Cross-sectional study on patients’ understanding and views on the informed consent procedure of a secondary stroke prevention trial

BACKGROUND Improving understanding of study contents and procedures might enhance recruitment into studies and retention during follow-up. However, data in stroke patients on understanding of the informed consent (IC) procedure are sparse. METHODS We conducted a cross-sectional study among ischemic stroke patients taking part in the IC procedure of an ongoing cluster-randomized secondary prevention trial. All aspects of the IC procedure were assessed in an interview using a standardized 20-item questionnaire. Responses were collected within 72 hours after the IC procedure and analyzed quantitatively and qualitatively. Participants were also asked regarding main reasons for participation. RESULTS 146 stroke patients (65±12 years, 38% female) were enrolled. On average, patients recalled 66.4% (95% CI 65.2%-67.5%) of the content of the IC procedure. Most patients understood that participation was voluntary (99.3%) and that they had the right to withdraw consent (97.1%). 79.1% of the patients recalled the study duration, 56.1% the goal. Only 40.3% could clearly state a benefit of participation and 28.8% knew their group allocation. Younger age, higher graduation and allocation to the intervention group were associated with better understanding. Of all patients, 53% exclusively stated a personal, 22% an altruistic reason for participation. CONCLUSIONS While understanding of patient rights was high, many patients were unable to recall other important aspects of study content and procedures. Increased attention to older and less educated patients may help to enhance understanding in this patient population. Actual recruitment and retention benefit of an improved IC procedure remains to be tested in a randomized trial.