Asian Hospital & Healthcare Management - Issue 19

Issue 19

2009

ÂŁ12 â‚Ź18 $25 Rs.300

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Between Public and Private Care in India

Cultural, Social & Linguistic Barriers

Can they be overcome?

21st Century Healthcare

New paradigms

Home Telehealth Understanding the outcomes

Foreword

Healthcare in India A picture of contradictions

“...whatever you can rightly say about India, the opposite is also true”.

- Professor Joan Robinson as quoted by Dr Amartya Sen

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his observation is perhaps best vindicated by the state of healthcare in India. While the private healthcare continues to grow buoyed by investments from domestic and international healthcare providers, the condition of state-owned healthcare institutions remains as appalling as it used to be before the private sector boom. According to the Government of India’s 10th Five-year plan, private sector accounts for “82 per cent of outpatient visits, 58 per cent of inpatient expenditure, and 40 per cent of births in institutions.”

This number has steadily grown post-independence when private sector used to account for 4 - 5 per cent of the total healthcare provided.

It is not difficult to understand why. Over the decades, the care provided by the state-owned institutions has steadily deteriorated thus forcing people to look for alternatives. The private sector, however, with its profitoriented approach and also , the encouragement from the government due to booming medical tourism, has grown from strength to strength.

The public spending on healthcare, at around 0.9 per cent, is among the lowest in the world. The problem with this situation, obviously, is that while people living in cities have access to the best healthcare money can buy; the majority of the country’s population that lives in rural areas has access to mediocre quality of care resulting in high-mortality rates even in cases that could be easily managed if the standards procedures are followed. This condition is further aggravated in times of natural disasters and pandemics. Employing the services of the private providers is often a big strain on their finances for the rural folks. It is imperative for the government to shift its focus to improve the present deplorable state of rural healthcare.

Fixing the healthcare system, however, will require a multi-pronged effort that targets various aspects of healthcare such as healthcare research, quality standards and infrastructure and so on. An approach that focusses on improving access to healthcare that adheres to minimal standards of safety and quality with continuous improvements is the need of the hour.

Among some of the positive steps towards overcoming these issues, the government has set up the National Accreditation Board for Hospitals and Healthcare providers. But this was long overdue when it was introduced in the year 2006. Stricter implementation of the Board’s standards and mandatory certification for private and public providers could go a long way in boosting the quality of care provided, especially in the staterun institutions. Also healthcare insurance needs to be encouraged all over the country so that financial strain is reduced for rural and urban patients alike.

This issue of Asian Hospital & Healthcare Management features expert views from Debasish Mishra, Executive Director at PricewaterhouseCoopers, India and Dr Pradeep Chowbey, one the leading surgeons in the country on the situation of healthcare in India and what factors will influence its future.

Akhil Tandulwadikar Editor

State of Indian Healthcare

18 Unfolding opportunities Debasish Mishra, PricewaterhouseCoopers, India

State of Indian Healthcare

22 A need for uniformity Pradeep Chowbey, Sir Ganga Ram Hospital, India

Healthcare Management 05 21st Century Healthcare New paradigms Sir J A Muir Gray, National Knowledge Service, UK

07 Effective Leadership for Patient Safety Lessons from the ‘Safer Patient Initiative’ Gren R D Kershaw, Conwy & Denbighshire NHS Trust, UK Annette Bartley, North Wales NHS Trust (Central Division), UK

11 Decision-Based Evidence Making Developing tools and strategies for comparative effectiveness Sean Tunis, Justine Seidenfeld Center for Medical Technology Policy, USA

24 Healthcare Disparities Closing the gap Mildred M G Olivier, Midwest Glaucoma Center, USA

27 Direct Practice Medicine Better outcomes, lower Costs Jordan Shlain, San Francisco, USA

44 The ‘vital signs’ of Performance Improvement in Cardiac Outcomes Lewis G Hutchison, Sheikh Khalifa Medical City, UAE

Medical Sciences 47 Bariatric and Metabolic Surgery Anaesthesia concerns Sunita Goel, Saifee Hospital, India

50 Stroke Assessment A medical emergency Anil Sharma, University Hospital Aintree, UK Hannah Jane Cronin, University Hospital Aintree, UK

53 Transcriptional Control of Heart Failure Recent developments M Saleet Jafri, George Mason University, USA

Surgical Speciality 56 Assessing surgical outcomes New techniques Graham P Copeland, North Cheshire Hospitals NHS Trust, UK

30 The Electronic Health Record Delivering healthcare for the 21st century Louise Liang, Kaiser Permanente, USA

33 Ensuring Patient Safety Role of regulation Jill Crawford, Nursing and Midwifery Council, UK

36 Cultural, Social & Linguistic Barriers Can they be overcome?

Marina Sleptsova, University Hospital Basel, Switzerland

40 Palliative Care Reaching out to patients with heart failure Miriam J Johnson, Hull and York Medical School, UK

Diagnostics 62 Predictive, Preventive & Personalised Medicine A novel strategy for healthcare Olga Golubnitschaja, Preventive & Personalised Medicine, Belgium

66 Lab-on-chip Innovative approach towards telemedicine in primary care Kurt Schicho, Medical University of Vienna, Austria

68 PET-CT A step towards personalised radiation medicine Anna Simeonova, Frederic Wenz University of Heidelberg, Germany

Contents 71 PACS Role of the end-users Bram Pynoo, Pieter Devolder, Tony Voet, Luk Adang Dries Ovaere, Jan Vercruysse, Philippe Duyck Ghent University Hospital, Belgium

Technology, Equipment & Devices 75 RFID for Medical Devices An exciting future Rajit Gadh, University of California Los Angeles, USA

79 Artificial Intelligence Applications in healthcare Prasanna Vadhana Kannan, Frost & Sullivan, Singapore

Facilities & Operations Management 81 Reducing ICU Mortality Strategies for the 21st century Djillali Annane, University of Versailles, France

84 Surgical Workflow Methods and applications Oliver Burgert, Universität Leipzig, Germany Thomas Neumuth, Universität Leipzig, Germany

Information Technology 88 Home Telehealth Understanding the outcomes Ronald Merrell, Virginia Commonwealth University, USA

94 Telehealth Strategies for successful, cost-effective implementation Kathryn H Bowles, University of Pennsylvania School of Nursing, USA

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Advisory Board

John R Adler Professor Neurosurgery and Director Radiosurgery and Stereotactic Surgery Stanford University School of Medicine, USA

Sandy Lutz Director Health Research Institute PricewaterhouseCoopers, USA

Pradeep Chowbey Chairman Minimal Access, Metabolic and Bariatric Surgery Centre, Sir Ganga Ram Hospital, India

Harald Becher Professor Cardiac Ultrasound Oxford University, UK

Peter Gross Chairman Internal Medicine Hackensack University Medical Center, USA

Editors Akhil Tandulwadikar Prasanthi Potluri Language Editor G Srinivas Reddy Copy editor Prity Jaiswal Art Director M A Hannan Senior Designer Ayodhya Pendem Sales Manager Rajkiran Boda Sales Associates Savita Devi Murali Manohar Sherley Jones Mark Twain Assistant Manager – Compliance P Bhavani Prasad CRM Yahiya Sultan Laveena Lalwani Swetha Kalal Subscriptions incharge Vijay Kumar Gaddam

John R Hawkins Director Information and Technology Services Abu Dhabi Health Service Company (SEHA), UAE Malcom J Underwood Chief Division of Cardiothoracic Surgery Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Gabe Rijpma Health and Social Services Industry Director Public Sector Group Microsoft Asia Pacific, Singapore Basri JJ Abdullah Professor Department of Biomedical Imaging Faculty of Medicine University of Malaya, Malaysia

Beverly A Jensen Associate Professor Communications UAE University, UAE

Steven Yeo Vice President and Executive Director HIMSS Asia Pacific, Singapore

Vivek Desai Managing Director HOSMAC INDIA PVT. LTD., India

IT Team Ifthakhar Mohammed Azeemuddin Mohammed Sankar Kodali Thirupathi Botla N Saritha Chief Executive Officer Vijay Chintamaneni Managing Director Ashok Nair

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Healthcare Management

21st Century Healthcare

New paradigms The 21st century is the century of the patient, or the citizen who might become a patient. Many health services are now based on a paradigm which assumes that the patient or citizen is competent and should be fully involved.

Sir J A Muir Gray Director National Knowledge Service, UK

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y the end of the 20th century very significant improvements had been made in the effectiveness of healthcare; half of the added years of life were due to the second healthcare revolution.

The first healthcare revolution took place in the 19th century when public health measures such as the provision of clean clear water led to the first great leap in population health. In the second half of the 20th century, the second healthcare revolution took place. Mirroring the developments that created computers,

The eight major problems of healthcare 1. Errors 2. Poor quality care delivery 3. Poor experience of patients 4. Waste 5. Unknowing variations in policy and practice 6. Failure to introduce high value interventions

aeroplanes, television and space flight, healthcare saw the introduction of hip replacement, transplantation and effective drug therapy for a wide range of conditions. The second healthcare revolution had a major impact on the health of populations, but at the end of the 20th century, the eight major problems still remained and these problems, set out in Table 1, show no signs of being diminished by the application of laboratory science or genome technology.

The five dimensions

Twenty-first century healthcare will have five dimensions which will be significantly different from 20th century healthcare. These dimensions, which together help in forming the 21st century paradigm, are: • Knowledge-based healthcare • Citizen-centred healthcare • Web-enabled care • Better value healthcare • Sustainable healthcare.

Knowledge-based healthcare

7. Uncritical adoption of low value interventions 8. Failure to recognise uncertainty and ignorance Table 1

The 20th century healthcare was based on bureaucracies—on hospitals, payers, insurance companies, primary care organisations and private providers. The 21st century healthcare system, however, will be based on knowledge-based systems

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Healthcare Management

Making decisions

nology inevitably drives social change, but neither is it important to ignore the contribution that technology can make to social change. As Manuel Castells emphasised, it is both knowledge and IT that citizens are using to transform society.

Values of the population Evidence of the Benefit of healthcare investment

Choice

Decision

Better value healthcare

Needs of the population Figure 1

Citizen-centred healthcare

The 20th century was the century of the clinician; the 21st century is the century of the patient, or the citizen who might become a patient. Many health services are now based on a paradigm which assumes that the patient or citizen is competent and should be fully involved, contrary to the 20th century assumption that patients were less intelligent and hence be given less information. The

A s ia n H o s p i ta l & H ea lt hcare M a nage ment

truth of the matter is that many patients are more intelligent than clinicians and that it is easier to help the public learn concepts, for example the appraisal of risk, than to help highly trained professionals unlearn the wrong concepts with which they were inculcated during their professional training. The involvement of citizens also emphasises the need to focus on healthcare and its outcomes.

Web-enabled healthcare

IT is an old-fashioned term which is still reasonably useful, but with the advent of cloud computing, the concept of technology changes and the most important step that an organisation can take is to use the power of the Internet. The power of the Internet allows: • every patient to have their own record • images to be passed easily from one organisation to another • Provide access to the up-to-date quality information to both patients and professionals Update the documents such as laboratory reports with upto-date findings or evidence.

It is important not to go too far down the road of ‘technological determinism’, namely that change in tech-

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of care. For example, it is possible to think of a National Epilepsy Service for India which would exist without any bureaucracy except that which was needed to run the web service, and this could be done by different organisations making a contribution. The National Epilepsy Service for India, England or Estonia would be an entity that would have: • A community of practice of patients and professionals • A dataset • A clear depiction of patient pathways using the Map of Medicine software • An evidence base updated annually.

These and other knowledge features will create 21 st century healthcare systems. Obviously, bureaucracies are needed to employ people and manage money, but the priority is for systems of care which create networks of individuals and organisations and pathways for those patients to follow. This requires the knowledge of using the web applications.

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Every society on earth is faced with the possibility of funding more ‘cost-effective’ services than it can afford, either in terms of money or manpower. Where there is a finite budget, decisions have to be made on the basis of value, both by individual patients and by those who make decisions about groups of patients or populations, as shown in Figure 1.

The key concept in the 21st century is better value healthcare, identifying ways in which the resources invested can be used to maximise value.

This is particularly important when taking into account the constraints imposed by the 21st century’s greatest challenge—climate change.

Sustainable healthcare

In many countries, healthcare takes about 10 per cent of the gross national product, and in many countries a significant footprint is left by the health service with, in the UK, the NHS being the major public sector carbon footprint. There is also good evidence that in almost every healthcare system there is very significant waste. Making better use of the resources available, the same amount of care could be provided from a smaller carbon footprint or, if more money were available to put into healthcare, that money could be used to provide services without increasing the carbon footprint.

Sir J A Muir Gray, CBE is the Director for National Knowledge Service in UK. He is also Chief Knowledge Officer to the NHS.

Healthcare Management

Effective Leadership for Patient Safety

Lessons from the ‘Safer Patient Initiative’ Achieving success in the area of patient safety requires leaders to adopt a new approach.

Gren R D Kershaw Former Chief Executive Conwy & Denbighshire NHS Trust, UK Annette Bartley Head of Modernisation North Wales NHS Trust (Central Division), UK

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stimates suggest that one in ten patients admitted to hospital, experience an incident which puts their safety at risk. These incidents may result in harm and in some circumstances death. A stark reality is the fact that about half of these events could have been avoided. In England alone there are over 100,000 cases of hospital acquired infections per year, which are estimated to cause over 5000 deaths and cost £ 1 billion. It is evident that patient safety needs to be placed high on the leadership agenda.

In 2005, in a response to this growing international problem, the Health Foundation launched the ‘Safer Patient Initiative’ (SPI), a UK-wide programme designed to bring about radical improvements in patient safety through the implementation of a range of specific interventions using improvement methodology. The pilot involved four UK National Health Service Hospital Trusts and runs over a four-year period. This paper will describe the progress made through the pilot but principally the work undertaken in the Welsh site, Conwy & Denbighshire NHS Trust, a large health organisation providing acute community and mental health services for a population of 250,000 in Wales, UK. Supported by the Institute of Healthcare Improvement from Boston, USA, the SPI pilot hospitals were given some specific objectives to achieve: • To reduce adverse events by 50 per cent

• To create a culture that puts patient safety at the centre • To demonstrate leadership that reflects safety as a strategic priority • To implement a range of evidence based changes in wards, operating theatres and intensive care units.

The programme also focussed on some cross cutting themes such as medicines management and infection control.

Results from the initiative

A formal evaluation of SPI is due for completion in late 2008. However, early results released by the Health Foundation in November 2006 showed impressive safety improvements at the four pilot hospitals. In the first two years of the programme the four sites had on average halved the number of adverse safety events. In addition some hospitals are already seeing improvements in their mortality.

At Conwy & Denbighshire NHS Trust the implementation of a Ventilator Associated ‘bundle’ saw the ventilator associated pneumonia rate being virtually eliminated. The Average Length of Stay (ALoS) in the Intensive Care Unit (ICU) was reduced significantly as patients were weaned from ventilators at an earlier stage (see Figure 1). Over £ 78,000 cost savings were identified in the ICU in the first 18 month of SPI. Hand hygiene compliance in all sites has increased by more than 95 per cent and associated reductions in MRSA rates have also been observed.

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Healthcare Management

ALoS ICU

Individual Value 12 10

Wearing & Extubation Guldeness

8 6 4

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Down Lisburn Health and Social Service Trust reduced the number of medication errors to below 10 per cent, following the development of system to track and manage the drugs that patients take. This system is helping to reduce mistakes in the primary care setting.

A reduction in cardiac arrest calls has been observed with the introduction of outreach teams (rapid response teams) and an early warning scoring system. The scoring system enables staff to effectively monitor patient’s condition and to take rapid action if they go into a decline.

A new leadership approach

The breadth and depth of change involved is significant, and the introduction of such an initiative requires a new approach in leadership for patient safety. There is emerging evidence that success in this area, is dependent on hospital leaders enhancing the priority given to patient safety and taking a real and continuing interest in patient safety within their organisations. Often the pressures placed on Chief Executives and their Boards relate to financial stability, or satisfying government and other regulatory targets.

It is generally accepted that it takes a significant change of emphasis by leaders to affect organisational culture.

In this initiative, Chief Executives were expected to introduce a set of initiatives in leadership, which included three key aspects:

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Figure 1

Establishing clear executive accountability for patient safety

Firstly, the Board of directors formally recognised patient safety as their number one priority. The Board signed up to this within its corporate objectives, and by directing more of their time and attention to quality and safety matters. Non-executive directors actively participated in some aspects of the Safer Patient Initiative, e.g.

Patient Safety Walk-rounds.

Whilst in principle SPI was a finite ‘project’, leaders were expected to ensure that the work was fully integrated into their organisation’s wider quality performance management and governance arrangements. The concept was to build a more sustainable infrastructure to support the quality and safety agenda.

The Chief Executive took a leading role in SPI by chairing the implementation team. Key responsibilities were to get the right team on board; a team containing not only enthusiastic local champions for specific clinical areas but also individuals Date

Topic

who could be trained as ‘Improvement Leads’ by IHI. ‘Go with the willing’ was a mantra IHI encouraged organisations to use. Rather than waste time trying to convince the ‘laggards’ to get on board with the initiative, change was driven through enthusiasts from across most professional groups.

The Chief Executive gained the personal commitment of his executive team which included the Director of Finance (an important and often overlooked resource / champion in improvement projects). Each executive director took on the role of executive champion for different aspects of the work streams.

Measurement was a key element of the programme. However, unlike other national target-driven projects, the data collection in SPI was designed to get the frontline teams to understand their own performance. They used the data to improve their processes of care, as opposed to the familiar system of using data to judge performance or to benchmark and compare teams. The concept in SPI was to understand your own performance and work to improve it, rather than shift your attention outside the organisation and lose focus on what matters. Teams began to measure compliance with agreed processes of care. They were able to monitor whether any of the changes they were implementing were actually resulting in improvement.

Demonstrating visible leadership in patient safety

The hospitals developed a communication strategy to ensure that patient safety was promoted at every opportunity.

Aim

June 2008

Sample identification

Reinforce correct process of identifying specimens, following an increase in inadequately labelled specimen samples.

July 2008

Passwords

Following a password breach, which caused a patient to be given the wrong treatment, staff are reminded to ‘log in’ and ‘log out’

August 2008

Prescription and Infusion charts

Following an audit of charts, staff are reminded of their obligations to record all prescribed medications.

Table 1

A s ia n H o s p i ta l & H ea lt hcare M a nage ment

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Healthcare Management

This ranged from specific ‘News-sheets’ to ‘Open days’ which involved employees, patients and the public. Promotion through local media was an important aspect.

On a practical level, ‘Patient Safety Walk-rounds’ were introduced. These consist of leaders drawing up a schedule of dates where an executive visits a ward/department to meet informally with staff to discuss safety issues. A standard set of questions was designed to ensure consistency of approach, and the results of discussions are recorded by a scribe.

Where safety concerns are highlighted, the corrective actions are suggested and concerned individuals are assigned with the responsibility.

A feedback / follow-up system is also put in place to ensure the actions happen.

Key themes from the Safety Walk-rounds are fed back to the Board.

Staff from all levels and professions, from senior doctors to volunteers, are encouraged to attend the discussions.

Typical discussions to start proceedings include: When was the last patient harmed in your unit / ward and how?

What have you done to prevent this happening again?

Hand hygiene improvement radar Feb 2006 - March 2008

Figure 2

These walk-rounds have been enormously successful. They not only enabled staff to see patient safety as a priority but also empowered and encouraged them to solve operational issues that can cause harm. Additionally, executives were requested to identify examples of good practice in patient safety. Instead of the focussing on the negative aspects of safety, good ideas were captured, celebrated and spread.

Whilst executives resisted the temptation to resolve operational problems, it was quickly recognised that the role of leadership is to remove barriers that

prevent frontline staff doing their work effectively and safely.

Addressing the need for cultural change

• The senior executive team needs to pay attention to how the clinical teams’ work is contributing to improvements in patient safety and how they can be spread across the hospital. It may be helpful to appoint a patient safety officer

As the Board begins to shift its way of doing business by channelling more attention to quality and safety, there is a need to demonstrate this throughout the organisation. One simple and effective means of achieving this in Conwy & Denbighshire was to make Patient Safety the first item on the Board’s agenda.

All monthly Board meetings commence with a Patient Safety issue which in turn becomes the first item on staff briefings and routine management meetings throughout the organisation. Nurses have now adapted this idea and incorporated safety items into their handover meeting on shift changes. Summarised examples of such items are given in Table 1: These practical steps encourage staff to pay more attention to patient safety issues and as a result the culture is gradually changing. As part of SPI there was a requirement to measure any shift in culture, all sites were expected to carry out a baseline culture survey. Figure 2 is an illustration of change in culture at Hand Hygiene.

• Focus attention on those most willing at the outset to create patient safety champions

Summary

Key Learning Points from SPI* • Support from the senior management team is vital. However, if the culture of an organisation truly is to change, people at all levels of the organisational need to make patient safety a priority • Efforts to improve patient safety need to be coordinated across the hospital. Senior teams need to emphasise the significance of patient safety in all they do. Clinical teams need to feel confident that they can report their concerns about patients’ safety

• For safety to improve, all members of the multidisciplinary team need to be actively involved. Each individual should be valued for the professional knowledge and expertise they contribute. *Sites taken from www.health.org.uk

The Health Foundation has demonstrated through the Safer Patients Initiative that significant improvements in patient safety can be realised with focussed effort.

Leadership is an essential ingredient in

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Healthcare Management

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A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

whole. The journey is not over by any means. The constant and relentless drumbeat of improvement needs to be continued.

To conclude, we will leave you with a simple yet profound quote. It was

A u t h o r s

the battle to reduce harm to patients.

There is still much to do in order to achieve a global reduction in the current levels of harm within healthcare and to implement programmes such as the Safer Patients Initiative. In the UK in November 2006, following on from the early successes of SPI, a second programme was launched involving a further 20 NHS organisations across the UK. This second programme is building on the learning from the original sites but the core elements of the programme remain the same.

The initiative has generated important discussions and activity at UK level.

It has also promoted the introduction of national patient safety campaigns in England, Scotland, Wales and Northern Ireland. The initiative has changed our way of thinking about safety and quality and has reaped many rewards for patients, staff and organisations as a

ISSUe - 19 2009

received from a member of the public who participated in a competition to find a slogan that captured what we were trying to achieve across the organisation: Patient safety is contagious—Pass it on!

Annette Bartley is a registered nurse with over 27 years experience in healthcare. Whilst her professional background is nursing, her passion for improving healthcare has taken her career into the field of service modernisation and quality improvement. A founder member of the Welsh Faculty for Healthcare Improvement, Annette is currently seconded part-time to the Welsh Assembly government as a faculty / content area lead in their 1000 Lives National Patient Safety campaign.

Gren Kershaw is Former Chief Executive, Conwy & Denbighshire NHS Trust, Wales, UK. He has worked in the UK National Health Service for 35 years. He has held a number of senior managerial positions in different health organisations covering acute, community and mental health services. He has advised the National Patient Safety Agency on the successful introduction of the National Reporting and Learning system. More recently he led the Safer Patients Initiative in his own organisation and is advising on leadership in the 1000 Lives campaign in Wales.

Healthcare Management

Decision-Based Evidence Making Developing tools and strategies for comparative effectiveness Despite the publication of over 18,000 Randomised Clinical Trials (RCTs) each year, available clinical evidence is often of limited quality. Generating the evidence needed to support an evidencebased healthcare system will require collective effort, and needs to be driven by decision makers in the healthcare community such as patients, physicians, policymakers and payers.

Sean Tunis MD Director Center for Medical Technology Policy USA Justine Seidenfeld Research Associate Center for Medical Technology Policy USA

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espite the steady increase in public and private funding of clinical trials and health services, the current research enterprise in the US is not meeting the rising demand from decision makers for studies demonstrating evidence of clinical effectiveness. According to the National Library of Medicine, results from over 18,000 randomised clinical trials were published in 2007 along with numerous other non-experimental studies, all intended to provide information about ‘what works in healthcare.’ Despite this healthy output of scientific literature, the majority of systematic literature reviews, technology assessments and clinical practice guidelines that evaluate all available published literature on virtually any topic have concluded that the available evidence is ‘limited’ and that many published studies are of ‘low quality.’

For these reasons, these reviews generally conclude that the available evidence does not support reliable conclusions about the most important clinical and policy questions related to the topic reviewed.

This paradox—the large volume of clinical and health services research and the low quality of evidence—requires some explanation if one is hoping to move further toward evidence-based clinical and health policy decision making. It is, therefore,

important to understand the nature of the gaps in evidence; how and why does the current body of research predictably fall short? This is particularly important as the US Federal government has recently decided to invest billions of additional dollars in clinical and health services research, including US$ 1.1 billion for comparative effectiveness research.

There are some key observations that provide insight into the apparent discrepancy between the volume and the quality of evidence. Systematic reviews, clinical guidelines and health technology assessments review evidence with the goal of informing decision makers—primarily patients, clinicians, payers, and policymakers. The process of conducting a review begins with a deliberate effort to identify the critical questions faced by these decision makers, and the literature search and appraisal process is conducted with reference to these key questions. Viewed through this prism, they commonly conclude that the available evidence on these key questions is limited. The process of generating evidence through clinical and health services research does not usually begin with a careful assessment of what information decision makers most need to know. Most research is investigator initiated, with topics selected and

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Healthcare Management

studies designed with reference to previously published studies and through dialogue with other researchers working on related issues. Decision makers are rarely involved in the process of refining study questions or the actual design of the studies. In those infrequent cases where they are included in some of these early discussions, their unfamiliarity with the technical content of research may limit their ability to participate meaningfully in the discussion. Given these very different starting points and perspectives, it is unsurprising that systematic literature reviews, which are guided by the questions faced by decision makers, generally highlight that these questions are not consistently addressed by research because it was designed and implemented without attention to or involvement of these decision makers.

be increased when scientific evidence is compiled and analysed through Health Technology Assessment (HTA) organisations (KT2), and this active transport mechanism is an important pathway by which the linkage between evidence and decision making can be considerably enhanced. Once decision makers have applied the available evidence to their decisions, they will frequently observe the gaps in knowledge on critical questions.

Ideally, these unanswered questions, or areas of ignorance, would be fed back to the research community so that further research could be focussed on these issues.

However, a defective transport mechanism (KT3) severely impairs the communication of these research priorities to the clinical research enterprise. This defective transport mechanism ensures that

The molecular basis of uncertainty

An analogy from molecular biology may be useful in communicating the disconnect that exists between those who generate scientific evidence and those who utilise this evidence to make clinical and health policy decisions. Figure 1 depicts the cycle of information flow from the ‘extracellular environment’ of the clinical research enterprise to the ‘intracellular world’ that is inhabited by the decision makers. On one side of the cell membrane is the realm of those who generate new scientific evidence through clinical and health services research—guided for the most part by their intellectual curiosity, and not particularly attentive to the needs of those on the other side of the cell wall. The evidence produced by these researchers encounters a number of barriers during the process of ‘diffusion’ across the membrane and into the cell. The first barrier in Knowledge Transfer (KT1) involves the commonly observed slow translation of knowledge into practice and policy, resulting in a lengthy time-lag between the publication of new evidence and the impact of that evidence on what is actually done.

The speed of translation can sometimes

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Decision makers are rarely involved in the process of refining study questions or the actual design of the studies.

many of these important questions remain unanswered, leading to an accumulation of ignorance which surrounds the decision makers. Potential interventions to improve the cycle of information flow between the intra and extra-cellular space will need to focus in part on improving the consistency with which the unanswered questions of decision makers are effectively communicated to the clinical and health services research community, and become a higher priority for attention.

Tools and strategies for decisionbased evidence making

The molecular model suggests that there is a need for tools and strategies through which the link between decision makers and researchers can be strengthened.

ISSUe - 19 2009

While there have been numerous informal and ad hoc efforts in this direction to increase dialogue between decision makers and researchers, such informal interactions are inconsistent in their ability to produce relevant and timely information for decision making. One general requirement is that communication about important gaps in evidence and the appropriate design of research to address those gaps must take place long before there is a decision to be made. When payers and policy makers are faced with a specific decision, it is generally much too late to begin a conversation about what sort of evidence would be useful. A number of tools and strategies intended to support ‘decision-based evidence making’ are currently being piloted the US-based Center for Medical Technology Policy (CMTP), a private, non-profit organisation that provides a neutral forum in which patients, clinicians, payers, manufacturers and researchers can work together to improve the quality and efficiency of clinical research to benefit decision-making in clinical and health policy.

These initiatives are made possible by the active collaboration of numerous public and private sector experts, stakeholders and policymakers.

Pragmatic clinical trials

One method of addressing evidence gaps is through the expanded use of Pragmatic Clinical Trials (PCTs)—prospective controlled studies designed specifically with the objective of assisting patients, clinicians and payers in making informed decisions about alternative medical therapies. A number of important characteristics generally distinguish pragmatic trials and traditional clinical trials. First, PCTs involve the deliberate selection of clinically relevant alternative interventions for comparison, chosen based on the most common decision-making scenarios. Many trials do not include highly relevant comparison arms, leaving decision makers to depend on less reliable, indirect comparisons with which to make clinical and policy choices. Second, PCTs are designed to make the results as

Healthcare Management

generalisable as possible, and therefore are more likely to include a more diverse population of study participants. While many important studies have been done with narrow inclusion and exclusion criteria, one of the common ways in which many RCTs fail to address important questions is by unnecessarily excluding patients with common co-morbidities and demographic characteristics, making the application of results to individual real-world patients more challenging.

Third, PCTs select outcomes that are intended to address the primary issues and concerns of patients, clinicians and payers. Many RCTs include outcomes that are of primary interest to regulators, and pay less attention to the postregulatory decision makers that will also use those studies to guide their choices.

These outcomes may include more quality-of-life information, and may involve longer follow-up periods than are typical for traditional clinical trials. Selecting the most useful and relevant outcomes requires direct consultation with decision makers during study protocol development. In fact, one of the keys to the successful design of clinical trials that are more useful for decision making is the greater engagement of decision makers in trial design.

CMTP has been working on methods for developing pragmatic clinical trials, and has recently begun a project in collaboration with experts, stakeholders and policy makers to create a conceptual, methodological and policy framework that will improve the design and implementation of pragmatic clinical trials for phase III pharmaceutical trials.

This initiative will clarify the nature of evidence desired by decision makers, explore methodological approaches to the design of phase III trials, identify regulatory, methodological, business, and other challenges to PCTs, and discuss potential strategies to overcome these challenges.

Effectiveness guidance documents

Another approach to improving the link between the evidence desired by decision

makers and the output of the clinical research enterprise is to develop a shared understanding of the nature of the desired evidence. CMTP has begun to develop a library of Effectiveness Guidance Documents (EGDs), which are analogous to the guidance documents issued by the U.S. Food and Drug Administration, intended to provide product developers and clinical researchers with guidance on the design of clinical studies intended to support regulatory approval. In contrast, EGDs provide recommendations for study designs about specific categories of technologies that are intended to provide

regulators, researchers and others. By setting clear prospective standards for evidence, decision makers can increase the chances that these recommendations will be incorporated into clinical studies, and that those studies will be more likely to produce the information that all of these stakeholders consider most relevant.

While EGDs have no legal or binding effect on any decision maker or stakeholder, their influence would derive from the transparency, creditability, neutrality and technical accuracy associated with the iterative multi-stakeholder development

Molecular basis of uncertainty

Figure 1

healthcare decision makers with a reasonable level of confidence that the technology will improve healthcare outcomes.

Current topics under development include gene expression profiling for cancer risk prediction, cardiac imaging and treatment of chronic wounds.

The target audience for EGDs is similar to the audience for FDA guidance documents—clinical researchers and product developers. The process for developing these documents involves integrating the perspectives of the full range of stakeholders, including consumer, payers, clinicians, product developers,

process. Product developers would not be required to design studies in accordance with the relevant EGD, and payers would not be bound to those principles in making coverage decisions. Nonetheless, these documents should reduce some of the uncertainty about what sort of evidence decision makers are looking for when considering the use of new technologies.

Coverage with evidence development

Decision makers in the public and private health insurance industries have long

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Healthcare Management

A u t h o r s

been faced with the problem of making coverage decisions for ‘promising’ but unproven medical technologies.

Frequently, they are torn between the demands of patients and their physicians for innovative healthcare techniques, and the desire to have definitive evidence about the clinical and comparative effectiveness of the new technology.

For most new technologies, substantial questions exist about their optimal use for many years after they are initially introduced, and the incentive for these questions to be addressed is substantially reduced once payment has been secured.

In 2005, the Center for Medicare and Medicaid Services (CMS), the federal agency that provides health insurance to special populations within the US, began a programme called ‘coverage with evidence development’ (CED.) CED was a new approach to offer coverage for promising technologies under the condition that patients participate in a registry or clinical trial, which would generate clinical evidence that could be used at a future date for more definitive decision making and coverage decisions.

While CED has its share of challenges to overcome as the programme is further refined, it has the potential to be an effective approach to allowing rapid coverage decisions while still generating valuable evidence for future decision making. CMTP is currently working with private payers as well as a range of other stakeholders in the US to develop a policy framework for private sector

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CED. The goal is to establish a routine process by which important emerging technologies can be identified for CED, and adequately designed studies can be developed. Individual health plans can then make a decision to participate in a given CED initiative, and the actual research will be sub-contacted to an independent and credible research organisation.

Conclusions

Important gaps in evidence for decision making have now become widely recognised, and this was a major factor behind the recent decision of the US Congress to provide US$ 1.1 billion to support comparative effectiveness research. In order for this money to be spent effectively, it will be important to have a meaningful and sustained collaboration between researchers and decision makers in deciding on research priorities, establishing methodological standards, developing methods that accurately reflect important questions and developing a sustainable framework to guide and support the work. CMTP has been working for the past several years to develop some specific tools and strategies to facilitate comparative effectiveness research. It is our hope that these ‘targeted interventions’ will address the ‘defective transport mechanisms’ that prevent communication between ‘intracellular’ decision makers and the ‘extracellular’ clinical research enterprise.

Sean Tunis is the Founder and Director of the Center for Medical Technology Policy, where he works with healthcare decision makers, experts, and stakeholders to improve the value of clinical research on new and existing medical technologies. He consults with domestic and international healthcare organisations on issues of comparative effectiveness, evidence-based medicine, clinical research and technology policy.

Justine Seidenfeld is a Research Associate at the Center for Medical Technology Policy, where she works on projects involving comparative effectiveness research, patient advocacy, and technology topic prioritisation. She graduated in 2008 from Stanford University with a degree in Human Biology, and a concentration in bioethics and science policy.

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

BOOK Shelf

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For more books, visit Knowledge Bank section of www.asianhhm.com

Debasish Mishra

Executive Director / Partner PricewaterhouseCoopers India

Pradeep Chowbey

Chairman, Minimal Access, Metabolic and Bariatric Surgery Centre Sir Ganga Ram Hospital, India

India’s healthcare sector is booming. Indians today have access to the best healthcare through the private care providers whose presence has grown at a rapid pace over the last decade. But the public healthcare system, which caters to most of the population of the country that lives in the smaller towns and villages of the country, is in disarray. Providing access to quality healthcare has been on the agenda of successive governments in the country, but the condition has hardly changed. There is, therefore, a need to fix the system before the situation goes out of hand. While some initiatives have been taken up by the government, there is a need to involve the private sector in the provision of healthcare across the country. www.asianhhm.com

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State of Indian Healthcare

Unfolding opportunities

Debasish Mishra Executive Director / Partner PricewaterhouseCoopers, India

Where does India stand with regards to the research happening in healthcare? What can be done to improve the scenario?

Indian Council for Medical Research (a Government of India agency) conducts research in areas related to healthcare.

The quality of research being done represents a mixed picture—while research in some institutes is on par with those being conducted in other parts of the world—the research on use of stem cells for movement disorders being a case in point, the research output on respiratory infections, diarrhoeal diseases, cardio vascular diseases, is insignificant compared to the burden of disease due to these conditions in India.

India is also a big destination for clinical trials given our population size and ethnic diversity.

Government of India has given incentives for research and development in health, pharma etc—expenses incurred on pharma R&D are tax deductible.

There is an immediate need for strategic planning to improve the level of research and also to collate and disseminate findings from various small scale community-based research projects that

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Healthcare Management

are being performed across the country. Creating a network of research and innovation centres—‘knowledge clusters’ will help improve the efficacy of research.

Institutions such as Public Health Foundation of India are a timely introduction in the field of public health and would go a long way in addressing the gap in Public Health Research appropriately.

What are your views on the current quality and patient safety standards in India?

Are the standards good enough?

The National Rural Health Mission has given a thrust on the rural healthcare system in India. For the first time in the country, infrastructure standards have been introduced for all public health facilities—primary, secondary and tertiary. The Indian Public Health Standards specify the infrastructural requirements for all facilities with the aim of standardising the quality of care imparted in all facilities. However, implementation is still an issue—while the new facilities are being built as per IPHS, the existing facilities across the country need upgradation.

There is no mandated quality and patient safety standards which private

hospitals are required to adhere to—the current standards are more voluntary in nature. National Accreditation Board for Hospitals and Healthcare providers has set up some standards on quality and patient safety but accreditation is a voluntary process. Similar standards exist for diagnostic laboratories, blood banks and wellness centres etc.

All large hospitals, however, have internal clinical audit processes through which they review events within the hospitals and institute appropriate corrective measures.

Since the standards are voluntary in nature and not mandatory, acceptability by providers is slow. However, the situation may improve if the purchasers of healthcare (insurance companies, corporate, government agencies) insist on adherence to standards before empanelling providers.

What are the current trends that are shaping the Indian healthcare sector?

Some of the current trends are: • Higher economic growth and higher disposable income leading to higher per capita health spend • Changing profile of disease from more infectious diseases to more lifestyle diseases which are chronic in nature • Health status of the urban poor is a growing concern, owing to the increase in migration to cities, and congested and unhygienic living conditions.

• Increased role of private sector in a completely unregulated manner is creating several qualities of service issues • Emergence of public private partnerships • Increased penetration of private health insurance, but the share of out-of-pocket purchases continues to be an overwhelming proportion of total healthcare spend • Better government schemes for healthcare delivery and health insurance for the poor

• Increased interest by private equity players in investments in healthcare delivery.

How has the growth of the private sector changed India’s healthcare scenario?

Private Sector now provides more than 70 per cent of the healthcare in India.

The growth of private healthcare has had many positive impacts on the healthcare scenario in India: • Availability of services has improved tremendously with all services available under one roof for example people do not need to travel abroad for any medical condition • Cost of services is lower in relation to rest of the world • Quality of healthcare has improved: Success rates of Indian healthcare providers is equal to or better than their counterparts in developed countries • Employment opportunities have increased. Healthcare sector now employs more than 5 million people and is now the second largest employer in the services sector after education • Growth and establishment of medical tourism to India. High quality medical services at corporate hospitals have positioned India on the global map as a preferred destination for high end medical / surgical care.

What are your views on the current boom in the investments happening in Indian healthcare?

The health industry is now receiving its due attention from financial investors. Tie ups with foreign universities and medical institutions are common place now with most up coming hospitals. This has led to a significant improvement in quality of care being imparted.

However, most of the current investments in private healthcare are taking place in the large metropolitan cities and in the tertiary care space. There

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Healthcare Management

is a crying need for investments in Tier II cities where there is demand for healthcare services and incentives from government for setting up health infrastructure.

The government health services, though, need much more focus than is being currently meted out. Health sector budget is less than 1 per cent of GDP and with a billion plus population, and significant proportion being below poverty line, the requirement is much more. The overall public health spend must go up.

What challenges does Indian healthcare face today? How can they be overcome?

The challenge in Indian Healthcare is to make healthcare access available and inclusive—improving budgetary allocation to public healthcare, reducing the urban / rural, male / female, rich / poor and social inequities in healthcare delivery. Another challenge is to ensure healthcare quality is consistent across the country. A third challenge is to reduce costs of delivery without reducing quality. A proper regulatory mechanism needs to be introduced (overcoming the Centre and State Government opposition to each others’ initiatives) to improve the quality of service delivery and keeping unscrupulous elements at bay. The large scale public health challenges need to be met with technology enabled solutions as well.

In the global arena, what do Indian healthcare providers need to do in order to become more competitive?

Indian providers have world class quality. They are also cost efficient as compared to developed countries.

However, Indian providers need to improve their understanding of cultural sensitivities of people of different countries to serve them better.

Patient participation (patient-centred care) is a relatively new phenomenon in

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Indian healthcare. Can Indian hospitals benefit from this?

Any healthcare system cannot be sustainable without active participation from the patient. Hospitals can use this trend of better informed patients to encourage awareness on the real risks that Indian population faces and the need for preventive care and healthy life style.

Providers can also use this knowledge to become more responsive to patient needs.

mobile phones in healthcare delivery • E-learning solutions and medical simulation to improve quality of training • Electronic Medical Records for coordinated care, Computerised Physician Order Entry and RFID to improve safety of care. b. Enter into Public Private Partnerships with the government for various health / subsidiary services and improve the overall quality of care—such as ambulance services, facilities management, diagnostics, urban health facilities, mobile medical units for rural areas.

There is a crying need for investments in Tier II cities where there is demand for healthcare services and incentives from government for setting up health infrastructure.

As compared to developed economies, Health insurance plays a relatively small role in Indian healthcare, what is your take on this issue?

Currently, health insurance has only 3 per cent coverage in India— that indicates a huge potential for growth in this industry, but it will need a quantum change in people’s attitude towards insurance and health in general.

There are many reasons for poor health insurance penetration • Poor awareness of need for insurance • Lack of innovative products in medical insurance • Lack of distribution channels • Inadequate provider network • Poor perception of consumers with regard to claims settlement and to a large extent the insurance companies are responsible for this perception.

• Regulatory requirements like very high start-up capital.

The situation is however, changing slowly. People are realising the benefit of health insurance; especially with the increase in lifestyle diseases such as diabetes, hypertension, asthma etc. and the insurance industry is likely see a 25 to 30 per cent growth over the next five years.

All over the world, the patient is becoming more and more knowledgeable about the options available to them. Is the same thing happening in India?

Awareness is largely in urban areas thanks to the role of the media and the Internet. Not so much in rural areas where the patients are largely dependent on the doctor for medical advice and in their absence on quacks.

What can today’s healthcare providers do to bring healthcare services to the poor?

Healthcare providers can a. Use technology extensively for • Telemedicine, medical call centres,

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State of Indian Healthcare

A need for uniformity

Pradeep Chowbey Chairman, Minimal Access Metabolic and Bariatric Surgery Centre Sir Ganga Ram Hospital, India

Where does India stand with regards to the research happening in healthcare? What can be done to improve the scenario?

India has a very large pool of qualified scientific man power which is essential for research in healthcare. It therefore follows that India now forms a hub for basic and advanced research in healthcare. A lot of activity has taken place in this connection in the last few years and as the research protocols and infrastructure fall in place, there is going to be a quantum jump in these activities here.

What are your views on the current quality and patient safety standards in India? Are the standards good enough?

India is a large and diverse country where facilities and expertise in healthcare are varied in different regions of the country. Since there is such a lot of diversity in healthcare delivery systems across the country, standards of healthcare vary within the country. Currently, we are in the process of accrediting our healthcare delivery systems from reputed organisations within the country and abroad to ensure an acceptable level of quality and patient safety standards in India.

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Healthcare Management

What are the current trends that are shaping the Indian healthcare sector?

Health insurance is a major factor that is shaping the development of the Indian healthcare sector at present.

How has the growth of the private sector changed India’s healthcare scenario?

The private sector has played a major role in advancing the frontiers of various specialities in medicine today.

Healthcare services available with in the large private and corporate hospitals compare with the best globally.

What are your views on the current boom in the investments happening in Indian healthcare?

With an expanding middle class in the country and an opening of the economy, the investment boom in Indian healthcare was waiting to happen. It would appear that the current investments in Indian healthcare are being made with a medium to long-term perspective.

What challenges does Indian healthcare face today? How can they be overcome?

The major challenge for Indian healthcare today is to provide a modicum of uniformity in healthcare services throughout the country. Healthcare

facilities at the peripheral areas in our country is patchy in some places and totally unavailable in others.

The Government needs to involve private and corporate healthcare providers to participate in providing basic and advanced healthcare facilities to the teeming masses in the country.

In the global arena, what do Indian healthcare providers need to do in order to become more competitive Strict and uniform accreditation procedures need to be adhered to ensure uniform and quality medical services.

There is no shortage of qualified and trained medical specialists, doctors, nurses and technicians. What is needed are protocols and audit to ensure that the quality of healthcare services remains uniformly high.

Patient participation (patient-centred care) is a relatively new phenomenon in Indian healthcare. Can Indian hospitals benefit from this?

Patient centred care appears to be the bay that we are headed. Patient follow-up, supervision and guidance may be provided at home by qualified healthcare professionals. This in turn can save patients several trips to the hospital and also reduce demand for beds for admission to hospitals. Selected

The Government needs to involve private and corporate healthcare providers to participate in providing basic and advanced healthcare facilities to the teeming masses in the country.

patients may be advised, supported and treated at home by appropriately trained healthcare delivery personnel.

This would ensure high patients satisfaction, increased patient comfort and acceptable results in the long term.

I can foresee that patient centred care is likely to be a key driving element in the expansion of healthcare facilities in the country.

All over the world, the patient is becoming more and more knowledgeable about the options available to them. Is the same thing happening in India?

With the expansion of the Internet to all nooks and corners of the country, patient awareness has increased tremendously. This phenomenon seems to have caught on more in the larger metros and it is quite likely that a patient undergoing treatment has done research on the Internet (for good or bad).

What can today’s healthcare providers do to bring healthcare services to the poor?

A concerted private and governmental effort has to be made to reach out to the poor. Insurance companies shall, no doubt, be the key element in such a scenario.

As compared to developed economies, health insurance plays a relatively small role in Indian healthcare, what is your take on this issue?

The quality of healthcare services provided today in India varies quite a bit from one region to another. This may be due to a variety of factors ranging from infrastructure and equipment to expertise available in a region. In such a scenario, health insurance companies may be trying to assess and then work on healthcare services that are provided in the country. There is a rapid growth of healthcare insurance within the country and it appears that a much larger segment of the population would be covered by health insurance in some form in time to come.

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Healthcare Disparities Closing the gap

Increasing awareness

Eliminating healthcare disparities is the need of hour. The author discusses various options—increasing self-awareness among physicians, increasing minority representation in the workforce and collecting data and evidence based medicine to increase the quality-of-care for all individuals.

Mildred M G Olivier President and Founder Midwest Glaucoma Center, USA

Educational resource tools were developed in terms of training programmes, videos, speakers’ kits, Internet-based materials, print materials and conferences.

A business case model, to educate medical professionals and their employers on workplace changes that contribute to the elimination of disparities, was part of the objective. All medical societies would be encouraged to incorporate disparities elimination into their strategic planning processes. Identification of practical, evidence-based solutions to eliminate disparities in specific conditions, diseases and clinical practices were developed. The Professional Awareness, Education and Training Advisory Committee developed a slide kit and DVD that are used in 3-hour workshops that discuss disparities and offers solutions focussed on improving patient-physician communication. The workshop materials use vignettes of patients from a variety of racial and ethnic backgrounds to break down stereotypes and demonstrate how language and cultural beliefs can affect the delivery of healthcare. Articles and references are provided for background information. The workshop can be tailored for physicians in different specialties and different geographic areas.

Patient / Physician communication and trust

Central to improving communication is sensitising physicians to the fact that nearly half of all adults and the non-English speaking patients in the US may have low health literacy. Developing community networks could help provide patients with understandable, respectful, culturally and linguistically appropriate information.

Healthcare Management

T

he Institute of Medicine (IOM) report documented that racial and ethnic minorities experienced higher mortality rates, worse health outcomes and were less likely to receive routine procedures. Such practices reduce high quality health and effective, patientcentered, timely and efficient management. Recent national data suggest that some disparities are declining or have been eliminated, but many others have remained the same or even increased in the last few years [National Healthcare Disparities Report, 2008].

Five years ago the Commission to End the Health Disparities was created and formed objectives regarding this subject.

The Commission is made up of medical and subspecialities. Their emphasis was on healthcare disparities rather than the more broad, complex landscape of health disparities. Different racial and ethnic groups have poorer health status for many reasons that are not directly linked with healthcare delivery. Even the most active leadership group would not be able to solve such widespread problems

as patients who live in poverty, lack transportation, or do not live within reasonable proximity to a physician’s office, while also trying to transform the current system into one that is more culturally sensitive and diverse.

The heart of their mission, the participants decided, was to attack disparities from the perspective they knew best: clinical medicine. Even though an array of social problems contribute to healthcare disparities, physicians can fulfill their roles in society most effectively by providing high-quality care regardless of patients’ racial or ethnic backgrounds. Unequal Treatment also suggested that although health professionals dedicate themselves to providing the highest quality of care possible to every patient, they also may harbour unconscious biases and stereotypes that affect their decision-making and attitudes towards minority patients.

For example, the report cited a 1999 study

by Schulman et al. that showed physicians were significantly less likely to refer black women for cardiac catheterisation than black and white men and white women,

even when they had the same symptoms.

Another study cited in the report (vanRyn and Burke, 2000) examined actual clinical encounters and revealed that physicians viewed black patients, in comparison with white patients, as less intelligent, less educated, more likely to abuse drugs or alcohol, and less likely to comply with treatment advice, despite their knowledge of patient income, education and personal characteristics. Based on research on the reverse situation—how patients’ biases and attitudes influence clinical encounters—the IOM report indicated that minority patients perceive higher levels of discrimination in healthcare settings than do non-minority patients.

The development of workshops to help train physicians to understand the impact of healthcare disparities and improve communications with their diverse patient populations was undertaken. More specific recommendations that addressed how to meet the ultimate goal of eliminating racial and ethnic disparities in healthcare were also put forward. Recommendations prioritised the following activities:

Leadership for the elimination of disparities

attracting and recruiting more underrepresented minorities into medical school and other health professions are being examined. Students are provided with information and strategies to gain competitive criteria for successful entry into medical schools.

The creation and maintenance of a diverse workforce changes the cultural experience of non-minority students and exposes those students to a culturally rich learning environment. Incentives such as loan repayment programmes could help reduce physician shortages in underserved communities. The Workforce Diversity Advisory Committee had focussed its efforts on increasing minorities in training programmes by taking an in-depth look at how medical schools’ admissions processes affect minority student enrollment.

A first step is to examine the racial and ethnic composition of admissions and selection committees, and factors involved in their first-tier selection process. Next,

a broader assessment would be made of the differences between schools that enroll higher proportions of minority students compared to those with lower minority enrollments.

The Committee also discussed plans to convene key stakeholders—educators, organisations representing minorities, financial groups, government agencies, and the media—in 2006 with the goal of implementing some of the 37 recommendations of the highly regarded report, Missing Persons: Minorities in the Health Professions. This 2004 report was released by the Sullivan Commission on Diversity in the Healthcare Workforce, which was named for its chair, former US Secretary of Health and Human Services Louis Sullivan. Recommendations in the report addressed the underlying reasons why minorities are under-represented in the health professions, in spite of the country’s increasingly diverse population.

Another way to increase representation

Increased political activity, obtaining cooperation from the Centers for Medicare & Medicaid Services in eliminating disparities, and creating a unified message that includes local-level solutions to address disparities would be key activities.

Cultural competence of physicians

Physicians would have to examine their own attitudes in order to recognise prejudice and avoid or eliminate biased medical decisions. Educational tools, mentoring programmes, and healthcare disparities content in Continuing Medical Education (CME) offerings could help build cultural competence.

A diverse professional workforce

A closer examination of how provider diversity relates to improved patient satisfaction and healthcare outcomes by

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Healthcare Management

Improving quality

Another goal is to help physicians recognise that inconsistent healthcare across different populations is a quality issue, and that disparate care affects patient safety. Physicians should be educated to recognise that cultural competence is related to technical competence.

Conditions such as cardiovascular disease, which present greater opportunities for improvement, should be prioritised.

Incentives such as discounts on medical liability premiums could enhance the success of quality improvement initiatives such as the use of practice-based assessment tools. Increased minority representation on accrediting bodies such as the Joint Commission also could help improve quality.

Addressing cultural diversity

A core curriculum on healthcare disparities could be developed and made a requirement for medical students and medical school accreditation. Medical students would benefit from more interactions with ethnically and racially diverse faculty and patients. Medical student selection committees should be made aware of provider diversity as an issue of meeting patient needs and increasing patient safety.

Residency and fellowship selection committees should consider the importance of recruiting under-represented minorities. Programme chair meetings should address identification of racial and ethnic disparities and strategies to reduce or eliminate them.

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Health disparities / cultural competence education should be required in states with CME requirements. Disparity and diversity issues should be included in certification examinations.

Focussed research

Race, ethnicity and language proficiency should be incorporated into clinical quality performance measures.

Healthcare disparities could be an important area for the AMA-convened Physician Consortium for Performance Improvement to consider in its work to develop and test evidence-based clinical performance measures. Additional research in healthcare disparities is needed to refine teaching techniques to improve cultural competence.

Collaborate with other organisations to reduce disparities in care

Collaboration could be established with health plans, Centers of Excellence, health and medical organisations including the American Heart Association and the American Cancer Society, the US Department of Veteran’s Affairs, the Association of American Medical Colleges, the Accreditation Council for Graduate Medical Education, the American Board of Medical Specialties (focussing on its role in recertification), and community and religious organisations that serve minority communities.

Interventions and tracking

Creation and dissemination of toolkits.

Toolkits are an important intervention that could energise physicians to implement initiatives to monitor and track

A u t h o r

is through the Doctors Back to School (DBTS) programme, was launched in 2002 by the AMA Minority Consortium.

Minority physicians and medical students who volunteer in the DBTS programme act as role models by visiting elementary and high schools to talk with students, particularly those in under-represented racial and ethnic groups, about careers in medicine. The programme demonstrates to minority students that a medical career is well within their reach.

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target diseases. In addition, they could enable state medical societies to offer frontline support. Programmes that improve the image of physicians could help build trust with minority patients.

A calendar of organized medicines events that address healthcare disparities could encourage physician participation and act as a planning guide.

Data collection to improve the factors effective to improve that quality improvement initiatives intended to eliminate disparities is needed.

Collection of patient data, identifying factors that help or hinder practitioners and organisations in their efforts to eliminate disparities and gathering physician and patient data on race, ethnicity and language groups (Hasnain-Wynia & Baber, 2006, Siegel 2007, IOM) should be collected by health plans, hospitals, large medical group practices and community health centres (Audet et al., Health Affairs 2005; Nerenz et al., HSR, 2006). Instead, many of this type of data are collected in a non-systematic and unreliable way (Hasnain-Wynia & Baber 2006). Among smaller groups of physicians—practices with 1-5 members—there is reason to believe that collecting and using demographic data to track and reduce disparities is even less common.

Implementation of these various objectives throughout the healthcare community allows each of us to take a part in trying to eliminate healthcare disparities by increasing our self-awareness, increasing minority representation in the workforce and collecting data and evidence based medicine to increase the quality-of-care for all individuals.

Mildred M G Olivier is an Associate Clinical Professor at Midwestern University and Assistant Professor at John H. Stroger, Jr., Hospital at Cook County and at Olympia Fields Osteopathic Hospital. She is currently the CEO of Midwest Glaucoma Center. Olivier received her bachelor’s degree from Loyola University and her medical degree from Rosalind Franklin University of Medicine and Science, formerly The Chicago Medical School.

Healthcare Management

Direct Practice Medicine Better outcomes, lower costs Direct Practice Medicine (DPM) is a new model for healthcare that emphasises a deepening of the doctor-patient relationship. It eliminates the disruptive impact of set pricing of healthcare services, and the control of reimbursements by thirdparty payers. DPM aligns the medical and fiscal interests of doctor and patient, fostering a trusted relationship that increases the opportunities for improving health outcomes.

Jordan Shlain Medical Director Current Health, USA

W

hile times and technology have changed dramatically in the last 50 years, the basic practice of medicine has remained the same through generations. A doctor is still a medical problem solver armed with three primary tools: knowledge, experience and technology. More importantly, even while the tools have evolved from penicillin and X-rays, to multi-drug regimens and PET scans, the pre-eminent criterion for successful medicine has nothing at all to do with technology, or even physician-training. The most critical criterion of good medicine is time. More specifically, it is the units of time that a patient spends with his or her physician.

In trying to improve my own clinical practice, I have given a name to this criterion. I call it the ‘healthcare minute.’ My premise is that simply by attending to the ‘healthcare minute’ we can do more to enhance outcomes than when we throw more money, or even the most innovative technologies, at the problem.

The value of the ‘healthcare minute’ has been squeezed to near irrelevance over the last several decades, in three ways: (1) The third-party payer system has eliminated individual accountability for healthcare costs; (2) set-pricing mechanisms in the payment system have removed free-market transparency; and (3) medical advances have, paradoxically, created a population that lives longer through more illnesses, magnifying the demand for healthcare minutes. Trouble is, there are a finite number of minutes in each day.

The perfect storm in healthcare

Of these three factors, the set pricing of healthcare services may be the most

perverse. Begun in 1965 as part of the National Social Security Act, the federal pricing model was intended to streamline billing systems fraught with variability and herd the cottage industry of doctors into a coherent framework. Logically, premium prices went to the most urgent, complicated and risky medical procedures —services that almost always take place in the late stages of care. In the pricing standards, however, too little consideration was given to the value of the services provided by the doctor responsible for the patient’s complete illness and wellness profile: the primary care physician.

Using Medicare as their guide, private payers similarly allocated their premium reimbursement dollars to specialists and sub-specialists who perform urgent or late-stage procedures. The unforeseen consequence of this was that it marginalized the very physicians who deliver the early, comprehensive services that should make costly, late-stage medical procedures unnecessary in the first place. [This is why, according to the annual Physician Fee Schedule Survey performed by the trade journal Physicians’ Practice the average reimbursement for an office visit with an existing patient was just US$ 71.67 in 2008—down from Tk in 1965. It is barely enough to cover office overhead.

Compare this to the average pacemaker procedure, which is reimbursed at US$ 3,500.]

Unable to bill competitively due to set-pricing, and watching as their http://209.85.173.132/search?q=cache:fUNbxGDvFr0J:www.physicianspractice.com/index/fuseaction/articles.details/articleID/1293. htm+average+reimbursement+for+primary+c are+office+visit+2008&cd=7&hl=en&ct=cln k&gl=us&client=safari

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reimbursement rates from private payers continued to shrank, primary care physicians are left with just one option to keep their practices solvent: see more patients.

This is how the precious ‘healthcare minute’ was unintentionally sacrificed to the costly ‘healthcare procedure.’ Forced to see as many patients in a single day as possible, primary care physicians have begun spending only enough time with each, to determine just which higher-cost specialist must see them next. Primary care physicians today refer approximately 50 per cent of their patients to specialists —up from just 20 per cent three decades ago. Stuck on the “referral treadmill,” doctors have reluctantly whittled down their average medical office visit to a mere seven minutes.

The real costs to the healthcare system of displacing 30 per cent more patients from early stage care, which costs less, to late stage care, which costs more, is enormous. What is worse, as late stage care grows bloated with patients, more and more resources are siphoned from primary care. This is a positive feedback loop with negative consequences that is slowly starving the physicians bestpositioned to improve overall health outcomes.

Can’t we do better than this? Isn’t there a model that efficiently allocates resources, while also prioritising the early inputs that provide the most value in the healthcare delivery chain? And what do patients really want, anyway? How many people would opt for bypass surgery, if the alternative were simply more time spent with their internist earlier in life?

I contend that most patients would opt for a deeper relationship with their doctor, given the choice.

Most patients want the comfort of close counsel, and information-rich advice on how to be healthy. When things go wrong, they want compassion, responsiveness, and confident crisis management.

It is time for physicians—especially young physicians, who lack the burden of entrenched interests or history—to turn the 20th Century model on its ear.

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Rather than minimising office visits with internists and family practitioners, we should be minimising visits to specialists. Instead of maximising late-stage procedures, we should be maximising the ‘healthcare minute’ shared by doctor and patient at the entry point of the medical ecosystem. This is the model of Direct Practice Medicine. I believe it can achieve the changes that providers and patients both want: increase access; decrease costs; and improve overall outcomes.

The Economics of Direct Practice vs. Managed Care / 20th Century Care

In business, the open market determines the value of goods and services. In its current state, the healthcare market is anything but open. In fact, it is like a black hole. As a consumer culture, it is hard to appreciate the value of something without knowing its cost. Very few could report the actual cost, in inflationadjusted dollars, of our annual physical exam, much less the cost of an inpatient colonoscopy. Direct Practice brings some fiscal rationale to healthcare in two ways.

One, it offers pricing transparency. Two it empowers a patient to determine precisely what market value he wishes to place on his healthcare. The benefit of this new sense of ownership is a more committed patient. An individual who is willing to invest discretionary income on their health

needs will be more committed to improving his or her health outcomes ultimately, their asset. An individual willing to invest discretionary income in their health and wellness, is also a person willing to invest more time in his care. Show me a person who invests in more healthcare minutes, and I’ll show dramatically improved health outcomes.

The math in the healthcare minute

The power of Direct Medicine, of course, is in the minutes—or rather, the math behind the minutes. I illustrate this by first drilling down into the standard, and very hurried visit, of a traditional clinician.

In the current US healthcare system, the average doctor has at least 2,000 and as many as 4,000 patients. This is why most doctors see 32 patients a day—and why the average clinical exam has been compressed to just seven minutes. What is often left out of this calculus, is that a doctor must review each patient’s chart before the exam, plus conduct follow-up paperwork—including calls to relevant specialists, and order prescriptions or lab tests. Charting and follow up requires about 20 minutes per patient, so even a seven minute exam can be as long as 35 minutes in total. Given that some patients require more comprehensive exams requiring even longer, to do a thorough job, a good doctor should see no more than 12 patients in an eight hour day.

