Assessment of Risk of Bias Among Pediatric Randomized Controlled Trials

Michael T. Crocetti · Diane D. Amin · Roberta W. Scherer

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Pharmaceutical industry and healthcare

Abstract

OBJECTIVE: The goal was to assess the risk of bias among pediatric, randomized, controlled trials (RCTs) reported in 8 high-impact journals. METHODS: We searched PubMed for all pediatric RCTs reported between July 1, 2007, and June 30, 2008, in 8 journals with high impact factors. Using Cochrane Collaboration methods for risk assessment, we evaluated all reports for risk of bias according to domain (ie, randomized sequence generation, allocation concealment, masking, incomplete outcome data, selective outcome reporting, and other). We used multiple logistic regression to test for associations between the presence of a high risk of bias according to domain and funding source, intervention type, trial registration, and multicenter status. RESULTS: Industry-funded RCTs were more likely to show a high risk of bias for sequence generation, compared with government-funded RCTs (adjusted odds ratio [aOR]: 6.1 [95% confidence interval [CI]: 1.70- 21.89]), and behavioral/educational trials were more likely to show a high risk of bias for sequence generation (aOR: 2.8 [95% CI: 1.06-7.36]) and allocation concealment (aOR: 4.09 [95% CI: 1.69-9.90]), compared with drug trials. Registered trials were less likely to have a high risk of bias for sequence generation, compared with nonregistered trials (aOR: 0.33 [95% CI: 0.15-0.71]). CONCLUSIONS: Overall, we found a large proportion of pediatric RCT reports with a high risk of bias for sequence generation and allocation concealment. Factors associated with a high risk of bias included industry funding and assessment of behavioral/educational interventions, whereas trial registration was associated with a lower risk of bias.

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References

2008Cochrane Handbook for Systematic Reviews of Interventions 1995Empirical Evidence of Bias 1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 2006The History and Meaning of the Journal Impact Factor 1999The Hazards of Scoring the Quality of Clinical Trials for Meta-analysis 1995Assessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists 2007Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials 2009Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

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