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Measuring Change from Alcohol Brief Interventions: Development of a Consensus Core Outcome Set

In response to two issues from the Secretariat.

1) The CC agreed to include information on the existing INEBRIA special interest groups on the website. On this regard, I would like to know, if possible, the following:

Title: Measuring Change from Alcohol Brief Interventions: Development of a Consensus Core Outcome Set

Leader/s:

Professor Dorothy Newbury-Birch.

Professor of Alcohol and Public Health Research, Health and Social Care Institute, Teesside University. D.newbury-birch@tees.ac.uk

Dr Emma L Giles, Senior Research Lecturer in Public Health, Institute of Health and Social Care, Teesside University, e.giles@tees.ac.uk
Dr Amy O’Donnell. NIHR School for Primary Care Research Fellow, Institute of Health and Society, Newcastle University. amy.odonnell@newcastle.ac.uk
Dr Aisha Holloway, CNO Clinical Academic Re-engagement Research Fellow, School of Health in Social Sciences, The University of Edinburgh, Aisha.Holloway@ed.ac.uk
Dr Gillian W Shorter, Visiting Fellow, Australian National University and Shorter Consulting, Belfast gillianwshorter@gmail.com
Professor Nick Heather, Emeritus Professor of Alcohol & Other Drug Studies, Faculty of Health & Life Sciences, Northumbria University, nick.heather@northumbria.ac.uk

Advisory Group:
Anne Berman, Associate Professor of Clinical Psychology, Department of Clinical Neuroscience, K8, CPF Berman, Centrum För Psykiatriforskning, Norra Stationsgatan 69, Plan 7 113 64, Stockholm, Sweden. Email: Anne.H.Berman@ki.se

Carolina Barbosa, Health Economist, RTI International, Health Economics Program, 230 West Monroe St., Suite 2100, Chicago, IL, USA, 60606-4901. Email: cbarbosa@rti.org

Aim: This research aims to develop an ABI core outcome set, to improve the measurement of alcohol-related change. Research from other healthcare areas shows that a core outcome set reduces selective and inconsistent reporting in research trials, improves the quality of guidance on how to deal with the condition, and increases the number of studies which can be combined in systematic reviews to determine best practice.

Actions planned:
Phase one: Rapid review and narrative synthesis of previous relevant work (6 months)

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

Method: We will conduct a rapid 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 (MEDLINE, CINAHL, EMBASE, PsycINFO, the Cochrane Library, Scopus, and Web of Knowledge) for ABI systematic reviews, consult with expert groups (INEBRIA members, ISAJE, SSA, KBS, Addaction and other service user groups), and use social media (Twitter) to identify relevant ongoing ABI reviews. Data extracted will include study details, domains, instruments and reporting standards. This will form a narrative review of the state of the heterogeneity in domains, instruments, and the usefulness of the reporting (e.g., if non-significant effects are found with an instrument, is there enough detail to inform a meta-analysis?).

The long list of domains and instruments will be supplemented with information from the NIH common data elements resource portal database (iv above) and the NIAAA assessing alcohol problems reference (v). The INEBRIA membership will be invited to contribute additional domains and instruments at an INEBRIA 2016 conference workshop, and via the INEBRIA google group for those unable to attend the conference.

Phase two: Building consensus on domains to form a Core Outcome Set (COS) (6 months)
Aim: To seek views on which domains are to form part of the COS for ABI research.

Methods: Phase two comprises 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 reviewers will comprise international experts in the field of ABI, trial design, outcome measures, service users, healthcare professionals, journal editors, and policy makers. To reach healthcare professionals, journal editors, and researchers we will contact all INEBRIA members, and ask for participants from international stakeholder groups, including distribution lists of Addict-L, Addiction Medicine, Drug Misuse Research, Alcohol Misuse (Scottish Addiction Studies), Drugtalk, Ewodor, and Kettil Bruun Society. GWS will contact key trial methodologists, and COS experts as a member of the UK Hubs for Trials Methodology Research. Service users will be contacted through Addaction, and local stakeholder groups, for example Belfast Experts By Experience. This will ensure our consensus process is transparent and adequately powered to detect differences in opinion, and to account for drop out between rounds.

In round one, participants will be asked to rate each measure using a scale of 1-9, with 1-3 labelled ‘not important for inclusion’, 4-6 labelled ‘important but not critical’ and 7-9 labelled ‘critical for inclusion’. Participants also have the opportunity to add additional outcomes and to comment on why they have ranked outcomes as they have. All outcomes will be carried through to the second round with first round scores displayed for each outcome. Consensus will be defined a priori; measures are likely to be included if they gain support from at least 70% of participants in the “critical” range (7-9). Ethics approval will be sought from Teesside University to conduct the Delphi analysis. Informed consent will be sought from all participants.

Phase three: 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. At the INEBRIA 2017 conference 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 AOD as the Early Career Researcher, 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 (Professor Mike Clarke, Queen’s University Belfast).

Phase four: 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.
Methods: A name and acronym for the new ABI statement will be created for ease of use and memory. This has not been decided a priori; it may be a function of the domains in the set. The statement will have 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: also included in the statement would be 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.

Participants:

Phase two – Experts in the field; INEBRIA members
Phase three – Experts in the field; INEBRIA 2017 Conference attendees.

Progress (until April 2016): This research is due to begin in July 2016.

More information:
Timescales of project:


Timelines

New time frame

July 2016 – Dec 2016

  • Rapid review: interim summary of domains and instruments to discuss at Inebria
  • Delphi ethics submission

 

Jan 2017 - June 2017

Two round Delphi analysis

July- Aug 2017

Consensus meeting (could occur at INEBRIA)

Sept 2017

INEBRIA CONFERENCE

Oct 2017 – Sept 2018

Reporting and dissemination

2) Would you like us to include a “note” in the news on the positive result of the research grant.

Yes please.



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