Institute of Gender and Health

The Women's Health Australia (WHA) project is a longitudinal study of several cohorts of Australian women, which aims to examine the relationships between biological, psychological, social and lifestyle factors and women's physical health, emotional well-being, and their use of and satisfaction with health care. Using the Medicare database as a sampling frame (with oversampling of women from rural and remote areas), 106,000 women in the three age groups 18-23, 45-50 and 70-75 were sent an invitation to participate and a 24-page self-complete questionnaire. Reminder letters, a nation-wide publicity campaign, information brochures, a freecall number for inquiries, and the option of completing the questionnaire by telephone in English or in the respondent's own language, were used to encourage participation. Statutory regulations precluded telephone follow-up of non-respondents. Response rates were 41% (N = 14,792), 54% (N = 14,200) and 36% (N = 12,614) for the three age groups. Comparison with Australian census data indicated that the samples are reasonably representative of Australian women in these age groups, except for a somewhat higher representation of women who are married or in a defacto relationship, and of women with post-school education. The most common reason for non-participation was lack of interest or time. Personal circumstances, objections to the questionnaire or specific items in it, and concerns about confidentiality were the other main reasons. Recruitment of three representative age-group cohorts of women, and the maintenance of these cohorts over a number of years, will provide a valuable opportunity to examine associations over time between aspects of women's lives and their physical and emotional health and well-being.

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.

OBJECTIVES: To examine associations between the perpetration of intimate partner violence and HIV risk behaviour among young men in rural South Africa. DESIGN: An analysis of baseline data from men enrolling in a randomized controlled trial of the behavioural intervention, Stepping Stones. METHODS: Structured interviews with 1275 sexually experienced men aged 15-26 years from 70 villages in the rural Eastern Cape. Participants were asked about the type, frequency, and timing of violence against female partners, as well as a range of questions about HIV risk behaviours. RESULTS: A total of 31.8% of men reported the perpetration of physical or sexual violence against female main partners. Perpetration was correlated with higher numbers of past year and lifetime sexual partners, more recent intercourse, and a greater likelihood of reporting casual sex partners, problematic substance use, sexual assault of non-partners, and transactional sex. Men who reported both physical and sexual violence against a partner, perpetration both before and within the past 12 months, or more than one episode of perpetration reported significantly higher levels of HIV risk behaviour than men who reported less severe or less frequent perpetration of violence. CONCLUSION: Young men who perpetrate partner violence engage in significantly higher levels of HIV risk behaviour than non-perpetrators, and more severe violence is associated with higher levels of risky behaviour. HIV prevention interventions must explicitly address the links between the perpetration of intimate partner violence and HIV risk behaviour among men, as well as the underlying gender and power dynamics that contribute to both.

OBJECTIVES: Our goals were to (1) determine adolescents' motivations (reasons) for engaging in the nonmedical (illicit) use of 4 classes of prescription medications and (2) examine whether motivations were associated with a higher risk for substance abuse problems. RESPONDENTS: The 2005 sample (N = 1086) was derived from one ethnically diverse school district in southeastern Michigan and included 7th- through 12th-grade students. METHODS: Data were collected by using a self-administered, Web-based survey that included questions about drug use and the motivations to engage in nonmedical use of prescription medication. RESULTS: Twelve percent of the respondents had engaged in nonmedical use of opioid pain medications in the past year: 3% for sleeping, 2% as a sedative and/or for anxiety, and 2% as stimulants. The reasons for engaging in the nonmedical use of prescription medications varied by drug classification. For opioid analgesics, when the number of motives increased, so too did the likelihood of a positive Drug Abuse Screening Test score. For every additional motive endorsed, the Drug Abuse Screening Test increased by a factor of 1.8. Two groups of students were compared (at-risk versus self-treatment); those who endorsed multiple motivations for nonmedical use of opioids (at-risk group) were significantly more likely to have elevated Drug Abuse Screening Test scores when compared with those who were in the self-treatment group. Those in the at-risk group also were significantly more likely to engage in marijuana and alcohol use. CONCLUSION: The findings from this exploratory study warrant additional research because several motivations for the nonmedical use of prescription medications seem associated with a greater likelihood of substance abuse problems.

