Evidence map›Paper›PMID 31109006›Full record

ReviewCells2019

Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies.

Flavia Franconi, Ilaria Campesi, Delia Colombo, Paola Antonini

Open access · goldAbstract readReview
In one paragraph

Review in Cells, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
11.5field-weighted citation impact, top 1% of its field
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

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Teaching gender medicine can enhance the quality of healthcare.American heart journal plus : cardiology research and practice · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Female Recruitment Into Cardiovascular Disease Trials.The American journal of cardiology · 2023
    Article
  18. Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  19. Article
  20. 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

4 authors at 3 institutions in 1 country.

Flavia FranconiLaboratory of Sex-gender Medicine, National Institute of Biostructures and Biosystems, 07100 Sassari, Italy. franconi.flavia@gmail.com.
Ilaria CampesiLaboratory of Sex-gender Medicine, National Institute of Biostructures and Biosystems, 07100 Sassari, Italy. icampesi@uniss.it.
Delia ColomboValue and Access Head, Novartis Italia, 21040 Origgio, Italy. delia.colombo@novartis.com.
Paola AntoniniNouscom SRL, 00128 Roma, Italy. thinkingabout807@gmail.com.
Nouscom (Italy) · ITNovartis (Italy) · ITUniversity of Sassari · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a clear sex-gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex-gender into clinical trials.

Indexed as

Gender IdentityPractice Guidelines as TopicRandomized Controlled Trials as TopicSex CharacteristicsAdultAge FactorsFemaleHumansMalePharmacological PhenomenaPrecision MedicinePregnancySex FactorsSexismSocial ClassTerminology as Topicbiomarkersbiorhythmsclinical trialspsycho-social and environmental factorssex–gender

Identifiers

PMID31109006
PMCPMC6562815
OpenAlexW2946701623

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.