The SIMI Gender '5 Ws' Rule for the integration of sex and gender-related variables in clinical studies towards internal medicine equitable research.
Clinical studies
Data collection
Gender
Internal medicine
Sex
Journal
Internal and emergency medicine
ISSN: 1970-9366
Titre abrégé: Intern Emerg Med
Pays: Italy
ID NLM: 101263418
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
received:
07
03
2022
accepted:
01
07
2022
pubmed:
7
8
2022
medline:
4
10
2022
entrez:
6
8
2022
Statut:
ppublish
Résumé
Biological sex and sociocultural gender matter when it comes to health and diseases. They have been both proposed as the undeniable gateways towards a personalized approach in care delivery. The Gender Working Group of the Italian Society of Internal Medicine (SIMI) was funded in 2019 with the aim of promoting good practice in the integration of sex and gender domains in clinical studies. Starting from a narrative literature review and based on regular meetings which led to a shared virtual discussion during the national SIMI congress in 2021, the members of the WG provided a core operational framework to be applied by internal medicine (IM) specialists to understand and implement their daily activity as researchers and clinicians. The SIMI Gender '5 Ws' Rule for clinical studies has been conceptualized as follows: Who (Clinical Internal Medicine Scientists and Practitioners), What (Gender-related Variables-Gender Core Dataset), Where (Clinical Studies/Translational Research), When (Every Time It Makes Sense) and Why (Explanatory Power of Gender and Opportunities). In particular, the gender core dataset was identified by the following domains (variables to collect accordingly): relations (marital status, social support, discrimination); roles (occupation, caregiver status, household responsibility, primary earner, household dimension); institutionalized gender (education level, personal income, living in rural vs urban areas); and gender identity (validated questionnaires on personality traits). The SIMI Gender '5 Ws' Rule is a simple and easy conceptual framework that will guide IM for the design and analysis of clinical studies.
Identifiants
pubmed: 35932381
doi: 10.1007/s11739-022-03049-y
pii: 10.1007/s11739-022-03049-y
pmc: PMC9522660
doi:
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1969-1976Informations de copyright
© 2022. The Author(s).
Références
Mauvais-Jarvis F, Bairey Merz N, Barnes PJ, Brinton RD, Carrero JJ, DeMeo DL, De Vries GJ, Epperson CN, Govindan R, Klein SL, Lonardo A, Maki PM, McCullough LD, Regitz-Zagrosek V, Regensteiner JG, Rubin JB, Sandberg K, Suzuki A (2020) Sex and gender: modifiers of health, disease, and medicine. Lancet 396(10250):565–582. https://doi.org/10.1016/S0140-6736(20)31561-0
doi: 10.1016/S0140-6736(20)31561-0
pubmed: 32828189
pmcid: 7440877
Johnson JL, Greaves L, Repta R (2009) Better science with sex and gender: facilitating the use of a sex and gender-based analysis in health research. Int J Equity Health 8:14
doi: 10.1186/1475-9276-8-14
Canadian Institute of Gender and Health Website–Shaping Science for a Healthier World https://cihr-irsc.gc.ca/e/48633.html Accessed date: 2nd Oct 2022
Bauer GR, Churchill SM, Mahendran M, Walwyn C, Lizotte D, Villa-Rueda AA (2021) Intersectionality in quantitative research: a systematic review of its emergence and applications of theory and methods. SSM Popul Health 16(14):100798. https://doi.org/10.1016/j.ssmph.2021.100798
doi: 10.1016/j.ssmph.2021.100798
Bauer GR (2014) Incorporating intersectionality theory into population health research methodology: challenges and the potential to advance health equity. Soc Sci Med 110:10–17
