Design Considerations for Clinical Trials in Aphasia.

The use of the randomised controlled trial (RCT) design to evaluate the effectiveness of new interventions in aphasia has increased in recent years in response to calls for high quality evidence of the effectiveness of interventions for this population. This view-point article highlights some of the important considerations when designing a trial for an aphasia intervention, illustrated with decisions made when designing the Big CACTUS RCT for self-managed computer-based word finding therapy in aphasia. Considerations outlined include whether an RCT is needed, readiness for conducting an RCT, choice of comparators, randomisation options, blinding/masking, selection of outcome measures, pragmatic versus explanatory approaches, and fidelity measurement.