Gilbert Mark, Bonnell Amanda, Farrell Janine, Haag Devon, Bondyra Mark, Unger David, Elliot Elizabeth
BC Centre for Disease Control, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.
BC Children's and BC Women's Hospital, Vancouver, British Columbia, Canada.
Int J Med Inform. 2017 Sep;105:38-48. doi: 10.1016/j.ijmedinf.2017.05.020. Epub 2017 Jun 3.
Autonomous use of online health care services without interaction with a health care provider challenges existing models for achieving informed consent (IC); current examinations of this issue have focused on commercial direct-to-consumer genetic testing. As IC is integral to publicly funded clinical testing services, we incorporated pre-test concepts necessary for IC in GetCheckedOnline (GCO), British Columbia's online sexually transmitted and blood-borne infection (STBBI) testing service.
We assessed the acceptability of this IC step and its design options among potential users during usability testing of GCO.
English-speaking participants≥19years were recruited from Craigslist and among provincial STI clinic clients for usability testing of an early version of GCO, which included a consent webpage presenting 8 pre-test statements for review prior to completing testing. Participants were interviewed regarding their acceptability, perceptions, and understanding of the consent page; transcripts were analyzed thematically.
We conducted 13 interviews (9 males, 4 females; 9 self-identified as heterosexual; all had previously tested for STBBI). We identified three main themes: i) the meaning of IC (consent page viewed as important and for protection of individual and organization; participants demonstrated varying understandings of specific components); ii) the impact of previous experience on understanding IC (participants understood difference between online and in-person testing; IC concepts were better understood by participants with more testing experience); iii) the role of website design on achieving IC (design of page to disrupt speedy click-throughs was valued and demonstrated seriousness of the consent page).
Our careful attention to both content and design of the consent page of GCO was highly valued by potential users of the service, and effective in disrupting routinization of consent on websites. We argue that principles of IC apply equally in online self-testing programs as in clinical practice, and can be effectively achieved without detracting from the user experience.
在不与医疗服务提供者互动的情况下自主使用在线医疗服务,对现有的实现知情同意(IC)的模式构成了挑战;目前对这一问题的研究主要集中在商业性的直接面向消费者的基因检测上。由于知情同意是公共资助的临床检测服务的一个组成部分,我们在不列颠哥伦比亚省的在线性传播和血源感染(STBBI)检测服务“在线检测”(GCO)中纳入了知情同意所需的检测前概念。
在GCO的可用性测试期间,我们评估了这一知情同意步骤及其设计选项在潜在用户中的可接受性。
从克雷格列表网站以及省级性传播感染诊所的客户中招募年龄≥19岁的讲英语的参与者,对GCO的早期版本进行可用性测试,该版本包括一个同意网页,在完成检测之前会展示8条检测前声明以供审查。就参与者对同意页面的可接受性、看法和理解进行了访谈;对访谈记录进行了主题分析。
我们进行了13次访谈(9名男性,4名女性;9人自我认定为异性恋;所有人之前都进行过STBBI检测)。我们确定了三个主要主题:i)知情同意的含义(同意页面被视为重要的,对个人和组织起到保护作用;参与者对具体内容的理解各不相同);ii)以往经历对理解知情同意的影响(参与者理解在线检测和面对面检测之间的差异;检测经验较多的参与者对知情同意概念的理解更好);iii)网站设计在实现知情同意方面的作用(重视页面设计以防止快速点击通过,这表明了同意页面的严肃性)。
我们对GCO同意页面的内容和设计给予的精心关注受到了该服务潜在用户的高度重视,并有效地打破了网站上同意程序的常规化。我们认为,知情同意原则在在线自我检测项目中与在临床实践中同样适用,并且可以在不影响用户体验的情况下有效实现。