A Randomized Controlled Trial of Opt-In Versus Opt-Out Enrollment Into a Diabetes Behavioral Intervention
A Randomized Controlled Trial of Opt-In Versus Opt-Out Enrollment Into a Diabetes Behavioral Intervention
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DOI：
10.1177/0890117116671673
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发表时间：
2018-03-01
影响因子：
2.7
通讯作者：
Volpp, Kevin
中科院分区：
文献类型：
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作者：
Aysola, Jaya;Tahirovic, Emin;Volpp, Kevin
目的：研究选择退出默认招募策略与传统选择加入策略对控制不良的糖尿病患者的入组和行为干预依从性的影响。设计：随机对照试验。背景：宾夕法尼亚大学初级保健实践。受试者：本试验的受试者包括：(1)年龄在18 - 80岁；(2)糖尿病诊断；(3)过去12个月内测量的血红蛋白A1c （HbA1c）大于8%。干预：我们在入组前将符合条件的患者随机分为选择加入组和选择退出组。那些选择退出组的人收到一封信，声明他们被纳入了一项有选择退出的糖尿病研究，而那些选择加入组的人收到一封标准的招募信。测量：主要终点包括入组率，定义为参加基线就诊的参与者比例，以及每日血糖监测的依从性。分析：我们为我们的研究提供了动力，以检测不同手臂对设备使用的依从性有20%的差异，并解释了10%的流失率。结果：在收到招募信的569名符合条件的参与者中，496名随机分配到选择加入组，73名随机分配到选择退出组。选择退出组的入组率为38%，选择加入组为13% （P < 0.001）。结论：在临床上适当的情况下，选择退出默认值可能是一种有用的方法，可以提高临床环境中测试行为干预的低风险试验的普遍性。
Purpose: To examine the effect of an opt-out default recruitment strategy compared to a conventional opt-in strategy on enrollment and adherence to a behavioral intervention for poorly controlled diabetic patients.Design: Randomized controlled trial.Setting: University of Pennsylvania primary care practices.Participants: Participants of this trial included those with (1) age 18 to 80 years; (2) diabetes diagnosis; and (3) a measured hemoglobin A1c (HbA1c) greater than 8% in the past 12 months.Intervention: We randomized eligible patients into opt-in and opt-out arms prior to enrollment. Those in the opt-out arm received a letter stating that they were enrolled into a diabetes research study with the option to opt out, and those in the opt-in arm received a standard recruitment letter.Measures: Main end points include enrollment rate, defined as the proportion of participants who attended the baseline visit, and adherence to daily glycemic monitoring.Analysis: We powered our study to detect a 20% difference in adherence to device usage between arms and account for a 10% attrition rate.Results: Of the 569 eligible participants who received a recruitment letter, 496 were randomized to the opt-in arm and 73 to the opt-out arm. Enrollment rates were 38% in the opt-out arm and 13% in the opt-in arm (P < .001).Conclusions: Opt-out defaults, where clinically appropriate, could be a useful approach for increasing the generalizability of low-risk trials testing behavioral interventions in clinical settings.