Update for Outcome Reporting in Brief Intervention Trials (ORBIT) SIG

Leader:

Professor Dorothy Newbury-Birch. Professor of Alcohol and Public Health Research, Teesside University. Email: D.newbury-birch@tees.ac.uk

Chair of the Advisory Group:

Professor Jeremy Bray (Chair of SIG), Professor and Department Head of Economics, The University of North Carolina at Greensboro. Email: jwbray@uncg.edu

Advisory Group members:

Dr Gillian W Shorter, ORBIT Project Manager, Teesside University.

Email for correspondence, more information, or to refer someone for the Delphi study: g.shorter@tees.ac.uk

Dr Emma L Giles, Senior Research Lecturer in Public Health, Teesside University.

Email: e.giles@tees.ac.uk
Dr Amy O’Donnell. NIHR School for Primary Care Research Fellow, Newcastle University. Email: amy.odonnell@newcastle.ac.uk
Dr Aisha Holloway, CNO Clinical Academic Re-engagement Research Fellow, University of Edinburgh. Email: Aisha.Holloway@ed.ac.uk
Professor Nick Heather, Emeritus Professor of Alcohol & Other Drug Studies, Northumbria University. Email: nick.heather@northumbria.ac.uk

Associate Professor Anne Berman, Associate Professor of Clinical Psychology, Karolinska Institutet.

Email: Anne.H.Berman@ki.se

Dr Carolina Barbosa, Health Economist, RTI International. Email: cbarbosa@rti.org

Funder: This project is funded by Alcohol Research UK http://www.alcoholresearchuk.org/

Overall ORBIT project aim

This four phase project aims to develop a Core Outcome Set for Alcohol Brief Interventions to improve the measurement of alcohol-related change. Core outcome sets in other healthcare areas have demonstrably reduced selective and inconsistent reporting in trials, improved the quality of guidance on how to deal with the condition, and increased the number of studies which can be combined in systematic reviews to determine best practice.

Phase 1: Systematic review to identify and appraise outcome measures and domains used in trials evaluating alcohol screening and brief interventions

Aim: To create a list of domains and instruments used to evaluate outcomes in ABI research.

Methods: We will conduct a systematic review of ABI reviews to identify domains and instruments in ABI evaluations across the range of settings. Using a pre-specified search strategy, registered at PROSPERO, we will search key electronic databases, consult with expert groups including service users, use social media, and search grey literature to identify all trials of alcohol brief interventions. Data extracted will include study details, domains, instruments and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) appraisal. The information will be used to form a narrative review of the state of the heterogeneity in domains, instruments, and reporting.

The INEBRIA membership will be invited to discuss plans and early findings at an INEBRIA 2016 conference workshop, and encouraged to contribute to the list via google group or through contacting the Project Manager (Dr Gillian Shorter) using the contact details above.

Phase 2: Building consensus on domains to form a Core Outcome Set (COS) (4 months)

Aim: To seek views on which domains are to form part of the COS for ABI research.

Methods: This will comprise a two round email Delphi study to evidence expert opinion and help identify a core set of priority measures for inclusion in the statement. Delphi ratings will be sought from international ABI experts, trialists, trial design, service users, healthcare professionals, journal editors, trial methodologists, COS experts, and policy makers. The breadth will ensure our consensus process is transparent and adequately powered to detect differences in opinion, and to account for drop out between rounds. You are welcome to suggest individuals to include, or find out more about the Delphi process by contacting Dr Gillian Shorter on the email above.

Ethics approval will be sought from Teesside University to conduct the Delphi analysis. Informed consent will be sought from all participants.

Phase 3: Consensus meeting to decide on Core Outcome Set (COS) (3 months)

Aim: To discuss the findings of the Delphi analysis and decide on the final COS domains.

Methods: The results of the Delphi analysis will be compiled and a manuscript prepared for publication. The list of ranked domains and corresponding instruments will be presented to the attendees for comment and discussion. This will include a draft of the final statement and ideas on dissemination methods. The workshop will be led by Dr Amy O’Donnell, supported by other investigators.

The results of the Delphi analysis, and from the results workshop above, will be fed into a closed consensus meeting which includes the IRMSG and service user representatives to decide the final COS domains and instruments. It will be chaired by an independent, experienced COS authority.

Phase 4: Reporting and dissemination (6 months)

Aim: To create and disseminate an ABI statement comprising a user-friendly COS of domains and instruments with corresponding reporting guidance.

Outputs: The new ABI statement will be created with the following elements:

  • Domains of the COS: What should be measured as a minimum standard for ABI research?
  • Instruments for each of the Domains of the COS: How the domain should be measured as a minimum standard for ABI research. Alternative instruments will also be listed to assist researchers, but the Core Instruments will clearly be identified.
  • Reporting guidance: Guidance on how specific measurements should be reported (e.g., alcohol consumption in standard drinks or units) and consensus would be sought in respect of a range of reporting conventions, including reporting of parameters and effect sizes even if no significant effects are found.

Timescales of project:

Timelines Activity
July 2016 – Dec 2016 Systematic review and Delphi ethics submission
Jan 2017 – Apr 2017 Two round Delphi analysis
May- June 2017 Consensus meeting
June – Dec 2017 Reporting and dissemination
Sept 2017 INEBRIA conference