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Pages 1-16

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From page 1...
... Ultimately, the committee concluded that the nation must significantly expand its capacity to use scientific evidence to assess "what works" in health care. This report recommends an organizational framework for a national clinical effectiveness assessment program, referred to throughout as "the Program." The Program's mission would be to optimize the use of evidence to identify effective health   Thissummary does not include references.
From page 2...
... In today's world, health care decisions are made by multiple people, individually or in collaboration, in multiple contexts for multiple purposes. The decision maker is likely to be the consumer choosing among health plans, patients or patients' caregivers making treatment choices, payers or employers making health coverage and reimbursement decisions, professional medical societies developing practice guidelines or clinical recommendations, regulatory agencies assessing new drugs or devices, or public
From page 3...
... Systematic reviews of multiple highquality studies have the advantage of providing summaries of the available research, which typically covers many different circumstances, and providing a snapshot of where more research is needed. The conceptual context for this study is the continuum that begins with research evidence, then moves to systematic review of the overall body of evidence, and then to the interpretation of the strength of the overall evidence for developing credible, clinical practice guidelines (Figure S-1)
From page 4...
... Below the S-1 dashed line, decision makers and developers of clinical recommendations interpret the findings of systematic reviews to decide which patients, health care settings, or other circumstances they relate to. SOURCE: Adapted from West, S., V
From page 5...
... developing trusted clinical practice guidelines. Setting Priorities for Evidence Assessment If we are to resolve current deficiencies in how the nation uses scientific evidence to identify the most effective clinical services, there must be a process for identifying the most important topics in order to preserve resources for evidence assessment itself.
From page 6...
... Systematic Reviews Are the Central Link Between Evidence and Clinical Decision Making Systematic reviews of evidence on the effectiveness of health services provide a central link between the generation of research and clinical decision making. Individual studies rarely provide definitive answers to clinical effectiveness questions.
From page 7...
... Observational and experimental studies each can provide valid and reliable evidence, but their relative value depends on the clinical question. For example, randomized controlled trials can best answer questions about the efficacy of screening, preventive, and therapeutic interventions while observational studies are generally the most appropriate for answering questions related to prognosis, diagnostic accuracy, incidence, prevalence, and etiology.
From page 8...
... It is not known how many researchers in the United States are adequately trained and qualified to conduct systematic reviews on the effectiveness of health services. Developing Evidence-Based Clinical Practice Guidelines The development of clinical guidelines in the United States today is highly decentralized and involves many public and private organizations -- medical professional societies, patient advocacy groups, payers, government agencies, and others.
From page 9...
... The key challenges stem from the fact that guideline development frequently forces organizations to go beyond available evidence to make practical recommendations for use in everyday practice. Given the gaps in the evidence base that frequently exist and the variable quality of the information that is available, some observers have suggested that one criterion of an effective guideline process is to have two separate grading systems: one for the quality of evidence and another for the recommendations themselves.
From page 10...
... The Program should •  priorities for, fund, and manage systematic reviews of clinical effectiveness set and related topics; • develop a common language and standards for conducting systematic reviews of the evidence and for generating clinical guidelines and recommendations; • provide a forum for addressing conflicting guidelines and recommendations; and • prepare an annual report to Congress. The secretary of Health and Human Services should appoint a Clinical Effectiveness Advisory Board to oversee the Program.
From page 11...
... Recommendation: The Program should develop standards to minimize bias due to conflicts of interest for priority setting, evidence assessment, and recommendations development. The committee envisions a Program -- whether a public entity or a public-private entity -- that develops standards and sets priorities and facilitates systematic reviews of priority topics by external organizations.
From page 12...
... Patients and health professionals require real time information for treatment decisions. Scientific rigor Methods minimize bias, provide reproducible results, and are completely reported.
From page 13...
... to develop and implement a priority setting process that will identify those high-priority topics that merit systematic evidence assessment. In contrast to the Clinical Effectiveness Advisory Board, which should provide broad oversight of the Program, the PSAC should be an active advisory body that meets frequently to advise the Program on topics that merit priority systematic review.
From page 14...
... The PSAC should post key documents on its website, including meeting announcements and decisions concerning priorities, and give time for public comment on documents that support the priority setting process. Recommendations for Conducting Systematic Reviews Recommendation: The Program should develop evidence-based, meth odologic standards for systematic reviews, including a common lan guage for characterizing the strength of evidence.
From page 15...
... Recommendation: Groups developing clinical guidelines or recommen dations should use the Program's standards, document their adherence to the standards, and make this documentation publicly available. Recommendation: To minimize bias due to conflicts of interest, panels should include a balance of competing interests and diverse stakehold ers, publish conflict of interest disclosures, and prohibit voting by members with material conflicts.


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