Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.
Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.
复制标题
DOI：
10.2196/jmir.6710
复制
发表时间：
2017-03-06
影响因子：
7.4
通讯作者：
Sullivan PS
中科院分区：
文献类型：
--
作者：
Hall EW;Sanchez TH;Stein AD;Stephenson R;Zlotorzynska M;Sineath RC;Sullivan PS
基于网络的调查越来越多地用于获取对人体免疫缺陷病毒（艾滋病毒）预防研究至关重要的数据。然而，在确保基于网络的研究参与者的知情同意方面存在挑战。我们研究的目的是开发和评估管理知情同意的替代方法在基于网络的艾滋病研究与男性同性性行为（MSM）的有效性。从2014年7月到9月，Facebook上的付费广告被用来招募居住在美国的成年MSM进行基于网络的风险和预防行为调查。参与者被随机分配到4种提供知情同意的方法之一：专业制作的视频，研究人员制作的视频，常见问题（FAQ）文本页面和标准知情同意文本页面。在行为调查之后，参与者回答了15个关于同意信息理解的问题。对每个问题的正确回答得1分，总分为15分。一般线性回归和事后Tukey比较用于评估平均同意理解评分的差异（P<.001）。中介分析被用来检查同意页面上花费的时间和同意理解之间的关系。在完成理解问题的665名MSM参与者中，24.2%（161/665）获得了标准同意，27.1%（180/665）获得了常见问题同意，26.8%（178/665）获得了专业同意视频，22.0%（146/665）获得了工作人员视频。总体平均同意理解评分为6.28（SD=2.89）。平均同意理解得分在同意类型（P<.001）、年龄（P=.04）、种族或民族（P<.001）和最高教育水平（P=.001）之间存在显著差异。与接受标准同意书的受试者相比，接受专业视频同意书的受试者（评分增加=1.79; 95% CI 1.02-2.55）和接受工作人员视频同意书的受试者（评分增加=1.79; 95% CI 0.99-2.59）的理解力显著更高。对于那些接受FAQ同意书的人来说，理解没有显著差异。参与者花在2个视频同意（工作人员视频中位数时间=117秒;专业视频中位数时间=115秒）比常见问题解答（中位数=21秒）和标准同意（中位数=37秒）更多的时间。中介分析表明，虽然在同意页面上花费的时间是造成理解差异的部分原因，但专业视频（得分增加=0.93; 95%CI 0.39-1.48）和工作人员制作的视频（得分增加=0.99; 95%CI 0.42-1.56）的直接影响仍然显著。基于视频的同意方法提高了MSM参与基于网络的HIV行为调查的同意理解。这种影响可能部分通过增加审查知情同意材料的时间来介导;然而，视频知情同意在改善参与者对关键研究事实的理解方面可能仍上级标准知情同意。Clinicaltrials.gov NCT 02139566; https://clinicaltrials.gov/ct2/show/NCT02139566（由WebCite存档，网址为http：//www.webcitation.org/6oRnL261N）。
Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant. Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts. Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N).