Patel Angira, Wilke Hans J, Mingay David, Ellis John E
Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL 60637, USA.
J Clin Anesth. 2004 Sep;16(6):426-34. doi: 10.1016/j.jclinane.2003.12.010.
To determine the factors that affect patients' decisions to provide informed consent to participate in perioperative clinical trials.
Survey instrument (questionnaire).
Urban, tertiary-care, university-affiliated hospital.
Of 52 patients who had been asked to participate in a randomized control trial (RCT), 43 agreed to be participate in our survey. Almost all consenters (97%), but only 62% of nonconsenters agreed to answer the survey questions (p = 0.002). No significant difference in gender, ethnic background, marital status, or education level was found between groups who were or were not willing to participate. Univariate correlates of agreement to participate in RCTs included older age (>60 yrs;p = 0.02), a reassuring attitude conveyed by study personnel (p = 0.02), and trust in study personnel (p = 0.02). Those who declined participation in clinical trials more frequently indicated that the study made them feel like a "guinea pig" (p = 0.02).
Patient age and personal attitudes predict the likelihood of participation in perioperative clinical trials. Neither gender nor race affected willingness to participate. Further work in larger groups is needed to identify predictors of consent and techniques to increase willing participation.
确定影响患者做出参与围手术期临床试验知情同意决定的因素。
调查工具（问卷）。
城市三级医疗大学附属医院。
在被邀请参与随机对照试验（RCT）的52例患者中，43例同意参与我们的调查。几乎所有同意者（97%），但只有62%的不同意者同意回答调查问题（p = 0.002）。愿意或不愿意参与的组间在性别、种族背景、婚姻状况或教育水平上未发现显著差异。参与RCT同意的单因素相关因素包括年龄较大（>60岁；p = 0.02）、研究人员传达的令人安心的态度（p = 0.02）以及对研究人员的信任（p = 0.02）。那些拒绝参与临床试验的人更频繁地表示该研究让他们感觉自己像“小白鼠”（p = 0.02）。
患者年龄和个人态度可预测参与围手术期临床试验的可能性。性别和种族均未影响参与意愿。需要在更大规模的群体中开展进一步工作，以确定同意的预测因素和提高参与意愿的技术。
