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1 Guiding Perspective: The Learning Healthcare System
Pages 39-58

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From page 39...
... The U.S. healthcare system is large, multifaceted, unorganized, and influenced by so many commercial forces, interest groups, and myriad decision points that it is sometimes described as a "nonsystem." This character translates also to the challenges of evidence development and application, with fragmentation and silos of expertise, services, and knowledge, as well as gaps in quality and shortfalls in the ability to translate biomedical research into clinical treatments and improved health outcomes (Institute of Medicine, 2000, 2001, 2007)
From page 40...
... Although evidence-based medicine sets a basic standard of care that patients should expect, it must be delivered by a system that learns, in which evidence development and application are built into the routine processes of care and results are fed back into the system to improve the entire healthcare system. To characterize the learning healthcare system and explore the key advances needed, the Roundtable initiated the Learning Healthcare System series of workshops to build on the findings and recommendations of earlier Institute of Medicine (IOM)
From page 41...
... 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 42...
... in January 2007. Key participants were from sectors represented on the Roundtable: patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employees and employers, and information technology developers.
From page 43...
... Kirk1 To provide a simple illustration of one of the challenges of moving the current patient experience to the ideal, consider the following situation: a 1 The patient perspective summarized here was presented by Margaret Kirk, chief executive officer of Y-ME National Breast Cancer Organization and chairperson-elect of the National Health Council. The opinions are hers.
From page 44...
... One important challenge in health care is to develop an evidence base that acknowledges that even with identical diagnoses, patients' life stages, underlying health, social support networks, attitudes about health and illness, faiths, cultures, and many other factors are important considerations in determining the course of treatment appropriate for each patient. The ideal patient experience would have to include the patient and his or her family as respected members of the healthcare delivery team from the outset of treatment decisions, which is equivalent to the National Health Council's definition of "patient-centered care." Although various stakeholders have emphasized the central role of patients and the importance of evidencebased medicine, the perspectives of these patients -- the group that all other stakeholders in the healthcare system serve -- must still be heard.
From page 45...
... Decisions based on evidence that also account appropriately for individual variation in patient needs are, of course, the ideal and the goal of both evidence-based medicine and personalized medicine. The focus should not be which medicines work the best, the fastest, or the cheapest but, rather, which treatment options are available under different circumstances and how they are best communicated to individual patients.
From page 46...
... As a successful example, the Y-ME National Breast Cancer Hotline empowers those touched by breast cancer with ways to communicate with their healthcare providers, encouraging callers to "become the lead player on their healthcare team." There is also the Partnership for Clear Health Communications and its Ask Me 3 program, which encourages patients to ask and keep asking three critical questions until they get satisfactory answers (National Patient Safety Foundation, 2008)
From page 47...
... In response, the Future of Family Medicine Project emerged in 2001 to assess the healthcare and technology needs of patients and providers and to identify the fundamental changes necessary to address these issues and transform family medicine. The final report highlighted existing issues in the practice of family medicine and identified a new model of practice that employs a patient-centered team approach, eliminates barriers to access, advances the use of information systems and electronic health records, operationally redesigns offices to function more efficiently, focuses on quality and outcomes, and improves overall practice finance and cost savings (Martin et al., 2004; Spann, 2004)
From page 48...
... As of the date of the 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. Key supporting elements of this model include patient access to care, patient access to information, information systems such as electronic health records with point-of-service reminders of best practices, redesigned offices to increase practice efficiency, an increased focus on quality and safety, efficient practice management, the provision of point-of-care services, and a team approach to providing care within the practice (TransforMED, 2007)
From page 49...
... By one estimate, only 10 percent of practices use their information systems to their fullest capacity. Within family medicine practices, 40 percent use electronic health records, which is up from 30 percent just since 2006.
From page 50...
... Finally, there is a lack of incentives for the next generation of healthcare professionals to practice family medicine, where a great deal of care is delivered. In the United States, specialists are paid 300 percent more than primary care doctors.
From page 51...
... All of the barriers listed above, in addition to misaligned and disproportionate financial incentives, result in a continued decrease in interest among medical students to pursue a primary care specialty, contributing to a significant shortage of primary care physicians in the foreseeable future. One of the motivating issues of the demonstration project described above is that transforming medical practices to meet the needs of today's patients and healthcare system, while improving the chance of financial viability of primary care practices, will also increase interest in the specialty.
From page 52...
... These aims could be supported by the development of a national health data repository and the capacity to self-populate electronic health records with patient data. A narrowing of the number of vendors (currently, more than 220 vendors maintain and sell proprietary electronic health record data)
From page 53...
... retrospective analyses of administrative claims data or electronic health record data, and (4) experimental or observational prospective studies.
From page 54...
... Because many critical healthcare decisions are dichotomous, one approach to coverage policy is to provide some options that meter decision making more precisely to the quality of the evidence. Medicare's coverage with evidence development policy, for example, provides additional coverage options that are linked to requirements such as patient participation in registries or clinical trials.
From page 55...
... In May 2006, the National Oncologic PET registry was initiated under the coverage with evidence development approach and requires self-reporting of changes in patient management by physicians in response to PET scan results. The lack of data on diagnostic utility makes this registry of questionable immediate value.
From page 56...
... In terms of the methodologies used to generate evidence, there is much discussion and certainly some promise in the improved utilization of alternatives to randomized controlled trials as well as the potential data from improved electronic health records. Along with these discussions, the notion has emerged that when the electronic health record is perfected, there will be a substantially reduced need for prospective controlled studies.
From page 57...
... Work should aim to facilitate more pragmatic clinical trials, promote the use of observational methods, and improve the data from electronic health records. The advances needed for these various methods are very different and will entail confronting distinct challenges.
From page 58...
... 2004. The future of family medicine: A collaborative project of the family medicine community.


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