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

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

The Implementation and Effectiveness of Mobile Health Interventions for Cardiometabolic Disease Management in China and Australia

© 2021 Enying GongIntroduction Cardiometabolic diseases are the leading causes of deaths globally. Although effective strategies for managing these chronic conditions have been proposed as clinical guidelines and action plans, the translation of evidence into practice is challenging. With the advancement of information and communication technologies (ICTs), digital health and mobile health (mHealth) technologies are increasingly applied to healthcare purposes and hold promise for the promotion of disease management and the strengthening of the healthcare system. Although there is a rapidly growing volume of studies in this field, the benefits of mHealth interventions and strategies for implementing mHealth innovations for disease management are still not evident. This thesis includes three studies that aim to provide evidence of the effectiveness of mHealth interventions for cardiometabolic disease management and illustrate how mHealth interventions could be better implemented in real-world settings. Methods The present thesis utilizes two cardiometabolic conditions, diabetes and stroke, as index conditions to anchor mHealth interventions for cardiometabolic diseases management. The thesis incorporates three studies: (1) a systematic review and evaluation of publicly available mobile applications for diabetes self-management in China; (2) a randomized controlled trial which evaluated a mobile app-based embodied conversational agent (My Diabetes Coach- MDC intervention) for improving diabetes self-management; (3) a cluster randomized controlled trial which evaluated a technology-enabled community-based intervention (SINEMA) for stroke management in rural China. The thesis utilizes the chronic care model to emphasize the important role of mHealth interventions in supporting patients’ self-management and improving coordinated care within the community for cardiometabolic diseases management. Multiple research methodologies, including quantitative and qualitative data analysis, are adopted, and evaluation and implementation research frameworks, such as the RE-AIM framework and the Medical Research Council (MRC) complex intervention framework, are applied. Thesis summary Chapter 1 presents an overview of cardiometabolic disease burden, challenges in cardiometabolic diseases management, and related concepts of digital health and chronic disease management. Chapter 2 provides a narrative review about the general effectiveness and implementation of mHealth interventions for cardiometabolic diseases. The review has a particular focus on mHealth interventions for diabetes self-management coaching and mHealth-enabled community-based interventions for cardiometabolic disease management. Chapter 3 reviews the methodologies used in evaluating mHealth programs and describes the overall study design. Chapter 4 reports the findings of a systematic evaluation of 67 Chinese publicly available Chinese mobile apps for diabetes self-management. The chapter provides additional evidence to the research literature by showing the key limitations of existing tools for helping people manage their diabetes conditions in China. Chapter 5 reports the findings on the effectiveness and implementation of the MDC intervention based on a randomized controlled trial, which involved 187 adults with type 2 diabetes in Australia. The chapter illustrates a large but declined program use over 12 months and demonstrates a significant benefit for health-related quality of life but insignificant impact on HbA1c reduction of the MDC intervention compared with usual care. Chapter 6 reports the findings on the effectiveness and implementation from the SINEMA cluster-randomized controlled trial, which recruited 1299 adults with stroke from 50 villages in rural China. The chapter shows that the SINEMA intervention reached a representative group of stroke survivors, delivered interventions with high program implementation fidelity, and resulted in a significant improvement in blood pressure control, medication adherence and other secondary or exploratory outcomes. Factors that influence the program implementation and the impact pathway on effectiveness are identified. Chapter 7 discusses some key aspects in the development of digital health interventions for improving cardiometabolic diseases management, including the design of tailored content, reaching vulnerable populations, building patient-doctor alliance and integrating with the healthcare system. Recommendations for future research, industry and public health practice are also proposed. Conclusion The research contained in the thesis contributes to the evidence base by investigating the quality, implementation, and effectiveness of mHealth solutions for cardiometabolic disease management. The findings indicated that digital health interventions could bring positive health benefits to patients with existing cardiometabolic conditions, even in the resource-limited setting, by empowering disease self-management, increasing patients’ access to and adherence to treatment, and strengthening the interaction between patients and providers. However, in “real-world” settings, the impact of digital health solutions is influenced by individual and contextual factors that determined the adoption, implementation, and engagement of digital health solutions. Rigorous evaluation of the quality and effectiveness of the health apps are essential before its access to the general population. Future studies could adapt the effective interventions into other contexts and explore strategies that may increase long-term program engagement and more in-depth system integration

