Development of Next-Generation COVID-19 Vaccines: BARDA Supported Phase 2b Study Designs.

In response to the COVID-19 pandemic, vaccines were quickly and successfully developed and deployed, saving millions of lives globally. While first generation vaccines are safe and effective in preventing disease caused by SARSCoV-2, next-generation vaccines have the potential to improve efficacy and safety. Vaccines delivered by a mucosal route may elicit greater protective immunity at respiratory surfaces thereby reducing transmission. Inclusion of viral antigens in addition to the spike protein may enhance protection against emerging variants of concern. Next-generation vaccine platforms with a new mechanism of action may necessitate efficacy trials to fulfill regulatory requirements. The Biomedical Advanced Research and Development Authority (BARDA) will be supporting Phase 2b clinical trials of candidate next-generation vaccines. The primary endpoint will be improved efficacy in terms of symptomatic disease relative to a currently approved COVID-19 vaccine. In this paper, we discuss the planned endpoints and potential challenges to this complex program.

Recommendations to Improve Services and Supports for Domestically Sex Trafficked Persons Derived from the Insights of Health Care Providers.

Health care providers are highly likely to encounter persons who have been domestically sex trafficked and, therefore, possess valuable insights that could be useful in understanding and improving existing services and supports. In-depth interviews were conducted with 31 health care providers residing and working in Canada's largest province, Ontario. Results were analyzed using Braun and Clarke's analytical framework. Across providers, a key theme was identified: "Facilitators to improve care", which was comprised of two sub-themes, "Address needs in service provision" and "Center unique needs of survivors". From these results, eight wide-ranging recommendations to improve services and supports were developed (eg, Jointly mobilize an intersectoral, collaborative, and coordinated approach to sex trafficking service provision; Employ a survivor-driven approach to designing and delivering sex trafficking services). These recommendations hold the potential to enhance services in Canada and beyond by reducing barriers to access and care, facilitating disclosure, aiding in recovery, and empowering those who have been domestically sex trafficked.

Exploring the experiences of wellbeing, health, and healthcare among women who have been domestically sex trafficked in Ontario, Canada: A qualitative study protocol.

INTRODUCTION: Although there is a growing body of evidence to suggest that persons who have been sex trafficked can suffer devastating health consequences and often face challenges accessing suitable care that addresses their health and overall well-being, little existing research has adopted a survivor-informed approach. Centering the voices of sex-trafficked women in this research will provide valuable insights into their health-related experiences and can help lay the foundation for survivor-centric healthcare responses. METHODS AND ANALYSIS: Using a semi-structured interview guide, we will interview women who have been domestically sex trafficked in Ontario; recruitment will continue until data saturation is reached. Interview questions and prompts will elicit information about women's experiences prior to, during, and after their trafficking ordeal, with particular attention paid to their encounters with healthcare providers. Intersectionality theory will inform strategies for recruitment, data collection, and data analysis. Data will be analyzed deductively as well as inductively using Braun and Clarke's six phases of reflexive thematic analysis. The study's design was informed by the consolidated criteria for reporting qualitative research (COREQ), which ensures a comprehensive and robust reporting of interview data. We will continue to adhere to the COREQ checklist throughout the data collection, analysis, and findings write-up phases, helping to ensure methodological accuracy and transparency. DISCUSSION: To our knowledge, this will be the first Canada-specific investigation to apply intersectionality theory to explore the experiences of well-being, health, and healthcare from the perspectives of women who have been domestically sex trafficked. The results of this study hold the potential to improve responses to trafficking within the healthcare sector. Specifically, the findings could be used to inform the development of education materials and curricula for medical students and continuing professional education for health and allied healthcare providers. They could also inform the creation of patient experience surveys and intake forms for sex trafficked patients.

Enhancing care for transgender and gender diverse survivors of intimate partner violence: an Ontario-wide survey examining health and social service providers' learning needs.

