Asian Hospital & Healthcare Management - Issue 17 by Ochre Media Pvt. Ltd.

Healthcare Management

Issue 17

2008

Medical Sciences

ÂŁ12 â&#x201A;Ź18 $25 Rs.300

Diagnostics

Information Technology

Surgical Speciality

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Advanced Colorectal Cancer Improving the survival rate

Care Pathways The basics

Devices for the Failing Heart The future is here w w w. a s i a n h h m . c o m

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Foreword

The adaptation continues For healthcare providers it is important to remember that globalisation is here to stay.

he global market place continues to be a test for healthcare providers. The technology boom, combined with trends such as rising costs, shortage of healthcare professionals, growing consumerism and a greater than ever focus on patient safety have meant that providers are in a seemingly endless cycle of adaptation. Like in other industries, globalisation brought with it opportunities and challenges for healthcare. The opportunity came in the form of a global market place to tap into, and the challenge involved reaching standards acceptable at the global level. As simple as it sounds, this has been anything but easy. In other words, the global opportunity came with global competition—and a need for level playing field. However, if the disparities that exist in global healthcare are anything to go by, globalisation of healthcare has a long way to go before it achieves its goal of healthcare for all. This is especially true for countries like India that are essentially playing catch-up with their western counterparts. While they have done a good job of attracting foreign patients to its shores, Indian hospitals and government face the challenge of bringing healthcare to the remote and poor parts of the country. The developed countries have their own set of worries. Ever changing technology, while enabling better care, has also resulted in growing operating costs. The Internet has made huge amounts of information to the

consumers, thereby making them aware of their options and more demanding of quality services. They are also more global in their outlook and don’t mind travelling a few thousand miles for getting similar—if not better—care at considerably lower costs. Standardising exchange of information across the globe is the need of the hour. The existing standards present varying levels of complexity depending on which part of the world you come from. Interoperability at a global level may not be easy to achieve, but without it a truly global healthcare may never take shape. The blurring international borders are a boon for the consumer and a challenge for the governments and healthcare providers around the world. In this issue's cover story we presnt these and other challenges facing the world of healthcare. Whether globalisation should be blamed for complicating the healthcare scenario or credited with standardisation of various elements of healthcare is debatable, but the truth that remains is this: it is here to say and in the years to come will continue to present challenges and opportunities for care providers around the world.

Akhil Tandulwadikar Editor

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50 Basri JJ Abdullah, Professor Ranjit Kaur, Lecturer Department of Biomedical Imaging, Faculty of Medicine University of Malaya, Malaysia

Management

Medical Tourism in India

Global Health Tourism with Qualified Rehabilitation

Vandana Wadhawan, Member, Editorial Team Asian Hospital & Healthcare Management Sangita Reddy, Executive Director Apollo Hospitals Group, India

Hartmut Hain, CEO Jasmin Porter, Key Account Manager

Ganesh Subramaniam, Co-Promoter AyurVAID Hospitals, India

Medical Park AG, Germany

Care Pathways

The basics

Ricard Rosique, Senior Consultant, Diomedes and Head, Medical Department, B. Braun Group, Spain

Care Pathway for Total Hip Replacement An innovative approach

Yosef D Dlugacz, Senior Vice President and Chief, Clinical Quality Education and Research Carolyn Sweetapple, Vice President for Finance and Business Operations Krasnoff Quality Management Institute, USA

MEDICAL SCIENCES

Heart Failure Management

Managing End-of-Life Services

Experience from England

Candy Cooley, Manager National Genetics Education and Development Centre, England

Medical Tourism

Role of telemedicine Suman Bhusan Bhattacharyya, Vice-President (Clinical Services) Karishma Software Limited Secretary, IAMI, India

Asian Hospital & Healthcare Management

ISSUE - 17 2008

Monitoring with implantable devices

Michael Gold, Professor Medical University of South Carolina, USA Yong Cho, Tom Bennett, Douglas Hettrick Medtronic Inc. USA

Treatment of Stroke

Seeking a differentiator

Acting on the symptoms

Caroline Watkins, Proffessor Stroke and Older People's Care Michael Leathley, Senior Research Fellow Stephanie Jones, Research Fellow Clinical Practice Research Unit, Department of Nursing, University of Central Lancashire, UK

Advanced Colorectal Cancer Improving the survival rate Graeme Poston, Surgeon Vivek Upasani, Specialist Registrar Aintree University Hospital, UK

Contents surgical speciality

Nano-Healthcare

Transection of the Liver

Overview of techniques

Biotechnology & biomedical perspective of disruptive potential Abhishek Dutta Senior Research Analyst, Technical Insights, Frost & Sullivan, Singapore

Alun Jones, Specialty Registrar Marv Rees, Surgeon

facilities & operations management

Department of Hepatobiliary Surgery, Basingstoke and North Hampshire Hospital, NHS Foundation Trust, UK

Treatment of Gastric Cancer

Patient Safety and Risk Management

Role of radiotherapy

A look at the basics

Marcel Verheij, Professor and Chair Department of Radiation, Oncology The Netherlands Cancer Institute, The Netherlands

Sarah Williamson, Consultant Patient Safety and Risk Management, SalSafe, UK

Trends in Surgery of Kidney Tumors

Shift to less invasive and nephron-sparing techniques

Improving Reliability for Safer Care

A proactive approach Peter Lachman, Consultant Paediatrician Great Ormond Street Hospital for Children NHS Trust, UK

Milan Hora, Head, Department of Urology Charles University Hospital PlzenĚ&#x152;, Czech Republic

State of Sustainable Design in Healthcare

A commentary

diagnostics Echocardiography

New and evolving roles

Robin Guenther, Architect Douglas D Pierce, Architect Perkins+Will, USA

Michael H Picard, Director, Echocardiography Massachusetts General Hospital, USA

Diagnostics for the Developing World

Challenges and constraints

Natarajan Sriram, Director, Tulip Group, Orchid Biomedical Systems, India

Asian Diagnostics Market

Emerging opportunities

Suresh Vazirani, Chairman & Managing Director Transasia Bio-Medicals Ltd., India

information technology Understanding SOA

Caring about IT architecture Ken Rubin, Healthcare Architect Martin Holzworth, Enterprise Architect EDS, USA

Telehealth in Asia Healthcare for the communities

technology, equipment & devices

Devices for the Failing Heart

Gabe Rijpma Health and Social Services Industry Director Public Sector Group Microsoft Asia Pacific, Singapore

Leveraging Authentic Health Information

The future is here

Key to patient empowerment

Diego Delgado, Professor Division of Cardiology and Transplantation University Health Network, Canada

Amir Hannan Lead, Information Management & Technology, Tameside & Glossop Primary Care Trust, Primary Care Lead North West Strategic Health Authority, UK

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Issue 17 2008 Editors : Akhil Tandulwadikar Prasanthi Potluri Editorial Team : Sridevi Prekke Vandana Wadhawan Consulting Editor : P Sudhir Language Editor : G Srinivas Reddy Art Director : M A Hannan Visualiser : Sk Mastan Sharief Graphic Designers : K Ravi Kanth Ayodhya Pendem Copy Editor : Omer Ahmed Siddiqui Prity Jaiswal Production : Suresh Giriraj Sales Manager : Rajkiran Boda Sales Associates : Sylas Makam Murali Manohar J B Narsing Rao Savitha Devi Compliance : P Bhavani Prasad CRM : Yahiya Sultan Vijay Kumar Gaddem Subscriptions Head : Sasidhar Kasina IT Team : Ifthakhar Mohammed Azeemuddin Mohammed Sankar Kodali Thirupathi Botla N Saritha Advisory Board John E Adler, Professor, Neurosurgery and Director Radiosurgery and Stereotactic Suregery, Stanford University School of Medicine,USA

Sandy Lutz, Director, PricewaterhouseCoopers, Health Reseach Institute, USA Malcom J Underwood, Chief, Division of Cardiothoracic Surgery, Department of Surgery, The Chinees University of Hong Kong, Prince of Wales Hospital, Hong Kong

Peter Gross, Charman, Internal Medicine, Hackensack University Medical Center, USA Pradeep Chowbey, Chairman, Minimal Access, Metabolic and Bariatric Surgery Centre, Sir Ganga Ram Hospital, New Delhi, India

Vivek Desai, Managing Director, HOSMAC INDIA PVT. LTD., Maharastra, India Asian Hospital & Healthcare Management is published by

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The international health tourism has increased in the last few years. Rehabilitation can play a significant role in improving healthcare tourism prospects. German experience in providing rehabilitation services illustrates the huge potential this sector holds in developing health tourism.

Global Health Tourism with Qualified Rehabilitation Hartmut Hain CEO Jasmin Porter Key Account Manager Medical Park AG, Germany

ehabilitation refers to the most comprehensive restoration of health and abilities, following sickness, accident or injury in a clinic that has been especially conceived, qualified and assessed for the rehabilitation. In Germany, prevention and rehabilitation have been regular features of a modern and overall medicine. With their vast experience in healthcare sector and in managing the multitude of qualified hospitals / clinics and because of great socio-political support they enjoy, Rehabilition-Clinics (medical park) offer high quality services in constitutional and rehabilitative measures.

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In Germany, rehabilitation after an illness, an operation or an injury is an inherent part of the treatment. However, in most countries of the world, such a complex treatment after operations, injuries or accidents fine-tuned to the patients’ needs is not available. There are two kinds of rehabilitation: inpatient and outpatient treatment. The most common type is the inpatient rehabilitation. Whether after a stroke, an accident, a heart attack or a hip or knee replacement—there are several medical procedures that need a systematic and comprehensive rehabilitation. Rehabilitation in Germany is an inherent part of the chain of treatment and guarantees for the ideal maintenance. Scientific studies have clearly shown that inpatient rehabilitation—a stay in so-called rehabilitation clinics for several weeks—almost always has positive effect on the health of the patient. In other words, without rehabilitation lasting damage often remains because patient is often unable to train his skeletal muscle system as thoroughly as he could. A merely outpatient-based therapy is often insufficiently tuned to the individual diagnosis, especially if the patient is not following a individual therapy plan and is only looking for sporadic training or massages. The patient needs to learn how to handle his disease and his responses to specific conditions so that further acute medical conditions are prevented and chronic disorders are controlled as far as possible. Further, the patient should also be aware of his daily activities that need to be performed for the restoration of health based on his recent medical condition. This forms a basis for his complete rehabilitation and healthcare.

German medical pathways 1. Consultation at the physician’s office; 2. Operation at a specialised hospital (stay in hospital for about 4 to 12 days, depending on indication) 3. Inpatient rehabilitation for at least three weeks (depending on indication); and 4. Control of operation / treatment at hospital or physician’s office. All the involved parties correspond with each other to maintain the status quo.

came to know about Rehabilitation Clinics in Germany through their acquaintances in Germany or somebody who had studied in a German university. But it took quite a while for most of the hospitals to recognise that there is a potential in this field. There are different kinds of patients: so called self-payers, people who are sent by their home country and those for whom the treatment is paid by a health ministry or some other sponsor and health insured patients. About ten years ago, the first agent showed up in the German market and initiated marketing of German hospitals in foreign countries. The focus was on self-paying patients. It was difficult for the agents because most of the German hospitals never needed marketing to receive patients. German hospitals received their local patients through physician’s office, either by self-hospitalisation or, by emergency medical services in case of an accident. So, the German hospitals were very doubtful about spending money on marketing and also did not have the budget. On the other hand, the hospitals in Germany could see how more and more patients from Arabic countries were advised to come to Germany for medical treatment after September 11 by their sponsors or the health ministries. Since last 20 years and more, the US and UK were the first

contact point for medical treatment of international patients. So, the interest for the German hospitals in this field went higher and the pressure on the political level rose. Bavaria was the first German federal state to invest in large advertisement programmes to attract international patients. The Bavarian ministries, with its headquarters in Munich, published brochures in different languages (English, Russian, Arabic, Turkish and much more), showed the public benefit during their international political appointments with foreign countries and started sponsoring programmes for Bavarian hospitals and medical companies to get them to attend international exhibitions. Success came and other German federal states followed. Until today, Bavaria is still the number one choice for the patients seeking medical treatment. Risks and opportunities

There are risks and challenges involved in the treatment of international patients: different mentalities, religions, nutrition habits, barrier of language. Further, the patients have to lay their lives in the hands of someone they have never seen before, and in a country they haven’t been to. They need to trust people without the chance to build up mutual trust

Medical tourism in Germany

Historically, patients travelled to Germany for medical treatment. Russian patients knew several cities like Berlin or BadenBaden from the tourist or political point of view. They knew about the quality of the treatment. In past, international patients

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particular sponsor. So, it is very important to clarify all the points of treatment in advance; and it is even better to inform the sponsers about the approximate costs to the sponsor and get his approval for all the possibilities before the treatment starts. These efforts ensure that there is clarity among all the involved parties. There is a huge scope for the growth of medical tourism. The countries around the world have the opportunity to prove their quality in healthcare and treatment. The

Asian Hospital & Healthcare Management

world is getting global and by welcoming international patients, there is opportunity for each side to study the different mentalities, learn much more about people and their countries at social levels and to get and stay open-minded about people, no matter where they come from. In Bavaria, the basis for all this is provided and everything is done to keep it this way. The hospitals and clinics are prepared to welcome anyone to help them stay healthy.

Hartmut Hain has vast experience in the field of rehabilitation as well as medicine. Before he took up his role as CEO of Medical Park, Hain was on the board of managers of the Rhรถn-Klinikum AG. He studied hospital and social management and is presently responsible for strategy, quality management, corporate communication, marketing and sales at Medical Park AG

A uthors

in advance. Every hospital or clinic worldwide has to look into this subject, get prepared and establish necessary standards / procedures to be followed in the treatment of international patients. For example, it is essential to make a professional native language speaker or translator available to the patient during his examinations and therapies. Further, the hospitals need to advise the patients on all aspects starting from hospitalisation to routine problems. Experiences have shown that some patients sponsored for treatment by health ministries or insurance agencies often exploit the sponsorers. For instance, a patient has the approval from his sponsors to get operated, maybe for a hip replacement. It happened that the patients took a chance and asked for more medical treatment, like whole check-up programme, examination of eyes, dental work and so on. This results in rise of costs and can end up in refusal of payment from the

Jasmin Porter has been working with Medical Park since 2004 as Key Account Manager for both national and international divisions. Earlier, she worked with the first German professional international health tourism organisation.

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Care Pathways The basics

Care pathways are considered to be one of the best tools hospitals can use to manage the quality in healthcare concerning the standardisation of care processes, since they promote organised and efficient patient care based on evidence. It has been proven that their implementation reduces the variability in clinical practice and improves outcomes.

Ricard Rosique Senior Consultant, Diomedes and Head, Medical Department B. Braun Group, Spain

are pathways are also known as Clinical or Critical pathways. A care pathway is a multidisciplinary healthcare management tool based on healthcare plans for a specific group of patients with a predictable clinical course, in which the different tasks or interventions by the professionals involved in the patient care (physicians, nurses, pharmacists, physical therapists, social workers etc.) are defined, optimised and sequenced either by hour (ED) or day (acute care). Outcomes are tied to specific interventions.

The care pathway concept appeared for the first time in 1985 inspired by Karen Zander and Kathleen Bower at the New England Medical Center in Boston (Massachusetts, USA). Care pathways are usually represented as a Gantt chart (Figure 1). So far, different systematisation tools were being used for clinical processes. The oldest and most known are medical and nursing protocols. Over the last years other tools were introduced, such as clinical practice guidelines and standardised nursing care maps. Care pathways are care protocols that embrace all of these tools (Figure 2). The main goal of care pathways is based on the improvement of the following areas: quality in healthcare, coordination / cooperation among professionals, efficiency and patient satisfaction. Thus,

Gantt chart Chronology / Location Day 0 / Admission

Day 1 / Ward

Day 2 / Ward

Consults Tests Assessment

Groups of Multidisciplinary activities

Meds Nutrition Activity Patient Information Expected Outcomes

the purpose of pathways is the enhancement of care processes in three areas: quality, safety and efficiency. Care pathways are a powerful tool for care process management, since they permit to check the compliance of all the interventions included in the healthcare plan, fix care standards and introduce clinical audits as a part of the process. Likewise, pathways are very useful to identify improvement areas in these standardised care processes, under the umbrella of the culture of Continuous Quality Improvement (CQI). The development and implementation of a care pathway involves a change in the organisational culture at any setting. This process may involve overcoming of some hurdles in its way of implementation. Following are some of the activities to be done to develop and implement a care pathway: • Preparing multidisciplinary documents • Reviewing the process by all the concerned staff • Holding care pathway meetings to facilitate the exchange of opinions about patient care by different professionals • Conducting periodic reviews to monitor some defined indicators • Analysing variances or deviations • Preparing common record documents for all the staff

Figure 1

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Some barriers in developing and implementing a pathway are identified: the heterogeneity of patients and diagnosis, the common reluctance among organisations and professionals to change. These barriers must be considered by hospital managers since they may threaten a successful implementation of care pathways. Methodology

The methodology of any project for care pathways implementation is divided in four phases: selection, development, implementation and evaluation. In this article all the steps will be comprehensively explained and some key points will be clarified in each one of these phases in order to help anyone who may be involved in such projects. Selection

This is a phase in which the consensus is reached on care procedure to be followed in care pathway. Pathways should be designed for frequent and important (high risk / high cost) care procedures with an expected clinical course. What should be the selection criteria? In order to standardise the process, following recommendations need to be considered: • Multidisciplinary implementation • Non-explained variability • Outcomes far from standard • Motivation by professionals to work on a specific condition • Evidence-based Medicine, recommendations of good professional practices and professional references • Possibility to reach a professional agreement at the hospital At the start of the project, there are some tips to be kept in mind in order to build strong basis to prepare a good project. First of all, you need commitment and leadership from top managers (CEO, Medical and Nursing Managers) and a good communication from top to bottom This apart, project planning (please do not forget project management tools) and adequate resources (staff, time and material), which means a planned

Scope of clinical pathways Clinical Pathways Medical Protocals

StandardisedCare Maps

Nursing Protocols

Clinical practice guidelines

Systematisation tools for clinical processes

financial investment, are required for the success of the project. Concerning the hospital staff, you should transfer the ownership of care pathways to them and give them good training and education right from the beginning. Above all, do not forget the economic incentives for staff to start a new organisational culture. When all the key points for success (vision, skill, incentives, resources and an action plan) are assured, one is very likely to get the key for changing the organisational culture (Figure 3). If not, this could result either in confusion, anxiety, frustration or a false start. Development

This is the phase in which the care pathway is designed and the consensus is reached. The goals of this phase are the constitution of a multidisciplinary team as a ‘Care Pathway Committee’ (with motivation and ability of agreement) and the design of all the documents for a specific care pathway. Requirements for developing a care pathway 1. Formation of the Care Pathway Committee by the Project Committee 2. Initial risk assessment by hospital managers 3. Examine the previous clinical audit of the process with retrospective data collected form medical histories 4. Evaluation of existing evidence and

Figure 2

external practices (considering clinical practice guidelines) 5. Definition of the starting and ending point 6. Define objectives for each care pathway 7. Description of inclusion and exclusion criteria 8. Agenda of meetings with the Care Pathway Committee The formation of the care pathway multidisciplinary teamwork (‘Care Pathway Committee’) is essential and the members should be very involved with the care pathway development. It is important to stress the need of consensus meetings. Professionals of the multidisciplinary team should reach agreements through the critical analysis of the different activities of the care process and the improvements to be introduced. Implementation

This is the phase in which pathway is implemented. The procedures required for a right implementation are as follows: 1. Final approval to the pathway matrix and the rest of accompanying documentation by the multidisciplinary team 2. Approval by medical and nursing managers 3. Education and training for all the rest of professionals involved in the care pathway who did not participate in the Care Pathway Committee

Key points for success Vision

Asian Hospital & Healthcare Management

Skill

Incentives

ResouRces

Action Plan

Change Figure 3

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Pathways vs ePathways Pathways

ePathways

Figure 4

4. Development of the ‘Implementation Plan’: a. Decision of the start date for the care pathway new documents b. Availability of the new record documentation c. Appointment of a responsible person for each care pathway d.New pre-implementation risk assessment e. Internal communication f. Training and education 5. Initial testing phase (usually two months is sufficient) 6. Review of the new documentation after this pilot phase 7. Official start of the care pathway implementation after this first review of the documentation Although until now most care pathways at hospitals worldwide are managed on paper, the introduction of electronic pathways (‘ePathways’) at some hospitals has opened a new field for the improvement of care processes management. EIRA© is the software for care pathways management that is currently being used at two Spanish hospitals. Electronic pathways are the driving force to succeed in the implementation of care pathways. And now let’s look at some lessons learnt during our projects for successfully implementing care pathways. The new record documents should be adapted to the existing ones in order to avoid too many changes for the staff,

and always avoiding the duplication of any medical or nursing recording. In case of electronic Pathways, this specific software must be integrated with the common hospital information system. Hospital top managers (CEO, medical and nursing managers) should ensure that each of these care pathways project is included in the hospital strategy planning and demonstrate their leadership from the beginning to the end. I always suggest them to attend the first care pathway committee meetings to show their personal commitment and interest in the project. At the same time, managers should promote the clinician management of care pathways to enhance the commitment of clinicians with pathways from the start. Of course, there should be a hospital coordinator for managing all the care pathways implemented in the hospital. The coordinator should be a dedicated person having relevant experience of coordinating care pathways, and should posses leadership and communication skills. And he should be able to use a project management software (i.e. Microsoft Project), defining milestones and resources for each project phase. Together with the hospital managers, the care pathways coordinator must plan a strategy for communication, education and training. A usual question is what to do with process management projects.

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Does process management interfere with care pathways projects? Must they start before or after care pathway projects? Process management means the upper dimension in the management of hospital processes. From my pointof-view, it’s more convenient to first define the core processes of the hospital with the respective process maps. If not, bottlenecks would be created when designing care pathways for concrete care processes and it could be already too late to solve them. ‘Evidence-based care pathways’ is the ambitious term used for any care pathway, but in fact you do not always find evidence for any procedure. Therefore we must search the best practice as a reference to design a care pathway. In healthcare literature one can find some articles about how to measure the quality of a care pathway. One of the best tools recommended is the Integrated Care Pathway Assessment Tool (ICPAT). Developed by Claire Whittle (University of Birmingham, England, UK) and sponsored by the Strategic Health Authority of West Midlands (England, UK), it is a very practical questionnaire that allows you to evaluate the process of design, development, implementation and follow-up of care pathways. A matter to be considered in the future is the involvement of patients in the process of designing care pathways. Since the main goal is enhancing their satisfaction during the care process, I think that we should face the patient needs together with the goals of the different professionals caring patients. The way to do it is an unknown factor, considering the problems sometimes to reach the consensus among the staff. Evaluation / Follow-up

In this phase, the care pathway should be controlled, analysed and updated. Pathways are dynamic tools to be periodically reviewed and adapted, not documents to be left in the drawer.

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Follow-up report for vaginal delivery pathway Indicator

formula

Outcome %

Number of cases with CP delivery

Coverage

Number of cases with complete record Number of cases with complete record

Record follow-up

Number of cases with CP delivery Number of US performed

Mean of US performed pre-delivery

Number of cases with CP delivery Number of NST pre-delevery

Mean of NST pre-delivery

Number of cases with CP delivery

Record of the doctor who decides inclusion in CP

Number of cases with record of the doctor who decides inclusion

Epidural catheter withdrawal at six hours post-delivery

Number of cases with record of catheter withdrawal 6h post-delevery

Fluids tolerance starts four hours post-delevery

Number of cases with record of fluids tolerajce start 4h post-delevery

Number of cases with CP delivery

X 100

100

X 100

See the record follow-up

X 100

3.10

X 100

2.60

X 100

12.50

X 100

67.31

X 100

87.50 Figure 5

7. Feedback to managers and staff regarding the follow-up of indicators / outcomes and variances (essential to incentive staff to continue working on care pathways) Updating the care pathway and documentation of its records is mandatory and should be done based on the publication of new scientific evidence, the information collected about the most frequent variances and considering the achieved objectives. Regarding the analysis and evaluation of the care pathway, one of the most specific features of this methodology is the ‘variance report’—the information gathered from the analysis of the variance sheets. Variances (or deviations) may include activities that were carried out but not defined in the care pathway and activities defined in the care pathA uthor

In this last phase, the first activity should be the appointment of a responsible person for the care pathway follow-up. Who is suited for the job, a doctor or a nurse? Involvement of professionals from both medical and nursing fields are recommended in order to not discontinue the pathway compliance by all concerned physicians and nurses. The next steps should be: 1. Establish dates for periodic reviews (recommended the first review after 6 months post-official implementation and then every 12 months) 2. A systematic and ongoing audit 3. Follow-up of the completion of the new record documentation (very useful in the first 12 months as a reminder for all the professionals) 4. Monitoring of variances with a fixed periodicity 5. A ssessment and evaluation of the outcomes from the information recorded in the care pathway documentation 6. A nalysis of the impact of the care pathway implementation on the care process

way but not carried out and medical complications. Different reasons may cause variances: patient and / or family, staff and organisation. Another essential document for the evaluation of care pathways is the ‘follow-up report’, which includes the follow-up of the completion of the new record documentation, the variance report, as well as the assessment of the outcomes through the predefined indicators, which are related to the agreed objectives of the pathway. You can see an extract of a follow-up report from the vaginal delivery pathway in figure 5. In conclusion, the methodology applied to care pathways projects is based on the continuous quality improvement (CQI), the P-D-C-A Cycle by Deming—Plan, Do, Check, Act. And start again.

Ricard Rosique is Senior Consultant at Diomedes and Head of Medical Department of B. Braun Group, Spain. He has contributed in developing methodology for the development of 120 Care Pathways (both surgical and medical pathways) in different Spanish hospitals. He shared his project experience at various conferences, seminars, congresses and courses in Spain, the UK, France and Portugal.

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Care Pathway for Total Hip Replacement An innovative approach

Using clinical pathways to standardise care across the continuum—from the physicians’ office to the O.R., recovery post operation—improves communication among the care-giving team. The pathways are also a tool to educate and involve patients in their care, as they identify variation from expected outcomes and goals. Pathways improve the delivery of care to patients through encouraging early ambulation for those patients who undergo total hip replacement surgery while increasing clinical and organisational efficiency and revenue.

Yosef D Dlugacz Senior Vice President and Chief, Clinical Quality Education and Research Carolyn Sweetapple Vice President for Finance and Business Operations Krasnoff Quality Management Institute USA

ew advances in promoting patient safety, such as requiring physicians to comply with evidence-based medicine, pay-forperformance initiatives supported by the government and transparency for

consumer information have been interpreted by some clinicians as an infringement on their autonomy. Healthcare organisations need to develop processes to bridge the physicians’ need for independence and the government’s and public’s pressure to deliver improved care. One of the most successful ways to build this bridge is through involving physicians in creating and implementing a valid and reliable methodology for communication about and accountability for evidencebased care. Clinical pathways, which are algorithms for care based on evidence that detail specific interventions and expected outcomes along a timeline, is such a method and successfully help to

resolve the conflict and promote trust between the healthcare organisation and the clinical staff. Ensuring continuum of care

To improve the delivery of care for patients who required total hip replacement, a partnership was established among a quality management methodologist, a nurse who understands clinical operations and an orthopaedic surgeon. The goal was to enable the surgeon to operate on as many patients as possible while maintaining excellent clinical excellent results. Because this increasingly popular surgery is performed to improve quality of life and pain-free mobility,

The Krauss1 Method Office

TJR Class

Pre-surgical Evaluation

PST

Surgery

Physiatrist consult

Post-op care

Medical Clearance

Rehab

Acute

Subacute

Office

Home

1Eugene S. Krauss, M.D. Director of Department of Orthopedics, Director of Orthopedic & Rehabilitation Institute, Chief of Total Joint Replacement Program, Glen Cove Hospital and Southside Hospital of the North Shore-LIJ Health System Copyright©2008, Krasnoff Quality Management Institute

Figure 1

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Medications

You may receive antibiotics through your intravenous line (I.V) and you may receive medication to prevent blood clots. Your pain medication will be based on your needs, how it is given will be ordered by your doctor.

DIET

Your dier will be ordered by your doctor. A Registered Dietician is available to speak to you about your diet needs.

Activity

Your activity will be ordered by your doctor and will be increased as tolerated. You will be instructed not to cross your legs, to prevent dislocating your new hip. You will be seen by a Physical Therapist and participate in therapy.

treatment must be more comprehensive than the surgical procedure itself and must include the entire continuum of care, from the pre-surgical physician office visit to effective postoperative rehabilitation. Technological advances have provided procedures and materials that can result in excellent outcomes for patients. In addition, these surgeries are among the most lucrative for hospitals. Therefore, healthcare organisations that strive to deliver excellent and efficient care, protecting patient safety while managing resources and costs benefit from improving the management of joint replacement surgeries. Developing a clinical pathway

To maximise efficiency and standardise the effective transfer of information

Figure 2

among the care-giving team, the collaborative initiative focussed on mapping the process of care from the physician’s office to the operating room to recovery and rehabilitation (Figure 1). The ‘mapping’ was done in a multidisciplinary group of healthcare providers involved in the care. A clinical pathway was developed that would permit the entire team to be on the ‘same page’. Expectations were established for daily therapeutic interventions and appropriate outcomes. The orthopaedic surgeon, with a background in engineering, demanded that each member of his team follow the detailed algorithm of care with the goal of standardising the process of care. It should be noted that many physicians avoid using clinical pathways because

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they perceive them as a nursing tool rather than a detailed method to coordinate and monitor the delivery of care. This surgeon recognised the benefit of following the pathway. The goal of the innovative programme was to focus attention on appropriate patient management. Appropriate management includes processes that reduce length of stay, unplanned returns to the operating room, unplanned return to the hospital, surgical wound infection rates, avoidance of blood clots and results in high patient satisfaction and level of functioning. The team—from surgeon through physiatrist—is educated and trained in the same way. The patient and family attend multidisciplinary educational sessions where they learn what to expect as regards mobility and pain management and meet with the team. Operating rooms and surgical trays are set up the same way. Pre- and postoperative care is managed in the same way. All patients are placed under a dedicated surgical unit. Patient-friendly clinical pathways were developed, which inform patients regarding what to expect from the surgery and recovery in lay language (Figure 2). Using these pathways to educate patients about the details of their episode of hospitalisation and post-surgical care, helped them to become active participants in their own healthcare. The pathways also help to reduce patient anxiety by effectively communicating information about pain management, the importance of nutrition and mobility and expectations for recovery. By standardising every aspect of the delivery of care, outcomes are predictable. Moreover, any variation from expected outcomes is immediately documented on the pathway and therefore quickly recognised and addressed. Noting variation in real time helps the staff focus on patient needs and real-time evaluation becomes integral to the care process. Physicians and nurses have an

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explicit focus for communicating about the patient’s progress and treatment.

