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

Abstract

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.

A Rapid Systematic Review of Worldwide Alcohol Use Disorders and Brief Alcohol Interventions in the Criminal Justice System

“…We found, as other studies have ( 10 , 17 ), that studies examining the effectiveness of risky drinking interventions are still scarce. Another challenge associated with conducting research in the CJS is the necessity of using self-report follow-up data ( 10 , 17 , 64 ). Another fundamental issue is that studies include different measurement tools and outcomes, with outcomes decided upon based on the research funding.…”

Few interventions support the affected other on their own: A systematic review of individual level psychosocial interventions to support those harmed by others’ alcohol drinking

“…More work is required to improve the evidence base and intervention development (Public health England, 2019), particularly to help and support those who experience the harm from others' alcohol use without the drinker having to change. The eld is in its infancy and needs urgent attention of researchers and policy makers, including developing a consensus on which outcomes are important such as for other ABI interventions (Shorter et al, 2021;Tiburcio et al, 2022) and should be studied in the context of these types of interventions, as well as plans for dissemination. In addition, while costeffectiveness of interventions was not established for any of the interventions in this review, understanding the cost of alcohol's harm to others alleviated by a well-designed intervention in addition to the effectiveness is important, and was also emphasized by Navarro (2011).…”

The effect of question order on outcomes in the orbital core outcome set for alcohol brief interventions among online help-seekers (QOBCOS): Findings from a randomised factorial trial

“…The primary outcomes were: (i) the 10 outcomes of the COS measured using the recommended questionnaires (listed in Appendix A 19 ), and (ii) the proportion of participants abandoning the questionnaire. These outcomes facilitated the primary analysis of order effects.…”

“… 17 Following two e-Delphi rounds, a consensus meeting, and psychometric evaluation, 18 10 outcomes formed the consensus-derived COS. 19 The outcomes are: Frequency of drinking Typical number of drinks consumed on a drinking day Frequency of heavy episodic drinking Combined consumption measure Hazardous and harmful drinking Standard drinks consumed in the past week Quality of life Alcohol-related consequences Alcohol-related injury Use of emergency health care services A consensus was also formed within the ORBITAL project on measures for the COS outcomes. These are listed in Appendix A, 19 and described in brief here. The WHO's Alcohol Use Disorders Identification Test – Consumption (AUDIT-C) tool 20 is used to measure the first five outcomes of the COS.…”