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

Gillian W. Shorter, Jeremy W. Bray, Nick Heather, Anne H. Berman, Emma L. Giles, Mike Clarke, Carolina Barbosa, Amy J. O’donnell, Aisha Holloway, Heleen Riper, Jean Bernard Daeppen, Maristela G. Monteiro, Richard Saitz, J. E.N.N.I.F.E.R. McNeely, L. E.L.A. McKnight-Eily, Alex Cowell, Paul Toner, Dorothy Newbury-Birch

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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. (J. Stud. Alcohol Drugs, 82, 638–646, 2021).

Original languageEnglish
Pages (from-to)638-646
Number of pages9
JournalJournal of Studies on Alcohol and Drugs
Volume82
Issue number5
DOIs
Publication statusPublished - 1 Sep 2021

Bibliographical note

Funding Information:
This study was supported by Alcohol Research UK (Research Innovation Grant Number: R2016/04). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. *Correspondence may be sent to Gillian W. Shorter at the Centre for Improving Health Related Quality of Life, School of Psychology, Queen’s University Belfast, David Keir Building, 18-30 Malone Rd, Belfast, BT9 5BN, or via email at: g.shorter@qub.ac.uk.

Funding Information:
This study was supported by Alcohol Research UK (Research Innovation Grant Number: R2016/04). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.The authors thank the INEBRIA Research Measurement Standardization Special Interest Group and participants at a workshop led by Professors Nick Heather and Jim McCambridge in Warsaw in 2014. We also thank Dr. Liz Gargon, Dr. Sarah Gorst, and Professor Paula Williamson for methodological advice on Core Outcome Sets and Dr. Sophie Chung from ICHOM for advice on psychometric presentation.

Publisher Copyright:
© 2021, Alcohol Research Documentation Inc.. All rights reserved.

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