Women's Participation in Cardiovascular Clinical Trials From 2010 to 2017

Background: Cardiovascular disease is the leading cause of death among women worldwide, yet, women have historically been underrepresented in cardiovascular trials. Methods: We systematically assessed the participation of women in completed cardiovascular trials registered in ClinicalTrials.gov between 2010 and 2017, and extracted publicly available information including disease type, sponsor type, country, trial size, intervention type, and the demographic characteristics of trial participants. We calculated the female-to-male ratio for each trial and determined the prevalence-adjusted estimates for participation of women by dividing the percentage of women among trial participants by the percentage of women in the disease population (participation prevalence ratio; a ratio of 0.8 to 1.2 suggests comparable prevalence and good representation). Results: We identified 740 completed cardiovascular trials including a total of 862 652 adults, of whom 38.2% were women. The median female-to-male ratio of each trial was 0.51 (25th quartile, 0.32; 75th quartile, 0.90) overall and varied by age group (1.02 in ≤55 year old group versus 0.40 in the 61- to 65-year-old group), type of intervention (0.44 for procedural trials versus 0.78 for lifestyle intervention trials), disease type (0.34 for acute coronary syndrome versus 3.20 for pulmonary hypertension), region (0.45 for Western Pacific versus 0.55 for the Americas), funding/sponsor type (0.14 for government-funded versus 0.73 for multiple sponsors), and trial size (0.56 for smaller [n≤47] versus 0.49 for larger [n≥399] trials). Relative to their prevalence in the disease population, participation prevalence ratio was higher than 0.8 for hypertension, pulmonary arterial hypertension and lower (participation prevalence ratio 0.48 to 0.78) for arrhythmia, coronary heart disease, acute coronary syndrome, and heart failure trials. The most recent time period (2013 to 2017) saw significant increases in participation prevalence ratios for stroke (P=0.007) and heart failure (P=0.01) trials compared with previous periods. Conclusions: Among cardiovascular trials in the current decade, men still predominate overall, but the representation of women varies with disease and trial characteristics, and has improved in stroke and heart failure trials

Hypertension in China: burdens, guidelines and policy responses: a state-of-the-art review.

Hypertension is a leading risk factor of cardiovascular disease and it is becoming increasingly prevalent globally. Correspondingly, the Chinese government and public health institutions have issued a series of policy documents and guidelines for hypertension. However, no comprehensive review of such documents has been conducted. Hence, this review aims to provide an up-to-date and comprehensive assessment of not only the disease burden, but also hypertension management policies and guidelines in China. A total of 15 epidemiological studies based on national population surveys, 15 Chinese Hypertension Guidelines, and seven policy documents were identified. We found a larger burden of hypertension in men, while the awareness, treatment, and control rates have remained low in both sexes. The ranges of hypertension prevalence, awareness, treatment, and control rate among hypertensive patients were 18.0-44.7%, 23.6-56.2%, 14.2-48.5%, and 4.2-30.1% respectively. Chinese hypertension guidelines provide evidence-based instructions to healthcare practitioners over hypertension management in which primary healthcare is increasingly emphasized. Finally, the policy documents set national goals for hypertension management and standardized the services provided in primary healthcare. The findings highlight the importance of integrating new guidelines into hypertension management provided by primary healthcare practitioners and the need to evaluate the implementation of guidelines and policies

A feasibility study on using smartphones to conduct short-version verbal autopsies in rural China

Background: Currently there are two main sources of mortality data with cause of death assignments in China. Both sources-the Ministry of Health-Vital Registration system and the Chinese Disease Surveillance Point system-present their own challenges. A new approach to cause of death assignment is a smartphone-based shortened version of a verbal autopsy survey. This study evaluates the feasibility and acceptability of this new method conducted by township health care providers (THP) and village doctors (VD) in rural China, where a large proportion of deaths occur in homes and cause of death data are inaccurate or lacking. Methods: The Population Health Metrics Research Consortium mobile phone-based shortened verbal autopsy questionnaire was made available on an Android system-based application, and cause of death was derived using the Tariff method (Tariff 2.0); we called this set of tools "msVA." msVA was administered to relatives of the deceased by six THPs and six VDs in 24 villages located in six townships of Luquan County, Hebei Province, China. Subsequently, interviews were conducted among 12 interviewers, 12 randomly selected respondents, and five study staff to assess the feasibility and acceptability of using msVA for mortality data collection. Results: Between July 2013 and August 2013, 268 deaths took place in the study villages. Among the 268 deaths, 227 VAs were completed (nine refusals, 31 migrations and one loss of data due to breakdown of the smartphone). The average time for a VA interview was 21.5 +/- 3.4 min (20.1 +/- 3.5 min for THP and 23.2 +/- 4.1 min for VD). Both THPs and VDs could be successful interviewers; the latter needed more training but had more willingness to implement msVA in the future. The interviews revealed that both interviewers and relatives of the deceased found msVA to be feasible, acceptable, and more desirable than traditional methods. The cost of conducting a new VA was $ 8.87 per death. Conclusions: Conduction of msVA by VDs in their own villages was feasible and acceptable in rural northern China. Broader implementation of msVA across rural China could potentially improve the coverage and quality of cause of death data, allowing for better national health evaluation and program planning.National Heart, Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services [HHSN268200900034C]; NHLBI-UHG Trainee Seed [email protected]

An economic evaluation of a primary care-based technology-enabled intervention for stroke secondary prevention and management in rural China : a study protocol

Introduction: Secondary prevention of stroke is a leading challenge globally and only a few strategies have been tested to be effective in supporting stroke survivors. The system-integrated and technology-enabled model of care (SINEMA) intervention, a primary care-based and technology-enabled model of care, has been proven effective in strengthening the secondary prevention of stroke in rural China. The aim of this protocol is to outline the methods for the cost-effectiveness evaluation of the SINEMA intervention to better understand its potential economic benefits. Methods: The economic evaluation will be a nested study based on the SINEMA trial; a cluster-randomized controlled trial implemented in 50 villages in rural China. The effectiveness of the intervention will be estimated using quality-adjusted life years for the cost-utility analysis and reduction in systolic blood pressure for the cost-effectiveness analysis. Health resource and service use and program costs will be identified, measured, and valued at the individual level based on medication use, hospital visits, and inpatients' records. The economic evaluation will be conducted from the perspective of the healthcare system. Conclusion: The economic evaluation will be used to establish the value of the SINEMA intervention in the Chinese rural setting, which has great potential to be adapted and implemented in other resource-limited settings

Excess mortality among patients with severe mental disorders and effects of community-based mental healthcare: a community-based prospective study in Sichuan, China.

BACKGROUND: High-quality primary care reduces premature mortality in the general population, but evidence for psychiatric patients in China is scarce. AIMS: To confirm excess mortality in patients with severe mental illness (SMI), and to examine the impact of community-based mental healthcare and other risk factors on their mortality. METHOD: We included 93 655 patients in 2012 and 100 706 in 2013 from the national mental health surveillance system in Sichuan, China to calculate the standardised mortality ratio (SMR). A total of 112 576 patients were followed up from 2009 to 2014 for model analyses. We used growth models to quantify the patterns of change for community management measures, high-risk behaviour, disease stability and medication adherence of patients over time, and then used multilevel proportional hazard models to examine the association between change patterns of management measures and mortality. RESULTS: The SMR was 6.44 (95% CI 4.94-8.26) in 2012 and 7.57 (95% CI 5.98-9.44) in 2013 among patients with SMI aged 15-34 years, and diminished with age. Unfavourable baseline socioeconomic status increased the hazard of death by 38-50%. Positive changes in high-risk behaviour, disease stability and medication adherence had a 54% (95% CI 47-60%), 69% (95% CI 63-73%) and 20% (4-33%) reduction in hazard of death, respectively, versus in those where these were unchanged. CONCLUSIONS: High excess mortality was confirmed among younger patients with SMI in Sichuan, China. Our findings on the relationships between community management and socioeconomic factors and mortality can inform community-based mental healthcare policies to reduce excess mortality among patients with SMI

Towards sustainable partnerships in global health: the case of the CRONICAS Centre of Excellence in Chronic Diseases in Peru.

Human capital requires opportunities to develop and capacity to overcome challenges, together with an enabling environment that fosters critical and disruptive innovation. Exploring such features is necessary to establish the foundation of solid long-term partnerships. In this paper we describe the experience of the CRONICAS Centre of Excellence in Chronic Diseases, based at Universidad Peruana Cayetano Heredia in Lima, Peru, as a case study for fostering meaningful and sustainable partnerships for international collaborative research. The CRONICAS Centre of Excellence in Chronic Diseases was established in 2009 with the following Mission: "We support the development of young researchers and collaboration with national and international institutions. Our motivation is to improve population's health through high quality research." The Centre's identity is embedded in its core values - generosity, innovation, integrity, and quality- and its trajectory is a result of various interactions between multiple individuals, collaborators, teams, and institutions, which together with the challenges confronted, enables us to make an objective assessment of the partnership we would like to pursue, nurture and support. We do not intend to provide a single example of a successful partnership, but in contrast, to highlight what can be translated into opportunities to be faced by research groups based in low- and middle-income countries, and how these encounters can provide a strong platform for fruitful and sustainable partnerships. In defiant contexts, partnerships require to be nurtured and sustained. Acknowledging that all partnerships are not and should not be the same, we also need to learn from the evolution of such relationships, its key successes, hurdles and failures to contribute to the promotion of a culture of global solidarity where mutual goals, mutual gains, as well as mutual responsibilities are the norm. In so doing, we will all contribute to instil a new culture where expectations, roles and interactions among individuals and their teams are horizontal, the true nature of partnerships

World Heart Federation Roadmap for Secondary Prevention of Cardiovascular Disease: 2023 Update.