We investigated sex differences and the role of estrogen receptor-beta (ERbeta) on myocardial hypertrophy in a mouse model of pressure overload. We performed transverse aortic constriction (TAC) or sham surgery in male and female wild-type (WT) and ERbeta knockout (ERbeta(-/-)) mice. All mice were characterized by echocardiography and hemodynamic measurements and were killed 9 wk after surgery. Left ventricular (LV) samples were analyzed by microarray profiling, real-time RT-PCR, and histology. After 9 wk, WT males showed more hypertrophy and heart failure signs than WT females. Notably, WT females developed a concentric form of hypertrophy, while males developed eccentric hypertrophy. ERbeta deletion augmented the TAC-induced increase in cardiomyocyte diameter in both sexes. Gene expression profiling revealed that WT male hearts had a stronger induction of matrix-related genes and a stronger repression of mitochondrial genes than WT female hearts. ERbeta(-/-) mice exhibited a different transcriptional response. ERbeta(-/-)/TAC mice of both sexes exhibited induction of proapoptotic genes with a stronger expression in ERbeta(-/-) males. Cardiac fibrosis was more pronounced in male WT/TAC than in female mice. This difference was abolished in ERbeta(-/-) mice. The number of apoptotic nuclei was increased in both sexes of ERbeta(-/-)/TAC mice, most prominent in males. Female sex offers protection against ventricular chamber dilation in the TAC model. Both female sex and ERbeta attenuate the development of fibrosis and apoptosis, thus slowing the progression to heart failure.

OBJECTIVES: Most US studies of national trends in medical and nonmedical use of prescription opioids have focused on adults. Given the limited understanding in these trends among adolescents, we examine national trends in the medical and nonmedical use of prescription opioids among high school seniors between 1976 and 2015. METHODS: The data used for the study come from the Monitoring the Future study of adolescents. Forty cohorts of nationally representative samples of high school seniors (modal age 18) were used to examine self-reported medical and nonmedical use of prescription opioids. RESULTS: Lifetime prevalence of medical use of prescription opioids peaked in both 1989 and 2002 and remained stable until a recent decline from 2013 through 2015. Lifetime nonmedical use of prescription opioids was less prevalent and highly correlated with medical use of prescription opioids over this 40-year period. Adolescents who reported both medical and nonmedical use of prescription opioids were more likely to indicate medical use of prescription opioids before initiating nonmedical use. CONCLUSIONS: Prescription opioid exposure is common among US adolescents. Long-term trends indicate that one-fourth of high school seniors self-reported medical or nonmedical use of prescription opioids. Medical and nonmedical use of prescription opioids has declined recently and remained highly correlated over the past 4 decades. Sociodemographic differences and risky patterns involving medical and nonmedical use of prescription opioids should be taken into consideration in clinical practice to improve opioid analgesic prescribing and reduce adverse consequences associated with prescription opioid use among adolescents.

OBJECTIVE: In adults, posttraumatic stress disorder (PTSD) is associated with adverse health outcomes and high medical utilization and cost. PTSD is twice as common in women and is associated with increased risk for a range of diseases, chronic conditions, and reproductive-health problems. Little is known about the health effects of PTSD in children. The purpose of this study was to explore patterns of physical comorbidity in female children and adolescents with PTSD by using population data. METHODS: This study was a cross-sectional, descriptive epidemiologic case-control analysis of a Midwestern state's Medicaid eligibility and paid-claims data for girls (0-8 years old) and teens (9-17 years old). Data were from 1994-1997. All those with the PTSD diagnostic code were compared with randomly selected controls in relation to 3 sets of outcomes: (1) International Classification of Diseases, Ninth Revision (ICD-9) categories of disease; (2) chronic conditions previously associated with sexual trauma and PTSD in women; and (3) reproductive-health problems. Analyses included bivariate odds ratios (OR) and logistic-regression models that control for the extent of insurance coverage and the independent associations of victimization and psychiatric comorbidity with the 3 sets of outcomes. The mental health covariate was categorical to allow consideration of a range of severity. There were 4 categories for the young girls: neither PTSD nor depression, PTSD without depression, depression without PTSD, and PTSD + depression. For the adolescent analysis, a fifth category reflecting a "complex PTSD" was added, defined as having PTSD complicated by a dissociative disorder or borderline personality disorder diagnosis. RESULTS: There were 647 girls and 1025 adolescents with the PTSD diagnosis. Overall, PTSD was associated with adverse health outcomes in both age strata. Victimization was sometimes independently associated with adverse health outcomes, but PTSD often was a mediator, especially in the adolescent age stratum. The importance of PTSD diagnosis as a predictor of the ICD-9 categories of disease or chronic conditions seemed to increase with age. In the younger age stratum, the increased bivariate ORs of significant associations with PTSD ranged from 1.4 for digestive disorders to 3.4 for circulatory disorders. Among younger girls, PTSD diagnosis was associated with significantly greater bivariate odds for 9 of the 12 ICD-9 categories of disease but not for neoplasms, blood disorders, or respiratory disorders and with threefold increased odds for chronic fatigue. They also had 1.8 times greater odds for sexually transmitted infections, some of which could be from congenital transmission in this age group, which includes infants. In the multivariate models for the young girls, the mental health variable seemed to mediate the relationship between victimization and increased odds of infectious and parasitic diseases, endocrine/metabolic/immune disorders, circulatory diseases, skin and cutaneous tissue disorders, and having any 1 of the 5 chronic conditions. The mental health categories that were significantly associated with health outcomes varied across the conditions. There were no health outcomes in which the depression-without-PTSD category was the only one significantly associated with the outcome condition. Circulatory and musculoskeletal disorders were significantly associated with all 3 of the mental health categories. Having any 1 of the 5 chronic conditions was significantly associated only with simple PTSD (PTSD without depression). Genitourinary disorders and signs/symptoms/ill-defined conditions were significantly associated with both simple and comorbid PTSD. PTSD with comorbid depression, the most severe of the mental health categories in this younger age group, was the only category associated with the endocrine/metabolic/immune disorders and skin disorders outcomes. In the adolescent age stratum, the bivariate ORs significantly associated with PTSD ranged from 2.1 for blood disorders to 5.2 for irritable bowel syndrome. Adolescents with PTSD were nearly twice as likely to have a sexually transmitted infection and 60% more likely to have cervical dysplasia. However, their rate of pregnancy was lower (23% vs 31%), a one-fourth decreased odds. In the adolescent group, only 4 outcomes (nervous system/sense organ, digestive, and genitourinary disorders and signs/symptoms/ill-defined conditions) remained statistically significantly associated with victimization after the mental health variable was added, suggesting an additive model of risk for these outcomes but a mediating role for PTSD in relation to the majority of the health outcomes. Among the adolescent girls, the range of ORs for the ICD-9 and chronic-condition diagnoses generally increased across the categories of the mental health variable in a dose-response pattern. Compared with adolescents with neither PTSD nor depression, those with PTSD without depression had statistically significant ORs from 1.5 to 3.6. Those with depression without PTSD had statistically significant ORs from 1.9 to 4.4. The significant ORs for those with PTSD comorbid with depression were from 2.3 to 6.6, and those in the complex-PTSD category had significant ORs of between 2.5 and 14.9. Only blood disorders seemed to be more strongly associated with depression alone than with the comorbid and complex forms of PTSD. The simple-PTSD category was not significantly associated with blood disorders, chronic pelvic pain, fibromyalgia, or dysmenorrhea. Depression without PTSD was not significantly associated with chronic pelvic pain or fibromyalgia. Fibromyalgia was only significantly associated with complex PTSD. CONCLUSIONS: In young girls who receive Medicaid benefits, PTSD was associated with increased odds of a range of adverse health conditions. The pattern and odds of physical comorbidity among adolescent recipients with PTSD was nearly as extensive as that seen in adult women. Overall, the pattern observed suggests that objective disease states (eg, circulatory problems, infections) may be associated with PTSD to an extent nearly as great as that of PTSD with more subjective somatic experience of loss of wellness. Using the concepts of allostatic load and allostatic support, professionals who work with children and adolescents may be able to decrease the toll that traumatic stress takes on health even if available interventions can only be thought of as supportive and fall short of completely preventing trauma exposure or completely healing posttraumatic stress. Clinical research to extend these exploratory findings is warranted.

