Asian Hospital & Healthcare Management - Issue 15

Healthcare Management Medical Sciences Diagnostics Information Technology Surgical Speciality

Issue 15

2008

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Art for Health’s Sake

Global Health Landscape

Medical Banking

An evidence-based approach

Healthcare “beyond borders”

A new stakeholder

In association with

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Asian Hospital & Healthcare Management

ISSUE-15 2008

Foreword Patient-Centred Healthcare Moving beyond ailment An involved patient is a blessing for healthcare organisations.

H

ealthcare providers—in Asia and the rest of the world—are yet to come to terms with the paradigm shift that is taking place in the provision of healthcare. A re-look at planning, delivery and evaluation of care is the order of the day. The healthcare processes need to be aligned to ensure that the patient is treated as a consumer.

Though this may seem like a minor change in perspective, the implications for healthcare providers are anything but small. The patient will move beyond being a mere recipient of service, and become a source of crucial feedback to the providers of healthcare. Indeed, if a process is to revolve around the patient, it’s only fair that hospitals seek their active participation in defining it.

An involved patient is a blessing for healthcare organisations, provided they are able to facilitate comprehensive communication between the staff, physicians and the patient. To enable this, providers would need to put in place an appropriate channel of communication. Unless healthcare establishments take it upon themselves to introduce a patient-centred approach organisation-wide, a change of this proportion can never be positive in the long run.

In the cover story, we present insights from industry experts on how the patient can be an active participant in creating processes that are meant to serve them best. It features three interviews and two articles. In the interviews, industry leaders who have been at the forefront of this change, share their opinions on the various aspects of providing patient-centred care.

The first article, ‘Listen to the Patient’ talks about improving the doctor-patient communication at every stage of healthcare provision. The feedback can prove to be crucial in improving the quality of life for the patient.

The next article, ‘Patient-centric modalities’, talks about the factors—tangible and intangible—that need to be considered during the design and implementation of patient-centric processes in healthcare. The article lays emphasis on making hospital stay as short as possible while providing the patient the best quality care.

The two key facilitators of this trend are Internet and Information Technology. The Internet has proved to be a blessing for patients seeking information about diseases and cure. Today, patients are better informed in their interface with providers. With the right systems in place, hospitals can leverage this knowledge to their advantage.

Developments in healthcare information technology have helped create data management systems that enable storage, analysis and retrieval of even the smallest bits of data. With so much information on call, the onus will be on hospitals to provide focussed care. How a hospital uses this opportunity could also affect its competitiveness.

The one entity that stands to gain most from this movement, though, is the patient.

Akhil Tandulwadikar Editor

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The Big Shift

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Stephen C Schoenbaum Executive Vice President The Commonwealth Fund USA

Meeting Diverse Needs

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Amy Wilson-Stronks Project Director, Division of Standards and Survey Methods, The Joint Commission USA

The New Challenge

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Gary Kaplan Chairman and CEO Virginia Mason Medical Center USA

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Listen to the Patient Assuring quality care

WF Bower, Assistant Professor CSK Cheung, Research Associate CA Van Hasselt, Professor MJ Underwood, Professor Department of Surgery, The Chinese University of Hong Kong, Hong Kong SAR

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Patient-Centric Modalities Strategies for better implementation Julio A Reategui, RA / QA and Compliance Asia Pacific MEDRAD, Inc., USA

HEALTHCARE MANAGEMENT

Chronic Diseases

Prevention is better than cure

Global Health Landscape

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Ori Karev, CEO UnitedHealth International, USA

Asian Hospital & Healthcare Management

Anna Coote, Commissioner for Health Sustainable Development Commission, UK

Vision Care

Healthcare “beyond borders”

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The next step in comprehensive disease management Cheryl Johnson, Vice President Health Care Services, VSP Vision Care, USA

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Contents Six Sigma in Healthcare

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Safety in Anaesthesia

Effective use of the Tool Box Maria H Foschi, Assistant Vice President, Virtua Health, USA Adrienne Elberfeld, Six Sigma Champion, Virtua Health, USA

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Promoting sustainable change for the future Alan F Merry Professor and Head of Department, Anaesthesiology University of Auckland, New Zealand

24 Lean and Six Sigma

Telemonitoring in Cardiac Device Therapy

Transforming healthcare

Enabling optimal management of patients

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Auricchio Angelo, Professor, Division of Cardiology, University Hospital, Germany

Jason Lebsack, Manager Six Sigma, Nebraska Medical Center, USA

SURGICAL SPECIALITY MEDICAL SCIENCES The Changing Face of Cancer Implications for Anaesthesia

Patient Safety in Surgery 27

Thomas W Feeley, Helen Shafer Fly Distinguished Professor Anesthesiology and Head, Division of Anesthesiology & Critical Care The University of Texas M.D. Anderson Cancer Center, USA

Multidisciplinary Collaboration in the ICU

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Promoting effective care

Philip F Stahel, Department of Orthopaedic Surgery Wade R Smith, Department of Orthopaedic Surgery Philip S Mehler, Department of Medicine Denver Health Medical Center, University of Colorado School of Medicine, USA

DIAGNOSTICS

Advanced CT Imaging

Ruth M Kleinpell, Professor Rush University College of Nursing, USA

Targeting the Stress of Diabetes

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Current ‘key’ issues

Effective diagnosis of coronary disease

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Michael Chun-Leng Lim, Medical Director Singapore Heart Stroke and Cancer Centre Singapore

Preserving vascular longevity Kenneth Maiese, Professor Departments of Neurology and Anatomy & Cell Biology Barbara Ann Karmanos Cancer Institute Center for Molecular Medicine and Genetics Institute of Environmental Health Sciences Wayne State University School of Medicine, USA

Embolic Protection During Carotid Stenting

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67 PACS in Indian Hospitals Catching up

Deepak Kumar, Chief Technology Officer Srishti Software, India

Technology, Equipment & Devices

Using FiberNet device

Devices Containing Membranes

Jennifer Franke, CardioVascular Center Frankfurt, Germany Horst Sievert, CardioVascular Center Frankfurt, Germany and Washington Hospital Center, USA

Nicholas Hoenich, Clinical Scientist Medical School Newcastle University, UK

Better membrane, improved outcomes

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C o ntents

Issue 15 2008

Facilities & Operations Management

73 Art for Health’s Sake

Editor : Akhil Tandulwadikar Consulting Editor : Sudhir Ponnala

Healthcare Editorial Team : Prasanthi Potluri Sridevi Prekke Vandana Wadhawan

Language Editor : G Srinivas Reddy

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An evidence-based approach

Upali Nanda, Vice President Director of Research American Art Resources, USA

Copy Editors : Omer Ahmed Siddiqui Prity Jaiswal

Production : Suresh Giriraj

Sales Head : Rajeev Kumar

Healthcare 78 Facilities Design A global perspective

Judith D Mitchell Director of Planning Harvard Medical International, USA

Lean Process Program Planning

Guidelines for optimum operations and design

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Creating sustainable improvements Wayne Ruga, Founder and President, The CARITAS Project, USA Annette Ridenour, President, Aesthetics, USA

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Chief Executive Officer : Vijay Chintamaneni Managing Director : Ashok Nair

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Thomas M Eberle, Senior Clinical Architect Digital Health Group, Intel Corporation, USA

Medical Banking

Shadaan Osmani Ifthakhar Mohammed Azeemuddin Mohammed Sankar Kodali Thirupathi Botla Saritha N

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A new stakeholder

John Casillas, Founder The Medical Banking Project, USA

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Asian Hospital & Healthcare Management

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Asian Hospital & Healthcare Management

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H ealthca r e M anagement

Global Health Landscape

Healthcare “beyond borders” At a time when the global citizen is transforming how healthcare is delivered worldwide, there’s a need for a vision for delivering coordinated, high-quality and affordable care “beyond borders.”

Ori Karev CEO UnitedHealth International, USA

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he rise of a global healthcare marketplace is underway.

Thanks to a new global citizen, whose work and life transcends borders, the delivery of healthcare worldwide is being transformed. Simultaneously, other economic and social realities are fuelling what will be a major shift from national to global approaches in healthcare delivery. Innovations in medical technology, strong economic pressures on individual countries to reinvent their healthcare systems, and a transparent, collaborative approach to prevention

and treatment, all contribute to an expanding global landscape that cannot be ignored.

We are already making strides towards a border-neutral healthcare system that freely shares knowledge and technology. This foundation will bring about an interconnected network of medical professionals, facilities and global best practice standards that will help drive seamless access to quality healthcare, regardless of where care is provided.

Stakeholders—both payers and consumers—want healthcare solutions

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that serve the new global citizen. We must understand, embrace and lead the global healthcare market’s evolution.

Healthcare payers will continue to innovate methods to serve healthcare needs through competition, risk pooling, mandatory insurance, wellness incentives and public sector funding.

The old healthcare paradigm is increasingly becoming outdated. In the past 15 years, per capita healthcare expenditures have risen dramatically, yet healthcare systems have not succeeded in delivering care to all citizens.

H ealthca r e M anagement

US healthcare spending, as a percentage of GDP, is the highest in the world, yet many US citizens have limited or no access to health insurance. Meanwhile, the European Union countries are striving to effectively manage costs while facing the challenge of providing timely access to care.

Global citizen-driven healthcare

The mechanisms for delivering global healthcare must be established in a systematic way, not as ad hoc solutions—some promoted by providers and others by consumers. Individual consumers around the world have access to an enormous pool of knowledge.

They are researching their conditions and making decisions on what treatments are needed and, more importantly, where they will be provided.

Individuals are searching outside their present healthcare systems for better answers, and are willing to travel and pay for them.

The elements shaping a new paradigm for global citizen-driven healthcare include: • Consumer mobility: In today’s global economy, many people no longer live exclusively in their country of origin. Workers are often expatriates or third country nationals who live and work outside their country of citizenship. This trend will likely increase, with the largest markets in Western Europe, the Middle East, North America and East Asia. As people become increasingly mobile for both temporary and permanent work assignments, they will need a healthcare system that can support their needs.

• Medical travel: While medical tourism in the past was associated with spa treatment and cosmetic surgery, today more than 100 hospitals worldwide are Joint Commission International (JCI) accredited, and others are building a massive presence in low-cost high-quality environments. It is worth noting that the

Making it work In order to drive the international coordination of high-quality healthcare for consumers at an affordable cost, there needs to be a greater degree of integration between global healthcare participants.

Specifically, most countries in the Asia Pacific region lack sufficient clinical data and the ability to analyse it. As these countries’ healthcare systems grow, and as demand grows, they will require healthcare intelligence to make good decisions about care delivery, resource allocation and treatment of chronic conditions. Robust analysis of clinical data translates into positive health outcomes. Clinical data analysis can prevent mega illnesses, improve preventive care, predict with a high level of accuracy which treatment has higher likelihood of success, reduce mortality rates and create a healthcare environment that is based on data, outcomes and best practices employed in other countries. As citizens of the global economy, we have a keen interest in making clinical data tools and analysis readily available where they are not today, to ensure the development of rational, efficient, high-quality healthcare systems in these countries.

JCI accreditation programme is not unique in its activities of accrediting. However, it is the JCI accreditation which transcends borders and contributes effectively to the necessary element of accreditation in the globalisation of healthcare. Accordingly, both providers and payers can gear up to meet an increased demand in global healthcare.

• Language and culture: To facilitate the rapid exchange of innovation, English is increasingly becoming the lingua franca of medicine. At the same time, an increase in migration to Europe and the US from Latin America, Asia and Africa is causing policy makers and healthcare providers to incorporate the diverse viewpoints of medical and technological professionals who have trained and gained practical knowledge outside their countries.

• Healthcare financing: Traditional funding methods for healthcare are being challenged. Globally, out of pocket spending is straining the healthcare consumer’s personal budget regardless of whether their country has nationalised healthcare coverage. In the US, employers

and government are reviewing the viability of employer health benefits programmes. Governments are experiencing increasing costs and as a result, they are shifting healthcare delivery and management to private providers. We are experiencing a major shift in funding, both from a public policy and an individual perspective.

Clinical analysis, predictive modelling and evidence-based medicine are all manifestations of the rising need to manage healthcare from an economic perspective. This is not to say “to reduce the cost of healthcare,” but only to reallocate resources in the proper direction. Simply put, a key element in the fulfilment of the globalisation trend in healthcare stems from our collective ability to generate and analyse useable clinical data During our lifetimes, each of us experiences medical challenges arising from current health conditions, wellness activities, our gene pool and our surrounding environment. Assuming we are able to categorise and catalogue such information or data from the outset, we would then be able to develop a personal clinical profile.

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A global legal framework

Another major challenge to the trend of globalisation of healthcare is the lack of an integrated, international legal framework. The healthcare market in the US has liability legislation and a massive body of common law that clearly establishes the patients’ right to sue if they feel they have been wrongfully treated.

It is this specific right (or perhaps even a sense of entitlement) which may be one of the key factors giving rise to the need for US medical providers to overtest, over-prescribe and practise defensive medicine. The fear of one’s medical decisions being challenged down the road, with the benefit of hindsight and a good legal counsel, drives US providers to seek extraordinary treatments, procedures and advice. This approach costs money. Accordingly, a portion of the high costs of US healthcare is the cost of protecting against litigation.

Those who participate in shaping global healthcare must take into account fundamental cultural and legal differences in the expectations of global healthcare consumers. Universally accepted solutions must be negotiated. An example of global negotiation would be ongoing worldwide efforts to develop common intellectual property protection, offering owners of intellectual property the assurance of marketing their products in other countries without placing their products or services at risk of duplication.

Lastly, the trend of globalisation of healthcare must go hand in hand with a robust solution for countryof-origin support systems. At some point, most patients who participate in global healthcare, may return home with ongoing health needs relative A uthor

Armed with that data, we can now begin to track various medical procedures and treatments and the effect of each on our overall health.

In short, by leveraging statistical analysis and measurement tools to evaluate efficiency (the equation of resource applied and the results obtained) we can predict outcomes, which helps us select the most appropriate treatment modalities for each individual.

Why is the issue so relevant in the Asia-Pacific region? First, most Asia Pacific countries neither rigorously adhere to clinical data generation and utilisation principles nor do they apply clinical data outcomes to their populations. In the meantime, Southeast Asian residents are earning higher incomes and demanding a say in the goods and services they purchase. Concurrently, they expect their countries to actively participate in processes that increase their well-being. As their healthcare systems mature, these countries now have the opportunity to improve care for their citizens In addition, as active participants in global healthcare, there must be common data platforms and effective linkages amongst data collecting entities. There is an inherent challenge in transporting critical clinical data—patient history, diagnosis of the presenting concern, prescription drug use etc.—between countries. From a data infrastructure viewpoint, clinical data must be readily transportable (HIPPA implications not withstanding) so that the patient, the treating physician, the examining physician, and the payer all have access. What is sometimes forgotten is that care coordinators and payers must also be able to access this information to coordinate care and pay the bills when the patient returns to his country of origin.

Personalised and transportable electronic health records are also critical to understanding costs and determining future insurance premiums, both locally and globally.

Asian Hospital & Healthcare Management

to their recovery that require clinical support. Outside of the legal considerations, the fundamental issue is ensuring that returning patients have access to the clinical support they need to continue their recovery. It is too early to tell whether clinicians accepting foreigntreated patients will be fully supportive of their patients who have received treatment overseas, but let’s assume that this is the case. Even the best intentioned, fully supportive providers will have a need for data, assessments and support to provide for appropriate continuity of care.

Trends in the globalisation of healthcare present us with a number of questions: What role will any specific healthcare industry assume during this period of transition? And, will the new paradigm of global healthcare simply emerge organically from these trends, or, will it be shaped thoughtfully, optimising healthcare for all of the world’s citizens?

I advocate for the latter.

Leadership for the transition to a truly global healthcare system is resident in the private industry that has insured, managed and administered healthcare for over a century. The industry has the knowledge, the technology, the scope, and the ability to drive efficiency and ensure quality outcomes. However, it is the public-private partnerships that will serve as the catalyst in transforming the healthcare industry into a truly global industry. Our challenge as future contributors or beneficiaries of the trend is to anticipate rapidly changing consumer requirements and be fully prepared to deliver the products and services that meet these needs. This is an exciting opportunity—an opportunity to improve a critical aspect of people’s lives on an unprecedented scale.

Ori Karev is the CEO of UnitedHealth International, a UnitedHealth Group company. He drives UnitedHealth International’s growth, advancing its position as the leading global health and well-being company. Under Ori’s leadership, the company actively pursues its local and global potential in its various market segments: global health insurance, third-party administration, healthcare management consulting and global health solutions for leading benefit plan sponsors.

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H ealthca r e M anagement

Chronic Diseases

Prevention is better than cure Regular physical exercise, healthier food and greater contact with the environment reduce the risks of chronic diseases and promote sustainable development.

Anna Coote Commissioner for Health Sustainable Development Commission, UK

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ustainable development is a longterm, whole-systems approach that gives equal weight to five principles: living within environmental limits; a strong, healthy and just society; a sustainable economy; good governance, and using sound science responsibly. By promoting sustainable development we help to prevent chronic disease. By preventing disease we help to promote low carbon living and prevent damage to the environment.

The policies we need to safeguard human life on the planet are the same or very similar to those we need to prevent human illness in general and chronic disease in particular. Global warming presents enormous new challenges to the way different countries treat each others’ citizens and to the way welfare systems across the world deal with risk and disadvantage. So, we need to transform social policy—at local, national and global levels, to meet the needs of the modern world.

Chronic disease is a global problem. The World Health Organization (WHO) says 66 per cent of all premature deaths are due to chronic diseases.

In the next decade, it is estimated that nearly 400 million people will die of a chronic condition.

In the developed world, there are three factors that greatly exacerbate the problem and point to higher rates and greater costs in future: 1. One is the rising epidemic of obesity—bringing with it grave risks of heart disease, cancer and diabetes.

In England, one in four is affected and the rates are rising rapidly. This currently costs US$ 7.4 billion (£3.7 billion) every year.

2. The second factor is the rising levels of mental ill-health. The WHO has predicted that by 2020, depression will be the second greatest contributor to the burden of disease for all ages and both sexes. We are learning that above a certain level, higher income does not make people happy any more. People in richer countries suffer from high levels of stress, anxiety and depression. These mental illnesses often lead to physical disorders. A recent report in The Lancet found that depression is more dangereous to health than the four major chronic conditions: angina, arthritis, asthma and diabetes.

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In England alone, one in 6 is affected by mental health problems and it costs the country US$ 152 billion (£76 billion) a year—in health and social care services, lost economic output, and associated costs.

3. The third factor is the ageing population. In the last two decades in England, life expectancy for men increased by just over 5 years, but healthy life expectancy increased by less than three years. So, more people are old and ill—suffering, in the main, from chronic mental and physical illness.

Furthermore, both poverty and insecurity result in chronic disease.

So, what can be done to prevent chronic disease? According to the WHO, the causes are known, the risks are largely preventable and the key is to focus on risk factors that link across the major killer diseases.

The three overlapping risk factors are: exercise, diet, and human contact with natural environment. It is with these ‘upstream’ determinants of

Projected global distribution of chronic disease deaths Low income countries

35%

20%

High income countries

8% 37%

Lower middle income countries

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Upper middle income countries

Graph 1

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health that we find the greatest synergy between sustainable development and health.

Exercise

There is strong evidence that physical inactivity is related to ill health. As a factor that contributes to heart disease, lack of exercise can be looked upon as serious as smoking.

In England, as in many other countries, very few people take exercise. Two in three men and three in four women fail to take the recommended minimum of 30 minutes’ moderate activity five times a week. This is partly because of the vast increase in the use of private car for transportation and also due to the road traffic conditions.

Reduction in motorised road traffic—and the resultant reduction of air pollution—combined with an increase in physical activity through walking and cycling would have multiple benefits like: reductions in lung disease, asthma, obesity, diabetes, cardiovascular disease, osteoporosis and certain cancers; improvements in mental health. This can also significantly reduce CO2 emissions and other environmental damages that in turn present threats to the cohabitant's health and well-being.

It’s a virtuous cycle. Public policies that promote sustainable and active travel—for everyone, not just the middle-classes, can reduce the risks of chronic disease, combat global warming and help us all live with the resources of one planet instead of three.

Diet

A poor diet made up of processed foods that are heavy in fat sugar and certain artificial additives is harmful for physical and mental health. It is an acknowledged cause of obesity and depression.

Processed foods are energy-intensive. Food items which are transported over long distances have a larger carbon footprint. Conversely, food bought locally helps to stimulate local economies, create jobs, reduce poverty and

give people greater control over their own lives—all important determinants of health.

Public procurement, planning, regulation and transport policies are all levers for government to promote sustainable food production and help people, regardless of their income, to maintain a good diet. This approach is now being actively applied by a group of hospitals in Cornwall, south-west England. They buy food from local suppliers, improving the diet of patients and staff and helping to bring new jobs into the area—all as a way of improving health and using resources more efficiently over time.

This suggests another virtuous cycle.

Fresh, affordable, locally produced food is good for health and better for the environment.

Contact with natural environments

There is sound evidence that people who have contact with natural environments have better physical and mental health. They take more exercise, feel better about themselves and reduce their risks of getting ill. A Dutch study has shown that the more green space people have access to, the better their general health would be—and the relationship is the strongest for lower socioeconomic groups. Research in Chicago, USA, compared groups of people living in buildings with and without trees and grass nearby. Those without trees and grass had a less positive attitude to life, while those with trees and grass around, used public space more often and made more social contacts, which is also known to have positive effects on health. Another study of patients recovering from gall bladder surgery found that those who looked out on greenery recovered faster than those who looked out on a brick wall.

Accessible, usable, natural green space encourages physical activity. Exercising in pleasant, natural surroundings improves people’s self-esteem and mood (hence the growing popularity of green gyms).

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Protecting green spaces—everything from wilderness and open countryside to parks, tree-lined streets and gardens— can help to protect the environment and—on the right scale—combat global warming.

The Royal Commission on Environmental Pollution remarked in 2007.

“The evidence is sufficiently strong (for planners) to recognise the health benefits of green space and to build green space into new and existing developments”.

Here is another virtuous cycle. Public policies that promote and safeguard high quality natural environments— and public access to them, especially for low-income groups—can promote better physical and mental health, reduce the risks of chronic disease and help to sustain the resources on which human life depends.

Barriers to change

It is simply not sustainable to address chronic disease as something that just needs to be managed. But, why do governments and health systems continue to give higher priority to managing rather than preventing ill health?

We must recognise the danger of ‘producer capture’. Health professionals are trained, managed and rewarded in ways that favour treatment and care, rather than prevention. Professional interest in treatment and care tends to drain away the lion’s share of resources— human energy, professional skills, political capital or financial resources—from the prevention agenda.

Much more money is invested in research into the efficacy of clinical interventions than into preventative measures. Politicians who run health systems want ‘quick wins’ to woo their electorates and have little patience with the unglamorous long-term efforts of prevention. In some countries—including England—health systems are still organised and run separately from local government and struggle to work in partnership with those who run services

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avoided, on reducing domestic and global poverty and on measures that safeguard the environment for our children and grandchildren In 2002, a report for the UK Treasury anticipated that failure to pursue what Derek Wanless, the author, called a ‘fully engaged scenario’ (focussing on preventing ill health and making better use of current resources), would cost the NHS up to US$ 60 billion (£30 billion) extra every year by 2020.

Virtuous Cycle Prevent the preventable

Towards a sustainable social policy

Pre v susentio tain n th abi rou lity gh

As

afe

r fu

ture

gh ou thr n in tio sta en Su prev

r tte be s th, ce eal ur r h eso tte f r Be se o u

Manage unavoidable disease

Figure 1

There are some encouraging signs.

The climate and health council, set up under the auspices of the British Medical Journal, has begun an intensive campaign to persuade doctors that it is their duty as guardians of health to reduce carbon emissions and promote sustainable practices. Another prestigious medical journal, The Lancet, has embraced the agenda, running a series on energy and health.

The National Health Service for England and Wales has set up a unit to promote what it calls ‘good corporate citizenship’, encouraging the NHS A uthor

that influence the wider determinants of health—education, planning, housing, transport. Media campaigns exert a vital influence over political behaviour and public opinion—newspapers and television usually find it easier to tell stories about things that go wrong than about things that prevent problems occurring.

And there are alluring ‘downstream’ solutions that can fulfil a health professional’s desire to ‘win the battle against disease’ but these solutions detract attention from doing what it takes to make that battle redundant. For example, why worry about urban planning to encourage walking and cycling and to increase access to green spaces, or about agricultural policy to increase access to fresh local food—if you can prescribe a pill such as statins and show positive results in clinical trials (even if the intervention remains controversial)?

Meanwhile, there is robust evidence showing that: • Most chronic diseases can be prevented • Given the choice, people will choose health rather than illness • Key measures that promote sustainable development will also help to prevent chronic disease—and vice versa • Tackling climate change should be a primary responsibility for health professionals and health systems, because failure to live within the natural limits of our planet is already putting the health of millions at risk, contributing to chronic disease worldwide, and threatening catastrophic effects on human health within a matter of decades • Failure to prevent chronic diseases will have devastating effects on health systems because of the vast and everincreasing costs of treating and caring people who have avoidable chronic diseases • All this amounts to a huge waste of precious resources—that could be much better spent on healthcare to treat illnesses that cannot be

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to spend that US$ 192 billion (£96 billion) to promote sustainable development—through procurement, employment, managing energy, buildings and transport. A web-based toolkit for NHS managers promotes this approach, showing that sustainable development can make good business sense and— crucially—help to prevent illness and improve health.

The WHO now advocates action on climate change—to reduce the causes and address the risks presented by global warming, especially for vulnerable people, with a view to improving population health.

In summary, it is possible and necessary to give higher priority to preventing chronic disease. Public health protagonists have been arguing the case for decades, but there is a new sense of urgency when it is linked with mounting concerns about climate change.

The key message is that we must move towards a more sustainable social policy. That means preventing what we can—probably preventing three-quarters of all chronic disease; pursuing the goals of sustainable development by preventing chronic disease; preventing disease by means of sustainable development; and releasing resources so that we can sustain our capacity to manage unavoidable disease in the longer term. If we do this, there is a double prize to be enjoyed—better health and quality of life, and more efficient use of resources, which in turn safeguards the future health and well-being of our children and grandchildren, the long-term viability of our health and social care services, and the natural resources on which human life depends.

Anna Coote is the Commissioner for Health on the UK Sustainable Development Commission. She is a policy analyst and writer specialising in health and social policy, sustainable development and public involvement. She is a Fellow of the Royal Society of Public Health.

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Vision Care

The next step in comprehensive disease management Vision care plays an important role in the early detection and prevention of disease.

The collaboration of evidence-based eye care with healthcare will have a positive impact on patient care and healthcare savings.

Cheryl Johnson Vice President, Health Care Services VSP Vision Care, USA

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n the US, all citizens are faced with healthcare costs that are increasing at alarming rates and they show no sign of slowing. Employers dealing with rising costs are promoting preventive care as a way to encourage wellness, and provide opportunities for early detection of disease. Hence, children and adults should get a comprehensive exam at least every two years.

More and more, vision care is becoming recognised as a key element in overall body health. It has become an integral part of the healthcare continuum.

Vision care is an easy, as well as effective, entry into the healthcare system.

Research from the US Census Bureau, the National Center for Health Statistics and VSP Vision Care show that working citizens with vision coverage get eye exams nearly four times more frequently than physicals, 61 per cent versus 16 per cent.

This is significant because the eyes are the only places on the body that provide an unobstructed, non-invasive view of the blood vessels.

Through comprehensive eye exams, eye doctors can diagnose serious eye diseases including glaucoma, macular degeneration and diabetic retinopathy. They can also detect symptoms of serious systemic conditions such as diabetes, high cholesterol and hypertension.

Often these conditions yield no symptoms in the early stages and early detection offers opportunities for disease management and prevention of blindness and more serious illness. According to the Center for Disease Control, more than 90 million Americans live with chronic diseases.

Treatment for these diseases account for more than 75 per cent of the nation’s US$ 1.4 trillion medical care costs.

The growing awareness about the connection between vision care and total body health is redefining what vision plans need to provide. It’s more than just coverage for glasses and contacts, but a more integrated approach to data sharing between practitioners health plans and disease management companies.

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H ealthca r e M anagement

Overview of the six conditions collected through the Eye Health Management Program® What is it?

How many Americans are affected?

How does a VSP doctor detect symptoms?

Diabetes

• Disease in which the body does not produce or properly use insulin, which is needed to convert food into energy

• 21 million • One-third are unaware they have the disease • Additional 54 million have pre-diabetes

• Sudden or severe loss of visual acuity • Presence of diabetic retinopathy

Hypertension

• Elevated blood pressure

• 65 million • 30 per cent are unaware they have the disease • 34 per cent do not manage it

• Narrowing of blood vessels • Fluid leaking from blood vessels • Spots on retina • Swelling of the macula and optic nerve • Bleeding in the back of the eye

Corneal Arcus (High Cholesterol)

• Ring around the cornea • Caused by fatty deposits • Possible indicator of high cholesterol

• Prevalence of arcus ranges from 25-30 per cent of the US population • High cholesterol affects 20 per cent of Americans over the age of 20

• White or yellow ring appears around the cornea

Diabetic Retinopathy

• Caused by changes in the blood vessels of the retina, usually when retinal blood vessels swell and leak fluid, or when new blood vessels grow on the surface of the retina

• Approximately 4.1 million adults 40 years and older • 1 in every 12 in this age group has advanced vision-threatening retinopathy • Diabetic retinopathy affects up to 80 per cent of all diabetics who have had diabetes for 15 years or more

• By performing dilation and examining the back of the eye

Glaucoma

• Group of eye diseases that causes pressure against the optic nerve and compression of the eye’s blood vessels • Results vary from slight vision impairment to total blindness

• 2.2 million • Half are unaware they have it

• By administering a test that measures the pressure inside the eye

Macular Degeneration

• Leaking of fluid or bleeding in the macula, an area in the back of the eye that produces the sharpest vision

• 2 million

• Yellow deposits appear in the macula • Patients vision can be tested with an Amsler grid Table 1

VSP Vision Care, the largest eye health benefit provider in the US with 52 million members and more than 24,000 private-practice network doctors, is at the forefront of a continuity of care approach.

VSP doctors, conducting comprehensive eye exams, can detect signs of serious eye conditions including glaucoma, macular degeneration, diabetic retinopathy and cataracts. In addition, annual eye exams can detect signs of systemic conditions including diabetes, high cholesterol, high blood pressure and heart disease before serious damage occurs.

Unique in the marketplace, their private practice doctors give personalised care and develop long-term relationships with patients and their families.

In fact, VSP doctors know their patients

so well that they can see even minor changes in their eyes over time. With their best practice medical guidelines, comprehensive eye exam standards and coordination with primary case physicians, all members receive quality care.

