Abstract
Objective: 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: The UK National Institute of Clinical Excellence Public Health Guideline 24: Alcohol use disorders: prevention informed ABI definition and COS scope. Development phases were a systematic review which identified 2641 outcomes in 401 ABI papers measured by 1560 different approaches. These outcomes were summarized into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This 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: 1) typical quantity; 2) typical frequency; 3) frequency of heavy episodic drinking; 4) combined consumption measure summarizing alcohol use; 5) hazardous or harmful drinking (average consumption); 6) standard drinks consumed in the past week (recent, current consumption); 7) alcohol-related consequences; 8) alcohol-related injury; 9) use of emergency healthcare services (impact of alcohol use); and 10) quality of life.
Interpretation: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve synthesis of new findings, reduce redundant/selective reporting (i.e. reporting only some, usually significant outcomes), improve between-study comparisons, and enhance relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other additional outcomes.
Method: The UK National Institute of Clinical Excellence Public Health Guideline 24: Alcohol use disorders: prevention informed ABI definition and COS scope. Development phases were a systematic review which identified 2641 outcomes in 401 ABI papers measured by 1560 different approaches. These outcomes were summarized into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This 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: 1) typical quantity; 2) typical frequency; 3) frequency of heavy episodic drinking; 4) combined consumption measure summarizing alcohol use; 5) hazardous or harmful drinking (average consumption); 6) standard drinks consumed in the past week (recent, current consumption); 7) alcohol-related consequences; 8) alcohol-related injury; 9) use of emergency healthcare services (impact of alcohol use); and 10) quality of life.
Interpretation: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve synthesis of new findings, reduce redundant/selective reporting (i.e. reporting only some, usually significant outcomes), improve between-study comparisons, and enhance relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other additional outcomes.
| Original language | English |
|---|---|
| Journal | Journal of Studies on Alcohol and Drugs |
| Publication status | Accepted/In press - 9 Jun 2021 |