Association between risk-of-bias assessments and results of randomized trials in Cochrane reviews: the ROBES meta-epidemiologic study

Ref ID 55
First Author J. Savović
Journal AMERICAN JOURNAL OF EPIDEMIOLOGY
Year Of Publishing 2018
URL https://pubmed.ncbi.nlm.nih.gov/29126260/
Keywords • Cochrane
• Author
• Risk of bias
• General medical
Problem(s) • Flawed risk of bias undertaken
Article Type Empirical
Article Subtype Meta-epidemiological analysis
First Author Country United Kingdom
Aim To estimate associations between bias judgements with intervention effect estimates using Bayesian hierarchical models for risk-of-bias judgements (for sequence generation, allocation concealment, blinding, and incomplete data) from a large collection of meta-analyses published in the Cochrane Library (issue 4; April 2011).
Level of Investigation Descriptive
Summary of Findings Bayesian analysis of 228 Cochrane meta-analyses found that intervention effect estimates were, on average, exaggerated in trials with high or unclear (versus low) risk-of-bias judgements for sequence generation (ratio of odds ratios (ROR) = 0.91, 95% credible interval (CrI): 0.86, 0.98), allocation concealment (ROR = 0.92, 95% CrI: 0.86, 0.98), and blinding (ROR = 0.87, 95%CrI: 0.80, 0.93). There was no consistently different bias for subjective outcomes compared with mortality. However, there was an increase in between-trial heterogeneity associated with lack of blinding in meta-analyses with subjective outcomes. Inconsistency in criteria for risk-of-bias judgements applied by individual reviewers is a likely limitation of routinely collected bias assessments. Inadequate randomization and lack of blinding may lead to exaggeration of intervention effect estimates in randomized trials.
Number of systematic reviews included 228
Number of eligible systematic reviews assessed 4371
Treatment impacted Yes
Treatment impacted description
Interpretation impacted Yes
Interpretation impacted description Bayesian analysis of 228 Cochrane meta-analyses found that intervention effect estimates were, on average, exaggerated in trials with high or unclear (versus low) risk-of-bias judgements for sequence generation (ratio of odds ratios (ROR) = 0.91, 95% credible interval (CrI): 0.86, 0.98), allocation concealment (ROR = 0.92, 95% CrI: 0.86, 0.98), and blinding (ROR = 0.87, 95%CrI: 0.80, 0.93). There was no consistently different in bias for subjective outcomes compared with mortality. However, there was an increase in between-trial heterogeneity associated with lack of blinding in meta-analyses with subjective outcomes.