Evidence map›Paper›PMID 31907000›Full record

SynthesisTrials2020

A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder.

Brittany B Dennis, Nitika Sanger, Monica Bawor, Leen Naji, Carolyn Plater, Andrew Worster, Julia Woo, Anuja Bhalerao, Natasha Baptist-Mohseni, Alannah Hillmer and 6 more

Registry-linked trialOpen access · goldAbstract readSystematic Review
In one paragraph

Synthesis in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05594121 (A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot), which is not on this map. Cited by 27 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 6 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05594121 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot (Sublocade®) vs Daily Sublingual Buprenorphine With Naloxone (Suboxone®) for the Treatment of Opioid Use Disorder

TypeinterventionalSponsorRoyal Victoria Hospital, CanadaRan2022 to 2024Enrolled90ConditionsModerate to Severe Opioid Use DisorderArmsExtended Release Subcutaneous Buprenorphine, Immediate Release Sublingual Buprenorphine
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 6 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Substance Use Disorder Treatment Outcomes: Methodological Overview of Metrics and Criteria.International journal of methods in psychiatric research · 2025
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  6. Role of microRNAs in the pathophysiology of addiction.Wiley interdisciplinary reviews. RNA · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Brittany B DennisMcMaster University Internal Medicine Residency Program, Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Canada.
Nitika SangerDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Monica BaworMcMaster University Internal Medicine Residency Program, Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Canada.
Leen NajiDepartment of Family Medicine Residency Program, Michael G. Degroote School of Medicine, McMaster University, Hamilton, Canada.
Carolyn PlaterDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.
Andrew WorsterDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Julia WooUniversity of Toronto Faculty of Medicine, University of Toronto, Toronto, Canada.
Anuja BhaleraoUniversity of Toronto Faculty of Medicine, University of Toronto, Toronto, Canada.
Natasha Baptist-MohseniDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.
Alannah HillmerDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.
Danielle RiceFaculty of Science, Department of Psychology, McGill University, Montreal, Canada.
Kim CoraceFaculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Brian HuttonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Peter TugwellWHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Zainab SamaanDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada. samaanz@mcmaster.ca.ORCID http://orcid.org/0000-0002-5974-9361
McMaster University · CAImpact · CAUniversity of Ottawa · CAUniversity of Toronto · CABruyère · CACentre for Advancing Health Outcomes · CAHamilton General Hospital · CAOttawa Hospital · CAPopulation Health Research Institute · CA

Funding

Canadian Institutes for Health Research Sponsorship Grant CIHR (sponsor award number 156306)CIHR Drug Safety and Effectiveness Network (DSEN) grant grant number: 126639
6 · The paper itself

Abstract

backgroundGiven the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no 'gold standard' measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature.

methodsWe searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment.

resultsWe identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials.

conclusionsThere is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important.

trial registrationPROSPERO, CRD42013006507.

Indexed as

Clinical Trials as TopicOpiate Substitution TreatmentOpioid-Related DisordersResearch DesignConsensusHumansQualitative ResearchTreatment OutcomeClinical trialsEfficacyMethodologyOpioid addictionPatient important outcomesTreatment effectiveness

Identifiers

PMID31907000
PMCPMC6945391
OpenAlexW3012030949

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.