PATIENTS PERCEPTIONS OF THEIR PARTICIPATION IN A CLINICAL-TRIAL FOR POSTOPERATIVE CROHNS-DISEASE

OBJECTIVE: To explore patients' perceptions of their participation in a randomized controlled trial. PATIENTS AND METHODS: A 27-item questio nnaire was mailed to all patients who participated in a randomized con trolled trial that determined the effectiveness of mesalamine in preve nting 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 t heir job or other activities. Seventy-five per cent and 62% of the pat ients would have liked more information and education, respectively, a bout 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 surgic al therapies. CONCLUSIONS: The majority of patients were satisfied wit h 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 m ay be helpful in the design of future trials.