doi: 10.1016/j.socscimed.2014.03.022
Pietrangelo A (2022) Internists or specialists-that is the question! Eur J Intern Med 98:41–42. https://doi.org/10.1016/j.ejim.2022.02.011
doi: 10.1016/j.ejim.2022.02.011
pubmed: 35172943
Mauvais-Jarvis F, Berthold HK, Campesi I, Carrero JJ, Dakal S, Franconi F, Gouni-Berthold I, Heiman ML, Kautzky-Willer A, Klein SL, Murphy A, Regitz- Zagrosek V, Reue K, Rubin JB (2021) Sex-and gender-based pharmacological response to drugs. Pharmacol Rev 73(2):730–762. https://doi.org/10.1124/pharmrev.120.000206
doi: 10.1124/pharmrev.120.000206
pubmed: 33653873
pmcid: 7938661
Biskup E, Marra AM, Ambrosino I, Barbagelata E, Basili S, de Graaf J, Gonzalvez-Gasch A, Kaaja R, Karlafti E, Lotan D, Kautzky-Willer A, Perticone M, Politi C, Schenck-Gustafsson K, Vilas-Boas A, Roeters van Lennep J, Gans EA, Regitz-Zagrosek V, Pilote L, Proietti M, Raparelli V, Internal Medicine Assessment of Gender differences IN Europe (IMAGINE) Working group within the European Federation of Internal Medicine (EFIM) (2022) Awareness of sex and gender dimensions among physicians: the European federation of internal medicine assessment of gender differences in Europe (EFIM-IMAGINE) survey. Intern Emerg Med. https://doi.org/10.1007/s11739-022-02951-9
doi: 10.1007/s11739-022-02951-9
pubmed: 35604515
pmcid: 9352607
Pelletier R, Ditto B, Pilote L (2015) A composite measure of gender and its association with risk factors in patients with premature acute coronary syndrome. Psychosom Med 77(5):517–526. https://doi.org/10.1097/PSY.0000000000000186
doi: 10.1097/PSY.0000000000000186
pubmed: 25984818
Pelletier R, Khan NA, Cox J, Daskalopoulou SS, Eisenberg MJ, Bacon SL, Lavoie KL, Daskupta K, Rabi D, Humphries KH, Norris CM, Thanassoulis G, Behlouli H, Pilote L, GENESIS-PRAXY Investigators (2016) Sex versus gender-related characteristics: which predicts outcome after acute coronary syndrome in the young? J Am Coll Cardiol 67(2):127–135. https://doi.org/10.1016/j.jacc.2015.10.067
doi: 10.1016/j.jacc.2015.10.067
pubmed: 26791057
Nauman AT, Behlouli H, Alexander N, Kendel F, Drewelies J, Mantantzis K, Berger N, Wagner GG, Gerstorf D, Demuth I, Pilote L, Regitz-Zagrosek V (2021) Gender score development in the Berlin Aging Study II: a retrospective approach. Biol Sex Differ 12(1):15. https://doi.org/10.1186/s13293-020-00351-2
doi: 10.1186/s13293-020-00351-2
pubmed: 33461607
pmcid: 7814714
Pohrt A, Kendel F, Demuth I, Drewelies J, Nauman T, Behlouli H, Stadler G, Pilote L, Regitz-Zagrosek V, Gerstorf D (2022) Differentiating sex and gender among older men and women. Psychosom Med 84(3):339–346
doi: 10.1097/PSY.0000000000001056
Raparelli V, Norris CM, Bender U, Herrero MT, Kautzky-Willer A, Kublickiene K, El Emam K, Pilote L, GOING‑FWD Collaborators (2021) Identification and inclusion of gender factors in retrospective cohort studies: the GOING-FWD framework. BMJ Glob Health 6(4):e005413. https://doi.org/10.1136/bmjgh-2021-005413
doi: 10.1136/bmjgh-2021-005413
pubmed: 33836996
pmcid: 8043043
Tadiri CP, Raparelli V, Abrahamowicz M, Kautzy-Willer A, Kublickiene K, Herrero MT, Norris CM, Pilote L, GOINGFWD Consortium (2021) Methods for prospectively incorporating gender into health sciences research. J Clin Epidemiol 129:191–197. https://doi.org/10.1016/j.jclinepi.2020.08.018
doi: 10.1016/j.jclinepi.2020.08.018
pubmed: 32980428
