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Abstract Introduction India grapples with a formidable health challenge, with an estimated 315 million adults afflicted with hypertension and 100 million living with diabetes mellitus. Alarming statistics reveal rates for poor treatment and control of hypertension and diabetes. In response to these pressing needs, the Community Control of Hypertension and Diabetes (CoCo-HD) program aims to implement structured lifestyle interventions at scale in the southern Indian states of Kerala and Tamil Nadu. Aims This research is designed to evaluate the implementation outcomes of peer support programs and community mobilisation strategies in overcoming barriers and maximising enablers for effective diabetes and hypertension prevention and control. Furthermore, it will identify contextual factors that influence intervention scalability and it will also evaluate the program’s value and return on investment through economic evaluation. Methods The CoCo-HD program is underpinned by a longstanding collaborative effort, engaging stakeholders to co-design comprehensive solutions that will be scalable in the two states. This entails equipping community health workers with tailored training and fostering community engagement, with a primary focus on leveraging peer supportat scale in these communities. The evaluation will undertake a hybrid type III trial in, Kerala and Tamil Nadu states, guided by the Institute for Health Improvement framework. The evaluation framework is underpinned by the application of three frameworks, RE-AIM, Normalisation Process Theory, and the Consolidated Framework for Implementation Research. Evaluation metrics include clinical outcomes: diabetes and hypertension control rates, as well as behavioural, physical, and biochemical measurements and treatment adherence. Discussion The anticipated outcomes of this study hold immense promise, offering important learnings into effective scaling up of lifestyle interventions for hypertension and diabetes control in low- and middle-income countries (LMICs). By identifying effective implementation strategies and contextual determinants, this research has the potential to lead to important changes in healthcare delivery systems. Conclusions The project will provide valuable evidence for the scaling-up of structured lifestyle interventions within the healthcare systems of Kerala and Tamil Nadu, thus facilitating their future adaptation to diverse settings in India and other LMICs.

Background Heart failure (HF) management is often challenging due to poor adherence to GDMT and self-care. Continuous monitoring of patients by a dedicated care manager may enhance adherence to self-care and treatment and prevent hospitalisations. For the adoption and acceptance of a collaborative care model (CCM) for HF management in Indian settings, understanding the perspectives of all stakeholders regarding its various components and feasibility is needed. Therefore, we aimed to obtain perceptions of potential challenges to care and suggestions on multiple components of the proposed CCM in managing HF and its feasibility. Methods In-depth interviews were done among HF patients, caregivers, nurses, and cardiologists from private, co-operative, and public sector tertiary care hospital settings that cater to HF patients in Kerala, India. An in-depth interview guide was used to elicit the data. Data were analysed using Python QualCoder version 2.2. We used a framework method for the analysis of data. Results A total of 22 in-depth interviews were conducted. We found that the existing care for HF in many settings was inadequate for continuous engagement with the patients. Non-adherence to treatment and other self-care measures, was noted as a major challenge to HF care. Healthcare providers and patients felt nurses were better at leading collaborative care. However, various barriers, including technical and technological, and the apprehensions of nurses in leading the CCM were identified. The stakeholders also identified the mHealth-assisted CCM as a potential tool to save money. The stakeholders also appreciated the role of nurses in creating confidence in patients. Conclusions A nurse-led, mHealth-assisted, and team-based collaborative care was recognised as an excellent step to improve patient adherence. Effective implementation of it could reduce hospitalisations and improve patients' ability to manage their HF symptoms.

BackgroundDiabetes and hypertension are leading public health problems, particularly affecting low- and middle-income countries, with considerable variations in the care continuum between different age, socio-economic, and rural and urban groups. In this qualitative study, examining the factors affecting access to healthcare in Kerala, we aim to explore the healthcare-seeking pathways of people living with diabetes and hypertension.MethodsWe conducted 20 semi-structured interviews and one focus group discussion (FGD) on a purposive sample of people living with diabetes and hypertension. Participants were recruited at four primary care facilities in Malappuram district of Kerala. Interviews were transcribed and analyzed deductively and inductively using thematic analysis underpinned by Levesque et al.’s framework.ResultsThe patient journey in managing diabetes and hypertension is complex, involving multiple entry and exit points within the healthcare system. Patients did not perceive Primary Health Centres (PHCs) as their initial points of access to healthcare, despite recognizing their value for specific services. Numerous social, cultural, economic, and health system determinants underpinned access to healthcare. These included limited patient knowledge of their condition, self-medication practices, lack of trust/support, high out-of-pocket expenditure, unavailability of medicines, physical distance to health facilities, and attitude of healthcare providers.ConclusionThe study underscores the need to improve access to timely diagnosis, treatment, and ongoing care for diabetes and hypertension at the lower level of the healthcare system. Currently, primary healthcare services do not align with the “felt needs” of the community. Practical recommendations to address the social, cultural, economic, and health system determinants include enabling and empowering people with diabetes and hypertension and their families to engage in self-management, improving existing health information systems, ensuring the availability of diagnostics and first-line drug therapy for diabetes and hypertension, and encouraging the use of single-pill combination (SPC) medications to reduce pill burden. Ensuring equitable access to drugs may improve hypertension and diabetes control in most disadvantaged groups. Furthermore, a more comprehensive approach to healthcare policy that recognizes the interconnectedness of non-communicable diseases (NCDs) and their social determinants is essential.

Abstract Background We aimed to identify clusters of health behaviors and study their associations with cardiometabolic risk factors in adults at high risk for type 2 diabetes in India. Methods Baseline data from the Kerala Diabetes Prevention Program (n = 1000; age 30–60 years) were used for this study. Information on physical activity (PA), sedentary behavior, fruit and vegetable intake, sleep, and alcohol and tobacco use was collected using questionnaires. Blood pressure, waist circumference, 2‐h plasma glucose, high‐density lipoprotein and low‐density lipoprotein cholesterol, and triglycerides were measured using standardized protocols. Latent class analysis was used to identify clusters of health behaviors, and multilevel mixed‐effects linear regression was employed to examine their associations with cardiometabolic risk factors. Results Two classes were identified, with 87.4% of participants in class 1 and 12.6% in class 2. Participants in both classes had a high probability of not engaging in leisure‐time PA (0.80 for class 1; 0.73 for class 2) and consuming =3 h per day (0.26 vs 0.42), tobacco use (0.10 vs 0.75), and alcohol use (0.08 vs 1.00) compared to those in class 2. Class 1 had a significantly lower mean systolic blood pressure (β = −3.70 mm Hg, 95% confidence interval [CI] −7.05, −0.36), diastolic blood pressure (β = −2.45 mm Hg, 95% CI −4.74, −0.16), and triglycerides (β = −0.81 mg/dL, 95% CI −0.75, −0.89). Conclusion Implementing intervention strategies, tailored to cluster‐specific health behaviors, is required for the effective prevention of cardiometabolic disorders among high‐risk adults for type 2 diabetes.

Background Heart failure (HF) management is often challenging due to poor adherence to GDMT and self-care. Continuous monitoring of patients by a dedicated care manager may enhance adherence to self-care and treatment and prevent hospitalisations. For the adoption and acceptance of a collaborative care model (CCM) for HF management in Indian settings, understanding the perspectives of all stakeholders regarding its various components and feasibility is needed. Therefore, we aimed to obtain perceptions of potential challenges to care and suggestions on multiple components of the proposed CCM in managing HF and its feasibility. Methods In-depth interviews were done among HF patients, caregivers, nurses, and cardiologists from private, co-operative, and public sector tertiary care hospital settings that cater to HF patients in Kerala, India. An in-depth interview guide was used to elicit the data. Data were analysed using Python QualCoder version 2.2. We used a framework method for the analysis of data. Results A total of 22 in-depth interviews were conducted. We found that the existing care for HF in many settings was inadequate for continuous engagement with the patients. Non-adherence to treatment and other self-care measures, was noted as a major challenge to HF care. Healthcare providers and patients felt nurses were better at leading collaborative care. However, various barriers, including technical and technological, and the apprehensions of nurses in leading the CCM were identified. The stakeholders also identified the mHealth-assisted CCM as a potential tool to save money. The stakeholders also appreciated the role of nurses in creating confidence in patients. Conclusions A nurse-led, mHealth-assisted, and team-based collaborative care was recognised as an excellent step to improve patient adherence. Effective implementation of it could reduce hospitalisations and improve patients' ability to manage their HF symptoms.

Abstract Background Structured lifestyle change education reduces the burden of cardiometabolic diseases such as diabetes. Delivery of these programs at worksites could overcome barriers to program adoption and improve program sustainability and reach; however, tailoring to the worksite setting is essential. Methods The Integrating Diabetes Prevention in Workplaces (INDIA-WORKS) study tested the implementation and effectiveness of a multi-level program for reducing cardiometabolic disease risk factors at 11 large and diverse worksites across India. Herein, we describe and classify program adaptations reported during in-depth interviews and focus group discussions with worksite managers, program staff, and peer educators involved in program delivery, and program participants and drop-outs. We used thematic analysis to identify key themes in the data and classified reported program adaptations using the FRAME classification system. Results Adaptations were led by worksite managers, peer educators, and program staff members. They occurred both pre- and during program implementation and were both planned (proactive) and unplanned (proactive and reactive). The most frequently reported adaptations to the individual-level intervention were curriculum changes to tailor lessons to the local context, make the program more appealing to the workers at the site, or add a wider variety of exercise options. Other content adaptations included improvements to the screening protocol, intervention scheduling, and outreach plans to tailor participant recruitment and retention to the sites. Environment-level content adaptations included expanding or leveraging healthy food and exercise options at the worksites. Challenges to adaptation included scheduling and worksite-level challenges. Participants discussed the need to continue adapting the program in the future to continue making it relevant for worksite settings and engaging for employees. Conclusion This study describes and classifies site-specific modifications to a structured lifestyle change education program with worksite-wide health improvements in India. This adds to the literature on implementation adaptation in general and worksite wellness in India, a country with a large and growing workforce with, or at risk of, serious cardiometabolic diseases. This information is key for program scale-up, dissemination, and implementation in other settings. Trial registration Clinicaltrials.gov NCT02813668. Registered June 27, 2016

Background: Lung cancer continues to be the leading cause of cancer-related deaths in men and women. A breakdown by level of economic development shows no differences in cancer deaths in men but a higher rate of lung cancer deaths in women in industrialized countries as compared with developing nations. The risk factors for lung cancer most commonly include lifestyle, environmental, and occupational exposures. The role these factors play varies depending on geographic location, sex and race characteristics, genetic predisposition, as well as their synergistic interactions. Materials and Methods: It was a hospital-based registry, wherein hospitals were selected from three zones—north, central, and south zones of Kerala. The study was registered with clinical trial registry of India with Registration No. CTRI/2021/02/031299. Registry of lung cancer patients was prepared at all sites and institutional ethical clearance was received from all sites. All patients with primary lung cancer, histologically proven of all age groups were included in the study. Results: A total of 761 patients were registered from six teaching hospitals in Kerala who were diagnosed with primary lung cancer during the period 2017–2019. The mean age of the study population was 65.1 ± 10.2 years. Of all, 81.1% of them were males and 18.9% were females. Histologically, 56.4% had adenocarcinoma and 25.6% had squamous cell carcinoma. Conclusion: It was observed that the proportion of females diagnosed with primary lung cancer is increasing. Patients get diagnosed at a later stage of the disease, which calls for screening and early detection of lung cancer. As it accounts for the highest mortality among all other cancers, there is high scope for prevention and screening strategies.

Abstract Background Peer support programs are promising approaches to diabetes prevention. However, there is still limited evidence on the health benefits of peer support programs for lay peer leaders. Purpose To examine whether a peer support program designed for diabetes prevention resulted in greater improvements in health behaviors and outcomes for peer leaders as compared to other participants. Methods 51 lay peer leaders and 437 participants from the Kerala Diabetes Prevention Program were included. Data were collected at baseline, 12 months, and 24 months. We compared behavioral, clinical, biochemical, and health-related quality of life parameters between peer leaders and their peers at the three time-points. Results After 12 months, peer leaders showed significant improvements in leisure time physical activity (+ 17.7% vs. + 3.4%, P = 0.001) and health-related quality of life (0.0 vs. + 0.1, P = 0.004); and a significant reduction in alcohol use (-13.6% vs. -6.6%, P = 0.012) and 2-hour plasma glucose (-4.1 vs. + 9.9, P = 0.006), as compared to participants. After 24 months, relative to baseline, peer leaders had significant improvements in fruit and vegetable intake (+ 34.5% vs. + 26.5%, P = 0.017) and leisure time physical activity (+ 7.9% vs. -0.9%, P = 0.009); and a greater reduction in alcohol use (-13.6% vs. -4.9%, P = 0.008), and waist-to-hip ratio (-0.04 vs. -0.02, P = 0.014), as compared to participants. However, only the changes in fruit and vegetable intake and waist-to-hip ratio were maintained between 12 and 24 months. Conclusion Being a peer leader in a diabetes prevention program was associated with greater health benefits during and after the intervention period. Further studies are needed to examine the long-term sustainability of these benefits.

Abstract Introduction Poor medical information transfer across healthcare visits and providers poses a potential threat to patient safety. Patient‐held health records (PHRs) may be used to facilitate informational continuity, handover communication and patient self‐management. However, there are conflicting opinions on the effectiveness of PHRs, other than in maternal and child care. Moreover, the experiences of users of PHRs in low‐ and middle‐income countries are critical in policy decisions but have rarely been researched. Aim This study aimed to explore similarities and differences in the perspectives of patients, carers and healthcare providers (HCPs) on the current PHRs for diabetes and hypertension in Kerala. Methods A qualitative design was used comprising semistructured interviews with patients with diabetes/hypertension (n = 20), carers (n = 15) and HCPs (n = 17) in Kerala, India. Data were analysed using thematic analysis. Results Themes generated regarding the experiences with PHRs from each user group were compared and contrasted. The themes that arose were organized under three headings: use of PHRs in everyday practice; the perceived value of PHR and where practice and value conflict. We found that in the use of PHRs in everyday practice, multiple PHRs posed challenges for patients carrying records and for HCPs locating relevant information. Most carers carried all patients' past PHRs, while patients made decisions on which PHR to take along based on the purpose of the healthcare visit. HCPs appreciated having PHRs but documented limited details in them. The perceived value of PHRs by each group for themselves was different. While HCPs placed value on PHRs for enabling better clinical decision‐making, preventing errors and patient safety, patients perceived them as transactional tools for diabetes and hypertension medications; carers highlighted their value during emergencies. Conclusion Our findings suggest that users find a variety of values for PHRs. However, these perceived values are different for each user group, suggesting minimal functioning of PHRs for informational continuity, handover communication and self‐management. Patient and Public Involvement Patients and carers were involved during the pilot testing of topic guides, consent and study information sheets. Patients and carers gave their feedback on the materials to ensure clarity and appropriateness within the context.

