The “Outcome Reporting in Brief Intervention Trials: Alcohol” (ORBITAL) Core Outcome Set: International Consensus on Outcomes to Measure in Efficacy and Effectiveness Trials of Alcohol Brief Interventions

Gillian W. Shorter*, Jeremy W. Bray, Nick Heather, Anne H. Berman, Emma L. Giles, Mike Clarke, Carolina Barbosa, Amy J. O'Donnell, Aisha Holloway, Heleen Riper, Jean-Bernard Daeppen, Maristela G. Monteiro, Richard Saitz, Jennifer McNeely, Lela McKnight-Eily, Alex Cowell, Paul Toner, Dorothy Newbury-Birch

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Objective:
The purpose of this study was to report the “Outcome Reporting in Brief Intervention Trials: Alcohol” (ORBITAL) recommended core outcome set (COS) to improve efficacy and effectiveness trials/evaluations for alcohol brief interventions (ABIs).

Method:
A systematic review identified 2,641 outcomes in 401 ABI articles measured by 1,560 different approaches. These outcomes were classified into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This process prioritized 15 of 93 outcome categories for discussion at a consensus meeting of key stakeholders to decide the COS. A psychometric evaluation determined how to measure the outcomes.

Results:
Ten outcomes were voted into the COS at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure summarizing alcohol use, (e) hazardous or harmful drinking (average consumption), (f) standard drinks consumed in the past week (recent, current consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) use of emergency health care services (impact of alcohol use), and (j) quality of life.

Conclusions:
The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve the synthesis of new findings, reduce redundant/selective reporting (i.e., reporting only some, usually significant outcomes), improve between-study comparisons, and enhance the relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other, additional outcomes.
Original languageEnglish
Pages (from-to)638-646
Number of pages9
JournalJournal of Studies on Alcohol and Drugs
Volume82
Issue number5
Early online date19 Sep 2021
DOIs
Publication statusPublished - Sep 2021

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