Evidence map›Paper›PMID 38939721›Full record

ArticleJACC. Advances2022

A Systematic Review of Sex-Specific Reporting in Heart Failure Clinical Trials: Trial Flow and Results.

Magdalene Au, Sera Whitelaw, Muhammad Shahzeb Khan, Mamas A Mamas, Lawrence Mbuagbaw, Sharon L Mulvagh, Adriaan A Voors, Harriette G C Van Spall

Abstract read
In one paragraph

Article in JACC. Advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Women's cardiovascular health in 2025:Saudi medical journal · 2026
    Review
  7. Review
  8. Article
  9. Underrepresentation of women in cardiovascular disease clinical Trials-What's in a Name?International journal of cardiology. Heart & vasculature · 2024
    Article
  10. Review
  11. JACC. Advances · 2023
    Article
  12. Review
  13. 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

8 authors.

Magdalene AuDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Sera WhitelawFaculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
Muhammad Shahzeb KhanDivision of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
Mamas A MamasKeele Cardiovascular Research Group, Centre for Prognosis Research, Keele University, Stoke on Trent, United Kingdom.
Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Sharon L MulvaghDepartment of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Adriaan A VoorsDepartment of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Harriette G C Van SpallDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Females are historically underenrolled in heart failure (HF) randomized controlled trials (RCTs) relative to disease prevalence. Sex differences in trial flow, including withdrawals and losses to follow up, may further limit the generalizability of results. Objectives: This study aimed to assess the frequency of sex-specific reporting of trial flow, treatment efficacy, and adverse events in HF RCTs. Methods: We systematically searched MEDLINE, Embase, and CINAHL for HF RCTs published between 2000 and 2020 in journals with an impact factor ≥10. We assessed whether trial flow, treatment effect, and adverse events were disaggregated by sex. We used multivariable regression to assess associations between trial characteristics and sex subgroup analysis. We analyzed temporal trends in sex-specific reporting. Results: We included 224 RCTs with 228,801 total participants (28.2% female). No RCT reported sex-disaggregated screening, consent, or withdrawal rates; and 2 (0.9%) reported sex-disaggregated losses to follow-up. Seventy-five RCTs (33.4%) presented sex subgroup analysis, and 63 (28.3%) reported sex-treatment interaction. No RCT reported sex-specific adverse events. Large trial size (odds ratio: 13.16, 95% CI: 5.67-30.52; Conclusions: HF RCTs rarely reported sex differences in trial flow or adverse events and uncommonly performed sex subgroup analysis. Improved sex-disaggregated reporting could highlight the causes and extent of sex differences in trial participation and facilitate appropriate inferences about treatment effect.

Indexed as

heart failurerandomized controlled trialssex- and gender-based analysistrial flow

Identifiers

PMID38939721
PMCPMC11198397

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.