BACKGROUND: Secondary prevention lifestyle and pharmacological treatment of atherosclerotic cardiovascular disease (ASCVD) reduce a high proportion of recurrent events and mortality. However, significant gaps exist between guideline recommendations and usual clinical practice. OBJECTIVES: Describe the state of the art, the roadblocks, and successful strategies to overcome them in ASCVD secondary prevention management. METHODS: A writing group reviewed guidelines and research papers and received inputs from an international committee composed of cardiovascular prevention and health systems experts about the article's structure, content, and draft. Finally, an external expert group reviewed the paper. RESULTS: Smoking cessation, physical activity, diet and weight management, antiplatelets, statins, beta-blockers, renin-angiotensin-aldosterone system inhibitors, and cardiac rehabilitation reduce events and mortality. Potential roadblocks may occur at the individual, healthcare provider, and health system levels and include lack of access to healthcare and medicines, clinical inertia, lack of primary care infrastructure or built environments that support preventive cardiovascular health behaviours. Possible solutions include improving health literacy, self-management strategies, national policies to improve lifestyle and access to secondary prevention medication (including fix-dose combination therapy), implementing rehabilitation programs, and incorporating digital health interventions. Digital tools are being examined in a range of settings from enhancing self-management, risk factor control, and cardiac rehab. CONCLUSIONS: Effective strategies for secondary prevention management exist, but there are barriers to their implementation. WHF roadmaps can facilitate the development of a strategic plan to identify and implement local and national level approaches for improving secondary prevention

THEMIS: A Parameter Estimation Framework for the Event Horizon Telescope

The Event Horizon Telescope (EHT) provides the unprecedented ability to directly resolve the structure and dynamics of black hole emission regions on scales smaller than their horizons. This has the potential to critically probe the mechanisms by which black holes accrete and launch outflows, and the structure of supermassive black hole spacetimes. However, accessing this information is a formidable analysis challenge for two reasons. First, the EHT natively produces a variety of data types that encode information about the image structure in nontrivial ways; these are subject to a variety of systematic effects associated with very long baseline interferometry and are supplemented by a wide variety of auxiliary data on the primary EHT targets from decades of other observations. Second, models of the emission regions and their interaction with the black hole are complex, highly uncertain, and computationally expensive to construct. As a result, the scientific utilization of EHT observations requires a flexible, extensible, and powerful analysis framework. We present such a framework, Themis, which defines a set of interfaces between models, data, and sampling algorithms that facilitates future development. We describe the design and currently existing components of Themis, how Themis has been validated thus far, and present additional analyses made possible by Themis that illustrate its capabilities. Importantly, we demonstrate that Themis is able to reproduce prior EHT analyses, extend these, and do so in a computationally efficient manner that can efficiently exploit modern high-performance computing facilities. Themis has already been used extensively in the scientific analysis and interpretation of the first EHT observations of M87

SYMBA: An end-to-end VLBI synthetic data generation pipeline: Simulating Event Horizon Telescope observations of M 87

Context. Realistic synthetic observations of theoretical source models are essential for our understanding of real observational data. In using synthetic data, one can verify the extent to which source parameters can be recovered and evaluate how various data corruption effects can be calibrated. These studies are the most important when proposing observations of new sources, in the characterization of the capabilities of new or upgraded instruments, and when verifying model-based theoretical predictions in a direct comparison with observational data. Aims. We present the SYnthetic Measurement creator for long Baseline Arrays (SYMBA), a novel synthetic data generation pipeline for Very Long Baseline Interferometry (VLBI) observations. SYMBA takes into account several realistic atmospheric, instrumental, and calibration effects. Methods. We used SYMBA to create synthetic observations for the Event Horizon Telescope (EHT), a millimetre VLBI array, which has recently captured the first image of a black hole shadow. After testing SYMBA with simple source and corruption models, we study the importance of including all corruption and calibration effects, compared to the addition of thermal noise only. Using synthetic data based on two example general relativistic magnetohydrodynamics (GRMHD) model images of M 87, we performed case studies to assess the image quality that can be obtained with the current and future EHT array for different weather conditions. Results. Our synthetic observations show that the effects of atmospheric and instrumental corruptions on the measured visibilities are significant. Despite these effects, we demonstrate how the overall structure of our GRMHD source models can be recovered robustly with the EHT2017 array after performing calibration steps, which include fringe fitting, a priori amplitude and network calibration, and self-calibration. With the planned addition of new stations to the EHT array in the coming years, images could be reconstructed with higher angular resolution and dynamic range. In our case study, these improvements allowed for a distinction between a thermal and a non-thermal GRMHD model based on salient features in reconstructed images