Asian Hospital & Healthcare Management - Issue 14 by Ochre Media Pvt. Ltd.

Healthcare Management

Medical Sciences

Issue 14 2007 ÂŁ12 â&#x201A;Ź18 $25

Diagnostics

Information Technology

Surgical Speciality

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Transparency in Healthcare

Small is Beautiful

Seeing is believing

Nanotechnology for medical devices

Treatment of Lung Cancer

Immunotherapeutic strategies

Healthcare Design Need for consumer-driven research

Patient Safety and Quality

Role of Governance

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Contents MEDICAL SCIENCES

HEALTHCARE MANAGEMENT

CoverStory

Treating Lung Cancer

Immunotherapeutic strategies

Dominik Ruttinger, Head, Laboratory of Clinical and Experimental Tumor Immunology, Department of Surgery, Grosshadern Medical Center Ludwig-Maximilians-University Munich, Germany

29 Truth in Ethics, Truth in Science - Different? Torbjorn Tannsjo, Professor and Chair Practical Philosophy Stockholm University, Sweden

SURGICAL SPECIALITY Surgical Response to Mass Casualty Incidents The Israeli experience

Transparency in todayâ&#x20AC;&#x2122;s globalised healthcare world has impressed governance with the necessity of becoming increasingly accountable for patient safety by introducing quality standards and methods in order to retain a competitive edge and attract market share. Yosef D Dlugacz, Senior Vice President, Chief of Clinical Quality Education and Research, Krasnoff Quality Management Institute, USA

Sharon Einav-Bromiker, Lecturer, Anesthesiology and Critical Care Medicine Hebrew University, Israel William P Schecter, Professor, Clinical Surgery, University of California San Francisco, USA

Surgical Skills Simulation

Effect on quality and safety Delivering consumer-driven healthcare

Patrick Cregan, Surgeon, Co-Chair, Sydney West Area Health Service Surgical Network and Chair, NSW Department of Health, Surgical Services Taskforce, Australia

John Leifer, President David Grazman, Vice President

Surgical PACS

McHealthcare

Design and implementation

CBIZ The Leifer Group, USA

Transparency in Healthcare Seeing is believing

Heinz U Lemke, Research Professor, Radiology, University of Leipzig Germany

R Carter Pate, Global and US Managing Partner Health Industries and Government Services Sandy Lutz, Director

DIAGNOSTICS

PricewaterhouseCoopers Health Research Institute, USA

Efficiency with automated system movements

What can the Operating Room Learn from the Cockpit?

Digital Radiography 17

Richard C Karl, Surgical Oncologist and Chairman, Department of Surgery College of Medicine, University of South Florida, USA

Communication Challenges and Opportunities During Handoffs

Richard M Frankel, Professor, Medicine and Geriatrics, Senior Research Scientist Regenstrief Institute, Indiana University School of Medicine, USA

NICE

Making the best use of healthcare resources Andrew Dillon, Chief Executive, National Institute for Health and Clinical Excellence (NICE), UK

Michel Claudon, Professor and Chief, Department of Radiology Childrenâ&#x20AC;&#x2122;s Hospital, University of Nancy, France

Advances in Breast Imaging

Impact in Asia Pacific Frost & Sullivan, Singapore

TECHNOLOGY, EQUIPMENT & DEVICES

Small is Beautiful Nanotechnology for medical devices

Jorg Vienken, Professor, BioSciences Fresenius Medical Care, Germany

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Asian Hospital & Healthcare Management

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2007

CONTENTS

FACILITIES & operations management

Issue 14

Healthcare Design

Visualiser : N Raju

Creating integrated surgical/imaging environments that do less harm Bill Rostenberg, Principal and Director, Research Anshen+Allen Architects USA

INFORMATION TECHNOLOGY 56

Enabling patient safety

Editorial Team : Prasanthi Potluri

Aala Santhosh Reddy Sridevi Prekke Art Director : M A Hannan

Nicholas J Watkins, Director, Research Cannon Design, USA

RFID in Healthcare

Editor : Akhil Tandulwadikar

The need for consumer-driven research

Desperately Seeking Safety

2007

Copy Editor : Jagadeesh Napa Head - Sales : V R Rajeev Kumar

Sales Manager : Naveed Iqbal

Project Coordination Team : Sam Smith Bhavani Prasad Pasupuleti Rajkiran Boda Project Associates :

Shadaan Osmani Ifthakhar Mohammed Madhubabu Pasulla Sankar Kodali

Asian Hospital & Healthcare Management is published by Ochre Media Pvt. Ltd. in association with Frost & Sullivan

Remko Van der Togt, Consultant, Geodan Mobile Solutions The Netherlands

EMR in a Large Healthcare Organisation Development and implementation

58 Where knowledge talks business

Yong Oock Kim, Professor, Department of Plastic & Reconstructive Surgery and Director, EMR committee Yonsei University Healthcare System, Korea

Applying Path Innovation Seeking revolutionary HIT

Chief Executive Officer : Vijay Chintamaneni Managing Director

Barry P Chaiken, Associate Chief Medical Officer, Bearing Point and Fellow, HIMSS, USA

Broadband Medical Network in Asia Pacific 65 Naoki Nakashima, Assistant Professor, Department of Medical Informatics Shuji Shimizu, Chairman, Medical Working Group of Asia-Pacific Advanced Network (APAN), and Associate Professor, Department of Endoscopic Diagnostics and Therapeutics Koji Okamura, Associate Professor, Computing and Communications Center

: Ashok Nair

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Kyushu University Hospital, Japan

Commoditising Healthcare IT The next wave

Werner van Huffel, Health and Social Services Industry Strategist, Regional Public Sector Group Microsoft Asia Pacific, Singapore

Interview RFID in Healthcare

Prashant Agrawal, Chief Executive Officer Orizin Technologies Pvt. Ltd., India

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Asian Hospital & Healthcare Management

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Foreword Healthcare Governance Time for a revamp For hospitals across Asia, a transparent and accountable governance structure is the need of the hour.

orporate governance structures across businesses are witnessing a sea change with hierarchies and egos being sacrificed for efficiencies. This change has been abetted by factors such as globalisation and growing consumer awareness. Organisations have realised the need to change and their leaders are working towards creating governing structures that recognise the importance of feedback from their frontline staff. The healthcare sector, on the other hand, has been a laggard in adopting this change. Hospitals continue to follow ageold practices as governing structures remain top-down in nature restricting the creation of a transparent and accountable organisation. Hospitals and doctors do a remarkable service to the society, they save lives. What this also means is that all the possible man-made errors have to be avoided as they can prove to be fatal. Medical science has made rapid progress in the last decade. Further, the advent of Information Technology has changed the face of healthcare delivery. Unfortunately, this progress has not been accompanied by similar improvements in patient safety. Reporting of important data (such as wrong medication, injury and infection rates) does not seem to be making it to the ‘top priorities’ list of the board. As a result, medical errors go largely unnoticed and unaccounted for. This scenario can be changed only if the governing board takes the initiative. Provided with the right data, the board can take decisions that make a huge difference to the healthcare quality and patient safety. Our cover story this time deals with this very issue. In the article, Yosef Dlugacz, Chief of Clinical Quality, Education and Research at the Krasnoff Quality Management Institute, USA, provides valuable insights on the role of the governing body in creating a feedback mechanism that results in the right data getting transmitted to the decision makers. The article brings to fore the importance of the human factor in the functioning of a hospital and improving quality outcomes.

At a time when competition in the healthcare sector is picking up and the consumer is asking for better care, hospitals cannot afford to continue functioning this way. Therefore, the importance of the top management in hospitals is going beyond mere administrative activities. The effort to make data available asks for the active involvement and participation of each and every employee of the organization. It’s for the governing board to recognise the importance of having the data and create an environment where employees participate actively in the syndication of data. For this to happen, the traditional top-down approach to governance needs to be done away with and replaced by a structure that gives importance to the patient and not the hierarchy. This, of course, involves a considerable investment of time, effort and money. The final outcome of this effort would, to a great extent, depend on how well the management is able to ‘sell’ the concept to the employees of the organisation. It makes considerable business sense to the hospitals. As the medical errors are brought under control, the quality of care improves. This in turn helps in attracting more number of patients. Of late, some positive signs have emerged. The number of hospitals in Asia opting for international quality accreditations has increased with most of them being private sector hospitals. For hospitals across Asia, a transparent and accountable governance structure is the need of the hour. The importance of this need not be emphasised more in an industry where patients trust doctors with their lives.

Akhil Tandulwadikar Editor

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H E A L T H C A R E M ana g ement

McHealthcare

Delivering consumer-driven healthcare McDonald’s consumer focus offers some important lessons for the healthcare providers to ponder as they are forced to transform into more consumer-driven organisations. John Leifer, President David Grazman, Vice President CBIZ The Leifer Group, USA

s industrialised societies pursue solutions for providing cost-effective healthcare services to their larger and older populations, consumerism is emerging as a new force with the potential to reshape the industry and its economics. Whether in the context of a fully public, fully private or a hybrid healthcare system, consumerism is now a global phenomenon that, many believe, may be the “holy grail” for achieving greater efficiency and value in healthcare, while keeping costs under control. Media reports and marketing campaigns touting the potential of healthcare consumerism proliferate, but what that means for providers—hospitals, in particular—remains cloudy. With so much attention focussed on mechanisms that empower patients to shoulder greater financial responsibility for their care, providers still need guidance as to what they can do to best cater to changing consumer needs. At a minimum, we can realistically expect that regardless of national boundaries, the consumer-driven hospital of tomorrow is going to need to look substantially different from the system-driven hospital of today. We first want to articulate clearly what we believe to be the newly emerging paradigm in healthcare consumerism around

Asian Hospital & Healthcare Management

the globe. While each national system can be characterised by its own unique context and trends, there are several key principles that, we believe, define consumer-driven healthcare environments. We highlight these basic principles in table 1. While consumerism has been a transformational force in other industries, it has yet to have the same impact in healthcare, making the right side of the comparision above more of a projection than a description. Even though healthcare service provision is so different than other consumer-driven services—not to mention exponentially more complex—we believe that there are key lessons to be learned from other industries that have weathered the challenges of providing consumers exactly what they want. In our search for example, one consumer-driven company boldly shines as an international success story. McDonald’s, the fast-food behemoth, is the envy of companies everywhere. With over US$ 21 billion in sales in 2006 and a US$ 3.5 billion profit, they have much to covet. Last year, it served more than 52 million people every day in one of its 30,000 restaurants in any of the 119 countries where it operates. Whether serving a McOz burger in Australia, or a

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McAloo Tikki Vegetarian burger in India, McDonald’s has mastered the art of satisfying its local customers. Health effects of fast food aside, McDonald’s can offer some interesting lessons to health providers worldwide. As an economic, social and cultural phenomenon, McDonald’s had adapted its operational and strategic model to every national culture. To achieve the success it has, McDonald’s has managed to stay true to some key principles as to how it can best suit the wants and desires of even the most demanding international customers. Predictability and consistency McDonald’s success is deeply rooted in its ability to deliver a product with great predictability and consistency, giving consumers great confidence in the McDonald’s brand. Whether a Big Mac is purchased in the US or Japan (depending on regional variations), customers have come to expect a similar experience. Even behind the product, the tight engineering process used minimises variations and results in tremendous efficiencies. To hardwire that predictability, over 275,000 graduates of McDonalds’ Hamburger University have worked in franchises worldwide.

H E A L T H C A R E M ana g ement

Traditional Healthcare

Consumer-Driven Healthcare

Patients paid a relatively small share of their cost of care, if any; government or insurance covered the rest.

Consumer-Driven plans, shifting responsibility for paying for care partially onto patients will lead to a greater awareness of choices and value.

Patients had little way of accessing data related to quality of care and thus, assumed that hospitals were fairly equal in terms of their care.

Technology and increasingly accessible data will allow patients to better assess the quality of care provided by hospitals and physicians.

Patients deferred to their physician regarding treatment, partly due to cultural norms, partly due to a lack of any means for meaningful comparison.

Technology, such as the Internet, will allow more informed patients to work in collaboration with their doctors in choosing appropriate courses of treatment.

Patients acquiesced to poor levels of service because there were simply no other choices available.

Patients will demand convenience, service excellence and high quality care. If they don’t get it, they can choose to go elsewhere. Table 1

What Consumer-Driven Lessons can McDonald’s Teach Healthcare? Key principles

Potential lessons for healthcare

Quality

Consumers desire predictability and consistency – in all aspects of their experience. Consistency is a hallmark of meeting consumer expectations. Though intuition and innovation are important characteristics to preserve in medicine, there is a pressing need to move towards broader adoption of pathways and protocols that are predicated upon efficacious and safe standards of care. By adopting “best practices,” providers ,make a major leap forward in assuring predictability.

Price and Value

Quality must be conveyed at all times to the consumer. Providers are responsible for not only providing high quality services, but for helping consumers understand what quality means and how it is measured. Providers must agree upon meaningful metrics for clinical, operational, and service quality, and then willingly disclose their performance on such standards.

Price and Value

Understanding price allows consumers to determine value. Providers should strive to make prices as transparent and understandable as possible – not only to their patients, but also to themselves as well. It will be difficult for providers to move towards value-based pricing without more sophisticated cost accounting systems that provide insight into the true cost of care at a patient or procedural level.

Accessibility

Consumers want more convenient access. Providers should strive to offer care in more accessible (by time of day, place, amenities, etc.) and innovative settings.

Service

In an increasingly commoditised consumer-driven industry, service differentiates one provider from another. Providers need to change consumer’s low expectations of healthcare by providing excellent and consistent service in a well-executed manner. Such a commitment must be both top-down and bottom-up driven, with service excellence becoming a core tenet of the organisation’s culture.

Safety

Safety concerns – whether for food or healthcare – are paramount. Safety issues must be addressed at every point in the value chain. A culture of openness and blame-free reporting are absolutely required. As with prices, transparency is crucial. Table 2

Healthcare is the antithesis of McDonalds: its ability to produce standard, replicable outcomes and processes is very limited. In the US, dramatic geographic variations in delivery and outcomes have been well documented. Physicians, the key health decision makers in all cultures, have tended to adopt pathways and protocols slowly, if at all, contributing to vast differences in how care is delivered.

Quality McDonald’s has been methodical in developing its supply chain to ensure timely and local access to the right ingredients for its products. It has set exceedingly high training expectations to ensure that its brand standards are understood, honoured and delivered every day. The healthcare industry is just beginning to make some inroads with quality indicators, though quality is

infinitely more complex and difficult to measure. Healthcare could benefit from more science and far less marketing hype related to conveying quality. In a consumer-driven environment, value cannot be assessed in the absence of reliable quality metrics. Price and value McDonalds’ customers can easily determine, by looking at value and price, whether they want to eat at another restaurant or not. Pre-packaged meal options, as well as portions of various sizes and prices, allow customers to select exactly what they wish with a clear sense of the value it offers them. When arriving at a hospital, few patients have any idea about the value of the care they receive. True compensation or reimbursement in many systems varies based upon contractual allowances invisible to patients. Though some insurers and hospitals have developed small, limited menus with prices, that practice is still rare. Accessibility In some markets, it seems as if there is a McDonald’s on every street corner. With 30,000 distribution points around the world (and growing), McDonald’s can offer its products to everyone, anytime and almost anywhere. The complexity of traditional healthcare precludes the easy distribution of many services. While some services can be offered in stand-alone ambulatory facilities, few innovative models exist that succeed on the same level. For privately insured systems, lack of health insurance also restricts accessibility. Service McDonald’s customers worldwide expect to be greeted rapidly and politely upon their arrival. They can quickly place their order and know it will be delivered promptly. If there are problems, the manager and staff can remedy them immediately. For many patients, service in healthcare is an oxymoron. Patients and providers have come to expect hassles, multiple forms, unreasonable wait times, mistakes and miserable conditions when they seek healthcare services. Many hospitals speak the language of service; yet fall short when it comes to delivering it.

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H E A L T H C A R E M ana g ement

Safety McDonald’s has successfully infused its restaurants and suppliers with a culture of safety that includes 72 daily safety checks per restaurant per day, 2,000 safety and quality checks in each chicken and beef supplier’s facilities, and 95 daily checks for potato providers. In the US, McDonald’s has a collaborative relationship with USDA inspectors—who have unfettered access to all points of production at all times. Issues of safety violations in healthcare abound around the world. With all its complexities, the healthcare industry is still rife with structural barriers to safety and a culture of “shame & blame” when it comes to reporting errors. Too often, episodic care models simply do not allow for sufficient safety monitoring of patients, resulting in unnecessary infections, costs and even deaths. Given McDonald’s unquestionable success as a global leader in providing consumers with exactly what they desire, what lessons might we extrapolate out to

Asian Hospital & Healthcare Management

the healthcare industry around the world? We summarise some of the key lessons in the table 2. The need for transformational change is being heeded by healthcare organisations across the globe, though the pace of change seems glacial at times. Among the leading organisations in the United States committed to such change are: • Intermountain HealthCare, Salt Lake City, Utah, which has been a pioneer in the adoption of clinical best practices, and devotes significant resources to ensuring the quality and safety of its services. • The Mayo Clinic, which has maintained a tradition of process standardisation and quality since its very inception. Today, it is a pioneer in the adoption of health information technology—which is transforming its organisation into a paperless provider of care. • US Oncology, a premier provider of ambulatory oncology services, that integrates diagnostic, medical and

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radiation oncology services in state-ofthe art facilities designed to meet the needs of consumers. US oncology represents an example of disruptive innovation whereby the market is fundamentally challenged by the emergence of a new model of care that resonates strongly with the needs and desires of consumers Summary As consumerism evolves in each national market, healthcare providers are going to be required to adapt to the unique demands and expectations of their patients and governments. To succeed, hospitals must quickly learn from other industries and take action to make themselves as responsive to consumers as possible. While there is much conceptual distance between fast food and healthcare, McDonald’s offers some important lessons for providers to ponder as they are forced to transform into more consumer-driven organisations.

CoverStory

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H E A L T H C A R E M ana g ement

Patient Safety and Quality

Role of Governance I

n any complex organisation, it is the role—and the responsibility—of the leadership to set standards for performance. This responsibility is especially important if healthcare organisations are to succeed, both clinically and financially. The governing body, as representatives of the community, must support processes for patient safety to be monitored and improved, and it must hold the administrative and clinical leadership accountable for good outcomes and quality care. Moreover, globalisation of healthcare services and competition for market share are encouraging standardisation, transparency and the use of measures to objectify the delivery of care. Governing bodies can no longer rely on CEOs or medical leadership to provide the impetus for improvement efforts. A central myth of healthcare—that doctors should not be questioned—must be reevaluated and exposed as antiquated. Today, doctors have to respond to the patients who insist on the best care and to leadership who insists on returning value for expenditure. In the US, government agencies and private groups are forcing physicians to document that they are delivering specifically defined indicators of care for specific patient populations. Further, the myth of the all-knowing doctor is diminishing as the media highlights the vulnerability of patients in the nation’s hospitals. In my experience educating healthcare leaders in various Asian countries, I have been struck not only by the variation in governance structures but also by the lack of clear lines of accountability for delivering safe, effective and efficient care. Many of the best healthcare organisations are looking to introduce quality management infrastructures into their institutions and to incorporate evidencebased medical standards of care in order to

10 Asian Hospital & Healthcare Management

Yosef D Dlugacz Senior Vice President Chief of Clinical Quality Education and Research Krasnoff Quality Management Institute USA

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compete on an international level and assure the public that their organisations provide excellent care. Several of the organisations where I consult, are looking to become accredited as a way to promote standardisation of care. Many of the leaders I meet ask for education and guidance about how to introduce these cultural changes into their hospitals and implement improvements. As part of the curriculum in educating CEOs in China and elsewhere, I instruct them on the role of the governing body, and of accountability as a tool to improve organisational performance and change clinical outcomes. In a recent visit to Singapore, I gave a workshop to physicians and nurses on the value of using statistics to improve the quality of care and promote a safer environment at the bedside. Once the governing body commits to its oversight responsibilities, both fiduciary and clinical, I encourage them to adopt quality management principles and methodologies to implement patient safety improvements. Through measurements of the specifics of care and through aggregated data reports, governing bodies can learn to effectively manage the complexities of clinical care and organisational processes. Improvements are implemented when members of the governing Board learn how to ask questions of the medical staff, gain experience understanding quality reports, evaluate how resources should be most productively spent, and make informed decisions about improving care. When the clinical staff receives strong and effective guidance from the governing body, individual agendas collapse and organisational goals become the yardstick for success. A strong and unified Board should empower the quality management department in their organisation to

CoverStory

Acute Care Quality Indicators Prior 12-Month Average

INPATIENT Quality Indicators

Prior 3-Month Average

Current Month

Volume (Discharges) Discharge ALOS Unplanned Readmissions Within 30 Days Admissions With Pre-Existing Pressure Injuries (%) Nosocomial Pressure Injury Rate (%) Nosocomial Infection Rate (%) Suspected Drug Reactions

PCD Fall Index (1,000 patient care days less newborns)

ple

Medication Incidents Relative To Discharges (%)

Number of CareMaps® Implemented Patients Discharged on CareMaps® CareMap® Patients Discharged With Variances (%) Restraint Rate (%)

Table 1

develop measures to monitor care, train staff on how to collect data regarding those measures, aggregate and analyse the data for trends that reflect opportunities for improvements and best practices, and develop high level reports to inform the Board on an ongoing basis about how care is delivered and processes managed. When leadership actively supports quality and the use of data to standardise, monitor and improve care, staff are compelled to view care as a complex process managed by a team that must effectively communicate with each other rather than use an individualised and idiosyncratic approach. As quality data gets collected regularly and reported, the Board becomes increasingly familiar with understanding the processes of care. They can begin to hold clinicians accountable for errors, gaps in care and adverse events, and begin to develop a proactive approach to medical error prevention, thus changing the culture.

Issue 9

Issue 8

Issue 7

Issue 6

Issue 5

Issue 4

Issue 3

Governance/Board of Trustees (Is it aligned with the Vision)

Issue 2

Issue 1

Prioritization Matrix (Importance of Governance)

Inputs

Governance/Board of Trustees (is it Aligned with the Vision) Finance (i.e., Cost) / Budget Benchmarking (Is it Used / Recognized by CMS, IHI, JCAHO, DOH) Inputs Total

Process

Operation (How We Treat Patients/Delivery of Card) Evidence-Based Medicine (Benchmark for Excellence of Care / Opportunity for Improvement Is it Measurable Process Total

Trending in Negative Pattern

Outcomes

Compliance (Is it a Deviation from Practice) Patient Satisfaction Surveys/Patient Complaints Malpractice Rates/Insurance Premiums HMOs/Denials Outcomes Total

Issue Total Table 2

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H E A L T H C A R E M ana g ement

Communication of Quality Information

Board of Trustees Executive Committee Committee on Quality Nurse Executive Committee

System Performance Improvement Coordinating Group

Medical Executive Committee

Table 3

For example, when cardiac mortality was reported as high in one of the hospitals I work with, the Board charged me to discover where the process of care was flawed and to develop improvements, monitor those improvements for effectiveness and report back to them. It was the Board who insisted that processes be changed, and the Board that supported new processes. Working with a multidisciplinary team, consisting of clinicians, administrators and quality professionals, we were able to decrease cardiac surgery mortality and become one of the best cardiac surgery departments in the state. The CEO alone could not have effected the change, nor could an individual physician. Change required aggressive action on the part of the Board, who took their oversight responsibility seriously. Once leadership commits to the oversight of patient care, a method has to be adopted to best communicate information from the bedside to the Board about the provision of patient care services. Data provide an effective communicative tool to encourage trust between governance and clinical leadership. With expert input from clinical staff, quality management developed a Table Of Measures of quality indicators about clinical and organisational processes (Table 1) that were regularly reported to the Board.

