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Evidence-Based Medicine and the Changing Nature of Health Care 1 The Changing Nature of Health Care INTRODUCTION The 20th century witnessed many truly revolutionary advances in health care. Research into the causes of infectious diseases and the development of vaccines and pharmaceuticals quelled once-devastating illnesses such as polio and smallpox. The first successful organ transplant occurred in 1954, and now, thousands of transplants each year—more than 28,000 in 2007—are prolonging the lives of recipients (UNOS, 2008). Over the past decade alone, better understanding of the mechanisms that cause disease has improved the ability to prevent, diagnose, and treat common afflictions such as diabetes and heart disease. The innovation underlying such progress continues to advance and accelerate change, while many new technologies and medical interventions provide new options for care and treatment. Between 1991 and 2003, for example, the number of medical device patents per year doubled (AdvaMed, 2004), and the biotechnology patents tripled over roughly the same time (BIO, 2006). Increasingly, discoveries in the biological sciences are being applied toward the development of medicines and treatments targeted to refined subsets of patients to better address genetic or life circumstances. Recent advances in research, however, are not producing commensurate improvements in the quality of the health care received. In a 2005 survey about perceptions of health care, 60 percent of Americans said they did not believe that the United States had the best healthcare system in the world, and 41 percent said they knew of a time when they or a family member had received the wrong care (Research!America, 2005). These perceptions are
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Evidence-Based Medicine and the Changing Nature of Health Care borne out by recent reports and analyses and were highlighted in several IOM Annual Meeting presentations summarized in this publication. For example, despite spending more on health care than other industrialized nations, the United States lags significantly in basic measures of quality such as overall life expectancy at birth and infant mortality (Anderson, 1997; Mathers et al., 2001; OECD health data, 2006). Additional reports characterize a healthcare system that is highly fragmented and prone to errors (IOM, 2000, 2001). Unnecessary spending, duplication of efforts, and widespread disparities in spending and health outcomes across geographic areas are also common features of health care (IOM, 2007b). Underlying many of these shortfalls is a system struggling to contend with the changing nature of health care—from shifting patient demographics and disease burden to the increased complexity of therapy and treatment options and factors to consider as part of clinical decision making. Systems of care, historically devoted to the prevention and treatment of infectious diseases and discrete episodes of acute care, are now increasingly occupied with the management of chronic health conditions such as heart disease, diabetes, and asthma. In fact, half of those reporting a chronic illness suffer from more than one (Wu and Green, 2000). Chronic illnesses make up the leading cause of illness, disability, and death in the United States, and also account for 78 percent of U.S. health expenditures (AHRQ, 1998). In contrast to acute care, chronic care processes often require sustained coordination across multiple specialists and facilities, a characteristic that is currently testing the limits of an often-fragmented healthcare system. Key system components are also under increased pressure. For example, as noted in Session 2 of the meeting, the traditional “physician-as-expert” model of care relies on a physician’s extensive knowledge, experience, and memory to guide care. However, clinical encounters often require providers to manage a significant number of variables and factors for any one medical decision (IOM, 2007a). The number of journal articles, technology assessments, and practice guidelines that any provider must read to stay current is now well beyond human capacity and the rapid evolution of care practices and availability of many therapeutic alternatives compound this already overwhelming body of information available to guide clinical decision making. Despite the quantity of information available, there are also substantial shortfalls with respect to the quality of information available to guide decision making. Evidence is often not available or not presented in a form useful to practitioners at the point of care delivery. Often, when evidence is available, it has little relevance to the questions and patients faced by healthcare professionals in clinical practice. For example, clinical trials of intervention efficacy are of limited generalizability—often excluding older populations or patients with multiple comorbidities, lim-