Eye Health Management Program®

VSP has taken quality care one step further by developing the Eye Health Management Program®, a complementary enhancement to all VSP plans, with the view that eye health, disease management, and total body health is a collaborative effort.

In a process compliant with privacy standards, the Eye Health Management Program® requires VSP eye doctors to report six disease states:

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diabetes, hypertension, high cholesterol, diabetic retinopathy, glaucoma and macular degeneration (Table 1).

In turn, VSP can then take this data and share patient-specific information with health plans and disease management companies.

This data collection process is unique to VSP because their private practice model allows consistent claim information to be submitted on routine vision claims. Capturing and sharing these conditions can result in significant health and cost benefits of early detection and treatment.

According to data from VSP, the U.S. Census and the National Center for Health Statistics, approximately 16 per cent of Americans see their primary care physicians regularly for preventive care, while about 61 per cent of

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Americans with coverage see their eye doctors annually. Using the Eye Health Management Program®, patientspecific information could be shared with health plans and disease management companies who may have been previously unaware of the patient’s condition as illustrated in the State of California Case study.

A major chronic disease focus is diabetes. Being one of the fastest growing diseases in the US, it affects 21 million Americans, and another 54 million have pre-diabetes.

In addition to data reporting, VSP also provides educational materials and exam reminders to identified members with diabetes.

Through the Eye Health Management Program®, VSP uses data collected by their doctor network to determine when the member last had an eye exam. If a diabetic patient hasn’t returned for an eye exam after a period of time, they’ll receive a reminder to visit their eye doctor.

Studies show that 90 per cent of diabetes-related blindness is preventable with a regular eye exam; yet only 50 per cent of people with diabetes receive a comprehensive eye exam.

Case study – State of California

A uthor

One of VSP’s largest clients, the State of California, announced that by utilising the Eye Health Management Program®, it could help avoid up to US$ 1 million in diabetic management costs. VSP used targeted communications to promote awareness about

the important health benefits of annual eye exams.

When the State’s 209,000 employees and dependents had eye exams, VSP doctors collected data on chronic diseases, including diabetes, and shared with the State’s health plan. So far, the results have identified 136 members with diabetes whose health plan was previously unaware of their condition.

Research by Medco Health Solutions, a leading prescription drug benefit management organisation, illustrated how diabetic patients can manage to keep their disease cost at US$ 4,300 or less annually; indicating that the longterm health and pharmacy cost savings for the State will be substantial.

Future impacts

To date VSP has 74 active clients and another 24 are in the process of participating in the data exchange feature of the Eye Health Management Program®.

Since inception, VSP doctors have identified more than 250 members with diabetes who are unaware of their condition.

The programme provides members with consistent, personalized care.

Focusing on early detection, treatment and education management of certain diseases, the programme mitigates costly surgeries, complications and hospital stays.

Additionally, the collection and exchange of medical data for VSP members help their clients manage their healthcare costs, and ensures that their members receive optimal care.

Cheryl Johnson as Vice President of VSP Vision Care’s Health Care Services division, is responsible for developing and maintaining VSP’s network of 24,000 private practice optometrists and ophthalmologists, and oversees functions such as doctor recruitment, credentialing, quality management, utilisation management, reimbursement, as well as VSP’s Eye Health Management® and mobile clinics programmes. Ms. Johnson joined VSP in 1993 and has more than 20 years experience within the healthcare industry.

She attended Pacific Lutheran University and is a graduate of the University of Washington.

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BOOK Shelf

Cardiac Resynchronization Therapy Editor(s) : Martin G St John Sutton Jeroen Bax Mariell Jessup Josep Brugada Martin Schalij Year of Publication: 2007 Pages

: 336

Description Cardiac resynchronization therapy (CRT) is one of the most exciting new advances in the treatment of chronic severe heart failure associated with dyssynchronous ventricular contraction that is refractory to medical treatment. This new text is edited by 5 experts in heart failure, electrophysiology and non-invasive cardiac imaging and is extensively illustrated with high quality figures and examples of clinical cases. The purpose of the book is to put into perspective this novel therapy with regards to traditional heart failure treatment and to provide criteria for identifying patients likely to have an optimal and sustained response to CRT using a practical “how to” approach. This text begins by describing the background and evolution of the technique to the current implementation and the impact of complications on clinical outcome. There are chapters describing “cutting edge” Doppler echocardiography for assessing dyssynchrony, reverse remodeling and triaging patients into those with greatest likelihood of responding to CRT with illustrative clinical case examples.

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

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D

Six Sigma

in Healthcare

Effective use of the Tool Box

The integration and coordination of the healthcare system’s process improvement tools, utilising Six Sigma concepts, Lean, Management Engineers and Information Services are the key to ensure that processes are first assessed and simplified before introducing anything new.

Maria H Foschi, Assistant Vice President, Virtua Health, USA Adrienne Elberfeld, Six Sigma Champion, Virtua Health, USA

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elivering outstanding patient care in the most safe, efficient manner through streamlined processes is the number one priority for Virtua Health. This is a common goal for many healthcare organisations but it is approached in a very different way at Virtua Health. Rich Miller, President and CEO of Virtua Health explains, “we are dedicated to providing an Outstanding Patient Experience and have harnessed advanced technologies, attracted renowned physicians, employed the very best people in their fields, and instituted processes and procedures to ensure the highest levels of quality and safety—all in the pursuit of providing excellent service within a caring environment.”

Serving and meeting customers’ needs, higher consumer expectations, rising healthcare costs, an ageing population, easy access to information, and continual advancements in technology are some of the challenges healthcare faces today. Through a strategic partnership with GE Healthcare, which began in 2000, Virtua has successfully leveraged the use of the Six Sigma Tool Kit to overcome these challenges.

From Virtua’s perspective, a prodigious benefit of the partnership has been the incorporation of new advanced tools and technologies to ensure the delivery of quality clinical service and patient safety.

Virtua promotes innovation, transformation and sustainment of gains or performance in improvements via the use of the Six Sigma Tool Kit which includes the methodologies of Six Sigma (Define, Measure,

H ealthca r e M anagement

Analyse, Improve, Control), Design for Six Sigma (Design, Measure, Analyse, Design, Verify), Lean, FMEA (Failure Modes Effects Analysis), Workout and most importantly, Change Acceleration Process (CAP). Tools and techniques are continually evolving and added to the Tool Kit. The DMAIC process and Six Sigma methodology tools are utilised across all of the healthcare processes to achieve process improvements in service, patient and family satisfaction, clinical quality and safety and financial performance.

Virtua Health is currently in its seventh year of project activity, where the use of these tools by internal resources of Black Belts, Green Belts, Management Engineers, Information Services, Operations and Clinical Informaticists, have been successful in improving, streamlining and standardising clinical and non-clinical processes throughout the organisation.

Individuals at all levels within the organisation participate in Six Sigma projects and utilise the tools not only in specific projects but also in their day-to-day operations. Upon hire, all employees receive training on the use of DMAIC as the model for improvement. All participants in a DMAIC, DMADV or Kaizen team receive foundational principles training for each Six Sigma process phase. All Virtua managers are required to obtain their Yellow Belt certification, which provides them with a general understanding of the Six Sigma Tool Kit, knowledge of statistical process control and the skills to facilitate the utilisation of these tools. Green Belt training is provided to key project facilitators and is available to anyone at any level within the organisation. All of these training efforts contribute to driving Six Sigma into the Virtua Health culture as the key process improvement method.

Senior management scopes, evaluates, prioritises and sponsors all projects throughout its lifecycle. All levels

of the organisation utilise these tools and participate in these projects. Senior leaders also participate, where titles are “checked at the door” promoting frank, two-way communication and dialogue with direct staff members.

There is a quarterly session at which a report out is provided on the projects utilising the tools and, the results and status are shared with Senior Management. All Senior Leadership including the CEO / President, Executive Vice President of Health Services, CMO and all Chiefs, Vice Presidents and Assistant Vice Presidents are expected to attend.

The report outs are also a way to reinforce empowerment and to motivate the team members by giving staff level employees an opportunity to “shine” by sharing their knowledge and content expertise with Virtua leadership.

Use of Six Sigma has resulted not only in statistically significant and sustained improvements but also recognition at local levels.

The use of the Tool Kit has realised a financial impact of more than US$ 25 million and it continues to grow; however, it is the quality of care influence, that has been most impressive, as the application of the methodologies in project activity has been transformational. Use of Six Sigma, (DMAIC), in addressing Centers for Medicare & Medicaid Services core measures for Cardiac Medication Administration, Pneumonia, Surgical Infection Prevention, and most currently Normothermia (Surgical Care Improvement Project), have resulted not only in statistically significant and sustained improvements but also recognition at national and local levels (Table 1). The application of Design For Six Sigma and Lean concepts partnered with Information Services has resulted

in designing a surgical registration and scheduling system based on the voice of the customer. This methodology was also utilised in creating a Breast Care Navigation Model, which supports patients diagnosed with breast cancer through the continuum of care.

The discipline of using the Six Sigma Tool Kit to obtain the true voice of the customer and rigour in improving current state processes is even more critical as Virtua breaks ground on a state-of-the-art acute care facility and two ambulatory centres, expands various clinical programmes, implements the newest technologies and applies for the Malcolm Baldridge Award for quality. “It’s our ability to identify the key processes that drive our business and work with operations to focus on the appropriate tools and resources to improve these processes that will be critical moving forward”, says Adrienne Elberfeld, Master Black Belt, Six Sigma Champion, Virtua Health.

Virtua Health uses in-process and outcome indicators to monitor the control and improvement of healthcare processes.

These measures are developed in the MEASURE phase of DMAIC when new processes are being designed or current processes are redesigned. Data collection and performance measures are determined in the MEASURE phase.

Critical To Quality (CTQ) are defined by customers as the key requirements of a particular healthcare process is obtained and the CTQ is translated into a “Y” or measurable outcome. During the MEASURE phase of DMAIC, the “Y” data is obtained to understand how the process is performing against customer specifications (defect rate) and a baseline of performance is established.

In ANALYSE, the team utilises the data to understand the process root cause drivers and then develops an improvement plan. IMPROVEMENT strategies are piloted and remeasured to determine if the strategies demonstrate

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Observed improvements Project Start Date

Initial Performance

Current Performance

Cardiac Medications (AMI & CHF)

10/2002

91%

96%

Surgical Infection Prevention (3)

8/2004

86%

98%

Pneumonia Core Measures (5)

4/2005

85%

95%

a statistically significant difference in improving the “Y” while decreasing process variation. In the CONTROL phase, the defined measures are tracked to assure statistical process control (stable and reliable) meet the customer’s specifications. The process is maintained and monitored by the DMAIC process owner. If the process becomes out of control and / or unstable, a review of root causes is commenced, and actions plans are implemented to regain control and stability. If the process owner needs assistance to understand why the process is not in control, resources are made available to implement DMAIC tools.

Improvement strategies developed are compliant with regulatory, accreditation bodies, payers, patient and operational requirements.

Virtua minimises overall costs, reduces redundancy and prevents errors and rework through improvement processes such as Lean, Six Sigma, DFSS and FMEA. These services and processes are piloted to test that errors, rework, safety and functionality requirements are intact.

Ninfa Saunders, Executive Vice President of Health Services, has recently challenged the organisation to also incorporate the Six Sigma Tool Kit in all technology implementations. Saunders states, “rather than just fixing a broken process with a technology solution, Black Belts, Green Belts, Informaticists, Management Engineers, Information Services, Clinicians and Operations will work together to assess the current state and determine which technologies could enhance our processes to deliver the best care to our patients.”

The biggest challenge, both from a resource and process perspective is the technology transformation.

Table 1

The integration and coordination of the system’s process improvement tools, utilising Six Sigma concepts, Lean and CAP have been the key to ensuring that current state processes are first assessed and simplified before introducing any new technology.

The appropriate tools are utilised in all technology implementations both in the clinical and non-clinical departments. The use of the improvement tools is incorporated in the technology project methodology business practice and they result in positive changes to the processes and workflow prior to the technology implementation. Systems are then designed and built to accommodate the new improved workflow. “No longer can new technology be implemented in a silo; it’s the on-going coordination with Operations and using the process improvement tools that will yield the best results”, explains Maria Foschi, Assistant Vice President, Information Services, Virtua Health. “This is a huge cultural change and we wouldn’t be successful if we didn’t appreciate the ‘people aspect’ as we change workflow, process and technologies.”

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Virtua Health is a multi-hospital healthcare system headquartered in Marlton, New Jersey, USA. Its mission is to deliver a world-class patient experience through its programmes of excellence in cancer treatment, cardiology, orthopedics, women’s health, pediatrics, surgery, neuroscience and geriatrics. A non-profit organisation, Virtua employs 7,450 clinical and administrative personnel, and 2,100 physicians serve as medical staff members.

Maria H Foschi is responsible for the management of information technology financials, processes, and planning for Virtua Health.

Foschi has more than 20 years of progressive experience implementing systems and managing information services in multiple areas. Prior to this position, Foschi served as interim CIO / VP of Information Services. She also was Assistant Vice President, Information Services for Customer Relations and Customer Support at Virtua Health.

A uthor

Core Measure / Project Focus

Virtua is utilising all the tools within the Tool Kit as they undertake a major implementation of a fully Electronic Medical Record (EMR) and many other clinical supporting systems.

Key individuals including clinicians, physicians, nurses and corporate staff across the enterprise are looking closely at each of the key healthcare processes early in the EMR planning and designing phases. Workflows and processes are designed to reduce risks and errors while minimising costs.

Systems are then designed and built to support the newly designed workflows and processes.

Voice Of the Customer (VOC) along with the use of all the Six Sigma Tool Kit is the major influence that adds value as Virtua successfully ensures that the delivery of patient care is safe and efficient.

Virtua Health has made effective use of the “Tool Kit” in improving processes and its innovative partnerships with nationally known organisations evolving into an to organisation dedicated to providing a world-class patient experience.

Adrienne Elberfeld is currently the Six Sigma Champion at Virtua Health in Marlton, New Jersey. As one of the Master Change Agents at Virtua, she also coordinated the training and development of the CAP and WorkOut processes. Her responsibilities include overseeing all Six Sigma Black Belts and Green Belts, co-developing curriculum for Six Sigma education, driving system-wide projects and customising the Six Sigma methodology to best suite Virtua’s needs. She is also a Malcolm Baldridge certified board examiner for the New Jersey Quality.

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E x pe r t tal k

Lean and Six Sigma

Transforming healthcare Lean and Six Sigma are powerful tools that help in making the leadership strong.

Jason Lebsack Manager, Six Sigma Nebraska Medical Center, USA

How will the application of Lean and Six Sigma help in improving the quality of services?

I think it will help in a number of ways.

Our organisation looks at the benefits in terms of what we call the ‘Three Goods’ that can come out of a project: improved clinical safety and outcomes for patient, improved efficiency and effectiveness of what you do at the hospital operation and improved work satisfaction among employees. Overall, we are looking at making the jobs easier for staff and for the physicians who practice in the hospital.

How have Lean and Six Sigma jelled when it comes to the healthcare sector?

I think they have jelled very well. In our organisation, for example, we feel like without having Lean as a part of our whole improvement tool kit, we would have not been able to identify many of the improvement opportunities that we have over the last five years within our project work. Because of the access to data and because of the

variations that exist in some process and some complexity, a lot of time can be saved by just using Lean thinking in terms of looking at the flow of people, material and information in a process.

You can find a wealth of opportunities right there. We’ve seen from colleagues around the country some more benefits that ensue through the application of Lean in combination with Six Sigma.

i.e. using it to sometimes work on projects that have no apparent financial benefit that can be clearly attached to it—perhaps, improved patient safety and patient care clinical outcomes are the most common results. I think it has caught up in a different way for a different reason and continues to be used and applied in different ways in many projects with great success.

Do you think Six Sigma has caught on in healthcare the way it has in other service sector industries?

I think so. Especially in last seven years, Six Sigma has caught on substantially within healthcare. The wave of implementation of Six Sigma Lean, has facilitated by the To Err is Human report that happened in late 90s. I think the difference that I see in the way it has caught on in the healthcare vs. any other industry is that their primary focus is on Revenue, Cost reduction and other financially-focussed kind of measures and metrics. In healthcare, you see that spectrum that I talked about before

What about the other parts of the world?

The other parts of the world, I am not so sure. I think that I have a glimpse of it from the conferences that are being held in Europe and other places.

I know from the folks who taught us, GE Healthcare, the consulting firm of General Electrics Healthcare, about the business they are doing in other parts of the world. I’ve also come across examples in recent months of Lean being applied in a number of hospitals across Canada. So, saying that it is growing in its application would be the best way I can describe it.

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E x pe r t T al k

It is said that Six Sigma improves any existing business process by constantly reviewing and retuning the process. How easy or difficult is this in healthcare?

Well, I think that in terms of ease or difficulty, one of the things I say is that it’s not just about how you can apply the technical aspects of either Lean or Six Sigma.

I think, for us the number one issue is the availability of data. A lot of times, when you get into the project, there isn’t any data colleted about what ultimately becomes the outcome measure or many times the input measure that you want to look at. The time and energy it takes for the project team to work through to development of the measurement system is quite considerable. Another important point is of ownership and sponsorship; that is, the leaders and their ability to hold accountability for the behavioural changes and process changes that are going to be a part of the improvement plan from a day-to-day and the long-term perspective. What does not help here in healthcare is that there isn’t necessarily a strong heritage of having operational measurement as a part of the leadership.

How can hospitals scope and create a project roadmap to run Six Sigma projects?

To begin with, there is a need to get a direction from your senior executives on the most important areas for improvement in the organisation. In other words, where do they want their finite resources within their quality improvement group to focus on? If you know those areas of focus, then it is really about using assessment tools, looking at data, spending time doing some initial investigation and getting some requests or some calls from the leadership to find out not just one project that would be helpful in that area but multiples, if any. And then to be able to run parallel projects within a particular area—like for example in our organisation it would be within our Operating Room—along with multiple belts or having one project getting done and the another one starting immediately and continuing to work in that area to get larger scale improvement. The idea of focussing on an area and having focussed projects to get out the little pieces of the problem is the key.

What are the areas to be covered while implementing Six Sigma in healthcare?

There is book by Jim Collins titled Good to Great: Why Some Companies Make the Leap...And Others Don’t, that talks about placing ‘Who’ before ‘What’.What he means is that the focus has to be on the people who are going to be doing work and the talent that you have in the organisation to get the task accomplished. In Six Sigma programmes, we have to look at people who are going to be dedicated resources for leading project efforts. The people need to have a unique combination of the ability to think about the technical, analytical and quantitative parts of what goes along with doing quality improvement work and a strong interpersonal skill set. They have to be able to build trust with a group, build team dynamics within the group and build relationships. So, that’s the one place I can say the effort must start.

What could be the time frame for the implementation?

When we were first taught about Six Sigma from GE Healthcare, they talked about a 4-6 months as the time frame for a project to go from beginning and defining phase to getting to an improvement and initiating a hand-off. That is the typical time frame we try to shoot for a good project. At the low end, we’ve had project where we worked on a 3060 days time frame. But they tend to be very focussed efforts on a very specific issue. We’ve had other projects at the maximum that have gone on for 18–24 months to get a particular thing solved.

And the thing I would emphasise about this is: it all depends on what you would call a project. Learning from experiences as an organisation is what adopting Six Sigma and Lean is all about. What we thought of as a single project today, we probably think about as three or four or

five distinct projects. And so, a piece of advice that I give to folks who are just getting started is to really focus on scoping down your projects to as narrower a topic as you can and think about getting improvements committed in that before going to the next thing, rather than trying to bite off a very huge chunk and feeling kind of defeated because it takes a long time to get all the things in place.

What happens after the implementation?

After you have initially implemented something what you should hope to have done is demonstrate your goal.

Once you can demonstrate a goal in first one or two projects, the key is to continue to build knowledge and skills within the organisation and the ability to lead projects gained by black belts and green belts.

Another key is to build in some steps for self-sustainability for teaching and mentoring projects. So, you will be working to develop those who are the internal master black belts so that you don’t have to rely upon external consulting to keep going. The focus then would be to continue to work all the way down to the staff level to build that skill set. In summary, the answer would be, continue to get the people to understand what it means to apply Six Sigma, and then you just need to continue to work on getting better at how you do it from the stand point of how long your projects take, how well you scope the project and learn from previous project work that you do— both for the improvements to come out of it and the way that you went about doing the project.

Do the benefits outweigh the costs involved in adopting Six Sigma?

You are asking the question to a biased guy. I say, absolutely they do, if you are committed. And this is the big If. If you are committed to applying the tools and principles appropriately, if you are dedicated to the idea that you are going

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E x pe r t tal k

to follow a process, that you are going to use data to drive decisions, that you are going to involve the people who are close to the work to come up with solutions and recommendations for improvements, Then you are going to put in accountability structures to hold people to keep up the improvement that would be made. So, absolutely, the benefits outweigh the cost and you have to look at it in healthcare to be a bigger thing than simply the financial returns that you get.

Considering the importance of the organisation’s leadership, could it be a roadblock to the success of a project?

Absolutely. The way I would describe the leadership and its importance is that I would say it is a critical, but not sufficient, component to making all this kind of work successful. What I mean by that is, if you do not have senior executive support, if you do

not have them serving as the people to be communicating the importance of quality improvement, as the people who are removing barriers in terms of getting improvement projects moving down the road and to be sponsored, if they are not the folks providing direction in terms of focal areas for where they would like the resources to be deployed, if they are not playing a part in holding people accountable, it will not work.

But, when I say it’s not sufficient, I say that a strong set of leadership in the absence of having people who are leading the project and most importantly the staff who are engaged and motivated in recognising the rewards of being involved in the actual problem solving. So, you need both pieces of it. But I am yet to see an example of an organisation who is successful in applying either Six Sigma or Lean where they did not have strong leadership.

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Could you share with us a real life situation from your experience, where the top management’s role was epitomised?

There are several examples. In one of the projects, some of the improvements that had come out were about getting some physical, technological changes and enhancements to the nursing ward. The work was queued up within the various groups of the hospital and wasn’t moving along. The sponsor of the project was made aware of that through the concerned black belt and got directly involved in working backwards with the areas responsible and initiated a continued follow-up with them. He got the work queued up and finished in the time frame needed.

Project sponsors in a number of situations have had to address leadership concerns in the areas involved.

In some cases this has meant making leadership changes.

medical sciences

The Changing Face of Cancer Implications for Anaesthesia

Given the unique skills of anaesthesiologists in pain management and regional anaesthesia, the role of anaesthesiologists is increasing in the care of cancer patients.

Thomas W Feeley Helen Shafer Fly Distinguished Professor Anesthesiology and Head, Division of Anesthesiology & Critical Care The University of Texas M.D. Anderson Cancer Center, USA

T

he global burden of cancer is increasing. Currently, about 11 million people develop cancer and 6.2 million people die every year.

This represents a greater than 15 per cent increase since 1990 in both incidence and mortality. Worldwide, 12 per cent of deaths are due to cancer, which is the third leading cause of death following infections and cardiovascular diseases. In the industrialised world, one in four people die from cancer. In the US, the lifetime risk of developing cancer is an astounding 41 per cent.

Cancer incidence in the developed world is twice that in the developing world.

This is due to the earlier onset of tobacco epidemic, earlier exposure to occupational carcinogens and the western diet and lifestyle. Worldwide, one-third of new cases are preventable while another third are amenable to early detection and treatment. Pain and palliative care strategies enhance quality of life but access to these services is limited.

Trends in cancer cases

By 2020, the global cancer burden is expected to rise by 50 per cent due

to increasing age of populations and rising trends in cancer risk factors. In the developed world, this explosion of cancer cases is beginning to happen due to the confluence of two trends.

The first is the fact that cancer strikes people over the age of 50 with greater frequency than it does youth. Both the incidence and mortality for cancer rises dramatically in people over the age of 50, and by age 60 that rate increases with each additional year.

The second trend, in the US in particular, is that the population is rapidly ageing due to the so called “baby boom

Pain management and palliative cancer care are the areas where anaesthesiologist can have significant impact worldwide.

generation” which began after the World War II. In 2008, the US population over the age of 50 will be about 91 million and by 2025 that number will rise to 130 million—a 42 per cent increase in 17 years or about one generation.

While mortality rates for cancer in the developed world have begun to decline, the increased number of cases will have dramatic implications for healthcare delivery systems within the first quarter of the 21st century. Currently in the US, cancer has surpassed cardiac disease as the leading cause of death of individuals under the age of 85.

Cancer in the developing world

By 2020, new cancer cases will grow from 11 million to 15 million per year and over 75 per cent of the new cases will be in the developing world. These countries will have only 5 per cent of the treatment resources. While cancer is a major problem worldwide, there are marked geographical differences in incidence and type. The most common cancers worldwide are breast, colorectal, prostate, cervical with the most lethal being lung, stomach and liver.

Preventing cancer is easier, cheaper and more effective than treating it. To transfer medical technology “as it is” to developing countries is difficult and usually economically impossible.

While prevention and treatment are desirable, most cases are diagnosed late with surgical resection being the only realistic treatment possible. Of India’s 1 billion people, for example, the incidence of cancer is 1 million per year with 80 per cent deemed incurable at the time of diagnosis.

Chemotherapy and radiation therapy are costly and are not widely available in most developing countries. Palliative care is a key priority but access to those services is also restricted since narcotic access is limited in many developing countries to prevent misuse of drugs. More than half of all cancer deaths occur in developing countries.

Resources for diagnosis and treatment of cancer in developing countries are limited or non-existent.

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M edical sciences

Cancer and the anaesthesiologist The unique skills of anaesthesiologists in pain management; regional anaesthesia, airway management and critical care make them important members of the healthcare team treating cancer patients. The functions of anaesthesiologist include management of the patient undergoing surgical and diagnostic procedures, management in the Intensive Care Unit (ICU), and management of cancer pain and delivering palliative care services.

During surgical anaesthesia, the anaesthesiologist must always be concerned about the airway. The highest prevalence of difficult airways, known, suspected and unrecognised, occur in cancer patients, especially those with head and neck malignancies. Additionally, chemotherapy can adversely affect cardiac, pulmonary and renal function. Radiation therapy can also have adverse effects on heart, lungs and the airway. The patient’s age and history, concurrent disease also influence the outcome.

In the ICU, the use of mechanical ventilation for post-operative ventilation is commonplace. Non-invasive ventilatory support is commonly used as a bridge to reintubation and intubation can be avoided in up to half of

properly selected patients using mask and pressure support ventilation.

Additional useful strategies in treating cancer are to minimise invasive monitoring; provide good pain management with regional anaesthesia and epidural techniques as needed.

Special attention should also be paid to prevention of ICU acquired infections such as Catheter Related Blood Stream Infections (CRBIS) and Ventilator Associated Pneumonias (VAP), which increase length of stay and morbidity in some patient populations. Care bundles for managing all patients receiving ventilatory support and requiring invasive venous access have been shown to reduce these infections.

Pain management and palliative cancer care are the areas where anaesthesiologist can have significant impact in the care of patients worldwide. It is estimated that 50 per cent of all cancer patients experience pain at some point of their illness; 70-80 per cent of all advanced cancer patients experience pain, 50 per cent moderate to severe pain, and 30 per cent severe pain. Pain management and palliative care are closely related—hence this tremendous role for anaesthesiology.

Cancer treatment disparities

1 million people experience cancer pain in India alone every year.

The simple implementation of known pain and symptom control techniques using narcotic analgesics could improve the lives of many patients dying of cancer. However, a major problem in developing world is simply obtaining and distributing narcotic analgesics.

For many years, the WHO has advanced its “pain ladder” approach to pain management in the cancer patient. According to this approach, if pain occurs, there should be prompt oral administration of drugs in the following order: nonopioids (aspirin

Tremendous disparities exist worldwide in the way cancer is treated. In the developed world, modern surgery, radiation and chemotherapy, often in combination with personalised and molecularly targeted approaches, have prolonged the time taken for cancer treatment. In the developing world, cancer is generally detected at a very advanced stage. As a result, the treatment would be limited only to palliative care to relieve suffering.

The WHO estimates over 50 per cent of cancer patients worldwide suffer unrelieved pain. It is estimated that

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and paracetamol); then, as necessary, mild opioids (codeine); then strong opioids such as morphine, until the patient is free of pain. To calm fears and anxiety, additional drugs—“adjutants”—should be used. To maintain freedom from pain, drugs should be given “by the clock”, that is every 3-6 hours, rather than “on demand”. This three-step approach of administering the right drug in the right dose at the right time is inexpensive and felt to be 80-90 per cent effective.

Anaesthetic and surgical intervention on appropriate nerves may provide further pain relief if drugs are not wholly effective. The use of such interventional techniques for pain management has been advocated by some a fourth step on ladder. This so-called fourth step on the ladder of interventional pain management has been poorly studied but could be more applicable than previously understood.

Local anaesthetics are more widely available than opioids, especially in some parts of the developing world and the skills required to provide nerve blocks are easily acquired by anaesthesiologist. The most useful interventional pain management procedures are celiac plexus block, epidural infusions, vertebroplasty, intra-thecal neurolytic blocks and intrathecal pumps.

Opioid availability is a major impediment to providing cancer pain relief in the developing world. In India, the Narcotic Drugs Act of 1985 produced stringent rules to prevent misuse and resulted in severe shortages of narcotics for care.

By 2004, 8 of 25 states amended their laws to liberalise the availability of narcotic analgesics. However, narcotic availability needs improvement at the local level in all countries. Worldwide data regarding the availability and use of narcotics has been compiled by researchers at the University of Wisconsin and demonstrate dramatic differences in the availability of these drugs, especially in developing nations.

M edical sciences

patients in Kerala. They provided free service and discovered that narcotic diversion was minimal and successfully brought palliative care services to villages and people who needed it most. More needs to be done; Dr Rajogopal estimates that currently less than 1 per cent of India’s 1.6 million people suffering from cancer pain get relief in Kerala since restrictive laws and fears limit narcotic availability in other states. In 2007, India’s Health Minister, Dr Anbumani Ramadoss, intervened with the Parliament to increase its national cancer plan’s budget for palliative care, thanks A uthor

A shining example of what can be done in palliative care comes from India. In the state of Kerala, which has a population of 30 million, 30,000 new cancer cases are adding every year.

Kerala liberalised their narcotic access in 2000. Cancer care is provided in six hospitals and one Regional Cancer Center. Cancer treatment is available on payment. However, most patients can afford limited treatment. The average daily income is US$ 0.25 and average daily cost of palliative care is US$ 1.

The Pain and Palliative Care Society, led by Dr M R Rajogopal, an anaesthesiologist who is the father of palliative care in India, developed a network of 33 palliative care clinics throughout Kerala. They provide outpatient treatment with home support with volunteer community assistance.