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Not only could the Board monitor census data such as volume, but also patient safety indicators such as falls and nosocomial pressure injury rates as well as proactive safety methods such as the number of patients on clinical guidelines or CareMaps, and the number of near misses reported about medication errors. Tables of Measures were developed for various levels of care, such as behavioral health, ambulatory care, long-term care and the environment. Through the means of data, the governing board was able to oversee care, and ask questions when variations were evident. Without quality data, they would have had no means to carry out their responsibility for oversight of patient care. Because the Board had the responsibility to evaluate competing areas for improvements, we developed a prioritisation matrix (Table 2) to help them weigh which improvements were most pressing. This tool enables members of the Board to make responsible decisions about how to allocate resources. Once an improvement has been identified as a top priority, steps can be taken to implement new processes. For example, if the leadership of the organisation determines that it is their priority to reduce the rate of hospital-acquired infections, how can they go about making this happen? One useful method

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is to ask the people closest to the problem for their input about the present process, potential problems and suggested solutions. Multidisciplinary task forces should be established with a physician champion as the leader to determine what processes need to be improved and establish accountability for those improvements. Measures then need to be carefully established with appropriate numerators and denominators. If central line infections are being monitored, the measure might be defined as the number of patients who contracted central line infections over the number of all patients who had central lines inserted during a specified period of time. Once the measure is defined, data has to be collected, either retrospectively or concurrently, and reported to various members of the organisation. The task force can suggest improvement efforts; perhaps introducing an improved sterilisation procedure and then monitor if that improvement has been effective. These cultural changes do not happen overnight. They take time. Finally, without an established effective communication structure, information cannot be used for improvements. Organisations should establish lines of communication that go from the front line staff to the people responsible for oversight (Table 3). Quality management should work with clinicians and administrators to form performance improvement committees that coordinate information with clinical leadership to report to the governing body. The communication must be bidirectional, with members of the Board interacting with clinicians and front line staff, asking questions and hearing firsthand about problems in the delivery of care. Through these processes and with improved education to the governing body, care can be standardised and patient safety issues promptly recognised and addressed. By creating an effective governance structure, the relationship between governance and clinicians can be redefined to create improved processes that will enhance patient care delivery. Open communication will foster cultural change within the organisation and promote a proactive approach to patient safety.

H E A L T H C A R E M ana g ement

Transparency in Healthcare Seeing is believing The growing demand for transparency in healthcare is lifting the veil on this notoriously murky industry, but achieving transparency is a problematic journey that requires unprecedented collaboration across sectors within the health industries and adherence to world-class standards.

R Carter Pate Global and US Managing Partner Health Industries and Government Services Sandy Lutz Director PricewaterhouseCoopers Health Research Institute USA

overnment and healthcare leaders around the world recognise that transparency is critical to the sustainability of health systems in the future. The presumption is that when consumers are armed with accurate information and informed choices, providers will improve the quality of care they deliver, government and other reimbursers can reward quality and efficiency and consumers will assume a greater role in the management of their own health. The combination of these forces would produce higher quality care at less cost—an imperative for the future as health systems falter under of weight of an ageing, obese and more prosperous population with more chronic diseases. As part of global research into the sustainability of health systems, PricewaterhouseCoopers talked to more than 700 health leaders in 27 countries around the world, including government leaders and policy makers, executives from hospitals and health networks, private insurers and other business leaders outside the health industries. More than half told us that they consider transparency of quality and pricing information to be “very important” to

the sustainability of national health systems. The notion that “seeing is believing” is the new mantra of consumer-driven healthcare. Without transparency in a consumer-driven healthcare market, confidence in the medical profession will erode, and market participants will remain vulnerable to competition, corruption and potential collapse. It is no secret that healthcare has lagged other industries in becoming transparent or that much of Asia is playing to catch up on this front. Yet throughout Asia, there are mounting public aspirations that the time has arrived for people to have full access to the benefits of the modern world, particularly when it comes to healthcare and medicine. Consumerism now dominates the minds of the new Asian middle class, even as it meets resistance from old world traditions that have slowed the progress of healthcare reform in many parts of the region. Achieving transparency is a problematic journey, one that requires cross-sector collaboration that is unprecedented in even the most advanced health systems. But best practices are beginning to emerge. As transparency starts to define business relationships in health, it is important to understand the expectations of all stakeholders and to anticipate unintended consequences. Stakeholders often disagree on the details of how data is collected and disseminated. Infusing a flood of information on the public can cause disruption and misunderstanding. Lack of agreement about the definition of quality or cooperation on standards can result in a ballooning number of diverse and potentially unfair quality measures. Then there is concern about the privacy and accuracy of information about patients or participants in clinical trial

activities. What’s clear is that transparency is viewed as both a negative and a positive. Skeptics contend that the health market is unique, and cannot be treated like other markets. The time and energy required to publish the usable and credible cost and quality of every medical procedure is simply too difficult and not practical. In theory, proponents of transparency outweigh the skeptics. But, in practice, transparency creates enormous challenges. So, we asked a group of health leadership across health industries how they thought a transparency health community would affect their sectors and what they thought they would need to achieve transparency. To create transparency, we believe that the framework must have the following features: • Information about cost and quality that is trusted by stakeholders • Incentives for patients, providers and government or other reimbursers that improve the efficiency and effectiveness of care • Connectivity to disseminate information through interoperable health information systems Information about cost and quality that is trusted by stakeholders Health systems that have made progress in making health quality data transparent, have been first to learn that publishing this data poses additional challenges around embedding quality standards into health services, treatments and processes. Each country’s unique combination of cultural, political, economic and historic factors shapes its definition of quality. In fact, the Commonwealth Fund International

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Exhibit : The needs and challenges of stakeholders in a transparent community. Stakeholder

What they need

Challenges

Providers

• Standard metrics for assessing quality • Performance-based payments • Reduced administrative paperwork • More information about the risks and benefits of drugs

• Unfair quality measures • Loss of patient-physician confidentiality • Reductions in payments • Increased uncompensated care • Additional regulations and paperwork requirements

Consumers

• Cost of an episode of care • Access to provider quality of care information • Quality data summarized in layman’s terms • Secure medical records • Cost of medications • Personalised medicine • Risk and benefits of treatments

• Inappropriate disclosure of personal information • Unaffordable medical care • Complicated medical information • Complicated EOBs (explanation of benefits)

Govt/ Reimbursers

• Standard metrics for assessing provider quality • Patient compliance data • Increased consumer involvement in care decisions • Reduction in inappropriate medical services • Information on overall cost of treatment • Provider capacity info

• Disclosure of proprietary discounts • Lack of trust from providers and consumers

Pharmaceutical Companies

• Patient compliance data • Adverse event reporting • Clinical trends that may impact product use

• Increased regulations • Increased costs to bring a drug to market

Employers

• Metrics for assessing provider quality • Range of medical services available • Patient compliance data • Health needs and goals of employees • Risks and benefits of specific drugs • Employee participation in wellness programs

• Continuing cost increases in providing healthcare benefits

Working Group on Quality Indicators found more than 1,000 potential indicators that could be measured across different health systems. Transparency of quality and pricing hinges on the availability of accurate, reliable and valid performance measures. Data is not always what it seems. It needs to be validated if it is to be useful, and much work still needs to be done in this area. The absence of global health standards is driving many health systems to adopt best practices in quality improvement used by other industries and other countries. Incentives for providers Real improvements in the quality of healthcare will occur only after incentives are properly aligned around creating value and performance can be rewarded appropriately. Because patients have been insulated from the cost of healthcare for generations, a key challenge goes beyond transparency of price and quality information. Patients not only need to understand how the cost of healthcare is directly connected to their own behaviour, but also how changing their behaviour helps drive down that cost. For

example, consumer-directed health plans in some markets are designed to increase costsharing that will make consumers more sensitive to the consumption of medical products and services. However, early evidence has shown that some patients have delayed or avoided getting care due to high price, which may result in even higher costs. In designing the incentives that are crucial to a transparent community, stakeholders should consider developing a therapeutic index for cost-sharing around certain diseases or treatments. The clinical term, therapeutic index (also known as the margin of safety), is a comparison of the amount of a drug that causes the therapeutic effect (good) to the amount that causes a toxic effect (bad). Consumer healthcare incentives have typically shown a very narrow therapeutic index, in other words, the “good” incentive (or therapeutic effect) does not outweigh the “bad” incentive (or toxic effect) to effectively incentivise the consumer to perform a desired behaviour. A portion of the complexity and disagreement stems from how transparency is discussed and defined. Many of the government-sponsored transparency initiatives are

defined in a pair wise fashion. The problem with this approach is that what any two sectors might agree on regarding transparency either aggravates or threatens another sector. For example, reimbursers and consumers may agree on certain quality metrics from physicians and hospitals. Yet, the hospitals may disagree about how “quality” is defined. Or, perhaps providers and employers agree that medical information should be openly shared with each other to aid in patient compliance initiatives, but patients may feel this violates their privacy. To move beyond these collisions of interests, incentives need to be aligned and definitions standardised across stakeholder groups. To begin to make progress, the following question needs to be answered: “What is the minimum bundle of transparency initiatives that can come together and make the pain equal so that the various sectors don’t feel like they are the target?” Connectivity to disseminate information through interoperable health information systems Quality improvements will ultimately rely on more widespread investments in electronic medical records, more effective policies governing national standards for health quality, and greater cross-border standards and information sharing such as development of a global “network of health networks”. Asia’s healthcare organisations, particularly those dealing with both first and third World issues, are urgently seeking solutions to temper costs while balancing the need to provide access to safe, quality care. Across boundaries, languages and cultures, successful initiatives – often involving technological innovation – are occurring, but the best practices are only beginning to be shared across geographic and industry boundaries. The vision of electronically connected health promises to revolutionise the way healthcare is delivered. Better use of technology and interoperable electronic networks will: • Improve access, equity, quality and accountability of care • Empower patients through enhanced interaction with providers • Erase geographical and physical barriers to care

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problems, including data security, miscoding issues attributed to language variations and lack of broadband capabilities. Creating a digital backbone requires capital, interoperability, standard-setting and cross-sector collaboration. Thus, implementing an e-Health strategy requires active involvement from government entities and private organisations working in a collaborative fashion with one another. Active partnerships are needed among hospitals, physicians, IT developers and suppliers, and colleges and universities so that they can work together to build the infrastructure, set industry standards and provide the training and research required for success. Conclusion and recommendations Improving transparency of healthcare is a priority for health systems around the world, but a complex issue with no easy solutions, creating additional challenges for healthcare organisations and government. These challenges are exacerbated as pay is tied increasingly to performance and care

OchreDesignLab

• Accelerate integration, standardisation and knowledge transfer of administrative and clinical information • Radically transform the way health professionals learn, train, teach and practice The use of personal health records is being implemented throughout Asia and efforts are being made to consolidate patient information on a common IT platform. Right now, multiple medical records are stored in different clinics and hospitals in different formats. They are not connected or consolidated. As a result, when patients visit different doctors, they have to have tests repeated and scans redone. This adds to unnecessary cost. Other regions of the world are seeking interoperability as well. Electronic health records have been accepted by the European Union as a standard to be achieved in all European countries regardless of their funding model or infrastructure. Most countries are seeking to achieve this goal in their own way. However, advanced information technology is not the panacea and can create additional

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is sought and delivered across national borders. Questions remain unanswered about who is responsible for mandating, monitoring and measuring quality standards, what information technology is needed to support transparency of quality and pricing, and how published quality data affects referral and payment for medical services. Moving towards a transparent health community requires maintaining focus on the ultimate goal: Packing information for patients around treatments for a given condition and creating information and incentives that direct providers and patients towards those treatments. Following are the recommendations: • Cooperate on efforts to create interoperarable networks for electronic medical records and clinical systems • Reduce administrative functions that don’t add value to the transparency continuum • Focus on information that can be shared without compromising competitive advantage of stakeholders

H E A L T H C A R E M ana g ement

What can the Operating Room Learn from the Cockpit? Though there are fundamental differences between flying an airliner and operating on the esophagus, simple airline lessons have a lot to offer.

Richard C Karl Surgical Oncologist and Chairman Department of Surgery College of Medicine University of South Florida USA

he cascade of interest in patient safety has prompted several experienced healthcare providers to look to other professions for clues as to how to be safe in dangerous situations. The nuclear power industry, the submarine service and commercial aviation all represent â&#x20AC;&#x153;high reliabilityâ&#x20AC;? systems that have posted enviable safety records. Not surprisingly, hospitals, insurers, patients and doctors have wondered what contributions might be made by these disciplines to patient safety. Because my own interests in aviation and medicine developed alongside each other, Iâ&#x20AC;&#x2122;ve been especially fascinated by the similarities of and differences between the two professions. Since commercial aviation is demonstrably very safe and healthcare is not, what can we learn from the former to make the latter better? Can aviation safety techniques be lifted from the airlines and deposited in hospitals with minor tweaking and be useful? Or is such a notion overly simplistic? What is realistic? There are some fundamental differences between flying airliners and

practising medicine. Some are regulatory. In most countries, pilots and airline operations are carefully regulated, inspected and evaluated by federal agencies. In the United States, most regulation of doctors is done by state medical boards, which are quite variable in their approach to regulation. Likewise, pilots work for airlines and if a pilot decides not to follow federal or company policies, he or she is fired. Doctors, on the other hand, are independent contractors in the United States. They are courted by hospitals to bring their patients to those hospitals. In most instances, they have no direct employment relationship with a hospital. Disciplining doctors is often a lengthy (and litigious) process. Some differences might be called emotional. When a big jet goes down, the headlines reach around the world. Medi-

and likely underestimated. Another difference is the primal motive for the aviator: the pilot is the first to the scene of the accident. In healthcare, only reputations are damaged if a mistake leads to a death or to harm. Despite these immutable differences, there are several aspects of commercial aviation that lend themselves to medical application; some with effort, some readily. The hard things would involve changes in credentialing and assessment of competency. Simulators, very advanced in aviation and still quite rudimentary in medicine, could be used to assess most clinical competencies. There is a lot of work to be done in this area, but experts reassure me that it can be done. There are other airline-like things that can be done right now that could have a profound effect on patient safety. We could commit right now to mentoring of new physicians and surgeons, realistic work hours to avoid fatigue related erThough there are fundamental ror and emphasis on teamwork differences between flying an airliner and communication. and operating on the esophagus, simple Teamwork and communicaairline lessons have a lot to offer. tion are especially fertile areas for safety advancement. Human factors experts long ago recognised what the ancients knew: to cal error, in contrast, accounts for one err is human. Teamwork and patterned death in hospital A, another in hospital B, communication strategies help avoid erso that no one doctor or administrator is ror, recognise error when it occurs and aware, in such a visceral way, of the enortrap errors before adverse events ensue. mity of the calamity. Yet, it is estimated JACHO (Joint Commission) analyses of that 100,000 patients a year die because wrong site operations, adverse post operof medical errors in the United States ative events and other horrors have conalone, the equivalent of several jumbo jet sistently found communication to be the crashes a week. Hard to believe, but true, most common cause of mistakes. When

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you consider that mistakes not only take lives, but cause other types of survivable harm (as many as 15 million “incidents of harm,” according to the Institute for Health Care Improvement), training in teamwork and communication seems a reasonably inexpensive and efficacious way to begin to tackle the patient safety problem. Here are four common, preventable harms occurring in operating rooms that are inflicted on our patients every day: 1. Hypothermia in operative patients: A 2 degree Centigrade difference can account for a three-fold increase in surgical site infection. 2. Glucose control: Moderate hyperglycemia (200mg/dl) at any time during the first post operative day increases the risk of a surgical site infection four fold. 3. Blood transfusion. A gratuitous unit of blood increases the risk of nosocomial infections by a factor of three and increases the chance of cancer recurrence in almost all cancers studied. 4. Fluid administration: Restricted fluid administration during an operation can significantly decrease complication rates. Each of these harms is easily avoidable if there is good communication among anesthesia, nursing and surgical staff. It is a simple matter. In the four years of its existence, the Surgical Safety Institute has learned a good deal about teamwork and communication training in a variety of different clinical settings. What are the key ingredients for successful application of simple, but very effective, methods in clinical areas where harm and death are common threats to patients and staff? 1. Create clear, cohesive, reliable policies that track the intent of the safety training. If retained, surgical instrument policies hold only nursing responsible, then team training that emphasises the involvement of surgeons, nurses and technicians will not be as powerful. Policies and job descriptions need to have teamwork and communication imbedded in their essence. 2. Hire for teamwork skills: Deal with disruptive team members. Too often disruptive behaviour is tolerated and

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tolerated again, until a breaking point is reached, when some draconian action is triggered. There must be a code of conduct that applies to everyone on the team. Make teamwork a cultural value held in high regard. This increases efficiencies. 3. Seize any opportunity to begin training. In some institutions a pilot surgeon brings the idea forward. In others a dedicated cath lab supervisor sees the need and urges administration to make plans for training. The call for improvement can come from any point in the organisation. Leaders, both clinical and administrative, succeed when they listen to those “in the trenches.” 4. Emphasise physicians as leaders. Their role in moving training from the hypothetical to reality is essential. “Pushback” from practitioners is reminiscent of airline captain behaviour thirty years ago. Yet even the crustiest pilot learned the value of teamwork when a first officer or flight engineer spotted a problem the captain had overlooked. Data driven, physicians are especially moved by compelling data that support increased safety and efficiencies with teamwork/ communication training. 5. Make the training brief, fun, riveting and logical. Teams are expensive. Training needn’t take all day. Sobering data detailing the consequences of error help motivate altruistic care givers; they come away committed to being safer and more efficient. Many teams report improved emotional environments after team training. Equipment, turnover and handoff frustrations largely disappear. One surgeon said, “This has made operating fun again. I’ve got better relationships now with nursing and anaesthesia than ever.” 6. Use tools. White boards, briefing packets, checklists and team observations all make the process intuitive, organised and even fun. Once teams recognise the value of these simple techniques they become enthusiastic; in some cases almost evangelical. 7. Support, support, support. Make sure administrative personnel join the physician leadership in making these simple, easy techniques important institutional values.

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Do these things work? In a word, yes. Studies are beginning to appear in peer reviewed literature that show a decrease in wrong site operations, fewer equipment issues, improved efficiencies, decreased nursing turnover and improved nursing and physician satisfaction. Though there are fundamental differences between flying an airliner and operating on the esophagus, simple airline lessons have a lot to offer. That said, and without any disrespect to aviation, it is useful to remember that medicine is more complex, less organised and in many ways, harder. These simple tools can decrease chaos and make it easier.

BOOK Shelf

Competency Management for the Operating Room

Author : Adrianne E Avillion Year of Publication: 2006 Pages: 158

Description: Competency Management for the Operating Room is a complete competency program created specifically for assessing, validating, and documenting the skills of your OR nurses. This resource has everything you need to meet and exceed the competency requirements of the Joint Commission and other regulatory bodies. Within its pages, you’ll also find many helpful tips and strategies for effectively assessing and evaluating the training needs of your staff. Competency Management for the Operating Room is jam-packed with expert advice to help you schedule and organize competency assessment, understand Joint Commission expectations, and develop your competency assessment program.

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

H E A L T H C A R E M ana g ement

Communication Challenges and Opportunities

During Handoffs Richard M Frankel Professor, Medicine and Geriatrics Senior Research Scientist Regenstrief Institute Indiana University School of Medicine USA

n medical care, a handoff (also known as sign-out or end-of-shift report) refers to information about a patient that is transferred by one professional or a team to another. “The primary objective of a ‘handoff’ is to provide accurate information about a patient’s care, treatment and services, current condition and any recent or anticipated changes.” The number and types of handoffs for any given hospitalised patient can vary and may involve physicians, nurses, pharmacists, transport, and even food service. Handoffs are not simply a mechanical means for transmitting and receiving information. In medical care, a handoff requires that the sender consider a patient’s present condition and his / her likely future over the next 8-12 hours; likewise, the receiver must comprehend what is being transmitted and feel confident about the clarity and reliability of the message. Thus, in addition to sheer information exchange, handoffs also involve the transfer of rights, duties and obligations as they relate to the meaning and interpretation of communication from one professional to another.

Orit Karnieli-Miller

Amber Welsh

Postdoctoral fellow, Indiana School of Medicine and Regenstrief Institute USA

Patient Safety fellow Roudebush VAMC USA

Interest in handoffs has grown steadily over the past decade as researchers, hospital administrators, educators and policy makers have learned that variations in communication during patient handoffs cause significant number of errors and “near misses” to occur, leading to adverse outcomes and suboptimal care. According to the Institute of Medicine (IOM), up to 98,000 patients die and another 15 million are harmed in US hospitals annually due to medical errors. Root cause analysis of reported sentinel events from 1994 to 2004 reveals that two-thirds of these errors were due to communication failures. Another reason for increased interest in handoffs is related to the adoption of duty restriction hours by the Accreditation Council for Graduate Medical Education (ACGME) that has dramatically increased the number of care transfers that take place among resident physicians during a typical hospital stay. The increased number of handoffs results in a parallel increase in the potential for near misses and errors and worsened quality of care. Residents and attending physicians have expressed

Variations in communication during patient handoffs cause a significant number of errors and “near misses” to occur, leading to adverse outcomes and sub-optimal care. The research interest in this area has been growing steadily. concerns that the increased number of handoffs results in loss of critical information and continuity of care. It is no secret that medical care in the US is fragmented. Often this is reflected in the patient’s experience of care as a series of confusing and sometimes conflicting communication exchanges with different types of healthcare providers, a situation in which “the left hand does not seem to know what the right hand is doing.” The lack of integration is also reflected in the fact that

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handoffs vary in approach and content across medical specialties, professional roles and sometimes even between shifts on a single service. Added to the fact that medicine and nursing handoffs typically occur in parallel; without any cross communication, it is little wonder that patients experience care as discontinuous and fragmented. Recognising the importance of improving inpatient handoff processes, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 2006 implemented a new requirement as part of National Patient Safety Goal No. 2, to “Improve the effectiveness of communication among caregivers.” Requirement 2E requires facilities to “implement a standardised approach to ‘handoff’ communications, including an opportunity to ask and respond to questions.” Notably, JCAHO requirements did not specify how a standardised approach was to be achieved. Instead each individual healthcare facility or health system was left to its own to address the requirements. While this is a good first step, it leaves open the question of developing generalised standards and evaluation metrics for handoffs. In many high reliability industries outside of medicine, such as aerospace, nuclear power and recombinant DNA research, handoffs are critical and mistakes can be fatal. In these industries, handoff skills are formally taught and practised repetitively, often using simulation and other educational techniques to optimise precision and anticipate errors. Research in these industries has shown that there are structured communication techniques that increase reliability and reduce the likelihood of misunderstanding and error. Unfortunately, these principles have not been transferred into medicine to any great degree. A recent study of handoffs that included a national survey of medical schools found that a mere 8% teach the handoff as formal part of the curriculum. This leaves students to observe and learn from those above them in the medical hierarchy. If residents and attending physicians perform handoffs poorly, risky and unreliable habits of practice may be transmitted through the “informal” or “hidden” curriculum of medicine from one cohort of students to the next. The haphazard nature of inpatient handoffs has been reported in case studies

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as well as through empirical analyses. In a matched case-control study of inpatient adverse events, the likelihood of preventable adverse events was significantly higher under the care of a cross-covering physician than under the admitting care team. Similarly, patients admitted to the hospital by a cross-covering physician (rather than the primary physician) had longer inpatient stays and more laboratory tests. In a study using critical incident and interview techniques, Arora et al. linked communication failures in handoffs in a sample of residents to adverse events, highlighting problem areas of missing content or errors in process (e.g. no face-to-face communication, illegible handwriting). Another study’s findings indicate that handoffs may lack information that could potentially affect patient care, such as anticipated patient events. A recent pilot study conducted by our research team suggests that there are various social, linguistic and technological factors that might contribute to a near miss or adverse event during a handoff. These factors may include: interruptions (e.g. people talking during a handoff, coming in and out of the room); unclear audio-taping or unreadable handwriting; lack of time to listen to all the reports (“running off” to the shift); inaccurate descriptions of (e.g. “the patient is listed as DNR and he’s not,”); lack of information provided, omitted information; gaps between rules and regulations and the actual handling of the handoff (e.g. listening to the handoff and only then reading the forms without the opportunity to ask clarification questions); second order handoffs (e.g. charge nurse summarises the patient’s report); and various behaviours that might negatively affect the ability to listen and absorb the information (e.g. not writing down information, eating, having parallel conversations). A further complexity in handoffs is the rapid spread of electronic medical records and the use of computer based tools. While these tools provide greater flexibility and access to data necessary for effective care, they also potentially reduce the amount of face-to-face contact time used to conduct handoffs, a feature recognised as critical for effective handoffs in virtually all highreliability industries. Moreover, the face-toface conversation during handoffs is highly complex and nuanced. This complexity is

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due to a number of factors, including the number of patients involved in the handoff, the complexity and criticality of patients’ conditions, competing demands, time pressures and contextual cues (sights, smells, sounds) nearby the exchange. Recent scholarship based on handoffs across a variety of high reliability organisations has produced a set of generalised handoff strategies that are associated with improved reliability and outcomes. These include being face to face, choosing a location that is quiet with no interruptions, the use of checklist procedures and “teach backs” or “talk backs” (i.e. the receiver of the information repeats it), to ensure that the intention and effect of a message have been heard and understood across an authority or power gradient. It is only when the content of the message has been repeated that the action contained in a request typically takes place. In medicine, checking for understanding of content, is rare. For example, a 1999 study by Braddock and colleagues looking at several dimensions of informed decision making showed that primary care physicians and surgeons assessed patient understanding an average of 1.5% of the time. Recent attempts to improve communication using standardised protocols such as Situation, Background, Assessment, and Recommendation (SBAR) and systematic training have shown promising results in physician and nurse handoffs. Handoff research in medicine is in its infancy. There is a need to better understand the range of ways that handoffs occur within and across professional roles. As well, there is a need to incorporate what we know from other high reliability organisations and apply them to medical care. Given the complexity of healthcare, some may translate more easily than others. Research suggests that there is a pressing need for better education in medicine, nursing and pharmacy about how to conduct high reliability handoffs. Continued fragmentation of care can only lead to increased risk of adverse events and “near misses”. Finally, the impact of the electronic medical record and information technology on handoffs deserves greater study. There will undoubtedly be increased costs associated with improving the reliability of transfers of medical care. Ultimately, the question is not whether we can afford to underwrite these costs but whether we can afford not to.