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Evidence-Based Medicine and the Changing Nature of Health Care ited to assessing short-term outcomes, or conducted under circumstances that minimize factors that might decrease an intervention’s effectiveness in practice. Also, as emphasized in several presentations, very little evidence exists on the comparative effectiveness of one course of treatment versus another. While 5 percent of the overall healthcare expenditure is devoted to research, the majority of that is spent on basic research or product development (Research!America, 2006). It is estimated that, currently, less than 0.1 percent of the nation’s $2 trillion health expenditures is invested in assessing the comparative effectiveness of available interventions (AcademyHealth, 2005; Moses et al., 2005). In today’s complex clinical environment, contending with the challenges and realizing the yet untapped potential of technological and biomedical research innovations will require a sharper focus on the evidence as a way to drive improvements in the effectiveness and efficiency of the healthcare system. To orient our existing expertise and emerging resources towards improved development and application of evidence in health care, a broad view of the changing nature of health care and implications for capacity and necessary cultural change is needed. The challenges to creating an evidence-driven healthcare system are great, but so, too, is the potential reward: affordable health care, based on evidence of what works that improves health outcomes for individual patients. Leadership is needed from the healthcare professions to reach consensus on the problems and solutions and to facilitate the necessary change. This was the focus of the 2007 Institute of Medicine (IOM) Annual Meeting. EVIDENCE-BASED MEDICINE AND THE IOM Since its establishment in 1970 by the National Academy of Sciences, the IOM has been committed to advancing the quality of health care in the United States and has undertaken many important studies on the topic. Perhaps the most widely known are a series of reports by the Committee on the Quality of Health Care in America. The first of these reports, To Err Is Human, estimated that as many as 98,000 patients die in any given year from medical errors that occur in hospitals and established ensuring patient safety a critical first step in improving quality of health care. A year later, a follow-on report, Crossing the Quality Chasm, focused on the delivery system as a whole and issued a call to action to improve system performance in the six dimensions of quality—to ensure safe, effective, patient-centered, timely, efficient, and equitable care. Expanding the evidence base to support quality medical care for each patient poses an ongoing challenge to healthcare improvement, and to contend with this issue, in 2006, the IOM convened the Roundtable on Evidence-Based Medicine. Over the last 2 years, the Roundtable has ex-
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Evidence-Based Medicine and the Changing Nature of Health Care plored, through its series of meetings and workshops on the learning healthcare system, the key opportunities and challenges to establishing evidence as the linchpin of the healthcare enterprise. Collectively, the Roundtable seeks the development of a healthcare system that is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care. Roundtable activities focus on accelerating the development of a learning healthcare system; expanding the capacity to generate evidence on medical care that is the most effective and produces the greatest value; and improving public understanding of the nature, importance, and dynamic character of medical evidence. The IOM convenes annual meetings dedicated to the examination of topical and critical issues in health care and health policy. With healthcare system reform at the top of the nation’s domestic agenda, the IOM Council’s selection of evidence-based medicine (EBM) as the subject for its 2007 annual meeting underscores its centrality and importance to fundamental improvements in the nation’s health and health care. The meeting was structured to provide an overview of some of the key issues and challenges as well as to present some of the primary opportunities for progress that have emerged from the work of the Roundtable. The chapters in this publication provide important perspectives on the changing nature of health care: from the forces driving the need for better medical evidence and the many new challenges confronting patients and providers to opportunities to transform the speed and reliability of new medical evidence and enable an evidence-based healthcare system. To provide context for these discussions, comments were provided by the meeting co-chairs Mark B. McClellan and Elizabeth G. Nabel and by session moderators Denis A. Cortese, Michael M. E. Johns, John W. Rowe, and John K. Iglehart. A summary of these perspectives follows. Challenges and Opportunities Mark B. McClellan, M.D., Ph.D., Brookings Institution Two core challenges are facing health care and health policy in the 21st century. Healthcare costs are rising and not sustainable, and a tremendous, largely untapped potential exists for much better health through better, more targeted treatments. In principle, better evidence will result in higher confidence about what works for every patient in the healthcare system. This is a precondition to achieving what health care should be about in the 21st century—care that is based on solid evidence about what will work in particular patients.
