Background: Biological sex-related factors influence pharmacokinetic, pharmacodynamic, and disease processes that may affect the predictability of drug dosing and adverse effects, which may in turn have clinical consequences for patients' lives. Nonetheless, sex-related factors are not always taken into account in clinical trial design or clinical decision-making, for multiple reasons, including a paucity of studies that clearly and objectively study and measure sex-disaggregated and sex-related outcomes, as well as gaps in regulatory and policy structures for integrating these considerations. Objectives: To complete a narrative review and use a case study to understand available evidence, inform future research, and provide policy considerations that incorporate information on sex- and gender-related factors into clinician-facing resources. Methods: A comprehensive review of available literature was conducted using a sex- and gender-based analysis plus (SGBA Plus) approach to identify sex- and/or gender-disaggregated information for gilteritinib, a chemotherapeutic agent. Systematic searches were performed in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Wiley), International Pharmaceutical Abstracts (Ovid), Scopus, and ClinicalTrials.gov, from inception to March 18, 2021. The information was then summarized and compared with the Canadian product monograph for this drug. Results: Of 311 records screened, 3 provided SGBA Plus information as a component of outcomes, rather than just as categories or demographic characteristics. Of these, 2 were case studies, and 1 was a clinical trial. No studies from the ClinicalTrials.gov database that were in progress at the time of this review provided details about sex-disaggregated outcomes. The Canadian product monograph did not include sex-disaggregated outcome data. Conclusions: The available evidence from clinical trials, other published literature, and guidance documents does not provide details about sex-disaggregated outcomes for gilteritinib. This paucity of available evidence may create a challenge for clinicians who are making decisions about the efficacy and safety of prescribed therapies in sex-specific populations that have not been well studied.
Contexte: Les facteurs liés au sexe biologique influencent les processus pharmacocinétiques, pharmacodynamiques et pathologiques, qui peuvent avoir une incidence sur la prévisibilité du dosage des médicaments et des effets indésirables. Ceci peut à son tour avoir des conséquences cliniques sur la vie des patients. Néanmoins, les facteurs liés au sexe ne sont pas toujours pris en compte dans la conception des essais cliniques ou la prise de décision clinique, et cela pour de nombreuses raisons notamment le manque d'études qui examinent et mesurent clairement et objectivement les résultats ventilés par sexe et liés au sexe ainsi que les lacunes dans les réglementations et structures politiques pour intégrer ces considérations. Objectifs: Mener un examen narratif et utiliser une étude de cas pour comprendre les preuves disponibles, éclairer les recherches futures et fournir des considérations politiques qui intègrent des informations sur les facteurs liés au sexe et au genre dans les ressources destinées aux cliniciens. Méthodes: Une revue complète de la littérature disponible a été réalisée à l'aide d'une analyse comparative fondée sur le sexe et le genre Plus (ACSG Plus) pour identifier les informations ventilées par sexe et/ou par genre pour le giltéritinib, un agent chimiothérapeutique. Des recherches systématiques ont été effectuées dans MEDLINE (Ovid), Embase (Ovid), CENTRAL (Wiley), International Pharmaceutical Abstracts (Ovid), Scopus et ClinicalTrials.gov, depuis la création de chaque base de données jusqu'au 18 mars 2021. Ces informations ont ensuite été résumées et comparées avec la monographie canadienne de produit pharmaceutique pour ce médicament. Résultats: Sur les 311 documents examinés, 3 ont fourni des informations ACSG Plus en tant que composante des résultats, plutôt que simplement en tant que catégories ou caractéristiques démographiques. Parmi ceux-ci, 2 étaient des études de cas et 1 était un essai clinique. Aucune étude de la base de données ClinicalTrials.gov en cours au moment de cette revue n'a fourni de détails sur les résultats ventilés par sexe. La monographie de produit canadienne ne comprenait pas de données sur les résultats ventilées par sexe. Conclusions: Les preuves disponibles issues d'essais cliniques, d'autres publications et de documents d'orientation ne fournissent pas de détails sur les résultats ventilés par sexe pour le giltéritinib. Ce manque d'éléments probants disponibles peut constituer un défi pour les cliniciens qui prennent des décisions sur l'efficacité et l'innocuité des thérapies prescrites chez des populations sexospécifiques qui n'ont pas été bien étudiées.
The regulation of prescription drugs is an important health, safety, and equity issue. However, regulatory processes do not always consider evidence on sex, gender, and factors such as age and race, omissions that advocates have highlighted for several decades. Assessing the impact of sex-related factors is critical to ensuring drug safety and efficacy for females and males, and for informing clinical product monographs and consumer information. Gender-related factors affect prescribing, access to drugs, needs and desires for specific prescribed therapies. This article draws on a policy-research partnership project that examined the lifecycle management of prescription drugs in Canada using a sex and gender-based analysis plus (SGBA+) lens. In the same time period, Health Canada created a Scientific Advisory Committee on Health Products for Women, in part to examine drug regulation. We report on grey literature and selected regulatory documents to illustrate the extent to which sex and gender-based analysis plus (SGBA+) is utilized in regulation and policy. We identify omissions in the management of prescription drugs, and name opportunities for improvements by integrating SGBA+ into drug sponsor applications, clinical trials development, and pharmacovigilance. We report on recent efforts to incorporate sex disaggregated data and recommend ways that the management of prescription drugs can benefit from more integration of sex, gender, and equity.
Prescription Drugs , Male , Humans , Female , Sex Factors , Advisory Committees , Prescriptions , Canada
Alcohol use is coming under increasing scrutiny with respect to its health impacts on the body. In this vein, several high-income countries have issued low-risk drinking guidelines in the past decade, aiming to educate the public on safer levels of alcohol use. Research on the sex-specific health effects of alcohol has indicated higher damage with lower amounts of alcohol for females as well as overall sex differences in the pharmacokinetics of alcohol in male and female bodies. Research on gender-related factors, while culturally dependent, indicates increased susceptibility to sexual assault and intimate partner violence as well as more negative gender norms and stereotypes about alcohol use for women. Sex- and gender-specific guidelines have been issued in some countries, suggesting lower amounts of alcohol consumption for women than men; however, in other countries, sex- and gender-blind advice has been issued. This article reports on a synthesis of the evidence on both sex- and gender-related factors affecting safer levels of drinking alcohol with an emphasis on women's use. We conclude that supporting and expanding the development of sex- and gender-specific low-risk drinking guidelines offers more nuanced and educative information to clinicians and consumers and will particularly benefit women and girls.
Intimate Partner Violence , Sex Offenses , Alcohol Drinking/epidemiology , Ethanol , Female , Humans , Interpersonal Relations , Male , Risk Factors
Accounting for the influences of sex- and gender-related factors on health is one of the most interesting and important challenges in contemporary health research. In biomedical research, models, experimental designs, and statistical analyses create particular challenges in attempting to incorporate the complex, dynamic, and context-dependent constructs of sex and gender. Here, we offer conceptual elaborations of the constructs of sex and gender and discuss their application in biomedical research, including a more mechanism-oriented and context-driven approach to experimental design integrating sex and gender. We highlight how practices of data visualization, statistical analysis, and rhetoric can be valuable tools in expanding the operationalization of sex and gender biomedical science and reducing reliance on a male-female binary approach.
Biomedical Research , Gender Identity , Data Visualization , Female , Humans , Male , Research Design , Sex Factors
Drug-related adverse events or adverse drug reactions (ADRs) are currently partially or substantially under-reported. ADR reporting systems need to expand their focus to include sex- and gender-related factors in order to understand, prevent, or reduce the occurrence of ADRs in all people, particularly women. This scoping review describes adverse drug reactions reported to international pharmacovigilance databases. It identifies the drug classes most commonly associated with ADRs and synthesizes the evidence on ADRs utilizing a sex- and gender-based analysis plus (SGBA+) to assess the differential outcomes reported in the individual studies. We developed a systematic search strategy and applied it to six electronic databases, ultimately including 35 papers. Overall, the evidence shows that women are involved in more ADR reports than men across different countries, although in some cases, men experience more serious ADRs. Most studies were conducted in higher-income countries; the terms adverse drug reactions and adverse drug events are used interchangeably, and there is a lack of standardization between systems. Additional research is needed to identify the relationships between sex- and gender-related factors in the occurrence and reporting of ADRs to adequately detect and prevent ADRs, as well as to tailor and prepare effective reporting for the lifecycle management of drugs.
