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.
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
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Systematic review
Step 1: Systematic literature review of outcomes and their measurement properties
Step 2: Delphi consensus study to prioritize outcomes
Step 3: Consensus meeting to decide the nature of the core outcome set