The SIMI Gender '5 Ws' Rule for the integration of sex and gender-related variables in clinical studies towards internal medicine equitable research

Valeria Raparelli^{1

2

3}, Francesca Santilli⁴, Alberto Maria Marra⁵, Giulio Francesco Romiti⁶, Elena Succurro⁷, Anna Licata⁸, Elena Buzzetti⁹, Salvatore Piano¹⁰, Maristella Masala¹¹, Patrizia Suppressa¹², Cecilia Becattini¹³, Maria Lorenza Muiesan¹⁴, Giuseppina Russo¹⁵, Chiara Cogliati¹⁶, Marco Proietti^{17

18

19}, Stefania Basili⁶; Italian Society of Internal Medicine (SIMI)

Affiliations

¹ Department of Translational Medicine, University of Ferrara, Via dei Borsari 46, 44121, Ferrara, Italy. valeria.raparelli@unife.it.
² University Center for Studies on Gender Medicine, University of Ferrara, Ferrara, Italy. valeria.raparelli@unife.it.
³ Faculty of Nursing, University of Alberta, Edmonton, AB, Canada. valeria.raparelli@unife.it.
⁴ Department of Medicine and Aging, and Center for Advanced Studies and Technology (CAST), University of Chieti, Chieti, Italy.
⁵ Department of Translational Medical Sciences, Italy and Center for Pulmonary Hypertension, Thoraxklinic, Member of the German Center for Lung Research (DZL), "Federico II" University of Naples, University Hospital Heidelberg, Heidelberg, Germany.
⁶ Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
⁷ Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
⁸ Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo Medical School, Palermo, Italy.
⁹ Department of Medical and Surgical Science for Children and Adults, University of Modena and Reggio Emilia, Modena, Italy.
¹⁰ Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University and Hospital of Padua, Padua, Italy.
¹¹ Department of Internal Medicine, University of Sassari, Sassari, Italy.
¹² Department of Internal Medicine and Rare Disease Centre "C. Frugoni" University Hospital of Bari, Bari, Italy.
¹³ Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy.
¹⁴ Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
¹⁵ Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
¹⁶ Internal Medicine, Department of Biomedical and Clinical Sciences, L.Sacco Hospital, ASST Fatebenefratelli Sacco, University of Milano, Milan, Italy.
¹⁷ Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
¹⁸ Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri, Milan, Italy.
¹⁹ Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.

PMID: 35932381
PMCID: PMC9522660
DOI: 10.1007/s11739-022-03049-y

Review

The SIMI Gender '5 Ws' Rule for the integration of sex and gender-related variables in clinical studies towards internal medicine equitable research

Valeria Raparelli et al. Intern Emerg Med. 2022 Oct.

. 2022 Oct;17(7):1969-1976.

doi: 10.1007/s11739-022-03049-y. Epub 2022 Aug 6.

Authors

Affiliations

¹ Department of Translational Medicine, University of Ferrara, Via dei Borsari 46, 44121, Ferrara, Italy. valeria.raparelli@unife.it.
² University Center for Studies on Gender Medicine, University of Ferrara, Ferrara, Italy. valeria.raparelli@unife.it.
³ Faculty of Nursing, University of Alberta, Edmonton, AB, Canada. valeria.raparelli@unife.it.
⁴ Department of Medicine and Aging, and Center for Advanced Studies and Technology (CAST), University of Chieti, Chieti, Italy.
⁵ Department of Translational Medical Sciences, Italy and Center for Pulmonary Hypertension, Thoraxklinic, Member of the German Center for Lung Research (DZL), "Federico II" University of Naples, University Hospital Heidelberg, Heidelberg, Germany.
⁶ Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
⁷ Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
⁸ Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo Medical School, Palermo, Italy.
⁹ Department of Medical and Surgical Science for Children and Adults, University of Modena and Reggio Emilia, Modena, Italy.
¹⁰ Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University and Hospital of Padua, Padua, Italy.
¹¹ Department of Internal Medicine, University of Sassari, Sassari, Italy.
¹² Department of Internal Medicine and Rare Disease Centre "C. Frugoni" University Hospital of Bari, Bari, Italy.
¹³ Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy.
¹⁴ Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
¹⁵ Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
¹⁶ Internal Medicine, Department of Biomedical and Clinical Sciences, L.Sacco Hospital, ASST Fatebenefratelli Sacco, University of Milano, Milan, Italy.
¹⁷ Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
¹⁸ Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri, Milan, Italy.
¹⁹ Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.

PMID: 35932381
PMCID: PMC9522660
DOI: 10.1007/s11739-022-03049-y

Abstract

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.

Keywords: Clinical studies; Data collection; Gender; Internal medicine; Sex.

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Conflict of interest statement

All authors have no disclosures to declare.

Figures

**Fig. 1**
The SIMI Gender ‘5 Ws’ Rule for clinical studies

See this image and copyright information in PMC

References

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The SIMI Gender '5 Ws' Rule for the integration of sex and gender-related variables in clinical studies towards internal medicine equitable research

Affiliations

The SIMI Gender '5 Ws' Rule for the integration of sex and gender-related variables in clinical studies towards internal medicine equitable research

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources