Meera Viswanathan1, Carrie D Patnode2, Nancy D Berkman3, Eric B Bass4, Stephanie Chang5, Lisa Hartling6, M Hassan Murad7, Jonathan R Treadwell8, Robert L Kane9. 1. RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center, RTI International, Research Triangle Park, NC, USA. Electronic address: viswanathan@rti.org. 2. Kaiser Permanente Research Affiliates Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, OR, USA. 3. RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center, RTI International, Research Triangle Park, NC, USA. 4. Johns Hopkins University Evidence-Based Practice Center, Baltimore, MD, USA. 5. Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, MD, USA. 6. University of Alberta Evidence-based Practice Center, Edmonton, Canada. 7. Evidence-based Practice Center, Mayo Clinic, Rochester, MN, USA. 8. ECRI Institute Evidence-Based Practice Center, Plymouth Meeting, PA, USA. 9. University of Minnesota Evidence-based Practice Center, Minneapolis, MN, USA.
Abstract
OBJECTIVES: Risk-of-bias assessment is a central component of systematic reviews, but little conclusive empirical evidence exists on the validity of such assessments. In the context of such uncertainty, we present pragmatic recommendations that promote transparency and reproducibility in processes, address methodological advances in the risk-of-bias assessment, and can be applied consistently across review topics. STUDY DESIGN AND SETTING: Epidemiological study design principles; available empirical evidence, risk-of-bias tools, and guidance; and workgroup consensus. RESULTS: We developed recommendations for assessing the risk of bias of studies of health-care interventions specific to framing the focus and scope of risk-of-bias assessment; selecting the risk-of-bias categories; choosing assessment instruments; and conducting, analyzing, and presenting results of risk-of-bias assessments. Key recommendations include transparency and reproducibility of judgments, separating risk of bias from other constructs such as applicability and precision, and evaluating the risk of bias per outcome. We recommend against certain past practices, such as focusing on reporting quality, relying solely on study design or numerical quality scores, and automatically downgrading for industry sponsorship. CONCLUSION: Risk-of-bias assessment remains a challenging but essential step in systematic reviews. We presented standards to promote transparency of judgments.
OBJECTIVES: Risk-of-bias assessment is a central component of systematic reviews, but little conclusive empirical evidence exists on the validity of such assessments. In the context of such uncertainty, we present pragmatic recommendations that promote transparency and reproducibility in processes, address methodological advances in the risk-of-bias assessment, and can be applied consistently across review topics. STUDY DESIGN AND SETTING: Epidemiological study design principles; available empirical evidence, risk-of-bias tools, and guidance; and workgroup consensus. RESULTS: We developed recommendations for assessing the risk of bias of studies of health-care interventions specific to framing the focus and scope of risk-of-bias assessment; selecting the risk-of-bias categories; choosing assessment instruments; and conducting, analyzing, and presenting results of risk-of-bias assessments. Key recommendations include transparency and reproducibility of judgments, separating risk of bias from other constructs such as applicability and precision, and evaluating the risk of bias per outcome. We recommend against certain past practices, such as focusing on reporting quality, relying solely on study design or numerical quality scores, and automatically downgrading for industry sponsorship. CONCLUSION: Risk-of-bias assessment remains a challenging but essential step in systematic reviews. We presented standards to promote transparency of judgments.
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