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Evidence-Based Medicine and the Changing Nature of Health Care With the advent of electronic medical records (EMRs), clinical data registries, and other new forms of electronic data, care is becoming rich with information that can reveal patterns of disease mechanisms and markers of risks and benefits. These data also hold promise for instilling a greater confidence in health care than currently exists for a system that offers widely varying medical practices, with possible consequences for outcomes and definite consequences for costs. In addition, even treatments effective for some may not be beneficial for others and may carry significant risks. With the cost of health care rising along with its benefits, creating an evidence-based system will be critical to achieving the promise of personalized medicine in which treatments are more effectively targeted to those that benefit, an achievement well worth its cost. Although there has been progress toward this goal, attaining such a system remains a distant prospect. Better disease models and evidence relevant to the treatment of individual patients is lacking, despite publications and news stories that seem to suggest otherwise. Also, much of the current data are not from traditional randomized controlled trials (RCTs), creating a dilemma about the relevance of EBM in clinical practice. Some practitioners believe that if evidence is developed using traditional RCTs, it may not be reflective of the complexities of populations and the delivery settings in real-world practice. For example, even if different practice methods appear to have a similar effect in an overall population, this may not be the case for different subgroups or different types of patients within that population. The key elements that should inform strategies for change are contained within these pages. As Michael E. Porter notes in Chapter 7, while simple steps such as price controls or restrictions on access to control costs might seem useful on the surface, they have failed in the past. Instead, a new vision is needed, marked by effective evidence and targeted treatments that account for the diverse characteristics—findings, histories, validated biomarkers, and preferences—of the various patient groups in this country. With the complement of secure EMRs, access to these patient and population characteristics will bring relevant evidence to healthcare decision making. This will, in turn, lead to better results and higher value. Clearly, there will be challenges along the way to gather the evidence necessary for the backbone of this type of healthcare system: data must be consistent; low-cost alternatives to RCTs must be agreed upon; electronic systems should be integrated; and sophisticated longitudinal databases, such as provider-led clinical registries, should be supported. In addition to studying the discrete interventions of particular drugs or particular modalities in treatments, the performance of healthcare systems themselves should be addressed. The variations in care discussed by Elliott S. Fisher in Chapter 2 must be aligned. Also, costs will increase and value
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Evidence-Based Medicine and the Changing Nature of Health Care will be compromised if patients receive care from a number of different providers who do not collaborate effectively. To study these delivery system issues in real-world practices, traditional approaches such as RCTs will not be effective. Policy challenges must also be addressed. As George C. Halvorson acknowledges in Chapter 6, small shifts in the system will not create fundamental change. Value and outcomes cannot be achieved by micromanaging practices, but rather by providing support for better care at a lower cost. Rewarding better quality and lower costs will give healthcare professionals the opportunity to deliver quality care and still make ends meet. By the first rule of economics, “You get what you pay for,” the healthcare support system must be changed to pay for the care we want. This includes changing reimbursements to focus on higher value. Making these changes will provide an opportunity for patients to become more involved, and not simply through cost sharing. Many opportunities exist for people with chronic diseases to improve their own health, since most care is actually self-care. In our traditional insurance system, these individuals do not always have the opportunity to make choices that can save money. However, recent reforms have begun to allow chronically ill patients in this country to control the services they receive. For example, the tiered benefits in Medicare allow beneficiaries to save money by switching to generic drugs—one of the main reasons that Part D in Medicare is less expensive than projected. There are a number of programs being implemented around this concept of shared savings, in which healthcare professionals working together reap savings when they document better outcomes at a lower cost. However those savings are accomplished—through system redesign, information technology (IT), or remote monitoring systems—they are a step toward a bundled reimbursement approach that focuses on the effective outcomes in our healthcare system while promoting better care for everyone in it. Clearly, the technical and policy challenges of fulfilling the vision of EBM are great. In spite of these challenges, the promise of EBM has put it at the forefront of policy making. The Food and Drug Administration is working to implement major new reforms, including plans for a public-private partnership to support a post-marketing surveillance system to gather data on drug risks and benefits. Also, Congress is considering proposals for a major initiative to support the generation of comparative effectiveness information about healthcare interventions. In addition to work by the federal government, the practice of EBM will require numerous public- and private-sector strategies and collaborations. Needed are new approaches to the evaluation and adoption of medical best practices, new methods for drawing appropriate conclusions from vastly expanded data resources, and new approaches for using evidence to improve care and
