Evidence map›Paper›PMID 31404063›Full record

SynthesisPloS one2019

Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review.

Monique Anderson Starks, Gillian D Sanders, Remy Rene Coeytaux, Isaretta L Riley, Larry R Jackson, Amanda McBroom Brooks, Kevin L Thomas, Kingshuk Roy Choudhury, Robert M Califf, Adrian F Hernandez

Registry-linked trialAbstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05358522 (Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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.

NCT05358522 nacompletednot on this mapstarted 2022, after this paper: background citation

Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines: a Stepped-wedge Cluster Randomized Trial

TypeinterventionalSponsorUniversity of PennsylvaniaRan2022 to 2023Enrolled26,562ConditionsSurgery, Opioid Use, Opioid Misuse, Prescription Opioid MisuseArmsOpioid Prescribing Report Cards
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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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

10 authors.

Monique Anderson StarksDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.ORCID 0000-0003-4719-399X
Gillian D SandersDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.
Remy Rene CoeytauxDepartment of Family and Community Medicine, Wake Forest School of Medicine; Winston-Salem, NC, United States of America.
Isaretta L RileyDivision of Pulmonary, Allergy, and Critical Care, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America.
Larry R JacksonDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.
Amanda McBroom BrooksDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.
Kevin L ThomasDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.
Kingshuk Roy ChoudhuryDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America.
Robert M CaliffDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.
Adrian F HernandezDuke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America.

Funding

Health Care Systems Research Collaboratory SupplementU54AT007748 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2012 to 2017
$15.1M
Research Project 3U54MD012530 · NIMHD · DUKE UNIVERSITY · PI JOHNSON, KIMBERLY S. · 2017 to 2022
$8.8M
NCCIH NIH HHS U54 AT007748NIMHD NIH HHS U54 MD012530
6 · The paper itself

Abstract

backgroundCluster-randomized trials (CRTs) are being increasingly used to test a range of interventions, including medical interventions commonly used in clinical practice. Policies created by the NIH and the Food and Drug Administration (FDA) require the reporting of demographics and the examination of demographic heterogeneity of treatment effect (HTE) for individually randomized trials. Little is known about how frequent demographics are reported and HTE analyses are conducted in CRTs.

objectivesWe sought to understand the prevalence of HTE analyses and the statistical methods used to conduct them in CRTs focused on treating cardiovascular disease, cancer, and chronic lower respiratory diseases. Additionally, we also report on the proportion of CRTs that reported on baseline demographics of its populations and conducted demographic HTE analyses. DATA SOURCES: We searched PubMed and Embase for CRTs published between 1/1/2010 and 3/29/2016 that focused on treating the top 3 Center for Disease Control causes of death (cardiovascular disease, chronic lower respiratory disease, and cancer). Evidence Screening And Review: Of 1,682 unique titles, 117 abstracts were screened. After excluding 53 articles, we included 64 CRT publications and abstracted information on study characteristics and demographic information, statistical analysis, HTE analysis, and study quality.

resultsAge and sex were reported in greater than 95.3% of CRTs, while race and ethnicity were reported in only 20.3% of CRTs. HTE analyses were conducted in 28.1% (n = 18) of included CRTs and 77.8% (n = 12) were prespecified analyses. Four CRTs conducted a demographic subgroup analysis. Only 6/18 CRTs used interaction testing to determine whether HTE existed.

conclusionsBaseline demographic reporting was high for age and sex in CRTs, but was uncommon for race and ethnicity. HTE analyses were uncommon and was rare for demographic subgroups, which limits the ability to examine the extent of benefits or risks for treatments tested with CRT designs.

Indexed as

Information Storage and RetrievalCardiovascular DiseasesData CollectionDelivery of Health CareHumansNeoplasmsRandomized Controlled Trials as TopicResearch DesignRespiration Disorders

Identifiers

PMID31404063
PMCPMC6690528

What OpenQuestion holds

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LicenceCC BY
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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.