Research participants may not recall their participation but have a better understanding of alternative management options than patients in routine care

Background: Patient understanding of care interventions, of the clinical uncertainty, and of their participation in clinical research is often poor. We hypothesized that compared to routine care, patients would better understand the prevailing uncertainty when they participated in research.

Methods: A questionnaire was administered to patients at the time they attended a follow-up neurovascular clinic 4 to 52 weeks after a care episode where they did or did not participate in a clinical trial. Patients were not reminded whether they had previously participated in a clinical trial. Questions concerned their understanding of the risks/benefits of interventions, the availability of alternative options, whether their personal opinion was taken into consideration, the reason for the final decision, their confidence at having received the best management, and whether they had been research participants.

Results: Between June 2019 and June 2020, 167 patients were recruited; 71 had truly been research participants, while 96 had not. A greater proportion of research patients were aware of the existence of management alternatives (65% versus 44%; P=0.008). Patients of both groups believed their personal opinion counted in the final decision (76% versus 70%), and patients were equally confident that they had received the best management (94%). Research patients believed they had participated in research 46% of the time, compared to 12% of routine care patients (P=0.003).

Conclusion: Many patients do not recall that they participated in a clinical trial, but they have a better understanding of the clinical uncertainty and of the availability of alternative management options.