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Evidence-Based Medicine and the Changing Nature of Health Care reduce health costs. The process will not be easy, but unlike previous times, there are now widespread calls from healthcare leaders for the reforms needed to develop a system that delivers efficient and effective care. The IOM has the opportunity to catalyze that change. Elizabeth G. Nabel, M.D., National Heart, Lung, and Blood Institute Healthcare reform will be one of the top domestic issues of the political agenda in the next presidential election, making our focus on EBM and the changing nature of health care very timely. The roles and responsibilities of all healthcare stakeholders are undergoing transformative change and—whether we approach reform as providers, payers, researchers, health product developers, or consumers—there is much to learn from all who are involved in these collaborative discussions about how to contend with the rapid changes in the healthcare system. Healthcare providers, whether involved in delivering or reimbursing care, face a unique set of challenges as care is increasingly informed by and organized around rapidly evolving evidence. Developing better approaches to reimbursement and other mechanisms that support the delivery of quality care are at the forefront for all providers, and many pilot projects are already under way. A key consideration, as illustrated throughout this report, is the strong influence of local cultures on practice patterns. They can prevent the infiltration of evidence-based decision making, but they can also lead to great innovation to support the application and development of evidence. The papers by William W. Stead and George C. Halvorson in Chapters 4 and 6 discuss lessons learned from their efforts to harness electronic health record (EHR) systems for improved application of evidence in practice and improved capacity for research and discovery, respectively. However, these local solutions may need restructuring to succeed at a national level. There has been considerable advocacy for sharing best practices nationwide, but it may be necessary to set goals and work backwards to align the systems. For consumers, access to care is a priority but an additional, emerging challenge will be to ensure that incentives for research and care are properly aligned to support care focused on individual patient needs, circumstances, and preferences. The very nature of patient-physician relationships is also undergoing a rapid change as healthcare data are increasingly captured and made available in various forms through IT. Patients will be presented with more health information from a variety of sources and, increasingly, they will be pivotal in making decisions about their own health care. As we are reminded by Peter M. Neupert in Chapter 5, most of health care is self-care and much of the care delivered throughout this country is family-based. Family health managers and the availability of secure personal health
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Evidence-Based Medicine and the Changing Nature of Health Care records will be critical to informing and providing increasingly individualized patient care. EBM will also impact researchers. Methodologies to generate evidence are evolving and need to be continually defined and adapted. EHRs will provide the opportunity to quickly gather large amounts of data from real-world practice and produce evidence in real time, but how these data can be used appropriately and effectively will be a major challenge for researchers and practitioners. Clearly, developing evidence that draws from and informs real-world care practices is a science, and improved methods for modeling and analyzing work processes and decision management are needed. This may require restructuring of the way we fund research. Federal agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Veterans Health Administration, the Centers for Disease Control and Prevention, and others, will be essential components of this dialogue and can demonstrate leadership by partnering across agencies, as well as with others in the private sector. Healthcare product developers in particular will be absolutely critical to the success of EBM, and collaborations that take advantage of this sector’s talent and expertise can be facilitated and encouraged through public-private partnerships. There is no doubt that the work to transform our healthcare system will be challenging. Many healthcare leaders have been working on improving the system for decades; but we all need to get on with finding a solution now. The Need for Better Medical Evidence Denis A. Cortese, M.D., Mayo Clinic In the United States the cost of health insurance is rising faster than wages at a rate that is not sustainable, but the quality of care—measured in outcomes, safety, and service—is much lower than it should be. Especially in comparison to other countries, the value of medical care in the United States is low but even among individual states of the United States the variability in the value of health care delivered is dramatic. Only 10 percent of the states provide high-value care on average, and the value of care in the United States on a whole is well below what should be expected. Given the current approach to health care, however, these shortfalls are not surprising. Across the healthcare system, competition and rewards are not based on value, and there are scant incentives for patients to seek—or for professionals to provide—high-quality, cost-effective health care. In reality there is no true healthcare system. There never has been a conscientious attempt to design and maintain a system that would create
