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

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: 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: The UK National Institute of Clinical Excellence Public Health Guideline 24: Alcohol use disorders: prevention informed ABI definition and COS scope. Development phases were a systematic review which identified 2641 outcomes in 401 ABI papers measured by 1560 different approaches. These outcomes were summarized into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This 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: 1) typical quantity; 2) typical frequency; 3) frequency of heavy episodic drinking; 4) combined consumption measure summarizing alcohol use; 5) hazardous or harmful drinking (average consumption); 6) standard drinks consumed in the past week (recent, current consumption); 7) alcohol-related consequences; 8) alcohol-related injury; 9) use of emergency healthcare services (impact of alcohol use); and 10) quality of life.
Interpretation: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve synthesis of new findings, reduce redundant/selective reporting (i.e. reporting only some, usually significant outcomes), improve between-study comparisons, and enhance relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other additional outcomes.
Original languageEnglish
JournalJournal of Studies on Alcohol and Drugs
Publication statusAccepted/In press - 9 Jun 2021

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