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Canadian Journal of Gastroenterology
Volume 12, Issue 4, Pages 287-291
http://dx.doi.org/10.1155/1998/274172
Original Article

Patients’ Perceptions of their Participation in a Clinical Trial for Postoperative Crohn’s Disease

ED Kennedy,1 JE Blair,1 R Ready,2 BG Wolff,2 AH Steinhart,3 PW Carryer,4 and RS McLeod1

1Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
2Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
3Department of Colorectal Surgery, Mayo Clinic, Rochester, Minnesota, Canada
4Department of Medicine, Mayo Clinic, Rochester, Minnesota, Canada

Received 29 January 1998; Accepted 30 April 1998

Copyright © 1998 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.