The outcome reporting in alcohol brief intervention trials (ORBITAL) core outcome set

The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project developed a core outcome set or minimum data standard (COS) to prioritize key measures and provide reporting guidance. Development of the COS required three phases a) systematic review to establish a contemporary map of outcomes used in efficacy/effectiveness trials b) outcome prioritization using an e-Delphi survey, and c) a consensus group meeting to select the final core outcome set. ABI definitions were informed by National Institute of Clinical Excellence Public Health Guideline 24. In 401 papers of 405 trials 2641 outcomes were measured in approximately 1560 different ways. A two-round e-Delphi study prioritized 15 outcomes that were subsequently discussed at an expert consensus meeting. Outcomes voted into the core outcome set were alcohol related problems or consequences, alcohol related injury, combined consumption measure which summarizes alcohol use, hazardous or harmful drinking, standard drinks consumed in a week, typical frequency of consumption, typical quantity of consumption, frequency of heavy drinking, quality of life, use of emergency healthcare services. Measurement instruments have been selected to ensure the COS can be implemented in ABI settings, with recommendations based on psychometric properties and relevance.