Introducing Direct Practice Medicine Practice Medicine emphasises a deepening of the doctor-patient relationship. It is based on a principle of mutually aligned incentives. The doctor commits to delivering a higher level of service, chiefly demonstrated by the hours spent with the patient, and other intellectual resources made available by the doctor. The patient promises to adhere to preventative medical regimens, and agrees to pay—up front—fees commensurate with the time and resources expended by the physician.

This implies that the patient values his or her health as an asset, takes responsibility for the management and growth of this asset, and is willing to pay for the professional advice and insights of a trusted adviser. Freed of the bureaucracy of thirdparty payers, formerly risk-averse physicians will suddenly become more enterprising, migrate to the latest technologies, adopt new clinical practices and deliver personalised services in more creative ways.

In these ways, Direct Practice eliminates the disruptive impact of set pricing. It dispenses with reimbursements of third-party middlemen. It aligns the medical and fiscal interests of doctor and patient.

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Healthcare Management

Introducing CurrentHealth

In 2009 my partners and I initiated a US$ 50-a-month membership program called CurrentHealth . Practicing medicine is historically a labour intensive endeavour. It takes one doctor and about 2.5 office support staff to schedule, conduct and manage a single office. To leverage so much overhead, and minimize the average cost per office visit, it is easier to ramp up the “throughput” of patients than it is to cut down staff – just one more reason why doctors try to see so many patients each day. In this scenario, outcomes suffer.

As an innovator, CurrentHealth offers patients open access through a variety of communication channels aimed at increasing value and reducing inefficiency. The Internet, e-mail, and SMS are all available options for contacting CurrentHealth doctors and our office 24 hours a day, seven days a week. Our patients can follow their medical progress with the latest communications tools, including Twitter and texting or emailing with their physician.

We believe the CurrentHealth model is scalable and can be replicated in most any market, including the Asian market – so long as patients value their health and doctors can practice in an economic framework where the health minute is prioritised. Starbucks and Apple have succeeded at branding a consumer experience across geographies. Why not in healthcare? Data is beginning to Also

in the US, the Society of the Innovative Practice of Medical Design is a relatively new organization that aggregates direct practice doctors. In five short years, their membership is well into hundreds and growing everyday.

The patient experience

If a Direct Practice doctor is not living up to his promise of service and quality, the patient community will learn about it. In the world of Twitter (CurrentHealth), Facebook (Current Health Medical Group), Myspace, Yelp, and Healthgrades, a practice cannot afford to say one thing and do another.

There are too many eyes and too much connectivity that will expose and chip away at inadequacies. Physicians have a great opportunity to step up and deliver a new brand of healthcare. To reiterate, this is nothing new rather a return to medicine’s roots. It’s all about patient care, the patient experience and the doctor-patient relationship. The direct practice model elevates the patient experience and improves outcomes.

The new model for 21st century medicine

To be fair [be fair or clear, not both], Direct Practice Medicine is not for everyone. It especially suits those who desire medical care that is competent, lean and engaging. Direct Practice appeals to patients who wish to invest in a system that rewards the doctorpatient relationship and improved health outcomes over transactions and marginal cost-savings. www.SIMPD.org <http://www.SIMPD.org>

A u t h o r

Furthermore, at any given time, two per cent of a physician’s patient panel will be ill. Therefore, a practice with 3,000 patients, 60 will be sick at any time. We would never expect a high school teacher to effectively tutor 60 students at one time. Few consumers would knowingly pay to be just one of 60 people competing for their doctor’s time and expertise. In the Direct Practice model there is no such competition.

Of course there are those in any society who will not wish to, or will not be able to, opt into a private system like Direct Practice Medicine. However, contrary to popular belief, this new model can scale to serve the needs of all kinds of patients. QuickHealth in San Francisco offers US$ 49-office visits and caters to the un-employed.

I believe that any healthcare system must have, at its core, a provision for a safety net to protect those who are stricken with unforeseen illnesses of especially high costs. But if we are to reform the healthcare system, at large, we must encourage—and enable—innovative thinking on the edges, too. By emphasizing the doctor-patient relationship, and eliminating the disruptive impacts of set pricing and third-party payers, Direct Practice Medicine offers one such opportunity for innovation. If we can succeed at aligning our fiscal and medical interests, and once again foster the trusted relationship between doctor and patient, Direct Practice Medicine will increase our opportunities for improving health outcomes. I believe that doctors, and patients, will follow.

Now let’s place this value proposition in a larger context: in the throws of a global recession, where your stock portfolio or your real estate holdings have all lost value, your most precious asset is surely your health. Most of us don’t think about our health as a depreciating asset, but it takes just one moment of living in medical peril to come to the realization that your health is an asset worth protecting. In this context I believe most patients would agree that investing a little extra money in their ongoing health makes sense.

Jordan Shlain is a pioneer in the evolving field of ‘direct practice’ medicine. He is board certified in Internal Medicine, lectures at University of California Berkeley on Healthcare Economics and is the medical director for the leader in direct practice medicine (www.currenthealth.md). He sits on the local San Francisco Medical Society board of directors as well as the national concierge physicians’ association. He is married to a Swiss and has three children. TWITTER: Follow his updates at http://twitter.com/CurrentHealth

www.currenthealth.md

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The Electronic Health Record Delivering healthcare for the 21st century An enhanced appreciation of the connection between quality and coast has made the question of mass-market penetration of the EHR an issue of broad importance.

Louise Liang Senior Consultant Kaiser Permanente, USA

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T

he delivery of healthcare has been largely unchanged in fundamental aspects for decades. Despite significant advances in science, medical diagnostic tools, surgical interventions and pharmacology, the basic transaction has remained almost solely face-to-face interaction between healthcare professionals and patients in institutional settings.

In almost all other spheres of business and industry, electronic information systems coupled with the Internet have driven fundamental shifts in how business is conducted and healthcare will not be different.

In 1999, the Institute of Medicine published To Err is Human followed by Crossing the Quality Chasm in 2001.

These publications attracted broad attention to quality and safety problems in American healthcare and identified four key factors underlying these quality gaps: (1) The increasing complexity of science and technology, (2) The rise in the incidence of chronic conditions, (3) A poorly organised delivery system and (4) A lack of critical information technology supports.

Concerns about the failure to deliver quality care have been linked with concerns about escalating costs in the minds of policy analysts, governmental agencies, purchasers and patients. Most recently, the US government forecast that healthcare spending will increase to 17.6 per cent of the economy in 2009. This combination of escalating costs, poor outcomes and 15 per cent of the population without health insurance is unsustainable and has drawn understandable scrutiny and criticism from many quarters.

Today, Electronic Health Records (EHR) has capabilities that can be brought to bear on the key factors that

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drive system quality. At the same time, an enhanced appreciation of the connection between quality and cost has made the question of mass-market penetration of the EHR an issue of broad importance.

President Obama has included significant funding for the implementation of EHR as part of his healthcare reform plan designed to stabilise healthcare costs and extend health insurance coverage.

In the US, services for patients with chronic disease now account for 75 per cent of total healthcare expenditures.

This is a consequence of the mastery of many aspects of the treatment of acute disease, and the increasing life expectancy of the populations we serve. Treatment of chronic disease requires longitudinal tracking of treatment and outcomes both for individual patients and identifiable populations made feasible via an EHR. The increasing complexity of medical science creates a burden for individual physicians to stay current. As knowledge in diagnosis and treatment expands, the time and processing speed required to achieve an optimal level of quality performance exceeds any individualâ&#x20AC;&#x2122;s capability. The number of years it takes for a medical advance to be broadly adopted into regular practice has been estimated at 17 years. In contrast, the EHR with clinical decision support has the capacity to summon current information, recommendations and research instantly at the point of care.

Patient Engagement

Once an EHR captures and organises the clinical information, offering a secure Internet-based view to the patient has a multiplying effect on the value and changes possible with a Personal Health

Healthcare Management

Record (PHR). Through My Health Manager, Kaiser Permanente patients can view key information in their medical records including office visit and hospital visit summaries, diagnoses and recommendations; send secure messages to physicians they have seen; view lab results; make appointments; and renew prescriptions. In the fourth quarter of 2008, 2.7 million (31 per cent) of our patients had secured access to these capabilities and generated 12.6 million among multiple, separate parties website visits for a variety of purposes including requesting 358,000 appointments, viewing 4.3 million test results, and sending 1.6 million secure emails to their physicians and other clinical team members. Almost a million

expanded to include family and community locations and resources. New transaction options made possible with an EHR and secure Internet capabilities have resulted in over a 20 per cent decrease in office visits. In the KP Hawaii Region, the first region to fully implement KP HealthConnect in the outpatient setting, between 2004 and 2007, the annual total office visit rate decreased 26.2 per cent, the primary care office visit rate decreased 25.3 per cent, and the specialty care office visit rate decreased 21.5 per cent.

Scheduled telephone visits increased more than eightfold, and secure e-mail messaging, which began in late 2005, increased nearly six-fold by 2007. Secure messaging and telephone visits have replaced office

The experience at Kaiser Permanente The experience at Kaiser Permanente in implementing and using an EHR may be instructive regarding the desired impact on advancing healthcare delivery. Kaiser Permanente provides health insurance and healthcare to 8.7 million people primarily in a fully integrated healthcare delivery system for a fixed monthly fee. It began the full-scale implementation of an integrated Electronic Medical Record (EMR) in 2004, covering over 420 medical offices and 36 owned hospitals and medical centres. We anticipated many changes, but significantly underestimated both the breadth and the challenge. To guide our work, we developed a set of principles to ensure that the implementation and use of the EHR, Kaiser Permanente HealthConnect would achieve the quality and strategic goals of the organisation. The past several years of implementation and use of KP HealthConnect has validated these principles and demonstrated the significant impact on the way healthcare is delivered.

patients visited the evidence-based health encyclopedia and 165,000 visited the featured seasonal health topic on colds and flu. Even when these website visits do not avoid a telephone call or office visit, our patients appreciate and benefit from the additional information and interchange at their convenience. Engaging patients in their care has long been an espoused value, but the PHR makes it a reality and the changes this will drive have only begun to become clear.

Beyond our walls

The home and other personal settings such as work or community have become the location of choice for much of care delivery. The care delivery system has

visits while increasing patient satisfaction, maintaining or improving quality outcomes, and increasing total patient contacts. Given our current experience and trajectory, our patients will likely choose alternatives to office visits to access care for well over a third of their interactions in the very near future. The rapidity and degree of patient adoption has been very strong, cutting across age, gender and socio-economic differences.

Obtaining healthcare has become similar to the way many of us shop, bank and work every day.

Integration and leveraging

Healthcare is mostly provided in very loosely organised delivery systems.

Whether coordinating care between physicians, nurses and other healthcare professionals in the same organisation or among multiple, separate parties across many organisations, the EHR supports the coordination of care. The 24-hour availability of patient information in a legible, organised format decreases medical errors, duplication of tests and other services including emergency room visits and hospitalisations.

At the same time that duplicative tests and services are eliminated, information technology can leverage scarce and specialised clinical resources via virtual consultations regardless of geography and time zone constraints. KP HealthConnect, combined with an integrated disease registry for chronic conditions has made it possible for a single nephrologist to oversee and consult on the care of the chronic renal failure patients for a population base of over 250,000, significantly improving clinical outcomes by delaying renal dialysis.

Reliability and customisation

Effective treatment for hypertension is well understood but only 40 per cent of the diagnosed patients receive the appropriate care in the US, resulting in needless complications and deaths.

Diabetes affects a rapidly growing per centage of the population, accounting for a substantial burden of illness and expense. Yet only half of patients with diabetes receive care proven to reduce or prevent serious complications. Data from KP HealthConnect populates panel management tools to help clinical teams to track and manage patients with chronic conditions such as cardiac disease, diabetes and chronic renal disease. This allows each team to efficiently and proactively identify which of their patients are in need of additional care and interventions. The tools support mail, phone and email outreach; pre-visit preparation; and referrals to other specialists.

In 2005, the Institute for Healthcare Improvement in Boston, Massachusetts

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launched the â&#x20AC;&#x2DC;Saving 100K Lives Campaignâ&#x20AC;&#x2122; to improve hospital care and prevent complications by ensuring the reliable delivery of evidence-based care. EHR-imbedded documentation templates and evidence-based orders make this task consistent and efficient.

A recent study of 41 hospitals in Texas reported the correlation of the level of sophistication of the EHR used with lower mortality and complications, lower costs and shorter hospital stays. While many clinical processes will be vastly improved by standardisation and the EHR, patient involvement and customisation are also readily supported. The easy availability of information on medical conditions and recommended care helps patients and families make knowledgeable choices based on personal preferences, constraints and values.

Seamless transitions

A u t h o r

Although the EHR can eliminate unwanted and unnecessary face-to-face encounters, healthcare is still fundamentally based on relationships. Patients and healthcare professionals alike need and benefit from in-person interaction, made richer by full availability of integrated longitudinal patient information coupled with the best knowledge and recommendations science can offer. By having complete information, every clinician contributing to the care of an individual patient has the advantage of providing a seamless experience for the patient. Valuable time during office visits, emergency visits, and hospital rounds can be devoted entirely to understand patient concerns, preferences and issues.

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Transitions in care are a time of particular risk in healthcare. Nurse shift changes, general medicine referrals to medical or surgical specialists, and hospital discharges are all vulnerable times. Personal communication style, verbal versus written communication and variation in what information is conveyed and where it is documented all contribute to the risk that critical information may be omitted or misinterpreted. The EHR provides the vehicle and the opportunity to design a consistent information flow to enhance safety and efficiency. Dozens of staff nurses learned techniques to design a process for shift change that is now the standard process in Kaiser Permanente hospitals. After incorporating information from patient and family interviews, a template was developed that is now imbedded in the hospital EHR. All clinical staff can access a single place for the same information on each patient. A similar process is underway to redesign the hospital discharge process informed by over 100 interviews including patients and families at home after discharge as well as doctors, nurses and pharmacists both in the hospital and in their medical offices.

Fundamentally, the EHR has the capacity to integrate and organise all patient information, facilitate its instantaneous distribution among all participants in the healthcare system including patients, and inform and support the work of practitioners with the most current evidence. In doing so, it will simultaneously change industry work processes, improve quality, patient safety and satisfaction, and alter our understanding of the process and cost of delivering healthcare in the 21st century.

Louise L Liang, a 25 year veteran in healthcare administration and operations, speaks, writes, and consults on a broad set of healthcare issues including electronic information systems, quality, safety, service, and practice redesign. From 2002 to 2009, Louise served as Senior Vice President, Quality and Clinical Systems Support, Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, where she oversaw the national quality agenda and led development and implementation of a US$ 4 billion+ organisation wide electronic health record.

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BOOK Shelf

Keys to EMR Success: Selecting and Implementing an Electronic Medical Record Author : Ron Sterling Year of Publication : 2008 Pages : 253 Published by : Greenbranch Publishing Description Electronic Medical Record (EMR) systems can dramatically improve patient care, office workflow, regulatory compliance, and profitability. So what keeps every medical practice from having an EMR? For starters, there is the significant investment and learning curve. Plus, implementing the wrong system can handicap practice growth, patient care and compliance with evolving standards and regulations for years to come. But now, Keys to EMR Success offers medical practices a clear and systematic way to evaluate what an EMR would contribute, choose the best system for today (and down the road), and get it up and integrated with your Practice Management System with a minimum of technical headaches and staff resistance.

For more books, visit Knowledge Bank section of www.asianhhm.com

Ensuring Patient Safety Role of regulation

T

he regulation in ensuring safety of the patient will play a very important role. The Nursing and Midwifery Council (NMC) was set up by the UK Parliament for the expressed purpose of safe-guarding the health and well-being of patients and the public.

The Council does this by establishing and maintaining standards of education, training, conduct and performance for nurses and midwives. Similar regulators exist to help ensure the other healthcare professionals, such as doctors, dentists and pharmacists practise to safe standards.

However, professional healthcare regulators like the NMC cannot work

Rules and regulations can only be truly effective in contributing towards patient safety if individual healthcare practitioners take on accountability for their own actions and omissions.

Jill Crawford President, Nursing and Midwifery Council, UK

in isolation. Patient safety is a shared responsibility between regulators, employers, service users and most importantly, practitioners. The NMC believes that the starting point for public protection rests with individual nurses and midwives, and the professionals on their register are personally accountable for their actions and omissions in their practice.

This principle is enshrined in the NMC Code through a set of standards nurses and midwives can use to demonstrate the safety of their working practice and behaviour to patients, members of the public, employers and colleagues. The NMC Code, which was updated and

re-launched earlier in April 2008, emphasises that nurses and midwives must make the â&#x20AC;&#x153;care of people their first concern, treating them as individuals and respecting their dignity.â&#x20AC;? It also states that they must, at all times, protect and promote the health and well-being of those in their care. The Code also emphasises that failure to comply with it could bring the fitness to practise of a nurse or midwife into question and endanger his or her registration. The Code is not just a tool for the professionals. It is also a document aimed at patients and the public to help them understand what they can expect from the nurse or midwife providing care.

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However, NMC Code cannot provide a blue print to nurses and midwives as to how to behave in every circumstance— professionals will always have to make judgements in a wide variety of changing circumstances. Fundamentally, the accountability of these professionals rests on their responsibility to weigh up the interests of patients using their professional knowledge, judgement and skills to make a decision. As mentioned above, it requires a partnership for the Code to be effective, involving the NMC, employers, nurses and midwives themselves.

A key element of the NMC’s role in this partnership is support for professionals. The NMC believes that regulation can only be effective when it ensures that nurses and midwives are encouraged in their efforts to achieve the highest standards, and to provide the best possible care at all times. This principle of supporting best practice of offering advice and guidance is becoming increasingly important as nurses and midwives take on new responsibilities, and are faced with fresh challenges and situations. These challenges include, for instance, working in multi-disciplinary teams. This can mean that nurses work under managers who are not qualified nurses, or that they are required to delegate tasks to a healthcare assistant who may not be registered with the NMC. Similarly, in the UK we are seeing a greater emphasis on delivering healthcare close to patient’s homes and moving away form the hospital model of care. This concept has come with many challenges that are directly impacting on nurses within both community and acute care. The NMC is aware of these challenges, and is doing what it can to support nurses and midwives, wherever they work, in giving the best care.

One way in which we do this at the NMC is through the Professional Advisory Service (PAS). This service facilitates professionals to get speedy advice from experts using a direct phone line and an e-mail address. Our professional advisors are often asked about how to maintain registration, the role of healthcare assist-

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ants and the rules around conscientious objections to particular procedures or types of care. To give an idea of the use of the service, we receive on average, around 29,000 enquiries a year. Another service the NMC provides is the Advice by Topic section of the NMC website. This facility allows nurses and midwives quick access to information on topics ranging from delegation to rules on receiving gifts from those in a nurse’s or midwife’s care.

Another strength of the NMC’s mandate is its capacity to undertake risk assessment in relation to public protection and the direction of practice, and act upon identified risks. NMC reflects that responsibility by providing guidance regarding those issues that affect practice in the 21st

No matter how effective a system of regulation and revalidation is, nurses and midwives can face conflicts when exercising professional accountability. century. One of the key challenges is to develop a revalidation mechanism, which demonstrates to patients and the wider public that nurses and midwives remain up-to-date in their education, training and skills and are fit to practise. It is currently working with Government and other healthcare regulators to develop a system of revalidation, which is proportionate to the risks inherent in the work with which nurses and midwives are involved.

The NMC is also working at improving networks and partnerships with other nursing and midwifery regulators, both within the European Union and beyond.

A major focus of such partnerships is developing systems for the exchange of information about practitioners seeking to practise across borders. Dialogue with other regulators, within the UK and more widely, also provides the NMC with

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opportunities to learn about innovations in regulatory systems, including advanced ways of applying IT to the goal of public protection.

But no matter how effective a system of regulation and revalidation is, nurses and midwives can face conflicts when exercising professional accountability. This is especially the case where resources are limited or badly managed. Employers— and ultimately Government—must ensure that systems are designed and resources are provided to support nurses and midwives in their practice. Patient safety can be compromised in circumstances in which there are inadequate staffing levels. For example, the potential risk to patient safety is increased if a midwife is left unsupported in charge of a busy maternity ward over a weekend shift. The risk increases further, if the midwife is exhausted by the lack a much-needed rest break due to lack of any cover. Individual nurses and midwives placed in such situation are faced with difficult decisions. It is their duty to raise concerns, if they feel their ability to provide safe care is being compromised.

Indeed the Code states specifically that, “You must inform someone in authority if you experience problems that prevent you working within this Code or other nationally agreed standards”. In practice, it can be difficult for nurses and midwives working in such high-pressured environments to make their voices heard.

The final element of responsibility for patient and public safety lies with service users themselves. Without a wellinformed public willing to get involved in the process of setting standards for healthcare professionals, regulation can never truly reflect the needs of society.

The NMC works hard to involve the public in its work—not just through lay membership of Council, but through wide consultations. These consultations take a variety of forms. For instance, in drafting the Code, the NMC consulted not just nurses and midwives, but patient groups, employers, trade unions, nurse and midwife educators, and the four government departments in England, Scotland,

Healthcare Management

patients is heard and their input flows directly into the business of regulation, although that is of course, a key element.

Lay participation also means the NMC benefits from the knowledge and skills of experts in different fields, such as law, accountancy and management. The structure of the new Council sets a clear message that modern regulation is aimed squarely at representing the interests of patients and the public, rather than representing interests of nurses and midwives, which is the role of trade unions and professional bodies.

In conclusion, healthcare regulators can and do set out standards, rules and

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Wales and Northern Ireland. The focus groups provided invaluable insight into how NMC as an organisation is viewed from the ‘outside’—and it certainly gave it food for thought.

The NMC, alongside the other healthcare regulators in the UK, is currently moving towards a governance structure that will see the lay voice being strengthened. Currently, the Council consists of 33 Members, of which 24 are elected nurses and midwives (although only 12 of those sit at Council meetings at any one time). Following proposals in the Government’s recent White Paper entitled “Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century”, the NMC will be moving to a smaller, fully appointed Council.

This new 14-member board-like Council, which will see parity between lay and professional members, will take up office on January 2009. Lay involvement is not just about making use; the voice of

guidance to enable healthcare practitioners to practise safely and effectively. But such activity can only be truly effective in contributing towards patient safety if individual healthcare practitioners take on accountability for their own actions and omissions. Where does the responsibility ultimately rest for patient safety?

Although, as previously explained, there is a shared responsibility for patient safety, ultimately such responsibility must start with the individual healthcare practitioner.

Rather than talking about ‘the buck stops here’, perhaps we should be talking about the buck starting somewhere—with individual healthcare practitioners.

Jill Crawford was elected President of the Nursing and Midwifery Council in August 2008, having been a lay member of the Council for six years. Jill has a background in campaigning for improvements in maternity services in the UK. She is a member of the National Childbirth Trust and has chaired Maternity Service Liaison Committees.

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Healthcare Management

Cultural, Social & Linguistic Barriers Can they be overcome?

Cultural, social and linguistic barriers are a great challenge for healthcare providers. In order to overcome these barriers, clinicians must rethink their daily clinical work. The data compared in this article show that immigrants in Europe differ from natives but also from their countrymen at home. The investigation of this population should help us to provide better healthcare.

Marina Sleptsova Clinical Psychologist and Master in Cognitive-behavioural Psychotherapy University Hospital Basel Switzerland

I

ncreasing migration worldwide leads to formation of multi-ethnic societies. In 2006, there were about 200 million immigrants worldwide. Ethnic and cultural diversity presents a great challenge for all healthcare providers.

Problems arising through this diversity are wide-ranging and require rethinking of already existing healthcare approaches and structures.

Talking about racial and ethnic differences highlights an important question: terminology of ethnic categories is often inconsistent and problematic. Use of such basic terms like ‘race’, ‘ethnicity’ and ‘minority’ is almost always undifferentiated. The diversity of minority groups less homogenous is not usually perceived by an observer who does not belong to this group. Usual terminology also does not take into account the degree of acculturation to the country of immigration.

Racial disparities in health and health treatment

Racial disparities in health have been welldescribed in current literature. Data shows that members of minority groups suffer disproportionately more cardiovascular disease, diabetes, asthma, and cancer.

Musculoskeletal pain is more prevalent among immigrants in Europe than among native Europeans. Mood disorders

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among immigrants to Europe have also been reported to be more prevalent than among native Europeans, but not all studies confirmed these findings.

Racial differences among migrants result in migrants receiving unequal treatment. Most studies find that various ethnic groups are not given equal healthcare. This inequality of healthcare for various ethnic groups was observed for instance in pain treatment for all types of pain (i.e. acute, cancer, chronic non-malignant) and in all settings (i.e. postoperative, emergency room).

Communication between doctor and patient is often negatively affected by these cultural differences. In medical consultation, both migrant patients and their providers interact differently than natives and their clinicians do. To reduce racial and cultural disparity in care, the authors recommend that healthcare providers and organisations employ a culturally sensitive approach.

Culturally competent approach

The quality of the relationship between the clinician and the patient is crucial for diagnosis, treatment and healing. Patientcentred encounters increase patient satisfaction and improve medical outcomes.

Similarly, cultural competency in treatment of migrant patients is recognised as an essential factor for the quality of

Healthcare Management

What characterises migrants in Europe?

In their host country, migrants differ from natives. Migrants are disrooted in many ways from their country of origin. At the onset of their migration, there are two possibilities. Either migrant who voluntarily leave their home country are more courageous and healthier than the average population in their country, or migrants forced to leave their country represent a sociologically handicapped section of the population. Healthy migrants to Europe consider their quality of life to be higher than that of their healthy fellow countrymen who remain home .

However, if Turkish migrant patients in Switzerland get ill, they assess their quality-of-life a great deal worse than their countrymen in Turkey do (See Table 1).

Sleptsova et al., 2008 114 Turkish migrant chronic pain patients

Tuzun et al., 2004 99 Turkish chronic pain patients in Turkey

Mean, SD

Mean; SD

Physical Functioning

39.35; 21.6

67.27; 18.59

Role-Physical

6.36; 20.7

39.09; 37.26

Bodily Pain

18.67; 16.5

33.18; 17.73

General Health

21.85; 14.9

36.42; 22.26

Social Functioning

37.06; 23.8

59.09; 28.17

Role-Emotional

11.4; 27.9

44.43; 43.83

Mental Health

32.04; 18,5

54.91; 21.85

Vitality

22.76; 17,8

39.32; 19.83

Scales, SF 36

Table 1. Comparison of Scales SF36 of Turkish migrant patients in Switzerland and Turkish patients in Turkey. Iranian and Turkish immigrants in Sweden report poorer health and poorer health-related quality-of-life than native Swedes do, unless socioeconomic status, Swedish language proficiency, and racial discrimination are also considered.

Likewise, Turkish chronic pain patients in Switzerland report lower quality-of-life than German native chronic pain patients do (See Table 2).

Sleptsova et al., 2008 114 Turkish migrant chronic pain patients

Huge et al., 2006 83 German native chronic pain patients

Mean, SD

Mean; SD

Physical Functioning

39.35; 21.6

50; 20.4

Role-Physical

6.36; 20.7

15.9; 32.3

Bodily Pain

18.67; 16.5

27.2; 13.5

General Health

21.85; 14.9

46.9; 18.3

Social Functioning

37.06; 23.8

56.3; 28.3

Role-Emotional

11.4; 27.9

66.7; 43.6

Mental Health

32.04; 18,5

59.1; 22.7

Vitality

22.76; 17,8

39.6; 22.4

Scales, SF 36

Table 2. Comparison of Scales SF36 of Turkish migrant patients in Switzerland and German patients in Germany.

Migrant workers coming from outside the European Union to Western Europe tend to be more socio-economically disadvantaged.

They are less educated than natives. Migrants work in low-paid and more hazardous jobs. The following comparison illustrates that Turkish migrant chronic pain patients in Switzerland have less formal education than native chronic pain patients in Germany.

Characteristics Number of participants

Basler et al., Germany

Sleptsova et al., Switzerland

220

116

No school education, %

0

23.3

First 5 school years, %

0

54.3

Further 3 school years, %

43.9

15.5

University, %

56.1

6.9

Education duration

Table 3. Comparison of formal education of Turkish migrant patients in Switzerland to that of native patients in Germany.

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Healthcare Management

Culture, culturally sensitive and culturally competent

An increasing quantity of current literature has begun to reflect on terminology. Fundamental terms such as ‘culture’, ‘culturally sensitive’ and ‘culturally competent’ in medical context begin to be used by clinicians who are confronted everyday by migrant patients. The need to articulate clear definitions of these terms and find consensus has been slowly recognised. One thing is clear: Culture is a dynamic concept. Moreover, culture varies within an ethnic group and is in change.

Most authors emphasise that clinicians must become aware of and also respect differences in cultures. Clinicians should recognise unique cultural and religious beliefs, ethnic values, and traditional practices—all of which can be in transformation—within any ethnic group.

Cultural sensitiveness and competency requires that the clinician reflect on his or her own cultural system. Self-reflection

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Several studies establish that professional interpreters have a positive impact on clinical care.

Lack of linguistic comprehension decreases patient satisfaction. is necessary to develop awareness of one’s own attitude toward persons of different ethnic or cultural groups.

Linguistic barriers in healthcare

Although current studies show that language is not the only influence on the quality of clinical communication, nevertheless language proficiency does play a very important role in medical encounter. Several studies establish that professional interpreters have a positive impact on clinical care. Lack of linguistic comprehension decreases patient satisfaction. Whereas concordance of language between the clinician and his or her patient does reduce emergency visits and their costs, in general, such enhanced interpreter service intervention does not significantly change hospital costs.

Growing use of the interpreter presents new problems to researchers and clinicians. The role of the interpreter in the clinician-patient consultation has not been clearly ascertained. The so-called transmission model of communication introduced by Shannon and Weaver requires precise and complete translation. In clinical reality, however, this theoretical model does not suffice.

The role of the interpreter in healthcare settings has been discussed, but consensus is yet to be achieved. One

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healthcare. Thus, patient-centred communication should contain the specification of cultural competency.

Many authors present ‘cultural competency’ as an integrative model of the healthcare system at both institutional and professional levels. The institutional level of such a culturally competent healthcare system requires primarily that both interpreter services and culturally and linguistically appropriate health education materials are available. Training programmes for healthcare providers to develop their cultural competency are necessary at the professional level of such a healthcare system. Such training programmes improve knowledge, attitudes, and skills of health professionals, which influence patient satisfaction positively.

The perspective of the patient to culturally sensitive healthcare has also been investigated. Along with universal themes like individualised treatment, effective communication and professional competency, results revealed that patients wish a culturally specific patient education and culturally sensitive staff.

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of these roles is that of the so-called ‘cultural broker’. Can culture really be translated?