H E A L T H C A R E M ana g ement

NICE

Making the best use of healthcare resources Several challenges ahead for the National Institute for Health and Clinical Excellence (NICE) in providing national guidance on the promotion of good health and the prevention and treatment of ill health.

Andrew Dillon Chief Executive National Institute for Health and Clinical Excellence (NICE) UK

long with the expected complexities of working in and on behalf of a rapidly changing health system, it has been an interesting year in the evolution of National Institute for Health and Clinical Excellence’s (NICE) work programme. The NHS is constantly striving to make tactical and strategic alterations to its structure in order to adapt and to operate as effectively and efficiently as possible, and the organisations that exist to support and advise it need to do the same. An important change took place in 2005 that saw the core functions of the Health Development Agency (HDA) transferred to the National Institute for Clinical Excellence, to form a new organisation: the National Institute for Health and Clinical Excellence (which will retain the abbreviation NICE). The decision to merge NICE and the HDA, taken as part of the government’s arms-length bodies review, has been seen by some as controversial, principally due to the predictable accusation that it is about

cutting costs and nothing more. But this is not a marriage of political convenience, and anyone who was familiar with the work of NICE and the HDA will see huge potential benefits from the merger. Transition The role of the new organisation is to produce guidance for health professionals, patients and the wider public in three areas of health: Public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector. Health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS. Clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Across all three programmes for work, NICE’s task is to produce intelligent and

well-resourced guidance that informs healthcare professionals and the public of the best way in which to improve and protect health. How does NICE approach economic evaluation? Decisions about the total resources available for healthcare are the responsibility of parliament and inevitably compete with other demands such as education, defence and transport. Within the allocations made by parliament, the resources for the NHS are finite, and the use of cost-ineffective, or less cost-effective, interventions in one area of practice will deny the availability of more cost-effective interventions in another. The Institute’s preferred approach to the economic evaluation of clinical interventions is cost–utility analysis. The principal measure of health outcome adopted by the Institute is the Quality-Adjusted Life Year (QALY). This embodies the important social value judgement that to count only

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gains in life expectancy, without considering the quality of the additional life years, omits important dimensions of human welfare. Value judgements embodied in health-related quality-of-life measures can be reasonably captured in terms of physical mobility, ability to self-care, ability to carry out activities of daily living, absence of pain and discomfort, and absence of anxiety and depression. QALYs are underpinned by an extensive body of empirical evidence and have been shown to be appropriate for a range of conditions, including mental health. The use of cost–utility analysis in resource allocation has aroused a substantial debate. Charges of discrimination against children, elderly and disabled people, and people who are terminally ill, have led some to conclude that the use of QALYs leads to impermissible trade-offs in setting priorities. Nevertheless, most bioethicists and political philosophers are generally prepared to accept cost–utility analyses provided they are used to inform, rather than direct, decisions about setting priorities, and that other considerations are available to constrain morally offensive trade-offs. The Institute’s own position is that while it endorses the use of cost–utility analysis in the economic evaluation of particular interventions, such information is a necessary, but not sufficient, basis for decision-making. Its advisory bodies have discretion, informed by advice from the Institute, on how to take the outcome of economic assessments into account in formulating their recommendations.

How will NICE fit into the public health sector? The audiences for the new public health guidance products extend beyond the NHS to local government and education, the public utilities, the private and voluntary sectors. Audiences also include a range of central government departments and their delivery arms with responsibility for taxation, benefits, roads, transport, housing, criminal justice and other aspects of services that contribute to the health of the public. NICE guidance will support evidencebased decision-making by public health physicians, medical and dental general practitioners, nurses, community practitioners, other NHS staff, local authority employees, employees of public utilities, teachers and others working in relevant fields. Examples of recent public health guidance include interventions on smoking cessation and physical activity, as well as a clinical guideline on the prevention, identification, assessment and management of overweight and obesity in adults and children1. Public health programme guidance is also being developed for primary care and employers on the management of long-term sickness and incapacity2 and on personal, social and health education focussing on sexual health and alcohol3. Implementing NICE guidance throughout the NHS The Department of Health document Standards for Better Health published in 2004 set core and developmental standards for NHS organisations. The

implementation of technology appraisals guidance and interventional procedures guidance is a core standard, whereas the implementation of other types of NICE guidance is a developmental standard. The recent introduction of the Healthcare Commission’s Annual Health Check should help ensure NICE guidance is implemented more quickly throughout the NHS. The Annual Health Check will require NHS bodies to declare whether they comply with the Department’s standards, which includes compliance with NICE guidance. The audits carried out in line with The Annual Health Check will explore how new guidance from NICE is being managed and introduced within trusts. Assessing the implementation of NICE guidance is a high priority for the Healthcare Commission in its role of encouraging improvement in the provision, safety and quality of patient care. Challenges for the future Due to the sensitive nature of our work, NICE is rarely out of the headlines. The quid pro quo of inclusiveness and consultation means that NICE guidance often takes longer to produce than stakeholders would like. We are however acutely aware of this, and have responded accordingly with the aforementioned STA process. We have also been flexible in terms of updating recently published guidance where new evidence has emerged. This was seen in our clinical guideline on Hypertension, where the subsequent emergence of the highly significant ASCOT trial findings resulted in an amended version of our guideline being issued before the official review date. We are also continuing to provide support to the NHS as it applies our guidance. Our implementation support programme now offers a range of tools and resources for most of the guidance at the time of, or soon after, its publication. Our aim is to do everything we can to make sure that those whom our guidance is intended to benefit are able to do so.

1. More details of which can be found on the NICE website at http://www.nice.org.uk/guidance/CG43 2. http://guidance.nice.org.uk/page aspx?o=350209&c=296726 3. http://guidance.nice.org.uk/page aspx?o=350208&c=296726

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M edical sciences

Treating Lung Cancer Immunotherapeutic strategies

New treatment modalities such as immunotherapeutic strategies may help improve the currently poor prognosis and outcome of patients suffering from lung cancer. However, thus far, lung cancer has not been considered an immune-sensitive malignancy. Now, there is an increasing evidence that specific humeral and cellular anti-tumour immune responses can be evoked.

Dominik Rüttinger Head Laboratory of Clinical and Experimental Tumor Immunology Department of Surgery Grosshadern Medical Center Ludwig-Maximilians-University Munich Germany

ung cancer is the deadliest cancer in the world. In 2005, in the US alone, there were an estimated 163,510 deaths in patients suffering from lung cancer, including 15,000 to 20,000 “never smokers”. These numbers clearly demonstrate that despite progress in the treatment of this disease over the past two decades, there are still few long-term survivors: only about 10% of all patients will ever be cured of this devastating disease. Given the modest effect and considerable toxicity of current standard treatment (surgery, chemotherapy, radiation therapy), there is clearly a need for novel treatment options. Currently, a wide variety of immunotherapeutic agents are being tested in lung cancer. Here, we review strategies based on the humeral and cellular immune system that are already in clinical use or well progressed in early clinical trials. Because Non-Small

Cell Lung Cancer (NSCLC) accounts for approximately 80% of all lung cancers, the focus is mainly set on immunotherapy of NSCLC. Antibody-based immunotherapy Today, at least 12 monoclonal antibodies (mAB) have received FDA approval and over 400 others are being tested in clinical trials. In lung cancer, a primary focus was put on mABs targeting the Epidermal Growth Factor Receptor (EGFR) and the Vascular Endothelial Growth Factor (VEGF). The most advanced in development are the anti-EGFR mAB cetuximab (Erbitux®) and the anti-VEGF mAB bevacizumab (Avastin®). Antibodies targeting growth factors

To block growth factors and their receptors seems an obvious strategy in fighting cancer because they are known to augment tumour cell proliferation and invasion and have

been shown to be overexpressed in many solid malignancies where the overexpression has been associated with a more aggressive course of disease and poor survival. C-erb B-1 and c-erb B-2 are the two growth receptor families that have been studied most extensively. C-erb B-1 is better known under the name HER1 or Epithelial Growth Factor Receptor (EGFR). HER2 is the more common name for c-erb B-2. Anti-EGFR (anti-c-erb B-1) monoclonal antibodies

Cetuximab (Erbitux®), a chimeric human: murine form of the original mAB 225, has demonstrated safety and was well tolerated in early phase clinical trials, but low patient numbers currently do not allow for final assessment of its therapeutic efficacy in lung cancer. A 28% partial response rate and 17% of patients with stable disease were observed in a Phase II trial with combination of cetuximab and docetaxel which exceeds response rates usually seen with docetaxel alone. In another phase II trial patients with recurrent or progressive NSCLC were treated with cetuximab after receiving at least one prior chemotherapy regimen. The response rate for all patients (n = 66) was 4.5% and the stable disease rate was 30.3%. The median time to progression for all patients was 2.3 months and median survival time was 8.9 months. The authors

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of this study concluded that, although the response rate with single-agent cetuximab in this heavily pretreated patient population with advanced NSCLC was only 4.5%, the disease control rates and overall survival seemed comparable to that of pemetrexed, docetaxel and erlotinib in similar groups of patients. More Phase I/II clinical trials have been conducted on the use of cetuximab in combination with systemic chemotherapy and / or radiation therapy confirming not only the low toxicity but also the clinical response rates. Grade 3 toxicities associated with the use of cetuximab were fatigue, infections and papulopustular rash. Development of the rash, usually located on the face and upper torso, has been related to a clinical response and has been suggested to potentially serve as a surrogate marker for cetuximab activity. Other anti-EGFR mABs currently in development include panitumumab (ABX-EGF), matuzumab (EMD 72000), pertuzumab (2C4) and MDX214. Early phase clinical trials with these agents in patients with lung cancer are currently ongoing with results pending.

Anti-HER2 (anti-c-erb B-2) monoclonal antibodies

Trastuzumab (HerceptinÂŽ), a humanised monoclonal antibody that targets the HER2 receptor, has been approved for metastatic breast cancer. However, to date, it failed to demonstrate clinical efficacy in patients suffering from lung cancer. Only few authors suggest further investigation of trastuzumab in HER2-positive lung cancer. In contrast, pertuzumab (2C4), a mAB designed to inhibit the dimerisation of HER2 with EGFR and other HER tyrosine kinases and, therefore, being independent of HER2 overexpression is currently under evaluation in NSCLC in early phase clinical trials. Monoclonal antibodies against other growth factors

Other factors relevant for tumour cell proliferation, such as the intercellular adhesion molecule-1 (ICAM-1), have been identified as targets for mABs. Of these, bevacizumab (AvastinÂŽ), which targets the Vascular Endothelial Growth Factor (VEGF) recently gained approval for the treatment of colorectal cancer. A phase II clinical trial using

bevacizumab alone or in combination with chemotherapy in patients with metastatic NSCLC revealed promising results. Other studies investigated the use of bevacizumab, for e.g., in combination with the EGFR-tyrosine kinase inhibitor erlotinib (TarcevaÂŽ) or as combination therapy with paclitaxel and carboplatin in the neoadjuvant setting. In the largest trial evaluating bevacizumab, 878 patients with recurrent or advanced NSCLC (stages IIIB and IV) were included. The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapyalone group. The median progression-free survival in the two groups was 6.2 and 4.5 months, respectively, with corresponding response rates of 35% and 15%. Rates of clinically significant bleeding were 4.4% and 0.7%, respectively. Other antibody-based immunotherapeutic approaches

In Small-Cell Lung Cancer (SCLC), an anti-idiotype vaccine targeting the ganglioside GD3 (BEC2) has been evaluated. The European Organization for

Figure 1. Therapeutic vaccination in lung cancer. Patients are vaccinated with formulations of tumour antigens (whole tumour cells, proteins, peptides, etc.), mostly subcutaneously or intradermally (1). Antigens are then taken up by antigen-presenting cells (e.g. dendritic cells), transported to the draining lymph nodes and presented to the immune system (2). Antigen (tumour)-specific T lymphocytes traffic to the tumour site (3) and elicit their anti-tumour activity (4).

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Monoclonal antibodies and tyrosine kinase inhibitors in clinical development for lung cancer Agent

Target

Stage of development

Monoclonal antibodies

Cetuximab (Erbitux®)

EGFR

III

Panitumumab (ABX-EGF)

EGFR

Matuzumab (EMD 72000)

EGFR

Pertuzumab (2C4)

EGFR-ErbB2 heterodimerization

MDX214

EGFR

Trastuzumab

HER2 (ErbB2)

I/II

Bevacizumab (Avastin®)

VEGF

III

KS1/4-methotrexate

Epithelial-cell derived carcinoma antigen

N901-blocked ricin

NCAM (CD56)

Lewis Y antigen

SGN-15 (-doxorubicin)

Tyrosine kinase inhibitors (TKI) Erlotinib (Tarceva®)

EGFR-TK

III

Gefitinib (Iressa®)

EGFR-TK

III

Lapatinib (GW572016)

EGFR/ErbB2-TK

Canertinib (CI-1033)

EGFR/ErbB2/ErbB3-TK

HKI272

EGFR/ErbB2-TK

ZD6474

EGFR/VEGFR-2-TK

AEE788

EGFR/VEGFR-2-TK

II Table 1

Research and Treatment of Cancer (EORTC) recently published data from a phase III trial using BEC2 in combination with induction chemoradiotherapy in limited stage SCLC. A total of 515 patients were randomly assigned to receive five vaccinations of BEC2 (2.5 mg)/BCG vaccine or follow-up. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Among vaccinated patients, a trend toward prolonged survival was observed in those who developed a humeral response. To increase their cytocidal potency, mABs are being linked to cytocidal agents, such as toxins, chemotherapeutic drugs or radionuclides. Approved for clinical use are, for e.g., gemtuzumab ozogamicin (Mylotarg®), which links the toxin calicheamicin to a CD33-specific antibody for use in the treatment of myelogenous leukemia and ibritumomab tiuxetan (Zevalin®), which links 90Y to a CD20-specific mAB. To date, the available data on comparable antibodies for the treatment of lung cancer is, however, very limited and very few reports on clinical applications are available.

Table 1 lists antibodies and tyrosine kinase inhibitors currently under clinical investigation for lung cancer. Therapeutic lung cancer vaccines In contrast to the prophylactic vaccination against infectious disease or cancers associated with viral infection (cervical cancer, hepatocellular carcinoma), for cancer patients the only relevant vaccination strategy must be therapeutic. Generally speaking, cancer vaccines incorporate a source of tumour antigens combined with some type of “adjuvant” to make these tumour antigens visible to the immune system. Sources of tumourassociated antigens include whole autologous or allogeneic tumour cells, defined proteins, or specific peptide epitopes (see Figure 1). Most likely due to the heterogeneous histology of lung cancers, the relevant immunologically dominant antigens remain unknown. Therefore, the use of autologous tumour cells might be especially suitable for vaccination strategies in lung cancer, because no prior knowledge of specific tumour antigens is necessary and the induced immunity may not be confined to a single, specific antigen that could be downregulated by the tumour.

GVAX®

The genetic modification of autologous tumour cells to secrete immunomodulatory cytokines has been shown to induce antitumour immunity in a number of preclinical models. Of these cytokines, GM-CSF has demonstrated the greatest induction of antitumour immunity. Two early-phase clinical trials using GM-CSF-secreting, autologous tumour cells (GVAX®) in patients with NSCLC have revealed encouraging preliminary results. Salgia and coworkers reported on safety and feasibility of this approach in 33 advanced NSCLC patients with the most common toxicities being local injection site reactions and flu-like symptoms. A mixed response in one patient and long recurrence-free intervals in two other patients following isolated metasectomy were observed. In another phase I/II trial using the GVAX® platform, autologous tumour cells were transduced with GM-CSF through an adenoviral vector (Ad-GM) and administered as a vaccine. 78% of patients developed antibody reactivity against allogeneic NSCLC cell lines. Three durable complete responses were observed. MUC1 vaccines

Mucin-1 (MUC1) is expressed on the cell surface of many common adenocarcinomas, including lung cancer. Because of its involvement in cell-cell interaction between malignant and endothelial cells, anti-MUC1 strategies may be useful in preventing metastatic spread of tumour cells in addition to their direct anti-tumour effect. A phase I study using a modified vaccinia virus (Ankara) expressing human MUC1, which also contains a coding sequence for human IL2 (TG4010), revealed a safe toxicity profile and some clinical activity. The phase II trial is currently underway as a multicentre study. MUC1 has also been targeted in another trial of patients with NSCLC using the vaccine L-BLP25 (Stimuvax®). A multicentre phase IIB study investigating the vaccine in NSCLC patients' stages IIIB and IV has recently been updated with promising results for safety and clinical effectiveness in the first publication. All patients had shown stable disease or a clinical response following standard first-line chemotherapy and were then vaccinated with Stimuvax or received best supportive care alone. Although the overall survival did not reach statistical significance, the survival in patients with stage IIIB

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Therapeutic lung cancer vaccines in clinical development Phase

No. of patients1

Vaccine

Best response2

Reference

Autologous/Allogeneic tumor cells GVAX® GVAX®

SD in 5 patients

Salgia et al. [26]

CR in 3 patients

Nemunaitis et al. [27]

B7.1 (CD80)

PR in 1, SD in 5 patients

Raez et al. [36]

(1,3)-galactosyl-transferase

SD in 4 patients

Morris et al. [41]

I I

CTX+GM-CSF

Under evaluation

Rüttinger et al. [46]

Belagenpumatucel-L

PR in 15% of patients with stage IIIB/IV disease

Nemunaitis et al. [39]

MUC1

SD in 4 patients

Autologous/Allogeneic tumor cells Palmer et al. [29]

IIB

MUC1

sign. advantage for stage IIIB (locoregional)

Butts et al. [30]

(Phase III ongoing)

ALVAC-CEA/B7.1

No clinical response in phase I

Horig et al. [42]

I/II

WT1

Decreased tumor markers in 3 patients

Oka et al. [43]

HER-2/neu

No response reported

Salazar et al. [44]

Telomerase (GV1001/HR2822)

CR in 1 patient, Immunol. response in 13 patients

Brunsvig et al. [55]

I/II

MAGE-3

No response reported

Atanackovic et al. [32]

MAGE-A3

122

Advantage for stage II (adjuvant)

Halmos et al. [33]

II (Phase III ongoing)

EGF

Seroconversion in 90% of pat., SD in 12 patients

Gonzalez et al. [40]

Dendritic cells I

DC rF-CEA(6D)-TRICOM

Increase in CEA-specific T cells

Morse et al. [35]

Antigen-spec. response in 6 patients

Hirschowitz et al. [34]

1 Number of lung cancer patients on trial. 2 Clinical or immunological responses.

(locoregional disease) improved at three years compared to stage IIIB patients with malignant pleural effusion and stage IV patients with 48.6% and 26.7%, respectively. An international, randomised, multicentre phase III trial for unresectable stage III NSCLC patients with stable disease or better following first-line chemoradiation has been initiated and the first patient has entered the trial in the US. Recombinant MAGE-A3 protein vaccine

Another protein vaccination strategy aims at the melanoma-associated antigen E-3 (MAGE-3), which is expressed in about 30% - 50% of lung cancers depending on stage and histological subtype and may be associated with poor prognosis. First results reporting the successful induction of humeral and cellular immune responses in patients with NSCLC following vaccination with MAGE-3 with and without adjuvant chemotherapy have been published in 2004. Seventeen patients were enrolled following surgical resection with no evidence of disease. Nine patients received 300µg of the MAGE-3 protein alone, whereas 8 patients were treated with MAGE-3 combined with the adjuvant AS02B. In the

first cohort (no adjuvant), only one patient showed a CD4+ T cell response. In contrast, 4 patients out of the second cohort (MAGE-3 plus adjuvant) developed a CD4+ T cell responses against the MAGE3.DP4-peptide. Based on these results, a multinational phase II trial investigating the therapeutic efficacy of the MAGE-3 vaccine in patients with resected MAGE-3positive stage IB/II NSCLC was initiated and recently completed. In this placebocontrolled study, 122 early-stage patients (MAGE-3-positive NSCLC) where vaccinated five times at three-week intervals. Preliminary analyses presented at the 2006 ASCO meeting revealed a 33% disease-free survival improvement for the resected and vaccinated patients. No significant toxicities were observed. A large multicentre phase III study is currently being initiated based on these results. Other vaccination strategies

More lung cancer vaccines are currently being tested, but review of all strategies in clinical development would go beyond the scope. Table 2 lists therapeutic lung cancer vaccines currently in clinical development.

Table 2

Summary and conclusion For long, lung cancer was not considered an immune-sensitive malignancy. With insufficient knowledge of relevant tumour antigens, lung cancer immunotherapy lags behind similar efforts in melanoma, renal cell and prostate cancer. However, there is increasing evidence that NSCLC and SCLC can evoke specific humeral and cellular anti-tumour immune responses. With increasing knowledge about the link between the induced immune response and a resulting objective clinical response, targeted agents may hold great promise in sequence with other (adjuvant) anti-tumour therapeutics. Obviously, not all of the immunotherapeutic approaches in the treatment of lung cancer can be mentioned in this review, e.g. adoptive cell transfer, immuno-gene therapy, inducers of apoptosis, certain signal transduction inhibitors and others have not found their way into later clinical development and, therefore, weren’t the focus of this review. Acknowledgement This work was supported by the Chiles Foundation, Portland, Oregon, USA, and the Walter-SchulzFoundation, Munich, Germany.

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t? en er iff D

Tr Tr u ut th h in in E Sc th ie ics nc e

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Torbjörn Tännsjö Professor and Chair Practical Philosophy Stockholm University Sweden

The notion of truth is same in ethics and science. However, the data in science and ethics are different. In science we rely on observation, in ethics we rely on considered moral intuitions. There is little agreement about when we should trust our ethical intuitions. It is remarkable, however, that neuroscience and psychology has recently shed new light on how our moral intuitions arise.

s truth in ethics different from truth in science? A way of understanding the question is this: Is the notion of truth in ethics different from the notion of truth in science? The answer to the question is then straightforward: no. In my opinion, shared by many but not all thinkers, there is just one notion of truth, and it is the same in all fields. In saying that it is true that there is a table in front of me, that it is true that 7+5=12, or that it is true that one should not torture innocent children just for fun, we are using the same notion of truth. However, this notion is a ‘thin’ or ‘deflationary’ one; it doesn’t mean much. For example, if I say that there is a table in front of me, and then goes on to say that it is true that there is a table in front of me, the further implicature may be that I am certain. However, I add no information. But are there any truths in ethics? The answer to this question is not straightforward. Many people (expressivists) believe that when we say that an action is wrong, we merely express a con attitude towards the

action in question, we express no proposition capable of being either true or false. To be sure, even expressivists can make sense of the word ‘true’, when used in ethical contexts. When, according to the expressivist, I say that it is true that it is wrong to torture innocent children just for the fun of it, this is merely a way of saying that it is wrong to torture innocent children just for the fun of it; and to say this, according to the expressivist, is not to express any proposition, but merely to express an attitude. But this means that, even if the expressivist has access to the word ‘true’ in ethical contexts, the expressivist, denying that there are moral propositions, must deny that there are truths (true propositions) in ethics. I disagree. I believe that, when we say that it is wrong to torture innocent children just for the fun of it, we do express a proposition capable of being true or false. As a matter of fact, I believe that this proposition is true. And I take it to be true (or false, if it happens to be false), independently of my conceptualisation or thinking. But this is not the place to argue the case. I will just take this ‘realistic’ understanding of ethics for granted. This means that I will both make the semantic assumption that when using moral language we express genuine propositions capable of being true and false, and the ontological assumption that some ethical propositions are true, i.e. I will assume that there are ethical facts. This allows me to ponder a further, epistemic, question: can we know the truth in ethics? If so, how do we gain ethical knowledge? Are the methods we use similar to, or different from, the ones we use in science?