Execution tactics team approach Office

Delivering efficient healthcare

Surgery

Post-op care

Rehab

Office

post-surgical care to discharge is seamless and predictable. Patients are housed at the appropriate level of care. Because the patient’s initial history and examination is so thorough, those patients who are at risk for complications are targeted early and carefully monitored by the surgeon and appropriate medical consultants. High-risk patients are moved to the ICU postoperatively if necessary, and encouraged to move to a lower level of care as soon as medically allowed. The successful programme has drawn patients to the hospital and the programme has been replicated in other hospitals. Results of the programme

Results of the programme have been successful. The volume of surgeries

A uthors

The team is trained to work together. Every member of the team gets to know each patient. Each member of the team assesses the patient before surgery; every member of the team is involved in postoperative care. Anaesthesia manages postoperative pain; physical therapy begins the first day after surgery, the physiatrist manages postoperative rehabilitation exercise and a case manager sets up discharge planning. Importantly, each member knows not only his or her own responsibility but understands the responsibility of the other team members as well (Figure 3). Compliance with the key interventions of the care pathway for total hip replacement surgery, for instance, is 100 per cent. Therefore, each patient who has undergone a physical therapy evaluation, is moved from the bed to a chair in a specified time frame, has appropriate pain management, receives anticoagulants and antibiotics prior to surgery, and discontinues antibiotics 24 hours after the end of surgery as the pathway specifies. These standardised interventions lead to predictable outcomes. For example, 100 per cent of patients tolerate getting out of bed to a chair and express an understanding of their pain management. Of course, not every outcome can be predicted, but most patients (over 90 per cent) have laboratory values within a therapeutic range and almost all patients (97 per cent) have incisions without redness, swelling or drainage. The ongoing monitoring by the surgeon reinforces appropriate behaviour of the team. The standardisation and predictability of the delivery of care has an impact on the organisational efficiency and financial integrity of the hospital. Operating rooms are booked and used productively. Materials, staff and supplies are efficiently allocated. Throughput, from the operating room to the

Pre-surgical Evaluation

Table 1

has increased, with a ten-fold increase over an eight-year period. During the same period, complications have been reduced. The rate of infection has decreased to almost zero. The rate of blood clots has also decreased. Patient perception of their physical and mental well-being (using SF-36 v2) is assessed at the preoperative visit, six weeks postoperatively and one year postoperatively. (Results are not available yet.) The pathway improved communication. The patient became a partner, which helped in their recovery; expectations were established and efficiency became an explicit part of the process. Medical responsibility for the ‘total continuum of care’ in combination with evidence-based methodology leads to positive results.

Yosef Dlugacz is an internationally recognised expert in the field of quality management in healthcare. His research focuses on developing models for improved patient safety and clinical outcomes. Dlugacz has educated clinicians and administrators throughout the United States and internationally, with academic appointments at New York University Medical Center, New York Medical College, Hofstra University, Baruch College, CUNY and Beijing University. Carolyn Sweetapple is responsible for the day-to-day business and financial operations of the institute as well as the development and success of the institute’s consulting. Sweetapple was the Administrative Director of Special Projects at Southside Hospital, of the NS-LIJHS. She is licensed as a certified public accountant and registered professional nurse in New York State. Ms Sweetapple is certified as a Six Sigma Master Black Belt and is currently completing a Master’s of Business Administration in Quality Management.

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Managing End-of-Life Experience from England Candy Cooley, Manager, National Genetics Education and Development Centre, England

For years, charities, hospices and small teams of specialist nurses and doctors held the monopoly of responsibility for end-of-life care. Recently, Primary Care (Community) services across England began to realise the importance of a coordination point for the development and management of services.

round half a million people in England die each year from many differing conditions, the majority of whom are over 75. The personal and social care given to these patients and families forms a major part of the dayto-day work for many health, social and voluntary staff. However, it has been identified that too often care for this vulnerable group, is not coordinated effectively across the different service providers and is not designed around peopleâ&#x20AC;&#x2122;s wishes and preferences about the place of care and care delivery. A recent review of healthcare by English National Health Service has clearly identified a number of areas where the lack of coordination and management of end-of-life care services led to a poor service for the patient and their families. It was observed that the current channels of communication within and among health, social and voluntary organisations are not swift enough to respond to the situation and ensure best care to the patients during the emergency situations which demand quick response. Identifying the need

From the early part of the 21st century there have been a number of projects looking to improve the current provision

of end-of-life services. These included education programmes on health and social care to increase the percentage of patients who received healthcare at home (DH 2001). The patients who are in their final stages of life are often placed in acute hospital setting, which is not only very expensive but also not conducive to the situation they are in. This is due to the lack of confidence in community teams to keep patients home, lack of support in an emergency in terms of primary medication, lack of ambulance services which help them in resuscitation and moving them to treatment centres and failure to provide rapid response service to deal with the needs of a dying patient. The NHS in England: The operating framework for 2007/08 published in December 2006, set out local plan of action for Primary Care (Community)

Services

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Trusts (PCTs) for future improvements in the provision of care for all. This included undertaking a local end-of-life care service baseline review in preparation for the development of an End-of-life Care Strategy. The strategy was part of its commitment to help all the end-oflife patients, whatever clinical condition they are in, to have their personal choice regarding the place of care and death. The purpose of the review was to provide PCTs and local authorities with information that would enable them to: • Assess the population need for end-oflife care services • Identify current provision including an evaluation of quality • Contrast the current provision with the identified population need • Decide where service improvements are needed • Be ready to respond to the end-oflife care strategy when published (DH2006) Lord Darzi was asked by the Prime Minister and Secretary of State for Health to lead the NHS Next Stage Review (2008). Seventy-four clinical working groups including over 2000 clinicians were set up within individual SHA localities. The aim of each group was to consider both clinical evidence and the needs of the local community. The groups

identified models of care for their areas to ensure that the NHS is up-to-date both clinically and to meet changing needs and expectations. The review looked at primary areas within the health service to identify if new ways of working might improve patient outcomes and service provision. The End-of-life Care was considered as one of its key pathways, and the End of life Care strategy was to follow on from the review ensuring that the commitment became a reality. End-of-life Care Strategy

Health Secretary Alan Johnson launched the End of Life Care Strategy with an allocation of funds worth £ 286 million in July 2008. The strategy aims to ensure that all adults with advanced, progressive illness receive care at a place of their own choice.The strategy was developed by an advisory board chaired by Professor Mike Richards, National Cancer Director, with stakeholders from health, social care, voluntary organisations and professional and academic organisations. The stated goal of the strategy is for better quality care for patients by making it easier for individuals to voice their choice with regards to the place of care; promoting dignity and respect, ensuring well coordinated services and supporting carers.The new ten-year strategy, the

Key objectives

Care pathways

Key objectives to deliver these improvements in end-of-life care have been identified: • To increase public awareness and discussion of death and dying: this discussion around end-of-life care improves choice and should also act as a lever to improve service quality • To ensure that all people are treated with dignity and respect at the end of their lives • To ensure that clinical symptoms and psychological distress amongst people approaching the end of their lives are kept to an absolute minimum • To ensure that all discussions around choices for end-of-life care are identified, documented, evaluated, respected and acted upon • To ensure that the services people need are coordinated, and deliver seamless care • To ensure that carers and families who take care of patient are supported both during a patient’s life and are offered bereavement support • To ensure that health and social care professionals at all levels receive the education and training that enables them to provide high quality care.

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first of its kind, continues and develops the progress made in end-of-life care services since 2000. Areas it focusses on include: Improved community services - Asking PCTs working with Local Authorities to ensure that rapid response community nursing services are available in all areas 24/7. This will enable more people to be cared for and die at home if they wish Workforce training and development - To train health and social care professionals in assessing the needs of patients and carers and providing the best possible quality care Development of specialist palliative care outreach services - To encourage PCTs and hospices to work together to develop specialist services in the community, which will support all adults regardless of their condition Setting up a national End-of-life Research initiative - To further understand how best to care for those at the end of their lives. Quality Standards - To work with SHA Next Stage Review End-of-life Care to develop quality standards against which PCTs and providers can assess themselves and be assessed by regulators. Care Pathways - Ensuring that there is documented evidence of the choices patients and their families make and the care that is given. (DH 2008)

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Integrated care pathways have been utilised within care settings from the 1990s as a way of ensuring locally agreed, multi-professional care based on guidelines and the clinical evidence (Overill 1998). The completed pathway forms all or part of the clinical record and documents the care given. It also supports the evaluation of outcomes for continuous service improvements. There are key common elements that constitute a care pathway: • Organising the process • Tracing the timeline • Gathering supportive evidence of practice

being admitted to hospital. This includes provision of other services such as equipment provision and ambulance response. GSF can evaluate the requirements and help them in better commissioning of local services. • It is aimed at care for patients living at home and in Care Homes where they are supported by primary care teams • It aims to educate and support community generalists (GPs, District/ Community nurses, Care Home and other staff), to improve the interface with specialists and hospices • GSF is for patients in the final stages of their lives and is applicable to patients with any advanced disease (heart failure, COPD, neurological disorders, renal failure etc.). Once GSF is in place across a community, it enables developments in end-of-life services including specialised palliative care services which lead to improved outcomes for patients and cost-efficient advice for health commissioners. Conclusion

The End-of-life Care Strategy for England has the potential to ensure equitable services for people dying from all conditions, including old age. However, to ensure A uthor

• Ensuring multidisciplinary collaboration • Care identified usually within an agreed time frame • Continuous review of practice • Assessment of variance • Ensuring definite outcome • Constituting all or part of the clinical record • Providing complete information regarding risks and benefits (Overill 1998). The Liverpool Care Pathway for the Dying Patient (LCP) (Ellershaw, Murphy 2005) was developed by staff working at Marie Curie services within an acute hospital and provides a research-based framework for the delivery of best practice care. The LCP encourages a multidisciplinary (MDT) approach to care delivery which focusses on the physical, psychological and spiritual comfort as this has been shown to empower generic staff in the delivery of care. The LCP ensures that patient choices and care are documented and that the information is shared within the MDT. It also allows good evidenced / researchedbased care to be identified if completed correctly. Research with patients at the end of their lives has been fraught with moral issues making it difficult to ensure not only best-evidenced practice but also a cost-effective management of resources to improve services. The Gold Standards Framework (GSF 2001) is a systematic approach to improve the care for the end-of-life patients in the community. Originally developed for primary care by Keri Thomas (a General Practitioner with a Special Interest in Palliative Care and NHS National Clinical lead for Generalist Palliative Care), and supported by a multidisciplinary reference group of specialists and generalists, it aims to improve the care provided in the community by the patient’s usual community care team. One of the key aims of the GSF is to develop community teams and service provision so that more patients are able to choose where they die, and avoid

the recommendations are implemented there needs to be a clear management strategy within the individual NHS Hospital and Community Trusts and Voluntary sector services that enables quick and effective communication to take place. It is imperative to ensure that a pathway of care is implemented properly and choices are documented. Each service needs to acknowledge that patient forms key to the care pathway and information regarding patient and family preferences and treatment decisions should be documented, shared and used accordingly. According to this Strategy, the days are gone when decisions were made by health professionals or based on the availability of services. This will mean some radical changes to both the culture and provision of services for the dying and their families which need to be both well managed and receive adequate financing. These changing expectations by individuals, their families and health and social care practitioners are being seen as key aspect of healthcare in many ‘western’ countries where ‘care’ is emerging as an important indicator of clinical excellence along with ‘cure’. References are available at http://www.asianhhm.com/magazine

Candy Cooley worked for over 14 years in an academic capacity teaching cancer and palliative care at undergraduate and post graduate level. She was the Consultant Editor of the International Journal of Palliative Care from 2004 until 2008. She also has a wide publication and conference presentation profile.

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Medical Tourism Role of telemedicine

Medical tourism has become an important alternative for patients to get timely treatment and to seek desired medical care in foreign countries. Telemedicine can play a vital role in medical tourism through an evaluation of the involved business processes.

Telemedicine Suman Bhusan Bhattacharyya Vice-President (Clinical Services) Karishma Software Limited and Secretary, IAMI, India

lthough it may easily be dismissed as another BPO-like fad, medical tourism is nothing short of a serious business that has the potential to revolutionise the global healthcare industry. It is worth US$ 300–375 million, and growing at a rate of 30 per cent annually (2004 figures). Today, patients are combining vacation with care because either the local treatment is too expensive or involves long waiting periods or both. Telemedicine is a serious attempt at bridging the gap between the care receivers and providers by making physical distances irrelevant and cutting down on travel. An essential cog in the wheel of medical tourism, it facilitates the patient and the care providers to “know each other” before they meet each other for the first time. It allows all the remote and local care providers to exchange health-related notes on an on-demand basis throughout the duration of the clinical care process beginning from the first encounter, to follow-up sessions until the patient is relieved. Consequently, it increases the efficiency, productivity and attractiveness of medical treatment as a whole and medical tourism in particular.

The word Telemedicine is a combination of the Greek word ‘Tελε’ (tele) meaning ‘distance’ and the Latin word ‘�� mederi��’� meaning ‘to heal’ and therefore literally means, ‘�� distance healing�� ’�� . It is not one specific technology but a means of providing health services from a distance using telecommunications and computer science. It spans every level of healthcare from the first responder or emergency medical systems to tertiary medical speciality consultations to performing invasive and / or surgical procedures delivering home care. The technology makes it possible to have the ‘right’ information (clinical information) available to the ‘right’ people (patients, care providers, family and friends) at the ‘right’ time (ondemand, during and after the treatment process). In short, telemedicine is a high-tech solution to the universal problem of access to healthcare irrespective of physical location of the various stakeholders of the clinical care process. Medical tourism

Medical tourism is a term applied to the process where people from all around the world travel to foreign countries to obtain medical, dental and surgical care. At the same time, it is a tour, a vacation and an experience of visiting them. Medical tourism companies help organise patients’ treatment, travel

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arrangements and tours. The modus operandi is to couple the medical treatment with travel and tourism at a fraction of cost incurred in the patient’s own country. This is a great value addition to all concerned. The patient gets relief quickly without compromising on the quality and quantity of care. The healthcare industry earns valuable revenues. The healthcare industry gets invaluable business. The countries where medical tourism is being actively promoted include Greece, South Africa, Jordan, India, Malaysia, Philippines and Singapore. Medical tourism definitely adds itself to the top-line of the various healthcare institutions. Even though the revenue model is volume-dependent, the capacity and quality of care is enough to ensure healthy profit margins at reduced rates. Medical tourism business process

In medical tourism, the basic business process is as follows: 1. A patient residing in an area where he is unable to get relief from his problems due to high treatment costs, long delays in getting the treatment or both, looks for ways and means to get relief as soon as possible at equal or lower cost 2. Patient decides to travel to a place where the cost of comparable quality and quantity treatment is same or less and is readily available 3. A competent care provider at an institution of patient’s choice located in

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a foreign country reviews patient’s case records and gives an appointment. 4. The patient then travels to the country where the institution is located and receives the treatment 5. Pre- or post-treatment, patient conducts some sightseeing according to his choice (and budget), and then at the termination of his visit travels back to his country with all his treatment records and post-treatment advice to his primary care physician 6. For follow-ups required at his place of residence, patient is provided with instructions regarding how these actions need to be undertaken The most important decision point being both the quality and quantity of care ensure patient safety while providing the best of care available anywhere. The prime area of concern however is that the patient visits and gets treated by a set of care providers who have never ever seen him before and will probably never see him again. This leaves only non-physical contact methods to interact when the need arises. If and when he requires any follow-up evaluation and advice for the actual treatment received, he will have to rely on those care providers who did not provide the treatment and most possibly have only limited information regarding the same. Consequently, he is left to rely on telecommunication to help him bridge this gap, perceived or otherwise.

The patient is thus left with several options such as letters, faxes, expensive long-distance telephone calls, instant messenger chatting, video conferencing (low grade: inexpensive and informal; high grade: expensive and formal requiring prior appointments) etc. Added to this cauldron is the inevitable mayhem of information lost in transmission and faulty instructions percolated through —all due to the existence of non-integrated information exchange mechanisms causing serious inefficiencies to creep in to the healthcare delivery system. Thus, records are neither correctly interpreted nor received on time in many instances. These invariably lead to a great deal of stress, which is extremely undesirable especially in a sector where stress-free environment should be the first requirement of both the provider and receiver. Telemedicine-enabled scenario

Let us now consider what would happen in telemedicine technology environment. Here, the patient would have a single medium through which a ‘virtual’ clinical encounter can take place where clinical data exchange—both textual and visual— can be done electronically on-demand at the speed of light. The entire medical record is available to all the stakeholders right from the beginning as the patient continues to receive his treatment irrespective of his physical location. Once he is

back in his country of residence, he can continue to receive follow-ups remotely with his care providers who treated him and are consequently in the best position to monitor his progress. His primary care physician or any other care provider based locally would have physical access to the patient and can use the technology to hold consultations with the foreign care providers either as a conference in the presence of patient or by direct interaction. The business process points that would get impacted through telemedicine would be as follows: 1. First encounter or a series of pre-procedural evaluation encounters—where the patient would interact with his foreign care providers. Telemedicine will allow a comprehensive remote-consultation face-to-face and one-on-one. If needed, medical records can be exchanged and reviewed. The primary care or the referral physician can actively participate to help clarify health issues and in devising a care plan 2. Procedural encounters—where the primary care physician can actively participate in all encounters, including surgeries as observers, and be an integral part of the care process 3. Follow-up encounters—where the patient gets in touch with his foreign care providers whenever he requires. Telemedicine allows a face-to-face interaction where the local primary

Medical tourism process Has time / money constraints? Patient has a problem and requires immedaite relief

Choose a medical tourist agent

Make contact with doctors in the medical tourist spot

Exchange information take appointment

Travel to the country, get treated, take a vacation

Travel back home, follow-up care locally

Have a problem / query

Yes

Can be tackled locally? No Contact foreign-based doctor; Get advice

End of Process

Yes

Problem alleviated/ query addressed

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Conclusion

Both telemedicine and medical tourism are here to stay. Both of them are bound to increase in acceptance and practicality to a point where it would be considered not a ‘nice to have’, i.e. want or premium requirement, but a ‘must have’, i.e. need or basic necessity.

There is a great synergy between telemedicine and BPO in healthcare in general and medical tourism in particular. For any healthcare process, there has to be a follow-up and it does not make much sense either to ask the patient to return or to forget about him once discharged. Therefore, follow-up advice and re-evaluation is imperative. Also, patient’s local care provider needs to be instructed regarding what all needs to be done further and what not. And, this is currently possible only through telemedicine. It may justifiably be stated that without telemedicine, medical part of medical tourism is incomplete. Telemedicine A uthor

care physician can actively participate to ensure better level of post-procedural and follow-up care to be delivered There are inevitable downsides of telemedicine technology ranging from issues related to patient privacy and secrecy due to electronic transmission of Protected Health Information (PHI) to differences in time zones leading to encounters taking place at odd hours to faulty connectivity. Since nothing comes without a price, the stakeholders need to be aware of the costs involved in it and concentrate more on its benefits. Then, the entire experience will truly be a fascinating one.

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allows for exchange of the patient’s medical record. Once the treatment cycle is over and the patient is fit for discharge, telemedicine becomes the medium-ofchoice to follow-up remote monitoring and consultation. Since the patient is always a tourist in medical tourism, he is expected to be at a physical distance that cannot be easily bridged. His local care provider may frequently be unable to provide adequate help in many clinical situations that has a direct causal relationship with the care received in a foreign land. Telemedicine accomplishes this and therefore needs to be an integral part of medical tourism.

Suman Bhusan Bhattacharyya is a healthcare domain expert with over two decades of experience. He is a business solutions architect for healthcare provider applications and has worked for several IT MNCs in India. Currently, he is working as Vice-President, Clinical Services, Karishma Software Limited and is the National Secretary to the Indian Association for Medical Informatics.

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Srishti Software Riding the Hospital Management Information Systems (HMIS) wave

he growth in medical tourism has forced the hospitals today to comply with some standards in their administration and the way they run their operations. Thus, they are implementing Information Technology in a big way. Following its success in HMIS, Srishti Software is today announcing its change to Channel Sales from the direct sales model it had been following so far. The healthcare industry in India is estimated to be worth US$ 20 billion, growing at a steady pace of about 20 per cent year-on-year, according to Mckinsey. According to Ajay Sharma, CEO, Srishti Software, “In the next few years implementation of high-end IT for operational and clinical integration, will be a key differentiator, and hospitals that do not do this will actually die.” This is mainly because to attract international patients, the criteria is being either JCI or NABH (National Accreditation Board for Hospital) compliant. Interestingly enough, NABH, which is an Indian accreditation, is more stringent than JCI. Today, only 20 hospitals across the country are NABH accredited. Advantage

In addition to automation of day-to-day admin and logistical processes, Srishti brings to the table highend clinical integration and analysis. Christened PARAS, Srishti’s range of HMIS products offer a robust centralised, well-integrated, real-time solution that plays a key role in the everyday workings of hospitals and plays a key role in clinical integration and decision-making. PARAS, has in the process been successfully implemented in more than 40 hospitals in India including: • Vinayaka Mission Medical College and Hospital, Salem • KG Hospital, Coimbatore

• Rashtrapati Bhawan, New Delhi • Narayana Nethralaya, Bangalore • TATA Chemicals Hospital (Babrala), UP • TATA Chemicals Hospital (Mithapur), Gujarat • Sri Jayadeva Institute of Cardiology, Bangalore • Mahavir Cancer Sansthan, Patna • Seventh Day Adventist Medical Centre, Bangalore • Shija Hospital, Imphal • Karnataka Government • Prashant Hospital, Muzaffarpur. Channel Sales Model

• Srishti today has regional master partners spread across the domestic market and one for North Africa and one for all six countries of the GCC. • The international regional partners have their own channels and value-added resellers and local distributors. • In the domestic market Srishti has 6 Value-Added Resellers (VARs) and around 20 resellers below them who are spread across the country. • The VARs, who are trained by Srishti do basic customisation, training and provide the first line of support. While the local resellers’ responsibilities are restricted to pure selling. • Srishti provides back-up support and handholding and steps in on a need basis whenever there is an AMC. Financial Picture

Srishti Software is confident of clocking US$ 5 million from sales in the current year, a big jump from the US$ 1.2 million in the same period last year. A growth of more than 4 times year-on-year is expected.

Ajay Shankar Sharma

CEO Srishti Software Applications Pvt.Ltd.

Advertorial

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Medical Tourism in India Seeking a differentiator

Incorporating Ayurveda into mainstream medicine could be an advantage to Indian hospitals in the medical tourism market.

Vandana Wadhawan Member, Editorial Team Asian Hospital & Healthcare Management

he rise of medical tourism in Asia over the last few years has been phenomenal. Along with the huge opportunity for growth, it also brought along a need for Asian healthcare providers to meet world-class standards of patient care in order to attract patients from the developed nations, especially USA. This change has been particularly visible in the Indian healthcare sector, which has grown with the steady influx of foreign patients. Coupled with the rise of the private sector, medical tourism has put India firmly on the global healthcare destinations map. With the best infrastructure, the best possible medical facilities, and the most competitive prices, India continues to attract patients. While this happens, however, remaining competitive over the long run will require them to develop core competencies unique to India. The core competence

India has been able to keep pace with the latest in technology and its applications, has been widely felt in the healthcare industry. That is to say, Indian hospitals offer the modern medical treatments available in other parts of the developing world as well. In such a scenario, the biggest differentiator could be the cost

of treatment. But costs are bound to rise and as that happens its value as a key differentiator comes down. In the long run a value add-on unique to India could be the best differnetator. In this case, considering the knowledge base that has its roots in the country since past several centuries, Ayurveda is an emerging option. Renowned for ancient alternative therapies such as Ayurveda, Yoga and Meditation, India has historically proved to be an oasis in the modern world, providing complete health and well being. Dr RV Karanjekar, former Medical Director at the Fortis Heart Institute, observed at a medical tourism conference in 2005* and said, “India will have to project itself as being a holistic medical destination to get an edge over other countries”. A small beginning seems to have been made in this regard with Apollo Hospitals announcing plans to start an Ayurvedacentred healthcare city. Sangita Reddy, Executive Director, Apollo Hospitals Group says regarding Apollo’s plans, “In keeping with our view to provide holistic care for improved quality of life, we have set up an Ayurveda centre that provides outpatient consultation and treatment therapies for a range of conditions.” Besides Apollo, AyurVAID Hospitals, a Kerala-based chain of hospitals Medical Tourism: Opportunities and Challenges for India

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offering exclusive Ayurvedic medical services opened its centre recently. Ganesh Subramaniam, one of the promoters says, “There is a void in mainstream healthcare which is being effectively complemented by Ayurveda. To that extent, appropriately integrating the two will enable delivery of comprehensive healthcare services to the market.” There already seems to be a precedent existing in the West where Ayurveda is gaining popularity and research taking place to study this domain of care. At Apollo hospital, Ayurveda will be a part of the centre’s outpatient department. “We view India’s indigenous systems of medicine as complementary to allopathic practices”, says Sangita Reddy. A need to explore synergies

The greatest hurdle to the integration of Ayurveda into mainstream healthcare could come from the fact that the two are inherently different. While today’s medicine is driven by published evidence, little or no evidence exists in regard to the treatments offered by Ayurveda. Further, research in this direction is little or non-existent. This is the key deterrent to integration of Ayurveda into mainstream healthcare. And till it is sorted out, Ayurveda might continue to be used only on the periphery of mainstream healthcare, like, in case of Apollo, its outpatient department. The entry of private players in the Ayurveda sector, however, could be the much needed initiative for bridging the

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Sangita Reddy Executive Director Apollo Hospitals Group India

What made Apollo Hospitals take the initiative of opening a 100 % Ayurveda Treatment Centre? What are Apollo’s future plans with regard to this new foray? Apollo views India’s indigenous systems of medicine as complementary to allopathic practices. In keeping with this view, we have pioneered Rehabilitation and Rejuvenation Centres, besides advocating the concept of ‘wellness’ as an absolute pre-requisite to preventing disease and promoting health. Also in keeping with our view to provide holistic care for improved quality of life, we set up an Ayurveda centre that provides outpatient consultation and treatment therapies for a range of conditions. The centre offers treatment therapies for rejuvenation, stress management, obesity etc. Can holistic medicine be incorporated in mainstream healthcare? Indigenous systems of healthcare have always had an important role to play in our country. The government too has openly acknowledged this, and talked about their integration with mainstream medicine as envisaged in the National Health Policy of 2002 and the National Rural Health Mission of 2005. Do you think that incorporation of Ayurveda into the mainstream science would give an edge to India over other Asian countries in the Medical Tourism sector? India has always healed the world, right from the days of Charaka and Sushruta. India’s traditional medicine methods are popular abroad, and Ayurveda, in particular, is a huge draw for tourists travelling to

India. The Medical Tourism industry, which initially operated on similar lines, catered to the demand for the holistic treatment of the mind and the body. Today, as the Indian healthcare industry is coming into its own on the strength of its value proposition in terms of the global quality of care at about a fraction of the cost, we have begun to attract a sizeable number of foreigners who seek our healthcare services for elective surgeries. But the concept of providing uniquely Indian value addition, in the form of the rejuvenation and therapeutic power of Ayurveda, remains valid yet small. What synergies do you see between Ayurveda and mainstream medicine? There has been very little work dedicated to research in this area. Apollo has plans to use the auspices of its AHERF (Apollo Hospitals Education and Research Foundation) to look into the possibilities of some groundwork in this area, especially in the realm of chronic conditions. Also, Medvarsity, Apollo’s distance education platform, already runs a one year online programme in Holistic Healthcare as a fellowship for graduates in any discipline of medicine, including MBBS. The emphasis of the programme is on eliminating the cause of disease, rather than treating its symptoms alone. The doctor-students taking the course are presented a wide array of therapies for treating disease and creating optimal health. They learn the scope of holistic medicine, in making it an essential part of the medicine of the new millennium.