Including sex and gender considerations in health research is considered essential by many funders and is very useful for policy makers, program developers, clinicians, consumers and other end users. While longstanding confusions and conflations of terminology in the sex and gender field are well documented, newer conceptual confusions and conflations continue to emerge. Contemporary social demands for improved health and equity, as well as increased interest in precision healthcare and medicine, have made obvious the need for sex and gender science, sex and gender-based analyses (SGBA+), considerations of intersectionality, and equity, diversity and inclusion initiatives (EDI) to broaden representation among participants and diversify research agendas. But without a shared and precise understanding of these conceptual areas, fields of study, and approaches and their inter-relationships, more conflation and confusion can occur. This article sets out these areas and argues for more precise operationalization of sex- and gender-related factors in health research and policy initiatives in order to advance these varied agendas in mutually supportive ways.
Policy , Research Design , Female , Health Policy , Humans , Male , Sex Factors
INTRODUCTION: Few studies have explored fathers' views and experiences of creating a smoke-free home, with interventions largely targeting mothers. This study aimed to identify barriers and facilitators to fathers creating a smoke-free home, to inform future intervention development. METHODS: Eighteen fathers who were smokers and lived in Scotland were recruited from Dads' community groups, Early Years Centres and through social media advertising. Semi-structured interviews explored their views and experiences of creating a smoke-free home. A theory-informed thematic analysis using the COM-B model highlighted ways in which capability, opportunity, and motivations shaped fathers' home smoking behaviors. RESULTS: Several fathers understood the health risks of second-hand smoke exposure through public health messaging associated with recent smoke-free legislation prohibiting smoking in cars carrying children. Limited understanding of effective exposure reduction strategies and personal mental health challenges reduced some fathers' ability to create a smoke-free home. Fathers were keen to maintain their smoke-free home rules, and their motivations for this largely centered on their perceived role as protector of their children, and their desire to be a good role model. CONCLUSIONS: Fathers' abilities to create a smoke-free home are shaped by a range of capabilities, opportunities, and motivations, some of which relate to their role as a father. Establishing a fuller understanding of the contextual and gender-specific factors that shape fathers' views on smoking in the home will facilitate the development of interventions and initiatives that fathers can identify and engage with, for the broader benefit of families and to improve gender equity and health. IMPLICATIONS: Our findings can inform future development of father-centered and household-level smoke-free home interventions. They identify fathers' views and experiences and help reframe smoking in the home as a gendered family-wide issue, which is important in building consensus on how best to support parents to create a smoke-free home. Our findings highlight the need for additional research to develop understanding of the ways in which gender-related aspects of family structures, heterosexual relationships, and child living arrangements influence home smoking rules and how to tailor interventions accordingly.
Fathers , Mothers , Child , Family Characteristics , Fathers/psychology , Female , Humans , Male , Parents , Qualitative Research
Substance use and misuse is a significant global health issue that requires a sex- and gender-based analysis. Substance use patterns and trends are gendered: that is, women and men, girls and boys, and gender-diverse people often exhibit different rates of use of substances, reasons for use, modes of administration, and effects of use. Sex-specific effects and responses to substances are also important, with various substances affecting females and males differentially. Nevertheless, much research and practice in responding to substance use and misuse remains gender blind, ignoring the impacts of sex and gender on this important health issue. This special issue identifies how various aspects of sex and gender matter in substance use, illustrates the application of sex- and gender-based analyses to a range of substances, populations and settings, and assists in progressing sex and gender science in relation to substance use.
