Lack of precision in the reporting of sex and gender in cancer clinical trials with a PRO endpoint: an exploratory literature review.
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| Title: | Lack of precision in the reporting of sex and gender in cancer clinical trials with a PRO endpoint: an exploratory literature review. |
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| Authors: | Krepper D; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Thurner AMM; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Komlenac N; Institute for Diversity in Medicine, Medical University of Innsbruck, Innsbruck, Austria., Sztankay MJ; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria., Wintner LM; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria. lisa.wintner@i-med.ac.at. |
| Source: | BMC medical research methodology [BMC Med Res Methodol] 2025 Nov 11; Vol. 25 (1), pp. 253. Date of Electronic Publication: 2025 Nov 11. |
| Publication Type: | Journal Article; Review |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288 (Electronic) Linking ISSN: 14712288 NLM ISO Abbreviation: BMC Med Res Methodol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, [2001- |
| MeSH Terms: | Neoplasms*/therapy , Patient Reported Outcome Measures* , Randomized Controlled Trials as Topic*/standards , Randomized Controlled Trials as Topic*/statistics & numerical data , Research Design*/standards, Humans ; Female ; Male ; Sex Factors |
| Abstract: | Background: Sex and gender are acknowledged as pivotal variables in clinical research. However, the differences between the concepts are frequently neglected in medical research, resulting in limited generalizability of research findings and potential bias. This review portrays current reporting of sex and/or gender in cancer clinical trials with a patient-reported outcome (PRO) endpoint. Methods: PubMed was searched to identify randomized controlled trials in patients with bladder, colorectal, and lung cancer, published between 2019 and February 2022. A double-review procedure was applied using the software DistillerSR. The data extraction form included information on the terms used to describe sex and/or gender. The Sex and Gender Equity in Research (SAGER) guidelines checklist was used to assess reporting quality. Results: The Pubmed search resulted in 2,450 identified records, of which 184 met the eligibility criteria. The term sex was used in 54.9%, gender in 21.2%, and both terms in 17.4% of the references, while 6.5% reported none. 39.1% of trials used the terms sex and/or gender correctly (i.e., referring to biological or social categories) and consistently. 60.9% of trials combined the terms in varying ways, which was not due to reporting of both concepts but rather to the interchangeable use of sex and gender. Most trials (96.6%) did not report sex/gender breakdowns, 34.2% disaggregated data, and only 3.3% disaggregated PROs. Regarding compliance with the SAGER guidelines, the median number of items meeting the requirements was 2 out of 17. With better compliance in journals with impact factor > 10 compared to ≤ 10. Female representation was below disease incidence in colorectal and bladder cancer, and above incidence in lung cancer. Conclusions: Our review shows that most trials lack precision in reporting sex and/or gender, highlighting the educational need for distinguishing these concepts in the field of clinical trials with PRO endpoints. The synonymous use of the terms sex and gender does not do justice to their different conceptualizations and can hinder further research that is inclusive of sex and/or gender. Raising awareness and compliance with the SAGER guidelines in cancer clinical trials is needed to enhance the credibility of findings drawn regarding sex and/or gender differences. (© 2025. The Author(s).) |
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| Grant Information: | 006-2021 EORTC |
| Contributed Indexing: | Keywords: Cancer; Clinical trial; Gender; Health equity; Oncology; Patient-reported outcomes; SAGER guidelines; Sex |
| Entry Date(s): | Date Created: 20251111 Date Completed: 20251113 Latest Revision: 20251205 |
| Update Code: | 20251206 |
| PubMed Central ID: | PMC12606981 |
| DOI: | 10.1186/s12874-025-02710-2 |
| PMID: | 41220038 |
| Database: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Background: Sex and gender are acknowledged as pivotal variables in clinical research. However, the differences between the concepts are frequently neglected in medical research, resulting in limited generalizability of research findings and potential bias. This review portrays current reporting of sex and/or gender in cancer clinical trials with a patient-reported outcome (PRO) endpoint.<br />Methods: PubMed was searched to identify randomized controlled trials in patients with bladder, colorectal, and lung cancer, published between 2019 and February 2022. A double-review procedure was applied using the software DistillerSR. The data extraction form included information on the terms used to describe sex and/or gender. The Sex and Gender Equity in Research (SAGER) guidelines checklist was used to assess reporting quality.<br />Results: The Pubmed search resulted in 2,450 identified records, of which 184 met the eligibility criteria. The term sex was used in 54.9%, gender in 21.2%, and both terms in 17.4% of the references, while 6.5% reported none. 39.1% of trials used the terms sex and/or gender correctly (i.e., referring to biological or social categories) and consistently. 60.9% of trials combined the terms in varying ways, which was not due to reporting of both concepts but rather to the interchangeable use of sex and gender. Most trials (96.6%) did not report sex/gender breakdowns, 34.2% disaggregated data, and only 3.3% disaggregated PROs. Regarding compliance with the SAGER guidelines, the median number of items meeting the requirements was 2 out of 17. With better compliance in journals with impact factor > 10 compared to ≤ 10. Female representation was below disease incidence in colorectal and bladder cancer, and above incidence in lung cancer.<br />Conclusions: Our review shows that most trials lack precision in reporting sex and/or gender, highlighting the educational need for distinguishing these concepts in the field of clinical trials with PRO endpoints. The synonymous use of the terms sex and gender does not do justice to their different conceptualizations and can hinder further research that is inclusive of sex and/or gender. Raising awareness and compliance with the SAGER guidelines in cancer clinical trials is needed to enhance the credibility of findings drawn regarding sex and/or gender differences.<br /> (© 2025. The Author(s).) |
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| ISSN: | 1471-2288 |
| DOI: | 10.1186/s12874-025-02710-2 |