Ganesh Subramaniam, Co-Promoter AyurVAID Hospitals India

Can holistic medicine be incorporated in the mainstream healthcare? There is a void in mainstream healthcare which is being effectively complemented by Ayurveda. To that extent, appropriately integrating the two will enable delivery of comprehensive healthcare services to the market. In fact, our USP of working with mainstream doctors for specific conditions is a step in this direction. What synergies do you see between Ayurveda and mainstream medicine? The few conditions in which there are demonstrated synergies include stroke rehabilitation, epilepsy management, multiple sclerosis, parkinsonism, low back ache etc. Do you think that incorporation of Ayurveda into the mainstream would give an edge to India over other Asian countries in the Medical

Tourism sector? How and why? It definitely will. Exporting our knowledge base should be one of the objectives of any tourism policy. What patients (domestic/ International) do you expect to come for the Ayurveda treatment? Our target market is the domestic sector. There is a huge demand supply gap as on date. Moving forward, it is possible that we may look at medical tourism. What is taking the Indian Hospitals so long to merge Ayurveda with the modern treatment? There are several reasons for this including lack of initiative on the part of the Ayurveda sector to bridge the gap and engage in dialogue with other stakeholders, absence of corporate hospitals in the Ayurveda sector and a lack of market awareness

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H ealthcare management

A brief history of medical tourism The concept of medical tourism is as old as medicine itself. In olden times, Asian countries had their own alternative / herbal medicine long before modern medicine came in. Some examples include: • People from France, Britain, Ireland and Italy travelled to Germany for spa treatment • Europeans went to Egyptian Nile River to experience hot mineral water baths • In China, traditional herbal preparations accounted for 30 per cent - 50 per cent of the total medical consumption • In Ghana, Mali and Nigeria, the first line of treatment for 60 per cent of children with high fever is use of herbal medicine • In India, yoga and ayurveda attracted a constant influx of medical scholars and travellers from all over Europe and Middle East hoping to master and benefit from these revered branches of alternative medicine. In the modern times it has acquired a new dimension. Low cost of the diagnostic procedures and the efficiency of the medical treatments is a guiding force that brings the patients from all over the world into the Asian hospital premises. With the underinsured and uninsured population growing in the US, the need to lower the medical costs increased. That was not easy and thus started the outflow of the patients. Asia seemed to be right destination with low cost and high quality

gap that exists between Ayurveda and allopathic medicine. As Sangita Reddy points out, Apollo plans to carry out research through the Apollo Hospitals Education and Research Foundation (AHERF) and look into the possibilities of some groundwork in this area with a focus on chronic conditions. This change in approach of India’s private sector towards Ayurveda is a sign of the Indian healthcare sector, “coming into its own on the strength of its value proposition in terms of the global quality

services. Asian hospitals had to achieve tough international patient safety standards, like the ones promoted by the Joint Commission International (JCI). Asia’s rendezvous with accreditation took the competition for medical tourists to a new level. Indraprastha Apollo Hospital became the first Indian hospital to get accredited by the JCI Today, more than nine hospitals in India have got the JCI accreditation, and more are in line. However, as the competition heats up—both at the national and the regional level—hospitals will need to come up with new differentiators. India is one of the preferred destinations in the world for Medical Tourism. Most familiar treatments include heart surgery, knee transplant, cosmetic surgery and dental care. In the year 2007, around 272,000 medical tourists visited India and brought revenue of US $ 656 Million. India has also come up with its own accreditation system through the National Accreditation Board for Hospitals & Healthcare Providers under the Government of India. Today’s medical tourists primarily come from US, Canada, Great Britain, Western Europe and Australia to receive medical treatments ranging from heart surgery to hip replacement.

of care at about a fraction of the cost”, adds Sangita Reddy. There’s a long way to go before Ayurveda gets it rightful position in the world of mainstream healthcare that is changing at a rapid pace. But this trend is a positive one and has the backing of the entrepreneurs shaping Indian healthcare’s future. With their focus on Ayurveda they could create for India a niche in the medical tourism market. And this augurs well for India’s ancient healing system.

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M edical sciences

Michael Gold Professor Medical University of South Carolina, USA Yong Cho, Tom Bennett Douglas Hettrick Medtronic Inc., USA

ong-term management of patients with Congestive Heart Failure (CHF) is a growing burden on healthcare systems throughout the world today. Management of patients with CHF is confounded by the observation that signs and symptoms in many of these patients are not well-correlated with actual disease status. Hemodynamic monitoring

Current methods for routine hemodynamic evaluation (e.g. Swan-Ganz catheterisation and echocardiography) are costly and not well-suited for repeated serial measurement in the ambulatory setting. Recently, considerable investigation has focussed on the development of alternative methods of assessing patientâ&#x20AC;&#x2122;s disease status. Implantable hemodynamic sensors may enable frequent monitoring of hemodynamic changes in CHF patients and be used as a surrogate for serial invasive catheterisations in tailoring and titrating medical therapy. Furthermore, continuous monitoring of hemodynamic measurements might provide unique insight regarding pathophysiological mechanisms and chronic responses to treatment regimens. Pressure monitoring system

A totally Implantable Hemodynamic Monitor (IHM) has been developed for outpatient HF management. The IHM system consists of a pacemaker-like device that processes and stores information and a transvenous lead incorporating a high fidelity pressure sensor near its tip. The implantation procedure is similar to that of a single chamber pacemaker system with the lead positioned in the right ventricular outflow tract or high right ventricular septum in an area of

Representation of intrathoracic impedance measurement: A low amplitude constant current pulse is transmitted from the right ventricular therapy lead to the device case and the resultant voltage and impedance is determined.

Figure 2

Monitoring with implantable devices Implantable devices, including pacemakers, defibrillators and cardiac resynchronisation systems, may play a role in helping monitor the progress of heart failure in an individual patient.

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M edical sciences

high blood flow. The IHM measures and stores heart rate, patient activity, right ventricular systolic and diastolic pressure, estimated pulmonary arterial diastolic pressure (ePAD), positive and negative dP / dt, right ventricular pre-ejection and systolic time intervals, and body temperature. A strong correlation (r=0.84) was demonstrated between actual pulmonary artery pressures and ePAD under a variety of physiologic conditions. The IHM system continuously measures and stores hemodynamic information that can be reviewed remotely via the Internet. The website automatically processes and concatenates new data received from the device with data from previous transmissions and provides visual representation of the data in the form of trends over time (Figure 1). Clinical trials

Several studies demonstrated safety and accuracy of the implantable hemodynamic monitoring system. The COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) study randomised 274 NYHA Class IIIIV patients, all of whom received an IHM, to the Chronicle-guided management group (n=134) or control group (n=140) over a 6-month follow-up period. The study demonstrated the IHM was safe and able to reduce the rate of heart failure-related events. However, this 21 per cent reduction in events did not reach statistical significance (p=NS) . Retrospective analyses from COMPASS-HF provided new insights to the pathophysiology of the transition from stable, compensated HF to the decompensated state in HF patient with reduced left ventricular ejection fraction (LVEF) and among HF patients with preserved LVEF (i.e. diastolic heart failure). These data suggest that chronic management of HF by the IHM may also be comparable in these two groups of HF patients. Another currently on-going trial (Reducing Events in Patients with Chronic Heart Failure; REDUCEhf ) will prospectively test the hypothesis that

the ambulatory hemodynamic monitoring can indeed reduce the rate of heart failure-related hospitalisation. Intrathoracic Impedance Monitoring

The correlation between changes in biological impedance and physiologic parameters, such as respiration rate and cardiac hemodynamics has been studied for decades. For example, the estimation of left ventricular volume using the impedance catheter technique is the gold standard of physiological research quantifying left ventricular pump function since the 1980s. Likewise, many implantable devices employ impedance as a method of monitoring therapy system performance. Also, some devices use changes in impedance associated with the respiratory cycle to help automatically adjust the pacing rate. More recently, the association between acute decreases in intrathoracic impedance and acute decompensation of CHF was investigated. Early clinical trials

The MidHeft trial provided the first clinical evidence that daily monitoring of intrathoracic impedance measured between the right ventricular defibrillation coil and the devise case could provide a clinically useful tool for

Asian Hospital & Healthcare Management

monitoring the onset of acute heart failure decompensation (Figure 2). Device recorded daily impedance data from this non-randomised double blinded prospective trial (n=33) was used to develop and validate an algorithm to detect acute pulmonary fluid accumulation based on day-to-day changes in the actual recorded daily intrathoracic impedance. The algorithm calculates dynamic reference impedance based upon trends in the measured daily intrathoracic impedance. Differences between the measured daily impedance and the calculated reference impedance are used, in turn, to increment or reset a â&#x20AC;&#x2DC;fluid indexâ&#x20AC;&#x2122; (Figure 3). According to the reported results of the study, the fluid index for patients who were hospitalised for acutely decompensated heart failure crossed a predetermined fluid index threshold (60 ohm days) prior to hospitalisation in over 77 per cent of the events. The changes in the calculated fluid index occurred on average 15 days prior to symptom onset. The trial also observed that the rate of fluid index threshold crossings not associated with imminent heart failure hospitalisation was about 1.5 events per patient per year. Initial results from the FAST trial, a follow-on prospective clinical trial in ICD and CRT patients, further validated

Visual representation of device data Note 1. Pressure increase noted. Patient contacted by phone, states she feels OK. 2. Reinitiated phone contact with patient. Patient admits deitary noncompliance. Weight increace 4kg Matalazone 205mg/dayinitiated 3. Carvedilol inditeated The trends show the daily median (black line) and the daily ranges (pink lines) over one month when the patient was non-compliant to dietary restrictions and ate salted popcorns. Clinical notes corroborate the pressure changes. Figure 1

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M edical sciences

same year as the crossing (Figure 4). In addition, changes in intrathoracic impedance also showed good correlations with both weight and BNP levels. All of these trials confirmed the fundamental hypothesis that intrathoracic impedance monitoring can provide a useful clinical tool to help manage patients with congestive heart failure. However, two current randomised multi-centre clinical trials including PRECEDE HF and DOT are independently testing the hypothesis that in-office and remote monitoring of device diagnostic data, including intrathoracic impedance monitoring, will improve a combined primary endpoint of death and heart failure hospitalisation.

Fluid index OptiVol fluld index

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Integrated diagnostics

Estimated filling pressure with intrathoracic impedance monitoring

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Sample implantable device patient diagnostic report including intrathoracic impedance fluid index and programmable threshold as well as the raw recorded daily and calculated reference impedance. Decreases in the trend of the measured daily impedance are reflected by consistent increases in the calculated fluid index. Fluid index values greater than the pre-programmed threshold indicate potentially worsening heart failure due to thoracic fluid accumulation.

Figure 3

the potential clinical utility of chronic intrathoracic impedance monitoring to manage heart failure. Recent clinical findings

Since the MidHeft and FAST trials, a number of other published investigations further validated the clinical utility of chronic heart failure monitoring using device recorded intrathoracic impedance. Vollmann and colleagues performed a multi-centre non-randomised investigation of 372 patients with CRT-D devices that included intrathoracic impedance monitoring. Many patients in this trial were automatically alerted to fluid index threshold crossings by an audible alert tone transmitted by the device. The authors reported an adjusted sensitivity and positive predictive value of the alerts to various clinically relevant events associated with heart failure of 60 per cent respectively. Ypenburg and

colleagues followed 115 CRT-D patients with intrathoracic impedance monitoring for an average of nine months. They reported that the sensitivity and specificity of the fluid index depended strongly on the programmed detection threshold. They concluded that optimal algorithm performance may require tailoring the threshold value to fit the needs of the particular patient. Small and colleagues also performed an analogous investigation in 326 US CRT-D patients with intrathoracic impedance monitoring but no audible alert, which are not yet approved for use in the US. That analysis included univariate and multivariate linear regression of changes in the fluid index as well as other device diagnostic parameters. The results indicated that each intrathoracic impedance fluid index threshold crossing was associated with a 51 per cent increased probability of a heart failure hospitalisation within the

Chronic monitoring of both estimated left ventricular filling pressure and Intrathoracic impedance represents the potential for further improvements and refinements to device-based remote clinical monitoring. The relationship between changes in these two parameters was investigated in a few small-scale clinical studies. These pilot data indicate good correlations between right ventricular pressure and intrathoracic impedancederived parameters of worsening heart failure. Therefore, chronic monitoring of both estimated filling pressures as well as intrathoracic impedance may substantially improve both the sensitivity and specificity of each respective parameter to predict acutely worsening heart failure as well as other clinically relevant events prior to manifestation of clinical symptoms. Clinical trials currently underway, such as the REDUCEhf trial, should help to elucidate these complex relationships in the heart failure population. Eventually, sophisticated computational algorithms that simultaneously consider multiple parametric changes determined separately from multiple independent sensors may be developed from such clinical data.

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M edical sciences

AF / CHF

The complex relationship between CHF and both atrial and ventricular arrhythmias is well described. However, hemodynamic and electrocardiographic data recorded by implantable devices have helped to further elucidate this complex interrelationship. Recent investigations have reported intriguing correlations between changes in intrathoracic impedance and the onset of both atrial and ventricular tachyarrhythmias. These results demonstrate that reductions in intrathoracic impedance often precede individual occurrences or â&#x20AC;&#x2DC;stormsâ&#x20AC;&#x2122; of arrhythmias. Likewise, the onset of a persistent atrial tachyarrhythmia often portends acute decompensation for congested heart failure. The nature of this interrelationship may vary from patient to patient or perhaps even within an individual patient. Thus, implantable device diagnostics that reveal intricate temporal relationship between arrhythmia onset and acute decompensation may play a key role in tailoring therapies for both co-morbidities. Heart rate variability

The longstanding ability of implantable devices to monitor both paced and intrinsic ventricular cycle lengths has fostered interest in leveraging that capability to monitor changes in heart rate variability and day and night heart rates. Such diagnostic data may provide relative insight into the condition of the autonomic nervous system. Several implantable devices now provide long-term diagnostic trends for such parameters. Recently, Adamson and colleagues demonstrated that reductions in device measured indices of heart rate variability often precede episodes of acute heart failure decompensation. Similarly, results of the OFISSER trial showed that increases in night heart rate were associated with acute heart failure decompensation in patients with CRTD therapy. These diagnostic parameters are somewhat limited by other factors. For example, if the patient is experiencing a persistent atrial arrhythmia,

Kaplan Meier survival analysis

Proportion wirhout heart failure hospitalisation

Intrathoracic inpedance fluid index threshod crossings(yr-1)

Months Kaplan Meier survival analysis of time to first HF hospitalisation for groups of patients with similar frequency of thoracic impedance fluid index threshold crossings: Patients with more frequent crossings were significantly associated with Heart Failure hospitalisations over the same time period Figure 4

or if the device is controlling the atrial rate by frequent pacing, then heart rate parameters such as heart rate variability are not calculated and the diagnostic information is hence unavailable. This scenario can represent the majority of time for some patients with implantable devices, especially those who are pacemaker dependent. Arrhythmia monitoring

The ability of implantable devices to detect and discriminate various atrial and ventricular tachyarrhythmias accurately has been exhaustively documented. These capabilities are required in order to apply automatic therapies safely and appropriately for both ventricular and, in some devices, atrial tachyarrhythmias. Many devices augment these automated detection capabilities by storing ventricular and atrial bipolar electrograms recorded prior to and during tachyarrhythmias. However, besides augmenting device therapy, the ability to record and report the precise date, time duration, cycle length and example electrograms of such arrhythmias can also have impor-

Asian Hospital & Healthcare Management

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tant diagnostic applications. For example, it has been shown that symptoms are a relatively poor indicator of atrial tachyarrhythmia occurrence. That is, most atrial arrhythmia episodes are asymptomatic. Likewise many reported arrhythmia symptoms are not associated with an actual arrhythmia. Therefore, device monitoring capabilities represent a reliable and diligent method of monitoring arrhythmias that may bay used to help manage pharmacologic and non-pharmacological rate and rhythm control strategies. The recent TRENDS clinical trial examined the potential of these implantable device atrial arrhythmia diagnostics to help monitor the risk of thromboembolic events. This study was underpowered to achieve the primary endpoint. However, a posthoc analysis of this multi-centre non-randomised trial (n=2486) showed that the thromboembolic event risk may be a quantitative function of atrial tachyarrhythmia burden. That is, atrial tachyarrhythmia AT / AF burden greater than 5.5 hours on any of 30 days prior to the event approximately doubled the

M edical sciences

thromboembolic risk. Hence, devicedetected AT / AF burden may help identify subgroups at higher risk for thromboembolic events. The ASSERT study is an even larger study with much longer follow-up and should answer many further questions regarding the predictive value of AF burden for strokes in high risk patients. Clinical adoption and remote monitoring

A uthor

The rapid advances in device monitoring capabilities have, to some extent, outstripped the ability of many clinics to leverage the plethora of available diagnostic information. However, many implantable devices now also contain telemetric capability that allows the device to transmit all sensor derived parameter trends from the patient’s home directly to the clinic. This is typically achieved through a bedside monitoring / telemetry device that can be programmed by the clinic to transmit automatically based on preset schedule. Alternatively, a transmission of device stored monitoring and diagnostic data can also be triggered based on detected clinical events. For example, some devices can be programmed to alert the clinic directly if the patient experiences the onset of atrial tachyarrhythmias or if the ventricular rate during a sustained atrial tachyarrhythmia exceeds a pre-programmed threshold. Such remote monitoring ‘care alerts’ may be quite useful to monitor rate and rhythm control strategies. These remote monitoring capabilities also foster the potential to transmit non-device recorded information automatically, such as weight, blood pressure and associated symptoms back to the managing clinic. Thus, the stage is set for a new paradigm of heart disease management based on continuous

remote monitoring rather than intermittent clinic visits. The future

The number and variety of physiologic sensors and the useful clinical parameters derived from those sensors is likely to continue to increase rapidly. For example, in addition to the capabilities described above, future devices may include additional sensors to track respiration parameters (including rate, minute ventilation and perhaps apnea and dyspnea detection), tissue perfusion (via optical sensors), cardiac output and stroke volume (via impedance acute ischemia or myocardial infarction via S-T segment monitoring), electrical alternans and heart rate turbulence. Indeed some recently released devices already contain some of these fascinating capabilities. The development of practical chemical sensors to monitor parameters, although less mature, is also feasible. However, some external glucose pumps for the chronic management of diabetes also contain chronic intermediate-term (i.e. several days) subcutaneous glucose monitoring capability. The ability of such chemical sensors to augment other device monitoring capabilities for heart failure or other risks will require investigation. References Bourge RC, Abraham WT, Adamson PB, Aaron MF, Aranda Jr JM, Magalski A, Zile MR, Smith AL, Smart FW, O’Shaughnessy MA, Jessup ML, Sparks B, Naftel DL, Stevenson LW. Randomised Controlled Trial of an Implantable Continuous Hemodynamic Monitor in Patients With Advanced Heart Failure: The COMPASS-HF Study. Journal of the American College of Cardiology. 2008;51:1073-1079.

Michael Gold is the Michael E Assey Professor of medicine, as well as the Director of the Division of Cardiology and Associate Dean of Interdisciplinary Clinical Programs at the Medical University of South Carolina in Charleston. He has authored over 125 articles in peer-reviewed journals, in addition to over 30 book chapters. He sits on the Editorial Board of several peer-reviewed journals, including American Journal of Cardiology, PACE, Heart Rhythm, and Journal of Cardiac Electrophysiology.

Undiluted Industry Knowledge Now also online!

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M edical sciences

Treatment of Stroke

Acting on the symptoms Prompt recognition of suspected stroke symptoms and immediate activation of Emergency Medical Services (EMS) are crucial to effective pre-hospital stroke care, early access to stroke specialist services and successful management.

Caroline Watkins Professor, Stroke and Older People's Care Michael Leathley Senior Research Fellow Stephanie Jones Research Fellow Clinical Practice Research Unit Department of Nursing University of Central Lancashire, UK

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ISSUE - 17 2008

stroke has been defined as “a focal, or at times global, neurological impairment of sudden onset, lasting more than 24 hours or leading to death, and of presumed vascular origin”. However, this definition has, as a result of time-dependent treatment and management, become redundant. Stroke is the third most common cause of mortality in the developed world and is also the leading cause of adult neurological disability. Due to ageing populations worldwide, it has been estimated that by 2020, stroke will be the leading cause of lost healthy life-years. Not only does stroke have a devastating impact on both patients and their families, there are also financial implications for society as a whole. Stroke costs the National Health Service (NHS) in the UK approximately £ 2.8 billion a year in direct costs. Moreover, an additional cost of £ 1.8 billion is incurred in terms of loss of productivity and disability. Annual informal care costs of home nursing are estimated to be at £ 2.4 billion. Considering Transient Ischaemic Attack

A Transient Ischaemic Attack (TIA) is often, mistakenly, described as a ministroke and has until recently been defined as “a neurological deficit caused by focal brain ischaemia that completely resolves within 24 hours”. According to a newly proposed definition by the TIA Working Party Group, TIA is “a brief episode of neurologic dysfunction caused by neurologic dysfunction or retinal ischaemia, with clinical symptoms lasting less than one hour, and with no evidence of acute infarction”. During the vascular event, of stroke or TIA, the symptoms would be the same. Unfortunately, as TIA symptoms resolve quickly, TIA is often perceived by the public as unimportant, and does not warrant any treatment. However, the evaluation and diagnosis of TIA should mirror that of stroke and so suspected stroke (regardless of whether the eventual diagnosis turns out to TIA or stroke)

M edical sciences

Treatments for TIA and stroke

The recommended assessments and treatment for TIA patients include brain imaging, carotid imaging, antiplatelet and antihypertensive therapy and statins. For stroke, effective and cost-effective investigation and treatment options include immediate brain scanning, thrombolysis and organised care in a specialist unit, as well as secondary prevention therapies as for TIA. Rapid access is the key to maximise the benefits from these investigations and treatments. To provide rapid access, the time from the onset of stroke symptoms to hospital arrival must be kept to a minimum. Studies have shown that activation of the EMS is the single most important factor in the rapid triage and treatment of acute stroke patients. Individuals who activate EMS arrive at Accident and Emergency Departments (A&E) earlier and are evaluated fasterâ&#x20AC;&#x201D;particularly when EMS is the first point of medical contactâ&#x20AC;&#x201D;and hence it is the provider of fast transportation to hospital. For example, one study showed that for patients who contacted the EMS first, the mean time from stroke onset to arrival was 2.7 hours compared to 6.3 hours for patients who contacted their community physician in the first instance. Similar delays were also found for patients who contacted EMS (3.8 hours) and for those who did not (7.5 hours). Many factors contribute to delays in seeking treatment including poor

awareness of stroke symptoms, reluctance to seek medical help and stroke not being viewed as a medical emergency. Of these factors, the principle ones are believed to be lack of public knowledge regarding stroke symptoms and the need for a rapid response. A recent campaign by the Stroke Association in the UK promoted the use of the Face Arm Speech Test (FAST) to inform symptom recognition and facilitate the rapid access for people with suspected stroke to the appropriate services. However, the effectiveness of this campaign has not yet been evaluated. Stroke screening, educational programmes and first aid training are some of the effective ways to increase knowledge about stroke. Educational tools have also been shown to increase stroke awareness across diverse populations. While it is appreciated that increasing knowledge does not necessarily lead to a change in behaviour, it could facilitate behavioural change. When people were asked about what action they would take if they suspected that they or one of their relatives was experiencing a stroke, approximately 50 per cent said that they would call the EMS or would visit a hospital emergency department. However, when stroke patients were asked about what they had actually done at the onset of

symptoms, only 18 per cent said that they had called EMS immediately. Those with lower levels of education have consistently shown poor levels of stroke knowledge. Participants who had higher levels of education are more likely to name at least one symptom of stroke or risk factor or to provide a correct explanation of the physiological processes of stroke. Higher levels of education and upper socio-economic status have also been associated with the increased ability to identify the brain as the organ affected by stroke. Other factors that affected knowledge are age and ethnicity. It is observed that older age groups and several ethnic groups have poor knowledge of the risks factors and symptoms of stroke. With ageing populations and a predicted rise in the incidence of stroke, the immediate recognition and reaction to symptoms is of increasing importance. Currently, the inability of the general public to recognise the symptoms of stroke and failure to contact the EMS results in delays in arrival at hospital. Increasing public awareness about stroke symptoms, the required emergency responses and the available treatment options must be a priority. References are available at http://www.asianhhm.com/magazine

Caroline Watkins, the only nursing professor of stroke care in the UK, has worked with the Department of Health Vascular Team on developing, and now in implementing, the National Stroke Strategy.

A uthors

should result in immediate access to EMS and be treated as a medical emergency. The variation in signs and symptoms from person to person depending on the areas of the brain affected often creates problems in recognising stroke. Stroke classically presents with sudden onset of neurological loss and can include one or more of: limb weakness, speaking difficulty or understanding speech, loss of vision, clumsiness or numbness of the arms or legs. Symptoms most commonly described by stroke patients include weakness, numbness or paralysis.

Michael Leathley is a Post-Doctoral Research Fellow at the University of Central Lancashire. His research interests include the long term follow-up of stroke patients, from admission to hospital with an acute stroke, to discharge and beyond, measuring provision of service, support, utilization of resources and charting mortality.

Stephanie Jones is a Research Fellow at the University of Central Lancashire. She co-ordinated the National Pre-Hospital guidelines Group and currently manages a National Institute for Health Research Stroke Programme Grant. She has worked collaboratively with the Royal College of Physicians.

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M edical sciences

Advanced Colorectal Cancer Improving the survival rate

The management of Colorectal Cancer liver metastases has evolved over the past decade as a result of using more sophisticated imaging technology, effective systemic therapies including multi-drug treatment regimes with advanced surgical techniques. This has greatly improved response rates, resectability rates and in turn survival.

Graeme Poston Surgeon Vivek Upasani Specialist Registrar Aintree University Hospital, UK

ife expectancy has increased dramatically over the last hundred years. In the western society it is 75-77 years for men and 80-81 years for women. The demographics of these changes have important consequences for healthcare professionals in oncology. Magnitude of the problem

Options for treatment

The management of Colorectal Liver Metastases (CRLM) has evolved over the past decade as reflected by the integration of effective systemic therapies with advanced surgical techniques. Fiveyear survival rates after resection have increased from 20 per cent to almost 60 per cent in recent series. Although the dramatic improvements may be due to the adoption of more sophisticated imaging technology, the introduction of multi-drug regimens including irinotecan, oxaliplatin, cetuximab, and bevacizumab as components of stand-

Colorectal Cancer (CRC) is one of the top three causes of cancer deaths, accounting for over one million new cases annually and over 500,000 deaths worldwide. The liver is frequently the only site of metastases in the patients diagnosed with advanced disease; only 20 per cent of patients with liver metastases are possibly amenable to surgical resection with curative intent. Synchronous liver metastases are present in about 20 per cent of patients with CRC, and metachronous liver metastases will subsequently appear in approximately 20â&#x20AC;&#x201C;50 per cent of patients. Generally, the median survival time of untreated advanced CRC is between 6-8 months. Those with solitary liver metastases have a better prognosis than those with more extensive disease. Very few patients with liver disease survive for five years without treatment.

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ard treatment has helped in improving response rates, resectability rates and survival considerably. Up to 20 per cent of patients with â&#x20AC;&#x2DC;liver onlyâ&#x20AC;&#x2122; disease are candidates for potentially curable surgery. The criteria for undertaking surgery include: control of the primary tumour, no extra hepatic disease and resection technically feasible with tumour free margins. A small number of patients with completely resectable extra hepatic disease may survive for a long term. Chemotherapy alone remains palliative but it can double the survival time for patients

CT scan of colorectal liver metastases initially deemed unresectable before (a) and after chemotherapy (b), by which time these tumours are easily resectable.

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M edical sciences

with unresectable disease. In addition, it may prolong the time to recurrence after resection of hepatic metastases and may bring patients previously judged inoperable to resectability. The combination of chemotherapy and surgery is currently accepted as a way forward for improving survival in patients with initially unresectable CRLM. Standard combination chemotherapy regimens comprising 5-fluorouracil (5-FU) plus leucovorin (LV, also known as folinic acid [FA]) in combination with either irinotecan, typically FOLFIRI or oxaliplatin (FOLFOX) have been reported to facilitate the resection of 9-40 per cent of initially unresectable metastases, with data emerging from randomised trials suggesting that the addition of targeted biologic agents or a third cytotoxic agent might be even more effective. Typically, the liver surgeon is faced with three clinical scenarios when assessing patients with colorectal liver metastases: i) Patients with clearly resectable metastatic disease, ii) Metastatic disease that is initially considered to be unresectable, principally due to location and iii) Patients that are unlikely to ever become resectable. Current treatment practice recommends surgery for resectable liver disease and palliative chemotherapy for those patients with initially unresectable and the patients who are unlikely to ever become resectable disease. However, such chemotherapy may be an integral part of treatment with ultimately ‘curative intent’ if regression means that surgical resection is subsequently possible. In any assessment of chemotherapy regimens, it is necessary for accurate patient classification / staging to facilitate, for example, a degree of cross-trial comparison in a clinical setting where few randomised trials are likely to be conducted and where resectability is such a subjective clinical endpoint. It has been proposed that a new staging system would facilitate

a move away from the old ‘catch-all classification’ of stage IV disease to allow stratification of patients from the outset in terms of potential resectability with a view to direct their therapeutic management. The advantages of such a new staging system would be to alert physicians early to the possibility of ‘curative intent’ strategies and to provide a clear indication of therapeutic strategy. Whilst, the ultimate aim of a new staging system would be the better stratification of patients for clinical trials. This is particularly important as moving forward there are likely to be more first-line randomised studies, like the CRYSTAL and OPUS studies where secondary surgical resection rates are important secondary end points of the analysis.

New trials need to be conducted that link R0 resection to survival and with new trial endpoints that can provide a better measure of the efficacy of the different treatment regimens.

Resectable colorectal liver metastases

Indications for hepatic resection have expanded with improvements in perioperative morbidity and mortality. The underlying surgical approach to CRLM is to identify and resect all macroscopic disease in order to obtain cure. However, debate continues over identifying those patients who may benefit from definitive surgery. The previous reports of prognostic scoring systems can be useful for proper patient selection, improving the outcome after surgery. Today, even in patients with resectable metastases, chemotherapy prior to surgery can increase the complete resection rate, facilitates limited hepatectomies, improves postoperative recovery, treats micrometastases, provides a test of chemo-responsiveness and identifies

aggressive disease and spares ineffective therapy. This is supported by the results of the EORTC 40983 / EPOC study where the Progression Free Survival (PFS) rate at three years was increased by 8.1 per cent in those patients who received perioperative chemotherapy and increased to 9.2 per cent by perioperative chemotherapy when compared with surgery alone in the actually resected group of patients. Historically, poor prognostic factors for patients with liver metastases are >1 liver metastasis, >5cm in diameter, synchronous presentation, lymph node positive primary and high tumour marker levels. This group of patients should receive neoadjuvant chemotherapy. The data from the EORTC study showed quite clearly that nearly all patients were able to tolerate neoadjuvant chemotherapy. However, patients with a 2 cm solitary metastasis should go straight to surgery, with the recognition that it accounts for less than 10 per cent of patients seen in routine clinical practice. All other patients with resectable metastases must be treated upfront with chemotherapy with the caveats that the patient is able to receive chemotherapy and the position of the lesion is not going to be lost. All resected patients should, if possible receive postoperative adjuvant chemotherapy based on the data for the resected patients in the EORTC-EPOC trial. The question then arises ‘how long should the period of treatment be�� ?’ One suggestion is that patients should receive a maximum of six months chemotherapy perioperatively. Thus, patients with technically resectable metastases would receive chemotherapy until first response. In the case of those patients whose metastases were initially classified as unresectable, chemotherapy should be administered until an adequate response has been achieved.

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M edical sciences

CT scan of the liver showing a solitary colorectal metastasis suitable for surgical resection

Unresectable colorectal liver metastases

Combination chemotherapy, typically infused 5-FU / LV, in combination with either irinotecan or oxaliplatin but also triple cytotoxic drug therapy, e.g. FOLFOXIRI and more recently combination chemotherapy regimens with the targeted agents cetuximab and bevacizumab can render initially unresectable metastases resectable in patients with advanced CRC. The presence of extrahepatic disease no longer precludes surgery provided that it is also resectable. Today, resection rates in excess of 20 per cent are rapidly becoming the norm in small single-centre and single-arm studies provided that patient selection is well done. As a consequence, 5-year survivals of 50 per cent are becoming increasingly common. Current treatment practice for patients with initially unresectable metastatic disease is to treat with the most effective regimen, in terms of response rate and Progression Free Survival (PFS) that the patient can tolerate coupled

with the recommendation that surgery should be conducted as early as possible to minimise the effects of chemotherapy on the liver. So, the question arises ‘what defines the most active regimen in this clinical setting?’ In an ideal world it would be hoped that ‘neoadjuvant’ chemotherapy in patients with colorectal liver metastases would not only shrink the tumour but also reduces the recurrence / relapse rate by killing any micrometastases that might remain post surgery. Since response rate correlates with resection rate, regimens that could be selected based on present knowledge are FOLFIRI / FOLFOX alone, these regimens plus a biologic or triple cytotoxic drug therapy in patients with good performance status. Both FOLFIRI and FOLFOX have been shown to be highly effective in facilitating hepatic resections in single-arm studies in selected patients. However, the trend may well be towards the use of three active agents in the form of either combination cytotoxic therapy plus a biologic

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or three cytotoxics. Certainly, data are beginning to emerge from randomised trials (CRYSTAL and OPUS) of the added benefit conferred by the targeted agent cetuximab on the response rates and resection rates achieved with standard first-line therapies in patients with advanced CRC. Generally, the median survival time of untreated advanced CRC is between 6-8 months. The efficacy of a regimen may primarily be related to its ability to induce sufficient tumour regression to permit R0 resection, but probably what matters most is that the occult tumour cells that the surgeon cannot remove are killed, resulting in a long, relapse-free survival (RFS) post resection. The main concern in the neoadjuvant setting for the treatment of CRLM is that we have no evidence for the impact different regimens have on recurrence rates post resection. Although the intent can properly be termed ‘curative’, cure is rarely achieved. Thus, new trials need to be conducted that link R0 resection to survival and with new trial endpoints that can provide a better measure of the efficacy of the different treatment regimens. New treatment strategy

Today, patients with metastatic CRC should be treated by multidisciplinary teams comprising surgeons, medical oncologists and radiologists. Evidence of the benefit of perioperative chemotherapy over surgery alone, and the demonstrable benefit of adjuvant chemotherapy (post-liver resection) in one trial caused a rethinking amongst the experts particularly in terms of the timing of the administration of chemotherapy for CRC patients with initially resectable liver and lung metastases. Discussion

Although the prognosis of metastatic CRC is poor with few patients surviving for five years or more, long term survival has been reported following surgical resection of isolated hepatic metastases.

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CT scan of colorectal liver metastases initially deemed unresectable before (a) and after chemotherapy (b), by which time these tumours are easily resectable.

Figure 2a

Figure 2b

margins) that can only be determined following liver surgery. Conclusions

Surgical resection of CRLM can be performed safely with low mortality and morbidity rates. It was observed that one-third of the patients who had undergone surgery were alive even after five years, which was not seen in those patients who were unsuitable for surgery. Perioperative chemotherapy will ensure

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Figure 2

three-year disease-free survival in patients following liver resection. In addition, modern chemotherapy will now convert a significant number (10-20 per cent) of patients deemed unresectable at presentation to surgical resectability. Future studies now need to address the question of whether even more patients can be brought to such surgery with curative intent using either conventional chemotherapy or chemotherapy in combination with the newer biological agents.

Graeme Poston is Director of the Division of Surgery, Digestive Diseases, Critical Care and Anaesthesia at University Hospital Aintree (UHA) Liverpool UK. He is also is a Council member of the European Society of Surgical Oncology and the UK and Ireland Neuroendocrine Tumour Society. He has authored eight textbooks of surgery, in addition to over 140 peer reviewed papers, mainly on the subject of HPB diseases.

A uthors

Surgical resection of hepatic metastases is safe. The median postoperative (30 days) mortality is of the order of 2.8 per cent (0-6.6 per cent). The long-term survival of patients undergoing R0 resections is significantly better (32 per cent at five years) than that seen following R1 resections (7.2 per cent at five years) and for those patients who did not come to resection (0 per cent at five years). Patients undergoing surgery may have a better prognosis than other patients with metastatic CRC as they are more likely to be of good performance status and have little or no co-morbidity. A few retrospective studies have attempted to determine the natural history of patients with isolated liver metastases. In a study of 125 patients with liver-only metastases, many who had had no therapy, the median survival was 12.5 months. All patients died within five years and survival correlated with the extent of liver disease. However, the presence of three or less liver metastases was associated with a prolonged median survival of 24 months. Recurrence of cancer is common after resection of CRLM because in the majority of cases the extent of the metastatic disease remains underestimated when using our current pre and intraoperative staging investigations. Of those who recur, one-third suffers from disease recurrence in the liver alone, and occasionally may be candidates for repeat liver resection. The others develop recurrence either synchronously both in the liver and extra hepatic sites, or only at extra hepatic sites. Identification of those prognostic factors that might predict the outcome following surgical resection of CRLM could be helpful. They could help in the identification of the patients most likely to benefit from this intervention, or equally assist in the identification of patients who were unlikely to benefit. However, the use of such scoring systems remains controversial and indeed those which are most published so far depend upon variables (such as surgical resection

Vivek Upasani is working as a Specialist registrar in the renowned supra-regional hepatobiliary unit at Aintree University Hospital, Liverpool. Add two more lines.

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surgical speciality

Transection of the Liver

Overview of techniques

Over the past 50 years, the postoperative mortality from liver resection has fallen from 33 to 1.5 per cent. Whilst this is multifaceted, one key ingredient is our ability to transect liver parenchyma in a ‘bloodless’ fashion. The emerging new techniques for liver transection not only improve survival rates but also reduce mortality rates considerably.

ver the past few decades, the management of liver tumours has become a truly multidisciplinary speciality. Advances in imaging, medical oncology and interventional radiology have now allowed treatment with curative intent for many lesions that previously would have received palliation only. However, surgical resection remains the mainstay of management of liver lesions and is the most important method of achieving a cure for primary and secondary tumours. Indeed, combined with the above modalities and in the presence of favourable prognostic indicators, the surgical resection of colorectal liver metastases can offer five-year survival rates of up to 40 per cent and a mortality of less than 5 per cent.

Alun Jones Specialty Registrar Marv Rees Surgeon Department of Hepatobiliary Surgery Basingstoke and North Hampshire Hospital, NHS Foundation Trust, UK

Principles of transection

Dissection through the liver parenchyma poses unique challenges. Firstly, the liver’s inherent vascularity poses a high risk of uncontrollable haemorrhage if blood vessels are not identified and sealed in a timely and effective manner. It is now well established that morbidity and mortality from liver resection is closely correlated with intraoperative blood loss.

Furthermore, the need for blood transfusions during liver surgery is strongly associated with poorer long-term outcomes. Therefore, surgical and anaesthetic techniques have focussed on reducing intraoperative blood loss when transecting the liver. Secondly, the complexity of the liver’s biliary structures necessitates careful dissection and occlusion to avoid postoperative bile leaks, another important source of morbidity and mortality in the post-liver resection patient. The ideal surgical instrument for liver transection must therefore be able to effectively cut through the parenchyma whilst simultaneously sealing any portal vessels or bile ducts. In reality, because no such single instrument yet exists, transection is achieved by a combination of instruments

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and techniques which firstly facilitate division of the liver tissue with subsequent identification and sealing of the vessels. In this way, a ‘Two-surgeon technique’ has evolved, whereby the first surgeon directs parenchymal dissection and the second surgeon is responsible for coagulation and vessel sealing. Also, it reduces the transection time—especially important in limiting liver ischaemia during use of the Pringle manouevre. It also acts as a valuable training tool. The significance of minimising intraoperative bleeding has led to methods aimed at achieving bloodless liver surgery, involving surgical techniques to occlude hepatic inflow and outflow vessels, and anaesthetic techniques to minimise central venous pressure. Inflow vessel occlusion

Pringle firstly described portal triad compression in 1908 in an attempt to control bleeding from the liver in trauma patients. The ‘Pringle manoeuvre’ is achieved by application of a soft (noncrushing) bowel clamp to the structures in the hepatoduodenal ligament at the porta hepatis. Whilst this is beneficial in limiting parenchymal bleeding from inflow vessels, it unfortunately has no effect on back bleeding from the hepatic veins and Inferior Vena Cava (IVC), which may still be alarmingly profuse. In addition, it renders the parenchyma ischaemic for the duration the clamp is applied, and intermittent clamping (e.g. 20 minutes on, 5 minutes off) is preferred by many surgeons, including our unit, to reduce the risk of post-hepatic liver insufficiency potentially caused by hepatocyte ischaemia. Where possible, inflow vessels to the segment to be resected should be ligated and divided prior to transection (the extra-hepatic approach). In addition to devascularising the segment to be resected, this has the advantage of demarcating the transection plane. Outflow vessel occlusion

Heaney and colleagues were the first to describe total vascular exclusion during a liver resection by control of the suprahepatic portion of the IVC. This method

Techniques of liver transection Finger fracture Historically, parenchymal division was firstly described via the finger fracture technique (‘digitoclasy’). Proposed by the Lin and colleagues in 1958, the friable liver tissue was fractured between the forefinger and thumb whilst identifying and isolating the key vascular and ductal structures, which could then be ligated and divided. This rather crude and imprecise technique was subsequently refined by the use of ‘crush clamp’, specially designed to crush liver tissue without damaging major vascular or ductal structures. However, the ‘near bloodless field’ described by the use of crush clamps was often achieved at the expense of compromised oncological margins, and soon led to the development of more precise and targeted dissecting instruments.

Ultrasonic dissection An ultrasonic dissector such as the CUSA (Cavitron Ultrasonic Surgical Aspirator, Tyco Healthcare, Mansfield, MA, USA) emits ultrasonic waves of a frequency high enough to divide the liver parenchyma whilst sparing structures greater than 2 mm in diameter, which can then be sutured or clipped. Using the same principle, the ultrasonic shears (Harmonic Scalpel, Ethicon, Cincinnati, OH, USA), often used in laparoscopic resections, uses ultrasound to divide and seal vessels up to 3 mm in diameter between its jaws.

High pressure water dissection Water jet dissectors use a pressurised jet of water to achieve transection. Both CUSA and water jet dissectors have the advantage of removing a 5 mm diameter line of tissue, important in achieving a margin where dissection is close to the tumour. Radiofrequency dissection The TissueLink dissecting sealer (TissueLink Medical Inc., Dover, NH, USA) uses radiofrequency energy coupled with a saline to achieve both dissection and coagulation of liver tissue. More recently, radiofrequency ablation, in which coagulative necrosis is induced in a sphere of tissue around the tip of a probe, has been used sequentially along the transection line to achieve ‘in line’ coagulation. A knife is then used to transect the pre-coagulated parenchyma.

Diathermy Diathermy uses high frequency alternating current to generate high local temperatures which induces local coagulative necrosis. Some of the most popular instruments currently available are the Argon beam coagulator (Valleylab, Tyco Healthcare, Boulder, CO, USA), which allows coagulation of small vessels, and more recently, a bipolar vessel sealing device (Ligasure, Valleylab, Tyco Healthcare, Boulder, CO, USA), which seals arteries up to 6 mm and veins up to 12 mm in diameter. Although some of these instruments (such as the harmonic scalpel and ligasure) claim to be able to both dissect parenchyma and seal vessels, reports of bile leaks are common following their use. It is, therefore, usually necessary following transection to formally seal vessels in order to ensure meticulous haemostasis and prevent bile leaks. Historically, this has been achieved by a combination of monofilament sutures, clips, diathermy and topical agents (such as coagulative glue and haemostatic collagen). More recently, stapling devices have also been successfully used to transect liver parenchyma in addition to large vessels.

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Low CVP anaesthesia

The higher the Central Venous Pressure (CVP), the greater the venous engorgement of the liver and the greater is its tendency to bleed on transection. This has led to an important role for the anaesthetist in reducing blood loss during liver surgery. The intraoperative use of fluid restriction and venodilators allows a CVP of 0â&#x20AC;&#x201C;5 mmHg in the face of a normal blood pressure, and minimises blood loss by limiting retrograde bleeding from the hepatic veins during transection. A number of studies have now shown that low CVP anaesthesia is well tolerated and that the theoretical risk of air embolism is very rarely clinically evident. Anatomical considerations

A better knowledge and understanding of the segmental anatomy of the liver, described in detail by Couinaud, has revolutionised liver resection strategies. The ability to perform segmental liver resections has allowed the radical excision of lesions whilst maximising the size of the remaining healthy liver, vital in avoiding postoperative liver insufficiency. In addition, the hepatic lesion must be well imaged prior to surgery to determine not only whether it is resectable, but also the nature of the intended resection with respect to the location of hepatic veins and major portal vein structures. Careful examination of preoperative imaging, further refined by intraoperative ultrasound allows anticipation of these structures during transection, thereby

avoiding their accidental division. It also enables an adequate resection margin to be established around the tumour, allowing curative excision. Transection at our institution

Basingstoke is a large volume centre with a throughput of 178 cases in 2007 and a total of 1657 patients resected so far. All patients are imaged preoperatively using liver-specific MRI, which uses two contrast agents (Gadolinium and Resovist). The liver is approached via a right subcostal incision and an assessment is made of resectability and the confirmation of the absence of peritoneal disease or nodes at the porta hepatis, which would render the case irresectable. The liver is mobilised and resectability is further confirmed by bimanual palpation and intraoperative ultrasound. The resection margins are delineated with diathermy. An extra-hepatic approach is preferred for inflow vessel occlusion where the tumour is close to the porta hepatis. In cases where the tumour is greater than 2 cm from the porta, extraGlissonian stapling of the portal triad is preferred. The hepatic veins are stapled where possible to enable total vascular occlusion. Parenchymal dissection is performed using an ultrasonic aspirator (Cavitron Ultrasonic Aspirator, CUSA, Tyco Healthcare, Mansfield, MA, USA) with intermittent portal triad clamping (20 minutes on, 5 minutes off. In steatotic and cirrhotic livers the times are 10 and 7 minutes, respectively). During transection, vessels less than 1 mm in diameter are sealed via the Argon beam coagulator

A uthors

allowed a true bloodless surgical field that could be safely maintained for a period of up to 60 minutes while the liver was transected. However, it was a complicated and time-consuming procedure, and was poorly tolerated in patients with low cardiorespiratory reserve, as evidenced by their mortality rates of up to 50 per cent. This technique has further been refined by the use of vascular stapling devices to seal individual hepatic veins after they are dissected out. Combined with inflow vessel occlusion, this provides a rapid and effective method of achieving a near bloodless field during transection.

(Valleylab, Tyco Healthcare, Boulder, CO, USA). Larger branches are clipped or ligated with monofilament suture. The two-surgeon technique is used, with the lead surgeon on the patientâ&#x20AC;&#x2122;s right operating the CUSA, and applying clips and sutures, and the second surgeon on the patientâ&#x20AC;&#x2122;s left operating the Argon beam coagulator. Both apply traction to the liver in opposing directions to accentuate the transection line. Following removal of the specimen, the freshly transected liver surface is sealed using coagulant glue (Quixil, OMRIX biopharmaceuticals, Belgium) and haemostatic collagen sheets (Fibrillar, Johnson & Johnson Medical, Ascot, UK). Using these techniques, a median clamp time of 32 minutes and blood loss of 330 ml was achieved for 2007, with a mortality of 0.3 per cent. Conclusion

There is currently no single instrument available that effectively addresses both tasks of parenchymal dissection and vessel sealing, and transection of the liver is generally achieved using combinations of the above instruments and techniques. There is little evidence from randomised controlled trials demonstrating superiority of one instrument over another, and the available literature suggests that all current strategies for transection can be used with equal effectiveness. Choice of transection instrument and technique is, therefore, based on individual surgeon preference, and the most significant factor in achieving an effective and safe liver resection remains the experience of the surgeon.

Alun Jones is a Specialty Registrar in General Surgery currently working in Basingstoke and North Hampshire Hospital. He graduated from the University of Cambridge Medical School in 2003 and subsequently completed a Basic Surgical Training Rotation at Norfolk and Norwich University Hospital. Merv Rees is a Hepatobiliary Surgeon based at Basingstoke Hospital, North Hampshire, UK. He is currently President of the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland.

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Treatment of Gastric Cancer Role of radiotherapy

Radical surgery is the cornerstone in the treatment of gastric cancer, but results in high locoregional recurrence rates and poor survival. Therefore, further improvement is sought in pre- and postoperative multimodality approaches. High-precision modern radiotherapy, in particular when combined with chemotherapy, plays an important role in optimising clinical outcome.

astric cancer is the fourth most frequent malignancy in the world. It is characterised by a high locoregional recurrence rate and poor prognosis. Radical surgical dissection is the basis of cure in this disease. However, because most patients are at advanced stages, surgery alone provides long-term survival of only 20-30 per cent. Randomised trials have shown that a more aggressive (D2) lymph node dissection does not result in a clinically relevant survival benefit, but is associated with increased morbidity and mortality. To improve clinical outcome, several therapeutic approaches have been pursued both in the preoperative as well as in the adjuvant setting.

Marcel Verheij Professor and Chair Department of Radiation, Oncology The Netherlands Cancer Institute The Netherlands

Postoperative radiotherapy

The role of postoperative radiotherapy in operable gastric cancer has been evaluated in several studies. In the British Stomach Cancer group study, 436 stage II and III patients were randomly assigned to receive surgery only, surgery followed by radiotherapy or surgery plus chemotherapy. The five-year survival rates were not statistically different between the three arms: 20 per cent, 12 per cent and 19 per cent, respectively. In an EORTC-initiated trial, 115 patients were randomised after surgery in four arms: radiotherapy only; radiotherapy with short term concurrent 5-FU chemotherapy; radiotherapy with long term 5-FU and combined shortand long-term chemotherapy. Again, no differences in survival were observed. In summary, radiotherapy as single modality

Radiotherapy as single modality treatment

Radiotherapy as single modality can be a palliative treatment for uncontrolled gastric bleeding and for irresectable tumours. While no significant effect on survival has been reported, locoregional control rates in the order of 70 per cent have been reported. Radiotherapy can be applied intra-, pre- or postoperatively (with or without concurrent chemotherapy). Intraoperative radiotherapy

In a small prospective trial patients with non-metastatic disease at surgery were randomised between Intraoperative

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Radiotherapy (IORT) and postoperative external beam radiotherapy. Locoregional recurrence rates were significantly lower in the IORT group (44 and 92 per cent, respectively), without an effect on survival. Although this trial did not show increased toxicity, recent studies indicate that IORT is associated with more surgical morbidity, which is most likely the reason that this technique is applied on a limited scale as compared to sophisticated external beam techniques, including three-dimensional conformal and Intensity-Modulated Radiotherapy (IMRT).

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in the postoperative setting may have a modest favourable impact on locoregional control, but does not result in a survival benefit. Preoperative radiotherapy

There are several reasons why preoperative irradiationâ&#x20AC;&#x201D;with or without chemotherapyâ&#x20AC;&#x201D;may be advantageous over postoperative radio (chemo-) therapy. First of all, the dimensions of the radiation fields can be reduced because of more accurate target definition. Also, downstaging / -sizing facilitates surgery, increases the chance of radicality and provides an early indication of treatment sensitivity. Finally, in general, fewer patients are lost to protracted postoperative recovery. A Russian trial which randomised 152 patients between surgery alone or radiation one week before surgery showed a non-significant difference in five-year overall survival of 30 per cent and 39 per cent, respectively. A large Chinese prospective randomised trial of 370 patients compared surgery only and surgery with preoperative radiotherapy. Five year overall survival was 19.8 per cent with surgery only and 30.1 per cent with preoperative radiotherapy (p<0.01). Resectability (79.4 vs. 89.5 per cent) and radical resection rates (61.8 vs. 80.1 per cent) were also superior after preoperative radiotherapy. Finally, a meta-analysis of studies comparing surgery with surgery preceded by radiotherapy, demonstrated a statistically significant improvement of three and five-year survival without an increase in postoperative complications, while compliance of the radiotherapy part was 100 per cent. Although these studies indicate an advantage of this neo-adjuvant strategy, most of the current approaches focus on postoperative radiochemotherapy and perioperative chemotherapy (see below). Radiotherapy as part of a multimodality treatment Postoperative radiochemotherapy

The postoperative delivery of combined radiotherapy and chemotherapy has been the topic of several studies. An early

trial from the Mayo Clinic reported on 62 patients with poor prognosis gastric cancer who were randomised between surgery and surgery with adjuvant radiotherapy combined with concurrent 5FU. Both five-year survival (23 vs. 4 per cent, p<0.05) and locoregional control rates were improved in patients receiving adjuvant radiochemotherapy. The Eastern Cooperative Oncology Group (ECOG) performed a study in patients with residual or unresectable gastric cancer randomising between chemotherapy and 5-FU based radiochemotherapy. This trial failed to demonstrate a clear survival benefit but did show increased toxicity after radiochemotherapy. The Gastrointestinal Tumor Study Group (GITSG) completed two randomised studies. In the first one, 90 patients were randomised between postoperative 5-FU and methyl-CCNU chemotherapy or split-course radiotherapy with the same chemotherapy. At initial analysis chemotherapy was associated with superior survival (68 vs. 44 per cent), but at five years follow up the outcome was in favour of the combination arm: 18 per cent vs. 6 per cent. In a subsequent study by the same group (GITSG 8281), a single course of radiotherapy with concurrent 5FU, methyl-CCNU and doxorubicinbased chemotherapy resulted in a worse outcome after radiochemotherapy. More recently, a retrospective study from the Mayo Clinic in 63 patients indicated that postoperative 5-FU based radiochemotherapy was most beneficial in those patients without residual disease upon surgery. Based on these studies, the SWOG/ Intergroup 0116 randomised 556 patients between surgery only and surgery plus postoperative radiochemotherapy. The adjuvant regimen consisted of 5-FU and leucovorin for five days, followed by 45 Gy of radiation over five weeks, combined with 5-FU and leucovorin on the first four and the last three days of radiotherapy. Two five-day cycles of 5-FU/leucovorin were given after

completion of the radiochemotherapy part. Despite significant (mainly hematological and gastrointestinal acute) toxicity observed in the combination arm, median overall survival was significantly better after radiochemotherapy: 27 vs. 36 months (p=0.005). In addition, relapse-free survival was prolonged from 19 months in the postoperative observation arm to 30 months in the radiochemotherapy arm (p<0.001). Although consensus guidelines in the US now consider postoperative radiochemotherapy as standard treatment, many have criticised this study, emphasising the suboptimal quality of surgery. Indeed, 54 per cent of all patients underwent a D0 instead of the prescribed D2 lymph node dissection. On the other hand, a large observational study from Korea showed that 544 patients receiving a comparable radiochemotherapy regimen after a D2 resection had a superior five-year overall survival as compared to those who did not receive adjuvant radiochemotherapy: 57.1 per cent vs. 51.0 per cent (p=0.02). This suggests that postoperative radiochemotherapy can improve survival and local control, even after an optimal D2-resection. In a meta-analysis 5-year survival was significantly (p<0.00001) improved in patients who were treated with postoperative radiochemotherapy, particularly when radiation doses exceeding 40 Gy were applied and modern linear accelerators were used. Another important comment on the SWOG/Intergroup 0116 study is the fact that no data on late complications were provided. We have shown that radiochemotherapy for gastric cancer is associated with a progressive decline in renal function when using common 2D or 3D radiation techniques. Radiotherapy dose planning studies, however, demonstrated that modern, Intensity Modulated RadioTherapy (IMRT) techniques are able to spare the kidneys and other critical organs. A final comment relates to the limited and therefore suboptimal interaction between radiation and

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Preoperative chemoradiotherapy

Based on the beneficial effect of preoperative radiochemotherapy as demonstrated in an increasing number of solid tumours, this approach has been evaluated in gastric cancer as well. High rates of radical resections and complete / partial pathological responses have been reported in several (small) series. In a cohort of 33 patients who completed a preoperative regimen consisting of 5-FU, leucovorin and cisplatin, followed by radiotherapy a 70 per cent R0 resection rate was achieved. Pathological complete and partial responses were found in 36 per cent and 29 per cent of operated patients, respectively. Comparable results were obtained in two other studies using a preoperative regimen consisting of two cycles of 5-FU, paclitaxel and cisplatin followed by radiotherapy with concurrent 5-FU and paclitaxel. A Swiss study also demonstrated promising results with preoperative cisplatin and 5-FU based radiochemotherapy and hyperfractionated radiotherapy. In this study, five-year locoregional control and overall survival were 85 and 35 per cent, respectively. Finally, a Polish study in 40 patients demonstrated a R0 rate of 75 per cent, a pathological response rate of 38 per cent and two-year survival of 63 per cent after 5-FU based radiochemotherapy. Collectively, these results illustrate the attractive combination of the effectiveness of radiochemotherapy and the advantages of a neo-adjuvant approach. We therefore emphasise the importance to further evaluate this preoperative radiochemotherapy strategy in clinical phase III trials. Perioperative chemotherapy

Although the role of chemotherapy as single modality falls somewhat

beyond the scope of this paper, the most important findings are briefly discussed. Preoperative or neo-adjuvant chemotherapy could potentially downstage (advanced) gastric cancer and thereby improves resectability and survival. Indeed, pilot phase II studies using this approach showed promising results. A randomised study by the Dutch Gastric Cancer Group, however, was unable to show a benefit from neo-adjuvant chemotherapy with a combination of 5-FU, adriamycin and methotrexate. Numerous studies have been carried out using chemotherapy in the postoperative setting. Several meta-analyses of these studies did not demonstrate a clinically relevant survival benefit for adjuvant chemotherapy. It should be noted, however, that most of these studies were underpowered and did not include members of the latest generation of cytostatic agents. Recently, a Japanese phase III study was published that randomised 530 patients to surgery only and 529 to surgery with 1 year of adjuvant S-1, an oral fluoropyrimidine. All patients had stage II or III disease and underwent gastrectomy with D2 lymph-node dissection. After median follow-up of 2.9 years, overall survival was 80.1 per cent in the S-1 group versus 70.1 per cent surgery only group (p=0.002); relapsefree survival were 72.2 and 59.6 per cent (p<0.001) respectively. This study demonstrates that, at least for Asian patients, prolonged S-1 chemotherapy after a D2 dissection improves outcome. In the United Kingdom, the Medical Research Council (MRC) randomised 503 patients with resectable gastric carcinoma between surgery only A uthor

chemotherapy as applied in the SWOG/ Intergroup 0116 study. Current approaches, including our own, focus on optimising postoperative radiochemotherapy using other cytostatic agents and more intensified schedules.

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and surgery with 3 preoperative and 3 postoperative courses of epirubicin, cisplatin and 5-FU (MRC Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial). After a median follow-up of four years, the group receiving perioperative chemotherapy had an improved five-year overall (36 vs. 23 per cent; p=0.009) and progression-free survival (p<0.001), despite the fact that only 42 per cent of patients in the chemotherapy group completed the entire treatment. A French phase III trial confirmed the improvement of disease free and overall survival with preoperative 5-FU/cisplatin chemotherapy (five-year overall survival 38 vs. 24 per cent; p=0.02). Concluding remarks

The treatment of gastric cancer is rapidly changing. Optimal results will be obtained after radical surgery in combination with some form of preor postoperative therapy. Which (neo) adjuvant strategy should be given for this treatment-resistant tumour is the subject of various ongoing clinical studies, but requires careful patient selection, intensive nutritional support and the use of state-of-the-art radiotherapy and optimal cytostatic drugs or biological agents. The Dutch Colorectal Cooperative Group is currently accruing patients in the CRITICS protocol (Chemoradiotherapy after Induction chemotherapy In Cancer of the Stomach; Clinicaltrials.gov NCT 00407186) a phase III trial that randomises patients after neo-adjuvant chemotherapy (ECCâ&#x20AC;&#x201D; epirubicin, cisplatin and capecitabine) and standardised surgery between postoperative chemotherapy (ECC) and 3D- or IMRT-based radiochemotherapy.

Marcel Verheij is a Professor in Translational Radiotherapy at the Free University in Amsterdam and chairman of the Department of Radiation Oncology at the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital. Here he holds a clinical / research position and supervises several basic, translational and clinical research projects.

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Trends in Surgery of Kidney Tumours

Shift to less invasive and nephron-sparing techniques Indications for nephron sparing surgery are expanding. In approach to partial nephrectomy, open surgery is still the gold standard. Laparoscopic approach is applied only in carefully selected patients. This method is more challenging, with a higher percentage of complications, however, it is expanding.

he incidence of kidney tumours in Czech Republic is the highest in the world. In 2005, it was in male 34.9 and in female 19.3 cases in 100.000 per year. Owing to this fact, urologists in Czech Republic are focussed on surgery of kidney tumours. At our department, we treat over 150 patients with kidney tumour surgically every year. We can define three main trends in less invasive surgery of kidney tumours applied up-to-date in everyday praxis: 1. Expansion of indications for nephron sparing surgery. 2. Less invasive techniques—laparoscopy and robotic surgery. 3. Ablative techniques. Of course, a lot of new technologies and methods are under investigation but they are still experimental and are not topics of this article.

some articles published recently, which supported nephron sparing surgery in greater tumours (meaning category of tumour cT1b-2, i.e. tumours over 4 cm – T1b or over 7 cm – T2) and

Milan Hora Head, Department of Urology Charles University Hospital Plzeň Czech Republic

Status post left radical laparoscopic nephrectomy

Expansion of indications for nephron sparing surgery

Broadly accepted indications for nephron sparing surgery are tumours of category T1a (less than 4 cm in the greatest diameter) and located peripherally. There were

Figure 1

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surgical speciality

in centrally located tumours as well. Oncological results of nephron sparing surgery are worse in T1b than T1a, but a worsening prognosis as the diameter increases shows no statistical differences for either nephron-sparing or radical surgery. There are three substantial notes to the technique of partial nephrectomy (open or laparoscopic): 1. Frozen section has minimal clinical significance. 2. For surgical margin—minimal layer is enough. 3. Enucleation has a high risk of incomplete excision. Nephron sparing techniques are not more expensive, oncological results are good, but patients profit a lot from saving of both kidneys.

