Andrew J Vickers, Emily A Vertosick, Mia Austria, Christopher D Gaffney, Sigrid V Carlsson, Scott Yh Kim, Behfar Ehdaie
{"title":"A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial.","authors":"Andrew J Vickers, Emily A Vertosick, Mia Austria, Christopher D Gaffney, Sigrid V Carlsson, Scott Yh Kim, Behfar Ehdaie","doi":"10.1177/17407745231185058","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aims: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10685,"journal":{"name":"Clinical Trials","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764653/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17407745231185058","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/7/4 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
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.
背景/目的:有人建议将随机试验的知情同意分为两个阶段,以减少信息过载和患者焦虑。我们比较了两阶段和传统的一阶段同意之间患者的理解、焦虑和决策质量。方法:我们在一个学术癌症中心对前列腺活检过程中程序性痛苦的心身干预进行了低风险试验。患者被随机分为一阶段同意和两阶段同意两组(n = 66 vs n = 59)。患者报告的结局包括知情同意质量(0-100);一般和同意特定的焦虑和决定的冲突,负担,和遗憾。结果:两阶段同意的知情同意评分质量无显著性优势,客观理解高0.9分(95%置信区间= -2.3,4.2,p = 0.6),主观理解高1.1分(95% CI = -4.8, 7.0, p = 0.7)。两组之间在焦虑和决策结果方面的差异同样很小。在事后分析中,两期对照患者的同意相关焦虑较低,可能是因为在接受实验干预的两期患者中,得分是在活检时间附近测量的。结论:两阶段同意维持了患者对随机试验的理解,有证据表明患者的焦虑有所降低。在高风险环境下,有必要对两阶段同意进行进一步研究。
期刊介绍:
Clinical Trials is dedicated to advancing knowledge on the design and conduct of clinical trials related research methodologies. Covering the design, conduct, analysis, synthesis and evaluation of key methodologies, the journal remains on the cusp of the latest topics, including ethics, regulation and policy impact.