Evidence map›Paper›PMID 41530879›Full record

ArticleTrials2026

Detecting racial and ethnic disparities in study exclusion: screening outcomes from a RCT for pregnant women with insomnia.

Carolyn Ponting, Candance Sorensen, Bernadette McClelland, Richelle Mah, John Neuhaus, Rachel Manber, Andrew D Krystal, Patricia Moran, Jennifer N Felder

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Carolyn PontingDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, USA. Cponting@uoregon.edu.ORCID http://orcid.org/0000-0002-5074-736X
Candance SorensenOsher Center for Integrative Health, University of California, San Francisco, San Francisco, USA.
Bernadette McClellandOsher Center for Integrative Health, University of California, San Francisco, San Francisco, USA.
Richelle MahOsher Center for Integrative Health, University of California, San Francisco, San Francisco, USA.
John NeuhausDepartment of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, USA.
Rachel ManberDepartment of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, USA.
Andrew D KrystalDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, USA.
Patricia MoranOsher Center for Integrative Health, University of California, San Francisco, San Francisco, USA.
Jennifer N FelderDepartment of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, USA.

Funding

Efficacy of digital cognitive behavior therapy for insomnia for the prevention of perinatal depression - supplementR01MH126040 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Jennifer Nicole Felder · 2022 to 2026
$3.9M
NIMH NIH HHS 3R01MH126040NIMH NIH HHS 3R01MH126040-02S2NIMH NIH HHS R01 MH126040
6 · The paper itself

Abstract

backgroundEligibility criteria are a critical component of a well-designed clinical trial, enhancing trial safety and internal validity. Yet, data suggest that exclusion rates based on these criteria often vary by participant race/ethnicity.

methodThis study compared the proportion of participants (n = 4235) from seven racial/ethnic groups, who were included versus excluded from participation in a randomized controlled trial (RCT) testing two digital sleep interventions for the prevention of perinatal depression. Eight 2 × 7 chi-squared tests were conducted to compare the proportion of each racial/ethnic group excluded due to each eligibility criterion. Logistic regressions were fitted to estimate the magnitude of the relationship between racial/ethnic group and exclusion based on each eligibility criterion.

resultsThe proportion of excluded participants differed by race/ethnicity across all eight eligibility criteria. For example, Black participants were more likely to be excluded due to comorbid conditions such as sleep apnea X

conclusionsEligibility criteria excluded prospective study participants at different rates dependent on their race/ethnicity. Differences in trial exclusion can contribute to the under-enrollment of minoritized pregnant people in RCTs for behavioral health. Quantifying and reporting eligibility disparities enables investigators to more precisely evaluate the trade-offs of specific inclusion criteria against the generalizability of findings to diverse populations.

Indexed as

Eligibility DeterminationEthnicityPatient SelectionPregnancy ComplicationsRacial GroupsResearch SubjectsSleep Initiation and Maintenance DisordersAdultChi-Square DistributionFemaleHumansLogistic ModelsOdds RatioPregnancyRace FactorsRandomized Controlled Trials as TopicClinical trialEligibility criteriaEthnicityExclusionRaceRecruitment

Identifiers

PMID41530879
PMCPMC12888375

What OpenQuestion holds

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Registered trials

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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.