The “Outcome Reporting in Brief Intervention Trials: Alcohol” [ORBITAL] framework: Protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention

Gillian W. Shorter, N Heather, JW Bray, EL Giles, A Holloway, C Barbosa, AH Berman, AJ O'Donnell, M Clarke, KJ Stockdale, DA Newbury-Birch

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Abstract

AbstractBackground: The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The Outcome Reporting in Brief Intervention Trials: Alcohol (ORBITAL) project aims to develop a Core Outcome Set (COS) and reporting guidance for its use in future trials of ABI in a range of settings.Methods/Design: An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI.Discussion: ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardization of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.
Original languageEnglish
JournalTrials
VolumeXX
DOIs
Publication statusPublished - 22 Dec 2017

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Keywords

  • Consensus methods
  • core outcome set
  • Delphi technique
  • screening
  • brief Intervention
  • alcohol
  • measurement
  • alcohol brief intervention
  • trial
  • outcomes standardization

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