Development of Next-Generation COVID-19 Vaccines: Biomedical Advanced Research and Development Authority (BARDA-)-Supported Phase 2b Study Designs.

In response to the coronavirus disease 2019 (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 SARS-CoV-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.

From not knowing, to knowing more needs to be done: health care providers describe the education they need to care for sex trafficked patients.

BACKGROUND: Sex trafficking is highly prevalent, pernicious, and under-recognized. When an individual is trafficked for the purpose of sexual exploitation within the borders of a single country, it is termed domestic sex trafficking. Sex trafficked persons can experience severe physical and mental health outcomes requiring medical attention and treatment. However, health care providers often fail to identify sex trafficked patients, missing opportunities to provide needed care and support. METHODS: In this qualitative study, we interviewed 31 health care providers (physicians, nurses, and social workers) working in Ontario, Canada to learn what they identified as their specific education and training needs to recognize and care for sex trafficked persons. Interviews were conducted over Zoom, recorded, and transcribed. Coding of the transcripts followed a standard framework for qualitative studies. Codes related to the education and training needs of providers were identified as a core issue suited to further analysis. RESULTS: Three themes related to providers' education and training needs emerged. These acknowledge basic (Foundational knowledge), as well as more specific learning needs (Navigating the encounter). The final theme, ("It just seems so much bigger than me") suggests that even with some knowledge of domestic sex trafficking, participants still experienced considerable distress and multiple challenges due to gaps in the broader system impacting the provision of appropriate care. CONCLUSIONS: Participants voiced their need for specialized sex trafficking education as well as role specific training to combat their sense of inadequacy and provide better care for their patients. Participants' education needs ranged from requiring the definition of domestic sex trafficking and the frequency of its occurrence, to the various circumstances associated with increased risk of recruitment into sex trafficking. In terms of desired training and specific skills, participants wanted to learn how to identify a person being sex trafficked, broach the subject with a patient, know what to do next including access to local resources and referrals, as well as connections to other critical services, such as legal and housing. The results can be used to inform the design and content of education and training on sex trafficking for health care providers.

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.

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.

Serious gaming: A tool to educate health care providers about domestic violence.

Due to many adverse health effects, victims of domestic violence are frequently seen in the health care system. Yet, health care providers may lack the training to assist them. Online curricula can be an effective instructional tool. Our competency-based, serious video game, Responding to Domestic Violence in Clinical Settings, was designed to address health care providers' knowledge gaps through 17 modules, each a half hour in length. Nearly 9,000 participants completed at least one module; nursing students completed the most modules, approximately five hours of instruction. This serious video game-based curriculum is useful in helping health providers and students learn about Domestic Violence.

Making connections across silos: intimate partner violence, mental health, and substance use.

BACKGROUND: Untold numbers of women worldwide are survivors of intimate partner violence (IPV) with a substantial number of these experiencing co-occurring mental health and substance use problems. Despite the complex interconnections among these problems, funding mechanisms and organizational structures and mandates have been designed to address just a single, focal problem. One of the challenges for frontline providers is the lack of effective, evidence-informed inter-professional education or training to help them identify and appropriately respond to co-occurring problems. We developed an evidence-informed, competency-based curriculum to address this gap. In this paper we report on its effectiveness in increasing knowledge, changing beliefs and enhancing skills of frontline workers from all three sectors. METHODS: The curriculum consists of multiple elements: a text manual; an interactive, online series of modules; and, an in-person workshop. Frontline workers (n = 1111) in the violence against women (VAW) (n = 499), mental health (n = 229), addiction treatment (n = 167), and associated sectors (n = 149) were recruited to attend the workshop and instructed to read the manual or complete the online modules before attending. Some failed to respond (n = 67). Online pre- and post-tests were used to assess changes in knowledge, beliefs and skills; evaluations of the workshop were also collected. RESULTS: Matched pre- and post-tests were available for over half of the participants (n = 624). Results show statistically significant improvements across all six competency domains from pre to post-test (p <0.0001). Significant changes in participants' knowledge and stigmatizing beliefs were achieved. There was no correlation among differences in sector, age, size of organization, years of experience or prior training. Participant feedback made evident prior misconceptions about women experiencing co-occurring problems, improved understanding about the need to bridge silos, as well as the need for enhanced self-care. CONCLUSIONS: An educational intervention designed to sensitize frontline workers to the realities of women's experiences of co-occurring problems, educate about the challenges of accessing help when there are co-occurring problems, and bridge discipline and practice-based silos, can effectively challenge and alter providers' negative attitudes and stigmatizing beliefs. Decreasing stigmatizing beliefs and increasing knowledge has the potential to help survivors access needed help.

