Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.
Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.
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DOI：
10.1097/md.0000000000028136
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发表时间：
2021-12-23
期刊：
影响因子：
1.6
通讯作者：
Ho PM
中科院分区：
文献类型：
--
作者：
Sandy LC;Glorioso TJ;Weinfurt K;Sugarman J;Peterson PN;Glasgow RE;Ho PM
文本中提供了补充的数字内容，有时使用选择退出程序来代替标准的同意做法，以使患者能够行使他们关于参与研究的自主偏好，同时减轻患者和研究人员的负担。然而，人们对选择退出研究的患者的特征以及他们这样做的原因知之甚少。我们在一项大型实用临床试验(PCT)中收集了这些信息，评估了理论知情短信对服药依从性的影响。通过电子健康记录确定的符合条件的患者被发送有关这项研究的信息，并提供选择退出的机会。那些选择退出的人被要求完成一份关于他们这样做的原因的自愿调查。使用卡方检验和对数二项回归模型比较了选择退出的患者和研究中包括的患者的人口统计学数据。在接受研究包的9046名患者中，906名患者(10.0%)退回了选择退出表格。在这些人中，451人(49.8%)返回了选择退出调查。与那些被纳入PCT的患者相比，选择退出的患者更有可能是年龄较大、白人和非西班牙裔的患者。调查受访者对他们的医疗保健提供者、研究和系统表示高度信任。近一半(46.6%)的受访者表示，对时间的担忧是选择退出的原因。在这项PCT中，10%的接受包裹的患者选择退出，与纳入的患者相比，他们在年龄、种族、性别和民族方面存在显著差异。未来的试验应该进一步调查患者选择退出研究的代表性和原因。
Supplemental Digital Content is available in the text Opt-out procedures are sometimes used instead of standard consent practices to enable patients to exercise their autonomous preferences regarding research participation while reducing patient and researcher burden. However, little is known about the characteristics of patients who opt-out of research and their reasons for doing so. We gathered such information in a large pragmatic clinical trial (PCT) evaluating the effect of theory informed text messages on medication adherence. Eligible patients, identified through electronic health records, were sent information about the study and provided with an opportunity to opt-out. Those opting out were asked to complete a voluntary survey regarding their reasons for doing so. Demographic data were compared among patients opting-out vs those included in the study using chi-squared tests and a log binomial regression model. Of 9046 patients receiving study packets, 906 (10.0%) patients returned opt-out forms. Of those, 451 (49.8%) returned the opt-out survey. Patients who opted out were more likely to be older, white, and nonHispanic than those who were included in the PCT. Survey respondents expressed high levels of trust in their health care providers, research, and system. Nearly half (46.6%) reported concerns about time as a reason to opt-out. In this PCT, 10% of patients receiving packets opted out, with significant differences in age, race, gender, and ethnicity compared to those included. Future trials should further investigate representativeness and reasons patients choose to opt-out of participating in research.