Evidence map›Paper›PMID 38678289›Full record

SynthesisTrials2024

Assessing fragility of statistically significant findings from randomized controlled trials assessing pharmacological therapies for opioid use disorders: a systematic review.

Leen Naji, Brittany Dennis, Myanca Rodrigues, Monica Bawor, Alannah Hillmer, Caroul Chawar, Eve Deck, Andrew Worster, James Paul, Lehana Thabane and 1 more

Open access · goldAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

11 authors at 7 institutions in 3 countries.

Leen NajiDepartment of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 3rdFloor, Hamilton, ON, L8P 1H6, Canada. leen.naji@medportal.ca.ORCID http://orcid.org/0000-0003-0994-1109
Brittany DennisDepartment of Medicine, McMaster University, Hamilton, ON, Canada.
Myanca RodriguesDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Monica BaworDepartment of Medicine, Imperial College Healthcare NHS Trust, London, UK.
Alannah HillmerDepartment of Psychiatry and Behavaioral Neurosciences, McMaster University, Hamilton, ON, Canada.
Caroul ChawarPhysician Assistant Program, University of Toronto, Toronto, ON, Canada.
Eve DeckDepartment of Family Medicine, Western University, London, ON, Canada.
Andrew WorsterDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
James PaulDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Zainab SamaanDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Impact · CAMcMaster University · CAImperial College Healthcare NHS Trust · GBMontefiore Medical Center · USUniversity of British Columbia · CAUniversity of Toronto · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe fragility index is a statistical measure of the robustness or "stability" of a statistically significant result. It has been adapted to assess the robustness of statistically significant outcomes from randomized controlled trials. By hypothetically switching some non-responders to responders, for instance, this metric measures how many individuals would need to have responded for a statistically significant finding to become non-statistically significant. The purpose of this study is to assess the fragility index of randomized controlled trials evaluating opioid substitution and antagonist therapies for opioid use disorder. This will provide an indication as to the robustness of trials in the field and the confidence that should be placed in the trials' outcomes, potentially identifying ways to improve clinical research in the field. This is especially important as opioid use disorder has become a global epidemic, and the incidence of opioid related fatalities have climbed 500% in the past two decades.

methodsSix databases were searched from inception to September 25, 2021, for randomized controlled trials evaluating opioid substitution and antagonist therapies for opioid use disorder, and meeting the necessary requirements for fragility index calculation. Specifically, we included all parallel arm or two-by-two factorial design RCTs that assessed the effectiveness of any opioid substitution and antagonist therapies using a binary primary outcome and reported a statistically significant result. The fragility index of each study was calculated using methods described by Walsh and colleagues. The risk of bias of included studies was assessed using the Revised Cochrane Risk of Bias tool for randomized trials.

resultsTen studies with a median sample size of 82.5 (interquartile range (IQR) 58, 179, range 52-226) were eligible for inclusion. Overall risk of bias was deemed to be low in seven studies, have some concerns in two studies, and be high in one study. The median fragility index was 7.5 (IQR 4, 12, range 1-26).

conclusionsOur results suggest that approximately eight participants are needed to overturn the conclusions of the majority of trials in opioid use disorder. Future work should focus on maximizing transparency in reporting of study results, by reporting confidence intervals, fragility indexes, and emphasizing the clinical relevance of findings.

trial registrationPROSPERO CRD42013006507. Registered on November 25, 2013.

Indexed as

Narcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersRandomized Controlled Trials as TopicAnalgesics, OpioidData Interpretation, StatisticalHumansResearch DesignTreatment OutcomeAnalgesics, OpioidNarcotic AntagonistsCritical appraisalFragility indexOpioid use disorderRandomized controlled trialsResearch methodsSystematic review

Identifiers

PMID38678289
PMCPMC11055220
OpenAlexW4395692418

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.