Background: A heavy burden of cardiometabolic conditions on low- and middle-income countries like India that are rapidly undergoing urbanization remains unaddressed. Indians are known to have high levels of triglycerides and low levels of HDL-C along with moderately higher levels of LDL-C. The genome-wide findings from Western populations need to be validated in an Indian context for a better understanding of the underlying etiology of dyslipidemia in India.Objective: We aim to validate 12 genetic variants associated with lipid levels among rural and urban Indian populations and derive unweighted and weighted genetic risk scores (uGRS and wGRS) for lipid levels among the Indian population.Methods: Assuming an additive model of inheritance, linear regression models adjusted for all the possible covariates were run to examine the association between 12 genetic variants and total cholesterol, triglycerides, HDL-C, LDL-C, and VLDL-C among 2,117 rural and urban Indian participants. The combined effect of validated loci was estimated by allelic risk scores, unweighted and weighted by their effect sizes.Results: The wGRS for triglycerides and VLDL-C was derived based on five associated variants (rs174546 at FADS1, rs17482753 at LPL, rs2293889 at TRPS1, rs4148005 at ABCA8, and rs4420638 at APOC1), which was associated with 36.31 mg/dL of elevated triglyceride and VLDL-C levels (β = 0.95, SE = 0.16, p < 0.001). Similarly, every unit of combined risk score (rs2293889 at TRPS1 and rs4147536 at ADH1B) was associated with 40.62 mg/dL of higher total cholesterol (β = 1.01, SE = 0.23, p < 0.001) and 33.97 mg/dL of higher LDL-C (β = 1.03, SE = 0.19, p < 0.001) based on its wGRS (rs2293889 at TRPS1, rs4147536 at ADH1B, rs4420638 at APOC1, and rs660240 at CELSR2). The wGRS derived from five associated variants (rs174546 at FADS1, rs17482753 at LPL, rs4148005 at ABCA8, rs4420638 at APOC1, and rs7832643 at PLEC) was associated with 10.64 mg/dL of lower HDL-C (β = −0.87, SE = 0.14, p < 0.001).Conclusion: We confirm the role of eight genome-wide association study (GWAS) loci related to different lipid levels in the Indian population and demonstrate the combined effect of variants for lipid traits among Indians by deriving the polygenic risk scores. Similar studies among different populations are required to validate the GWAS loci and effect modification of these loci by lifestyle and environmental factors related to urbanization.

Abstract Introduction India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. Objectives The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. Methods The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. Discussion Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. Trial registration Australia and New Zealand Clinical Trials Registry–(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Objective: To develop and validate a sensitive tool for assessment of quality of life (QoL) in heart failure (HF) patients in Indian settings. Methods: The authors conducted literature review, in depth interviews, clinical observations and designed the first draft of the QoL tool. The tool was validated using content and face validity by a panel of experts. For internal consistency reliability, the questionnaire was administered among 270 HF patients. Test-retest reliability was assessed in 20 HF patients. Principal component factor analysis with varimax rotation was employed to assess the dimensionality and to reduce the number of items. Cronbach's alpha, and Intra-class correlation coefficients (ICCs) were employed to investigate reliability of questionnaire. The responsiveness data were collected 6 months after the baseline data collection from 30 HF patients. IBM® SPSS® Statistics Version 21 was used for statistical analysis. Results: The principal component factor analysis revealed mainly 5 domains. The final tool included 25 items. Cronbach's alpha (α) for the overall tool was 0.915. Intra-class correlation coefficients (ICCs) based on test-retest was 0.734. The final tool showed good responsiveness to changes with a mean ± SD of the change in response of 46 ± 12.4 and a standardized mean response of 3.7 within six-months. Conclusion: The HF specific QoL tool developed for Indian patients is a valid and reliable instrument and it can be applied in daily clinical practice, and research. Short summary: We had developed and validated a quality-of-life tool for heart failure patients in India. This is the first ever attempt to develop a measure for heart failure patients in India. We had used a mixed methodology approach to identify all the domains in the tool. The newly developed tool is a valid, reliable, sensitive and responsive tool to measure quality of life in HF patients in India. This tool can be applied in daily clinical practice, research and health system for patients with HF in India.

We aimed to study the knowledge of diabetes among individuals with a high risk for developing type 2 diabetes in the Trivandrum district of the Indian state of Kerala. The baseline data collected from 1007 participants of the Kerala Diabetes Prevention Program were analyzed. Diabetes knowledge was assessed using a scale adapted from a large nationwide study conducted in India. The composite score of the scale ranged from 0 to 8. The mean age of the participants was 46.0 (SD: 7.5) years, and 47.2% were women. The mean diabetes knowledge score was 6.9 (SD: 2.1), with 59.5% having the maximum possible score of 8. Of the 1007 participants, 968 (96.1%) had heard the term diabetes, and of them, 87.2% knew that the prevalence of diabetes is increasing, 92.9% knew at least one risk factor for diabetes, 79.6% knew that diabetes can cause complications in organs, and 75.9% knew that diabetes can be prevented. While the overall level of knowledge of diabetes about its risk factors, complications, and prevention was generally high, an alarmingly low proportion of participants knew that diabetes can affect key organs such as the eyes (24.0%), heart (20.1%), feet (10.2%), and nerves (2.9%), and nearly a quarter (24.1%) were not aware that diabetes can be prevented. It is essential to educate high-risk individuals about diabetes complications and the importance of and strategies for diabetes prevention in the Trivandrum district of Kerala.

Abstract Aims Limited data on the uptake of guideline‐directed medical therapies (GDMTs) and the mortality of acute decompensated HF (ADHF) patients are available from India. The National Heart Failure Registry (NHFR) aimed to assess clinical presentation, practice patterns, and the mortality of ADHF patients in India. Methods and results The NHFR is a facility‐based, multi‐centre clinical registry of consecutive ADHF patients with prospective follow‐up. Fifty three tertiary care hospitals in 21 states in India participated in the NHFR. All consecutive ADHF patients who satisfied the European Society of Cardiology criteria were enrolled in the registry. All‐cause mortality at 90 days was the main outcome measure. In total, 10 851 consecutive patients were recruited (mean age: 59.9 years, 31% women). Ischaemic heart disease was the predominant aetiology for HF (72%), followed by dilated cardiomyopathy (18%). Isolated right HF was noted in 62 (0.6%) participants. In eligible HF patients, 47.5% received GDMT. The 90 day mortality was 14.2% (14.9% and 13.9% in women and men, respectively) with a re‐admission rate of 8.4%. An inverse relationship between educational class based on years of education and 90 day mortality (high mortality in the lowest educational class) was observed in the study population. Patients with HF with reduced ejection fraction and HF with mildly reduced ejection fraction who did not receive GDMT experienced higher mortality (log‐rank P 120 ms, atrial fibrillation, mitral regurgitation, haemoglobin levels, serum sodium, and GDMT independently predicted 90 day mortality. Conclusion One of seven ADHF patients in the NHFR died during the first 90 days of follow‐up. One of two patients received GDMT. Adherence to GDMT improved survival in HF patients with reduced and mildly reduced ejection fractions. Our findings call for innovative quality improvement initiatives to improve the uptake of GDMT among HF patients in India.

