Patients' perceptions of their participation in a clinical trial for postoperative Crohn's disease.
OBJECTIVE
To explore patients' perceptions of their participation in a randomized controlled trial.


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
ED
Department of Surgery, Mount Sinai Hospital, University of Toronto, Ontario.
Blair
J E
JE
Ready
R
R
Wolff
B G
BG
Steinhart
A H
AH
Carryer
P W
PW
McLeod
R S
RS
D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use; D003113:Colonoscopy; D003424:Crohn Disease / Q000517:prevention & control / Q000523:psychology* / Q000628:therapy; D005500:Follow-Up Studies; D006801:Humans; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000517:prevention & control / Q000523:psychology* / Q000628:therapy; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D055502:Secondary Prevention; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine