Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
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.

Authors:
Shorter, G. W. Bray, J. W. Giles, E. L. O'Donnell, A. J. Berman, A. H. Holloway, A. Heather, N. Barbosa, C. Stockdale, K. J. Scott, S. J. Clarke, M. Newbury-Birch, D.

Publication

Journal:
Journal of studies on alcohol and drugs
Volume:
80
Issue:
3
Pages:
286 - 298
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):
Alcohol Research UK (Research Innovation Grant Number: R2016/04).

Health Area

Disease Category
Tobacco, drugs, & alcohol dependence

Disease Name
Addiction (abuse or dependence)
Alcohol problems

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Systematic review

Stakeholders Involved

None

Study Type

Systematic review of outcomes measured in trials

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