Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 7, 2020
Date Accepted: Oct 13, 2020
The effect of question order on outcomes in the core outcome set for brief alcohol interventions among online help-seekers (QOBCOS-1): protocol for a factorial randomized trial
ABSTRACT
Background:
A core outcome set (COS) for trials and evaluations of effectiveness and efficacy alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. This is a protocol for studies to assess if there are order effects among the questions included in the COS.
Objective:
This is a protocol for studies to assess if there are order effects among the questions included in the COS.
Methods:
The 10 items of the COS are organized into four clusters. A factorial design will be used with 24 arms, where each arm represents one order of the four clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to one of the 24 arms (double blind with equal allocation). Participants will be included if 18 years or older. The primary analyses will: (1) estimate how the order of the clusters of outcomes affect how participants respond; (2) investigate patterns of abandonment of the questionnaire.
Results:
Data collection is expected to commence in September 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 results are expected to be published no later than December 2022.
Conclusions:
Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step towards this goal. Gaining knowledge on the degree to which there may be issues with the order in which the COS is asked 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 COS to build up a worldwide repository and provide materials to support such an analysis. Clinical Trial: Prospectively registered with ISRCT on 2020-08-05 (ISRCTN17954645).
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