Objective: Despite the increasing numbers of published trials of quality improvement (QI) interventions in diabetes, little is known about the risk of bias in this literature.
Design: Secondary analysis of a systematic review.
Data sources: Medline, the Cochrane Effective Practice and Organisation of Care (EPOC) database (from inception to July 2010) and references of included studies.
Eligibility criteria: Randomised trials assessing 11 predefined QI strategies or financial incentives targeting health systems, healthcare professionals or patients to improve the management of adult outpatients with diabetes.
Analysis: Risk of bias (low, unclear or high) was assessed for the 142 trials in the review across nine domains using the EPOC version of the Cochrane Risk of Bias Tool. We used Cochran-Armitage tests for trends to evaluate the improvement over time.
Results: There was no significant improvement over time in any of the risk of bias domains. Attrition bias (loss to follow-up) was the most common source of bias, with 24 trials (17%) having high risk of bias due to incomplete outcome data. Overall, 69 trials (49%) had at least one domain with high risk of bias. Inadequate reporting frequently hampered the risk of bias assessment: allocation sequence was unclear in 82 trials (58%) and allocation concealment was unclear in 78 trials (55%). There were significant reductions neither in the proportions of studies at high risk of bias over time nor in the adequacy of reporting of risk of bias domains.
Conclusions: Nearly half of the included QI trials in this review were judged to have high risk of bias. Such trials have serious limitations that put the findings in question and therefore inhibit evidence-based QI. There is a need to limit the potential for bias when conducting QI trials and improve the quality of reporting of QI trials so that stakeholders have adequate evidence for implementation.