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.

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.

Addressing alcohol in routine healthcare in Sweden-population-based surveys in 2010 and 2017.

BACKGROUND: The aim of the study was to compare how alcohol was addressed in routine healthcare practice in Sweden in 2010 and 2017, following the 2011 implementation of national drinking guidelines. METHODS: Population-based cross-sectional surveys were conducted in 2010 and in 2017. Subjects were 3200 respondents in 2010 (response rate 54%) and 3000 respondents in 2017 (response rate 51%) in Sweden. Both the 2010 and 2017 surveys collected data on: socio-demographics; alcohol consumption; healthcare visits in the past 12 months and characteristics of alcohol conversations in healthcare (duration, contents, experience and effects). RESULTS: It was significantly more likely that respondents had a conversation about alcohol in healthcare in 2017 than in 2010 (OR = 1.49; 95% CI = 1.27-1.75; P<0.001). Conversations about alcohol in the healthcare were mostly short (<4 min), both in 2010 and 2017. The alcohol conversations in 2017 included less information about alcohol's influence on health (P = 0.002) compared with 2010. The experience of the conversation about alcohol was perceived as less dramatic in 2017 than in 2010 (P = 0.038). CONCLUSIONS: The results suggest that conversations about alcohol were more embedded in routine healthcare practice in Sweden in 2017 than in 2010. This development has occurred since the 2011 publication of the national guidelines. Alcohol conversations targeted also specific groups of drinkers as recommended by the guidelines. However, our study design does not allow for conclusions about the relationship between the guidelines and the changes in healthcare practice.

The Variability of Outcomes Used in Efficacy and Effectiveness Trials of Alcohol Brief Interventions: A Systematic Review.

OBJECTIVE: The purpose of this study was to characterize recent alcohol brief intervention (ABI) efficacy and effectiveness trials, summarize outcomes, and show how variability in outcomes and reporting compromises the evidence base. METHOD: A systematic review and narrative synthesis of articles from 10 databases were undertaken (January 2000-November 2017); study selection represented recent, readily available publications. The National Institute of Care Excellence (NICE) Public Health Guideline 24 (Alcohol use disorders: prevention) informed ABI definitions. The review was conducted using Centre for Reviews and Dissemination (CRD) guidance and pre-registered on PROSPERO (CRD42016047185). Seven a priori specified domains were used to classify outcomes: biomarkers, alcohol-related outcomes, economic factors/resource use, health measures, life impact, intervention factors, and psychological/behavioral factors. RESULTS: The search identified 405 trials from 401 eligible papers. In 405 trials, 2,641 separate outcomes were measured in approximately 1,560 different ways. The most common outcomes used were the number of drinks consumed in a week and frequency of heavy episodic drinking. Biomarkers were least frequently used. The most common primary outcome was weekly drinks. By trial type, the most frequent outcome in efficacy and effectiveness trials was frequency of heavy drinking. CONCLUSIONS: Consumption outcomes predominated; however, no single outcome was found in all trials. This comprehensive outcome map and methodological detail on ABI effectiveness and efficacy trials can aid decision making in future trials. There was a diversity of instruments, time points, and outcome descriptions in methods and results sections. Compliance with reporting guidance would support data synthesis and improve trial quality. This review establishes the need for a core outcome set (COS)/minimum data standard and supports the Outcome Reporting in Brief Interventions: Alcohol initiative (ORBITAL) to improve standards in the ABI field through a COS for effectiveness and efficacy randomized trials.

Prioritization of Outcomes in Efficacy and Effectiveness of Alcohol Brief Intervention Trials: International Multi-Stakeholder e-Delphi Consensus Study to Inform a Core Outcome Set.

OBJECTIVE: Outcomes used in alcohol brief intervention trials vary considerably. Achieving consensus about key outcomes can enhance evidence synthesis and improve healthcare guidelines. This international, e-Delphi study sought to prioritize outcomes for alcohol brief intervention trials as part of a larger program of work develop an alcohol brief intervention core outcome set. METHOD: In total, 150 registrants from 19 countries, representing researchers, policymakers, and patients, participated in a two-round e-Delphi study. In Round 1, participants (n = 137) rated 86 outcomes, derived from a review of the literature and a patient and public involvement panel, by importance. In Round 2, participants (n = 114) received feedback on importance ratings for each outcome, and a reminder of their personal rating, before rating the outcomes for importance a second time. Seven additional outcomes suggested in Round 1 were added to the Round 2 questionnaire. We defined consensus a priori as 70% agreement across all stakeholder groups. RESULTS: Seven consumption outcomes met inclusion criteria: typical frequency, typical quantity, frequency of heavy drinking, alcohol-related problems, weekly drinks, at-risk drinking, and combined consumption measures. Others meeting the threshold were alcohol-related injury, quality of life, readiness to change, and intervention fidelity. CONCLUSIONS: This is the first international e-Delphi study to identify and prioritize outcomes for use in alcohol brief intervention trials. The use and reporting of outcomes in future alcohol brief intervention trials should improve evidence synthesis in systematic reviews and meta-analyses. Further work is required to refine these outcomes into a core outcome set that includes guidance for measurement of outcomes.