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Physicians' attitudes towards and reasons for participation in the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial.

Author(s): Rahman M, Morita S, Fukui T, Sakamoto J

Affiliation(s): Clinical Practice Evaluation and Research Center, St. Luke's Life Science Institute, Tokyo 104-8560, Japan. marahman@luke.or.jp

Publication date & source: 2005-03, J Epidemiol., 15(2):38-40.

BACKGROUND: Physicians' perception and attitudes towards a research topic and trial management could influence their participation in a randomized controlled trial. The objectives of this study were to determine the reasons for physicians' participation in and attitudes towards the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial. METHODS: CASE-J's main objective is to compare the effectiveness of an angiotensin II receptor antagonist (candesartan cilexetil) with that of a calcium channel blocker (amlodipine besilate) in terms of the incidence of cardiovascular events among high-risk hypertensive patients. We conducted a questionnaire survey among the physicians (n = 512) participating in that trial to determine the reasons behind their participation and to elicit their reactions to the trial management. RESULTS: Eighty-eight percent of the 512 participating physicians responded to our survey. The main reasons for participation were clear objectives of the trial (85.1%), a simple protocol (61.1%), interest in finding out the inhibiting effects of the drugs on cardiac events (80.2%), and a well-organized support system (59.8%). As for negative factors, case registration and follow-up were considered cumbersome by 28.6% and 10.8%, respectively while 44.2% stated that support by the clinical research coordinators provided by the trial management authority was necessary for case screening, recruitment process, patient registration, and follow-up. Multivariate logistic regression analysis showed that participants who did not use a computer very regularly (odds ratio = 1.9, 95% confidence interval = 1.1-3.6) were more likely to consider the case registration and follow-up procedures as a cumbersome. CONCLUSION: The information generated by this study could be useful in designing future randomized controlled trials in Japan and abroad.

Page last updated: 2006-01-31

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