Non-fatal Road Traffic Crashes and Near Misses among Adolescents Aged 16-18 in Galle, Sri Lanka

<p>Background: Sri Lanka is experiencing an epidemic of road traffic crashes and injuries but little is known about the burden among adolescents and associated risk factors. The objective of this paper is to assess the prevalence of road traffic crashes and injuries among adolescents aged 16-18 years old and to estimate the effect of risk factors, including demographic characteristics, behaviors and built environment characteristics around school, on the occurrence of both crashes and near misses. Methods: First, A survey was anonymously administered to determine demographics, behavior, and experience of road traffic crashes and related injuries among adolescents from 16 public high schools in Galle, Sri Lanka. Second, a built environment observation was also conducted near school surroundings. Descriptive analysis and multivariate regression analysis was conducted to assess the relationship between built environment and road traffic crashes/near misses by using STATA. The results were displayed in the map by using ArcGIS. Results: Among 1307 students from 16 public high schools aged between 16-18 years old, 206 students self-reported road traffic crash involvement in the past 6 months with 98 students reporting minor injury and 7 students suffering severe injury. In addition, 27.8% of respondents were involved in near misses in the past 6 months. Male students, who demonstrated poor road behaviors, and students who experienced near misses are more likely to be involved in road traffic crashes. Additionally, more than half of the roads around these schools are in poor condition with little infrastructures to separate pedestrians and cyclists from vehicles. The occurrence of road traffic crashes and the severity of road traffic injuries are significantly related to some environmental characteristics, which tend to include road type and road visibility. Conclusions: Adolescents in Galle, Sri Lanka are facing a comparatively high burden of road traffic crashes. Conducting intervention programs among male students and improving built environment on the way to school are potential effective strategies to prevent adolescents from road traffic crashes and injuries.</p>Thesi

Feasibility assessment of invigorating grassrooTs primary healthcare for prevention and management of cardiometabolic diseases in resource-limited settings in China, Kenya, Nepal, Vietnam (the FAITH study): rationale and design

Background: Cardiometabolic diseases are the leading cause of death and disability in many low- and middle-income countries. As the already severe burden from these conditions continues to increase in low- and middle-income countries, cardiometabolic diseases introduce new and salient public health challenges to primary health care systems. In this mixed-method study, we aim to assess the capacity of grassroots primary health care facilities to deliver essential services for the prevention and control of cardiometabolic diseases. Built on this information, our goal is to propose evidence-based recommendations to promote a stronger primary health care system in resource-limited settings. Methods: The study will be conducted in resource-limited settings in China, Kenya, Nepal, and Vietnam using a mixed-method approach that incorporates a literature review, surveys, and in-depth interviews. The literature, statistics, and document review will extract secondary data on the burden of cardiometabolic diseases in each country, the existing policies and interventions related to strengthening primary health care services, and improving care related to non-communicable disease prevention and control. We will also conduct primary data collection. In each country, ten grassroots primary health care facilities across representative urban-rural regions will be selected. Health care professionals and patients recruited from these facilities will be invited to participate in the facility assessment questionnaire and patients’ survey. Stakeholders – including patients, health care professionals, policymakers at the local, regional, and national levels, and local authorities – will be invited to participate in in-depth interviews. A standard protocol will be designed to allow for adaption and localization in data collection instruments and procedures within each country. Discussion: With a special focus on the capacity of primary health care facilities in resource-limited settings in low- and middle-income countries, this study has the potential to add new evidence for policymakers and academia by identifying the most common and significant barriers primary health care services face in managing and preventing cardiometabolic diseases. With these findings, we will generate evidence-based recommendations on potential strategies that are feasible for resource-limited settings in combating the increasing challenges of cardiometabolic diseases

