JMIR Publications

ABSTRACT

Background:

Information about patients’ preferences of the way a trial is organised could inform the trial planning to enhance participation rate.

Objective:

To describe patients’ preferences on the organisation of a randomised controlled trial (RCT) (visits on site or remotely) and evaluate the potential impact of fulfilling preferences on their willingness to participate in a clinical trial.

Methods:

Study design: Vignette-based survey. Vignette development: Vignettes were case scenarios of real clinical trials assessing pharmacological treatments. These RCTs evaluated six prevalent chronic diseases (i.e., osteoporosis, osteoarthritis, asthma, cardiovascular diseases, diabetes and endometriosis). Each vignette described: 1) the RCT and characteristics of treatment tested (i.e., doses, administration route), 2) the trial procedures and different options (son site or remotely) for how the trial was organised for i) informed consent; ii) follow-up visits; iii) communication of results when the trial is completed. Participants: We recruited participants from ComPare (www.compare.aphp.fr), a French e-cohort of patients with chronic diseases. Outcomes: Outcomes were participants’ preferences for the way trial was organised (on site or remotely) and their willingness to participate in the trial.

Results:

628 participants (78% female, median age 55) with different chronic diseases ranging from 59 patients with endometriosis to 133 patients with asthma answered the vignettes. Only 6% wanted to have informed consent and all trial visits on site, 28% wished to participate in a trial entirely remotely, 66% wanted to combine remote-based and hospital-based visits. Considering the trial as a whole, when the trial was organised in a way that patients preferred, the median (Q1-Q3) likelihood of participation in the trial was 90% (80-100) versus 60% (30-80) if the trial followed patients’ non-preferred model.

Conclusions:

There is an important diversity in participants’ preferences. Most participants preferred hybrid organisation involving both onsite and remote visits. Participants were more likely to participate in a trial organized according to their preferences.