BACKGROUND/AIMS It has been proposed that informed consent for randomized trials should be split into two stages, with the purported advantage of decreased information overload and patient anxiety. We compared patient understanding, anxiety and decisional quality between two-stage and traditional one-stage consent. METHODS We approached patients at an academic cancer center for a low-stakes trial of a mind-body intervention for procedural distress during prostate biopsy. Patients were randomized to hear about the trial by either one- or two-stage consent (n = 66 vs n = 59). Patient-reported outcomes included Quality of Informed Consent (0-100); general and consent-specific anxiety and decisional conflict, burden, and regret. RESULTS Quality of Informed Consent scores were non-significantly superior for two-stage consent, by 0.9 points (95% confidence interval = -2.3, 4.2, p = 0.6) for objective and 1.1 points (95% CI = -4.8, 7.0, p = 0.7) for subjective understanding. Differences between groups for anxiety and decisional outcomes were similarly small. In a post hoc analysis, consent-related anxiety was lower among two-stage control patients, likely because scores were measured close to the time of biopsy in the two-stage patients receiving the experimental intervention. CONCLUSION Two-stage consent maintains patient understanding of randomized trials, with some evidence of lowered patient anxiety. Further research is warranted on two-stage consent in higher-stakes settings.

中文翻译：

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低风险随机试验的两阶段同意与传统一阶段同意的随机比较。

背景/目的 有人建议，随机试验的知情同意应分为两个阶段，据称其优点是减少信息过载和患者焦虑。我们比较了两阶段同意和传统一阶段同意之间的患者理解、焦虑和决策质量。方法 我们在一家学术癌症中心接触了患者，进行一项低风险试验，对前列腺活检过程中的程序性困扰进行身心干预。患者被随机分配以通过一阶段或两阶段同意来了解该试验（n = 66 vs n = 59）。患者报告的结果包括知情同意的质量（0-100）；一般性和同意特定的焦虑和决策冲突、负担和遗憾。结果 两阶段同意的知情同意质量并未显着优于客观的 0.9 分（95% 置信区间 = -2.3, 4.2, p = 0.6），客观的 1.1 分（95% CI = -4.8, 7.0, p = 0.7）用于主观理解。各组之间的焦虑和决策结果差异同样很小。在事后分析中，两阶段对照患者中与同意相关的焦虑较低，可能是因为在接受实验干预的两阶段患者中，分数是在接近活检时间测量的。结论 两阶段同意可以维持患者对随机试验的理解，并有一些证据表明患者焦虑程度降低。需要对高风险环境中的两阶段同意进行进一步研究。