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Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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Summary

This volume reports on discussions among multiple stakeholders about ways they might help transform health care in the United States. The U.S. healthcare system consists of a complex network of decentralized and loosely associated organizations, services, relationships, and participants. Each of the healthcare system’s component sectors—patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employers and employees, and individuals involved in information technology—conducts activities that support a common goal: to improve patient health and well-being. Implicit in this goal is the commitment of each stakeholder group to contribute to the evidence base for health care, that is, to assist with the development and application of information about the efficacy, safety, effectiveness, value, and appropriateness of the health care delivered.

Because the nation falls far short of the possible in this respect, the Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine was established in 2006 as a unique and neutral venue where the key stakeholders could work cooperatively to help transform the way in which evidence on clinical effectiveness is generated and used to improve health and health care and to drive improvements in the effectiveness and efficiency of medical care in the United States (Fisher, 2005; IOM, 2007; McGlynn et al., 2003; Wennberg et al., 2002).

The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteur and Roundtable staff as a factual summary of workshop discussions

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

Central to the Roundtable’s work are the notions that, collectively, the healthcare sectors possess the knowledge, expertise, and leadership necessary to transform the healthcare system and that what is most acutely needed is a shared commitment to improving the development and use of information about the efficacy, safety, effectiveness, value, and appropriateness of the health care delivered. Roundtable members have developed a vision for a learning healthcare system needed to achieve their goal: by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information and will reflect the best available evidence.

Fostering the collaborative work necessary to achieve this goal is the aim of the IOM Roundtable’s sectoral strategies process, which took place through the activities of nine sector-specific groups over several months in 2007 and culminated on July 23 and 24, 2007, in the third workshop in the Learning Healthcare System series, titled Leadership Commitments to Improve Value in Health Care: Finding Common Ground. The ideas presented and discussed at the workshop are summarized here. The three goals of the workshop were (1) to consider stakeholder capacity for stronger progress toward a learning healthcare system; (2) to explore transformational opportunities; and (3) to identify possibilities for collective initiatives that might be considered by Roundtable sectors.

In the months before the workshop, Roundtable members were asked to reach out to colleagues in their sectors to describe perspectives on the key challenges and opportunities for healthcare improvement, as well as how each sector might contribute to advancing progress toward the Roundtable’s goal. Background papers summarizing these discussions were prepared and presented at the July workshop to provide context for cross-sector discussions. The elements of this process are presented in Appendix A and summarized as follows

  • January: the initial formation of nine Roundtable sectoral discussion groups

  • February and March: reaching out to other sectoral participants in preparing background material

  • April: completion and circulation of strategy background paper to sector participants

  • May: circulation of sector review draft to Roundtable members in each sector group

  • June: consolidation of draft sectoral strategy background papers and dissemination to all Roundtable members

  • July: presentation of authored background papers for public discussion at an IOM workshop on sectoral strategies

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

The workshop presentations of these sector-oriented perspectives were designed by presenters to highlight their views of the key advances, transformational opportunities, and cross-sector collaborations needed to achieve the stated goal.

The nine sectoral discussion groups were not Academy-appointed committees, and there was no attempt to ensure group consensus. The background papers reflect the views of the individuals who participated in the discussions prior to and during the workshop, as interpreted by the group coordinators and staff.

The purpose of this summary is to present lessons from experience; outline the range of key issues, stakeholder concerns, barriers, and challenges; and offer some potential responses as described by workshop participants. This chapter briefly summarizes workshop presentations, discussions, and relevant background materials and their relation to the workshop goals and to the overall Learning Healthcare System series of meetings. It has been prepared in consultation with the authors of sectoral background papers and reviewed independently by a committee appointed by the National Research Council to ensure that it is accurate and faithful to the meeting’s purpose and content. It does not, however, represent an Academy consensus document, nor does it contain recommendations. Later chapters describe the presentations in more depth.

The greater part of workshop discussions focused on finding areas of common ground in which participants might join together on activities most important to the improvements necessary to fulfill the Roundtable’s goal. Part One of this publication, Finding Value in Common Ground, presents a synthesis of the workshop discussions in the context of the Roundtable’s focus and the workshop goals: the perspective guiding the sectoral strategies process (Chapter 1), important conceptual foundation stones needed for progress (Chapter 2), transformational opportunities recognized by participants as priority areas for focus and immediate work (Chapter 3), and areas for enhanced cross-sector collaboration (Chapter 4).

Drafts of the authored background papers were revised to incorporate the workshop discussions, and final versions are included in their entirety in Part Two of this publication, Leadership Commitments to Improve Health Care (Chapters 5 to 13). Appendix B provides the workshop agenda, Appendix C presents biographical sketches of the speakers, and Appendix D lists the workshop participants.

COMMON CONCERNS AND THEMES

The spirit of the workshop discussion was one of open exchange, and over the course of the 2-day meeting, participants underscored many pressing concerns common to all sectors, the following in particular:

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×
  • Rising costs and limited resources. Whether they are borne by those receiving or providing care or accrued during research on or the development of treatments and therapies, participants cited costs as limiting factors for access to and innovation in health care.

  • System inefficiencies. The quality of health care in the United States is uneven and delivered by a system characterized by inefficiency and waste. The existing evidence is poorly applied, and the delivery of care for similar conditions varies widely throughout the country. Standards for care, healthcare system components, and even research are often inconsistent.

  • Increasing complexity. Whether it is because of the increased importance of genetic variation, the rapidly evolving landscape of medical technologies, or the growing prevalence of chronic disease, medicine is becoming increasingly complex.

  • Expanding evidence gap. Across the practice of health care, information is lacking for many key personal health or policy decisions. The “inference gap” between the evidence available and that needed to treat real-world populations will only widen as new interventions are introduced into the marketplace and health care moves further in the direction of personalized treatments.

  • Limited system capacity and flexibility. The number of questions that need to be addressed to ensure appropriate care continues to expand exponentially, rendering impractical the current approach to the development of evidence. Although randomized controlled trials are important in certain circumstances, they cannot provide all the information necessary. The availability of technologies lags the demand. Whether through habit or other circumstances, evidence is neither getting translated to the extent that it needs to be nor distributed as widely as it should be.

  • Entrenched cultures. Health care has various customs and practices often not conducive to reform. Caregiving and caregivers are often “siloed,” with inadequate communications among the various functional areas of the healthcare system. Information is not shared as widely as it should be within specific healthcare systems, let alone between systems, contributing to inefficiency and distrust in the system. In general, providers, patients, and other sectors do not yet believe that the development of evidence is an activity relevant to their experience in the routine delivery of care.

Several general themes were recurrent over the course of the meeting as issues important across stakeholder categories (Box S-1).

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

BOX S-1

Common General Themes

  • Build trust and collaboration

  • Foster agreement on “value” in health care

  • Improve public understanding of evidence

  • Characterize the impact of shortfalls in the evidence

  • Identify the priorities for evidence development

  • Improve the level, quality, and efficiency of the research

  • Clarify and promote transparency

  • Establish principles for the interpretation and use of evidence

  • Improve engagement in the full life cycle of interventions

  • Focus on frontline providers

  • Foster a trusted intermediary for evidence

  • Build the capacity to meet the demand

  • Create incentives for change

  • Accelerate advances in health information technology

  • Build trust and collaboration. How can the distrust that has emerged in health care—for example, distrust between and among patients and providers, providers and insurers, insurers and manufacturers, and manufacturers and regulators—be reduced? Health care depends for its effectiveness on the close cooperation of all parties involved. Building trust and facilitating transformative change will require broader-based collaboration and cooperative stakeholder engagement.

  • Foster agreement on “value” in health care. What constitutes value in health care: reduced death or disease, better function, less pain, a better sense of well-being, fewer hospital days, or lower costs? Although all participants agreed on the centrality and importance of the value achieved from health care, different groups think of value in different ways. A multistakeholder effort might drive clarity and consensus on the principles and elements of value common to all stakeholders.

  • Improve public understanding of evidence. What can be done to improve public understanding, acceptance, and demand for evidence-based care? Too often, people perceive that certain common terms such as “evidence based,” “research,” “medical necessity,” and “risk” suggest a restrictive or experimental element to their care. It will take a systematic and coordinated communi-

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

cation strategy to better convey the central concepts that medical evidence is dynamic, that evidence-based medicine is the provision of care that the evidence suggests is best for any given patient at any given time, and that health care is a joint patient-provider endeavor.

  • Characterize the impact of shortfalls in the evidence. What might be the tangible impact of broad improvements in the availability and application of appropriate evidence for healthcare decisions on patients, on providers, and on society? Documenting the consequences of provision of care on the basis of too little evidence or the potential benefits of providing care on the basis of the right evidence is a prerequisite to obtaining an improved understanding of and demand for evidence-based care and stakeholder activation.

  • Identify the priorities for evidence development. Which medical care dilemmas represent the most challenging and pressing needs for better comparative information and guidance on choices among the available and the emerging diagnostic and treatment options? The first step toward a systematic and coordinated effort to conduct the most important assessments is identification of priorities as a sort of consensus national problem list and research agenda for the most pressing issues for medical care decisions.

  • Improve the level, quality, and efficiency of research. How can the healthcare system take better advantage of emerging clinical record resources to gain insights into the evidence? Policies that facilitate the ability to use clinical data to monitor the effectiveness of interventions are needed. Novel approaches to the conduct of clinical trials are also needed. A more structured lexicon for “best practices” in undertaking observational studies may be necessary.

  • Clarify and promote transparency. What principles define openness in health care, clinical research, the interpretation of evidence, coverage decisions, regulatory policy, marketing practices, oversight, and the governance of use of clinical data? Consensus is needed to establish common principles of transparency and standards for how they should be applied in each sector. One starting point might be with principles for evidence interpretation.

  • Establish principles for the interpretation and use of evidence. What guiding principles related to application of the available evidence might be used to help decision makers determine when they should apply a proposed diagnostic or treatment intervention? Decisions about market approval, insurance coverage, provider use, and patient acceptance are all informed by some interpretation of the evidence. Clarity of the guiding principles is important.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×
  • Improve engagement in the full life cycle of interventions. How should assessments and decisions on proposed healthcare services be tailored to ensure that each stage of the development and application process for a given intervention builds efficiently to the next? Many factors are at play for each intervention—for example, similarity to previously tested interventions, the safety and effectiveness of an intervention for some populations but not others, the availability of biomarkers predictive of efficacy, and costs that vary by scale and stage of application or by the need for later services. Facilitating innovation, access, and effective information gathering while emphasizing patient safety, appropriate application, improved outcomes, and efficiency will require a set of life cycle-oriented decision-making rules that are more carefully considered than they are at present.

  • Focus on frontline providers. What key levers might help ensure that both primary care and specialty providers are taking full and appropriate advantage of the best available evidence in the care they provide? Accelerating the translation of clinical research into practice involves addressing matters of professional education, credentialing, licensure, practice support, economic incentives, patient acceptance, and the culture of care. It will require the central and coordinated involvement of the organizations that represent those providers.

  • Foster a trusted intermediary for evidence. How can patients, providers, healthcare organizations, employers, insurers, and others know when they have the best evidence on which to base the healthcare decisions they make? In this information age, health-related information is presented constantly through news reports, marketing, professional organizations, journals, and the Internet; but it is often confusing and even contradictory. A trusted information source—one that is independent but that engages all stakeholders—is needed to identify gaps; set priorities; establish standards; and guide the development, interpretation, and dissemination of evidence on clinical effectiveness.

  • Build the capacity to meet the demand. What mechanism is necessary to close the current and emerging gaps in evidence on the relative effectiveness of various interventions, to ensure the quality and integrity of the studies used to establish the evidence, and to provide a sustained capacity to meet the need? Currently, the combined resources of the various public and private organizations involved in studying comparative clinical effectiveness meet but a small and scattered fraction of the demand. The centrality of this problem to the quality and efficiency—the viability, according to

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

some—of the nation’s healthcare system may require the creation of a new independent entity devoted to the work.

  • Create incentives for change. What practice-based economic and policy incentives might help enhance the next generation of new evidence and transform the ability and commitment of providers to use the best available evidence and more fully engage patients in the clinical decision-making process? Approaches include the alignment of purchasing incentives when value is determined; use of the reimbursement power of insurers and other financial incentives to generate new insights from medical care (e.g., coverage with evidence development); and the linkage of purchaser and payer decisions to performance incentives for best practices, outcomes, and the better secondary use of routinely collected data.

  • Accelerate advances in health information technology. What can stakeholders do to accelerate the nation’s progress toward the goal of the universal application of interoperable—or functionally accessible—personal and organizational electronic health records, as well as toward the goal of providing real-time electronic access to the best information available? Health information technology can facilitate the development of learning networks and accelerate the generation of evidence, enable data aggregation and utilization, deliver evidence to the point of care, and expand research capacities. Coordinated stakeholder action—and financial incentives—should be able to speed the progress necessary on both the basic interoperability issues (e.g., standards and vocabulary) and, possibly, the development of more radical data search innovations.

Several opportunities for collaborative activities by Roundtable members and participating sectors were identified by participants in the discussions:

  • Development of a priority assessment inventory. Termed a “national problem list” by meeting participants, this is a multisector collaborative effort to develop criteria and a list of the diagnostic and treatment interventions that might be viewed as particularly important for the development of comparative effectiveness studies. The list will serve as a means of illustrating and prompting discussion on the key evidence gaps and on the design, support, and execution of the studies needed.

  • Pursue agreement on the value proposition. Identify key concepts and elements to be considered in assessing and characterizing value from health care, setting the stage for discussions on approaches to assessing those elements and applying to add perspective and inform decision making. An IOM workshop, Value in Healthcare:

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

Accounting for Cost, Quality, Safety, Outcomes, and Innovation, was convened in November 2008, with publication of the workshop summary expected in 2009.

  • Identify common principles for evidence interpretation and use. Identify the core principles underpinning activities in interpretation and use of evidence, as background for discussion of the implications and of the ways the principles might be applied in the development of a framework adaptive to different circumstances related either to the evidence base or the condition of interest.

  • Foster cooperative data sharing. Several issues are important in this regard: platform compatibilities, standards, economic incentives and disincentives, the regulatory and privacy environment. Health Insurance Portability and Accountability Act issues are being addressed by an IOM Committee expected to issue its report and recommendations in 2009, including those related to the use of clinical data for knowledge development. The Roundtable’s February 2008 meeting, Clinical Data as the Basic Staple of Healthcare Learning: Creating and Protecting a Public Good, addressed a number of the other issues related to sound data stewardship. And collaborative work has been sponsored by the Roundtable on mining electronic health records for postmarket surveillance and clinical safety and effectiveness insights.

  • Pursue a public communication initiative on evidence-based medicine. Use the Roundtable membership’s collective communication expertise to explore improving terminology and advancing public awareness on the nature and importance of evidence in medical care, the key needs, and the centrality of patient and provider communication around the state of the evolving evidence for individual treatment choices. The Roundtable’s Evidence Communication Collaborative has a working group actively working on a communication initiative proposal.

  • Support progress on a trusted intermediary for evidence promotion. The Roundtable’s Sustainable Capacity working group oversaw the development of a comprehensive Issue Brief, framing the issues and options under discussion related to enhancement of the national capacity to develop, evaluate, organize, validate, and disseminate information on the comparative effectiveness of health interventions. Technical assistance and related information is provided on an ongoing basis to the various policy discussions of the issue.

  • Identify the potential from best practices in the use of evidence. It is important to assess and underscore the best practices in evidence development and application, including consideration of ongoing methods of identifying and disseminating those best practices. A

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

working group is underway to characterize the potential returns from implementing certain established best practices.

  • Enlist front-line healthcare providers more effectively. Charge the sectoral working group on providers with proposing approaches to convening a coalition of provider groups, perhaps under Roundtable auspices, to consider sustained, coordinated work on health professions education, testing, credentialing, and practice setting tools and structure to improve focus, accessibility, use, and generation by providers of the best evidence. A Roundtable collaborative of providers is being formed to engage this issue.

PART ONE:
FINDING VALUE IN COMMON GROUND

The Learning Healthcare System series of workshops sponsored by the IOM Roundtable on Evidence-Based Medicine is designed to both identify and discuss the most important advances needed to transform health care, with sector leadership and collaboration in this work. This workshop was aimed at considering how various sectors could make a difference. The sectoral strategies perspective development process engaged participants in the development of authored background papers to be presented during the workshop, as a first step toward the national conversation needed on how to facilitate a better alignment and better collaboration among the various sectors of the healthcare system. Part One provides a synthesis of the workshop discussion among participants from different sectors. The material presents the individual views of the participants of the workshop and does not represent the consensus of the discussion groups, the workshop participants, the Roundtable, or the IOM.