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opt for one common answer, without arguing that it is the right, or best one: A person, S, is justified in the belief that p if, and only if, p coheres with the rest of his beliefs. This goes for ethics just as well as for science. What I just said is not only a bit dogmatic, but it is also simplistic. However, I will not go into detail here. I will only note that the notion of coherence employed in the present context is a bit special. Coherence is not merely a matter of logical consistency, but also a matter of explanatory relations between propositions. All this means that justification is a matter of degree, the more closely connected your beliefs are, the stronger is your justification. We can put this in terms of what must be given up, if you jettison a particular belief. The more other beliefs you have to give up, when you give up on p, the better is your justification for p, according to this notion of justification. It should be noted that justification is different from truth. You may be justified in holding false beliefs. Our hope is, however,

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Knowledge Just as we asked whether truth is different in ethics from science, we can ask the same thing about knowledge. Is knowledge in ethics different from knowledge in science? Once again I am prepared to claim that the notion of knowledge is the same. What does it mean, then, for a person, S, to know that p? According to received wisdom, dating back to Plato’s dialogue Theaetetus, it means roughly that three conditions are satisfied: (i) S believes that p, (ii) it is true that p, and (iii) S is justified in the belief that p. Some complications with this definition have been noted by Russell and Gettier, but we need not bother about them in the present context. Is there knowledge in ethics? I believe there is. This means that I believe we have moral beliefs, that some of them are true, and that we are justified in having them. What does it mean, then to be ‘justified’ in a belief? Plato found no satisfactory answer to this question. Philosophers disagree. Once again I will be a bit dogmatic and just

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that our adherence to scientific methods leads us closer to the truth. Once again, I see little difference here between ethics and science. Evidence Some of our justified beliefs are such that we have no evidence for them. Observational beliefs are typically of this kind. I am justified in my belief that there is a table in front of me. If asked for evidence to the effect that there is a table in front of me I am at a loss. I see that there is a table in front of me, period. It is not that my seeing the table gives me evidence for the proposition that the table is there. In a sense one could say that it does; I could say that I seem to see a table in front of me, a table being in front of me is the best explanation why I do seem to see it, and hence the fact that I seem to see it is evidence for its presence. However, I need no evidence for this proposition so I don’t take my seeing the table as evidence for its presence. How could I? How do I know that I see a table in front of me? Am I more certain

M edical sciences

about my seemingly seeing a table than of a table being there? I think not. This does not mean that my observation of the table is incorrigible, however. I may learn that a psychologist is now and then making fun of my philosophy lectures and me by cleverly projecting a hologram in front of me, just to get a chance to mock me, when I say that I am certain that there is a table in front of me. If I do learn this, then my justification in the belief that there is a table in front of me is lost (undermined). Furthermore, if I try to touch the table and find that my fingers run smoothly through it, then I have to give up my belief that there is a table in front of me. I now have evidence against the proposition that there is a table in front of me. I will return below to the possibility that further knowledge undermines our firm beliefs. Now, even if we hold some justified beliefs for which we lack evidence, this is not true about scientific theories. Typically, we are only justified in our belief in a scientific theory if we have evidence for it. And, typically, the evidence for a scientific theory lies in observation. We say that something we observe, say that p, is evidence for the theory T, if T gives the best explanation of p (we make an ‘inference to the best explanation’, as Gilbert Harman has famously put the point (Harman, 1965)). Can we say something similar of ethics? Testing ethical theories Similarities with science Typical ethical theories state which actions are right and which actions are wrong and also why they are right and wrong respectively. Two examples of such theories are explained in this article, utilitarianism and the sanctity of life doctrine. According to utilitarianism, an action is right if and only if it maximises the sum-total of well-being in the universe; if it is not right, then it is wrong. And the fact that an action maximises the sum-total of well-being in the universe, if it does, is what makes it right. The sanctity-of-life doctrine (as I here conceive of it) concurs in the idea that one should maximise the sum-total of well-being in the universe, but claims that the end doesn’t justify the means. It is wrong actively and intentionally to kill an innocent human being, even if killing this innocent human being means that the sum-total of well-be-

ing in the universe is maximised. The fact that an act is an act of intentional and active killing of an innocent human being (murder), if it is, makes it wrong, irrespective of its consequences. How should we go about if we want to test these and other ethical theories? Some philosophers, of a rationalist bent, have thought that morality can be derived from reason itself, i.e. they have believed that, once we understand each moral theory thoroughly and clearly, we can simply grasp which one is true. Few stick to this belief now-a-days, however, and, I think, wisely so. When we assess putative moral theories, we must proceed in a manner, which is similar to how we assess scientific theories. We have to put our moral hypotheses to test. We test our scientific theories against our observations. In a similar vein, we have to test our moral hypotheses against not observations, but our considered moral intuitions. A moral intuition is an immediate reaction to an action with which one is presented, to the effect that the action is right or wrong. It is ‘immediate’ in the sense that it is not the result of any conscious process of reasoning. I will return to the requirement that our moral intuitions should be considered. A scientific theory that is at variance with (the content of ) our observations is rejected. A scientific theory must be empirically adequate. In a similar vein, an ethical theory must give the right answer to moral questions; it must conform to our considered moral intuitions. However, empirical adequacy or conformity with our considered moral intuitions respectively, is just a necessary requirement, it is not a sufficient one. The theory must also, in order to gain support from the observation (intuition), give the best explanation of (the content of ) our observations and considered intuitions. This means that it must be general, simple, theoretically fruitful and so forth. Once again, I see no difference here between ethics and science. On a structural level, what goes on in the testing of both moral and scientific theories is the same. And yet, if we look closer to the ethical case, an important difference surfaces: in science we normally rely on real experiments. In ethics we must rest satisfied with thought experiments.

The trolley cases If we want to put utilitarianism and the sanctity of life doctrine to a crucial test, then we have to turn to thought experiments. The reason that we must resort to thought experiments and not real life cases, is that it is impossible to form any definite and reliable moral intuitions with respect to real cases. An action can be wrong, according to both theories, because it does not maximise the sum-total of well-being in the universe. But we cannot know for sure about any action whether it maximises the sum-total of well-being in the universe. We can certainly not observe this. Furthermore, according to the sanctity of life doctrine, an action is wrong if it is an act of murder. But we cannot know for sure whether an act is an act of murder or not (we cannot know for sure whether it is intentional killing or not). In abstract though experiments we need not bother with such details. We can simply assume that an action has better consequences than another, alternative, one and we can stipulate that a certain action was an act of murder and so forth. Then we can tease out our intuitions in relation to the examples. Now, if we want to choose between utilitarianism and the sanctity of life doctrine it might be a good idea to turn to the so-called trolley-cases, developed and elaborated upon, by the philosophers Philippa Foot (Foot, 1967) and Judith Jarvis Thomson (Thomson, 1967). As we will see, these examples seem to allow for crucial tests between these two theories. Here is the first, simple switch, case. A trolley is running down a track. In its path are 5 people who have been tied to the track. It is possible for you to flip a switch, which will lead the trolley down a different track. There is a single person tied to that track. Many believe that they should flip the switch. This is in agreement with utilitarianism, of course. More lives are saved. But it is also consistent with the sanctity of life doctrine, since the killing of the single person is not intended; it is a merely foreseen consequence of your saving the five. If there had been a third track, with no one on, you would have opted for this one, I assume. Here is the second, the so-called footbridge case. You are on a bridge under which the trolley will pass. There is a big man next to you and your only way to stop the trolley is to push him onto the track, killing him

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to save five. Few think this would be right, even among those who are prepared to flip the switch in the original example. According to utilitarianism, this is what you ought to do however. But according to the sanctity of life doctrine, you should not push the man since, if you do, you kill him deliberately, and you use him merely as a means to the rescue of the five. It may seem that people at large have intuitions that square better with the sanctity of life doctrine than with utilitarianism, then. But here comes a third version of the example. The third case, often referred to as the loop, as in the simple switch case, you can divert the trolley onto a separate track. On this track is a single big man. However, beyond the big man, this track loops back onto the main line towards the five, and if it weren’t for the presence of the big man, flipping the switch would not save the five. Now many people, even among those who hesitate to push the big man, accept to flip the switch. But this is at variance with the sanctity of life doctrine and in accordance with utilitarianism. It seems, then, that neither utilitarianism nor the sanctity of life doctrine can gain support from the intuitions of people at large. I claimed above, however, that we should seek evidence in our considered intuitions. Is there a way of critically assessing our spontaneous reactions to the examples? Well, one question we should ponder is how we have arrived at our intuitions. And this is where neuroscience comes in. Neuroscience enters the picture Joshua D. Greene at Harvard University and his collaborators have studied extensively how we reach our verdicts in the trolley cases. Here are, in a very simplified form, some of their results about what happens when people react to the trolley-cases. It seems as though a dual model makes best sense of how we function. On the one hand, controlled cognitive processes drive our utilitarian judgements, while non-utilitarian judgements (don’t push the man) are driven by automatic, intuitive emotional responses. Different parts of our brains are responsible for these different responses, as can be seen from neuroimaging of our brains. ‘Utilitarian’ responses are associated with increased activity in the dorsolateral prefrontal cor-

tex, a brain region associated with cognitive control (Greene et al. 2004). By cheering people up, before we confront them with the examples, it is possible, to move them closer to the utilitarian camp (Greene at al. 2004). By keeping people busy with intellectual tasks, while giving their verdicts on the trolley-cases, it is also possible to move people closer to the non-utilitarian camp. Moreover, those who reach the utilitarian verdict have to overcome their own emotional resistance to the conclusion, which takes some time, and so forth (Greene at al, 2004). And people suffering from focal bilateral damage to the VentroMedial Prefrontal Cortex (VMPC), a brain region necessary for the normal generation of emotions and, in particular, social emotions, easily reach the utilitarian solution when asked about the cases (Koenig et al., 2007). When we know more about the origin of our moral intuition, can this help us to select the right moral hypothesis, utilitarianism, the sanctity of life doctrine, or some other doctrine? The results from neuroimaging of our brains and experimental psychological studies do not contradict our intuitions, Neither do they provide any evidence against them. It is not like the case in the opening of this paper where I can feel that there is no table in front of me. But perhaps they can help us to undermine the justification for some of the intuitions, in the same way that my knowledge that psychologists sometimes project holograms in front of me undermines my justification for my belief that there is a table in front of me. Which ones have their justification undermined, in that case? This is a tricky question. It is obvious that some immediate intuitions among people at large just have to yield-you have to admit that even if you are among the majority. You have to admit that since there is no plausible theory consistent with all the intuitions. But if you want to get rid of some, but not all intuitions, which ones should yield and which ones should be retained? One could argue that we should try to muster the same emotional response to the loop as the one we exhibit in relation to the footbridge and opt for the sanctity of life doctrine. Or one could argue that our gut feelings, just because they are immediate and probably the result of a selective pressure way back in our human history, lack

credibility and hence opt for the utilitarian solution. There is something to each line of argument. However, the proper way of approaching our intuitions, it seems to me, is to see what our reactions to the examples are, once we know about the origin of respective kind of emotion. We should not rely on our intuitions before we know all that can be known about their origin. We should expose them to a kind of cognitive psychotherapy, then. This is not enough, however. We need philosophical therapy as well. We must ascertain that we have correctly understood the examples. We are easily misguided when we ponder thought examples. We read things into them that should not be there. The scientists who have studied our reactions have tried to compensate for this, but they may not have been entirely successful. It is also important to make some distinctions, which are simply absent in the abstract description of the examples. We are here invited to assess what course of action is ‘morally permissible’. It is not quite clear what this means. One question is what kind of response is right and what kind of response is wrong, when we abstract from long-term consequences (by assuming that there are no such consequences of importance). Another question is: what sort of people should we be, people who push or people who don’t push the big man onto the tracks? A utilitarian may well admit that in the long run it is better that people at large are such that they don’t push. And yet, in the situation, we ought to push. Some may be less willing to make this kind of distinction and claim that the crucial question is what sort of people we should be. But then they cannot respond to the trolley cases in a reasonable manner! Philosophical subtleties like these are lost in the experiments. When they are added, together with information about how our intuitions are formed, and comprehended, then, I submit, we are allowed to rely on the kind of (firm) intuitions we still hold. They are what I have called ‘considered’ intuitions. Our justification of them is not undermined by any knowledge we have been able to gain. Hence, quite reasonably, we take them to be indicative of the truth. Can we expect inter-subjectivity in our thus considered moral intuitions? Perhaps,

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justified in my belief in utilitarianism, while the Pope is justified in his belief in the sanctity of life doctrine, provided we have each scrutinised our intuitions properly â&#x20AC;&#x201D; and provided we have not just deduced them from our respective favoured theory. This may well be so, but since utilitarianism and the sanctity of life doctrines contradict one another, they cannot both be true. The possibility of such epistemic relativism may prompt us to believe that, after all, there is no truth in ethics. The idea that we should give up on some of our intuitions, because they have been undermined by knowledge about their origin, may come to be generalised to all our moral intuitions. We may be tempted to accept moral nihilism and moral scepticism. I think we ought to resist this temptation, but I must admit that, in the present context I have not given any good argument to this effect. Conclusion The notion of truth (just as the notion of knowledge and justification) is the same in

OchreDesignLab

in the very long run, but I doubt it. In this, ethics may well be different from science. Observations in science may be highly theory-laden and thus controversial, but there is always a possibility of moving to neutral ground when we account for them. The physicist may claim that he has observed a path of a positron in a cloud chamber. Another scientist claims that there is no such thing as a positron. He sees no trace of any positron. Now, there is a way of switching to a less theory-laden level of description of the content of their respective observations. Perhaps they can agree, at least, that there are certain traces of a certain shapes, which they are watching. The person who believes he sees traces of a positron can urge the other scientist to explain what, if not traces of a positron passing, the traces both see are traces of. However, in ethics there is no similar neutral ground, no clearly observable traces to which we can move. This means, then, that different people may very well be justified in their beliefs in competing moral hypothesis. I may be

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ethics and science. We gain moral knowledge in a way similar to how we gain scientific knowledge: we have evidence for ethical theories when these theories can best explain our data. However, the data in science and ethics are different. In science we rely on observation, in ethics we rely on considered moral intuitions. There is little agreement about when we should trust our ethical intuitions. It is remarkable, however, that neuroscience and psychology have recently shed new light on how our moral intuitions arise. We should ponder these data and submit our intuitions to cognitive psychotherapy. When they resist this kind of therapy, when they do not go away, once we know how we have come to hold them, we are justified in relying on them. They have then become considered moral intuitions. We are then justified in our moral beliefs. If they happen to be true, furthermore, then we know them. All this means that theoretical moral knowledge is possible, at least in principle.

S u r g ical specialit y

Surgical Response to Mass Casualty Incidents

The Israeli experience

When a Mass Casuality Incident occurs, the establishment of a defined system with central control is critical for the orderly evacuation and transfer of patients through a cascade of treatment from resuscitation and damage control to definitive care and eventually to rehabilitation.

he frequency of recorded Mass Casualty Incidents (MCIs) has increased over the past 50 years with almost 2 billion people being affected by disasters during the past 10 years alone. Approximately half of all natural disasters occur in Asia even though it comprises only 31% of the total world area. In the second half of the last century approximately 70% of all disaster-related deaths occurred in this region that contains 58% of the total world population. The medical sequelae of an MCI generally occur in three phases. The largest number of deaths occurs in the Initial Phase due to injuries incompatible with survival. The largest number of preventable deaths occurs in the Second Phase, occurring minutes to hours following the MCI. The key medical issues during the Second Phase are rescue of the victims, provision of timely first aid and early evacuation of patients with life and limb threatening injuries to medical facilities. The initial responders to MCIs resulting in complete destruction of social infrastructure are often uninjured local citizens. The large number of casualties presenting for care usually overwhelms surviving local medical personnel and facilities.

Sharon Einav-Bromiker Lecturer, Anesthesiology and Critical Care Medicine, Hebrew University Israel William P Schecter Professor, Clinical Surgery University of California, San Francisco USA

The major issue in the Third Phase, which occurs days to weeks following the disaster, is preventive medicine. Provision of adequate food, potable water, clothing, energy sources and shelter is essential. Organisation of human waste and garbage disposal is also important. Provision of primary healthcare for the local population should optimally begin as soon as 24-48 hours after the MCI. Circumstances will differ depending upon the location of the incident, the previous level of medical care received by the local population and the degree of destruction of local infrastructure. Access to emergency medical care, delivery room services and maintenance medication are all important issues requiring consideration. Surviving

community hospitals must respond to waves of civilian and military casualties while maintaining routine medical and surgical service to the community depending upon the nature of the incident. Treatment of late medical complications such as sepsis, multiple organ failure and the psychological sequelae of the incident are also major issues which occur in the Third Phase. Pre-event management A thoughtful disaster plan outlining the mobilisation and optimal utilisation of available medical resources is critical. Fewer additional resources are required if systems are in place to optimise the use of existing resources. Individual patient survival is highly dependent on early transfer to a medical facility capable of providing life and limb salvage surgery. The utility of front-line military evacuation hospitals was demonstrated both during the 1973 Yom Kippur War in the Sinai Peninsula and during the 1982 Lebanon War. A similar concept has been employed in other military deployments and by civilian rescue organisations responding to disasters. Following resuscitation and initial damage control surgery, patients are transferred in an orderly fashion to hospitals remote from the incident for definitive care freeing up beds in the evacuation hospital for the next wave of casualties. During the Second Lebanon War in 2006, most casualties were evacuated to nearby civilian medical centers because of the proximity of the conflict to civilian population centers. Four hospitals in the north of Israel were designated as receiving hospitals. Only one of these hospitals functions as a Level 1 Trauma Centre during peacetime. Prior preparation for a disaster response is imperative to ensure a smooth transition to the changed circumstances. Optimal prior preparation includes not only a disaster plan but organisation of a system that has a central control responsible for conducting regularly scheduled MCI drills as well as ensuring provision of adequate supplies. The establishment of a defined system with central control is critical for the orderly evacuation and transfer of patients through a cascade of treatment from resuscitation and damage control to definitive care and eventually to rehabilitation. Inter-hospital competition can be minimised when a disinterested third party governs

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S u r g ical specialit y

the system. The Israel Emergency Medical System (Magen David Adom) determines the evacuation destination after MCIs during peacetime. The Israel Defense Forces Medical Corps determines the evacuation destination for casualties during war. The goal is conversion of an MCI in the field to a multiple casualty event for each receiving hospital. A recent review of the Military Trauma System in Iraq identified a number of key clinical issues which are important for disaster planners. These issues include transfer of casualties from point of injury to the most appropriate level of care, the development of trauma clinical practice guidelines, the use of standard forms at all care stations, the institution of standard prophylactic antibiotic regimens, on-line regulation of medical evacuation, implementation of a performance improvement programme including a careful report of morbidity and mortality statistics and trauma registry data. Estimation of receiving hospital surge capacity including alternate site capacity is a key element in disaster planning. Unfortunately, the optimal method of surge capacity evaluation remains unknown. Both computer simulation models and annual bed statistics have been used to estimate surge capacity. Annual bed statistics do not account for daily variation in patient volume and within-year variation in bed supply and may, therefore, be misleading. Some types of MCIs result in increased use of specific resources (e.g. intensive care, surgery) and prolonged hospital stay thereby affecting surge capacity. Although many patients can be discharged from the hospital within 24-72 hours following injury to increase bed availability, overzealous early ICU discharge may adversely affect outcome. Staff training is an obvious crucial element of disaster planning. Training should include: 1. The principles of Advanced Trauma Life SupportÂŽ, 2. Acquaintance with the unique patterns of injury caused by manmade and natural disasters, 3. Participation in mass casualty drills and 4. Mental preparation for acceptance of adequate rather than optimal care of the injured under dire circumstances requiring triage. Finally, the disaster plan should clearly delineate the in-hospital chain of command to limit the inevitable competition and egoclashes that occur within hospitals. Senior surgeons assume the clinical leadership role

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in almost all Israeli hospitals following a mass casualty event. Event management All hospitals in the vicinity of a mass casualty event will likely participate in the care of casualties. The key concepts for orderly patient management are unidirectional patient flow throughout the hospital and thorough documentation. Anaesthesiologists, general and orthopaedic surgeons are in immediate demand. Initial triage of patients should occur outside of the department of emergency medicine (ED). Physicians and nurses who do not have special training in the surgical disciplines should segregate ambulatory patients in an area outside of the ED itself where they can be evaluated. Ambulatory patients injured in a blast should be screened for asymptomatic pneumothorax and / or tympanic membrane rupture at diagnostic ENT and radiology stations prior to discharge from hospital. Stretcher cases should be admitted directly to the ED for secondary triage to Immediate or Delayed Care. Following initial resuscitation, Immediate Care patients are transferred to the operating theater (OR), intensive care unit, the Post-Anaesthesia Care Unit (PACU) or the Radiology department depending on the diagnostic and therapeutic requirements of the individual patient. The PACU is an ideal venue for establishing an extended ICU to accommodate the surge of critically ill patients. Most patients will require diagnostic Xrays and many require CT imaging. Insidious and missed injuries are a major concern. The Radiology department is the main bottleneck impeding the orderly flow of patients through the diagnostic and therapeutic intrahospital triage cascade. This can be prevented with staff training and prior preparation of radiology protocols unique to MCIs. Critically ill patients who have suffered penetrating injuries or traumatic amputations may require immediate access to the OR. Upon notification of a disaster, elective surgery should be immediately suspended until the scale of the event is clarified. Patients who have not yet been anaesthetised should be returned to the pre-operative holding area or their wards. Patients who have been anaesthetised but have not yet received surgery can be considered on an individual basis. Depending upon the severity of their

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condition, the anticipated length of the procedure and the scale of the event, a decision may be made to either abort the procedure or proceed with surgery. Surgical procedures underway at the time of notification of the incident should proceed to completion. Post-event management Early debriefing, usually on the day of the event, is important to record the events, create order out of the initial confusion and identify opportunities for performance improvement. An orderly and timely flow of casualties through the diagnostic and therapeutic triage cascade will clear the ED which may easily be inundated otherwise and hastens return of the hospital to routine operation. Return to normal hospital routine may, however, take hours to days, dependant on the number of casualties received and the nature of the incident. The medical consequences of the event in terms of prolonged ICU and hospital care, the need for multiple reconstructive operations, rehabilitation care as well as psychiatric and social services are immense. The psychological impact of MCIs (and in particular those that have been caused by human acts of aggression) on healthcare workers should not be underestimated. Post-Traumatic Stress Disorder (PTSD) is common among healthcare workers deployed to combat settings. Work in a directly threatened civilian environment (e.g. a general hospital targeted by missiles, a community comonly affected by acts of terror) predisposes hospital staff to PTSD. Conclusion A coordinated response to a disaster or MCI requires a system-wide plan with central control. The initial medical issues include rescue of victims, provision of first aid and evacuation of patients with life and limb threatening injuries to more sophisticated medical facilities. Early attention to provision of food, potable water and sources of energy, clothing and shelter and waste disposal are critical to prevent epidemic disease following a disaster. All hospitals in the vicinity of the incident will likely be called upon for help. A hospital disaster plan is essential to define lines of authority, identify diagnostic and therapeutic triage stations and facilitate the orderly treatment of a large number of patients. The goal is conversion of an MCI in the field to a multiple casualty event for each hospital.