Status post right laparoscopic resection of papillary renal cell carcinoma of ventral part of kidney

Less invasive techniques – Laparoscopy and robotic surgery

Laparoscopic Radical Nephrectomy (LRNE) in clinical stages T1-2N0M0 is from oncological point-of-view equivalent of open nephrectomy. Radical laparoscopic nephrectomy is accepted even in the EAU (European Association of Urology) guidelines as the gold standard for tumours T1-2. And skilled surgeons are able to perform this procedure in advanced cases as well (category T3a-b, N+ = positive lymph nodes). These advanced cases need careful individual assessment of case with respect to skills of surgeons. Successful and safe radical nephrectomy has a lot of conditions: skilled and patient surgeon able to convert the operation, skilled assistants and nurses and good technical equipment (bipolar instruments, vessel sealing systems or harmonic scalpel, staplers, clips with lock, endo-catch bag like a landing-net for fishes). Laparoscopic Partial Nephrectomy (LPN) has intermediate-term oncologic and functional outcomes (renal function) similar to those of open in experienced centres. The main advantage of LPN is miniinvasivity. But LPN has its disadvantages as well: It is still under development. LPN is challeng-

Figure 2

ing, is technically difficult, and needs a very skilled surgeon and long learning curve. There is a longer ischemia time, higher rate of complications, mainly hemorrhagic. Relatively good results are published by ‘centres of excellence’ only and the question is, what will be the results in everyday urological practice. At least in the first phase of introduction LPN to urological departments—only highly selected tumours can be indicated for LPN. Larger series with longer follow-up and prospective randomised studies are needed to confirm the safety and efficacy of LPN. In solitary kidney and in chronic kidney disease, open approach is a preferred method because in LPN, there is a higher risk of temporary or permanent dialysis after operation. Robotic-assisted radical nephrectomy is feasible, but today it has probably no substantial advantages. In roboticassisted partial nephrectomy, learning curve is truncated, it is helpful mainly

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in complicate cases due to less difficult suturing in restrictive spaces (including tumour of upper pole inaccessible for regular laparoscopic instrument) and suturing is faster as well. The most important disadvantage is price of the robotic surgery. In laparoscopic surgery, it is recommended to know the topographic anatomy of renal vessels through biphasic CT angiography. This evaluation needs high-quality CT (MDCT) scanner. Ablative techniques

RadioFrequency Ablation (RFA) and cryoablation are used routinely only. Other techniques (HIFU, LITT, microwaves) are still rather experimental. RFA and cryoablation are applied percutaneously or laparoscopically. Percutaneous application is really minimally invasive. Laparoscopic application needs general anaesthesia of course, but it is technically strongly easier in comparison with LPN. But they are still not accepted for every-

surgical speciality

laparoscopy. One port laparoscopy is performed through the navel mainly, it needs special equipment—special port, articulating graspers end endo-shears and laparoscope with deflectable tip. It has a lot of synonyms (SPA—Single Port Access, SLIPP—Single Laparoscopic Port Procedure, OPUS—One Port Umbilical Surgery, E-NOTES – Embryonal Natural Orifice Transluminal Endoscopic Surgery). In animal experiments, scarless laparoscopy is applied (combination of transgastric and transvaginal or tranvesical or transcolonic approach). These techniques are not suitable for clinical practice to date. We can read as well first notes about using of microrobots working

Compared to laparoscopic partial nephrectomy, laparoscopic cryoablation has some advantages.

in abdominal cavity. It sounds to be fantasy, but can be a reality in the next ten years. There has been intensive discussion about the role of follow-up (active surveillance) instead of surgery or ablative methods (suitable mainly for tumours < 3 cm in polymorbide patients) and the role biopsy has in this connection. What is the foundation of this approach? There is negligible growth rates in vast majority of small renal masses (under 3 cm), rapid growth correlates with higher grade. Follow-up is an alternative mainly to the formerly mentioned percutaneous ablation techniques. A uthor

day practice; some of these methods can be labelled as experimental and can be recommended mainly for clinical trials. The main disadvantage: In situ destruction of tumours has a risk of residual tumour. Higher risk of residual tumour is in RFA (13,4 per cent) than in cryoablation (3,9 per cent). Due to this fact, cryoablation seems to be more reliable than RFA. Cryoablation is a very promising, safe and feasible technique with minimal morbidity, excellent shortterm efficacy. Compared to laparoscopic partial nephrectomy, laparoscopic cryoablation has some advantages. Less blood loss, it doesn’t involve hilar clamping and technically difficult reconstructive technique, it is easier to treat less exophytic tumours. But longer follow up is needed. Percutaneous cryoablation is still under development, monitoring is possible with MRI, CT and ultrasonography. Laparoscopic or percutaneous RFA has no imaging control of lesion during ablation, there was indentified viable tumours cell within treated lesion due to ‘skipping’ at vessels or tissue junctions (collecting system). RFA has a higher rate of local progression and metastatic progression compared to cryoablation. RFA at this time can not be recommended as a first line treatment modality in ablative techniques. Routine application of ablative techniques can be recommended only in highly selected cases (polymorbide patient—but they can be followed-up only, solitary kidney mainly with multiple tumours, m. von Hippel-Lindau—i.e. multiple bilateral tumours). We can not forget the broad spectrum of experimental methods—microwave therapy—nearly abandoned technique, HIFU, microwaves, lasers (LITT—Laser Interstitial Thermal Therapy, bloodless resections—to date mainly in animal models), one-port

With respect of facts said above, we can give the algorithm for treatment of kidney tumour under 3 cm. We have to add 2 important pieces of knowledge: over 20 per cent are benign and in renal cell carcinoma is poorly differentiated (grade 3) in less than 5 per cent. Preferred method is laparoscopic resection with following exceptions—tumour of upper pole (open resection), centrally located tumour (laparoscopic nephrectomy or open resection), moderate risk patient (percutaneous RFA or laparoscopic cryoablation) and high risk patient (follow-up only). Conclusions

New trends in surgery of kidney tumours for everyday praxis are followed: Indications for nephron sparing surgery are expanding to cT1b and centrally located tumours. Laparoscopic nephrectomy is the gold standard in cT1-2 and facultative in cT3a-b, cTXN1-2. In approach to partial nephrectomy, open surgery is still the gold standard. Laparoscopic approach is applied only in carefully selected patients. This method is more challenging, with a higher percentage of complications, however, it is getting popular. Robotic systems make laparoscopic partial nephrectomy easier. Laparoscopic or percutaneous in situ destruction are still experimental methods and are recommended only in highly selected cases or in clinical trials. Cryoablation is safer than RFA. Highrisk patients with a tumour diameter under 3 cm can only be followed-up as well.

Milan Hora is the Associate Professor, head of department of urology in Charles University Plzeň, Czech Republic. He specialises in urooncology, mainly for kidney tumour and laparoscopy. He is also Editor-in-chief of the journal Czech Uroloogy.

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ood health for all populations is a recognised international goal. There have been broad gains in life expectancy over the past century, but the health inequalities between the rich and the poor still persist. The prospects for future health depend increasingly on the relatively complicated process of globalisation. Health is not only a benefit of development, but is also indispensable to development. Illness too often leads to ‘medical poverty traps’, creating a vicious circle of poor nutrition, forgone education and more illness. All of these undermine the economic growth that is necessary, although not sufficient, for widespread improvements in health status. Social determinants of health, broadly stated, are the conditions under which people live and work, which affect their opportunities to lead healthy lives. Good medical care is vital, but unless the root social causes that undermine people’s health are addressed, the opportunity for well-being cannot be achieved. Globalisation results in greater integration within the world economy, through movements of goods and services, capital, technology and labour, which leads increasingly to economic decisions being influenced by global conditions. This resulted in the increasing interdependence and interaction among people, companies, and governments of different nations, driven by international trade and made possible by innovations in information technology. Globalisation has become a two-way street as developed and developing countries tap each other’s markets and economies creating a virtual world labour and market force. Globalisation

today is viewed as a more comprehensive phenomenon which is being shaped by a multitude of factors and events but at the same time is reshaping our society rapidly. Globalisation should not be seen as a process that is inherently ‘bad’ or ‘good’ but rather, a process capable of both positive and negative outcomes. The outcomes of globalisation are entirely dependent on how policies are guided and implemented. The promotion and resistance of globalisation has taken shape both at a population and governmental level. It is believed that such efforts can only hope to steer globalisation and not alter it. Sadly, globalisation, to a large extent, appears to have economically benefited the heavily industrialised countries with serious adverse consequences for developing nations, with some notable exceptions. They are alternative pathways for developing countries to allow a more gradual approach to introducing market economics thus allowing developing nations to claim

a stake on the potential profits of globalisation. In the medical domain, economic aspects of globalisation of healthcare have been the driving force behind the overall process of globalisation over the last two decades. Irrespective of the state of development, globalisation has resulted in the increased speed with which information about new treatments, technologies and strategies for health promotion can be diffused. There are also more opportunities for enhanced political participation and social inclusion that are offered by new, potentially widely accessible forms of electronic communication. The consumer of the 21st century is increasingly critical of quality and service, but more importantly he wants the consultation, diagnosis and treatment, and if possible, cure, right there! In addition, these consumers have educated themselves on their medical condition and are prepared to question their healthcare provider on the choices available to them. They even come with stacks of printed copies of information

The emergent global marketplace has following features • New global governance structure influences the interdependence among nations as well as the nation state’s sovereignty • It is characterised by the emergence of global markets and a global trading system • Global communication and diffusion of information enable the sharing of information and the exchange of experiences around common problems • Global mobility resulted in a major increase in the extent, intensity and speed of movements and by a wide variety in ‘types’ of mobility • Cross-cultural interaction between global and local cultural elements • Global environmental changes threatening the ecosystems include global climate change, loss of biodiversity, global ozone depletion and global decline in natural resources.

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With the increasing complexity of globalisation, escalating cost of healthcare and rapid advances in technologyâ&#x20AC;&#x201D;both equipment and ITâ&#x20AC;&#x201D;the challenges and choices facing the practising physician, managers and leaders are daunting. The effects of these changes on patient care may be even more difficult to discern. Basri JJ Abdullah, Professor Ranjit Kaur, Lecturer Department of Biomedical Imaging Faculty of Medicine, University of Malaya, Malaysia

downloaded from the Internet for confirmation and clarification. The increased presence of the Personal Health Records (PHR), centered on consumer, is empowering them with full control over their healthcare needs. It is not unthinkable for them to insist that their health information is updated into their records for second opinion and safe keeping. They will become their own gatekeepers. With the growing trend in healthcare toward higher operational costs, reduced reimbursement and heightened competition among imaging service providers, healthcare facilities must carefully plan capital equipment acquisitions and budgets. Many of todayâ&#x20AC;&#x2122;s high-end

modalities such as CT, MRI and PET / CT are multi-million dollar purchases that require strategic planning for implementation as well as detailed marketing initiatives that can help maximise utilisation. For organisations or practices to remain competitive in this global environment, they must recognise the new healthcare marketplace and its effects on their practices. These changes encompass health consumerism, marketing, service, recruiting and the networks.

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Global marketing

While consumers search the Internet to gain better knowledge about their health and medical conditions, they are also seeking out the most attractive healthcare provider locally, regionally and internationally. They look at comments by third-party providers and by the patients themselves on blogs or testimonials. Virtual services

Healthcare providers must now make their services more readily accessible than was ever physically possible and at an amazingly reduced cost. Already, this inevitability has reached the individual clinician where doctors / institutions / service providers recognise that Webbased technologies will inevitably become more central to their work. Health tourism is another consequence of this trend where we will see greater collaboration between services and

centres across oceans providing complex care. For example, health insurance companies providing services for their clients in other nations. The rationale being increased speed of care at lower cost with a seaside holiday thrown in for recovery. Global / Virtual recruiting

There is increasingly much broader and more severe worldwide shortage of healthcare workers than the periodic shortages over the past four decades. This shortage reflects growing demand, shifting demographics, a change in career expectations and attitudes about work, and worker dissatisfaction within healthcare as well as greater mobility and international recognition. To meet this demand, providers will be forced to recruit staff worldwide taking into consideration the heterogeneous needs of workers from various cultures.

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Global networks

Global networks in medicine have allowed individuals an access to organisational and business linkages in both international health and global medicine. These networks have promoted cooperative relationships in areas such as standards and formulation of practice guidelines, research in multi-centre and multinational trials, visitor exchange, humanitarian service as well as medicine and supply donation. Even though branding is very often used to sell products with no real value beyond what is often perceived by the buyer, the promotion of vital and good technology i.e. digital image management, in the bigger picture may be pointless unless its â&#x20AC;&#x2DC;brandâ&#x20AC;&#x2122; is perceived to be of value and requires the necessary buy-in from governments, professionals, managers and the public. Therefore, the use of price as the sole criterion for success in

the information-based industry may not be enough as the tools for conducting business electronically are low. Other than medical imaging, digital imaging and Information Technology (IT) are also productivity drivers as they allow providers to better manage vast volumes of data at a lower cost. The prevailing perception amongst hospital administrators and physicians is that implementation of IT will provide a competitive advantage. The better use of technology and interoperable electronic networks should accelerate integration; standardisation and knowledge transfer of the administrative and clinical information especially in the context of the globalisation of healthcare and efforts in many countries to create a sustainable health system. Only two elements exist in a connected world: the customer and the information. The key to the former lies in managing the latter. There is a trend toward using IT solutions and sophisticated practice management tools to help physicians and administrators manage their practice as a business. It is envisioned that the key business data would be seamlessly available for decision support. This could cut costs by identifying and managing process inefficiencies and track revenues to improve business. Ultimately, it is hoped that such use of data-mining would result in better outcomes, more cost-effective processes and overall improved healthcare. The future of healthcare outsourcing and offshore services will vary across the provider, payer, and supplier sectors. The jury is still out, since major challenges occur when one looks at issues of cross-border transfer of digital image information whether for purposes of reading or management. This is, in part, due to the highly regulatory environment and national compliance requirements. It is essential that organisations consider the use of offshore services as a strategic tool which must be integrated with their business model. For example, would the offshore services support and improve the

As the accrued benefits of globalisation vary between the developed and less-developed nations, globalisation of healthcare raises some serious issues including: • How can countries deal with globalisation in the context of their existing cultures, beliefs, resources and systems? • How do we deal with the impact of globalisation on the healthcare delivery systems of the various jurisdictions? • How does one cope with the massive impact on a country’s economy of claiming a share of the economic activity that the health industries and service sectors represent, which incidentally is the largest industry on a global scale? • How can developing nations protect their indigenous treatments from being patented in industrialised nations? • How can the serious brain drain of the limited healthcare personnel from developing nations toward the industrialised West be moderated to ensure the needy have access to the services of this invaluable resource? • What mechanisms should be in place to ensure universal access to essential medication and basic imaging facilities

organisation’s overall ability to deliver quality services? Would patient safety or improved care delivery efficiencies and service levels get better? On the downside, the implementation of sophisticated healthcare IT systems requires heavy initial investment. Upgrades or changes to the systems to stay current come with risks and inconvenience to the users who have to learn to use a variety of different logins, platforms and formats to access the data mergers, and acquisitions between organisations— big and small and raises additional issues of integration of the digital management systems. In addtion, the role of IT in healthcare in developing nations, where the basic healthcare needs have not been met, has not been clearly defined. Technology is very often promoted as the saviour to overcome the myriad of challenges faced by developing nations. Technology is not infrequently seen as an end in itself and not an enabler. Nations are often seduced into acquiring expensive technology because it is seen as sexy! Or, technology is acquired as a marketing tool to convince the public that this is

the “happening” community or hospital at the forefront of healthcare! Would the accrual of benefits highlighted for the developed nations be applicable to others? At what level and at what cost? What models will be most appropriate for this wide range of development states? What level of technology would be most appropriate? What necessary actions have to be taken by nations to make IT deliver its potential and promise in healthcare sector? Is the promotion of healthcare information technology relevant? Are doctors to be equally blamed for these excesses as a result of creative marketing? We may not have the answers today, but these are the issues that we must face sooner or later. Conclusion

The increasingly complex and integrated world is blurring the borders between economics, culture and politics. This has resulted in changes in how our societies function today. These changes have the potential for serious consequences, which challenge the economic and political stability of the world. However, these very changes could provide tremendous

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ties and interests between the nations, governments, business and communities. Even though we are unable to predict the future, we have an opportunity to shape our operating systems, determine the future scope and design of our healthcare systems. The need to balance health-

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care costs while providing high-quality care and universal access is nothing less than an exercise in leadership for this 21st century. References are available at http://www.asianhhm.com/magazine

Basri JJ Abdullah is currently teaching at the Department of Biomedical Imaging, University of Malaya and Consultant Radiologist at the Biomedical Imaging Unit, University of Malaya Medical Centre. He is currently a member of the Executive Committee of the Asian Ocean Society of Radiology as well as the President of the ASEAN Association of Interventional Radiology and Treasurer for the ASEAN Association of Academic Radiologists.

A uthors

opportunity for us to create a better world. Therefore, to comprehend the interconnected nature of a globalised world and to understand the consequences of our policy choices and grasp the new face of the world, all of us need to understand how globalisation works, what policy choices we have now, and what are the consequences of such choices. While thoughtful, deliberate, and innovative leadership is necessary to help shape globalisation, the process itself is inevitable, even if the final form may be very different. Due to the rising costs of living, access to affordable health has become an area of increased concern to the public. The need to embrace sustainable development that ensures equitable access to healthcare for our future generations is both a necessity and yet a tremendous challenge in view of the different perspectives, priori-

Ranjit Kaur is currently a lecturer in the Department of Biomedical Imaging, University of Malaya and Consultant Radiologist at the Biomedical Imaging Unit, University of Malaya Medical Centre. Ranjit is currently actively involved in womenâ&#x20AC;&#x2122;s imaging and musculoskeletal radiology. She is also a fellow of the Royal College of Radiologists.

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D iagnostics

Echocardiography

New and evolving roles Echocardiography plays a key role in the diagnosis of many cardiac conditions and in the assessment of response to therapies. Despite the emergence of new, advanced diagnostic tools such as cardiac computer tomography and cardiac magnetic resonance, echocardiography still plays an important role in patient care because of its unique capabilities.

Michael H Picard Director Echocardiography Massachusetts General Hospital USA

on-invasive imaging of the heart continues to evolve and improve. Cardiovascular ultrasound or echocardiography continues to play a key role in the diagnosis and assessment of response to therapy of many cardiac conditions. The advantages of echocardiography are that it is a safe non-invasive test without radiation exposure and is a relatively inexpensive method to rapidly evaluate the structure and functions of heart. New uses for echocardiography include : • providing point-of-care cardiac imaging with miniaturised transthoracic echocardiographic devices • three-dimensional transesophageal echocardiography for assessment of valve disease prior to surgical and transcatheter repair • two-dimensional and three-dimensional transesophageal echocardiography for guiding catheter-based interventions • playing a key role in personalised genetic medicine

• monitoring cardiac side effects in patients undergoing chemotherapy for cancer, • providing perfusion imaging and • helping in the early detection of subclinical disease. This review will briefly highlight some of these exciting new areas.

Point-of-care echocardiography – Miniaturisation

Echocardiography has two main advantages: mobility—it can be brought to the patient bedside very easily—and capability to provide real-time assessment (immediate processing of images without any delay). In fact, ultrasound machines

Real-time three-dimensional transesophageal echocardiographic view of the mitral valve

The valve is viewed from the perspective of the left atrium which is similar to the manner in which a surgeon would visualise the valve during an operation. A = atrial surface of anterior mitral valve leaflet; P = atrial surface of posterior mitral valve leaflet Figure 1

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diagnostics

Catheter-based procedures utilising echocardiographic guidance Percutaneous closure • Patent foramen ovale • Atrial septal defect (secundum type) • Ventricular septal defect (muscular and membranous types) • Paravalvular leak • Aortic pseudoaneurysm Percutaneous valve repair/replacement • Mitral valve (repair) • Aortic Valve (replacement) Percutaneous mitral valvuloplasty Left atrial appendage exclusion Alcohol septal ablation • Hypertrophic cardiomyopathy Table 1

continue to evolve such that full capabilities including three-dimensional echo, two-dimensional echo, transesophageal echo, spectral and colour Doppler imaging, strain rate imaging and even intracardiac imaging can be performed on devices that are increasingly smaller in size. Some of these machines are now as small as or smaller than a laptop computer. Thus, it is easier to provide echocardiography anywhere in a hospital, office or other environments including underserved areas of the world. Three-dimensional echocardiography

Much of medical imaging has switched to three-dimensional (3D) display and this is true even with echocardiography. Real-time 3D echo imaging is in its infancy and we are still learning its strengths and weaknesses. To date, however, the transthoracic 3D echo has shown value in accurately assessing the contractile function of the left ventricle and the transesophageal 3D approach has helped in improving the visualisation of some of the valve pathologies (Figure 1). Standard machines are now outfitted with the hardware and software to perform real-time 3D echocardiographic imaging.

Guiding cardiac interventions

Many cardiovascular procedures that once were performed in the operating room and required open heart surgery can now be performed with catheters in a much less invasive manner, thanks to newly developed devices. Percutaneous coronary interventions such as balloon angioplasty and coronary artery stent placement are the most common examples of this evolution in cardiovascular care. However, there are many other new treatment opportunities in the catheterisation laboratory that require imaging of the heart in a manner different from routine fluoroscopy so that the position of the devices can be optimised (Figure 2). By virtue of its ease of use, safety, lack of radiation, low cost and portability, echocardiography has come to play a key role in selecting patients for and guiding these procedures. Table 1 lists some of these representative procedures. For example, recently transcatheter percutaneous delivery of prosthetic aortic valves—an aortic valve replacement without a chest incision or cardiopulmonary bypass—has become possible. To achieve this, an expandable stented bioprosthetic valve is mounted onto and delivered to the correct location by a balloon catheter. Echocardiography has helped refine this technique in several ways. The echocardiogram is used 1) to help select potential patients with severe aortic stenosis, 2) to guide delivery of the transcatheter valve, 3) to assess the integrity of the device once it is deployed and determine if repeat balloon inflations are required for optimum position and function, and 4) to follow the durability of the new valve. Efforts are now underway to regenerate portions of diseased hearts through the delivery of stem cells, genes and small molecules. Current investigations involve patients with ventricular dysfunction from extensive myocardial infarction and other cardiomyopathies. While catheters can perform the delivery, imaging such as with transthoracic, transesophageal or

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intracardiac echocardiography is critical to identify the diseased portions of the heart and direct the delivery catheters to specific regions. There are many other examples of how echocardiography has helped in minimising the invasive procedures. All of these examples highlight a future role of the cardiac imager and echocardiography for identification of appropriate patients for these less invasive treatments and in the real-time guidance of the procedure. A role in genetic medicine

Echocardiography has played a major role in advancing our understanding of cardiovascular physiology, disease mechanisms and even treatment development. There is hope that in the near future we will be delivering care in a new way based on the genetic characteristics of each individual. This has been termed Personalised or Genetic Medicine. However, before we can enter this phase we need to understand what role various genes play in the cardiovascular system. Echocardiography has a role in this arena since it allows for descriptions or phenotyping of cardiac structure and function which can be related to various genes. Two examples where echocardiographic identification of pathology can be linked to genetic characteristics are arrhythmogenic right ventricular dysplasia and hypertrophic cardiomyopathy. Arrhythmogenic Right Ventricular Dysplasia (ARVD) is a rare cardiomyopathy predominantly affecting young adults but it accounts for up to 5 per cent of the cases of sudden death in young adults. Interestingly, vigorous athletic activity is a common trait of these individuals. Affected individuals frequently have palpitations and ventricular arrhythmias. Pathologically, RV dilation and fat infiltration of the RV free wall are seen. The echocardiographic features include RV aneurysms, RV enlargement, regional RV dysfunction and RV trabecular derangement. Recently a variety of mutations have been

diagnostics

Echocardiographic imaging of Atrial Septal Defects (ASD) during transcatheter closure The Amplatzer ASD closure device attached to a catheter

Two-dimensional transesophageal echocardiographic image of a secundum ASD between the left atrium (LA) and right atrium (RA)

Real-time three-dimensional transesophageal echocardiographic view of the interatrial septum and its secundum defect (*) viewed from the right atrium

Two-dimensional transesophageal echocardiographic image of a secundum ASD closed by an Amplatzer ASD closure device (SVC = superior vena cava)

Real-time three-dimensional echocardiographic â&#x20AC;&#x153;en faceâ&#x20AC;? view of the Amplatzer closure device (+) from the left atrial perspective showing that it has effectively sealed the defect. Figure 2

identified in ARVD patients in genes coding for the desmosomes. The desmosomes are proteins responsible for cell to cell adhesion. It is hypothesised that defective desmosomal proteins permit loosening of the myocardial cellular bonds and this initiates a series of events in which there is fatty and fibrous replacement of myocardial cells. In turn, this leads to ventricular arrhythmias and dysfunction. This degenerative process may be accelerated by exercise as this increases contractile load on the cell to cell bonds and would first be noted in the RV which is more vulnerable than the thicker LV. At present it is not cost- or time-effective to embark on a search for genetic mutations in all people with PVCs. However, echocardiography can help to identify those with the phenotype of abnormal right ventricles. Echocardiography thus provides an opportunity to narrow down the search and identify only those individuals and their families who need to undergo more intensive genetic work ups and treatment. Hypertrophic cardiomyopathy includes a spectrum of myocardial diseases with regional or diffuse ventricular hypertrophy with or without a component of obstruction to outflow of blood from the left ventricle. Though it is among the most common causes of syncope and sudden death in young athletes, it does affect all the age groups. Mutations or defects in genes encoding several components of heart muscle have been identified in this disease. Similar to ARVD discussed above, the structural abnormalities in this disease are evident on echocardiography. As it is not cost-effective to perform genetic analyses at present on all patients with syncope or sudden death, the echocardiogram can be used as an initial screen for the disease thus narrowing the population for the genetic evaluation. In addition, echocardiography can identify those patients who will benefit from treatments such as surgical removal of obstructing heart muscle or the new catheter-based treatment to reduce obstruction.

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diagnostics

Monitoring and reducing side effects from chemotherapy for cancer

injected intravenously they travel through systemic and pulmonary circulations. Newer agents with enhanced stability and which can be easily be detected in the myocardium are thus capable of functioning as a marker of coronary artery perfusion. Such agents are currently under development. Preliminary trials of these agents suggest that when they are combined with vasodilator stress, the transthoracic echocardiogram can accurately assess myocardial perfusion and detect significant coronary artery disease. If these observations hold true in larger clinical trials, then stress echocardiography could evolve to combine imaging of myocardial perfusion and regional LV wall motion in a fashion similar to current

involvement of the heart in these diseases and thus trigger interventions at early stages of the cardiac riskâ&#x20AC;&#x201D;when the chances are higher that such efforts will reduce development of cardiac disease. It remains to be seen, however, if interventions on patients identified with these early echocardiographic markers of dysfunction can improve outcomes. If such a link is established, then it is exciting to think of how we can utilise the miniaturised point-of-care echocardiographic machines to screen large populations at risk, identify those who would benefit from interventions and potentially reduce the worldwide burden of cardiac disease.

Perfusion imaging

Echocardiographic contrast agents are utilised to enhance image quality and especially to improve the detection of left ventricular endocardial borders. These are microbubbles and microspheres that are smaller than red blood cells and when

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Deaths from cancer have not declined to the degree that heart disease mortality has improved but there continues to be significant advances in cancer treatment. Unfortunately, there is a dark side to some of these treatments. It is well known that some of the popular chemotherapeutic agents have toxic and irreversible effects on myocardial function. Echocardiography is used to monitor cardiac function to enable patients to receive optimum doses of chemotherapy. This allows patients to receive the treatments without development of significant decreases in left ventricular function. Appropriate utilisation of echocardiography With echocardiography, we are also gaining insights as to why With these limited examples one these cardiac side effects occur can see the broad spectrum of Echocardiography also has a future role and this may help in devising new future applications of echocarditreatment strategies to reduce the ography. However, there is also in the public health disorders of diabetes, side effects. One explanation for a danger of over-utilisation of obesity and metabolic syndrome. this cardiotoxicity involves free echocardiography and that would radical production that results add unnecessary costs to healthin cardiomyocyte cell death also care systems. To prevent such a known as apoptosis. Once symptomatic, radionuclide tests. The advantages of the problem, it is critical that all who utilise recovery from this cardiac dysfunction echocardiographic approach include no echocardiography practice appropriate is rare. So, our challenge is to find the radiation, a rapid real-time assessment, use of the technology. Although there tools that identify cardiac effects of the lower cost and the fact that additional are complementary roles for various chemotherapy before they are clinically structures such as heart valves, other cardiac imaging techniques, it is should evident so that doses can be modified or chambers and the pericardium can be be ensured that there is no unnecessary not given and thus prevent irreversible evaluated at the same time. redundancy. heart failure. Likewise, we need these tools to be able to tell us when it is safe to Early detection of cardiac disease in Conclusion risk populations continue the drugs. Investigations with Due to new and evolving uses of nonechocardiography are currently underEchocardiography also has a future role invasive cardiac imaging that are critical way to try to identify those markers of in the public health disorders of diabetes, to patient care, the future for echocardisubclinical cardiac dysfunction. Thus, our obesity and metabolic syndrome. Heart ography remains bright. Cardiovascular future use of echocardiography in patients disease is an important component of ultrasound, therefore, will stay viable and undergoing certain cancer treatments may all of these disorders. Novel echocardioits uses in clinical care and research are be more than just a monitoring of the graphic techniques can identify subtle bound to grow in the future. development of cardiac dysfunction.

Asian Hospital & Healthcare Management

Michael H Picard is the Director of the Clinical Echocardiography at Massachusetts General Hospital and he is the Associate Professor of Medicine at Harvard Medical School. Among the awards he has received are the Young Investigator Award from the American College of Cardiology and the Richard Popp Award for Excellence in Teaching from the American Society of Echocardiography.

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diagnostics

Diagnostics for the Developing World

Challenges and constraints In view of limited funding for healthcare, there is a great need and potential for simple, high quality and affordable diagnostic products in the developing world. At present, Immunochromatography-based Rapid Diagnostic Tests are able to meet their requirement to some extent. Innovative molecular diagnostic tools are seen as the future successful products.