Patients who undergo heart valve replacements with mechanical valves need to take Vitamin K Antagonists (VKA) drugs (Warfarin, Nicoumalone) which has got a very narrow therapeutic range and needs very close monitoring using PT-INR. Accessibility to physicians to titrate drugs doses is a major problem in low-middle income countries (LMIC) like India. Our work was aimed at predicting the maintenance dosage of these drugs, using the de-identified medical data collected from patients attending an INR Clinic in South India. We used artificial intelligence (AI) - machine learning to develop the algorithm. A Support Vector Machine (SVM) regression model was built to predict the maintenance dosage of warfarin, who have stable INR values between 2.0 and 4.0. We developed a simple user friendly android mobile application for patients to use the algorithm to predict the doses. The algorithm generated drug doses in 1100 patients were compared to cardiologist prescribed doses and found to have an excellent correlation.

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.

BackgroundThe lifetime risk of stroke has been calculated in a limited number of selected populations. We sought to estimate the lifetime risk of stroke at the regional, country, and global level using data from a comprehensive study of the prevalence of major diseases.MethodsWe used the Global Burden of Disease (GBD) Study 2016 estimates of stroke incidence and the competing risks of death from any cause other than stroke to calculate the cumulative lifetime risks of first stroke, ischemic stroke, or hemorrhagic stroke among adults 25 years of age or older. Estimates of the lifetime risks in the years 1990 and 2016 were compared. Countries were categorized into quintiles of the sociodemographic index (SDI) used in the GBD Study, and the risks were compared across quintiles. Comparisons were made with the use of point estimates and uncertainty intervals representing the 2.5th and 97.5th percentiles around the estimate.ResultsThe estimated global lifetime risk of stroke from the age of 25 years onward was 24.9% (95% uncertainty interval, 23.5 to 26.2); the risk among men was 24.7% (95% uncertainty interval, 23.3 to 26.0), and the risk among women was 25.1% (95% uncertainty interval, 23.7 to 26.5). The risk of ischemic stroke was 18.3%, and the risk of hemorrhagic stroke was 8.2%. In high-SDI, high-middle-SDI, and low-SDI countries, the estimated lifetime risk of stroke was 23.5%, 31.1% (highest risk), and 13.2% (lowest risk), respectively; the 95% uncertainty intervals did not overlap between these categories. The highest estimated lifetime risks of stroke according to GBD region were in East Asia (38.8%), Central Europe (31.7%), and Eastern Europe (31.6%), and the lowest risk was in eastern sub-Saharan Africa (11.8%). The mean global lifetime risk of stroke increased from 22.8% in 1990 to 24.9% in 2016, a relative increase of 8.9% (95% uncertainty interval, 6.2 to 11.5); the competing risk of death from any cause other than stroke was considered in this calculation.ConclusionsIn 2016, the global lifetime risk of stroke from the age of 25 years onward was approximately 25% among both men and women. There was geographic variation in the lifetime risk of stroke, with the highest risks in East Asia, Central Europe, and Eastern Europe. (Funded by the Bill and Melinda Gates Foundation.).

BackgroundThe lifetime risk of stroke has been calculated in a limited number of selected populations. We sought to estimate the lifetime risk of stroke at the regional, country, and global level using data from a comprehensive study of the prevalence of major diseases.MethodsWe used the Global Burden of Disease (GBD) Study 2016 estimates of stroke incidence and the competing risks of death from any cause other than stroke to calculate the cumulative lifetime risks of first stroke, ischemic stroke, or hemorrhagic stroke among adults 25 years of age or older. Estimates of the lifetime risks in the years 1990 and 2016 were compared. Countries were categorized into quintiles of the sociodemographic index (SDI) used in the GBD Study, and the risks were compared across quintiles. Comparisons were made with the use of point estimates and uncertainty intervals representing the 2.5th and 97.5th percentiles around the estimate.ResultsThe estimated global lifetime risk of stroke from the age of 25 years onward was 24.9% (95% uncertainty interval, 23.5 to 26.2); the risk among men was 24.7% (95% uncertainty interval, 23.3 to 26.0), and the risk among women was 25.1% (95% uncertainty interval, 23.7 to 26.5). The risk of ischemic stroke was 18.3%, and the risk of hemorrhagic stroke was 8.2%. In high-SDI, high-middle-SDI, and low-SDI countries, the estimated lifetime risk of stroke was 23.5%, 31.1% (highest risk), and 13.2% (lowest risk), respectively; the 95% uncertainty intervals did not overlap between these categories. The highest estimated lifetime risks of stroke according to GBD region were in East Asia (38.8%), Central Europe (31.7%), and Eastern Europe (31.6%), and the lowest risk was in eastern sub-Saharan Africa (11.8%). The mean global lifetime risk of stroke increased from 22.8% in 1990 to 24.9% in 2016, a relative increase of 8.9% (95% uncertainty interval, 6.2 to 11.5); the competing risk of death from any cause other than stroke was considered in this calculation.ConclusionsIn 2016, the global lifetime risk of stroke from the age of 25 years onward was approximately 25% among both men and women. There was geographic variation in the lifetime risk of stroke, with the highest risks in East Asia, Central Europe, and Eastern Europe. (Funded by the Bill and Melinda Gates Foundation.).

Abstract Background Cardiac disease in pregnancy is a major contributor to maternal mortality in high, middle and low-income countries. Availability of data on outcomes of pregnancy in women with heart disease is important for planning resources to reduce maternal mortality. Prospective data on outcomes and risk predictors of mortality in pregnant women with heart disease (PWWHD) from low- and middle-income countries are scarce. Methods The Tamil Nadu Pregnancy and Heart Disease Registry (TNPHDR) is a prospective, multicentric and multidisciplinary registry of PWWHD from 29 participating sites including both public and private sectors, across the state of Tamil Nadu in India. The TNPHDR is aimed to provide data on incidence of maternal and fetal outcomes, adverse outcome predictors, applicability of the modified World Health Organization (mWHO) classification of maternal cardiovascular risk and the International risk scoring systems (ZAHARA and CARPREG I & II) in Indian population and identify possible gaps in the existing management of PWWHD. Pregnancy and heart teams will be formed in all participating sites. Baseline demographic, clinical, laboratory and imaging parameters, data on counselling received, antenatal triage and management, peripartum management and postpartum care will be collected from 2500 eligible participants as part of the TNPHDR. Participants will be followed up at one, three and six-months after delivery/termination of pregnancy to document study outcomes. Predictors of maternal and foetal outcome will be identified. Discussion The TNPHDR will be the first representative registry from low- and middle-income countries aimed at providing crucial information on pregnancy outcomes and risk predictors in PWWHD. The results of TNPHDR could help to formulate steps for improved care and to generate a customised and practical guideline for managing pregnancy in women with heart disease in limited resource settings. Trial registration The TNPHDR is registered under Clinical Trials Registry-India ( CTRI/2020/01/022736 ).