To improve the outcomes of research and medicine, government-based international research funding agencies have implemented various types of policies and mechanisms with respect to sex as a biological variable and gender as a sociocultural factor. After the 1990s, the US National Institutes of Health (NIH), the Canadian Institutes of Health Research (CIHR), and the European Commission (EC) began requesting that applicants address sex and gender considerations in grant proposals, and offering resources to help the scientific community integrate sex and gender into biomedical research. Although it is too early to analyze data on the success of all of the policies and mechanisms implemented, here we review the use both of carrots (incentives) and sticks (requirements) developed to motivate researchers and the entire scientific research enterprise to consider sex and gender influences on health and in science. The NIH focused on sex as a biological variable (SABV) aligned with an initiative to enhance reproducibility through rigor and transparency; CIHR instituted a sex- and gender-based analysis (SGBA) policy; and the EC required the integration of the "gender dimension," which incorporates sex, gender, and intersectional analysis into research and innovation. Other global efforts are briefly summarized. Although we are still learning what works, we share lessons learned to improve the integration of sex and gender considerations into research. In conjunction with refining and expanding the policies of funding agencies and mechanisms, private funders/philanthropic groups, editors of peer-reviewed journals, academic institutions, professional organizations, ethics boards, health care systems, and industry also need to make concerted efforts to integrate sex and gender into research, and we all must bridge across silos to promote systemwide solutions throughout the biomedical enterprise. For example, policies that encourage researchers to disaggregate data by sex and gender, the development of tools to better measure gender effects, or policies similar to SABV and/or SGBA adopted by private funders would accelerate progress. Uptake, accountability for, and a critical appraisal of sex and gender throughout the biomedical enterprise will be crucial to achieving the goal of relevant, reproducible, replicable, and responsible science that will lead to better evidence-based, personalized care for all, but especially for women.

Women and men, female and male animals and cells are biologically different, and acknowledgement of this fact is critical to advancing medicine. However, incorporating concepts of sex-specific analysis in basic research is largely neglected, introducing bias into translational findings, clinical concepts and drug development. Research funding agencies recently approached these issues but implementation of policy changes in the scientific community is still limited, probably due to deficits in concepts, knowledge and proper methodology. This expert review is based on the EUGenMed project (www.eugenmed.eu) developing a roadmap for implementing sex and gender in biomedical and health research. For sake of clarity and conciseness, examples are mainly taken from the cardiovascular field that may serve as a paradigm for others, since a significant amount of knowledge how sex and oestrogen determine the manifestation of many cardiovascular diseases (CVD) has been accumulated. As main concepts for implementation of sex in basic research, the study of primary cell and animals of both sexes, the study of the influence of genetic vs. hormonal factors and the analysis of sex chromosomes and sex specific statistics in genome wide association studies (GWAS) are discussed. The review also discusses methodological issues, and analyses strength, weaknesses, opportunities and threats in implementing sex-sensitive aspects into basic research.

OBJECTIVES To determine the prevalence of medical and nonmedical use of prescription opioids among high school seniors in the United States and to assess substance use behaviors based on medical and nonmedical use of prescription opioids. DESIGN Nationally representative samples of high school seniors (modal age 18 years) were surveyed during the spring of their senior year via self-administered questionnaires. SETTING Data were collected in public and private high schools. PARTICIPANTS The sample consisted of 7374 students from 3 independent cohorts (2007, 2008, and 2009). OUTCOME MEASURES Self-reports of medical and nonmedical use of prescription opioids and other substance use. RESULTS An estimated 17.6% of high school seniors reported lifetime medical use of prescription opioids, while 12.9% reported nonmedical use of prescription opioids. Sex differences in the medical and nonmedical use were minimal, while racial/ethnic differences were extensive. More than 37% of nonmedical users reported intranasal administration of prescription opioids. An estimated 80% of nonmedical users with an earlier history of medical use had obtained prescription opioids from a prescription they had previously. The odds of substance use behaviors were greater among individuals who reported any history of nonmedical use of prescription opioids relative to those who reported medical use only. CONCLUSIONS Nearly 1 in every 4 high school seniors in the United States has ever had some exposure to prescription opioids either medically or nonmedically. The quantity of prescription opioids and number of refills prescribed to adolescents should be carefully considered and closely monitored to reduce subsequent nonmedical use of leftover medication.

