Exception from informed consent in the era of social media: The SEGA stroke trial experience.
Exception from informed consent in the era of social media: The SEGA stroke trial experience.
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DOI：
10.4103/bc.bc_44_21
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发表时间：
2021-10
影响因子：
1.9
通讯作者：
Chen PR
中科院分区：
文献类型：
--
作者：
Inam ME;Sanzgiri A;Lekka E;Sheth SA;Barreto AD;Savitz SI;Artime C;Pedroza C;Engstrom A;Sheriff FG;Ambrocik A;Chen PR
急性缺血性脑卒中（AIS）和神经功能缺损患者往往无法提供同意并被排除在紧急研究参与之外。除知情同意外，在促进可能挽救生命的紧急干预措施研究方面的经验有限。在这里，我们描述了我们为EFIC批准的一项正在进行的随机临床试验的多方面方法，该试验比较了镇静和全身麻醉（SEGA）方法在AIS期间进行血管内血栓切除术。我们发布了一个包含EFIC信息的大学临床试验网站。我们在Facebook上发起了一场社交媒体活动，在德克萨斯医疗中心方圆50英里的范围内。广告链接到我们的网站，并发布了一份新闻稿，介绍了有关试验的信息。进行了面对面的社区咨询，并收集了自愿调查信息。共有193人（65%为女性，年龄46.7±16.6岁）参加了7次焦点小组社区咨询。在完成调查的144人（75%）中，88.7%的人同意他们愿意让自己或家人在EFIC下参加这项试验。Facebook广告的浏览量为134,481次（52%为女性，60%≥45岁），点击量为1,630次。该网站的浏览量为1130次（56%为地区浏览量，44%为全国浏览量），平均浏览量为3.85分钟。我们的机构审查委员会没有收到要求提供额外信息或选择退出的电子邮件。我们的社交媒体活动和社区咨询方法为潜在的中风患者提供了重要的外展服务。我们希望我们的经验将为寻求EFIC的试验提供信息和帮助。
Patients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS. We published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected. A total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout. Our social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.
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American Heart Association Statistics Committee and Stroke Statistics Subcommittee
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