OBJECTIVES: To better understand healthcare and social/community service providers' learning needs associated with supporting transgender and gender diverse (trans) persons who have experienced intimate partner violence (IPV). SETTING: An online survey was distributed through the trans-LINK Network in Ontario, Canada. RESPONDENTS: 163 of 225 healthcare and social/community service providers completed the survey (72.4% response rate) between November 2022 and February 2023. MAIN OUTCOME MEASURES: Expertise, training, workplace practices and learning needs related to supporting trans survivors of IPV. METHOD: Quantitative survey results were analysed descriptively and open-ended responses were organised thematically. In March 2022, survey results were shared with 33 stakeholders who helped define goals and objectives for an e-learning curriculum using Jamboard, data from which were collated and organised into themes. RESULTS: Most (66.3%) survey respondents described having provided professional support to trans survivors of IPV, but only one-third (38.0%) reported having received relevant training, and many of the trainings cited were in fact focused on other forms of violence or trans health generally. The majority reported a mid (44.9%) or low-mid (28.5%) level of expertise and almost unanimously agreed that they would benefit from (further) training (99.4%). The most commonly recommended goal/objective for a curriculum emerging from the stakeholder consultation was to facilitate collaboration, knowledge sharing and (safe) referrals among organisations. CONCLUSIONS: The results of this study highlight the critical need for an IPV curriculum specific to trans survivors and responsive to the needs of providers. As no one profession can address this complex issue in isolation, it is important that the curriculum aims to facilitate collaboration across sectors. In the absence of appropriate training and referrals, practitioners may perpetuate harm when caring for trans survivors of IPV.

Impacts of the COVID-19 Public Health Crisis on Caring for Sex-Trafficked Persons.

BACKGROUND: Sex trafficking of persons, a pervasive public health issue disproportionately affecting the most marginalized within society, often leads to health as well as social consequences. Social service provision to meet the resulting needs is critical, however, little is known about the current pandemic's impact on providers' capacity to deliver requisite care. METHOD: To examine social service providers' perspectives of care provision for domestically sex-trafficked persons in Ontario, Canada, during the COVID-19 pandemic, we conducted semi-structured interviews with 15 providers and analyzed these using Braun and Clarke's analytic framework. RESULTS: Impacts of the COVID-19 pandemic on social service care provision were connected to individuals' increased vulnerability to trafficking, difficulties safely and effectively providing services to sex-trafficked persons amid pandemic restrictions, and reduction in in-person educational activities to improve providers' capacity to serve this client population. Securing safe shelter was particularly difficult and inappropriate placements could at times lead to further trafficking. CONCLUSION: The pandemic created novel barriers to supporting sex-trafficked persons; managing these sometimes led to new and complex issues. Future efforts should focus on developing constructive strategies to support sex-trafficked persons' unique needs during public health crises.

Exploring physician gender bias in the initiation of prescribing cascades for older men and women: a qualitative clinical vignette study protocol.

INTRODUCTION: A prescribing cascade occurs when a drug is prescribed to manage the often unrecognised side effect of another drug; these cascades are of particular concern for older adults who are at heightened risk for drug-related harm. It is unknown whether, and to what extent, gender bias influences physician decision-making in the context of prescribing cascades. The aim of this transnational study is to explore the potential impact of physician implicit gender biases on prescribing decisions that may lead to the initiation of prescribing cascades in older men and women in two countries, namely: Canada and Italy. METHODS AND ANALYSIS: Male and female primary care physicians at each site will be randomised 1:1 to a case vignette that features either a male or female older patient who presents with concerns consistent with the side effect of a medication they are taking. During individual interviews, while masked to the true purpose of the study, participants will read the vignette and use the think-aloud method to describe their ongoing thought processes as they consider the patient's concerns and determine a course of action. Interviews will be recorded, transcribed verbatim and thematic analysis will be conducted to highlight differences in decisions in the interviews/transcripts, using a common analytical framework across the sites. ETHICS AND DISSEMINATION: This study has received ethics approval at each study site. Verbal informed consent will be received from participants prior to data collection and all data will be deidentified and stored on password-protected servers. Results of this study will be disseminated through peer-reviewed journal articles and presented at relevant national and international conferences.

"Coming out of the closet about sexual assault": Intersectional sexual assault stigma and (non) disclosure to formal support providers among survivors using Reddit.

Sexual assault is a pervasive, violent and often gendered crime that can result in significant negative consequences. Many sexual assault survivors consider disclosing to health and social care providers, therapists, and others who collectively fall under the banner of formal support, in order to access information, referrals, treatment and/or emotional support, however barriers to disclosure remain. This qualitative study is unique in its application of an intersectional sexual assault stigmatization framework to understand (non)disclosure to formal support providers among diverse sexual assault survivors. Through anonymous online narratives posted to the platform Reddit, survivors documented experiences of intersectional sexual assault stigma (perceived, internalized, anticipated, experienced) showing that they were not only stigmatized through negative gender stereotyping, but they were also marginalized through other structural inequities. The experience of multiple marginalization that arose from intersectional sexual assault stigma often impeded survivors in accessing and/or utilizing the formal support they wished for. The findings suggest that formal support providers could benefit from stigma reduction training related specifically to sexual assault survivors and that current models of stigma and discrimination training need to be expanded to include intersectional stigma. Further, the findings suggest that beyond training at an organizational level, a broader intervention aimed at reducing structural stigma and discrimination toward sexual assault survivors at a societal level appears warranted. Implications for future research related to the unique disclosure, health, and social care needs of diverse sexual assault survivors and support-seeking online alongside or in lieu of formal support are discussed.

Recommendations for Canada's National Action Plan to End Gender-Based Violence: perspectives from leaders, service providers and survivors in Canada's largest city during the COVID-19 pandemic. / Recommandations pour le Plan d'action national pour mettre fin à la violence fondée sur le genre : points de vue de dirigeants, de fournisseurs de services et de survivantes dans la plus grande ville du Canada pendant la pandémie de COVID-19.

INTRODUCTION: The Canadian government has committed to a national action plan (NAP) to address violence against women (VAW). However, a formalized plan for implementation has not been published. Building on existing recommendations and consultations, we conducted the first formal and peer-reviewed qualitative analysis of the perspectives of leaders, service providers and survivors on what should be considered in Canada's NAP on VAW. METHODS: We applied thematic analysis to qualitative data from 18 staff working on VAW services (11 direct support, 7 in leadership roles) and 10 VAW survivor participants of a community-based study on VAW programming during the COVID-19 pandemic in the Greater Toronto Area (Ontario, Canada). RESULTS: We generated 12 recommendations for Canada's NAP on VAW, which we organized into four thematic areas: (1) invest into VAW services and crisis supports (e.g. strengthen referral mechanisms to VAW programming); (2) enhance structural supports (e.g. invest in the full housing continuum for VAW survivors); (3) develop coordinated systems (e.g. strengthen collaboration between health and VAW systems); and (4) implement and evaluate primary prevention strategies (e.g. conduct a gender-based and intersectional analysis of existing social and public policies). CONCLUSION: In this study, we developed, prioritized and nuanced recommendations for Canada's proposed NAP on VAW based on a rigorous analysis of the perspectives of VAW survivors and staff in Canada's largest city during the COVID-19 pandemic. An effective NAP will require investment in direct support organizations; equitable housing and other structural supports; strategic coordination of health, justice and social care systems; and primary prevention strategies, including gender transformative policy reform.

Sex Trafficking of Women and Girls in Canada: A Scoping Review of the Scholarly Literature.

Sex trafficking has been identified as a prominant health and human rights concern in Canada. However, there has been little empirical research on the topic and existing studies are largely found within the grey literature. This review sought to identify and summarize the current scholarly literature about sex trafficking of women and girls in Canada. We identified empirical studies using a keyword search in ProQuest, Web of Science, and Scopus. Eligible articles were published in English in 2000 or later, included a focus on women victim/survivors, and analyzed human/participant data. Only 14 studies met eligibility criteria. Most studies were qualitative, based on interviews or focus groups primarily with stakeholders, and set in the province of Ontario. Key findings highlighted challenges in conceptualizing sex trafficking centered largely around issues of coercion and consent. Pathways into trafficking (economic displacement, past abuse, and broken ties with family and community) and gaps and barriers in anti-trafficking responses (narrow or conflicting definitions, stigmatization and criminalization of sex work, and a lack of accessible or appropriate services) particularly impacted Indigenous, im/migrant, and other marginalized women and girls. There is a pausity of empirical studies on sex trafficking in Canada and this has implications for the development of data-driven policies and protocols. Further research should seek to highlight the voices of survivors and impacted communities and evaluate strengths and limitations of Canadian anti-trafficking interventions.

ThinkCascades: A Tool for Identifying Clinically Important Prescribing Cascades Affecting Older People.

BACKGROUND AND OBJECTIVE: Prescribing cascades occur when a drug is prescribed to manage side effects of another drug, typically when a side effect is misinterpreted as a new condition. A consensus list of clinically important prescribing cascades that adversely affect older persons' health (i.e., where risks of the prescribing cascade usually exceed benefits) was developed to help identify, prevent, and manage prescribing cascades. METHODS: Three rounds of a modified Delphi process were conducted with a multidisciplinary panel of 38 clinicians from six countries with expertise in geriatric pharmacotherapy. The clinical importance of 139 prescribing cascades was assessed in Round 1. Cascades highly rated by ≥ 70% of panelists were included in subsequent rounds. Factors influencing ratings in Rounds 1 and 3 were categorized. After three Delphi rounds, highly rated prescribing cascades were reviewed by the study team to determine the final list of clinically important cascades consistent with potentially inappropriate prescribing. RESULTS: After three rounds, 13 prescribing cascades were highly rated by panelists. Following a study team review, the final tool includes nine clinically important prescribing cascades consistent with potentially inappropriate prescribing. Panelists reported that their ratings were influenced by many factors (e.g., how commonly they encountered the medications involved and the cascade itself, the severity of side effects, availability of alternatives). The relative importance of these factors in determining clinical importance varied by panelist. CONCLUSIONS: A nine-item consensus-based list of clinically important prescribing cascades, representing potentially inappropriate prescribing, was developed. Panelists' decisions about what constituted a clinically important prescribing cascade were multi-factorial. This tool not only raises awareness about these cascades but will also help clinicians recognize these and other important prescribing cascades. This list contributes to the prevention and management of polypharmacy and medication-related harm in older people.

A protocol for a qualitative study on sex trafficking: Exploring knowledge, attitudes, and practices of physicians, nurses, and social workers in Ontario, Canada.

INTRODUCTION: There has been limited research on sex trafficking in Canada from a health and health care perspective, despite U.S. research which points to health care providers as optimally positioned to identify and help those who have been sex trafficked. We aim to better understand health care providers' knowledge about, attitudes towards, and care of those who have been sex trafficked in Ontario, Canada. METHODS AND ANALYSIS: Using a semi-structured interview guide, we will interview physicians, nurses, and social workers working in a health care setting in Ontario until data saturation is reached. An intersectional lens will be applied to the study; analysis will follow the six analytic phases outlined by Braun and Clarke. In the development of this study, we consulted the consolidated criteria for reporting qualitative research (COREQ) with regards to reflexivity and study design. We will continue to consult this checklist as the study progresses and in the writing of our analysis and findings. DISCUSSION: To our knowledge, this will be the first study of its kind in Canada. The results hold the potential to inform the development of standardized training on sex trafficking for health care providers. Results of the study may be useful in addressing sex trafficking in other jurisdictions.

Exploring the Lived Experience of Diabetes Through an Intersectional Lens: A Qualitative Study of Adults With Type 1 and Type 2 Diabetes.