In any case, the quality of clinical consultation depends on mutual agreement by all participants about the interpreter’s role. However, innovative strategies of medical translation, for instance Remote Simultaneous Medical Interpreting (RSMI) have been introduced and tested in the clinical practice.

This strategy of translation removes the person interpreting from the presence of the patient. Patients believe their privacy is better protected and feel more satisfied than in consultations with usual interpreting.

Conclusion

In healthcare systems today, the problems of cultural diversity seem to be perceived and taken seriously than ever before. Nevertheless, far too little research has been made on this topic. A natural tendency of most health researchers is to take on the cultural perspective of the majority ethnic group to which they belong, at the expense of the perspective of minority ethnic groups. Development of culturally competent researchers is in any case needed. Such culturally competent researchers could initiate both needed investigations as well as culturally competent practice. Because there is so little research about the effectiveness of culturally competent healthcare systems, it could not even be determined.

If ethnic and racial disparity and its ensuing consequences are to be reduced or even eliminated, healthcare systems must overcome cultural, linguistic and social barriers.

References are available at http://www.asianhhm.com/magazine

Marina Sleptsova Schwander is a clinical psychologist and psychotherapist, was born in the Russian Republic of Sakha. She studied psychology in St. Petersburg. She earned her MA in cognitive behavioural therapy at the University Basel, Switzerland. Since 2000, she has been working at the Psychosomatic Department of the University Basel Hospital. She is married and is mother of two children.

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Palliative Care

Reaching out to patients with heart failure

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Healthcare Management

Patients with end stage heart failure and their carers carry a prolonged and heavy symptom burden that affects all domains of life. Moreover, access to supportive and palliative care is patchy, and recognition of the dying stage remains poor.

Extending palliative care to this group of patients is now an important priority.

Miriam J Johnson Senior Lecturer Palliative Medicine Hull and York Medical School, UK

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atients with heart failure, and those who care for them, carry a prolonged burden of symptoms which affect all domains of life. The burden is similar to those with cancer, but with less access to supportive and palliative care. Recent years have seen a raised awareness of this issue and services which integrate palliative care for patients with heart failure are growing in the UK and elsewhere in the world, although they remain patchy.

Reasons for poor access to supportive and palliative care

Historically, palliative care services have grown around cancer services and, in the UK at least, with a heavy dependence on cancer charities. It is taking time to extend organisational boundaries to people with non-malignant disease and address the potential lack of skill and confidence of palliative physicians in this area. Services which have been successful have adopted an extended team model of cardiology and palliative care services

working together, rather than a mutually exclusive approach.

Given the pattern of slow decline punctuated by episodes of severe decompensation and risk of death, much is made of the difficulties of estimating prognosis in heart failure. This is used by some to explain the late referral for palliative care. Successful services give less weight to prognostication, but rather, use a problem-orientated approach working alongside cardiology colleagues. Palliative care clinicians use their skills to address the problems when their services are required and discharge the patients once they are resolved. This approach helps to reassure the cardiology colleagues that the palliative care team will not stop vital optimal cardiac medication unless this is no longer tolerated.

There can be a misperception that palliative care is only for the imminently dying. This leads to referrals that are too lateâ&#x20AC;&#x201D;if at allâ&#x20AC;&#x201D;and a potential reluctance to discuss palliative care referral as it is generally misconceived as telling a patient that he is about to die.

Many clinicians also lack confidence in their ability to communicate serious issues regarding different management options in the context of advanced disease

Barriers to palliative care access Palliative care services are traditionally developed around oncology services Uncertainties regarding prognosis lead to late referral to palliative care, or none at all Misperception that palliative care is only for the imminently dying contributes to late referral Poor confidence regarding palliative care skills (cardiologists) Poor confidence regarding cardiology skills (palliative physicians) Lack of communication skills (cardiologists)

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Learning point: Symptoms in heart failure patients Symptoms affect all areas of the patient’s life: physical, psychological, social, spiritual and financial Symptoms may be experienced over a prolonged time Those looking after the patient such as family and friends may also require support A full assessment is needed of needs of both patient and those who care for them An extended team approach between cardiology and palliative care seems to be effective.

without taking away a patient’s hope, and causing great distress. To address these issues, communication skills training must be recognised as important by clinicians and managers. Advanced communication skills training is now mandatory for UK oncologists enabling this sort of discussion and patient involvement in key decisions to become routine.

Just as palliative physicians may feel uncertain of their cardiology skills, so cardiology clinicians may feel uncertain of their palliative care skills. However, the majority of palliative care skills are those with which all clinicians should be competent. There is a need for the usual care team to be educated in assessment and palliation skills so that they can deal with most of the problems themselves, but refer to specialist services if the problem persists. Likewise, palliative care teams need education regarding optimal cardiac medication and diuretic management.

Symptoms in heart failure and their management Breathlessness

Breathlessness is a cardinal symptom of heart failure and forms a key part of the assessment of New York Heart Association class. As with any

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symptom control, a full initial assessment is important looking for reversible / treatable features such as decompensated failure, infection, pulmonary embolus, sub-optimal management of chronic pulmonary disease. Other co-morbidities such as lung cancer may also be found. It is also important to distinguish a history of paroxysmal nocturnal dyspnoea due to decompensation from alarming nocturnal ‘breathlessness’ episodes due to sleep apnoea. The heart failure patient may have intractable breathlessness despite optimal cardiac treatment and dry weight, with no other explanatory causes. This is due to several factors including enhanced chemosensitivity resulting in abnormal ventilatory patterns. Management includes non-pharmacological approaches such as a breathing training and exercise programme along with anxiety management. Some patients may benefit from a hospital type bed where not only the head, but also the feet, can be raised to prevent slipping down in the night. A hand-held fan may also be helpful. Pharmacological approaches include low dose opioids (e.g. morphine 2.5 – 5 mg qds or morphineequivalent dose of opioid), taking care with opioids that are renally excreted if there is renal dysfunction, and low dose benzodiazepine (e.g. lorazepam 0.5-1 mg sublingually) where panic is a prominent feature. Currently there is little evidence that oxygen administration helps the sensation of breathlessness, and unless the patient is hypoxic, should not be routinely prescribed. If sleep apnoea is demonstrated with episodes of nocturnal desaturation, nocturnal oxygen, or continuous positive airways pressure may be helpful to prevent nocturnal distress.

Fatigue

Fatigue is the other common debilitating symptom. Assessment should look for reversible factors like over-diuresis with a postural drop in blood pressure, hypokalaemia from loop and thiazide diuretics, anaemia, insomnia or depression.

As with breathlessness, exercise training programmes may play an important role and should be encouraged.

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Pain

Pain is a less recognised feature of end stage disease and may be due to ischaemia, gout or musculoskeletal co-morbidities.

Optimisation of cardiac medication is important, and consideration of other measures such as trans-cutaneous nerve stimulation (in the absence of devices) may help. The World Health Organization (WHO) analgesic ladder is applicable.

The use of colchicine or low dose steroid is preferable to Non-Steroidal AntiInflammatory Drugs (NSAIDs) in the management of gout. NSAIDS should be avoided in heart failure because of the risk of decompensation due to fluid retention.

Other physical symptoms

Constipation may cause much misery. Bulk laxatives such as ispaghula husk should be avoided unless there is another indication such as irritable bowel disease, as a high fluid intake is required for them to work best.

Nausea may be caused due to medication (digoxin, spironolactone), renal dysfunction, or liver engorgement and gut oedema. Attention to oral hygiene is important and they may require an antiemetic such as a prokinetic (metoclopramide or domperidone 10-20 mg t-qds) or a small dose of haloperidol (1.5 mg once a day). Theoretically, cyclizine may impair cardiac function but evidence that this is a problem in practise is slight. It may be wise to avoid cyclizine if possible, but if a nauseated heart failure patient was endstage and cyclizine was the only available anti-emetic then it seems inappropriate to with-hold it. Poor appetite may herald the cardiac cachexia of late stage disease or be due to poor fitting dentures and lack of energy to prepare food. A dietary assessment is important with use of proteincalorie supplementation if necessary. If, however, it is judged that cachexia is the underlying cause of anorexia and weight loss, then the patient should be advised to eat little, but regularly.

Dry skin is asignificant problem which is often overlooked. Good skin care with regular use of emollients is necessary to

Healthcare Management

prevent breaks in the skin which allow a portal of entry for bacteria, leading to cellulitis.

Care of the dying Recognition of the dying phase can be difficult but not always impossible

Psychological symptoms

Care of the dying Recognition of the dying phase

Patients with heart failure may have several episodes of decompensation, often triggered by an intercurrent event such as infection, where they are severely ill, but then respond to hospital treatment.

However, as the disease progresses, decompensation may occur spontaneously, ACEinhibition and beta-blockade are no longer tolerated due to hypotension, and diuretic requirements increase or frank diuretic resistance may occur. Renal failure adds to the difficulty of optimising medication.

Recurrent ‘revolving door’ admissions are often a feature of the patient nearing the end of life. Other prognostic markers such as a rising Brain Natriuretic Protein (BNP) or falling serum albumin and persistently

Open and gentle discussion regarding the stage of the illness is required Pulmonary oedema can be a problem, and loop diuretics administered by intravenous or subcutaneous infusion In general, the skills used to care for other dying patients are transferable to those dying with heart failure ‘Do not resuscitate orders and re-programming’ of implantable cardioverter devices (if present) should be arranged

low serum sodium may also help, if available. In this context, the patient who fails to respond to optimal treatment in the first few days after decompensation, or becomes bedbound, unable to manage oral medication, is no longer able to eat but only manages to sip water, and is progressively more fatigued and less responsive, is likely to be in the dying phase.

General palliative care measures for the dying are transferable to the heart failure patient and are not discussed here.

However, particular issues may need to be addressed. Pulmonary oedema is not necessarily a problem, especially when the patient is unable to drink. But if it is, parenteral administration of a loop diuretic (either by stat injections or continuous infusion intravenously or subcutaneously) may be needed in addition to an antisecretory such as hyoscine. Discussions regarding the futility of an attempt at cardio-pulmonary arrest may be needed, particularly if a patient or their family have unrealistic expectations. If an inter-

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Depression and heart failure seem to be integrally connected with an increased prevalence compared with the general population. In addition, patients who are depressed are more likely to develop heart failure. Heart failure patients who are depressed are more likely to be admitted to hospital and die sooner. Diagnosis and treatment are, therefore, crucial. Nonpharmacological management includes exercise and cognitive behavioural therapy programmes, if available. Pharmocological therapy centres on the use of the serotonin-reuptake-inhibitors and tetracyclic antidepressants which appear to be safe.

Tricyclics should be avoided because of their pro-arrhythmic potential. Anxiety is, likewise, a common problem and may respond to a full assessment, addressing specific symptoms and issues of concern.

Non-pharmacological approaches to anxiety management should be used, and intermittent use of benzodiazepines for panic may be helpful. Maintenance of anxiety states may benefit from serotoninreuptake-inhibitors rather than long-term benzodiazepines which may increase the risk of memory loss and falls.

nal cardioverter device is present, similar discussions related to its reprogramming to pacemaker mode should take place, if not done already to prevent distressing multiple activations as the patient dies. CheynesStoke’s respirations may be marked to the extent of causing distressing apnoeic induced arousals in the patient. These can usually be minimised by small doses of opioid medication.

Conclusions

Optimised medical, device and surgical therapy for the heart failure patient has made a massive impact on quality and quantity of life. This approach should be coupled with access to supportive and palliative care to address the remaining symptom burden experienced by such people and their families. A problem, rather than prognosis approach will ensure timely access to services. An extended team approach between cardiology and palliative care will ensure the best management for both treatment of the heart failure itself and its unwanted effects on the person involved. Excellent communication skills are needed to enable clinicians to have the courage and sensitivity to inform the patient of the stage of their illness and discuss the aims for possible treatment in the light of the issues that the patient and their family consider important.

If this does not happen, then patients with heart failure will continue to have poor understanding of their disease, be denied best symptom control, support for their families, and the opportunity to make plans for their own death. It is said, “you have to have cancer to have good palliative care”—this should no longer be acceptable.

References are available at http://www.asianhhm.com/magazine

Miriam Johnson is Senior Lecturer in Palliative Medicine at HullYork Medical School and Honorary Consultant to St. Catherine’s Hospice. Her research interests include breathlessness and palliation for patients with heart failure. In conjunction with her local cardiology service, she has developed one of the UK’s first integrated cardiology -palliative care services for patients with heart failure.

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43

Healthcare Management

The ‘vital signs’ of Performance Improvement in Cardiac Outcomes Every healthcare executive, administrator and clinical staff member has heard and understands the phrase ‘vital signs’. The vital signs play an important role in monitoring the well-being of the patient.

Using the analogy of ‘vital signs’, author explains the importance of identifying Key Performance Indicators (KPI) to improve the healthcare services offered by the hospitals.

Lewis G Hutchison Quality Management & Accreditation Director Sheikh Khalifa Medical City (managed

by Cleveland Clinic), UAE

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E

very healthcare executive, administrator and clinical staff member has heard and understands the phrase ‘vital signs’. Temperature, blood pressure, heart rate, and respiration, and come to mind. Vital signs are used to assess and measure the state of the patient and monitor their progress to a desired ‘cure’ or outcome. But what about your organisation’s ‘vital signs’ and ‘outcomes’?

What organisational disease states will you improve or ‘cure’?

Sheikh Khalifa Medical City (SKMC) is located in Abu Dhabi City, the capital of UAE. SKMC consists of a 550-bed Acute Care Hospital and 14 Specialised Outpatient Clinics accredited by the Joint Commission International (JCI).

SKMC also operates 120-bed Behavioral Sciences Pavilion, an 88-bed Rehabilitation Center, 9 Primary Healthcare Centers and 2 Dental Centers distributed over the city of Abu Dhabi. SKMC employs over 4,600 caregivers and administrators from different nationalities. SKMC is a Governmental Healthcare Institution managed by Clinic Cleveland in partnership with HAAD and SEHA, the Abu Dhabi Health Services Company.

Cleveland Clinic is consistently named one of the top hospitals in the USA by U.S. News & World Report.

Diseases and disorders of the circulatory system rank as the number one diagnostic category at SKMC. This tertiary care programme offers comprehensive surgical, cardiac and interventional care for adult patients with acquired heart disease.

ISSUe - 19 2009

The programme offers the entire scope of modern adult cardiac diagnostic and cardiac surgery including mechanical circulatory support but excluding heart transplantation. Given the scope, volume and complexity of such an important service line, it is imperative that the performance of this department be monitored, measured and managed with patient and process outcomes at the ‘heart’ of ones focus.

Process Improvement is defined by Joint Commission as “The continuous study and adaptation of an healthcare organisation’s functions and processes to increase the probability of achieving desired outcomes and to better meet the needs of patients and other users of services” and outcomes as “the effect an intervention has on a specific health problem’. So instead of stethoscope and blood pressure cuff one can select from a variety of Performance Improvement tools to take its operational ‘pulse’ and improve outcomes. Current methodologies and literature identify many Performance Improvement tools including Plan Do Study Act (PDSA), Total Quality Management (TQM), Six Sigma and Lean Sigma processes are available for use in assisting an organisation in its outcome management process. The overlay below compares the various systems.

In a multidisciplinary approach, the PDSA process uses a centralised Quality Department, an oversight body, the Quality Improvement and Patient Safety Committee, and through the

Healthcare Management

TQM, PDSA, Six Sigma, & Lean Overlay

t

DO

Act

Study

Make Changes

trol

ate

Con

Celebr

Plan

e

ar lP

ta To

lyz

a An

Impr

ove

ipa

tic

n

tio

Measure Results

Ch Veri an ty ge s

oc es Pr ing nn Do it agai n

ure

en em

as

ag

an

Me

ty ali Re heck C

Pla

sM

e th ity e n fin rtu e o D p op

Ma k sta e th nd is ar the d

Pla me n Co as unt ure er s

Identify Waste

es

t en m ity u c l Do Rea

oc Pr

s

Customer Focus

ov

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sI

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o

Pr

An example of performance indicator

placement of Quality Review Officers (QROs) designated in each department or area, including Cardiac Sciences. The QRO’s role is to facilitate and direct departmental process improvement activities. Each QRO is made aware of performance improvement methodologies, tools and team building techniques to enable and empower departmental ownership. This process is coordinated and monitored to ensure that six steps of alignment are maintained.

Alignment involves, first, reviewing the process to identify the Key Performance Indicator (KPI) or performance outcome to be achieved. Outcomes may include, but are not limited to mortality, complications, readmissions, distribution of appropriate discharge instructions, Door to PCI time and ‘All or none compliance’ to evidence-based quality measures. Second, determine the pivotal actions in the process to achieve

nt

e em

Figure 1

the desired outcome. Documenting the flow of the process to be monitored is critical. This allows for a point-by-point or action-by-action review and visually illustrates the intended and actual process. Third, identify who performs the pivotal actions and ensure communication and documentation of expectations.

Fourth, determine the wherewithal and resources needed to achieve the actions.

Fifth, establish the time lapse between when a pivotal action does not occur and notification of follow up (i.e. feedback loop). This is most easily done by faceto-face communication, simply paging or telephoning a colleague for clarification or comment.

Other effective ways of closing the feedback loop include the use of Grand Rounds, Peer-conducted Mortality and Morbidity Review (M&M), Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA). Lastly, validate the align-

ment of the process. Validation includes measuring and analysing whether your organisation has met its goal, improved outcomes, reassigned thresholds and benchmarks or implemented an improvement process change.

Documentation is important. The outcome, its metric and definition are recorded on a PI template tool (see Figure 1) and a record of action documented through the use of a QRO template.

Dashboards are then used to compile the results into an easy-to-use, simple graphical representation. Hyperlinks are provided to move between dashboard and PI Template views. This gives the user the ability to review the outcomes at the macro and micro level. Each of these tools is available and recorded on the SKMC intranet to provide access (feedback) and enhance ease of use. SKMC & Cleveland Clinic use an intranet-based format to share and disseminate results throughout the system.

Registries are also widely used in the compilation, management, analysis and comparison of performance outcomes and data. According to the Agency for Healthcare Quality and Research (AHRQ), a patient registry is defined as “an organised system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s)”. Cardiac Science registries currently used at SKMC include the European Society of Cardiology Euro Heart Survey PCI Registry, Euro Heart Survey—ACS Registry, Global Registry of Acute Coronary Events and The Get with the Guidelines-Heart FailureSM (GWTG-HF) programme.

With over 140,000 registered patients and more than 450 hospitals participating, it is the largest hospitalbased heart failure registry in the US. Recently published studies of GWTGHF, and its predecessor, by Fonarow, et al. OPTIMIZE-HF, “have clearly

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Healthcare Management

STEP 1

Identify a KPI or performance outcome to be achieved

STEP 2

Determine the pivotal actions in the process to achieve the desired outcome

STEP 3

Identify who performs the pivotal actions and ensure communication and documentation of expectations

STEP 4

Determine the wherewithal and resources needed to achieve the actions

STEP 5

Establish the time lapse between when a pivotal action does not occur and notification of follow up (i.e. feedback loop)

STEP 6

Validate alignment

demonstrated the ability of this programme and the GWTG-HF PMT® to improve care.”

Sheikh Khalifa Medical City is the first institution outside of the US to be permitted to attempt the first use of the American Heart Association’s Get with the Guidelines programme to analyse and describe HF epidemiology and outcomes. The programme emphasises protocols created to ensure that cardiovascular patients are cared for according to accepted standards and current evidence-based guidelines and recommendations. Over 140 elements are recorded for analysis and comparison. In addition, this programme was modified to include 36 additional elements unique for the Middle East and Asia. GWTG is effective as hospital and achieved quantifiable care improvement in a short time.

Globally, More than 50 clinical trials

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A u t h o r

Performance through 6 Step Alignment

have shown that process affects outcomes.

These include studies regarding ACE inhibitor, Angiotensin Receptor Blockers (ARBs), and beta blockers and their performance in reducing mortality, readmission and reduce symptoms.

In the interest of transparency, SKMC shares its operational ‘pulse’ with patients, caregivers and community. A healthrelated publication is in print and was distributed to healthcare providers and interested parties. Outcomes books for each of our major clinical service lines are in the process of being published. One outcomes book will be ready for issue each quarter of 2009 with the first of these centering on Cardiac Sciences. Four (4) SKMC Performance Improvement Projects received awards at the 2008 Arab Health Awards, recently held in Dubai, UAE. Of the four, three received were “Highly Commended.” The Cardiac Science Performance Improvement Project “Four years of Delivering Primary Angioplasty in the U.A.E” was named the winner of Arab Health 2008 Achievement and Innovation Awards in Emergency Medical Services. This process used most of the techniques previously described, including, PDSA, Lean, Morbidity and Mortality Review, feedback through weekly team meeting and registries to document the reduction of Door to PCI times from 101 minutes in the year 2006 to 85.5 minutes in the year 2007 to an average of 82.6 minutes in 2008.

Anecdotally, teams using similar processes have won three out of four top awards in the Cleveland Clinic Patient Safety Best Practice Awards programme in 2007 and 2008. This included a programme Called ‘Code Crimson’, a Door to Balloon (PCI) improvement process, which is now the recommended

ISSUe - 19 2009

best practice for PCI and AMI care in the Cleveland Clinic Healthcare system.

In addition, 86 ‘vital signs’ or KPIs are monitored throughout the Sheikh Khalifa Medical City. In 2008, 86 quality-related Key Performance Indicators were monitored with 68 or 79 per cent showing improvement or achieving their target value. New outcomes and KPIs are currently being reviewed and revised for 2009.

Through a multidisciplinary process SKMC created and implemented a comprehensive Quality and Leadership Education Programme. All presentations are posted on the SKMC intranet and are available for use by any interested party at SKMC, its parent organisation and the Government of Abu Dhabi. Courses are open to not only SKMC employees but also other SEHA hospitals, HAAD and other medical facilities. A curriculum of 31 topics covering all aspects of continuous process improvement and leadership was initiated in 2008 and is continuing in 2009. CME credits are approved and awarded. As of 2008, 14 courses have been conducted with over 770 persons having attended with approximately 11 different content experts contributing to them. Overall satisfaction scores and individual speaker evaluations are quantified and forwarded for speaker use. Courses have been very well received with 90 per cent of the scores in the ‘Good’ to ‘Excellent’ categories.

Our organisational ‘vitals’ are strong, but we’ll continue to ‘take our pulse’ (monitor) and administer ‘treatment’ (performance improvement practices) in the interest of improving our organisational ‘well-being’ and enhance the health status of the patients and communities we serve.

Lewis Hutchison joined Sheikh Khalifa Medical City (SKMC) in January 2008 as the Director of Quality Management Department and resides in Abu Dhabi, UAE. He is currently focussed on the application of Performance Improvement techniques and evidencebased practice in the provision of International Healthcare services, outcomes improvement and patient safety.

Medical Sciences

Bariatric and Metabolic Surgery

Anaesthesia concerns As it has been realised that western diagnosis criteria for obese and metabolic syndrome do not hold true for Asian patients, anaesthesia care providers should be completely aware of the pathphysiology, risks and difficulties encountered by obese patients during the bariatric surgeries.

Sunita Goel Consultant Anaesthesiologist Saifee Hospital, India

T

he word ‘bari’ is the plural of ‘baros’. In Greek, ‘baros’ means weight / burden / load or heaviness. From this stems ‘Baris’ referring to the obese or fat / heavy / overweight people.

Obesity has reached epidemic levels within a short span of time with an alarming rise in the number of Type 2 diabetics globally. Asia Pacific itself has seen an upsurge of more than 50 million Type 2 diabetics with no signs of regression. It has also been seen that specifically in Asia the comorbidities, especially diabetes and cardiovascular disease, develop at a lower BMI and develop significant complications leading to fatality at a low age.

Health effects of obesity

As per the WHO criteria, the prevalence of obesity in Asia Pacific region is lower than western regions. According to research studies, health hazards occur at a much lower BMI in the Asian region.

It has been predicted that by 2010 the number of diabetics in Asia alone would constitute to 130 million of the total 236 million worldwide, thus constituting more than half of the world’s diabetics.

Treatment of obesity

Treatment of obesity includes various options outlined below as well as a team effort as obesity is multifactorial and needs a combined effort by various specialists like the physician, nutritionist, psychologist, physiotherapist and last, but not the least, surgical intervention and the anaesthesia care giver.

• Assessment of Weight • Dietary Therapy

• Physical Activity • Behaviour Therapy • Drug Therapy • Combined Therapy • Surgery It has been observed that a weight loss of even 10 per cent significantly lowers the comorbidities, which is significantly seen in case of obstructive sleep apnoea wherein a weight loss of even 10 per cent might decrease the sleep apnoea by 50 per cent Because bariatric surgery has become common these days, it is imperative that anaesthesia care providers be knowledgeable about the pathophysiology, risks and difficulties encountered during their care. Problems include difficulties with intravenous access, tracheal intubation and extubation, appropriate use of narcotics, muscle relaxants and other drugs. Based on Body Mass Index (BMI), humans may be classified as non-obese, overweight, obese, morbidly obese and super-morbidly obese.

Cardiovascular system

With the onset and progression of obesity, patients develop hypertension, increased blood volume and dyslipidemia. Even when they are normotensive, there is echocardiographic evidence of a significantly larger internal diameter of ventricles, thicker end diastolic septum and posterior wall of the left ventricle. These changes are related to the increased amount of intra-abdominal fat deposition. The hypertension is mild to moderate in the majority but severe in 5 to 10 per cent. For every 10-kg gain in body weight, systolic blood

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Medical Sciences

pressure is reported to increase by 3 to 4 mm Hg and the diastolic increases 2 mm Hg. Obesity is also associated with Ischemic Heart Disease (IHD). This is because obese patients are prone to hypercholesterolemia, a reduced density of lipoprotein levels, hypertension and diabetes mellitus. The Framingham study noted a direct correlation between angina pectoris, sudden death and obesity. Obese patients are also prone to cardiac arrhythmias because of increased fat infiltration of the cardiac conduction system, the presence of cardiomyopathy and coronary artery disease. Extra-cardiac factors such as obstructive sleep apnoea with the associated hypoxia, hypercapnia and electrolyte imbalance along with an increase in circulating catecholamines increase this predisposition. Many obese patients are asymptomatic even though they have varying degrees of cardiovascular dysfunctions. The primary reason is limitation of mobility. As a result of

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this, they may not complain of symptoms such as angina on exertion or exertional dyspnea.

Respiratory system

Obesity exerts profound effects on the respiratory system. The anatomic changes result in Obstructive Sleep Apnoea (OSA) and Obstructive Hypoventilation Syndrome (OHS) because of a reduction in pharyngeal free space. This is because of deposition of adipose tissue into the pharyngeal walls including the uvula, tonsils, tongue and aryepiglottic folds. The compliance of the chest wall and difference between extraluminal and intraluminal pressures along with oropharyngeal muscle tone determines airway patency. In obese individuals, collapse of the soft walled oropharynx and obstruction of the airway occurs easily because the pharyngeal free space is markedly diminished and extraluminal pressure is increased.

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As a single independent factor, obesity is responsible for OSA in 60â&#x20AC;&#x201C;90 per cent of the population with this disorder. OHS is different from OSA in that there is no cessation of airflow. Both OSA and OHS repeatedly disrupt sleep due to increased ventilatory effort induced arousal and causes daytime sleepiness and cardiopulmonary dysfunction.

Pulmonary function tests may be necessary to note effects on lung capacities and airflow mechanics. Arterial blood gases will indicate if the patient is retaining carbon dioxide or has hypoxemia.

The presence of polycythemia will suggest long-standing hypoxemia. A chest x-ray will evaluate the anatomical status of the lung and cardiac structures Effects of obesity on the liver

Obesity predisposes patients to NonAlcoholic Steatohepatitis (NASH) and cholelithiasis. However, metabolic function of the liver is not affected in

Medical Sciences

Deep Vein Thrombosis (DVT)

Both polycythemia and venous stasis predispose obese individuals to DVT. Venous stasis results from increase in intra-abdominal pressure and accompanying immobilisation noted in obesity.

Decreased fibrinolytic activity along with increase in fibrinogen concentrations has been observed in obese individuals.

The risk of DVT is doubled in obesity (48 per cent vs. 23 per cent) when compared to lean individuals during abdominal surgery. This automatically increases the likelihood of Pulmonary Embolus (PE) and is reported as being between 2.4-4.5 per cent following bariatric surgery. To reduce the risk of DVT and PE in obese patients, most surgical protocols favour the use of anticoagulant prophylaxis and pneumatic compression lower extremity stockings.

The morbidly and super-morbidly obese are particularly challenging patients because of their size. In addition to routine evaluation, areas of concern in this patient group are as follows: Intravenous access – The presence of excessive subcutaneous tissue decreases the easy visibility of peripheral veins. Portable ultrasound equipment may be required for identification and cannulation of peripheral veins Preoperative airway assessment – Obese patients are more difficult to mask ventilate and intubate. This is because of their size, presence of a neck that has a widened circumference, is shorter and the presence of excessive pharyngeal tissue with a tongue that has a large base. It is imperative that every obese patient be carefully examined for the feasibility of mask ventilation and intubation including aspiration risk. Neither obesity nor body mass index has been associated with difficult intubation. Large neck

The various associated health hazards • Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis (RA) • Cancers, Breast Cancer, Cancers of the Esophagus and Gastric Cardiac, Colorectal Cancer, Endometrial Cancer (EC), Renal Cell Cancer • Birth Defects • Cardiovascular Disease (CVD), Stroke, Hypertension • Carpal Tunnel Syndrome (CTS) • Daytime Sleepiness, Sleep Apnoea • Deep Vein Thrombosis (DVT), Chronic Venous Insufficiency (CVI • Diabetes (Type 2) • End Stage Renal Disease (ESRD) • Gallbladder Disease • Gout • Heat Disorders • Impaired Immune Response • Impaired Respiratory Function • Liver Disease, Pancreatitis • Low Back Pain • Obstetric and Gynecologic Complications, Infertility • Surgical Complications, Infections Following Wounds • Urinary Stress Incontinence

and Mallampati score are the only two predictors of potential intubation problems. Also, patients with a Mallampati score greater than or equal to three have increased difficulty with tracheal intubation. Other routine assessments namely, jaw and neck mobility, dental status, patency of nostrils, and inspection

A u t h o r

the majority of obese patients. Diabetes mellitus predisposes obese patients to NASH. Patients with NASH may have elevated liver enzymes, increase in triglycerides, hepatomegaly and cirrhosis.

of oropharynx should be done prior to implementation of an anaesthesia care plan for obese patients.

Patients undergoing bariatric surgery are prone to slipping off the table, so they must be securely strapped to the table.

Anaesthetic pharmacology – The physiological changes associated with obesity lead to alterations in distribution, binding and elimination of many drugs. Many doses have to be calculated according to the ideal body weight or more accurately according to the lean body mass. In 20 to 40 per cent of obese individuals, ideal body weight and lean body mass are not identical. This is because increase in body weight may be due to an increase in lean body mass.

