Davis S Iris, Staugaitis Abbey, Rines Ian, Roy Akash, Rogers Anthony D, Stalin Karen, Bentho Oladi, Khatri Pooja, Adeoye Opeolu M, Baretto Andrew D, Broderick Joseph P, Grotta James C, Derdeyn Colin, Streib Christopher D
University of Cincinnati Neurology, OH (S.I.D., A.D.R., P.K., J.P.B.).
University of Minnesota, Minneapolis (A.S., K.S., O.B., C.D.S.).
Stroke. 2025 Apr 16. doi: 10.1161/STROKEAHA.124.049369.
Obtaining timely informed consent is a key barrier in acute ischemic stroke clinical trial recruitment. Electronic consent (eConsent) allows electronic delivery and documentation of the informed consent process, which may optimize recruitment. eConsent in acute ischemic stroke clinical trials, however, is limited and understudied. We conducted a post hoc analysis of eConsent adoption in MOST (Multi-Arm Optimization of Stroke Thrombolysis Trial), a phase III acute ischemic stroke clinical trial, and studied the impact on recruitment.
From October 10, 2019, to July 5, 2023, MOST enrolled 514 participants at 57 sites in the United States. Study databases were reviewed to determine informed consent modality for each participant: paper-in person, paper-remote, eConsent-in person, and eConsent-remote. Study sites could use paper consent or eConsent for each enrollment. eConsent adoption trends and participant demographic diversity were reported using descriptive statistics. We utilized χ and Kruskal-Wallis tests to compare individual site enrollment, remote consent utilization, baseline neuroimaging-to-randomization times, data clarification requests, and reportable consent-related unanticipated events.
eConsent was utilized for 173 (33.7%) of 514 participants. Of 57 sites, 32 (56.1%) utilized eConsent at least once: those sites had higher median enrollment over the course of the entire trial than non-eConsent sites (7.5 [interquartile range, 5-17] versus 3 [interquartile range, 2-4]; <0.001). eConsent was completed remotely more frequently than paper consent (46.2% versus 1.2%; <0.001). Participant demographic diversity and baseline neuroimaging-to-randomization times were similar between eConsent-in person and paper-in person (median, 58.5 [interquartile range, 46.5-72.5] versus 55 [interquartile range, 39-70] minutes). Consent documentation adherence was superior with eConsent-in person compared with paper-in person including decreased data clarification requests (44 versus 81 per 100 participants) and reportable unanticipated events (6 versus 25 per 100 participants).
eConsent in MOST was associated with higher individual site enrollment, higher remote consent rates, and improved consent documentation adherence over paper consent. Our study outlines the potential advantages of eConsent adoption in future acute ischemic stroke clinical trials and stroke research networks.
及时获得知情同意是急性缺血性中风临床试验招募中的一个关键障碍。电子同意书（eConsent）允许以电子方式交付和记录知情同意过程，这可能会优化招募工作。然而，急性缺血性中风临床试验中的电子同意书使用有限且研究不足。我们对III期急性缺血性中风临床试验MOST（中风溶栓试验的多臂优化）中电子同意书的采用情况进行了事后分析，并研究了其对招募的影响。
从2019年10月10日至2023年7月5日，MOST在美国57个地点招募了514名参与者。审查研究数据库以确定每位参与者的知情同意方式：纸质当面、纸质远程、电子同意书当面和电子同意书远程。研究地点在每次招募时可以使用纸质同意书或电子同意书。使用描述性统计报告电子同意书的采用趋势和参与者人口统计学多样性。我们使用χ检验和Kruskal-Wallis检验来比较各个地点的招募情况、远程同意书的使用情况、基线神经影像学检查至随机分组的时间、数据澄清请求以及可报告的与同意书相关的意外事件。
514名参与者中有173名（33.7%）使用了电子同意书。在57个地点中，32个（56.1%）至少使用过一次电子同意书：在整个试验过程中，这些地点的招募中位数高于未使用电子同意书的地点（7.5[四分位间距，5 - 17]对3[四分位间距，2 - 4]；<0.001）。电子同意书通过远程完成的频率高于纸质同意书（4
