Core Outcome Measures in Effectiveness 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

General Information

Abstract:
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.

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

Publication

Journal:
Journal of studies on alcohol and drugs
Volume:
80
Issue:
3
Pages:
299 - 309
Year:
2019
DOI:
Further Study Information

Date:
January 2017 - September 2017
Funding source(s):
Alcohol Research UK Research Innovation Grant No. 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)

Delphi process

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.


Stakeholders Involved

Clinical experts
Consumers (patients)
Ethicists
Funders
Guideline developers
Policy makers
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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