PT  - JOURNAL ARTICLE
AU  - Bredan McEvoy
AU  - David Haidar
AU  - Jason Tehranisa
AU  - William J. Meurer
TI  - Optimizing Communication of Emergency Response Adaptive Randomization Clinical Trials to Potential Participants
AID  - 10.1101/091819
DP  - 2016 Jan 01
TA  - bioRxiv
PG  - 091819
4099  - http://biorxiv.org/content/early/2016/12/07/091819.short
4100  - http://biorxiv.org/content/early/2016/12/07/091819.full
AB  - 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% Cl 17-33%). The RAR group with interactive video had a higher odds of correct identification of allocation method (O.R. 2.767, 95% Cl [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.