Background: Short term outcomes of patients with pulmonary hypertension are not available from low and middle-income countries including India. Methods: We conducted a prospective study of 2003 patients with pulmonary hypertension, from 50 centres (PROKERALA) in Kerala, who were followed up for one year. Pulmonary hypertension (PH) was mainly diagnosed on the basis of Doppler echocardiography. The primary outcome was a composite end-point of all-cause death and hospital admission for heart failure. All cause hospitalisation events constituted the secondary outcome. Results: Mean age of study population was 56 ± 16 years. Group 1 and Group 2 PH categories constituted 21.2% and 59% of the study population, respectively. Nearly two-thirds (65%) of the study participants had functional class II symptoms. 31% of Group 1 PH patients were on specific vasodilator drugs.In total, 83 patients (4.1%) died during the one-year follow-up period. Further, 1235 re-hospitalisation events (61.7%) were reported. In the multivariate model, baseline NYHA class III/IV (OR 1.87, 95% C.I. 1.35–2.56), use of calcium channel blockers (OR 0.18, 95% C.I. 0.04–0.77), vasodilator therapy (OR 0.5, 95% C.I. 0.28–0.87) and antiplatelet agents (OR 1.80, 95% C.I. 1.29–2.51) were associated with primary composite outcome at one-year (p

BackgroundType 2 diabetes mellitus (T2DM), a common chronic health condition, has major health and socioeconomic consequences. In the Indian subcontinent, it is a health condition for which individuals commonly consult Ayurvedic (traditional medical system) practitioners and use their medicines. However, to date, a good quality T2DM clinical guideline for Ayurvedic practitioners, grounded on the best available scientific evidence, is not available. Therefore, the study aimed to systematically develop a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.MethodsThe development work was guided by the UK’s National Institute for Health and Care Excellence (NICE) manual for developing guidelines, the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. First, a comprehensive systematic review was conducted which evaluated Ayurvedic medicines’ effectiveness and safety in managing T2DM. In addition, the GRADE approach was used for assessing the certainty of the findings. Next, using the GRADE approach, the Evidence-to-Decision framework was developed, and we focused on glycemic control and adverse events. Subsequently, based on the Evidence-to-Decision framework, a Guideline Development Group of 17 international members made recommendations on Ayurvedic medicines’ effectiveness and safety in T2DM. These recommendations formed the basis of the clinical guideline, and additional generic content and recommendations were adapted from the T2DM Clinical Knowledge Summaries of the Clarity Informatics (UK). The feedback given by the Guideline Development Group on the draft version was used to amend and finalize the clinical guideline.ResultsA clinical guideline for managing T2DM in adults by Ayurvedic practitioners was developed, which focuses on how practitioners can provide appropriate care, education, and support for people with T2DM (and their carers and family). The clinical guideline provides information on T2DM, such as its definition, risk factors, prevalence, prognosis, and complications; how it should be diagnosed and managed through lifestyle changes like diet and physical activity and Ayurvedic medicines; how the acute and chronic complications of T2DM should be detected and managed (including referral to specialists); and advice on topics like driving, work, and fasting including during religious/socio-cultural festivals.ConclusionWe systematically developed a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.

Cardiovascular, respiratory, and related disorders (CVRDs) are the leading causes of adult death worldwide, and substantial inequalities in care of patients with CVRDs exist between countries of high income and countries of low and middle income. Based on current trends, the UN Sustainable Development Goal to reduce premature mortality due to CVRDs by a third by 2030 will be challenging for many countries of low and middle income. We did systematic literature reviews of effectiveness and cost-effectiveness to identify priority interventions. We summarise the key findings and present a costed essential package of interventions to reduce risk of and manage CVRDs. On a population level, we recommend tobacco taxation, bans on trans fats, and compulsory reduction of salt in manufactured food products. We suggest primary health services be strengthened through the establishment of locally endorsed guidelines and ensured availability of essential medications. The policy interventions and health service delivery package we suggest could serve as the cornerstone for the management of CVRDs, and afford substantial financial risk protection for vulnerable households. We estimate that full implementation of the essential package would cost an additional US$21 per person in the average low-income country and $24 in the average lower-middle-income country. The essential package we describe could be a starting place for low-income and middle-income countries developing universal health coverage packages. Interventions could be rolled out as disease burden demands and budgets allow. Our outlined interventions provide a pathway for countries attempting to convert the UN Sustainable Development Goal commitments into tangible action.

BackgroundThe burden of cardiovascular diseases (CVDs) remains unclear in many regions of the world.ObjectivesThe GBD (Global Burden of Disease) 2015 study integrated data on disease incidence, prevalence, and mortality to produce consistent, up-to-date estimates for cardiovascular burden.MethodsCVD mortality was estimated from vital registration and verbal autopsy data. CVD prevalence was estimated using modeling software and data from health surveys, prospective cohorts, health system administrative data, and registries. Years lived with disability (YLD) were estimated by multiplying prevalence by disability weights. Years of life lost (YLL) were estimated by multiplying age-specific CVD deaths by a reference life expectancy. A sociodemographic index (SDI) was created for each location based on income per capita, educational attainment, and fertility.ResultsIn 2015, there were an estimated 422.7 million cases of CVD (95% uncertainty interval: 415.53 to 427.87 million cases) and 17.92 million CVD deaths (95% uncertainty interval: 17.59 to 18.28 million CVD deaths). Declines in the age-standardized CVD death rate occurred between 1990 and 2015 in all high-income and some middle-income countries. Ischemic heart disease was the leading cause of CVD health lost globally, as well as in each world region, followed by stroke. As SDI increased beyond 0.25, the highest CVD mortality shifted from women to men. CVD mortality decreased sharply for both sexes in countries with an SDI >0.75.ConclusionsCVDs remain a major cause of health loss for all regions of the world. Sociodemographic change over the past 25 years has been associated with dramatic declines in CVD in regions with very high SDI, but only a gradual decrease or no change in most regions. Future updates of the GBD study can be used to guide policymakers who are focused on reducing the overall burden of noncommunicable disease and achieving specific global health targets for CVD.

Background: Heart failure (HF) is a multi-morbid chronic condition, which adversely affects the quality of life of the affected individual. Engaging the patient and their caregivers in self-care is known to reduce mortality, rehospitalisation and improve quality of life among HF patients. The PACT-HF trial will answer whether clinical benefits in terms of mortality and hospitalisation outcomes can be demonstrated by using a pragmatic design to explore the specific effects of physical activity, and cognitive behavioural therapy in HF patients in India. Methods: We will conduct a 2 × 2 factorial, randomized, open-label trial, which aims to see if rehabilitation strategies of structured physical activity training and cognitive behavioural therapy for depression and self-management reduce the risk of repeat hospitalisation and deaths in HF patients in India. Patients will be randomised to (1) physical activity + usual care (2) cognitive behaviour therapy + usual care, (3) physical activity + cognitive behaviour therapy + usual care, and (4) usual care at 1:1:1:1 ratio. Time to mortality will be the primary outcome. A composite of mortality and hospitalisation for HF will be the main secondary outcome. Additional secondary outcomes will include ‘days alive and out of hospital’, cumulative hospitalisation, quality of life, Minnesota Living with Heart Failure questionnaire score, depression score, six minutes walking distance, handgrip strength, and adherence to medicines and lifestyle. The effects of intervention on the primary outcome will be estimated from Cox proportional hazard models. For the continuous secondary outcome variables, differences between randomised groups will be estimated from linear mixed models or generalised estimating equations (GEE) as appropriate. Discussion: PACT-HF is designed to provide reliable evidence about the balance of benefits and risks conferred by physical activity and cognitive behavioural therapy-based cardiac rehabilitation for those with HF, irrespective of their initial disease severity.