Guiding Perspective: The Learning Healthcare System

The Roundtable’s goal for 2020 specifies what ought to be expected from a healthcare system that “draws upon the best evidence to provide care that is the most appropriate for each patient, emphasizes prevention and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improvements in the nation’s health.” Central to this vision is the development of a healthcare system that learns by generating and applying evidence as a natural component of the process of providing health care (IOM Roundtable on Evidence-Based Medicine, 2006).

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×
The Learning Healthcare System

The guiding perspective for the Roundtable’s vision and for the development of background papers from each sector is that of a learning healthcare system. Its key characteristics were discussed at the Roundtable’s inaugural workshop and summarized in the annual report of the Roundtable, Learning Healthcare System Concepts v. 2008 (Institute of Medicine, 2008):

  • Continuous improvement in the value delivered. A learning healthcare system is one that maintains a constant focus on the health and economic value returned by care delivered and continuously improves in its performance.

  • Learning in health care as a partnership enterprise. Broad culture change is needed to enable the evolution of the learning environment as a common partnership of patients, providers, and researchers alike.

  • Developing the point of care as the knowledge engine. Given the rate at which new interventions are developed, along with new insights about individual variation in response to interventions, the point of care must be the central focus for the continuous learning process.

  • Full application of information technology. The rate of learning—both the application and the development of evidence—will depend on the full and strategic application of information technology, including electronic health records central to long-term change.

  • Database linkage and use. The emergence of large, electronically based datasets offers important new sources for quality improvement and evidence development. Progress requires fostering interoperable platforms, linking analyses, establishing networks, and developing new approaches for ongoing searching of those databases for patterns and clinical insights.

  • Advancing clinical data as a public utility. Meeting the potential for using new datasets as central sources of evidence on the effectiveness and efficiency of medical care will require recognition of their qualities as a public good, including assessing issues related to ownership, availability, and use for real-time clinical insights.

  • Building innovative clinical effectiveness research into practice. Improving the speed and reliability of evidence development requires fostering development of a new clinical research paradigm—one that deploys careful criteria for trial conduct, draws clinical research more closely to the experience of clinical practice, advances new study methodologies adapted to the practice environment, and engages cultural incentives to foster more rapid learning.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×
  • Patient engagement in the evidence process. Accelerating the potential for better development and application of evidence requires improved communication between patients and healthcare professionals about the nature of the evidence base and the need for partnership in its development and use.

  • Development of a trusted scientific intermediary. Greater synchrony, consistency, and coordination in the priority setting, development, interpretation, and application of clinical evidence require a trusted scientific intermediary to broker the perspectives of different parties.

  • Leadership that stems from every quarter. Strong, visible, and multifaceted leadership from all involved sectors is necessary to marshal the vision, nurture the strategy, and motivate the actions necessary to create the learning healthcare system we need.

Patients, Providers, and Evidence Stewardship

In addition to these background features of the learning healthcare system, perspectives to inform the workshop discussions were provided by presentations on the issues of importance to patients, healthcare providers, and the evidence base for medical decisions. To frame these key perspectives, three authorities were asked to envision what an ideal experience for patients and providers and ideal stewardship of the evidence within a learning healthcare system might look like and, by contrasting the ideal situation in these areas with the current situation, to identify some priority areas for improvement. Margaret C. Kirk, chief executive officer of the Y-ME National Breast Cancer Organization and chairperson-elect of the National Health Council, commented from the patient’s perspective. Terry McGeeney, a family physician and chief executive officer of a physician practice redesign initiative, commented from the provider perspective. Sean Tunis, founder and director of the Center for Medical Technology Policy, offered his thoughts on stewardship of the evidence. The full texts of their observations can be found in Chapter 1 of this document. Brief summaries follow here.


Patients Drawing upon her experience working as a patient advocate, Margaret Kirk advised that because the ideal patient experience varies according to the patient’s circumstance, maintaining the perspective of the patient as an individual is particularly important. Balancing the understanding that patients can react differently to treatments with the nation’s urgent need to ensure quality care and use healthcare resources wisely will be a key challenge. Evidence-based medicine can be a powerful tool to ensure the best possible medical outcome; help close the quality chasm across geographic

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

regions, treatment settings, and socioeconomic levels; and channel resources to their most effective use. However, to be applied successfully, evidence-based medicine must be structured to reflect the reality that what works for most patients may not be appropriate for others and that many other factors, such as patient life-stage and circumstances, should be considered alongside the evidence in determining any course of treatment. To achieve this vision of patient-centered care, the evidence base must be strengthened considerably; focus on outcomes important to patients, including quality of life; and account for variations among individuals. Better comparative, patient-directed risk-benefit information is needed, and the patient—as well as his or her family—must be considered an active and respected member of the healthcare delivery team from the outset of treatment decisions.

Fundamentally, patients who understand the evidence will make better decisions regarding their health care. However, studies have demonstrated that quality or a lack of adherence to evidence-based guidelines is not the primary concern of patients, emphasizing the importance of better communication with the general public about the importance of evidence to improve their health care, health, and well-being. Patients must also be encouraged to take an active part in healthcare decision making through a process in which both patients and providers engage in a thorough discussion of treatment options and consideration of patient preferences. The development of effective communication techniques and tools will rely on an improved understanding of patient needs and adherence to high standards of clear health communication to avoid patient misunderstanding and mistrust.


Providers Terry McGeeney offered a perspective garnered from his years in practice as well as from his broader work dedicated to revitalizing family medicine. He began by noting that although all healthcare professionals strive to provide the best care to their patients, many practical realities present barriers to the consistent delivery of efficient, high-quality care. The medical home model was discussed as a possible approach to care that could help providers contend with these types of barriers and deliver care guided by the principles of patient centeredness, orientation toward the whole person, and a continuous relationship between provider and patient. Important supporting elements of the medical home include ensuring patient access both to care and to information, provision of information systems such as electronic health records with point-of-service reminders to support best practices, redesigned offices to increase practice efficiency, increased focus on quality and safety, efficient practice management, point-of-care services, and a team approach to providing care.1 At the time of the

1

The TransforMED Medical Home Model can be found at http://www.transformed.com.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

workshop, four primary care organizations representing 365,000 physicians had signed on to this model, including the American Academy of Pediatrics, the American College of Family Physicians, the American College of Physicians, and the American Osteopathic Association.

Current practice experience falls short of this ideal in part because of inefficient workflows and support systems—which result in long delays for straightforward tasks such as patient follow-up or appointment scheduling—and because of the lack of adequate training and information systems needed to support the practice of evidence-based medicine. Overall, the fragmentation of information, expertise, and care delivery processes greatly compounds the complex task that healthcare professionals face when they try to deliver the right care at the right time.

McGeeney also viewed misaligned financial incentives and the poor adoption of technologies that support clinical practice as important barriers; however, he identified the need to change the culture of medicine as the most difficult challenge. Current practice is dominated by the notion of the physician as “captain of the ship,” but it is characterized by weak coordination of care and limited information sharing. High-quality point-of-care services, including wellness promotion, disease prevention, and acute and chronic disease management, will increasingly depend upon the adoption of a team approach to care. Physicians and practices will have to work to coordinate their care with other providers, including colleagues in mental health centers, community health centers, social workers, pharmacists, physical therapists, nurse practitioners, and physician assistants. Communication and information sharing among healthcare professionals and with patients will be paramount, and clinical practices must gain a better understanding of how they should communicate with patients to encourage their participation in the decision-making process. Leadership by healthcare providers will be fundamental to progress but must be backed by broad changes to the healthcare system, including the development and availability of actionable comparative effectiveness information and electronic health records that meet the needs of patients and providers.


Stewardship of the evidence To create the ideal experience for patients and providers, the development of evidence that is timely, reliable, and relevant is essential. Sean Tunis’ work at the Centers for Medicare and Medicaid Services (CMS) and, more recently, the Center for Medical Technology Policy has informed his view that evidence stewardship should be characterized by the use of efficient and reliable methods for the development, dissemination, and application of evidence. Looking specifically at evidence development, Tunis noted that the ideal method for developing the necessary evidence is not yet known, and a willingness to support and try various approaches and strategies is of acute importance to improving stewardship of the evidence.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

Several innovative approaches that are being used or are under development to improve and accelerate evidence generation were discussed.

