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The effect of question order on outcomes in the core outcome set for brief alcohol interventions among online help-seekers: Protocol for a factorial randomized trial
The effect of question order on outcomes in the core outcome set for brief alcohol interventions among online help-seekers: Protocol for a factorial randomized trial
- Source :
- Bendtsen, M, Garnett, C, Toner, P & Shorter, G W 2020, ' The effect of question order on outcomes in the core outcome set for brief alcohol interventions among online help-seekers: Protocol for a factorial randomized trial ', JMIR Research Protocols, vol. 9, no. 11, e24175, pp. e24175 . https://doi.org/10.2196/24175, https://doi.org/10.2196/24175, JMIR Research Protocols, JMIR Research Protocols, Vol 9, Iss 11, p e24175 (2020)
- Publication Year :
- 2020
-
Abstract
- BackgroundA core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. ObjectiveThis is a protocol for studies to assess if there are order effects among the questions included in the COS. MethodsThe 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. ResultsData collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire. Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. ConclusionsHomogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community. We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis. Trial RegistrationISRCTN Registry ISRCTN17954645; http://www.isrctn.com/ISRCTN17954645 International Registered Report Identifier (IRRID)PRR1-10.2196/24175
- Subjects :
- brief alcohol intervention
Efficacy
Computer applications to medicine. Medical informatics
efficacy
R858-859.7
order effects
question order bias
outcomes
factorial trial
randomized trial
online intervention
alcohol
protocol
effectiveness
Brief alcohol intervention
Effectiveness
Question order bias
Outcomes
Online intervention
Order effects
Protocol
Sjukgymnastik
Physiotherapy
Medicine(all)
Factorial trial
Medicine
Randomized trial
Alcohol
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Bendtsen, M, Garnett, C, Toner, P & Shorter, G W 2020, ' The effect of question order on outcomes in the core outcome set for brief alcohol interventions among online help-seekers: Protocol for a factorial randomized trial ', JMIR Research Protocols, vol. 9, no. 11, e24175, pp. e24175 . https://doi.org/10.2196/24175, https://doi.org/10.2196/24175, JMIR Research Protocols, JMIR Research Protocols, Vol 9, Iss 11, p e24175 (2020)
- Accession number :
- edsair.pmid.dedup....2e56536cc1bac3285ba1fa716d1bb30d
- Full Text :
- https://doi.org/10.2196/24175