In 2000, they treated 6,000 new patients or about 25 per cent of cancer

largely to the efforts of physicians like Dr Rajogopal and others.

Conclusion

In summary, cancer is becoming an increasing health problem worldwide as world population ages and western lifestyles encroach upon developing nations with limited resources. Anaesthesiologists can have important roles not only in the OR and ICU where patients are treated, but also in pain centres and the community where improved palliative care and pain management can impact the lives of millions suffering from this disease.

Thomas W Feeley is Division Head of Anaesthesiology & Critical Care and VP for Medical Operations at UT MD Anderson Cancer Center. He has served in this capacity for the past ten years and coordinates the medical operations of the institution to ensure high quality and safe patient care.

BOOK Shelf

Cancer Pain Management

Description Introducing the first definitive guide to pain management in the cancer patient This pioneering book is the first to provide in-depth coverage of all the interventional and medical strategies needed for effective cancer pain management. Logically organized, this immensely practical guide starts with general principles in cancer pain management, followed by management of specific cancer pain syndromes, unique issues, interventional techniques, and other specialized approaches. Reflecting an approach to pain management developed at the prestigious M. D. Anderson Cancer Center, Cancer Pain Management addresses the full spectrum of cancer pain syndromes and reviews the selection and administration of various treatment options.

Cancer Pain Management features: • Discussions of the psychosocial aspects of pain and how to resume and retain function for specific pain- or disease-affected areas, such as in muscle tissue and bowels • An incisive examination of all cancer pain syndromes

Editor(s) : Michael Fisch Allen Burton Year of Publication: 2006 Pages

: 544

• Evidence-based pain management algorithms for each pain syndrome (included in each chapter) and synoptic tips for ensuring optimal patient care and pain relief • Special issues in cancer pain management, such as ethical issues; dealing with regulatory concerns related to the prescription of opioids; chronic pain in the cured cancer patient; complementary and alternative approaches to cancer pain; intervention, spiritual, family and cultural issues; wound care; and procedural pain management • Coverage of advanced technical protocols involved in interventional pain management

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

• Chapter-ending summary bullets and references that provide important opportunities for further study • Helpful, practical appendices • And more

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Multidisciplinary Collaboration in the ICU Promoting effective care

Collaboration and communication among all the team members of the Intensive Care Unit (ICU), where patient activity is high, goes a long way in promoting effective care of critically ill patients.

Ruth M Kleinpell Professor Rush University College of Nursing, USA

C

ollaboration between physicians and nurses is an important component of effective care in the hospital setting. When working together toward common goals, collaboration has been identified as a way of improving care for the critically ill patients as it enables input from the multidisciplinary team members in promoting decision-making based on more useful information. Patient care depends on the interactions of various providers, especially in the Intensive Care Unit (ICU), where patient acuity levels are high and critical illness states often result in sudden changes, some of which are life-threatening. As a result, collaboration is vital in ensuring appropriate care and treatment of the critically ill patient.

The importance of collaboration and communication and its impact on patient outcomes in the ICU is well recognised by many national and international organisations. The Joint Commission, the American Association of Critical Care Nurses, the Society for Critical Care Medicine and the National Institutes of

Health have previously advocated for interdisciplinary communication and collaboration for patient care in the ICU. Recent recommendations from the American College of Chest Physicians and the American Association of Critical Care Nurses also focus on the importance of skilled communication and true collaboration as essential elements for transforming work environments. The Society of Critical Care Medicine’s clinical practice guidelines for patient-centered care in the ICU advocate for communication and shared decision-making to enhance care for the critically ill patient. Most recently, the results of a critical care consensus initiative identified that improving communication among providers and formal training on the interdisciplinary team model are advocated to improve the management of ICU services. As communication and collaboration are essential to patientfocussed care, open communication and interdisciplinary collaboration are key components in achieving patientcentred care and meeting patient care goals.

Clinical practice guidelines for patient-centered care highlight that collaboration, good communication skills and conflict management skills are needed for the shared decision making model to be effective in the ICU. Characteristics of

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collaboration include collegiality, communication, cooperation, mutual trust, respect and shared decisionmaking (Table 1). Research has demonstrated associations between increased nurse-physician collaboration and lower risk of negative patient outcomes including lower risk of re-admission to the ICU and risk-adjusted mortality. In a series of prospective multisite studies, Shortell, Knaus, and Zimmerman and colleagues Qualities Essential for Building Collaboration • Cooperation • Shared decision-making • Communication • Dependability • Willingness to listen • Accessibility • Reliability • Open dialogue • Teachable Willingness to listen & learn new things

• Intelligence Ability to work independently

• Modest Not afraid to ask questions if something wasn’t known or understood

• Team player Table 1

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changes, consultations, family communication and other aspects of care can be discussed among the team to clarify the focus of patient care for the day.

Use of the daily goal sheet promotes collaboration among the ICU team members as it establishes priority areas of patient care and promotes further discussion throughout the day with updates for team members. In working to achieve the patient goals identified in the daily goal sheet, ICU team members further collaborate to meet those goals.

Opportunities for improving collaboration

A number of opportunities have been identified for improving collaboration in the ICU including participation of the multidisciplinary team in grand rounds, research and quality improvement initiatives (Table 2). Rapid response teams are one specific example of an institution-wide initiative that promotes collaboration among the ICU team members who serve as responders. Forming multidisciplinary teams to address clinical issues, formulating new protocols, or implementing best practices help to promote collaboration among the ICU team members. Specific examples of initiatives include forming a committee or task force to focus on sepsis identification, management, and implementation of the Surving Sepsis Campaign Guidelines, targeting hypoglycemia prevention for patients on intravenous insulin protocols, or promoting palliative care consultations in the ICU. Conducting research in

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demonstrated that organisational characteristics including communication and collaboration influenced patient outcomes. In examining characteristics of effective care in the ICU in 17,440 patients across 42 ICUs, Shortell and colleagues found that caregiver interaction including leadership, coordination and communication was significantly associated with lower risk of adjusted length of stay (beta=.34), lower nurse turnover (beta=-.36), higher evaluated technical quality of care (beta=.81) and greater evaluated ability to meet family members needs (beta=.74). In a sample of 3,672 ICU admissions involving 316 nurses and 202 physicians, Zimmerman and colleagues demonstrated that superior organisational practices among ICUs with increased risk-adjusted survival were related to a patient-centered culture, strong medical and nursing leadership, effective communication and coordination and open, collaborative approaches to solving problems and managing conflict.

Additional studies have found significant associations between the use of effective multidisciplinary rounds and collaboration. In a study assessing the impact of an intervention focussed on improving communication and collaboration in the ICU which included daily multidisciplinary rounds, the addition of a nurse practitioner and the appointment of a hospitalist medical director to oversee patient care, increased collaboration.

This is attributed to the interactions of the nurse practitioner with medical and nursing staff along with multidisciplinary rounds. The use of a daily goal sheet in rounds can be a useful adjunct to promote awareness of the patient care goals as well as to promote improved communication and collaboration in the ICU. In using a goal sheet on daily rounds, the patient care goals for the day can be discussed and areas that need addressing can be easily identified. For example, ventilator weaning goals, nutritional goals, medication

Opportunities for Collaboration in the ICU • Patient care • Daily rounds • Institutional recognition i.e. Grand rounds • Quality improvement projects i.e. implementation of the surviving sepsis campaign guidelines; targeting hypoglycemia prevention for patients on intensive insulin therapy

• Specific initiatives i.e. rapid response teams

• Scholarly writing projects • Professional presentations • Community projects • Research Table 2

the ICU offers additional experiences to promote collaboration among the ICU team. Other opportunities including publications and presentations of ICU team initiatives at local, regional and national forums, also promote collaboration among the ICU team members.

Summary

Multidisciplinary collaboration in the ICU is vital in ensuring appropriate care and treatment of the critically ill patients as well as an important component of establishing and meeting patient care goals. Collaboration should be encouraged and promotedon the ICU team as it is an essential component of high performance and helps to promote best patient outcomes.

Ruth M Kleinpell is currently the Director for Clinical Research and Scholarship at Rush University Medical Center and a Professor at Rush University College of Nursing. She maintains active practice as a Nurse Practitioner at Our Lady of the Resurrection Medical Center in Chicago, Illinois. She is an experienced researcher and clinician, an active member of several critical care organisations, and a member of the editorial boards of several journals.

She is also a fellow of the American Academy of Nursing, the American Academy of Nurse Practitioners, the Institute of Medicine of Chicago and the American College of Critical Care Medicine.

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Targeting the Stress of Diabetes Preserving vascular longevity Diabetes Mellitus occurs in more than 165 million individuals worldwide and leads to both acute and longterm cardiovascular complications that can be tied to cellular oxidative stress. Three exciting novel therapeutic strategies offer significant promise to extend vascular longevity.

B

y the year 2030, it is predicted that more than 360 million individuals will be affected by the complications of Diabetes Mellitus (DM). Type 1 DM, also known as insulin dependent DM, affects approximately 10 per cent of diabetics while type 2 DM, non-insulin dependent DM, is found in the remaining majority of diabetic indi-

Kenneth Maiese Professor Departments of Neurology and Anatomy & Cell Biology Barbara Ann Karmanos Cancer Institute Center for Molecular Medicine and Genetics, Institute of Environmental Health Sciences Wayne State University School of Medicine, USA

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viduals. Furthermore, the significance of DM and its complications in the vascular system should not be underestimated, since it is believed that the incidence of undiagnosed DM in the population worldwide is increasing.

Individuals with impaired glucose tolerance have a risk of developing diabetic complications two times greater than those with normal glucose tolerance.

M edical sciences

Both type 1 and type 2 DM can lead to complications in the cardiac and vascular systems, such as impairment of vascular integrity and alter cardiac output that may ultimately affect brain cognitive function. DM can increase the risk of vascular dementia in elderly subjects and can potentially alter the course of Alzheimer’s disease. Some studies suggest a modest adjusted relative risk of Alzheimer’s disease in patients with DM compared to those without diabetes to be 1.3. Costs to care for cognitive impairments resulting from DM that can mimic Alzheimer’s disease can approach US$ 100 billion per year.

Diabetes Mellitus and oxidative cell damage

Although a number of pathways in the body can lead to DM most of its complementory arise due to cellular oxidative stress. During oxidative stress, the release of Reactive Oxygen Species (ROS) occurs, that is associated with mitochondrial DNA mutations.

These processes together can lead to apoptotic cellular injury.

Apoptosis, also known as programmed cell death, can contribute to several disease states such as DM, dementia, stroke, and trauma. At the cellular level, apoptosis has an early occurrence that leads to the exposure of Phosphatidylserine (PS) residues, which can attract immune system cells for the phagocytosis of injured cells and a later event that involves the cleavage of genomic DNA into fragments. Mitochondrial membrane transition pore permeability is also increased during oxidative stress that results in a significant loss of mitochondrial NAD+ stores and the further generation of ROS. In disorders such as DM, elevated levels of ceruloplasmin have been suggested to represent increased ROS and acute glucose fluctuations have been described as a potential source of oxidative stress. Elevated serum glucose

also has been shown to lead to increased production of rROS in endothelial cells. However, prolonged duration of hyperglycemia does not necessarily lead to oxidative stress injury, since even short periods of hyperglycemia can generate ROS in vascular cells. Recent clinical research correlates support these experimental studies to show that acute glucose swings in addition to chronic hyperglycemia can trigger oxidative stress mechanisms in DM. The maintenance of cellular energy reserves and mitochondrial integrity also becomes a significant factor in DM, since insulin resistance in the elderly also has been

Both type 1 and type 2 DM can lead to complications in the cardiac and vascular systems.

associated with reduction in mitochondrial oxidative and phosphorylation activity.

Identifying novel strategies to tackle vascular injury A precursor for the coenzyme ß-nicotinamide adenine dinucleotide (NAD+)

One potential pathway to consider for the maintenance of cellular metabolism in DM is nicotinamide, a precursor of the coenzyme ß-nicotinamide adenine dinucleotide (NAD+). Oral nicotinamide protects ß-cell function and prevents clinical disease in islet-cell antibody-positive first-degree relatives of type 1 DM. Furthermore, treatment with nicotinamide in patients with recent onset type 1 DM, combined with intensive insulin therapy for up to two years after diagnosis, can significantly reduce HbA1c levels. In addition, nicotinamide has been shown to reduce intestinal absorption of phosphate and prevent the development of hyperphosphatemia and progressive renal dysfunction, which would be of significant medical

assistance to diabetics with renal compromise. During periods of oxidative stress, nicotinamide can improve glucose utilisation and prevent excessive lactate production in ischemic animal models.

Nicotinamide is believed to be responsible for the preservation of endothelial cell integrity during periods of oxidative stress and it assists left ventricular cardiac function. Nicotinamide also employs the modulation of unique transcription factor pathways, such as with the forkhead family member Foxo3a, to promote cellular protection. The NAD+ precursor may derive its protective capacity through two separate mechanisms of post-translational modification of Foxo3a. Nicotinamide can not only maintain phosphorylation of Foxo3a and inhibit its activity, but also can preserve the integrity of the Foxo3a protein to block Foxo3a proteolysis that can yield pro-apoptotic amino-terminal fragments.

Cysteine-rich glycosylated Wnt proteins

Wnt proteins, derived from the Drosophila Wingless (Wg) and the mouse Int-1 genes, are secreted cysteinerich glycosylated proteins that can control cell proliferation, differentiation, survival and death. Abnormalities in the Wnt signaling pathways, such as with transcription factor 7-like 2 gene, may yield an increased risk for DM in some populations and have increased association with obesity. Other studies demonstrate an increased expression of Wnt family members in adipose tissue, the pancreas, and the liver in diabetic patients, illustrating a potential regulation of adipose cell function by Wnt. Impaired Wnt function has also been observed in patients with the combined metabolic syndrome of hypertension, hyperlipidemia and DM. Interestingly, Wnt may offer glucose tolerance and increased insulin sensitivity and also protect kidney cells from elevated glucose injury and apoptosis. New work shows that Wnt is sufficient for cellular protection during

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M edical sciences

A growth factor and cytokine

EPO is a 30.4 kDa glycoprotein with approximately 50 per cent of its molecular weight derived from carbohydrates. As a growth factor and cytokine, EPO is considered to be ubiquitous in the body, since it can be detected in the breath of healthy individuals. Although EPO is currently approved for the treatment of anemia, the role of EPO is far-reaching beyond the need for erythropoiesis. Plasma EPO is often low in diabetic patients whether or not anemia is present and is believed to have limited response to progressive anemia onset in diabetics.

However, EPO secretion is regulated in diabetic pregnancies that may suggest the body’s effort to protect against the complications of DM. Treatment with EPO has been shown in diabetic patients with severe, resistant congestive heart failure to improve vitality, increase cardiac output, and remarkably decrease the number of required days in the hospital. In studies that examine the toxic effects of elevated

glucose upon vascular cells, EPO is protective and prevents early apoptotic membrane PS exposure and late DNA degradation in vascular cells at concentrations that are clinically relevant.

Vascular protection by EPO is closely tied to the maintenance of mitochondrial membrane potential to prevent cell injury and the subsequent blockade of apoptotic cascades.

Yet, similar to nicotinamide, EPO may require the forkhead transcription factor Foxo3a to prevent vascular injury during DM. Foxo3a is involved in pathways responsible for cell metabolism, DM onset, and diabetic complications. Administration of a high-fat diet in animals induced with hyperinsulinemic insulin-resistant obesity was associated with an increased expression of Foxo3a.

Additional studies have linked diabetic nephropathy to Foxo3a, by demonstrating that phosphorylation of Foxo3a increases in rat and mouse kidney cells, after the induction of diabetes by streptozotocin. Interestingly, prevention of Foxo3a activation

by EPO during oxidative stress, also protects against vascular cell injury.

Considerations for the future

Although application of novel agents and pathways may offer great promise to extend vascular longevity during conditions such as DM, nicotinamide, Wnt and EPO can raise potential concerns similar to the consideration of any new therapeutic strategy. For example, in some reports nicotinamide has resulted in impaired ß-cell function.

Although nicotinamide can protect cells

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against oxidative stress in millimole concentrations, lower concentrations of nicotinamide can inhibit sirtuin function that may be beneficial and that has been tied to increased lifespan in yeast and metazoans. In addition, both Wnt and EPO, under certain conditions, have been associated with malignancy. For example, EPO may sometimes enhance tumour progression by assisting with tumour angiogenesis. EPO has also been associated with increased incidence of thrombotic vascular effects, progression of cardiac insufficiency, potential vascular stenosis, elevation in mean arterial pressure, and increased metabolic rate and blood viscosity. It is, therefore, evident that for novel therapeutic strategies to effectively and safely extend vascular cell longevity, future studies that involve basic and clinical research must carefully and systematically address both the potential benefits and disadvantages of new therapies. As a result, enthusiasm for developing new therapeutic agents to preserve vascular longevity during debilitating conditions such as DM will continue to grow at an exponential pace and avoid clinical complications to offer patients the best available care.

Acknowledgments This work was supported by the following grants (KM): American Diabetes Association, American Heart Association (National), Bugher Foundation Award, Janssen Neuroscience Award, LEARN Foundation Award, MI Life Sciences Challenge Award, Nelson Foundation Award, NIH NIEHS (P30 ES06639), and NIH NINDS/NIA.

Kenneth Maiese is a physician-scientist. At present, he is the Chief of the Division of Cellular and Molecular Cerebral Ischemia and is Professor in Neurology, Anatomy & Cell Biology, Barbara Ann Karmanos Cancer Institute, Molecular Medicine, and the Institute of Environmental Health Sciences at Wayne State University School of Medicine. His investigations are designed to translate basic science into successful therapeutic treatments for conditions such as metabolic disorders, cancer, cardiovascular disease, diabetes, stroke, and Alzheimer’s disease.

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elevated glucose exposure and is a vital component for vascular protection provided by growth factors such as erythropoietin (EPO). Wnt prevents apoptosis through the inhibition of glycogen synthase kinase-3ß (GSK-3ß) and ß-catenin. Inactivation of GSK-3ß by small molecule inhibitors or RNA interference, prevents toxicity from high concentrations of glucose to suggest a possible targeting of GSK-3ß during DM. Clinical applications for GSK-3ß that are tied to EPO are also worthy of consideration.

The benefits of EPO to improve cardiovascular function in diabetic patients and the positive effects of exercise to improve glycemic control during DM appear to rely upon the inhibition of GSK-3ß activity. EPO can prevent GSK-3ß activity and combined with exercise may offer synergistic benefits, since physical exercise also has been shown to phosphorylate and inhibit GSK-3ß activity.

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M edical sciences

Embolic Protection During Carotid Stenting Using FiberNet device

The FiberNet device is the first embolic protection device, which combines features of a filter, and an occlusion device in one system to overcome the complications of carotid angioplasty like distal embolisation of debris.

Jennifer Franke CardioVascular Center Frankfurt, Germany Horst Sievert CardioVascular Center Frankfurt, Germany and Washington Hospital Center, USA

A

fter having performed angioplasty in coronary and peripheral vascular disease with excellent results, carotid angioplasty was thought to be an opportunity to simplify the treatment of carotid stenosis. Until then, there was no apparent reason to protect patients against distal embolisation. With the development of carotid angioplasty and stenting, prevention of distal embolisation of arteriosclerotic debris and thrombus became a main focus of the intervention. There has been rapid development in new techniques and equipment for carotid artery stenting, including embolic protection devices as adjunctive devices to trap potentially harmful debris that is dislodged during the procedure.

Several physicians have reviewed the results for carotid artery stenting with and without embolic protection devices and have shown superior results utilising embolic protection devices during percutaneous interventional procedures. The use of embolic protection devices as an adjunctive device during carotid artery stenting procedure has

now become a standard of care. There has been little interest in conducting randomised trials to examine carotid stenting both with and without embolic protection. Most physicians believe that debris that can be seen in the filters is evidence enough. Another explanation is that the complication rate of carotid interventions without embolic protection devices is already low (<5 per cent), which means a large number of procedures would be necessary to prove the benefit of these devices. Currently, there are three types of embolic protection devices for carotid arteries: Distal filter devices, distal occlusion systems and proximal occlusion systems.

• Distal filter devices generally capture only up to a certain size of the particle while allowing continuous blood flow throughout the procedure. Most of these devices have a pore size of 100 microns or larger. Potential disadvantages with filter devices include problematic tracking of the device to the proper location for deployment, the inability to capture small particles, and poor apposition in eccentric or severely diseased vessels.

• Distal occlusion devices interrupt flow to the lesion. The debris from the interventional procedure is aspirated prior to deflating the device. These devices have a low-crossing profile and allow the potential capture of particles less than 100 microns that

are dislodged during the procedure.

The disadvantage of occlusion devices is the temporary restriction of blood flow in the artery, which may not be well tolerated by patients.

• Proximal occlusion devices interrupt blood flow from the common carotid artery to the lesion along with blocking flow in the external carotid artery.

The debris from the interventional procedure is aspirated prior to deflating the device. These devices allow for the potential capture of particles less than 100 microns that are produced from the procedure. Proximal occlusion devices do not require a device to cross the lesion prior to protection. The disadvantage of proximal occlusion devices is, as with the distal occlusion devices, the temporary restriction of blood flow in the artery, which may not be well tolerated by the patient. These devices also require a large introducer sheath and are quite bulky compared to the other available protection devices.

First-in-man trial

The first-in-man trial was reported by M. Henry et al. in June 2007. Since then, 35 high-grade lesions of the internal carotid artery have been treated in 34 patients by stent implantation under embolic protection with the new FiberNet device. Mean patient age was 71.4 ± 8.8 years (range 50-85 years).

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M edical sciences

FiberNet - The technology FiberNet device - Closed

Figure 1

FiberNet device - Expanded

Figure 2

Retrieval Catheter

Figure 3

67.6 per cent were male. 29.4 per cent of the lesions were symptomatic.

The procedure was technically successful in 34 / 35 (97 per cent) interventions. There was no stroke or death within 30 days. Two permanent amaurosis and one amaurosis fugax occurred. Visible debris was captured in all cases. No changes were noted in CT/MRI during 30 days

The FiberNet device developed by Lumen Biomedical is the very first embolic protection device, which incorporates the advantages of both occlusion, and filter distal protection devices. The proprietary filter design promotes conformability to asymmetrical vessels, minimising openings through which emboli can pass.

The unique 3D filter design has the goal of providing continuous blood flow and efficient capture of emboli as small as 40 Microns (µm). In addition, the FiberNet has a low-crossing profile (1.7–2.9 French). All of these features could lead to possible advantages of the FiberNet device and meeting unique needs over the other commercially available embolic protection devices.

Device specifications The FiberNet Embolic Protection System is a filter system mounted on a 0.014 high-performance guide wire. It is designed to be placed distal to the vessel lesion. The system consists of an expandable, threedimensional Polyethylene Terephthalate (PET) fiberbased filter mounted onto a 190 cm long wire, an aspiration catheter and retrieval catheter. The FiberNet device has radiopaque markers for visualisation of the device under fluoroscopic imaging. The FiberNet device is shown in Figure 1 (closed) and Figure 2 (expanded). When deployed, the filter device is designed to capture and recover emboli that may be produced during the interventional procedure while allowing antegrade blood flow to continue. Upon completion of the procedure, the retrieval catheter is advanced over the wire and positioned just proximal to the expanded filter. The retrieval catheter is shown in Figure 3. A syringe is used to provide suction through the retrieval catheter while the filter is collapsed and drawn into the catheter. The entire system is then removed and discarded.

post-procedure. The mean surface area of debris caught was 63.8 mm² (range 37.7-107.5mm²).

EPIC European Study Evaluating the use of the FiberNet Embolic Protection Device in Carotid Artery Stenting

Recently, enrolment in the European multi-centre EPIC study (FiberNet™ Emboli Protection Device

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in Carotid Artery Stenting Study) has been completed. Data presentation is pending. Patients with symptomatic, atherosclerotic stenosis ≥50 per cent or asymptomatic atherosclerotic stenosis ≥70 per cent of the internal carotid artery according to NASCET (North American Symptomatic Carotid Endarterectomy Trial) Criteria were included.

M edical sciences

Plaque debris analysis

In addition to the feasibility study, plaque debris was collected during randomly selected carotid stenting procedures in which the FiberNet device and other CE marked embolic protection devices were used. Visible debris was captured in all cases. The debris was classified for quantity, analysed

histologically and differentiated into atheromatous plaque, cholesterol crystals or macrophage foam cells. Data evaluation is still pending. But, our experience shows that the average mean debris surface area captured with use of the FiberNet device or with proximal occlusion devices was larger than with the use of existing competitive filter devices.

RETRIEVE Feasibility Study Evaluating the Use of the FiberNet Embolic Protection System in Saphenous Vein Grafts

This is a multi-center prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during Saphenous Vein Graft (SVG) intervention. This study will enroll up to 30 participants in up to 10 centres in the United States and Europe.

The lesion must be located within the SVG and must be ≥50 per cent and <100 per cent stenosed. The patient

BOOK Shelf

Common Clinical Dilemmas in Percutaneous Coronary Interventions

Editor(s) : Eulogio Martinez Pedro A Lemos Andrew T L Ong Patrick W Serruys Year of Publication: 2007 Pages

: 352

may have one or two SVG grafts to be treated and each SVG may have more than one lesion. The primary objective of the study is to evaluate the safety and performance of the FiberNet Embolic Protection System during SVG interventions. The primary endpoint is Major Adverse Cardiac Events (MACE) rate during 30 days post-procedure. The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.

Conclusion

Embolic protection with the FiberNet device is an interesting new concept to prevent peri-procedural stroke in patients with carotid stenosis. Debris may be kept back more efficiently than with other embolic protection devices. To substantiate this theory a larger number of patients treated with competitive filters and proximal protection devices should be analysed.

Jennifer Franke is a fellow in cardiology, angiology and intensive care medicine at the Sankt Katharinen Hospital in Frankfurt, Germany. She has been the study coordinator of over 20 clinical trials at the Cardiovascular Center Frankfurt under the direction of Horst Sievert, the scientific secretary of the International Course on Carotid Angioplasty (ICCA).

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NASCET Criteria: Degree of stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any post-stenotic dilation.

Primary endpoint for this study was defined as all death and stroke within 30 days post-procedure. Secondary end points included: • Death due to any cause, all stroke, including major, minor, ischemic and non-ischemic and myocardial infarction • Non-stroke neurological events, such as visual / speech disturbances, amaurosis fugax, confusion, seizure, weakness, and TIA • Technical success (Successful placement, deployment, and retrieval of the FiberNet device) • Procedural success (Device success with the absence of any stroke, death, or MI during the hospitalisation) • Access site complications requiring transfusion or surgical intervention (AV fistula, dissection, hematoma, hemorrhage, pseudoaneurysm, puncture site infection)

Horst Sievert is the Director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany and Director of the Catheterization Lab for Peripheral Vascular Laboratory / Structural Heart Defects. He is also an Associate Professor of Internal Medicine/Cardiology at the University of Frankfurt.

Description Coronary stenting is the most commonly used method of myocardial revascularisation, with approximately 2 million stents implanted in 2004 throughout the world. The development of drug eluting stents has resulted in very low rates of repeat intervention and will further increase the scope for percutaneous coronary intervention. The evidence from large randomized trials is generally accepted to be the gold standard source of information for patient care in interventional cardiology. However, it is well recognised that information from these trials is frequently insufficient to guide the wide-ranging clinical situations found in routine practice. In this context, decision-making is often based on a composite of information from multiple clinical studies, pathophysiological considerations and importantly, personal experience or ‘gut-feeling’.

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

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M edical sciences

Safety in Anaesthesia

Promoting sustainable change for the future

Alan F Merry Professor and Head of Department, Anaesthesiology University of Auckland, New Zealand

I The future of safety in anaesthesia lies partly in technological advances in countries that can afford them.

The priority, however, is to address the unacceptable deficiencies in anaesthesia services globally.

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t is widely claimed that anaesthesia today is very safe. As a teacher, I often ask trainee anaesthetists two questions: “What is the risk of dying from an anaesthetic today?” and “What risk would be acceptable?” The answer to the second question is really the starting point for thinking about safety in anaesthesia.

The answer depends on context. If a surgical procedure could be done under local anaesthetic, and / or is not really essential to preserve life or limb, then the risk of dying from the anaesthetic has to be very low indeed. If, on the other hand a surgical procedure has the potential to save life, a higher risk would be acceptable; if the odds faced by the patient (perhaps expressed in quality-adjusted life years or QALYs) are better with the procedure and anaesthetic than without, it would make sense to proceed.

What then is the answer to the first question? The astonishing fact is that we don’t really know.

M edical sciences

In developed countries, estimates of avoidable anaesthetic mortality vary from as low as 1:2,00,000 to as high as ~1:10,000. Australia probably provides the best data in the world about anaesthesia mortality, but even there it is difficult to determine a true rate with confidence. A rate of 1 in 79,509 was cited in the “Review of Anaesthesia Related Mortality” published by the Australian and New Zealand College of Anaesthetists for triennium 1997-1999. However, the rate for the next triennium (20002002) was 1 in 56,000. Does this mean that anaesthesia was becoming more dangerous over time? No! In fact, the apparent increase in risk in the second report is attributable to improved collection of denominator data. Of course, this implies that the rate in the first report is wrong, which raises the question as to whether further refinements in data collection will show that the current rate is not reliable either. In reality, there has been a wide variation in reported rates from many countries over the last 30 years. Difficulties in data collection certainly contribute to this variation, but a more significant factor is the lack of an agreed international definition of anaesthetic mortality.

What the numbers say

Most current estimates of anaesthetic mortality pertain to the first 24 or 48 hours after an anaesthetic (with perhaps a few extra deaths after that), but there is no particular reason to choose either of these time periods. In developed countries, it is quite unusual for a patient to die on the operating table, and relatively few die within 24 hours of an anaesthetic. On the other hand, families are probably interested in having their loved ones leave hospital and come home in good health and the rates for in-hospital death or 30-day mortality have not been widely evaluated.

The risk of death attributable to anaesthesia also depends on the condition of the patient. For a fit young patient undergoing minor surgery

in countries like Australia, this risk is obviously very low (although not zero). However, the risk to patients at the extremes of life, with co-morbidities, and undergoing major surgery is much higher. As I have said, this may be acceptable from a pragmatic standpoint, but it is not ideal. Anaesthesia is not in itself therapeutic, and it should not add to the risks faced by patients, even if they are unwell in the first place.

There is, therefore, considerable room for improvement.

Regional disparities

In developing countries, the situation is much worse. The risk of avoidable mortality associated with anaesthesia in some rural areas of the world may be as much as 1,000 times higher than in cities that can afford to invest in well-trained anaesthetists, expensive drugs and modern technology. Illustrative estimates vary from 1:3,000 in Zimbabwe to 1:150 in Togo. This high risk reflects a failure to invest in anaesthesia as part of the provision of surgical services. Surgery without safe anaesthesia cannot be safe, but it can be marketable. Countries may claim to provide “essential surgical services” when, in fact, the net effect of these services may be to the detriment of public health, because of inadequate infrastructure including the necessities for safe anaesthesia (trained anaesthetists being the foremost requirement, but oxygen, equipment and drugs are also essential).