Raparelli V, Pilote L, Dang B, Behlouli H, Dziura JD, Bueno H, D’Onofrio G, Krumholz HM, Dreyer RP (2021) Variations in quality of care by sex and social determinants of health among younger adults with acute myocardial infarction in the US and Canada. JAMA Netw Open 4(10):e2128182. https://doi.org/10.1001/jamanetworkopen.2021.28182
doi: 10.1001/jamanetworkopen.2021.28182
pubmed: 34668947
pmcid: 8529414
Tadiri CP, Gisinger T, Kautzky-Willer A, Kublickiene K, Herrero MT, Norris CM, Raparelli V, Pilote L, GOING-FWD Consortium (2021) Determinants of perceived health and unmet healthcare needs in universal healthcare systems with high gender equality. BMC Public Health 21(1):1488. https://doi.org/10.1186/s12889-021-11531-z
doi: 10.1186/s12889-021-11531-z
pubmed: 34332567
pmcid: 8325202
Azizi Z, Gisinger T, Bender U, Deischinger C, Raparelli V, Norris CM, Kublickiene K, Herrero MT, Emam KE, Kautzky-Willer A, Pilote L, GOING-FWD investigators (2021) sex, gender, and cardiovascular health in Canadian and Austrian populations. Can J Cardiol 37(8):1240–1247. https://doi.org/10.1016/j.cjca.2021.03.019
doi: 10.1016/j.cjca.2021.03.019
pubmed: 33785367
Azizi Z, Shiba Y, Alipour P, Maleki F, Raparelli V, Norris C, Forghani R, Pilote L, El Emam K, GOING-FWD investigators; GOING FWD Investigators (2022) Importance of sex and gender factors for COVID-19 infection and hospitalisation: a sex-stratified analysis using machine learning in UK Biobank data. BMJ Open 12(5):e050450. https://doi.org/10.1136/bmjopen-2021-050450
doi: 10.1136/bmjopen-2021-050450
pubmed: 35584867
Dev R, Raparelli V, Pilote L, Azizi Z, Kublickiene K, Kautzky-Willer A, Herrero MT, Norris CM, GOING-FWD Consortium* (2022) Cardiovascular health through a sex and gender lens in six South Asian countries: findings from the WHO STEPS surveillance. J Glob Health 12:04020. https://doi.org/10.7189/jogh.12.04020
doi: 10.7189/jogh.12.04020
pubmed: 35265330
pmcid: 8876159
Nielsen MW, Stefanick ML, Peragine D, Neilands TB, Ioannidis JPA, Pilote L, Prochaska JJ, Cullen MR, Einstein G, Klinge I, LeBlanc H, Paik HY, Schiebinger L (2021) Gender-related variables for health research. Biol Sex Differ 12(1):23. https://doi.org/10.1186/s13293-021-00366-3
doi: 10.1186/s13293-021-00366-3
pubmed: 33618769
pmcid: 7898259
Tannenbaum C, Ellis RP, Eyssel F, Zou J, Schiebinger L (2019) Sex and gender analysis improves science and engineering. Nature 575(7781):137–146. https://doi.org/10.1038/s41586-019-1657-6
doi: 10.1038/s41586-019-1657-6
pubmed: 31695204
Mele BS, Holroyd-Leduc JM, Harasym P, Dumanski SM, Fiest K, Graham ID, Nerenberg K, Norris C, Parsons Leigh J, Pilote L, Pruden H, Raparelli V, Rabi D, Ruzycki SM, Somayaji R, Stelfox HT, Ahmed SB (2021) Healthcare workers’ perception of gender and work roles during the COVID-19 pandemic: a mixed-methods study. BMJ Open 11(12):e056434. https://doi.org/10.1136/bmjopen-2021-056434
doi: 10.1136/bmjopen-2021-056434
pubmed: 35139035
White J, Tannenbaum C, Klinge I, Schiebinger L, Clayton J (2021) The integration of sex and gender considerations into biomedical research: lessons from international funding agencies. J Clin Endocrinol Metab 106(10):3034–3038. https://doi.org/10.1210/clinem/dgab434
doi: 10.1210/clinem/dgab434
pubmed: 34137862
pmcid: 8475217
Shapiro JR, Klein SL, Morgan R (2021) Stop ‘controlling’ for sex and gender in global health research. BMJ Glob Health 6(4):e005714. https://doi.org/10.1136/bmjgh-2021-005714
doi: 10.1136/bmjgh-2021-005714
pubmed: 33846145
pmcid: 8048018
International Committee of Medical Journal Editors (2022) Preparing a Manuscript for Submission to a Medical Journal. Available at http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html . Accessed date: 22nd Feb 2022