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.
Highlights
The meeting delegates agreed the core outcome set (COS) questions should begin with a clear guide to a standard drink in the country to help accurate estimation of alcohol use
alcohol brief interventions (ABIs) are a support to alcohol use change and can reduce the impact of unhealthy alcohol use on morbidity and mortality worldwide
The evidence to identify which ABIs are effacious/effective is compromised by the variability in the conduct and reporting of trials and other evaluations (Shorter et al, 2019a)
Summary
The consensus meeting was held in New York (United States) on the day before the 14th International INEBRIA conference. Invitations were sent to 31 individuals based on experience in the ABI field, and 17 attended (delegate background, ABI area, and related experience summarized in Supplemental Material A). Those who refused could not attend the day before the conference or were not attending the full INEBRIA conference. With votes from the e-Delphi displayed by the stakeholder group (those with experience of unhealthy alcohol use, health care or other professionals, or researchers). Emails of approach to delegates, materials provided in advance and on the day, votes, discussion summaries, psychometric properties, and rankings are available at http://osf.io/m57nv. Co-authors/delegates and six individuals with experience of unhealthy alcohol use were invited to review the applicability of measures to the Material A
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