Evidence map›Paper›PMID 42711075›Full record

ArticleBMJ open2026

Cross-sectional analysis of safety reporting in sleep disorder clinical trials.

Makalie Lackey, Caden Forbes, Kellen Keefer, Rachel Hazlitt, Tag Harris, Daniel Archer, Logan Corwin, Alicia Ito Ford, Matt Vassar

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Makalie LackeyOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA makalie.lackey@okstate.edu.ORCID http://orcid.org/0009-0006-3612-375X
Caden ForbesOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.ORCID http://orcid.org/0009-0001-3375-0364
Kellen KeeferOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.ORCID http://orcid.org/0009-0004-1573-9745
Rachel HazlittOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
Tag HarrisOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.ORCID http://orcid.org/0009-0003-7979-5343
Daniel ArcherOklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
Logan CorwinOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.ORCID http://orcid.org/0000-0001-8271-7600
Alicia Ito FordOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.ORCID http://orcid.org/0000-0002-6866-2639
Matt VassarOffice of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesAdverse event reporting is critical for evaluating the safety of interventions in sleep disorders. Inconsistent reporting between trial registries and publications may alter clinical decision-making and patient safety. We assessed the concordance of adverse event reporting between ClinicalTrials.gov and peer-reviewed publications for interventional trials in sleep disorders. Primary outcomes included the consistency of reporting serious adverse events, other adverse events and patient/event counts. The location and detail of adverse event reporting within publications were also evaluated.

methods

resultsAmong 168 trials, 143 (85.1%) showed discrepancies in serious adverse event counts between registry and publication. Patient count variations occurred in 73.2% and 35.1% of publications reported no adverse event data. Post-Final Rule trials demonstrated improved registry-based reporting, though discordance remained.

conclusionsSubstantial inconsistencies in adverse event reporting between registries and publications persist in sleep disorder trials. Improved standardisation and adherence to reporting guidelines are necessary to protect patient safety. TRIAL REGISTRATION DETAILS: Registered on Open Science Framework.

Indexed as

Clinical Trials as TopicPatient SafetySleep Wake DisordersCross-Sectional StudiesHumansRegistriesAdverse eventsClinical TrialPatient Reported Outcome MeasuresRandomized Controlled TrialResearch DesignSLEEP MEDICINE

Identifiers

PMID42711075
PMCPMC13560966

What OpenQuestion holds

Textmetadata
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.