[Sex and gender equity in research: rationale for the SAGER guidelines and recommended use]. / Equidad según sexo y de género en la investigación: justificación de las guías SAGER y recomendaciones para su uso.

BACKGROUND: Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. METHODS: A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literatura search on sex and gender policies in scientific publishing. RESULTS: The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. CONCLUSIONS: The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process.

[Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use]. / Equidade de sexo e gênero na pesquisa: fundamentação das diretrizes SAGER e uso recomendado.

BACKGROUND: Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. METHODS: A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literature search on sex and gender policies in scientific publishing. RESULTS: The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. CONCLUSIONS: The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process.

CONTEXTO: Diferenças de sexo e gênero são muitas vezes negligenciadas no desenho da pesquisa, na implementação do estudo e no relato científico, bem como na comunicação científica em geral. Este descuido limita a capacidade de generalização dos achados das pesquisas e a sua aplicabilidade à prática clínica, em particular para as mulheres, mas também para os homens. Este artigo descreve a fundamentação lógica para um conjunto internacional de diretrizes, com o intuito de encorajar uma abordagem mais sistemática para o relato de sexo e gênero na pesquisa entre disciplinas. MÉTODOS: Um painel de 13 peritos, representando nove países, desenvolveu as diretrizes por meio de uma série de teleconferências, apresentações em conferências e uma oficina de dois dias. Realizou-se uma pesquisa na internet com 716 editores de revistas, cientistas e outros membros da comunidade editorial internacional, bem como uma busca bibliográfica sobre políticas de gênero e sexo na publicação científica. RESULTADOS: As diretrizes sobre Equidade de Sexo e Gênero em Pesquisa (Sex and Gender Equity in Research - SAGER) são um procedimento abrangente para relatar informações sobre sexo e gênero no desenho do estudo, na análise de dados, nos resultados e na interpretação dos achados. CONCLUSÕES: As diretrizes da SAGER destinam-se principalmente a orientar os autores na preparação de seus manuscritos, mas também são úteis para os editores, como guardiões da ciência, para integrar a avaliação de sexo e gênero em todos os manuscritos como parte integrante do processo editorial.

Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use.

BACKGROUND: Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. METHODS: A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literature search on sex and gender policies in scientific publishing. RESULTS: The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. CONCLUSIONS: The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process.

A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies.

INTRODUCTION: The effect of clinical interventions can differ because of sex/gender. Studies have shown that women are often under-represented in medical research. The aim of this systematic literature review was to characterize women's participation in HIV clinical studies of antiretroviral drugs (ARV), prophylactic vaccines (VAX), and curative strategies (CURE). METHODS: Systematic PubMed searches were conducted to identify ARV, VAX, and CURE studies. Data were extracted on the number of women, date of publication, sources of funding, country of study, and trial phase. Correlates of female participation were assessed. RESULTS: Women represented a median of 19.2% participants in ARV studies (387), 38.1% in VAX studies (53), and 11.1% in CURE studies (104). Funding source was not correlated with the proportion of female participants in VAX and CURE studies but was for ARV studies (P = 0.03). ARV trials funded by private noncommercial sources had the highest proportion of women, whereas publicly funded trials had the lowest female participation (median 16.7%). The median proportion of women in ARV trials that were fully or partially funded by the National Institutes of Health was significantly lower than the median in trials funded by other sources (19.6% vs. 22.3%, P = 0.001). CONCLUSIONS: Although women comprise nearly half of people living with HIV, they continue to be under-represented in clinical studies. Despite federal policies that have been established to address this, our study shows that publicly funded ARV trials recruit even fewer women than other trials. There is an urgent need to ensure that HIV clinical studies consider sex/gender dimensions.

Gender-sensitive reporting in medical research.

Sex and gender differences influence the health and wellbeing of men and women. Although studies have drawn attention to observed differences between women and men across diseases, remarkably little research has been pursued to systematically investigate these underlying sex differences. Women continue to be underrepresented in clinical trials, and even in studies in which both men and women participate, systematic analysis of data to identify potential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensure provision of complete, transparent and critical information. An important step in addressing the gender imbalance would be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT) guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethical obligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promoters of ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses should be integrated into editorial policies as a matter of urgency.