Establishing a core endpoints set for studies examining treatments for opioid use disorder

Arising from overprescription and illicit opioids such as fentanyl, opioids have resulted in a healthcare crisis. The impact of this epidemic is substantial, and opioid use disorder (OUD) has noteworthy implications on mortality, morbidity, healthcare use and societal costs. People
living with OUD urgently need the best treatments to be made available to them. Unfortunately there currently exists considerable variability in endpoints used to look at treatment benefits amongst research studies in this area, complicating the ability to consider comparisons of findings between studies.

In this work our objectives are to:
(1) conduct a systematic review with planned meta-analyses to assess the relative benefits of different psychosocial therapies in people with opioid use disorder receiving opioid agonist therapy; and
(2) using information gathered from the review along with structured Delphi surveys, establish a core outcomes set of patient oriented outcomes to be used in future studies comparing interventions for treatment of individuals with opioid use disorder.

Contributors


-Principal Investigators Brian Hutton (Ottawa Hospital Research Institute), Kim Corace (The Royal Ottawa Mental Health Center and University of Ottawa)

-Co-Investigators Zainab Samaan (McMaster University), Brittany Dennis (St George’s Hospital Medical School, University of London), Peter Tugwell (Ottawa Hospital Research Institute), Bev Shea (Ottawa Hospital Research Institute), Dorcas Beaton (St. Michael’s Hospital), Beth Sproule (Centre for Addiction and Mental Health), Patricia Poulin (The Ottawa Hospital), Danielle Rice (McGill University and Ottawa Hospital Research Institute), David Moher (Ottawa Hospital Research Institute), Dianna Wolfe (Ottawa Hospital Research Institute), Kednapa Thavorn (Ottawa Hospital Research Institute), Nitika Sanger (McMaster University); Lehana Thabane (McMaster University); Alessia D’Elia (McMaster University); Alannah Hillmer (McMaster University); Caroul Chawar (McMaster University); Engeny Krupitsky (St. Petersburg Pavlov State Medical University); Frances R Levin (Columbia University Irving Medical Center); Joe Schofield (University of Stirling, Scotland); Victor Makanjuola (University of Ibadan/University College Hospital Ibadan, Nigeria); Flavio Pechansky (Center for Drugs and Alcohol Research, Federal University of Rio Grande do Sul, Brazil); Thomas Schulze (University Hospital, LMU Munich, Nußbaumstr); Kristina Adorjan (University Hospital, LMU Munich, Nußbaumstr); Lize Weich (Stellenbosch University, Department of Psychiatry); Davood Omrani (Shahid Beheshti University of Medical Sciences); Sarah Afjeh (Shahid Beheshti University of Medical Sciences); Aida Ansari (Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute); Gillinder Bedi (University of Melbourne, Australia)

-Knowledge Users: Amy Porath and Sheena Taha (Canadian Center on Substance Use and Addiction); Gary Garber (Public Health Ontario); Melanie Willows (the Royal Ottawa Mental Health Center and president elect of the Canadian Society of Addiction Medicine); Community Addictions Peer Support Association (www.capsa.ca); Moms United and Mandated to Saving the Lives of Drug Users (www.mumsdu.com)

Further Study Information

Current Stage: Ongoing
Date: March 2018 - March 2019
Funding source(s): Funded by the Canadian Institutes of Health Research (funding received in March 2018).


Health Area

Disease Category: Tobacco, drugs, & alcohol dependence

Disease Name: Opioid use disorder

Target Population

Age Range: 12 - 75

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Families
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Delphi process
- Literature review
- Survey
- Systematic review

Our planned work consists of two objectives: (1) performance of a systematic review to evaluate the benefits of different psychosocial interventions (in conjunction with opioid agonist therapy) for treatment of individuals with opioid use disorder; and (2) development of a core outcome set for future studies related to interventions for treatment of opioid use disorder.

Details of the systematic review and planned meta-analyses/network meta-analyses will be described in depth in our planned open access protocol. The core outcomes set will be derived by use of well established methods for the development of such information, including a thorough review of the literature to identify candidate clinical and patient related outcome measures as well as use of consensus Delphi methods to determine agreed upon core outcomes for opioid use disorder. To pursue the second objective, we will establish candidate measures reflecting the outcomes, and subsequently we will evaluate their face validity, feasibility and measurement properties. Our planned deliverables from this work include: (a) a published protocol describing methods for our systematic review and approach to core outcome set development; (b) one (and possibly multiple) publications describing findings from our systematic review; and (c) a core outcomes set for opioid use disorder for dissemination to inform the design of future research studies.

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