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Evidence-Based Medicine and the Changing Nature of Health Care value. We now have an opportunity to take the steps to develop a vision, create a strategy, and specify goals for a true system of health care in the United States. Yet what should a healthcare system do? Some important elements would include enabling the assessment of an individual’s risk for developing an illness; rewarding the prevention of the onset of illness; making accurate, precise, and timely diagnoses; tailoring specific treatments to individual needs; and controlling chronic illness. In sum, a healthcare system should improve the quality of life and aim to keep people as well as possible, while ensuring that healthcare expenditures are affordable for both individuals and the nation. In essence, a reformed healthcare system should provide individuals with high-value health and health care. The overarching vision of a learning healthcare system conceived by the IOM’s Roundtable on Evidence-Based Medicine begins to describe the healthcare system needed to truly support value and improve health. Such a system would be “designed to generate and apply the best evidence for the collaborative choices of each person and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care.” Essential to informing this vision is an understanding of some of the key forces driving the need for better evidence. As outlined in Chapters 2 and 3, these forces include rising and unsustainable costs, wide variations in the quality and cost of health care delivered across the United States, and the complexity of care introduced by the emerging insights from genetic research and the diversity of new health products. Contending with the Changes Michael M. E. Johns, M.D., Emory University Many of the issues discussed throughout this publication are important for moving forward with needed healthcare system reform, but my focus is on key considerations for providers and, to some degree, patients. Most pressing in this respect is an improved understanding of what constitutes good evidence of effective care and outcomes. For a profession that adopted the scientific method about a century ago, there is alarmingly little evidence for the effectiveness of much of what is taught and practiced today. To get to an evidence-based, value-driven health system we have to align all of our professional educational programs to teach new systems and capabilities. Introduction to key concepts in EBM should begin, at the very least, at the college level. In addition, the dissemination and incorporation of new knowledge into practice must be accelerated so that it does not require a decade or more for the average provider to adopt new knowledge and skills. As more and better evidence is developed, effective processes
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Evidence-Based Medicine and the Changing Nature of Health Care and IT systems are needed to ensure that healthcare practice utilizes best evidence. These systems should also have feedback loops to continuously improve on the evidence. Systems must be interoperable and scalable and must also incorporate the patient into the decision-making and care provision processes. To be effective, systems must include the proper rewards, incentives, and financing for providers, as well as the means to pay for required processes and IT systems and innovations. The general public will need education and support to be able to use the copious medical information becoming available, as well as to gain an appreciation for information that is backed by solid evidence. Practitioners need to work with the public to help ensure that we find the right healthcare solutions for individual patients. The complexity of clinical evidence is daunting even for experienced, trained professionals who diagnose and treat disease; but it is far more challenging to the non-expert. Reducing this complexity is key to empowering patients—not only as better informed consumers of health care, but also as active partners in improving health outcomes. In addition, the right kinds of professional support should be made available to patients, whether through health coaches or other sorts of new professionals who can support and educate patients on the best evidence-based processes for health care and healing. It is clear that we are still at a rudimentary level of conceptualization and implementation of an evidence-based, value-driven healthcare system and that we still have a long way to go. Finding ways in which patients and providers can be proactive in catalyzing and implementing the needed changes is essential. The Promise of New Evidence John W. Rowe, M.D., Mailman School of Public Health, Columbia University A learning healthcare system is defined as one in which the usual and customary activities associated with the production, distribution, utilization, and financing of healthcare services result in the simultaneous development and capture of data that are essential to the monitoring and evaluation of health care delivered. A wide variety of information is contained in these data including, but not necessarily limited to, patient characteristics (e.g., genetics, race, ethnicity, socioeconomic status, behaviors, clinical conditions, functional status), environment, biologically targeted interventions, providers, outcomes, and costs; and opportunities are emerging to take better advantage of these data to guide care. Through efficient organization and analysis, and provision of findings at the point of care, these data are a rich resource for informed decision making.
