Advisory Group Chair:
Professor Jeremy Bray (Chair of SIG), Professor and Department Head of Economics, The University of North Carolina at Greensboro. Email: jwbray@uncg.edu
The activity of the group to date has primarily been focussed on the creation of a core outcome set for alcohol brief interventions in all settings. This project, the Outcome Measures in Brief Intervention Trials: Alcohol (ORBITAL) has been funded by Alcohol Research UK. In Mid-Late 2019, we hope to publish the Core Outcome Set in full, and will be developing new strands of research to extend the work. If you are interested in taking part in the extension, please contact the group Chair jwbray@uncg.edu
ORBITAL PROJECT DETAILS
ORBITAL Project Principal Investigator:
Professor Dorothy Newbury-Birch. Professor of Alcohol and Public Health Research, Teesside University. Email: D.newbury-birch@tees.ac.uk
ORBITAL project team members:
Dr Gillian W Shorter, Reader in Psychology and former ORBITAL Project Manager and Consensus Meeting Chair, Ulster University. Email for correspondence: gw.shorter@ulster.ac.uk
Dr Emma L Giles, Reader 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
Dr 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
Overall ORBITAL project aim
This 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 reduced selective and inconsistent reporting in trials, improved the quality of guidance, and increased the number of studies which can be combined in systematic reviews to determine best practice. The protocol has been published in Trials and is freely available http://rdcu.be/C9Wo It has four phases:
Phase one: Systematic review to identify 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.
Method: We conducted a systematic review of ABI trials to identify domains and instruments in ABI evaluations across the range of settings. We searched key electronic databases (e.g. MEDLINE, CINAHL, EMBASE, PsycINFO, the Cochrane Library, Scopus, and Web of Knowledge) for ABI trials, consult with expert groups (INEBRIA members, ISAJE, SSA, KBS, Addaction and other service user groups) to identify the readily available published, peer reviewed trials of alcohol brief interventions. Data extracted included study details, domains, instruments, and psychometric properties of potential outcome measures (COSMIN). The information will be used to form narrative reviews of the state of the heterogeneity in domains, instruments, and reporting. The review was registered on PROSPERO CRD42016047185 https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=47185
This review has now been published in Journal of Studies on Alcohol and Drugs. For a copy please email Dr Gillian Shorter gw.shorter@ulster.ac.uk
Shorter, G. W., Bray, J. W., Giles, E. L., O’Donnell, A. J., Berman, A. H., Holloway, A., … & Clarke, M. (2019). The variability of outcomes used in efficacy and effectiveness trials of alcohol brief interventions: A systematic review. Journal of studies on alcohol and drugs, 80(3), 286-298.
Key findings:
In 405 trials, 2641 outcomes were measured in approximately 1560 different ways – this is considerable variability in outcomes, instruments, time points, and outcome descriptions.
This paper provides a comprehensive outcome map to help inform your next alcohol brief intervention evaluation.
Consumption outcomes predominated, with few trials reporting biomarkers or other objective measures.
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.
Phase two: Building consensus on domains to form a Core Outcome Set (COS)
Aim: To seek views on which domains are to form part of the COS for ABI research.
Methods: This comprised 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 were sought from international ABI experts, trialists, trial design, service users, healthcare professionals, journal editors, and policy makers. To reach these groups we contacted all INEBRIA members, asked for participants from international stakeholder groups and distribution lists, and used personal referral (particularly to recruit those with lived experience). In round one, participants rated 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 had the opportunity to add additional outcomes and to comment on why they have ranked outcomes as they have. All outcomes were carried through to the second round with first round scores displayed for each outcome. Ethics approval was sought and granted from Teesside University to conduct the Delphi analysis.
Key findings:
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.
Seven consumption outcomes met inclusion criteria and represent the priorities of this international expert group. These were: 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.
Phase three: Consensus meeting to decide on Core Outcome Set (COS)
Aim: To discuss the findings of the Delphi analysis and decide on the final COS domains.
Methods: The results of the Delphi analysis was compiled and presented to a consensus panel prior to the start of the INEBRIA 2017 conference. Participants at the consensus meeting debated the reasons why outcomes should not be included in the Core Outcome Set. The consensus meeting was Chaired by Dr Gillian Shorter who did not vote on the outcomes.
UPDATE Sept 2019: A ten item core outcome set was debated and agreed on (from 15 outcomes ranked in the Delphi exercise. These are:
- Alcohol related problems or consequences
- Alcohol related injury
- Combined summary consumption measure
- Hazardous or harmful drinking
- Standard drinks consumed in a week
- Typical frequency
- Typical quantity
- Frequency of heavy drinking
- Quality of life
- Use of emergency healthcare services
We need to improve standards in the ABI field, and we ask that you consider using this COS to improve evidence synthesis in the field. Please send Gillian feedback on how well it works for you gw.shorter@ulster.ac.uk
We will present the full COS at INEBRIA 2019 with the paper to follow shortly after. If you would like the full COS including measurement instruments, please email gw.shorter@ulster.ac.uk for a short briefing.
Phase four: Reporting, dissemination, and next steps
Aim: To disseminate the ABI statement which includes a user-friendly COS of domains and instruments with corresponding reporting guidance.
Methods: The ORBITAL statement will include the following:
- 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.
Update Sept 2019: The team are busy creating this ORBITAL statement to share with the ABI community at the INEBRIA 2019 conference. We are also interested in discussing next steps for the measurement and standardisation in the field of alcohol brief interventions. If you would like to be involved or have ideas and time to contribute, contact the SIG Chair Professor Jeremy Bray jwbray@uncg.edu If you have questions about the Core Outcome Set, please contact Dr Gillian Shorter gw.shorter@ulster.ac.uk