Natarajan Sriram Director, Tulip Group Orchid Biomedical Systems India

he healthcare challenges faced by the developing countries are vastly different from those in the developed nations. Owing to the high poverty levels, there is a great dependency on the state for healthcare, the delivery of which has at best been mediocre and highly mismanaged. With very limited budgets available for healthcare, the developing countries have not been able to put up any significant infrastructure to address their huge disease burden. The resulting high morbidity and mortality rates and huge treatment costs further impact their economies. Lack of clear cut policies and a poor regulatory environment further add to the suffering of the people. Treatable and manageable infections and communicable diseases such as Tuberculosis, Malaria, HIV, Typhoid and Dengue still take a huge toll on the populations and economies of the developing world. Apart

from inadequate preventive measures such as improper sanitation, hygiene and vector control, one of the most important reasons for the failure to cure these diseases is inappropriate treatment. As the treatment interventions are largely empirical and based on clinical diagnosis, wrong treatment arising out of misdiagnosis not only increases the cost of treatment by way of further costly interventions, but could also lead to morbidity and mortality. It is also the main cause for

building resistance to conventional drugs. Effective diagnosis is a prerequisite for successful therapy and early and accurate diagnosis results in timely and appropriate treatment. In vitro Diagnostic (IVD) tools are available for providing effective diagnosis. IVD includes a broad spectrum of technologies and technological platforms comprising reagents, test kits and equipments. These are used singly or in combination to detect / estimate specific

Region-wise segmentation of global IVD markets Europe

Asia

34%

15% 11%

ROW

43%

USA

Figure 1

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diagnostics

analytes and disease-specific markers in specimen such as blood, urine, saliva, tears, cerebrospinal fluid and other body fluids, stool and tissues outside the body. IVDs are used in human healthcare for various purposes. These include: 1. Accurate diagnosis of clinical condition and disease; 2. Screening population for disease / disease prevalence / disease predisposition; 3. Prenatal and postnatal screening; 4. Transfusion medicine— screening of blood for compatibility and blood-borne diseases; 5. Clinical management of patients—monitoring treatment and treatment efficacy; 6. Detecting treatment failures / drug resistance; 7. Disease surveillance / epidemiology. However, as can be seen from the worldwide market analysis of IVDs in figure 1, there is very limited usage of these tools in the developing world. Almost 85 per cent of the global IVD market is dominated by USA, Europe and Japan. (Figure 1) USA itself accounts for over 43 per cent of the market. Asia contributes to 15 per cent of this market followed by rest of the world at 11 per cent. The reasons why IVDs are not widely used for diagnosis in the developing world are: • Affordability. Limited funds for healthcare • Lack of priority for diagnostics over treatment • Non-availability of relevant and appropriate kits • Lack of laboratory infrastructure • Lack of trained laboratory manpower • Lack of awareness • Logistic issues such as storage, pack size, shelf life, transportation etc. • Poor regulatory and quality control environment • Lack of direction / initiative in this regard. Keeping these reasons in mind, the challenges in inducting IVDs as a part of health intervention in resource poor countries can be summarised as:

An ideal IVD tool for the developing world should, therefore, have the following features: • Adequate sensitivity and specificity • Reliability and accuracy • Potential to provide quick results and minimum hands on time • Simple and minimum procedure • All the required features not needing any additional equipment and / or accessories • Minimal training without need for specialised staff • No special storage conditions and long shelf life • Smallest pack size • Single testing and batch testing possibility • Self-validation of each test • Lowest effective cost per test.

• Making available affordable, practical and relevant and high quality diagnostic kits • Strategising health programmes to include diagnostics for better disease management • Creating uniform regulatory mechanism and quality assurance system • Mobilisation of funds to meet the above objective • Comprehensive insurance / social security to cover diagnostics • Focussed research and funding for development of new reagents / markers and for new and emerging technologies • Mass education and awareness campaigns, especially in endemic areas. In the last few years, the developing markets have seen a significant rise in the use of Rapid Diagnostic Tests (RDTs) that meet most of the criteria of an ideal IVD. RDTs, as the name indicates, provide quick results (5-30 minutes), are simple, user-friendly, ready to use products that do not require instrumentation

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or trained manpower and have a long shelf life at ambient conditions. They are also ideal for use as Pointof-Care Tests (POCT) where the testing can be done alongside the patient in any setting. Some examples are: While they have made a significant impact in diagnosis of some diseases such as malaria and HIV, RDTs for many more diseases are available and are in the process of integrating into healthcare systems. However, RDTs still have limitations of sensitivity and specificity for many conditions and hence, further improvements and refinement is required in this technology to make these tests more universal. Currently, molecular diagnostic platforms that allow direct detection of target DNA / RNA of the infecting organism require instru-

Rapid test for HIV

Rapid test for malaria

Negative

PV Positive

Pf Positive

Positive mixed infection

Figure 2

diagnostics

such as WHO, FIND, DFID etc. are funding projects to provide better and novel technologies for the developing world including the development of IVDs for ‘orphan’ diseases that were earlier neglected by the industry for the lack of profit motif. There is also tremendous activity in the industry itself with many regional players entering the market with better quality products and creating a competitive environment that can only see more

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mentation, trained manpower, special storage conditions, special laboratory infrastructure etc. and hence are not ideal for the developing countries. However, the future is likely to see the development of novel, simple and inexpensive molecular platforms and other technologies such as microfuidics and nanotechnology that could be used for better disease management in these countries. Humanitarian and aid agencies are playing a big role in providing and encouraging the use of IVDs in developing countries. The global fund for malaria, HIV and TB is also making available funds for procurement of IVDs by the recipient countries. World Health Organization (WHO) is playing an important role in setting quality standards and evaluation criteria for ensuring the quality of IVDs by procurement agencies. Organisations

novel products, higher standards of quality at more affordable prices. All these efforts are bound to bring about a big change in the healthcare strategies of the developing world in the coming years. These strategies will help to mitigate the sufferings of millions of people, improve their quality of life, reduce disease burden of the country and also make a positive impact on the economies of these countries.

Natarajan Sriram is the founder Director / Managing Partner of a group of companies under the banner of “Tulip Group”, all in the field of medical biotechnology, based in Goa, India and manufacturing and marketing a range of medical diagnostic reagents and kits. He is a panel member of Diagnostics Evaluation Experts Panel set up by the WHO, functioning as a temporary advisor to WHO. He was also a panel member of the experts committee set up by the Drugs Controller General (India) that formulated the current national Diagnostics Guidelines.

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Asian Diagnostics Market Emerging opportunities Suresh Vazirani Chairman & Managing Director Transasia Bio-Medicals Ltd. India

What are your views on the Asian diagnostics market? How has it evolved over the past decade? Asiaâ&#x20AC;&#x2122;s ageing population is expected to double by 2025, increasing the number of people likely to require medical treatment. Rising average life expectancies along with more affluent populations is expected to boost expenditure on healthcare treatments, including IVD. Currently, lack of proper health insurance in most countries coupled with constrained personal finances has resulted in low levels of consumer spending. In the absence of a strong medical insurance sector, most of the healthcare expenditure is borne by the individuals themselves especially in countries like India and China. The Asian In Vitro Diagnostics (IVD) market has, over the past few years, been the only market experiencing a doubledigit growth rate. A growing and ageing population and widening health insurance penetration are advancing growth opportunities in this high potential market. For the Emerging technologies in the IVD Industry, Lab automation continues to evolve. The drive or thrust for smaller, faster and more accessible devices is increasing. Emerging markets have different needs with respect to the test menus, technologies used and oper-

Advances in nanotechnology and genomics have enhanced the role of diagnostics in the healthcare market, allowing more tests to be performed at the point-of-care and facilitating the shift towards personalized medicine.

ating procedures. Thus, made to order solutions need to be developed for these markets. Lab automation has also taken on a new level of importance in the ability

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to actually get instruments interfaced to various laboratory information systems. Information technology has taken a giant leap in the IVD industry thereby reducing the dependence on a technically

diagnostics

The diagnostics market in India has been growing steadily over the years, what areas of growth are likely to drive the market here? The emerging industry structure is headed towards providing healthcare services as an integrated comprehensive package rather than the traditional concept of providing healthcare infrastructure and reactive medical care. Growing health consciousness among middle and highincome families in India is heralding a new business opportunity—Preventive healthcare. This has shifted focus from in-patient treatment to a regular preventive health check. Corporates offer annual health check for their employees; insurance companies conduct pre-insurance policy check; and self paid health checks have also led to the growth in the market. Today the diagnostics business is mainly based on technology. The Indian companies with their R&D facilities have developed a range of good quality products for the local market amidst fierce competition. What are the new technologies driving today’s diagnostics market? The global diagnostics market is undergoing radical change. Advances in nanotechnology and genomics have enhanced the role of diagnostics in the healthcare market, allowing more tests to be performed at the point-ofcare and facilitating the shift towards personalized medicine. There are new opportunities in infectious disease testing, molecular oncology and pharmacogenomics.

How do you think personalised medicine and genomics are affecting the diagnostics market? Personalised medicine is rightly called the ‘future medicine’ as it makes it possible to give the appropriate drug, at the appropriate dose and at the right time. This has unleashed the potential of significantly more effective diagnosis, therapeutics and patient care. With the breakthroughs in molecular diagnostics and advances in laboratory equipment, this piece of the diagnostics pie is going to play an increasingly large role in early diagnosis, monitoring and targeted pharmaceutical intervention.

Delivering the right data in a timely and cost effective manner while improving the sensitivity and specificity of the test is the need of the hour and the industry needs to gear up for single workstations that can carry multiple workloads.

Diagnostics are increasingly moving closer to the patient through pointof-care and home-based monitoring. What do you make of this trend? Timely, accurate diagnosis can mean the difference between life and death for a patient. The driving

profile

qualified individual to be present at all times during the analytical procedure without compromising on established levels of care. Delivering the right data in a timely and cost effective manner while improving the sensitivity and specificity of the test is the need of the hour and the industry needs to gear up for single workstations that can carry multiple workloads.

notion behind point-of-care testing is to bring the test conveniently and immediately to the patient. Now most clinicians acknowledge that point-ofcare testing is a prerequisite for early recognition of life-threatening conditions as they require that laboratory results be made available in real-time and, if possible, at the critically ill patient’s point–of-care. Point-of-care testing has come a long way from a handful of simple waived tests to what is today a multibillion dollar global market that holds great promise for the future. However, it is not the magical potion or remedy for all the ills of our current healthcare system. Point of care acting as a complement, and not as a replacement, to central laboratory services can bring about a complete turnaround in clinical diagnostic testing. Any other comments you would like to make? Good quality healthcare is a basic fundamental right and should be made available for all but our government’s health systems are not able to provide even basic healthcare to the poor people. Per capita healthcare spending by Indian government, which is one of the lowest in the world, needs to be increased substantially and all healthcare products should be made totally free of taxes, to make them affordable. Public-private partnership should also be encouraged in running Government Hospital / Healthcare centres. This will immensely help the common man in getting access to the latest technologies in healthcare system at an affordable cost.

Suresh Vazirani graduated as an electrical engineer from the Nagpur University. He founded Transasia Bio-Medicals Ltd in the year 1979. Over the last three decades the company has grown to become India’s number one diagnostics company. TRANSASIA today follows a 360 degrees approach to its business from Manufacturing and Marketing to service and research.

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technology , e q uipment & devices

Mechanical circulatory support is an important adjunct to the management of patients with advanced heart failure. Technology advances in this area have improved overall survival. The challenge for clinicians is to translate the clinical evidence into selection of the most appropriate device that will provide benefit for an individual patient.

Devices for the Failing Heart The future is here

Diego Delgado Professor Division of Cardiology and Transplantation University Health Network Canada

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echanical Circulatory Support (MCS) is an important adjunct to the management of patients with severe heart failure. Because the number of donor hearts available for transplantation is limited, the use of MCS is growing as a valid alternative to save the lives of patients who are facing death. There is substantial evidence that MCS is able to revert the cascade of pathophysiologic events observed in patients with advanced heart failure. Although there are established protocols to assess ventricular recovery post-MCS, there is still no parameter available that allows estimation of how long the improved cardiac function will persist. Let us have a look at the current clinically available mechanical support devices, their indications for use and the specific advantages and disadvantages associated with each device.

technology , e q uipment & devices

Indications for support

MCS is a life-saving option for the patients who fail to improve or stabilise with intravenous inotropes or vasodilators, intra-aortic balloon pump support, and mechanical ventilation. Patients requiring mechanical support generally fall into four categories: those with 1. Cardiogenic shock resulting from Acute Myocardial Infarction (AMI); 2. Post-surgical myocardial dysfunction; 3. Acute cardiac failure from myocarditis and 4. Decompensated chronic heart failure. Patients who present a cardiogenic shock after an AMI are excellent candidates for either short- or long-term mechanical support because they have not developed the systemic organ dysfunction seen with chronic end-stage heart failure and have the potential for myocardial recovery. For patients with the potential for recovery, temporary short-term support should be considered for a period of 5-7 days. Patients who fail to demonstrate myocardial recovery within seven days should be considered for conversion to a long-term device. In patients who are not eligible for transplant, device withdrawal should be considered if destination therapy with a long-term implantable device is not an option. Patients with post-surgical shock can be divided into 1) Those with pre-existing ventricular dysfunction and therefore a low chance of recovery and 2) Those who had normal ventricular function before surgery and may recover with short-term support. An Abiomed BVS 5000 may be the most appropriate choice for the patient with previously normal cardiac function while immediate use of an implantable left ventricular assist device (LVAD) may be the wisest choice in patients with preexisting severe myocardial dysfunction. Acute myocarditis is another common indication for cardiac mechanical support. Short-term support is indicated in patients with persistent hemodynamic instability despite maximal medical therapy. Failure to demonstrate adequate myocardial

recovery should prompt evaluation for conversion to a long-term device. Decompensation of chronic heart failure is the most common indication for long-term MCS. Goals of mechanical circulatory support

The majority of experience with MCS has occurred in patients supported temporarily as a bridge to transplantation. One important observation during the bridge-to-transplant experience was that some hearts recovered sufficient function to have the device removed. Given the shortage of donor organs, all patients undergoing MCS should be systematically evaluated for evidence of myocardial The Thoratec extracorporeal pump

Ventricular assist devices

There are several FDA-approved Ventricular Assist Devices (VAD), in addition to the intra-aortic balloon pump. Extracorporeal devices include the Abiomed BVS 5000 and Thoratec, which are both capable of biventricular assistance. Implantable devices designed for left ventricular support are the Novacor N1000PC, the HeartMate Pneumatic and the Vented Electric LVADs. The next-generation devices consist of axial flow pumps with non-pulsatile flow, totally implantable LVADs. The HeartMate II LVA System (Thoratec), MicroMed DeBakey VAD System (MicroMed), Jarvis 2000 Heart (Jarvik Heart) and the VentrAssist LVA System (Ventracor) are the subject of ongoing clinical evaluation. Extracorporeal Devices Abiomed BVS 5000

The Abiomed BVS 5000 is an external, pulsatile, mechanical support system that can be used for univentricular or biventricular support. The advantages of this support system are its ease of use and availability. Thromboembolic, bleeding and infectious complications limit support periods generally to less than 14 days. Thoratec

Figure 1

recovery. The bridge-to-recovery will be most successful in patients with postsurgical cardiac failure, acute myocarditis and AMI who have a high chance for cardiac improvement in accordance with the nature of their diseases. The use of LVADs as an alternative to heart transplantation (destination therapy) has demonstrated significant survival benefits in these patients.

The Thoratec paracorporeal pump is a pneumatically driven, polyurethane sac designed for long-term use (Figure 1). The Thoratec VAD system is indicated as a bridge to transplantation and a bridge to recovery. The pump is positioned on the external abdominal wall with cannulae tunnelled subcostally into the mediastinum. The Thoratec VAD provides uni- or bi-ventricular support. These cannulae are connected to an external pump (one for each ventricle), consisting of a rigid housing chamber containing a polyurethane blood sac. An external drive console sends pressurised air to the pump, compressing the blood sac and ejecting blood through mechanical valves. The external position of the pump allows device exchange in cases

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technology , e q uipment & devices

The heartmate-VE left ventricular assist device

Figure 2

of malfunction, thrombus or infection. Furthermore, this also enables use in patients who are poor candidates for implantable devices. Patients require systemic anticoagulation for the duration of the Thoratec VAD implantation. Continuous flow pumps

Axial or rotatory blood pumps have been developed with the goal of intermediate-term as well as long-term ventricular assistance. These non-pulsatile-flow systems have shown some advantages in contrast to pulsatile systems: smaller size, higher efficiency, less infections, lower incidence of thromboembolic events and lower cost. Early clinical experience has shown that long-term non-pulsatile blood flow is well tolerated. Intracorporeal devices HeartMate

The HeartMate LVAD is implanted in a preperitoneal pocket, anterior to the posterior rectus sheath and just below the left costal margin (Figure 2). The inflow cannula is connected to the apex of the left ventricle and the outflow cannula is anastomosed to the ascending aorta. There are two types of HeartMate devices. The Implantable Pneumatic LVAD (IPLVAD) is powered and controlled by an external pneumatic drive console that rests on a wheeled cart. The Vented Electric

LVAD (VE-LVAD) contains an electric motor within the blood pump housing. It receives external power and control signals from an external microprocessor via a vented drive-line. Both systems have porcine valves and textured blood-contacting surfaces that become covered by a â&#x20AC;&#x2DC;pseudoneointimalâ&#x20AC;&#x2122; layer. This results in a very low incidence of thromboembolic events and, therefore, patients do not require systemic anticoagulation. Insertion of the HeartMate is difficult in patients with a body surface area less than 1.5 m2 due to anatomical constraints. The major complications occur early and include haemorrhage and right heart failure. Infection remains a common complication (30-50 per cent) with prolonged use and is the biggest impediment to long-term success. Novacor

The Novacor is an implantable, electric, dual pusher plate device designed for longterm cardiac support. The pump housing is constructed of a smooth polyurethane pump sac with gelatin-sealed inflow and outflow polyester grafts containing porcine bioprosthetic valves. The Novacor shares many similarities with the HeartMate system including an external drive system with a portable power pack option. The device is implanted via sternotomy with an inflow conduit to the left ventricular apex and an outflow conduit to the ascending aorta. The pump itself is positioned in an abdominal subfascial plane or intraperitoneally with the tunnelled drive-line exiting the abdominal wall. A console or portable system regulates the pumping rate. The Novacor LVAD device requires systemic anticoagulation to prevent thromboembolism (risk 5-7 per cent). The incidence of primary device failure is very rare.

contains dual spherical polyurethane chambers. The dual ventricular chambers are anastomosed to native atrial cuffs and the outflow conduit is anastomosed to the great vessels. Dual pneumatic drivelines exit transcutaneously to a console control system which monitors pump pressures and performance. Antiplatelet and systemic anticoagulation are needed. This device is used as bridge-to-transplant in patients with biventricular failure. AbioCor TAH

The AbioCor TAH is the first fully implantable replacement heart. It has been approved by the FDA as an investigational new device to be tested on selected patients. The AbioCor consists of an internal thoracic unit, an internal rechargeable battery, an internal miniaturized electronics package and an external battery pack. The thoracic unit is equipped with an internal motor that is able to move blood through the lungs and the rest of the body. The use of transcutaneous energy transmission eliminates the need for the patient to be immobilised permanently by tubes or wires connected to an external power source thus possibly reducing risk of infections. Devices in clinical trials include the Heartmate II, the Micromed DeBakey VAD, and the Jarvik 2000 (Figure 4). The DeBakey pump has already been successfully implanted in a small number The CardioWest Total Artificial Heart (TAH)

CardioWest Total Artificial Heart (TAH)

The CardioWest is currently the only total artificial heart approved for use in the US under an FDA investigational device exemption (Figure 3). This device is pneumatically driven and implanted in the orthotopic position. The pump consists of a rigid pump housing that

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Figure 3

technology , e q uipment & devices

Continuous-flow devices

Heartmate II

Device Selection

Device selection depends not only on specific patient characteristics and the etiology of the patientâ&#x20AC;&#x2122;s heart failure, but also on device characteristics, device availability and the experience of the surgical team. Patients in profound post-surgical cardiogenic shock require support to avoid permanent end-organ dysfunction and increase their chances of survival. The preferred devices are the Abiomed BVS 5000 and Thoratec device. These devices may provide full biventricular support reestablishing near normal haemodynamics while awaiting myocardial recovery. If prolonged support is expected, conversion to a longer-term device such as an implantable LVAD or TAH should be considered. The Thoratec device has the advantage of providing long-term, extracorporeal support. Device selection for long-term support is much more complicated and often is subjective and based on the surgeons experience and bias. For smaller patients (BSA <1.5m2), the Thoratec A uthor

of patients in Europe. The Heartmate II and the Jarvik 2000 have also been successfully implanted in humans. Unfortunately, there are few options or backup mechanisms other than replacement. Additionally, since these devices do not have valves, if a malfunction occurs the patient may develop the equivalent of wide-open aortic insufficiency. Short-term support provided by centrifugal pumps has been shown to be a safe and simple cardiac support system with an overall wean rate of 50 to 60 per cent and a survival to discharge rate of 25 to 40 per cent. The use of short-term devices in selected high-risk patients as a bridge to long-term devices has shown survival rates no significantly different from the survival rate after long-term support alone. Successful transplantation is accomplished in 60 to 65 per cent of patients who received a long-term device. Between 28 to 38 per cent of all supported patients are discharged from hospital and managed as outpatients. Patients with LVAD have a higher survival to transplantation rate than the non-LVAD patients. CardioWest TAH provided a survival to transplantation rate of 75 per cent and a survival rate post-transplant >80 per cent There are limited published data regarding axial flow pumps, AbioCor TAH, and other LVADs; however, early results have shown safety, efficacy and reliability.

Micromed DeBakey VAD

Jarvik 2000

Figure 4

device and eventually a continuous flow pump are the only options. For the larger patient, all devices are potential options. Most frequently an implantable LVAD is used but the CardioWest is useful for severe biventricular failure. Summary

Mechanical circulatory systems have been shown to be an effective shortterm therapy as a bridge to transplantation and as permanent cardiac support. The technological and human resources required to implement a mechanical assist device programme represent major limitations. Unfortunately, this technology is currently used only in dedicated centres. The next generation of mechanical assist devices will provide hope for the burgeoning number of patients with end-stage heart failure, regardless of their eligibility for transplantation. References are available at http://www.asianhhm.com/magazine

Diego Delgado is an Assistant Professor in the Division of Cardiology and Transplantation at the Toronto General Hospital, Canada. His interests are immunologic aspects of heart failure and transplantation. He is the Past-Chair of the Canadian Cardiac Transplant Group. He is the Vice-President of the Interamerican Society of Cardiology.

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technology , e q uipment & devices

Nano-Healthcare

Biotechnology & biomedical perspective of disruptive potential Nanotechnology has all the potential to become a disruptive and revolutionary technology in terms of its healthcare application. However, there are a few ethical concerns which need to be sorted out before its wide-spread use in healthcare.

Abhishek Dutta Senior Research Analyst Technical Insights Frost & Sullivan, Singapore

anotechnology, or the science of the small, has become the buzzword of academic and industrial circles, which has diversified across various verticals such as healthcare, aerospace, defense, materials and many more. The beginnings of nanotechnology could be attributed to Sir Richard Feynman who in his landmark lecture titled ‘There is Plenty of Room at the Bottom’ envisioned the possibilities of manipulating nanoparticles essentially of atomic scale to modify and enhance the properties of materials that are in use today. Studies in the field have shown that the constituent particles of nanoscience—namely fullerenes, dendrimers and Carbon Nanotubes (CNTs)—are the fundamental building blocks of nanotechnology. Further, the change of physical properties at the atomic level that typically behave differently when viewed at the macrolevel, beckons the possibility of developing novel materials with unique properties. Owing to these changes, these nanomaterials could find use across an array of applications.

The word ‘nano’ is being synonymously used with innovation in every domain and the healthcare and life sciences domain is no different. The cardinally important application of nanotechnology is in the field of materials; biomaterials to be more specific. But since the application of biomaterials is in variegated medical applications, the penetration of nanotechnology is seen in a myriad of uses in the medical device realm. The main reason behind the hype of nanotechnology, in the biotechnology and medical realms, is due to the basic nanometer size of its material particles. The nanometer size, allows the particles to be accouter in heterogeneous biotechnological / diagnostic device applications because the miniscule size allows the nanoparticle to be used in situations where a penetrating skin barrier is needed. Further, due to the nano size, the particles can be coated or attached to individual molecules and used to target specific molecules within the human body. Facilitating the research and commercial focus on nanotechnology is the fact that an assortment of nanoparticles, due to their submolecular size, exhibit variegated properties of molecular interaction. One such property is ‘self-assembly,’ which is primarily exhibited by

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carbon CNTs, graphite nanoparticles and organic fullerene particles. The property of self-assembly allows the particles when excited using a chemical or electromagnetic means to form a spherical or rod-shaped assembly of particles due to atomic forces such as van der Waals forces and so on. Some of the key properties of nanoparticles and how it helps in unlocking potential applications in medical field is depicted in Figure 1. Key Unique Selling Prices (USP) are generated through the application of nanotechnology in most technology / product domains. Conventional technologies can be developed into variegated applications based on the unique properties rendering unique selling price or unique value propositions. Examples of such devices would be: Application: Nanoanalytical devices and reagents USP:

• The nanoscale sizes will render lesser samples to be used, thus saving on wastage of reagents because the acutely small sample size requires lesser amount of samples • More surface area for better diagnostic testing • More surface area will also provide greater reactivity.

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technology , e q uipment & devices

NanoBiotechnology: The lock & key integration The key properties: • Self-assembly • Better penetration • More reactivity • Compatibility

Nanotech:

Biotech & Biomed:

The key

The lock

Better research tools for testing gene expression, proteomic analysis, diagnostics & imaging

The Application Domains: • Drug Discover & Delivery – DNA Nano Bio Technology & Lab Anaemia, Nano Fluidis Cancer Therapeutics • Coatings – Cell Staining, Antibody Coatings, Coatings an Prostmetics, Coatins on Sients • NEMS – Nanobots (Swarm Ingranostics) for cancer, Quantum Dots, Nano Piezoelectric Sensors Therapeutic Electrodes, Nanomagnetic sensors • Microscopy – AFM (Cantilever), MFM Figure 1

Application: Nanobiomaterials USP:

• Nanoscale particles can help in developing nanofilms thus enabling efficient orthopaedic coatings • More surface area resulting in more reactivity and thus better bioactivity of bioabsorbable coating materials • Self-assembly property resulting in uniform coatings. Application: Nano targeted drug delivery and nanorobotics USP:

• Nanoscale sizes result in easier penetration and aids in targeting diseased cancerous cells of micrometer sizes for delivery of medicines • More reactivity due to more surface area results in more accurate sensing of the diseased region inside the body • Self-assembly property enhances the effect as the nanoparticles will be able to home into each other’s signals towards the diseased region. To the general population, nanotechnology is just another out-of-the-world concept while in reality it is not so. Here, it would be wise to keep in mind that nanoparticle technology, or rather nanotechnology, is not an out-of-thebox concept that has been recently used. Research performed by a Russian scientist, Mal'tseva T. A., in the late 1960s exhibited

the antimicrobial facets of silver particles, where the scientist coated fabric with tiny silver particles, to render antimicrobial property to the cloth. Hence the use of miniscule metallic particles dates back to antiquated research. Further, ancient medicinal fields such as Ayurveda quintessentially made use of powdered versions of various substances as an effective cure for a myriad of ailments. Hence, the questions that automatically haunt the mind are why there is any need to mobilise funding and resources and take a nosedive to explore nanotechnology on a large scale through a national initiative? What will be the use and impact of such an endeavour? And how will it aid in developing better solutions? It is best to state at this point, that the intriguing part behind nanotechnology is not in its conceptualisation, but in our present day capability to create and control nanoparticles (of different materials) in vitro resulting in studying and excavation of newer properties and applications. Hence, here lies the driving force behind the need to theoretically understand, practically research, and conclusively analyse the developments in nanotechnology in depth as only through further and organised research can the truthful implications and futuristic applications of nanotechnology be achieved. But a national initiative doesn’t end the work process. It should

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rather serve to be the stepping stone to segregate work, take up responsibilities and bring out safe and effective applications or product innovations with technical advantages and high-end utilities. In case of some diseases, such as cancer, a national nanotechnology endeavour with a cardinal focus on biotechnology or medical applications can bring forth novel diagnostic or therapeutic kits and life-saving technologies. Nanobiotechnology and product development are more of ‘An Evolution than Revolution’. This was the comment made by Phil Bond, the US Undersecretary of Commerce in a conference. However, on a closer look into this concept, it is found that not only nanotechnology, but most technological developments in the present day world happen through the process of necessity and evolution. In this evolution of technology, the advancements happen in a plethora of verticals, starting from materials to electronics to energy. A sudden revolution is seen when different verticals suddenly come together and integrate with each other, resulting in the development of a quite out-ofthe-world technology from the present day perspective. From Frost & Sullivan's perspective, nanotechnology has all the potential to become a disruptive and revolutionary technology in terms of its healthcare application. However, this will depend on smaller and individual developments, which will eventually lead to a revolution disrupting the present world technology. VC funding in nanobiotechnology has seen a mushroom growth since 2005. This is owing to the fact that the VCs have, in recent times, seen constructive practical healthcare applications of nano-based products enter the commercial markets. This has helped them allay their scepticism and fear of the high risks in this domain and invest more. However, there is still a huge lack of standardisation and regulatory gaps in the nanoanalytical tools and devices domain, which might make product commercialisation a big problem at a later stage.

technology , e q uipment & devices

Ethical concerns Nanotechnology as a field does have many bioethical concerns which might work against it as a commercial product. Bioethics pertains to the ethical questions that arise in the field of medicine and biology. Disagreement exists about the proper scope for applying ethical evaluation while developing or licensing a technology for patients. Bioethics generally deals with public policy questions, which are often excessively publicised and politicised. There is a tendency among medical engineers, scientists and others involved in the development of a technology to perceive ‘bioethics’ as an attempt to derail their work and obstruct it regardless of the true intent. Nanoparticles have emerged as a source of concern due to the possibility that they may be absorbed through the skin, or inhaled, with as yet unknown health consequences. Lab animal tests have indicated that some nanomaterials, such as carbon nanospheres and nanotubes, can cause fatal inflammation in the lungs of rodents; they can also cause organ damage in fish, and can kill ecologically important aquatic organisms and soil-dwelling bacteria. A recent research published in Nature Nanotechnology reveals that some long strands of CNTs are as toxic as asbestos and can cause cancer. Nanoparticles can also stunt the growth of roots on several crops. A number of bodies—including the Royal Society, Britain's scientific body, and the Royal Academy of Engineering—have stated that nanoparticles could be a cause for concern.

environment, and in its capability to be replaced in case of defects. At present, the US and Europe lead the way in applying nanotechnology for medical applications. The funding from federal governments, extensive collaborations and opportunities for spin-offs are the key reasons for the leadership of these countries in the field. Asian countries serve as hubs for contract research for American and European conglomerates. The revenue generated from such outsourcing has slowly begun to boost the Asian economy towards investing heavily in indigenous research and application. Conclusion

The development of nano-healthcare applications is influenced directly by the policies and principles of bioethics because the end user is primarily a diseased

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At present the vendor and supplier bargaining power is high in this industry owing to lesser number of industry players with an effective commercial product to penetrate the market. This makes the threat of new entrants higher into this industry both as raw material suppliers and as technology or product vendors. The consumer bargaining power is also high due to alternative technologies present in the market. All these above mentioned factors make this industry extremely attractive and competitive. With the advent of nanotechnology and introduction of new concepts based on the new technology, the field of biosensors received a boost. Much funding and capital is being invested in the development of nanobiosensors, which has promise to be a disruptive technology once it hits the commercial stage. Although they could provide a non-surgical invasive biosensing alternative, nanobiosensors have to undergo enormous development from the standpoint of biocompatibility, controlling a nanoswarm in its environment, with the capability to be replaced in case of defects. Similarly, with the advent of nanotechnology, the field of neurostimulators, like many others, will receive a boost, since many new concepts are to be introduced and implemented. This will continue to happen as and when the excavation through research and corresponding developments in the field of nanotechnology happen. Concepts such as self-targeting brain and neuronal implants, which can invasively attach themselves at specific locations of the nervous system, providing automated in vivo neuronal therapy, now seems to be a definite possibility. Much funding and capital is being invested in the development of nanoneuroprosthetics, which will promise to be a disruptive technology once it hits the commercial stage. Although nanotechnology could provide a myriad of variegated applications, nanoparticle therapeutic devices have to undergo enormous advancements from the standpoint of biocompatibility, controlling nanoswarms in the in vivo

human being who has his / her own set of values, principles, and ethics. Hence, nano-healthcare applications, especially invasive ones, have to undergo a scrutiny at the end-user level, despite all FDA approvals. A lot of turmoil is brewing as nano-healthcare applications emerge and arise because they are objects that the patients can never perceive with their own eyes. Moreover, their small size could make it impossible to replace the sensor in case of a defect. Furthermore, products such as nanobiosensors and nanobots are yet to be approved as ‘safe’ by the FDA, although huge funds are already at stake in their research. Here lies the rift between nanohealthcare applications and bioethics, which only time and dedicated research towards maintaining patient safety can resolve.

Abhishek Dutta is a Research Analyst with the Frost & Sullivan Technical Insights team. He focusses on tracking and analysing global emerging trends and technologies pertaining to the Healthcare industry. He has authored several research studies in the medical device domain and has consulted very many top medical companies on technology/industry. He contributes to the medical device and medical imaging alerts on a regular basis.

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facilities & operations management

he need to consider and manage the safety of patients within healthcare has been widely recognised over the past decade. The ‘science’ of patient safety has grown, and is constantly seeking to identify how and why things go wrong in patient care and what we can learn from other industries and from other disciplines such as psychology to make care safer. The emphasis has moved away from ‘blame’ towards looking at how modern healthcare is delivered in complex, busy hospitals and clinics, and recognising that sometimes the systems themselves create problems. What can go wrong?

The sort of things that can go wrong for patients are as varied as patients themselves and the people who care for them. This includes errors such as receiving the wrong drug or wrong site surgery, or complications of surgery and other treatments, or failure to diagnose correctly or to spot the patient whose condition is deteriorating and to do something about it.

The outcomes for patients can range from little or no harm and minor annoyance to permanent disability or death. The outcomes for families can be sudden bereavement; for clinicians involved in a serious error or incident can be loss of career, or even criminal charges, and lifelong distress. When all the evidence that is now being gained from wide spread studies of patient safety incidents indicates that a significant number of these are preventable, there is no excuse for failing to take patient safety seriously. In specific incidents such as these, patients can be let down by healthcare systems which do not provide the best care. This happens only when clinicians do not keep themselves up-to-date with new developments in care, and do not review and change their own practice when there is evidence that other methods are more effective. The basic principles for safety and quality of care

The basic principles for patient safety are the principles for quality of care: to do the right thing for the right patient using the right method and at the right time, and to communicate well with the patient and the rest of the clinical team—record findings, planning actions promptly and clearly, ensure that instructions are understood and carried out, and report concerns to a senior colleague when necessary.

Sarah Williamson, Consultant, Patient Safety and Risk Management, SalSafe, UK

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These principles sound very simple, but most of the serious patient incidents result from a sequence of small errors or failures to act, rather than one large dramatic event. If each of these principles are analysed in more detail, the implications for both patient safety and good quality of care will become clearer. Doing the ‘right thing’

This might mean ensuring that the correct test is carried out in line with the patient’s symptoms; that the correct drug is chosen and is given at the correct dose; that surgery is performed on the correct side of the body; and that observations are carried out on a sick patient at the correct frequency. The procedures and training to guide all the staff on various means to improve safety and quality of care—unambiguous and clear prescription of drugs, proper and safe administering of drugs, marking and preparing patients for surgery, knowledge of appropriate timing of tests and

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Patient Safety and Risk Management A look at the basics

Even as modern healthcare continues to achieve excellent results, all too often patients are put at risk either through errors or through failure to assess their needs properly, manage their care and recognise deterioration.

different methods of interpretation of results—should be provided. The ‘right thing’ might also mean having up-to-date knowledge and skills to allow clinicians to give their patients the best care. Much of the patient safety activity in the USA and UK at the moment is focussed on good patient management—using proven methods to avoid ventilation pneumonia, for instance, or researching invasive procedures and frequently used drug regimes to see if they actually benefit the patient. A classic example is to restrict the use of antibiotics to patients with bacterial infections rather than viruses, to reduce the spread of antibiotic resistance and opportunistic bowel infections. The need to do this has been recognised for decades, but changing practices can be

painfully slow. All healthcare organisations need to consider how much they can rely on individual clinicians’ judgement and to what extent they can intervene with directives or by taking action to force compliance with changes. The right patient

This sounds painfully obvious, but many errors occur because patients have similar names. Errors could occur when the wrong patient is taken to X-ray, or a doctor picks up the wrong set of notes, or specimens are mislabelled, or even because in a busy ward there is a new patient on the bed. It should be routine for staff to check at each stage of care that they are dealing with the correct patient, and if they have heard the patient’s name correctly when they are asked to carry out an instruction. The right method

This includes, for instance, ensuring that diagnostic tests are performed and interpreted correctly. Similarly, many errors occur where drugs are given by the wrong route or in the wrong concentration. One very well known case in England involved a chemotherapy

drug, Vincristine, being administered into the spine instead of a vein. When this happens it is always fatal. Obviously all invasive procedures must be carried out by competent staff or staff under competent supervision. It is important that training and written procedures are in place to ensure that ‘right method’ is followed. It is also very important that untrained staff know that (and abstain from) they should not perform certain tasks which carry significant risks. Ensuring the right method also means having systems in place to keep medical equipment clean and in good working order. Patients are safer when staff do not have to choose between similar pieces of equipment which work in different ways, such as one-hour and 24-hour infusion pumps. It is not always easy to standardise equipment, but when new equipment is chosen, ease of use and potential risks should be taken into account. The right time

Again it seems obvious, but this includes giving drugs as prescribed and not getting confused by 24-hour clock. More subtle care management such as not giving a drug or treatment when there is a contraindication, checking the patient and recording observations when required, recognising the need for pain relief or other symptom control and

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Developing a patient safety culture and systems This article has frequently referred to the need to have policies, procedures and training for patient safety. These are important, but they will achieve nothing unless they are part of a patient safety culture where everyone, from the most senior staff to the most junior, understands the importance of patient safety and why it matters. Training of staff should show how everything they learn affects the safety of patients. Senior staff should lead by example—juniors will imitate what they do. Staff should understand why it is important that equipment is properly used; that infection control and hygiene are carried out properly; that instructions are clearly understood and followed; that prescriptions are written carefully; and so on. One way of helping staff to understand about safety and learn from mistakes is to have an incident reporting system. When something goes wrong, the staff involved should be able to report what has happened without fear of undue blame, and the events leading up to the incident or error should be reviewed to know what went wrong, and to see if it can be prevented in the future. Many useful lessons about safety have been learnt from similar incidents reported in different places. As a result, the common causes have been identified and the knowledge has been shared. It can be useful to have designated staff with responsibility for coordinating all the patient safety activities; for instance, ensuring that policies are up-to-date and that staff receive training when they need to. But it is important that they are not seen as the person or team responsible for patient safety. The people responsible for patient safety are the members of staff who have anything to do with that patient—whether as doctor or nurse, therapist or technician, cleaner or cook, engineer or purchase clerk paying for drugs. Anyone who has a job in a hospital makes patients safer when they do their job properly, and work well as part of the hospital team.

Good communication

“In healthcare, information, especially the one related to a patient’s health, is key to the care provided. Faulty treatments, in most cases, can be attributed to improper communication of critical data.” This opening comment in the editorial of Asian Hospital and Healthcare Management Issue 16, illustrates clearly why good communication about patient care is as important a component of safety as all the treatments that a patient receives. Other articles in that issue and recent editions talk about the need to communicate well with the patient and

their family. It helps not only patients in understanding their condition but also healthcare providers in providing proper care to patients. Listening to what patients have to say and respecting their wishes forms the basis to healthcare in the 21st century. Moreover, patients who feel involved and in control of their care tend to do better, and more satisfied with the care they receive. Patient records

Many teams are involved in the care for patients in a modern hospital. This includes doctors, nurses, therapists, tech-

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acting promptly if the patient’s condition is deteriorating. Many hospitals in the UK and USA have introduced ‘early warning systems’ designed to alert staff about a deteriorating patient and to guide and empower them to seek senior assistance.

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nicians, pharmacists. Their relationship with each other requires sharing of information and acting on instructions. The doctor or nurse on duty must know what was done to the patient the previous day and what is planned for the next day— and why. And in their shift they must record changes in the patient’s condition, results of tests, new plans for care and anything else that everyone caring for the patient needs to know. The vital information remains useless if it is not shared. It will not be shared if records are kept in different places, or if different professionals keep their own records. Hospitals should review their systems for storing patient information and sharing it, through team reports, ward meetings or any other means. Many errors occur when messages are not passed on, or something is not written in the notes, or when what has been written is not clear and can be misunderstood. There should be policies and training to ensure that all records are kept properly. The details of when and who should write in the records should be clearly mentioned. They should also specify the means to ensure that all the information is filed correctly and new information is seen (such as test results) and dealt with appropriately. Openness

Good communication is important beyond the patient records—in how staff talks to patients, and each other. Many industries have learnt that it is important for safety to have a culture where no one is above criticism (because any human being can make a mistake) and where junior staff can put forward suggestions or concerns, and have these treated with respect.

Sarah Williamson is a registered nurse with special interests in clinical risk management, governance, organisational and cultural change, and staff development. She was Clinical Risk Manager at Sheffield Teaching Hospitals NHS Trust 2002-2007. She is a MA in Communication Studies and currently a freelance consultant in patient safety. She is regular conference speaker and has published several articles.

ISSUE - 17 2008

Improving Reliability for Safer Care A proactive approach

Reliability and safety are now essential components of healthcare. However, providing better care requires a proactive approach from the providers.

Peter Lachman Consultant Paediatrician Great Ormond Street Hospital for Children NHS Trust, UK

rom a scientific point-of-view, healthcare has improved dramatically over the past 50 years. The development of new treatment modalities has had a significant impact on many people. This, of course, differs from country to country, as well as within

countries and communities. Access to the standardised and reliable care that should be provided is often difficult to obtain. It is a truism that if we applied the knowledge we now possess, even without any new innovations, millions of people would be cured of the

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conditions that afflict them. The issue now is to improve the delivery of healthcare rather than the development of new treatment modalities. The urgent need is to move from quality assurance to quality improvement, to learn how to measure improvement and to develop systems that facilitate safety and reliable delivery of healthcare which inherently minimises risk. In many countries, there has been a move to examine the delivery of healthcare in terms of quality and safety. The domains of quality, as delineated by the Institute of Medicine (IOM) in the USA, can be used as a framework to define the way we approach the provision of healthcare worldwide. Although these concepts of quality were developed in the most sophisticated of health systems, they are sufficiently simple to be applied to any system. The key factor is that quality places the needs of the patient at the centre of all that we do in healthcare. The emergence of evidencebased medicine over the past 20 years has focussed our attention on ensuring the effectiveness of healthcare, though there was no surety that this will happen every time. It is therefore necessary to reconsider the way we organise and deliver healthcare. The challenge is to deliver the correct care reliably all the time, according to patient needs. What does reliable healthcare mean?

The science of reliability was developed in other industries and is now being adapted for use in healthcare. The examples of highly reliable organisations could be found in the field of nuclear power, railways and airlines. The key issue in highly reliable industries is the central belief that systems need to be in place to ensure the safety of consumers. It is the only reason for them to survive in their respective fields. In essence, the patient should expect to receive the correct and effective care that is affordable every time he or she

Some approaches to develop a highly reliable healthcare organisation • Safety should be the business of healthcare • Ensure that reliable care is provided first time every time • Understand the design of the organisation • Place the patient as consumer at the centre of all you do • Make prevention of failure a central component of your work • Develop a culture of safety at all levels—from the CEO to the front line to the patient • Embrace diverse opinions • Move from risk management to situation awareness • Develop resilience • Study and spread success • Encourage the front line to innovate and implement • Simplify and standardise • Eliminate artificial variability in processes • Use care bundles to deliver complex delivery of care

visits the doctor or nurse. Unfortunately, this is not the experience even in the most highly financed healthcare systems. The variability of healthcare provision is immense and as providers we need to redesign the systems in which we operate to approach an environment where the patient receives what they need every time. The concept of reliability requires some understanding of the need for safety. Safety is not inherent in the systems within which we work. In order to have a reliable system, one need to move from risk management and reaction to proactive situation awareness, this mitigates harm.

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Reliability principles, which include evaluation and calculation of the overall consistency of a complex system, are effective tools used in other industries to improve both safety and the rate at which a system produces consistent quality outcomes. The challenge is to adapt this reliability methodology to the healthcare delivery system so as to ensure the safe delivery of healthcare. From an abstract point-of-view, reliability is measured as the number of actions that achieve the intended result divided by the total number of actions taken over time. The concept of reliability in healthcare is defined in terms of the number of times the evidence-based care is not provided. Level One (10-1) reliability results when there is a failure rate of one out of ten, i.e. we get it right at least 90 per cent of the time. The next level of reliability, Level Two (10-2) refers to a failure rate of one in a hundred. Nuclear power, which is at the sixth level, operates at a failure rate of less than one in million (10-6). Chaos exists when the failure rate is more than two out of ten attempts. The provision of healthcare rarely reaches more than the first level of reliability. Most healthcare systems operate in the ‘chaotic’ zone without common articulated processes and many doctors and health professionals continue to work as individuals. Although it is essential, the common approaches of asking professionals to work harder, undertake more training and to follow guidelines do not produce more than the Level One reliability. To attain Level Two reliability, organisations need to recognise the impact of human factors on the delivery of safe healthcare. This implies the need to introduce checklists, memory aids, redundancy in processes, and defaults in decision-making. Level Three reliability requires a redesign of the system so that it focusses on processes, structure and their relationship to outcomes.

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The first issue one needs to address is an understanding of the need to approach safety from a more proactive stance and to accept that the human factors that cause harm can be controlled if one designs a system that prevents harm in the first place. In our daily lives, we accept reliability in most of what we do; for example, how the trains run, how airlines view safety, food quality etc. We have often used the individual requirements of the patient to assume that it is not possible to apply some of the key principles required e.g. standardisation, routine, checklists. The problem in the past was that we expected hard work and good intentions to deliver reliable healthcare. Insisting that providers be more careful and vigilant simply has not worked. Once safety becomes the method of operation, one moves to examine the system in which we work, viz. how we have designed the complex process in reaction to previous mistakes, or as a system that has placed safety in the forefront. For example: • Do we have systems that prevent common errors from occurring? • Do we define the way we want to deliver healthcare to ensure that the patient is protected from harm? • Can we break down the problems into small bites so that the system can be addressed in a simple way? Medication errors are a good example, which probably account for the maximum harm in hospitals. The aim could be to decrease the number of errors year on year, until zero error is achieved. This is a goal we have set at Great Ormond Street Hospital as we strive to achieve a transformational goal of Zero Harm. To reach this ambitious goal, the organisation is committed to develope a culture of not accepting the inevitability of harm but rather developing one that accepts its preventability. This requires a total

redesign of the way we deliver healthcare; not merely addressing external targets. Understanding and then eliminating the artificial variability—which is introduced by providers—and managing the natural variability brought by clinical need go a long way in ensuring consistency. The standardisation of healthcare without decreasing the individual requirements of the patient is a difficult task and will require an understanding. The use of care bundles, the packages of evidence-based care to ensure that all elements are delivered, has helped to eliminate most of the common problems like line infections and medication

The emergence of evidence-based medicine over the past 20 years has focussed our attention on ensuring the effectiveness of healthcare, though there was no surety that this will happen every time.

errors in hospitals in Europe and North America. The WHO World Alliance for Patient Safety initiative introduced checklists to improve outcomes in surgical care. This is a key element in the move from Level One to Level Two reliability. This approach requires a rethink of how we deliver heathcare. We can no longer accept delivery by health professionals acting as individuals. How does one bring this to a universal audience?

In reality, the concept of reliable healthcare should not be difficult to sell either A uthor

How does one develop highly reliable healthcare delivery?

to the consumer or the provider. The problem is that we have a preconceived notion that we are already delivering reliable care. The right approach must, therefore, include recognition that unless one accepts the inherent inconsistencies in the present healthcare system, one will not develop a coherent approach to safety. The theorists have tended to make the concepts inaccessible to the patient and to the healthcare provider. To address this problem, and to ensure that this is not a concept only applicable to wealthy economies, one needs to reinterpret the issues for the relevant audience, using examples from outside healthcare and then applying them to the local environment. For example, one can look to other organisations that have solved the problem, adapt the solution for local use, measure the outcome and then apply small tests of change. Conclusion

The ideas of reliability can either excite or turn off healthcare providers. In order to make this an attractive option, one needs to reframe the debate for managers, clinicians and patients. Once the patient is in the centre of the debate, the argument becomes an essential component of solutions for healthcare. Demystification of this concept is essential. From a management point-of-view, ensuring that the patient gets the correct evidencebased treatment the first time every time, has a financial gain that will make most executives satisfied with the knowledge that the quality has been enhanced.

Peter Lachman is Consultant in Service Redesign and Transformation at Great Ormond Street Hospital for Children and a consultant paediatrician at the Royal Free Hospital in London. He was a Health Foundation Improvement Fellow at the Institute of Healthcare Improvement (IHI) in 2005-2006. He leads on the transformation programme at GOSH.

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State of Sustainable Design in Healthcare A commentary

A more transformative vision of ‘living’ and ‘regenerative’ hospital buildings is beginning to coalesce worldwide. Primarily, this vision finds its roots in the connection between buildings and health. Robin Guenther Architect Douglas D Pierce Architect Perkins+Will, USA

he buildings that support the delivery of healthcare services encompass a broad range of building types—ranging from small community outpatient clinics to large acute care hospitals—and an equally broad range of owners—philanthropic non-profits to corporate entities. Globally, healthcare is a significant service economy—while the percentage of the Gross Domestic Product (GDP) varies widely between nations, there is general agreement that the healthcare sector has the capacity to define markets through what they build, purchase and how they operate. The US healthcare building sector is making explicit links between the built environment and health. The American Society of Healthcare Engineering (ASHE) framed green building initiatives as early as 2002 around protecting health at three scales: the immediate health of building occupants, health of the surrounding community, and health of the larger global community and natural resources. The Green Guide for Health Care, in defining green strategies for the healthcare sector, includes specific ‘health issue’ statements that introduce each

construction and operation topic—the Green Guide is the foundation for the US Green Building Council’s LEED for Healthcare. Providence Health and Services CEO John Koster, MD, in describing their new LEED Gold Certified hospital in Newberg, Oregon, summed it up this way: “In healthcare, sustainable building represents a bold move toward precaution and prevention. The building stands for health. In creating it, the organisation is essentially saying, ‘We’re investing in keeping people healthier.’ Being attentive to sustainability, wellness and resource stewardship presents a holistic view of healthcare that has an impact. We may not be able to measure or test, but I’m convinced it has a tremendous impact on a person’s ability to attain health. Not just to be not sick, but to be in health” (Guenther and Vittori, 2007). Beginning with operations, healthcare organisations globally are moving towards total elimination of mercury and implementation of Environmentally Preferable Purchasing (EPP). EPP practices prioritise less-toxic cleaners and disinfectants, phthalate-free medical

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devices, elimination of flame retardants and formaldehyde in furniture and casework, and solvents in labs. Waste reduction efforts combine non-incineration technologies for regulated medical waste disposal with substitution of mercurycontaining devices and PVC plastics. Healthcare Without Harm is a global campaign assisting healthcare organisations in this important work. State of the industry

Many healthcare organisations in the US have begun environmental stewardship programme by focussing on operations and then have moved into sustainable building. The US healthcare built environment is highly developed—at the time of writing this article, it is the second most energy-intensive US building sector (consuming energy at an average of twice the intensity of commercial office buildings). Acute care hospitals drive this excessive consumption, although they represent only 25 per cent of the total area of healthcare buildings. The average age of a US hospital building is 27 years—for the most part, the hospital infrastructure is completely mechani-

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cally conditioned, and is characterised by deep floor plate, non-daylit diagnostic and treatment blocks, with little regard to orientation or passive system design. These buildings operate continuously, 365 days per year, with multiple back-up and redundant mechanical and electrical systems, and only increase in energy intensity as medical diagnostic equipment with large heat loads continue to enter the market place. In 1996, a comparative study of energy consumption between hospitals in Europe and North America revealed that North American buildings operate at approximately twice the energy intensity of their European counterparts. While the study did not look at system differences, the most important ones are obvious: European hospitals require daylight in all occupied spaces, leading to enclosed courtyard planning in lieu of deep floor plates. Nursing units continue to be naturally or passively conditioned, and when mechanical conditioning is installed, the prevalent system is displacement ventilation (which introduces air at the floor rather than the ceiling). As the US healthcare market seeks ways to

reduce energy consumption, the examples of European healthcare buildings, as well as leading sustainable buildings in other regions, provide important ‘best practices.’ Since the introduction of the Green Guide for Health Care and the US Green Building Council’s LEED programme, the more than 340 healthcare buildings have registered and more than 30 have certified. This year, in a survey conducted by Health Facilities Management and ASHE, more than 50 per cent of the 600 respondents indicated they were using the Green Guide or LEED on some of their projects. The first LEED -Platinum medical office building, Oregon Health and Science University’s Center for Health and Healing, opened in 2006, and the first LEED-Platinum hospital is anticipated to receive certification this year. Collectively, the first 30 projects have reported energy demand reductions ranging from 15 to 30 per cent, potable water reductions in the range of 30 per cent, successful integration of local and regional materials palettes alongside a host of environmentally preferable material choices, and report improved indoor

air quality through enhanced ventilation and occupant controls, low-emitting materials, and an increased focus on connection to nature (often through the integration of outdoor places of respite, or healing gardens). While the majority of LEED-certified projects are new constructions, a number of major renovations or adaptive reuse projects have achieved certification. These early adopters have reported limited capital cost ‘premiums’ associated with their green building achievements. For many, the basic design parameters of total mechanical conditioning and deep floor plates remain unchallenged—only those that are achieving Platinum appear to have optimised passive design elements and floor plate depth. What lies ahead

A more transformative vision of ‘living’ and ‘regenerative’ hospital buildings is beginning to coalesce worldwide. Primarily, this vision finds its roots in the connection between buildings and health that opened this article. Practically, it is manifested in a small group of projects globally, including the

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Waste management at Embassy Medical Centre With an anaerobic digester, organic waste, such as food waste, farming residue and even human waste, can be converted into bio-methane (natural gas), and used as energy. As a means to collect enough organic waste, the Embassy Medical Center has the potential to employ an infrastructure system that would not only suit the needs of the hospital, but also serve the surrounding community. Stationary, sanitation points placed throughout neighborhoods, can provide safe sanitation, proper garbage disposal, and showers. They would be places where a community can connect, and promote healthy practices. As many as 2,000 sanitation points will be needed, and serviced regularly to harvest enough waste. The organic waste will be transported from sanitation points to temporary storage sites, before being brought back to the Embassy Medical system (all transportation via electric vehicles). It can than be placed in the digester and converted into clean energy.

ecosystems and ecological concerns. The authors of Sustainable Healthcare Architecture conclude, “By critically reinventing the hospital as a regenerative place of healing, marshalling purchasing power, and modelling health and wellness ... the healthcare industry can signal a new relationship to healing and health.” Through green construction and operations initiatives, hospitals can demonstrate a broad commitment to more than high quality patient care. They can demonstrate a commitment to save lives and improve health without undermining ecosystems or diminishing the world. Embassy Medical Center

Sambhavna Clinic in Bhopal, India and Embassy Medical Center in Sri Lanka (profiled here). It is informed by The Living Building Challenge, a framework developed by the Cascadia Green Building Council in the US , and Health Care Without Harm, a global non-profit that has taken up the challenge of transforming healthcare infrastructure from today’s standard practice to zero-energy, toxic-free, zero-waste, water-balanced

solutions. The long-awaited LEED® for Healthcare, with increased focus on daylighting, material health, and energy demand reduction, will assist hospitals in North America in beginning the journey to this transformation. The healthcare sector should not need to argue that delivering high quality healthcare requires a passport for waste and energy intensity—or that saving lives is somehow outside of broader

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Healing institutions have a core mission to regenerate the health of those they serve. ‘Living’ or ‘Regenerative’ hospital design builds from that mission to include nurturing the environment and people in ways that extend deep into the community. Social equity, environment, economics and education are the four chambers of regenerative design and they are much like threads in a piece of cloth, woven together into a uniform fabric that becomes an inseparable whole. The Embassy Medical Center is taking the next step in design consciousness to become a regenerative influence in the city of Colombo, Sri Lanka. The Hospital will synthesise knowledge and perspectives from around the world, merging local needs, customs and bioregional influences with appropriate technologies and global financing to form a balanced union of regional and global connectivity. Much of Sri Lanka’s population is challenged to meet their basic daily needs, making the project’s regenerative goals extensive. The project will create a state-of-the-art hospital and healing centre in an environmentally distressed urban area; to serve effectively a broad population of varying economic means; to act as a regional economic incubator; to educate its own staff and the technical trades that assist in their design

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Sustainability Concept for Energy, Water and Sewage 1. Absorption Chiller—Utilises very hot water to provide chilled water for cooling. 2. High Temperature Anaerobic Digester for BioMethane with conversion to pipeline grade Natural Gas. The Anaerobic Digester will also act as the ‘Sewage’ Treatment plant for the facility. 3. Solar Hot Water Panels provide High Heat Hot Water for the Absorption Chiller and Domestic Use. Use Natural Gas from Digester to boast water temperature if needed. 4. Co-generation Plant—Generates Electricity with steam heated by natural gas from Digester—Hot Condensate is then sent to Absorption Chiller. 5. Ground Contact Earth Tubes—Pre-cool and Pre-Dehumidify fresh air for final touch-up and filtering by the Mechanical System. 5A. Desiccant Dehumidification using hot water or natural gas as an energy source will touch-up the fresh air after exiting the Earthtubes. Due to environmental constraints, and the magnitude of the new facility, it is critical that the Embassy Medical system has the ability to generate it’s own sustainable energyso as to maintain high quality indoor environments, and conduct healthcare practices. Sustainability Concept for Energy, Water and Sewage: The goal is to have the facility function off-grid, using grid sourced electricity and grid sources natural gas (If available) only as 2nd tier back-up. Wind Power Potential for the site is low and Solar Electric (PV) technologies are expensive and space consuming at the scale required for this facility. Therefore, a primary goal is to use as little electricity as possible, relying on renewable sources of heat (Solar Thermal and Bio-mass) as the main energy drivers. A High-Temperature Anaerobic Digester creating pipe-line grade natural gas (conditioned Bio- Methane) coupled with a solar hot water system will be pivotal energy technologies. Biomass Feedstock Goals are: 1/2 to 3/4 Sewage and 1/2 to 1/4 Agricultural Residue and Organic Garbage. Sewage and organic garbage will come from the feasibility and from the surrounding community. Agricultural residues will come from the rural areas on the island. Electricity will be generated on-site using a natural gas fired co-generation plant.

and construction; to be a self-maintaining place of community refuge; and to provide all of their own power, water, sewage and medical waste recycling in ways that are beneficial to the environment and the surrounding neighborhood. Few things are as regenerative to individual and community health as access to clean water. In 2007, the World Health Organization (WHO) reported that there are 4 billion cases

of diarrheal disease and 1.8 million deaths each year globally from unsafe water and hygiene. Thus, one regenerative thread at the heart of the Embassy project is to act as a ‘clean water center,’ providing sewage treatment and potable water to several of Colombo’s underdeveloped neighborhoods. The medical centre will use living roofs to capture and pre-filter rainwater. A reverse osmosis system, coupled with carbon and ultra-violet filters, will

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6. Thermal Chimney used to ‘pull’ air through the earthtubes for delivery to the Mechanical System. Use Mechanical System to boast ‘pull’ if needed. 7. Cisterns for collection of rainwater—used for flushing toilets and as feedstock for Domestic Water Filtration System. Cisterns can be used as ‘Overnight’ Solar Hot Water storage. 8. Domestic Water Filtration System—NonChemical. 9. Living Roof Area(s)—Pre-Filtration Rainwater heading to Cisterns.

for

10. Stormwater Ponds for retention and filtration. Use water for Irrigation and as feedstock for Domestic Water Filtration System if Cisterns run low due to an extended dry period.

purify the rainwater for use in the hospital and distribution to underdeveloped neighborhoods. Water from showers and lavatories will be filtered through constructed wetlands and ultra violet filters for use in flushing toilets. Another essential clean water strategy involves converting sewage from the hospital and Colombo’s underdeveloped neighborhoods into carbon-neutral renewable energy using a high-temperature thermophilic anaerobic digester.

facilities & operations management

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Used in Western European cities, this hi-tech compost system will naturally create bio-methane that will be polished into Bio-Natural Gas (BNG). The BNG is then used in a co-generation plant to power the hospital and water purification systems. Excess BNG will be generated by the hospital and used to seed the transformation of Colombo’s transportation sector to this clean burning fuel, improving the respiratory health of the community and ultimately providing an improved environment for the medical centre itself. Water and energy efficiency are essential to the project as it is more cost-effective to conserve resources than to produce them. Water efficient toilets and lavatories will be used throughout the facility where appropriate. To improve energy efficiency and patient health, narrow floor plates, courtyards and light shafts will be used to harvest daylight and natural ventilation. This facility will also be the first of its kind to consider high sea flooding, Tsunami, earthquake and other catastrophic issues. The facility is being designed to withstand the forces of nature and remain open and functioning during a natural disaster—not only to provide medical care for patients but to provide refuge for the community. Of course, providing regenerative care for patients will be a key to the facilities’ success. The Embassy Medical

Center will contain 180 private patient rooms as well as full-service operational medical support with a comprehensive outpatient medical clinic. The facility will include advanced medical innovations, technologies and design features to assist its doctors in offering worldclass medical treatment. As a result, the facility will assist Sri Lanka in becoming a worldwide medical destination, providing a much-needed boon to the area’s economy. Though contemporary and cuttingedge in terms of its medical advancements, the facility’s design will be appropriate to its specific location and embody culturally specific design solutions. The facility will demonstrate a fine balance between Sri Lankan culture and advanced medical design and technology that will result in a ‘healing home’ environment. For example, each private room will reflect all aspects of natural healing, offering private open air balconies so that patients and their families can take advantage of the healing benefits of nature. Upon completion, the Embassy Medical Center will be the most sustainable and regenerative medical facility in the world. It seeks to expand the fundamental meaning of ‘Healthcare’ beyond immediate medical services, to include the much needed work of creating healthy environments and healthy communities.