Extubation – Obese patients must be extubated when they are fully awake and after they have returned of motor power.

It is less threatening to extubate those that were not difficult to mask ventilate and or intubate. Factors that play a role in determining successful extubation include the severity of obstructive sleep apnoea, duration and type of procedure.

Either facemask, nasal Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) support with oxygen may be required in some patients following extubation.

This is usually the case for those with a history of sleep apnoea or those using CPAP before surgery and supplemental oxygen is usually required.

Conclusion

Caring for obese patients remains a challenge for anaesthesia providers.

Some patients require special care in a low-cost obesity care unit while others may need prolonged care in the intensive care unit.

Sunitha Goel is a Consultant Anaesthesiologist in Saifee Hospital, Dr L.H. Hiranandani Hospital, Cumbala Hill Hospital and Breach Candy Hospital. She was awarded Industry Leadership Award in 2004.

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49

Stroke Assessment A medical emergency T

he World Health Organization (WHO) estimates that worldwide 15 million people suffer a stroke each year. Within the UK, stroke is the third most common cause of death and the single largest cause of adult disability. It is estimated that 110,000 new strokes occur within the UK annually and currently there are 900,000 people living in England who have had a stroke.

It has long been recognised that rapid and accurate stroke assessment and management improve patientsâ&#x20AC;&#x2122; outcome from stroke.

However, there have been many obstacles to this in the past, some of which persist today.

Rapid recognition of stroke enables rapid treatment of stroke.

In ischaemic stroke, thrombolysis is proven to be the most effective initial treatment reducing the number of patients with long-term disability from stroke by 30 per cent. The faster this is delivered, the greater the chance of reducing long-term disability and death given that the potential benefit from thrombolysis decreases over time. The need to treat stroke as a medical emergency is key, time delay costs neurones!

Alteplase is currently the only licensed drug for thrombolysis in the UK. It was first licensed in the US in 1996, a restricted license was granted in Europe in 2003. Several landmark thrombolysis trials, including the NINDS trial in 1995, have proved the efficacy of the drug.

More recently, the ECASS III trial published in September 2008 established a favourable outcome with thrombolysis delivered within 4.5 hours of stroke onset.

The National Sentinel Audit for Stroke 2008 assessed stroke care within the UK over the previous two years (2006-2008). Currently, 215 hospital sites offer thrombolysis within the UK. However, only 72 of the 215 relevant sites gave Alteplase to one or more of their patients.

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Medical Sciences

Anil Sharma Consultant Physician, Divisional Medical Director for Medicine, RCP Regional Advisor for Stroke, University Hospital Aintree, UK Hannah Jane Cronin Specialist Registrar, Stroke Unit, University Hospital Aintree,UK

During this period, 204 patients were thrombolysed, i.e. only 1.8 per cent of patients with ischaemic strokes. Clearly we have a long way to go to improve stroke care within the UK. The National Stroke Strategy was published in December 2007. Its aim was to improve stroke care across the UK and outlined 10 key goals to help achieve this. The need to improve awareness of stroke symptoms by the public and health professionals, the need to treat stroke as a medical emergency involving specialist teams, 24-hour access to specialist care and early transfer to a stroke unit were all key goals highlighted in the document. The target for thrombolysis for acute ischaemic stroke within the UK is 10 per cent by 2011. However, this is unlikely to be achieved.

Public recognition and perception of stroke remains a significant factor in the delay of initial stroke assessment and transfer to hospital as an emergency.

Although most patients are able to identify the symptoms of a myocardial infarction, a MORI poll performed by the Stroke Association UK in 2005 revealed only 50 per cent of patients were able to identify what a stroke is and only 40

per cent were able to name three stroke symptoms. The FAST test, a validated stroke recognition tool, was developed in 1998 from the Cincinnati Prehospital Stroke Scale. It was initially designed to assist ambulance technicians in the recognition of acute stroke and aid rapid transfer to hospital. Nor et al., Stroke 2004, assessed the agreement between ambulance technicians and paramedics and stroke specialists when using the FAST tool to identify neurological signs in 278 patients with suspected stroke.

They concluded that the use of FAST by ambulance technicians and paramedics showed moderate to excellent agreement with stroke physicians.

The FAST test comprises four elements (F) facial weakness, (A) arm weakness, (S) speech problems and (T) time to call 999. The Act FAST campaign was commenced across the UK in February this year. It compromises adverts on TV, radio and in print and aims to raise public awareness of the symptoms of stroke and that emergency stroke treatment can limit stroke damage and save lives (see Image 1). It’s hoped that this campaign will increase the number of patients contacting emer-

gency services and therefore arriving at Accident and Emergency within 1-3 hours.

The rapid and accurate assessment of stroke by emergency physicians within the A&E department is vital in aiding appropriate and emergency referral to the stroke team. The ‘Recognition of Stroke in the Emergency Room’ or ROSIER tool is used by emergency physicians to aid stroke diagnosis (see Table 1). It is proven to help differentiate stroke from common stroke mimics, such as seizure and syncope, with a score of greater than one necessitating urgent stroke referral. Initially developed and validated by Nor et al. the tool was found to have a 92-93 per cent diagnostic sensitivity and 83-86 per cent specificity for the diagnosis of stroke. It has now been widely adopted by A&E departments throughout the UK. The development of an effective model for stroke care within individual trusts is the key to providing a comprehensive stroke service. Immediate blue-light transfer by ambulance to a hospital with hyper-acute stroke services, with a stroke triage system,

when stroke strikes act f.a.s.t.

Image 1

Early recognition of stroke signs and symptoms by the public and professionals, rapid transfer of the stroke patient to hospital, early stroke specialist assessment and treatment including thrombolysis and transfer to a specialist acute stroke unit are all evidencebased interventions leading to improved outcome with lower disability and mortality from stroke.

Images taken from The Department of Health’s Stroke: Act F.A.S.T campaign. www.dh.gov.uk

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Medical Sciences

Recognition of Stroke – ROSIER SCORE Assessment

Score

1) Has there been loss of consciousness or syncope?

Yes (-1 point)

No (0 point)

2) Has there been seizure activity

Yes (-1 point)

No (0 point)

Asymmetrical facial weakness

Yes (+1 point)

No (0 point)

Asymmetrical arm weakness

Yes (+1 point)

No (0 point)

Asymmetrical leg weakness

Yes (+1 point)

No (0 point)

Speech disturbance

Yes (+1 point)

No (0 point)

Visual field defect

Yes (+1 point)

No (0 point)

Is there a new acute onset (or on awakening from(sleep) In the following:

Patients total score = TOTAL SCORE ………… (-2 to = +5) NB: Stroke is unlikely but not excluded if total score is <zero Provisional Diagnosis Stroke

Non Stroke

(specify).....

Conclusion

IF STROKE IS LIKELY CONTACT STROKE TEAM An example of the ROSIER tool used within the University Hospital Aintree Trust Table 2

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1993 and started offering thrombolysis in 2004, 24-hour thrombolysis has been available since September 2008.

The stroke service starts at the front door of the hospital having established links with our local ambulance trust to ensure rapid transfer to hospital and a pre-alert system to A&E Resus and the stroke team for suspected thrombolysis cases. The stroke team comprises four stroke nurse clinicians, who triage and coordinate all new suspected stroke cases, three consultant stroke physicians and one consultant neurologist, two specialist registrars and a team of nurses and therapists specialising in stroke who are

A u t h o r s

24-hour access to specialist stroke team assessment, 24-hour access to thrombolysis and early transfer to a designated acute stroke unit are vital to delivering effective stroke care. There is overwhelming evidence in support of acute stroke unit care. In 2007, a systematic review of stroke unit care was performed by the Stroke Trialists Collaboration, Cochrane database. It concluded that patients treated within an organised stroke unit are more likely to survive their stroke, return home and become independent in looking after themselves and that the benefits are proven over five and ten years. The National Sentinel Audit for Stroke 2006 estimated that if 75 per cent of stroke patients had timely access to stroke unit care 500 deaths per year would be prevented and 200 more individuals would live independently per year. The key to stroke unit success is a multidisciplinary approach, including early rehab assessment, goal setting and discharge planning, early swallow assessment and dietician review, as well as access to stroke specialist medical input and specialist nursing care.

The Stroke Unit in University Hospital Aintree was established in

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based on the stroke unit. The stroke nurse clinicians work closely with the radiology services to ensure a rapid CT brain scan and with the unit as a whole to ensure rapid transfer of patients to the acute unit.

The Stroke Team for Audit and Research (STAR) is an integral part of the system enabling data collection and analysis to inform service developments.

We have thrombolysed 79 patients to date—4 patients in 2004, 20 patients in 2008 and 13 since Christmas 2008.

Our target for this year is 50 patients, which is around 12 per cent of the total number of stroke patients admitted to Aintree.

It is vital that we continually strive to improve the care we deliver to stroke patients within this rapidly evolving speciality. Basic principles, however, are the key. The rapid assessment, recognition and triage of stroke are all fundamental factors to enable effective management of stroke and improve patients’ outcome. The need to raise public awareness of stroke as an emergency is also crucial in order to increase the number of patients arriving to hospital within 4 hours of stroke to enable thrombolysis for ischaemic stroke within 4-5 hours to be an option for these patients.

References are available at http://www.asianhhm.com/magazine

Anil Sharma has been a Consultant Physician at University Hospital Aintree since 1980 and is in charge of the Clinical and Research Stroke Unit at Aintree. He has been the Divisional Medical Director of Medicine since 2003 and the RCP Regional Advisor for Stroke and has lectured widely at national and local meetings.

Hannah Cronin graduated from the University of Leicester in 2002.

She has been working as a Specialist Registrar within the Mersey Deanery since 2006 and is currently working as a Specialist Registrar within Stroke Medicine at University Hospital Aintree, Liverpool.

Medical Sciences

Transcriptional Control of Heart Failure Recent developments Heart failure is a major health problem worldwide.

Current therapies manage the symptoms of heart failure. New experimental findings suggest possible future therapies that arrest the development of heart failure.

M Saleet Jafri Professor and Chair Department of Bioinformatics and Computational Biology George Mason University, USA

H

eart failure afflicts 1-2 per cent of the general population and 6-10 per cent of the elderly (<65 years) population in developed nations. The five-year survival rate for heart failure patients is 50 per cent. There is a growing incidence of reported heart failure in other parts of the world including Asia, Africa and the Middle East.

Pathological cardiac hypertrophy exhibits increased ventricular-wall tension and cardiac contractile dysfunction, and is a major predictor of heart failure.

The current treatments of heart failure address normalisation of its symptoms by using pharmacological agents to improve contractile performance. For example, drugs such as digitalis can improve beatto-beat force generation, drugs such as

Angiotensin Converting Enzyme (ACE) inhibitors and β-blockers modulate neurohumeral signalling to enhance contractile performance, and drugs such as calcium channel blockers normalise cardiac calcium handling. Furthermore, it has been shown that exercise helps to normalise cardiac function by reversing some of the systemic changes seen during heart failure. In spite of these therapies, there currently exist no approved drugs that can reverse or prevent the development of heart failure.

In order to understand the disease progression of heart failure, it is necessary to understand the changes to heart contractile function at the cellular level. Heart failure is characterised by changes in the expression of the proteins

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Medical Sciences

Schematic of selected signalling pathways involved in pathological cardiac hypertrophy.

Figure 1

governing ionic currents and calcium handling. This is most easily studied in laboratory animals. Examples of pathological cardiac hypertrophy in laboratory animals include agonist-stimulated hypertrophy, hormone-induced hypertrophy (e.g. Norepinephrine (NE), Phenylephrine (PE), or Isoproterenol (ISO), and pressure-overload hypertrophy induced by banding of the thoracic aorta.

The physiological symptoms of cardiac hypertrophy and heart failure are accompanied in part by renewed expression of the fetal cardiac genes i.e. there is dysnormalisation of gene expression concomitant on the disturbed signalling that cascades in diseased cardiomyocytes.

Translocation of the transcription factor NFATc2 (nuclear factor of activated Tlymphocytes) to the nucleus has been shown to be required for the induction of hypertrophy. Export of the signalling protein class II HDAC (histone deacetylase) has been observed to accompany the translocation of NFAT into the nucleus.

The elevation of intracellular calcium is a common regulatory factor in both NFAT import into the nucleus and class II HDAC export from the nucleus. The activation of NFAT requires the calcium / calmodulin dependent activation of calcineurin, which dephosphorylates NFAT allowing its import into the nucleus (Figure 1). In fact, calcineurin

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has been implicated as a necessary signalling molecule in the induction of cardiac hypertrophy. In the heart, the cytosolic calcium concentration is elevated periodically as calcium is elevated to cause contraction of the myocyte. A number of investigators have suggested that the periodic release of contractile calcium can trigger activation of the transcription factors that lead to hypertrophy and heart failure. In fact, there are several lines of evidence that suggest this. For example, the rapid pacing (tachycardia) of the canine ventricle by an implanted electrode (about four beats a second or 4 Hz) for prolonged periods has been used to induce hypertrophy and heart failure.

Furthermore, other work has shown that in neonatal rat ventricular myocytes, exposure to angiotensin II caused an increase in the rate of contractile cytosolic calcium transients and an increase in the amount of NFAT translocated to the nucleus. Additionally, these investigators also showed that increasing the pacing of neonatal ventricular myocytes by field stimulation also resulted in an increase in NFAT translocation to the nucleus. Activation of NFAT leads to the expression of MCIP1 that acts to inhibit calcineurin. Experiments have shown that overexpression of MCIP1 inhibits cardiac hypertrophy. Furthermore, NFAT transclocation to the nucleus can be blocked

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by immunosuppresants such a cyclosporin A and FK506. Unfortunately the use of immunosuppresants would leave the patient immunocompromised.

Another important class of transcription factor involved in the advent of heart failure are proteins that regulate the histone proteins. The DNA in the nucleus is tightly wrapped around histone proteins. Histone Acetyltransferases (HATs) acetylate the histones allowing portions of the DNA to become accessible for transcription. Histone Deacetylases (HDACs) oppose the action of HATs. Nuclear class I HDAC inhibits anti-hypertrophic gene transcription. Inhibitors of class I HDAC such as tricostatin A, sodium butyrate, and HC-toxin block cardiac hypertrophy and improve contractility in failing hearts.

Nuclear class II HDAC inhibits prohypertrophic gene transcription, in fact, nuclear class II HDAC is thought to block the activation of NFAT-activated genes. Thus, it has been proposed that normalising cardiac gene expression with small molecules, such as class II HDAC inhibitors, will halt cardiac remodelling processes by controlling the disrupted signalling cascades, and thus might be a successful â&#x20AC;&#x2DC;transcriptional therapyâ&#x20AC;&#x2122; for the failing heart. In fact, knockout of class II HDACS produced spontaneous hypertrophy in mice and antiviral overexpression of active mutants of class II HDAC prevented agonist-induced hypertrophy in cultured myocytes.

The export of class II HDAC requires activation of calmodulin kinase II and local calcium release from perinuclear IP3. Hypertrophic growth can be blocked by expression of a calmodulin kinase II resistant mutant HDAC in COS cells. Nuclear export of HDAC-GFP in isolated myocytes in response to endothelin-1 activation can be blocked by the IP3 receptor antagonist 2-APB. In these studies, contractile calcium transients were not sufficient to cause HDAC export from the nucleus suggesting another source of calcium, such as release of calcium from the nuclear

Medical Sciences

DNA transcription of hypertrophic proteins. Curcumin is a natural polyphenolic compound found in turmeric that does just that. Curcumin blocks phenylephrine- and pressure overload-induced cardiac hypertrophy in primary cultured rat cardiac myocytes through inhibition of P-300 HAT activity. Hence, this provides another potential mechanism to control hypertrophy.

There are also other pathways that might be exploited. For example, resveratrol is a non-flavinoid polyphenol found in the skin of red grapes. Resveratrol activates the AMP-Activated Protein Kinase (AMPK) and inhibits Akt pathways.

A u t h o r

envelope triggered by inositol 1,4,5trisphosphate (IP3).

Protein kinase D also regulates HDAC through a related pathway as follows: Activation of phospholipase C, typically in response to agonist cleaves phosphatidyl inositol into Diacylglycerol (DAG) and IP3. DAG activates protein kinase C which activates protein kinase D which in turn promotes class II HDAC export from the nucleus. DAG kinase phopshorylates DAG and hence decreases its concentration. This reduction in DAG concentration reduces class II HDAC export from the nucleus through protein kinase C and D. Additionally, DAG kinase has been shown to suppress cardiac hypertrophy and loss of left ventricular function in mice. It blocks endothelin-1 induced growth and activation of fetal gene programs caused through the PKC pathway.

Inhibition of HAT, which opposes the action of HDAC, leads to reduced

Resveratrol inhibits pressure overloador phenylephrine-induced heart failure in rats. This drug also has other potential applications. For example, resveratrol is currently under phase II clinical trials for prevention of colon cancer.

In summary, recent experiments have given insight into the complex signalling pathways associated with cardiac hypertrophy and heart failure.

These suggest potential drug targets and lead compounds that warrant further study. Due to the complexities of the signalling pathways, further studies are likely to additional drug targets and lead compounds.

M Saleet Jafri received his BS from Duke University, MS from New York University and PhD from CUNY/Mt. Sinai School of Medicine.

Previous positions include Assistant Professor at University of Texas at Dallas, Research Associate at Johns Hopkins University, and post-doctoral researcher at University of California, Davis.

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Surgical Speciality

Methods that assess individual patient variables would appear to offer the best methodology for assessing surgeon and anaesthetist performance.

Graham P Copeland Consultant General Surgeon North Cheshire Hospitals NHS Trust, UK

Assessing surgical outcomes New techniques

C

linicians have struggled with the capricious nature of predicting surgical outcomes for hundreds of years. If one wanders of the beaten track to the basement of the Louvre in Paris you will come across a black diorite plinth inscribed with hieroglyphics from the time of King Hammurabi of Babylon (Figure 1). As early as 1750BC he was issuing edicts aimed at practising clinicians. The best known being: ‘If a surgeon operates on a free man and the man dies or goes blind then the surgeon should have his hand cut off’.

‘If a surgeon operates on a slave and the slave dies then it is the responsibility of the surgeon to replace the slave’.

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Surgical Speciality

It would appear at first sight that little has changed over the intervening four thousand years, but over the past thirty years there has been an increasing clinical awareness of the importance of clinical audit and clinical governance as tools to help with overall quality improvement. Although mortality alone is often used as a quality measure itself, clearly a number of factors can influence the outcome from surgical endeavour. The quality and experience of the surgeon and the anaesthetist preparing the patient for surgery and its subsequent performance can have a significant effect on outcome. However, the patient themselves will often bring with them the major prognostic factor with regard to subsequent outcome, that of their physiological fitness. This may be reflected in their chronic disease status or the acute physiological disturbance caused by their acute illness. Finally, the procedure itself will have a major affect on surgical outcome.

All these variables are amenable to change. We can expand our clinical knowledge to encompass new procedures. We can contract our practice to those areas in which we can excel.

We may be able to improve a patientâ&#x20AC;&#x2122;s

Index and (Standard)

Jan 1983-Dec 1992

Jan 1993-Dec 2002

% Cancer patients seen within 2 weeks (100%)

87%

100%

% Cancers with preoperative diagnosis (>90%)

68%

95%

% Patients with adequate FNA or core biopsy (>80%)

57%

87%

Benign to malignant surgery ratio (<1:1)

3.1:1

0.4:1

Radiotherapy and chemotherapy compliance against guideline at that time (100%)

86%

99%

Local recurrence rate (<5%)

6.7%

1.2%

121

76

12

1

4

0

Standardised mortality ratio (SMR) (no standard but norm 100) Complaints (no standard) Successful litigation (no standard)

The relationship between clinical audit standards and outcome in one unit in the North West of England. Comparison between 2 ten year periods Table 1

chronic disease status or devise new methods of anaesthesia to minimise risk in particular patients or we may be able to amend a patientâ&#x20AC;&#x2122;s acute physiological disturbance. We can even alter the magnitude of our surgical intervention to a degree. It was with these thoughts in mind, rather than fear of lawyers and legislators, that probably led clinicians to look at methods for measuring and predicting the outcome from surgical intervention.

Let us look at some of the methodologies available for predicting and measuring surgical performance and examine the application of clinical audit and outcome measures to this field.

Figure 1

Clinical audit tools

King Hammurabi of Babylon: Diorite plinth to be found in the Louvre Paris 1750BC

Clinical audit techniques use existing research or effectiveness data to formulate the design of quality standards against which it is possible to assess performance. In the main, these standards are process rather than outcome driven and assume that improvements in process will result in improvements in care and thus, ultimately, outcome There is now available a wealth of published guidelines produced by national and international bodies as well as local specialist networks.

In the UK The National Institute for

Health and Clinical Excellence (NICE) publishes guidelines with regard to new treatments, new interventions and clinical treatment with an expectation that the health service as a whole will comply with this guidance within a three month period. The currently available NICE treatment guidelines focus mainly on high volume disease states such as cancer, chronic disease states (e.g. diabetes, ischaemic heart disease, hypertension) and a smaller number of acute conditions (e.g. depression, anxiety). Nationally, there is now some evidence to suggest that improvements in process measures have resulted in improvements in outcome with regard to mortality at least in medical specialities like myocardial infarction and stroke.

There is, however, little national data for the surgical specialities that clinical audit has as yet significantly improved outcome. At a local level there is some evidence that implementation of guidelines and audit quality improvement programmes can improve survival and reduce complaints and litigation (see Table 1) but it is always difficult to assess the contribution made to quality improvements by audit, the introduction of new staff and the development of multidisciplinary team working.

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57

Surgical Speciality

Patient risk Mortality

10%

30%

70%

1st Year Trainee

9% (5-15)

28% (22-36)

65% (55- 80)

5th Year Trainee

10% (5-15)

25% (20-35)

70% (60-80)

Consultant

10% (5-15)

35% (25-40)

70% (60-80)

Variation in predictive ability of various grades of staff.

Study based on three standardised patient histories with defined predicted outcomes of 10 per cent, 30 per cent and 70 per cent with regard to mortality using the POSSUM system. 50 clinicians in each category were requested to assess the likely outcome as a percentage for each of the three patient histories. The median value and ranges are shown.

Table 2

Patient risk Morbidity

10%

30%

70%

1st Year Trainee

8% (5-20)

25% (20-40)

75% (50- 80)

5th Year Trainee

9% (5-15)

28% (22-40)

70% (60-80)

Consultant

5% (2-12)

20% (10-35)

50% (40-70)

Variation in predictive ability of various grades of staff.

Study based on three standardised patient histories with defined predicted outcomes of 10, 30 and 70 per cent with regard to morbidity using the POSSUM system. 50 clinicians in each category were requested to assess the likely outcome as a percentage for each of the three patient histories.

The median value and ranges are shown Table 3

Index procedure: Crude mortality rate (95% confidence limits) Carotid endarterectomy

Infrainguinal bypass

Unruptured AAA repair

Ruptured AAA repair

ALL

<61 yrs

0.3% 0.1-1.4%

1.5% 0.7-3.2%

3.8% 1.7-7.9%

25% 14.8-38.6%

2.3% 1.6-3.4%

61-70

1.2% 0.7-2.0%

2.5% 1.5-4.0%

3.5% 2.4-5.1%

27.9% 22.5-34.0%

4.3% 3.6-5.1%

71-80

0.9% 0.5-1.6%

5.7% 4.3-7.4%

7.1% 5.9-8.6%

43.2% 38.4-48.0%

8.1% 7.3-9.0%

>80

2.7% 1.4-5.0%

9.9% 7.1-13.5%

14.9% 11.5-19.0%

58.9% 51.1-66.4%

15.3% 13.4-17.4%

Unspecified

0% 0-6. 9%

7.1% 1.2-25%

6.7% 1.2-23.5%

66.7% 24.1-94%

7.5% 3.6-14.8%

ALL

1.1% 0.8-1.5%

4.6% 3.9-5.5%

6.8% 5.9-7.8%

41% 37.7-44.3%

7.2% 6.7-7.7%

Vascular society of Great Britain and Ireland mortality standards 2004 Table 4

Whatever the contribution, there can be little doubt that regular clinical audit monitoring of process guidelines prevents performance slippage and will identify outliers at an early stage, providing the guidelines up to date and widely available.

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A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

Techniques for assessing true outcome

Whereas clinical audit methods tend to concentrate on process and structures, most patients and indeed surgeons are more interested in true outcome. These could fall into three main end points

ISSUe - 19 2009

death, complication or survival. Most experienced surgeons and anaesthetists are ableâ&#x20AC;&#x201D;accepting wide confidence limitsâ&#x20AC;&#x201D;to guess the probable mortality outcome from a particular intervention. Interestingly, the ability to predict morbidity often deteriorates with the seniority of the clinician (see Tables 2 and 3). Some specialist societies are now attempting to define outcomes for individual procedures (vascular, colorectal and orthopaedics in particular) to allow comparisons to be made between units.

The Vascular Society of Great Britain and Ireland has produced mortality ranges for surgical intervention for abdominal aneurysm and peripheral vascular disease (Table 4). And the Association of Coloproctology for Great Britain and Ireland also produces mortality rates for emergency and elective colon resection and anastomotic leaks rates for anterior resection and other anastomoses (Table 5). In England the Department of Health now publishes Standardised Mortality Ratios (SMR) for 4 procedures (hip and knee replacement, elective and emergency aneurysm).

Although the latter has tried to introduce some form a risk adjustment for age, sex, social deprivation and co-morbidity. The methodology is far from accurate and confidence limits are wide. It remains to be seen whether the availability of such SMRs to the general public reassures them of the equality of care or produces patient flows from units with SMRs above 100 to those below 100 despite all units performing within 99 per cent confidence limits.

As with many surgeons, the public at large do not always understand complex mathematical models but do understand the concept of good (SMR under 100) and bad (SMR over 100).

Perhaps differing models may provide the solution. Models which merely produce an assessment of high or low risk with various graduations between such as ASA clearly do not offer the solution.

Neither do those similar systems apportioning risk but without a numerical

Surgical Speciality

Standard Mortality rate

Anastomotic leak rate

Elective

<7%

Emergency

<20%

Anterior resection

<8%

Other anastomosis

<4%

Table 6: The POSSUM surgical scoring system

Colorectal quality standards: Association of Coloproctology of Great Britain and Ireland 2007 Table 5

individual patient outcome prediction.

APACHE requires observation over a twenty four hour period and the worst variables are applied to a mathematical formula which has extensive correction weightings for individual disease conditions. In comparison with those methods discussed previously it produces an individual numerical patient prediction for mortality but clearly more variables are necessary and the mathematics can be complex usually requiring significant hardware and software support. These APACHE problems have limited its application in general surgery where successful surgical intervention can have a major and immediate effect on physiological status.

In an attempt to overcome some of these difficulties, general surgeons during the late 1980s began to develop a methodology which would produce an individual patient prediction of both mortality and morbidity utilising data which was regularly collected and easy to obtain. This lead to the development of the POSSUM system (see Table 6 and 7), first published in 1991, which has now become one of the best known and widely applied methods for surgical audit. It has been validated in a wide range of surgical specialities including vascular surgery, colorectal surgery, thoracic surgery and general surgery. An orthopaedic POSSUM has been recently described and validated in which the general equations are still utilised but there are minor modifications to the

Table 6

operative severity score assessment. A modification of the POSSUM system has been devised which is of particular use in individual patient prediction. The p-POSSUM (Portsmouth POSSUM) system has proved to be particularly popular in vascular surgery. The same variables are assessed but a linear rather than logistic model (Table 8) is used making it an easier mathematical model to use and to self-design applicable software.

More recently further refinements of the original POSSUM system have been described specifically for colorectal and oesophageal surgeons. Tekkis et al. have described both a CR-POSSUM for colorectal surgeons and an O-POSSUM (Table 9) for oesophagogastric surgeons.

These have the advantage of reducing the variables required for prediction and improving the accuracy for these particular fields of surgery. O-POSSUM, is however, somewhat complex and requires knowledge of individual variables, coefficients similar to the APACHE systems.

As yet unlike the original POSSUM equations they have not been validated in units outside the UK but the original estimation data set was obtained from

many differing sites across the UK, and as the variables and weightings are similar to the original POSSUM scoring system, it is likely that their accuracy will be confirmed by other observers.

However, all these adaptations, unlike the original POSSUM system, have as yet no morbidity predictive model and cross speciality comparison is, of course, not possible.

Using predictive models of surgical outcome

If one has the ability to assess and predict individual patient outcomes how can this information be utilised? The easiest and most widely utilised technique is as an audit aid when discussing adverse events.

However, it soon became apparent that techniques of this sort could be used to assess individual surgeon / anaesthetist and unit performance.

Systems such as POSSUM and APACHE which produce such a prediction have obvious advantages in this regard. Some authors have suggested that the p-POSSUM mathematical model has advantages in individual case review and this may well be the case in low risk cases as both the POSSUM

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59

Surgical Speciality

Operative C lasses

Examples of operative magnitude within the operative severity score

Minor

Intermediate

Major

Major+

Hernia Varicose Veins Breast lumps Simple lumps: Epidiyamal cysts Hydrocele Circumcision

Cholecystectomy TURT TURP Prosatatectomy Appendectomy Mastectomy Thyroidectomy

Cholecystectomy – Exploration of CBD Rt Hemicolectomy Lt Hemicolectomy Anterior resection Gastrectomy Bowel resection Any laparotomy Amputation Vascular: Femoro – Popliteal bypass

Aortic aneurysm Aorto – bifem graft APR resection Oesophago – gastrectomy Pancreactectomy Hepatectomy

Table 7

Score

1

2

3

4

8

Variable

Physiological score Age (years)

<60

Cardiac failure

None or mild

Moderate

61-70 Severe

Systolic Blood pressure (mmHg)

100-170

>170 or 90-99

<90

Pulse (beast/min)

40-100

101-120

>120 or <40

Urea (mg/L)

<10

10.1-15.0

>15.1

Haemoglobin (g/dl)

13-16

10-12.9 or 16.118

<10 or >18.1

71-80

>81

Peritoneal soiling

Minor None or minor serous

Operative urgency

Elective

Cancer Staging

None or Dukes A-B

POSSUM Physiological score (see table 3)

0.080

No malignancy

0

Primary only

0.168

Nodal disease

0.365

Metastatic disease

1.042

Urgency of Surgery (x2)

Major

Major complex

Free pus or faeces Urgent

Dukes C

0.055

Elective

0

Emergency

0.678

Type of Surgery (x3)

Intermediate Local pus

Age POSSUM STAGING (x1)

Operative severity score Operative severity

Emergency

Dukes D

COLORECTAL POSSUM

Oesophagectomy

0

Total gastrectomy

0.283

Partial gastrectomy

-0.767

Palliative gastrojejunostomy

-0.366

The O-POSSUM scoring system. Tekkis et al Br J Surg 2004, 91, 288-295: The coefficients β are inserted in the equation as indicated below. Logit R = In (R/(1-R) = -7.566 + 0.055(age in years) + 0.080 (POSSUM Physiological score) + POSSUM staging (x1) + urgency of surgery (x2) + type of surgery (x3).

