Peduzzi Peter, Guarino Peter, Donta Sam T, Engel Charles C, Clauw Daniel J, Feussner John R
Department of Veterans Affairs Cooperative Studies Program Coordinating Center, 151A Building 35, VACT Healthcare Systems, 950 Campbell Avenue, West Haven, CT 06516, USA.
Control Clin Trials. 2002 Apr;23(2):184-97. doi: 10.1016/s0197-2456(01)00167-2.
In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.
在退伍军人事务部合作研究（VACSP）#470中，这是一项针对海湾战争病退伍军人的多模式疗法随机、多中心对照试验，设计了一项子研究，其主要目的是比较由一组海湾战争退伍军人焦点小组制定的知情同意书（焦点小组制定）与由包括研究调查人员的标准流程制定的知情同意书（调查人员制定）的效用。1998年12月，一个由五名海湾战争退伍军人组成的焦点小组在协调中心召开会议，并在三次会议期间制定了一份同意书。焦点小组以调查人员制定的同意书为“起点”，然后通过协商一致进行修改。他们还审查并修改了子研究的评估问卷。将通过直接比较接受焦点小组制定的同意书与接受调查人员制定的同意书的退伍军人之间选定的以患者为中心的结果，对参与母研究VACSP #470的1092名退伍军人的效用进行评估。在1年随访期内要评估的主要结果包括知情同意过程的指标，如患者回忆、对参与风险和益处的期望以及对同意自愿性的理解。次要结果将评估子研究对母研究在招募和依从性方面的影响。VACSP #470于1999年5月在20个地点启动，这些地点被随机分配使用焦点小组制定或调查人员制定的同意书。各地点不知道分配的同意书类型。本文重点介绍知情同意子研究的基本原理和设计，并讨论潜在的伦理问题。
