智能手机平台在急性中风试验中用于电子知情同意书的应用

Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

作者信息

Haussen Diogo C, Doppelheuer Shannon, Schindler Kiva, Grossberg Jonathan A, Bouslama Mehdi, Schultz Meagan, Perez Hilarie, Hall Alex, Frankel Michael, Nogueira Raul G

机构信息

From the Grady Memorial Hospital, Emory University, Atlanta, GA.

出版信息

Stroke. 2017 Nov;48(11):3156-3160. doi: 10.1161/STROKEAHA.117.018380. Epub 2017 Oct 6.

DOI:10.1161/STROKEAHA.117.018380

PMID:28986425

Abstract

BACKGROUND AND PURPOSE

The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy.

METHODS

The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017.

RESULTS

During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; =0.002).

CONCLUSIONS

e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes.

摘要

背景与目的

知情同意程序是急性卒中临床研究入组的主要限制因素。我们旨在描述智能手机电子知情同意（e-Consent）在脑动脉取栓术试验中的新应用。

方法

e-Consent工具由一个基于REDCap（研究电子数据采集；田纳西州范德堡大学）的安全/符合《健康保险流通与责任法案》的智能手机平台组成，该平台使用位于静态网页上的一个调查项目。该网页的链接通过短信或电子邮件发送给法定授权代表。在智能手机浏览器中填写e-Consent表格并添加手写电子签名；自动生成一个记录ID和一份e-Consent流程证明表格。e-Consent应用在一项比较晚期就诊患者血管内治疗与药物治疗的随机试验（DAWN [觉醒及晚期就诊卒中接受Trevo神经介入治疗的分诊临床不匹配研究]）中进行了试点。试验入组于2015年1月开始；e-Consent于2016年12月获得当地机构审查委员会批准，该研究于2017年2月停止。

结果

在试验期间，格雷迪纪念医院进行了273例取栓术，47例患者签署了知情同意书，38例患者入组DAWN试验。在随机分组的患者中，29例（76%）是从外院转来的。共有6名替代者通过e-Consent签署了知情同意书，2例患者筛查未通过。与传统方式签署知情同意书的患者（n = 25）相比，入组的通过e-Consent签署知情同意书的患者（n = 4）年龄相似（73±14岁对69±12岁；P = 0.65），美国国立卫生研究院卒中量表评分也相似（16±5对16±5；P = 0.88）。通过e-Consent签署知情同意书使从入院到随机分组的时间缩短（28±9分钟对57±24分钟；P = 0.002）。