Table 8

and APACHE models are logistic equations based on populations of patients rather than individuals. Certainly the p-POSSUM and POSSUM systems are the ones recommended by the Royal College of Surgeons of both England and Edinburgh and by NCEPOD and are probably the methods of choice.

The POSSUM system is the only system that produces a numerical

60

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

Coefficient β

prediction of morbidity across the surgical spectrum.

Clinical audit of adverse outcomes can be a particularly depressing affair.

While it can be of great value to discuss cases where death occurs and predictive models indicate a risk of death of less than 20 per cent, the opposite end of the spectrum (risk greater than 80 per cent) often yields little audit gain except

ISSUe - 19 2009

Table 9

to discuss whether the operation was indeed indicated. Predictive models of these types can produce a new audit spectrum, that of the patients whose risk exceeds a certain level (for example >50 per cent) but who survive. Often, audit of these cases can identify best practice and produces changes in resuscitative protocols which produce a sustained quality improvement. Such an approach

Surgical Speciality

Surgeon and speciality

Mortality %

Morbidity %

O/E mortality

O/E morbidity

A Vascular

4.8

13.0

1.02

1.03

B Hepatobiliary

2.6

10.0

0.96

0.96

C Colorectal

2.9

15.1

1.00

0.99

D Vascular

3.5

13.6

0.98

0.98

E Gastrointestinal

3.1

11.7

1.04

1.03

F Urology

0.3

2.1

0.5

0.75

G Urology

1.0

4.9

1.00

1.02

Raw and risk adjusted outcome measures for a 12 month period in one unit. Results apply to all non day case surgery in 7 individual surgical teams within one hospital. The O/E ratio indicates the Observed number of adverse outcomes (O) / the Predicted number of adverse outcomes (E) Table 10

Year

Mortality %

Morbidity %

O/E ratio mortality

O/E ratio Morbidity

2002

3.8

16.7

0.99

0.97

2003

3.7

15.5

1.01

1.00

2004

3.2

13.9

0.97

0.98

2005

3.8

13.9

0.97

0.98

2006

3.1

12.9

1.02

1.01

2007

3.4

14.2

0.98

0.95

All patients scored represent those undergoing non day case surgery Use of the POSSUM system to assess hospital performance over time. The hospital shown is a United Kingdom district general hospital providing emergency general surgery, non cardiac vascular surgery, and cancer surgery.

Table 11

Assessing performance

Over the past fifteen years, there has been increasing interest in the outcomes from individual unit as well as individual surgeon endeavour. If one simply applied mortality ratesâ&#x20AC;&#x201D;as any mathematician will point out if you choose to take a radical stance and close the worst performing 5 per cent, after 10 years you will have closed 40 per cent of units and probably still not improved overall care. Fortunately no country has chosen, to date, to take such a radical decision.

Methods that assess individual patient variables would appear to offer the best methodology for assessing surgeon and

anaesthetist performance. Table 10 illustrates the marked differences in outcome of surgeons with varying case mix. However, with the application of the POSSUM system it is possible to predict the expected number of deaths and comparing this with the actual number yields a ratio (the observed to expected ratio; O/E ratio) which potentially produces a true quality measure (see Table 10 and 11). There is now commercially available software (the

A u t h o r

has the added value of making clinical audit an uplifting rather than depressing experience.

CRAB system: available from CRAB Clinical Informatics Ltd) which includes all available POSSUM algorithms and which allows for the first time analysis of all POSSUM related quality indicators from audit aid to surgeon, unit and specialty specific outcome measures.

These techniques have now been widely validated and from personal observations it would appear that when performance deteriorates, it is in the management of patients whose risk lies between 10-80 per cent that major differences in unit performance have been identified. Where O/E ratios are persistently above 1.00 examinations of individual patient deaths and of the morbidity spectrum, when compared to similar clinician or unit spectra, can often identify the cause of poor performance.

Local complications and wound related problems are often surgeon related.

Respiratory and cardiac problems are often anaesthetist related. Renal and to a lesser extent respiratory problems are often related to the availability of appropriate high dependency facilities and the overall quality of nursing services.

While these may be oversimplifications, from a personal perspective I have found them to be useful tools over the past ten years when assessing both my own and other units.

Conclusion

It would seem that when assessing surgical performance process and structures are best measured using classical clinical audit techniques. When assessing true outcome, be this mortality or morbidity, then some form of refined risk adjustment is necessary to avoid the risks of utilising simple mortality or morbidity rates.

Graham Paul Copeland is a Consultant General Surgeon at North Cheshire Hospitals NHS Trust with a special interest in biliary and breast disease. I am the inventor of the POSSUM surgical audit scoring system and the CRAB audit software system.

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Diagnostics

Predictive, Preventive & Personalised Medicine A novel strategy for healthcare Predictive medicine is a new philosophy in the healthcare and novel strategic activity aimed at a potential application of innovative biotechnologies in the prediction of human pathologies, a development of well-timed prevention and individual therapy-planning.

Essential components of this approach include well-organised population screening protocols using novel diagnostic biomarkers of disease states, targeted prevention of common human pathologies such as Diabetes mellitus Type 2 and breast cancer, optimal treatment planning and personalised medicine, thereby resulting in substantial improvement of the quality-of-life.

Olga Golubnitschaja Secretary-General, The European Association for Predictive, Preventive & Personalised Medicine, Belgium

62

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

C

urrent healthcare practices essentially rely on emergence of signs and symptoms of human pathologies prior to initiation of interventional modalities. A major limitation of this approach relates to the fact that often the disease process has already taken its toll through manifestation of its complications. As a result, despite high costs associated with care of these individuals, long-term prognosis usually remains poor due to inadequate control of disease manifestations, treatment failure, disease-recurrence and the appearance of severe secondary complications, among others, thereby contributing to relatively low life-quality of the treated persons, high morbidity and mortality.

ISSUe - 19 2009

Here we demonstrate some examples on both Diabetes care and Diagnostics and treatment of breast cancer.

Applications in diabetes care

The ever increasing number of diabetic patients presents a serious healthcare challenge to most industrialised countries and developing societies with a large population: every 10 seconds, one patient dies of diabetes-related consequences. Diabetic care faces a whole spectrum of problems including the necessity for population screening, targeted preventive measures, ethics, economics and broad dissemination of the issue-related information that still wait for a dramatic improvement

Diagnostics

Importance in long-term outcomes of breast cancer

Breast cancer is the most common cause of cancer death in female population with

New philosophy of predective medicine & targered prevention of deseases

Life quality

Current healthcare

appearance of symptoms therapy Development of pathologies, years

Figure A. Strategies in the current healthcare systems—a major limitation of those approaches relate to the fact that the disease process has already taken its toll through manifestation of the complications.

Desirable healthcare

Life quality

in each of them. Currently we already recognise: • The epidemic scale of the disease • The contemporary onset of the dominant diabetes Type 2 in early adulthood or even in childhood and • A permanently growing number of well-acknowledged severe complications for which diabetes predisposes and .which have only now been associated with diabetes.

Diabetes Mellitus (DM) Type 2, historically characterised as an adult-onset disorder, now comprises approximately one-third of new DM-cases already in the second decade of life. Imbalanced nutrition and widespread ‘fast food’ consumption as well as low body activity in childhood currently result in the increasing prevalence of obesity in young people.

Consequently, the mean age at diagnosis of DM Type 2 in young people is 1214 years. Despite the current progress in individualised insulin therapy, the common onset of DM Type 2 in early adulthood breeds dramatic consequences linked with the early onset of diverse severe complications that are secondary to DM such as retinopathy, nephropathy, silent ischemia and dementia. The recent years have brought new knowledge concerning the predisposition to cancer in diabetics. The large population studies performed indicate an increased risk of liver, pancreas, bladder, digestive and urinary tracts, and endometrium cancer types in DM with some age-specific differences and gender-dependent preferences.

Consequently, the costs of diabetes care are growing dramatically. In the USA, the cost burden compared for the years 2002 and 2007 grew from US$ 132 to 174 billion. These statistics do not include intangible costs (e.g. care provided by unpaid caregivers, pain and suffering) or individuals with undiagnosed diabetes or impaired fasting glucose.

predictive diagnosis targered prevention appearance of symptoms

Development of pathologies, years Figure B. Advanced strategies by predictive diagnostics followed by the personalised patient treatment in favour of targeted prevention and optimised therapy planning. (The figure originates from the book .)

an average incidence rate of 10-12 per 100 women. Advanced stages of breast cancer lead to development of metastasis predominantly in lymph nodes, bone, lung, skin, brain and liver. In 2005, breast cancer led to 502,000 deaths (7 per cent of cancer deaths; almost 1 per cent of all deaths) worldwide. During the past three decades, the incidence of breast cancer continually increases worldwide.

Although induced population screening by mammography and application of adjuvant therapies keep breast cancer mortality mostly unchanged or even

persistently declined over last ten years, currently applied diagnostic approaches, however, are frequently unable to recognise early stages in tumour development that impair the outcome. The approach of breast-MRI is currently the most sensitive diagnostic tool for breast imaging.

However, its specificity is limited resulting in a negative impact for surgical management in approximately 9 per cent of cases.

Early diagnosis has been demonstrated to be highly beneficial for significantly enhanced therapy efficiency and possibly full recovery in breast cancer.

Novel strategies

Predictive medicine is a new philosophy in the healthcare and an attractive subject for currently initiated research activities aimed at a potential application of innovative biotechnologies in the prediction of human pathologies, a development of well-timed prevention and individual therapy-planning. Novel strategies using predictive, preventive & personalised medicine are illustrated in Figure B compared to those of the currently existing healthcare systems in Figure A. The major premise of the improved strategies is that initially, chronic pathologies are generally triggered at the molecular level followed by pathology-specific molecular events predisposing the potentially affected organs to certain pathologies long before organ damage and symptomatic manifestation of the disease. Therefore, detection of pathology-specific molecular patterns can create a well-founded basis for the predictive approaches desirable in good healthcare. It advocates the application of innovative biotechnologies to predict human pathologies, devise appropriate and timely preventive strategies and individualised treatment planning.

As a result, predictive medicine offers great promise for the future practice of medicine. Essential components of this approach include well-organised population screening protocols using novel diagnostic biomarkers of disease states,

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63

Diagnostics

The mission of the ‘European association for predictive, preventive & personalised medicine’ The decisive progress in the current healthcare can be achieved only by well-coordinated fulfilment of the following components that are crucial for the practical realisation of this new philosophy in healthcare: • Adequate investment creating novel technologies • Development of non- or minimally-invasive diagnostic tools • Well-organised process for exchange and transfer of knowledge among biomedical research entities and biotechnological industries for production of the advanced diagnostic tools

• Providing and disseminating accurate and up-to-date information and educational materials on predictive & personalised medicine and targeted preventive measures • Encouraging the adequate allocation of resources for predictive, preventive and personalised medicine; • Encouraging and suggesting advanced programmes for personalised patient treatment

• Quality assurance through the introduction of international standards for technological tools and devices, patenting and licenses

• Promoting high-quality research focussed on predictive diagnostics and personalised patient treatment

• Correct professional education in terms of the application of biotechnological high-tech in medicine

• Promoting the standardisation of bio-analytical technologies for predictive pre-clinical and clinical applications

• Intelligent political regulations in the healthcare sector—introduction of the obligatory guidelines and clear regulations for the health insurance industry to ensure patients’ needs are met

• Consolidating professionals for effective European Network in predictive, preventive and personalised medicine

• Measures to ensure confidentiality of patient information and personal databank • Distribution of relevant information among healthcare professionals and users.

These coordinated measures should be focussed on solving the accumulating problems in healthcare and the increasing, concomitant economical burden that societies face across the globe. The mission of the European Coordinator in this field is performed by the ‘European Association for Predictive, Preventive and Personalised Medicine’ (EPMA).

Following objectives are registered in Brussels by the ‘Statutes’ of the Association: • Raising awareness and recognition of Predictive, Preventive and

targeted prevention of common human pathologies, optimal treatment planning and personalised medicine, thereby resulting in substantial improvement of the quality-of-life. This approach also offers the advantage of delivering care at potentially reduced costs to the population at large, and, as a result, addressing social and ethical issues related to access to and affordability of healthcare.

More about the innovative approaches

People from various walks of life and socio-economic status are increasingly demanding to be better informed of anticipated changes in their health status as they progress through life. Although

64

Personalised Medicine (PPPM) throughout all member-countries of the European Union and Associated countries

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

• Coordinating multidisciplinary efforts in predictive, preventive, and personalised medicine • Having an advisory role in issue-related inter / national projects as the official European Representative of predictive, preventive and personalised medicine • Contributing to creation of Guidelines in European healthcare with the accentuated role of prediction, prevention and personalised patient treatment in favour of improved life-quality of the European population.

All EPMA-activities are summarised at www.epmanet.eu. As one can see at this website ‘Patient is in the Focus’ by EPMA, the real application of the innovative technologies for the predictive diagnostics, targeted preventive measures and personalised patient treatment in the European healthcare is the central idea of the Association.

not simple, it is now feasible to predict tissue / organ deregulation associated with predisposition to particular pathologies such as premature ageing, neurodegenerative processes, cardiovascular disorders and various cancers. Thus, high-accuracy protein-expression maps of human body fluids open new perspectives for early and even predictive molecular diagnostics of chronic disorders before the usual symptoms appear, and, therefore, allow welltimed prevention. Further, the minimallyinvasive approach of expression profiling in blood holds the promise of a revolution in population screening, predictive disease diagnostics and prognostic indicators. An individual’s susceptibility and predisposition to premature ageing and

ISSUe - 19 2009

common pathologies such as development of chronic complications in Type 2 diabetes mellitus, breast and prostate cancer can be discerned non-invasively. A broad distribution and a routine clinical utilisation of these advanced technological approaches could enable a significant portion of the population to reach the 100-year age limit yet remaining vibrant in excellent physical and mental health and as actively contributing members of society.

A large group of 60 leading experts from 16 countries has recently prepared the pioneering book on the predictive, preventive & personalised medicine to summarise the most advanced approaches in the branch ‘Predictive Diagnostics

Diagnostics

Bookshelf

Predictive Diagnostics and Personalized Treatment: Dream or Reality?

Author: Olga Golubnitschaja

and Personalized Treatment: Dream or Reality?’ .

In closing, we hope that the information provided here will stimulate further discussions to address many issues in relation to the future practice of predictive and personalised medicine.

multidisciplinary approaches and learn the mindset of border areas and other scientific branches. A partial list of those who will especially benefit from the information provided in this book is as follows: • Professionals in conventional and molecular diagnostics, biomedicine, biotechnologies, ethics, and economics • Universities, research units, private

A u t h o r

This book is for everyone! On reading this book, you can learn a new philosophy in medicine, novel trends in healthcare and biomedical education.

These may help you and your family to define your own way of creating a well chosen life-style. The book provides important information for individuals of various professional and scientific backgrounds. Professionals can consider the general concept of

and public hospitals • Patients and their family members • Scientific journals as well as public journals with medical sections • International associations with healthcare-oriented scientific, research and public health-related activities/responsibilities • Political organisations and authorities active in the healthcare sector • Healthcare industry.

Olga Golubnitschaja was born in 1962 in Ukraine. She is educated in medicine, biotechnology, journalism, music: each Diploma with distinction. Since 2008 she is Secretary-General of “European Association for Predictive, Preventive & Personalised Medicine”.

Scientific focus: non-invasive predictive molecular diagnostics, personalised patient treatment.

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65

Diagnostics

Lab-on-chip Innovative approach towards telemedicine in primary care The project POCEMON uses telemedicine to enable point-ofcare monitoring of diseases such as multiple sclerosis and rheumatoid arthritis.

Kurt Schicho Medical University of Vienna, Austria Heimo Grüssinger PCS Professional Clinical Software GmbH, Austria Leandro Lorenzelli Fondazione Bruno Kessler, Materials and Microsystems Area - BioMEMS Research Unit, Italy

T

elemedicine can be defined as “any transmission of medical information by means of telecommunication technology”. Numerous well-known teleconsultation applications in medicine are based on the transmission of imaging data, for example, from computed tomography (‘store and forward’) or also on live video streams such as from endoscopic interventions.

A solution for point-of-care-monitoring and diagnostics of autoimmune diseases is the usage of a lab-on-chip device that communicates with a laboratory infor-mation server. This concept is subject of a recently started largescale integrating project founded by

Massimiliano Decarli Fondazione Bruno Kessler, Materials and Microsystems Area - BioMEMS Research Unit, Italy Andrea Adami Fondazione Bruno Kessler, Materials and Microsystems Area - BioMEMS Research Unit, Italy Lara Odorizzi Fondazione Bruno Kessler, Materials and Microsystems Area - BioMEMS Research Unit, Italy

the European Commission, known by the acronym ‘POCEMON’ (Point of Care Monitoring).

The main objective of this project is the development of a LOC (labon-chip) platform for the entering of the Human Leukocyte Antigen ( HLA) complex where information on autoimmune diseases like multiple sclerosis and rheumatoid arthritis is coded. However, the range of potential applications of this project’s technology is not at all limited to multiple sclerosis and rheumatoid arthritis. At present, diagnostic tests concerning the majority of autoimmune disorders are mainly carried out in large-scale

The point-of-care monitoring concept based on LOC diagnostics for DNA-SNP detection Point-of-Care

Communication

Medical Centre

PDA

Fabio Macciardi University of Milan, Italy Fanis Kalatzis University of Ioannina, Unit of Medical Technology and Intelligent Information Systems, Department of Computer Science, Greece

Multipurpose Lab-On-Chip Primary Care Practitioner (PCP)

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Data Management Server (DMS)

Intelligent Data Analysis

Diagnostics

Overview of the technical concept

LOC systems based on Polymerase Chain Reaction (PCR) modules and cantilever ar-ray detectors will be integrated with Personal Digital Assistants (PDA) and diagnostic software for the realisation of an automated and portable diagnostic system. The investi-gation of correlations between HLA Single Nucleotide Polymorphisms (SNPs) and autoimmune diseases based on HLA-typing is the prerequisite for the realisation of this idea in a distributed architecture for point-of-care applications.

The concept comprises the combination and integration of high-end information and communication technologies based on microfluidics, microelectronics and microarrays as well as intelligent diagnostic algorithms.

From the technical point-of-view the development of a LOC that is capable of reli-ably detecting a sufficient number of SNPs is the fundamental prerequisite for the whole concept: SNPs can be observed in the human genome frequently (in about one of 1000 nucleotides) and, consequently, biosensors for SNP detection have been gaining in signifi-cance over the last years. As an example, for Multiple Sclerosis (MS) a number of 49 SNPs has been found to show an association with the disease in a study published

by Hafler D et al. 2007.

The Lab-on-chip (Micro-electromechatronic system)

The chip, a Micro-Electromechatronic System (MEMS), incorporates two main functionalities: the first part is a microfluidic module. It is constituted

by the microfluidic channels for sample injection, reaction chamber for PCR amplification and the detector chamber, as well as the integrated microheaters and thermometers for the control of temperature in different parts of the chip. An external LOC reader is required in order to feed the microfluidic module with sample, reagents, power supply and control signals for the manage-ment of the fluidic components

tion of the detector module, which is the core of the system. When high sensitivity is required, a proper technology is required in order to reduce the beam thickness to sub-micron scale. As fabrication and release of such thin structures is critical, we tested the technological feasibility of this approach along with a procedure suitable for the functionalisation of high-density cantilever arrays with DNA probes.

Conclusion

The development of computer-based miniaturised laboratories would permit any level of healthcare—and especially primary—to diagnose genetic abnormalities, diseases or the patient’s general state of health within a matter of minutes.

and microheaters. The second part of the LOC chip is the detector module, based on an array of microcantilevers functionalised with the DNA probes relevant for the detection of MS and RA. A number of cantilevers suitable for the detection of the relevant SNPs can be integrated on a single chip, also allowing replica-tions of each probe on multiple cantilevers, in order to provide the statistical significance of results. This work is mainly focussed on the descrip-

A u t h o r

laboratories and the patient only gets the results a few days later. The development of computer-based miniaturised laboratories would permit any level of healthcare—and especially primary—to diagnose genetic abnormalities, diseases or the patient’s general state of health within a matter of minutes.

The key benefits of LOCs as compared with conventional PCR analysis are their port-ability, automation, the reduction of required sample and reagent volume, leading to a reduction of costs and time.

In combination with the described telemedicine set-up and the laboratory information server infrastructure, this technology provides the perspective to advance primary healthcare across Europe by supporting point-of-care diagnostics and monitoring of immune system status for the management of chronic autoimmune dis-eases such as MS and RA. The combination of Lab-on-Chip technologies with genomic microarrays of HLA-typing and the integration with intelligent software systems may pro-vide a state-of-the-art diagnosis at primary care level for a large number of autoimmune disorders, so the field of possible future applications is not at all limited to MS and RA. The principle that is being investigated and prepared for clinical routine can be adapted to other pathologies and bring progress for their early detection.

References are available at http://www.asianhhm.com/magazine

Kurt Alexander Schicho is Professor of Biomedical Engineering at the Medical University of Vienna. His areas of research include Telemedicine, Computer Assisted Surgery. He is a regular speaker at international conferences. He is the scientific consultant at the European Community Research Projekt “POCEMON” (Point-ofCare-Monitoring”). A Lecturer at several private universi-ties of applied sciences, his hobbies include music, sailing.

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Diagnostics

PET-CT

A step towards personalised radiation medicine The introduction of functional data into the radiotherapy treatment planning is currently the focus of commercial, technical, scientific and clinical development.

The integrated Positron Emission Tomography / Computer Tomography (PET / CT) offers a lot of advantages in terms of tumour delineation and the description of biological processes. To define the real impact of the PET / CT on the radiotherapy planning, experimental and clinical analyses are required.

Anna Simeonova Physician Frederic Wenz Professor and Chairman University Medical Center Mannheim Department of Radiation Oncology University of Heidelberg, Germany

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I

n radiation oncology, progress has been made not only because of a combination with systemically active antineoplastic agents, but also because of technical improvements and the integration of modern imaging. The objective of the radiotherapy is to improve the dose distribution tailored to the borders of the target volume, and to reduce the dose to normal tissues because the efforts to improve the dose escalation are valuable and may improve the treatment outcomes. This means that the precise definition of the tumour volume and the involved lymph node (i.e. in lung cancer) is essential. Conventional imaging modality for treatment planning is Computer Tomography (CT), but it is not always possible to define the exact limits between the tumour and the normal tissue (i.e. oesophageal tumour and oesophageal tissue). Accumulating evidence showed advantages of the Positron Emission Tomography (PET) over CT for detection of the primary tumour, involved lymph nodes and distant metastasis. This is of enormous importance because if no distant metastases are found, local tumour control remains crucial for successful therapy achieved either by radiation therapy or by surgery. Disadvantages of PET include the poor correlation to precise anatomic structures and the physiologic accumulation in normal tissues. The answer to these problems was the PET / CT scanner. There are a number of ways in which PET / CT images can be used for the treatment planning: PET and CT from separate scanners registered in software, PET / CT images registered to a planning

ISSUe - 19 2009

CT scan or an integrated planning PET / CT scan. The use of a PET / CT planning scan has the advantage of reducing uncertainties in the patientâ&#x20AC;&#x2122;s positioning, but the value of this scanner still has to be evaluated. Though, a small number of centres may have this integrated machine, in practice, the separate PET / CT and treatment planning CT will remain more common for the majority of patients for whom this imaging is an option.

PET / CT imaging in the treatment planning

A lot of studies have shown that PET / CT imaging in the treatment planning results in significant changes by the definition of the gross tumour volume (GTV) and the Planning Target Volume (PTV).

For example, Wong et al. showed 97 per cent accuracy in the tumour definition for PET / CT versus 69 per cent for CT and 40 per cent for MRI. Most of the changes occur frequently in patients with head and neck cancer and NonSmall-Lung Cancer (NSCLC). There are studies for the NSCLC, which show that a PET in a combination with chest CT increases the accuracy of mediastinal lymph node staging to around 92-95 per cent compared to 68-85 per cent for CT alone. Another important aspect is that GTV delineation in the NSCLC, and also in other malignancies is subject to major inter-observer variations and this adds considerable uncertainty to the target volume definition. The problem is that there is no Standardised Uptake Value (SUV) for quantitative determination of the tumour for all patients.

Upstaging (occurs in 10-25 per cent

Diagnostics

PET / CT). Another problem of the treatment planning of the NSCLC with the integrated scanner is the tumour motion. By the use of non-integrated PET / CT scanner, the patient’s position and the breathing protocol used for diagnostic scans often differ form those used in CT simulation and radiotherapy treatment. A new study from Grgic Figure 1 et al. shows that, if there is no planning for PET / CT, significantly better fusion of CT and PET images can be reached if the patient is in the same position (the planning position) for both examinations. Additionally, quality can be improved by using a special breathing protocol—images should be taken in a mid-breath hold.

The PET / CT also has advantages in the treatment planning of head and neck cancer. Because of the close proximity to several critical structures in this region, accurate details of tumour and normal tissue is important. As in the case of NSCLC, in the case of head and neck cancer there are a lot of studies, which

Gross tumour volume definition using PET / CT in the lung

of the patients), for example, means a larger GTV with potentially undeliverable radical radiotherapy because of excessive radiation dose to normal lung (pneumonitis, atelectasis). Downstaging (in 15-35 per cent of the patients) means a smaller GTV, excluding suspicious but PET negative lymph nodes, allows a dose escalation with an improvement of the tumour control and survival. Ashamalla et al. demonstrated that in the lung there is a GTV variability decrease from a mean volume difference of 28.3 cm³ in the CT-based planning to 9.12 cm³ in PET / CT-based planning. PTV also decreases from 69.8 cm³ (in CT) to 23.9 cm³ (in

Gross tumour volume definition using CT (A) vs. PET / CT (B) in left nasopahrynx

A

B

investigate the difference between the GTV in the CT and the same volume in the PET / CT. A study from Paulino et al. could show a decrease of the GTV from 37.2 cm³ (in CT) to 20.3 cm³ (in PET / CT). Another important question is, whether there is a correlation between higher SUV on the PET with the clinical outcome. This is still controversial.

Braun et al. reported a study consisting 47 patients with head and neck cancer, who undertook a PET / CT planning scan. Above-median metabolic rate was associated with remission in 62 per cent of the cases versus 96 per cent in the cases with below-median metabolic rate. Two other studies could not show the same outcomes. Schwartz et al. and Vernon et al. showed that maximum SUV on staging PET / CT is not predictive of a treatment failure, comparing maximum SUV or primary tumour, nodes or the higher of the two. If there is a correlation between higher SUV and poor outcome, the dose for these areas can be escalated and to improve the local control. However, study is required to confirm these findings.

For patients with anorectal carcinoma, PET / CT is frequently used to diagnose the stage, evaluate the treatment response and assess for a tumour recurrence. For example, the exact staging is of huge importance to the treatment planning of anal carcinoma. If there are nodal metastases, there will be another treatment technique compared to the situation without nodal metastases.

Cohade et al. determined in a study of 45 patients that PET / CT improved the staging and restaging accuracy from 78 to 89 per cent compared with PET alone. Trautmann et al. detected in the PET nodal metastases in 24 per cent of patients who were considered node negative in CT. Although several studies have demonstrated the utility of PET scans for the detection of colorectal primary tumours, data on its impact on radiation treatment fields for rectal and anal tumours continues to emerge. Ciernik et al. estimated the value of PET / CT

Figure 2

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Diagnostics

CT- GTV and PET- GTV highlighted with red and yellow contours, respectively.

PET / CT in post-treatment or evaluation during the course of radiation

PET / CT could also be used as posttreatment or evaluation during the course of radiation or combined chemo radiation treatments. In post-treatment situation, it can be used to predict durable treatment response, but during the treatment it may be much more limited. Many investigators are hesitant to use this imaging during or immediately after the radiotherapy because of concerns of increased uptake secondary to inflammation in necrotic tumour and nearly normal tissues incorrect by interpreted as metabolically active tumour. A study from Schwartz et al. could show that performing PET / CT during radiation therapy for patients with cervical carcinoma is feasible. They investigated the metabolic response from

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36 patients during and post-treatment and showed a complete response during the treatment of 6 patients and partial metabolic response for 26 patients. And, as we know, tumour volume regression during the course of radiation therapy is predictive for both local recurrence and survival after treatment of carcinoma of the cervix. Additional studies with larger group of patients are necessary to determine whether metabolic response during the radiation therapy is indeed predictive of post-treatment response and survival outcome after the radiation therapy for cervical cancer.

New investigations show advantages in the PET / CT in the differentiation between tumour progression and a posttreatment effect particularly in patient with glioblastoma. This could be useful in predicting the patientâ&#x20AC;&#x2122;s outcome if

A u t h o r s

on radiation planning for patients with rectum and anal carcinoma. In more than half of all patients (56 per cent), the GTV delineation was significantly altered. GTV increases were seen in 50 per cent of the patients with rectal primaries and the PTV increase in 20 per cent. In patients with anal canal primaries, the mean change of GTV was 34 per cent.

CT showed a more caudal extension of GTV; PET showed uptake in a presacral lymph node.

ISSUe - 19 2009

treated with a combined therapy (chemo and radio therapy). This imaging may allow selecting patients who may benefit from additional radiation boost.

In summary, we suggest that the use of a PET / CT scanner in the daily routine treatment planning is beneficial for many anatomic regions. Data gathered from this imaging modality can lead to invaluable knowledge on the true extent of the primary lesion and metastatic spread and can lead to changes in radiation treatment planning that may alter clinical outcomes either by improving local tumour control or reducing toxicity.

To date, PET / CT images have been applied in the routine radiotherapy planning in many radiotherapy departments for non-small-cell lung cancer, oesophagus, anorectal carcinoma and head and neck cancer. This fact shows that the use of PET in treatment planning has recently gained huge acceptance in the radiation oncology community. However, there is still not enough published data about the use of PET / CT for the rest of the malignancies. Therefore, future clinical studies based on the integrated PET / CT or on PET / CT / MRI image fusion, which compare the outcome of biologically directed treatment regimes, need to be conducted for each individual tumour entity before biological treatment volume definition can generally be recommended.

References are available at http://www.asianhhm.com/magazine

Anna Simeonova is a Physician in the Radiation Oncology, Department of University Medical Center Mannheim, University Heidelberg. She is working in the department since September 2007. Her research focuses on radiotherapy treatment of lung carcinoma.

Frederic Wenz is a Professor and Chairman of Radiation Oncology, Department at the University medical center of Mannheim, at the University of Heidelberg.

CaseStudy

PACS

Role of the end-users To fully achieve the benefits of PACS, the end-users (both radiologists and referring physicians) need to make some necessary efforts.

