Objective: The objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention.
Methods: Using the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective.
Results: The developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review.
Conclusion: Reporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs.
Keywords: CONSORT guidelines; Controlled clinical trials; SPIRIT guidelines; Study design; Unequal allocation; Unequal randomization.
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