Integrating and evaluating sex and gender in health research.

Both sex (biological factors) and gender (socio-cultural factors) shape health. To produce the best possible health research evidence, it is essential to integrate sex and gender considerations throughout the research process. Despite growing recognition of the importance of these factors, progress towards sex and gender integration as standard practice has been both slow and uneven in health research. In this commentary, we examine the challenges of integrating sex and gender from the research perspective, as well as strategies that can be used by researchers, funders and journal editors to address these challenges. Barriers to the integration of sex and gender in health research include problems with inconsistent terminology, difficulties in applying the concepts of sex and gender, failure to recognise the impact of sex and gender, and challenges with data collection and datasets. We analyse these barriers as strategic points of intervention for improving the integration of sex and gender at all stages of the research process. To assess the relative success of these strategies in any given study, researchers, funders and journal editors would benefit from a tool to evaluate the quality of sex and gender integration in order to establish benchmarks in research excellence. These assessment tools are needed now amidst growing institutional recognition that both sex and gender are necessary elements for advancing the quality and utility of health research evidence.

Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials.

In 2011 and 2012, the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health, held a series of meetings to provide guidance to investigators regarding study design of clinical trials of vaccines and antimicrobial medications that enroll pregnant women. Assessment of congenital anomalies among infants born to women enrolled in these trials was recognized as a challenging issue, and a workgroup with expertise in epidemiology, pediatrics, genetics, dysmorphology, clinical trials, and infectious diseases was formed to address this issue. The workgroup considered 3 approaches for congenital anomalies assessment that have been developed for use in other studies: (1) maternal report combined with medical records review, (2) standardized photographic assessment and physical examination by a health professional who has received specific training in congenital anomalies, and (3) standardized physical examination by a trained dysmorphologist (combined with maternal interview and medical records review). The strengths and limitations of these approaches were discussed with regard to their use in clinical trials. None of the approaches was deemed appropriate for use in all clinical trials. Instead, the workgroup acknowledged that decisions regarding the optimal method of assessment of congenital anomalies will likely vary depending on the clinical trial, its setting, and the agent under study; in some cases, a combination of approaches may be appropriate. The workgroup recognized the need for more research on approaches to the assessment of congenital anomalies to better guide investigators in optimal design of clinical trials that enroll pregnant women.

Laboring to mother in the context of past trauma: the transition to motherhood.

The occurrence of interpersonal trauma is a reality for many women, with effects that often persist long after the traumatic events end. The purpose of this feminist grounded theory study was to examine how past trauma shaped the lives of women as they became new mothers. We recruited a purposive sample of 32 women from two Canadian communities and conducted semistructured, dialogic interviews during the second trimester of pregnancy. We analyzed data using thematic content analytic methods, including open coding whereby we read transcripts line by line and applied codes to portions of text that illustrated concepts or themes. The substantive grounded theory, "laboring to mother in the context of past trauma," describes the exceedingly difficult emotional and cognitive work undertaken by pregnant women with histories of trauma as they anticipate becoming mothers. In this article, we present key components of the theory and offer recommendations for health and social service providers.

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.

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.

The mental health of staff at violence against women organizations during the COVID-19 pandemic: Findings from a mixed-methods study of service providers in Canada's largest city.

OBJECTIVES: Staff at violence against women (VAW) organizations provide essential services for survivors of violence. The increase in VAW during the COVID-19 pandemic placed additional pressures on VAW staff. We investigated the impacts of the pandemic on the mental health of VAW staff in the Greater Toronto Area to inform recommendations for policy and practice. METHODS: We conducted a community-based, mixed-methods study on the processes, experiences, and outcomes of adapting VAW programming during the pandemic using a sequential explanatory approach. Throughout 2021, we conducted a survey of direct support and leadership staff who worked on VAW services ("VAW staff") followed by semi-structured interviews with VAW staff purposively sampled from the survey. We descriptively analyzed quantitative survey data on the mental health of 127 VAW staff. We then applied thematic analysis to qualitative data from 18 interviews with VAW staff. We used the qualitative data to support interpretation and enrich the quantitative findings regarding staff mental health. RESULTS: In the survey, 81% of leadership and 61% of direct support staff indicated that their work was more distressing during the pandemic. Participants reported moderate symptoms of vicarious trauma and mild symptoms of anxiety and depression. We generated three themes from the qualitative data to help explain these findings: (1) challenges related to changing work environments; (2) distress over not meeting client needs; and (3) difficulties in adapting self-care strategies in response to pandemic stressors. CONCLUSION: VAW organizations require increased resources and flexible funding to hire and retain more staff to respond to higher and more complex caseloads during public health emergencies. With more structural supports in place, VAW organizations could create more time and space to develop their trauma-informed organizational practices: for example, establishing a culture of connection and learning among staff virtually and in-person and facilitating a range of self-care opportunities.