Bram Pynoo Researcher Pieter Devolder Project Engineer Tony Voet Senior Information Technology Project Manager Luk Adang Database Nurse Dries Ovaere Project Engineer Jan Vercruysse Care Manager Clinical Support Sector

W

hen a hospital decides to make the switch to a Picture Archiving and Communication System (PACS), it is not only a huge financial decision; it is also the start of a journey with an unsure outcome. With PACS, a whole new world of possibilities opens upâ&#x20AC;&#x201D;both for radiologists and referring physicians.

Next to the advanced image processing capabilities, we believe that some of the most important features of PACS relate to the increased accessibility and availability of images. With PACS, images are available to all entitled users as soon as the images are in the PACS, from wherever they are: in the hospital, at home or in the surroundings of a WiFi-spot at Waikiki beach. When we compare the digital way of working (PACS) to its analogue counterpart (radiological images printed on film), PACS provides

Philippe Duyck Medical-logistic Head Radiology Department Department of Radiology and Medical Imaging Ghent University Hospital, Belgium

more benefits like a reduced need for storage space, reduction of costs and less waiting time for patients. So, the benefits of PACS are tangible on all levels throughout the hospital. Table 1 displays an overview of the benefits of PACS. To fully achieve these benefits, the end users (both radiologists and referring physicians) need to make some necessary efforts. A major step for the end users is adapting their workflow and moving from an analogue to a digital way of working. With this change in workflow, there is also a shift in the way tasks are done. Tasks that were previously executed by a nurse or a clerk now have to be done by the physician himself, e.g. retrieving radiological images. This shift could lead to physicians feeling threatened regarding their autonomy and power vis-Ă -vis their subordinates. Next to changing the workflow, the end-users

The Unified Theory of Acceptance and Use of Technology Performance Expectancy Behavioral Intention

Effort Expecrancy

Use

Social Influence Facilitating Conditions Gender

Age

Experience

Voluntariness of use Figure 1

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have to become proficient in working with PACS. So training must be provided to the end-users. This is not straightforward considering the busy schedule of most physicians. Moreover, as their education did not focus on working with computers, some physicians will need some extra training. Both the training and the change of workflow have to be done in the period in which both systems coexist, leading to a trade-off: this period should be sufficiently long to give the end-users the time to learn to work with PACS and change their workflow, and as quickly as possible as it is very costly to maintain both systems.

But, after the end-users made the transition to PACS, its return-on-investment is huge. So it is no surprise that from then on (almost) nobody desires to go back to the pre-PACS era. However, as long as the end-users haven’t made the switch, a lot of barriers could hinder or even stop the adoption process. Four types of barriers could arise on any time during the implementation process; here, the focus is on the behavioural barriers—the acceptance of PACS by the end-users.

To assess the acceptance of PACS by the end-users, questionnaires were issued to the end-users at different times during the implementation process: preimplementation (T1), shortly after the introduction of PACS (T2), and one year after the radiology department stopped printing film (T3). The questionnaires were grounded on the Unified Theory of Acceptance and Use of Technology (UTAUT) presented in Figure 1, a derivation of the Technology Acceptance Model (TAM). According to this theory, four factors predict the acceptance of PACS: • PE – Performance Expectancy: usefulness of PACS • EE – Effort Expectancy: ease of use of PACS • SI – Social Influence: pressure from peers and superiors to use PACS • FC – Facilitating Conditions: provision of support of all kinds.

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Benefits of PACS Level

Benefit

Management

Cost reduction

Radiology department

Reduction of report turnaround time Increased productivity Higher job satisfaction Lowered need for physical storage space

Physicians

Increased reliability of image delivery; significant reduction of the number of lost images and a faster availability of the images Decreased time for image searching Availability of images 24/7

Patients

Faster availability of the images Improved patient care Reduction in average hospital-stay Table 1

Overview of the PACS project and timing of the questionnaires Date

Action

02/06/2003

Request for proposal

15/01/2004

Decision: GE Centricity PACS

01/09/2004

Start implementation

01/01/2005

Introduction speech recognition

16/02/2005

Upgrade RIS

03/2005

Questionnaire 1: radiologists

14/03/2005

Go live PACS in radiology (radiologists & nurses/technicians)

08/2005

Questionnaire 1: physicians

25/08/2005

Go live PACS web in the hospital (physicians)

10/2005

Questionnaire 2: physicians

14/02/2006

Radiology department stops printing film

01-02/2007

Questionnaire 3: radiologists & physicians Table 2

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CaseStudy

end-users gained access to PACS. During the transition phase both systems—PACS and analogue film printing—coexisted, while in the post-implementation phase the users had no choice but using PACS as the radiology department stopped printing film.

Evolution of physicians’ (left side) and radiologists’ (right side) scale ratings.

Preparation phase

Figure 2

The acceptance of PACS is measured as BI (Behavioural Intention to use PACS) and / or Use. Next to the UTAUT-constructs, the users’ attitudes toward PACS (ATT) were also questioned. Scale items had to be rated on a 7-point Likert scale from 1 (completely disagree) to 7 (completely agree) with 4 as a neutral point.

Setting

The Ghent University Hospital has a capacity of 1,062 beds and employs about 660 physicians and 1,500 nurses. Table 2 presents a schematic overview of the PACS project.

In the hospital, two main groups of PACS-users exist: radiologists and referring physicians. Radiologists work on a PACS workstation, where PACS is integrated with the Radiology Information System (RIS) and speech recognition.

They use PACS almost continually to view images and compare with old images, to report on radiological images, to tutor radiologists in training. Referring physicians use the PACS web on their personal computer, whenever they need to consult radiological images and reports.

A project team was responsible for the PACS project from start, when the purchase of the PACS was planned, up to now. The PACS project team consisted initially of the head and head nurse of the radiology department, two engineers and two nurses / technicians. A psychologist

and one more engineer were later added to the team.. The tasks of the team are comprehensive, including writing the tender, preparing the end-users, provision of support, scientific research etc. The scientific research concerns the acceptance of PACS by the end-users.

The next section of the article covers three different phases of the PACS project. The preparation phase starts at the time when the implementation of PACS was planned and ends when the T1

T2

T3

Adj. R² (BI)

.37

.18

.30

PE

.43***

.26*

.26**

EE

.14

.12

.02

SI

.08

-.11

.14

FC

.15*

.18

.32***

Adj. R² (USE)

.50

.03

BI

.73***

.10

FC

-.06

.14

Results of regression analysis with the physicians’ data. The values reported are standardised Beta regression coefficients. The values in bold denote how well (on a scale of 0 to 1) the independent variables explain the dependent variable.

Notes: Significance level *p<.05, **p<.01, ***p<.001 Table 3

PACS was a point of attention on the radiology staff meetings for two years, so no further introduction of PACS for the radiologists was needed. A letter was sent to all hospital physicians—including radiologists—to announce the advent of PACS. Letters to referring physicians were accompanied by the first questionnaire (T1). The project team opted for a slow and gradual diffusion of PACS. Therefore, no further introduction on PACS was given at this moment. In this phase, the project team developed training material for the end-users to learn to work with PACS. A distinction was made between the radiologists and the referring physicians. For the referring physicians, a digital learning environment, a blotting pad and a mouse pad were developed.

The radiologists had the choice between following a training course and receiving hands-on training by an application specialist of the project team. Prior to the introduction of PACS, the IT-department upgraded all computers to meet the minimum requirements for PACS. The results of the first questionnaire showed that both the radiologists and physicians were ready for PACS. A graphical overview of their responses is presented in Figure 2. For radiologists PACS was much more concrete, so it is no wonder that they held higher expectations concerning PACS and experienced more pressure to use it. As Table 3 shows, it is critical for physicians that PACS is useful and that there is support in case of problems, to start using PACS. Transition phase

When PACS was introduced, physicians knew that they eventually had to work with PACS but that they could

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Post-implementation phase

The project team is responsible for the daily support and solving user problems.

Recurrent problems were incorporated into the digital learning environment, leading to a gradual decrease of support calls.

The questionnaire at T3 revealed that the implementation has succeeded.

Physicians’ mean scale ratings were higher than at T2, except for EE, while the physicians didn’t feel that they were put under pressure to use PACS. The most important reason for physicians to continue using PACS is the usefulness of PACS and the availability of support. The scale ratings of the radiologists were still higher than at T1, approximating the maximum.

Radiologists’ ratings were also higher than those of the physicians.

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Conclusion

The transition to PACS went smoothly.

This is due to two main causes: the features of PACS, and the work of the project team. The advantages of PACS for the end-users, when fully deployed, are immense. However, the end-users need to do some efforts and it takes time to become a proficient PACS-user. The project team

plays an important role in highlighting the benefits of PACS and providing support and training to the end-users. The training through e-learning proved to be a good way to train a large group of professionals with a busy schedule.

References are available at http://www.asianhhm.com/magazine

Bram Pynoo obtained a master in experimental and theoretical Psychology at the University of Ghent. His research interests concern the psychological processes in changing environments. He is also interested in the design of digital learning environments and computational modelling.

Pieter Devolder being trained as an industrial civil engineer, his interests lie in optimising workflow at all levels. His research interests include acceptance of information systems, Human Interface design, fuzzy analysis, software ergonomics and workflow optimisation.

Tony Voet obtained a master of science in electrotechnical engineering. His coordinating efforts in the automation projects of the department both revolutionised work methods and optimised work flow for all members of the personnel.

A u t h o r s

take time to make the transition. In this phase, the project team invested more time and effort on training the physicians: several members of the project team visited on three separate occasions the staff meeting of every service. These visits had multiple goals: introducing the digital learning environment, solving user problems, showing advanced possibilities of PACS etc.

The radiologists had to make the transition to PACS immediately. This was not a big step as they had already taken several steps towards a digital way of working with the introduction of speech recognition and the upgrade of the RIS. The second survey (T2) was sent to the physicians only. It was taken about two months after the introduction of PACS into the hospital. First, the impact of the digital learning environment was assessed. It was found that users who had used the e-learning were more positive towards PACS than others. In general, mean scale ratings were slightly higher than at T1, as is shown in Figure 2. At this time, the most important reason for accepting PACS and continue using it, is its usefulness.

Luk Adang is the designer of the e-learning environment used to train hospital physicians and other medical staff in using PACS.

Dries Ovaere recently joined the PACS project team of the radiology department. Being trained as a master of science in electronics engineering, his interests lie in the technical background of information systems.

Jan Vercruysse was the head nurse of the radiology department, at the time of the transition to PACS; and thus responsible - together with the department’s Medical Logistic Head - for guiding his department into the digital era. His research interests are mainly change management processes in medical and nursing settings.

Philippe Duyck is a published author in thoracic radiology and in the acceptance of clinical information systems. As medical-logistic head of the Radiology department he was responsible for guiding this department into the digital era. His current research focuses on PACS-acceptance.

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Technology, Equipment & Devices

RFID for Medical Devices An exciting future Imagine an RFID tag travelling through the human body such as in Sci-Fi movie Fantastic Voyage. In biotechnology, bioengineering and healthcare, RFID has a lot of interesting research opportunities.

Rajit Gadh Professor University of California Los Angeles USA

In various industries like Retail, RFID has not taken off the way it was expected to. What are your views on the usage of RFID in healthcare?

Let us first talk about RFID in retail. In retail, RFID can be applied to the pallet or the carton or the items in it. RFID has already taken off in a big way in its application on the pallet—where the pallets are tracked from the manufacturing floor to the distribution centre to the warehouse.

Companies like Wal-Mart and some big European companies such as Tesco are already using RFID. So in retail, I would say the tracking at the pallet level has already been a success. And companies and suppliers are able to automatically track the inventory without any human intervention. Now, if you look at the other levels i.e. case level and the item level the technology is now coming out to enable that. The case level is progressing along nicely and in certain industries such as apparel, individual shirts and jeans are now being tracked at the item level. So, I would say in retail, we have already had some successes. We have got to the pallet level and now there is intense research being done on case and item level in labs like ours.

I would say overall that retail is coming along nicely. Now let us look at healthcare. Here, the problem is a bit more challenging because every hospital has a very unique IT infrastructure. That means all the hospitals do not share the same standardised databases or security systems or networking architecture or computing platform. And that makes RFID in healthcare more challenging and that is why it has taken a little bit longer to get RFID into healthcare. But, it is already starting to happen. Our lab

is involved in development of variety of research projects which are resulting in the development of different systems.

One of the systems we have developed for healthcare is called SpecimentrakTM. SpecimentrakTM system is the system that is being used to track medical specimens.

And of course, what happens is that even though we may have implemented it for one hospital, going from one to the next to the third to the fourth takes some customisation. It cannot just plug ‘n play because of the same reason I have mentioned that the IT infrastructure of different hospitals is different. And that’s what slows down the scaling up for RFID across different hospitals for a given application.

Another application we have been developing is called ‘Pediatrak TM’ that tracks babies in the hospitals so as to prevent theft of babies as well as to monitor various activities about the babies. This is a bit more challenging in the context of the healthcare system in the US because here we are regulated by certain laws such as privacy laws of HIPAA. Some of those US-based requirements make any technology implementation whether it is RFID or another IT-based technology a bit challenging. Of course these technologies are to protect to the privacy of the patient which is very important.

Nevertheless, progress is being made in healthcare. There’s another system we are developing is called ‘RadiologyTrak TM ’ that is meant for tracking X-ray plates.

Here the problem (and the opportunity) opportunity is that sometimes the identity of two different people gets exchanged or their X-ray plates get exchanged. In this context, one can put RFID tags on the wrist band of the patient and RFID

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Technology, Equipment & Devices

tag on the X-rays so that you can keep tracking things at every step so that errors don’t happen. And yet another area we are working on is called Patient ID and Patient Information. For example, in an RFID tag of the patient you can store an ID and the ID can be connected to the entire patient record.

So if you want to pull out a patient record you know all the information is connected to the RFID tag. Or, you can think about eventually putting certain types of information about the patient such as the medication, blood pressure, weight and height and so forth can be put directly on the RFID tag. What that does is that if a patient walks with that information into the hospital then the RFID infrastructure automatically reads the data from the tag and the patient does not have to keep sending out all this information again and again which in the US is a very big problem. So there are a lot of interesting opportunities and I think the healthcare system is looking aggressively at this. There is one more system that we are developing which is PharmaceuticalTrakTM that tracks pharmaceutical medicines in supply chain with the objective of preventing counterfeit.

Is current technology available meeting the requirements?

In certain cases ‘Yes’ and in certain cases ‘No’. For instance, in Specimentrak, the current RFID technology is meeting the requirements very nicely. We have used very low frequency RFID tags with mobile hand-held readers. But for certain other, more complicated applications, current technology I would say still needs more work. If you wish to track the location of the baby but in combination suppose you wish to track with the same RFID tag the oxygen, blood pressure, body temperature and all the variables of the baby at the same time with the single tag, then that technology either may not be available or may be too expensive. So, there are certain things where we need to do lot of preparation.

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All the hospitals do not share the same standardised databases or security systems or networking architecture or computing platform.

And that makes RFID in healthcare more challenging

What challenges does a tracking medical device bring to RFID? Let us look at tracking of medical devices, where the work is going on and what are the types of medical devices that need to be tracked. Tracking medical devices needs to have a reason. There has to be some benefit since there will be some cost.

The cost of tracking should be justified by an appropriate benefit. For example, there are some types of medical devices that government needs to know actually where they are. So, for devices that you are required to track, you either track them with a human being every day or you track them automatically with RFID. In this scenario, the cost justification is easier because to have somebody track the cabinet manually daily is a very expensive proposition. So that is one class of tracking requirements for medical devices.

There is another class of medical devices which are implantable devices inside the human being where you want to query the device, you want to ask the device a simple question like what is the status of the battery—this is because for some of the devices you have to change the battery every so often. So, if you could query the device for status or problems via RFID, or if the device had some problem and it could communicate that wirelessly to a remote monitoring location a wireless sensor networks, then the device becomes an intelligent device and may not need to be removed from the body.

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Another type of RFID requirement in hospitals is used for locating a device.

For example, consider a hospital that has four or five ECG units in a 200-bed.

These devices being expensive, hospitals do not purchase them in large numbers.

And when a nurse or a doctor uses this device in a patient room, sometimes due to the rush to see the next patient, they’ll leave it there and the next nurse comes in when the shift changes and wants to use the device but can’t find it and they send someone to find it. Hospitals typically use a few extra units of these devices for such a situation. If you could track exactly which room the device is in at every instant in time through say AA cell phone, then the hospital may not need as many ECG units and by finding the unit when it’s needed, may actually save more money and lives.

So finding asset locations is another justification for investment in an RFID system.

What are the research opportunities in RFID for medical devices, equipment and medicines?

There are a lot of research opportunities. If you look at all possible devices, medicines and patients and every possible mobile asset in the hospital, you’ll notice that a very small number of them actually have an RFID tag. The opportunity exists in terms of identifying what all can be tagged. And this can

Technology, Equipment & Devices

be linked to the business benefits, but before you do that, you have to make sure that the technology works. If not 100 per cent, then at least up to a reasonable level. The research opportunities are pretty significant. For example, we talked about the implantable devices.

The first generation of RFID tags gave you the ID, the second generation has been giving information about the status via sensors—for example, the RFID tag can give you vital statistics like blood pressure from within the body? So, the opportunity here is in making RFID tags have many different sensing capabilities, the third could be what is called controlling RFID. For example, could an RFID tag send a signal to an insulin injecting pump attached outside to the human body? Finally, if these smart tags could be made really small and injected into the human body, you could use a cell phone to send instructions and receive data remotely. Imagine an RFID tag travelling through the human body such as in Sci-Fi movie Fantastic Voyage.

In biotechnology, bioengineering and

healthcare, RFID has a lot of interesting research opportunities.

There have been reports about RFID interfering with a device’s functioning.

What are the quality and safety precautions to be taken when it comes to RFID in medical devices?

The analogy I would draw here would be about a cell phone interfering with the functioning of another cell phone. The fact is they do not necessarily need to interfere with each other – for example how many times have you made a cell phone call from a room with another person on their cell phone and had interference? Probably none. . This happens because there is something called frequency bands. Each frequency band is very intelligently allocated and managed. And so, you could have a large

number of phone conversations going on at the same time between the cell tower and many cell phones because the communications systems manage the bands very efficiently. It’s the same thing with RFID. If the RFID reader is designed in the correct fashion, it can read hundreds if not thousands of tags at the same time. If there is a device in the room that is getting interference from an RFID reader, it could be that either the device or the reader has not been designed correctly. If the design is correct, it would not interfere.

What are the risks / issues involved in RFID tags for critical care equipment?

I would say the same thing again. Suppose you want to use some critical care equipment and RFID in the same vicinity, you should run tests with the RFID

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Technology, Equipment & Devices

readers to make sure that there is no interference. What we would do in our lab (UCLA RFID Lab) is we would measure the different frequencies and signal strengths and we would see whether there is interference or not. If indeed there is interference, then one needs to figure out who is it that has developed the flawed design. I would like to give an example of analogue cell phone networks and today’s digital networks. If you took old analogue network phone and put in the same room with a digital network cell phone, they may interfere because they are completely different technologies. It is pretty straight forward in today’s day and age the way frequencies are shared in say the cellular networks or the Wi-Fi space to redesign old technology. Generally, it should be noted that if the medical equipment is old then the electronics of the medical device may need a redesign to make sure that it operates on the same principles as the RFID reader and then you’d see that the interference can be avoided.

If you look back a few years, RFID has evolved pretty quickly. Where according to you is RFID headed in the future?

There are several areas where innovations are happening and will continue to happen. Five years ago, the hand-held readers had a read range of only 5-6 feet.

Today, these readers have a read range of 20-25 feet. The read range has gone up five times. In the next five years I expect the size of the tags to go down; the ability to read large number of tags to increase, the speed of reading to increase and the memory in tags to increase. Also, we would be able to put more sensors on a single device to perform specific functions like monitoring a patient’s vital statistics.

The idea is that as RFID technology gets smaller and as you can integrate more and more sensors into a single tag, more stuff would be possible. I also think that technologies like nanotechnology will be contributing heavily into the reduction of the RFID tag size even smaller. The idea is to look at what happened in the semiconductor industry with Moore’s law.

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I look at a similar type of a trend here in the RFID space. I think we will follow a very similar trend. The virtuous cycle of price decline resulting in increase in business applications and tag volumes, resulting in turn in further decrease in prices, will continue for a long time, putting downward pressure on tag prices. I won’t be surprised if RFID tag manufacturing price on the low starts to see the 1 penny level in the next five years.

Because of this convergence RFID could be placed in pretty much any device. I foresee a lot of changes coming to both the embeddable and the nonembeddable side of the medical equipment marketplace. It’s the R&D that is going to drive the costs down, improve

Tracking medical devices needs to have a reason. There has to be some benefit since there will be some cost. The cost of tracking should be justified by an appropriate benefit.

the quality and reduce the size. This is what will allow people to do more with RFID. Hitachi has already developed tags that are thinner than a human hair. It is costly right now since it is relatively low volume, but who knows what we would be able to do in the future?

Is the latest technology in RFID able to overcome the information security challenges?

Information security is an important challenge. In the US, HIPAA regulates who can look at a healthcare record. It is very restrictive as to who can and who cannot look at a record. When you start putting patient information into a tag, then there is going to be concern in any

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hospital as to who can read the tag. A lot of hospitals have overcome this problem by assigning a random I.D. number to the tag and reader looks it up in the enterprise database behind a firewall and until the system (governed by HIPAA) does not know who it is that’s querying it will not divulge the information. Hence the data related to specific patients is protected.

Any other comments?

RFID has progressed a lot in many different disciplines. For example, in the aerospace industry RFID is being used to track aircraft parts. It is being used by the automotive industry to track cars in storage facilities after they are assembled and ready to be shipped . It is being used by the shipping industry to track containers as they move across the planet.

So, RFID is already being used in a lot of different industries and the healthcare industry will have to learn from the other industries. The important thing is that to have a successful system, you have to put technologies together and make them work. A lot of technologies are already in place and the healthcare profession can benefit in a big way. The opportunities in healthcare are really large.

I was in Washington a couple of weeks ago, and the city is abuzz with talk about President Obama’s stimulus package, which includes US$ 20 billion for healthcare IT. I look at this as an opportunity to modernise the paper-based infrastructure in the United States and move it towards the path of modernisation that has encompassed every other industry in the world. A paperless healthcare system will make it much easier for us to provide RFID technology and integrate it into the infrastructure of the healthcare system. The benefits will be ten-fold and cost of tags could see a non-linear decline in price beyond even what we have been predicting. So, I am very excited about the future of RFID in healthcare and am seeing a significantly rapid increase in interest in our RFID Program from healthcare organisations.

Technology, Equipment & Devices

Artificial Intelligence Applications in healthcare For improving the efficiency of treatments and avoiding costs by minimising the risks of false diagnosis, it is important to integrate Artificial Intelligence tools in everyday medical applications.

This facilitates more targeted pre-operative planning and reduces the risk of intra-operative complications.

Prasanna Vadhana Kannan Research Analyst Frost & Sullivan, Singapore

I

nitially, Artificial Intelligence (AI) buzzword was introduced as a concept to mimic human brain and investigate the real-world concerns with a holistic human approach. Scientists and researchers all over the world are very excited about advancements in innovation that have arisen from an innate desire to create newer and better technologies that facilitate mankind to extend beyond their own physical calibre. The promise of AI concept has always been on the horizon from realistic science to the imagination in movies and literature.

AI largely enables the capacity to store and process huge amounts of data in an intelligent manner, and more specifically translate that information into functional tools. Since its inception, AI has been deployed for highly selective defence or space exploration applications wherein its success in solving problems for specific areas just like risk prediction is involved.

Now, gradual transition of its utility in healthcare is being widely experienced through AI-based systems that allow for better diagnosis, cure and treatment of debilitating conditions.

Scope of AI in medicine

AI is a study realised to emulate human intelligence into computer technology that could assist both doctors and patients in the following manner: • By providing a laboratory for the examination, representation, and cataloguing of medical information • By devising novel tools to support decision-making and research • By integrating activities in medical, software and cognitive sciences and finally • By offering a content-rich discipline

for future scientific medical community.

Thus, increased integration of intelligent AI tools in everyday medical applications could improve the efficiency of treatments and avoid costs by minimising the risks of false diagnosis, facilitate more targeted pre-operative planning, and reduce the risk of intra-operative complications.

The recent usage of AI in performing sophisticated tasks and computations has gradually led it to be introduced as a key component of MRI and computed tomography systems. The added advantage of these systems is in the ability to effectively acquire information, and sync with established decision support databases. Further, AI has begun transforming the field of surgical robotics wherein it has enabled the advent of robots that perform semi-automated surgical tasks with increasing efficiency. One of the ultimate challenges faced in robotics could be mimicking of human intelligence and body motion. In spite of such a critical challenge, robotics has attained considerable progress and is now applied across a wide array of applications ranging from the defence industry to the diagnostics.

Basically, robots are not built smartly, but are integrated with certain software components to make them intelligent.

Recent advances in the field of AI such as neural networking, natural language processing, image recognition, and speech recognition / synthesis research, have spurred our creativity and the future of robotics looks very bright indeed.

It is worth mentioning here that the biggest hurdle towards adoption of medical robotic surgical systems is the high initial capital equipment costs involved.

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automated ECG, medical imaging, clinical laboratory analysis, respiratory monitoring, electroencephalography, and anaesthesia.

Insights on current systems using AI

Agilent Technologies (Andover, Massachusetts) has developed a smart ECG device that estimates the probability of acute cardiac ischemia/ACI. This ACI time-insensitive predictive instrument holds good promise in increasing the accuracy of diagnosing ACI Intelligent Medical Imaging, Inc. (Florida) has designed the Micro21 microscopy workstation that successfully integrates neural network technology into blood analysis to identify and display white blood cells as well as red blood cells ATL Ultrasound, Inc. (Seattle-based firm) has developed a range of diagnostic ultrasound systems for imaging and monitoring cardiac tissue structures and activity. This system utilises an adaptive intelligence algorithm to scrutinise tissues by optimising millions of parameters during a patient examination, thereby eliminating irrelevant frequencies in returned signals Neuromedical Systems, Inc. (New Jersey) uses an application of neural networks to scan Pap smears& identify cells for review during cancer screening.

Development plans and key understanding

With the effective implementation of neural network technology in analysis of blood, medical image interpretation, and other complex tasks, a need to evaluate these technologies in order to deter-

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Many of these systems often require new infrastructure to be constructed and the staffing of high bill rate specialists who are well-trained in these techniques emerges to be a key hindrance in its widespread adoption. A basic AI computer used today in clinical practice could be visualised to be applied for automation of routine tasks and for other functions listed below: • Alerts and reminders In most general forms of AI integration, the machine scans a patient’s lab results, drug orders, and updates the patient with an appropriate reminder. In this manner for generating alerts and reminders, more advanced AI programs can be directly interfaced with a patient monitor and used for detecting changes in a patient’s condition • Diagnostic Help • Therapy fore-planning Specific conditions that require elaborate treatment plans could benefit from AI tools during therapy planning. By incorporating an AI system that can automatically formulate plans based on specific conditions would add certain value to the physicians as well as patients • Information Retrieval Similarly, software search agents can be created for complex medical applications that are much more efficient than current generation web-crawling agent’s performance.

This aids in information retrieval and upgradation of data automatically • Image Interpretation Multiple medical images can be instantaneously identified, from plane X-rays through to highly complex images like angiograms, CT, and MRI scans. Such systems for image recognition and interpretation have increasingly been adopted for clinical use Another key application of AI systems is in the process of scientific research through applying expert systems and decision support systems. Such systems are programmed to learn, i.e. to aggregate & retain vast amounts of patterned data for specific purposes. Today, DSS technology has been successfully employed in the medical device industry that encompasses cardiac monitoring and

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mine their real potential to develop into future standards has emerged. The medical expertise that these AI systems use must be subjected to thorough research and all issues must be clearly identified and well documented at the beginning itself. This generates the demand for detailed interviews with experts in this field apart from considering secondary sources of information. Collating in this manner the information gathered from domain experts will certainly help to better understand the digital machine and key logical patterns that emerge from its data interpretation. The operational understanding of the field under study, as required by the AI computer will arrive from iterative know-how & transfer from human to machine protocols.

Some of the key influencing factors like maturity attained by the AI systems, user acceptance, and glitches in communications along with technical infrastructure stand as huge barriers to the commercialisation opportunities that currently exist for AI. However, given the thought that ongoing innovations in this domain are poised to move from academia and theory into reality, all of which prove or exist as a definite sign of growing momentum in this field. Most advanced decision support systems are guiding medical faculty to interpret complex results and devise future plans accordingly. The promising growth rates demonstrated by companies in this field are sure to drag attention to their developed technologies and increase investments in these companies, which will in turn drive the future of healthcare.

Rising adoption of AI in medical devices indicates that its way forward is certain and AI could definitely be a major feature of the future landscape of healthcare.

Prasanna Vadhana Kannan is a Research Analyst with the Frost & Sullivan. She focuses on tracking and analysing global emerging trends and technologies pertaining to the healthcare industry

Facilities & Operations Management

Reducing ICU Mortality Strategies for the 21st century Over the years, Intensive Care Units have become the hot corner of hospitals.

In the near future, new automated systems will ease ICU patient monitoring and secure delivery of sophisticated treatments.

Djillali Annane Director, General ICU, Raymond PoincarĂŠ Hospital, University of Versailles, France

C

laude Bernard has introduced the concept of intensive care when arguing in favour of restoring homeostasis as a key point of diseases management. Intensive care became more concrete to people in the middle of the 20th century when the introduction of lung iron to support respiratory function prevented death in most of victims of the poliomyelitis pandemic. Politics rapidly got the importance of creating specific places to deliver life-supporting treatments for acutely ill patients. Thereafter, Intensive Care Units (ICUs) were built all around the world including industrialised and emerging countries and became the hot corner of hospitals. Amazingly, there is no consensus on what should be an optimal ICU. They are markedly different across countries in design and resources and in management and care delivery.

Thus, unsurprisingly, death rates in the ICUs vary on an average from 8 to 20 per cent around the world. Analysing the causes of death in ICUs is risky. Basically, people may die as a direct consequence of the critical illness, as a consequence of underlying co-morbidities, secondary to iatrogenic events, or as a consequence of withholding, withdrawing life-supportive treatments. Intuitively, there is little to do on co-morbid conditions or decision to terminate care. Thus, reducing ICU mortality should focus on advances in the management of critical

illness and the prevention of iatrogenic complications.

Sepsis accounts for a greater number of diseases related deaths in the ICU. Severe sepsis and septic shock are even today associated with 20-25 per cent and 40-45 per cent of mortality rates, respectively. Halting sepsis related deaths should be a priority for physicians, researchers, health policy makers and pharmaceutical industries. This is a reasonable goal to achieve. Undoubtedly, some progress has already been done and implementing the Surviving Sepsis Campaign bundles results in substantial survival benefit.

