J. Med. Internet Res. - The Sexunzipped trial: optimizing the design of online randomized controlled trials.

Tópicos

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Resumo

CKGROUND: 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).

Resumo Limpo

ckground sexual health problem unwant pregnanc sexual transmit infect import public health concern huge potenti health promot use digit intervent evalu digit intervent increas conduct onlin trial administr data collect onlin offer mani advantag concern remain fraudul registr obtain compens qualiti selfreport data high attritionobject studi address feasibl sever dimens onlin trial designrecruit onlin consent particip ident verif random conceal alloc onlin data collect data qualiti retent month followupmethod young peopl age year resid unit kingdom recruit sexunzip onlin trial novemb march n particip fill baselin demograph sexual health questionnair onlin random sexunzip interact intervent websit informationon control websit particip also random alloc postal request request urin sampl genit chlamydia test receipt lower us higher us valu shop voucher compens month outcom dataresult major valid particip age year enrol four countri unit kingdom white school train sampl femal total registr appear invalid anoth particip gave inconsist respons within questionnair higher valu compens us increas respons rate boost retent month submiss onlin selfreport sexual health outcom return chlamydia urin sampl postconclus quick effici recruit young peopl onlin trial procedur obtain onlin consent verifi particip ident autom random conceal alloc work well optim respons rate onlin sexual health outcom measur compar facetofac trial multipl method particip contact request onlin data higher valu compens increas trial retent month followuptri registr intern standard random control trial number isrctn httpwwwcontrolledtrialscomisrctn archiv webcit httpwwwwebcitationorglbkxdpkf

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