OBJECTIVE: To determine the extent to which prenatal post-traumatic stress disorder (PTSD) is associated with lower birthweight and shorter gestation, and to explore the effects of childhood maltreatment as the antecedent trauma exposure. DESIGN: Prospective three-cohort study. SETTING: Ann Arbor and Detroit, Michigan, United States. SAMPLE: In all, 839 diverse nulliparas in PTSD-positive (n = 255), trauma-exposed, resilient (n = 307) and non-exposed to trauma (n = 277) cohorts. METHODS: Standardised telephone interview before 28 weeks of gestation to ascertain trauma history, PTSD, depression, substance use, mental health treatment history and sociodemographics, with chart abstraction to obtain chronic condition history, antepartum complications and prenatal care data, as well as outcomes. MAIN OUTCOME MEASURES: Infant birthweight and gestational age per delivery record. RESULTS: Infants born to women with PTSD during pregnancy had a mean birthweight 283 g less than infants of trauma-exposed, resilient women and 221 g less than infants of non-exposed women (F(3,835) = 5.4, P = 0.001). PTSD was also associated with shorter gestation in multivariate models that took childhood abuse history into account. Stratified models indicated that PTSD subsequent to child abuse trauma exposure was most strongly associated with adverse outcomes. PTSD was a stronger predictor than African American race of shorter gestation and a nearly equal predictor of birthweight. Prenatal care was not associated with better outcomes among women abused in childhood. CONCLUSIONS: Abuse-related PTSD may be an additional or alternative explanation for adverse perinatal outcomes associated with low socio-economic status and African American race in the USA. Biological and interventions research is warranted along with replication studies in other nations.

The purpose of this ethnographic study was to understand how immigrant women caregivers accessed support from community resources and identify the barriers to this support. The study included 29 Chinese and South Asian women caring for an ill or disabled child or adult relative. All experienced barriers to accessing community services. Some possessed personal resources and strategies to overcome them; others remained isolated and unconnected. Family and friends facilitated connections, and a connection with one community service was often linked to several resources. Caregivers who failed to establish essential ties could not initiate access to resources, and community services lacked outreach mechanisms to identify them. These findings contribute new understanding of how immigrant women caregivers connect with community resources and confirm the impact of immigration on social networks and access to support.

OBJECTIVES: To determine the prevalence of medical use of 4 classes of prescription medications relative to nonmedical use (illicit use), to examine the relative rates among the 4 drug classes, and to assess whether gender differences exist in the trading, selling, loaning, or giving away of medications. DESIGN: A Web-based survey was administered to 7th- to 12th-grade students residing in 1 ethnically diverse school district; a 68% response rate was achieved. SETTING: During a 3-week period in May 2005, teachers brought students to their schools' computing center where students took the survey using a unique personal identification number to sign on to the survey. PARTICIPANTS: There were 1086 secondary students, including 586 girls, 498 boys, 484 black students, and 565 white students. MAIN OUTCOME MEASURES: Students were asked about their medical and nonmedical use of sleeping, sedative or anxiety, stimulant, and pain medications. Diversion of prescription medication was assessed by determining who asked the student to divert his or her prescription and who received it. RESULTS: Thirty-six percent of students reported having a recent prescription for 1 of the 4 drug classes. A higher percentage of girls reported giving away their medications than boys (27.5% vs 17.4%, respectively; chi(2)(1) = 6.7; P = .01); girls were significantly more likely than boys to divert to female friends (64.0% vs 21.2%, respectively; chi(2)(1) = 17.5; P<.001) whereas boys were more likely than girls to divert to male friends (45.5% vs 25.6%, respectively; chi(2)(1) = 4.4; P = .04). Ten percent diverted their drugs to parents. CONCLUSION: Physicians should discuss the proper use of prescription medications with their patients and their patients' families.

