Investigating modifications to participant information materials to improve recruitment into a large randomized trial.

ABSTRACT:

Background

Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it.

Methods

Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during

SUBMITTER: HPS2-THRIVE Collaborative Group 

PROVIDER: S-EPMC6896768 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature