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bioRxiv · 10.1101/091819

Optimizing Communication of Emergency Response Adaptive Randomization Clinical Trials to Potential Participants

Meurer, W. J.·Haidar, D.·Tehranisa, J.·McEvoy, B.
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Abstract

Introduction: Acute clinical stroke trials are challenging to communicate to patients and families considering participation. Response adaptive randomization (RAR) is a technique that alters the proportion of trial subjects receiving active treatment, based on the outcomes of previous subjects. We aimed to determine how well interactive videos would improve understanding of a simulated acute stroke trial scenario that incorporated a design with RAR. Methods: We performed a cross-sectional study of emergency department patients who were without stroke, altered mental status, or critical illness. Subjects viewed a hypothetical stroke and clinical trial scenario. They were randomized into one of four groups with either an RAR or fixed randomization clinical trial design and with either a standard consent video, or an interactive video. Results: We enrolled 720 participants. In the RAR group with interactive video, 128 out of 149 (85.9%) of the subjects were able to correctly identify the allocation method, compared to the 172 out of 285 (61.6%) in the RAR group with the uninterrupted video for an absolute increase of 25.6% (95% CI 17,33%). The RAR group with interactive video had a higher odds of correct identification of allocation method (O.R. 2.767, 95% CI [1.011,7.570] while controlling for age, sex, ethnicity, education, self-reported understanding of protocol, stroke awareness and agreement to participate in trial. Conclusions: The interactive video increased participant understanding of an RAR design in a simulated stroke scenario. Future research should focus on whether acute trial recruitment can be enhanced using similar techniques.

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Meurer, W. J., Haidar, D., Tehranisa, J., McEvoy, B.. 2016-12-07. Optimizing Communication of Emergency Response Adaptive Randomization Clinical Trials to Potential Participants. https://doi.org/10.1101/091819

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