We analyzed the impact of a requirement introduced in December 2010 that all applicants to the Canadian Institutes of Health Research indicate whether their research designs accounted for sex or gender. We aimed to inform research policy by understanding the extent to which applicants across health research disciplines accounted for sex and gender. We conducted a descriptive statistical analysis to identify trends in application data from three research funding competitions (December 2010, June 2011, and December 2011) (N = 1459). We also conducted a qualitative thematic analysis of applicants' responses. Here we show that the proportion of applicants responding affirmatively to the questions on sex and gender increased over time (48% in December 2011, compared to 26% in December 2010). Biomedical researchers were least likely to report accounting for sex and gender. Analysis by discipline-specific peer review panel showed variation in the likelihood that a given panel will fund grants with a stated focus on sex or gender. These findings suggest that mandatory questions are one way of encouraging the uptake of sex and gender in health research, yet there remain persistent disparities across disciplines. These disparities represent opportunities for policy intervention by health research funders.

Individualization of drug therapy requires that the right drug be administered at the correct dose to patients who are likely to achieve the highest benefit and lowest risk. Female sex and age comprise two important risk factors for altered drug exposure and response. This review summarizes the current state of science for considering age and sex-related factors along the drug development pipeline, from cell culture and animal research through all phases of clinical trials in humans. A set of recommendations is provided to improve standards for integrating age and sex into the study design, analysis, and reporting of pre-clinical and clinical assessment of new molecular entities and biologics in adults.

BACKGROUND: Over the past decade, the Canadian Institutes of Health Research (CIHR) has implemented multicomponent interventions to increase the uptake of sex and gender in grant applications. Interventions included mandatory reporting on applicant forms, development of resources for applicants and evaluators, and grant review requirements. Here, we aim to inform science policy implementation by describing the 10-year outcomes and lessons learned from these interventions. METHODS: This is a prospective longitudinal study. The population is all applicants across 15 investigator-initiated CIHR competitions from 2011 to 2019 and grant evaluators from 2018 to 2019. Quantitative data were derived from applicants' and grant evaluators' mandatory reporting of sex and gender integration in the grants management database. The application was the unit of analysis. Trends in sex and gender uptake in applications were plotted over time, stratified by research area. Univariate logistic regression was used to assess associations between the sex of the applicant and the uptake of sex and gender, and the latter with funding success. Qualitative review of the quality and appropriateness of evaluators' comments informed the development of discipline-specific training to peer review committee members. Feedback was compiled from a subset of evaluators on the perceived usefulness of the educational materials using a brief questionnaire. RESULTS: Since 2011, 39,390 applications were submitted. The proportion that reported integration of sex rose from 22 to 83%, and gender from 12 to 33%. Population health research applications paid the greatest attention to gender (82%). Across every competition, applications with female principal investigators were more likely to integrate sex (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.50-1.63) and gender (OR 2.40, 95% CI 2.29-2.51) than those who identified as male. Since 2018, applications that scored highly for the integration of sex (OR 1.92, 95% CI 1.50-2.50) and gender (OR 2.53, 95% CI 1.83-3.50) were more likely to be funded. Qualitative observations revealed persistent conflation of the terms sex and gender. Eighty-six percent of evaluators appreciated the tailored discipline-specific coaching. CONCLUSIONS: A number of policy interventions improved sex and gender uptake in grant applications, with higher success rates observed over time for applications that integrated sex and gender. Other funders' action plans around sex and gender integration may be informed from our experiences of the timing, type and targets of the different interventions, specifically those directed at evaluators.

BACKGROUND: The importance of sex and gender in the diagnosis and management of health conditions is well established, but the extent to which this evidence is integrated into clinical practice guidelines remains unknown. We aimed to determine the proportion of Canadian clinical practice guidelines that integrate evidence on sex and gender considerations. METHODS: We searched the Canadian Medical Association's CPG Infobase, PubMed, all provincial/territorial websites and websites of professional organizations for English- and French-language Canadian clinical practice guidelines published between January 2013 and June 2015 on selected conditions identified as priorities by policy-makers and practitioners. Citations and text were searched electronically using keyword terms related to sex and gender. Three investigators independently analyzed and categorized the content of text-positive clinical practice guidelines based on clinical relevance for practitioners. RESULTS: Of the 118 clinical practice guidelines that met the inclusion criteria, 79 (66.9%) were text-positive for sex and/or gender keywords; 8 (10%) of the 79 used the keywords only in relation to pregnancy. Of the remaining 71 guidelines, 25 (35%) contained sex-related diagnostic or management recommendations. An additional 5 (7%) contained recommendations for sex-specific laboratory reference values, 29 (41%) referred to differences in epidemiologic features or risk factors only, and 12 (17%) contained nonrelevant mentions of search keywords. Twenty-five (35%) of the text-positive guidelines used the terms "sex" and/or "gender" correctly. INTERPRETATION: Recommendations related to sex and gender are inconsistently reported in Canadian clinical practice guidelines. Guidelines such as the Sex and Gender Equity in Research guidelines may help inform the meaningful inclusion of sex and gender evidence in the development of clinical practice guidelines.