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Evidence-Based Medicine and the Changing Nature of Health Care Two general categories of decisions require an expanded evidence base. The first category includes the use of drugs, devices, and procedures. The second category concerns the management of care itself, including the organization of care, IT, types and effectiveness of providers, and clinical pathways. Both categories require not only effectiveness information but also comparative effectiveness information, including cost or value. As emphasized in Chapter 2, attention is needed on the evaluation of drugs, devices, and procedures, as well as on systems of care and the healthcare professionals that are involved in the provision of the care. One of the major strategies proposed to hasten development of the required evidence base includes migration away from traditional reliance on RCTs and inclusion of a variety of other approaches and data sources. These include cluster analyses, registries with or without “coverage with evidence development” financing, and other innovative approaches. While such efforts may indeed supplement RCTs and accelerate the development of the needed evidence, there are concerns among many that such approaches do not have the reliability of the “gold standard” RCT, and that the time saved may not be worth the price paid in quality and reliability of the evidence. Is the question really black and white, or are there strategies to enhance the types of data being used to build the evidence while at the same time hedging against the pitfalls of lower quality and less reliability? The papers featured in Chapter 6 offer insights on the opportunities presented by EHRs and clinical registries, as well as some of the challenges of using these data to inform the development of effective healthcare interventions. Policies to Improve Value from Health Care John K. Iglehart, Health Affairs Public policy has a major role in shaping and driving the development of an improved healthcare system. The following chapters illustrate the potential of EBM to transform health care, and important policy considerations are detailed in Chapter 7. However, it is vital to keep in mind the substantial challenges inherent to the processes of policy making. In short, these processes are badly in need of repair because they have been corrupted by the corrosive impact of election campaign finance monies. Today, many members of Congress are in a permanent state of running their campaigns for reelection. It is not unusual for campaigns to raise millions from the very private interests that seek a return on their investments in the form of public policies that serve their own narrow interests, rather than the public’s interest. Presidential politics has become a billion-dollar enterprise, and one has to wonder what kind of impact that sort
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Evidence-Based Medicine and the Changing Nature of Health Care of money has on public policy. Is the public being served or sacrificed through this process? COMMON THEMES FROM THE 2007 IOM ANNUAL MEETING As suggested by the opening comments, the 2007 IOM Annual Meeting highlighted both the shortfalls of the current system, as well as the tremendous potential for an evidence-driven and value-based health care. The meeting was structured to provide an overview of the key challenges and opportunities for progress and improvement. Session 1 (Chapters 2 and 3) reviewed the need for better medical evidence, characterizing not only the waste and inefficiency endemic to health care and the unsustainable trajectory of healthcare expenditures, but also the challenges presented by medical technologies of increased diversity and complexity and an increasingly sophisticated understanding of genetic contributions to disease. Challenges faced by patients and providers in using evidence to better guide healthcare decisions were reviewed in Session 2 (Chapters 4 and 5). Also considered in these chapters were ways that advances in IT affect opportunities for improved access to health information and decision support. IT will also help transform how evidence is developed. The potential of EHRs, clinical data registries, and new research methods to speed the generation of evidence, as well as drive innovation and the development of tailored therapies were discussed in Session 3 (Chapter 6). The last session of the day was devoted to discussing how policy changes might facilitate better stakeholder alignment on how health care is structured and incentivized to deliver high-value health care. During the course of the meeting, a number of common themes were identified (Box 1-1). Increasing complexity of health care. New pharmaceuticals, medical devices, technologies, and predictive data offer much promise for improving health care, but they also introduce high levels of complexity, requiring changes on the parts of both caregivers and their patients. Unjustified discrepancies in care patterns. The intensity of healthcare services delivered for similar conditions varies significantly across geographic regions, particularly in areas that require discretionary decision making. However, the higher-spending regions often do not deliver better-quality care, hence offering substantial opportunity for reduced spending without sacrificing health outcomes. Importance of better value from health care. The current healthcare system is not designed to deliver value, and the nation’s long-term
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Evidence-Based Medicine and the Changing Nature of Health Care BOX 1-1 The Changing Nature of Health Care Common Themes Increasing complexity of health care Unjustified discrepancies in care patterns Importance of better value from health care Uncertainty exposed by the information environment Pressing need for evidence development Promise of health information technology Need for more practice-based research Shift to a culture of care that learns New model of patient-provider partnership Leadership that stems from every quarter fiscal challenges are serious and are being driven predominately by excessive medical spending, often on interventions of no clinical benefit. Opportunities exist to eliminate wasteful spending with no reduction in health care, as well as to improve the overall health outcomes, but agreement is needed both on what constitutes best care and on what constitutes value in health care. Uncertainty exposed by the information environment. An irony of the information-rich environment is that information important to clinical decision making is often not available, or is provided in forms that are not relevant to the broad spectrum of patients—with differing levels of health, socioeconomic circumstances, and preferences—and the issues encountered in clinical practice. This is due to too little clinical effectiveness research, to poor dissemination of the evidence that is available, and to too few incentives and decision supports for evidence-based care. Pressing need for evidence development. More and better evidence—including comparative and longitudinal data—is needed to determine the effectiveness and usefulness of new medical interventions, treatments, drugs, devices, and genetic information. There is an untapped potential to reduce healthcare costs and improve quality by developing evidence not only for specific medical interventions, but also for the way health care is delivered. Promise of health information technology. EMRs and clinical data registries offer tremendous potential both to generate new evidence and to augment RCTs. Addressing privacy and proprietary issues
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Evidence-Based Medicine and the Changing Nature of Health Care that limit data access and sharing would help to support a system in which EMRs, clinical registries, and other types of electronic data could contribute to building a more robust evidence base. Need for more practice-based research. How might the system better support the notion of a “living textbook of medicine” in which physicians routinely collect and record data on the treatment and outcomes of their patients in order to better care for those in the future? Shift to a culture of care that learns. To develop best evidence for the delivery of medicine that is geared toward the needs of individual patients, investment is needed into infrastructure for the gathering and analysis of healthcare data and information, as well as standards and protocols to ensure their accuracy and reliability. This changing role will require healthcare providers and patients to adopt a culture that supports the generation and application of evidence. Effective culture change must also be accompanied by insurance and reimbursement system reform that encourages development and application of the systems necessary. New model of patient-provider partnership. With the increasing complexity of care, and the need and demand for more patient involvement, the traditional “physician-as-expert” model will need to adapt to support patients as integral partners in medical decisions. Leadership that stems from every quarter. Adapting to and taking advantage of the changes in the healthcare environment will take broad leadership. A strategic focus on the development and application of evidence will require the involvement of both the public and private sectors working together, and of policy makers, providers, patients, insurers, and other stakeholders in the steps toward change. REFERENCES AcademyHealth. 2005. Placement, coordination, and funding of health services research within the federal government. http://www.academyhealth.org/publications/placementreport.pdf (accessed May 15, 2008). AdvaMed (Advanced Medical Technology Association). 2004. The medical technology industry at a glance. Chart 3.6, p. 16. AHRQ (Agency for Healthcare Research and Quality). 1998. Medical expenditure panel survey. http://www.meps.ahrq.gov/mepsweb/ (accessed March 26, 2008). Anderson, G. F. 1997. In search of value: An international comparison of cost, access, and outcomes. Health Affairs 16(6):163-171. BIO (Biotechnology Industry Organization). 2006. Total biotechnology patents granted per year. htttp://www.bio.org/speeches/pubs/er/statistics.asp (accessed December 31, 2007).
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Evidence-Based Medicine and the Changing Nature of Health Care IOM (Institute of Medicine). 2000. To err is human: Building a safer health system. Washington, DC: National Academy Press. ———. 2001. Crossing the quality chasm: A new health system for the twenty-first century. Washington, DC: National Academy Press. ———. 2007a. The learning healthcare system: Workshop summary. Washington, DC: The National Academies Press. ———. 2007b. Learning what works best: The nation’s need for evidence on comparative effectiveness in health care. http://www.iom.edu/ebm-effectiveness (accessed January 22, 2008). Mathers, C. D., C. J. L. Murray, A. D. Lopez, J. A. Salomon, R. Sadana, A. Tandon, T. B. Ustün, and S. Chatterji. 2001. Estimates of healthy life expectancy for 191 countries in the year 2000: Methods and results, in global programme on evidence for healthy policy discussion, paper no. 38. Geneva, Switzerland: World Health Organization. Moses, H., 3rd, E. R. Dorsey, D. H. Matheson, and S. O. Thier. 2005. Financial anatomy of biomedical research. JAMA 294(11):1333-1342. OECD (Organisation for Economic Co-operation and Development) health data. 2006. How does the United States compare? Paris, France: Organisation for Economic Co-operation and Development. Research!America. 2005. National survey. Germantown, MD: Charlton Research Company. ———. 2006. 2005 investments in U.S. health research. http://www.researchamerica.org/app/webroot/uploads/healthdollar2005.pdf (accessed March 6, 2008). UNOS (United Network for Organ Sharing). 2008. The organ procurement and transplantation network. Chart: Transplants by donor type, January 1, 1998-November 30, 2002. http://www.optn.org/latestData/rptData.asp (accessed March 6, 2008). Wu, S.-Y., and A. Green. 2000. Projection of chronic illness prevalence and cost inflation. Santa Monica, CA: RAND Corporation.
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