Perspectives of older participants on the delivery of individual results: Study within a trial (SWAT) hosted by the HAEL Study

Background Communicating and disseminating individual results to research participants is an ethical imperative, however, this practice is still unusual. In the present study, we investigated two delivery formats of individual results to older participants on the perspectives of understanding (main outcome), satisfaction, and short-term psychological impact. Methods This Study Within A Trial (SWAT) is a randomized, single-blinded (outcome assessors), parallel-group intervention hosted by “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, two-arm, randomized trial (HAEL Study). Participants who entered the HAEL Study in July 2019 or after were eligible. Randomization was generated by computer and allocation concealment by an independent investigator. The delivery of individual results was carried out in individual or group meetings between December 2019 and September 2020 at a Clinical Research Center. Outcomes were assessed by an unvalidated questionnaire on a 5-point Likert scale and multiple choice questions. Results Of the 20 participants who agreed to participate in the SWAT, 10 from the individual format and 7 from the group format, with a mean age of 68 years old, were evaluated through per-protocol analysis. Most participants showed good understanding of their results in both delivery formats - individual 70% (7/10) and group 71% (5/7) (p=1.00). Satisfaction with the results delivery format was reported in both groups, with moderate negative emotional impact. Any research-related physical harms were not identified. Conclusion Both formats for delivering individual results generated adequate understanding and satisfaction with low negative emotional impact to a partial sample of older participants in the HAEL Study.