In the developed world, the level of training for anaesthesia providers is comparable similar to that provided to surgeons. In the UK, Australia and New Zealand, anaesthetists (called anaesthesiologists in the US) must be medically qualified and require seven years of training after qualifying as a doctor.

In the US, Scandanavia and certain other countries, many anaesthetics are provided by nurses, but these providers must satisfy high standards of training and examination, and typically work

in teams that include medically qualified anaesthesiologists. In some countries, on the other hand, anaesthetics are given by people with no medical or nursing background, and with little if any specific training: in fact, it is not uncommon for the surgeon to take responsibility for the anaesthetic as well as the surgery. This might possibly be workable if the surgeon were also an adequately trained anaesthetist, but that is often not the case. Under these circumstances, poor anaesthesia technique, lack of monitoring and lack of expertise have been identified as factors contributing to the high death rate. In addition to lack of training and expertise, anaesthesia providers in these circumstances usually face a shortage of the most basic facilities, equipment and drugs, particularly in rural areas. A recent study from Uganda, where there are few medically qualified anaesthesia providers (13 anaesthesiologists for 27 million vs. 12,000 for 64 million in the UK), identified deficiencies in running water, electricity and the availability of oxygen for example. Even sterile gloves were in short supply.

Do no harm

The goal of the American Society of Anaesthesiologists is “no harm from anaesthesia”. Even in developed countries we are a long way from achieving this. The most obvious problems today involve avoidable errors, particularly in the assessment of patients before administering their anaesthetics, and in the processes of administering anaesthetics.

For example, it has been shown that a wrong drug is given once every 150 anaesthetics. Often, this is without serious consequence, but occasionally the results are catastrophic. For countries that can afford it, technological advances will build on the gains already made and lead to continued if gradual improvements in safety. These will include the use of bar coding (or other technologies, such as radio frequency identification devices or RFIDs) to improve the safety

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M edical sciences

Promoting sustainable change

To improve the safety of anaesthesia globally, the greatest gains will come from addressing the completely unacceptable risks of anaesthesia in much of the developing world. The World Federation of Societies of Anaesthesiologists (WFSA), many of its member societies and the World Health Organisation (WHO) recognise this fact and are investing in projects to promote the safety of anaesthesia globally. The

The way ahead The future of safety in anaesthesia lies in a world in which all patients can enjoy essential surgical services with a standard of anaesthesia that I (as a trained anaesthetist) would be willing to accept for my family. For essential surgical procedures, this does not imply everything that can be done to increase safety, but it does imply well trained anaesthetists, minimal standards of monitoring (including the presence of the anaesthetist and a pulse oximeter), and an adequate infrastructure with running water, electricity and supplemental oxygen. Other than in an extreme emergency, there is certainly no excuse for accepting a lower standard for anyone, anywhere.

Global Oximetry (“GO”) initiative is an excellent example of a practical contribution being made by these organisations. It involves the WFSA, and the Association of Anaesthetists of Great Britain and Ireland and GE Healthcare.

Regional support has been forthcoming from local societies, notably the New Zealand Society of Anaesthetists. Pulse oximetry is mandatory in all developed countries, because it has been recognised as a major aid to safety by their anaesthesia organisations. The GO initiative involves a package of education and aid to kick-start the use of this increasingly inexpensive technology in regions that do not have it. The aim is to promote a sustainable change in practice, with the engagement of both local government and local anaesthesia providers. A key insight is that limited resources should be directed to those things which really will make a difference (oximetry and training being the two examples promoted in this project).

The WHO’s Second Global Patient Safety Challenge, Safe Surgery Saves Lives (under the leadership of Atul Gawande), is another key example of an initiative to address the risks of surgery worldwide. It is highly significant that A uthor

of drug administration, computerised systems for facilitating the pre-operative assessment of patients, and further improvements in the drugs available for anaesthesia. Adjunctive agents designed to mitigate the cardiac and renal effects of anaesthesia and surgery will be as important as anaesthetic agents, and research will increase our understanding of how to mitigate the stress response of the human body to the assault of surgery. Improvements in surgery (the greater use of endoscopic “keyhole” techniques) and lesser need for major radical and mutilating procedures will also help. The holy grail of a synthetic, effective and safe substitute for blood will be another important advance if it is ever achieved.

The high standards of training in anaesthesia will need to be maintained, and in fact, extended. Increased expertise in diagnostic imaging (notably echocardiography) will enable anaesthetists to improve their pre-operative assessment and their intra-operative management of patients. In addition, there is considerable evidence of over treatment in relation to a number of surgical procedures. An important part of reducing the risk of anaesthesia is to limit surgery to those operations that are truly indicated and genuinely likely to improve the quality of the patient’s life. It seems likely that this insight will gain traction over the next few decades and anaesthetists, as perioperative physicians, will have a greater role in ensuring the appropriateness of surgery.

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the WHO has recognised that surgery is a major issue for public health. Surgical operations today are twice as common as births, and substantially more dangerous. Much of the risk lies with anaesthesia, and in simple avoidable errors (such as operating on the wrong patient or with unsterile instruments). The aim of the challenge is to introduce a checklist for use in every surgical procedure, and ensure safe anaesthesia as per the checklist. A key objective is the promotion of teamwork. The whole team (anaesthetists, nurses and support staff as well as surgeons) should be well trained and empowered to contribute to the overall management of the risk in the operating room, only then could we achieve real gains in the health of the population.

All of this will cost money, and concerns are sometimes raised that the real problem is that of access to essential surgical services. Yes, access to life-saving surgery is a priority, but, in fact, many operations that are not essential are carried out everywhere.

Moreover, the lack of access is not constructively addressed by providing services with a death rate of 1 in 150 anaesthetics.

Alan F Merry is Professor of Anaesthesiology, University of Auckland, a Councillor of ANZCA, and Chair of its Quality and Safety Committee. He is co-author of Errors, Medicine and the Law (CUP, 2001), Essential Perioperative Transoesophageal Echocardiography (Butterworth Heinemann 2003), Safety and Ethics in Healthcare (Ashgate, 2007) and various peer-reviewed papers.

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M edical sciences

Telemonitoring in Cardiac Device Therapy

Enabling optimal management of patients The vastly increased complexity of cardiac rhythm therapy over the past several years, demands commensurate improvements in overall device monitoring and telecommunication technology.

Auricchio Angelo Professor, Division of Cardiology University Hospital, Germany

I

n stark opposition to the undeniable demographic changes and medical advancements taking place throughout the world, healthcare payers are increasingly pressurising the treating physicians to reduce their costs. Because of the inherent chronicity of cardiac disease, the costs for managing these patients have risen notably in recent years, while the technological options for the best possible care of the patients have made astounding leaps forward.

Demographics drive the increased prevalence of cardiac device usage

Parallel to these demographic and health related changes come significant technological and medical advances in cardiac rhythm therapy. Because of the improvements in device functionality and impressive medical innovation in cardiovascular medicine, the total number of cardiac device patients is rising rapidly. Depending on one’s cardiac situation, a patient may receive a standard pacemaker, an implantable

cardioverter defibrillator, a device for heart failure-related dyssynchronies or a combination of devices all built into one small implanted device. In addition to the implanted device, the physician must also implant one or more electrical leads, which conduct large and small electrical signals between the microchip device and the heart’s chambers virtually each time the heart beats.

While most cardiac lead implants are considered permanent hardware in the body, the longevity of the implanted device varies by the patient’s cardiac condition and other programmed device functions. Notable improvements in battery technology and more energy-efficient device function, however, have greatly extended the longevity of most devices to several years, at which point the device can typically be safely removed from the patient in the hospital and replaced with a new implanted device during a brief surgical procedure.

Advent of remote telemonitoring

For years, a very simple patientdriven telemetry has been available for cardiac device patients. With this decades-old system of data transmission from home, the patient places a magnetised wand over the cardiac device and the stored data are extracted

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from the device, processed in a small home-based receiver, then transmitted via standard telephone line to the physician’s office for appropriate interpretation. However, with the increasing complexity of today’s devices and their multiple functions, this rather rudimentary approach to collecting limited device data is losing its appeal. Furthermore, this form of data transmission costs valuable time of physician and clinic staff. It also requires a certain degree of patient involvement, which is typically not preferred when one considers today’s complexity of functions and the average age of patient. Clearly, the vastly increased complexity of cardiac rhythm therapy over the past several years, demands commensurate improvements in overall device monitoring and telecommunication technology. Industry has kept pace with these demands for more robust monitoring and data processing. Arguably, the implantable cardiac device manufacturers are at the forefront of highly advanced biomonitoring and implantable sensor technology. Moreover, both Heart Rhythm Society and European Heart Rhythm Association have recently recommended that cardiac rhythm management device manufacturers should develop and utilise wireless and remote

M edical sciences

monitoring technologies to identify abnormal device behavior as early as possible. To reduce under reporting of device malfunctions, its functional status has to be determined more frequently and more accurately.

Fully automated monitoring picks up asymptomatic events

An ‘intelligent’ automated telemonitoring system that communicates bidirectionally back and forth, preferably daily with the implanted device, is required for recognising errant device behaviour, as well as the patient’s immediate physiological response to the multitude of programmable therapies these devices now

are functioning as anticipated, the physician does not require a special report. When appropriate, the physician can safely rely on a home monitoring-based follow-up routine for ICD-patients to significantly reduce the follow-up burden in their clinics. An abbreviated mode of patient follow-up was recently confirmed by Brugata, whereby the predictive value of a remote-based device follow-up routine (with one annual follow-up visit) was considered clinically equivalent to standard quarterly patient follow-ups. The total office followup burden for defibrillator devices in this study was reduced by nearly one-half.

Completely automated telemonitoring systems In today’s advanced telemonitoring systems, the patient’s device and physiologic parameters are collected daily throughout the life of the device and are automatically channelled into a series of easy-to-use reports for the physician to review. Standard nightly data transmissions are sent from the implanted cardiac device to a small tabletop receiver, which then sends the encrypted patient and device data via standard telephone line to a central server for immediate processing. Depending on the device manufacturer, individualised patient data are posted in a comprehensive report format with informative trends, charts, parameters, high definition IEGMs and graphs. One device manufacturer also offers a fully mobile, worldwide patient monitoring system via cellular phone network (Biotronik GmbH & Co. KG, Berlin (Germany). offer. Additionally, device patients frequently experience asymptomatic cardiac-related events, the knowledge of which may be of clinical relevance in appropriate patient care. Some of today’s more refined home monitoring systems have the capacity to monitor whether the patient has experienced short periods of tachycardia, atrial fibrillation, inadequate pacing stimuli or a declining heart failure status. Since patients may experience such events completely without pain or in their sleep, a fully-automated system should monitor, review and deliver occasional special reports to the treating physician, so that he or she can respond quickly to problem. If device and patient

In past, physicians would first learn about many critical device malfunctions and physiolgical changes when the patient returned to the clinic for a regularly scheduled follow-up and manual device interrogation, which would only take place two to four times per year, depending on patient status. In one study by Lazarus, the author suggests that widespread cardiac telemonitoring offers information that could allow for the early detection of adverse events two to five months sooner, respectively, than what is currently feasible by using the standard in-office follow-up model, which often tracks device patients quarterly or biannually.

Even the best monitoring systems in the world are not foolproof

Despite the incredible advances we have witnessed in implantable cardiac device function and reliability over the past several years, it is important to note that even the best functioning cardiac device systems can develop structural defects after days, months or years of use.

Unfortunately, these product failures are very difficult to anticipate and can occur at any given point in the devices’ life. Furthermore, the most advanced device system has to be able to adapt immediately to the variances that can arise at any moment within the dynamic human heart.

With continuous automatic home monitoring, virtually every imaginable system disturbance can be measured and quickly communicated to the treating physician if the severity of the problem is deemed to be highly relevant clinically.

The physician is in control of the data reporting

Today’s implanted devices have the potential to monitor many dozens of device parameters and automatically give the physician important early detection information on heart rhythm disturbances, advanced therapy delivery, medication effects and device status via fax, text messaging or a secure website from the doctor’s own laptop.

Access to the report data is secure, and physicians have large control over many aspects of early detection reporting and the data management process. Physicians control how, when and where the alerts are sent, so that office staff could also view the reports, if the physician permits such access. By delivering comprehensive data comparable to a standard in-office visit, there is a reduced need for patients to come into the clinic for frequent routine follow-ups, which in turn reduces scheduling strain on the clinic and staff.

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M edical sciences

Early detection of serious lead failures

In recent months, there have been a number of published clinical reports regarding post-implant reliability and malfunction of certain types of defibrillator leads. Current telemonitoring systems make daily painless impedance checks of pacing and shock coils and continually monitor significant changes in these values. Today’s device monitoring should be able to quickly

Ventricular impedance >3000

Evénem ImpV ImpV

Evénem

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An episode alert was generated because of highly abnormal lead function

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Today’s telemonitoring is unique in that standard data transmissions can also be supplemented with special alert messages if the patient or device experiences some clinically urgent functional change. In the event of silent arrhythmias, asymptomatic device and lead changes and delivered shock therapies trigger the telemonitoring to deliver additional special alert messages to the physician via internet, fax or text messaging. Because the triggering and reporting requires no action on the part of the patient or physician, these unique systems are able to recognise and deliver critical messages within a very short time of their actual occurance, as opposed to the old system of standard in-clinic devices follow-up at pre-set quarterly or semi-annual intervals. Although current bidirectional home monitoring systems do not provide for the remote reprogramming of implanted devices, this feature may become reality in the near future.

Impédances de stimulation

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Special alerts will quickly notify physician of device, patient problems

Device lead alert report

Imp. stim. [ohms]

The world’s first fully automated CRM home monitoring system was developed for commercial application in 2001. Currently, approximately 200,000 device patients are being managed via home monitoring systems worldwide, and this patient population is expected to grow significantly in the coming years with the increased adoption of the technology.

Temps (jours)

Rapid, clinically-significant changes in cardiac lead impedance measurements caused by a short circuit in the patient’s lead; two days after the first monitored episode, the impedance abruptly increased (shock lead was replaced on October 23rd). Patient was a 49 years old French male who had received an implanted, prophylactic cardioverter defibrillator device for a genetic anomaly called Brugada Syndrome, which can cause sudden cardiac death.

Figure 1

and reliably recognise faulty lead performance, providing the highest degree of patient safety and security.

Figure 1 is an example of a device lead alert report generated with one manufacturer’s telemonitoring system as soon as a defective shock lead was detected in a middle-aged male.

The real-life situation shown in figure 1 is an example of very early detection of a potentially life-threatening cardiac lead failure. Without an intelligent telemonitoring system, this patient would have retained his defective lead up until the next standard in-clinic follow-up, which could have been months from the date of actual

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lead failure. Fortunately, the defective lead was quickly identified and immediately replaced within two days once the alert report was automatically sent directly to the treating physician.

Another example of the value of automated home monitoring is the very early detection of atrial fibrillation, a frequent symptom-free precursor to debilitating embolic strokes and also a common co-morbidity in cardiac device patients. If atrial fibrillation can be recognised early in its course, appropriate medical care—antithrombotic drugs or cardiac ablation—can be initiated to greatly reduce the risk of future strokes. The following Intra-cardiac

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M edical sciences

Electrogram (IEGM) was generated the very day a patient developed atrial fibrillation for a pre-specified duration of time (Figure 2).

Intra-cardiac Electrogram (IEGM)

What does the future hold for remote cardiac device monitoring?

What are the future prospects for widespread cardiac device telemonitoring?

Essentially, cardiac telemonitoring has very positive near-term growth aspects for a variety of reasons. User-friendly monitoring systems have now been

This patient had just experienced new-onset atrial fibrillation. Since this event qualifies for alert report generation, a high-definition Intra-cardiac Electrogram (IEGM) was automatically sent to the physician’s laptop in a pdf file. The treating physician was then able to rapidly respond to this change in patient’s cardiac function with appropriate adjunctive therapy.

Figure 2

developed by industry and are becoming more prevalent in daily practice across the globe.

Though the clinical advantages of continuous telemonitoring are quite apparent, major ongoing trials are soon expected to more specifically quantify the economic benefits of using this exciting technology. Also, new sensor technology research suggests that numerous physiologic functions might be included in future cardiac monitoring systems, thus widening their applicability.

Because the use of novel technologies also requires a willingness to drop old processes and adopt new ones, A uthor

For one thing, the automatic monitoring outside the hospital provides clear clinical benefits for the patients, physicians and healthcare providers. Potential medically-relevant problems can be recognised and addressed proactively, avoiding unnecessary hospitalisation costs. The clinical value of such home monitoring systems for cardiac device patients is already well. It appreciated, as is the improved Quality of Life for the patients who are monitored at home daily. This probably is no more apparent than in the management of heart failure patients.

Secondly, the robust incorporation of (cardiac) telemonitoring into a given clinic’s work routine will likely require a commitment to redirect certain internal resources and work processes in order to reap the full benefits of a telemetric patient monitoring. Unlike many medical innovations, the true benefits of cardiac telemonitoring will be spread over many of those involved in the patient care cycle.

Finally, a growing number of hospitals and pacemaker clinics have already recognised the inherent value of adopting this new technology to improve work efficiency, deliver more timely urgent medical responses when cardiac events occur, and to use this monitoring tool for establishing a more productive professional interface with a given patient’s non-specialist physicians and caregivers.

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clinics and physicians are greeting cardiac telemonitoring with varying degrees of comfort and eagerness.

Another structural hurdle is the current lack of reimbursement to the physician or clinic for adopting a system of cardiac telemonitoring.

In countries where healthcare reimbursement for remote monitoring has been instituted, the uptake of this valuable technology has become much more attractive.

The US may soon become the model and leader for widespread telemonitoring of cardiac device patients.

Auricchio Angelo is Director since 2006, Heart Failure and Electrophysiology program, Fondazione Cardiocentro Ticino, Lugano, Switzerland. Since 2007 he is Co-chair (EHRA), HRSEHRA Task Force on Implantable Cardiac Device Monitoring and he is also the Chairman, Scientific Documents Committee, European Heart Rhythm Association (EHRA).

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The concept of patient-centred care is taking root in healthcare.

For hospitals, this is a paradigm shift. Processes hitherto designed around the disease or physicians, are now being redesigned keeping the patient in mind. This also means that the patient will be more involved with the care providers.

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Stephen C Schoenbaum Executive Vice President The Commonwealth Fund, USA

Healthcare processes are mostly diseasecentred. How big a shift is it then for hospitals to create processes that are patient-centred?

I do not believe that the main issue is shifting from disease-centred to patient-centred care. It is shifting from physician-centred or providercentred to patient-centred, and that is a very big shift. It is a big change because in order to accomplish it one has to re-think every aspect of the patient’s journey from the patient’s perspective. Patients wish to understand the medical treatment offered to them and how it would affect them immediately and in the longer run.

In early 1990s, Picker Institute, an organisation that promotes patientcentred care, where I am a board member, convened groups of patients in order to define the attributes of care that patients felt were essential.

This process led to a set of eight dimensions of ’patient-centred care’ including: • respecting the patient’s values, preferences and expressed needs • Informing and educating the patients about their treatment • Patient’s access to care • Emotional support to relieve fear and anxiety • Involvement of family and friends • Continuous and secure transition between health care settings • Physical comfort • Coordination of care

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The Big Shift Shifting to patient-centred care implies a re-think of every aspect of the patient’s journey through an episode of care from the patient’s perspective.

I would add that simplicity is a very important attribute of patient-centred care. Patients must be told what is necessary and the care they receive must be explained to them in the terms that are comprehensible to them. The shorter the patient’s stay is in the hospital, the better it is.

I cannot overstress the importance of co-ordination of care and smooth transitions in a healthcare set up.

A patient’s stay in the hospital is like a complex relay race wherein the patient and information about the patient, are the baton. The baton must be passed on securely from one provider to the next. If the baton is dropped, there is waste and a poorer outcome. Unfortunately, we know from surveys that about one-third of the time, patients think that their care has been poorly coordinated, and the transitions, poorly managed.

What systems need to be put in place in order to provide care that best suits the patient’s needs (i.e. patient-centred care)?

Most importantly, one needs to have a system that can obtain and assess the patient’s experience. It is only through the patient’s feedback you know if you are patient-centred or not.

Some aspects of patient-centred care can be facilitated by ’systems’. For example, engaging the patient in the process of shared-decision making is an important aspect of patient-centred care. There are information tools such as DVDs that can help patients learn about common procedures or situations—choice of treatment for breast cancer or prostate cancer or back pain, and make it easier to engage the patient in shared decisio-making.

When one looks at healthcare organisations that are patient-centred, first thing one discovers is that the patient-centred care is highly valued by leadership and it has worked hard to establish those values within the organisation.

How important a role does technology play in this scenario? Is there enough technology available to push for a patient-centred care model?

Health information technology makes it easier to coordinate care. Having the electronic medical records available to all care providers, with accurate laboratory results, information on allergies, medications etc. makes it easier to ‘pass the baton’ and eliminate waste and duplication.

What role does the leadership play in bringing about a patient-centred approach throughout the organisation?

Patient-centred care can occur even in a single clinical encounter. However, it is important that it happens throughout a patient’s stay in the health care set up. For that, leadership is absolutely essential.

When one looks at health care organisations that are patient-centred, first thing one discovers is that the patientcentred care is highly valued by leadership and it has worked hard to establish those values within the organisation.

Any other comments that you would like to make?

Yes. I’d like to make a couple of comments: 1. Measuring of patient’s experience is just beginning to become a standard in hospitals in the US. For the first time in March 2008, results for almost all hospitals using the standardised HCAHPS instrument were made public.

They showed tremendous variation in performance and large opportunities for most hospitals to improve some aspect of the patient-centred care they delivered.

2. Do not think about patientcentred care as an ‘add-on’ or a ‘frill’.

It is absolutely essential to achieve excellent care. Patient-centred care is one of the six aims of the high-quality care that the US Institute of Medicine delineated in its report ‘Crossing the Quality Chasm’. It is intimately related to the other five: safety, effectiveness, efficiency, timeliness and equity.

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Amy Wilson-Stronks Project Director Division of Standards and Survey Methods The Joint Commission, USA

Healthcare processes are mostly diseasecentred. How big a shift is it then for hospitals to create processes that are patient-centred?

I have been fortunate to serve as the Principal Investigator of a study (Hospitals, Language and Culture: A Snapshot of the Nation) that investigated how hospitals across the US are meeting the diverse cultural and linguistic needs of the patients they serve. A key principle of patient-centred care is, sensitivity and responsiveness to the patients’ cultural health beliefs and communication needs. Our study found that hospitals in the US are challenged to meet these needs. Despite the challenges, some hospitals have implemented promising systems and practices to better meet diverse needs. Our most recent research report, One Size Does Not Fit All: Meeting the Health Care Needs of Diverse Populations found that hospitals need to consider several things in order to become more patient-centred: • They need to consider how the focus on culturally competent, patientcentred care is reflected in their policies, procedures, mission, vision and values • They need to collect and use data and information to improve their systems to meet patient’s needs • They must determine the specific needs of their patient populations and consider how they may need to make adjustments to their service systems to accommodate the needs of specific populations and

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Meeting Diverse Needs Patient-centred care means sensitivity and responsiveness to the cultural health beliefs and communication needs of patients.

• They must engage in collaborative relationships, both internally and externally These ‘themes’ represent a systematic approach that results in action, tailored to the specific needs of the patient. Through our work, we observed that “one size fits all” approach does not exist and hospitals must be willing to continually assess, monitor and evaluate how they meet the patients’ needs. Since demographics and needs change, this is a continuous process. It becomes a difficult concept for hospitals to grasp since they are driven by metrics and patient-centred care is difficult to measure. It is often considered to be ‘soft’ and of a lesser merit than other safety imperatives.

What systems need to be put in place in order to provide care that best suits the patient’s needs (i.e. patient-centred care)?

As I mentioned above, we have identified four main areas or ‘themes’ that should be present in a hospital in order to provide care that suits best to patient’s needs. These are rather broad-based themes, which allow a hospital to focus their approach towards resources and needs. There is a growing appreciation of the need for patient-centred care among providers, hospitals and patients.

Healthcare systems that can provide appropriate monitoring and evaluation of patient-centred approach needs to be improved. While many promising practices have been identified for providing patient-centred care, many

remain untested for their effectiveness.

Better mechanisms to monitor the needs and effectiveness of systems to respond to those needs must be in place, so that there is a greater evidence base of quality and safety. But individual hospitals can look at these systems through their quality improvement initiatives. Integrating patient-centred and culturally competent care principles into quality improvement effort was one amongst the 32 recommendations that were made in our first research report, Exploring Cultural and Linguistic Services in the Nation’s Hospitals: A Report of Findings.

How important a role does technology play in this scenario? Is there enough technology available to push for a patient-centred care model?

I think technology can support patientcentred care, but I don’t believe that patient-centred care is entirely dependent upon it. I believe that technology can facilitate systems for information sharing that can improve the way needs are met. But, there must be an organisational commitment to providing culturally competent, patient-centred care. As a part of our research, we interviewed administrators and clinical staff at 60 hospitals in the US. In some cases, responses to our interviews indicated a desire for better technology to address the issues. However, patient-centredness is not simply information management, nor is a specific practice or procedure.

It is the provision of the type of care that is able to adapt to changing needs,

is sensitive to different beliefs and can accommodate and assist patients as they navigate a complex system. As I reflect on some of the hospitals I visited that were particularly adept at providing culturally competent patient-centred care, I recall that I was impressed not with the technology, but with the human element that was present within the hospital’s systems.

These were also hospitals that made use of information technology to assist in the collection and use of data; and invested in systems such as remote video interpreting and telephone interpreting systems to compliment human resources to meet the language needs. So, there is a need for technology, but it is secondary to the need for organisational commitment.

What role does the leadership play in bringing about a patient-centred approach throughout the organisation?

Leadership support and organisational commitment is essential. Without this commitment, patient-centred care can not be achieved at an organisational level. Leadership brings attention to the issues allowing discussion and collaboration to occur and bring about proposed solutions. It also provides the necessary financial and human resources to make certain that in the domain of healthcare, quality is achieved.

Any other comments that you would like to make?

I think it is important that we define patient-centred care. To define, it should include attention to the myriad of health care needs that individual and populations of patients wish to be fulfilled. These needs may include issues like cultural, educational, physical and environmental constructs that may impact how care is interpreted by the patient. It is also important for hospitals to consider how their processes, systems and environment can influence the way care is provided.

For more information, please visit http:// www.jointcommission.org/PatientSafety/ HLC/

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CoverStory

The New Challenge The challenges presented by this shift in focus can be overcome with strong leadership, clarity of purpose

Gary Kaplan Chairman and CEO Virginia Mason Medical Center, USA

Healthcare processes are mostly diseasecentred. How big a shift is it then for hospitals to create processes that are patient-centred?

Most care providers are drawn to healthcare, in large part, because they want to make a difference in people’s lives, but that healthcare processes can make delivery of patient-centred care challenging. At Virginia Mason, we recognise that we would not exist without our patients. Everything we do is ultimately to improve their health and well-being. Otherwise we wouldn’t be here. That’s why our patients are at the top of our strategic plan. This clear and unequivocal focus on the patient helps remind us, in everything we do, to place the patient’s requirements on top priority. This focus is somewhat of a shift and presents challenges that can be overcome with strong leadership, clarity of purpose and a shared vision of what patient-centred care can mean in terms of an optimal patient experience.

What systems need to be put in place in order to provide care that best suits the patient’s needs (i.e. patient-centred care)?

Systems that provide opportunities for active participation of patients and family members in policy and programme development, to enhance clinical care and improve outcomes, need to be put in place. We have been fortunate at Virginia Mason to be able to involve patients and families in our improvement work; from evaluating patient education to assisting with major programme redesign like in our Cancer Institute. When the focus is on patient centredness all processes and systems can be modified to ensure that they truly add value for our patients.

How important a role does technology play in this scenario? Is there enough technology available to push for a patient-centred care model?

Technology is playing an ever-increas-

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ing role in healthcare; however, the emphasis must be on using technology in a way that makes a difference for our patients and does not merely automate longstanding inefficient processes that are not designed to be patient-centred. We, therefore, work hard to re-design and re-engineer our processes using our Virginia Mason Production System methods prior to automating with innovations such as CPOE. What role does the leadership play in bringing about a patient-centred approach throughout the organisation?

Leadership’s role is critical in articulating the vision, helping connect the dots between the vision and the work people do every day and helping remove barriers to patientcentred care. Virginia Mason’s strategic plan, helps us to put the patient’s requirements first.

Listen to the Patient

Assuring quality care In striving for excellence in patient care via scientific means, clinicians may be omitting a potent source of relevant information—the patients themselves.

WF Bower, Assistant Professor CSK Cheung, Research Associate CA Van Hasselt, Professor MJ Underwood, Professor Department of Surgery The Chinese University of Hong Kong Hong Kong SAR

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s noted in a previous dissertation of this publication, embracing healthcare quality assurance in Asian healthcare requires the commitment of all parties involved in the patient’s hospital journey (Underwood 2006). It is incumbent upon the institutions to provide appropriate frameworks to facilitate data collection and analysis, and to support a culture of response to findings and continuous change toward improved safety and high quality outcomes. To this end, discipline-specific data registers can be established that include independent risk factors and summated risk scoring systems. Mortality along with the spectrum of secondary outcomes, will be incorporated and with relative ease it becomes possible to translate practice into quantified end points. This is crucial in providing transparency and Quality Assurance Programmes for Surgery – How and why in Asia? Published in Issue 12 (March ‘07) of Asian Hospital & Healthcare Management.

accountability to patients, professionals and administrators and is the hallmark of excellence.

What is often missing in this evaluation of quality of care is the patient’s voice. Throughout the hospital journey, opportunities exist to incorporate the patient as a source of report, information and opinion, and to include their preferences in decision-making. In some units, evaluating outcomes routinely includes patient-completed measures, so that functional and quality of life aspects can be incorporated into overall outcome analysis. In Asia, we have been slow to appreciate the benefits that accrue from patient feedback in aspects of care and assessment of efficacy.

Symptoms scores

Possibilities of input exist for the patient, right from admittance till discharge from hospital. Validated symptoms scores are the first level of patient input and summarise the reality of living with

a particular set of problems. Information gained from patients about their symptoms can influence how doctors manage and prioritise their care. It can also affect a patient’s compliance with medical recommendations and their satisfaction with treatment. The process of “being heard” may alter the path to recovery.

Quality of life measures

Until recently, the paradigm “Quality of life” (QoL) has been associated more with individuals facing life-threatening diseases than those with organic or treatable disorders (Gerharz 2003).

