• Susan L Norris, David Atkins, Wendy Bruening, Steven Fox, Eric Johnson, Robert Kane, Sally C Morton, Mark Oremus, Maria Ospina, Gurvaneet Randhawa, Karen Schoelles, Paul Shekelle, and Meera Viswanathan.
• Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR 97239, USA. norriss@ohsu.edu
• J Clin Epidemiol. 2011 Nov 1;64(11):1178-86.

ObjectiveSystematic reviewers disagree about the ability of observational studies to answer questions about the benefits or intended effects of pharmacotherapeutic, device, or procedural interventions. This study provides a framework for decision making on the inclusion of observational studies to assess benefits and intended effects in comparative effectiveness reviews (CERs).Study Design And SettingThe conceptual model and recommendations were developed using a consensus process by members of the methods workgroup of the Effective Health Care Program of the Agency for Healthcare Research and Quality.ResultsIn considering whether to use observational studies in CERs for addressing beneficial effects, reviewers should answer two questions: (1) Are there gaps in the evidence from randomized controlled trials (RCTs)? (2) Will observational studies provide valid and useful information? The latter question involves the following: (a) refocusing the study questions on gaps in the evidence from RCTs, (b) assessing the risk of bias of the body of evidence of observational studies, and (c) assessing whether available observational studies address the gap review questions.ConclusionsBecause it is unusual to find sufficient evidence from RCTs to answer all key questions concerning benefit or the balance of benefits and harms, comparative effectiveness reviewers should routinely assess the appropriateness of inclusion of observational studies for questions of benefit. Furthermore, reviewers should explicitly state the rationale for inclusion or exclusion of observational studies when conducting CERs.Copyright © 2011 Elsevier Inc. All rights reserved.

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