OBJECTIVE: To explore patients' perceptions of their participation in a randomized controlled trial. PATIENTS AND METHODS: A 27-item questionnaire was mailed to all patients who participated in a randomized controlled trial that determined the effectiveness of mesalamine in preventing the recurrence of Crohn's disease postoperatively. RESULTS: The response rate was 66% (99 of 149). Fifty-five per cent of the patients felt that they received better medical care than they otherwise would have and 53% liked taking the medication. Sixty-eight per cent of the patients did not feel that annual colonoscopy was too frequent and 81% felt that the time commitment did not significantly interfere with their job or other activities. Seventy-five per cent and 62% of the patients would have liked more information and education, respectively, about Crohn's disease incorporated into the trial. Although 91% of the patients would agree to participate in a future randomized controlled trial comparing medical therapies, only 44% would agree to participate in a future randomized controlled trial comparing medical with surgical therapies. CONCLUSIONS: The majority of patients were satisfied with their participation in the trial. A large proportion of the patients would participate again but would like more information and education incorporated into the trial. Furthermore, post-trial questionnaires may be helpful in the design of future trials.
Kennedy, E. D., Blair, J. E., Ready, R., Wolff, B. G., Steinhart, A. H., Carryer, P. W., & McLeod, R. S. (1998). Patients’ perceptions of their participation in a clinical trial for postoperative Crohn’s disease. Canadian Journal of Gastroenterology, 12(4), 287–291. https://doi.org/10.1155/1998/274172