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Comparative Effectiveness Reviews are systematic reviews of existing research on the effectiveness, comparative effectiveness, and harms of different health care interventions. They provide syntheses of relevant evidence to inform real-world health care decisions for patients, providers, and policymakers. Strong methodologic approaches to systematic review improve the transparency, consistency, and scientific rigor of these reports. Through a collaborative effort of the Effective Health Care (EHC) Program, the Agency for Healthcare Research and Quality (AHRQ), the EHC Program Scientific Resource Center, and the AHRQ Evidence-based Practice Centers have developed a Methods Guide for Effectiveness and Comparative Effectiveness Reviews. This Guide presents issues key to the development of Comparative Effectiveness Reviews and describes recommended approaches for addressing difficult, frequently encountered methodological issues. The Methods Guide for Comparative Effectiveness Reviews is a living document, and will be updated as further empiric evidence develops and our understanding of better methods improves. Comments and suggestions on the Methods Guide for Effectiveness and Comparative Effectiveness Reviews and the Effective Health Care Program can be made at www.effectivehealthcare.ahrq.gov. The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the view of AHRQ or the Veterans Health Administration. Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: • The task of assessing the risk of bias of individual studies is part of assessing the strength of a body of evidence. In preparation for evaluating the overall strength of evidence, reviewers should separate criteria for assessing risk of bias of individual studies from those that assess precision, directness, and applicability. • EPCs may choose to use the terms " assessment of risk of bias " or " quality assessment. " EPCs should define clearly the term used in their systematic review (SR) and comparative effectiveness review (CER) protocols and describe the constructs included as part of the assessment. • We recommend that AHRQ reviews: o Opt for tools that are specifically designed for use in systematic reviews; have demonstrated acceptable validity and reliability; specifically address items related to methodological quality (internal validity) and preferably are based on empirical evidence of bias; where available, are specific to the study designs being evaluated; and avoid the presentation of risk of bias assessment as a composite score. o Do not use study design labels (e.g., RCT, cohort, case-control) as a proxy for …

Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions