Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
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) and Kim Corace (The Royal Ottawa Mental Health Center and University of Ottawa)
-Co-Investigators 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)
-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 / type of Intervention
Any

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.


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

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