Cluster randomized trials of individual-level interventions were at high risk of bias

Abstract

Objectives: To describe the prevalence of risks of bias in cluster-randomized trials of individual-level interventions, according to the Cochrane Risk of Bias tool.

Study design and setting: Review undertaken in duplicate of a random sample of 40 primary reports of cluster-randomized trials of individual-level interventions.

Results: The most common reported reasons for adopting cluster randomization were the need to avoid contamination (17, 42.5%) and practical considerations (14, 35%). Of the 40 trials all but one was assessed as being at risk of bias. A majority (27, 67.5%) were assessed as at risk due to the timing of identification and recruitment of participants; many (21, 52.5%) due to an apparent lack of adequate allocation concealment; and many due to selectively reported results (22, 55%), arising from a mixture of reasons including lack of documentation of primary outcome. Other risks mostly occurred infrequently.

Conclusion: Many cluster-randomized trials evaluating individual-level interventions appear to be at risk of bias, mostly due to identification and recruitment biases. We recommend that investigators carefully consider the need for cluster randomization; follow recommended procedures to mitigate risks of identification and recruitment bias; and adhere to good reporting practices including clear documentation of primary outcome and allocation concealment methods.

Keywords: Cluster randomized trials; Individual-level interventions; Risk of bias; Selection bias.