Robin Guenther is a practicing healthcare Architect whose built work has been published both nationally and internationally. She has been playing an important role in defining the sustainable design agenda in healthcare through a wide range of advocacy initiatives. She coordinates the Green Guide for Health Care, serves on LEEDHC committee, is a board member of Practice Greenhealth and the Center for Health Design, and is the co-author of Sustainable Healthcare Architecture with Gail Vittori. Contact her at Robin. Guenther@perkinswill.com. Douglas D Pierce is a practicing Architect with over 25 years of experience in sustainability theory and green design. He is an advocate for carbon neutral, regenerative design within his profession and teaches graduate level classes on the subject at the University of Minnesota, School of Architecture.

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Understanding SOA

Caring about IT architecture Increasingly, healthcare organisations are looking towards healthcare IT to help drive efficiencies and improve care quality. However, they need to sort out the common misconceptions regarding SOA before adopting it in their organisations.

Ken Rubin Healthcare Architect Martin Holzworth Enterprise Architect EDS, USA

ealthcare organisations face many challenges today. Though each organisation has its own specific obstacles, a quick review of industry literature quickly highlights that there are many common problems: How do we manage with the budget we have? How can we do a better job of treating our patients and improving care quality? How can we prevent medical errors? How can our EHR investment be successful where others have been unsuccessful? Which product or products are best for us? How do we make all this technology work in our organisation? Globally, populations are both growing and ageing, creating pressure on the healthcare organisations that manage and treat them, a problem further exacerbated by significant shortages of skilled healthcare staff. Result is the burgeoning needs and limited budgets, where many organisations are looking to healthcare IT for answers on how to do more with less. Before we can entertain a reasonable discussion about either Healthcare IT architecture or Service-Oriented Architecture (SOA), we must first begin with the business principles and rationale behind making such investments. This stems from the business functions

we enable, the objectives we are trying to achieve and the outcomes we hope to achieve as a result of our IT investment. We must first have a foundation, and architecture to provide that foundation. Understanding Architecture

It all seems too easy to cobble together some requirements, pick a product and be done with it. The downside is that this model is proven time and time again to fail, and for a variety of reasons: • No single vendor is best-of-breed at everything • Legacy systems do (and will continue to) exist • Organisational boundaries are constantly changing, driving the need to adapt. When making IT investments within an organisation, we must not only consider the needs of the users, but the needs of the organisation itself as a business entity. What are our drivers? Who are we looking to benefit (clinician, patient, organisation)? What returns do we hope to get on this investment? (Improved outcomes? Streamlined workflow? More accurate reporting?) Enterprise Architecture (EA) is the key discipline and building block to help align business needs to IT investment. In brief, EA models our understanding of the business, captures business requirements, relates those requirements to IT investment and demonstrates accountability of that investment back to the business. The result is a blueprint that frames how technology components, products, processes

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and policies all come together to support the needs of the Enterprise. How does this work ‘in the real world’? Let’s take an EHR example. Suppose, one specific EHR vendor-offering appears ideally suited to our business need. It provides the clinicians with the information quality and fidelity they want. It has a user interface that is easy to understand, multilingual and supports the modalities (desktop, tablet PC, mobile phone) that interest us. Seemingly, this would be a good investment were it not for considerations around the architecture. Further investigation reveals that this ‘ideal’ product that is unable to integrate with our existing laboratories (both government and commercial) is unable to ingest data from our existing registration system. It is unable to support our planned personal health record. Quite simply, the product doesn’t fit within the context of our organisation. How do we know this? We know this because an Enterprise Architecture documents a bigger picture, formalising where we are and where we plan to go, giving us the raw data and insight to make informed decisions. Though there are dozens of EA frameworks and methodologies, most accepted approaches share the following dimensions. These dimensions are comprehensive and distinct, but interrelated as the context of one view affects the others: Business View: Describes the purpose, functions and organisational considerations of the business. This view would capture the core functions provided by

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the organisation, its policies, drivers and so on. For example, Emergency department, laboratory, financial management; objectives such as reduced wait times, improved patient safety Information View: Identifies the information of interest and pertinent information standards / terminologies, such as what might be captured in forms or stored in systems (administrative data, registration information, medical record information, patient demographics etc.). Systems View: Discusses the applications, software, messaging, software services and standards that comprise the IT landscape within our organisation. It would include commercial packages, such as our EHR and speciality / subspeciality systems, integration engines, workflow packages etc. Technology View: Identifies the underlying infrastructure components upon which systems will be built, such as the physical network, hardware platform, key software

in the technology stack (operating system, Java / .NET etc.). So, what about SOA ?

If Enterprise Architecture is what helps in making informed decisions about IT purchases, why care about service-oriented architecture? What is it? How does SOA relate to EA? More importantly, why would a business person care about SOA? There is a common misconception in the industry that SOA is a technology—the embodiment of a solution that is offered through a variety of vendor products that will solve all our problems. Just as its moniker, SOA is an approach, a philosophy, a method for integrating a broad spectrum of tools, processes and people for business to realise its objectives through adherence to a set of core tenets. SOA is fundamentally based on the services that an organisation provides and is thus owned by the business and not the IT shop.

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One of the pre-eminent SOA organisations—the SOA Consortium articulates its purpose to “Promote and enable business agility via Service Oriented Architecture which allows businesses to compete, innovate and thrive.” Their focus is to help change the public perception, particularly from business executives that SOA is an IT integration platform when it is more appropriately considered a business agility tool. How does this relate to healthcare then? Quite simply, healthcare organisations are making significant investments without an architecture. The result is that they have little or no confidence that their purchases will integrate, adapt and evolve to support changing business needs. SOA provides a framework for thinking about healthcare IT that naturally aligns to the needs of healthcare organisations, improving alignment, traceability, and ultimately consistency with good EA practices.

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Healthcare is service-oriented

Very often, care delivery is conducted not by one individual, but by a care team, each member of which has specific capabilities and responsibilities. They collectively engage and collaborate to meet the needs of a given patient. For instance, a care team may comprise many specialists: cardiologists, radiologists, physiologists, nurses, nutritionists and so on. Each member of the team provides a unique expertise and performs specific functions. The team is collectively governed by an authority with an overall responsibility for the care delivery, which orchestrates its operation and coordinates its activities. SOA embodies many of these principles

Services themselves are not expected to do everything, as they require collaboration with others. A given service has well defined role and responsibility, based on a commonality of function and capability. They require coordination among multiple parts to work effectively, and work together within the context of some governance with responsibility for orchestrating workflow among them. Authority is the underpinning of a successful SOA

To adopt SOA in an organisation, we must align our business processes, our policies, our systems and the role that those systems perform within our organisation. It is not enough to purchase a new demographics system that supports a web services / XML interface. The new software does not make that system authoritative, especially if we do not have plans to “turn off” the legacy system that also contains demographics information. The key difference lies in the policies and expectations of the new system. Consider, instead, deploying our new demographics system with a policy: As of January 1, all demographics-of-record will be stored in the new system, and all Enterprise systems will look to it as their source for demographic information. The difference may be subtle, but is

profound. This new system, coupled with the above-stated policy is now moving toward service-orientation. The demographics service is the authoritative source for this information within the enterprise (e.g. well-defined scope, responsibility, authority). SOA is not about technology

Web-services implementations and XML do not make the organisation SOA-enabled, as both can be used to build point-to-point solutions as easily as SOA-based ones. While it is true that many SOA solutions do in fact leverage technologies such as XML, SOAP and Web-Services, the technologies themselves do not fulfill the objectives of SOA. It is how those technologies are applied within the context of a total solution that makes something SOA-based or not. Get the core tenets right

There are hundreds of industry publications and articles highlighting key qualities needed to realise effective SOA implementations. These qualities—a clearly defined scope, formal interface specifications, loose-coupling (e.g. minimal direct dependencies on other services)—ultimately benefit the autonomy and composability of services. Some of the tenets that drive this flexibility include: Abstraction – Supports the ‘hiding’ of underlying implementation details, enabling and preserving the described loose-coupling of SOA components. Autonomy – Provides independent, selfcontained function of a service that is not controlled or inhibited by other services. Composability – The ability to bring together autonomous services in potentially dynamic or unforeseen ways allows SOA to grow to support complexities of business needs. Discoverability – The ability to identify and leverage services as assets, resulting in improved Return-On-Investment (ROI) and ability to bring online and leverage new capabilities as they become available.

Why is this important? Services are not systems. They are capabilities with singularity of purpose that need to collaborate with other services in support of business needs. With services being defined and scoped autonomously, but with the capability to ‘orchestrate’ workflow among the parts, SOA-based solutions are more adaptable and flexible than alternative approaches. Moving to SOA

Health organisations need to keep in mind several aspects of SOA before adopting it. Many have jumped onto the technology bandwagon thinking that by installing a Enterprise Service Bus, moving interfaces to web services, you have SOA. The migration to SOA is a carefully architected process that needs to balance business and technology domains concurrently. SOA is as much an organisational and cultural change as it is technical. SOA cannot be seen as the quick fix to the complexity that has accumulated over the history of the legacy landscape in healthcare. Adopt a maturity-model approach

By adopting this approach, organisations can carefully plan the maturity of their transformation. Industry maturity models typically follow a similar pattern of incremental improvement across domains (architecture, technology, information, governance, business process etc.) It is critical to adopt a balanced approach, particularly in a SOA environment, and avoid the tendency to become too focussed in one domain at the expense of another. This is a long journey spanning several years and requires commitment, flexibility and governance in order to be successful. Standards matter

Healthcare is a collaborative effort, involving participants from across a broad spectrum of people, organisations, and systems that support them. Even if your organisation were to architect, deploy and operate a SOA-based system absolutely perfectly, there are factors beyond your control. Vendors change their offerings and technical direction. Health systems interact with new organisations and

Acknowledgement: The views in this article reflect the personal opinions of the authors and are not intended to be an endorsement by EDS, Health Level Seven, the Healthcare Services Specification Project or the Object Management Group. w w w. a s i a n h h m . c o m

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Act Locally

The mainstream ‘business as usual’ approach toward buying products and leaving healthcare institutions to force products that do not fit well or integrate effectively. This approach is not sustainable, particularly as increasing reliance and investments are made in healthcare IT. The decisions you make within your own institution have broad industry impact, as vendors won’t supply what isn’t

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being demanded. The onus is on each of us to move the industry in the direction that meets our needs. That means placing requirements such as standards-based interfaces and open architectures into our purchasing, sending a clear message to industry of our needs. Irrespective of which technology path and architecture you choose, you have to recognise that there is no way to reach your destination if it is not defined clearly.

Ken Rubin is a Senior Healthcare Architect with EDS, is focussed on informatics, EA and EHR interoperability, and has supported the (US) Veterans Health Administration and the (UK) National Programme for IT. Rubin chairs committees for the OMG, HL7, Open Health Tools and the Healthcare Services Specification Project (HSSP).

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business partners. Technologies change and are replaced. Standards form a basis to mitigate these challenges. Even if we institute a SOA-service to manage patient identities (e.g. a Patient ID Service), what assurances do we have that our business partners will be able to interact with it? It is for these reasons that efforts such as the Healthcare Services Specification Project (HSSP) exist. This effort is a collaboration involving primarily Health Level Seven (HL7) and the Object Management Group (OMG) to develop health industry SOA standards. These specifications establish an industry position on the scope of healthcare SOA services, their responsibilities and bindings for their implementation using specific technologies (such as web services). Efforts such as these promote interoperability among organisations while still providing autonomy to vendors and organisations to realise SOA in the way that best fits their needs.

Martin J Holzworth is an internationally experienced Enterprise Architect with expertise across healthcare, financial services, telecommunications, and government sectors with an outstanding track record of success. Holzworth has worked with numerous clients in Australia, Asia and USA and is currently working with a large government healthcare provider in Australia.

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Telehealth in Asia Healthcare for the communities The Internet and next generation communication technologies are revolutionising the delivery of care and are increasingly utilised to deliver better and more comprehensive care to communities that need it most. Telecare or the delivery of care virtually supported by Internet and communication tools is breaking new ground.

Gabe Rijpma Health and Social Services Industry Director, Public Sector Group Microsoft Asia Pacific, Singapore

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sia is increasingly challenged by the social disparities between its urban and rural populations due to the massive growth it experienced in the recent years. Of the region’s 4 billion people, 80 per cent live in rural areas often without adequate access to education and healthcare. Today, there is an immediate need for the region’s governments, communities and industry partners to address the challenges of the region’s existing healthcare structures and ensure that everyone has an access to adequate healthcare. Currently most people in Asia rely on state subsidies, while more than 130 million people can pay for private healthcare. The majority of people in the region survives on US$ 1 per day and would by no means be able to access basic medical care (The World Bank, World Development Report 2008). Governments, companies and communities need to find solutions that will allow medical care to cross the geographical, social and cultural barriers within the health sector and ensure that everyone is able to access healthcare. In the developed world, the growing availability of broadband Internet, Wi-Fi, cellular networks and the move to digital television are opening doors to an amazing array of telemedicine and telehealth services. But even in far less developed economies where broadband is scarce and electricity and phone service may be unreliable, commodity communications technologies are being used to extend healthcare services to those in need. Microsoft believes that bringing together of the region’s technology capabilities with telehealth or the use of Information and Communication Technology (ICT) can help deliver health services, expertise and information over distances. Countries will be able to improve the quality of care, increase access and manage the cost of implementation and management. Telehealth allows us to access the innovations and technological advancements within the region and apply them to

support the communities including rural and the aged. Reaching the remote communities

Healthcare facilities in most rural areas are usually non-existent or lack proper resources. Further, transportation problems to metropolitan hospitals pose a real barrier to access for the rural population. The low population density in rural areas makes it inherently difficult to deliver services that target persons with special health needs, including people with HIV/AIDS, people with chronic illnesses, mothers and children, the aged and people with disabilities. Telehealth is not designed to replace clinicians or other healthcare staff, but to improve access to healthcare for people in remote locations or those for whom the access to healthcare is limited by culture, language or clinical resources. One key success has been the Microsoft pilot project with Dristee in India’s Barielly and Madhubani districts. Seventy per cent of India’s population (some 700 million people) lives in rural areas and the per capita expenditure on healthcare is not more than US$ 7 per day. Limited financial resources coupled with the limited medical resources (there are about 60 doctors per 100,000 people in India) make the delivery of healthcare more challenging. With the assistance of a medical facilitator and by means of a computer and dial-up Internet connection, villagers are able to discuss their health concerns with a medical professional at an urban centre. Vital signs, photos, medical records and other information can also be shared. Simple problems can often be addressed then and there. People needing more care can be referred for an appointment in a town, but with greater assurance that when they make the long trip to get there, they will see the appropriate specialist for their particular ailment. The computer is fitted with a solution developed by Neurosynaptic, a Bangalore-based firm Microsoft is partnering with.

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The pilot project is a key example of how technology is able to bring the world of specialised healthcare to those in need of it. Dristee’s team of workers also educates the villagers who are unaware of their health conditions or the necessary steps required to treat them. The programme aims to provide a technology platform for rural communities and gives citizens greater access to qualified health information and medical services. The platform uses simple dial-up Internet access, computers and web cams to connect care givers and patients in remote villages with more highly qualified medical professionals in urban centers. Digamber Jha, a retired school teacher in Mangrauni South Village suffers from a persistent stomach disorder and goes for regular check-ups and follow-up sessions with his doctor who is 150 miles away via telelink. “I am confident that the doctors there will be more qualified than those in Madhubani. Despite my poverty, I will try to follow the treatment they prescribe to the best of my ability”, he says. Preparing to care for the aged

A key priority for Asian governments is the provision of adequate care for the ageing population. Over the past 50 years, the proportion of older people has been rising steadily, and in the next 20 years almost a quarter of the region’s population will require aged care, placing an enormous strain on existing healthcare systems.

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increases. Commodity telemedicine solutions and an entire range of ehealth services will emerge to help meet the demand for health information and medical care around the world. Conclusion

Microsoft has a long standing commitment to support the underserved through technology. Our Unlimited Potential programme ensures that we invest in providing technology that enhances education and employment opportunities. We are applying this belief to our partnership in healthcare and through the adoption of telehealth solutions, we believe communities will be better supported. Costs will be managed, care given and innovation will continue. At Microsoft, we believe that the greatest impact will be through strong public private partnerships. Through these partnerships, telehealth solutions will ensure that more efficient and effective care is delivered across the region. Already, an Internet-enabled, commodity telemedicine and telehealth service plays an increasingly important role in extending care to those who need it. By ensuring that these communities are supported by public private partnerships, they will be better supported. costs are better managed and innovation will be continued. Telehealth is real and has begun to make an impact on the lives of people in our communities. Microsoft looks forward to the implementation of telehealth solutions and strong partnerships across the region that will ensure that the sick in our communities are in better contact with their health providers, care givers and others dealing with similar challenges.

Gabe Rijpma is the Director of Government Solutions for Microsoft Asia Pacific, working from Singapore. Gabe started his career at Microsoft in 2000 and joined as a Principal Technology Specialist focused on helping government customers realize the value from their Microsoft technology investments. Prior to joining Microsoft he was the Principal Consultant at Software Spectrum Inc in Sydney Australia looking after the business solution development practice delivering solutions on both the IBM and Microsoft platforms.

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“This is for the villages that have few medical facilities. It will save their time and money. This works on a low bandwidth on normal dial-up connections. It can connect to any one in the world. It can transmit reports and prescriptions can be printed out,” says PL Bhartheesha, an Engineer with Neurosynaptic.

The situation is further exacerbated by the shortage of qualified health workers. According to the World Bank, there is a shortage of 4.3 million health workers around the world and 57 countries do not have enough health workers to provide even basic health services. A key to manage the rising demand of aged care is to empower patients. As Professor Branko Celler, CEO of Australia’s TeleMedCare explains, “the empowerment of patients with the tools and the knowledge to self-manage a longterm condition, the facilitation of an allpopulation approach to improve healthcare outcomes at a distance by integrating social care, telecare and telehealth services throughout the primary care sector.” Professsor Celler’s team has developed Medications Management and Reporting System, MEDSafe that is designed to facilitate medication administration at the point-of-care. Delivered via a medical grade tablet computer, the system works to reduce the possibility of medication errors and provides comprehensive management reporting. TeleMedCare conducted a trial with 22 patients aged between 58 and 82 with chronic illnesses. The patients found the solution easy to use and agreed that it helped them manage and control their health conditions better. Empowering patients to better manage their own medication, takes the pressure off care takers and allow patients to get involved in their own treatment. At Microsoft, we believe that as the reach of the Internet grows, and the number of ways to extend low cost, two-way audio and video into the home

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Leveraging Authentic Health Information

Key to patient empowerment Advancements in medical knowledge have led to increased complexity of care delivered by multiple teams often across organisations. As the population ages, delivering such care will become increasingly difficult. Real-time digital medicine, enabling patients to view their own medical records, which contain high quality information, and enable them to make choices about the care they receive affords the opportunity to empower patients and clinicians.

Amir Hannan Lead Information Management & Technology Tameside & Glossop Primary Care Trust Primary Care Lead North West Strategic Health Authority, UK

n the 1960s, a patient admitted into hospital with a suspected myocardial infarction would be in bed for six weeks. He was looked after and monitored by the concerned nurses. After six weeks, he would either be discharged all ‘cured’ or succumb whilst in his bed and die. No further follow up, tests and no medication was needed. What is the current scenario? Today, we are able to do ECGs, measure troponin T levels, arrange coronary angiograms and perform primary angioplasty or provide thrombolysis. In the immediate post-myocardial infraction period, we can closely monitor patients’ every passing second, beat by beat monitoring for cardiac arrhythmias and institute treatment appropriate to the patient’s needs and even adjusted to the patient’s own physiological parameters. Patients are assessed for hypercholesterolaemia and diabetic status and further ongoing treatment is provided. They are put through a cardiac rehabilitation

programme which then continues for the rest of their lives. A great deal of effort is now being placed on trying to identify people at risk of heart disease and even on preventing it by targeting children and young adults to improve their lifestyle. As populations age and more and more elderly people continue to live with ever increasing chronic disease, the complexity of healthcare as well as the cost of treating and maintaining them rises. It is envisaged that by 2050, the number of people needing care will rise to four times of what it is today. Already we have more people over age of 65 than those aged below 18 in the UK, indicating that there will be more and more people who will need to be looked after by ever fewer people who are at work.

How good is the information that patients and the public have today?

The advancement of medical knowledge has accompanied a plethora of information to help the patient and the public gain a better understanding of what is available and what can be done. (See Table 1) There is ample information available to patients about anything they want, whenever they need it. The advent of the Internet has made searching for information even easier. But there are doubts regarding the authenticity of the information provided by it. Compliance is poor even for conditions such as arthritis (see Figure 1) suggesting that the system at the moment is not meeting the needs of patients and a need for a new approach.

Information sources for patients and the public • Highly trained-clinicians (continuous professional development, appraisals, professional meetings, specialist journals informing latest developments) • Patient leaflets (information prescriptions) • Posters (in waiting rooms, on billboard) • Advertisements (in magazines, TV and radio, health provider websites) • Self-help groups (chronic disease specific, e.g. Diabetes UK; or other broader areas e.g. Arthritis Care) • Patient Information Forum / Patient Associations Table 1

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(Data leads to knowledge). Conversely they may think about reducing their risk of death and realise that they need to check their blood pressure and then find out how to control their blood pressure as a result (Knowledge leads to what data to collect). This leads to a better understanding of the care they are receiving or what choices they can make to ensure good health or even encourage providers to meet their needs instead of just providing a service.

Percentage of patients NOT complying with medication by disease area 90 80 70 60 50 40 30 20

But do people care about finding out about their health?

10 0

Asthma

Diabetes

Hypertension

Creating knowledge-based healthcare systems

We now have the ability to economically check patientâ&#x20AC;&#x2122;s blood pressures (data) with sphygmomanometers that are available in the market. If patients browse high quality websites which inform them about blood pressure (information), they can monitor their own blood pressure and identify high and low blood pressure (knowledge). But to do this safely, patients should be taught certain skills (how to check blood pressure, what size cuff to use, use a machine that has been validated for this purpose and is regularly serviced and calibrated etc.) and certain attitudes (e.g. being aware of what needs to be done in case of high blood pressure). People should also learn where to check their blood pressure (e.g. provider institution, pharmacy, doctorâ&#x20AC;&#x2122;s waiting room, home). Once identified as having hypertension, they should be treated according to certain guidelines / protocols (processes) to achieve a specific outcome (reduction in risk of death, myocardial infarction or cerebrovascular accident). Healthcare systems have tended to focus on doing things without encouraging patients to think through why and what the consequences might be if these things do not happen. Hence, patients have not truly understood the implications of not following the advice

Epilepsy

Arthritis

Figure 1

given to them by their clinicians. Clinicians can let patients see their health information but not abdicate their responsibility for providing care. Those patients that are able to look after themselves should be enabled to do so. But clinicians should also be aware of the patients who are unable to manage themselves well and who need their help and support. Multiple IT systems operating in different healthcare organisations or departments should be made interoperable to pull together data to display the information required for both patient and clinician wherever necessary. As people travel increasingly around the world, SNOMED-CT may become the common language to share such data in a semantic interoperable way so that data (such as blood pressure) can be displayed on the local clinical system. Such knowledge, skills and attitudes will be necessary for both clinicians and the patient to understand. This will lead to a certain type of practice and experience which can then also be measured e.g. through surveys or recording patient journeys. In a knowledge-based healthcare system, a patient or citizen may think about checking their blood pressure and begin to understand how to reduce their risk of death by understanding how to monitor and control their blood pressure.

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According to comScore in August 2007, there were 37 billion health searches on Google and 8.5 billion on Yahoo. Online Health Search 2006 found 80 per cent of American Internet users, or some 113 million adults, have searched for information on at least one of seventeen health topics. Forty-eight per cent of heath seekers searched on information for somebody else. Thirty-six per cent of health seekers claimed their last search was for their own health needs. Fifty-three per cent of health seekers felt the information they had found an impact on themselves or how they cared for themselves. Whilst 74 per cent felt reassured that they could make healthcare decisions, 25 per cent felt overwhelmed by the amount of information they saw. Small groups felt frustrated by the lack of information, confused by the information or frightened by the serious or graphic nature of what they found online. People are searching the Internet to understand their health-related problems. But the quantity of information is enormous. A search on Google for myocardial infarction reveals over 5.6 million results. The quality of information is variable and clearly not everybody has time to appraise the information whilst they need to make decisions on how to care for themselves or their patient. Even if people know that they should learn about their health, it is not clear where they should go, why they

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should go and how it will help them get better care.

Knowledge-Driven Healthcare Systems Data

Towards a partnership of trust

information

Whilst the clinician may be an ‘expert’ in what modern day medicine has to offer and what is available locally to the patient population, the patient is an ‘expert’ in how the disease is affecting him or her or what they might be at risk of, e.g. family history of conditions, environmental factors or personal behaviours that put them at increased risk of developing certain conditions. The mutual trust and shared understanding between patient and clinician will help in forming a Partnership of Trust. It helps in formulating the future plan of the treatment and also improves compliance from the patient.

areas It is being deployed around the world and is available for patients in the UK at present. Patient data can be linked with information from the Map of Medicine as well as other trusted websites to develop knowledge. That knowledge should enable the patient to improve their compliance with treatment and the agreed shared plan.

Ensuring better outcomes

Role of the service provider

Patients need to know what conditions they suffer from, e.g. myocardial infarction or hypertension. These are terms that will be stored in their health record. Giving patients access to their own health records is the fundamental key to a better unified understanding between patient and clinician. If this is contained in an electronic health record, then the information can be instantly shared with the patient as well as the clinician as and when the need arises (Real time Digital Medicine). The patient can confirm the accuracy of the record (past history, medication, allergies as well as go over consultations, results of tests and the plan of action including next steps that have been jointly agreed as well as reviewing any other communication from other clinicians or healthcare providers). These terms in the record, e.g. myocardial infarction, can then be linked to high quality information that the service provider has vouched for. An example that has the support of the World Health Organization (WHO) is the Map of Medicine . It is an evidence-based knowledge management tool that can be localised for particular geographical

During consultations, the clinician can record the shared plan of action, what has been agreed by the patient and the clinician and what should happen if problems are encountered or a change is needed. The patient may even be able to add their own comments as well so that a shared record is formed. This builds transparency into the Partnership of Trust and enables the patient and clinician to know what to do. As it is in the record and the patient can view it, the patient can also choose to share it with others who may also help (e.g. other clinicians, allied health professionals) or others whom the patient trusts, (e.g. carers).

Knowledge

Skills

Attitudes

Structures

Processes

Outcomes Figure 2

Enabling access

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The first step is to recognise the problem and gain a better understanding of the issues. The second step is to recognise

that a solution does exist that allows patients and the public to access their health records online. Here in the UK over 40 GP practices are now offering the service. Almost 60 per cent of GP practices have been enabled to offer the service to their patients. We are currently developing guidelines for patients and clinicians on how to share health records safely with patients for clinicians and system suppliers. These could in future be adapted to a world-wide audience. In my own practice, over 400 patients are now accessing their own GP records. We ask everybody ‘Are you eMPOWERed yet?’ (The bottom-up approach of www.htmc. co.uk, see attached poster). The third step is to raise the issue at the WHO. The International Council for Medical & Care Compunetics is presenting a paper to the WHO on patient access to electronic health records . Raise this issue with your member healthcare organisations (the top-down approach). Enabling patients to access their own health information can lead to a patient-centred healthcare system that does not provide tokenistic information but rather patient-specific information that is fit for purpose and could lead to better and healthier outcomes for an organisation as well as the individual concerned.

Amir Hannan is a full-time General Practitioner in Hyde, England. He is the Primary Care IT Lead for North-West Strategic Health Authority and is on the HealthSpace Reference Panel and the National Clinical Reference Panel for the Summary Care Record at NHS Connecting for Health.

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