.33

Aluvia

6.00

5.04

10.29

4.00

6.44

Combivir

2.17

0.46

-1.71

-2.00

-1.08

DDI

1.42

1.21

1.00

-1.42

0.26

EFV

57.67

3.12

4.21

6.58

4.64

3TC

61.17

2.21

7.41

3.25

4.29

NVP

3.50

-0.83

-2.72

-2.58

-2.04

Reyataz

0.00

0.75

1.46

1.00

1.07

D4T

49.50

-14.08

-16.54

-32.5

-21.04

TDF

4.17

16.58

26.04

34.66

25.76

Truvada

2.50

3.96

5.50

10.67

6.71

AZT

7.92

0.79

0.58

-1.92

-0.18

DDI = didanosine; EFV = efavirenz; 3TC = lamivudine; NVP = nevirapine; D4T = stavudine; TDF = tenofovir; AZT = zidovudine.

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treatment at ≤350 cells/μl v. ≤200 cells/μl; frequency and timing of blood tests after initiation of ART; number of drug substitutions (including the reason for and timing of substitution); evidence of comorbidity based on pharmacy records for any antituberculosis treatment issued; and the time (months) to drug substitution to comply with the new treatment guidelines.

Laboratory tests

Data regarding laboratory tests were extracted from the hospital computer system. All laboratory tests requested by doctors during patient visits at baseline and during subsequent monitoring visits were done by 1MH. Laboratory tests routinely requested included full blood count (FBC); urea and electrolytes (U&E);

liver function tests (LFTs) (total protein, albumin, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase, alkaline phosphatase and γ-glutamyl transpeptidase), hepatitis B serology; CD4+ count and HIV viral load (VL).

Laboratory tests, each highly drug specific, were assessed to determine whether the correct suggested blood tests, and timing of their monitoring, were done as recommended by the 2010 guidelines.

For example, FBC is recommended at 1, 2, 3 and 6 months if the patient is receiving AZT; creatinine needs be monitored at months 3 and 6, and thereafter annually, if the patient is receiving TDF; and fasting cholesterol and triglycerides monitored at month 3 if the patient is receiving Aluvia (lopinavir/ritonavir; Abbott Laboratories), and then annually thereafter.[9]

Table 4. Blood tests done at monitoring visits for each group per regimen (mean n) Regimen

FBC

U&E

LFTs

CD4

VL

HEP

2.81

2.75

2.75

2.81

1.50

0.56

Group 1 (before April 2010) New regimen D4T Old regimen D4T

3.22

3.24

3.24

3.20

2.82

-

TDF

4.00

4.00

4.00

4.00

3.00

-

AZT/NVP

3.50

3.50

3.50

3.50

2.00

-

5.56

5.56

5.56

5.63

5.13

-

D4T

5.49

5.51

5.47

5.49

4.92

-

TDF

5.00

5.00

5.00

5.00

4.50

-

AZT/EFV

6.25

6.25

6.25

6.25

5.75

AZT/NVP

4.50

4.50

4.50

4.50

4.50

-

D4T

5.92

5.92

5.85

5.92

4.85

0.23

TDF

5.89

5.89

5.89

5.89

4.44

0.22

TDF

5.76

5.76

5.71

5.76

5.48

AZT/EFV

5.56

5.56

5.44

5.56

4.56

-

AZT/EFV

5.75

5.75

5.50

5.75

4.75

-

AZT/Videx/Aluvia

4.00

4.00

4.00

4.00

4.00

-

D4T

2.00

2.00

1.00

2.00

0.00

1.00

TDF

2.38

2.38

2.28

2.28

1.88

0.24

Abacavir

3.00

3.00

3.00

3.00

2.50

-

NVP

3.00

3.00

3.00

3.00

3.00

-

D4T/EFV

2.82

2.82

2.73

2.82

2.27

-

TDF/EFV

2.60

2.60

2.60

2.60

2.30

-

AZT/Aluvia

2.00

2.00

2.00

2.00

2.00

-

Group 1 (after April 2010) New regimen D4T Old regimen

Group 2 (year 1 of 2010 guideline adoption) New regimen

Old regimen

Group 3 (year 2 of 2010 guideline adoption) New regimen

Old regimen

FBC = full blood count; U&E = urea and electrolytes; LFTs = liver function tests; CD4 = CD4+ count; VL = viral load; HEP = hepatitis B serology; D4T = stavudine; TDF = tenofovir; NVP = nevirapine; AZT = zidovudine; EFV = efavirenz.

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Statistical analysis

Descriptive statistics for categorical data were summarised and tabulated while mean and/or median values were calculated for continuous variables such as age. Analysis of variance was used to compare drugs in the first- and second-line regimens during the analysis period (between the two periods and among the groups, respectively, where required). Fisher’s exact test was used to compare mean values for blood tests, time intervals and CD4+ count outcome variables during the analysis period (between the two periods and among the groups, respectively, where required). Statistical analysis was done using SAS 9.2 statistical software, with p-values of <0.05 considered statistically significant.

Results

Demographic characteristics are summarised in Table 1. Of note, the number of men receiving treatment was higher in all three groups.

When assessing the predominant drugs used over the duration of this study (Tables 2 and 3), it was noted that the mean number of d4T prescriptions used in first-line regimens declined significantly in all groups (p<0.001). There was a resultant decrease of 21 scripts when comparing pre-2010 data with an average of the three groups, post-implementation of the 2010 ARV guidelines. Use of TDF was limited prior to introduction of the 2010 guideline, with a subsequent statistically significant (p<0.001) increase within the years following implementation of the 2010 guidelines. This resulted in an increase of 25 scripts when comparing pre-2010 data with an average of the three groups post-implementation.

These data also describe the decline in DDI use (p<0.001), which was no longer recommended. While there was no significant difference (p<0.145) in 3TC across the groups, owing to its use in both first and second line regimens, there was a trend suggesting a preference for the fixed-dose combination of Truvada (emtricitabine and TDF; Gilead Sciences, USA) over TDF with 3TC in the later stages of the study.

According to the 2010 ARV guidelines, the CD4+ criterion for initiation was ≤200 cells/μl, with the exception of special cohorts of patients presenting with pregnancy or tuberculosis (TB), who were initiated on therapy with CD4+ counts <350 cells/μl.

The number of patients with CD4+ counts ≤200 cells/μl or 200 350 cells/μl, both pre-and post-April 2010, including the special cohorts, was therefore compared. This yielded no significant differences in the non-specialised population (p=1.00), pregnant women (p-value not applicable owing to small sample size), or patients with TB (p=0.233 and 0.466, respectively, before and after guideline implementation).

Baseline tests conducted regularly included FBC, U&E, LFTs, CD4+ count, VL and, in a minority population where warranted, hepatitis B serology. Comparing baseline blood tests conducted pre- and postimplementation using a χ2 test, there was no statistically significant difference. This suggested that clinicians were recommending a standard panel of tests to which they had become accustomed.

The number of blood tests done for newly initiated patients, and for those already receiving treatment, was the same at baseline regardless of the drug regimen (Table 4). The same blood tests done at initiation were routinely done during follow-up, despite there being no guideline indication for doing so. However, omission of LFTs and hepatitis B serology was adhered to, as recommended in the ARV guidelines.

Assessment of the time interval in months for follow-up monitor­ ing visits revealed that the choice of blood tests was similar across all regimens. Only in group 3, and 2 years post-implementation of the 2010 guidelines, was a slightly more drug-dependent approach

498

Table 5. Time interval for monitoring blood test for each respective regimen Regimen

Time interval (months), mean

Group 1 (before April 2010) New regimen D4T

3.67

Old regimen D4T

3.31

TDF

2.57

AZT

3.25

Group 1 (after April 2010) New regimen TDF

4.04

Old regimen D4T

4.33

TDF

4.50

AZT

3.91

Group 2 (year 1 of 2010 guideline adoption) New regimen D4T

3.85

TDF

3.68

Old regimen D4T

3.96

TDF

4.55

AZT/Aluvia

5.75

AZT/EFV

3.86

Group 3 (year 2 of 2010 guideline adoption) New regimen D4T

4.00

TDF

2.50

Old regimen NVP

3.50

D4T

4.26

TDF

3.50

Truvada

3.60

AZT/EFV

4.13

D4T = stavudine; TDF = tenofovir; AZT = zidovudine; NVP = nevirapine.

observed regarding prescription of TDF and d4T and timing of blood tests (Table 5).

The most prevalent side-effects (Table 6) that resulted in drug substitution included hepatotoxicity, peripheral neuropathy and lipodystrophies and lipoatrophies, most often associated with d4T. Additional reasons for d4T substitution included virological failure, which was higher in groups 1 and 2 and involved 12 and eight patients, respectively, compared with only three patients in group 3 (which was probably associated with the decreased use of d4T to comply with the 2010 guidelines).

Additionally, ten, 11 and two patients in groups 1, 2 and 3, respectively, substituted d4T with TDF or Truvada to comply with the 2010 guidelines.

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Table 6. Side-effects as reasons for drug substitution in all three groups Aluvia, n

AZT, n

D4T, n

EFV, n

TDF, n

Total, N

Anaemia

-

Diarrhoea

2

1

-

-

-

1

-

-

-

-

Dizziness or confusion

2

-

-

-

1

-

1

Hepatoxicity

-

3

4

-

-

7

Lipodystrophies and atrophies

-

3

18

-

-

21

Peripheral neuropathy

-

-

11

-

-

11

Renal dysfunction

-

-

-

-

2

2

Unexplained weight loss

-

-

4

-

-

4

Total, N

2

7

37

1

2

47

Anaemia

-

-

-

-

-

0

Diarrhoea

2

-

-

-

-

2

Dizziness or confusion

-

-

-

2

-

2

Hepatitis

-

-

1

-

-

1

Lipodystrophies and atrophies

-

-

9

-

-

9

Peripheral neuropathy

-

-

12

-

-

12

Side-effect Group 1

Group 2

Renal dysfunction

-

-

-

-

1

1

Unexplained weight loss

-

-

1

-

-

1

Total, N

2

-

23

2

1

28

Hepatoxicity

-

-

2

-

-

2

Lipodystrophies and atrophies

-

-

6

-

-

6

Peripheral neuropathy

-

-

0

-

-

0

Psychosis

-

-

-

1

-

1

Renal dysfunction

-

-

-

-

5

5

Unexplained weight loss

-

-

-

-

-

0

Total, N

-

-

8

1

5

14

Group 3

AZT = zidovudine; D4T = stavudine; EFV = efavirenz; TDF = tenofovir.

Survival analysis indicated that patients in group 3 required changes in treatment due to treatment failure at a much later stage than patients in groups 1 and 2.

Time taken in months to comply with the new guidelines of 1 April 2010 was measured by determining the time required for d4T to be replaced by TDF in the first-line regimen, and DDI by 3TC in the second-line regimen. In the first-line regimen, only patients who substituted drugs on the basis of complying with the new guidelines were considered, substitutions due to side-effects being excluded. The decrease in d4T and increase in TDF scripts for first-line regimens occurred in groups 2 and 3, at least 1 year post-implementation.