Decision making—whether clinical or policy related—is based on the development of evidence through systematic reviews of the literature, decision modeling on the basis of the findings from literature reviews, retrospective analyses of administrative claims data or electronic health record data, and experimental or observational prospective studies. Confidence in the quality of the evidence derived by these methods ranges from low to high, but for decision makers, there is often no clear point at which evidence can be considered adequate to demonstrate improved net health outcomes. In the context of policy decisions this challenge is compounded by the evolving nature of the evidence, with important information about a technology or treatment not always available at the time that Food and Drug Administration (FDA) approval or coverage decisions are made. Because the necessary data are often accumulated only after the introduction of an intervention into clinical practice, some coverage policies have begun to provide options that allow decision making to be linked more precisely to evolving evidence. Examples of conditional approval policies include coverage with evidence development, value-based insurance design, and risk-sharing price models. These approaches allow postponement of further decision making until sufficient evidence is generated, allowing the reimbursement process to promote rather than create a barrier to the generation of additional evidence. Initial lessons learned include the need to ensure that the data collected are useful and informative and that appropriate mechanisms are in place to ensure support for projects carried out to obtain evidence. Other challenges include achieving stakeholder consensus on issues such as the adequacy of the evidence, determination of the additional evidence needed, and appropriate methodologies for the gathering of evidence.

The most pressing need is for work on study design and execution to better characterize the limits and appropriate uses of the various methodologies. The limits of randomized controlled trials (RCTs) and the promise of data from electronic health records have been widely touted, fueling an increased interest in pragmatic studies in real-world settings and observational methods using claims and electronic health record data. However, improvements in all study designs are needed to help develop a better understanding of what works under which circumstances. Prospective clinical trials will continue to be an important source of information, and exploration of the range of methodologies is needed to facilitate more efficient RCTs and, as appropriate, the increased use of pragmatic clinical trials and observational methods. In these efforts to improve methodologies, stakeholders must be engaged meaningfully, and patients and clinicians must be maintained as an organizing focus.

Finally, a recent proposal for the creation of a central enterprise for

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

comparative effectiveness studies was discussed as a possible opportunity to improve stewardship of the evidence by improving the capacity for study execution and coordination of the dissemination of results. However, Tunis reminded workshop participants that some capacity for comparative effectiveness research exists and could be expanded without the creation of a new entity. Since previous efforts to conduct similar activities have largely failed, careful consideration is needed to determine whether and how these proposals will allow true progress.

Foundation Stones in the Common Ground

The first goal of the workshop was to consider elements of the stakeholder capacity to foster progress toward a learning healthcare system. As component players in health care, individuals from various sectors came to the workshop committed to exploring areas of common interest. The majority of the discussion was focused on achieving broader stakeholder cooperation and leadership. In 2 days of dialogue, frequent mention was made of certain basic characteristics of a more efficient and effective healthcare system (see Chapter 2).

Building Trust: Transparency and Value

The effectiveness of health care depends on the close cooperation of all parties involved, yet to some extent, certain levels of distrust pervade the healthcare system. Constructive steps are needed to build higher levels of trust into the fabric of the system. Workshop participants discussed the need for increased process transparency and establishing a shared sense of value in health care. Increased transparency was noted as a prerequisite for trust, meaning work to transform health care into a system whose processes, decisions, policies, and practices are developed in a manner that is more open to scrutiny and have appropriate levels of accountability. As a first priority, principles for the interpretation and use of evidence were mentioned several times as key. The push for greater transparency was also reflected in a discussion focused on clarifying various stakeholders’ perspectives on value. In health care, value hinges on the ability to foster the best outcomes, ensure the best safety, and deliver the best service at the most affordable or the lowest cost; however, although stakeholders agree on the centrality and importance of the value achieved from health care, different groups conceptualize value in different ways. Clarification of the common elements of a value proposition for health care was viewed as essential to establishing a greater degree of trust among stakeholders.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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Shared Commitment to Evidence-Driven Care

The presentations from various sectors included an array of opportunities and activities that could be used to better support evidence-driven care, ranging from the technical advances needed in information technology systems to the structuring of incentives to support an evidence-driven system that consistently applies evidence and captures the results for improvement. Importantly, a visible and shared commitment to evidence-driven care was constantly underscored as necessary to expand these activities across the healthcare system as a whole and to discover untapped resources and new opportunities for collaboration.

Building Learning into the Culture of Health Care

Making learning an explicit component of the experience and culture of heath care will require work on many important, interrelated dimensions. Participants noted the importance not only of developing the tools necessary for clinical experience to capture and apply new knowledge, but also of the culture change to ensure the priority given it by physicians. The value of evidence-based practice needs to be better incorporated into medical school curricula and made an integral part of continuing education for physicians. It was also noted that physician graduates often find a wide gap between discussions of evidence in medical school and applications of evidence in actual practice. Strategies are needed to embed the collection and use of evidence in individual medical practices, particularly for physicians in small private practices. Concomitant with cultural changes, mechanisms must be created to enable, support, and reward education and related practice support for evidence-based medicine. From more robust databases to improved methodologies for clinical trials and studies and the development of innovative tools by the use of information technology, systems need to consciously link research with practice in the development of knowledge. Frequent comments were made about the need for incentives to be structured so that they clearly support and reward practices that link evidence with learning. Education is needed, too, to help patients understand how the collection of evidence and the learning derived from that evidence can affect the quality of individual health care.

Common Focal Point and a Trusted Source

The need for coordination in the development and dissemination of information on clinical effectiveness was a prominent issue in workshop discussions. Most stakeholder presenters spoke in favor of the establishment of some version of a national entity, that is, a trusted source that

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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is independent but engages all stakeholders; that has a certain degree of authority; and that could serve to identify gaps, set priorities for research, establish standards for interpretation and use of evidence, or otherwise guide the development, interpretation, and dissemination of evidence on clinical effectiveness. Such an entity might perform a number of important functions, including establishing a national research agenda on the basis of priority interventions for which the development of evidence about the relative risks and benefits of competing therapies is needed, ensuring the generation of valid and reliable evidence, and developing and interpreting research results. It could disseminate research-based knowledge to all stakeholders, including the public; discern where gaps in research now exist and marshal the resources, including the research expertise, infrastructure, and funding, needed to fill such gaps; or serve as a clearinghouse to ensure the ongoing and widespread sharing of evidence. Others felt that even if a new entity was not created, stronger coordination was needed to improve the consistency and effectiveness of the evidence development process. Some cautioned that care must be taken to ensure the ongoing encouragement of innovation.

Stakeholder Leadership for Change

Participants commented that illustrating the importance of evidence in improving health and guiding healthcare decisions should be a high priority for all sectors and that leadership is needed above all to promote the systemwide adoption of evidence-driven care. Although presenters for each sector commented on the clear potential of information about what works in health care and more rigorous application of clinical evidence to drive significant improvements in the outcomes derived from the healthcare system, this perspective was often not shared or articulated broadly within each sector. Fostering intrasectoral outreach and communication efforts could offer a substantial opportunity for stakeholders to demonstrate a shared commitment to evidence-driven care. In addition, sectors could develop a systematic, coordinated communication strategy to better inform the general public and other key audiences, such as opinion shapers and policy makers, about the central principles of evidence-based medicine. Together, these efforts would advance an important dimension of improving the generation and uptake of evidence by creating a demand for it. In this area, an important opportunity for collaboration among the sectors might be exploration of a follow-on approach to the sectoral strategies statements that would help expand the sphere of sectoral engagement, cooperative consideration, and action on crosscutting issues.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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Transformational Opportunities

The second goal of the workshop was to explore potentially transformational opportunities for the sectors to help improve value from health care. Change on a significant scale is predicated to create the evolution of a learning healthcare system that returns the value needed, and the workshop discussions were therefore broad and ambitious in scope. Nonetheless, participants emphasized certain areas or activities as particularly key to progress. Areas of focus and some practical next steps are noted below and discussed in Chapter 3.

