Crafting the international standard: Establishing and implementing core outcome measures for alcohol brief interventions

Abstract
Background: Alcohol brief interventions can support those aged 16 or over to reduce the harm associated with their alcohol use outside the formal treatment setting. Applied in a variety of contexts including online, primary and other healthcare, workplaces, Universities, and other settings, there is a diversity of outcomes used to evaluate whether alcohol brief interventions are effective/efficacious. This diversity reduces the quality of research and the ability to synthesise evidence to understand what works. We report the “Outcome Reporting in Brief Intervention Trials: Alcohol” (ORBITAL) recommended core outcome set (COS) for efficacy/effectiveness evaluations for alcohol brief interventions (ABIs) and how this was developed.
Methods: To develop the core outcome set we followed COMET Initiative methods including a systematic review, e-Delphi, consensus meeting, psychometric evaluation, explored question order bias, and reflected on the approach. The development was supported by the International Network on Brief Interventions for Alcohol and Other Drugs (INEBRIA) Measurement Special Interest Group.
Results: The review identified 2,641 outcomes in 401 ABI articles measured 1,560 different ways. In a two-round e-Delphi, 150 participants from 19 countries prioritized 15 outcome categories which were discussed at the consensus meeting. The ORBITAL COS has 10 outcomes, decided at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure, (e) hazardous drinking (average consumption), (f) past week standard drinks (recent consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) emergency healthcare service use (impact of alcohol use), and (j) quality of life. A psychometric evaluation and vote determined how to measure outcomes including those experiencing unhealthy alcohol use providing living expertise to decision making. An evaluation of question order bias revealed that the order of the questions matters for implementation.
Conclusions: The ORBITAL COS is the recommended minimum and does not exclude the measurement of additional outcomes alongside the core. Online testing of the questions in the COS showed they were easy and quick to complete. Core outcome sets improve evidence synthesis, improve the inclusion of new research works, reduce redundant/selective reporting, improve between-study comparisons, easily justify measure choice to funders, and enhance the relevance of evaluation findings to decision makers. The review has identified the urgency of addressing the diversity of the field, and provides the tools to advance. We critically reflect on processes and lessons learned, plans for reviewing the core outcome set, and invite the development of core outcome sets to improve the quality of evaluation in the addiction the field.