PATIENTS WILLINGNESS TO ENTER CLINICAL-TRIALS - MEASURING THE ASSOCIATION WITH PERCEIVED BENEFIT AND PREFERENCE FOR DECISION PARTICIPATION
PATIENTS WILLINGNESS TO ENTER CLINICAL-TRIALS - MEASURING THE ASSOCIATION WITH PERCEIVED BENEFIT AND PREFERENCE FOR DECISION PARTICIPATION
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DOI：
10.1016/0277-9536(91)90124-u
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发表时间：
1991-01-01
影响因子：
5.4
通讯作者：
ERLICHMAN, C
中科院分区：
文献类型：
--
作者：
LLEWELLYNTHOMAS, HA;MCGREAL, MJ;ERLICHMAN, C
同意和拒绝进入临床试验的患者可能对决策控制和试验组相关获益的态度不同。这些差异，如果存在的话，对获得知情同意的过程和临床试验结果的推广都有影响。本文介绍了旨在检测这种差异的方法的发展和初步应用，开发工作涉及创建一个旨在确定患者参与治疗决策的态度的工具清单，允许随机选择治疗，并承担与试验中各种治疗相关的风险和益处。最初的应用涉及根据结肠腺癌的实际化疗试验来修改这些工具，从60名不合格的结肠直肠癌患者中寻求对这些措施的反应，然后确定那些同意参加试验的人与那些表示他们将拒绝这样的试验的人是否在这些措施上存在系统性差异。他们会同意试用入境：35人会拒绝。拒绝者要求更多地参与决策（卡方;P= 0.01）和更大的治疗获益增量（t检验;P= 0.0001）。35例拒绝者中有22例报告厌恶随机化是他们拒绝试验的主要原因，由于他们的特定内容可以修改，这些措施可能适用于所有临床试验。它们可以用来研究患者接受或拒绝试验的原因，并确定同意者-拒绝者的态度差异是否会破坏试验结果的普遍性。
Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences.Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial.Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square;P= 0.01) and a greater increment in treatment benefit (t-test;P= 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal.Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trial's results.