S u r g ical specialit y

Surgical Skills Simulation Effect on quality and safety There is an increasing evidence emerging that simulation in surgical training is effective. However, the problem remains that if all patients had completely error-free technical aspects to their admission approximately 97% of medical errors and bad outcomes would still occur.

o give patients the best possible care, healthcare providers need to combine the three S’s. These are the best Systems, the best Science and the best Skills. The outline of this is seen in figure 1. Best Science incorporates concepts such as evidence-based care, the use of randomised control trial data, meta-analyses, cochrane collaborations, the development thereafter of guidelines, well-kept clinical data bases, protocols and, of course, textbook learning. These things are assessed usually by a form of cognitive assessment. Best Skills include technical communication, ethical and other skills and confident assessment is more difficult. These are taught in an apprenticeship model although simulation offers a great opportunity for better assessment of skills in trainees and the workforce. Finally, there are Best Systems. These include things such as physical facilities, clinical governance, appropriate culture in the workforce, human factors, good teamwork, best protocols etc. Many aspects of this domain are never assessed. The range of skills amongst practicing surgeons is quite varied and Gallagher et al., in an article in the Journal of the American College of Surgeons in 2003, demonstrated a wide range of variation in surgical skill based on the number of errors in a MIST-VR simulated environment. Outcomes for a long time have been known to indicate differences in individual surgeons practice and volume has certainly been well demonstrated as a predictor of good surgical outcomes.

The question then is, what contribution can surgical skills simulation realistically make to safety and quality? In the published Abstracts from Medicine Meets Virtual Reality the word ‘safety’ is used 61 times in 21 published Abstracts, and ‘quality’ 75 times in 39 published Abstracts. Thus, quality and safety seen to be drivers of the simulation movement in surgery as well as anaesthesia, emergency care and nursing. Unfortunately, quality and safety can be over-promoted and used out of context to justify the need for simulation. The ‘To Err is Human - Crossing the Quality Chasm’ publications by the National Institute of Medicine in the United States are two of the triggers for the quality and safety movement are frequently cited in the simulation literature as drivers for the adoption of simulation, as is the response of

Patrick Cregan Surgeon, Co-Chair, Sydney West Area Health Service Surgical Network and Chair, NSW Department of Health Surgical Services Taskforce Australia

the General Medical Council in the United Kingdom to the Bristol Inquiry. In these documents, not more than a paragraph on simulation is present. If one looks at a variety of publications on quality and safety, one can see what might be termed “failure of surgical skills” contributes a relatively small amount to poor patient outcomes. Zhan & Miller found in a major paper reviewing 20% of admissions to US hospitals that only 2.2% of patient safety-indicator events were due to “technical difficulty / problem”. This compares to approximately 20% of postoperative physiologic and metabolic derangement, 6.5% of venous thromboembolic disease and 7.2% of decubitus ulcers, amongst other patient safety indicators. The overall rate per thousand discharges at risk was in fact only 3.2%. Gawande et al. found that adverse events, in fact occurred in approximately 3% of

Image courtesy: Davide Lomanto, Director, MISC, NUH, Singapore

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Three Ss of Best Care Best Systems Protocols Team Work Human Factors Appropriate Culture Clinical Governance Physical Facilities ?Assessment?

Best Science

Best Care

Evidence Based Care Randomised Controlled Trials Meta-analyses/Cochrane Guidelines Clinical Databases Protocols Cognitive Assessment

surgical and obstetric patients but adverse events overall were no more likely in surgical than non-surgical care. If one looks at the safety literature, very little mention is made at present of simulation as a methodology to improve safety. By way of example, Leape in his evidence report # 43 2001 from the EvidenceBased Practice Centre at Stanford, (an article which has been criticised for its focus on error rather than systemic problems) identified 73 practices, 11 of which had the greatest strength of evidence. When these are reviewed, four of the seventy three may possibly have been helped by the use of simulation, and simulation itself is mentioned only once in the paper and this is in the second lowest group (“lower impact or strength of evidence”). Does simulation work? The Australian Safety and Efficacy Register for New Interventional Procedures—Surgery (ASERNIP-S) reviewed surgical simulation by way of a systemic review. This work was subsequently published in scientific format in Annals of Surgery. The conclusion of the assessment was that “while there may be compelling reasons to reduce reliance on patients, cadavers and animals for surgical training, none of the methods of simulator

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Best Skills Technical Communication Ethics ?Assessment? Simulation

training has yet been shown to be better than other forms of surgical training”. This is hardly surprising given the relative novelty of surgical simulator training and the fact that even in aviation it has been identified that at least 70% of aircraft accidents and incidents are caused not by a pilot’s technical skill but lack of human factor skills. The aviation comparison is frequently thought to be analogous to the situation in the operating room. Why simulators? Why then should we teach surgical skills on simulators? This has been addressed in particular in an article by Gallagher in which a model of attentional resources for the master versus the novice surgeon was described. This model proposes that because the novice surgeon, much like the learner driver early in his experience, devotes nearly all his attentional resource to psychomotor performance, depth and spatial perception and operation judgement and decision making. This significantly reduces their attentional resources which can otherwise be devoted to comprehending instructions and gaining knowledge. By pre-training on the simulator, the amount of psychomotor performance, depth and spatial judgement, operative judgement and decision making,

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attentional resource that is required can be reduced. This model has subsequently been explored by Fried and his colleagues at McGill University (personal communication). They have confirmed this using a laparoscopic simulator trainer and having the candidates solve mathematical problems as well as perform tasks within the trainer. Indeed, it has even been suggested within Gallagher’s model that the attentional resources of the below average surgeon may be so challenged by the laparoscopic environment as to reduce their overall effectiveness. There is increasing evidence emerging, however, that simulation in surgical training is effective. Further reviews that we have conducted with ASERNIP-S have tended to indicate that skills acquired by simulation-based training are transferable to the operative setting. This has been demonstrated in ten randomised control trials and one non-randomised study to date. Unfortunately, these studies have been of variable quality and did not use comparable simulation-based training methodologies. There is, therefore, a need for larger numbers of trainee assessments in different techniques but using equivalent methodologies. However, the problem remains that if all patients had completely error-free technical aspects to their admission, approximately 97% of medical errors and bad outcomes would still occur. Simulator training may enable us, to reduce the attentional resource needed by novice and master surgeons in any particular setting so as to improve their situational awareness, teamwork and human factors and thereby prevent these other larger (by number) causes of harm. Conclusion Technical skills contribute about 2-3% of quality & safety problems. Surgical simulation cannot be restricted to procedural simulation alone if it is to have a real impact. We in the simulation community should not make exaggerated promises (that we cannot keep). Simulation should be assessed with the same rigour as any other intervention in healthcare and we should not lose sight of the fact that outcomes are the ultimate measure of any intervention in healthcare.

S u r g ical specialit y

Surgical PACS

Design and implementation The OR and image-based interventional suites are the most cost-intensive sectors in the hospital, therefore, the optimisation of workflow processes has become of particular concern to healthcare providers. The understanding and management of workflows should become an integral part in the planning and implementation of complex digital infrastructure supporting diagnostic and interventional procedures.

Heinz U Lemke Research Professor Radiology University of Leipzig Germany

odel Guided Therapy (MGT) is a methodology complementing Image Guided Therapy (IGT) with additional vital patient-specific data. It brings patient treatment closer to achieving more precise diagnosis, more accurate assessment of prognosis, and a more individualised planning, execution and validation of a specific therapy. MGT in its simplest instantiation is an intervention with a subset, a single or a set of voxels representing locations within the patient’s body. With this view, it is an extension from Image (pixel) Guided Therapy (IGT) to Model (voxel) Guided Therapy. Examples of Model Guided Therapy are: a) interventions within a subset of a voxel, e.g. cells, organelles, molecules etc. b) interventions with a voxel, e.g. small tissue parts of an organ or lesion etc. c) interventions with a set of voxels, e.g. part of functional structures of organs, organ components, soft tissue, lesions etc. Considering the needs of therapy specifically, the workflows for diagnosis and therapy need to be linked via the Patient Specific Model (PSM). In addition to demographic data, the PSM comprises the core information data set of the electronic medial record. The building of this data set,

i.e. the PSM, commences in the diagnostic workflow, making use for example of computer aided diagnosis and associated technologies. Subsequently, it proceeds in all phases of the therapeutic workflow including after care. By default, the broader the spectrum of different types of interventional/surgical workflows which have to be considered, the more effort has to go in designing appropriate PSMs and associated services. The following list contains some examples of modelling tools and aspects, derived from different types of surgical workflows, which may have to be considered: • Geometric modelling including volume and surface representations • Properties of cells and tissue • Segmentation and reconstruction • Biomechanics and damage • Tissue growth • Tissue shift • Prosthesis modelling • Fabrication model for custom prosthesis • Properties of biomaterials • Pharmakokinetics and Pharmakodynamics of normal and pathologic tissue • Atlas-based anatomic modelling • Template modelling • FEM of medical devices and anatomic tissue • Collision response strategies for constraint deformable objects • Variety of virtual human models • Lifelike physiology and anatomy • Modelling of the biologic continuum • Animated models

• Multi-scale modelling • Fusion/integration of data/images • Coordinate systems between different models including patient, equipment and the OR • Modelling of workflows MGT is based on the gathering of all available medical information concerning a patient and, with the use of modern engineering principles and information technology, the construction of a patient-specific medical model. When implemented, a PSM is a multi-level data structure (e.g. matrices, tensors, graphs, lists, tables, fractales and other mathematical artifacts) combining n-D n-dimensional and multi resolutional data of a patient in a coherent, reproducible and adaptable manner. Based on this patient-specific medical model, diagnostic and prognostic determinations and therapeutic decisions can be made, and responses to therapeutic treatments can be monitored and recorded. MGT requires the transition from an image-centric world-view driven by imaging technology to the model-centric world-view driven by the needs of the patient and the medical profession. Therapy Imaging and Model Management System (TIMMS) Appropriate use of Information and Communication Technology (ICT) and Mechatronic (MT) systems is considered by many experts as a significant contribution to improve workflow and quality of care in the Operating Room (OR). Different imaging modalities and a wide spectrum of other

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S u r g ical specialit y

Modules of a Surgical Assist System Therapy Imaging and Model Management System (TIMMS)

Repository

Images and signals

IO Imaging and Biosensors

WF and K+D tools

Computing tools

Modelling tools

Modelling

Kernel for WF and K+D Management

Simulation

Data Exch.

Engine

Control

Devices/ Mechatr. tools

Presentation tools

Visualisation Manager

Validation tools

Intervention

Validation

Therapy Imaging and Model Management System (TIMMS) ICT infrastructure (based on DICOM-X) for data, image, model and tool communication for patient model-guided therapy

Data and information

Models (Simulated Objects)

information sources need to be digitally integrated to build a suitable patient model. This will require an IT architecture supporting Surgical Assist System (SAS) which can be adapted to specific surgical interventions and patient care situations. A proper design of a TIMMS, taking into account modern software engineering principles such as service oriented architecture, will clarify the architectural and functional features of a SAS in general and its components in particular. Such a system must provide a highly modular structure in order to be able to adapt to different clinical workflows and specific variances in their execution. Modules may be defined on different granulation levels. Adaptability is achieved through a design concept-based on cognitive/intelligent agents. The construction of the patient-specific medical model will be used as the central construct within a TIMMS, which may be described as an adaptive SAS. Ideally, the PSM engines and repositories will be integrated by a suitable TIMMS infrastructure to support the planning, execution and validation of an intervention. In the

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WF’s, EBM, “cases”, MBME

long-term, TIMMS can be expected to serve as a facilitator for a Model-based Medical Evidence (MBME) methodology providing a complement to Evidence-Based Medicine (EBM). Considering the software engineering principles such a system needs to be designed to provide a highly modular structure. Modules may be defined at different granulation levels. A first list of components (e.g. high and low level modules) comprising engines and repositories of an SAS, which should be integrated with a TIMMS, is currently being compiled in a number of R&D institutions. Figure 1 shows a concept of a logical structural model (meta architecture) of a high level generic modular architecture of an SAS. The high level modules are abstracted from many specific CAS/IGT systems which have been developed in recent years. In general, a combination of these can be found in most R&D as well as commercial SAS. A central position in figure 1 is occupied by the “Kernel for workflow and knowledge and decision management”. It provides the strategic intelligence for

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Models and intervention records Figure 1

preoperative planning and intraoperative execution. Often this module (or parts thereof) is integrated into some of the other engines, as the need may have demanded. In any case, adaption of the therapeutic workflow to an actual patient care situation will be based on the PSM and realised by the Kernel. Realisation of a TIMMS All of the engines, tools, repositories, ICT infrastructure, data sources - including the operative team - are linked through a distributed network, providing for the full functionality of TIMMS, including planning, guidance, learning and data mining and processing. The ICT infrastructure used by TIMMS includes structures, objects, processes and interfaces from well established sources, to ensure compatibility and interoperability. This includes, but is not limited to: • IHE • HIS • RIS • PACS • DICOM • HL7

S u r g ical specialit y

Interventional Cockpit/SAS modules IT Model-Centric World View Therapy Imaging and Model Management System (TIMMS)

Repository

Data Exch.

Engine

Control

Prototypical implementation Images and signals

IO Imaging and Biosensors

Computing tools

Modelling tools

Modelling

Simulation

WF and K+D tools

Kernel for WF and K+D Management

Devices/ Mechatr tools

Presentation tools

Visualisation Manager

Validation tools

Intervention

Validation

Therapy Imaging and Model Management System (TIMMS) ICT infrastructure (based on DICOM-X) for data, image, model and tool communication for patient model-guided therapy

Data and information

Models (Simulated Objects)

WF’s, EBM, “cases”, MBME

Models and intervention records Figure 2

Interfaces are provided for the input of data and information from the outside world which are then processed and utilised by the functional components of TIMMS and stored within the repositories. A possible physical realisation of interfaces required between major functional groups within and outside TIMMS is shown in Figure 2. Appropriate use of standards (for example S-DICOM) allows for the implementation of flexible pilot systems and in turn contributes to their further developments. Interfaces are also provided for the output of various models, intervention records, report data and information that have been synthesised within the TIMMS structure. Each possible realisation implies to give special attention to security, safety, systems recovery issues and the infrastructure for rapid prototyping. Only a subset of the indicated engines and repositories of TIMMS are typically implemented in a real clinical setting (see Figure 3 as an example).

Significant hardware and software infrastructure is required to support research, particularly in IGT areas, that involve medical imaging and navigation. Hardware support can include a number of different imaging systems (CT, MRI, X-ray, ultrasound, etc.) and several 3D tracking systems based on a variety of technologies (optical, electromagnetic, etc.). Software support includes standards such as DICOM, as well as open such as VTK, ITK, DCMTK, 3D Slicer, OpenTracker, and IGSTK. In contrast, there is no off-the-shelf-robot system—with an open interface—that is suitable for medical use and no mature open source packages for robot control. DICOM working group 24 “DICOM in Surgery” Standards for creating and integrating information about patients, equipment and procedures are vitally needed when planning for an efficient OR and TIMMS. The DICOM Working Group 24 (WG24) has been established to develop DICOM

objects and services related to Image Guided Surgery (IGS). To determine these standards, it is important to define day-today, step-by-step surgical workflow practices and create surgery workflow models per procedures or per variable cases. As the boundaries between radiation therapy, surgery and interventional radiology become bleak, precise patient models will become the greatest common denominator for all therapeutic disciplines. In addition to imaging, the focus of WG24 should, therefore, also be to serve the therapeutic disciplines by enabling modelling technology to be based on standards. A more detailed discussion which emphasises a model-centric world-view of therapeutic disciplines as a complement to the traditional image-centric worldview of diagnostic radiology is presented in figure 3. Following the inauguration of WG24 on June 25, 2005 during CARS 2005 in Berlin, the following roadmap has been agreed on by the members of WG24:

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S u r g ical specialit y

Therapy Imaging and Model Management System (TIMMS)

Monitors and Visualization Devices

Control and Input Devices

Enterprise-Wide Electronic Medical Record Including PACS, HIS, RIS, Data Warehouse TIMMS Medical Workstation

TIMMS Surgical Workstation Interfaces for Operative Tools

Engines and Repositories

Robotic and other Surgical Devices(S)

Server(S) Containing TIMMS Engines

Server(S) Containing TIMMS Repositories

Model Building Devices(S)

Positioning Devices(S)

Monitoring And Sensor Devices(S)

Imaging Devices(S) e.g. X-ray CT, MR, US

Navigation Devices(S)

Figure 3

1. Identify and build up a user community of IGS disciplines in WG24. Initially five surgical disciplines (Neuro, ENT, cardiac, orthopaedics, thoracoabdominal and interventional radiology) are selected. Anaesthesia is included as long as surgery is affected. 2. Encourage experts from vendor and academic institutions to join WG24. Vendors of endoscopic and microscopic devices as well as implants (templates) should be included in addition to the classic vendors of medical imaging and PACS. 3. Compile a representative set of surgical workflows (with a suitable high level of granularity and appropriate workflow modeling standards and surgical ontologies) as a work reference for the scope of WG24. Initially, 3-5 workflows, characteristic for each discipline, should be recorded with sufficient level of detail. Workflow tools can be provided by the Innovation Center Computer Assisted Surgery, Leipzig, Germany.

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4. Derive potential DICOM services from these surgical workflows. 5. Design an information/knowledge model based on Electronic Medical Record (EMR) related work and identify IOD extensions to DICOM. Because of similarities to the IHE activities, a close relationship to IHE should be established. 6. Take account of the special image communication (1D - 5D) requirements for surgery and mechatronic devices. A close cooperation with WG 2 and 17 should be established. 7. Work in close cooperation with DICOM experts from radiology, cardiology, radiotherapy and related fields which are represented in WG1 - WG23. 8. Encourage close cooperation with working groups in the International Society for Computer Aided Surgery (ISCAS), Japan Institute of CARS (JICARS), German Society for Computer- and Robot-Assisted Surgery (CURAC), European Federation for Medical Informatics (EFMI), European

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Association for Endoscopic Surgery, American College of Surgery, International Society for Surgery, etc. 9. Disseminate knowledge gained following the roadmap through workshops, conferences and special seminars. Special presentations should be planned each year for CARS, SPIE, RSNA, DICOMMeeting, and at a minimum for one surgical conference. 10. Connect to integration profiles specified for surgery by IHE activities. The first two work items WG24 is involved with are “Polygonal Segmentation” (cooperatively with Working Group 17 (3D)) and “Implants”. DICOM always combines Objects with the Services they are using in Service Object Pair Classes (SOP-Classes). WG24 is therefore working on the Services which are needed for Polygonal segmentation Storage/Retrieval and implant usage (repositories and implant planning). Both SOP-Classes are making use of a common Surface Mesh Module. They are considered as supplements for DICOM in Surgery.

D ia g nostics

Digital Radiography

Efficiency with automated system movements The introduction of a flat panel system in a filmless computerised radiology unit allows the productivity of a radiology department to be noticeably increased, while providing ergonomic comfort and ease of use. It is particularly suitable for the field of paediatric radiology.

Michel Claudon Professor and Chief Department of Radiology Children’s Hospital University of Nancy France Co-authored by Luc Guillaume, Thomas Joris, Bernd Weber, Damien Mandry and Laurent Kammacher

here are numerous factors that drive a radiology department to adopt digital imaging technology. The use of the Picture Archiving and Communications System (PACS) and hospital managements' need to optimise operating costs for higher efficiency are only two examples. With these factors and the impending obsolescence of the existing conventional radiography system in some regions, the radiology department (University Hospital of Nancy, France) decided on a fully automated digital flat detector radiography system. Reasons for this decision were the preference for a Flat Detector (FD) system that delivers a high level of automated system movements. Numerous independent studies have proved that flat detector imaging systems improve productivity and deliver significant dose-saving advantages. Comparing FD and CR systems This study was performed in a paediatric radiology department of a university hos-

pital with an annual patient throughput of 30,000 for general radiography. 40% of these imaging examinations are emergency cases with the patient throughput remaining at a stable level in recent years. There are two general radiography rooms. The digital flat detector radiography system is installed in one of them while the other room has a conventional radiography unit with a Computerised Radiography (CR) imaging system. The study focussed on the comparative evaluation of the FD system and the CR system with regard to three key indicators: patient throughput, changes of workload within the rooms and user satisfaction. The equipment that allowed the radioluminescent plate system to be tested is the Siemens (with a free-floating table and of variable height) installation (ceiling-suspended installation), connected to a PCR AC 3000 Philips RLMS system. The tested DR system is an Axiom Aristos FX Siemens installation (Erlangen – Germany) with a flat panel (Trixell, Moirans – France), large screen (43 cm x 43 cm), with a matrix of 3000 pixels x 3000 pixels. Movements of the panel and the X-ray tube are completely automatic. The computer interface is provided by means of a syngo platform running on Microsoft Windows. Methods and evaluation The first part of the study focussed on the comparative evaluation of overall patient throughput. A total of 193 patients were evaluated during the study, with 94 patients examined on the conventional/CR

system and 99 patients examined on the FD system. Of these 193 patients, five categories of examinations were evaluated; chest, abdomen, pelvis as well as upper and lower extremities. The examinations were further divided into those with a single exposure and those with two exposures (where frontal and lateral projections are standard). Throughput and average examination time of these procedures were also measured. Additionally, each examination was broken into three phases to analyse where the most benefits were experienced. The three phases were: • Positioning phase: Patient positioning and placement of detector or CR cassette for each respective system. • Execution phase: Execution of the imaging process including exposure, access to patient data, CR cassette processing and visualisation of image for FD system. • Acquisition phase: Consisting of archiving via PACS for the two radiographic systems. The comparison of the different times for each step of the execution of the action, then by anatomic area explored was done by comparison to averages, using the t test and the Mann-Whitney nonparametric test (SPSS 11.0 software). The second focus of the study assessed the workload distribution of patients to the two different radiographic rooms over the one year study period. Activity curves were created to allow a time comparison of results and an evaluation of stability over the long-term. Changes in organisation and division of duties among technicians occasionally

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involved in the installation of the DR were likewise studied. Finally, a satisfaction survey was carried out among fourteen technicians of the paediatric radiology department, for a total of 16 persons. To find out the opinion of the users regarding ease of use, speed of examination, image quality and user-friendliness of each of the two systems the following valuation system was used: • +2 for DR much better than RLMS • +1 for DR better than RLMS • 0 if the two systems are equivalent • -1 for RLMS better than DR • -2 for RLMS much better than DR Results of comparison Comparative evaluation of the complete patient treatment time found a 30% reduction from 403 seconds to 266 seconds with the FD system compared to the CR system. The patient treatment time was defined as the time when the patient arrived at the waiting room to the time the acquired image was available on the internal network. On an average, time savings between 48% and 59% were achieved for the various examinations from chest to pelvis, with the greatest time savings for pelvis examinations. It was also measured that on an average, 55% time savings could be achieved for single exposure studies and 51% for double exposure studies. While the time requirements of the installation phases were comparable, most timesavings occurred in the film execution phase and especially in the imageprocessing phase with timesavings values of 42% and 83% respectively. It should be noted that a distance of about 15 meters between the room connected to the RLMS reading system requires an average movement of the technician of about 15 seconds, with sometimes a waiting time if the other room is in use. The time of the undressing phase was measured at an average of 40 seconds, while the phase following the transfer of the image to the Intranet via the PACS took 95 seconds for both systems. Consequently, a total of 135 seconds on average were reserved for handling a paediatric patient outside of the specific execution of X-ray activity. For workload distribution, it was observed that by the end of the study, 84%

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of patients were assigned to the room with the installed flat detector radiography system. This is largely due to preference of the new technology by the users for its image quality, dose savings of up to 40%, and reduction in mAs values while achieving identical image density and contrast. Eleven of the 14 users surveyed preferred the flat detector system on all performance criteria while three users found the flat detector and CR systems to be similar for one criterion each. Discussion The values demonstrated during the time measurements are unambiguous. The flat panel system technology is significantly faster in the three examination phases. These results allowed us to quantify our technological choice of a DR system in a paediatric radiology department with much regular and emergency activity (40% of the total activity), rather than justify to the institution the benefit of the investment. During the film phase, the flat-panel system allows the image to be visualised within 6 seconds after exposure, while it takes 35 to 55 seconds for reading based on the size of the screen for the RLMS system. The presetting of the opening of the diaphragms as well as automatic marking considerably reduce the time of the image handling phase. This leaves the installation part, which, due to its automation, allows a considerable savings of time with regard to the placement of the material. The “all in one” system which offers the flat panel system allows a large savings of time in personnel movement, as opposed to the RLMS system which requires technicians to move back and forth between the radiodiagnostics room and the plate reader. The speed of visualising a quality image and the system’s ergonomic design make it a pleasure to use. The paediatric radiology staff is making the utmost attempt to have the patients, parents and staff from clinical departments accompanying the child benefit from this technology, which allows waiting time to be reduced. The productivity increase of the system frees up technician time and requires a different way of thinking about patient care. This has enabled the staff to devote more time to the quality of patient

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reception, hygiene regulations and tracking images for archiving and distribution to clinicians. On the other hand, this requires a minimum of two, even three, technicians to ensure continuous use of the installation when there is an overflow of patients. However, the flat panel system, in its current configuration, may not always be able to completely handle the activity of two radiology installations. The dimensions of the panel do not allow for use in patient beds or on a stretcher. As with any motorised system, manual movement of the suspended system supporting the X-ray tube proved to be difficult and required significant physical effort of the staff. Placement of the bed in the radiology room, moreover, is not easy, taking into account the installed examination table. These drawbacks cause a significant decrease in patient care, which exceed the time needed with a conventional system and cancels out timesavings. Areas of exploration greater than 43 cm (legs and femurs of adolescent patients, teleradiography of the spine and lower extremities) will soon be examinable by means of multiple exposures and image-fusing software. However, performing teleradiography of the spine or lower extremities will still remain impossible for patients with multiple handicaps requiring time for short exposure, thus the use of a single exposure. In addition, parallel to this study, dosimetric studies confirmed that it was possible to decrease the number of necessary mAs by 40%, while still maintaining identical density and contrast, which proved satisfactory to radiologists and clinicians. This lowering of the applied dose is a major advantage for paediatric X-ray departments where radioprotection is a constant concern. Conclusion The flat panel system is a new technology, which allows for a considerable savings of time in standard examinations. The future availability of software for performing teleradiography could further expand the uses of the system. It has been demonstrated to be particularly effective for the management of a high number of patients in a paediatric department, including an important ratio of emergency cases.