BACKGROUND: Our aim in this study was to explore the lived experience of adults living with type 1 and type 2 diabetes through an intersectional sex- and gender-based analysis plus lens. METHODS: Qualitative interviews with 15 adults (9 women, 6 men) were conducted in February and March 2021. Interviews were recorded, transcribed and analyzed for semantic and latent themes noting differences in participants' accounts of living with diabetes by gender, age, race and ethnicity, type of diabetes and other key demographics. RESULTS: Participants' experiences differed substantively by gender, age and racialization. "Resilience" was identified as a central feature in participants' lives. Factors that contributed to resilience included supportive relationships, a feeling of agency and social acceptance; confounding factors included unsupportive relationships, a lack of agency and experiences of stigma, discrimination and microaggressions. CONCLUSIONS: Lived experiences of diabetes can best be understood through an intersectional lens that considers peoples' diverse socioeconomic locations and identities. Those who experience discrimination, including women, older individuals and racialized people, may also experience the compounding effects of multiple marginalization, requiring greater investment in factors that contribute to their resilience. Considering the varied needs of diverse individuals should be integrated into routine diabetes care.

Gender disparity between authors in leading medical journals during the COVID-19 pandemic: a cross-sectional review.

OBJECTIVES: Evaluate gender differences in authorship of COVID-19 articles in high-impact medical journals compared with other topics. DESIGN: Cross-sectional review. DATA SOURCES: Medline database. ELIGIBILITY CRITERIA: Articles published from 1 January to 31 December 2020 in the seven leading general medical journals by impact factor. Article types included primary research, reviews, editorials and commentaries. DATA EXTRACTION: Key data elements were whether the study topic was related to COVID-19 and names of the principal and the senior authors. A hierarchical approach was used to determine the likely gender of authors. Logistic regression assessed the association of study characteristics, including COVID-19 status, with authors' likely gender; this was quantified using adjusted ORs (aORs). RESULTS: We included 2252 articles, of which 748 (33.2%) were COVID-19-related and 1504 (66.8%) covered other topics. A likely gender was determined for 2138 (94.9%) principal authors and 1890 (83.9%) senior authors. Men were significantly more likely to be both principal (1364 men; 63.8%) and senior (1332 men; 70.5%) authors. COVID-19-related articles were not associated with the odds of men being principal (aOR 0.99; 95% CI 0.81 to 1.21; p=0.89) or senior authors (aOR 0.96; 95% CI 0.78 to 1.19; p=0.71) relative to other topics. Articles with men as senior authors were more likely to have men as principal authors (aOR 1.49; 95% CI 1.21 to 1.83; p<0.001). Men were more likely to author articles reporting original research and those with corresponding authors based outside the USA and Europe. CONCLUSIONS: Women were substantially under-represented as authors among articles in leading medical journals; this was not significantly different for COVID-19-related articles. Study limitations include potential for misclassification bias due to the name-based analysis. Results suggest that barriers to women's authorship in high-impact journals during COVID-19 are not significantly larger than barriers that preceded the pandemic and that are likely to continue beyond it. PROSPERO REGISTRATION NUMBER: CRD42020186702.

Identifying key prescribing cascades in older people (iKASCADE): a transnational initiative on drug safety through a sex and gender lens-rationale and design.

PURPOSE: To describe the objectives, methods and expected impact of an international consortium (iKASCADE) whose purpose is to improve drug safety for older adults by addressing prescribing cascades through a sex and gender lens. METHODS: To create a comprehensive, internationally relevant inventory of prescribing cascades affecting older adults, the consortium has created a modified Delphi procedure where international experts in prescribing and managing pharmacotherapy for older adults will rank a list of prescribing cascades as to their clinical importance. We will use administrative and clinical data on older adults to evaluate the frequency of prescribing cascades by sex internationally, in the hospital, long-term care and community settings. Finally, we will use semi-structured interviews and realistic, country-specific vignettes, each incorporating a prescribing cascade with identified sex differences, to explore how socially constructed gender roles contribute to the experience, presentation and management of prescribing cascades. RESULTS: The consortium will synthesize the quantitative and qualitative results to produce a position paper and products-aimed at knowledge users within and outside of academia-designed to elevate the importance of integrating a gender dimension in the identification and prevention of prescribing cascades. CONCLUSION: Findings will improve our understanding of how adverse drug events are different between older women and men and inform the development and dissemination of tailored knowledge translation products to reduce the frequency and impact of prescribing cascades.

Doing better: eleven ways to improve the integration of sex and gender in health research proposals.

BACKGROUND: Integrating a sex and gender lens is increasingly recognized as important in health research studies. Past failures to adequately consider sex in drug development, for example, led to medications that were metabolized differently, proved harmful, or ineffective, for females. Including both males and females in study populations is important but not sufficient; health, access to healthcare, and treatment provided are also influenced by gender, the socially mediated roles, responsibilities, and behaviors of boys, girls, women and men. Despite understanding the relevance of sex and gender to health research, integrating this lens into study designs can still be challenging. Identified here, are nine opportunities to address sex and gender and thereby strengthen research proposals. METHODS: Ontario investigators were invited to submit a draft of their health research proposal to the Sex and Gender Research Support Service (SGRSS) at Women's College Hospital in Toronto, Ontario. The service works to build capacity on the integration of sex, gender, and other identity factors, in health research. Using the SAGER Guidelines and the METRICS for the Study of Sex and Gender in Human Participants as guides, proposals were reviewed to enhance their sex and gender considerations. Content analysis of the feedback provided these investigators was subsequently completed. RESULTS: Nearly 100 hundred study proposals were reviewed and investigators provided with suggestions on how to enhance their proposal. Analyzing the feedback provided across the reviewed studies revealed commonly overlooked opportunities to elevate consideration of sex and gender. These were organized into nine suggestions to mirror the sections of a research proposal. CONCLUSION: Health researchers are often challenged on how to integrate a sex and gender lens into their work. Reviews completed across a range of health research studies show there are several commonly overlooked opportunities to do better in this regard. Nine ways to improve the integration of a sex and gender lens in health research proposals have been identified.

Readmission rates following heart failure: a scoping review of sex and gender based considerations.

BACKGROUND: Although hospital readmission for heart failure (HF) is an issue for both men and women, little is known about differences in readmission rates by sex. Consequently, strategies to optimize readmission reduction programs and care strategies for women and men remain unclear. Our study aims were: (1) to identify studies examining readmission rates according to sex, and (2) to provide a qualitative overview of possible considerations for the impact of sex or gender. METHODS: We conducted a scoping review using the Arksey and O'Malley framework to include full text articles published between 2002 and 2017 drawn from multiple databases (MEDLINE, EMBASE), grey literature (i.e. National Technical information, Duck Duck Go), and expert consultation. Eligible articles included an index heart failure episode, readmission rates, and sex/gender-based analysis. RESULTS: The search generated 5887 articles, of which 746 underwent full abstract text consideration for eligibility. Of 164 eligible articles, 34 studies addressed the primary outcome, 103 studies considered sex differences as a secondary outcome and 25 studies stratified data for sex. Good inter-rater agreement was reached: 83% title/abstract; 88% full text; kappa: 0.69 (95%CI: 0.53-0.85). Twelve of 34 studies reported higher heart failure readmission rates for men and six studies reported higher heart failure readmission rates for women. Using non composite endpoints, five studies reported higher HF readmission rates for men compared to three studies reporting higher HF readmission rates for women. Overall, there was heterogeneity between studies when examined by sex, but one observation emerged that was related to the timing of readmissions. Readmission rates for men were higher when follow-up duration was longer than 1 year. Women were more likely to experience higher readmission rates than men when time to event was less than 1 year. CONCLUSIONS: Future studies should consider different time horizons in their designs and avoid the use of composite measures, such as readmission rates combined with mortality, which are highly skewed by sex. Co-interventions and targeted post-discharge approaches with attention to sex would be of benefit to the HF patient population.