IntroductionAccess to patients' documented medical information is necessary for building the informational continuity across different healthcare providers (HCP), particularly for patients with non-communicable diseases (NCD). Patient-held health records (PHR) such as NCD notebooks have important documented medical information, which can contribute to informational continuity in the outpatient settings for patients with diabetes and hypertension in Kerala. We aimed to use the theoretical domains framework (TDF) to identify the perceived HCP factors influencing informational and management continuity for patients with diabetes and hypertension.MethodsWe re-analyzed semi-structured interview data for 17 HCPs with experience in the NCD programme in public health facilities in Kerala from a previous study, using the TDF. The previous study explored patients, carers and HCPs experiences using PHRs such as NCD notebooks in the management of diabetes and hypertension. Interview transcripts were deductively coded based on a coding framework based on the 14 domains of TDF. Specific beliefs were generated from the data grouped into the domains.ResultsData were coded into the 14 domains of TDF and generated 33 specific beliefs regarding maintaining informational and management continuity of care. Seven domains were judged to be acting as facilitators for recording in PHRs and maintaining continuity. The two domains “memory, attention and decision process” and “environmental context and resources” depicted the barriers identified by HCPs for informational continuity of care.ConclusionIn this exploration of recording and communicating patients' medical information in PHRs for patients with diabetes and hypertension, HCPs attributions of sub-optimal recording were used to identify domains that may be targeted for further development of supporting intervention. Overall, nine domains were likely to impact the barriers and facilitators for HCPs in recording in PHRs and communicating; subsequently maintaining informational and management continuity of care. This study showed that many underlying beliefs regarding informational continuity of care were based on HCPs' experiences with patient behaviors. Further research is needed for developing the content and appropriate support interventions for using PHRs to maintain informational continuity.

Introduction: Many Ayurvedic medicines have the potential for managing type 2 diabetes mellitus (T2DM), with previous systematic reviews demonstrating effectiveness and safety for specific Ayurvedic medicines. However, many of the reviews need updating and none provide a comprehensive summary of all the Ayurvedic medicines evaluated for managing T2DM.Objective: The objective of this systematic review was to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing T2DM.Inclusion criteria: Published and unpublished RCTs assessing the effectiveness and safety of Ayurvedic medicines for managing T2DM in adults.Methods: The JBI systematic review methodology was followed. A comprehensive search of sources (including 18 electronic databases) from inception to 16 January 2021 was made. No language restrictions were applied. Data synthesis was conducted using narrative synthesis and random effects meta-analyses, where appropriate. Pooled results are reported as mean differences (MD) with 95% confidence intervals (CI).Results: Out of 32,519 records identified from the searches, 219 articles were included in the systematic review representing 199 RCTs (21,191 participants) of 98 Ayurvedic medicines. Overall, in the studies reviewed the methodology was not adequately reported, resulting in poorer methodological quality scoring. Glycated hemoglobin (HbA1c) was reduced using Aegle marmelos (L.) Corrêa (MD -1.6%; 95% CI −3 to −0.3), Boswellia serrata Roxb. (−0.5; −0.7 to −0.4), Gynostemma pentaphyllum (Thunb.) Makino (−1; −1.5 to −0.6), Momordica charantia L. (−0.3; −0.4 to −0.1), Nigella sativa L. (−0.4; −0.6 to −0.1), Plantago ovata Forssk. (−0.9; −1.4 to −0.3), Tinospora cordifolia (Willd.) Hook.f. and Thomson (−0.5; −0.6 to −0.5), Trigonella foenum-graecum L. (−0.6; −0.9 to −0.4), and Urtica dioica L. (−1.3; −2.4 to −0.2) compared to control. Similarly, fasting blood glucose (FBG) was reduced by 4–56 mg/dl for a range of Ayurvedic medicines. Very few studies assessed health-related quality of life (HRQoL). Adverse events were not reported in many studies, and if reported, these were mostly none to mild and predominately related to the gastrointestinal tract.Conclusion: The current evidence suggests the benefit of a range of Ayurvedic medicines in improving glycemic control in T2DM patients. Given the limitations of the available evidence and to strengthen the evidence base, high-quality RCTs should be conducted and reported.

Background: Proper diet is necessary to control hypertension and diabetes. This paper describes the combined fruit and vegetable, and salt intake of adults (>=18 years) who were detected to have hypertension or diabetes. Methods: We analysed the data from a state-wide survey of 12012 adults using the World Health Organization STEPs for NCD risk factor surveillance. We evaluated the recommended intake of fruit and vegetable (>=5 servings/day) and salt (

Summary: Background: Low- and middle-income countries (LMICs) bear a disproportionately higher burden of Cardiovascular Disease (CVD). Team-based care approach adds capacity to improve blood pressure (BP) control. This updated review aimed to test team-based care efficacy at different levels of hypertension team-based care complexity. Methods: We searched PubMed, Embase, Cochrane, and CINAHL for newer articles on task-sharing interventions to manage hypertension in LMICs. Levels of tasks complexity performed by healthcare workers added to the clinical team in hypertension control programs were categorized as administrative tasks (level 1), basic clinical tasks (level 2), and/or advanced clinical tasks (level 3). Meta-analysis using an inverse variance weighted random-effects model summarized trial-based evidence on the efficacy of team-based care on BP control, compared with usual care. Findings: Forty-three RCT articles were included in the meta-analysis: 31 studies from the previous systematic review, 12 articles from the updated search. The pooled mean effect for team-based care was a -4.6 mm Hg (95% CI: -5.8, -3.4, I2 = 80.2%) decrease in systolic BP compared with usual care. We found similar comparative reduction among different levels of team-based care complexity, i.e., administrative and basic clinical tasks (-4.7 mm Hg, 95% CI: -6.8, -2.2; I2 = 79.8%); and advanced clinical tasks (-4.5 mmHg, 95%CI: -6.1, -3.3; I2 = 81%). Systolic BP was reduced most by team-based care involving pharmacists (-7.3 mm Hg, 95% CI: -9.2, -5.4; I2 = 67.2%); followed by nurses (-5.1 mm Hg, 95% CI: -8.0, -2.2; I2 = 72.7%), dieticians (-4.7 mmHg, 95%CI: -7.1, -2.3; I2 = 0.0%), then community health workers (-3.3 mm Hg, 95% CI: -4.8, -1.8; I2 = 77.3%). Interpretation: Overall, team-based hypertension care interventions consistently contributed to lower systolic BP compared to usual care; the effect size varies by the clinical training of the healthcare team members. Funding: Resolve To Save Lives (RTSL) Vital Strategies, Danielle Cazabon, Andrew E. Moran, Yvonne Commodore-Mensah receive salary support from Resolve to Save Lives, an initiative of Vital Strategies. Resolve to Save Lives is jointly supported by grants from Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

Background Low birth weight (LBW) is susceptible to neonatal complications, chronic medical conditions, and neurodevelopmental disabilities. We aim to describe the determinants of very low birth weight (VLBW) in India and compare it with the determinants of LBW based on the National Family Health Survey – 4 (NHFS-4) Methods Data from the NFHS-4 on birthweight and other socio-demographic characteristics for the youngest child born in the family during the five years preceding the survey were used. Data of 147,762 infant–mother pairs were included. Multiple logistic regression models were employed to delineate the independent predictors of VLBW (birth weight