Substance-Related Disorders , Age Factors , Female , Humans , Male , Sex Factors
Currently, boys and men use cannabis at higher rates than girls and women, but the gender gap is narrowing. With the legalization of recreational cannabis use in Canada and in multiple US states, these trends call for urgent attention to the need to consider how gender norms, roles and relations influence patterns of cannabis use to inform health promotion and prevention responses. Based on a scoping review on sex, gender and cannabis use, this article consolidates existing evidence from the academic literature on how gender norms, roles and relations impact cannabis-use patterns. Evidence is reviewed on: adherence to dominant masculine and feminine norms and cannabis-use patterns among adolescents and young adults, and how prevailing norms can be both reinstated or reimagined through cannabis use; gendered social dynamics in cannabis-use settings; and the impact of gender roles and relations on cannabis use among young adults of diverse sexual orientations and gender identities. Findings from the review are compared and contrasted with evidence on gender norms, roles and relations in the context of alcohol and tobacco use. Recommendations for integrating gender transformative principles in health promotion and prevention responses to cannabis use are provided.
Cannabis , Gender Identity , Marijuana Use/psychology , Adolescent , Female , Humans , Male , Marijuana Smoking , Sexual Behavior , Young Adult
There is evidence that sex- and gender-related factors are involved in cannabis patterns of use, health effects and biological mechanisms. Women and men report different cannabis use disorder (CUD) symptoms, with women reporting worse withdrawal symptoms than men. The objective of this systematic review was to examine the effectiveness of cannabis pharmacological interventions for women and men and the uptake of sex- and gender-based analysis in the included studies. Two reviewers performed the full-paper screening, and data was extracted by one researcher. The search yielded 6098 unique records-of which, 68 were full-paper screened. Four articles met the eligibility criteria for inclusion. From the randomized clinical studies of pharmacological interventions, few studies report sex-disaggregated outcomes for women and men. Despite emergent evidence showing the influence of sex and gender factors in cannabis research, sex-disaggregated outcomes in pharmacological interventions is lacking. Sex- and gender-based analysis is incipient in the included articles. Future research should explore more comprehensive inclusion of sex- and gender-related aspects in pharmacological treatments for CUD.
Marijuana Abuse/drug therapy , Sex Factors , Substance Withdrawal Syndrome/drug therapy , Cannabis , Female , Humans , Male
Cannabis is the second most frequently used substance in the world and regulated or legalized for recreational use in Canada and fourteen US states and territories. As with all substances, a wide range of sex and gender related factors have an influence on how substances are consumed, their physical, mental and social impacts, and how men and women respond to treatment, health promotion, and policies. Given the widespread use of cannabis, and in the context of its increasing regulation, it is important to better understand the sex and gender related factors associated with recreational cannabis use in order to make more precise clinical, programming, and policy decisions. However, sex and gender related factors include a wide variety of processes, features and influences that are rarely fully considered in research. This article explores myriad features of both sex and gender as concepts, illustrates their impact on cannabis use, and focuses on the interactions of sex and gender that affect three main areas of public interest: the development of cannabis use dependence, the impact on various routes of administration (ROA), and the impact on impaired driving. We draw on two separate scoping reviews to examine available evidence in regard to these issues. These three examples are described and illustrate the need for more comprehensive and precise integration of sex and gender in substance use research, as well as serious consideration of the results of doing so, when addressing a major public health issue such as recreational cannabis use.