RéSUMé: OBJECTIFS: Le personnel des organisations de lutte contre la violence envers les femmes (VEF) fournit des services essentiels aux survivantes de la violence. L'augmentation de la VEF pendant la pandémie de COVID-19 a exercé des pressions supplémentaires sur le personnel de la VEF. Nous avons étudié les impacts de la pandémie sur la santé mentale du personnel de la VEF dans la région du Grand Toronto afin de formuler des recommandations pour les politiques et les pratiques. MéTHODES: Nous avons mené une étude communautaire basée sur des méthodes mixtes sur les processus, les expériences et les résultats de l'adaptation des programmes de VEF pendant la pandémie, en utilisant une approche explicative séquentielle. Tout au long de l'année 2021, nous avons mené une enquête auprès personnel de première ligne et des cadres travaillant sur les services de VEF (personnel de VEF), suivie d'entretiens semi-structurés avec un échantillon intentionnel de ce personnel tiré de l'enquête. Nous avons analysé de manière descriptive les données quantitatives de l'enquête sur la santé mentale de 127 membres du personnel de VEF. Nous avons ensuite appliqué une analyse thématique aux données qualitatives provenant de 18 entretiens avec le personnel de VEF. Nous avons utilisé les données qualitatives pour soutenir l'interprétation et enrichir les résultats quantitatifs concernant la santé mentale du personnel. RéSULTATS: Dans l'enquête, 81 % des cadres et 61 % du personnel de première ligne ont indiqué que leur travail était plus stressant pendant la pandémie. Les participants ont signalé des symptômes modérés de traumatisme indirect et des symptômes légers d'anxiété et de dépression. Nous avons dégagé trois thèmes à partir des données qualitatives pour aider à expliquer ces résultats : (1) défis liés aux environnements de travail changeants; (2) détresse liée à l'incapacité de répondre aux besoins des clients; et (3) difficultés à adapter les stratégies de soins personnels en réponse aux facteurs de stress de la pandémie. CONCLUSION: Les organisations de VEF ont besoin de ressources accrues et de financements flexibles pour recruter et retenir plus de personnel afin de répondre à des charges de travail plus élevées et plus complexes pendant les urgences de santé publique. Avec davantage de soutiens structurels en place, les organisations de VEF pourraient dégager plus de temps et d'espace pour développer leurs pratiques organisationnelles tenant compte des traumatismes. Par exemple, établir une culture de connexion et d'apprentissage entre le personnel, à la fois virtuellement et en personne, et faciliter une gamme d'opportunités de soins personnels.

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.

Integrating gender analysis into research: reflections from the Gender-Net Plus workshop.

Gender equality has been a crosscutting issue in Horizon 2020 with three objectives: gender balance in decision-making, gender balance and equal opportunities in project teams at all levels, and inclusion of the gender dimension in research and innovation content. Between 2017 and 2022, the EU funded, in collaboration with national agencies, 13 transnational projects under "GENDER-NET Plus" that explored how to best integrate both sex and gender into studies ranging from social sciences, humanities, and health research. As the projects neared completion, forty researchers from these interdisciplinary teams met in November 2022 to share experiences, discuss challenges, and consider the best ways forward to incorporate sex and gender in research. Here, we summarize the reflections from this workshop and provide some recommendations for i) how to plan the studies (e.g., how to define sex and/or gender and their dimensions, rationale for the hypotheses, identification of data that can best answer the research question), ii) how to conduct them (e.g., adjust definitions and dimensions, perform pilot studies to ensure proper use of terminology and revise until consensus is achieved), and iii) how to analyze and report the findings being mindful of any real-world impact.

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.

"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.

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.