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


CONCLUSIONS
The information generated by this study could be useful in designing future randomized controlled trials in Japan and abroad.
Rahman
Mahbubur
M
Clinical Practice Evaluation and Research Center, St. Luke's Life Science Institute, Tokyo 104-8560, Japan. marahman@luke.or.jp
Morita
Satoshi
S
Fukui
Tsuguya
T
Sakamoto
Junichi
J
D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001291:Attitude of Health Personnel; D001562:Benzimidazoles / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007564:Japan; D016015:Logistic Models; D010820:Physicians / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D011795:Surveys and Questionnaires; D013777:Tetrazoles / Q000627:therapeutic use*
D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C077793:candesartan cilexetil