Cannabis , Marijuana Smoking/epidemiology , Female , Gender Identity , Humans , Male , Marijuana Smoking/trends , Sex Factors
Enabling parents to create a smoke-free home is one of the key ways that children's exposure to second-hand smoke (SHS) can be reduced. Smoke-free home interventions have largely targeted mothers who smoke, and there is little understanding of the barriers and facilitators that fathers experience in creating a smoke-free home. Systematic searches combining terms for fathers, homes, and SHS exposure were run in April 2019 in Web of Science's Citation Indices, PsycINFO, and PubMed for English-language studies published since 2008. The searches identified 980 records for screening, plus 66 records from other sources. Twelve studies reported in 13 papers were included in this scoping review. Eight of the studies were conducted in Asian countries (five in China, one in India, one in Japan, and one in Iran), three were conducted in Canada, and one in Turkey. Findings were extracted in verbatim text for thematic analysis. The review identified that attitudes and knowledge, cultural and social norms, gender power relations, and shifting perceptions and responsibilities related to fatherhood can impact on fathers' views of their role in relation to creating and maintaining a smoke-free home. There were too few published studies that had assessed smoke-free home interventions with fathers to draw conclusions regarding effective approaches. Research is clearly needed to inform our understanding of fathers' roles, successes and challenges in creating and maintaining a smoke-free home, so that father-inclusive rather than mother-led interventions can be developed to benefit entire households and improve gender equity as well as health.
Fathers/psychology , Tobacco Smoke Pollution/analysis , Adult , Child , Family Characteristics , Female , Humans , Male , Mothers
Rates of smoking during pregnancy remain high in Canada, and cessation rates are low among women who are younger than 24 years and who are socially disadvantaged, that is, have few social and economic resources because of poverty, violence, or mental health issues. On the basis of findings from literature reviews and consultation with policy makers, we developed and operationalized four approaches that can be used by health care providers to tailor interventions for tobacco use in pregnancy. These four approaches are woman centered, trauma informed, harm reducing, and equitable. Public health initiatives that address smoking in young and socially disadvantaged women could be more sharply focused by shifting to such tailored approaches that are grounded in social justice aims, span pre- and postpregnancy periods, and can be used to address women's social contexts and concerns.
Mental Health/standards , Pregnancy Complications , Pregnant Women , Smoking Reduction , Smoking , Women's Health Services/standards , Canada/epidemiology , Female , Health Services Needs and Demand , Humans , Pregnancy , Pregnancy Complications/prevention & control , Pregnancy Complications/psychology , Pregnant Women/education , Pregnant Women/psychology , Smoking/epidemiology , Smoking/psychology , Smoking/therapy , Smoking Reduction/methods , Smoking Reduction/psychology , Smoking Reduction/statistics & numerical data , Socioeconomic Factors , Young Adult
Recreational cannabis use is in the process of being legalized in Canada, and new products and devices for both nicotine and cannabis vaping are being introduced. Yet, research on the harms of involuntary exposure to electronic nicotine delivery systems (ENDSs) and cannabis vaping is in its infancy, and there is a lack of investigation on sex-specific health effects and gendered patterns of exposure and use. We argue that responses to ENDS and cannabis vaping exposures should align with policy and progress on restricting exposure to tobacco secondhand smoke (SHS). Furthermore, we argue that sex, gender, and equity considerations should be integrated in both research and policy to benefit all Canadians.
Air Pollution, Indoor/adverse effects , Cannabis/adverse effects , Electronic Nicotine Delivery Systems/statistics & numerical data , Nicotine/administration & dosage , Vaping , Age Factors , Canada , Humans , Policy , Sex Factors , Tobacco Smoke Pollution/adverse effects
Pregnancy is often framed as a "window of opportunity" for intervening on a variety of health practices such as alcohol and tobacco use. However, there is evidence that interventions focusing solely on the time of pregnancy can be too narrow and potentially stigmatizing. Indeed, health risks observed in the preconception period often continue during pregnancy. Using a scoping review methodology, this study consolidates knowledge and information related to current preconception and interconception health care interventions published in the academic literature. We identified a total of 29 intervention evaluations, and summarized these narratively. Findings suggest that there has been some progress in intervening on preconception health, with the majority of interventions offering assessment or screening followed by brief intervention or counselling. Overall, these interventions demonstrated improvements in at least some of the outcomes measured. However, further preconception care research and intervention design is needed. In particular, the integration of gender transformative principles into preconception care is needed, along with further intervention design for partners/ men, and more investigation on how best to deliver preconception care.