Background: Multimorbidity or co-existence of two or more chronic conditions is common and associated with reduced quality of life and increased risk of death. We aimed to estimate the prevalence and pattern of multimorbidity in primary care settings in Kerala and the associated treatment burden, and quality of life. Methods: A cross-sectional survey was conducted among 540 adult participants in Malappuram District, Kerala. A multi-stage cluster sampling method was employed. Hypertension, diabetes, chronic obstructive pulmonary disease, depression and anxiety screening were done by trained medical professionals. The remaining medical conditions were self-reported by the respondent and verified with patient held health records. The health-related quality of life [HRQoL] was measured using the EQ-5D-5L tool. The MTBQ tool was used for measuring the multimorbidity treatment burden. Logistic regression was used to identify variables associated with multi-morbidity. Results: Overall, the prevalence of multimorbidity was 39.8% (35.7 – 44.1). The prevalence of multimorbidity among men (42.6%) was relatively higher than that in women (38.1%). Lower educational attainment, higher age group, and overweight or obesity status were independently associated with higher prevalence of multimorbidity. The most common pairs of coexisting chronic conditions reported in the study were hypertension and diabetes in males (66.7%) and females (70.8%). All domains of quality of life were impaired in individuals with multimorbidity. Conclusion: Multimorbidity is a norm and affects two of five participants seeking care in primary care settings in Kerala. The social gradient in the prevalence of multimorbidity was evident with higher prevalence in individuals with low educational attainment. Multimorbidity seriously impairs quality of life and increases treatment burden. The focus of management should move beyond individual diseases, and pivot towards interventions targeting multi-morbidity management, with a specific focus for people living in lower socio-economic strata.

Background Population‐wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task‐sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom‐made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross‐sectional survey conducted immediately after the intervention phase of 18‐months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, −0.21 to 3.70). Conclusions Task‐sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.

Abstract Aim Long‐term outcome data of acute decompensated heart failure (HF) are scarce from India. The aim of the study was to collect in‐hospital and long‐term outcome data of HF patients admitted during 2001–2010 in a tertiary‐care centre in South India. Methods and results Consecutive patients admitted with first episode of decompensated HF were part of the registry. Data regarding diagnosis, risk factors, treatment, early (in‐hospital), and late (5 and 10year) mortality outcomes were captured. During this period, 1502 patients were admitted with first episode of decompensated HF [37.7% of women, mean age of 51.1 (SD = 14.3) years]. Common causes were ischaemic heart disease (36.2%), rheumatic heart disease (34.3%), and cardiomyopathies (9.9%). HF with reduced ejection fraction (HFrEF) was present in 26.9% of patients, and 33.8% had atrial arrhythmias. Diabetes, hypertension, and renal dysfunction were prevalent in 27.4%, 28.6%, and 37.4%, respectively. Median duration of hospitalization was 6 days (interquartile range: 3–10), and 247 patients (16.4%) died during index admission. The total time at risk was 6248 person years, and 1051 patients died during the study period with a median survival time of 3.7 years. Overall mortality rate was 16.8 per 100 person years (95% CI: 15.8–17.9 per 100 person years). Older age [hazard ratio (HR) = 1.08, 95% CI: 1.02–1.14, P = 0.007], anaemia (HR = 1.34, 95% CI: 1.08–1.65, P = 0.007), renal dysfunction (HR = 1.38, 95% CI: 1.20–1.59, P < 0.001), HFpEF (HR = 0.61, 95% CI: 0.52–0.73, P < 0.001 against HFrEF), and the use of guideline‐directed therapies (GDT; beta blockers: HR = 0.57, 95% CI: 0.49–0.66, P < 0.0001; and angiotensin converting enzyme inhibitor/angiotensin receptor blocker: HR = 0.59, 95% CI: 0.51–0.69, P < 0.001) were important predictors of mortality. Patients with HF and mid‐range EF also benefited from GDT. Conclusion In our cohort, ischaemic and rheumatic heart diseases were the leading contributors for HF. Anaemia, renal dysfunction, poor ejection fraction, and suboptimal prescriptions of GDT were the main predictors of long‐term mortality. Both patients with HFrEF and mid‐range EF benefited from GDT.

Background Evidence shows that a gap in the documentation of patients’ past medical history leads to errors in, or duplication of, treatment and is a threat to patient safety. Home-based or patient-held records (HBR) are widely used in low and middle-income countries (LMIC) in maternal and childcare. The aim is to systematically review the evidence on HBRs in LMICs for (1) improving informational continuity for providers and women/families across health care visits and facilities, (2) to describe the perceived usefulness by women/families and healthcare providers, and (3) maternal and child health outcomes of using HBRs for maternal and child health care. Methods The protocol was registered in PROSPERO (CRD42019139365). We searched MEDLINE, EMBASE, CINAHL, and Global Index Medicus databases for studies with home-based records from LMICs. Search terms pertained to women or parent-held records and LMICs. Two reviewers assessed studies for inclusion using a priori study selection criteria- studies explaining the use of HBRs in LMIC for maternal and child health care. The included study quality was appraised using the Mixed Methods Appraisal Tool (MMAT). Results from all study designs were summarised narratively. Results In total, 41 papers were included in the review from 4514 potential studies. Included studies represented various study designs and 16 countries. The least evaluated function of HBR was information continuity across health care facilities (n = 6). Overall, there were limited data on the usefulness of HBRs to providers and mothers/families. Home-based records were mostly available for providers during health care visits. However, the documentation in HBRs varied. The use of HBRs is likely to lead to improved antenatal visits and immunisation uptake, and skilled birth delivery in some settings. Mothers’ knowledge of breastfeeding practices and danger signs in pregnancy improved with the use of HBRs. One randomised trial found the use of HBRs reduced the risk of cognitive development delay in children and another reported on trial lessened the risk of underweight and stunted growth in children. Conclusion There is limited literature from LMICs on the usefulness of HBRs and for improving information transfer across healthcare facilities, or their use by women at home. Current HBRs from LMICs are sub-optimally documented leading to poor informational availability that defeats the point of them as a source of information for future providers.

Abstract Background Adults in urban areas spend almost 77% of their waking time being inactive at workplaces, which leaves little time for physical activity. The aim of this systematic review and meta-analysis was to synthesize evidence for the effect of workplace physical activity interventions on the cardio-metabolic health markers (body weight, waist circumference, body mass index (BMI), blood pressure, lipids and blood glucose) among working adults. Methods All experimental studies up to March 2018, reporting cardio-metabolic worksite intervention outcomes among adult employees were identified from PUBMED, EMBASE, COCHRANE CENTRAL, CINAHL and PsycINFO. The Cochrane Risk of Bias tool was used to assess bias in studies. All studies were assessed qualitatively and meta-analysis was done where possible. Forest plots were generated for pooled estimates of each study outcome. Results A total of 33 studies met the eligibility criteria and 24 were included in the meta-analysis. Multi-component workplace interventions significantly reduced body weight (16 studies; mean diff: − 2.61 kg, 95% CI: − 3.89 to − 1.33) BMI (19 studies, mean diff: − 0.42 kg/m2, 95% CI: − 0.69 to − 0.15) and waist circumference (13 studies; mean diff: − 1.92 cm, 95% CI: − 3.25 to − 0.60). Reduction in blood pressure, lipids and blood glucose was not statistically significant. Conclusions Workplace interventions significantly reduced body weight, BMI and waist circumference. Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies. Intervention acceptability and adherence, follow-up duration and exploring non-RCT designs are factors that need attention in future research. Prospero registration number: CRD42018094436.

