Objective: It has been suggested that randomised controlled trials (RCTs) of health behaviour change (HBC) interventions are less rigorously designed than - for example- drug trials. This study presents an approach to clarifying whether this is due to poor trial design, incomplete trial reporting and/or the inappropriateness of commonly applied risk of bias assessment criteria.
Design: First, a framework of key sources of bias and common strategies for reducing bias risk is developed based on a literature review. Second, we describe the design of a multi-site RCT evaluating the cost-effectiveness of an HIV-treatment adherence intervention (case study). The choices made by the multidisciplinary team trying to minimise the risk of bias are compared against the risk of bias framework.
Main outcome measures: Implementation of common strategies for reducing the risk of bias in the case study; alternative or additional strategies applied; a justification for each deviation from the risk of bias framework.
Results: Most of the common strategies for reducing the risk of bias could be implemented. Alternative strategies were developed for minimising the risk of performance bias and contamination. Several additional, domain-specific risk of bias strategies were implemented.
Conclusions: The literature provides useful guidance for reducing the risk of bias in HBC trials. Yet, the case study suggests that HBC trial designers may face specific challenges that require alternative/additional measures for reducing the risk of bias. Using the risk of bias justification table (RATIONALE) could lead to better-designed HBC trials, more comprehensive trial reports and the data necessary for evaluating the appropriateness of commonly applied risk of bias assessment criteria to HBC trials.
Keywords: Cochrane; behaviour change; intervention; methodology; randomised controlled trial; risk of bias.