Patient Education as Topic/methods , Preconception Care/methods , Pregnancy Complications/prevention & control , Reproductive Health/standards , Adult , Female , Humans , Pregnancy , Primary Health Care/methods
BACKGROUND: There has been a recent swell in activity by health research funding organizations and science journal editors to increase uptake of sex and gender considerations in study design, conduct and reporting in order to ensure that research results apply to everyone. However, examination of the implementation research literature reveals that attention to sex and gender has not yet infiltrated research methods in this field. DISCUSSION: The rationale for routinely considering sex and gender in implementation research is multifold. Sex and gender are important in decision-making, communication, stakeholder engagement and preferences for the uptake of interventions. Gender roles, gender identity, gender relations, and institutionalized gender influence the way in which an implementation strategy works, for whom, under what circumstances and why. There is emerging evidence that programme theories may operate differently within and across sexes, genders and other intersectional characteristics under various circumstances. Furthermore, without proper study, implementation strategies may inadvertently exploit or ignore, rather than transform thinking about sex and gender-related factors. Techniques are described for measuring and analyzing sex and gender in implementation research using both quantitative and qualitative methods. The present paper describes the application of methods for integrating sex and gender in implementation research. Consistently asking critical questions about sex and gender will likely lead to the discovery of positive outcomes, as well as unintended consequences. The result has potential to strengthen both the practice and science of implementation, improve health outcomes and reduce gender inequities.
Sex Factors , Female , Humans , Male , Research Design , Sex Distribution
BACKGROUND: This study examined the formulation, adoption, and implementation of a ban on smoking in the parks and beaches in Vancouver, Canada. METHODS: Informed by Critical Multiplism, we explored the policy adoption process, support for and compliance with a local bylaw prohibiting smoking in parks and on beaches, experiences with enforcement, and potential health equity issues through a series of qualitative and quantitative studies. RESULTS: Findings suggest that there was unanimous support for the introduction of the bylaw among policy makers, as well as a high degree of positive public support. We observed that smoking initially declined following the ban's implementation, but that smoking practices vary in parks by location. We also found evidence of different levels of enforcement and compliance between settings, and between different populations of park and beach users. CONCLUSIONS: Overall success with the implementation of the bylaw is tempered by potential increases in health inequities because of variable enforcement of the ban; greatest levels of smoking appear to continue to occur in the least advantaged areas of the city. Jurisdictions developing such policies need to consider how to allocate sufficient resources to enhance voluntary compliance and ensure that such bylaws do not contribute to health inequities.
Smoke-Free Policy/legislation & jurisprudence , Smoking/legislation & jurisprudence , Tobacco Smoke Pollution/legislation & jurisprudence , Bathing Beaches , British Columbia , Canada , Cities , Humans , Policy Making
Background. National data from Canada and the United States identify women to be at greater risk than men for the misuse of prescription opioid medications. Various sex- and gender-based factors and patient and physician practices may affect women's use and misuse of prescription opioid drugs. Objectives. To explore the particular risks, issues, and treatment considerations for prescription opioid misuse among women who experience chronic noncancer pain and trauma. Methods. A scoping review for articles published between January 1990 and May 2014 was conducted on sex- and gender-based risks and treatment considerations among women who experience chronic noncancer pain and trauma. Results. A total of 57 articles were identified. The present narrative review summarizes the specific risks for the misuse of prescription opioid medication among women who have experienced violence and trauma, Aboriginal women, adolescents and young women, older women, pregnant women, women of a sexual minority, and transwomen. Discussion. The majority of the literature is descriptive, with few studies that evaluate approaches and interventions to respond to the issue of chronic pain, trauma, and misuse of prescription opioids among women, particularly vulnerable subgroups of women. Conclusions. Trauma-informed and women-centred approaches that address women's vulnerabilities and complex needs require further attention.
Analgesics, Opioid/adverse effects , Chronic Pain/drug therapy , Prescription Drug Misuse/statistics & numerical data , Wounds and Injuries/drug therapy , Canada/epidemiology , Female , Humans , United States/epidemiology
