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Generalisability of an online randomised controlled trial: an empirical analysis.

ABSTRACT: BACKGROUND:Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China. METHODS:Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%. RESULTS:In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority. CONCLUSIONS:Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up. TRIAL REGISTRATION NUMBER:NCT02248558.

SUBMITTER: Wang C

PROVIDER: S-EPMC5880638 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Generalisability of an online randomised controlled trial: an empirical analysis.

Wang Cheng C Mollan Katie R KR Hudgens Michael G MG Tucker Joseph D JD Zheng Heping H Tang Weiming W Ling Li L

Journal of epidemiology and community health 20171128 2

<h4>Background</h4>Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China.<h4>Methods</h4>Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. On ...[more]

PMID: 29183956

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Project description:BackgroundAdolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adults and shows promise for adolescents. However, given the scale of the problem of adolescent SAD and the limited availability of psychological therapists in child and adolescent mental health services, there is a substantial gap in service provision. Delivering therapy via the Internet may provide part of the solution to this problem. An Internet version of adult Cognitive Therapy for SAD has been developed, with outcomes similar to face-to-face therapy. We have recently adapted this treatment for use with adolescents with SAD. Here, we describe a randomised controlled trial designed to test the efficacy of Internet Cognitive Therapy for adolescent SAD compared to waitlist.Methods/designForty adolescents aged 14-18?years with a diagnosis of SAD will be recruited via schools. Participants will be randomly allocated to Internet Cognitive Therapy or to waitlist. All participants will be assessed three times during the study-at baseline (pretreatment/wait), midtreatment/wait (week 8) and posttreatment/wait (week 15). Participants in the experimental arm will also complete weekly measures as part of the online program and they will be assessed at 3 and 6?months. Postwait, participants in the waitlist arm will be offered Internet Cognitive Therapy, and weekly and posttreatment data will also be collected for them. The trial aims to test whether Internet Cognitive Therapy is superior to waitlist in reducing social anxiety symptoms and in reducing the proportion of adolescents meeting criteria for SAD. Other outcomes of interest include depression and general anxiety symptoms. Acceptability of the online treatment will also be evaluated.DiscussionThis randomised controlled trial will provide preliminary evidence on whether this intervention, requiring relatively low levels of therapist input, is safe and clinically effective. If this is shown to be the case, Internet Cognitive Therapy for adolescents has the potential to provide a service to the large population of adolescents with untreated SAD.Trial registrationISRCTN Registry, ISRCTN15079139 . Version 1 registered on 06/02/2019.

Project description:INTRODUCTION:School canteens are the most frequently accessed take-away food outlet by Australian children. The rapid development of online lunch ordering systems for school canteens presents new opportunities to deliver novel public health nutrition interventions to school-aged children. This study aims to assess the effectiveness and cost-effectiveness of a behavioural intervention in reducing the energy, saturated fat, sugar and sodium content of online canteen lunch orders for primary school children. METHODS AND ANALYSIS:The study will employ a cluster randomised controlled trial design. Twenty-six primary schools in New South Wales, Australia, that have an existing online canteen ordering system will be randomised to receive either a multi-strategy behavioural intervention or a control (the standard online canteen ordering system). The intervention will be integrated into the existing online canteen system and will seek to encourage the purchase of healthier food and drinks for school lunch orders (ie, items lower in energy, saturated fat, sugar and sodium). The behavioural intervention will use evidence-based choice architecture strategies to redesign the online menu and ordering system including: menu labelling, placement, prompting and provision of feedback and incentives. The primary trial outcomes will be the mean energy (kilojoules), saturated fat (grams), sugar (grams) and sodium (milligrams) content of lunch orders placed via the online system, and will be assessed 12 months after baseline data collection. ETHICS AND DISSEMINATION:The study was approved by the ethics committees of the University of Newcastle (H-2017-0402) and the New South Wales Department of Education and Communities (SERAP 2018065), and the Catholic Education Office Dioceses of Sydney, Parramatta, Lismore, Maitland-Newcastle, Bathurst, Canberra-Goulburn, Wollongong, Wagga Wagga and Wilcannia-Forbes. Study results will be disseminated through peer-reviewed publications, reports, presentations at relevant national and international conferences and via briefings to key stakeholders. Results will be used to inform future implementation of public health nutrition interventions through school canteens, and may be transferable to other food settings or online systems for ordering food. TRIAL REGISTRATION NUMBER:ACTRN12618000855224.

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Generalisability of an online randomised controlled trial: an empirical analysis.

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Generalisability of an online randomised controlled trial: an empirical analysis.

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