Focus on the Value Proposition

Already noted as essential to establishing a greater degree of trust between stakeholders, agreement on the value proposition in health care is clearly central to framing priorities, setting standards, and developing incentives that can produce the desired outcomes for the system as a whole. Cross-sectoral conversations about value were considered particularly pressing, given the number of reform efforts that focus on measuring and rewarding value. The perspectives of various stakeholders on the value proposition were discussed throughout the workshop, and as a priority item, participants suggested that a multisectoral effort is needed to explore how these perspectives might be brought into closer alignment. Roundtable members offered to provide input on the key elements that need to be considered in assessing and characterizing value from health care, as well as the ways in which those elements might be applied. Stakeholder input could be summarized and distributed for comment and discussion by the Roundtable and at a possible future workshop.

Transparent Principles and Processes for Evidence Interpretation and Use

Increased transparency was also suggested as being essential for greater stakeholder trust and collaboration. The principles and processes for evidence interpretation relate to questions of value, and ensuring transparency in these processes was viewed as a natural prerequisite to clarification of the value proposition. Discussants noted that work is needed to define the principles that guide the application of evidence when decisions between various diagnostic or treatment interventions have to be made, as well as the interpretation of evidence in processes such as market approval, insurance coverage, provider use, and patient acceptance. Some participants suggested that the Roundtable might seek input from stakeholders on the key elements to be considered in identifying principles that could govern the way evidence is interpreted and used and that should ensure the needed

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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transparency. Input could be summarized and synthesized into a common set and then advanced for public and Roundtable discussion.

National Priorities: Challenges of Unused and Unavailable Evidence

Defining a set of national priorities for evidence production and application was viewed by participants as possibly enabling greater stakeholder focus and collaboration in more effective deployment of resources and improvement of the healthcare system. Participants suggested that a collaborative effort that engages all sectors is necessary to develop a set of priorities representing the key needs for evidence development and improved application of best clinical practices. The term commonly used was a “national problem list.” Specifically, what are the most compelling needs for information about the relative benefits and risks of competing therapies, and what are the key opportunities to better apply interventions that are proven but unused? Exploring priorities could serve as the starting point for collaborative work on the support, design, and implementation of the studies needed. It was also noted that of equal importance is the utility of identifying criteria for determining priorities and learning more about the process challenges.

Producing the Evidence for Today’s Decision with Tomorrow in View

Throughout a product’s life cycle, from development and approval to introduction into clinical practice and use with broader populations, evidence continually evolves. However, healthcare decisions must be made at specific junctures, often in the absence of sufficient information. Any system designed to improve the way evidence is both applied and generated for healthcare decisions needs to consider how evidence relevant to today’s decisions should be produced while providing the means to develop and integrate additional evidence throughout a product’s life cycle. The ability to enable access and innovation while maintaining a constant focus on assessing the risks and benefits of treatments in practice will require a sophisticated capacity to capture and analyze data, particularly in the post-marketing environment, as well as a more carefully considered set of life cycle-oriented decision rules. Other needs that many participants identified included developing incentives to support the generation of new evidence, improving access to and use of secondary data to assess care delivered in the practice setting, building capacity for research by addressing infrastructural and methodological needs, and establishing a trusted source to serve as an evidence intermediary.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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Medical Informatics: The Nerve Center of the Learning Healthcare System

The central value of medical informatics—which is where information sciences, technology, and health care intersect—is the capability to track and link the many processes and actors in the healthcare system. Because of this capability, informatics is an important driver of progress, and the participants viewed informatics as a key means of driving systemwide transformation in health care. Opportunities made available by health information technology include enhancing the development of evidence through learning networks, linked databases, registries, and electronic medical and personal health records and its application at the point of care and developing other types of clinical decision support systems to aid complex decision making. Stakeholder engagement via increased access for patients, providers, and the public to the best available evidence, along with systemwide tracking and improvement, is expected to benefit from advances in medical informatics. Fundamental to progress are broader access and system interoperability and standards that would enable information technology to serve as a conduit for the distribution and collection of knowledge throughout the healthcare system. Information technology tools could help provide a wider entrée, for example, to repositories of medical knowledge, evidence-based guidelines, and decision support systems in all care settings.

Interdisciplinary Evidence-Driven Team Care as Standard Care

Workshop discussions were largely predicated on a central belief that evidence-based care should be delivered by interdisciplinary teams, an approach that requires a significant shift in the culture of health care, including embracing the patient as part of the team. To make team-driven care the norm, attention is needed on retooling practices in the areas of clinical education, ongoing training, testing, and credentialing for front-line healthcare providers. The development of decision tools and prompts for use in the practice setting and the establishment of infrastructures to improve the focus, accessibility, use, and generation of the best evidence by providers would also help make evidence-based, team-driven care the norm. Similarly, practices could be designed and implemented to ensure that existing data from patient care loops back to inform the generation of new evidence. Other levers noted to promote broader uptake of the use of evidence in clinical practice include education, payments, measurement and assessment, enhanced patient engagement, and reporting requirements.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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Moving Forward

As part of their preparation for this workshop, participants were asked to discuss specific areas in which cross-sector collaboration could inform the wider adoption of evidence-based practice in solving some of healthcare’s most pressing problems. More than just a tool, broad stakeholder collaboration in health care is viewed as imperative for accomplishing what no single sector can accomplish on its own. Fundamentally, cooperative work among sectors offers an important way to define common goals, set priorities for the application of evidence to improve health care, and identify practical ways to move to action. Moreover, joint work among the sectors could facilitate the articulation, clarification, and definition of values, principles, and a vision for the reform of health care; help ensure better coordination of reform initiatives; and advance the identification of good practices and accelerate their wider dissemination as models.

The benefits of collaboration mentioned include possible advances in several critical areas, including the establishment of standards and common terminology; the development of new tools, products, and methodologies, particularly those driven by information technology; further development of an improved information technology infrastructure; improved thinking and practice in healthcare finance; the education of important audiences, from policy makers to the public, about the value of evidence-informed health care; and the support of additional evidence-based research.

PART TWO:
LEADERSHIP COMMITMENTS TO IMPROVE HEALTH CARE

The core preparatory activity for the workshop discussion was the work of those from the nine sectors—patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employees and employers, and individuals involved with information technology—to develop authored background papers on sector perspectives. These papers were summarized in presentations at the workshop and provided an opportunity for participants to present an overview of sector activities relevant to improving the generation and application of evidence and to articulate some promising, potentially transformational opportunities for individual and collaborative work. The authored sector papers are included in their entirety in Part Two (Chapters 5 to 13) of this publication. Each chapter contains an overview of the sector, key activities, leadership commitments, and initiatives. Final content was left to the discretion of sector authors, and similar elements may be presented in slightly different formats. The sector background papers are included in this publication to inform the discussions of the Roundtable and

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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do not represent recommendations of the Roundtable or the IOM. During the workshop, the sector authors highlighted the key components of their papers and identified their priorities for work to advance the Roundtable’s goal. Their comments are summarized below; each section begins with a description of the sector profile.

Patients and Consumers

Patients and other “consumers” in health care do not represent a monolithic profile, and neither do the organizations that represent them. Just as demographic characteristics, education, and socioeconomic factors distinguish individuals, organizations representing consumers and patients differ by size, purpose, organizational structure, governance, and source of funding. Consumer organizations representing the patient’s point of view include condition-specific advocacy groups, public education organizations, labor unions, population-specific organizations, targeted-purpose organizations, and crosscutting, consensus-building groups. Although each organization is dedicated to improving patient health and health care, collectively they come to the table with various levels of decision-making skills, patient engagement, health literacy, access to information, and knowledge about the use of evidence in medicine. Their core focus is engaging the public, enhancing public understanding of issues in health care, and ensuring meaningful consumer participation in health care. Their primary activities include advocacy, education, training, and the development and distribution of information. Generally, patient organizations participate as stakeholders in policy development and research design to ensure that such work is transparent, is clinically important, and reflects consumers’ interests and preferences.

The goal of consumers is to generate more and better evidence to support a patient-centric approach to healthcare delivery that reflects evidence-informed clinical and patient decision making and leads to improved healthcare outcomes and an improved quality of life for patients. Integral to achieving this goal will be ensuring that patient decisions are informed by evidence, that greater patient activation is realized, that self-management and physician-patient communication are enhanced, and that care is patient focused and coordinated across healthcare settings.

