Informed consent in the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial: a survey of collaborating physicians.
An anonymous postal survey was conducted among the physicians collaborating in a randomized controlled trial to examine their method of convincing patients, their consent process, the factors related to higher accrual, and the predictors of 100% success in the process of obtaining informed consent (IC). A total of 512 questionnaires were sent out and 448 responses were received, for a response rate of 87.5%. The 448 physicians solicited a total of 5371 eligible patients (12.0 per physician), among which 3763 patients (8.4 per physician) agreed to participate. One-fifth (22.3%) of the physicians were able to obtain IC from 100% of the patients they solicited. Physicians who thought that the information on the IC sheet was sufficient to obtain consent (odds ratio [OR] = 2.0, 95% confidence interval [CI] = 1.1-3.9; p = 0.03) and those who did not consider that the patient's decision was influenced by relatives and friends (OR = 0.2, CI = 0.1-0.4; p = 0.001), were significantly more likely to obtain IC from 100% of the eligible patients. Three-fourths (73.2%) of the physicians targeted only patients who they perceived would easily provide IC, and 81.2% favored some form of incentives for patients. The results of this study should be useful for efficiently implementing randomized controlled trials in Japan.
Fukui
Tsuguya
T
Clinical Practice Evaluation and Research Center, St. Luke's Life Science Institute, St. Luke's International Hospital, Tokyo, Japan. fkts@luke.or.jp
Rahman
Mahbubur
M
Morita
Satoshi
S
Sakamoto
Junichi
J
D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D001713:Biphenyl Compounds; D003625:Data Collection; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D007564:Japan; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010820:Physicians; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013777:Tetrazoles / Q000627:therapeutic use*
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C081643:candesartan