Finding What Works in Health Care Standards for Systematic Reviews (2011) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-44
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The committee's charge was two-fold: first, to assess potential meth odological standards that would assure objective, transparent, and scientifically valid systematic reviews (SRs) of comparative effectiveness research and, second, to recommend a set of method ological standards for developing and reporting such SRs.
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in July 2009 to produce both studies at the same time. 1 The IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines defines CPGs as "statements that include recommendations intended to optimize patient care that are informed by an SR of evidence and an assessment of the benefits and harms of alternative care options." 2 Public Law 110-275, Section 304.
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WHAT IS COMPARATIVE EFFECTIVENESS RESEARCH? In recent years, various terms such as evidence-based medicine, health technology assessment, clinical effectiveness research, and comparative effectiveness research have been used to describe healthcare research that focuses on generating or synthesizing evi dence to inform real-world clinical decisions (Luce et al., 2010)
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Body of Evidence for Systematic Reviews of Comparative Effectiveness Research The body of evidence for an SR of CER includes randomized controlled trials (RCTs) and observational studies such as cohort
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However, to be applicable to real-world clinical decision making, SRs should assess well BOX 1-2 Types of Comparative Effectiveness Research Studies Experimental study: A study in which the investigators actively intervene to test a hypothesis. • ontrolled trials are experimental studies in which a group receives C the intervention of interest while one or more comparison groups receive an active comparator, a placebo, no intervention, or the standard of care, and the outcomes are compared.
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Observational research is particularly useful for identifying an intervention's potential for unexpected effects or harms because many adverse events are too rare to be observed during typical RCTs or do not occur until after the trial ends (Chou et al., 2010; Reeves BOX 1-3 Four Examples of the Use of Observational Studies in Systematic Reviews of Comparative Effectiveness Research Important outcomes are not captured in randomized controlled trials (RCTs) More than 50 RCTs of triptans focused on the speed and degree of migraine pain relief related to a few isolated episodes of headache.
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STUDY SCOPE This report presents methodological standards for SRs that are designed to inform everyday healthcare decision making, especially for patients, clinicians and other healthcare providers, and develop Participants in trials comparing percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG)
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, Drug Effectiveness Research Project (DERP) , National Institutes of Health, Centers for Disease Control and Prevention, and U.S.
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Finally, the utility of an SR is only as good as the body of individual studies available. A considerable literature documents the shortcomings of reports of individual clinical trials and observational research (Altman et al., 2001; Glasziou et al., 2008; Hopewell et al., 2008b; Ioannidis et al., 2004; Plint et al., 2006; von Elm et al., 2007)
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. Relationship with the Committee on Standards for Developing Trustworthy Clinical Practice Guidelines The boundaries of this study were defined in part by the work of the companion CPG study (Box 1-4)
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In this context, the committee should: 1. Assess whether, if widely adopted, any existing set of standards would assure the development of unbiased, scientifically valid, and trustworthy clinical practice guidelines.
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. These more complex reviews often include multiple clinical questions that will each need a separate review of the literature, analysis, and synthesis.
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In addition, the committee commissioned two reports: one on the role of consumers in developing SRs in the United States and another that helped identify the evidence base for the steps in the SR process.7 Criteria for Assessing Potential Standards The overarching goals of the criteria are to increase the usefulness of SRs for patient and clinician decisions while minimizing Shield Technical Evaluation Center; the ECRI Institute; Geisinger health care system; Institute for Clinical Systems Improvement; Kaiser Permanente (Southern California) ; Medicare Evidence Development & Coverage Advisory Committee; National Comprehensive Cancer Network; National Heart, Lung, and Blood Institute; and the Veteran's Health Administration.
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• Applicability (generalizability) : Healthcare interventions found to be effective in one patient population may not be effective in other patient populations.
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For example, a standard that requires the review team to solicit feedback from patients about which clinical outcomes to address in review would enhance patient-centeredness. • Scientific rigor: Potential standards should be considered if evidence shows that they increase the scientific rigor of the review.
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These organizations were DERP, the ECRI Institute, National Institute for Health and Clinical Excel lence (UK) , and several Evidence-based Practice Centers (EPCs)
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For example, the first standard in Chapter 3 is: Standard 3.1 Conduct a comprehensive systematic search for evidence Required elements: 3.1.1 Work with a librarian or other information specialist training in performing SRs to plan the search strategy 3.1.2 Design the search strategy to address each key research question 3.1.3 Use an independent librarian or information specialist to peer review the search strategies etc.
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. Private organizations also conduct SRs of CER, including the Blue Cross and Blue Shield Association's Technology Evaluation Center, the ECRI Institute, and Hayes, Inc.
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AHRQ awards Care Program 5-year contracts to EPCs to develop evidence reports and technology assessments. Currently, there are 14 EPCs in university and private settings.
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Hayes, Inc., is a for-profit organization, established in 1989, to develop health technology assessments for health organizations, including health plans, managed-care companies, hospitals, and health networks. Hayes, Inc., produces several professional products, including the Hayes Briefs, the Hayes Directory, and the Hayes Outlook.
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Final SRs are published in the peer-reviewed monograph series, Campbell Systematic Reviews. The International Secretariat is hosted by the Norwegian Centre for the Health Services.
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. TABLE 1-6 Examples of Organizations That Use Systematic Reviews Organization Description Drug DERP is a collaboration of public and private organizations, Effectiveness including 13 state programs, which develops reports Review Project assessing the comparative effectiveness and safety of drugs (DERP)
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Examples of performance measurement organizations include the AQA Alliance and the National Quality Forum. Professional Many professional medical societies have instituted processes medical and directed resources to developing clinical practice societies guidelines on the basis of systematic reviews.
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2007. Comparative effectiveness of percutaneous coronary interventions and coronary artery bypass grafting for coronary artery disease.
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2009. Initial national priorities for comparative effectiveness research.
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In Methods guide for comparative effectiveness reviews. http://effectivehealthcare.ahrq.
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statement: Guidelines for reporting observational studies. Annals of Internal Medicine 147(8)
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