In the second-line regimen, substitution to 3TC followed development of virological failures as recommended in new guidelines made available during the study. From the time of introduction of the new guidelines, which was considered baseline, an average of 2.42 scripts for DDI were given in group 2, which was already a year after implementation of the new guidelines. However, in compliance with the guidelines, zero scripts for DDI were dispensed for group 3 (2011 - 2012), with, however, a delay of over a year for DDI prescrip­ tions to cease completely.

499

Discussion

In the year prior to implementation of the 2010 guidelines, d4T prescriptions were high, with 590 prescriptions dispensed v. only 50 for TDF in the same time period. This paradigm began to shift within the first year of the new ARV guidelines. A striking rise in the choice of Truvada over the single TDF and 3TC was observed, which may be expected to increase in the years to come.

According to the 2010 guidelines, the recommended blood tests at baseline include CD4+ count, haemoglobin (Hb) or FBC if starting on AZT, serum creatinine if TDF is considered, and ALT if nevirapine (NVP) is initiated. The 2010 guidelines suggested that VL and CD4+ count be done only during monitoring of treatment at 6 months, then at 12 months, and thereafter at annual intervals.[8] Hepatitis screening was not included in the 2010 guidelines; however, the 2013 guidelines included hepatitis screening at baseline, with ALT required only if the patient was prescribed NVP and developed rash or symptoms of hepatitis.[9] On average, tests for monitoring were conducted more frequently than indicated in the guidelines. Baseline tests ordered at the clinic were excessive, and did not take into account the choice of initial drug/s prescribed.

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There was no difference in the number or types, of blood tests ordered for the d4T-based regimens before and after implementation of the 2010 guidelines. While timing intervals of blood tests for AZT-based regimens more closely complied with guidelines in the last year of the study, there was no evidence of Hb or FBC measured monthly for the first 3 months for patients newly initiated on AZT, as per recommendation.

The d4T-based regimen had 619 blood tests for each of FBC and LFTs, not all of which were indicated; however, ALT was warranted if the regimen included NVP and symptoms of hepatitis became evident. There were 225 unjustified FBCs and LFTs in patients receiving the TDF-based regimen over the same period. It was also noted that an average of three blood tests were routinely done for abacavir, which has no known side-effects warranting blood test monitoring. These unnecessary tests incurred significant costs.

Patients in all three groups on Aluvia-based regimens had no blood tests done for fasting cholesterol and triglycerides to monitor the side-effects of these drugs, despite their recommendation in the new guidelines. This potentially places patients at risk of developing dyslipidaemias, and cardiovascular events, which are strongly associated with this drug.

The 2010 guidelines clearly stated that ART be initiated at a CD4+ count ≤200 cells/μl with the exception of pregnancy and TB, where the CD4+ count for starting treatment is 350 cells/μl.[8] (Within the 2013 guidelines, SA has fully implemented the new CD4+ count criteria where the level of CD4+ count for initiation is ≤350 copies/μl, and at any CD4+ count where TB or pregnancy is present.)

It was not surprising to see that there were no pregnant women with a CD4 count <200 copies/μl, because at 1MH all HIV-positive pregnant women are placed on ARV treatment regardless of CD4+ count as part of the prevention of mother-to-child transmission programme. Following delivery, those eligible for ARV treatment continue while treatment is discontinued in those not eligible. TB patients continue to present very late in their disease course, when the CD4+ count is already very low; hence only 10 patients had CD4+ counts of 200 - 350 copies/μl at initiation v. 23 patients with <200 copies/μl.

TDF was already being dispensed at 1MH by the time the new 2010 guidelines were implemented, but was reserved for patients experiencing side-effects of d4T. However, implementation was associated with an impressive decline in side-effects, implying that the rising use of TDF was yielding positive patient outcomes with potentially lower numbers of patients experiencing treatment failure.

500

Study limitation

This study was conducted at only one site.

Conclusion

The lifespan of HIV patients receiving ARV treatment is improving, but risk factors associated with long-term drug treatment are increasing.

This is one of the first studies in SA to use objective evidence-based approaches to critically assess variance from ARV guidelines to determine compliance on the part of prescribing clinicians.

We found that compliance to ARV guidelines at the roll-out clinic at 1MH was satisfactory in some areas and not in others.

Improvement in patient outcomes was demonstrated by a declining number of side-effects, most notably in the first-line regimen where TDF demonstrated a greater tolerability than d4T. However, an increased need for vigilance is required with regard to blood test monitoring, where clinicians fail to comply with the ARV guidelines.

Addressing these issues may significantly alleviate the financial burden faced by healthcare organisations.

Acknowledgements. We thank Prof. D G van Zyl of Kalafong Hospital for his contributions to the methodology, as well as Dr T Rossouw from the University of Pretoria who assisted with the study design, Mr L Sibitsiwa of 1MH who aided in data capturing, and Prof. L Schoemanof and Mr L O Kondlo who assisted in the statistical analysis.

References 1. Machtinger EL, Bangsberg DR. Adherence to HIV Antiretroviral Therapy. HIV InSite Knowledge Base Chapter. San Francisco, USA: HIV InSite, 2005. http://hivinsite.ucsf.edu/InSite?page=kb-03-02-09# (accessed 24 March 2014).

2. Dykes PC. Practice guidelines and measurement: State-of-the-science. Nurs Outlook 2003;51(2):6569. [http://dx.doi.org/10.1016/s0029-6554(02)05459-3] 3. Spallek H, Song M, Plok DE, Bekhuis T, Frantsve-Hawley J, Aravamudhan K. Barriers to implementing evidence based-clinical guidelines: A survey of early adopters. Evid Based Dent Pract 2010;10(4):195206. [http://dx.doi.org/10.1016/j.jebdp.2010.05.013] 4. National Department of Health. National Antiretroviral Treatment Guidelines. 1st ed. Pretoria: Jacana, 2004. http://southafrica.usembassy.gov/media/2004-doh-art-guidelines.pdf (accessed 24 March 2014).

5. Boulle A, Orrell C, Kaplan R, et al. Substitutions due to antiretroviral toxicity or contra-indications in the first 3 years of antiretroviral therapy in a large South African cohort. Antivir Ther 2007;12(5):753-760.

6. Bolhaar MG, Karstaedt AS. A high incidence of lactic acidosis and symptomatic hyperlactatemia in women receiving highly active antiretroviral therapy in Soweto, South Africa. Clin Infect Dis 2007;45(2):254-260. [http://dx.doi.org/10.1086/518976] 7. WHO, UNICEF, UNAIDS. Global Update on HIV Treatment 2013. Geneva: WHO, 2013. http://www. who.int/iris/bitstream/10665/85327/1/WHO_HIV_2013.9_eng.pdf (accessed 24 March 2014).

8. National Department of Health. The South African Antiretroviral Treatment Guidelines 2010.

Pretoria: NDoH, 2010. http://www.uj.ac.za/EN/CorporateServices/ioha/Documentation/Documents/ ART%20Guideline.pdf (accessed 24 March 2014).

9. National Department of Health. The South African Antiretroviral Treatment Guidelines 2013.

Pretoria: NDoH, 2013. http://www.auruminstitute.org/phocadownload/guidelines-short.pdf (accessed 24 March 2014).

Accepted 24 February 2014.

July 2014, Vol. 104, No. 7

RESEARCH

Childhood cancer survival rates in two South African units D K Stones,1 MB ChB, MMed, DCH; G P de Bruin,2 MB ChB, MMed, FCPaed, DCH; T M Esterhuizen,3 MSc (Epidemiol); D C Stefan,2 MD, MMed, FCPaed, CMO, MSc, PhD epartment of Paediatrics and Child Health, Universitas Academic Hospital Complex, Faculty of Health Sciences, University of the Free State, D Bloemfontein, South Africa 2 Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa 3 Biostatistics Unit, Centre for Evidence-Based Health Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa 1

Corresponding author: D C Stefan (cs@sun.ac.za) Introduction. Childhood cancer is relatively rare, but there is a very good chance of cure. While overall survival rates of >70% are reported from developed countries, survival is much less likely in developing countries and unknown in many countries in Africa.

Objective. To analyse survival rates of childhood cancers in two South African paediatric oncology units.

Methods. This retrospective review included all children (0 - 15 years) admitted with a malignancy at two paediatric oncology units (Universitas Hospital Academic Complex in Bloemfontein, Free State, and Tygerberg Hospital in Cape Town, Western Cape) between 1987 and 2011. The protocols used in the units were similar, and all the diagnoses were confirmed histologically.

Results. There were 3 241 children, 53.5% of whom were males. Median follow-up was 17 months. The most common cancers were leukaemia (25.0%), brain tumours (19.5%), lymphoma (13.0%) and nephroblastoma (10.0%). The prevalences of neuroblastoma and retinoblastoma were similar at 5.8% and 5.7%, respectively. Overall survival was calculated to be 52.1%. Lymphoma and nephroblastoma had the highest survival rates at 63.9% and 62.6%, respectively. Brain tumours had the lowest survival rate at 46.4%. A comparison between ethnic groups showed white children to have the highest survival rate (62.8%); the rate for children of mixed racial origin was 53.8% and that for black children 48.5%.

Conclusions. Overall survival rates for children admitted to two paediatric cancer units in South Africa were lower than data published from developed countries, because many children presented with advanced disease. New strategies to improve cancer awareness are urgently required.

S Afr Med J 2014;104(7):501-504. DOI:10.7196/SAMJ.7882

Childhood cancer is uncommon, representing 1 - 10% of all cancers reported globally.[1] Globally, about 160 000 new cases of childhood cancer are diagnosed annually,[2] 13 000 in children and adolescents (<20 years) living in the USA. The annual average age-adjusted incidence rate in the USA is 158/million children.[3] Most childhood cancers (~60%) occur in low- and middle-income countries where there is limited access to therapy, resulting in poor survival rates.[1,4] Information about childhood cancer in Africa is lacking, as there are few formal cancer registries across the continent. The annual incidence of childhood cancer was estimated to be between 33.4 and 47.2/million between 2003 and 2007.[5] The age-standardised annual incidence for all childhood malignancies has been estimated at 87.8 and 62.6/million in the Western Cape and Free State provinces of South Africa (SA), respectively (Stefan DC et al., childhood cancer incidence in South Africa, 1987 - 2007, unpublished data). Increased resources, improved care and ongoing research have resulted in a consistent improvement in survival of children with cancer in developed countries, with the 5-year survival rate of children and adolescents in the USA approaching 80% and a mortality rate of 2.8/100 000.[2] Similar results are reported from Europe, with the 3-year survival rate for all childhood cancers being 81%.[6] Determinants of mortality and survival in children in the deve­ loping world (including Africa) differ markedly from those in the developed world. Survival rates of children with cancer in developing

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countries are far lower than those in the developed world.[4] Deaths from paediatric cancer often go unreported, so the true mortality rate is unknown.

