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Patient accrual and understanding of informed consent in a two-stage consent design
Clinical Trials ( IF 2.7 ) Pub Date : 2021-02-02 , DOI: 10.1177/1740774520988500
Andrew J Vickers 1 , Emily A Vertosick 1 , Sigrid V Carlsson 1, 2, 3 , Behfar Ehdaie 2 , Scott Y H Kim 4
Affiliation  

Background:

We previously introduced the concept of “two-stage” (or “just-in-time”) informed consent for randomized trials with usual care control. We argued that conducting consent in two stages—splitting information about research procedures from information about the experimental intervention—would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process.

Methods:

Patients approached for consent for the biopsy trial were asked to complete the standard “Quality of Informed Consent” questionnaire to assess their knowledge and understanding of the trial.

Results:

Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74–76) for the knowledge section and 86 (95% confidence interval = 81–90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87–90).

Conclusion:

We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.



中文翻译:

两阶段同意设计中的患者应计和对知情同意的理解

背景:

我们之前为具有常规护理控制的随机试验引入了“两阶段”(或“即时”)知情同意的概念。我们认为,分两个阶段进行同意——将有关研究程序的信息与有关实验干预的信息分开——将减少通常与知情同意相关的决策焦虑、混乱和信息过载。我们在一项低风险随机试验中实施了两阶段同意,该试验针对接受前列腺活检的患者的程序性痛苦进行了正念冥想干预。在这里,我们报告应计率和患者对同意过程的理解。

方法:

要求获得活检试验同意的患者完成标准的“知情同意质量”问卷,以评估他们对试验的了解和理解。

结果:

Accrual 非常好,110 名患者中有 108 名 (98%) 接受了签署第一阶段同意书的同意。所有 51 名患者随机分配到实验组,随后接受活检的患者签署了第二阶段同意书并接受了正念干预。分配到正念治疗组的 48 名患者和 44 名对照组的知情同意质量数据可用。冥想组和对照组的知情同意质量平均得分相似,知识部分的总体平均值为 75(95% 置信区间 = 74-76),理解部分的总体平均值为 86(95% 置信区间 = 81-90),与 80 和 88 的规范分数相当。 在进一步分析和患者访谈中,在正念干预的两阶段同意研究的背景下,发现知情同意的质量问题中有两个具有误导性。排除这些问题将知识分数提高到 88(95% 置信区间 = 87-90)。

结论:

我们发现了有希望的数据,即两阶段知情同意在不影响患者对随机试验的理解或对分配治疗的依从性的情况下促进了累积。需要进一步研究将两阶段同意与标准同意方法的随机比较、测量患者焦虑和痛苦作为结果、对知情同意质量问卷和更高风险的试验进行适当修改。

更新日期:2021-02-03
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