Female participation, and sex-specific reporting practices, in polypill randomised controlled trials in the prevention of atherosclerotic cardiovascular disease: a secondary analysis of a systematic review.

BACKGROUND: The polypill is an emerging strategy for the prevention and management of cardiovascular disease. We assessed the participation of females in randomised controlled trials evaluating polypills for prevention of cardiovascular disease and subsequent sex-specific analyses and reporting. METHODS: Cardiovascular polypill trials were identified through a systematic review. Data were extracted on the use of sex-specific eligibility criteria, female participation, and the conduct, findings, and interpretation of sex-specific analyses. RESULTS: Of 26 trials included, 12 (46%) excluded groups of females, mainly if pregnant or lactating or of childbearing potential. Female participation ranged from 10% to 73% across trials. Overall, 42% of included participants were female. Of 18 trials conducted in a mostly primary prevention population, females represented 49% of trial participants. In mixed or exclusively secondary prevention trials (n=8), females represented 26% of trial participants. Females represented 46% of trial participants in trials that excluded groups of females (n=12). In trials without explicit exclusion criteria (n=13), females represented 32% of trial participants. Nine out of 26 trials reported sex-stratified analyses (35% of trials; 70% of all participants). Of these, two found some evidence for possible sex differences, both reporting larger blood pressure effects in females than males. Four trials provided sex considerations in the discussion section of the report. CONCLUSION: The participation of females in cardiovascular polypill trials is substantially higher in primary prevention trials as compared to trials conducted in mixed or exclusively secondary prevention populations. The use of sex-specific eligibility criteria was not linked to lower female participation. Sex-specific reporting is sparsely conducted, although most frequent in larger trials.

Historically, women have been underrepresented in clinical trials, making it difficult to determine if treatments work differently in males and females. Despite efforts to include more females, their participation in cardiovascular research remains lower than expected. This study investigated the participation of females in clinical trials that evaluate the effectiveness of polypills. Polypills, which combine multiple medications into a single pill, are a promising approach for managing cardiovascular diseases. We conducted a systematic review of 26 trials to assess how many females were included, whether there were sex-specific eligibility criteria, and if the trials analysed and reported results separately for males and females. We found that nearly half of the trials (46%) excluded certain groups of females, often due to pregnancy or the potential to become pregnant. The participation of females in these trials varied 10% to 73%, with an overall average of 42%. Females were better represented in trials in individuals with a history of cardiovascular disease (49% participation) than in those treating existing conditions (26% participation). The explicit exclusion of specific female groups did not result in lower overall female participation. Only 35% of the trials reported results separately for males and females, and just two of these found differences between sexes, specifically in blood pressure outcomes. The study concludes that while females are reasonably well-represented in some polypill trials, there is still a lack of consistent sex-specific analysis and reporting, which is crucial for understanding how treatments may affect males and females differently.

Policies on the collection, analysis, and reporting of sex and gender in Australian health and medical research: a mixed methods study.

OBJECTIVE: To explore the policies of key organisations in Australian health and medical research on defining, collecting, analysing, and reporting data on sex and gender, and to identify barriers to and facilitators of developing and implementing such policies. STUDY DESIGN: Mixed methods study: online planning forum; survey of organisations in Australian health and medical research, and internet search for policies defining, collecting, analysing, and reporting data by sex and gender in health and medical research. SETTING, PARTICIPANTS: Australia, 19 May 2021 (planning forum) to 12 December 2022 (final internet search). MAIN OUTCOME MEASURES: Relevant webpages and documents classified as dedicated organisation-specific sex and gender policies; policies, guidelines, or statements with broader aims, but including content that met the definition of a sex and gender policy; and references to external policies. RESULTS: The online planning forum identified 65 relevant organisations in Australian health and medical research; twenty participated in the policy survey. Seven organisations reported at least one relevant policy, and six had plans to develop or implement such policies during the following two years. Barriers to and facilitators of policy development and implementation were identified in the areas of leadership, language and definitions, and knowledge skills and training. The internet search found that 57 of the 65 organisations had some form of sex and gender policy, including all ten peer-reviewed journals and five of ten research funders; twelve organisations, including eight peak body organisations, had published dedicated sex and gender policies on their websites. CONCLUSION: Most of the organisations included in our study had policies regarding the integration of sex and gender in health and medical research. The implementation and evaluation of these policies is necessary to ensure that consideration of sex and gender is adequate during all stages of the research process.