An Exploration of Sexual Assault Survivors' Discourse Online on Help-Seeking.

Although sexual assault is associated with significant negative psychological health outcomes, few survivors seek support from formal providers. This study explored the barriers to accessing and benefitting from services for sexual assault, as disclosed in narrative posts on social media, using qualitative methodology. Of the 1,179 narratives posted to the subreddit'r/rapecounseling' that were reviewed, 81 data extracts from 52 women were included in this study based on predefined inclusion/exclusion criteria. Six themes were identified that prevented survivors from accessing or benefitting from help. Internal barriers included feeling overwhelmed and avoidance-based coping. External barriers included availability of services, suitability of services, and therapist-caused harms. Stigma was the only barrier that was experienced both internally and externally. These findings suggest a need for more supportive mental health services.

Recognizing and Responding to the Commonly Misunderstood Reactions to Sexual Assault: Evaluation of an Online Curriculum.

Background: Sexual assault remains a serious public health issue with significant impacts on the health and well-being of individual women. Many women's reactions and behaviors post sexual assault are not well understood by the general public, or more worrying, among professionals to whom women frequently turn to for help. An innovative and evidence-informed online curriculum was developed to educate health and social service providers about the range of possible psychological responses and associated behaviors post sexual assault and to better equip them in supporting survivors in their recovery. Methods: The curriculum was evaluated using pre- and post-training tests designed to measure changes in fact-based knowledge, self-assessed knowledge, and procedural knowledge, that is, perceived competency. Results: A total of 759 participants registered to complete the curriculum between July 2018 and July 2019 and 175 completed both the pre- and post-training surveys. Data analyses showed significant improvement in the mean number of correct answers to the fact-based knowledge, self-reflection, and procedural knowledge questions from pre- to post-training. The response to the training was also very positive. Conclusions: The online curriculum was effective in improving participants' knowledge about and response to women who, in the aftermath of a sexual assault, may exhibit reactions or behaviors that are commonly misunderstood.

Measuring the data gap: inclusion of sex and gender reporting in diabetes research.

BACKGROUND: Important sex and gender differences have been found in research on diabetes complications and treatment. Reporting on whether and how sex and gender impact research findings is crucial for developing tailored diabetes care strategies. To analyze the extent to which this information is available in current diabetes research, we examined original investigations on diabetes for the integration of sex and gender in study reporting. METHODS: We examined original investigations on diabetes published between January 1 and December 31, 2015, in the top five general medicine journals and top five diabetes-specific journals (by 2015 impact factor). Data were extracted on sex and gender integration across seven article sections: title, abstract, introduction, methods, results, discussion, and limitations. RESULTS: We identified 155 original investigations on diabetes, including 115 randomized controlled trials (RCTs) and 40 observational studies. Sex and gender were rarely incorporated in article titles, abstracts and introductions. Most methods sections did not describe plans for sex/gender analyses; 47 (30.3%) articles described plans to control for sex/gender in the analysis and 12 (7.7%) described plans to stratify results by sex/gender. While most articles (151, 97.4%) reported the sex/gender of study participants, only 10 (6.5%) of all articles reported all study outcomes separately by sex/gender. Discussion of sex-related issues was incorporated into 21 (13.5%) original investigations; however, just 1 (0.6%) discussed gender-related issues. Comparison by journal type (general medicine vs. diabetes specific) yielded only minor differences from the overall integration results. In contrast, RCTs performed more poorly on multiple sex/gender assessment metrics compared to observational studies. CONCLUSIONS: Sex and gender are poorly integrated in current diabetes original investigations, suggesting that substantial improvements in sex and gender data reporting are needed to inform the evidence to support sex- and gender-specific diabetes care.