Evidence map›Paper›PMID 26489415›Full record

SynthesisTrials2015

Opioid substitution and antagonist therapy trials exclude the common addiction patient: a systematic review and analysis of eligibility criteria.

Brittany B Dennis, Pavel S Roshanov, Leen Naji, Monica Bawor, James Paul, Carolyn Plater, Guillaume Pare, Andrew Worster, Michael Varenbut, Jeff Daiter and 4 more

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  14. Ranking evidence in substance use and addiction.The International journal on drug policy · 2020
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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

14 authors.

Brittany B DennisDepartment of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. dennisbb@mcmaster.ca.
Pavel S RoshanovSchulich School of Medicine and Dentistry, University of Western Ontario, 4, 1465 Richmond Street, London, ON, N6G 2M1, Canada. proshano@uwo.ca.
Leen NajiMichael G. Degroote School of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. leennaji2@gmail.com.
Monica BaworMcMaster Integrative Neuroscience Discovery and Study Program, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. baworm@mcmaster.ca.
James PaulDepartment of Anesthesia, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. james_paul@sympatico.ca.
Carolyn PlaterCanadian Addiction Treatment Centres, 13291 Yonge Street, Richmond Hill, ON, L4E 4L6, Canada. cplater@toxpro.ca.
Guillaume PareDepartment of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. pareg@mcmaster.ca.
Andrew WorsterCanadian Addiction Treatment Centres, 13291 Yonge Street, Richmond Hill, ON, L4E 4L6, Canada. worster@mcmaster.ca.
Michael VarenbutCanadian Addiction Treatment Centres, 13291 Yonge Street, Richmond Hill, ON, L4E 4L6, Canada. MVarenbut@canatc.ca.
Jeff DaiterCanadian Addiction Treatment Centres, 13291 Yonge Street, Richmond Hill, ON, L4E 4L6, Canada. jdaiter@toxpro.ca.
David C MarshCanadian Addiction Treatment Centres, 13291 Yonge Street, Richmond Hill, ON, L4E 4L6, Canada. dmarsh@nosm.ca.
Dipika DesaiPopulation Genomics Program, Chanchlani Research Centre, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. dipika.desai@phri.ca.
Zainab SamaanDepartment of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. samaanz@mcmaster.ca.
Lehana ThabaneDepartment of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada. thabanl@mcmaster.ca.

Funding

Canadian Institutes of Health Research 126639
6 · The paper itself

Abstract

backgroundEligibility criteria that result in the exclusion of a substantial number of patients from randomized trials jeopardize the generalizability of treatment effect to much of the clinical population. This is important when evaluating opioid substitution and antagonist therapies (OSATs), especially given the challenges associated with treating the opioid-dependent population. We aimed to identify OSAT trials' eligibility criteria, quantify the percentage of the clinical population excluded by these criteria, and determine how OSAT guidelines incorporate evidence from these trials.

methodsWe performed a systematic review to identify the eligibility criteria used across trials. We searched Medline, EMBASE, PsycINFO, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry (CTR), World Health Organization International CTR Platform Search Portal, and the National Institutes of Health CTR databases from inception to January 1, 2014. To quantify the effect of trials' eligibility criteria on generalizability, we applied these criteria to data from an observational study of opioid-dependent patients (n = 394). We then accessed the Canadian, American, British, and World Health Organization (WHO) OSAT guidelines to evaluate how evidence is used in the recommendations.

resultsAmong the 60 trials identified the majority (≥50 % of trials) exclude patients with psychiatric (60 %) and physical comorbidity (51.7 %). Additionally, we found 19 trials exclude patients with current alcohol/substance-use problems (31.7 %), and 29 (48.3 %) exclude patients taking psychotropic medications. These criteria were restrictive and in some cases rendered 70 % of the observational sample ineligible. North American OSAT guidelines made strong recommendations supported by evidence with poor generalizability. National Institute of Health and Care Excellence (NICE) and WHO guidelines for opioid misuse provide a critical assessment of the literature used to inform their recommendations.

conclusionsTrials assessing OSATs often exclude patients with concurrent disorders. If the excluded patients respond differently to treatment, results from these trials are likely to overestimate the true effectiveness of OSATs. North American guidelines should consider these limitations when drafting clinical recommendations.

Indexed as

Drug UsersEligibility DeterminationOpiate Substitution TreatmentPatient SelectionComorbidityEvidence-Based MedicineHumansNarcotic AntagonistsOpioid-Related DisordersPractice Guidelines as TopicRandomized Controlled Trials as TopicTreatment OutcomeNarcotic Antagonists

Identifiers

PMID26489415
PMCPMC4618532

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.