Theory of change for addressing sex and gender bias, invisibility and exclusion in Australian health and medical research, policy and practice.

Sex and gender are inadequately considered in health and medical research, policy and practice, leading to preventable disparities in health and wellbeing. Several global institutions, journals, and funding bodies have developed policies and guidelines to improve the inclusion of diverse participants and consideration of sex and gender in research design and reporting and the delivery of clinical care. However, according to recent evaluations, these policies have had limited impact on the inclusion of diverse research participants, adequate reporting of sex and gender data and reducing preventable inequities in access to, and quality provision of, healthcare. In Australia, the Sex and Gender Policies in Medical Research (SGPMR) project aims to address sex and gender bias in health and medical research by (i) examining how sex and gender are currently considered in Australian research policy and practice; (ii) working with stakeholders to develop policy interventions; and (iii) understanding the wider impacts, including economic, of improved sex and gender consideration in Australian health and medical research. In this paper we describe the development of a theory of change (ToC) for the SGPMR project. The ToC evolved from a two-stage process consisting of key stakeholder interviews and a consultation event. The ToC aims to identify the pathways to impact from improved consideration of sex and gender in health and medical research, policy and practice, and highlight how key activities and policy levers can lead to improvements in clinical practice and health outcomes. In describing the development of the ToC, we present an entirely novel framework for outlining how sex and gender can be appropriately considered within the confines of health and medical research, policy and practice.

Integrating sex and gender into biomedical research requires policy and culture change.

Most biomedical, health and care research does not adequately account for sex and gender dimensions of health and illness. Overlooking and disregarding the influence of sex and gender in research reduces scientific rigour and reproducibility, which leads to less effective treatments and worse health outcomes for all, particularly women and sex and gender diverse people. Historically, there has been minimal sex and gender policy innovation in UK medical research. To address this, stakeholders from across the UK research sector have been collaborating since spring 2023 to co-design a sex and gender policy framework to be implemented by research funders, as part of the MESSAGE (Medical Science Sex and Gender Equity) project. In the first Policy Lab, held in London in May 2023, 50 participants, including representatives from funding organisations, medical journals, regulators, clinicians, academics and people with lived experience, identified two key priorities for future action: 1) A whole system approach to policy change, and 2) Technical capacity-building and wider culture change efforts. In pursuing these priorities and collaborating cross-sectorally, UK stakeholders are engaged in an internationally innovative approach aimed at realising sustainable and impactful sex and gender policy change. Drawing on MESSAGE Policy Lab discussions, we set out key actions needed for the UK research sector to embed meaningful accounting for sex and gender as a new norm for research practice.

Protocol for process evaluation of ARTEMIS cluster randomised controlled trial: an intervention for management of depression and suicide among adolescents living in slums in India.

INTRODUCTION: There are around 250 million adolescents (10-19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation. METHODS: Case study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council's guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured. DISCUSSION: The process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes. ETHICS AND DISSEMINATION: Ethics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry's Screening Committee has approved to the study (ID 2020-9770). TRIAL REGISTRATION NUMBER: CTRI/2022/02/040307.

Gender disparities in lost productivity resulting from non-communicable diseases in Mexico, 2005-2021.

