Testing the Risk of Bias Tool Showed Low Reliability Between Individual Reviewers and Across Consensus Assessments of Reviewer Pairs

Published in: Journal of Clinical Epidemiology, v. 66, no. 9, Sep. 2013, p. 973-981

Posted on RAND.org on January 01, 2012

by Lisa Hartling, Michele Hamm, Andrea Milne, Ben Vandermeer, P. Lina Santaguida, Mohammed T Ansari, Alexander Tsertsvadze, Susanne Hempel, Paul G. Shekelle, Donna M. Dryden

Read More

Access further information on this document at Journal of Clinical Epidemiology

This article was published outside of RAND. The full text of the article can be found at the link above.

OBJECTIVES: To assess the reliability of the Cochrane Risk of Bias (ROB) tool between individual raters and across consensus agreements of pairs of reviewers and examine the impact of study-level factors on reliability. STUDY DESIGN AND SETTING: Two reviewers assessed risk of bias for 154 randomized controlled trials (RCTs). For 30 RCTs, two reviewers from each of four centers assessed risk of bias and reached consensus. We assessed interrater agreement using kappas and the impact of study-level factors through subgroup analyses. RESULTS: Reliability between two reviewers was fair for most domains (κ=0.24-0.37), except sequence generation (κ=0.79, substantial). Reliability results across reviewer pairs: sequence generation, moderate (κ=0.60); allocation concealment and "other sources of bias," fair (κ=0.37-0.27); and other domains, slight (κ=0.05-0.09). Reliability was influenced by the nature of the outcome, nature of the intervention, study design, trial hypothesis, and funding source. Variability resulted from different interpretation of the tool rather than different information identified in the study reports. CONCLUSION: Low agreement has implications for interpreting systematic reviews. These findings suggest the need for detailed guidance in assessing the risk of bias.

Research conducted by

This report is part of the RAND Corporation external publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.