There are many obstacles to early diagnosis and effective treatment of childhood cancer in Africa. Limited resources, late presentation of disease,[7] co-morbid infections (such as HIV) and malnutrition are among the barriers preventing improvement in survival

Methods

A retrospective demographic analysis of all children aged 0 - 15 years diagnosed with a malignancy between 1 January 1987 and 31 December 2011 in two SA paediatric oncology units (POUs) (Universitas Hospital Academic Complex (UHAC) in Bloemfontein, Free State, and Tygerberg Hospital in Cape Town, Western Cape) was performed. Both units have dedicated POUs admitting children referred from the large surrounding areas they serve.

Tygerberg Hospital is a tertiary hospital located in Cape Town, serving the eastern metropolitan region of Cape Town and the north-eastern districts of the Western Cape. The hospital provides healthcare to over 3.6 million people (2.4 million children) and is the largest hospital in the Western Cape and the second-largest in SA. The POU admits on average 50 - 60 new patients per year, with an average hospital stay of 5 days per admission.

The Universitas Hospital Academic Complex (UHAC) in Bloemfontein provides cancer care to over 1.5 million children. It is the referral POU for the whole of the Free State and Northern Cape

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RESEARCH

provinces, as well as some areas of both the North West and Eastern Cape provinces and Lesotho. This unit sees approximately 100 new oncology patients per year.

Data for this study were obtained from the children’s tumour registries at the respective POUs and cross-checked with the South African Paediatric Tumor Registry. The registries of both units are similar, collect the same information and are part of the SA Paediatric Tumour Registry. Classification of childhood cancers in the registry is based on standards set by the International Classification of Childhood Cancers, 3rd edition.[8] The protocols used in the two units were similar. The National Health Laboratory Service confirmed the histological diagnosis of malignancy in all cases where samples were available. In only a few cases (e.g. brainstem glioma) was diagnosis made on the clinical findings and relevant imaging, without histological studies.

The following variables were extracted and entered into a Microsoft Excel worksheet: date of birth, diagnosis, age at diagnosis, gender, ethnicity, HIV status, date last seen, and outcome at the end of the study.

SA has an ethnically diverse population, broadly classified as black, white and of mixed racial ancestry. The Western Cape population is 32.9% black, 48.8% mixed ancestry and 15.7% white (with 1% Asian/ Indian). In the Free State 87.6% are black, 3.1% of mixed ancestry, 8.7% white and 0.4% Asians/Indians.[9] All children under 15 years of age were included. Disease was staged according to international guidelines. Survival was correlated with the stage of the disease and the ethnic group to which each patient belonged.

The five most common cancers were leukaemia, brain tumours, lymphoma, nephroblastoma and retinoblastoma. Nephroblastoma and retinoblastoma were further analysed with regard to survival rates, stage and patient ethnic groups. The staging of nephroblastoma was based on abdominal ultrasound and computed tomography (CT) of the abdomen and, if indicated, of the chest. Magnetic resonance imaging (MRI) was done in selected cases to facilitate surgery. The staging of retinoblastoma included ophthalmological examination, cerebrospinal fluid (CSF) analysis, bone marrow examination and a brain CT scan or MRI. All children were followed up from the date of diagnosis until 31 December 2012, or until they died or were lost to follow-up.

Outcomes were defined as overall survival at 1, 3 and 5 years. The dates on which patients died or were last seen were documented.

Patients who were lost to follow-up, either while on treatment or after treatment, were included in the analysis as censored observations.

Patients from the two POUs were analysed both together and separately, to compare survival rates for the most common malignancies encountered. Kaplan-Meier curves were constructed

for each comparison, and where possible median survival time and 95% confidence intervals (CIs) were reported. Where cumulative survival probability did not drop below 50%, mean survival times were reported. Log-rank tests were used to compare groups in terms of survival times. All calculations were performed using SPSS software (IBM SPSS Statistics, version 21). A p-value of <0.05 was considered statistically significant.

Ethics approval was obtained from the human ethics research committees of the two participating centres. Confidentiality was maintained by using de-identified data throughout.

Results

The initial database included 3 292 children diagnosed with malig­ nancy from both units. Excluded from the analysis were ten children who were missing at the end-date of their follow-up period, so survival periods could not be calculated; 36 who died before receiving treatment or had no outcome information; one whose ethnic background was not recorded, and four for whom data were incomplete. A total of 3 241 children were therefore included in the study. There were 1 735 males (53.5%) and 1 506 females (46.5%) in the combined group (p=0.67). Of the children, 1 449 (44.7%) were aged 0 - 4 years, 962 (29.7%) 5 - 9 years, 808 (24.9%) 10 - 14 years and 22 (<1%) >14 years.

The median duration of follow-up was 17 months (range 1 day 26.4 years). Between 1 January 1987 and 31 December 2012 in both POUs, 1 551 children died from cancer or cancer-related infection or toxicity, giving an overall survival rate of 52.1% (median survival time 45.7 months; 95% CI 29.9 - 61.5).

There was a 67.8% 1-year survival probability overall, with a median survival time of 9.3 months (95% CI 9.16 - 9.46). At 3 years this had changed to 56.4% (mean 22.9 months; 95% CI 22.4 - 23.5), and at 5 years to 53.8% (mean 34.8 months; 95% CI 33.9 - 35.8).

Survival in all age groups was similar (p=0.43).

The five most common malignancies were the same in the two units and echoed the pattern of the SA Paediatric Tumour Registry. In both units lymphoma and nephroblastoma had the highest survival rates at 63.9% and 62.6%, respectively. Brain tumours had the lowest survival rate at 46.4% (Table 1).

The overall survival rates in the two units were similar (55.8% for Tygerberg Hospital, 50.6% for UHAC), with a combined overall rate of 52.1%.

Over half the children were black (n=1 886, 58.2%); followed by children of mixed ancestry (n=829, 25.6%) and white children (n=522, 16.1%) (ethnic group was known for 3 237 children). Cancer deaths were significantly more common among children in the former two groups than among white children, with black children having the shortest mean survival time (p<0.001). Survival was best

Table 1. Prevalences and survival rates for the most common malignancies in children in two paediatric oncology units in SA Prevalence, n (%) Malignancy

UHAC (N=2 284)

Tygerberg Hospital (N=957)

Overall survival n (%)

Median survival time (months)

Leukaemia (N=762)

490 (21.5)

272 (28.4)

372 (48.8)

46.5

Brain tumours (N=627)

437 (19.1)

190 (19.9)

291 (46.4)

18.2

Lymphoma (N=416)

282 (12.3)

134 (14.0)

266 (63.9)

Mean 185.3*

Nephroblastoma (N=329)

253 (11.1)

76 (7.9)

206 (62.6)

308.0

Retinoblastoma (N=182)

155 (6.8)

27 (2.8)

86 (47.3)

20.5

SA = South Africa; UHAC = Universitas Hospital Academic Complex. *Median could not be calculated.

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Table 2. Comparison of survival rates for the five most common childhood malignancies between three ethnic groups Children who survived, n/N (%) Malignancy

Black

Mixed race

White

Leukaemia (N=762)

151/371 (40.7)

115/212 (54.2)

106/179 (59.2)

Brain tumours (N=627)

146/340 (42.9)

88/187 (47.1)

57/100 (57.0)

Lymphoma (N=415)

140/240 (58.3)

82/112 (73.2)

43/63 (68.3)

Nephroblastoma (N=329)

131/225 (58.2)

49/70 (70.0)

26/34 (76.5)

Retinoblastoma (N=182)

61/144 (42.2)

19/31 (61.3)

6/7 (85.7)

Table 3. Nephroblastoma survival according to ethnic group and stage Children who survived, n/N (%) Nephroblastoma (N=321)*

Black

Mixed race

White

Stage 1 (N=95)

46/56 (82.1)

19/25 (76.0)

12/14 (85.7)

Stage 2 (N=42)

19/29 (65.5)

6/9 (66.7)

4/4 (100.0)

Stage 3 (N=92)

36/67 (53.7)

13/17 (76.5)

5/8 (62.5)

Stage 4 (N=79)

26/62 (41.3)

7/12 (58.3)

3/5 (60.0)

*Stage 5 (n=13) excluded. Data on stage missing n=8.

1.0

0.8

Cumulative survival

among white children (62.8%), followed by children of mixed ancestry (53.8%) and black children (48.5%).

Similar differences in survival times were found for all the five most common malignancies, with black children doing consistently least well (Table 2).

The overall survival rate for nephroblastoma (all stages) was 62.6%. Survival for stage 1 nephroblastoma (81.1%) was the best of all the cancer types, with a mean of 220 months. Children with disease at the other stages did progressively worse, and survival for stage IV disease was only 45.6%. Differences in survival times between the stages were highly significant (p<0.001).

Black children presented predominantly with stage 3 and 4 disease. Analysis of survival between ethnic groups in different stages of disease demonstrated that black children had a significantly lower survival for all except stage 1 disease (log-rank test adjusted for stage, 7.4; p=0.02) (Table 3).

Patients with retinoblastoma were divided into two groups, depending on whether they had early or late-stage disease (early defined as limited local, intraorbital involvement, and late as involvement of bone marrow and/ or CSF, and/or with brain metastases). Early and late stages of retinoblastoma, occurring in equal numbers in both units (90 v. 92), had survival rates of 84.4% and 10.9%, respectively (overall survival 46.3%). Black children presented predominantly with latestage disease (56.9%), as opposed to 29% of children of mixed ancestry and 14.3% of white children. Although sample sizes were small, black children demonstrated a nonsignificant trend towards a lower survival with stage 1 disease (82.3%) v. 100% of white and 86.4% of mixed-ancestry patients.

0.6 Ethnic group Blacks Mixed ancestry Whites

0.4

0.2

Discussion

This is the first study of survival rates for children with cancer in SA. The results demonstrate that overall survival in childhood cancer remains low (52.1%) when compared with international data. In the past 40 years, the overall survival rate for childhood cancer in the UK has increased from 10% to nearly 90%.[6,10] The five most common malignancies in our cohort were similar to those commonly found in children in developed countries,[11] but survival rates were lower.

Black children consistently had worse survival rates than other ethnic groups for all the five most common malignancies and in almost all stages of nephroblastoma and retinoblastoma (Fig. 1). No differences in survival were found between the genders or between different age groups. Possible

0.0 0.0

100.0

200.0

300.0

400.0

Duration of follow-up, months

Fig. 1. Comparative cancer survival in children according to ethnic group.

reasons for these differences in outcome for the different groups include late presentation, poor nutritional status, genetic factors and associated comorbidities (e.g. HIV infection and tuberculosis).[12] Children from low-income countries are often malnourished when a malignancy is diagnosed. Malnutrition in children with cancer renders them vulnerable to chemotherapy-related toxicity and infections, and ultimately increases the risk of

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death. Many studies document inadequate nutrition in black and coloured (mixed ancestry) children in SA, which is reflected in high rates of stunting and underweight.[13] Oelofse et al.[13] also found a substantially higher prevalence of micronutrient deficiencies among disadvantaged black and coloured infants in urban communities in the Western Cape than in other groups.

All the above factors may result in a worse outcome for black children.

RESEARCH

During the study period, 23 HIV-infected children with a malig­nancy presented to Tygerberg Hospital and 93 to UHAC, giving a prevalence of HIV-infected children with a malignancy of 2.4% in the former and 4.05% in the latter. Many social and demographic factors differ in the various ethnic groups, profoundly affecting survival rates. These include employment-related issues, transport-associated factors, caregivers, traditional attitudes to cancer and other ethnic beliefs.

The fact that most black children with nephroblastoma and retinoblastoma presented at an advanced stage of disease is attributable to the few points at which to access care in low socioeconomic areas, late referral from the primary health sector, and little knowledge about paediatric malignancy on the part of healthcare workers, parents and the community as a whole. A previous study in the Tygerberg Hospital referral area showed that a considerable delay in diagnosis could be attributed to physicians making a wrong initial diagnosis, delay in performing clinical tests, and delay in obtaining histopathological results.[14] Children in lower socioeconomic areas have less access to care than those in higher-income groups.

Awareness campaigns in SA can improve knowledge about child­hood malignancies and facilitate early diagnosis, particularly among these underprivileged children. However, stage of disease at presentation on its own cannot account for the differences in survival between the ethnic groups, black children showing significantly poorer survival at all stages of nephroblastoma (except stage 1) and retinoblastoma.

It has been shown that children with cancer in low-income countries commonly fail to complete treatment.[15] Abandonment of therapy was not a significant factor in our study, as most of the patients from distant areas were provided with lodging by the CHOC (Childhood Cancer Foundation South Africa). Notably, in the cohort attending Tygerberg Hospital, with a geographically smaller referral area, no cases were lost to follow-up.

Differences in outcome between the various ethnic groups have also been demonstrated in SA children with Hodgkin’s lymphoma.[16] Further research into ethnic differences is needed to investigate such survival discrepancies.

Study limitations

There are number of limitations to this study. It was retrospective, so we were unable to ascertain the full impact of factors such as nutrition on survival. Data on nutritional status at presentation were not collected, and nutritional influence on survival is an aspect demanding further attention and research.

These results, from only two POUs, cannot be extrapolated to the broader SA population, as some units have only had a comprehensive tumour registry since 1987. It is estimated that two-thirds of childhood malignancies in SA are not reported to the registry, either because they are not diagnosed or because the patient is not referred to an appropriate treatment centre.[17] Sufficient staging information to perform a comparison was only available for two of the five most common malignancies. Further

504

studies comparing staging information with survival for other solid tumours would be of interest.

Conclusion

Survival rates for childhood cancer in SA remain low when compared with international data. Children of black ethnic origin had significantly lower overall survival for all malignancies. Greater awareness of the danger signs of paediatric malignancy will foster earlier diagnosis of disease and lead to improved outcomes for all ethnic groups.

Author contributions. DKS collected the data in one POU, did the interpretation, and contributed to the discussion and editing of the paper.

GDB wrote the protocol, collected the data in the other POU, and wrote the first draft of the paper. TME performed the statistical analysis and contributed to editing and discussions. DCS designed the study, and contributed to the writing and editing. All authors read and approved the manuscript.

References 1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008.

Int J Cancer 2010;127(12):2893-2917. [http://dx.doi.org/10.1002/ijc.25516] 2. Ribeiro R. Improving survival of children with cancer worldwide: The St. Jude International Outreach Program approach. Stud Health Technol Inform 2012;172:9-13. [http://dx.doi.org/10.3233/978-161499-088-8-9] 3. Linabery AM, Johnson KJ, Ross JA. Childhood cancer incidence trends in association with US folic acid fortification (1986-2008). Pediatrics 2012;129(6):1125-1133. [http://dx.doi.org/10.1542/peds.2011-3418] 4. Ribeiro R, Pui C. Saving the children – improving childhood cancer treatment in developing countries.

N Engl J Med 2005;352(21):2158-2160. [http://dx.doi.org/10.1056/NEJMp048313] 5. Stefan DC. Epidemiology of childhood cancer and the SACCSG tumour registry. Continuing Medical Education 2010;28(7):317-319.

6. Gatta G, Botta L, Rossi S, et al. Childhood cancer survival in Europe 1999-2007: Results of EUROCARE-5 – a population-based study. Lancet Oncol 2014;15(1):35-47. [http://dx.doi.org/10.1016/ S1470-2045(13)70548-5] 7. Magnani C, Pastore G, Coebergh JW, et al. Trends in survival after childhood cancer in Europe, 19781997: Report from the Automated Childhood Cancer Information System project (ACCIS). Eur J Cancer 2006;42(13):1981-2005. [http://dx.doi.org/10.1016/j.ejca.2006.05.006] 8. Steliarova Foucher E, Stiller C, Lacour B, Kaatsch P. International Classification of Childhood Cancer, third edition. Cancer 2005;103(7):1457-1467. [http://dx.doi.org/10.1002/cncr.20910] 9. Statistics South Africa. http://www.statssa.gov.za/Publications/P03014/P030142011.pdf (accessed 5 December 2013).

10. Pritchard-Jones K, Pieters R, Reaman GH, et al. Sustaining innovation and improvement in the treatment of childhood cancer: Lessons from high-income countries. Lancet Oncol 2013;14(3):e95-e103. [http://dx.doi.org/10.1016/S1470-2045(13)70010-X] 11. CureSearch for Children’s Cancer. http://www.curesearch.org/Childhood-Cancer-Statistics/ (accessed 2 March 2014) 12. Sinfield RL, Molyneux EM, Banda K, et al. Spectrum and presentation of pediatric malignancies in the HIV era: Experience from Blantyre, Malawi, 1998-2003. Pediatr Blood Cancer 2007;48(5):515-520. [http://dx.doi.org/10.1016/S1470-2045(13)70010-X] 13. Oelofse A, Van Raaij JM, Benadé AJ, et al. Disadvantaged black and coloured infants in two urban communities in the Western Cape, South Africa differ in micronutrient status. Public Health Nutr 2002;5(2):289-294. [http://dx.doi.org/10.1079/PHN2002263] 14. Stefan D, Siemonsma F. Delay and causes of delay in the diagnosis of childhood cancer in Africa.

Pediatr Blood Cancer 2011;56(1):80-85. [http://dx.doi.org/10.1002/pbc.22714] 15. Arora RS, Eden T, Pizer B. The problem of treatment abandonment in children from developing countries with cancer. Pediatr Blood Cancer 2007;49(7):941-946. [http://dx.doi.org/10.1002/pbc.21127] 16. Stefan D, Stones D, Dippenaar A, et al. Ethnicity and characteristics of Hodgkin lymphoma in children.

Pediatr Blood Cancer 2009;52(2):182-185. [http://dx.doi.org/10.1002/pbc.21804] 17. Stefan DC, Stones D. The South African Paediatric Tumour Registry – 25 years of activity. S Afr Med J 2012;102(7):605-606.

Accepted 11 April 2014.

July 2014, Vol. 104, No. 7

GUEST EDITORIAL

Paediatric palliative medicine In November 2013, the International Children’s Palliative Care Network (ICPCN), based in South Africa, and the United Nations Children’s Fund (UNICEF) released a document entitled Assessment of the Need for Palliative Care for Children. Three Country Report: South Africa, Kenya and Zimbabwe.[1] It reported that, even though an underestimate, >800 000 children in South Africa were in need of generalised palliative care and >300 000 in need of specialised palliative care. Moreover, it was estimated that only 5% of children requiring specialised care were being reached. This low coverage was a result of ‘inadequate inclusion of children’s palliative care within policy and strategy frameworks; widespread lack of knowledge and adequate understanding among health professionals; narrow target focus of services being provided already; the reluctance of health workers to prescribe and/or administer morphine despite the availability of essential palliative care pharmaceutical agents, resulting in a major barrier for access to comprehensive pain management; funding constraints and attendant poor integration of palliative care into the health system’.[1] In South Africa, children’s palliative care is still in its infancy, even though in many other countries palliative medicine and paediatric palliative medicine are recognised medical specialties. Adult palliative medicine came about in the 1960s through the initiative of Dame Cecily Saunders and the opening of St Christopher’s Hospice in London. In 1982, the first children’s hospice, Helen House in Oxford, was established, and since then attention has increasingly focused on the needs of children with life-limiting and life-threatening illnesses and their families.[2] The World Health Organization (WHO) defined palliative medicine for the first time in 1990, with the children’s definition being added in 1998.[3] Initially, palliative medicine was defined as being accessed when curative care is no longer possible, but it is now widely accepted and understood that palliative medicine should be fully integrated into the care of any life-threatening and life-limiting illness.[4] Recent consensus statements emphasising the growing understanding of the need to advocate strongly for palliative care integration into the continuum of care for all patients, came from the African Palliative Care Association Conference held in Johannesburg in September 2013.[5] An international resolution encouraging all member states to take a greater interest in palliative care, including palliative care for children, was adopted by the WHO in January 2014,[6] and also by the 67th World Health Assembly in Geneva, Switzerland, in May 2014.[7]

Children’s palliative care is unique, covering a wide spectrum of ages – from birth to at least 18 years and sometimes beyond. It is unique in that children’s developmental needs, understanding and capabilities differ. They have distinct educational needs, and perceptions of illness, dying and death, which are influenced by their developmental stage, cultural and family traditions, and religion. Diseases of childhood are diverse and complex and often no longer seen in adults, as many congenital and childhood diseases severely constrain life expectancy.

Furthermore, perinatal palliative medicine is becoming an area of growing importance, interest, research, training, and advocacy. Disease symptoms present differently in children, who cannot be treated as small adults. Assessment is specialised and requires knowledge of the stages of development, communication and care needs. Medication doses are complex, largely weight related, and side-effect profiles can differ from those of adults. This illustrates the need for a unique understanding of the palliative care needs of children affected by lifelimiting and life-threatening illnesses. Despite the necessity for special training and experience, non-specialists and palliative care specialists should work together as a team in the service of children and their families who require this type of care.

The articles in this edition of CME discuss the ethical aspects of end-of-life dilemmas in children, communication with children, counselling, breaking bad news, pain control, and self-care, and have been written by palliative care professionals currently working in paediatric palliative medicine in South Africa. There are few specialist services for children’s palliative care in South Africa, and even fewer hospital- and community-based programmes that can rely on specialist knowledge. Therefore, the generalist doctor must have a working understanding of some children’s palliative care issues. Even specialists may find these articles of interest, as there are limited training and educational opportunities for dissemination of this type of knowledge.

(Available online resources for further reading and short courses are listed below.) There is still much work to be done. The authors and I hope that children’s palliative care gains a much deserved place and acceptance in the area of policy development, resource allocation, educational opportunities and service provision in South Africa.