The Internet of Things: impact and implications for healthcare delivery

The Internet of Things (IoT) is a system of wireless, interrelated, and connected digital devices that can collect, send, and store data over a network without requiring human-to-human or human-to-computer interaction. The IoT promises many benefits to streamlining and enhancing health care delivery to proactively predict health issues and diagnose, treat, and monitor patients both in and out of the hospital. Worldwide, government leaders and decision makers are implementing policies to deliver health care services using technology and more so in response to the novel COVID-19 pandemic. It is now becoming increasingly important to understand how established and emerging IoT technologies can support health systems to deliver safe and effective care. The aim of this viewpoint paper is to provide an overview of the current IoT technology in health care, outline how IoT devices are improving health service delivery, and outline how IoT technology can affect and disrupt global health care in the next decade. The potential of IoT-based health care is expanded upon to theorize how IoT can improve the accessibility of preventative public health services and transition our current secondary and tertiary health care to be a more proactive, continuous, and coordinated system. Finally, this paper will deal with the potential issues that IoT-based health care generates, barriers to market adoption from health care professionals and patients alike, confidence and acceptability, privacy and security, interoperability, standardization and remuneration, data storage, and control and ownership. Corresponding enablers of IoT in current health care will rely on policy support, cybersecurity-focused guidelines, careful strategic planning, and transparent policies within health care organizations. IoT-based health care has great potential to improve the efficiency of the health system and improve population health

Identifying implementation strategies to address barriers of implementing a school-located influenza vaccination program in Beijing

Abstract Background The school-located influenza vaccinations (SLIV) can increase influenza vaccination and reduce influenza infections among school-aged children. However, the vaccination rate has remained low and varied widely among schools in Beijing, China. This study aimed to ascertain barriers and facilitators of implementing SLIV and to identify implementation strategies for SLIV quality improvement programs in this context. Methods Semi-structured interviews were conducted with diverse stakeholders (i.e., representatives of both the Department of Health and the Department of Education, school physicians, class headteachers, and parents) involved in SLIV implementation. Participants were identified by purposive and snowball sampling. The Consolidated Framework for Implementation Research was adopted to facilitate data collection and analysis. Themes and subthemes regarding barriers and facilitators were generated using deductive and inductive approaches. Based on the Consolidated Framework for Implementation Research—Expert Recommendations for Implementing Change (CFIR-ERIC) matching tool, practical implementation strategies were proposed to address the identified barriers of SLIV delivery. Results Twenty-four participants were interviewed. Facilitators included easy access to SLIV, clear responsibilities and close collaboration among government sectors, top-down authority, integrating SLIV into the routine of schools, and priority given to SLIV. The main barriers were parents’ misconception, inefficient coordination for vaccine supply and vaccination dates, the lack of planning, and inadequate access to knowledge and information about the SLIV. CFIR-ERIC Matching tool suggested implementation strategies at the system (i.e., developing an implementation blueprint, and promoting network weaving), school (i.e., training and educating school implementers), and consumer (i.e., engaging students and parents) levels to improve SLIV implementation. Conclusions There were substantial barriers to the delivery of the SLIV program. Theory-driven implementation strategies developed in this pre-implementation study should be considered to address those identified determinants for successful SLIV implementation

Are public health researchers designing for dissemination? Findings from a national survey in China

Abstract Background Research findings are not always disseminated in ways preferred by audiences, and research dissemination is not always considered a priority by researchers. While designing for dissemination (D4D) provides an active process to facilitate effective dissemination, use of these practices in China is largely unknown. We aimed to describe the designing for dissemination activities and practices among public health researchers in China. Methods In January 2022, we conducted a cross-sectional survey in 61 sub-committees of four national academic societies which include a wide range of health disciplines. The sample mainly involved researchers at universities or research institutions, the Centers for Disease Control and Prevention at national or regional levels, and hospitals. Participants completed a 42-item online questionnaire. Respondent characteristics, dissemination routes, dissemination barriers, organizational support, and personal practice of D4D were examined with descriptive analyses. Results Of 956 respondents, 737 were researchers. Among these researchers, 58.1% had disseminated their research findings. Although there were some variation in the commonly used routes among different groups, academic journals (82.2%) and academic conferences (73.4%) were the most frequently used routes. Barriers to dissemination to non-research audiences existed at both organizational level (e.g., a lack of financial resources, platforms, and collaboration mechanisms) and individual level (e.g., a lack of time, knowledge, and skills, and uncertainty on how to disseminate). About a quarter of respondents (26.7%) had a dedicated person or team for dissemination in their unit or organization, with university researchers reporting a significantly higher proportion than their counterparts (P < 0.05). Only 14.2% of respondents always or usually used frameworks or theories to plan dissemination activities, 26.2% planned dissemination activities early, and 27.1% always or usually involved stakeholders in the research and dissemination process. Respondents with working experience in a practice or policy setting or dissemination and implementation training experience were more likely to apply these D4D strategies (P < 0.05). Conclusion Considerable room exists for improvement in using impactful dissemination routes, tackling multiple barriers, providing organizational support, and applying D4D strategies among Chinese public health researchers. Our findings have implications for structural changes in academic incentive systems, collaborations and partnerships, funding priorities, and training opportunities

Association of APOE ε4 genotype and lifestyle with cognitive function among Chinese adults aged 80 years and older: A cross-sectional study.

BackgroundApolipoprotein E (APOE) ε4 is the single most important genetic risk factor for cognitive impairment and Alzheimer disease (AD), while lifestyle factors such as smoking, drinking, diet, and physical activity also have impact on cognition. The goal of the study is to investigate whether the association between lifestyle and cognition varies by APOE genotype among the oldest old.Methods and findingsWe used the cross-sectional data including 6,160 oldest old (aged 80 years old or older) from the genetic substudy of the Chinese Longitudinal Healthy Longevity Survey (CLHLS) which is a national wide cohort study that began in 1998 with follow-up surveys every 2-3 years. Cognitive impairment was defined as a Mini-Mental State Examination (MMSE) score less than 18. Healthy lifestyle profile was classified into 3 groups by a composite measure including smoking, alcohol consumption, dietary pattern, physical activity, and body weight. APOE genotype was categorized as APOE ε4 carriers versus noncarriers. We examined the associations of cognitive impairment with lifestyle profile and APOE genotype using multivariable logistic regressions, controlling for age, sex, education, marital status, residence, disability, and numbers of chronic conditions. The mean age of our study sample was 90.1 (standard deviation [SD], 7.2) years (range 80-113); 57.6% were women, and 17.5% were APOE ε4 carriers. The mean MMSE score was 21.4 (SD: 9.2), and 25.0% had cognitive impairment. Compared with those with an unhealthy lifestyle, participants with intermediate and healthy lifestyle profiles were associated with 28% (95% confidence interval [CI]: 16%-38%, P ConclusionsIn this study, we observed that healthier lifestyle was associated with better cognitive function among the oldest old regardless of APOE genotype. Our findings may inform the cognitive outlook for those oldest old with high genetic risk of cognitive impairment

My Diabetes Coach, a mobile app–based interactive conversational agent to support type 2 diabetes self-management: randomized effectiveness-implementation trial

Background Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health. Objective This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months. Methods This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models. Results A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (&minus;0.04%, 95% CI &minus;0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04). Conclusions The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users&rsquo; HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement. Trial Registration Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=1261400122966