Evidence-Based Medicine and the Changing Nature of Health Care 2007 IOM Annual Meeting Summary (2008) / Chapter Skim
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Pages 1-32
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Because of its emphasis on integrating the best available external evidence with clinical experience, evidence-based medicine (EBM) provides a guiding framework for the development of systems and approaches necessary to deliver the promise of 21st century health care -- in which knowledge is both applied and generated as a natural outgrowth of the care process, to ensure delivery of the care most appropriate for each individual patient.
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. With the guidance of members and expert panels, the Roundtable has conducted a series of meetings and workshops aimed at fostering progress toward the "learning healthcare system" -- a system in which both evidence development and application flow naturally from the care process.
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Discussions focused on four themes: the forces driving the need for better medical evidence; the challenges with which patients and providers must contend; the need to transform the speed and reliability of new medical evidence; and the legislative and policy changes that would enable an evidence-based healthcare system. During the course of meeting presentations, a number of common themes were identified (Box S-1)
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There is an untapped potential to reduce healthcare costs and improve quality by developing evidence not only for specific medical interventions, but also for the way health care is delivered. • Promise of health information technology.
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• Shift to a culture of care that learns. This changing role will require healthcare providers and patients to adopt a culture that supports the generation and application of evidence.
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Needed evaluation of interventions and delivery system issues in real-world practice will require that we look beyond the traditional research focus to new methods and new opportunities presented by emerging data sources, including electronic health records (EHRs) and clinical registries.
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Essential to progress toward this shared vision is a better understanding of the forces driving the need for better medical evidence. Chapters 2 and 3 summarize presentations on several of the key issues introduced by Cortese: the tremendous negative economic consequences of the rising, unsustainable costs of health care; implications of the variations in healthcare spending and health outcomes in different regions of the country; the quality and quantity of evidence needed to guide clinical decisions; the increasing diversity of new health products; and the complexity of insights generated by genetic research.
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John W Rowe, Professor, Columbia University In introducing the presentation summarized in Chapter 6, Rowe emphasized that a key characteristic of the Roundtable's vision of a learning healthcare system is continual evidence development and refinement.
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A close examination of national and regional healthcare spending trends and health outcomes reveals much about where the system is falling short and identifies opportunities for improvement. Presentations at the meeting made the case for more and better medical evidence, which could simultaneously reduce unnecessary healthcare expenditures and improve health outcomes for patients.
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Fisher, 2007. When there is strong medical evidence, physicians tend to agree on courses of treatment across regions of different spending levels, but they differ widely in areas that require discretionary decision making, such as how often to see a patient with well-controlled hypertension and when to hospitalize a patient with heart failure.
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Therefore developing the capacity to better evaluate the effectiveness of both categories of treatments offers an immediate opportunity for improving the costs and the quality of care. Fortunately, the information systems and analytic approaches required to improve the evidence base for both biologically targeted interventions and care delivery are fundamentally the same.
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Utilization of a broader range of studies -- including those using clinical registry or EHR data -- will have greater effects, but real gains in improving the quality of health care and reducing costs will come when the results of research are built into incentive payments for healthcare providers. In sum, there is a pressing need for better medical evidence on what works best for whom.
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Coye, founder and chief executive officer, Health Technology Center, discussed the challenge presented by the increased complexity and diversity of new medical devices and interventions to the development of adequate evidence to support healthcare decision making (Figure S-1)
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Often costly and targeting rare or lifethreatening diseases, these drugs are in urgent need of assessment, but high patient demand often limits trial participation. Off-label uses for biotech drugs often target unrelated diseases and may quickly become accepted in practice, again limiting opportunities for clinical trials.
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These transformative technologies -- which include telemedicine, remote monitoring of chronic disease, the tele-ICU (remote monitoring of intensive care units) , pharmacogenomics, hemofiltration for congestive heart failure, and remote video interpretation -- enable a wide range of positive changes in clinical care and administrative processes, reducing net expenditures and improving the value of health care.
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Progress in identifying the genetic causes of common diseases holds great promise to catalyze the development of new insights into pathophysiology. However, testing for genetic variations is of uncertain value for the individual patient and the healthcare system.
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A key challenge is determining whether and how clinical testing for such genetic variations can improve patient care. To evaluate this question for Type II diabetes, researchers from Massachusetts General Hospital and the Diabetes Prevention Program (DPP)
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Adopting new technologies and medical interventions and embedding emerging information into practice will require a cultural shift in the behaviors, beliefs, and practices of individual healthcare providers and delivery organizations. Evaluating the quality and usefulness of medical evidence, putting the evidence into practice, and continuing to adjust and monitor patients' treatment and health outcomes are tasks that both providers and patients will have to perform.
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The constantly evolving biological systems that healthcare providers work with, combined with the variability of individuals and conditions, make it impossible to standardize treatments. Other industries are able to isolate change in their systems and adjust accordingly, but the rate of discovery in the biological sciences and the introduction of new technologies require rapid experimentation and iterative change.
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Healthcare providers need to appreciate the expert's role in the systems approach and understand that the systems approach does not replace or devalue the expert. The Partnership Imperative in an Evidence-Driven Environment Underscoring that each individual patient has differing life circumstances, cultural needs, preferences, and socioeconomic status, Marc Boutin of the National Health Council discussed the importance of developing an evidence base that takes into account the unique needs of each patient to deliver and ensure the "right" health care for each person.
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Information Technology Tools to Support Best Practices of Healthcare Providers Robert Hayward, associate professor of the Departments of Medicine and Public Health Sciences and director of the Centre for Health Evidence (CHE) at the University of Alberta, noted that in the messy informational environment of front-line care, the availability of evidence alone will not lead to improved health.
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Neupert of Microsoft's Health Solutions Group suggests that consumers are taking a more active role in navigating the health system out of necessity, and that these engaged consumers will increasingly become disruptive agents of change in the health ecosystem -- demanding better and more integrated information as well as tools to support their healthcare decisions. The availability, portability, sharing, and use of health information will be key to achieving this transformation.
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EMRs and clinical registries offer the opportunity to capture important data and information at the point of care and speed the generation of evidence to inform clinical practice. New tools such as biomarkers, modeling, adaptive trial designs, and patient enrichment approaches are helping to accelerate the development and evaluation of tailored therapies.
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Research Methods to Speed the Development of Better Evidence -- The Registries Example Eric D Peterson, professor of medicine at the Duke Clinical Research Institute, outlined how clinical registries provide infrastructure and resources that help to address current shortfalls in the cycle of evidence development and adoption.
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As registries enter the electronic age, progress in several areas -- such as standardization of data elements; clarification of patient privacy rules; development of new data harvesting tools; connection of longitudinal databases; and growing collaboration among professional societies, insurers, and government regulators -- is allowing for more integrated and crosspurpose clinical registries. The data and infrastructure provided by clinical registries can aid evidence generation in several ways -- for example, providing data for national epidemiological and health services research.
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Registries could improve efficiency in the design and conduct of RCTs, and practical clinical trials might eventually be embedded within clinical registries. In situations where randomized treatment comparisons are not possible, observational comparative effectiveness studies using registries provide another source for evidence development.
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Tailored therapies represent a paradigm shift for drug development away from traditional approaches such as phased clinical trials to what is termed "value-based" drug development, which identifies the subpopulations of patients that would most benefit. This allows drug companies to stratify clinical development by identifying which agents should move to phase II or phase III clinical trials, and also assists in terms of marketing drugs.
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Therefore, the expectation that Medicare or Medicaid can lead efforts to reform healthcare delivery through introducing more evidence should be questioned. Despite a strong evidence base for many proposals, each step toward implementing change affects a constituency and the members of Congress supported by those constituencies.
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Much of the confusion around improving health care comes from different definitions of value for the various actors in the system (e.g., healthcare providers, insurers, device manufacturers, patients) working at cross-purposes toward undefined goals.
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Like outcomes, costs should be measured for medical conditions over the cycle of care. Providers and health plans need to work together to measure the cumulative costs by activity for each individual patient over time.
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Health Affairs (Millwood) Supp Web Exclusives:W96-W114.
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