Are we promoting a true informed consent for participation in randomized clinical trials?

详细信息    查看全文

• 作者：DeLuca ; Sue A. ; Korcuska ; Lisa A. ; Oberstar ; Belinda H. ; Rosenthal ; Monique L. ; Welsh ; Patricia A.
• 刊名：Controlled Clinical Trials
• 出版年：1995
• 出版时间：June, 1995
• 年：1995
• 卷：16
• 期：3
• 页码：44S
• 全文大小：59.6 K

文摘

The purpose of this study is to determine variables contributing to patient participation in randomized clinical trials while assessing their potential relationship to a valid consent process. Two hundred fifty consecutive patients eligible for enrollment into one of several interventional cardiology protocols were administered a questionnaire after they made their decision about participation. Numerous variables were explored for their relationship to patient participation. Of particular significance were the variables of education, perception of enough time to decide, and the person approaching the patient. Consent rates according to furthest education level were: grade school, 7 (47 % ), high school, 90 (67 % ), college, 59 (78 % ), and graduate school, 16 (76 % ). There is a statistically significant trend towards a higher rate of consent among the more highly educated (p = .020 using the Mantel-Haenzel x²). The feeling of having enough time to decide did influence consent. Seventy-three percent of patients who felt they had enough time agreed to participate, while less than half (49 % ) of patients who did not feel that they had enough time agreed to join (p < .01). Interestingly, consenting and nonconsenting patients each averaged about 4.5 hours to decide, suggesting that having enough time is a perception of the patient. Of 35 patients initially approached by a physician, 96 % (n = 33) agreed to join. Nineteen consenting patients answered the question about how a physician enhanced their desire to consent, 10 (53 % ) reported trust, 3 (16 % ) respect, 2 (10 % ) knowledge, 2 (10 % ) no answer and 1 (5 % ) afraid. Each of the variables identified raised a question. Are those less educated given information in a manner they can best assimilate? Does the perception of not having enough time to make a decision pressure the patient against signing the consent? Does a patients' trust in the physician detract from the autonomy of their decision making? As these concerns are identified, the informed consent process needs to be refined.