QoL has now come to denote a general and holistic measure of well-being and disease impact (Wallander 2001). It is a validated way of measuring a patient’s perspective of their life situation both before and after intervention (Donovan 2002). In adult patients such measures are obtained via self-completion of a psychometrically robust questionnaire.

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CoverStory QoL tools can be used as a potent summary of disease impact on an individual’s well-being. Scores also serve as an outcome measure of symptom control following interventions, and may discriminate between treatment approaches. QoL results assist clinical decision-making by serving as surrogate end points in chronic disease when there may be only a small difference in symptom severity following treatment.

In fact, QoL measures can detect greater change in patient status than the subjective report (Osoba 2003). Lastly, QoL data is commonly scrutinised in the substantiation of service provision or resource allocation.

Patient-reported outcomes

Once hospitalised and undergoing treatment, the patient becomes a reliable source of clinically useful information that can facilitate doctor-patient communication. Including the patient enquiry “What matters” can augment the overriding clinical process driven by questions about symptoms. A recent study reported that one-half of cancer patients preferred to have a collaborative relationship with their doctor rather than play a passive role (Wilson 2000).

For a variety of reasons, face-toface encounters between doctors and patients regularly fail to unmask the entirety of the patients’ concerns. There may be discordance between how the patients and physicians view the presence and effect of individual symptoms (Wilson 2000). Consultation times are often short and patients experience stress during the course of disease. They feel reluctant to bother a doctor with apparently unrelated problems and present a positive effect in gratitude for treatment, and even respond to questions in ways they feel would most please the clinician. Patients expect and need clinicians to make decisions about their disease and both parties may resist diversion of attention to apparently non-medical issues. Aspects of care, such as QoL, threatening side effects

of treatment or depressive or adjustment problems that are unrecognised and thus untreated, may compromise adherence to therapy (Fallowfield 2001). Alternatively, improvement in patients managed with explicit inclusion of their own reported outcomes i.e., collaborative care, is likely to be clinically meaningful (Velikova 2004).

Clinical care that comprehensively addresses both medical and key areas of the patient’s well-being is associated with higher levels of patient satisfaction (Jackson 2005). Patients may be offered a disease-specific “happiness today” questionnaire on tablet or touch screen computers, where the results are available to doctors prior to reviewing the patient. Graphical representation facilitates single-occasion or longitudinal interpretation.

experience, knowledge and expectations and may not be readily appreciated by doctors or fully explored in available metrics. However, since satisfied patients are more likely to follow planned care and make better use of health services institutions must find a way to understand the tenants underpinning satisfaction within their population (Fitzpatrick 1990).

Cultural appropriateness of available measurement tools

Having decided to include the patient’s voice in the evaluation of care outcomes, the next step is to identify valid and reliable measurement tools. Scrutiny of electronic databases reveals ever increasing number of patient-completed metrics, however, they are commonly reported in English and developed in Western

Including the patient’s voice Including the patient’s voice as an integral part of health service evaluation is logical and time-efficient.

Deriving data from the combination of patient and doctor’s knowledge and experience broadens the pool of available feedback. What we do with this information is critical. In a transparent environment the issues are offered for discussion and mediative measures proposed. This forms the basis of an audit exercise, where changes are made to processes or practices and the original measure then re-applied to evaluate efficacy. This reactive response to quality concerns raised by patients extends from voicing of bothersome symptoms right across the board to major issues with service provision.

If, however, patients are not seen as valuable sources of relevant information, the individual clinician, doctor, nurse or administrator will miss a potent opportunity to tailor their input to meet the true needs of the patient.

Patient satisfaction

Patient’s evaluation of medical care reflects performance of the system as whole, as well as specific aspects of advice and intervention (Hall 1988).

It has been argued that satisfaction is a desirable outcome of healthcare in its own right (Donabedian 1988) and allowing “feedback” becomes an integral part of quality assurance and accountability (Redfern 1990).

Satisfaction is also an indicator of patient acceptability of new forms of care or intervention and is frequently used as an outcome variable in trials (Koh 1994; Thompson 1990).

Aspects of in-hospital care that are important to patients are derived by them from their own values,

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countries. Concerns arise as to whether it is appropriate to use these tools within an Asian context and assume findings to be representative. One example of divergence in the same tool administered in either Chinese or English is reported

by Cheung and colleagues (2004) who explored equivalence in cancer-specific, health-related quality-of-life questionnaires. Chinese translation of the question “I have a lack of energy” produced results that differed from the results generated by the original English version.

The adaptation of existing measures involves stages. Translation is the first step and necessitates a forward-backward procedure, independently carried out by two native-speakers of the target language or a professional translator (Kholler 2007).

QoL measures available in Asian languages Instrument

Version

Reference

Brief Fatigue Inventory (BFI-C)

Chinese version

Wang XS 2004

Cancer Fatigue Scale

Taiwanese version

Shun SC 2006

Chinese WHOQOL-BREF

Hong Kong version

Leung KF 2005

EORTC QLQ-BR23

Taiwanese version

Chie WC 2003

EORTC QLQ H&N35

Taiwanese version; Japanese version

Chie WC 2003; Toth G 2005

Functional Living Index â&#x20AC;&#x201C; Cancer (Quick-FLIC)

Singapore version

Cheung YB 2004; Cheung YB 2005

Functional Assessment of Cancer-G Therapy General (FACT-G)

Hong Kong version

Yu CL 2000

Gastrointestinal Quality of Life Index (CGQLI)

Hong Kong version; Taiwanese version

Yeung SM 2006; Lien HH 2007

Hospital Anxiety and Depression (HAD)

Hong Kong version; Chinese version

Lam CL 1995; Wang W 2006

Impact of Event Scale-Chinese Version (IES-C)

Taiwanese version

Chen SC 2005

Impact of Event Scale-Revised (CIES-R)

Hong Kong version

Wu KK 2003

Inflammatory Bowel Disease Questionnaire

Hong Kong version; Chinese version

Leong RW 2003; Ren WH 2007

Irritable Bowel Syndrome (IBS-QOL)

Chinese version

Huang WW 2007

McGill Quality of Life Questionnaire

Hong Kong version; Taiwanese Version

Lo RS 2001; Hu WY 2003

Minnesota Living With Heart Failure Questionnaire (MLHFQ)

Taiwanese version

Ho CC 2007

Myocardial Infarction Dimensional Assessment Scale (MIDAS)

Chinese version

Wang W 2006

Quality of Life in Constipation Patients

Hong Kong version

Chan AO 2005

SF-36

Chinese version; Hong Kong version

Li L 2003; Lam CL 2005; Wei YY 2006

St. George Respiratory Questionnaire (SGRQ-HK)

Hong Kong version

Chan SL 2002

Voice Outcome Survey (VOS)

Taiwanese version

Fang TJ 2007

Worry Scale (WS)

Hong Kong version

Shiu AT 2004

Table 1 WF Bower is an Assistant Professor and Surgical Audit Team Leader, Department of Surgery Chinese University of HK. Executive Board member of the International Continence Society and past executive of The International Childrenâ&#x20AC;&#x2122;s Continence Society.

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Discrepancies are arbitrated by a third consultant and solutions are reached by consensus. Translated questionnaires then undergo a pilot-testing for conceptual appropriateness and wording acceptability. At this stage, ambiguities and cultural nuances are identified and corrected. Common problems include: lack of expressions for specific symptoms in various languages, the use of old-fashioned language, and different priorities of social issues between cultures (Kholler 2007).

Table 1 summarises QoL measures in Asian languages.

If the measurement tool has already been reported extensively, it may not be necessary to re-examine its face validity and inter- and intra-reliability. However, within a new cultural context, it is mandatory to establish content validity. This process involves questionnaire completion by at least 200 local subjects, with a caregiver available to clarify individual difficulties. Complex statistical analysis follows to identify items that do not generate useful information within the local population. Problematic items within the original measurement tool are then either removed or modified before the tool can be used as a valid population-specific research or outcome measure.

CSK Cheung is a Research Associate, Department of Surgery, joined Department of Surgery, The Chinese University of Hong Kong as Research Associate, participating and contributing work involving patient satisfaction initiatives across public hospitals and cardiac surgery registry.

CA Van Hasselt is a Professor of Surgery and Chairman, Department of Surgery Chinese University of Hong Kong, Prince of Wales Hospital, Professor of ENT Surgery.

MJ Underwood is a Professor and Chief, Division of Cardiothoracic Surgery, Chinese University of Hong Kong, previously Consultant Cardiac Surgeon and Audit Lead in Cardiac Surgery, Bristol Royal Infirmary, United Kingdom.

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Patient-Centric Modalities Strategies for better implementation Care providers must consider some key factors they need to balance for effective implementation of patient-centric modalities.

Julio A Reategui RA / QA and Compliance, Asia Pacific MEDRAD, Inc., USA

I

n recent times there has been a trend towards adoption of patient-centric modalities as a cost-effective way.

These modalities address the needs of various groups of the population, including the ageing population segment, a large percentage of which are affected by chronic conditions that are the leading causes of illness, disability and death. Patient-centric modalities aim for effective integration of technologies, information and tools to address patient care needs and to enable comprehensive treatment, and close physician guidance and coordination. Ideally, in this environment, physicians will be able to make critical decisions for their patients with complete and relevant information, real-time input from online clinical decision tools and access to electronic health records.

The current health system and technology and / or disease-centric approaches to the design of medical devices and therapies offer, in most cases, fragmented care that is inconsistent with the scope of needs described above. These

needs can only be addressed effectively by a patient-centric view of medicine, technology and regulations.

How it all plays together

The typical factors that we must balance for effective implementation of patient modalities are: patient / profile, disease, healthcare factors, choice of treatments, available technologies and specialised tools, patient data, regulations & reimbursement and environment (Figure 1).

Intangible factors

The factors listed above plus other intangibles such as the quality of the relationship between the patient and the healthcare provider are closely linked and must be balanced to ensure a successful outcome.

Positive relationship

A positive relationship between the care provider and the patient can lead to full understanding of the patient profile. The patient profile involves looking at a variety of factors that provide the full picture

of the patient. They include elements such as gender, age, weight, height, overall health, dietary preferences, genetics, background and ethnic characteristics, lifestyle, personality, religious beliefs, psychological profile and mental health.

The understanding of the patient profile together with the patientâ&#x20AC;&#x2122;s views and priorities is the first step in developing a successful patient-centric modality.

Understanding the disease

The second set of factors requires an understanding of the stage of the disease or diseases, for instance, is it an acute or a chronic condition? Is it a single or multiple conditions? Do we understand the trade-offs of therapies, monitoring and sample requirements, e.g. type, frequency, quantity and how these parameters affect the patient and the selection of any available treatments.

This can be accomplished through a systematic series of examinations and gathering of data and correlation with the medical history of patient. One opportunity in this area is the education of the patient about the disease. The level

w w w . a s i a n h h m . c o m 57

of education that the patient has about his or her condition and the awareness of the progress and constraints faced by the provider will enhance the chances of a successful outcome.

Healthcare factors

The third set of factors is designated as the healthcare factor. The elements connected to healthcare are mainly driven by the care provider and the provider preferences, level of care, availability and affordability of treatment, quality of provider services, socialised medicine or for profit model, provider policies and insurance coverage.

The three set of factors above can help narrow down the treatment plan or choice of treatments, including deciding among traditional, non-traditional and holistic medicine. Also, there is an array of alternatives available depending upon the condition being treated. In recent times, there has been an increased attention to therapies combined with dietary practices.

Along with the above, we have a choice of technologies and tools that allow deeper investigation, going from laboratory testing to imaging to genomics. The promise of genomics is that we would evolve into a truly personalised medicine by including the patient’s genotype and levels of gene expression. This allows precise tailoring of the treatment to the individual. In the area of medical devices, we are already observing a shift towards providing the physician with the tools to personalise treatments. Many companies are using this as a way to differentiate their products. Figure 2 illustrates a contrast injector used to enhance imaging procedures. This device allows entering a patient’s physiologic parameters to recommend personalised settings for delivering a customised contrast protocol (volume and flow rate) to a specific patient.

The resulting patient data offers challenges of its own. The collection, storage, retrieval and analysis of the data coupled with the logistics of managing the information itself has opened up a

Factors influencing patient-centric modalities

CoverStory

Figure 1

series of opportunities for a new technical discipline, Healthcare IT. Other factors include ensuring portability, data accuracy and integrity, plus data security and privacy issues.

Additional considerations include the regulatory and reimbursement environment. In an ideal world, these two factors would be considered non-issues.

However, depending on the conditions being treated and the type of therapy being pursued, they may pose major constraints on the patient and the provider.

Last but not least, the environment around the patient plays a crucial role, for instance the hospital versus home care setting; and urban versus rural setting.

The quality of patient’s life, occupation, living conditions, support networks, all influence the outcome of the treatment.

Once all the above mentioned are considered, one is ready to narrow down the development of a treatment plan,

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which would include the type of therapy and testing, observation, periodic assessment and rationale for plan updates and possibly referral and follow-up. Table 1 illustrates the aggregate of elements that come into play. We can see that the analysis and integration of factors can become a complex decision requiring formal tools to ensure an effective patient-centric therapy.

Opportunities and challenges

Opportunities to facilitate the evolution towards patient-centric modalities include a strategic and behavioural shift from the pharmaceutical industry since they currently develop and commercialise drugs that are targeted to broad segments of the population as opposed to targeting designated sub-populations. The medical device industry also needs to increase its efforts in developing diagnostic tests that would enhance the definition of those sub-populations.

Medical device manufacturers are increasingly providing computerised tools that allow personalised protocols

In this picture we show MEDRAD’s Stellant, an injector of intravenous contrast media for enhancing images in diagnostic studies in Computerised Tomography applications. A new feature of this device computes a personalised patient protocol for cardiac studies (P3T CardiacFlow). P3T CardiacFlow takes into consideration several variables including patient weight, cardiac output, and scan duration. P3T will then recommend a customised injection protocol specific to that patient’s condition, leading to more reproducible and consistent results, which are vital to the evaluation of progressive disease(s).

Figure 2

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Elements to be considered in establishing an effective Patient-Centric Modality 1. Patient Profile - Age / Weight / Height - Overall Health & Dietary habits - Gender & Genetics - Ethnic Background - Personality / Lifestyle / Religion - Mental Health/Psychological

2. Disease(s)

4. Choice of Treatments - Traditional vs. Non-Traditional vs. Holistic Medicine - Detoxification / Dialysis - Therapy vs. Surgery - Radiology vs. Drugs - Chemotherapy vs. Radiotherapy vs.TK Inhibitors - Experimental Treatment - Psychiatric

- Imaging - Physiologic Monitoring - Pharma-biotech / Molecular Diagnostics - Laboratory Testing - Genomics / Proteomics

6. Patient Data - Data Entry / Sharing / Paper vs. Electronic records / Portability.

- Distributed vs. Centralized information - Record Accessibility and Location - Data Accuracy / Interpretation capability - Data Transmission / Storage / Retrieval / Analysis / - Patient Education/Learning - Data integrity / Security / Privacy concerns

8. Environment

9. Analysis and Integration of Factors

- Hospital vs. Specialist vs. Home Setting - Demographics & Socio-economic factors - Urban vs. rural Setting - Quality of life / Living Conditions / Occupation - Work Environment / Support Networks

- Translating Requirements - Decision Making Models - Integration of ptatient care needs, Technologies, therapies, Information, Regulations and Environment.

the provider’s perspective in a chronological sequence of events. However, they do not support physician-patient interaction or ease communication with the patient. For the next generation of data systems to be fully supportive of patientcentred modalities, they are expected to look at presenting the data in a way that the patient can get the full educational benefit from his / her own health assessment and affect to his or her behaviour.

Further, this data can also be combined in a way to facilitate decision-making and help narrow down choices of treatments.

Additional opportunities exist in the use of systems engineering techniques for translating individual patient and situation requirements into actual therapy or modality and implementation maps.

To establish objective decision-making, these models optimise the integration of patient care needs, technology and tools, therapy alternatives, information

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Also, the regulatory environment in most countries fosters above practices by requiring expensive and lengthy clinical trials that add to drug development costs.

A concept being proposed in recent times is to allow for expedited approvals of drugs that have demonstrated effectiveness to a smaller sub-set of the population, e.g. by targeting a population segment with a common genetic characteristic and require testing for that characteristic prior to administering the drug.

Another opportunity is related to the current training of physicians and what is expected from them is acceptable behaviour when it comes to treating a disease. Traditional methods can be compared with trial and error-repair strategies, as opposed to a carefully crafted treatment plan.

On the healthcare system side, we are challenged with systems that establish providers’ compensation plans that are largely focussed on completing procedures and prescribing medications as opposed to early disease detection and prevention.

In terms of patient data, some of the upcoming challenges in this area require adopting a different paradigm. Traditional patient records, even in electronic format, organise the patient history from

- Care Provider & Provider Preferences - Level of care - Availability & Affordability of treatment - Quality of Provider Services - Socialized Medicine vs. for profit - Provider policies & Insurance coverage

5. Technologies / Tools

7. Regulations & Reimbursement - Approvals of Devices & Therapies - In-country Regulations - Reimbursement - Payer / Payee models - Intellectual Property concerns

3. Healthcare Factors

- Disease and Disease stage - Multiple Conditions - Chronic vs. Acute conditions - Therapy/Monitoring/ - Sample Requirements

Table 1

requirements, regulatory constraints and environmental factors.

Conclusion

Patient-centric modalities improve the effectiveness of our healthcare systems thereby benefiting patients.

While the extent of changes required at industry, governance legislation, provider and consumer levels are numerous and profound, the shift towards patient-centric modalities has already begun and is expected to accelerate in the coming years.

Acknowledgements Many thanks to Larry Kopyta, Tito Aldape, Anthony Emerick and Linda Rachul-Rymniak from MEDRAD Inc. that reviewed the draft and provided valuable inputs to this manuscript. Many thanks also to Al DiRienzo, Susan Alpert, Javad Seyedzadeh and Tom Taylor, for their valuable comments and insight during the forum discussion on Patient-Centric Modalities. “Translating Requirements and Integrating Technology” at Frost & Sullivan’s Medical Device Conference in March 2006.

These early discussions helped establish the groundwork for this article.

Julio A Reategui is Director of RA / QA and Compliance, Asia-Pacific, at MEDRAD, Inc. He has over 25 years of experience developing and commercialising clinical, laboratory and field instrumentation and disposable devices for the medical industry, life and analytical sciences, and environmental monitoring applications, worldwide. He has also authored / co-authored seven patents and over 15 technical publications.

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S u r gical S pecialit y

Patient Safety in Surgery Current ‘key’ issues

Increased vigilance for key patient safety issues will impact quality assurance in the future and help to reduce the incidence of iatrogenic morbidity and mortality after surgery.

Philip F Stahel, Department of Orthopaedic Surgery Wade R Smith, Department of Orthopaedic Surgery Philip S Mehler, Department of Medicine Denver Health Medical Center, University of Colorado School of Medicine, USA

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omplications due to individual surgeons’ errors and system failures are inherent in surgical practice and represent important preventable causes of morbidity and mortality. In spite of the increasing public attention to medical errors in general, a new level of transparency for consumers, and the current trend to process preventable adverse events systematically, surgical complications appear to represent a persistent taboo throughout different countries and institutions. One would assume that a patient scheduled for a surgical procedure would expect to be better off after the intervention than before. However, while physicians strive to achieve excellent results and favourable patient outcomes in daily practice, this noble task has failed more often than one expects.

Perioperative communication breakdown

A recent analysis of the American College of Surgeons’ closed claims study revealed that most events leading to iatrogenic patient injuries involved a delay in diagnosis, a failure to diagnose. Thus, patient safety in surgery appears to be challenged more by the mistakes and failures that occur before and after surgical procedures than by

the operative intervention itself. Interestingly, technical intra-operative errors resulting in surgical complications represent less than half of all events leading to a claim. Indeed, about 25 per cent of all medico-legal surgical claims related to errors leading to an adverse patient outcome are attributed to a perioperative breakdown in communication. Thus, the surgical patient appears to be more at risk of

Malpractice Insurers Medical Error Prevention Study recently provided information related to trainee involvement in medical errors. Teamwork breakdowns in the form of (1) a lack of adequate supervision and (2) “handoff” problems were causative in 70 per cent of all errors leading to malpractice claims (Source: Archives of Internal Medicine 2007).

A written form of communication appears to protect from erroneous reporting, since written communication breakdowns occur in only about 4 per cent of all cases. An alarming aspect is the finding of 81 instances (14 per cent) of communication breakdowns which involved a miscount

Three “key” issues related to patient safety in surgery (1) perioperative communication breakdown; (2) the concept of a surgical “time-out” and (3) the reporting of medical errors and complications in surgery. These topics should provide the foundation for development of institutional quality assurance protocols and thereby reduce the incidence of system errors, which potentially jeopardise the safety of patients undergoing surgical procedures.

sustaining an adverse outcome from hidden system errors than from an individual surgeon’s human failure. A detailed analysis of communication breakdown patterns revealed an equal distribution of occurrence during the pre-, intra-, and postoperative phases of surgery. More than 90 per cent of communication breakdowns appeared to occur verbally. Of these, information was either transmitted in an inaccurate fashion (about 40 per cent of cases) or it was never transmitted at all (about 50 per cent of cases). Similarly, the

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of instruments or sponges in the operating room (Journal of the American College of Surgeons 2007). According to the National Quality Forum (NQF) consensus report, the unintended retention of a sponge or other foreign body after surgery is defined as one of the five “serious adverse surgical events” (Table 1). These are informally termed “neverevents”, since they should never happen and they can never be defended successfully on a medico-legal basis.

An adequate approach for improving “communication safety” in the

S u r gical S pecialit y

operating room should include the implementation of standardised “readbacks” of received information, and the unambiguous assignment and transfer of responsibilities. These strategies have long been implemented in other highrisk domains, such as nuclear reactor control rooms, submarine services and commercial aviation safety protocols.

In clinical practice, clear-cut algorithms should define triggers which mandate the communication with an attending surgeon (Journal of Patient Safety & Quality 2007). Furthermore, standardised protocols for patient handoffs and transfers should be defined at the institutional level. Written orders and checklists should support inter-individual verbal communication, including the count of lap sponges and surgical instruments, in order to reduce the incidence of adverse events related to communication breakdowns in surgery.

Currently, the development of specific communication skills is underemphasised in residency programmes and may contribute to the missing system factors, which beget poor results of patient care.

The concept of a surgical “time-out”

Any intervention involving a wrong site (wrong side / wrong level / wrong anatomic structure), a wrong procedure, or a wrong patient, represents an unacceptable surgical complication “neverevents” (Table 1). A lesson learned from aviation safety is that a “culture of blame” approach for dealing with individual surgical errors is not helpful in improving patient safety or reducing the incidence of severe complications. On the contrary, wrong site surgery represents a “classical” system error rather than pure human failure by an individual surgeon. Ten years ago, this notion led to the implementation of a standardised surgical “time-out” in North America as an improved method of verifying patient identity, correct procedure and intended-site operations. Since then, the concept of a surgical time-out has

Serious reportable surgical events (“never-events”), as defined by the National Quality Forum (NQF consensus report, update 2006) Surgical “never-events” 1.

Surgery performed on the wrong body part

2.

Surgery performed on the wrong patient

3.

Wrong surgical procedure performed on a patient

4.

Unintended retention of a foreign object in a patient after surgery or other procedure

5.

Intra-operative or immediate postoperative death in an ASA class I patient Table 1

been widely implemented in operating rooms throughout the US and represents a standard recommendation by the Joint Commission on Accreditation of Healthcare Organizations . A culture of zero tolerance for “never events” is a key to keeping patients safe. From a patient safety perspective, the fact that this surgical time-out paradigm has not yet been implemented as a standard of care in most parts of the world appears incomprehensible and ethically unacceptable.

Of note, the time-out concept can never be 100 per cent protective from wrong site interventions. Potential loopholes in this system include relegating the time-out to a robotic hackneyed type ritual or the continuing “dilution” of the time-out by expanding to secondary safety issues, such as antibiotic and venous thromboembolism prophylaxis, as implemented in the so-called “expanded surgical time-out” or “universal protocol”. The (ab)use of the formal time-out as a quality control tool for secondary parameters may deflect from its original purpose of ensuring correct site, correct procedure and correct patient surgery. Another risk factor for wrong site surgery is represented by the situation of multiple simultaneous procedures performed during the same surgical session. This is exemplified by the case of a patient undergoing multiple surgical interventions for different injuries, thereby obscuring the focus of the time-out on a particular operation.

In addition, some specific anatomic locations may represent “black boxes” during the time-out, and thus represent www.jointcommission.org

a particular risk for wrong site interventions. These include orthopedic procedures at the torso (spine, pelvis), dental surgeries, neurosurgical interventions, and intra-abdominal or intra-thoracic operations. For example, an orthopaedic surgeon may perform a sacroiliac screw fixation on the wrong side or fuse a wrong intervertebral segment of the spine.

An example of a wrong site complication in general surgery is the erroneous clipping of the common bile duct, instead of the cystic duct, during laparoscopic cholecystectomy. Furthermore, interventional radiology procedures pose a similar risk for wrong site surgery, e.g. by the erroneous coiling of a wrong artery. Finally, neurosurgical interventions on the wrong part of the brain are reported on a scarily frequent basis.

Unlike symmetric external body parts, such as extremities, eyes and ears, these “hidden” surgical sites may not be easily identified, confirmed and marked prior to surgery. Thus, these particular circumstances may mandate an accurate intraoperative localisation under fluoroscopy, in conjunction with a careful evaluation of the surgical site by additional preoperative diagnostics, such as CT, MR, angiography, or cholangiography.

Recently published studies indicate that wrong-site / wrong-procedure / wrong-patient surgeries surprisingly continue to occur in North America.

For example, adverse event data from the state of Florida, US, reported 178 wrong site, 82 wrong procedure and 34 wrong patient cases for the years 2000-2003 (Archives of Surgery 2006). A detailed analysis of an extensive database

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S u r gical S pecialit y

Reporting of medical errors in surgery

Systematic medical errors represent an essential “information problem”. While the intellectual argument for reporting medical errors in surgery is compelling beyond a doubt, surgeons remain inherently reluctant to disclose surgical failures and complications in public.

The main barriers for reporting surgical errors are based on the fear of medicolegal lawsuits, potential loss of professional prestige among peers, and the well-engrained tenet of non-admission of guilt and fallibility among surgeons (“blame and shame culture”). In this regard, the major ethical concern is that the suppression of data on surgical errors will deprive other surgeons of adequate scientific knowledge, which may help prevent identical errors in the future. In contrast to aviation safety, where the implementation of systematic error reduction policies has led to an irrefutable, impressive drop in fatal accident rates in the past decades,

surgeons remain reluctant to recognise, analyse, and officially report their own errors. The “human factor” which may help explain the discrepancy between the situations in aviation versus surgery is based on the fact that a pilot is usually killed with a crashed plane, whereas a surgeon suffers no personal physical harm from a patient’s complication.

Thorough reporting and peer-review of surgical errors creates a new dilemma for the surgeon in practice: an increased quality of reporting leads to an increased official number of complications and adverse events, thus affecting the individual surgeon’s professional track record and the respective institution’s ranking among peers. Until legislation provides legal protection for medical error disclosure and analysis, we continue to rely on the inadequate reporting of errors and complications in the peer-reviewed biomedical literature. A recently launched open-access online journal, Patient Safety in Surgery , was designed to complement traditional journals in surgery by filling this essential void, through providing a forum for discussion, review, and “root cause” analysis of failures in the management of surgical patients. This scientific forum should create a focal point www.pssjournal.com

for critical discussion of surgical errors and lower the threshold for reporting adverse events in all fields of surgery. As a result, the long-term goal of increasing safety and quality of care for patients undergoing surgical procedures will be effectuated.

Conclusion

In summary, surgeons who wish to decrease errors in their practice should consider implementing the following three-standard procedures: 1. Standardised pre- and post-operative communication handoffs between medical consultants, surgeons, anesthesia, and nursing staff, and formal “readbacks” supported by written checklists and protocols.

2. Standardised surgical time-out for all cases.

3. Systematic error reporting and real-time (weekly) peer-reviewed analysis of all complications, “near-misses”, and “no harm” events.

Acknowledgments We thank Drs Ted Clarke, Mike Victoroff, Dennis Boyle, Alan Lembitz, and Jeff Varnell for providing access to the comprehensive, physician self-reported adverse events database at COPIC, Denver, Colorado.

Philip F Stahel is an Attending Surgeon, Department of Orthopaedic Surgery, Associate Professor, University of Colorado School of Medicine, Denver Health Medical Center. He has also involved in many research activities. He has been honoured Yearly Award for Experimental Surgery by The Swiss Surgical Society.

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at the Colorado Physician Insurance Company (COPIC) on 20,775 physician self-reported complications, we detected 99 cases of wrong-site surgery and 20 cases of wrong-patient procedure in the years 2002-2007 (Stahel et al., unpublished results).

The persistent occurrence of these “never-events” in the era of a surgical time-out may be explained by individual surgeons’ non-compliance and by numerous pitfalls related to accurate surgical site determination, as outlined above.

Also, the time-out should not absolve the individual surgeon from taking full responsibility in ensuring by all available means that the correct procedure is performed at the correct site on the correct patient. All institutions have to now consider adapting a formal time-out concept as a standardised quality assurance tool. Patients must be educated to inquire their surgeons whether a formal time-out procedure will occur in the elective surgical suite.

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Wade R Smith is a Surgeon, Department of Orthopaedic Surgery, Denver Health Medical Center, University of Colorado School of Medicine, USA. He is DH Executive, Patient Safety Committee since 2006. He is also an External Fixation Working Group Member, AO Foundation Technical Committee (AOTK) since 2005.

Philip S Mehler has been at Denver Health since training there as a resident in the early 1980s. Philip Mehler is also a Professor of Medicine at the CU Medical School where he holds the Glassman Endowed Chair of Medicine. He has been honoured by 5280 Magazine numerous times as the Top Internist in Denver, Best Doctors in America for the last twelve years is listed in Who’s Who in American.

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DIAGNOSTICS

Advanced CT Imaging

Effective diagnosis of coronary disease Michael Chun-Leng Lim Medical Director Singapore Heart Stroke and Cancer Centre, Singapore

The advent of 256 and 320-slice CT scanners will eliminate many of the technical difficulties that affect the temporal resolution of coronary CT angiogram. As technology advances, MDCT imaging of the coronary arteries will become the diagnostic tool of choice for the detection of coronary artery disease.

T

he main trigger for the onset of Acute Coronary Syndromes (ACS) following a prolonged period of coronary atherosclerosis is the rupture of an atherosclerotic coronary plaque followed by localised coronary thrombosis and / or spasm. The major factors that predispose to rupture of a vulnerable plaque are a relatively large lipid core, a thin cap, and an accumulated macrophage content. None of these determinants of plaque rupture are related to each other or to the severity of luminal stenosis.

Plaque rupture typically occurs at milder stenoses with 40 to 60 per cent diameter narrowing or less. These mild stenoses generally do not give rise to symptoms or ischemia on treadmill testing.

The degree of stenosis in focal plaque segments on coronary

angiograms does not correlate with the risk of plaque rupture. Plaques which have developed more recently are lipid laden, cause minor luminal narrowing and are more likely to rupture than older, hardened plaques with more severe luminal narrowing.

It is therefore, not surprising that 65 per cent of stenoses associated with subsequent myocardial infarction have <50 per cent luminal diameter narrowing, and 85 per cent have <70 per cent diameter narrowing.

Conventionally, non-invasive methods for detection of coronary disease using stress treadmill testing, stress echocardiography and myocardial perfusion scan provide indirect means of diagnosing significant coronary disease where the coronary luminal diameter narrowing is more than 70 per cent. But they are unable to

detect the vulnerable plaques that do not cause any significant functional stenoses, though they account for the large number of patients who eventually develop ACS. Coronary CT Angiography (CCTA) is one of the new modalities of coronary artery imaging.

It is playing an important role in the assessment of coronary artery disease.

CCTA is performed by imaging the coronary arteries with a Multi-Detector CT scan (MDCT).

Multiple sub-millimeter detector elements mounted on a gantry with a sub-second gantry rotation time, allow high-resolution axial images of the coronary arteries to be recorded while the patient holds his breath. A 16 channel MDCT scanner will have a lower volume coverage than a 64 channel MDCT scanner. Hence, the breath holding duration for

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a 16 MDCT CCTA is between 20 to 25 seconds, whereas for a 64 MDCT CCTA, it is 7 to 10 seconds. With newer 256 and 320-slice CT scanners which will become commercially available next year, the scanning time will be about 1 to 2 seconds.

Accuracy of Coronary CT Angiography

With such a wide choice of non-invasive cardiac imaging modalities, it is important to assess each new modality on its own merits. Compared to current modalities, CCTA must be able to demonstrate accuracy of inferior quality for it to be used routinely.

Conventional non-invasive modalities for coronary artery assessment are performed to detect the likelihood of significant flow-limiting lesions but provide no information as to the presence of vulnerable plaques. They are also unable to detect the presence of sub-clinical atherosclerosis, which may predispose the patient to future cardiac events. Gender, cardiac rhythm, inability to exercise and the number of vessels involved may influence the results of these tests.

The sensitivities, specificities and accuracy of treadmill tests, stress echocardiography and myocardial perfusion scan are mentioned in Table 1.

Many centres, including our centre, have demonstrated that compared to invasive coronary angiography, CCTA has a high sensitivity and specificity for detection of coronary artery disease. At our centre, we were able to demonstrate a sensitivity of 99 per cent, specificity of 98 per cent, Positive Predictive Value (PPV) of 94 per cent and Negative Predictive Value

(NPV) of 99 per cent for the detection of significant coronary artery stenoses. This compares very favourably with the other conventional modalities of non-invasive cardiac imaging.

Hence, amongst the non-invasive tests, CCTA has the highest specificity and sensitivity for detection of coronary artery disease.

It is also consistent in most of the published papers that CCTA has a high NPV. The PPV of CCTA varies from centre to centre as different protocols and different post-processing methods are used. There is a tendency towards over-diagnosis initially, as there is a learning curve for CCTA. However, with proper patient preparation, experience, optimal protocols and appropriate post-processing techniques, a high PPV is achievable.

Comparison with invasive coronary angiography

Increasingly, CCTA is being compared with Invasive Coronary Angiography (ICA). Unlike CCTA, which is able to provide a three-dimensional image of the coronary vessel including the vessel wall and the presence of plaque, ICA is a “lumenography” demonstrating only the lumen of the coronary artery without visualisation of the vessel wall or plaque. The presence of a plaque in a coronary artery segment is inferred from the narrowing of that segment relative to a wider adjacent segment. Hence, plaques which are not visible by ICA are visible by CCTA. A “normal” angiogram by ICA assessment may be abnormal on CCTA as some of the plaques may not cause an obvious reduction in the lumen size; this is usually seen in bifurcation plaques or diffuse plaques.

Sensitivities, specificities and accuracy of non-invasive cardiac imaging modalities Treadmill Testing

Stress Echocardiography

Myocardial Perfusion Scan

Sensitivities

68

77

73

Specificities

85

84

87

Accuracy

89

80

89 Table 1

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The limitation of ICA as a lumenography is particularly apparent in diffuse coronary artery disease.

Intra-vascular ultrasound (IVUS) has been able to demonstrate the presence of diffuse, extensive coronary atherosclerosis in the absence of vessel stenoses on angiography. Compared to IVUS of the coronary arteries, the sensitivity of ICA to the diagnosis of diffuse coronary artery disease ranges from 7-43 per cent, with a specificity of 95 per cent.

In addition, the diagnostic errors in visually interpreted coronary arteriograms, where vessel diameter narrowing is visually estimated, are well documented. Even for cardiologists with extensive experience in coronary angiography, the severity of diameter narrowing is commonly overestimated by 30-60 per cent.

Hence, visual assessments of coronary angiograms severely underestimate mild or diffuse coronary artery disease and overestimate the severity of plaques which have >50 per cent diameter stenosis. Therefore, ICA as the “gold standard” for coronary artery disease has several limitations.

CCTA holds much potential as a highly accurate modality for assessment of coronary artery disease. Unlike ICA, which provides two-dimensional imaging and is essentially a lumenography, CCTA provides three-dimensional imaging and is able to visualise the coronary plaques and other cardiac structures. In addition, CCTA also has the advantages of being non-invasive, is less costly and is an outpatient procedure. In contrast to the known stroke and myocardial infarction risks of ICA, in the first 4000 CCTAs performed in our centre, there were no myocardial infarctions, no strokes and no mortality risks.

However, CCTA has certain interpretative pitfalls resulting from artifacts. The artifacts may be due to respiratory (poor breath holding) or cardiac motion (sinus tachycardia,

DIAGNOSTICS

irregular rhythm), beam hardening effects (caused by the presence of severe calcification, metallic stents, pacing wires), contrast related artifacts (produced by filling of adjacent chambers and coronary venous vessels) and post-processing artifacts (common cause of overestimation of luminal stenosis is due to “partial volume effect” during post-processing).

In experienced centres, using the 64-slice MDCT, CCTA may be comparable to ICA in sensitivity and specificity for the detection of significant coronary artery disease for the majority of patients. So it increasingly being used as the non-invasive tool of choice.

In the CARDIAC study (CT Angiogram as Replacement Diagnostic Investigation for Angioplasty of Coronary arteries—submitted for publication), a total of 121 consecutive patients in our centre, who were listed for PTCA solely based on the results of coronary CT angiogram were picked up for the study. We assessed the diagnostic accuracy of coronary CT angiography on a per patient basis. Peri-procedural complications such as Major Adverse Cardiac Events (MACE), stroke and emergency bypass graft surgery were evaluated. MACE including death from any cause, Qwave myocardial infarction, and target vessel revascularisation during the next 30 days, were analysed. At the catherisation laboratory, following the pre-PTCA invasive diagnostic angiograms, 118 respondent (97.5 per cent) proceeded with coronary artery stenting. There were no periprocedural complications. Durng the 30 days, there was no episode of death from any of the causes: Q-wave myocardial infarction or target vessel revascularisation. Hence, in addition to providing an alternative to ICA, CCTA may allow better pre-planning of PTCA and hence, low complication rates.

Safety of CCTA

The main risks associated with CCTA are the use of iodine-based contrast agents potential risks arising from radiation exposure during the scan.

Contrast risks are low. Post marketing surveillance of one particular contrast agent, Ultravist (data from Schering), showed that there were 14 serious adverse drug reactions in 75,000 patients (<0.02 per cent) Contrast risks are minimal and comparable for both CCTA and ICA for native coronary angiography. In the case of ICA of bypass grafts, the contrast load will be significantly higher as compared to CCTA of bypass grafts. With the 64 slice MDCT, Coronary CTA can be performed with as low as 50cc of iodinated contrast. The precau-

With a wide choice of non-invasive cardiac imaging modalities, it is important to assess each new modality on its own merits.

tions to be taken for those with renal insufficiency are the same as in any examination, which require contrast agents. Most adverse contrast reactions present with rash and in rare cases, anaphylaxis can occur. From our centre’s experience, for the first 4000 Coronary CTA examinations, we only had one case where adrenaline had to be given as a result of anaphylaxis. The patient did not go into shock and did not require hospitalisation.

The other main risk associated with CCTA is the radiation risk. In understanding the potential risks of radiation, it is important to understand the terminology. The term “radiation exposure,” which quantifies the ionisation in the air produced by X-ray photons does not equate with the term “radiation dose”, which quantifies the amount of radiation absorbed by the

patient’s body as a result of exposure to X-rays.

Radiation dose assessment is important for decisions on the riskbenefit value of the CT examination and to assess the effectiveness of measures for minimisation of radiation during CCTA. The fundamental radiation dose parameter in CT is the Computed Tomography Dose Index (CTDI), which is a measured parameter. The Effective Dose (ED) is the main parameter, which is used to compare the potential biological risk of X-ray examinations. It is commonly used to compare the different absorbed radiation dose and radiation risks of different X-ray examinations.

Unlike the CTDI, which is a measured parameter, the ED is derived from the CTDI. The SI unit for measurement of ED is the sievert (Sv) or millisievert (mSv). The ED is calculated from the relative weight radiation risks of each specific organ.

Reduction in radiation dose during CCTA has been made possible by two different methods.

The first method utilises the fact that due to the elliptical axial section of the human body, the attenuation of the Xray is less if the X-ray beam traverses in an anterior-posterior (AP) direction as compared to a lateral direction. Hence, less X-ray energy is required to produce a comparable image in an AP direction when compared to X-ray source in a lateral direction. The second method involves the optimisation of radiation exposure by ECG-controlled tube current modulation during periods of the cardiac cycle where cardiac motion artifact is minimised (ventricular diastole). Reduction of the tube current output in systole, when the likelihood of cardiac motion artifact is higher, can result in dose reductions of 45-48 per cent, depending on the patient’s heart rate.

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DIAGNOSTICS

Hence, with proper optimisation of the protocols and settings, the radiation risk of CCTA can be minimised and the overall mortality and morbidity risks of CCTA as compared to ICA can be made favourably weighted towards CCTA. The main risk of CCTA is radiation risk. So protecting the patients from radiation is necessary. This means the justification for the radiological procedure is based on the premise that the potential benefit for the patient outweighs the potential risk of radiation. It also means that the ED for each procedure is calculated to assess the risk-benefit value of the CT examination and the effectiveness of the protocols and the settings in minimising radiation risks.

The development of the new CT scanners means that radiation doses will continue to decrease. Using prospective ECG gating protocols and new imaging sequences, radiation doses in 64-slices CCTA have been reduced to doses comparable to invasive coronary angiography.

Conclusions

CCTA can provide three dimensional view of the coronary vessel wall structure, heart muscle, valves, pericardium and even ventricular contractility function. It has a higher sensitivity and specificity for the detection of coronary artery disease compared with conventional non-invasive tests. Its main disadvantage is its potential radiation risk.

This is, however, balanced by it being the only non-invasive cardiac imaging modality with the ability to

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Many studies have been performed to study the radiation dose of CCTA. Some of the earlier studies had shown that the radiation dose from MDCT was approximately 4–7 mSv and was comparable to that from uncomplicated conventional coronary angiography. In a study where the ICA was performed by different cardiologists, the average dose varied from 3.1 mSv to 8.6 mSv. In a more recent study, continuous scanning with the newer 64-slice CT scanner without using ECG-controlled tube current modulation resulted in an ED of 13.4 mSv for males and 18.9 mSv for women. With dose modulation, the ED was reduced to 7.45 to 8 mSv for men and 10.25 to 11.3 mSv for women. This study assumed an effective mAs of 880. At our centre, when using the 64-slice CT scanner, the tube current for CCTA studies is routinely set between 500 to 600 mAs. The increased radiation risk of CCTA is offset by the increased morbidity and mortality risks of ICA. In one prospective study, which investigated the risk of stroke embolisation following ICA, asymptomatic new cerebral infarction detected using MRI following left cardiac catheterisation occurred in 15 per cent of patients.

Hence, invasive cardiac catheterisation carries a significant risk of embolic stroke­—mainly “silent strokes”.

ICA carries a non-radiogenic risk of mortality of 0.11 per cent, a major complication risk (excluding contrast reaction) of 1.3 per cent, radiogenic risk of mortality of 0.02 per cent and an overall mortality risk of 0.13 per cent (nearly two times that of CCTA) and major complication risk of 1.3 per cent. These risks do not include contrast reactions and silent strokes. In comparison, CCTA carries no non-radiogenic risk of mortality and no major complication risk. It carries a radiogenic risk of mortality of 0.07 per cent.

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detect sub-clinical plaques, which may predispose to myocardial infarction and its ability to provide plaque characterisation. Hence, it can potentially play a role in risk stratification of patients with cardiovascular risk factors and provide physicians with added information on treatment decisions.

In contrast to ICA, which only visualises the lumen of coronary arteries, CCTA holds the potential for a comprehensive examination of the heart using one single examination technique. In addition, it can provide information on plaque distribution and characteristics which cannot be obtained on ICA. The examination is easily reproducible, objective and has a very high negative predictive value. In high-volume experienced centres, a high PPV is also attainable.

CCTA may potentially provide patients an alternative to ICA. In our centre, CCTA has replaced ICA as the diagnostic tool of choice for patients who are suspected to have coronary artery disease.

However, in some patients, the presence of severe calcification can present significant diagnostic challenges. The advent of 256 and 320 slices CT scanners will eliminate many of the technical difficulties that affect the temporal resolution of coronary CT angiogram.

As technology advances, MDCT imaging of the coronary arteries will be increasingly used and will grow in importance as a diagnostic tool for the management of coronary artery disease.

Michael Chun-Leng Lim is an internationally renowned Cardiologist and is the Medical Director of Singapore Heart, Stroke & Cancer Centre. He is currently the Dean of the College of the Asian Pacific Society of Cardiology (CAPSC), Chairman, Board of Trustees (CAPSC), Scientific Advisory Board, World Heart Federation and Immediate Past President of the Asian Pacific Society of Cardiology (APSC).

ISSUE-15 2008

DIAGNOSTICS

PACS in Indian Hospitals Catching up

More and more physicians and radiologists have started preferring the PACS systems to hard copies.

Deepak Kumar Chief Technology Officer Srishti Software, India

How has the response to PACS been?

PACS in India, the response has been very good so far. In fact, there are quite a few hospitals that are fully using the PACS software. The hospitals that we have been targeting have shown very keen interest in PACS. We feel that market is getting mature and is set to boom.

How is the technology likely to evolve in the coming years?

PACS technology has been changing quite rapidly. Initially it was newer and more sophisticated equipment, like good quality CT, MRI, PET/ CT etc. These have already allowed clinicians to diagnose with much better accuracy. In future we anticipate that with more development in algorithms and computing power, Computer Assisted Diagnosis based on radiology data will evolve as a feasible technology and will enhance quality of diagnosis to unprecedented level.

What are the basic requirements to implement a PACS across an organisation?

Assuming that a hospital already has a radio diagnosis facility with equipments and radiologists, the following would be additional requirements: • Equipments must be DICOM compliant. Some of non-compliant equipments may still be used with additional DICOMisers • A PACS server that will receive studies from equipments, store those, allow queries & retrieval, archive, and allow automated routing • DICOM workstations that would be used by Radiologists for viewing, processing, analysing, and reporting the studies

• A good quality network to connect equipments, PACS server and DICOM workstations • Storage and backup infrastructure for reliably storing the studies How have physicians and hospitals responded to the technology, since they have been used to hard copies of X-ray reports for so long now?

That’s quite interesting. In fact, we are finding that more and more physicians and radiologists have started preferring the PACS systems to hard copies. Turn around time for modalities connected with PACS is much faster in comparison to traditional films. Further there is no easy way to keep hard copies of 64-slice

Are hospitals in India self-sufficient as far as using this technology is concerned?

Yes, to a great extent. In fact, Indian hospitals are well equipped with the PACS technology.

There is good quality support available from various vendors. Additionally number of radiologists, who are comfortable in using sophisticated PACS workstations, is growing and hence pushing the utilisation of PACS infrastructure in hospitals.

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India are treating IT as a strategic area and willing to invest.

How do you view the market for PACS in India?

Quite good. In fact, the market is getting very exciting. Most of the top league hospitals are already using PACS while most other progressive are exploring PACS. Earlier significant high cost of ownership, due to high license fee and hardware & storage costs.

However the crashing prices of hardware & storage, combined with reasonably priced solutions from some of the vendors has removed that barrier. Today hospitals of any size can acquire highest quality PACS server and specialist workstation at a price affordable to them.

CT, PET / CT, 4D / 5D etcetera and keeping these digitally remain the only viable option.

What are the benefits of PACS when you look at it from the point of view of the entire healthcare continuum?

IT applications that a hospital uses can be categorized as PAS [Patient Administration System], CAS [Clinical Administration System], EMR [Electronic Medial Records] and ERP [Enterprise Resource Planning]. In order to get complete view of a patientâ&#x20AC;&#x2122;s EMR, one needs complete radiology studies as well, which is maintained in PACS. This makes PACS an integrated part of full patient care applications and workflows.

Does it raise the issue of security of data?

In any form of Medical records, we get privacy and data protection issues.

These need to be understood and handled by hospitals that implement PACS. Hospitals needs to additionally understand the security issues and risks involved when PACS is used to enable tele-radiology to allow access of study outside hospital premises.

Does PACS help in providing telemedicine?

Most of PACS solutions, when implemented properly, will allow out of the box tele-radiology. Enabling studies to be reported by remote radiologists. However there may be additional application required to allow handling of transfer of clinical data, appointments, tele-conferencing, billing etc.

Do you think Indian hospitals are interested enough in Healthcare IT? All the hospitals we have been interacting are considering IT as their way to improve quality, processes and bring cost down. So we feel that in hospitals

From your experience in implementing PACS in India, what are issues you came across as a service provider?

In few occasions, hospital may not be clear on human resource needed from their side to maintain and use their PACS environment. For example, to effectively use PACS Radiologists, Clinicians, Operators and PACS administrators must get trained properly.

These need to be properly planned and executed; otherwise all benefits from PACS might not be realised. Another set of issues comes when hospital does not have clarity about the duration for which they want to retain studies, making estimation of storage complicated.

Any other comments?

Indian healthcare is fast moving to a stage where hospitals will need to compete more for the same set of patients and in order to do so improve quality while keeping the costs in control. In this regard, many hospitals have started looking or otherwise should look in to way to improve their quality and controlling costs. IT can be a strategic enabler, however hospitals should be careful and engage with a vendor only with proper due-diligence.

Industry Report Advances in PACS Technologies

Today, PACSs are being widely implemented in radiology departments for routine clinical diagnosis. Though there are several hundreds of first-generation PACSs currently used by many hospitals to support direct radiological softcopy readings they are not capable of integrating other related text-based information. But the subsequent development of second-generation PACSs, which is now known as hospital integrated PACSs (HI-PACSs) or enterprise PACSs, meets this criteria, which is integration of PACSs with heterogeneous information systems such as HIS and RIS, transition to an open client / server system architecture, and the implementation of recognized imaging standards such as DICOM and HL7.

Sangeetha Prabhakar Research Analyst, Technical Insights (Healthcare), Frost & Sullivan, Singapore For the full report, visit Knowledge Bank section of www.asianhhm.com

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T echn o l o g y , e q uipment & devices

Devices Containing Membranes Better membrane, improved outcomes

Devices containing artificial membranes for the treatment of kidney disease lack the ability to replace or augment metabolic and endocrine functions, which are non-selective and biologically reactive.

CTA

PEPA® Frsenius Polysulfone® PAN Arylane®

a Polysulfone Rexeed®

PMMA DIAPES® PEPA® EVAL®

Cellulose-diacetate Cellulose-triacetate

PAL PMMA Polymax®

Fresenius Polysulfone® Polysulfone® Arylane® Toraysulfone®

CUPROPHAN® SCR Cuprammonium Rayon

HEMOPHAN® SMC® Cellulose-diacetate Cellulose-triacetate Excebrane® PEG-RC

DIAPES® ­Polyamix® Fresenius Polysulfone® a Polysulfone

UFC >20 ml/h/mmHg

Synthetic

DIAPES® ­AN69® AN69ST Polyamix® Toraysulfone®

UFO 10-20 ml/h/mmHg

Early experimental dialysis treatments used membranes based on cellulose, namely, collodion formed from the mixture of cotton, sulphuric and nitric acid redissolved in alcohol. This material is difficult to produce, sterilise, is subject to leakage and has a lack of consistency with respect to the pore size. All of this contributes to its limited clinical

application. By the early 1940s, cellulose was manufactured using the viscose process replacing collodion.

With the availability of a reliable method of vascular access in the 1960s, treatment of renal failure became more widespread and retained its reliance on membranes manufactured from cellulose. Widely used membrane variant being Cuprophan, used primarily in a flat sheet or tubular form. By the late 1960s, technology became available to produce such membranes in a hollow fibre format, which is used almost universally in the treatment of renal failure.

Concerns began to arise in the 1970s regarding the poor biocompatibility of cellulose-based membranes as well as the narrow range of molecules that could be

UFO < 10 ml/h/mmHg

Currently used membranes and demography of their use

Sythetically modified cellulose

T

he ability to separate molecular species in a solute using a membrane was first described

by Thomas Graham in 1861, and today the process is widely used in a variety of industrial and clinical applications. In the latter, commonly used applications are: plasma separation, oxygenation and the augmentation of renal function (Haemodialysis).

In plasma separation, 2-3 litres of plasma is removed from the patient during treatment and replaced. The frequency of the treatment and the volumes exchanged depends onthe disease being treated and the patient’s response to the treatment. Membrane oxygenation is used during cardiac procedures or also over extensive periods to provide support for patients with pulmonary distress. The most widely used application is haemodialysis, a treatment that is generally performed three or more times a week to sustain life. In haemodialysis, the membrane ontained within a haemodialyser, or artificial kidney, acts as a selective barrier between two phases, regulating the transport of substances, which occur as a consequence of concentration difference across the

membrane. Variations of this concept are the newer modalities of treatment, which introduce an element of convection to the process. Such approaches, however, retain their reliance on a membrane, but tend to utilise membranes with a high hydraulic permeability (Table 1).

Un modified Cellulose

Nicholas Hoenich Clinical Scientist, Medical School Newcastle University, UK

Table 1

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T echn o l o g y , e q uipment & devices

removed by such membranes. This led to extensive studies on the biocompatibility or blood contacting behaviour of membranes used in clinical procedures as well as the development of more open-pored synthetic membranes and new treatment techniques.

The poor biocompatibility of cellulose-based membranes was found to be due to the presence of OH or hydroxyl chemical groups on the membrane surface and modifications either by chemical replacement of groups, or by the grafting of polyethylene glycol chains onto the membrane ensued. The structural modifications used may be tertiary amino groups such as Di-EthylAmino-Ethyl (DEAE) or acetate groups as used in the production of cellulose acetate or cellulose triacetate with the magnitude of the hydroxyl group substitution varying between 1 and 100 per cent.

Synthetic membranes are produced by the chemical transformation of polymers, which may be either hydrocarbon or heterochain. One, two or more polymers may be mixed to produce the membranes, which can be symmetric, whereby both sides of the membrane are identical in structure, or asymmetric. In asymmetric membranes, a thin dense inner layer normally in contact with the blood overlies a porous substructure. As the base materials used in the production of synthetic membranes tend to be hydrophobic, the manufacturing process involves their blending with a hydrophilic material, generally, polyvinylpyrrolidine (PVP). Such membranes due to their different surface structure compared to cellulose-based membranes, are generally more biocompatible, but currently no membrane is available for clinical use, which is inert.

Grassmann and colleagues, analysing global trends in the treatment of renal failure by dialysis showed in 2000 that when 1.297 million patients underwent treatment, 46 per cent of dialysers used

were high-flux and 50 per cent contained synthetic membranes. Their later survey in 2005 indicated that 62 per cent of all dialysers sold were high-flux and 73 per cent contained synthetic membranes.

To curtail costs, haemodialysers were historically reused on the same patient. Whilst this continues, globally, the number of patients treated with reused dialysers decreased steadily from around 34 per cent in 2000 to 26 per cent in 2005, a development that was driven primarily by the abandonment of reuse in many clinics in the USA and in Eastern European countries.

It has been estimated that the global growth rate of haemodialysis is around 6 per cent per annum, with trends observed to date dominated by econom-

The manufacture of membranes has been optimised to produce materials with a tightly modulated pore size distribution.

ically well-developed countries, such as the USA, Japan and Germany. Based on the status as of 2005 and the observed growth rates, the emerging picture of dialysis treatment in the year 2010 is one with a global population approaching two million patients, furthermore it is estimated that by this time around 800,000 of the patients receiving treatment will be living in countries that are presently defined as low- or middle-income countries.

Limitations of current membranes

Membranes, whether they are manufactured from cellulose or synthetic materials, are subject to limitations in their solute transport characteristics.

Membranes may be considered as porous structures that act as non-selective molecular sieves i.e. molecules of a specific molecular weight, the membranes

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cut-off weight (~25kD) traverse the membrane irrespective of whether they are implicated in uraemia or not.

The rate of solute transport across the membrane is inversely proportional to the square root of the molecular weight of the chemical species. This means that a molecule such as B2 microglobulin, a compound with a molecular weight of 15kD implicated in the evolution of long-term problems associated with regular dialysis therapy, diffuses approximately at 7 per cent of that for urea (60 daltons) and clearly highlights the limitations of membranes in removing larger molecules. In both cellulose and synthetic membranes there is a distribution of pore sizes. Increasing this distribution means that whilst there may be an improvement of middle-size molecules, there will also be loss of proteins such as albumin, unless the pore size distribution is tightly controlled. The issue of protein leakage in high flux membranes has long been recognised. Today, protein-leaking membranes are available and have been used in a small number of clinical trials in which improvement in anemia, decreased plasma total homocysteine and reduced plasma concentrations of glycosylated and oxidised proteins was demonstrated.

It remains unclear if routine use of such membranes is warranted.

Today, manufacture of membranes has been optimised to produce materials with a tightly modulated pore size distribution, thereby improving the removal of specific compounds.

However, such manufacturing alterations cannot be leveraged further to generate improvements in selectivity. An alternate approach to improving solute transport is to move away from the circular or elliptical pores to a rectangular slit, an approach that offers considerable advantages in terms of solute transport.

In membranes used in the treatment of chronic kidney disease, the primary focus

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T echn o l o g y , e q uipment & devices

Future approaches

Membranes used in the treatment of chronic renal disease are manufactured in large quantities and their production has been optimised.

However, currently used membranes are at their limit with respect to transport characteristics, although some improvements are possible with the use of slit shaped geometries, rather than the currently used cylindrical pore configuration or by the development of membrane absorbers. Alternately, the surface grafting of macromolecules to capture solutes of interest may also offer solute transport enhancement.

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has been to improve removal of metabolites from blood. However, in a haemodialyser, the blood side of the circuit is sterile, but the dialysis fluid side is not. Unless the water distribution system is cleaned on a regular basis, a potential for the development of a biofilm within the water distribution network, as well as the hydraulic circuit of the dialysis machine, leading to the release of endotoxin fragments and bacteria exists. Bacteria, due to their size, cannot cross the membrane but endotoxin fragments are able to do so. And this has raised concerns that membranes with a large pore size may confer a risk to the patient of exposure to cytokine-inducing bacterial substances in the dialysate, thereby contributing to the microinflammatory state of patients undergoing regular dialysis. A number of studies have demonstrated that such transport across the membrane is dependent not just on the size of the pores, but also the membrane material, due to the ability of synthetic membrane materials to absorb cytokine-inducing bacterial substances.

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With respect to biocompatibility, current approaches aim to minimise or suppress the patho-physiological mechanisms by the shielding or manipulation of the hydrophobic and hydrophilic domains in the polymer blend. Whereas this approach yields positive results, totally inert membranes are not yet available.

Finally, it should be stressed that all currently used membranes lack the ability to provide replacement or augmentation of the human kidneys, metabolic and endocrine functions. This issue is now being addressed as polymeric membranes offer a considerable potential as supports or anchors for cells.

Nicholas Hoenich is a scientist University of Newcastle upon Tyne.

He serves on the Editorial Boards of several bioengineering journals, is a member of the Research Committee, British Renal Society, and expert advisor to the Medicines and Healthcare Products Regulatory Agency for the UK. He is the author of over 100 peer group reviewed publications and has contributed to several textbooks dealing with the treatment of renal failure.

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T echn o l o g y , e q uipment & devices

Art for Health's Sake An evidence-based approach

Upali Nanda Vice President, Director of Research American Art Resources, USA

The human mind and body are so intrinsically linked that “feeling” better is a huge step towards “being” better. This makes the role of art very critical in today’s healthcare.

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hey say a picture is worth a thousand words. In a museum, we can stand and ponder on what these thousand words may be. We can look at a picture, wonder, and let our thoughts wander.

But, what about art in a hospital?

In a hospital, patients, visitors and staff are all under constant pressure and in a state of stress and anxiety. Patients

want to feel better and care givers want to make patients feel better. Good doctors, good infrastructure, good medication and a clean, safe environment is all that should be needed to achieve this objective. And yet, there is a growing movement away from the cold, sterile, pearl-white and disinfectant-smelling environments of yore to more humane environments that are

less frightening to the patient and less stressful to the staff. The key is in perceptions—the human mind and body are so intrinsically linked that “feeling” better is a huge step towards “being” better.

And this is where the role of art becomes so critical.

Today, nearly 50 per cent of all hospitals in the US have art programmes.

In 2003, the Society for the Art in

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Healthcare (SAH) and the National Endowment for the Art (NEA) undertook an analysis of Joint Commission on Accreditation of Healthcare Organizations (JCAHO)-affiliated hospitals to determine the current level and characteristics of art activities in healthcare (Wikoff, 2004). Two thousand hospitals responded that they had art programmes in place—73 per cent of those reported permanent displays of visual art in the hospital; 32 per cent reported having rotating exhibits, typical art by local or regional artists.

The study found that 96 per cent of hospital art programmes were intended to “serve patients directly.” The primary reason given for having art programmes was “benefit to patients” (78.8 per cent), noting them “specifically to be a part of their mental and emotional recovery (72.8 per cent).” The study also found that 25 per cent of hospitals with art programmes allow patients an opportunity to choose their own art. In the US$ 41 billion healthcare construction industry in the US, by a conservative estimate, US$ 2 billion will be spent on art for new hospital constructions this year. Yet, despite the obvious support for art in the healthcare setting, finding resources for information on how to create a successful and empathetic art programme is difficult. The popular notion is to consider Visual Art as nothing more than pictures that can entertain, but not heal. Over the past decade or so, there has been a growing body of evidence

to prove otherwise. Studies have now linked the effect of Art to measurable health outcomes, such as reduction in stress, pain perception and anxiety and increase in satisfaction and restoration. These studies form the evidence base for a more responsible and ethically driven aesthetic of what is being termed as “Evidence-based Art.” The evidence base on healthcare visual art: A quick overview

In Florence Nightingale’s Notes for Nursing ([1860], 1969), she describes the patients’ “need” for beauty and argues that the effect of beauty is not only on the mind, but on the body as well. Since that first emphasis more than a century ago, art has continued to have a presence in the healthcare environment. During the Depression, artists were put to work on painting murals in US hospitals. In the 1970s and 1980s, hospitals in the US began to “decorate” with art—but without particular consideration to the “therapeutic benefit” art might have had. The early 1990s saw a new interest in therapeutic environments, which emphasised art that was intended to contribute more than decorative value to the hospital environment. Today, there is yet another shift to more rigorous evidence-based design, which is both the process and product of scientific analysis of healthcare environments (Hamilton, 2003).

In the context of art, this refers to the process and product of scientific analysis of the impact of art on healthcare environments; on patients

In addition to appropriate image content, three aspects of art need to be taken into consideration for creating healing environments (Hathorn, 1998) 1

Location of artwork - The exact location of the artwork so as to enhance the physical environment and also develop a healing atmosphere. For example, when patients undergo mammography, the screening happens one breast at a time. This positioning creates limitations in terms of the lines of view, which must be taken into consideration. If possible it is recommended pictures, one for each line of view. For MRI and CT scans, where patients have to lie on their backs, placing art on the ceiling, or using artwork that is large enough to fill the patients view, is advisable (Hathorn, 1998).

2

The needs of the special patient populations - Evaluating the unique needs of the kind of patients who will view the artwork. For example art for pediatrics may differ from art for palliative care.

3

Role of demographics in the healing environment - Understanding the ethnic, gender and age make-up of the location of artwork and choosing art accordingly.

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and care givers. This implies that art interventions must not only base decisions on the best available research findings, but also commit to the process of generating new evidence base on these interventions. According to Ulrich and Gilpin (2003), within the healthcare environment, the important outcomes relevant to art / health research are the health outcomes, which include: 1. Clinical indicators: Observable signs and symptoms related to patients conditions such as length of hospital stay, intake of pain medication or biological markers such as blood pressure and heart rate 2. Patient / Staff / Family-based outcomes, such as patient ratings of perceived pain, satisfaction with healthcare services, staff-reported satisfaction etc and 3. Economic outcomes such as cost of patient care or cost related to nursing turnover etc.

Focussing on the above outcomes allows the development of an evidence base that can guide best practices for creating therapeutic art programmes. In the medical community, Art interventions are often used as “positive distractions” for patients. For example, adult patients in a procedure room reported better pain control when exposed to a nature scene with nature sound in the ceiling (Diette, Lechtzin, Haponik, Devrotes, & Rubin, 2003). Murals (as distraction) resulted in a significant decrease in reported pain intensity, pain quality and anxiety by burn patients (Miller, Hickman, & Lemasters, 1992).

Breast cancer patients reported reduced anxiety, fatigue and distress during chemotherapy when exposed to virtual reality intervention displaying underwater and art museum scenes (Schneider, Ellis, Coombs, Shonkwiler, & Folsom, 2003). A similar finding was made when patients were asked to enter a virtual environment by playing video games or wearing a headset (Hoffman, Patterson, Carrougher, & Sharar, 2001). In a 2002 study researchers found that with the

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Treatment Room at Mays Clinic use of soundless nature video there was a significant increase in pain threshold and pain tolerance.

Art has also been seen to have ‘stress reducing’ effects. Evidence from heartrate recordings and questionnaires showed that stress in a dental clinic was appreciably lower on days when a large mural was hung at the back of a waiting room (Heerwagen, 1990). In another study, ceiling mounted pictures shown to highly stressed pre-surgical patients on gurneys, resulted in lower blood pressure when the images were of serene nature scenes (Ross, 1990). While it has become increasingly common to use art interventions to distract patients from their pain or stress, the body of work on the appropriate image content used for such interventions remains small.

Research by Ulrich and Gilpin (2003, p.123) suggests that nature art (or art with views or representations of nature) will promote restoration if “it contains the following features: calm or

slowly moving water, verdant foliage, flowers, foreground spatial openness, park-like or Savannah like properties (scattered trees, grassy undershot) and birds or other unthreatening wildlife,” Ulrich and Gilpin (2003) also suggest that in addition to nature art, humans are genetically predisposed to notice, and be positively affected by smiling or sympathetic human faces.

In a landmark study conducted in 1984 in Pennsylvania, Ulrich found that post-operative gall-bladder surgery patients whose rooms had windows with views of a park had better outcomes than those patients whose rooms had windows with views of a brick wall. Patients complained less to staff, needed analgesic pain medication of lesser strength, and were discharged earlier (Ulrich, 1984). In a study with post-operative heart patients in Sweden (Ulrich, Lunden and Eltinge, 1993), it was found that exposing heart surgery patients in intensive care units to pictures of nature improved outcomes. On the other hand patients reacted strongly in a negative manner to abstract art. This is one of the few studies that highlights not only the positive impact of appropriate art, but the potentially harmful effect of inappropriate art. The study shows that it is risky to place art in a hospital that is ambiguous, subject to interpretation, or that has obvious negative connotations.

Because, when viewers are stressed or in a negative emotional state, which they often are in a healthcare setting, they are likely to respond in a negative manner to art that they cannot understand or that contains negative images or icons.

Ulrich and Gilpin (2003) suggest that the explanation for the appropriateness of nature images, and inappropriateness of abstract or ambiguous images, lies in the two basic theories: Evolutionary Theory and Emotional Congruence Theory. Evolutionary Theory holds that man’s evolutionary survival skills in a natural world have hardwired humans to find nature calming and restorative.

Emotional congruence suggests a person

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perceives his or her emotional state in a manner congruent with their current emotional state. In a hospital environment, it is likely that the high stress that patients and staff are under colours their responses to the art.

In fact, the usual yardstick for art evaluation may be quite inadequate and inappropriate in healthcare settings.

Nanda and Hathorn (2006) conducted an art preference study with inpatients at St.Lukes Episcopal Hospital in Houston, and found that patients preferred nature scenes and representative images overstylised or abstract art, even when the latter were rated as “best-sellers” by different online art vendors. The study is yet another indicator that high quality art, or even popular art, is not always appropriate art for healthcare settings.

In fact, there were many pictures, which the patients said they would like to put in their homes, but not in their hospital rooms. This shows the distinction patients make between their emotional state at home and in the hospital.

An area where more investigation is warranted in an increasingly global healthcare market is the role of ethnicity on Art Preferences. In a small preliminary survey conducted in a large urban midwestern hospital Hathorn and Ulrich (2001) found that Caucasians’ and African-Americans’ responses to figurative art depicting caring faces and positive body language were the same.

Results also showed that both groups preferred representational paintings of nature landscapes and rural areas showing spatially open settings in clear, sunny weather, with water features and verdant vegetation. Paintings of gardens with flowers were also rated as appropriate.

Implementing evidence-based art: Mays Clinic, M.D. Anderson Cancer Center, Houston, Texas, USA

In 2002, the University of Texas M. D. Anderson Cancer Center made a decision to change the fundamentals of its art programme from an art-for-art’s sake to a evidence-based approach; one

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The art selection criteria were as follows: • Landscapes: Regional, generic or seasonal • Positive fall and winter landscapes • Waterscapes: Regional, generic, or seasonal • Floral: Familiar flowers, garden / bouquet style • Flowers in vases (used sparingly for variety) • Figurative: Observational rather than Interpersonal, people in positive relaxed nature surroundings • Still lifes (used sparingly for variety) In February 2007, a Post-Occupancy Public Corridor at Mays Clinic

Evaluation (POE) of the Art programme implemented at the Mays Clinic, M.D. Anderson was undertaken to understand the effectiveness of the applied guidelines, and the need to change based on user feedback. Five units were identified to conduct the surveys with the patients and visitors: Radiation / Oncology, Breast Imaging, CT Imaging, MRI and Outpatient and Diagnostics. Each of these clinics hosted artwork that adhered to one or more of the art criteria. An onsite questionnaire was administered to 210 patients and visitors, and an online questionnaire was administered to 240 staff members. Eighty-four per cent of Patients / Visitors thought the artwork in the Mays Clinic, overall, made them feel much better (15 per cent) or better (68.5 per cent). When asked about the role of art, patients / visitors mentioned that art served as a distraction, made the hospital de-institutionalised, gave comfort, was cheering and uplifting, helped get rid of anxiety and contributed to the perception of the overall quality of care. The staff of M.D. Anderson were also asked about how appropriate they thought the artwork in the Mays Clinic was for the patients. Ninty-seven per cent of the staff thought the art was highly appropriate (56 per cent) or moderately appropriate (41 per cent).

Overall, both the quality of the artwork and the emotional / healing effect of the art were rated positive. Also, the rate of response was indicative of an involvement in art by all the users, which is significant. Finally, it is important to note certain themes that were emergent from the qualitative data in the POE about the role of art: • Healing: Making patients and staff “feel” better A uthor

that used previous research to determine appropriate art content for patients and staff in the hospital. The approach was also committed to evaluating the results of any art intervention, and collecting evidence on the effectiveness of the artintervention that was implemented.

An art programme based on guidelines developed from previous research was developed to address the following goals: • Create a healing and hopeful environment • Relieve stresses associated with a healthcare environment • Reflect and enhance images developed through design and architecture • Address a culturally and regionally diverse population • Accommodate needs of special patient populations • Reflect overall standard of excellence

• Positive Distraction: Allowing patients and visitors to focus on something other than their (and the people around them) condition • Branding: Improving the perception of care at the hospital, and serving as an element that users identify with • De-institutionalisation: Making the hospital less intimidating • De-stressor: Both patients / visitors and staff use favourite pieces of art to de-stress This is particularly true for the staff • Way finding: Prominent pieces of art serve as landmarks for patients The M.D. Anderson case study is an example of basing design decisions on best available evidence, and then evaluating the success of the implemented design decisions. While the tools used (on-site and on-line surveys) are basic, they form the foundation for an ethical approach to healthcare art, one that goes beyond mere aesthetic considerations.

If a picture is worth a thousand words, then these words must be carefully chosen, and clearly spoken, via the medium of art, to convey the message to patients and care-givers alike that every aspect of their environment is aimed at making them feel better and get better.

About American Art Resources: American Art Resources is USA’s leading evidence-based art consulting firm. Their expertise is in producing award winning art programmes, unique to each client, that are based on patient specific needs, community resources, and produced within defined budget / time constraints, targeted exclusively at the healthcare industry.

Upali Nanda, has a Bachelor of Architecture from School of Planning and Architecture, New Delhi, a Master of Arts from National University of Singapore, and a PhD from Texas A&M University.

She is the Vice President and Director of Research at American Art Resources, where she conducts research on Visual Images for Healthcare Environments.

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Healthcare Facilities Design

A global perspective The battle to deliver high-quality care at affordable costs will only be won through refinement of process flows and a thorough understanding of long-term operational costs as well as initial capital costs.

Judith D Mitchell Director of Planning Harvard Medical International, USA

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oday, we are seeing an unprecedented global boom in healthcare facilities development fuelled by a wide variety of economic and social factors: • The Private Finance Initiative that is spawning significant new development in the UK • The creation of free zones giving rise to entire healthcare “cities” in the Middle East • China’s transformation from a monolithic public system to a hybrid public / private model of care delivery, which is necessitating a complete rethinking of their healthcare infrastructure • Privately held companies leading the way in building new hospitals in India • Public outcry in Australia forcing policy makers and developers to work together to provide improved quality and access to care • The realisation that massive rebuilding of decaying infrastructure will be essential to the future of Eastern Europe’s healthcare system

Simultaneously, a multitude of forces—a shift in the burden of disease towards chronic illness, rising costs coupled with heightened demands on the part of more educated health consumers, and a global shortage of healthcare professionals—are giving rise to new thinking about how to design integrated care environments that serve patients’ needs while allowing healthcare organisations to attract and retain quality healthcare professionals.

The healthcare building boom across Asia and the Middle East provides a clean slate for facility designers and a unique opportunity to forge new models without the constraints that often limit existing medical centres in North America and Europe. Most significantly, these greenfield developments create the potential to break down traditional barriers in support of multi-disciplinary practice. Service lines may now be

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Acibadem (Bursa and Kozyatagi Facilities) Architect: Ertum Artunga Architecture, Instanbul.

Photos courtesy: Harvard Medical International

rethought and organised around disease rather than in traditional departments, thereby creating a more patient-friendly experience where clinicians have the ability to engage in cross-speciality consultation for more efficient and effective patient care. Advancements in information systems are enabling a complete rethinking of radiology and a movement towards more dispersed models where imaging capability is decentralised and spread throughout the medical and surgical specialities. Ultrasound, CT scanners and MRIs are conveniently located in proximity to the patient populations they serve and radiologists now have the option to leverage their time by supporting multiple practices from remote

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Mohammed Bin Rashid Al Maktoum Academic Medical Centerâ&#x20AC;&#x2122;s University Hospital Architect: Ellerbe Becket, Minneapolis.

Artistâ&#x20AC;&#x2122;s Renderings provided courtesy of Ellerbe Becket

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Acibadem (Bursa and Kozyatagi Facilities) Architect: Ertum Artunga Architecture, Instanbul. Â Photos courtesy: Harvard Medical Internation

locations. While the shift from inpatient to outpatient care has been occurring gradually over the last 25 years in North America, it has lagged far behind in Asia and the Middle East. However, the new developments in these regions present an opportunity to leap ahead with facilities designed to accommodate highvolume intake of ambulatory patients in welcoming environments that do not compromise patient privacy or dignity.

Development of modular approaches to the planning of both inpatient and outpatient units promise increased flexibility to accommodate shifts in patient volumes as well as medical advances we cannot predict today.

Pioneering new models

Todayâ&#x20AC;&#x2122;s healthcare leaders have tremendous opportunities to change the healthcare scenario, and their challenge will be to craft financially sustainable models uniquely tailored to the communities they serve. Healthcare facilities planning, like healthcare itself, is increasing

in complexity at a rapid pace. Hospital design is perhaps the most demanding of all building types, requiring designers to stretch across all scales of design addressing issues related to urban planning and campus site development, coordination of complex building systems as well as detailed room and furniture design.

Poor design can have long-term impacts resulting in increased staffing and operational inefficiencies, which unnecessarily burden an organisation and may not be immediately visible to a healthcare administrator. The introduction of high tech equipment and the proliferation of computers necessitates sophisticated mechanical systems which today may account for as much as 45 per cent to 50

Hospital design is perhaps the most demanding of all building types, requiring designers to stretch across all scales of design.

per cent of a total construction budget.

So, making the right decisions regarding systems has become increasingly important. In the United States, healthcare facility design has long been an area of specialisation for architects and engineers; however, in many parts of the world, design teams are yet to develop the expertise necessary to successfully accomplish these complex building

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projects. Finding a qualified design team is central to the success of any significant healthcare project and poses a special challenge for developers in many parts of Asia and the Middle East.

Many institutions, investors and developers have a tendency to focus on high tech equipment as a tangible evidence of progress. It is important to recognise, however, that planning a state-of-the-art hospital involves much more than creating a wrapper for high tech equipment. A successful hospital design must reflect local circumstances and, in a competitive marketplace, the battle to deliver high-quality care at affordable costs will only be won through refinement of process flows and a thorough understanding of long-term operational costs as well as initial capital costs.

The design of support spaces is critical for attaining operational efficiency and central to a top-quality infection control programme. Thus, the planning of a successful hospital encompasses far more than the accommodation of equipment. It intertwines building design with the design of care, with the clinical programme serving as the first critical blueprint in the development of any physical structure. Clinical programming must drive hospital design and the planned functions of the facility must be addressed in its form.

At Harvard Medical International (HMI), we have participated in a

facilities & o pe r ati o ns management Xiamen University/Fupond International Hospital Architect: AKS, Beijing and Xiamen Faculty Architects, Xiamen.

Rendering provided courtesy of AKS and Xiamen Faculty Architects.

new models, which local government officials may then use to demonstrate the effectiveness of proposed regulatory changes. It’s a win-win situation for all involved, and can produce a powerful ripple effect throughout the broader healthcare community.

Global examples indicate the way forward Addressing regulatory obstacles

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wide range of facilities design and development projects, in a wide variety of social, environmental and regulatory contexts. Our core objective of creating sustainable models for delivery of high-quality care, is reflected in our approach. We use the design process to foster dialogue about local practices and explore applicability of models being used elsewhere around the world.

Through these discussions, we seek to initiate operational advancements, explore new approaches to staffing, and identify training needs. In attempting to meet this objective, we have tried to adhere to a singular guiding philosophy during the planning process: to consistently strive to make decisions and create solutions that result in a patient-centred environment, where patients want to go for care and where top healthcare professionals want to practice and teach utilising the latest healthcare technologies.

In the healthcare facilities planning process, this is accomplished by making the design process a collaborative effort involving every member of the care team. Healthcare planners work in close collaboration with doctors, nurses, quality experts and administrative leaders, all of whom bring a unique perspective on healthcare. We use tools such as computer-generated prototypical designs to simulate and study workflows within the hospital, and instigate discussions aimed at discovering how best to create effective models of delivery that meet their needs.

The local regulatory environment is another key factor which healthcare developers and institutional leaders must consider in developing a sound development strategy. Often, healthcare regulations lag far behind current medical practice and present obstacles to forward-looking planning. This is particularly true in the developing economies where healthcare facilities have long been neglected and a rapidly expanding economy is now propelling rapid advancement in the state of care. Often, executive leaders fail to understand or consider the negative impact these regulations may have on the long-term success of their institution. In other instances they simply do not feel empowered to challenge the regulations that are out of step with advances in healthcare. We have learned that developers and institutions can influence public policy—for the betterment of healthcare delivery—through their own projects. By proactively engaging regulators early in the design process, it is often possible to identify issues of mutual concern and a strategy for addressing them. Often, projects may be used as pilots for

Not very long ago, the US academic medical centres stood alone as examples of state-of-the-art facility design. Today, innovations in healthcare facilities are taking place in all corners of the globe. In response to the catastrophic SARS outbreak of 2003, Chinese architects and engineers are creating new models for control of airborne infection. In Australia, design teams are assisting government officials in responding to a massive public outcry for improved quality of care. Lower population densities in that part of the world are driving providers to more distributed, community-based models of care that in turn will rely on highly advanced IT systems. In the UK, design firms are exploring modular prefabricated systems in an effort to build ambulatory clinics quickly and cost-effectively to meet demand for greater access to quality care. These are just a few examples of the kinds of innovation that will define healthcare environments of the future. Healthcare facilities must continue to be designed to respond to local context and needs, but increasingly, healthcare leaders will look to all corners of the globe for inspiration.

Judith D Mitchell is Director of Planning at Harvard Medical International. She has served as a consultant to Harvard Medical International since 1996 and joined HMI on a full time basis in 2000. She consults with HMI’s partners in the early stages of planning on real estate development strategies, master planning and regulatory issues. She is a member of the American Institute of Architects and currently serves on the National Advisory Board to the American Institute of Architects Committee on International Practice.

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Lean Process Program Planning Guidelines for optimum operations and design

Lessons learnt from the appropriate incorporation of â&#x20AC;&#x153;Leanâ&#x20AC;? considerations during the functional and space programming phases and then the conceptual and preliminary design phases, can positively impact immediate, short-term and long-range operational expenses.

George Pressler President Planning Decision Resources, Inc., USA

O

ver the past several decades, healthcare planning and design have developed into a multi-speciality arena beyond most of any other building type. This has been mandated as a result of the increasing complexity of factors like: intertwining codes, regulations, technologies, reimbursement and insurance impacts, medical systems, informatics, equipment, staffing patient care ratios, patient confidentiality, safety, risk management and quality of care guidelines. Increasing attention has been given to rising operational costs and capital costs for new construction and renovation.

A myriad of new trends have flooded the industry with solutions to improve select foci, either service line or department-based. These have included: Centres of Excellence, Patient-Focussed Care, Family-Centred Care, Focussed Hospitals and Healing Environments.

Healthcare leadership has been introduced to various approaches, such as Six Sigma, Evidence-Based Design, Sustainability and Green Buildings towards planning and design.

Figure 1

Terminology has expanded beyond high tech / high-touch to include: Single-Care, Same-Handed, Flexibility, Adaptability, and Modularity.

And now, LEANâ&#x20AC;Ś

The origin of Lean and the Lean Production System is certainly credited to Toyota manufacturing

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developed in the early 1990s. Like no other industry, healthcare has attempted to learn from other successful enterprises. These approaches, many geared toward marketing, business development and patient satisfaction improvement, have explored the hospitality and resort industry. Lessons learned from these settings explored

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support services such as food service, materials management and logistics as well.

Lean Process Program Planning (LPPP) has successfully demonstrated an incredible potential for improvement in operational efficiency while incorporating a multitude of goals and objectives of many of the trends and philosophies identified above. In addition, Lean process improvement extends well beyond the planning and design process into construction and engineering and transition planning.

It was observed that constructions and project costs have been reduced due to lean process improvements.

It appears that further exploration of the intent and lessons from Lean thinking may result in a winning solution for all stakeholders— Patient, Family, Physician, Staff and Leadership.

As the Lean process was developed around production, significant thought has been given to application towards healthcare, resulting in multitudes of statistics and promises for amazing improvement in operations and cycle times. New vocabularies have evolved and are now commonplace.

Caution! Beware!

If healthcare leadership—the “C-Suite” (offices of CEO, COO, CFO, CIO and CNO)—becomes interested in the Lean process, merely because of the enticement of the metrics, the process will ultimately fail. Promises of 25 per cent reduction in operational costs, 50 per cent reduction in errors, and 7 per cent gains in annual revenue, 55 per cent reduction in response times, 43 per cent reduction in required FTEs per adjusted patient discharge, and 40 per cent reduction of area—are all very enticing lures. These promises are enticing especially to those individuals who formulate budgets and form Board financial expectations in a highly competitive industry. This must be emphasised to encourage and educate

COST Vs EFFICIENCY Volum e opera Capacity tional Efficie ncy

Opera tio Cons nal Cost tr uctio nC Space SqMt ost .

Figure 2

leadership on the true, more global values of the Lean process. While gains will be achieved in most of the areas outlined above, the actual figures may vary from one institution to another.

The variables include new or extensive remodelling of facilities, the existing or proposed integration of advanced informatics systems, the plan and budget for acquisition of new technologies and medical equipment, and new organising tools for all administrative functions. Other significant variables relate to logistics, material supply and distribution systems.

A key consideration is the willingness for change, and the executive team’s willingness to devote the support and financial resources for the investment of time and dollars on the long-term basis. A basic principle of Lean is the investment in the future and the understanding that this approach is not a static solution, but one that requires continuous improvement with the goal of zero defects and zero waste of time and resources.

From significant experience with Lean approaches as applied to programme, planning, and design, lessons have been learnt as to the appropriate level of detail to attain significant benefit. The principle is to remove waste in the form of time, number of steps in a process, distance travelled for each step, the number of individuals required per step in a

process, and resources that may be redundant or unnecessary in the process. Examples and actual experience has shown that the majority of waste can indeed be greatly reduced or eliminated. This allows for awesome change in clear thinking of what can be achieved if these applications are incorporated throughout the facility— or as in Lean thinking—the entire enterprise.

Principle concepts include elimination of “departmental” thinking to adopt a systems approach. Standardisation of spaces, resources, equipment and supplies, as well as actual processes to the degree possible are all primary considerations. It is very important to accept that quality in all aspects must be maintained to highest potential possible. This includes elimination of risk, and promotion of safety and security as applicable in all areas.

Flexibility in the utilisation of spaces and other resources has proven to be of significant value in multiple ways. As with decrease of throughput times, these concepts can, on one hand, decrease the quantity of spaces that must be constructed—decreasing construction costs, or on the other hand, increase volume capacity which can increase return on investment by allowing for future growth while reducing operational costs.

Each facility, as well as each application of Lean Thinking, must be

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emergencies or unscheduled events, but the process encourages Lean Thinking to consider and plan for how these emergency needs can be met in other ways.

It considers the ways, that do not force “our” enterprise to pay the cost for excessive inventories, costs for space to house the excessive stock, personnel to clean, maintain, and inventory the excess, and then transport the inventory when needed to where needed. This is just one example of stretching the standard thinking into totally new approaches.

Opportunities abound within this new approach for programming more functional spaces that utilise less space and provide greater capacity for increased volumes. Programming net PDR lean statement of rights 1. Right Staff

7. Right Size

2. Right Place

8. Right Distance

3. Right Quality

9. Right Information

4. Right Time

10. Right Care

5. Right location

11. Right Reason

6. Right Supplies

usable spaces with much tighter grossing factors for decreased wasted space for circulation is achievable. Relocating non-essential spaces outside of expensively constructed hospital or acute patient care zones, and placing these services in less expensive structures can be considered. An alternative approach is to outsource many of these functions to other vendors. This reduces cost for construction as well as the staff required to operate these functional zones.

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Focus on the bottom line is not incorrect, and in fact is a necessity. Focus on the construction costs and bottom line, without considering greater longterm costs may be a risky proposition.

Although long-term solutions impact operational costs, they prolong the life of the building.

The side benefits of the Lean Process Program Planning approach include exemplary team building and streamlined communications through simplified organisational and reporting structures. Focus on the “whole” while not ignoring the detail, has longterm benefit. The continual improvement and simplification of each step and process, with incorporation of improved technologies and informatics, is virtually unlimited in scope. These constant changes emphasise the need for flexibility and adaptability in space and facility planning and design. Engineering participation very early in the conceptual programming and planning stage is a necessity. New approaches in structural, electrical and mechanical systems play a significant role in accomplishing the ultimate potential of lean thinking.

Where, in the past, new emerging concepts and trends-of-the-moment had fleeting moments of excitement in the healthcare industry. The Lean approach, however, shows greater, more significant opportunity for complete integration of the broader range of ideas, encompassing the positive benefits both operationally and related to capital expenditure.

George Pressler is the Founder and President of Planning Decision Resources, Inc. (PDR). He provides planning, programming, and design services throughout the world to healthcare systems, facilities, architects, and consultants. He maintains a leadership role with the AHA/Health Forum, AIA, The Healthcare Facilities Symposium, Health Care Executives of Southern California, and the Hospital Association of Southern California. He continues as faculty, as he has been for the past fourteen years, with California State University Northridge, Graduate Program in Health Administration as well as UCLA School of Public Health, and USC Graduate Program in Health Administration.

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customised to the needs of specific owner. The development and implementation of Lean can be applied to specific functional areas, entire service or product-lines, throughout the facility or throughout the healthcare system. Of primary importance is the acceptance and support of leadership for the right reasons. Planning Decision Resources (PDR) has developed a simple tool to be utilise as a test for decision-making called the “PDR Lean Statement of Rights”.

Collapsing barriers, separating healthcare operational departments is not restricted to the physical barriers of walls and corridors. The barriers are more often in the mind—preparing to accept change—for the overall good of the enterprise. Patient and family satisfaction as well as Healthcare Givers’ satisfaction are the true goals of a longrange solution. These are the factors that can ultimately benefit and impact the bottom line.

From a facility planning and design perspective, Lean Thinking is not to simply reduce construction costs. It is for operational improvement, which in turn reduces operational costs, thereby improving capacity for greater return on investment. This in turn results in decreasing cost of construction.

In the past too, often from unsuccessful approaches to cost maintenance, costs were cut simply through Value Engineering. Although this short-term approach fulfilled immediate needs, if failed in the event of unforeseen circumstances. The Lean process certainly considers the immediate need of responsible project cost maintenance, but in the realm of the larger long-term picture.

Continual improvement seeking ways to reduce, or even totally eliminate inventory is an incredible thought.

This creates the necessity of total reliance and trust in persons or outside organisations, to meet the scheduled needs without fail. Certainly some degree of backup is required to consider

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facilities & o pe r ati o ns management

Generative Space

Creating sustainable improvements The Leading by Design research project is working with 11 case studies in three countries to operationalise ‘generative space’ as a means to use the environment to make systemic and sustainable improvements in healthcare.

Wayne Ruga Founder and President The CARITAS Project, USA Annette Ridenour President, Aesthetics, USA

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he CARITAS Project was launched in 1999 by Dr Wayne Ruga, who had also founded the annual Symposium on Healthcare Design and The Center for Health Design. The purpose of The CARITAS Project is to pioneer the development of the next generation of resources to systemically and sustainably improve health and healthcare delivery with design of the environment.

The Leading by Design research project is the third project that The CARITAS Project has initiated. Now on the verge of beginning its fifth year, Leading by Design is actively working with 11 individuals in three countries to demonstrate the tangible benefits that ‘generative space’ (see definition below) can offer to improve healthcare as a whole.

Each one of these 11 Leading by Design individual participants represents a different set of stakeholders within the healthcare industry. All the Leading by Design participants represent non-competing stakeholder organisations. They holds a senior-level executive positions within their respective organisations, and several of these organisations are large multi national companies.

Research context

Practical application

Leading by Design is an applied research project that is based on an action research methodology with an integral reflexive practice. It uses a case study format and conventional qualitative research methods to produce its evidence. he methods include: personal interviews diary writing and focus group meetings.

Leading by Design is based upon original research that was conducted

by Dr Ruga as a four-year pilot study, funded by the UK government.

The second stage of this research, currently in progress, involves the on going field-testing of these initial findings across a much larger industry-wide stakeholder group and geographical area.

Leading by Design is a learning process that supports each participant in actively exercising ‘health design leadership’. It is through this exercise that participants develop increasing mastery at cultivating ‘generative space’.

The purpose of the 22 themes in the learning process is to enable deep personal learning in the ability to cultivate ‘generative space’, which can be measured and documented as a performance- effectiveness improvement strategy to make sustained improvements in health and healthcare with design of the environment.

The individual participant works closely with Dr Ruga to learn this process and then applies it to the contextual situations that are unique

‘Generative Space’­ - A working definition ‘Generative space’ is a place—both physical and social—where the experience of the participants fulfills not only the functional requirements but also materially improves the health, healthcare and / or quality of life for those participating in that experience in a manner that they can each articulate it in their own terms.

Additionally, and by its very nature, a ‘generative space’ is a place that progressively and tangibly improves over time.

