Core Outcome Measures in Effectiveness Trials

Outcome Reporting for Brief Intervention Trials (ORBIT)

General Information

Summary:
The evidence base to assess the efficacy and effectiveness of alcohol brief intervention (ABI) is weakened by variability in measured outcomes and/or by inconsistent reporting. The Outcome Reporting in Brief Intervention Trials (ORBIT) project aims to develop a core outcome set and reporting guidance for use in future trials of ABI in a range of settings.

Through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs), an international Special Interest Group was convened to guide the development of this Core Outcome Set (COS). ORBIT will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties (using the COnsensus-based Standards for the selection of health Measurement INstruments [COSMIN] criteria). This will support a Delphi study to prioritise outcome domains. Delphi panellists will be drawn from a range of settings and stakeholder groups. The Delphi study will also be used to determine if a single COS is relevant for all settings, or whether a core set with additional setting specific outcomes would be better suited to the needs of the field. A consensus meeting will be held with key stakeholder representation to determine the final COS and the associated guidance for use.

ORBIT will develop a COS for alcohol screening and brief intervention trials, including the domains and recommended instruments. The standardisation of outcome measurement and reporting across ABI studies will support the ongoing development of ABIs and the systematic synthesis of emerging research findings. We will track the extent to which the COS is delivering on this promise through an exploration of the use of the guidance in the decade following COS publication.

Contributors:
Professor Dorothy Newbury-Birch (PI: Teesside University)
Dr Gillian W Shorter (Project Manager: Teesside University(Primary), also Inspire, Ulster University, and Australian National University)
Professor Nick Heather (Northumbria University)
Professor Jeremy Bray (Chair: University of North Carolina at Greensboro)
Dr Aisha Holloway (University of Edinburgh)
Dr Carolina Barbosa (RTI International)
Dr Anne Berman (Karolinska Institutet)
Dr Emma Giles (Teesside University)
Dr Amy O'Donnell (Newcastle University)
and the INEBRIA ORBIT Special Interest Group.

Further Study Information

Current Stage:
Ongoing
Date:
July 2016 - March 2018
Funding source(s):
Alcohol Research UK (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
Not specified

Method(s)

Consensus meeting
Delphi process
Systematic review

Step 1: Systematic literature review of outcomes and their measurement properties
Step 2: Delphi consensus study to prioritize outcomes
Step 3: Consensus meeting to decide the nature of the core outcome set


Stakeholders Involved

Charities
Clinical experts
Conference participants
Epidemiologists
Journal editors
Methodologists
Patient/ support group representatives
Policy makers
Researchers
Service commissioners
Service providers
Service users
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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