WHO definition of palliative care for children[3]

Palliative care for children represents a special, albeit closely related, field of adult palliative care. The WHO definition of palliative care appropriate for children and their families is as follows:

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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CONTINUING MEDICAL EDUCATION

• Palliative care for children is the active total care of the child’s body, mind and spirit, and also involves giving support to the family.

• Palliative care begins when illness is diagnosed, and continues regardless of whether or not a child receives treatment directed at the disease.

• Health providers must evaluate and alleviate a child’s physical, psychological, and social distress.

• Effective palliative care requires a broad multidisciplinary approach that includes the family and uses available community resources; it can be successfully implemented even if resources are limited.

• Palliative care can be provided in tertiary care facilities, in community health centres and even in children’s homes.

• Together for Short Lives is a prominent UK children’s palliative care charity that supports families, professionals and services and has many online resources in palliative care pathways and policies. http://www.togetherforshortlives.org.uk/professionals (accessed 3 June 2014).

• The website for palliative care news, views and inspiration around the world is given here. The international children’s Palliative Care News is hosted by ICPCN. http://www.ehospice.com/internationalchildrens/ en-gb/home.aspx (accessed 3 June 2014).

These principles also apply to other chronic paediatric disorders.

Online resources and short courses

• Palliative Treatment for Children (PATCH) South Africa is an inclusive and compassionate network that aims to share specialised knowledge, tools and opportunities to ensure the best possible care for children with life-threatening and life-limiting illnesses, and to provide support to families and lay caregivers. http://www.patchsa. org/#about (accessed 3 June 2014).

• ICPCN raises awareness for children’s palliative care through lobbying for global development, and sharing expertise, skills, and knowledge. It has online educational programmes. http://www. icpcn.org/ (accessed 3 June 2014).

• The Hospice Palliative Care Association of South Africa can assist with accessing a hospice organisation locally, regionally and nationally. http://www.hospicepalliativecaresa.co.za/ (accessed 3 June 2014).

• Umduduzi, a Durban-based children’s palliative care service, provides palliative services to children and families in KwaZuluNatal and training in paediatric palliative care locally, nationally and internationally. http://www.umduduzi.co.za/ (accessed 3 June 2014; site temporarily under construction).

Patricia Lück Guest editor patricialuck@me.com 1. United Nations Children’s Fund (UNICEF)/International Children’s Palliative Care Network (ICPCN).

Assessment of the Need for Palliative Care for Children. Three Country Report: South Africa, Kenya and Zimbabwe. November 2013. New York: UNICEF/ICPCN, 2013. http://www.unicef.org/aids/files/ Palliative_Care_Three_Country_Report_Nov13.pdf (accessed 24 March 2014).

2. Baum D, Curtis H, Elston S, et al. A Guide to the Development of Children’s Palliative Care Services.

Bristol: ACT/RCPCH, 1997.

3. World Health Organization. The WHO definition of paediatric palliative care. http://www.who.int/ cancer/palliative/definition/en/ (accessed 24 March 2014).

4. Stjernswärd J, Foley KM, Ferris FD. The public health strategy for palliative care. J Pain Symptom Manage 2007;33:486.

5. African Palliative Care Association. Consensus statement for palliative care integration into the health system in Africa: Palliative Care for Africa. African Palliative Care Association Conference, Johannesburg, South Africa, 17 - 23 September 2013.

6. World Health Organization. Strengthening of Palliative Care as a Component of Integrated Treatment Within the Continuum of Care, 2014. http://www.thewpca.org/resources/resolution-to-strengthenpalliative-care/ (accessed 24 March 2014).

7. eHospice Palliative Care News. Adoption of resolution on palliative care at the 67th World Health Assembly Meeting, Geneva, Switzerland, 23 May 2014. http://www.ehospice.com/ArticleView/ tabid/10686/Articleld/10614/language/en-GB/View.aspx (accessed 3 June 2014).

S Afr Med J 2014;104(7):505-506. DOI:10.7196/SAMJ.8428

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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REVIEW

When is the right time? Complex issues around withdrawing life-sustaining treatment in children J Ambler, MB ChB, MRCGP (UK), Dip Pall Med (Cardiff ), DCH (SA) Department of Paediatrics, University of KwaZulu-Natal and Umduduzi Hospice Care for Children, Durban, South Africa Corresponding author: J Ambler (julia@umduduzi.co.za)

When should one withdraw treatment in children? The challenge is to recognise when a decision needs to be made. Parents may be in denial, and deciding which questions to ask may be difficult. Ethically, the guiding principle should be the child’s best interests. May the parents or primary caregiver decide what the child’s best interests are? Legislation in South Africa prevents a parent or caregiver from refusing treatment that medical professionals deem to be in the child’s best interests. This article discusses the ethical and legal aspects around the decision to palliate in children.

S Afr Med J 2014;104(7):507-509. DOI:10.7196/SAMJ.8427

Healthcare practitioners are often faced with difficult decisions, but the real challenge is to recognise when a decision needs to be made. In a busy general practice, managing a chronically ill child you are not attending to daily, the most straightforward approach may be to continue with a treatment plan for the child and family without reflecting on the course of events over time. The parents may be in denial about the condition of the child and it may be particularly difficult to step back and identify which questions need to be asked.

Case study

Let me introduce Sara and Jade. Sara is a 10-year-old girl with quadrispastic cerebral palsy. Her mother, Jade, has been bringing her to you since they moved to the area many years ago. Sara is profoundly impaired – physically and mentally. Both her sisters are much older and have left home already. Sara is the centre of Jade’s life. Sara’s father and Jade are divorced. He could not cope with Jade’s ‘obsession’ with Sara.

Sara does not make eye contact and is unable to communicate.

Although she barely moves and has severe spasticity, she has generally been well – until recently. During the past 9 months Sara has refused to eat, vomited frequently, and has been admitted to the local hospital five times for pneumonia. She does not sleep well and cries much of the time. She has undergone numerous invasive investigations,

but her condition is not improving. Gastrostomy feeding has been discussed, but the surgical team did not feel it was necessary as neither parent was in favour of Sara undergoing surgery.

Jade is not coping and feels that Sara is misbehaving. Sara’s father doesn’t see her often as he travels for work and finds it easier not to interfere with Jade’s management of Sara.

Your heart sinks as you see they have another appointment. When Jade and Sara enter, you immediately realise that Sara has pneumonia.

She is short of breath and moaning. Her muscle spasms seem worse. Jade is exhausted. Sara has lost more weight and refuses her normal feeds.

You call their paediatrician and again Sara is admitted to the ward, with referrals to the physiotherapist and dietician. As Jade leaves your rooms she asks, ‘What are we going to do next?’.

Jade’s question is very important. In such a case it is very easy to practise reactive medicine, responding to each acute episode individually without asking difficult questions. Perhaps we need to ask, ‘What should we do next?’.

How do we approach a case such as this one?

There are three key considerations when regarding difficult ethical decisions in caring for children: • What is the ethical issue in this case?

• Who should make this decision?

• How is the decision made?

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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What is the ethical issue in this case?

Before you can make decisions, you must define the questions. Sara is a chronically ill, neurologically impaired child whose clinical condition is deteriorating. She is uncomfortable and does not tolerate food. The burden of caring for her is enormous and taking its toll on her mother.

We need to consider whether managing Sara in this reactive manner is in her best interests. What is the benefit versus harm of recurrent hospitalisation? Do we have alternative options with regard to her management? What should we be doing about feeding her?

Who should make this decision?

Very often, healthcare decisions are left to the parents or primary caregiver as it is assumed that they will understand the child’s best interests. Parents and healthcare workers should be working as a team, ensuring open and honest communication at all times. The healthcare professional must identify the key decision makers in a family. However, it is important to note that legislation in South Africa prevents a parent or caregiver refusing treatment that medical professionals deem to be in the child’s best interests.[1] Dealing with children is complex – one must be able to manage the parents and the child.

What about the child?

In our case study, the child lacks the capacity to be autonomous as she is severely mentally impaired. There is, however, increasing evidence that children should be involved in their own healthcare decisions.[2-5] The Children’s Act 38 of 2005 (amended by Act 41 of 2007), promulgated in 2010, emphasises child participation. ‘Every child that is of such an age, maturity and stage of development as to be able to participate in any matter concerning that child has the right to participate in an appropriate way and views expressed by the child must be given due consideration.’[6] The act also states, ‘Patients, including children, have a right to have sufficient information about their health to enable them to make an informed decision about treatment. The information must be “relevant and must be in a format accessible to children, giving due consideration to the needs of disabled children”.’[6] This is echoed in the Health Professions Council of South Africa’s Guidelines for the Withholding and Withdrawing of Treatment.[7] Deciding whether a child has the capacity to make decisions may be difficult, but should take into account the child’s ability to reason, their understanding (which may be based on previous experience), their willingness to consent and the seriousness of the situation.[4] There are no hard-and-fast rules, as children vary greatly depending on age, rate of development, social circumstances and educational level. Each situation needs to be assessed individually. In South Africa, children are very seldom involved in their healthcare decisions and a shift in attitude needs to occur if we are to comply with the Children’s Act.[6]

Many healthcare professionals have been involved in Sara’s care over a long period of time. It is imperative that everyone be included in the discussions and decision making to prevent conflicts arising in the team. Both her parents, and possibly even the adult siblings who are also affected by the decisions, should be included in the discussion.

How do decisions get made?

Key ethical principles • Autonomy • Beneficence • Non-maleficence • Justice

When considering children, the standard of ‘best interests’ applies.

Best interests usually refer to the ‘highest net benefit among the available options that apply to any situation in which a decision has to be made regarding the health of the child’.[8] The Children’s Act[6] states that ‘The best interests of a child are of paramount importance in every matter concerning the child’. This has to take into account every aspect of the child’s life, including age, maturity, family dynamics, illness, educational needs and disability.

It is not always easy to know what is in the child’s best interests, but Kopelman[9] argues that taking a child’s best interests into account does not require what is ideal, but what is reasonable. In deciding what is in the child’s best interests, most healthcare workers try to calculate the consequences of the various treatment options available and choose the one likely to do the least harm (non-maleficence) and the most good (beneficence) to the child.

Although the best interests of the child must carry the most weight, ‘any decision made in respect of the child must carefully consider the interests of all potentially affected persons, most usually other family members, old or young, who will live with the child or are dependent upon the immediate family in other ways’.[10] To apply the standard of best interests we need the following: • a good understanding of the ethical principles • all the available information relevant to the case • an understanding of the child’s quality of life • a clear idea of treatment goals • the ability to examine our own motives.

Quality of life

Quality of life is difficult to define but has been described as an individual’s satisfaction or happiness with life in domains he or she considers important.[11] It is a subjective measure, but in the case of the disabled child it is important to consider the primary caregiver’s opinion on the quality of the child’s life.