The purpose of cultivating ‘generative space’ is to improve performance effectiveness. Depending upon the interests of the particular individual, the organisation, or the community—the measurements of effectiveness will vary. However, in all cases, whatever these measures are—they will be used to encourage, support and reinforce increasing performance effectiveness in health, healthcare, and / or quality of life.

The goal of understanding how to cultivate ‘generative space’ is to be able to produce it consistently, reliably and predictably across the full range of life’s contextual situations including: 1. Our personal lives 2. Our professional and organisational work and 3. The vast spectrum of our community engagements

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Case Study: Annette Ridenour, President, Aesthetics

At Aesthetics, Inc., the company I founded in 1980, our 35-person interdisciplinary team leads interior architectural design programmes, creates way finding systems, assists with regional arts programmes, codesigns healing gardens, and provides a number of other arts-related services to healthcare institutions.

I attended the first CARITAS Leadership Summit, convened by Dr Wayne Ruga, I arrived with many questions and left with even more. What makes a healing environment? What is required to permit us to work harmoniously and with genuine collaboration across design disciplines and throughout the construction process? What will sustain a positive, healing vision for healthcare design in general and for my company in particular? The answers to those and many other questions lay in Dr Ruga’s profound concept of generative space, I was sure. In 2003, I agreed to join Leading by Design and to make my life and practice an action-learning research project on how to create generative space.

I decided that if I was going to help others create generative space, I ought to start in my own backyard. I carried out a survey in my company, Aesthetics and was surprised to note that my staff were not nearly as satisfied as I thought they would be. With guidance from Dr Ruga, I turned over the resolution of many of the issues raised by staff to a task force led by an executive who was very vocal about the incongruence at Aesthetics.

As a result, we are now a much more aligned staff, focussing on learning how to deliver generative space to our clients. We have made exciting progress on several major projects, one of which, at the Atlantic City campus of AtlantiCare Regional Medical Center, I will briefly describe here.

AtlantiCare’s hundred-year-old campus was tired and in need of an upgrade. The administration wanted the best of evidence-based patient-centric care, it wanted a technologically sophisticated medical centre, and it wanted to reinvigorate its relationship with the diverse community around it.

Asked to be involved from the beginning, we began our work of cultivating generative space throughout the institution by our guiding collaborative visioning sessions to capture everyone’s aspirations. To keep those aspirations as focal points of the redesign work, a Partnership Agreement was created, expressing not only the key goals but also a set of communication guidelines to honour a commitment to hear and respect all members of the team.

We helped institute a process through which community members, using guidelines jointly created with AtlantiCare staff, selected and acquired all of the more than 500 original works by local artists that are displayed at the facility. A 400-foot display was installed to communicate the organisation’s values, which also were reflected in the wayfinding design and in the building and pavilion names: Harmony,

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Heritage, Wellness, Friendship and Community.

A particular example of how an open-minded administration used design to engage with the community in a generative and sustainably lasting way occurred when leaders from all the area’s faith communities were invited to oversee the design of the medical center’s chapel. The physical outcome of that involvement is a beautiful, functional chapel design that serves all religions with respect.

The larger outcomes for AtlantiCare have included a greater understanding of faith-based perspectives on healing and a deeper relationship with an influential group of community leaders to whom AtlantiCare can turn for advice on a wide range of topics.

Conclusion

Sustainability only occurs when you bring along people who have similar philosophies, train them, provide them with resources, and trust them to do the right thing—that is, when you empower them. This requires balancing feelings of vulnerability with the enormous value that comes from growing people and giving away power responsibly.

Leading by Design is a bold experiment. Now, almost eight years into its development, it is beginning to provide documentation of sustained improvements that reflect the robust character of the 22 thematic findings that are embedded in its unique learning process.

Wayne Ruga founded The CARITAS Project in 1999 for the purpose of ‘pioneering the next generation of resources to improve health and healthcare with design of the environment’. He is a US registered architect and a Loeb Fellow at Harvard University.

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to his / her own respective situation.

This practical personal approach, linked with the action research methodology and the reflexive practice, provides the real-world opportunity for the participants to practice the cultivation of ‘generative space’ in situations that can make sustainable improvements in health and healthcare.

Annette Ridenou is founder and president of Aesthetics, Inc., a multidisciplinary design firm creating healing environments since 1980. Annette is an internationally recognised specialist in interior design, wayfinding, arts and music for healthcare, and is a highly sought after consultant and lecturer. She is currently authoring books on wayfinding and evidence-based arts programs.

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I nf o r mati o n techn o l o g y

Digital Ward

Hospital of the future

Imagine a future where hospital wards have no paper case notes or files. Information on a Patient’s medical condition is automatically captured via intelligent context-aware devices and sent directly to the central computer systems.

Noah Tay Chin Seng Manager Fong Choon Khin Group Chief Technology Officer Grace Ng Yi Lin IT Specialist Yvonne Eng Systems Specialist, InfoTech department Singapore Health Services Pte Ltd (SingHealth), Singapore

"The Digital Ward project was initiated by Singapore Health Services (SingHealth), Singapore’s largest public healthcare group, with the objective of transforming the way healthcare professionals capture and access clinical information."

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he Digital Ward project team is made up of IT professionals from SingHealth’s iTAG (Innovative Technology Application Group). The project team works closely with users such as clinicians, nurses and operations colleagues of various SingHealth institutions, to innovate and develop systems that bring value to the patients and improve operational efficiency in the institutions such as: • Creating a paper-less environment • Reducing disruptions to patients' rest • Reducing time incurred in menial tasks • Enhancing the efficiency in the

control of infectious disease • Improving the response time to patient’s vital signs and abnormalities • Providing online assessment of patient’s medical conditions • Reducing errors in documentation Digital ward innovations

The various wireless technologies and devices being implemented in the digital ward are: Computer on Wheels (COWs)

COWs are WiFi-enabled notebooks on ergonomically designed mobile trolleys, which enable clinicians to access patients’ medical records and digital radiology images as well as document patients’ progress electronically anywhere, any time in the ward.

Mobile Electronic X-Ray Computing (MERC)

MERC is a motorised WiFi-enabled system with dual, triple or quadruple panel display screens, which enable patients’ electronic medical records and digital radiology images to be displayed across different screens. Clinicians can access these records and images wirelessly at the patients’ bedside to explain various therapies and clinical options to them. This innovation serves to enrich the face-to-face communication not only with patients, but also with their family members.

VEGA

The integrated wireless VEGA system enables remote automated monitoring of patients’ vital signs, such as blood

pressure, pulse rate, electrocardiogram (ECG), pulse oximetry (SPO2), temperature and respiration rate. The system also provides proximity contact tracing and location tracking.

The patients’ vital signs are captured automatically via customised monitoring devices (using WiFi and Active RFID technologies) and clinicians can view the vital signs charts online.

This reduces potential human errors and enhances patient safety. With this system, nurses also spend less time on tedious menial tasks, enabling them to devote more time in delivering quality patient care. In addition, patients can have an undisturbed rest without having their vital signs taken manually by the nurses.

To enable proximity contact tracing, specially designed wearable tags (using both WiFi and Active RFID technologies) are issued to the patients and hospital staff in the ward for the purpose of automatically and wirelessly recording and tracking people with whom they have come into contact within the ward. The contact data captured in the tag is then automatically and periodically uploaded into the server using industry standard WiFi access points. Hospital staff can search, view and print records of the contact tracing details online.

This system is especially useful in handling infectious disease outbreaks such as SARS and Bird Flu. It helps to ring-fence the spread of contagious

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diseases. In addition, it also has the ability to effectively track staff and patients’ location within the ward.

Patient Bedside Terminal (PBT)

PBT is a touch screen integrated information system that provides both the clinicians and patients an efficient and convenient means to access information within the hospital and globally.

With PBT, clinicians can retrieve and display patients’ medical records and digital radiology images, as well as discuss their medical conditions at patients’ bedside. Through the terminals, patients can speak to the nurses on duty using a video nurse-call function, while nurses can order meals for patients electronically instead of ordering manually. In addition, patients can also access a wide variety of entertainment and Internet services.

productivity by enabling clinicians to quickly retrieve and document patients’ information. This is especially critical in a fast-paced environment like a hospital’s Accident & Emergency Department.

Mobile Clinical Assistant (MCA)

MCA is a specially designed highly portable healthcare tablet PC, equipped with an integrated camera for visual clinical documentation. The built-in barcode / RFID reader is used to verify the patient’s identification. MCA is also WiFi-enabled, empowering the clinicians with secured “anywhere, any time” access to the hospital’s EMR systems and other clinical information systems.

Through the integrated Bluetooth wireless technology, it can interface with other medical devices (e.g. vital signs monitors) to obtain patient data from existing medical devices and directly transmit captured patient data into hospital’s clinical applications in real time.

Such a mobile point-of-care solution helps in improving the quality of patient care and enhancing the

Smart card

With the use of smart card technology, hospital staff carries only one card for multiple purposes. Besides door access control, the same smart card can be used for tracking of attendance at staff events or trainings. Its “tap-andtrack” method makes the whole process faster and easier. Staff immunisation records can also be tracked by the same smart card.

Future applications can be built into the smart card to automate processes and to continuously improve the physical security, patient services and operational efficiency of the hospital.

Qualitative results COWs

Patient Safety

PBT

Smart card

MCA

•On the spot and more eligible documentation of patient’s condition

• On the spot and more eligible documentation of patient’s condition

MERCs

• Detection of abnormalities within a few minutes instead of hourly or 4 hourly reports

VEGA

• Minimises loss of critical information due to misplaced paper records

• Manpower can be redeployed to perform Ward Patrol & anti-crime rounds

• Minimises loss of critical information due to misplaced paper records

• Minimises loss of critical information due to misplaced paper records

• Minimises loss of critical information due to misplaced X-ray films

• Minimises contact during infectious disease outbreak

• On the spot and more eligible documentation of patient’s condition

• Enhanced patients and staff safety. Only authorised personnel are allowed entry

• On the spot and more eligible documentation of patient’s condition

• Continuous and automatic recording of people-to-people contact information

• Accessibility can be restricted and controlled easily to staff and patients

• Reduces human error with real time automatic update of data

Operational Efficiency

COWs

MERCs

VEGA

PBT

Smart card

• Less time spent on menial tasks, more time can be spent on delivering patient care

• Immediate access to critical patient information

• Reduction in the use of pen and paper during registration of event

• Immediate access to critical patient information

• Facilitates discussions during ward rounds

• Facilitates discussions during ward rounds

• Avoid duplication of work

• Facilitates discussions during ward rounds

• Reduced usage of paper

• Reduced usage of paper

• Fast and easy attendance report generation

• Reduced usage of paper

• Immediate access to critical patient information

• Immediate access to critical patient information

• Facilitates discussions during ward rounds • Reduced usage of paper

MCA

Patient Services

• Tool to track staff movement and contact tracing purposes

COWs • Improves patientdoctor discussions

MERCs • Improves patient-doctor discussions

VEGA

PBT

• Minimal disruption to patients’ rest

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• Improves patient’s hospital stay with a variety of entertainment services • Improves patient-doctor discussions

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Smart card

MCA

• Enhanced operation and safety efficiency

•Improves patientdoctor discussions

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Time Savings (per ward)

Quantitative results COWs

MERCs

VEGA

PBT

• Saves 10 minutes of nurses’ time

• Saves 10 minutes of nurses’ time

On average: • Wireless vital signs monitoring saves nurses time by 4 minutes per patient

• Saves 10 minutes of nurses’ time

• Saves about 30 per cent of time spent to administer & manage the staff cards

• Saves 10 minutes of nurses’ time

• Concurrent viewing of patient’s record

• Concurrent viewing of patient’s record

• Online location tracking saves 81 per cent of the time taken to track manually

• Concurrent viewing of patient’s record

• Saves about 1.5 hours to lock / unlock & checking of doors

• Concurrent viewing of patient’s record

• Contact tracing saves 2 to 10 minutes per nurse per shift of nurses time

Case study results

Since the implementation of this Digital Ward project in 2004, the team has been gathering results on how the innovations benefit both staff and patients.

The quantitative and qualitative results are summarised in the tables below.

Lessons learnt

The team has learnt many valuable lessons and acquired good experiences in the process of implementing the Digital Ward project. It has enabled the team to better manage subsequent projects. The lessons are categorised into two main groups, the stakeholders and the processes.

Samrt card

MCA

• Saves about 4 hours for 2 staff in register staff attendance for events / trainings

confidential medical and financial information d. Abide to policy and regulatory issues in the organisation Summary

Research has shown that the innovative use of IT not only results in a more efficient and effective operational workflow in hospitals, but also brings about enhanced personalised patient care.

SingHealth is one such organisation that paves the way by introducing various IT innovations in its institutions.

The innovation team at SingHealth

makes continuous and concerted efforts to work closely with the hospital staff and patients in activities such as data verification checks, surveys on the systems, as well as to ensure that the systems are functioning effectively.

Hospital staff are also trained to use the new systems and periodically briefed on the benefits of the new changes to motivate them to adopt the changes.

Creating such an innovation culture is an important step in SingHealth’s journey towards embracing innovation as a strategic priority and bringing the Digital Ward into fruition.

For stakeholders

For processes

a. Study, streamline and re-engineer clinical, operational and administrative processes for optimal returns b. Adopt common data standards for a seamless information flow and shared care c. Adopt network security standards and policies to safeguard

Noah Tay Chin Seng More than 20 years’ of working experience in the information technology industry. He is currently a Manager with SingHealth InfoTech department. As a team member from iTAG (Innovative Technology Application Group) which is part of InfoTech, he works with Clinicians, nurses and other collaborators in exploiting IT innovations to reap benefits in Healthcare services.

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a. Perform routine checks to ensure that hospital staff adheres to the new workflow b. Provide sufficient staff training on the usage of the new system c. Secure clinicians’ and patients’ buyin to ensure success of the project d. Motivate the staff in adopting and incubating innovations; ensure employee commitment e. Provide strong leadership in managing and supporting the project f. Solicit funding from the main stakeholders

Fong Choon Khin is currently Group Chief Technology Officer of Singapore Health Services Pte Ltd (SingHealth). In this leadership role, he is responsible for the SingHealth IT Vision. He also oversees the Corporate Office Emergency Preparedness Committee, Business Continuity Planning and the Information Security Office. Choon Khin has more than 27 years experience in the IT industry.

Grace Ng Yi Lin is currently an IT Specialist in Singapore Health Services Pte Ltd. As a team member of SingHealth’s Innovative Technology Application Group (iTAG), she works closely with clinicians, nurses and other collaborators in exploring, identifying, building and implementing new emerging IT solutions to bring an idea from concept to deployment.

Yvonne Eng is a Systems Specialist in the InfoTech department of Singapore Health Services Pte Ltd (SingHealth) and has 8 years of experience working in the IT industry. She is part of the Innovative Technology Application Group (ITAG). She has worked on pilot projects which test the concept and effectiveness of innovative patient-focused solutions.

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Healthcare IT

Innovations for better care Innovations will move to areas of consumer empowerment by providing greater access to services and information including personal health applications populated with data.

Thomas M Eberle Senior Clinical Architect Digital Health Group Intel Corporation, USA

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he unique aspects of the US healthcare system result in a huge underinsured or uninsured population with income too high to qualify for governmental healthcare.

The need to provide even minimal care to this growing number of uninsured Americans results in some degree of cost shifting to those with insurance, further adding to the cost burden of employers.

Intel Corporation Chairman and former CEO Craig Barrett is a member of the United States Health and Human Services American Health Information Community and has taken a strong affirmative position on the role of employers in health care reform. “The current healthcare system is economically unsustainable and negatively impacting our nation’s ability to compete globally”, noted Barrett at the eHealth Initiative’s Health Information Technology Summit. “It’s time for a systemic transformation, and US employers must lead,” he said.

Barrett at the eHealth Initiative’s Health Information Technology Summit went on to describe ways in which the technological approaches that companies have adopted to solve their problems could be adapted to healthcare. This will require overcoming barriers to IT adoption and acceptance

of interoperability standards to foster data exchange. Employers, due to their purchasing power, should be in the forefront of driving system changes.

“Employers and their employees have the most to gain from creating a viable healthcare system”, said Barrett. “Improved healthcare depends on good information. The employer’s role is to get this information into the hands of their employees to make better healthcare and lifestyle choices.”

Traditional wellness programmes

It is well established that direct links exist between disease and lifestyle. Tobacco, alcohol, poor diet and sedentary lifestyle have documented connection to serious diseases such as cancer, chronic obstructive pulmonary disease, diabetes mellitus, hypertension and atherosclerosis.

An analysis based on literature review

by Colditz in 1999 estimated the direct costs of sedentary lifestyle (defined as absence of leisure time physical activity) at US$ 2.4 billion or 2.4 per cent of US health expenditures in 1995 dollars.

They estimated the cost of obesity (BMI greater than 30) independent of sedentary lifestyle at US$ 70 billion. Together, this comprised an estimated 9.4 per cent of healthcare expenditure in the US. When other potentially modifiable causes are added to the equation, it is clear that this is a reasonable target for intervention.

The advent of the Internet and freely available web-based applications resulted in an opportunity for employers and vendors of wellness applications. Not

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only could these applications provide all types of wellness information, but also the capability to interact with an online tool, gave the employee the opportunity to enter health data and receive a complete health risk assessment. The challenge has been getting employees to use these tools, and once they have used them, to act on the results. Various methods have been employed to increase uptake including direct incentives (cash, gift cards, etc.). Similarly, employers have used incentives to modify employees’ high-risk behaviour; though monitoring compliance with smoking cessation or exercise is more problematic. Though health savings from these types of programmes can be difficult to measure and published data is sporadic, the city of Glendale, Arizona reported in the early 1990s that its nine-year-old wellness programme was saving US$ 10 for every dollar spent.

Consumer-centric health and PHRs

The logical extension to the wellness application is the concept of a Personal Health Record (PHR). Although there is as yet no uniformly accepted definition of what constitutes a PHR, it is generally agreed that it contains an electronic record of an individual’s health information. In this context, we will consider the PHR as a portable, life-long record with data from a variety of sources that remains under the control of the consumer. The availability of personal data allows the application to offer health data to the consumer tailored to his / her particular needs.

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One of the major issues with PHRs of medical data. Any employer-initiated of applications. According to consumer has been consumer adoption. Many efforts will need to assure users that there research by the Markle Foundation entrants in the industry have provided is an arms-length relationship to the as part of the Connecting for Health applications that are totally or mainly personal health repository and that there project, adoption is likely to be highest dependent on the consumer to enter is no chance of this data being used to among those with chronic conditions, his / her own health data. The dynamic affect employment status or insurability. younger consumers comfortable with nature of health data, not to mention the A myriad of state and federal laws need the internet, and those who act as carearcane terminology, makes this difficult to be considered in dealing with special takers for others. and limits acceptance. Recently, a coalicategories of data (e.g. mental health, 4. Provider acceptance: For PHRs to tion of large employers including Intel, chemical dependency) and users (e.g. be truly meaningful to consumers, they Wal-Mart, Pitney Bowes, AT&T, sanofi adolescents). will need to become tools for interaction aventis, Applied Materials, BP America 2. Data availability: As of 2005, and partnership with their care providand Cardinal Health have created a according to a survey by the National ers. For this reason, clinicians will need not-for-profit organisation to fund and Ambulatory Medical Care Survey, only to be engaged early and actively in the foster the development of a personal a quarter of the US physicians were fully discussion. Data sharing with patients health infrastructure called Dossia. This or partially utilising an electronic medineeds to be seen as mutually benefiis being developed with the assistance of cal record, and though the numbers cial and not a hindrance to work flow. the Boston Childrens Hospital Inforare steadily increasing, much medical Furthermore, physicians who are often matics Program based on their Indivo data is still inaccessible electronically. distrustful of data, where the source is architecture. The goal of this effort is to Even when EMRs are used, they often not clear, must have a level of assurance create a system that will allow users who lack interoperability with other systems, that the PHR will differentiate the data opt in to have their health data that is patient-sourced from the auto-populated to their records data that comes from within the from a variety of sources. These healthcare system.

The advent of the Internet and freely sources will initially be insuravailable web-based applications ance claims databases, but it is Conclusion hoped that ultimately this data Employers are increasingly resulted in an opportunity for employers will be superseded by actual engaging in discussions of ways and vendors of wellness applications. clinical data derived from electo lower healthcare costs. Traditronic medical record systems. tional wellness solutions are Sitting atop this infrastructure evolving to include new appliwill be an ecosystem of personal health making smooth data exchange a probcations that will give employees access applications that the consumer chooses lem. For this reason, many efforts in the to more of their personal health data to organise, track, and display the data to PHR area are utilising data from payer and will provide tools to help them meet her particular needs, whether they claims databases and pharmacy benefit act positively on this data. Informed be wellness, disease management, health managers. and engaged consumers, in partnership finance, caretaker support or others.

3. Consumer acceptance: Adopwith their care providers, can reduce tion of PHRs has been consistently low. costs by improving high-risk behavContentious issues There are many factors that include lack iours, reducing errors and eliminating Ultimately, a system of this type if fully of understanding, need to self-populate redundancy. Barriers exist, but broad realised could give consumers and their and maintain data, and lack of trust. consumer acceptance has the chance of care providers a common set of data It is documented, however, that when driving change that will benefit not only on which to collaborate. The benefits the concept is explained to consumers, employees and their employers but also include reduction in errors, elimination many indicate an interest in these types society as a whole. of duplicate services, and more efficient delivery of care utilising new paradigms of partnership. While these goals are Thomas M Eberle has worked on a number of IT projects, with a doubtless worthwhile, there are many concentration on the area of database technologies. Since late 2005 he has been working in the Digital Health Group as a clinical barriers that remain to be resolved. architect on the Personal Health Records team.

1. Privacy and security: Both physicians and consumers are highly concerned about security and privacy

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I nf o r mati o n techn o l o g y

Medical Banking A new stakeholder

Healthcare Data

Medical Bank Infomediary

Banks

As the management of healthcare data progressively moves to an electronic platform, banks are realising that their technical systems, privacy and security frameworks, identity management engines and marketing channels can be leveraged to fast forward e-Health.

F

or many years, banks have been considered as “money changers” that apply their trade in between the healthcare stakeholders. The emergence of privacy and security mandates like Health Insurance Portability and Accountability Act (HIPAA), coupled with the growth of account-based health plans, increasingly managed by banks, is challenging this paradigm. Banks are starting to throw off the mantle of backroom payment processing agent to take on a more active role in health data management. This area, called “medical banking”, may be defined as the latent integration of banking technology, infrastructure and credit with healthcare administrative operations.

In healthcare, major banks are rescoping their role from offering funds management to becoming a value-added data hub in between stakeholders—a bank infomediary. This is evolving in four key areas (See Table 1).

Administrative Processing Using high efficiency, real time tools for health data management.

Medical Internet Creating the technical connective tissue for securing, distributing and in some cases, holding health data that is accessible only by the customer (not even the banking staff) and those authorised by the customer.

Health Information Broker As consumers purchase account-based health plans like Health Savings Accounts (HSAs), portal solutions are expanding to include medical research and thus the bank is serving up health information to help consumers make better decisions.

Community Care Platform Creation of a robust platform to better manage patient eligibility and collection of funds, including charity and / or philanthropic services.

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Table 1

ISSUE-15 2008

John Casillas Founder The Medical Banking Project, USA

Systemic impact regulations

of

privacy

The banking industry’s response to a global matrix of privacy and security regulations has resulted in the creation of cross-industry, featurerich, data processing platforms. Global compliance morph has led to increasing layers of security within this platform like multi-factor authentication. Bankers, ever risk-averse, aren’t readily willing to engage new services. Yet, even the most conservative among them will admit that the twin impact of privacy regulations and consumer-driven healthcare has levied a broad impact on traditional banking.

These drivers have opened new doors for bank and non-bank competitors,

I nf o r mati o n techn o l o g y

A medical Internet Another build-out of the bank infomediary is distribution of health records to requesting online banking customers. The online banking channel is becoming increasingly securitised as banks respond to global threats to a person’s online identity. Banks are locked into an identity theft arms race unparalleled by any other industry segment.

A global consumer poll by Unisys found that banks are the most trusted entity worldwide to manage digital identity. As the number of households using online banking is increasing, the use of this secure gateway into the home for eHealth is becoming a credible option. Not only can these portals present sensitive health data, but they can also provide tools that help patients keep track of medication regimes, measure the benefits of losing weight against “healthcare spend” so that there is more money at retirement.

The tools will be presented in an identity theft-resistant portal that is continuously and rigorously monitored. Banks understand that losing data is tantamount to losing public trust, an essential cornerstone that banks must have in order to exist. forcing traditional banks to defend their payment franchise. Essentially, a red carpet has been rolled out for banks to enter the highly inefficient administrative domain in healthcare.

As banks wrestle with return on investment for complying with a global matrix of data privacy regulations, they have had to make hard business decisions about whether to serve or exit the existing market. These facts set the table for the first axiom in medical banking: as compliance laws escalate in the digitisation of health data, banks will increasingly specialise their portfolio of healthcare services.

An example of this is Bank of New York Mellon (BNY). The bank is implementing a pilot accreditation programme developed at the Medical Banking Project that will give it a “Gold Seal” in the area of privacy and security. Alongside this effort, BNY Mellon entered into an alliance with a national claims clearinghouse, SSI Group that provides services to over one third of US hospitals. The organisation intends to reduce transaction costs in healthcare, leverage marketing channels and create new medical banking services.

Thus, the substantive engines that banks own for data processing, security systems, identity management and formidable marketing arsenal, are now used to streamline healthcare costs and to create demand for new products and services. Compliancy across industries and geographies invokes not just HIPAA, Gramm Leach Bliley (GLB), Fair and Accurate Credit Transactions Act (FACTA) and other US laws but the European Directive on Data Protection and other overseas laws as well. As a result, banks have developed geographically seamless and compliant platforms that can host new eHealth tools as a natural product evolution.

A unified platform

Developing services that link cash management with claims clearinghouses is an area that is in full swing today. Major banks have announced new healthcare relationships. Traditional stakeholders are finding highly capitalised banks sitting at the table, actively participating in legislative efforts and making an increasing number of health information technology acquisitions. This market

dynamic leads to a second axiom in medical banking: Banks will increasingly invest in healthcare IT, leading to broader adoption of electronic healthcare services as banks exercise economy of scale.

As banks use their power to distribute new services, the services themselves are transforming both in terms of tighter integration with claims processes and cost point. This will tend to increase the number of physicians using electronic claim services, expedite claims-to-payment and even affect the very structure of health data transactions.

In fact, traditional healthcare groups are already inviting banks to sit on workgroups to learn how to make claims processing work seamlessly (i.e., National Council for Prescription Drug Programs (NCPDP), Workgroup for Electronic Data Interchange (WEDI)).

A major product innovation today focusses on using a bank’s computational and imaging capability, embedded in mail transport systems, to proactively secure payments, reconcile payments with bank accounts, categorise denial and / or adjustment reason codes and present claim images within a logical, computer-assisted workflow.

Loosely configured services on a banking platform are becoming tightly linked with health data partners to automate daily patient accounting tasks. An example of this is PNC Bank, which used a hybrid revenue platform to help a national provider save US$ 4 million in processing costs in 2006.

Concomitantly, these types of platforms enable insurers to ramp providers onto a digital workflow, reducing processing costs for both parties.

Rationalising interactions

point

of

service

The “hybrid revenue platform” can also streamline front-end processes.

Imagine going to a kiosk at a retail clinic (Wal-Mart, CVS), typing in

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94 Asian Hospital & Healthcare Management

ISSUE-15 2008

I nf o r mati o n techn o l o g y

Health information brokers

More consumers are turning to the Internet for basic healthcare research.

Coupled with market demand for digital tools, banks are increasingly linking to health data sources. As they do this, banks may team with well-known brands in the academic world, pharmaceutical manufacturers and others. These organisations will provide high quality, easy to understand information to bank customers.

A special feature of this service will enable personalisation and automation of research, “e-clipping” data that an online banking consumer may want for future reference.

Medical banking holds the potential of shaping a broader understanding of “human capital”. This area offers a value-centred view of healthcare as opposed to focussing on cost alone.

In this line of reasoning, banks will seek to provide quality health information to account holders for their better lifestyle decision-making. Banks that follow such rationale will retain HSA assets and tend to have larger profits. A report by Booz Allen suggests that major banks will yield over US$ 1 billion in net revenues in part by meeting this key challenge.

Co-ordinating better care

Banks are scoping out a broader platform to enable robust front end processing for care providers. This type of a system will be used to categorise patients that come into the emergency room, for instance, into an action-driven platform that better co-ordinates care resources in the community.

Web Mobile-Based Applications for Healthcare Management

BOOK Shelf

Editor(s) : Latif Al-hakim Year of Publication: 2007 Pages

: 421

Sixty per cent or more of the people treated in high-cost emergency room settings are non-urgent cases.

The platform will address this issue and make it easier to exchange data and funds between stakeholders. For a major bank that serves millions of consumers, there is a direct correlation between the health of a community and increased deposits, a mainstay in banking.

Conclusion

As the “health-wealth” equation evolves, banks will increasingly be viewed as a partner in quality living, linking everyday banking to the decisions we make about our lifestyle choices. The consumer will drive the bank infomediary and stretch it in the ways yet to be discovered. In the meantime, banks are investing heavily along this product pathway, creating increasingly sophisticated processing platforms that are well-suited to reduce transaction costs in healthcare.

John Casillas founded the Medical Banking Project, an industry think tank and action group, to facilitate the convergence of banking and healthcare systems to improve healthcare. Over 60 global corporations, from providers, insurers, banks, IT/consultants and even entertainment giant Disney are now involved in industry efforts to create value with a new banking stakeholder. The Project reports out its work every year at an annual Institute (April 1-3, 2008 in Marietta, GA).

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your ID just like using an ATM, and gaining immediate access to your HSA / HRA records, making payments (which are automatically reconciled and posted onto the provider’s system), pulling down healthcare records and forwarding your current demographics, so you don’t have to fill out those forms over and over again. Variations of this type of a product are being tested in US markets and it’s not hard to imagine that they will become a global model, especially as medical tourism takes flight necessitating on-demand access to health records and health accounts.

Description: Healthcare organisations are constantly designing effective systems aiming to help achieve customer satisfaction. Web-based and mobile-based technologies are two forms of information technologies that healthcare executives are increasingly looking to merge as an opportunity to develop such systems. Web Mobile-Based Applications for Healthcare Management addresses the difficult task of managing admissions and waiting lists while ensuring a quick and convincing response to unanticipated changes of the clinical needs. Web Mobile-Based Applications for Healthcare Management tackles the limitations of traditional systems, and takes into consideration the dynamic nature of clinical needs, scarce resources, alternative strategies, and customer satisfaction in an environment that often imposes unexpected deviation from planned activities.

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

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