Koziol-McLain Jane, McLean Christine, Rohan Maheswaran, Sisk Rose, Dobbs Terry, Nada-Raja Shyamala, Wilson Denise, Vandal Alain C
Centre for Interdisciplinary Trauma Research, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.
J Med Internet Res. 2016 Oct 25;18(10):e281. doi: 10.2196/jmir.6515.
Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months.
The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures.
In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual.
The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were accrued (completed baseline assessments). The majority (n=52, 58%) of the 89 women who dropped out between enrollment and accrual never logged in to the allocated isafe website. Of every 4 accrued women, 3 (314/412, 76.2%) identified the classified ad as their referral source, followed by friends and family (52/412, 12.6%). Women recruited through a friend or relative were more likely to self-identify as indigenous Māori and live in the highest-deprivation areas. Ads increased the accrual rate by a factor of 74 (95% CI 49-112).
Print advertisements, website links, and networking were costly and inefficient methods for recruiting participants to a Web-based eHealth trial. Researchers are advised to limit their recruitment efforts to Web-based online marketplace and classified advertising platforms, as in the isafe case, or to social media. Online classified advertising in "Jobs-Other-volunteers" successfully recruited a diverse sample of women experiencing intimate partner violence. Preintervention recruitment data provide critical information to inform future research and critical analysis of Web-based eHealth trials.
Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by WebCite at http://www.webcitation/6lMGuVXdK).
基于网络的自动化电子健康研究试验为人们提供了一个可及、保密的机会,让他们参与对自己重要的研究。在寻求医疗保健可能伴随着羞耻和不信任的敏感问题上,电子健康试验可能特别有用。然而,对于人们从招募到干预前自动注册过程中对电子健康试验的早期参与情况,我们知之甚少。最近一项随机对照试验测试了一种电子健康安全决策辅助工具对新西兰一般人群中经历亲密伴侣暴力的女性(isafe)的有效性,该试验提供了一个机会来研究招募情况以及干预前参与者对一个完全自动化的基于网络的注册过程的参与情况。该试验旨在在24个月内招募340名女性。
我们研究的目的是检查isafe试验中参与者干预前的参与情况和招募效率,并分析从招募到资格筛选、同意参与,再到完成基线测量的整个注册过程中的退出情况。
在这个案例研究中,数据收集来源包括试验招募日志、谷歌分析报告、注册和项目元数据以及成本。分析包括对招募经历的定性叙述以及干预前参与者参与情况和退出率的描述性统计。一个科伊克模型研究了基于网络的在线营销网站广告与参与者纳入情况之间的关系。
isafe试验于2012年9月17日启动。在一个在线分类广告平台投放广告使每月招募的参与者平均数量从2人增加到25人。在23个月的招募期内,注册网站记录了4176名独立访客。在1003名符合资格标准的女性中,51.55%(517人)同意参与;在501名登记(同意、验证并随机分组)的女性中,412人(82.2%)被纳入(完成基线评估)。在89名在登记和纳入之间退出的女性中,大多数(n = 52,58%)从未登录分配的isafe网站。每4名被纳入的女性中,有3名(314/412,76.2%)将分类广告视为她们的推荐来源,其次是朋友和家人(52/412,12.6%)。通过朋友或亲戚招募的女性更有可能自我认定为毛利原住民,并且生活在贫困程度最高的地区。广告使纳入率提高了74倍(95%CI 49 - 112)。
印刷广告、网站链接和人际网络对于招募基于网络的电子健康试验的参与者来说成本高且效率低。建议研究人员将招募工作限制在基于网络的在线市场和分类广告平台上,如isafe试验的情况,或者社交媒体上。在“工作 - 其他 - 志愿者”类别中的在线分类广告成功招募了经历亲密伴侣暴力的不同女性样本。干预前的招募数据为未来基于网络的电子健康试验的研究和批判性分析提供了关键信息。
澳大利亚新西兰临床试验注册中心(ANZCTR):ACTRN12612000708853;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN = 12612000708853(由WebCite存档于http://www.webcitation/6lMGuVXdK)