Background: Non-communicable diseases (NCDs) cause long-term impacts on health and can substantially affect people's ability to work. Little is known about how such impacts vary by gender, particularly in low- and middle-income countries (LMICs), where productivity losses may affect economic development. This study assessed the long-term productivity loss caused by major NCDs among adult women and men (20-76 years) in Mexico because of premature death and hospitalisations, between 2005 and 2021. Methods: We conducted an economic valuation based on the Human Capital Approach. We obtained population-based data from the National Employment Survey from 2005 to 2021 to estimate the expected productivity according to age and gender using a two-part model. We utilised expected productivity based on wage rates to calculate the productivity loss, employing Mexican official mortality registries and hospital discharge microdata for the same period. To assess the variability in our estimations, we performed sensitivity analyses under two different scenarios. Results: Premature mortality by cancers, diabetes, chronic cardiovascular diseases (CVD), chronic respiratory diseases (CRD) and chronic kidney disease (CKD) caused a productivity loss of 102.6 billion international US dollars (Intl. USD) from 2.8 million premature deaths. Seventy-three percent of this productivity loss was observed among men. Cancers caused 38.3% of the productivity loss (mainly among women), diabetes 38.1, CVD 15.1, CRD 3.2, and CKD 5.3%. Regarding hospitalisations, the estimated productivity loss was 729.7 million Intl. USD from 54.2 million days of hospitalisation. Men faced 65.4 and women 34.6% of these costs. Cancers caused 41.3% of the productivity loss mainly by women, followed by diabetes (22.1%), CKD (20.4%), CVD (13.6%) and CRD (2.6%). Conclusions: Major NCDs impose substantial costs from lost productivity in Mexico and these tend to be higher amongst men, while for some diseases the economic burden is higher for women. This should be considered to inform policymakers to design effective gender-sensitive health and social protection interventions to tackle the burden of NCDs.

The health workforce conundrum for burn care in Uttar Pradesh, India: a qualitative exploration.

Delivering specialised care for major burns requires a multidisciplinary health workforce. While health systems 'hardware' issues, such as shortages of the healthcare workforce and training gaps in burn care are widely acknowledged, there is limited evidence around the systems 'software' aspects, such as interest, power dynamics, and relationships that impact the healthcare workforce performance. This study explored challenges faced by the health workforce in burn care to identify issues affecting their performance. Qualitative in-depth interviews were conducted with a purposively selected sample (n = 31, 18 women and 13 men) of various cadres of the burn care health workforce in Uttar Pradesh, India. Inductive coding and thematic analysis identified three major themes. First, the dynamics within the multidisciplinary team where complex relations, power and normative hierarchy hampered performance. Second, the dynamics between health workers and patients due to the clinical and emotional challenges of dealing with burn injuries and multitasking. Third, dynamics between specialised burn units and broader health systems are narrated in challenges due to inadequate first response and delayed referral from primary care facilities. These findings indicate that burn care health workers in India face multiple challenges that need systemic intervention with a multipronged human resource for health framework.

Why does a public health issue (not) get priority? Agenda setting for the national burns programme in India.

There is growing scholarly interest in what leads to global or national prioritization of specific health issues. By retrospectively analysing agenda setting for India's national burn programme, this study aimed to better understand how the agenda-setting process influenced its design, implementation and performance. We conducted document reviews and key informant interviews with stakeholders and used a combination of analytical frameworks on policy prioritization and issue framing for analysis. The READ (readying material, extracting data, analysing data and distilling findings) approach was used for document reviews, and qualitative thematic analysis was used for coding and analysis of documents and interviews. The findings suggest three critical features of burns care policy prioritization in India: challenges of issue characteristics, divergent portrayal of ideas and its framing as a social and/or health issue and over-centralization of agenda setting. First, lack of credible indicators on the magnitude of the problem and evidence on interventions limited issue framing, advocacy and agenda setting. Second, the policy response to burns has two dimensions in India: response to gender-based intentional injuries and the healthcare response. While intentional burns have received policy attention, the healthcare response was limited until the national programme was initiated in 2010 and scaled up in 2014. Third, over-centralization of agenda setting (dominated by a few homogenous actors, located in the national capital, with attention focused on the national ministry of health) contributed to limitations in programme design and implementation. We note following elements to consider when analysing issues of significant burden but limited priority: the need to analyse how actors influence issue framing, the particularities of issues, the inadequacy of any one dominant frame and the limited intersection of frames. Based on this analysis in India, we recommend a decentralized approach to agenda setting and for the design and implementation of national programmes from the outset.

A life-course approach to tackling noncommunicable diseases in women.

Women's health has been critically underserved by a failure to look beyond women's sexual and reproductive systems to adequately consider their broader health needs. In almost every country in the world, noncommunicable diseases are the leading causes of death for women. Among these, cardiovascular disease (including heart disease and stroke) and cancer are the major causes of mortality. Risks for these conditions exist at each stage of women's lives, but recognition of the unique needs of women for the prevention and management of noncommunicable diseases is relatively recent and still emerging. Once they are diagnosed, treatments for these diseases are often costly and noncurative. Therefore, we call for a strategic, innovative life-course approach to identifying disease triggers and instigating cost-effective measures to minimize exposure in a timely manner. Prohibitive barriers to implementing this holistic approach to women's health exist in both the social arena and the medical arena. Recognizing these impediments and implementing practical approaches to surmounting them is a rational approach to advancing health equity for women, with ultimate benefits for society as a whole.

Using formative research to inform a mental health intervention for adolescents living in Indian slums: the ARTEMIS study.

BACKGROUND: Adolescents are vulnerable to stressors because of the rapid physical and mental changes that they go through during this life period. Young people residing in slum communities experience additional stressors due to living conditions, financial stress, and limited access to healthcare and social support services. The Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) study, is testing an intervention intended to improve mental health outcomes for adolescents living in urban slums in India combining an anti-stigma campaign with a digital health intervention to identify and manage depression, self-harm/suicide risk or other significant emotional complaints. METHODS: In the formative phase, we developed tools and processes for the ARTEMIS intervention. The two intervention components (anti-stigma and digital health) were implemented in purposively selected slums from the two study sites of New Delhi and Vijayawada. A mixed methods formative evaluation was undertaken to improve the understanding of site-specific context, assess feasibility and acceptability of the two components and identify required improvements to be made in the intervention. In-depth interviews and focus groups with key stakeholders (adolescents, parents, community health workers, doctors, and peer leaders), along with quantitative data from the digital health platform, were analysed. RESULTS: The anti-stigma campaign methods and materials were found to be acceptable and received overall positive feedback from adolescents. A total of 2752 adolescents were screened using the PHQ9 embedded into a digital application, 133 (4.8%) of whom were identified as at high-risk of depression and/or suicide. 57% (n = 75) of those at high risk were diagnosed and treated by primary health care (PHC) doctors, who were guided by an electronic decision support tool based on WHO's mhGAP algorithm, built into the digital health application. CONCLUSION: The formative evaluation of the intervention strategy led to enhanced understanding of the context, acceptability, and feasibility of the intervention. Feedback from stakeholders helped to identify key areas for improvement in the intervention; strategies to improve implementation included engaging with parents, organising health camps in the sites and formation of peer groups. TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries, Reference number: CTRI/2022/02/040307. Registered 18 February 2022.

Structural capacity and continuum of snakebite care in the primary health care system in India: a cross-sectional assessment.

BACKGROUND: In 2019, the World Health Organization, set a target to halve the burden of snakebite, by 2030, and identified 'health systems strengthening' as a key pillar of action. In India, the country with most snakebite deaths, the Union Government identified (in September 2022) training of health workers as a priority action area. In this policy context, we provide empirical evidence by analysing the most recent nationwide survey data (District Level Household and Facility Survey - 4), to assess structural capacity and continuum of snakebite care in primary health care system in India. METHODOLOGY: We evaluated structural capacity for snakebite care under six domains: medicines, equipment, infrastructure, human resources, governance and finance, and health management information systems (HMIS). We categorised states (aspirant, performer, front-runner, achiever) based on the proportion of primary health centres (PHC) and community health centres (CHC), attaining highest possible domain score. We assessed continuum of snakebite care, district-wise, under five domains (connectivity to PHC, structural capacity of PHC, referral from PHC to higher facility, structural capacity of CHC, referral from CHC to higher facility) as adequate or not. RESULTS: No state excelled ( front-runner or achiever) in all six domains of structural capacity in PHCs or CHCs. The broader domains (physical infrastructure, human resources for health, HMIS) were weaker compared to snakebite care medicines in most states/UTs, at both PHC and CHC levels. CHCs faced greater concerns regarding human resources and equipment availability than PHCs in many states. Among PHCs, physical infrastructure and HMIS were aspirational in all 29 assessed states, while medicines, equipment, human resources, and governance and finance were aspirational in 8 (27.6%), 2 (6.9%), 17 (58.6%), and 12 (41.4%) states respectively. For CHCs, physical infrastructure was aspirational in all 30 assessed states/UTs, whereas HMIS, medicines, equipment, human resources, and governance and finance were aspirational in 29 (96.7%), 11 (36.7%), 27 (90%), 26 (86.7%), and 3 (10%) states respectively. No district had adequate continuum of snakebite care in all domains. Except for transport availability from CHC to higher facilities (48% of districts adequate) and transport availability from PHC to higher facilities (11% of districts adequate), fewer than 2% of districts were adequate in all other domains. CONCLUSION: Comprehensive strengthening of primary health care, across all domains, and throughout the continuum of care, instead of a piece-meal approach towards health systems strengthening, is necessitated to reduce snakebite burden in India, and possibly other high-burden nations with weak health systems. Health facility surveys are necessitated for this purpose.

