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Pages 1-36

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From page 1...
... 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.
From page 2...
... 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.
From page 3...
... 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.
From page 4...
... Expanding evidence gap. Across the practice of health care, infor • mation is lacking for many key personal health or policy deci sions.
From page 5...
... 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
From page 6...
... 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?
From page 7...
... Foster a trusted intermediary for evidence. How can patients, pro • viders, healthcare organizations, employers, insurers, and others know when they have the best evidence on which to base the healthcare decisions they make?
From page 8...
... 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 capaci ties.
From page 9...
... The Roundtable's Febru ary 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.
From page 10...
... 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.
From page 11...
... • 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.
From page 12...
... 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.
From page 13...
... 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, pointof-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.
From page 14...
... 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.
From page 15...
... 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.
From page 16...
... 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.
From page 17...
... 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.
From page 18...
... 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.
From page 19...
... 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.
From page 20...
... 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.
From page 21...
... 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.
From page 22...
... 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.
From page 23...
... 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
From page 24...
... 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.
From page 25...
... 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.
From page 26...
... 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.
From page 27...
... 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.
From page 28...
... 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.
From page 29...
... 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.
From page 30...
... 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.
From page 31...
... 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,
From page 32...
... 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.
From page 33...
... 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.
From page 34...
... 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.
From page 35...
... 2007. The learning healthcare system.


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