Evidence map›Paper›PMID 41296008›Full record

SynthesisClinical research in cardiology : official journal of the German Cardiac Society2025

​Consideration of sex/gender aspects in cardiovascular clinical trials.

Maximilian Bley, Linda Mathez, Susanne Menz, Isabella Stephan, Vera Regitz-Zagrosek, Marc J Lerchenmueller, Carolin Lerchenmüller

Abstract readSystematic Review
In one paragraph

Synthesis in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. 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. Review
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

7 authors.

Maximilian BleyChair for Gender Medicine, University of Zurich, Zurich, 8006, Switzerland.
Linda MathezChair for Gender Medicine, University of Zurich, Zurich, 8006, Switzerland.
Susanne MenzChair for Gender Medicine, University of Zurich, Zurich, 8006, Switzerland.
Isabella StephanChair for Gender Medicine, University of Zurich, Zurich, 8006, Switzerland.
Vera Regitz-ZagrosekInstitute of Gender in Medicine, Charité Universitaetsmedizin Berlin, Berlin, 10115, Germany.
Marc J LerchenmuellerUniversity of Mannheim, Mannheim, 68161, Germany.
Carolin LerchenmüllerChair for Gender Medicine, University of Zurich, Zurich, 8006, Switzerland. carolin.lerchenmueller@uzh.ch.ORCID http://orcid.org/0000-0002-5620-0285

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnderstanding sex/gender in the context of health and disease is critical to deliver the best care. However, sex/gender have not been consistently considered in cardiovascular clinical trials. Global initiatives, including the Sex and Gender Equity in Research (SAGER)-guidelines, aim to improve the quality of the reporting, but it remains unclear if they are used consistently.

methodsWe conducted a systematic analysis of cardiovascular clinical trials published in PubMed between 2018 and 2024. To investigate the representation of women/females, we first analyzed the participation-prevalence-ratio (PPR). Second, we measured sex/gender-sensitive reporting (SGR) applying modified SAGER-guidelines. In addition, we determined whether study author sex/gender impacts the other variables.

findingsWe identified 1593 clinical trials with a total of 716,569 woman/female participants (38.5%). The median PPR of all trials remained suboptimal at 0.77 (95%-CI: 0.74-0.79) throughout the years with a modest positive trend towards 2024 and significant underrepresentation in some disease entities (e.g., ischemic heart disease, heart failure). Analyzing an evenly distributed sample of 632 trials, we found suboptimal SGR, especially for endpoints and discussions. We found a positive correlation of increased participation of women/females and SGR with women/females as authors.

interpretationOur results suggest an ongoing imbalance for the participation of women/females and suboptimal SGR in cardiovascular clinical trials, especially for certain diseases, with a modest positive trend. More women/females in the authorship team correlate with an increased PPR and are associated with an increase in SGR.

Indexed as

Cardiovascular DiseasesClinical Trials as TopicGender EquityFemaleHumansMaleSex FactorsCardiovascular medicineClinical trialsGender equityParticipationReporting

Identifiers

PMID41296008
PMCPMC12708832

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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.