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Advances in Breast Imaging Impact in Asia Pacific

While the technology is relatively new, digital mammography and CAD have already entered. A large part of this growth has come from the rising level of awareness and education on the importance of breast screening. The continuous efforts in organising breast cancer awareness programmes as well as promoting breast health screening, where patients enjoy subsidies in mammogram screening, has created a demand for better and faster mammogram services.

Frost & Sullivan Singapore

cost of investment is up to 4 times higher than the film version, digital mammography offers several advantages such as; Higher accuracy for certain patients

reast cancer is ranked the number one cancer among women, worldwide, and is the fifth most common cause of cancer deaths. It is known to occur as a result of either inherited or spontaneous gene mutations. According to the WHO, more than 1.2 million people will be diagnosed with breast cancer each year, worldwide; the good news is that if detected early, breast cancer is highly curable. Detection is facilitated by mammography an imaging technique that uses low-dose x-rays to examine the breast for cancerous tissue. While this process may cause some discomfort, it is considered vital to undergo this screening regularly, for women aged 40 and above, as mammography is currently the only diagnostic procedure that has been proven to reduce mortality from breast cancer. Digital Mammography - New technology in the market Mammography is one of the last modalities to enter the digital arena, where most diagnostic imaging procedures that include standard radiographs, MRI, CT, ultrasound, are already being performed using digital means. With digital mammography, the image of the breast is acquired electronically and stored directly in a computer. While the

Digital mammography offers significantly better results in early detection of breast cancer than film mammography in screening women who are pre-menopausal, or who have dense breasts. This includes younger women (under age of 50) who tend to have dense breasts, which have a lot of gland tissue compared to fat. Digital mammography may detect 15 to 28 percent more cancers in women possessing any of the above characteristics. Better image clarity

A major advantage that digital mammography offers is the clarity of the image, which shows higher resolution and clearer contrasts. This is particularly important, as tumors in dense breasts do not show up as well on the film as they do on the digital mammograms.

Digital advantages

Since the images can be stored and sent electronically, the immediate benefits that one enjoys include: • Ease in access, transmission, retrieval, and storage of images • The image is immediately available for diagnosis • Digital mammograms are likely never to be lost The digital diagnostic tools that are available can significantly increase the productivity of the reporting radiologist, due to: • The ability to “zoom in” on to suspicious areas for clearer diagnosis • Manipulating an “underexposed” film to adjust the contrast and signal-to-noise ratios, thereby, helping reporting radiologist ‘see’ certain breast tumours that are currently difficult to visualise on film. This improves the workflow of the entire diagnostic process, with fewer women

Typical Workflow of Digital Mammography Patient Registration

Reading and Reporting

Source: Frost & Sullivan

Storage Management

Image Processing and Quality Check

Image Acquisition

Figure 1

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needing to return for extra views, as digital images are available almost instantly upon being acquired. In addition to allowing better cancer detection, digital mammography examination requires less compression of the breasts, hence is less painful than film mammography. Most importantly, digital mammography uses less radiation than film mammography, with no compromise in diagnostic accuracy. Spell Checker for digital mammograms

Another development in the field of breast imaging is Computer Aided Detection or CAD. CAD acts as â&#x20AC;&#x2DC;a second pair of eyesâ&#x20AC;&#x2122; in reviewing digital mammograms by using sophisticated pattern recognition to search for abnormalities that may indicate the possibility of cancer. These findings are then highlighted to the reporting radiologist for further examination / interpretation.

Rising adoption in Asia Pacific While the technology is relatively new,

OchreDesignLab

Tele-Mammography With digital mammography, one can have a mammogram performed at a

rural area and have the images transmitted and interpreted at a remote medical center, which allows quicker access to expert advice and second opinions as opposed to getting the same through mail, courier and related delivery services. While the file size of digital mammograms is relatively large, transmission of these images over long distances is still possible over broadband Internet or through wireless networks (such as through satellites). A study conducted by Dr. Alan R Melton of the New York Presbyterian Hospital, Columbia University Medical Center, demonstrated the transmission of digital mammogram through Internet (in a secure environment) to an interpreting workstation 110 miles away, with each image transmitted in less than 45 seconds.

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digital mammography and CAD have already entered the region, with installation sites in Singapore, Malaysia, Australia, Japan, South Korea and Thailand. A large part of this growth has come from the rising level of awareness and education on the importance of breast screening by various government agencies and NGOs. The continuous efforts in organising breast cancer awareness programmes as well as promoting breast health screening, where patients enjoy subsidies in mammogram screening, has created a demand for better and faster mammogram services. Boost of medical tourism in the region, due to the hospitals intending to draw foreign patients is also boosting the adoption of digital mammography. With increasing activities and programmes promoting breast health awareness in the region, the market for digital mammography technology is only likely to grow.

T E C H N O L O GY , E Q U I P M E N T & D E V I C E S

Small is Beautiful Nanotechnology for medical devices

Medical devices and their components are currently being scaled down to molecular levels and successfully applied in diagnostics and clinical therapies.

any of us might know Isaac Asimov´s science fiction novel “Fantastic voyage” from 1965. Here, a submarine has been scaled down to the size of a microbe and including a miniaturised crew, has been injected into the blood stream of a scientist. These scientists were able to successfully remove a blood clot in the brain of a famous physicist, and by this, guarantee his survival. During the days when Asimov wrote his novel, Richard Feynman, the famous physicist and Nobel laureate further stated: “There is plenty of room at the bottom!” Feynman believed that new and yet unpredictable material properties on the level of atoms and molecules should be explored

Jörg Vienken Professor BioSciences Fresenius Medical Care Germany

and exploited for research and device application. In the 60s of the last century, both, the novelist and the physicist, would have never dreamt that part of their fantasy and expectations would have partially come true. Medical devices and their components are currently being scaled down to molecular levels and successfully applied in diagnostics and clinical therapies. Atoms and molecules

are typically measured in nanometers, i.e. in a scale of 10-9 meters. Nanoobjects as compared to other objects of the living world are shown in figure 1. Nanoscale indeed refers to biological dimensions and should, thus, be ideal for application to medical devices. Following developments of the electronics industry in miniaturising devices such as electric circuits etc., it is not a surprise that other areas of technology would follow. The number of scientific publications on nanotechnology and its applications in life sciences is rising exponentially. Consequently, governmental institutions and private equity companies are investing in research and development of nanoproducts for application in construction, biotechnology and medical devices. Expectations for a turnover in nanotechnology in the year 2015 count on US$ 15 billion worldwide. Is this hype justified and where are the most active groups working on nanotechnology? Figures on the number of patents applied may provide the first answer to this question: Following an analysis of Ernst & Young from 2007, about 5,340 patents have been granted till 2004 in the USA, 2,559 in Europe and 1,220 in Asia. Countries leading in nanotechnology in Asia are Korea and Japan. We can assume that the number of granted patents in nanotechnology will further increase and more and more areas, such as construction, biotechnology and life sciences will profit from developments in this field. Further, most of the innovative companies dealing with R&D in nanotechnology are small and middle-sized enterprises with less than 30 employees. This implies a permanent need for financial support, investments and continuous patenting. “NanoScience is the study of phenomena and manipulation of materials at atomic, molecular and macromolecular scale, where properties differ significantly from those of larger scales.” …and… “Nanotechnology is the design, characterisation and application of structures, devices and systems by controlling shape and size at the nanometer scale!” defines the Royal Academy of Engineering in London in 2004. Applications in drug delivery (>50%), in vitro and in vivo diagnostics (>25%) and implant technology (>20%) are currently the preferred and successful realms of nanotechnology application. What are the tools and structures used in

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nanotechnology for the application in life sciences or in medical device technology? Regularly shaped cages, which are made up of a network of hexagonally and pentagonally arranged carbon atoms may serve as tiny reservoirs for drugs. They are named after its discoverer Richard Fuller as Fulleren Cages. Liposomes or other polymeric micelles are used as drug transporters once they have been modified with specific ligands. Conjugated ligands modify the surface of such nanocarriers in such a way that they are able to pass the blood-brain barrier and thus, deliver drugs to the tumour targets hidden behind this barrier. Oligonucleotide modified gold nanoparticles can be used for intracellular gene regulation. These particles are less susceptible to degradation by cellular enzymes and exhibit greater than 99% cellular uptake and were, at least under the conditions studied, non-toxic to the cells. Further application stems from nanofibres obtained through electrospinning. These fibres may serve as stable or biodegradable scaffolds in bioreactors, as reinforcing structures for blood vessels, biodegradable compounds for wound healing or as a coverage for otherwise bioincompatible materials such as stainless steel for drug-eluting stents. Nanotechnology also offers promising tools for surface modification of biomaterials through coating with nanoparticles and thus achieving an optimal blood and cell-compatibility. Such biomaterials are currently used in procedures, such as hip implants or bioartificial blood vessels. Extracorporeally applied medical devices, such as membranes for hemodialysis or tubing systems for drug delivery, also profit from this kind of surface

modification. A controlled attachment of nanoparticles with defined chemical properties may be used for the analysis of optimal structures to either repel bacterial cells or promote protein absorption and thus help the bioengineer to identify the most promising biomaterials. Quantum dots are a novel class of inorganic fluorophores which are gaining widespread recognition because of their exceptional photophysical properties. They are nanometer-scale semiconductor crystals which are engineered to emit light at a variety of precise wavelenghts from ultraviolet to infrared. The narrow emission and broad adsorption spectra of these dots makes them well suited to multiplexed imaging, in which multiple colours and intensities are combined to encode genes, proteins and small-molecule libraries. They are ideal tools for future tumour diagnostics, drug delivery systems or body-imaging processes. Figure 2 provides an overview of possible applications of nanotechnology in life sciences. The interested reader is already convinced about the advantages of nantechnology application in medical device technology outlined here by only a few examples. However, questions may still arise regarding the possible pitfalls of these highly promising applications? Nanosized particles may give rise to cellular uptake or at least interaction with cellular structures in the body. They may act as catalysts or nuclei for the induction of protein fibrillation and thus increase the risk for toxic clusters, e.g. in amyloid formation. Nanoscale surfaces can act as platforms for protein association, but depending on its chemical composition, may also prevent fibrillation of proteins. Uptake of nanoparticles by biological cells

Nanotechnology and Structures:

The Nanoscale - A Biological Scale

-Potential medical applications-

Figure 1

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may also stimulate pathways of oxidative stress and thus lead to inflammatory reactions at low levels. Clusters of nanoparticles may also prevent the correct association of nerve cells in vitro. As a consequence, a case-by-case approach is needed in order to predict reactions caused by nanostructures, which renders the establishment of safety regulations for nanoparticles difficult. A further pitfall is the still lacking and worldwide accepted regulatory rules for approval of nanodevices. Prerequisites for approval procedures are widely accepted terminologies for medical, health and personal care applications of nanotechnology. As long as no clear rules for approval are available, companies hesitate to further invest in the development of nanodevices. Fortunately, efforts are currently made all around the world to solve this problem and therefore, nanotechnology remains one of the most promising innovations in life sciences today. Hans Christian Anderson, the famous Danish author of short stories published the “The emperors’ new clothes” in 1837. Here, two scoundrels, who had heard of an emperor’s vanity, pretended to be extraordinary tailors and offered him a cloth so light and fine that it looks invisible. As a matter of fact it was invisible to anyone, who is too stupid and incompetent to appreciate its quality. The emperor took it for granted and presented himself virtually without clothes. A child finally unmasked the situation by stating: “…look, he is naked!” Nanofibres applied today, however, are indeed invisible to the naked eye. The old story of Anderson might have finally come true.

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Figure 2

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Healthcare Design The need for consumer-driven research Nicholas J Watkins, Director, Research, Cannon Design, USA

The pivotal role of healthcare design in the improvement of healthcare delivery has become widely accepted under the rubric of evidencebased design. However, there is a need for consumer-driven, comprehensive programming methodology applicable to healthcare design projects in Asia and the United States.

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he sheer number and magnitude of healthcare challenges in Asia offer a compelling argument for conducting research with findings applicable to the structure and design of healthcare organisations. China’s gross domestic product has grown at 8% the last 25 years, but this has not translated into improved healthcare for the 900 million Chinese living in rural areas and who largely go uninsured (Blumenthal & Hsiao, 2005). Overall, there are not enough healthcare facilities located in the right places. Other countries in Asia fair as well. India supports privatised healthcare with 82% of all healthcare expenditure being private (Arellano, 2007). Though profitable, investing in high-tech medical equipment and cutting-edge drugs caters to Indian expatriates and foreigners who contribute to the projected US$ 1 billion “medical tourism” industry. Also, a recent study of 12 Intensive Care Units (ICUs) in India found that device-associated infections accounted for 22.5 infections per 1000 ICU days (Mehta et al., 2007). Many Asian countries eagerly adopt precedents from the United States to resolve their healthcare challenges. Is the United States a good role model? It ranks 37th in overall health performance when compared with 191 other countries, yet its healthcare spending is 15% of gross domestic product (World Health Organization, 2006). The United States is the primary example of how high-tech medical services have contributed to the overuse of and exorbitant cost of healthcare (Blumenthal & Hsiao, 2005). Finally, in the United States, medical errors account for 44,000 to 98,000 deaths a year (Kohn, Corrigan, & Edelson, 1999). Evidence-based design research offers solutions Healthcare organisations in the United States have taken strides toward improving all aspects of healthcare. The pivotal role of healthcare design in the improvement of healthcare delivery has become widely accepted under the rubric of Evidence-Based Design (EBD). Evidence-based healthcare designs, “...are used to create environments that are therapeutic, supportive of family involvement, efficient staff performance and restorative for workers under stress” (Hamilton, 2003).

It has been argued that healthcare organisations have seen a decrease in nosocomial infection rates, medical errors, length of stay and nurse turnover by adopting basic EBD principles like private patient rooms, family zones and nurse respite areas. EBD permeates organisational structure and operations since it encourages design principles that foster a patient-centered culture. For instance, it is believed that EBD features like sub-nursing stations improve staff and patient relationships and the efficiency of healthcare delivery. EBD’s popularity continues to rise among healthcare organisations in the United States. The American Institute of Architect’s Guidelines for Design and Construction of Health Care Facilities, 2006, stipulates the use of private rooms for med / surge and post-partum beds. Attendance at the Healthcare Design ‘06 in Chicago exceeded 2,400 healthcare executives, design professionals, product manufacturers, educators, students, and others (Center for Health Design). Yet, EBD has not taken off at a faster rate. Why? One of the first studies credited as EBD research is Ulrich’s study of the positive impact of window views of nature on gall bladder surgery patients’ recovery time (1984). However, the study’s findings were published more than 20 years ago. Obstacles to evidence-based design The below table summarises some of the challenges to EBD and EBD research in the United States. These challenges follow from a lack of goals and processes for EBD research shared by designers and EBD researchers. I will briefly explain the obstacles listed in the Table 1. EBD research is “lost in translation” between research findings and their application to building projects. The “lost in translation” obstacle could be for a variety of reasons including little consensus over the definition of EBD, the lack of EBD research findings, and a history of EBD research that does not use proven research methodologies (Watkins & Keller, 2007). Second, despite the growing interest in EBD research, most building projects involve a separation among researchers, designers, clients and end consumers like patients and healthcare staff

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Figure 1

(McCormack & Shepley, 2003). As a result, end consumers have minimal or no say in design decisions. These obstacles reflect a conflict over EBD research’s role in the United States healthcare design market and one that is evident with medical tourism in Asia. Simply put, should healthcare design be market-driven or research-driven? (Watkins & Keller, 2007) For an example of how research can influence the market, design practitioners cite studies of window views and healing gardens when promoting EBD to clients. However, these studies and their findings might be too broad for designers who need to know whether an enclosed or exterior healing garden is better for a specific facility. Research that is entirely market-driven can forego rigour for quick and dirty research findings that might not hold water, but capture interest (Rostenberg, 2007). For example, currently there are no peer-reviewed, published findings of same-handed patient rooms. Yet, it is easy to find sources that make strong arguments for or against

their use (Kong, 2007). Also, results from conjoint analyses are appealing to clients and marketers, but do not measure the impact of design since the research relies on consumer preference and is performed outside of healthcare settings. Theoretical differences between designers and researchers pose an obstacle to the growth of EBD. Traditionally, researchers are taught positive theory. According to positive theory, there is an objective reality that can be tested, explained and predicted by revealing causal links (Groat & Wang, 2002). On the other hand, designers are trained with normative theory. As such, designers use facts based on intuition, convention and experience. Positive and normative theories foster two different mindsets. Researchers want to contribute to existing knowledge, advance existing knowledge and reveal new findings. Findings should be publicly accessible for the greater good of society (Fisher, 2004; Kuo, 2002). On the other hand, designers want to make a profit from novel ideas. Designers might prefer research methods and findings kept inhouse and copyrighted Challenges to Goals and Processes Shared By Design and as intellectual property. Research in the United States of America Academia-industry Definitions of Terms for Evidence-Based Design partnerships could imGap among Consumers of Healthcare Design prove the relationship Market-Driven Research versus a Research-Driven Market between design and Positive versus Normative Theory research. For instance, Proprietary versus Shared Information the author’s healthcare design firm continues Academic-Industry Partnerships to support an annual Value-Based Research healthcare design stuResearch versus Design Standards (Including) dio at the University of “Good” or “Bad” Judgment of Results versus Limitations of Method Illinois, Urbana-ChamPurpose of Research and Methodology paign. Also, the firm’s Generalisable versus Project Specific Research Findings staff includes a master’s level architecture stuImmediate versus Long-Term Results dent who assists the Table 1

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Director of Research with literature searches and data collection. Such partnerships assure future designers become sympathetic to research and know how to apply it. Research could have a greater impact by including characteristics that interest designers and administrators (Kuo, 2002). For greater impact, EBD research should: • Clearly define its audience. The audience can include hospital administrators, nurses, staff and others • Be shared in a trusted and persuasive format such as a newsletter, at a conference, part of an exhibit or part of an instructional video • Identify design interventions that affect the audience’s practices. These can include nursing unit configurations, nursing station types, sustainable systems, and electronic medical records (EMR) • Prioritise design interventions. For instance, statistics might demonstrate the client would be wiser to invest in sustainable design before sub-nursing stations Overall, research should be value-based where value is defined as the ratio of quality to cost (Evans, 2006; Porter & Teisberg, 2004). For example, staff retention can stand for quality. The expense to promote and maintain patient safety through design can stand for cost. Thus, value can be a useful and objective measurement of performance. Designers and EBD researchers have different standards for successful research. Designers judge research as either “good” or “bad” depending on its applicability to a project and whether it wins commissions. Researchers often judge research based on the limitations of its methods. For example, a study with a thorough literature review, large sample size, patients randomly assigned to control and experimental groups, and with a pre and post-occupancy format would get a lot of attention from EBD researchers. Overcoming obstacles EBD research should be integral to design process so that research findings translate into superior building projects. Under this premise, a building project becomes a valuebased entity with which design practitioners maximise the client's return on investment. With this aim, EBD research should advance towards a methodology that resolves the obstacles listed in table 1 and assists

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• Research and researchers assume a mediary role among designers, clients, staff and patients throughout programming. • Theoretical differences between design practitioners and researchers are resolved • Inferential statistics help establish causal relationships among several design features and outcomes (e.g., medical errors) • Pre-occupancy measurements can establish a solid baseline with which to compare post-occupancy measurements • Mixed methods using quantitative (e.g., questionnaires) and qualitative (e.g., focus groups) tactics support one another • Research findings inform immediate and long-term solutions Based on prior comprehensive programming efforts, the author’s healthcare design firm devised project-specific design solutions. These solutions considered nursing units as consolidations of several interacting design features. See Figures 2 and 3 for examples. Currently, the author’s healthcare design firm uses aspects of comprehensive programming to evaluate infusion area designs, translational research facility designs and human interactions with sustainable systems.

Centralized

Clustered 1:6 or 1:8 Decentralized 1:1 or 1:2 Figure 2

with functional programming. By addressing all these obstacles, the programming methodology can be designated as comprehensive programming. Comprehensive programming should be market-driven to reflect the healthcare organisation’s interest in attracting market share. Also, research should impact the mar-

ket by advocating the needs of users (e.g., patients, staff, etc). To strike a balance, EBD research should investigate users as consumers of healthcare. Consumers make decisions on healthcare and are impacted by experiences during a hospital visit. The emphasis on consumer driven, comprehensive programming offers several advantages:

Figure 3

Evidence-based design research in Asia EBD-related research findings have already made an impact on healthcare design in Asia. The Alexandra Hospital in Singapore will be able to respond effectively to epidemics and disasters with thermal scans at the entry to its emergency department. Also, the hospital will dedicate two below grade floors to an autonomous treatment facility with its own mechanical and electrical system (Gifford, Green, & McCarter, 2006). Ongoing research in Taiwan of malllike healthcare complexes demonstrates that “normalising” entire healthcare facilities attracts market share by appealing to patient’s wants without sacrificing patients’ needs (Kuo & Wang, 2007). These and other research efforts demonstrate that Asian countries have every opportunity to achieve design solutions by performing rigorous EBD research. With the continued development of methodologies like comprehensive programming, Asian healthcare organisations can develop novel solutions tailored to healthcare market needs and the standards of research.

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Desperately Seeking Safety Principal and Director Research Anshen+Allen Architects USA

Creating integrated surgical/imaging environments that do less harm

Paul Barach Visiting Professor Anesthesia & Emergency Medicine Center for Patient Safety Utrecht University Medical Center The Netherlands

The need for healthcare facilities designed for safety and the convergence of surgery and imaging are resulting in new types of space where medical technology is complex and where safe environments are essential.

Bill Rostenberg

ealth care is plagued by an insurmountable abundance of medical errors. It is estimated that over 100,000 preventable deaths occur each year in the US hospitals alone. This is equal in magnitude to a 747 jumbo jet liner crashing every three days with no survivors aboard. While there are only limited data identifying the role that the built environment contributes to medical errors, this knowledge is on the increase as part of a growing area of interest known as evidence-based design (EBD). It is clear that facility design has an impact on safetyÂâ&#x20AC;&#x201D; either beneficial or detrimentalâ&#x20AC;&#x201D;depending on how each particular facility is designed. At the same time the world is in the midst of the largest hospital construction boom in half a century. There remains a

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large disconnect between designers and facility users with the result that little formal knowledge is implemented in preventing patient harm by better building design. This disconnect is particularly apparent in designing peri-operative settings (i.e., preop, surgical operating room, interventional procedure suite, recovery room). Additionally, medical advances are causing some traditional departmental boundaries to disappear, yielding new types of procedural spaces in which modern medicine is practiced. This in turn is changing medical culture as specialists collaborate in ways that differ from past tradition. Nowhere is this change more apparent than in the convergence of surgery and interventional radiology. The epidemic of preventable medical errors, the growing need for healthcare

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facilities designed for safety, and the convergence of surgery and imaging are resulting in new types of space where medical technology is complex and where safe environments are essential. Errors and accidents common in surgical and imaging environments Researchers have found that approximately 10.5% of all adverse medical events and 19.7% of all serious adverse medical events may be related to surgery while many others are related to medical imaging. Categories of medical errors and safety include wrong site surgery, wrong person surgery, radiation exposure, magnetic resonance imaging accidents and hospital-acquired infections. While the majority of these errors may not be directly related to facility design,

F acilities & operations mana g ement

knowledge of how the built environment affects safety and medical outcomes is essential in designing healthcare facilities that do not further contribute to unnecessary iatrogenic outcomes (a condition that has resulted from treatment, as either an unforeseen or inevitable side effect).

Some surgical suites are being outfitted with control rooms (similar to those found in diagnostic imaging departments) adjacent to the operating room anticipating the increased frequency and complexity of radiation emitting devices being used within the operating room.

Handed or universal rooms One theory among practitioners of evidence-based design is that if all operating rooms and other procedure rooms are configured identically (sometimes referred to as handed or universal rooms) the rooms would be safer because during an emergency staff would intuitively know where to look for supplies and instruments because they would all be in the same place regardless of which room they were in. While this hypothesis seems logical there’s no quantifiable evidence supporting this conclusion. Furthermore, if all rooms look alike, they might actually contribute to an increase of wrong person surgery due to the lack of visual cues, such as distinctive landmarks in the room providing guidance to which room, and thus which patient, the staff is attending to. Therefore, if operating rooms are “handed” some form of distinguishing accent or landmark should be provided.

Magnetic resonance imaging safety Accidents related to ferrous objects inappropriately brought into an MRI suite are one of the top ten safety concerns of healthcare executives. While very few deaths caused by ferrous objects pulled into a magnet have been documented, accidents of this nature are known to occur frequently. As a result of one fatality in 2001 the American College of Radiology (ACR) developed a white paper with guidelines for designing safe MRI suites. While these guidelines are relatively easy to apply to MRI suites used for diagnostic imaging it is challenging to incorporate them into the design of intra-operative MRI (I-MRI) suites. This is because intraoperative MRI procedures often require surgical instruments that are attracted by magnetic field to be used in close proximity to the magnet itself. Therefore, the design of intra-operative MRI suites requires particular attention be placed on safeguards such as metal detectors, that alert staff when metal objects are brought into the general vicinity of the magnet.

Radiation protection Radiation emitting devices continue to become safer. However, permissible accumulated levels of radiation exposure are rapidly becoming more conservative. As a result, radiation shielding requirements continue to become more stringent, even as most radiology equipment is becoming more reliable. In addition, there is growing interest in associating the long-term effects of radiation exposure with an increased incidence of survivor cancer. While most imaging facilities are designed to ensure adequate radiation protection, surgical facilities are not always designed with this in mind. As surgery becomes increasingly dependent on image guidance, adequate radiation protection becomes more critical. For example, many operating rooms where x-ray technology is used typically rely on small ceiling-mounted lead shields and surgical staff wearing personal radiation protection. However, dedicated space is rarely provided for technologies that control the imaging equipment to work within a radiation controlled zone.

Lighting and tripping hazards Minimally invasive surgery (MIS) is typically performed in operating rooms with very low levels of illumination, in order to better visualise anatomical information. Because as the name suggests minimally invasive surgery is not an “open” surgical procedure. The flat panel monitors are the essential “eyes” of the surgical team and provide a multitude of indispensable data to guide the procedure. Performing complicated procedures in a dark room in and of itself is dangerous leading to staff tripping accidents, miscommunication and degradation in performance. Cables, tubes and wires connecting various medical and information management systems create additional tripping hazards. Therefore, it is advisable to mount devices on walls and ceilings wherever practical when this can eliminate cables

that cross paths of traffic. Wireless devices may also reduce the need for cables and wires. In addition, there is growing interest in illuminating operating rooms with green colored lights, as research by the US Navy has demonstrated improved visualisation of data on flat panel monitors while still maintaining a relatively high illumination level throughout the room. Green surgical lights are another seemingly good idea, with insufficient data, to prove or disprove its efficacy. Conclusions Surgical suites and imaging suites are both areas where medical errors can occur commonly and where the built environment has a profound impact on injuries to patients and staff, medical outcomes and overall safety and well-being. When the practices of surgery and imaging are integrated into one comprehensive area as is becoming increasingly more common designing these spaces for safety and improved medical outcomes becomes increasingly more complex and costly. Design is more complicated because each medical specialty has different traditions of work flow, different regulatory guidelines that govern how they perform medical procedures and they often use different instruments and supplies (i.e., disposable versus reprocessed instruments). Therefore, designers of integrated surgical and imaging facilities need to prioritise the importance of safety as an essential concern in their designs. Understanding the impact that designs have on patient well-being is essential. Key safety issues to consider include reducing nosocomial infection rates, helping prevent wrong site and wrong person procedures, protecting people from unnecessary radiation exposure and helping prevent MRI accidents. Several organisations provide information about reducing medical errors, improving healthcare safety and learning more about evidence based design. These include: the Institute for Healthcare Improvement (IHI) www.ihi.org, The American College of Radiology (ACR) www.acr.org, The American College of Surgeons (ACS) www.facs.org, The American Society of Anesthesiologists (ASA) www. asahq.org. and The Center for Health Design www.healthdesign.org.

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RFID in Healthcare

Enabling patient safety With the size and costs of RFID tags decreasing, their incorporation in surgical sponges, endoscopic capsules and endotracheal tubes is creating potential benefits in patient safety and diagnostics.

Remko van der Togt Consultant Geodan Mobile Solutions The Netherlands

n 2005, the Dutch Ministry of Health, Welfare and Sport initiated a project with RFID in healthcare. Capgemini, Geodan, Intel and Oracle implemented three applications at the Academic Medical Center (AMC) in Amsterdam. The applications were based on the use of active and passive RFID tags. The Geodan Movida platform managed all identification, location and other attribute information. Next to these applications the project created an overview of best practices and standardisation issues of RFID inside and outside Europe. Applications that facilitate logistics and inventory management of expensive medical equipment appear particularly promising in the healthcare industry. And because the size and costs of RFID tags are decreasing; their small size permits incorporation in surgical sponges, endoscopic capsules and endotracheal tubes with potential benefits in patient safety and diagnostics. Essentially, Radio Frequency Identification (RFID) systems collect information about physical objects automatically. Because information about tagged objects can be transmitted for multiple objects

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simultaneously through physical barriers and from a distance, RFID has an advantage compared to reading barcodes that require ‘line-of-sight’ and active user interaction to access the enclosed information. RFID systems exist of three main parts: (1) the tag, which is the identification device attached to the object being tracked, (2) the reader that recognises the presence of a tag and reads and processes the information which is stored on the tag and (3) the antenna, which is part of the communication between tag and reader. Tags are also called transponders and basically exist of three types. First, passive tags do not have a battery and derive their power from the radio frequency signal broadcasted by the reader in order to be able to transmit their data. Second, active tags have a battery and a transmitter, and do not rely on the power derived from the reader to operate. Third, semi-active (or semi-passive) tags have a battery and use the radio frequency signal broadcasted by the antenna to be activated in order to communicate. Semi-active tags can also contain sensors (i.e. temperature or humidity) that can be used as data-loggers. The tag ‘wakes up’ at pre-defined times to update the data collected by the sensor. Activation by an antenna is not required. RFID systems operate at frequencies ranging from low frequency (LF) at 125 kHz to microwave at 2.45 GHz. The latest one is also known as the technology used for Wireless Local Area Networks (WLAN). Lower frequencies are able to penetrate

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through materials, while better and higher frequencies can process more data. Based on these and other characteristics like the risk of electromagnetic interference or the object of interest, the most suitable RFID system can be applied. In order to track patients or medical equipment through your facility, an active or semi-active RFID system could be appropriate. For inventory control or blood product patient matching at the Operating Room (OR) a passive RFID system might be sufficient. In the pilot, a semi-active RFID tag with a temperature sensor was used for tracking blood products. RFID at the AMC The application of RFID at the AMC in Amsterdam were conducted in a largescale pilot that was carried out at the Operating Rooms, the Intensive Care Units (ICU) and Blood transfusion laboratory. The purpose of the pilots was to show the added value of RFID in Healthcare, with a special focus on patient logistics, patient safety and disposables efficiency. The goals of the first pilot were (1) to acquire insight into the patient’s journey through the OR-complex and (2) to understand movement in and out of the operating room. The second pilot addressed the issue of location and temperature monitoring of blood during the entire transportation and storage process. The third pilot focussed on the accurate measurement of the use of expensive disposables. The central software system Geodan Movida, collected and processed data of the ID and location of patients, blood products and disposables. It also provides alerting capabilities, to prevent, for instance, the administration of the wrong blood product

I N F O R M A T I O N T E C H N O L O GY

Resource management in a hospital environment based on indoor location services. The picture shows four pieces of equipment in the emergency floor of a medium size hospital.

Source: Macchi Hospital in Varese (Italy).

to patients. The system presents real-time insights in patient flows, blood products and equipment use. The data stored and collected during the pilots were the basis for deriving information on the usefulness of RFID and the assessment of the accuracy and completeness of the collected data. Besides the functionality that was used in the pilot at the Academic Medical Center, Geodan Movida offers a portfolio of location, identification and RFID services for healthcare, such as: • Expensive equipment tracking and maintenance: ‘Where is the EKG?’ (Figure 1) • Patient safety: ‘Does this blood product match with this specific patient?’ • Patient flows: ‘When did patient Brown leave the department?’ • Medical staff safety: ‘Nurse Jensing requests urgent assistance in Room 3A45.’ • Patient logistics: ‘Did Mr Jones already arrive?’ • Material use: ‘How many pieces of product X have we used today in the surgery theater?’ • Equipment availability: ‘There is an insufficient number of wheelchairs in the ER department!’

Figure 1

• Blood quality: ‘Where is the blood for this patient? And what is the temperature profile in the last 10 hours?’ By combining the processed ID and location data of patients, blood products and disposables, patient safety and the efficiency of these processes can be improved. For instance, personnel at the operating room are warned when a blood product might be administered to the wrong patient. Second, hospitals can register the use of disposable material and equipment per patient automatically and more accurately. This also induces a variety of new possibilities on the level of the individual patient. Within the pilot, special care was taken of electromagnetic interference of RFID equipment on medical equipment. Strict tuning and organisational measures are needed to establish an infrastructure that does not cause interference but at the same time provides complete and accurate RFID data processing. First, all medical equipment that could be influenced by the electromagnetic fields broadcasted by RFID was tested for electromagnetic interference by RFID. Second, the adjustment of the radio fields of,

especially the active RFID infrastructure is important. When readers or antennas are too close to each other tags can be picked up by several readers simultaneously and might produce wrong information, like the wrong location or otherwise. Besides these technical challenges other points of interest are education of users, a clear insight of the processes that will be supported by RFID and privacy issues. Conclusion RFID can provide tangible benefits in the healthcare industry especially when it comes to: • Establishing safe working environments for patients and physicians • Improving workflow and logistic processes by tracking and tracing of patients, physicians, blood products, equipment and so on • Providing patients and their relatives with better services In order to support this, innovative applications of mature technologies, based on platforms of proven quality and reliability are already realised.

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EMR in a Large Healthcare Organisation

Development and implementation The YUHS planned a new EMR system that integrated pre-existing systems within the new system. The philosophical objective was to achieve first class medical services with safety, reliability and convenience through IT.

Yong Oock Kim Professor Department of Plastic & Reconstructive Surgery and Director EMR committee Yonsei University Healthcare System Korea

very healthcare organisation always tries to deliver better services for its customers. Information Technology (IT) can be a representative tool for enhancement of healthcare services. The scope of IT can be a simple one to more complex one. However, in case of medical healthcare system any application of IT has to have the fundamental philosophy of “patient-oriented care”. To fulfill this philosophy, the application process of IT should be creative and innovative for individual health organisation. The best adaptation of IT to individual health organisation will guarantee the best ‘care processes’ for their patients. According to the scope of IT application in the organisation, the objectives and process of development and implementation would vary. Yonsei University Healthcare System (YUHS) is a healthcare organisation with four hospitals, three colleges and two graduate schools. YUHS has 2,500 beds and is the first westernised health organisation in Korea since 1880. Sixty four specialised medical departments are involved, and 600 clinicians and 8,000 employees are working in the main hospital. With respect to Hospital Information System (HIS), YUHS has used

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several information systems in last 10 years, such as Order Communication System (OCS, same term with computerised patient order entry), Picture Archiving & Communication System (PACS), Human Resource System (HRS). The YUHS planned a new HIS that integrated pre-existing systems and newly-developed systems, such as Enterprise Resource Planning (ERP), Groupware (GW), Activity-Based Cost analysis (ABC), Clinical Data Repository (CDR), Disaster Recovery (DR) systems on basis of new system that included renovation OCS and EMR systems. Objectives and master planning YUHS planned for an effective and ubiquitous HIS. The philosophical objective was to achieve first class medical services with safety, reliability and convenience through IT. To achieve this objective, YUHS planned the EHR system as a core system, which was beyond a simple order exchange system. Therefore, the master plan focussed on renovation of OCS, development of EMR system and then the integration of these two systems. The prime objective of the EMR system was the security of data and the privacy protection. On the basis of these objectives, the system has developed with the strategic consideration of standardisation, customisation, and authentication principles. The standardisation was done from code to the clinical document. The customisation focussed on user interface and special needs of end users. The authentication was done by adoption of new technology. Considerations For many clinicians, EMR system, instead of paper recording, is regarded as a hard job

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to do, because there are too many patients for individual clinicians to take care and too many medical records to write in a limited time. This situation makes many clinicians hesitate to use the electronic recording system. They are afraid that they may not finish their work in proper time and may not have positive return on investment (ROI) consequently. Therefore, the development and implementation of EMR system in Korea meant more than the development of the system itself. The EMR system had to be a realistic one that is fast enough to use, easy enough to learn, and also cost-effective. It also has to keep basic pre-requisites of EMR system, such as standardised terminology system and Clinical Document Architecture (CDA) that are necessary for future sharing of information and integrity of documents. This is not easy to realise. Therefore, many clinicians should give their knowledge and efforts, and all departments should change their working process under the new digital environment. The acting groups were organised into several working groups (WGs). There were terminology WG, clinical document WG, User Interface (UI) WG, Authentication WG, Security WG, Nursing WG, CDR WG, Equipment interface WG, and CDR WG. All working groups comprised clinicians, nurses, paramedical personel and IT engineers. These WGs were focussed on their specific interest, such as standardisation of terminology, unification of data, maximum customisation of UI, job-defined authentication, nursing process, and security and private protection.

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Process of standardisation The standardisation of terminology was accomplished by clinicians and nurses inside the organisation. Simultaneously, all codes of previous system were gathered from all the departments and unified between departments. This work of standardisation can provide the basis for a successful EHR system implimentation. Codes consist of codes of accounts, resource, medicine, laboratory, operation/treatment and departmental codes that are managed separately by each department. The standardisation of terminology was done by accumulation, analysis, classification, and new concept creation of terms. All record items with entered value were defined as Medical Record (MR) items and were gathered from the 926 paper-based clinical documents. As a result, MR items (15,092 items), Standardised Severance Terminology Dictionary (SSTD; 62,232 terms) and medical images (1,445 images) have been classified after a filtering and mapping process. On the basis of intra-organisational terminology, we develop the Clinical

Document Generator (CDG) that can create XML formatted clinical document forms by simple selection of MR items (See Figure 1) This innovative process of clinical document generation makes possible convenient use and fast adaptation of the EMR system among clinicians. Basic architecture of the EHR system After the establishment of SSTD and database of MR items, we mapped terms of SSTD and MR items with terms of the internationally accepted terminology system, to achieve future global sharing of information, such as, SNOMED-CT, ICD-10 ICD-9CM, ICNP, NINDA, NANDA, NOC. On the basis of above terminological architecture, all clinical document forms were created by CDG. The formation of document can be done by clinicians themselves and recorded. All recorded data is stored into the file server and database server for 22 months until now. ( Figure 1) All clinical documents are stored in two ways. One is a storage of XML file with

signature, and the other is a storage into the database of individual value of MR item. XML file storage maintains the interoperability and integrity of medical record, and database storage of MR item enables more efficient use of the information for the research and management of hospital. As next steps of implementation, we included the Disaster Recovery (DR) system into the basic architecture for the security of data at six months later, and built the Clinical Data Repository (CDR) at 22 months later for better clinical research and hospital management. Development of specialised functions of EHR system We decided to develop several specialised functions that reflect the organisationâ&#x20AC;&#x2122;s unique situation and culture, in order to enhance the safety and security of patient. They are as follows. Drug Adverse Effect Report System, Insurance Acceptance Guide System, Diagnosis Guide System, Antibiotics Dosage Control System, Child TPN Support System, Nursing Process System, Patient Information

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Architecture of Clinical Documents Electronic Clinical Documents XML File Storage

U-Severance System DB Storage

Medical Record Items Mobile Standardized Severance Terminology Dictionary PACS

ABC

SEM

EMR

u Integrated S HIS & CDR M A R T

926 Paper-based Clinical Documents

Order, Account, Resource Terminology

Architecture of clinical document & terminology in U-SMAET

Control System, Specific Disease Marker System, Patient Education System, Double Check System with Barcode and RFID. These special functions were the results of active participation of clinicians and nurses in the project. Therefore, these functions can be the most ideal functions for the YUHS. After implementation, feedback from the users of these functions was obtained to improve and further develop functions to accommodate the users continuously. As for the authentication part, an ID-password system was developed. The smart card system with Public Key Identification (PKI) was adopted to verify the right individual for viewing and recording the data. This system is connected with the human resource system (HRS) of YUHS; therefore, change in job status can directly change the authority of medical recording. Finally, we named this core EHR system ‘µ-SMART’ (Severance Medical information Archiving & Retrieval System). Implementation (Go-live) After 12 months of development, the Go-live plan was initiated and the final implementation was accomplished after 16 months of development. Go-live planning is crucial to the successful implementation of the system. The plan consisted programmes of education, simulation, and rehearsal with mock patients. The most important process was the education of end users. We planned three education programme; key user’s program, individual repetitive program and group program according to position, job and department.

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Figure 1

Dental PACS (Infinit) Yongdong PACS

The lessons Getting the clinicians to participate was a tough task during the development. They don’t want to change their working process abruptly, and sometimes they cannot catch what they have to help or how they participate. Same as clinicians, there can be conflicts among paramedical departments due to their working boundaries. These situations can be aggravated because nobody can show the final result intuitively until the end of development. However, it can be safely said that the most important thing during the process was to continuously encourage of participation with passion. Any health organization has its unique culture and special working processes. As a result of participation, the individuals can know the strong and weak points of the organisation and their working processes. Only active participation can overcome any difficulties and can make the most effective EHR system. When everyone participates, it helps in learning more about the HIS itself as every participant can share his/her

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Integrated Homepages

Sister Hosp

PI OA

Scematic diagram of U-Severabce & U-SMART system

The process of maximum customisation of UI is also important to the successful implementation. The customisation process of UI is a continuous interaction between final users and IT engineers. Post implementation, µ-SMART provides information to the other information systems, such as Enterprise Resource Planning (ERP), Activity Based Cost analysis (ABC), Groupware (GW), i-Severance (homepage), Parking system, Smart Card system (Figure 2). As a whole we have the system as ‘µ-Severance system’.

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Severance OCS

Medical Terminology (CC, Dx, Tx, etc.)

Cardiovascular cine PACS

Dental OCS

SNOMED-CT, ICNP, ICD-10, ICD-9CM, 3N

ERP Yongdong OCS

Severance PACS (GE)

EIP

CRM

Figure 2

knowledge and have a strong interest for further development and better utilisation of the system. This kind of organisational upgrade was another result from the hard work put into the development of the EHR system. Perspectives Already 23 months have passed after the implementation. Now no clinicians and nurses can imagine working without µ-SMART system. Also we have found evidence of evolution, like the self standardisation of terminology, faster innovation of clinical document formation, better quality of recording, better working process and voluntary participation of new HIS projects. The economical effect and the Return on Investment (ROI) is still under investigation, however, we can be sure that there are many positive ROIs of EHR system. Further reports will be prepared in near future. We also have to keep the value innovation of EHR system to improve quality of care and to enhance the research capability, and also have to keep the technical innovation to integrate IT into the individualised home care of health. In conclusion, I am sure that the EHR system improves clinical working process, patient’s safety and active utilisation of medical information. And it will realise ubiquitous environment of medical service in near future. The results of current EHR system will be another foundation for the sophisticated EHR system of the future, and knowledge-based medical services will become a reality. However, we should remember that people are always at the centre of the system.

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Applying Path Innovation Seeking revolutionary HIT

Healthcare requires a revolution in the way we deliver care by utilising IT in new and innovative ways. Path innovation allows experts to work together in the development of workflows that best leverage HIT.

Barry P Chaiken Associate Chief Medical Officer BearingPoint and Fellow of HIMSS USA

o country in the world spends more of its GDP on healthcare than the US Compared to other countries in the Asia Pacific region, the US spends anywhere from 33 to 500% more, and when compared to other Organisation for Economic Co-operation and Development (OECD) countries it spends 50 to 100% more (Figure 1). Yet according to a report published by the California Healthcare Foundation in May, 2007, the US ranked last or next to last on 9 of 10 measures of healthcare delivery. On the measure of deaths due to surgical or medi-

cal mishaps, the US experienced about 75% more deaths than the average OECD country (Figure 2). Don Berwick, an international leader in healthcare quality improvement observed that “every system is perfectly designed to get the results it gets.” Building on Dr. Berwick’s notion, other experts have defined insanity as doing the same thing over and over again and expecting different results. Perhaps for some of us, deployment of healthcare IT is our expression of insanity. Many organisations, led by dedicated and intelligent professionals, successfully implement—as defined by technical specifications—a variety of healthcare information systems only to discover that their process and outcomes measures change little. Unfortunately, without changing the underlying processes and workflows that existed before the implementation of healthcare IT, little change in those measures should be expected.

Healthcare Spending as a % GDP, 2003

Source: WHO. The World Health Report, 2006; Commonwealth Fund. Healthcare spending and Use of IT in OECD Countries, May/June 2006.

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Deaths Due to Surgical or Medical Mishaps per 100,000 Population in 2004

Figure 1

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Time for a revolution Revolution is defined as a “drastic and farreaching change in ways of thinking and behaving.” Healthcare systems require a Health Information Technology (HIT) revolution, a drastic change in the way we deliver care by utilising IT in new and innovative ways. Aggressively deploying IT, to replicate the processes and workflows that currently deliver disappointing results on so many measures, only guarantees continued sub-optimal and unacceptable outcomes. Touted as a source of great efficiency and effectiveness, information technology currently offers limited healthcare examples of significant and documented gains. Considering the millions of dollars spent on healthcare IT by organisations around the world, these results are quite discouraging. To best understand why our gains from IT investments have not materialised, let’s look at other industries as models.

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Source: J. Cylus and G.F. Anderson, Multinational Comparisons of Health Systems Data, 2006 (New York: the Commonwealth Fund, april 2007).

Figure 2

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Early investment by other businesses in information technology delivered very unsatisfactory results through the early 1990s. Executives, expecting computer systems to provide increased efficiencies and worker productivity, realised few, if any, benefits from investing is these systems. The idea of a paperless office never materialised as many workers printed out each and every email message, handling correspondence as they would a mailed letter or an interoffice memo. Then sometime in the mid-1990s, that all changed. Rather quickly, over a threeyear period, using computers to communicate, transact purchases and transfer documents became normal business practice. Developers and users together conceived more and more activities that could be conducted online. Across most industries that deployed IT, a lag period occurred where quality and costs savings did not appear. As frustrating as this period was, companies that continued to invest in IT, slowly began to experience the jumps in productivity and profit that were long expected. Each organisation reached a tipping point where processes and workflow evolved to take advantage of the new IT tools to deliver unprecedented results. To look at the benefit of IT on these companies

in isolation is to miss the true lesson to be gained from their experiences. Early on, the deployment of IT was viewed as the solution. Only after companies recognised it to be just a tool, did they formulate the real solutions based upon revised processes and workflow which then provided much of the benefits. Focus of revolutionary IT Revolutionary HIT requires a focus on three key areas: 1) processes and workflows, 2) information technology tools and 3) healthcare provider tasks, duties and responsibilities. Solutions come from an indepth understanding of tools and creative thinking around what healthcare professionals can do and how best to use their individual skills. Bringing together experts in clinical medicine, information technology and process redesign creates an environment where the best processes and workflows effectively leverage the new HIT tools. Such diverse working groups allow meaningful knowledge transfer and the development of solutions that transcend the

expertise inherent in each silo of knowledge. The failure of clinical IT tools to deliver safer and more efficient care is due to many factors; yet all of them have origin in the concept inherent in the phrase â&#x20AC;&#x153;path innovation.â&#x20AC;? Although the theories and expertise that form the basis of path innovation are not new, their interaction with and subsequent impact on clinical IT is. Three key factors of path innovation Path innovation is dependent upon three key factors: 1) Process improvement or reengineering, 2) Clinical guidelines, clinical paths and evidence-based medicine, and 3) IT system design. Although subject matter experts exist in all these areas, it is unclear how well these experts historically worked together in the design and implementation of clinical IT systems. Process improvement experts understand how processes impact outcomes and what analytical steps are needed to evaluate processes. They are able to suggest changes in processes and predict the potential improvements such changes will deliver. Experts in clinical content understand what various clinical paths deliver as outcomes. They are able to link various interventions with probabilistic results.