BACKGROUND: Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants. METHODS: We searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second. RESULTS: The search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12-6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined "sex" and/or "gender." No publication carried out a comprehensive sex and gender analysis. CONCLUSIONS: Findings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research.

BACKGROUND: The number of e-mental health apps is increasing rapidly. Studies have shown that the use of some apps is beneficial, whereas others are ineffective or do not meet users' privacy expectations. Individuals and organizations that curate, recommend, host, use, or pay for apps have an interest in categorizing apps according to the consensus criteria of usability and effectiveness. Others have previously published recommendations for assessing health-related apps; however, the extent to which these recommendations can be generalized across different population groups (eg, culture, gender, and language) remains unclear. This study describes an attempt by Canadian stakeholders to develop an e-mental health assessment framework that responds to the unique needs of people living in Canada in an evidence-based manner. OBJECTIVE: The objective of our study was to achieve consensus from a broad group of Canadian stakeholders on guiding principles and criteria for a framework to assess e-mental health apps in Canada. METHODS: We developed an initial set of guiding principles and criteria from a rapid review and environmental scan of pre-existing app assessment frameworks. The initial list was refined through a two-round modified Delphi process. Participants (N=25) included app developers and users, health care providers, mental health advocates, people with lived experience of a mental health problem or mental illness, policy makers, and researchers. Consensus on each guideline or criterion was defined a priori as at least 70% agreement. The first round of voting was conducted electronically. Prior to Round 2 voting, in-person presentations from experts and a persona empathy mapping process were used to explore the perspectives of diverse stakeholders. RESULTS: Of all respondents, 68% (17/25) in Round 1 and 100% (13/13) in Round 2 agreed that a framework for evaluating health apps is needed to help Canadian consumers identify high-quality apps. Consensus was reached on 9 guiding principles: evidence based, gender responsive, culturally appropriate, user centered, risk based, internationally aligned, enabling innovation, transparent and fair, and based on ethical norms. In addition, 15 informative and evaluative criteria were defined to assess the effectiveness, functionality, clinical applicability, interoperability, usability, transparency regarding security and privacy, security or privacy standards, supported platforms, targeted users, developers' transparency, funding transparency, price, user desirability, user inclusion, and meaningful inclusion of a diverse range of communities. CONCLUSIONS: Canadian mental health stakeholders reached the consensus on a framework of 9 guiding principles and 15 criteria important in assessing e-mental health apps. What differentiates the Canadian framework from other scales is explicit attention to user inclusion at all stages of the development, gender responsiveness, and cultural appropriateness. Furthermore, an empathy mapping process markedly influenced the development of the framework. This framework may be used to inform future mental health policies and programs.

Translating policy into action is a complex task, with much debate surrounding the process whereby US and Canadian health funding agencies intend to integrate sex and gender science as an integral component of methodological rigor and reporting in health research. Effective January 25, 2016, the US National Institutes of Health implemented a policy that expects scientists to account for the possible role of sex as a biological variable (SABV) in vertebrate animal and human studies. Applicants for NIH-funded research and career development awards will be asked to explain how they plan to factor consideration of SABV into their research design, analysis, and reporting; strong justification will be required for proposing single-sex studies. The Canadian Institutes of Health Research is revising their peer review accreditation process to ensure that peer reviewers are skilled in applying a critical lens to protocols that should be incorporating sex and gender science. The current paper outlines the components that peer reviewers in North America will be asked to assess when considering whether SABV is appropriately integrated into research designs, analyses, and reporting. Consensus argues against narrowly defining rules of engagement in applying SABV, with criteria provided for reviewers as guidance only. Scores will not be given for each criterion; applications will be judged on the overall merit of scientific innovation, rigor, reproducibility, and potential impact.