The patient sector presentation emphasized the importance of establishing an independent, public–private entity tasked with coordinating comparative effectiveness research. Noting that the better use of health information technology will facilitate patient access to and dissemination of valuable information, it underscored that health information technology has the potential to help patients become more active partners in their health care, improve patient-physician communication, and revamp medical education

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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curricula to help providers recognize the need to engage their patients’ decision-making skills and preferences. A related goal would be medical education designed to help physicians and other healthcare professionals acquire motivational communications skills to increase consumer and patient engagement in their own health care. Finally, the sector material encouraged transformation to a healthcare system that is patient focused, better integrated, and better coordinated and that embeds more rational incentives around desired outcomes in the provider payment system. Any large-scale change will require patient participation as partners in decision making on every dimension.

Healthcare Professionals

The presentation focused on the healthcare professionals who ultimately determine and deliver care, noting that by the fundamental nature and scope of their work, they are cornerstones in any effort to reform health care. With more than 600,000 physicians, 3 million nurses, and 200,000 pharmacists currently practicing in the United States, these groups represent the frontline of health care. Engaging this sector, the primary interface for patients, is essential to making progress in the wider application of evidence in health care.

Although efforts are under way to ensure the standard application of best evidence in many sector activities—through education, accreditation, and leadership—a refocusing of these efforts to better support the training in and adoption of evidence-based methods, lifelong learning, and interdisciplinary team-based care is important to improve current practices. Specific suggestions include the development and implementation of innovative cross-disciplinary curricula that train integrated teams of faculty and students for a stronger focus on the evolution of evidence at all stages of a practitioner’s career and for credentialing criteria that align with core competencies in evidence-based medicine. To increase the generation of medical evidence, the sector paper discusses the enhanced education of healthcare professionals about how existing information from patient care can be used as clinical research data. To expose healthcare professionals to the generation of the science base from which evidence-based recommendations are developed, increased opportunities are needed for them to participate in practice-based research.

Related changes in practice setting systems are also discussed, as government agencies, insurers, and hospitals invest in the acquisition of electronic health records. Full use depends on the development and implementation of a common vocabulary and interoperable technology.

A more robust information technology infrastructure will enable more universal access to electronic medical records; allow inquiry of databases

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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containing patient data for quality assessment; and enable broader access to repositories containing medical knowledge, evidence-based guidelines, and decision support systems in all care settings.

Healthcare Delivery Organizations

Although 89 percent of the physicians in the United States work in solo practices or small-group practices (less than 10 physicians), larger healthcare delivery organizations—including integrated delivery systems, large physician or multispecialty groups, hospitals, and hospital systems—care for a significant number of patients and account for a significant proportion of healthcare expenditures. For example, the nearly 5,800 hospitals in the United States account for about 30 percent of all healthcare expenditures. Because of their size and integrated capacities, these organizations play a critical role in the provision of health care overall by virtue of their ability to drive practice trends, set standards, and influence smaller practices by sharing information, resources, and guidelines. Because of the substantial investment that many of these organizations have made in implementing an information technology infrastructure as well as developing a substantial research capacity, they lead the field in the generation and use of evidence in clinical decision making. Several case studies illustrate the potential for systems that can identify relevant evidence and embed it in the practice setting by providing decision support that makes the relevant knowledge available to clinicians and patients at the point of care and enables the tracking and continual improvement of performance. Informed by these experiences, discussions in this sector emphasized the fundamental importance of enabling significant data aggregation as well as establishing a culture that uses everyday healthcare delivery as a learning tool and a means of generating evidence.

Expanding the evidence base and improving practice guidelines depend on access to data from large patient populations. Information technology is essential in this respect not only for supporting increased data aggregation and use across care settings and time but also for establishing research networks. Information technology is central to improving the application of evidence by providing decision support at the point of care and enabling systematic quality measurement and reporting to monitor, improve, and support evidence-based practices. In addition, a culture and leadership that support transformative change are needed—particularly given the need for interoperable healthcare information technology systems that bring greater coherence to the multiple—and often conflicting—reporting requirements for different payers. The existing adversarial relationships between hospitals and physicians reduce hospitals’ leverage to effect the needed changes in practice behavior and culture and have to be ameliorated.

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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As entities at the interface of patients, providers, and payers, healthcare delivery organizations have a unique opportunity to identify and implement the needed change. The background paper from this sector emphasized the interest in creating a national entity to develop and disseminate needed evidence, increasing the demand for evidence-based care through communication efforts, and increasing the support for evidence-based care through improved linkage of evidence with performance standards and incentives. Finally, large healthcare delivery organizations can lead the way in the adoption of electronic health records as well as encouraging their broader adoption by smaller physician groups through the provision of technical assistance and expertise and the provision of assistance with the establishment of learning networks of organizations that have implemented electronic health records to disseminate knowledge to all providers—both organized and nonorganized.

Healthcare Product Developers

More than 20,000 companies worldwide produce more than 80,000 brands and models of medical devices and diagnostics for the U.S. market. The biopharmaceutical portion of the market includes more than 2,000 companies worldwide that collectively introduce 25 to 30 new innovative products each year and that currently have some 2,000 products in development. In bringing pharmaceuticals to the market, developers often invest an average of 15 years and more than $800 million. By conducting high-quality clinical research to meet regulatory requirements, to adhere to coverage and coding policies, and for clinical decisions, product developers play a pivotal role in the development of evidence. Likewise, participants from the health product sector discussed their work to interpret evidence to meet formulary access and coverage requirements and to encourage the application of evidence through the dissemination and communication of information on specific clinical issues to providers, patients, and payers. Because the tasks of developing and translating evidence into practice are core capabilities of the industry, members of this sector underscored their potential to add far more value to healthcare delivery and the appropriate use of medications and devices than has yet been realized.

Several key questions were presented as pivotal in developing a system that better generates and uses evidence in healthcare decision making: who will decide the priorities for more evidence, who is responsible for generating evidence, who is responsible for synthesizing evidence, who pays for the generation and synthesis of evidence, and who is responsible for ensuring that evidence is translated into practice? Thus, three key transformational opportunities were identified by participants for this sector’s work: (1) establishing principles for interpretation of the evidence, (2) developing new methods for

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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the generation of evidence, and (3) accelerating the application of evidence by identifying behavioral approaches that speed the translation of clinical research into practice, thereby driving the learning healthcare system.

The extensive experience of this sector across the spectrum of activities related to the development and application of evidence creates numerous opportunities for collaboration. As critical stakeholders, product developers believe that they can contribute extensively to discussions related to the interpretation and use of evidence. Their understanding of evidence development and the potential methodological or data limitations, for example, could be used to inform the development of standards of evidence for product approval, healthcare policy decision making, and patient care decisions. Other relevant conversations might focus on the development of principles governing how evidence is integrated into coverage decisions; the development of best-practice standards for interpretation of the evidence; and education about the uncertainties of decision making from studies conducted with nonrepresentative populations. The sector’s methodological expertise was also noted as potentially useful to discussions about how to develop evidence that better addresses individual patient needs.

In the area of application of the evidence, the sector paper emphasized the needed development of a process for setting coverage and payment policies that are open, transparent, and trustworthy; that consider a wide range of relevant evidence; and that can help foster a better understanding of real-world data requirements for the developers of clinical practice guidelines. Additionally, communications expertise developed through investments in sophisticated advertising offers possible utility in the development of refined methods of communicating evidence to consumers to assist with (1) consumer-based decision making and (2) the development and implementation of a research agenda focused on systems changes and behavioral approaches important to improving the translation of evidence-based guidelines into clinical practice and adherence to therapeutic regimens. To achieve all of these goals, discussions of healthcare product developer opportunities recognized the need to partner with many stakeholders, particularly the patient sector, healthcare delivery organizations, clinical investigators and evaluators, insurers, and regulators.

Clinical Investigators and Evaluators

The work of clinical investigators and evaluators includes quantitative and qualitative evaluations of specific healthcare interventions, projects that improve population health, cost-benefit analyses, and organizational studies. The principal activities of the sector include those involved in evidence development: design and implementation of clinical trials and registries, database development, study reviews, standards development,

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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evaluation of the application of evidence in clinical practice, methodology development, and modeling and simulation studies.

