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

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.

Contributors

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

Publication

Journal: J Stud Alcohol Drugs
Volume: 82
Issue: 5
Pages: 638 - 646
Year: 2021
DOI:

Further Study Information

Current Stage: Completed
Date: July 2016 - March 2018
Funding source(s): Alcohol Research UK (Grant Number: R2016/04)


Health Area

Disease Category: Tobacco, drugs, & alcohol dependence

Disease Name: Addiction (abuse or dependence), Alcohol problems

Target Population

Age Range: 16 - 100

Sex: Either

Nature of Intervention: Not specified

Stakeholders Involved

- Charities
- Clinical experts
- Conference participants
- Epidemiologists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- 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