Informed consent and subject motivation to participate in a large, population-based genomics study: The Marshfield Clinic Personalized Medicine Research Project
Informed consent and subject motivation to participate in a large, population-based genomics study: The Marshfield Clinic Personalized Medicine Research Project
复制标题
DOI：
10.1159/000096274
复制
发表时间：
2007-01-01
期刊：
影响因子：
--
通讯作者：
Giarnpietro, Philip F.
中科院分区：
文献类型：
--
作者：
McCarty, Catherine A.;Nair, Anuradha;Giarnpietro, Philip F.
背景。本研究的目的是衡量受试者对参与个性化医疗研究项目 (PMRP) 的看法和反应，并确定预测对研究要素的理解的因素。方法：向 1,593 名受试者（10% 样本）邮寄自填问卷。调查问卷分为三个部分：A 部分包含 21 个事实问题； B 部分包含 14 个问题，用于评估对 PMRP 概念的理解程度，C 部分询问 PMRP 的目的。结果：924 名调查受访者的平均年龄为 52 岁（SD = 16.9），年龄范围为 18-95 岁。大多数参与者是女性（n = 561，61%）。与男性相比，女性 A 部分的总正确反应百分比显着较高（男性：58.4%，女性：60.4%，t 检验 = -2.18，p = 0.03），并且年龄与正确反应百分比显着负相关（β 系数 = -0.122，p < 0.001）。超过三分之一的参与者表示，20 美元极大地影响了他们参与该项目的决定。在多元逻辑回归模型中，居住在马什菲尔德以外的人们更有可能表示 20 美元极大地影响了他们的参与决定（优势比 = 1.40，95% 置信限 = 1.06, 1.86），而年龄与货币对参与决策的影响呈反比（优势比 = 0.98，95% 置信限 = 0.97, 0.98）。结论：未来的社区咨询工作应重点关注理解程度较低的领域。此外，研究协调员可能需要花更多时间向男性和老年人通报项目细节，以便他们就参与研究做出真正明智的决定。版权所有 (c) 2007 S. Karger AG，巴塞尔。
Background. The objective of this study was to measure subject perspective and reaction to participation in the Personalized Medicine Research Project (PMRP) and to identify factors predicting understanding of the study elements. Method: Self-administered questionnaires were mailed to 1,593 subjects (10% sample). The questionnaire had three sections: section A consisted of 21 factual questions; section B consisted of 14 questions to assess the level of understanding about the PMRP concepts, and section C asked about the purpose of the PMRP. Results: The mean age of the 924 survey respondents was 52 years (SD = 16.9), with a range of 18-95 years. The majority of participants were female (n = 561, 61%). The percent of total correct responses for section A was significantly higher for females compared with males (males: 58.4% and females: 60.4%, t test = -2.18, p = 0.03) and age was significantly inversely related to percent of correct responses (beta coefficient = -0.122, p < 0.001). More than one third of the participants indicated that the USD 20 greatly influenced their decision to participate in the project. In a multiple logistic regression model, people living outside of Marshfield were significantly more likely to indicate that the USD 20 greatly influenced their decision to participate (odds ratio = 1.40, 95% confidence limit = 1.06, 1.86) and age was inversely related to the monetary influence on decision to participate (odds ratio = 0.98, 95% confidence limit = 0.97, 0.98). Conclusion: Future community consultation efforts should highlight areas of lower understanding. In addition, research coordinators may need to take more time informing males and older individuals about project details so that they are making truly informed decisions about study participation. Copyright (c) 2007 S. Karger AG, Basel.