The Royal College of Paediatrics and Child Health (RCPCH), UK, has defined the following five situations associated with poor

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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or absent quality of life where life-sustaining therapies may be withdrawn or withheld ethically and legally:[12] • brainstem death • persistent vegetative state • ‘no chance’ situation – further treatment is futile • ‘unbearable’ situation – suffering is intolerable and disease is progressive and irreversible (burden of treatment exceeds benefit) • ‘no purpose’ situation – prolonging life is possible, but at the cost of severe physical or mental impairment.

We could argue that Sara’s quality of life has deteriorated significantly and that she fits into the ‘no purpose’ situation. By inserting a gastrostomy tube and allowing recurrent hospitalisation we can, in all likelihood, prolong Sara’s life but at what cost to her and her family? This decision would have to take into account her fitness for an operation and the potential negative side-effects of surgery and gastrostomy feeding. This needs to be discussed with the family and team in a sensitive manner.

Furthermore, it is clear that Sara is in pain. We have an ethical responsibility to identify the sources and manage them accordingly to ensure comfort and thereby improve her quality of life.

Goals of treatment

quality of life. If you have been involved with a family and a child over many years, this can be very difficult.

Requirements for good ethical decision making

• Good understanding of basic ethical principles • Good understanding of the Children’s Act and how it applies to your practice • All the medical facts • Teamwork • Excellent communication skills • Common sense • Compassion

Conclusion

Making ethical decisions is never easy. As healthcare practitioners we first need to be able to identify when an ethical decision needs to be made and then have a framework of ethical principles to guide us in making the decision. Decisions need to be made in the child’s best interests, taking into account all the relevant facts, impact on the family and goal of care.

References

Understanding what we are hoping to achieve can guide our decisionmaking process. On the one hand, the goal may be to cure the child, in which case forcing the child to endure unpleasant treatments or investigations is reasonable. On the other hand, when cure is not possible, as in Sara’s case, the goal may be to ensure the child’s comfort and maximise her quality of life. In this situation one would certainly limit hospitalisation and exposure to painful procedures.

Defining the goals of treatment must be done together with the parents, considering the impact of the treatment on the entire family.

Motives

Examining one’s own motives is exceptionally important, particularly when one is close to a family and child. Knowing that you did everything possible for the child does not mean it was the right thing to do, especially if ‘everything’ had a negative impact on the child’s

1. Jamieson L, Lake L. Children’s Act Guide for Health Professionals. 5th ed. Cape Town: Children’s Institute, University of Cape Town, 2013. http://www.ci.org.za/depts/ci/pubs/pdf/resources/guides/2013/ (accessed 1 March 2014).

2. United Nations Childrens Fund (UNICEF). Convention on the Rights of the Child. http://www.unicef. org (accessed 24 March 2014).

3. King NM, Cross AW. Children as decision makers: A guideline for pediatricians. J Pediatr 1989;115(1):10-16. [http://dx.doi.org/10.1016/S0022-3476(89)80321-X] 4. Aspinall C. Children and parents and medical decisions. Hastings Center Report 2006;36(6):3. [http:// dx.doi.org/10.1353/hcr.2006.0088] 5. Lansdown G. Implementing children’s rights and health. Arch Dis Child 2000;83:286-288.

6. Children’s Institute. Consolidated Children’s Act. http://www.ci.org.za/depts/ci/pubs/pdf/lawreform/ billsacts/consolidated_childrens_act_1april2010.pdf (accessed 3 March 2014).

7. Health Professions Council of South Africa. Guidelines for the Withholding and Withdrawing of Treatment, May 2007, Booklet 13, Section 14.4. http://www.hpcsa.co.za (accessed 11 November 2013).

8. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th ed. Oxford: Oxford University Press, 2001.

9. Kopelman LM. The best-interests standard as threshold, ideal, and standard of reasonableness. J Med Philos 1997;22:271-289. [http://dx.doi.org/10.1093/jmp/22.3.271] 10. Nuffield Council on Bioethics. Critical care decisions in fetal and neonatal medicine: Ethical issues.

November 2006. http://www.nuffieldbioethics.org/sites/default/files/CCD%20web%20version%20 22%20June%2007%20 (accessed 6 March 2014).

11. Oleson M. Subjectively perceived quality of life. Image 1990;22:187-190.

12. Royal College of Paediatrics and Child Health (RCPCH). Withholding or Withdrawing Life Sustaining Treatment in Children: A Framework for Practice. 2nd ed. London: RCPCH, 2004. http://www.gmcuk.org/Withholding.pdf_40818793.pdf (accessed 6 March 2014).

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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ARTICLE SUMMARY

Talking to children: What to do and what not to do T Brand, BSocSci (SW), MSW (Clinical Practice) Umduduzi Hospice Care for Children, Durban, South Africa Corresponding author: T Brand (tracey@umduduzi.co.za)

Talking to children can be very daunting. Talking to a sick child can be even more daunting. How can we ensure that our message comes across in a way that is suitable and will not cause more harm than good?

Effective communication with children requires communication styles and behaviours that are appropriate to the age and cognitive development of the child.

Children effectively speak three languages – body language, play language and spoken language. If you want to speak to children, you need to be proficient in all three.

Tips for talking to children • • • •

Take time and don’t rush them.

Listen, listen, listen.

Be open to talk about anything.

There is much that children don’t know and for which they do not have words.

• Don’t interrupt, but wait for the child to finish talking.

• Use language that the child understands, but be careful not to talk down to them.

• Take note of the child’s facial expressions and body language.

• Make eye contact and repeat what has been said.

• Ask specific questions to prove that you are listening to what they have said.

Talking to children, and topics such as illness and death, need not be daunting. Children need to be included – they want to be included.

It is therefore the responsibility of healthcare providers to find a way of communicating with them that is age appropriate and effective.

Children have a basic need to be cared for and about: ‘I don’t care what you think unless I think you care about me!’

S Afr Med J 2014;104(7):510. DOI:10.7196/SAMJ.8429

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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Basic counselling skills T Brand, BSocSci (SW), MSW (Clinical Practice) Umduduzi Hospice Care for Children, Durban, South Africa Corresponding author: T Brand (tracey@umduduzi.co.za)

George Bernard Shaw stated, ‘The single biggest problem in communication is the illusion that it has taken place’. In the medical world, and especially one involving children, this is unfortunately a reality.

We all communicate. Whenever we are in contact with other people, we send and receive messages. Because we all communicate, we tend to take communication for granted and assume that our natural communication abilities are adequate.

Children have a right to participate in decision making with regard to their healthcare, and parents/caregivers have a right to be told the whole truth. Not talking about something does not mean that we are not communicating. Avoidance is a message in itself. But how do we do this?

Breaking bad news is never easy. Good breaking of bad news can enhance a family’s coping ability. Poor breaking of bad news may have

a profound effect on the family’s functioning and anticipatory grief response. Robert Buckman highlighted the following six steps, which can ensure good breaking of bad news: Step 1 – Getting started Step 2 – Finding out how much the patient knows Step 3 – Finding out how much the patient wants to know Step 4 – Sharing the information Step 5 – Responding to the patient’s feelings Step 6 – Planning and follow-through.

Knowing what not to say is as important as knowing what to say!

S Afr Med J 2014;104(7):511. DOI:10.7196/SAMJ.8434

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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Managing pain in children at the end of life: What the GP should know M A Meiring, MB ChB, FCPaed (SA), MMed (Paed) Department of Paediatrics and Child Health, and Division of Family Medicine, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town; Sarah Fox Convalescent Hospital, Athlone, Cape Town; and Palliative Treatment for Children (PATCH-SA), Cape Town, South Africa Corresponding author: M A Meiring (ma.meiring@uct.ac.za)

Managing disease- and procedure-related pain in children is paramount. Chronically ill children experience a significant burden of pain. If poorly managed, it has a negative impact on quality of life and parent-child relationships.

This article discusses aspects of pain management relevant to most stages of illness, but focuses on the terminal stage. Several studies have demonstrated the importance of good terminal pain management – not only for the child, but also for the family. Failure to manage terminal pain adequately may have a lasting impact and result in complicated grief. A pain-free home death is a common wish.

The case of a child with relapsed disseminated leukaemia is discussed. This study demonstrates how pain can be managed with good forward planning, excellent communication between generalist and specialist, and access to hospice- or home-based care services in the community.

Understanding the pathophysiology of pain and advance care planning may help GPs to obtain the necessary knowledge, drugs and resources to successfully manage most complications and avoid unnecessary stress.

The cornerstone of good pain management is assessment and recognising that pain is not merely physical but ‘total’, with psychological, spiritual and social components. The gold standard of pain assessment is patient self-reporting, using the PQRST acronym: P = provoking and palliating factors, Q = quality and quantity, R = region and radiation, S = severity, and T = timing. The Eland body tool is especially useful for evaluating multiple sites of pain.

One of the key components of successful home-based pain management is that someone is able to accurately detect changes

in the patient’s condition and carry out instructions. It may be the primary caregiver or hospice nurse, but they must be able to assess pain objectively.

The gold standard of cancer pain management is the World Health Organization (WHO)’s 3-step ladder, in which a lower dose of morphine can be used at step 2. Because of its variable bioavailability, codeine is no longer recommended for pain management in children. Co-analgesics (adjuvants) are useful for the management of neuropathic pain. Morphine remains the gold standard for the management of severe pain and the dose should be titrated against pain, without fear of causing respiratory depression, especially in progressive malignant disease. Tolerance develops to most of the minor side-effects of morphine (sedation, nausea and pruritus), with the exception of constipation, which necessitates prophylactic use of laxatives in older children and adults. ‘Pseudotolerance’, especially in progressive malignant disease, is common, necessitating large doses of morphine, but true tolerance is rare. If the latter is suspected, one should consider switching opioids. Complex pain management may require specialist assistance and hospitalisation. Syringe drivers are useful when oral medication is not tolerated. They can be used at home to manage most terminal symptoms. No child should be allowed to die with uncontrolled pain.

Finally, the impact of caring for a terminally ill child on the healthcare professional should not be underestimated. Professionals should ensure that they care for themselves and have access to support when necessary. However, a well-managed death can also bring a tremendous sense of professional satisfaction, despite the loss.

S Afr Med J 2014;104(7):512. DOI:10.7196/SAMJ.8462

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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ARTICLE SUMMARY

Physician self-care J Kirby,1 MB ChB, DCH (SA), DipObst (SA), MFamMed, Dip Homeopathy (SA), MFHom (UK); P Lück,2 MB ChB, MPhil Palliative Medicine Integrative Practice (Family Medicine and Homeopathy); St Bernard’s Hospice, East London; and Mindfulness-Based Stress Reduction Programme, East London, South Africa 2 Gauteng Centre of Excellence for Palliative Care, Chris Hani Baragwanath Academic Hospital, Wits Centre for Palliative Care, Johannesburg, South Africa 1

Corresponding author: J Kirby (janine@hazymoon.co.za)

Burnout and compassion fatigue among doctors and medical students is a well-recognised entity, with an estimated prevalence of up to 60%. Burnout refers to the stresses between doctors and their work environment, while compassion fatigue relates to stresses in the doctorpatient relationship. Both have a negative impact on patient care by increasing the number of medical errors, lowering patient and physician satisfaction and lengthening the recovery phase.

Challenges facing healthcare workers in palliative care include pathological altruism, exhaustion, vicarious trauma, moral distress and systemic violence.

In order to be a well-rounded healthcare professional not at risk of burnout or compassion fatigue, one should learn to view oneself as a resource that needs nurturing and care, rather than a limitless skilled tool at the mercy of one’s environment.

Simple lifestyle changes can make an enormous difference in quality of life. Enough sleep, moderate exercise and a healthy diet are key cornerstones. Strong supportive social networks are also valuable.

Clinicians who are aware of themselves tend to experience greater job satisfaction and empathic and mutually healing relationships with their patients. They tend to be patient centred and consequently their patients are more satisfied.

The following three emotional states have been identified:

Empathy

Empathy is the capacity to sense the inner emotional state of another person. Unlike emotional contagion, the person is aware that their emotional state has been provoked by another. The more you are aware of your own bodily state, the more the insula and anterior cingulate cortex light up, and the better you are at tuning in to the emotions of others.

Compassion

This has been defined as the emotion that one experiences when feeling concern for someone else’s suffering and is linked to the desire to alleviate it. Practitioners who are aware and in touch with themselves have a greater compassion and an ability to cope with the stresses and burdens of patient care.

Mindfulness has been defined as paying attention nonjudgementally and in a specific way. Exercises include awareness of breathing, sitting, eating, daily routine activities and walking meditation. When healthcare practitioners practise these regularly, they cultivate patience, awareness, attention, discernment, openness, kindness and compassion for themselves and their patients.

Emotional contagion

This is the automated tendency to mimic and mirror the emotions of another person.

S Afr Med J 2014;104(7):513. DOI:10.7196/SAMJ.8472

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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ABSTRACTS

Grafts versus stents in multivessel disease

The result of a study recently published in JAMA Internal Medicine points out that recent trials of percutaneous coronary intervention (PCI) v. coronary artery bypass grafting (CABG) for multivessel disease were not designed to detect a difference in mortality. Consequently, the comparative effects of these two revascularisation methods on longterm mortality are still unclear. In the absence of hard evidence for mortality difference, PCI is often preferred over CABG in these patients, given the less invasive nature of the former.

Sipahi et al. used a meta-analysis of all randomised clinical trials of the current era that compared the two treatment techniques in patients with multivessel disease to determine the comparative effects of CABG v. PCI on long-term mortality and morbidity.

These included randomised trials with ≥1 arterial grafts used in at least 90% and ≥1 stents used in at least 70% of cases, reporting outcomes in patients with multivessel disease. The number of events at the longest possible follow-up time and the sample sizes were extracted.

Six randomised trials enrolling a total of 6 055 patients were included, with a weighted average follow-up time of 4.1 years.

There was a significant reduction in total mortality with CABG compared with PCI. There were also significant reductions in myocardial infarction and repeat revascularisation procedures. A trend towards excess strokes with CABG was observed, but this was not statistically significant.

In patients with multivessel coronary disease, CABG compared with PCI leads to an unequivocal reduction in long-term mortality and myocardial infarction and to a reduction in repeat revascularisations, regardless of whether patients are diabetics or not. These findings have implications for the management of such patients.

Sipahi I, Hakan Akay M, Dagdelen S, et al. Coronary artery bypass grafting vs percutaneous coronary intervention and long-term mortality and morbidity in multivessel disease. Metaanalysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med 2014;174(2):223-230. [http://dx.doi.org/10.1001/jamainternmed.2013.12844]

Diabetes and ageing

There are, and will continue to be, larger populations of older adults with type 2 diabetes mellitus in nearly all countries. Consequently, it will be even more important to try to understand the clinical course of this disease in the elderly to establish evidence-based clinical practice recommendations, identify research priorities, allocate resources and

set healthcare policies in those countries most affected. Huang et al. report on the ‘Diabetes and aging study’, recently published in JAMA Internal Medicine.

They analysed contrasting rates of diabetes complications and mortality across age and diabetes duration categories using a cohort study (2004 - 2010) that included 72 310 older patients (≥60 years) with type 2 diabetes mellitus enrolled in a large, integrated healthcare delivery system. Incidence densities (events per 1 000 person-years) were calculated for three age categories (60 - 69, 70 79, and ≥80 years) and duration of diabetes (shorter (0 - 9 years) v. longer (≥10 years)).

The main outcome measures were acute hyper- and hypoglycaemic events, microvascular complications (end-stage renal disease, peripheral vascular disease, lower limb amputation, and diabetic eye disease), cardiovascular complications (coronary artery disease, cerebrovascular disease, and congestive heart failure), and all-cause mortality.

They found that among older adults with diabetes of short duration, cardiovascular complications followed by hypoglycaemia were the most common non-fatal complications. For example, among individuals aged 70 - 79 years with a short duration of diabetes, coronary artery disease and hypoglycaemia rates were higher compared with end-stage renal disease, lower limb amputation, and acute hyperglycaemic events. A similar pattern among patients in the same age group with a long duration of diabetes, with some of the highest incidence rates of coronary artery disease and hypoglycaemia (18.98 per 1 000 person-years and 15.88 per 1 000 person-years, respectively) compared with end-stage renal disease (7.64 per 1 000 person-years), lower limb amputation (4.26 per 1 000 person-years), and acute hyperglycaemic events (1.76 per 1 000 person-years), was found. For a given age group, the rates of each outcome, particularly hypoglycaemia and microvascular complications, increased dramatically with longer duration of the disease. However, for a given duration of diabetes, rates of hypoglycaemia, cardiovascular complications, and mortality increased steeply with advancing age, and rates of microvascular complications remained stable or declined.

The conclusion is that duration of diabetes and advancing age independently predict diabetes morbidity and mortality rates. As longterm survival with diabetes increases and the population ages, more research and public health efforts to reduce hypoglycaemia will be needed to complement ongoing efforts to reduce cardiovascular and microvascular complications.

Huang E, Laiteerapong N, Liu JY, et al. Rates of complications and mortality in older patients with diabetes mellitus: The diabetes and aging study. JAMA Intern Med 2014;174(2):251-258. [http:// dx.doi.org/10.1001/jamainternmed.2013.12956]

The full version of each article is available online. Use the QR code above to access.

FOR FURTHER PRODUCT INFORMATION CONTACT PHARMA DYNAMICS: CUSTOMER CARE LINE: 0860-PHARMA (742 762).

Zytomil 10 mg. Each film coated tablet contains 10 mg escitalopram. Reg. No./Nr.: RSA S5 42/1.2/0912.

NAM NS3 10/1.2/0478. Zytomil 20 mg. Each film coated tablet contains 20 mg escitalopram. Reg.No./ Nr.: RSA S5 42/1.2/0914. NAM NS3 10/1.2/0481. For full prescribing information, refer to the package insert approved by the Medicines Regulatory Authority. ZLA17/01/2014.

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July 2014, Vol. 104, No. 7

PROFESSIONAL ADVERTISING Tel: 021 681 7000 | E-mail: bronlyne.granger@hmpg.co.za www.hmpg.co.za | www.professionalads.co.za We accept credit card payments - Visa or MasterCard.

GP’s and Dentists wanted Experienced Dentists and GP’s wanted for a new fully equipped medical centre in a shopping mall in Orange Farm near Vereeniging. Must have high standards of ethics, be fully registered with HPCSA for independent practice and have malpractice indemnity insurance.

If you wish to apply for space in the medical centre Email CV to: thabo@njabulomedical.co.za or fax 0866401202. For more info you may email or call Thabo on 0118844717.

PHYSICIAN AND NEUROLOGIST required Specialist Physician and Neurologist in Richardsbay are seeking similarly qualified specialist with a view to a locum tenens for Sept/ Oct 2014 and for permanent placement from March 2015.

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PROFESSIONAL ADVERTISING

The National Health Laboratory Service (NHLS) is a leading public health laboratory service with laboratories across South Africa. Its activities comprise diagnostic laboratory services, research, teaching and training, and production of sera for anti-snake venom, reagents and media.

South African Field Epidemiology and Laboratory Training Programme

CALL FOR APPLICANTS: 2015 INTAKE The South African Field Epidemiology and Laboratory Training Programme (SAFELTP) is requesting applications for the incoming 2015 class from qualified health professionals with an interest in public health and a commitment to public service.

SAFELTP is jointly sponsored by the National Department of Health (NDOH), the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services (NHLS), the University of Pretoria (UP) and the US Centers for Disease Control and Prevention (CDC). The Programme is a combination of didactic and practical training in which the resident is grounded in the academic basics of public health and is assigned to field sites where s/he learns by doing while being mentored by supervisors in projects that address key public health priorities.

This residency programme is a 2-year, full-time commitment, from which residents graduate with a Master’s in Public Health (MPH) from the University of Pretoria. The 2015 cohort will begin in January 2015 and end December 2016.

The growing field of public health and epidemiology in South Africa and globally brings exciting opportunities for graduates and professionals from health-related fields to become competent in applied epidemiology of diseases and conditions relevant to South Africa. It also develops their leadership and management skills relevant to public health system strengthening and management. The training focuses on investigations of public health outbreaks (an acute health event or other epidemiological activity) and using epidemiology and biostatistics to conduct descriptive and analytical studies.

Bursaries/stipends may be available for South African applicants fulfilling predetermined criteria. South African applicants working currently within the South African Government at various levels, who plan to take study leave to participate in the Programme and afterwards return to their workplace, must have written approval from their departments for the entire two years. Please note that NDOH staff that have been funded and granted study leave will be required to continue working for the NDOH for at least 2 years after completing the MPH programme.

Work experience requirements: • Professional experience in a health field or other fields relevant to health • Experience in working in the public health system is desirable.

Minimum educational requirements (all degrees should be in a health, laboratory or public health-related field from an accredited university): A medical, veterinary or dentistry degree; OR a doctorate degree in a medical/ health-related field; OR a Master’s degree in a medical or health-related field; OR an Honours degree with at least 2 years’ applicable work experience; OR a 4-year bachelor’s degree with at least 3 years’ applicable work experience; OR a 3-year bachelor’s degree plus at least 5 years’ applicable work experience.

Please note that a BTech degree does not fulfill the minimum educational requirements of the University of Pretoria and the SAFELTP. www.humanjobs.co.za

109616 NHLS A4.indd 1

Key requirements: Applicants must: • Be registered with their respective professional bodies • Be fluent in spoken and written English • Be computer literate and proficient in Microsoft Word, Excel, PowerPoint and Outlook for use in communication, word processing, analysis, presentation and report generation • Have a valid driver’s licence and be willing to drive a hired car • Provide proof of current physical residential address for future purposes of Domicilium citandi et executandi.