Sector discussants identified several important and overarching challenges. Resources for research and development are limited both in terms of participation in research activities by healthcare providers and the public and in financial terms. Investigators must also contend with what is characterized as the inefficient use of existing data—including, for example, the inefficient secondary use of data. Systemic constraints inherent in the way healthcare organizations deliver care or use information are barriers to the creation of new evidence. Needs for new and improved research methodologies permeate the sector’s work.

Sector presenters suggested several major transformational initiatives if clinical investigators are to promote a learning healthcare system: improved and sustained investment in applied research and development; reengineering of healthcare delivery to facilitate structured learning about best practices; use of information developed during the routine delivery of health care to assess outcomes; clarifying the ways in which outcomes assessment can be performed in compliance with HIPAA regulations; better standardization of institutional review board practices; greater interaction between regulators, payers, and investigators in the generation of evidence; and the development of new policies and approaches concerning advanced coverage for new therapies. Of central importance is expanding the use of a broad range of clinical research designs to compare approved treatments. Examples of these designs include not only conventional RCTs but also large pragmatic trials and cluster randomized trials. To allow this expansion, creating an environment in which both providers and patients see participation in such trials as an expected, desirable activity was considered especially important. To improve data quality, use, and access, presenters emphasized the development of improved database architectures, policies, and governance procedures. Finally, participants felt that increased activity is needed to expand the workforce of trained investigators and evaluators and to develop innovative methodologies that will improve research quality and accelerate the translation of evidence into practice.

Regulators

Federal agencies, including FDA and CMS, regulate different aspects of the healthcare system: the former regulates the introduction and use of medical products, whereas the latter regulates the quality of care through its reimbursement decisions for healthcare products and services under Medicare and Medicaid. With expenditures of approximately $650 billion in 2006 and serving more than 90 million beneficiaries, CMS naturally plays a key role in the overall direction of the healthcare system, particu-

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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larly through management of coverage decisions, payment structures, and accountability measures under Medicare. With Medicaid, although CMS sets global policy, each state has substantial flexibility to determine the final form of the program as carried out in its jurisdiction. Moreover, the states directly regulate the practice of medicine, the healthcare workforce, and the commercial (including nonprofit) health insurance that is purchased from health insurance companies or commercial managed care health plans.

Participants noted that regulators share a critical mandate and interest in the safety and effectiveness of the pharmaceuticals, devices, and services used in medical care. Because regulators are responsible for assessing medical products at various points in their life cycles, they collect and analyze substantial amounts of data to evaluate whether a product is safe and effective for its indicated use. As the nation moves toward personalizing treatment, those developing the background paper for the regulatory sector underscored the centrality of a better evidence base to their work. FDA’s contribution to this effort resides primarily in its ability to improve the quality and type of evidence generated during the early phases of a medical product’s life cycle, as well as to improve the development, communication, and use of risk information throughout a product’s life cycle. CMS’s key contribution—at the state and federal levels—lies in its ability to leverage the broad healthcare system through the implementation of initiatives and incentives that advance evidence-based medicine, as well as the potential value of coverage requirements to generate new evidence

Unique challenges in regulation lie in the tension between innovation and access to new therapies and the need for greater evidence about performance. For example, the FDA Critical Path Initiative includes programs aimed at reengineering and streamlining clinical trials, facilitating better understanding of product performance, hastening the implementation of personalized medicine, increasing the quality and quantity of information that can be derived from clinical trials and other data analyses, and easing administrative and other burdens associated with the conduct of complex, multisite studies. In addition, work is under way to modernize management of the nation’s medical product safety information by developing a national electronic standard for a medical product adverse event report, called the individual case safety report, as well as laying the foundation for a sentinel system, a national postmarketing surveillance system. CMS uses coverage with evidence development policies to accelerate the development of evidence and has several other programs aimed at modernizing and supporting the use of information technology capabilities. Projects under development include Lifecycle Evidence Development, which embodies a substantial culture change by way of continuous data acquisition, evaluation, and response to findings, and the Chronic Condition Data Warehouse,

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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a new research resource. CMS is also working to build pay-for-performance incentives into its payment systems.

Certain initiatives emphasized by participants focused on the state level. With Medicaid coverage decisions made locally, for example, it is anticipated that states will continue to work with each other and with not-for-profit organizations, federal partners, and others—as they are doing now—to expand the use and availability of evidence in clinical and administrative decision making. Increasingly, deliberations among state insurance policy makers are shaped by the inclusion of research evidence, as is work to articulate state standards of effective medical practices. State regulators are playing a catalytic role in moving toward a more consistent, relevant, and accessible approach to measuring and communicating information about a physician’s competence throughout his or her career.

The regulatory sector presentation focused on two key possibly transformational initiatives. First, a national think tank or large national collaborative effort is considered important to identify evidence needs, agree on priorities, and assign projects to fill gaps in the evidence knowledge base. Second, a national problem list or national research agenda is needed both to illustrate the pressing need for more evidence development and to identify areas and projects of priority for research on the basis of the most significant evidence gaps in health care today.

Insurers

In 2005, private health insurance plans and other private spending, including consumers’ out-of-pocket costs, accounted for almost 55 percent of total U.S. healthcare expenditures (approximately $1.09 trillion of $2 trillion). Public spending, including spending by Medicare, Medicaid, the State Children’s Health Insurance Program, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs health benefits program, accounted for the remaining 45 percent of total healthcare expenditures. The insurance industry operates in a variable and volatile marketplace. After a period of relatively low cost increases in the mid-1990s, healthcare costs again began to rise, resulting in the growth of health insurance premiums that peaked at 13.9 percent in 2003. The number of uninsured Americans grew during the same period, rising from 14 percent in 2000 to 15.3 percent in 2005. Although the growth in premiums slowed during from 2003 to 2006, healthcare costs continue to outpace inflation and place significant pressure on the cost of insurance coverage, as evidenced by the approximately 46 million Americans who remain uninsured and the recent increase in the numbers of uninsured or inadequately insured.

Presentation and discussion noted that, in addition to the general challenges related to rising costs, waste, and the provision of ineffective care

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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that characterize the healthcare system, insurers face issues related to new treatments and higher-priced technologies; the increased bargaining power of providers; increased consumer demand; an aging population; and chronic conditions associated with obesity, smoking, and substance abuse. Accompanying pressures on the insurance industry are wide regional variations in treatment, the significant underuse and misuse of recommended best practices, and an undue reliance on treatments of little or no value. In some cases, legislative mandates and regulatory processes have contributed to the challenge of basing decisions on evidence.

The payer sector has been deeply engaged in the promotion of medical policy based on evidence. For example, committees of physicians, pharmacists, and other healthcare professionals research the scientific evidence on drugs, depending in part on comparative effectiveness data, to determine which drugs to place on formularies. New technologies are assessed before insurers pay for them. Patients and providers are offered customized tools to modify their behavior, encourage the use of preventive care, monitor potential medication interactions, and improve health. Both public and private health insurers have begun to offer performance-based incentives measured by selected evidence-based standards and performance measures.

The insurer sector discussion suggests four major transformational activities: (1) a comparative effectiveness board, to help coordinate reform and set priorities; (2) a national research strategy focused on gaps in the evidence that, if filled, have the potential to significantly improve patient outcomes; (3) the transparency of actionable information that is used to make healthcare decisions; and (4) increased investment in the healthcare infrastructure, including improved workforce training. In addition, insurers called for focused, coordinated research efforts to address the gaps in evidence that have been identified and factors that drive physician decision making. One model might come from health insurance plans that are collaborating to implement a national strategy to aggregate data from multiple plans and other sources to produce and report on an increasingly sophisticated set of quality and cost measures throughout the country. Sector participants also supported policies that would both reinforce the FDA’s capacity to assess the long-term safety and effectiveness of new drugs and strengthen the FDA’s review of certain devices and its capacity to track device safety. Also emphasized were investments in several key areas of infrastructure, including improved systems for aggregating administrative data and electronic health record information reliably.

With respect to cross-sector collaboration, sector participants underscored, in addition to a national comparative effectiveness board, the development of a more transparent and consistent approach to judging evidence with broad-based involvement of plans, product developers, evaluators, patients, employers, and government; collaboration among providers,

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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payers, and developers to balance evidence with the effects of demographics, genomics, patient preferences, family history, and other factors; and aligning benefit language with the language of innovations in evidence-based medicine to ensure that the public understands that the goals of evidence-based medicine and comparative effectiveness are not a reduction in access, but an improvement of health care.

