Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Clin Trials. 2021 Jun;18(3):377-382. doi: 10.1177/1740774520988500. Epub 2021 Feb 2.
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.
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.
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).
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.
我们之前介绍了随机对照试验中“两阶段”（或“即时”）知情同意的概念。我们认为，将研究程序的信息与实验干预的信息分开进行两次知情同意，将减少与知情同意相关的决策焦虑、困惑和信息过载。我们在一项低风险的随机试验中实施了两阶段同意，该试验是为了减轻接受前列腺活检的患者在程序性痛苦中进行正念冥想干预。在这里，我们报告了入组率和患者对同意过程的理解。
对参加活检试验的患者进行询问，要求他们完成标准的“知情同意质量”问卷，以评估他们对试验的知识和理解。
入组情况非常好，有 110 名患者中有 108 名（98%）在入组时签署了第一阶段同意书。所有 51 名随机分配到实验组并随后接受活检的患者都签署了第二阶段同意书，并接受了正念干预。有 48 名接受正念治疗组和 44 名对照组的患者提供了知情同意质量的数据。在正念治疗组和对照组中，知情同意质量的平均得分相似，知识部分的平均得分为 75（95%置信区间=74-76），理解部分的平均得分为 86（95%置信区间=81-90），与 80 和 88 的标准得分相当。进一步分析和患者访谈发现，在一项针对正念干预的两阶段同意研究中，有两个知情同意质量问题存在误导性。排除这些问题后，知识得分提高到 88（95%置信区间=87-90）。
我们发现有希望的数据表明，两阶段同意有助于增加入组率，而不会影响患者对随机试验或对分配治疗的遵守。需要进一步研究，将两阶段同意与标准同意方法进行随机比较，将患者的焦虑和困扰作为结果进行测量，使用适合的修改后的知情同意质量问卷和风险更高的试验。