HOW TO APPLY

If you meet all the requirements, download and complete the application and two reference forms that are available on our website: http://www.nicd.ac.za/?page=how_to_apply&id=120 Additional forms required: • Certified copies of qualification certificates • Statement of purpose: In 700 words or less, describe your career goals and your interest in applying for this programme • A 2-page (or less) Curriculum Vitae (CV) • Results of the National Benchmark Test (please visit the website of the National Benchmark Test at www.nbt.ac.za and tel. +27 (0)21 650 3523 for more information on dates and venues of the test).

Non-South African/non-SADC citizens who are accepted must complete the Test of English as Foreign Language (TOEFL) and have their original degrees accredited by the South African Qualifications Authority (SAQA).

These completed forms should be submitted to SAFELTP via Athalia Mathatho at e-mail: safeltp@nicd.ac.za or athaliam@nicd.ac.za You may also hand deliver the above application forms to Athalia Mathatho, SAFELTP Administration Office, Room L6, PRF Reception Building, NICD, No 1 Modderfontein Road, Sandringham, Johannesburg.

In addition, visit the University of Pretoria website at http://web.up.ac.za/default.asp?ipkCategoryID=34 and follow the process for applying online (this does not imply that you have been accepted by the University of Pretoria).

For enquiries or more information, please contact Athalia Mathatho at e-mail: safeltp@nicd.ac.za or athaliam@nicd.ac.za Closing date: 31 July 2014 It is your responsibility to ensure that your application has been received by SAFELTP. Non-certified copies of qualifications will not be considered, neither will those received after the closing date. Reference checks will be conducted.

All applications that meet the above requirements and received before the closing date will be acknowledged and given a reference number.

Correspondence will be with short-listed candidates only. If you have not heard from SAFELTP within 4 weeks of the closing date, please consider your application unsuccessful. For further information, please visit the website: http://www.nicd.ac.za/?page=safeltp&id=74

For further information about the NHLS, please visit www.nhls.ac.za Human Communications 109616

2014/06/09 3:41 PM

PULSE

Free iPad app displays up-to-the-minute claim statistics

MediSwitch is proud to announce the launch of its first mobile app, ClaimWatch. This will enable its clients to manage their claim submissions effectively and timeously.

The free app will allow healthcare professionals to view daily, monthly and month-to-date claim statistics with regard to claim volumes, accepted v. rejected claim volumes, and top five reasons for rejection.

Daily or monthly claim statistics can be viewed in a pie or bar chart and compared with previous months’ and/or days’ statistics.

Information displayed will include claims submitted, accepted and rejected. Healthcare professionals will also be able to view information on the top five reasons for rejections during a selected month.

‘The ClaimWatch iPad app shows our commitment to ensuring that all MediSwitch customers benefit from the latest technology available,’ says Peter Kennedy, MediSwitch Managing Director.

Please note: ClaimWatch is currently exclusively available for iPad, and MediSwitch is working on adding more mobile platforms.

For more information, contact MediSwitch on 0800 111 703 or info@ mediswitch.co.za; alternatively, visit www.mediswitch.co.za

July 2014, Vol. 104, No. 7

CPD

NOTIFICATION

Dear CPD client, We wish to take this opportunity to thank you for your continued support through the completion of our online CPD questionnaires as well as to share some exciting news with you. HMPG’s journal CPD questionnaires will be moving to the Medical Practice Consulting (MPC) CPD platform (www.mpconsulting.co.za) as part of a strategy to consolidate all South African Medical Association (SAMA) members’ CPD certificates and history.

All SAMA CPD certificates (whether for annual conferences, branch meetings or workshops) are already available online on the MPC CPD platform and moving all active HMPG online CPD questionnaires to the same platform will mean that all SAMA member CPD certificates will be issued in one central, convenient location – resulting in less admin for our CPD clients.

An additional benefit is that the MPC CPD manager can complete your IAR form on your behalf (no more countless hours of reconciling CPD records before a compliance audit) and submit your CPD history to the HPCSA once you have approved it and are happy with the results. All that is required of you, when you are ready, is to click a single button to submit your CPD Activity Record to the HPCSA. Nothing will, of course, ever be submitted without your prior approval and consent.

The MPC system also adds additional functionality to the CPD questionnaires and the system has been set up to make the process as easy to follow as possible.

The South African Medical Association (SAMA) board has concluded that the CPD services associated with the South African Medical Journal (incorporating Continuing Medical Education) and the South African Journal of Bioethics and Law will only be offered to registered and fully paid-up SAMA members, as per the SAMA member benefit schedule; therefore, you will be required to register a profile on the MPC CPD system (if you do not already have one – if you already have one, login as usual) and to supply your SAMA membership number. You will be required to do this only once. Your membership will be validated in real-time and you will be able to access the journal CPD questionnaires. This once-off registration should not take more than 2 minutes and you will be on your way to completing the CPD questionnaires.

Below are some questions and answers that will assist you in getting started.

When will the CPD questionnaires move to MPC? All HMPG-issued journal CPD questionnaires will move to the MPC CPD platform from February 2014 onwards. This will include all prior CPD questionnaires that are still active.

What website do I access to complete the HMPG questionnaires? www.mpconsulting.co.za

Who is MPC? Medical Practice Consulting (MPC) is a group company of SAMA. MPC has historically hosted CPD at SAMA’s annual conferences, issued all SAMA member CPD certificates and has hosted SAMA’s online branch elections. By moving active HMPG journal CPD questionnaires to the MPC system, SAMA members will have all their CPD certificates in one central, convenient location. MPC has also been supplying the Foundation for Professional Development distance learning courses online for the last 2 years and has hosted some of the largest online training initiatives in the South African healthcare industry.

What do I need to register a profile on the MPC CPD system?

MPC does not retain any confidential information on their database, so you will not be requested to share your telephone number, practice or home address. All that is required for registration is your name, surname, specialty, SAMA membership number and HPCSA number (which is included on your CPD certificate to comply with HPCSA CPD requirements).

How long will registration take?

Completing registration should take no longer than 2 minutes – please remember to have your HPCSA (MP Number) and SAMA membership number at hand.

What about my historic CPD certificates on the www.cpdjournals.co.za website?

If you register on the MPC CPD platform with the same email address as you were using on the www.cpdjournals.co.za website, MPC will import all your CPD certificates for the last 36 months into your MPC CPD manager for you. Alternatively you can still login to www.cpdjournals.co.za and save any CPD certificates that are still valid (remember that CEUs have a 24-month shelf life and expire after 24 months).

What happens if I run into technical difficulties?

Simply complete an online contact form and MPC will assist you with your technical problem. If your SAMA number for some reason does not match that in the SAMA membership database, MPC will assist with rectifying the problem. MPC’s contact details are available online: www.mpconsulting.co.za/contact-us Sincerely, Gert Steyn CEO, Health and Medical Publishing Group (HMPG)

CPD

JULY 2014

Effective in 2014, the CPD programme for SAMJ will be administered by Medical Practice Consulting: CPD questionnaires must be completed online at www.mpconsulting.co.za

True (A) or false (B): National expenditure on health research in South Africa (SA) 1. High-quality research is essential for identifying the health needs and improving health outcomes of a population.

2. Remarkable medical advances have occurred in SA, such as the invention of computed tomography.

3. The SA government’s current allocations to health research equate to approximately 2% of the national health budget.

Self-reported use of evidence-based medicine and smoking cessa­ tion 6 - 9 months after acute coronary syndrome (ACS) 4. Recent projections suggest that by 2030 ischaemic heart disease will become a leading cause of death in Africa, surpassing HIV/AIDS. 5. Good evidence exists to support the use of secondary preven­ tion medications (aspirin, statins, beta-blockers and angiotensinconverting enzyme inhibitors or angiotensin receptor blockers) and smoking cessation in patients after ACSs. 6. Patients who continue to smoke after an ACS have a significantly increased risk of a future acute myocardial infarction compared with those who quit.

7. Evidence suggests that two-thirds of smokers will successfully give up smoking in the 9 months following an acute coronary episode.

Predicting outcome in severe traumatic brain injury (TBI) using a simple prognostic model 8. Following TBI, an ipsilateral fixed and dilated pupil suggests lateral transtentorial herniation, while bilaterally fixed and dilated pupils are consistent with central transtentorial herniation in a fully resuscitated patient.

9. Bilateral pupil reactivity, a Glasgow Coma Score (GCS) of 6 - 8 and oxygen saturation ≥90% were shown to predict a positive outcome following severe TBI, and the higher the GCS score, the better the outcome.

Adherence to the 2010 antiretroviral guidelines in the antiretroviral roll-out clinic at 1 Military Hospital, South Africa 10. Advances in management and treatment of HIV/AIDS have trans­ formed HIV into a chronic condition rather than a debilitating terminal illness.

When is the right time? Complex issues around withdrawing lifesustaining treatment in children 11. According to South African legislation, a parent or caregiver may refuse a treatment that medical professionals deem to be in a child’s best interests.

12. Unless a child has suffered brainstem death or is in a persistent vegetative state, withholding life-sustaining treatments is not permissible legally or ethically.

Talking to children: What to do and what not to do 13. Children are frequently aware of the severity of their illness and will be able to talk about what is going to happen to them.

14. Children like to be told by an adult what is going to happen to them, because adults know best and children trust them.

Basic counselling skills 15. The WPC method of breaking bad news requires us to warn, pause, check back.

16. Key factors to take into account when breaking bad news are time, acknowledging emotion, confidentiality and setting the scene.

Managing pain in children at the end of life: What the GP should know 17. The gold standard of pain assessment is patient self-report.

18. Short-acting morphine should be given 4-hourly and not as required.

Physician self-care 19. One of the symptoms of burnout is overwhelming physical and emotional exhaustion.

20. Pathological altruism is a condition in which the practitioner is unable to clearly define boundaries between him/herself and the patient.

CPD questions include articles from CME. The full versions of each article can be found on the SAMJ website (http://www.samj.org.za)

A maximum of 3 CEUs will be awarded per correctly completed test.

INSTRUCTIONS 1. Read the journal. All the answers will be found there.

2. Go to www.mpconsulting.co.za to answer the questions.

Accreditation number: MDB001/007/01/2014 (Clinical)

July 2014, Vol. 104, No. 7

JULY 2014

VOL. 104 NO. 7

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Government expenditure on health research

468

More on RWOPS Antimicrobial resistance: The South African context Smoking cessation after acute coronary syndrome Predicting outcome in traumatic brain injury CME: Paediatric palliative care

SAMF

JULY 2014 VOL. 104 NO. 7 451-514

Strengthening Health Systems – new HMPG journal to be launched

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The convenient pocket-sized design enables you to fit it comfortably into your hospital bag or coat pocket, so it can always be at hand for ready reference. South African Medicines Formulary (SAMF), produced by the Division of Clinical Pharmacology of the University of Cape Town, provides easy access to the latest, scientifically accurate information, including full drug profiles, clinical notes and special prescriber’s points.

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and allied professionals with an interest in cardiac health are warmly invited by the organising committee to attend.

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07/03/2014 13:41