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Designers of IT systems understand the flow of digital information within computer systems and the user interfaces that receive and deliver data to users. They are able to conceptualise how a data point can be stored or reformatted with other data points. Experts worked independently Almost universally, these experts work and apply their expertise independently of each other. IT system designers develop clinical IT systems using specifications developed by product managers who attempt to bridge IT with healthcare. These product managers are rarely experts in clinical medicine or clinical processes. Clinical content experts develop clinical content focussed solely on clinical issues, rarely incorporating IT system design or clinical process considerations in their work. This is evident in the effort invested by many organisations to modify existing guidelines to fit their newly implemented clinical IT systems. Their reported struggles are indicative of the difficulty of this type of work. Process redesigners often appear on the scene late in implementations, if at all. Working within the environment as presented to them, they try to change existing processes without the advantage of being able to change the inputs (e.g., clinical path) or tools (e.g., clinical IT system and its functionality) of the processes. To implement and effectively leverage clinical IT systems, a new approach in the use of experts is required. Path innovation integrates different subject matter experts in unique ways to leverage their expertise throughout the design and implementation of clinical IT systems. Even for systems already built, path innovation can be used to better leverage existing functionality in these clinical IT systems. It can help enhance outcomes while reducing the probability of unacceptable results such as system related medical and medication errors. Form a path innovation team Path innovation requires the formation of a team of subject matter experts that apply their skills during an entire clinical IT system project. During the

Currently patient delivery relies upon an unreliable system of poorly integrated and highly variable healthcare professionals. Revolutionary HIT solutions provide needed support tools that increase the reliability of the human components, while integrating these components through effective processes and efficient workflows. Revolutionary HIT fundamentally changes what physicians, nurses and other healthcare professionals do. Physician activities become more challenging on a cognitive level as other routine tasks such as drug dose recall, use of best practice order sets, and drug-allergy checking become automated. Physician expertise is assigned to more important tasks including solving difficult diagnostic problems, devising customised patient treatment plans, and influencing patient adherence to chronic disease care regimens. Work for nurses and other healthcare professionals changes dramatically too. These professionals, guided by intelligent processes and workflows that include meaningful HIT, The failure of clinical IT tools to deliver complete more tasks formerly safer and more efficient care is due to done by physicians or other many factors; yet all of them have origin healthcare specialists. Revolutionary HIT places in the concept inherent in the phrase the right professional, with the â&#x20AC;&#x153;path innovation.â&#x20AC;? right knowledge in the right process, utilising the right workflow to d liver the best evidenceneed to identify subject matter experts who based care to the patient. Care delivery are also able to achieve a basic understandis focussed on the patient and their ing of the disciplines of their expert colneeds rather than the requirements of leagues. Then together, these experts work unchanged, ineffective workflows estabto create new processes that incorporate the lished before the dawn of information needs of the institution with the promise of technology. new IT systems and clinical content. For information technology to play Valued solutions offer these professiona valuable role in reducing healthcare als HIT tools that leverage their unique costs while enhancing quality of care, skills, while organising the processes and it must be deployed in a revolutionary workflows to deliver a consistently high way that completely reinvents how care is quality, safe and efficient healthcare outdelivered, professionals provide the care, come. and technology is leveraged throughout care delivery. In addition, if we embrace Need to Change path innovation, and incorporate it Inherent in revolutionary HIT is the need proactively into our deployment of for change; change in what professionals healthcare information technology, do and how they do it. Therefore, effective we will then be able to accrue the huge change management techniques must be increases in quality, patient safety utilised to facilitate the acceptance of the and efficiency we expect from these new processes and workflows, in addition revolutionary tools. to any new responsibilities and duties.

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system design phase, clinical and process design experts share their understanding of their discipline with the IT system developer. During the implementation phase, the IT system designer and the clinical content expert act as consultants to the process redesigner to develop new processes that are both radically different from existing processes and that could only be implemented utilising functionality made available by the new clinical IT system. In addition, the clinical content expert can use this functionality to conceive of clinical paths impossible without this digital healthcare capability. Although path innovation builds upon existing approaches, it reflects a new way of thinking and approaching problems. Instead of looking at how an existing process could be modified, path innovation requires the birth of brand new processes, formerly impossible in the institution before the installation of the new clinical IT system. To accomplish this, organisations

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Broadband Medical Network in Asia Pacific

Naoki Nakashima Assistant Professor Department of Medical Informatics Shuji Shimizu Chairman, Medical Working Group of Asia-Pacific Advanced Network and Associate Professor, Department of Endoscopic Diagnostics and Therapeutics Koji Okamura Associate Professor Computing and Communications Center Kyushu University Hospital, Japan

we established multiple stations during and after each APAN meeting by adding new institutions /countries (Figure 1).

The Asia-Pacific Advanced Network (APAN) can transmit high-quality moving images over broadband Internet lines. This network system is being extended to the entire Asia-Pacific region to promote the exchange of medical knowledge and standardisation.

he Asia-Pacific Advanced Network (APAN) is a network communication system that can transmit real-time, high-quality moving digital video (DV) images over Internet Protocol (IP). We are now able to use international submarine fiber-optic cable networks in the Asia Pacific region for broadband transmission. The distribution of medical information by means of DV over IP beyond national borders makes medical staff keenly aware of differences in medical services between countries and uncovers the relative advantages and disadvantages of each. History In February 2003, Japanese and Korean medical groups collaborated to use the

Korea-Japan Cable Network (KJCN) for medical purposes. AQUA (Asia-Kyushu Advanced medical network) joined the Asia Pacific Advanced Network (APAN) consortium in January 2004 (APAN-Honolulu). After three subsequent demonstrations of telemedical conferencing during APAN meetings, which are held twice a year, the medical working group was formally approved by APAN by a vote during the APAN-Taipei meeting in August 2005. We met many medical doctors/researchers at each APAN meeting and therefore built a human network to help expand our project. We also gained partner institutions in Asia-Pacific countries through our attendance at each APAN meeting by asking different institutions to the stations. Thus,

How it was achieved We used public optic submarine cables for international connections and for domestic research and educational networks in Asia Pacific countries. From Japan, we connected the QGPOP (domestic) network and the Korea Advanced Research Network (KOREN) via the Asia Pacific International Infrastructure (APII) (1 Gbps), which uses the KJCN. In China, we connected to the China Education and Research Network (CERNET) through the KORENCERNET submarine link (155 Mbps). In Taiwan, we used the Academic Service Network (ASnet), with the connection from Super SINET or Asia Pacific Advanced Network-Japan (APAN-JP) at 1 Gbps through an optic submarine cable, which was prepared by ASnet. In Thailand, we connected to the Thai Social Scientific, Academic and Research Network (ThaiSarn) via Super SINET (45 Mbps). The United States was connected through the TransPAC network. Australiaâ&#x20AC;&#x2122;s Research and Education Network (AARNet) was connected to Abilene from APAN-JP. We did not have a direct connection with Singapore; thus, we used a combination of the JapanTaiwan connection and the ASnet-Singapore connection (155 Mbps), using the Advanced Research and Education Network (SingAREN) in Singapore. Trans-Eurasia Information Network 2 (TEIN2), which was launched in 2006, made connections to South Asian and European countries easier. We connected Vietnam, Hong Kong and Indonesia in the summer of 2006 and the Philippines,

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Malaysia and India in the winter of 2007. We also changed the route to Singapore and Thailand in 2006, because we were able to directly connect to these countries via Japan Gigabit Network 2 (JGN2) from Japan. Additionally, we used the Asia Broadband program line (ASIA-BB) for the connection to Thailand starting in late 2005. Medical-quality moving images and security Since the beginning of the project, we have thought that high-quality moving images are essential for medical purposes. We have used DV over IP in this network for transmission of moving images with standard definition. We usually use the Digital Video Transport System (DVTS) over IP. DVTS is open source freeware, downloadable from a Web site. Thus, terminal stations are inexpensive enough to be set up throughout the Asia-Pacific region. We also transmit High Definition Television (HDTV) images compressed by Mpeg2 on the network. The quality of transmitted moving DVTS images is as good as that of the original digital video. A frame rate of 30 per second was obtained by 30 Mbps bandwidth, and the images were smooth and not sluggish. The sound was clear, however, audio jitter was sometimes present during the entire course due to packet loss. The time delay was less than 0.3 sec between Japan and Korea and slightly longer for other countries (maximum 1.0 sec), which made for minimal to no stress at each endpoint. During live transmissions, we used the AR550S (Allied Telesis Co.) VPN router at each station as a security system to protect patients’ privacy. Multiple stations for each event We conducted an increasing number of events over the past 4 years, for a total of 96 by March 2007 (Figure 1). The percentage of multiple-station events (three stations or more) increased each year—reaching 50% in 2006—although the technical level of these events is higher than that of peer-to-peer connections. When an event has multiple stations, we often use a QualImage/Quatre system (Information Services InternationalDentsu, Ltd., Tokyo, Japan) that can integrate four DV signals into one digital image without analog conversion. At the APANManila meeting in January 2007, we connected eight stations in eight countries. The

66 Asian Hospital & Healthcare Management

The numbers in columns are the number of stations per event. The number of multiple-station events has increased every year. Connected countries are shown by abbreviations (JP: Japan, KR: Korea, US: United States, AU: Australia, CN: China, TW: Taiwan, TH: Thailand, SG: Singapore, VN: Vietnam, ID: Indonesia, PH: Philippine, MA: Malaysia, and IN: India). The position of each country on the graph shows the time of incited participation.

Figure 1

number of events has increased gradually every year (Figure 1), the total number of stations involved in each event has increased more rapidly (14 stations in 2003; 50 in 2004; 59 in 2005; 89 in 2005; 86 between January and March 2007). Interactive communication between hundreds of doctors For effective teleconferencing, we always transmit moving images and voice in both directions, and we use additional transmission to show other images. Usually, the surgeon has a high level of experience with regards to the technique being presented or is using a cutting-edge device. The surgeon can hear and talk to other stations during the procedure if he/she allows it. Thus, we can communicate interactively with the surgeon from remote areas. Another use of transmission of live images is telementoring. We have transmitted live demonstrations of medical procedures in actual patients to international academic meeting venues. We are able to introduce a

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procedure to hundreds of specialists in the field in different countries. For example, we connected the venue of the 94th Annual Meeting of the Japanese Urological Association in Fukuoka, Japan, and an operating room at Hanyang University Hospital in Seoul, Korea. We transmitted a live endoscopic urological surgery to the venue, where more than 700 urologists were present. The urologists were able to learn about the procedure and discuss the surgery with doctors and the surgeon at the Korean station. This project has played two roles with respect to satisfactory growth of the network in the Asia Pacific region. First, it has served as the hub of the telemedical network within the Asia Pacific region. While the project promoted the exchange of medical knowledge only between Japan and Korea in the first year, after our involvement in several APAN meetings, many more Asia Pacific countries have participated in the project. We have already connected 13 countries and a total of 274 stations, and we plan to expand throughout the Asia-Pacific region. Second, it has functioned as the communication center for medical knowledge and network technology. Those in the medical field want to use advanced information and communication technologies for multimedia and high-speed transmission of high-quality moving images to exchange medical knowledge with their colleagues in remote places. However, such contact has either been sporadic or not well integrated. The online and offline activities of this project function to close the IT gap between the well-served and underserved areas. In the future, we will add other technologies to our system to improve telecommunication efficiency. For example, we want to facilitate transmission of high definition moving images, and try stereoscopy images and image processing. In conjunction with participation in APAN meetings, we have established a high-quality video transmission system over IP throughout the Asia Pacific region that is easy to use, reliable and economical. This useful system is a promising tool for the standardisation of medical systems and medical procedures in the Asia Pacific region.

I N F O R M A T I O N T E C H N O L O GY

Commoditising Healthcare IT The next wave

With the costs of healthcare rapidly increasing, the monolithic model of HIT is no longer sustainable. HIT commodity capability that provides a new level of convenience and serviceability to the healthcare environment while being cost-effective.

Werner van Huffel Health and Social Services Industry Strategist Regional Public Sector Group Microsoft Asia Pacific Singapore

ealthcare and Information Technology (IT) have been linked for decades. Some of the earliest uses of IT in healthcare were for the creation of Artificial Intelligence and Expert Systems—such as MYCIN and CADEUS—in the 1970s. These early implementations were heavily influenced by mathematics. Their implementation was labour-intensive as they utilised bespoke development techniques. They were complex to use and monolithic in structure. Monolithic systems are generally unique to clinical domains and are: • Costly to develop and maintain • “Closed loop”: not designed for easy integration with other systems • Tightly-bound to the requirements of the clinical domain they service: it would be easier to write an entirely new application than to reapply the functionality Monolithic systems also have other, less obvious, implications: • They impede the diffusion of technology innovation within healthcare because systems development is slow and expensive • They waste capital expenditure as they cannot easily be reused • Patient safety is compromised because it is difficult to change system interfaces to comply with clinical domain or area standardisation requirements As the field of Healthcare Information Technology (HIT) has progressed, our ability to manage, manipulate and invent Information Technology (IT) solutions outside of HIT has grown at a rate comparable to Moores’ Law. Our understanding of architectural frameworks, such as Enterprise Application-centric schemas (e.g. Zachman, TOGAF and others), has grown to incorporate more loosely defined capabilities such as those

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covered within Service Oriented Architecture frameworks. These architectural strategies are based on the implemented technologies: rules processing engines, workflow and document process management systems, databases and development environments. While these should all be part of the core IT infrastructure, many domain-specific solutions are still developed within the monolithic model (i.e. reproducing these core software capabilities as bespoke components). To the objective observer, HIT has progressed very slowly in most areas and very quickly in others. As the clinical environment has become more complex, the data storage and processing requirements of the clinical domains have also increased. The data explosion caused by the advent of genomics, large scale requirements for electronic medical / health records and the widespread use of electronic documents is straining existing monolithic systems. No one system will do everything for healthcare, ever. One has only to review the sheer number and the complexity of systems in a healthcare institution’s infrastructure to realise that “one size does not fit all”. Furthermore, the rapidly increasing costs of healthcare means that the monolithic model of HIT is no longer sustainable. What is a HIT commodity? A HIT commodity is a cost-effective capability that provides a new level of convenience and serviceability to the healthcare environment. From general experience, a commodity is also a capability which has become ubiquitous, to the extent that it becomes background “noise” to the standard operation of an environment. In other words, successfully commoditised IT implementation becomes transparent to the people using its functionality. The transition from monolithic to commodious models is an ongoing, ever-increasing, drive within HIT. In HIT, the technology implemented in healthcare has been undergoing continuous commoditisation since the earliest initial bespoke implementations. This is primarily because, in many cases, we understand the requirements of pure technology implementations better than we understand those of healthcare. Much

68 Asian Hospital & Healthcare Management

of HIT operates within silos—information exchange is disjointed and collaboration is limited. This is a legacy of the history of healthcare itself, as well as the uses and implementation of IT within healthcare. Where are we going? In some respects, technology in healthcare has not come very far in the past 40-odd years. There are many reasons for this; some studies have shown that poor communication between healthcare professionals and the IT systems they use may be a contributor. Many developments within healthcare still utilise the legacy method of monolithic, bespoke development similar to the era of MYCIN and CADUES—consuming substantial development and infrastructure resources and delivering little interoperability capability. Generalised technologies such as processing engines, databases and unified communications have begun to penetrate healthcare. There is a growing understanding that technological rigidity is not always the best approach to solving healthcare problems. To be fair, IT is not as mature as healthcare and is still coming to terms with the mechanics of change in areas other than itself (such as clinical domains). Standards can facilitate transformation, but standards change. When this happens, standards can initiate the very confusion that they attempt to alleviate. In order to be effective in the future and have an impact in healthcare IT, systems need to be: • modular (be able to plug-and-play with varying clinical domain requirements) • user friendly (to increase their reach and minimize pushback from clinicians around data collection and monitoring systems perceived as ‘Orwellian’ initiatives) • commoditised (cost-effective with high societal usefulness) The work done by standards bodies is an attempt to bring collaboration and information interchange capabilities to the healthcare domain in usable chunks. In many respects, standards bodies are leading attempts to drive commoditisation of IT in healthcare. Global bodies such as the IHE, HL7 and

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others are actively attempting to facilitate interoperability through the definition of standards. However, implementation of collaborative capability in HIT still depends on technologists and technology companies working in concert with healthcare professionals. The key to commoditised HIT is for technology companies to further embed HIT requirements as capabilities within their products and architectures. Those requirements will include: • increased use by vendors of frameworks that support dislocated applications, such as Software as a Service(SaaS) and Service Oriented Architecture • creation of standards-agnostic (not atheistic) systems that extend capability directly to the desktop through the addition of modular, user-friendly functionality to enable the clinical information worker to exchange clinical documents without the need for costly and complex software • introduction and penetration of systems which deliver high-end valueadded capabilities, such as Electronic Medical / Health Records, as a commoditised unit of production rather than an ad-hoc amalgam of systems • healthcare domain-enabled search, as opposed to generalised search • creation of platforms for interoperability in which the entire background infrastructure of an operating system or physical architecture can be geared to facilitate healthcare information exchange Many enterprise-scale and niche providers are working in collaboration with clinicians to understand the requirements for such healthcare solutions. This will deliver greater choice in HIT and can improve the chances of an organic resolution of the issues plaguing HIT, rather than the present dipolar battle that appears to be raging. As more and more healthcare domain requirements are embedded onto the operational substrate of IT, proof of their applicability and suitability increases. This will in turn create more of a market for commoditisation. This ability to meet and further commoditise HIT requirements, without detrimentally impacting the delivery of care, is the next wave.

I N F O R M A T I O N T E C H N O L O GY

Interview

RFID in Healthcare RFID is helping hundreds of healthcare facilities across UK, US and Germany to improve overall safety and operational efficiency as it operates without line-of-sight while providing read/write capabilities for dynamic item tracking.

Prashant Agrawal Chief Executive Officer Orizin Technologies Pvt. Ltd. India

1. The Indian healthcare sector is evolving. In this scenario how has RFID been received by the healthcare providers? RFID is generating significant interest in the marketplace because of its robust application capabilities. RFID is helping hundreds of healthcare facilities across UK, US and Germany to improve overall safety and operational efficiency because it operates without line-of-sight while providing read/write capabilities for dynamic item tracking. We receive lots of queries from CIOs of the top Indian Hospitals to know more about RFID solutions and their benefits to healthcare. Some of the hospitals have already implemented RFID based “Dynamic Queue Management” solution for regular patients to reduce the wait time for lab testing. We plan to install the solution at some of the major hospitals in India this year. 2. Given the potential of its applications, are hospitals in India likely to take to RFID like the Retail sector has? Definitely! If we go back five years, barcodes were visible only on products like garments and that too mostly on imported ones. Today it is in the main stream and noticeable everywhere whether one buys a coke or gets a routine check-up at a

hospital. We feel, as we go along, RFID would be more ubiquitous than barcode as it makes lots of applications possible. We cannot track patient and assets in real-time using barcode but it’s very much possible with active RFID technology RFID is moving from retailers to hospitals, manufacturing and other sectors. It would be adopted faster than barcode due to its obvious benefits. 3. Countries like the US have led the way in using RFID, how have India and other Asian countries fared in comparison? Although adoption of RFID in India has been slow (due to lack of awareness) the number of inquiries is increasing these days mainly for patient and asset tracking. In India, the general tendency is to follow the adoption rather than lead the revolution. Singapore and other neighboring countries are doing much better. Some of the major hospitals in Singapore like, Alexandra Hospital, and The National University Hospital, Singapore General Hospitals had implemented RFID technologies to track patients, staff and assets. The solution was a huge success during SARS outbreak. Similarly it is seen that there are lots of implementations in countries like China,

Philippines, South Korea, Japan, UAE and other technology leading countries. 4. What all applications are possible with RFID? Which departments of a hospital could benefit from its application? RFID can bring lots of benefits in healthcare in managing various resources like blood samples, assets and patients. RFID is considered as a key technology in eliminating some of the major bottlenecks in hospital management and improving process efficiencies. In one of the major surveys in the US on benefits of the RFID technology in healthcare, 70% cited the patient safety as the major factor to implement RFID. Using RFID active RFID wristband tags like the ones provided by Orizin, a patient can be easily tracked across hospital and their movement can be controlled to un-wanted places. Asset tracking and utilisation is another bottleneck in hospital management that RFID promises to eliminate. In an emergency situation, locating crucial equipment like a ventilation pump could be a challenging task, which could be easily facilitated by RFID. Moreover, a major number of equipment in hospitals is rented and it becomes very difficult to estimate the usage and maintenance.

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standard to communicate with existing healthcare solutions. Lack of this standard could poise a real-challenge in implementation. There are minor challenges like accommodating RFID devices in the existing infrastructure, as it requires ethernet and power connectivity and a hospital may need to upgrade the facilities. This is acceptable. We are also launching Wi-Fi based RFID sensors that could easily fit in hospitals existing infrastructure. Unlike, other segments, RFID does not demand change in existing business process when it comes to hospital. Please provide your opinion on the second part of the question related to the cost aspect.

Some of the benefits as observed by the actual users are mentioned below: • Virginia Hospitals in US has deployed a RFID network to track mobile medical equipment at three Virginia hospitals operated by Bon Secours Richmond Health System. The three facilities are St. Mary’s Hospital, Richmond Community Hospital and the Memorial Regional Medical Center • Birmingham hospital NHS trust in UK has tagged patients with RFID chips to improve safety and ensure that correct operations are carried out on the right patients. • Blood bank supplies at Saarbruecken

Clinic are equipped with RFID chips so to prevent any confusion or mix ups in regard to blood transfusion and blood treatments. In the first phase, almost thousand bags of bloods are being labeled. The solution makes sure that correct blood is given to each patient. 5. What challenges exist in the implementation of this technology in Indian hospitals? How important a factor is cost? We don’t see any major challenge in implementing active RFID technology, as the it is robust and stable. We follow HL-7 protocol, a widely used industry

Very Important

Somewhat Important

Important

Not Important

N/A

Achieve compliance with policy

26%

30%

27%

10%

Antitheft/anticounterfeit/antitampering

42%

22%

25%

Improve asset visibility

37%

28%

22%

Improve business processes

45%

30%

16%

Improve patient flow management

48%

25%

15%

11%

Improve patient safety

67%

14%

11%

Improve productivity

48%

31%

15%

Improve security

44%

28%

19%

Precision location

36%

30%

24%

Reduce inventory

34%

26%

Reduce labor costs

42%

22%

23%

7% Table 1

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6. How do you see the future of RFID in healthcare shaping up, globally as well as in India? We are very much upbeat with the potential of RFID in healthcare segments. As per some of the major reports, healthcare vertical’s consumption of RFID tags and services will rise from US$ 90 million this year to US$ 2.1 billion in 2016. We feel what we see today is just the tip of the iceberg; the best is yet to come. 7. Any other comments you would like to make? I would like to share an excerpt from the report “RFID in Healthcare: Poised for Growth”, a survey of health care executives, by Bearing Point and the National Alliance for Health Information Technology, November 2005. How hospitals rate RFID’s business benefits The top four business benefits expected by using RFID are: improved patient safety, patient flow management, productivity and business processes. The majority rated achieving compliance with policy as only “somewhat important” as opposed to “very important.” (Table 1) Most facilities are in the discovery and information gathering stage in evaluating RFID. In 12 months, most expect them to be in the experimentation test phase, and in 24 months the majorities are expected to have projects deployed.

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Suppliers Guide Company

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