How and why snakebite became a global health priority: a policy analysis.

BACKGROUND: Snakebite was added to the WHO neglected tropical disease (NTD) list in 2017, followed by a World Health Assembly resolution in 2018, and an explicit global target being set to reduce the burden in 2019. We aimed to understand how and why snakebite became a global health priority. METHODS: We conducted a policy case study, using in-depth interviews, and documents (peer-reviewed and grey literature) as data sources. We drew on Shiffman et al's framework on global health network to guide the analysis. RESULTS: We conducted 20 interviews and examined 91 documents. The prioritisation of snakebite occurred in four phases: pre-crescendo, crescendo, de-crescendo and re-crescendo. The core snakebite network consisted of academics, which expanded during the re-crescendo phase to include civil society organisations and state actors. The involvement of diverse stakeholders led to better understanding of WHO processes. The use of intersecting and layered issue framing, framing solutions around snake antivenoms, in a background of cross-cultural fascination and fear of snakes enabled prioritisation in the re-crescendo phase. Ebbs and flows in legitimacy of the network and reluctant acceptance of snakebite within the NTD community are challenges. CONCLUSION: Our analyses imply a fragile placement of snakebite in the global agenda. We identify two challenges, which needs to be overcome. The study highlights the need to review the WHO criteria for classifying diseases as NTD. We propose that future prioritisation analysis should consider identifying temporal patterns, as well as integrating legitimacy dimensions, as in our study.

A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial.

BACKGROUND: Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, "SMARThealth Pregnancy," to improve health during pregnancy and the first year after birth. METHODS: A pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire). DISCUSSION: Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women's lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world. TRIAL REGISTRATION: ClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.

Health systems research in burn care: an evidence gap map.

BACKGROUND: Burn injury is associated with significant mortality and disability. Resilient and responsive health systems are needed for optimal response and care for people who sustain burn injuries. However, the extent of health systems research (HSR) in burn care is unknown. This review aimed to systematically map the global HSR related to burn care. METHODS: An evidence gap map (EGM) was developed based on the World Health Organization health systems framework. All major medical, health and injury databases were searched. A standard method was used to develop the EGM. RESULTS: A total of 6586 articles were screened, and the full text of 206 articles was reviewed, of which 106 met the inclusion criteria. Most included studies were cross-sectional (61%) and were conducted in hospitals (71%) with patients (48%) or healthcare providers (29%) as participants. Most studies were conducted in high-income countries, while only 13% were conducted in low-and middle-income countries, accounting for 60% of burns mortality burden globally. The most common health systems areas of focus were service delivery (53%), health workforce (33%) and technology (19%). Studies on health policy, governance and leadership were absent, and there were only 14 qualitative studies. CONCLUSIONS: Major evidence gaps exist for an integrated health systems response to burns care. There is an inequity between the burden of burn injuries and HSR. Strengthening research capacity will facilitate evidence-informed health systems and policy reforms to sustainably improve access to affordable, equitable and optimal burn care and outcomes.

