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  • Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

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Commentary
Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines
  1. Alice Palmer-Ross1,
  2. Pavel V Ovseiko2,
  3. Shirin Heidari1,3
  1. 1GENDRO, Geneva, Switzerland
  2. 2Radcliffe Department of Medicine, University of Oxford, Oxford, UK
  3. 3Global Health Center, Graduate Institute of International and Development Studies, Geneva, Switzerland
  1. Correspondence to Alice Palmer-Ross; alicepr26{at}gmail.com

https://doi.org/10.1136/bmjgh-2021-004997

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    Summary box

    • Women are under-represented as research participants in most interventional and observational studies on COVID-19.

    • Main outcome data from interventional and observational studies are rarely reported disaggregated by sex.

    • Sex and gender differences are inadequately examined in the analysis of the data.

    • Lack of sex and gender analysis are seldom justified, and gender implications rarely discussed.

    • There is a renewed rationale for strengthening the reporting of sex and gender dimensions in clinical research using the Sex and Gender Equity in Research guidelines.

    Introduction

    The COVID-19 pandemic has brought to the fore the implications of sex and gender differences to human health and well-being.1 Evidence to date indicates that men are at higher risk of severe disease and death than women, while women seem more likely to suffer from long-term COVID-19, and experience negative social and economic impacts.2 3 Biological sex as well as gender roles and behaviours can affect exposure to the virus and influence the prevalence of pre-existing conditions or harmful habits.4 Incorporating sex and gender considerations into clinical research on COVID-19 from the outset would help to identify differential patterns of risk, underlying reasons for disparate outcomes and to develop interventions to effectively respond to the various needs of women and men.5 Given the growing recognition of the relevance of sex and gender in the COVID-19 pandemic, the rationale for this analysis was to examine whether these dimensions are taken into account in clinical research on COVID-19.

    We carried out a systematic review of COVID-19 research to examine how sex and gender are integrated and reported using the Sex and Gender Equity in Research (SAGER) guidelines recommendations as analytical categories.6 A PubMed search for interventional and observational trials on COVID-19, published from 1 December 2019 to 12 September 2020 resulted in 2066 studies. PubMed was …

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