Employers and Employees

Employers and employees shoulder a large share of healthcare expenditures in the United States. In return, they depend on the healthcare system to ensure the well-being and productivity of the workforce. Rising costs over the last decade have led to an erosion of employer-sponsored healthcare coverage, and healthcare benefits are an increasingly major factor in labor negotiations between employers and potential employees. Currently, only two-thirds of employees under 65 years of age have employer-sponsored coverage, and 40 percent of the employer market is self-insured. Employer expenditures rose 140 percent over the last decade, and healthcare spending is projected to continue to rise at a rate of 7 percent annually over the next decade, twice the rate of inflation. In 2006, employee premiums and out-of-pocket spending averaged $3,136, up 12 percent from 2005. Costs, however, are only part of the challenge. In the face of wasteful spending and poor outcomes because of the overuse, underuse, and misuse of healthcare services, employers have increasingly supported efforts to improve healthcare quality, safety, and efficiency, including the use of combined purchasing power to strengthen the system by improving quality and managing costs.

The primary opportunities for employers and employees to encourage evidence-based medicine include provider contracting, benefit plan design, employee decision support, and public policy advocacy. As provider contracts are set, vendors can be selected and rewarded as they incorporate standards of medical evidence. Through benefit design, differential coverage encourages effective care—as, for example, when coverage tiers are based on the strength of the evidence of effectiveness; network selection is based on performance; employee cost sharing encourages the use of high performers; and physicians, hospitals, and networks recognized for excellence receive higher payments. By developing and using decision support tools and resources, employers and employees can promote decision making informed by the evidence as well as risk-benefit profiles; and in a broader sense, employers and employees can shape public policy and advocate for patient safety, healthcare information technology, and comparative effectiveness research.

Participants from the employer and employee sector identified several opportunities for immediate progress. First, the expansion of the evidence

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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base through comparative effectiveness research and the improved capture and use of information generated as part of clinical experience could, in part, be assisted by policy advocacy and the provision of support for the adoption and implementation of health information technologies. Second, the evidence could be appropriately incorporated into coverage and payment policies by targeting purchasers and payers, building on existing performance measurement and payment programs, and establishing cross-sector agreement on transparent methods and standards. Last, creating a demand for evidence-based medicine through a collective communications campaign is fundamental to the success of the other initiatives. Such a campaign should build on existing efforts and bring to bear the research and marketing expertise of stakeholders to promote the development of a learning environment and sustained change toward an evidence-based healthcare system.

Healthcare Information Technology

As key players in the healthcare arena, those in information technology have evolved from a focus on the delivery of stand-alone “smart” medical equipment (echocardiography systems, radiology systems, etc.) to the development and delivery of increasingly integrated clinical systems, full-function electronic health records, and related complex and evolving systems for healthcare professionals. Key players in healthcare information technology include clinical source system providers that create systems for use in specific functional areas (e.g., laboratories, radiology departments, and surgeries); electronic health record companies, which provide consolidated and integrated clinical systems that support inpatient and outpatient practices; administration and chain data management companies, which develop administrative systems in support of clinical care and research; World Wide Web–based patient and consumer information companies; personal health record companies; and niche companies, such as those that provide education tools, data warehousing, enterprise information management, and data analysis. Fundamentally, the work of this sector focuses on improving consumer access to reliable health and disease management information, enhancing patient-provider communication and interaction, developing operational effectiveness and efficiency, improving the ability to manage and analyze large quantities of data, and improving research on clinical effectiveness and quality of care.

The background paper from the information technology sector identified seven priority areas or challenges on which current work aims to improve the sector’s ability to support the transformative change implied in the Roundtable’s goal. Perhaps the single most transformational step toward achieving the goal of a learning healthcare system lies in the development and

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
×

implementation of information technology industry standards. In conjunction with these standards, healthcare information technology sector participants underscored the need for collaboration with other sectors to develop a common vocabulary to facilitate the interoperability of clinical systems and the interpretation of clinical data across multiple sites. In the area of workflow, the dual goals of seamless movement of data between various patient care environments and just-in-time delivery of the right information are important to ensure that the best decisions can be made in partnership with patients. In part, this requires streamlining the complex tools that enable the collection, aggregation, synthesis, delivery, and interpretation of and access to data as part of provider clinical decision support systems. It also requires developing new ways to view clinical data, and their relationship to other data, to help users interpret the significance of relationships and make appropriate and informed patient care decisions. Other sector themes included addressing questions in the area of connectivity to ensure that healthcare networks connecting various stakeholders provide the seamless transfer of relevant and appropriate information, minimizing the sources and number of data inputs while increasing data integrity and reliability.

The paper from the information technology sector translated these challenges into three transformational initiatives. The first involves building and promoting the foundational technologies needed to enable healthcare information technology-assisted evidence-based medicine. Achieving the goal of a learning healthcare system would be enhanced by the development and implementation of information technology industry standards and common vocabularies in health care. This would support healthcare information technology at every level and provide building blocks for bringing computational intelligence to aid human cognition in evidence-based medicine.

The second initiative involves the establishment of a government-industry collaborative ecosystem for the ongoing evolution and development of clinical information technology standards. A virtuous cycle, or the continual feeding of outputs back into the cycle as inputs—as illustrated by eBay, Flickr, and YouTube—would result in more users of the standards and therefore more feedback. In the term “ecosystem,” it is assumed that both community and technology are included, as they are in blogs and wikis. Participants suggested that an evaluation of technical barriers to the adoption of existing publicly supported, open-standard vocabularies and tools by healthcare information technology providers would be useful. Initiatives could be provided to remedy technical barriers, and success could be measured by determination of the rates of adoption and utilization of the technologies. Because information in the healthcare system is partitioned into silos without connectivity, a clinical data and analytic infrastructure must be created to enable evidence-based medicine, especially given the fact

Suggested Citation:"Summary." Institute of Medicine. 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/11982.
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that doctors spend 60 percent of their time seeking data. To achieve this, convening or supporting initiatives would be useful, perhaps by the IOM, to identify metrics around accessibility of core clinical data and core analytic tools (e.g., reporting specifications and data visualization).

To speed these initiatives and realize the goals of the information technology sector, the third initiative discussed would involve the provision of an incentive for dramatic innovation similar to the robot race of the Defense Advanced Research Projects Agency in which researchers competed with each other to create a driverless car. The collective investment of resources by competitors and the innovative research that resulted far exceeded what could have been achieved by direct investment of the $1 million prize. This contest might act as a model for healthcare information technology because a diverse population should be engaged in the radical technological innovation needed in evidence-based medicine. Such innovation could guide clinical decisions based on individual data, along with relevant clinical evidence and experiential information gathered from the mining of data on previous patients with similar conditions, all with just-in-time evidence delivery, alerts, and flexible data views. One option might be a challenge sponsored by the IOM as an Advanced Technical Strategies Innovations Initiative.

REFERENCES

Fisher, E. S. 2005. More care is not better care: Regional differences show that spending more does not improve—and may hurt—patients. More accountability can help. Expert voices (7). Washington, DC: National Institute for Health Care Management Foundation.

Institute of Medicine. 2007. The learning healthcare system. Washington, DC: The National Academies Press.

———. 2008. Learning healthcare system concepts, v. 2008. Washington, DC: The National Academies Press.

IOM Roundtable on Evidence-Based Medicine. 2006. Charter and vision statement: Roundtable on evidence-based medicine. Washington, DC.

McGlynn, E., S. Asch, J. Adams, J. Keesey, J. Hicks, A. DeCristofaro, and E. Kerr. 2003. The quality of health care delivered to adults in the United States. New England Journal of Medicine 348(26):2635-2645.

Wennberg, J., E. Fisher, and J. Skinner. 2002. Geography and the debate over Medicare reform. Health Affairs Suppl. Web Exclusives:W96-W114.

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This volume reports on discussions among multiple stakeholders about ways they might help transform health care in the United States. The U.S. healthcare system consists of a complex network of decentralized and loosely associated organizations, services, relationships, and participants. Each of the healthcare system's component sectors--patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employers and employees, and individuals involved in information technology--conducts activities that support a common goal: to improve patient health and wellbeing. Implicit in this goal is the commitment of each stakeholder group to contribute to the evidence base for health care, that is, to assist with the development and application of information about the efficacy, safety, effectiveness, value, and appropriateness of the health care delivered.

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