The \u2018Outcome Reporting in Brief Intervention Trials: Alcohol\u2019 (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention

G W Shorter,C Barbosa,M Clarke,K J Stockdale,E L Giles,A H Berman,Jeremy W Bray,A J O’Donnell,D Newbury-Birch,A Holloway,N Heather

doi:10.1186/s13063-017-2335-3

Abstract

BackgroundThe 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/designAn 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, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI.DiscussionORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation 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.

Highlights

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
Outcome Reporting in Brief Intervention Trials: Alcohol’ (ORBITAL) will develop a core outcome set (COS) for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments
The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings

Summary

Discussion

This protocol describes a programme of work to develop a COS for assessing the efficacy and effectiveness of ABI in clinical trials across all settings. The scope for the COS is deliberately broad, given the wide variety of locations and types of ABI. This in itself is a challenge, and the nature of the COS will depend greatly on the findings of the systematic review. To the best of our knowledge, this will be the first Delphi study to ask for comment on the suitability of outcomes across such a wide range of settings, and to raise the possibility of having a COS which is based around a core subset with some sub-core aspects depending on the setting or

Background

Findings