A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in women in India. Early identification is crucial to reducing deaths. Hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) carry independent risks for future CVD, and antenatal care is a window to screen and counsel high-risk women. In rural India, community health workers (CHWs) deliver antenatal and postnatal care. We developed a complex intervention (SMARThealth Pregnancy) involving mobile clinical decision support for CHWs and evaluated it in a pilot cluster randomized controlled trial (cRCT). OBJECTIVE: The aim of the study is to co-design a theory-informed intervention for CHWs to screen, refer, and counsel pregnant women at high risk of future CVD in rural India and evaluate its feasibility and acceptability. METHODS: In phase 1, we used qualitative methods to explore community priorities for high-risk pregnant women in rural areas of 2 diverse states in India. In phase 2, informed by behavior change theory and human-centered design, we used these qualitative data to develop the intervention components and implementation strategies for SMARThealth Pregnancy in an iterative process with end users. In phase 3, using mixed methods, we evaluated the intervention in a cRCT with an embedded qualitative substudy across 4 primary health centres: 2 in Jhajjar district, Haryana, and 2 in Guntur district, Andhra Pradesh. RESULTS: SMARThealth Pregnancy embedded a total of 15 behavior change techniques and included (1) community awareness programs; (2) targeted training, including point-of-care blood pressure and hemoglobin measurement; and (3) mobile clinical decision support for CHWs to screen women in their homes. The intervention focused on 3 priority conditions: anemia, HDP, and GDM. The evaluation involved a total of 200 pregnant women, equally randomized to intervention or enhanced standard care (control). Recruitment was completed within 5 months, with minimal loss to follow-up (4/200, 2%) at 6 weeks postpartum. A total of 4 primary care doctors and 54 CHWs in the intervention clusters took part in the study. Fidelity to intervention practices was 100% prepandemic. Over half the study population was affected by moderate to severe anemia at baseline. The prevalence of HDP (2.5%) and GDM (2%) was low in our study population. Results suggest a possible improvement in mean hemoglobin (anemia) in the intervention group, although an adequately powered trial is needed. The model of home-based care was feasible and acceptable for pregnant or postpartum women and CHWs, who perceived improvements in quality of care, self-efficacy, and professional recognition. CONCLUSIONS: SMARThealth Pregnancy is an innovative model of home-based care for high-risk pregnant women during the transitions between antenatal and postnatal care and adult health services. The use of theory and co-design during intervention development facilitated acceptability of the intervention and implementation strategies. Our experience has informed the decision to initiate a larger-scale cRCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03968952; https://clinicaltrials.gov/ct2/show/NCT03968952. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fgwh.2021.620759.

Burden of non-communicable diseases and behavioural risk factors in Mexico: Trends and gender observational analysis.

Background: There is scarce gender-disaggregated evidence on the burden of disease (BD) worldwide and this is particularly prominent in low- and middle-income countries. The objective of this study is to compare the BD caused by non-communicable diseases (NCDs) and related risk factors by gender in Mexican adults. Methods: We retrieved disability-adjusted life years (DALYs) estimates for diabetes, cancers and neoplasms, chronic cardiovascular diseases (CVDs), chronic respiratory diseases (CRDs), and chronic kidney disease (CKD) from the Global Burden of Disease (GBD) Study from 1990-2019. Age-standardized death rates were calculated using official mortality microdata from 2000 to 2020. Then, we analysed national health surveys to depict tobacco and alcohol use and physical inactivity from 2000-2018. Women-to-men DALYs and mortality rates and prevalence ratios (WMR) were calculated as a measure of gender gap. Findings: Regarding DALYs, WMR was >1 for diabetes, cancers, and CKD in 1990, indicating a higher burden in women. WMR decreased over time in all NCDs, except for CRDs, which increased to 0.78. However, WMR was <1 for all in 2019. The mortality-WMR was >1 for diabetes and cardiovascular diseases in 2000 and <1 for the rest of the conditions. The WMR decreased in all cases, except for CRDs, which was <1 in 2020. The WMR for tobacco and alcohol use remained under 1. For physical inactivity, it was >1 and increasing. Conclusions: The gender gap has changed for selected NCDs in favour of women, except for CRDs. Women face a lower BD and are less affected by tobacco and alcohol use but face a higher risk of physical inactivity. Policymakers should consider a gendered approach for designing effective policies to reduce the burden of NCDs and health inequities.