@Article{信息:doi 10.2196 / / jmir。2668,作者=“Bailey, Julia V和Pavlou, Menelaos和Copas, Andrew和McCarthy, Ona和Carswell, Ken和Rait, Greta和Hart, Graham和Nazareth, Irwin和Free, Caroline和French, Rebecca和Murray, Elizabeth”,标题=“Sexunzipped Trial:优化在线随机对照试验的设计”,期刊=“J Med Internet Res”,年=“2013”,月=“12”,日=“11”,卷=“15”,数=“12”,页=“e278”,关键词=“互联网;随机对照试验为主题;结果评估(保健);性的健康;性传播疾病;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,使用数字干预手段促进健康的潜力巨大。对数字干预措施的评估越来越多地在网上进行。在线试用管理和数据收集提供了许多优势,但人们仍然担心为了获得补偿而进行的欺诈注册、自我报告数据的质量以及高流失率。目的:本研究探讨了在线试验设计的几个维度的可行性——招募、在线同意、参与者身份验证、分配的随机化和隐藏、在线数据收集、数据质量和3个月随访的保留。 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 ({\textsterling}10/US{\$}16) or higher ({\textsterling}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 ({\textsterling}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). ", issn="14388871", doi="10.2196/jmir.2668", url="//www.mybigtv.com/2013/12/e278/", url="https://doi.org/10.2196/jmir.2668", url="http://www.ncbi.nlm.nih.gov/pubmed/24334216" }
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