Pictorial enhanced written plus audiovisual information versus standard written information alone for disseminating trial results to trial participants: A Study Within A Trial (SWAT) Protocol

<ns3:p>Background Trial participants have repeatedly indicated that they would like to receive the results of the trials they were enrolled in. Limited evidence, however, on the optimal methods for sharing trial results with trial participants appears to exist. This highlights the need to expand the methodological evidence base for this important trial process. To address this, we propose to conduct a Study Within A Trial (SWAT) to evaluate the effectiveness of two different formats for sharing trial results with trial participants. Methods The SWAT will be a two-group parallel randomised trial within the PREterm birth Prevention with Oral Probiotics (PRE POP) trial (the ‘host’ trial). The SWAT intervention will be a pictorial enhanced mailed written summary complemented by an animated audiovisual of the host trial results. The SWAT control will be a standard written summary report of the host trial results. The primary outcome is participant satisfaction with dissemination formats. The secondary outcomes are participant satisfaction with the information provided, participants understanding of the summary results, opinions about receiving the results and preferences for how trial results should be shared with participants in future maternity care trials. Participants of PRE POP will be randomly allocated to the SWAT intervention or control group using computer-generated block randomisation with block sizes of four and six. Outcome data will be collected using online questionnaires, administered one-week post intervention and control distribution. Descriptive statistics will be used to present summary data. Odds Ratios with 95% Confidence Intervals will be used to compare group outcomes. Conclusion The conduct and findings of this SWAT will add to the evidence base on trial processes and may be replicated in future SWATs. The findings will contribute to future systematic reviews designed to evaluate methods for disseminating trial results to trial participants.</ns3:p>