Most of the recommendations are simple measures (the first 6-hour bundles), e.g. early antibiotic treatment and source control and restoring cardiovascular homeostasis, that can be applied right away almost everywhere and may have a substantial impact on survival. Similarly, when sepsis is associated with acute lung injury or acute respiratory distress syndrome, keeping plateau pressures in the airway low, e.g.

25 cmH20 or less may prevent death in many patients. More complex strategies need to be used as second line measures in patients who failed to respond to the first 6-hour bundles. They may include maintaining blood glucose levels below 150 mg / dl, infusing activated protein C for four days, and low dose of corticosteroids, i.e. 200 mg of hydrocortisone or

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ProductShowcase

Intensive care became more concrete to people in the middle of the 20th century when the introduction of lung iron to support respiratory function prevented death in most of victims of the poliomyelitis pandemic.

should be included in the development of novel drugs particularities related to critical illness. The incidence of ICU acquired superinfections is still unacceptably high, albeit the efficacy of several preventive measures is already recognised. The attributable mortality of blood stream infection or ventilator associated pneumonia may reach 20 per cent.

A u t h o r

equivalent, for a week. These second line strategies are aimed at restoring metabolic, haemostatic and immune homeostasis. So, applying the original concept developed

by Claude Bernard of maintaining homeostasis seems a very successful approach to deadly critical illness like sepsis.

In the very near future, one expects that most, if not all, patients with severe sepsis or septic shock will be treated according to the Surviving Sepsis Campaign. In addition, prioritising a better understanding of the mechanisms behind the chaotic nature of critical illness and designing diagnostic tools to recognise subtle loss in biological systems, homeostasis are key determinants for the development of successful treatments for sepsis and non-septic systemic inflammatory response syndromes.

Right now, the prevention of iatrogenic complications in the ICU is a top priority to reduce deaths. The critically ill patient is exposed to a number of drugs.

Yet, for most of the medications, the pharmacokinetics during critical illness remain unclear, and little is known about interactions between drugs. For example, activated protein C and corticosteroids may be widely used in combination to treat septic shock, though safety data are lacking. The pharmaceutical companies

Djillali Annane is a Professor in Medicine at university of Versailles and the Director of the general ICU at Raymond Poincaré Hospital (Assistance Publique Hopitaux de Paris). His main research area is pathomechanisms and treatment of sepsis. He has written more than hundred and fifty papers in medical journals and textbook, including NEJM, JAMA, Lancet.

Classic Scientific laboratory and scientific equipment Environmental Test Chamber Classic environmental test chamber has cutting edge technology to challenge and maintain climatic conditions above freezing point.

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There is an urgent need for tools allowing a more efficient translation of evidence based information to the bedside.

It is also paramount to develop new strategies for the prevention of multi-resistant microorganisms. Life-support therapies that are so paramount to surviving critical illness, e.g. mechanical ventilation, renal replacement therapy or vasopressor therapy, are also associated with lifethreatening complications. These treatments need to be adjusted a la carte in individual patients on a continuous basis, which is almost unfeasible by humans.

Thus, researchers are developing closeloop systems providing computer guided adjustments of life-supportive therapies.

In the near future, new automated systems will ease ICU patient monitoring and secure delivery of sophisticated treatments. So, it is expected that the cost related to ICU will continue to increase and this may be accepted by people only if ICU risk of death is minimised.

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

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Laboratory Ovens Classic laboratory ovens find wide application accross industries.

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Facilities & Operations Management

Surgical Workflow Methods and applications Given a great demand for a rigorous analysis of surgical interventions, Surgical Workflow Analysis proves to be a powerful methodology to understand and describe surgical procedures.

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Facilities & Operations Management

T

he performance of today’s business processes is strongly supported by information systems. Constant adaptation of the business processes to market requirements is achieved by business process analysis and optimisation.

Until now, it was not possible to analyse surgical and intraoperative interventions for optimisation potentials and to support their execution by information systems. Reasons for this were the high variability of surgical processes caused by patient-specific properties, lack of methods for structured description of surgical processes as well as missing data acquisition methods.

The investigation of surgical workflows is an innovative approach for describing surgical interventions. Based on a rigorous Surgical Process Analysis, the acquired data can be used to optimise surgical procedures, to guide the development of new surgical assist systems or to compare different surgical approaches.

The term ‘Surgical workflow’ relates to the description of surgical intervention courses. Surgical workflow is an abstraction of the surgical procedure.

Its descriptions are useful for several user groups including surgeons, health administrators, or medical engineers. To use surgical workflows, e.g. for analysis, it is necessary to describe them in a formal language.

Characteristic for Surgical Workflows is the high amount of potentially useful information. However, the choice of the suitable sampling of information restricts, which surgical questions might be answered by the help of surgical workflows. A simple surgical question such as “Who is doing what and when?” results in highly complex descriptions and large amount of information to be processed.

One objective of the work of the Innovation Center Computer Assisted Surgery (ICCAS) at the Universität Leipzig, Germany, is to use Surgical Workflow Analysis to find answers to typical questions arising during optimisation of surgical interventions: “Does using an intraoperative navigation system is more time-saving then the conventional approach without the system?”, “Surgeon A has less complications than surgeon B for similar cases. What’s the difference between both approaches?” or “Will the investment in the development of a new surgical tool pay off for my company?

Will it bring significant benefit?”

When applying surgical workflow methods, three subsequent steps are to be performed: 1. Surgical Process Analysis: Surgical Process Analysis records the existing processes and stores the intervention courses in a formal Surgical Process Model (SPM). This model can be visualised end explored by the end user and it can be used for statistical analysis.

2. Surgical Workflow Modelling: Based on the recorded SPMs, a Surgical Workflow is defined. It shall be capable of considering all variants of the surgical intervention which appear during normal and extraordinary intraoperative situations.

3. Workflow Management System (WFMS): A WFMS can be used to guide the real world processes based on the Surgical Workflow Model. This step is rather visionary since there is no methodology available to automatically determine the current state of an intervention.

Structured recording of surgical process models

The most important step in each and every study is to acquire a solid data base. There are established methods in nearly every scientific field for measuring each and every aspect, but in surgery one has to rely on the verbal description of intervention courses given by experienced surgeons. Even though structure interviews are a valuable tool during a Surgical Workflow Analysis, we strongly recommend to record real surgical interventions. The data recorded is more accurate and steps which might be forgotten by the expert since they are ‘unimportant’ or ‘well known by everyone’ will be captured.

Oliver Burgert Head, The Research Group, Scientific Methods Thomas Neumuth Head, The Research Group, Workflow and Knowledge Management Innovation Center Computer Assisted Surgery (ICCAS), Universität Leipzig, Germany

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Facilities & Operations Management

Examples of granularity levels for surgical work steps Activity (i)

Surgeon

Cutting (contains cutting and suctioning)

(ii)

(iii)

Cutting suctioning

non-suctioning

Cutting

Surgeon (right hand)

Suctioning

Surgeon (left hand)

non-cutting suctioning

Cutting non-suctioning

suctioning

Surgeon (right hand) Surgeon (left hand)

Time

Since the amount of information which could be recorded during a surgical intervention is enormous, we developed dedicated software for structured recording of surgical interventions: The surgical workflow editor. The manifold of possible questions for surgical workflow analyses needs data acquisition methods with high flexibility, therefore, the software can be customised by anontology to support every possible surgical intervention.

The surgical workflow editor is a software application running on a tablet PC which is operated by trained medical staff for data acquisition. Using human observers adds additional flexibility to the recording process since the observer can move around or ask questions. Observerbased recording reaches its limitations if a high amount of detailed information needs to be recorded or surgical work steps are performed with high frequency.

For structuring surgical interventions, basic considerations need to be made regarding the desired granularity of the observations. In the next section, an approach for segmenting surgical interventions in surgical worksteps with different granularity levels is presented and an information model for acquiring surgical work step information is shown.

How can a surgical work step be modelled? If, for instance hemorrhages are caused by the surgeons while cutting tissue, the blood needs to be suctioned in parallel to the cutting of the tissue.

This simple step might be considered and

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ICCAS surgical workflow-editor

Exucuted by

A s ian H o s p i t a l & H ea lt h ca re M a n a ge ment

Figure 2

described under various viewpoints and granularity levels (cp. Figure 2): (i) A work step “Cutting” is defined, that consists of the sub work steps cutting and suctioning, performed as smallest atomic unit by the surgeon. (ii) A second choice would be the definition of cutting and suctioning as two independent working units, performed by the “Left hand of the surgeon” and the “right hand of the surgeon” as atomic organisational units. (iii) A third option would be the consideration of the work steps of one hand with the temporal segmentation “suctioning-non-suctioning-suctioning”.

This granularity level shows a further segmentation of (ii) and considers short breaks by pausing suctioning by the surgeon.

The choice of the granularity level reveals a further challenge: the relation of temporal and causal coherency. If the choice (i) is made, the work step ‘cutting’ contains implicitly the work step ‘suctioning’ for supporting the cutting work step. A granularity level according to (ii) requires in contrast an explicit representation of the suctioning, which is performed in parallel to the cutting. If the surgeon suctions at another location at the same time, when he cuts, both work steps have a temporal, but no causal relation, because then the suctioning was not necessary caused by the cutting. Considering granularity level (iii), between the work steps

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Figure 3

‘suctioning’ and ‘non-suctioning’ exists a causal, but no temporal and parallel relation, because both work steps cannot be performed by the surgeons hands at the same time.

If the objective of the observation is a more detailed recording, a consideration of the performed work steps at least at granularity level (ii) is necessary.

Recording surgical procedures on such level of detail is a demanding task. For example, if work steps of the assistant or the scrub nurse should be acquired in addition to the work steps performed by the surgeon, the number and frequency of activities can not be handled without software support. For this objective, the Surgical Workflow Editor was developed.

With the help of the software, detailed information of procedure courses can be acquired and analysed for clinical questions. Figure 3 shows a screenshot of the Surgical Workflow Editor. The frame in the foreground is used to enter a new surgical activity or an event. The intervention course containing all work steps is visualised in the background.

After recording, the SPM can be analysed. Statistical methods can be applied to count occurrence of certain activities or instrument usage, or to analyse the duration of certain phases of the intervention. For exploration of several recorded processes or interdisciplinary discussion about an intervention, a graphical representation of the SPM is helpful. Figure 4 shows a visualisation of an interven-

Facilities & Operations Management

Visualisation of a microlaryngoscopy intervention from otorhinolaryngology Surgeon

Nurse

Position teeth protection upper jaw Position laryngoscope larunx suction aspirator glottis Position laryngoscope larunx Fasten laryngoscope Position microscope

take photo AIDA edema on plicae vocales

cut sickle knife edema on plicae vocales Hold forceps edema on plicae vocales

1x suction aspirator plicae vocales Take photo AIDA plicae vocales

remove microscope fasten fiber cable remove laryngoscope remove teeth protection

A u t h o r s

tion protocol for a surgical intervention of the type Microlaryngoscopy from Otorhinolaryngology. This visualisation is automatically generated from a SPM and can even be displayed in parallel to the intervention course e.g. for live transmissions of surgical interventions during conferences. The visualisation of a surgical workflow, which contains all possible variations of a certain intervention type, is more challenging. We developed different methods for visual exploration of process graphs to provide

Figure 4

good support for non-technical people working with the surgical workflow.

To evaluate the surgical workflow editor, it was applied to several intervention types from multiple disciplines.

These included intervention types form otorhinolaryngology, neurosurgery, cardiovascular surgery, interventional radiology, and eye surgery. Intervention courses have been recorded at international sites in Germany, France and the US. The methodology has been used in many ways, for example to optimise patient pathways, to compare different surgical approaches, to compare different surgical devices, for the development of use cases for an international standardisation body, or for generating educational material.

Surgical workflow analysis is a powerful tool to understand and describe surgical procedures at a formerly unknown level of detail. The methods for recording surgical processes are effective and applicable to surgical routine without major restrictions. Statistical and visual exploration of recorded SPMs are a powerful method to select from the large amount of available information, the most relevant ones for answering a specific surgical question. In the future, workflow management systems will be used to support the surgeon during the intervention, for example by providing the information needed during a specific step. Basic research providing the necessary situation awareness and automated process recording is currently being performed in several research institutions all over the world.

Oliver Burgert is Head of the Research Group ‘Scientific Methods’ at the Innovation Center Computer Assisted Surgery (ICCAS), Universität Leipzig, Germany. He studied Informatics at the Research University Karlsruhe, Germany and did his PhD on Surgical Planning Systems. His research at ICCAS includes modular surgical assist systems, Surgical Workflows, Ontologies and Surgical DICOM. Thomas Neumuth is Head of the Research Group ‘Workflow and Knowledge Management’ at ICCAS. He studied Electrical Engineering Management at the University of Applied Sciences in Leipzig. Subsequently, he graduated with a Master of Engineering in Automation at the UAS Leipzig. His research focus is on procedural ontologies, data acquisition, data analyses and workflow schemes.

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Information Technology

Home Telehealth Understanding the outcomes

The use of telemedicine to embrace the home as a health venue recognises the possibility to maintain patient independence for rehabilitation and disease management.

Ronald Merrell Professor, Surgery Virginia Commonwealth University, USA

H

ome telehealth is the use of telecommunications tools to amplify, initiate or replace home health visits in person. Care of patients in the home has a greater application now than at any time since healthcare arrived on horseback. The merits of home healthcare have been extensively studied and validated in terms of cost-efficiency and improved clinical outcomes. The incentive for care at home has several dimensions. Home healthcare can: permit earlier discharge from the very expensive inpatient environment; reduce the need for rehabilitation stays in nursing facilities; and extend the period of independent living outside nursing homes by providing services and by supporting family members engaged in providing care. In disease management, home care can reduce the need for emergency department visits and inpatient stays by early recognition of disease trends,

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improved compliance with a treatment regimen and better education of patients and families. Standard home health visits can be organised into a system with facilitated access to caregivers through call centres or direct calls to the health agency which has the records of the patient and an awareness of the medical situation.

Home health has been greatly successful mainly due to reduced costs, patient satisfaction and improved clinical outcomes. Can this success be secure if telecommunications and other technology replace the physical visit by a home health worker? How is success measured?

What are the guidelines to assure success in the design and implementation of a home telehealth programmes?

The success of home telehealth is of fairly recent vintage and there are many reports of less than successful outcomes.

As recently as early 2006, the Agency for Healthcare Research and Quality (AHRQ) reported that despite many studies on the values of home telehealth, there was great need for properly designed studies to test the hypothesis that home telehealth was valid in general and with specific diagnoses. In 2004, Winters and Winters reported that home telehealth could be a promising model for rehabilitation. Jannett in her review of telehealth outcomes and home telehealth in 2004, reported clear improvement in terms of both outcomes and patient education. The overall results for outcomes were mixed but there was a consistent case to be made for costeffectiveness. In order to evaluate a study to guide decisions relative to an investment in home telehealth, it is prudent to understand this history, proper study criteria and the abundance of articles by true believers as opposed to critics. In fact good decisions by healthcare managers and health systems must come only from the best data.

For Congestive Heart Failure (CHF), Whitten published an early study in 2007 and a more comprehensive assessment in 2009. In order to know the merits of an intervention, there surely must be a study that measures health, economic and

social outcomes and carefully explains the technology used in the intervention. In Whittenâ&#x20AC;&#x2122;s later work, 50 patients were engaged in a programme of telehealth with a strong message of education. All the patients suffered from CHF and were evaluated before the intervention and two months after using well validated survey instruments. The patients had an average of 39 telehealth visits and 14 home visits in the study period.

Complaints of shortness of breath fell from 24 to 12 per cent while medication compliance rose to 84 per cent from 49 percent. Improvement in activity, edema, fatigue and hospitalisation were at the p<0.05 significance. The patients found

the set-up easy to use and equivalent to face-to-face visits. These outcomes are entirely appropriate measures for CHF management. For diabetes mellitus, the parameter of choice would be Hemoglobin (Hgb) A1c for glycemic control and for hypertension measure of diastolic blood pressure. For asthma, the parameter or interest is avoidance of emergency visits and for chronic obstructive lung disease (COPD), spirometry and hospitalisation would be the data of note. For a home telehealth programme to be worthwhile, the health outcomes should at least be equivalent to home health visits. If the outcomes are not better and not equivalent, there should be some considerable advantage in reducing the overall cost for service. For health systems, avoidance of more advanced service levels is the cost benefit.

Finkelstein in 2006 concluded home telehealth improved clinical outcomes at a lower cost in a study in Minnesota.

He compared controls that had a home nurse visit with home nurse plus video sessions and nurse, video and home health monitoring in 53 patients with CHF or COPD. Transfer to a higher level of care, either hospital or skilled nursing facility, was record in 42, 21 and 15 per cent respectively. The advantage of telehealth intervention is striking and the value added by home monitoring is very impressive. Here, the costs are reduced primarily due to the avoidance of a higher level of care.

The best database for the measured effect of home telehealth is through the Veteransâ&#x20AC;&#x2122; Administration (VA) in the US. It is generally considered that the huge VA databases almost never support the excited results of early reports on clinical interventions. The story for telemedicine is quite different. In 2004 a VA study from Connecticut reported 104 patients with CHF, pulmonary disease or diabetes mellitus in a randomised controlled trial of home telehealth. The reduction in bed use was significant at p<0.0001 and use of the emergency department p=0.023. Hgb A1c decrease was significant

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at p<0.0001 and patient satisfaction at p<0.001. Therefore, the intervention was a success with clinical outcomes, patient perception and cost. Continuing the VA experience, which has been very carefully collated and studied, Barnett in 2007 reported that for diabetes mellitus Care Coordination/Home Telehealth, the growing VA system was cost-effective in one-third of 370 respondents. In this instance, the technology of the VA system was evolving. DelliFraine in 2008 did a metanalysis of 29 articles out of 154 potentially acceptable reports and found better outcomes for CHF or psychiatric diagnoses but discerned that there was a tremendous impact of the technology on outcome. Telehealth is not the same all over. The instrumentation is crucial to success. The educational materials are, of course, important. The quality of the medical care product is highly relevant.

Telehealth in its interpretation and implementation calls for a careful assessment of the equipment, hardware, middleware and software plus a clear set of instructions for patient and training of the personnel.

These elements are perhaps best applied in the VA again as described by Darkins in 2009. Between 2003 and 2007 the VA Coordinated Care / Home Telehealth (CCHT) programme has treated 31,750 patients. In a recent cohort of 17,025 there was a 25 per cent reduction in bed days and a 19 per cent drop in admissions with an 86 per cent satisfactory rating by the patients. The telehealth cost was

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Standard home health visits can be organised into a system with facilitated access to caregivers through call centres or direct calls to the health agency which has the records of the patient and an awareness of the medical situation.

US$ 1600 per patient per annum. The plan is for CCHT to provide 50 per cent of all non-institutional care for the VA by 2011.

The older papers do not provide enough evidence on the efficacy of home telehealth. However, the newer ones that report large numbers of patients are clearly better. At this juncture, there are no analyses or reviews of strong evidence in the Cochrane Library. However, there surely will be soon for home telehealth and when available decision makers can consider their choices with Level I evidence. In the meantime, careful reading of what is published will allow sound decisions in evidence based medicine as to technology, programme design and the setting of both clinical and financial expectations.

ISSUe - 19 2009

An interesting paper by Gagnon followed the course of a programme in Canada and concluded that decision makers needed to be involved in the scientific outcomes of a programme as it evolved to make the best decisions for ultimate success. Home telehealth like any other endeavour can fail to meet the expectations of patients, medical personnel, clinical outcome predictions, cost containment or profit. Success requires a clear understanding of the product, service and market. Patients will readily accept a well-designed service as equivalent to a face-to-face intervention if they feel empowered, have improved access and confidence. The technology of the imaging devices, sensors, video and transmission must of course be thoughtful for patient and family concerns and abilities.

Health workers will accept a telehealth programme if it makes their work easier, better and more rewarding. They are likely to make a system work that is technically reliable and intuitive. Long technical delays or lost connections will doom a programme while professional connectivity will make success much more likely.

For the health worker, if telehealth is just extra work acceptance will be less. The expectations of home health physiological sensors or monitoring for improved clinical outcomes will not be met if the education, implementation and operation of the programme fail. Next, we must also consider money.

It is logical that improved diabetic management, wound management, airway management, heart failure regimens etc. lead to lower costs. However, administrators may only see the cost of the telehealth equipment and technical personnel. In order to avoid the temptation to economise on equipment and technical support, it is quite important to write into a plan a way to track savings to offset the cost. The overall business plan should include Return on Investment (ROI), amortisation, depreciation of equipment and staff training. It is, of course, unrealistic to assume that telehealth system will work, as it seemed

Information Technology

service. Home telehealth need not add any expense to aggregate patient care if the system is well-researched, designed, implemented and monitored for an appropriate patient population. Success of home telehealth can be defined and assured by the stakeholders (parties, patients, caregivers, public and fiduciaries) by careful reading, planning and administration. The extension of telemedicine to the home is least expensive when it is appended to an existing telemedicine programme and an existing information system to share some resources Therefore, health systems with those programmes in A u t h o r

in the advertisement, without providing proper task-specific modification, training and technical support. Furthermore, there must be careful consideration as to the scale of the service in the business and operational planning. Installing a very expensive telehealth system for a handful of patients will never look good in a cost analysis. This is where the ROI estimate becomes crucial. The successful plan must recruit enough patients to be cost-effective. Pilot efforts may be expensive in terms of initial costs but their value comes later as the full plan incorporates lessons learnt from the pilot study in terms of the application intended.

In the current economic climate in general and for medicine in particular, there is no likelihood that an enhancement in care that is prohibitively expensive can come to reality. Any innovation really should reduce costs through better health outcomes or some economy of

place are most likely to succeed. Home telehealth appended to an existing home health programme is also favoured for success as in the case of the VA system.

Home telehealth is like all permutations of telemedicine programmes in that they are most expensive as a stand-alone. As part of a mature electronic medical record effort in a health system with a salutary experience in home health, a home telehealth programme should flourish and show early sustained profit. It is the right thing to do for patients and, in this case the right thing to do for patients is the best thing to do for health system finances.

Ronald Merrell is Professor of Surgery at Virginia Commonwealth University in Richmond, Virginia. He has been a long time researcher in telemedicine supported by NASA with an emphasis on technology, the surgical suite and remote environments. He is an editor-in-chief of Telemedicine and e-Health, the official journal of the American Telemedicine Association

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eClinician: Clinical Decision Support System A unique differential diagnosis tool

C

oresys’ differential diagnosis module, eClinician, is a valuable tool for practicing doctors. Clinical decision making is a required skill for every physician based on his subject knowledge and clinical acumen, which is a combination of science and art. A physician should have enough knowledge and a logical mind, which support his intuitive mind to derive a conclusion.

Good conclusions (diagnosis) are based on facts in the basis of accurate clinical judgment. eClinician is a unique system, supporting the physician in the whole process of decision making.

The database of 4568 diseases is more valuable than keeping all specialty text books on consultation table. But the real value of eClinician is not just the amount of information provided. It is the method of reaching differential diagnosis from signs & symptoms that is the real value of eClinican to the physician.

There are two categories of signs & symptoms listed in eClinician. Major Presentations and Other Presentations. The Physician may choose one or two major presentations and other presentations of the patient as given in Image 1, and the system will generate differential diagnosis with five possible diseases (Image 2).Particular disease information—

clinical examinations, etiology, lab, treatment, medications etc.—are also displayed for immediate access.

The system has been developed in a user friendly interface, enabling physicians with no prior software experience to use eClinician with a simple demonstration.

Product Review Message from a leading Physician: “eClinician is practical & quite simple. I believe every GP would be immensely benefitted by it and I would very strongly recommend it to them. If the benefit are not immediately apparent to an average GP who is mostly hard pressed for time, those who are forward looking and willing to invest the required time to learn it and actively use it, will soon enough make it as much a part of their equipment as an ECG machine or even a BP apparatus”. eClinician has been adopted by over 3000 users in India in a short time of 24 months in market.

About the Developer: Coresys is an ISO 9001:2000 certified software company offering products and services in healthcare industry. Coresys has a team of in-house software developers and doctors who work together to adapt latest technologies.

Other Products A. Cortex, Hospital Management System. This is a completely integrated web application, capable of meeting demands of hospitals of any size. The system has been evolved with over 12 years of expertise in the domain. Cortex is available in a customized version for managing Clinics without In patients.

The system also comes integrated with complete Electronic Medical Records which has been developed on international standards with easy to use and access user interface.

B. Campas: Campus management system is offered to schools and colleges on a SaaS model. The system is hosted on our servers and institutions can subscribe to the service on a pay per student model.

This solution minimizes start up cost of implementing the management system at educational institutions.

For more information, contact: info@coresysit.com

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Advertorial

Information Technology

Telehealth

Strategies for successful, cost-effective implementation Telehealth is best used in patients with illnesses that respond to monitoring and rapid intervention. It is ideal for patients with heart failure because the weight monitoring provides information that is responsive to health interventions.

Kathryn H Bowles Associate Professor, New Courtland Center for Transitions and Health, University of Pennsylvania School of Nursing, USA

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T

elehealth provides remote physiologic monitoring of patients with chronic illness such as diabetes mellitus or heart failure. Most commonly, it is provided at homes in conjunction with nurse home visits. Chronically ill patients use devices that measure blood pressure, weight, blood oxygen or glucose levels on a daily basis. Healthcare providers, patients and family caregivers closely monitor the readings and rapidly respond to deviations from normal. Several studies have shown the benefits of telehealth in providing rapid response and, therefore, reducing hospitalisation and emergency department use. The benefits are many, but the technology does present some challenges for the agency providing the services. Here is a look at suggested strategies to overcome the challenges and provide successful, cost-effective telehomecare.

The outcome of telehomecare intervention is heavily, if not completely, dependent on the people providing the intervention. Their attitude towards the value of the technology is important to a successful programme. Often, the attitude starts from the top management.

Management must communicate the value of the programme to their staff and implement support structures that enable operations to proceed. For example, managers must recognise that telehealth adds time to the nurse’s day because of equipment set-up and patient teaching. Expectations about productivity

ISSUe - 19 2009

may need to be adjusted. Also, the staff must be properly trained for installing and using the equipment. One strategy when developing the procedures for the programme is to get staff at all levels of operation involved in conversation, education and feedback. Any barriers should be identified and solutions devised.

• Choose staff that are interested in technology and have the ability to work with new ideas • Explore interests, understanding, and comfort level with the use of technology at all staff levels • Specifically ask staff if they are interested in having telehealth in their organisation and if they are opposed discuss the reasons • Share these concerns back to management for resolution.

Successful telehealth requires teamwork and coordination. There are two models of care delivery. In one, the home care nurse is responsible for home visits, monitoring the telehealth data, and responding to deviations in the telehealth data. In another model, the home care nurse does in-person visits only and another telehealth nurse monitors the data and coordinates a response with the home care nurse. Either model requires teamwork and coordination to install the equipment in a timely manner and to assure a rapid response to patient needs. Often, the type of equipment used dictates which model is most practical.

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Possible visit pattern • Week 1: 2 Home Visits (HV), install and begin daily monitoring • Week 2: 1 or 2 HV and 1 Telehealth video visit (TH) • Week 3: 1 HV and TH daily monitoring and one video • Week 4: TH • Week 5: 1 HV and TH • Week 6: TH • Week 7: 1 HV and discharge Table 1

The period of highest risk for the newly admitted home care patients is the first 24-48 hours. Therefore, the goal should be to deliver and begin using the equipment within the first week of home care. Agencies must also determine how long to leave equipment in the home and how to use the technology in conjunction with in-person visits to be most efficient and effective. A suggested pattern is found in Table 1.

Once the equipment is installed, several process strategies can be employed to promote successful telehealth. Provide guidelines for nurses on the content of the conversation via video or telephone.

This assures consistency in the monitoring procedures and teaching content for patients. To assist with rapid response, secure collaboration with physicians for medical orders based on monitoring results. Seek standing orders for faster response. For example, often physicians may have a standing order for heart failure that whenever the patient’s weight increases by >2 pounds in 24 hours, the

A u t h o r

If the equipment is web–based, then the first model works well; if video is used then the latter model is required because the nurse must be at the office to use the video equipment and interact live with the patient.

Telehealth is best used in patients with illnesses that respond to monitoring and rapid intervention. It is ideal for patients with heart failure because the weight monitoring provides information that is responsive to health interventions. Telehealth is best used with patients who are cognitively intact, able to pull a blood pressure cuff on their arm and stand on a scale. Also, motivated patients are necessary to gain cooperation in using the devices regularly. Those recently hospitalised are often ideal since the fresh memory of hospitalisation can be motivating and a recent hospitalisation puts them at risk for future events.

Equipment selection and installation is another important challenge.

Determine the devices needed by matching them to the population being served.

For example, with diabetics, a glucometer is needed, but perhaps not a scale.

Also, decide whether to use video or just monitoring and ask if wireless devices are available because they are easiest to install and place into the patients’ home environments. Choose a reliable vendor with a good reputation and strong business history. Seek equipment that is simple to set up and use. Consider initial and ongoing cost of the equipment and ask about data storage or monitoring fees.

Consider direct delivery right to the home from the manufacturer and determine how the equipment will be installed, collected, cleaned and redeployed. Home care nurses prefer that these tasks are not their responsibility. Some manufacturers provide these services for a fee.

Early on, map out the work flow and define roles and responsibilities.

Some roles and responsibilities include delivering the equipment and supplies, installing , monitoring and acting on the data, and training the patient and caregiver on its usage.

nurse should instruct the patient to take an additional diuretic. Nurses should also use the data as a ‘teaching moment’.

Nurses can show the patient changes in their readings and how they correlate to their behaviours. This helps to reinforce healthy behaviours and adherence to diet to medication.

Track outcomes continuously to measure and communicate the value of the programme to payers. Most commonly, hospitalisation and emergency department use are measured.

Others monitor patient knowledge about healthy behaviours, adherence to therapies, symptom improvements and use of the equipment for self-care.

Costs in time, personnel and equipment should be compared to gains in efficiency and savings due to preventable readmissions.

Finally, it is important to publish and present results and lessons learned so that others learn the value of this technology for chronic illness and how to administer the programme most effectively. Further, payers may decide to adopt the model for their patients and reimburse it as a valued service.

Adequate training, staff attitude, management support, careful selection of equipment and the right patients all contribute to a successful telehealth programme. Developing a satisfactory and efficient workflow is crucial to match nurse, agency and patient needs; install the equipment in a timely manner; and provide coordinated care efficiently. The main goal is to use the technology to improve patient outcomes and prevent costly readmissions and emergency department use.

Kathryn H Bowles is an Associate Professor in the New Courtland Center for Transitions and Health at the University of Pennsylvania School of Nursing, leads an interdisciplinary programme of research that blends transitional care and the use of health information technology to improve the care of the elderly. Bowles has led as Principal Investigator or been a Co-Investigator on 5 telehomecare studies in a variety of home care agencies in Pennsylvania. Her NIH funded work includes an ongoing clinical trial testing the effects of telehealth with heart failure patients.

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