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Sexunzipped试验:优化在线随机对照试验的设计。

The Sexunzipped trial: optimizing the design of online randomized controlled trials.

作者信息

Bailey Julia V, Pavlou Menelaos, Copas Andrew, McCarthy Ona, Carswell Ken, Rait Greta, Hart Graham, Nazareth Irwin, Free Caroline, French Rebecca, Murray Elizabeth

机构信息

e-Health Unit, Research Department of Primary Care and Population Health, University College London, London, United Kingdom.

出版信息

J Med Internet Res. 2013 Dec 11;15(12):e278. doi: 10.2196/jmir.2668.


DOI:10.2196/jmir.2668
PMID:24334216
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3868980/
Abstract

BACKGROUND: Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition. OBJECTIVE: This study addresses the feasibility of several dimensions of online trial design-recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up. METHODS: Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the "Sexunzipped" online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data. RESULTS: The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health outcomes and 47.4% (118/249) for return of chlamydia urine samples by post. CONCLUSIONS: It was quick and efficient to recruit young people to this online trial. Our procedures for obtaining online consent, verifying participant identity, automated randomization, and concealment of allocation worked well. The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials. Multiple methods of participant contact, requesting online data only, and higher value compensation increased trial retention at 3-month follow-up. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/ISRCTN55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).

摘要

背景:意外怀孕和性传播感染等性健康问题是重要的公共卫生问题,利用数字干预措施促进健康具有巨大潜力。对数字干预措施的评估越来越多地在网上进行。在线进行试验管理和数据收集有许多优点,但对于为获取补偿而进行的欺诈性注册、自我报告数据的质量以及高损耗率仍存在担忧。 目的:本研究探讨在线试验设计的几个方面的可行性,包括招募、在线同意、参与者身份验证、随机化和分配隐藏、在线数据收集、数据质量以及3个月随访时的留存率。 方法:2010年11月至2011年3月期间,招募了居住在英国、年龄在16至20岁之间的年轻人参加“Sexunzipped”在线试验(n = 2036)。参与者在线填写基线人口统计学和性健康问卷,并被随机分配到Sexunzipped互动干预网站或仅提供信息的对照网站。参与者还被随机分配接受邮寄请求(或不请求)提供用于生殖器衣原体检测的尿液样本,并因提供3个月的结果数据而获得较低(10英镑/16美元)或较高(20英镑/32美元)价值的购物券补偿。 结果:2006名有效参与者中的大多数(90.98%,1825/2006)在入组时年龄在18至20岁之间,来自英国的所有四个国家。大多数是白人(89.98%,1805/2006),大多数在上学或接受培训(77.48%,1545/1994),样本中62.81%(1260/2006)为女性。总共有3.88%(79/2036)的注册似乎无效,另有4.00%(81/2006)的参与者在问卷中给出了不一致的回答。较高价值的补偿(20英镑/32美元)使回复率提高了6 - 10%,将3个月时的留存率提高到77.2%(166/215)用于在线自我报告性健康结果的提交,以及47.4%(118/249)用于通过邮寄返还衣原体尿液样本。 结论:招募年轻人参加这项在线试验既快速又高效。我们获取在线同意、验证参与者身份、自动随机化和分配隐藏的程序运行良好。在线性健康结果测量的最佳回复率与面对面试验相当。多种参与者联系方法、仅请求在线数据以及较高价值的补偿提高了3个月随访时的试验留存率。 试验注册:国际标准随机对照试验编号(ISRCTN):55651027;http://www.controlled-trials.com/ISRCTN55651027(由WebCite存档于http://www.webcitation.org/6LbkxdPKf)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3181/3868980/1d0730eb16ac/jmir_v15i12e278_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3181/3868980/72057f7448b5/jmir_v15i12e278_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3181/3868980/1d0730eb16ac/jmir_v15i12e278_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3181/3868980/72057f7448b5/jmir_v15i12e278_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3181/3868980/1d0730eb16ac/jmir_v15i12e278_fig2.jpg

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本文引用的文献

[1]
The Sexunzipped trial: young people's views of participating in an online randomized controlled trial.

J Med Internet Res. 2013-12-12

[2]
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JMIR Res Protoc. 2012-11-19

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What young people want from a sexual health website: design and development of Sexunzipped.

J Med Internet Res. 2012-10-12

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J Med Internet Res. 2009-4-3

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Efficacy of computer technology-based HIV prevention interventions: a meta-analysis.

AIDS. 2009-1-2

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