Abstract Connective tissue diseases (autoimmune rheumatic diseases) are a group of disorders of unknown etiology. The term mixed connective tissue (MCTD) is used when two or more autoimmune diseases occur in the same individual simultaneously, for example, systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis in various combinations. Here, we report a case of MCTD presenting as trigeminal neuralgia.

Background: Heart failure (HF), which is an emerging public health issue, adversely affects the strained health system in India. The adverse impact of HF on the economic well-being has been narrated in various anecdotal reports from India, with affected individuals and their dependents pushed into the vicious cycle of poverty. There is limited research quantifying how HF impacts the economic well-being of households from low- and middle-income countries. Methods: We describe the methods of a detailed economic impact assessment of HF at the household level in India. The study will be initiated across 20 hospitals in India, which are part of the National heart Failure Registry (NHFR). The selected centres represent different regions in India, stratified based on the prevailing stages of epidemiological transition levels (ETLs). We will collect data from 1800 patients with acute decompensated HF and within 6-15 months follow-up from the time of initial admission. The data that we intend to collect will consist of a) household healthcare expenditure including out-of-pocket expenditure, b) financing mechanisms used by households and (c) the impoverishing effects of health expenditures including distress financing and catastrophic health expenditure. Trained staff at each centre will collect data by using a validated and structured interview schedule. The study will have 80% power to detect an 8% difference in the proportion of households experiencing catastrophic health expenditures between two ETL groups. After considering a non-response rate of 5%, the target sample size is approximately 600 patients from each group and the total sample size is 1800 patients. Potential Impact: Our study will provide information on catastrophic health spending, distress financing and household expenditure in heart failure patients. Our findings will help policy makers in understanding the micro-economic impact of HF in India and aid in allocation of appropriate resources for prevention and control of HF.

BackgroundIndia has a massive noncommunicable disease (NCD) burden, at an enormous cost to the individual, family, society, and health system at large, despite which prevention and surveillance are relatively neglected. If diagnosed early and treated adequately, risk factors for atherosclerotic cardiovascular disease would help decrease the mortality and morbidity burden. Surveillance for NCDs, creating awareness, positive lifestyle changes, and treatment are the proven measures known to prevent the progression of the disease. India is in a stage of rapid epidemiological transition, with the state of Kerala being at the forefront, pointing us towards likely disease burden and outcomes for the rest of the country in the future. A previous study done by the same investigators in a population of >100,000 revealed poor awareness, treatment of NCDs, and poor adherence to medicines in individuals with CVD. ObjectiveThis study aimed at assessing a sustainable, community-based surveillance model for NCDs with corporate support fully embedded in the public health system. MethodsFrontline health workers will check all individuals in the target group (≥age 30 years) with further follow-up and treatment planned in a “spoke and hub” model using the public health system of primary health centers as spokes to the hubs of taluk or district hospitals. All data entry done by frontline health workers will be on a tablet PC, ensuring rapid acquisition and transfer of participant health details to primary health centers for further follow-up and treatment. ResultsThe model will be evaluated based on the utilization rate of various services offered at all tier levels. The proportions of the target population screened, eligible individuals who reached the spoke or hub centers for risk stratification and care, and community-level control for hypertension and diabetes in annual surveys will be used as indicator variables. The model ensures diagnosis and follow-up treatment at no cost to the individual entirely through the tiered public health system of the state and country. ConclusionsSurveillance for NCDs is an essential facet of health care presently lacking in India. Atherosclerotic cardiovascular disease has a long gestation period in progression to the symptomatic phase of the disease, during which timely preventive and lifestyle measures would help prevent disease progression if implemented. Unfortunately, several asymptomatic individuals have never tested their plasma glucose, serum lipid levels, or blood pressure and are unaware of their disease status. Our model, implemented through the public health system using frontline health workers, would ensure individuals aged≥30 years at risk of disease are identified, and necessary lifestyle modifications and treatments are given. In addition, the surveillance at the community level would help create a general awareness of NCDs and lead to healthier lifestyle habits. Trial RegistrationClinical Trial Registry India CTRI/2018/07/014856; https://tinyurl.com/4saydnxf International Registered Report Identifier (IRRID)DERR1-10.2196/27299

The World Heart Federation (WHF) Roadmap series covers a large range of cardiovascular conditions. These Roadmaps identify potential roadblocks and their solutions to improve the prevention, detection and management of cardiovascular diseases and provide a generic global framework available for local adaptation. A first Roadmap on raised blood pressure was published in 2015. Since then, advances in hypertension have included the publication of new clinical guidelines (AHA/ACC; ESC; ESH/ISH); the launch of the WHO Global HEARTS Initiative in 2016 and the associated Resolve to Save Lives (RTSL) initiative in 2017; the inclusion of single-pill combinations on the WHO Essential Medicines’ list as well as various advances in technology, in particular telemedicine and mobile health. Given the substantial benefit accrued from effective interventions in the management of hypertension and their potential for scalability in low and middle-income countries (LMICs), the WHF has now revisited and updated the ‘Roadmap for raised BP’ as ‘Roadmap for hypertension’ by incorporating new developments in science and policy. Even though cost-effective lifestyle and medical interventions to prevent and manage hypertension exist, uptake is still low, particularly in resource-poor areas. This Roadmap examined the roadblocks pertaining to both the demand side (demographic and socio-economic factors, knowledge and beliefs, social relations, norms, and traditions) and the supply side (health systems resources and processes) along the patient pathway to propose a range of possible solutions to overcoming them. Those include the development of population-wide prevention and control programmes; the implementation of opportunistic screening and of out-of-office blood pressure measurements; the strengthening of primary care and a greater focus on task sharing and team-based care; the delivery of people-centred care and stronger patient and carer education; and the facilitation of adherence to treatment. All of the above are dependent upon the availability and effective distribution of good quality, evidencebased, inexpensive BP-lowering agents.

Objective To review the available evidence on the benefit of patient-held health records (PHRs), other than maternal and child health records, for improving the availability of medical information for handover communication between healthcare providers (HCPs) and/or between HCPs and patients in low-income and middle-income countries (LMICs).Methods The literature searches were conducted in PubMed, EMBASE, CINAHL databases for manuscripts without any restrictions on dates/language. Additionally, articles were located through citation checking using previous systematic reviews and a grey literature search by contacting experts, searching of the WHO website and Google Scholar.Results Six observational studies in four LMICs met the inclusion criteria. However, no studies reported on health outcomes after using PHRs. Studies in the review reported patients’ experience of carrying the records to HCPs (n=3), quality of information available to HCPs (n=1) and the utility of these records to patients (n=6) and HCPs (n=4). Most patients carry PHRs to healthcare visits. One study assessed the completeness of clinical handover information and found that only 41% (161/395) of PHRs were complete with respect to key information on diagnosis, treatment and follow-up. No protocols or guidelines for HCPs were reported for use of PHRs. The HCPs perceived the use of PHRs improved medical information availability from other HCPs. From the patient perspective, PHRs functioned as documented source of information about their own condition.Conclusion Limited data on existing PHRs make their benefits for improving health outcomes in LMICs uncertain. This knowledge gap calls for research on understanding the dynamics and outcomes of PHR use by patients and HCPs and in health systems interventions.PROSPERO registration number CRD42019139365.

Background: Heart failure (HF), which is an emerging public health issue, adversely affects the strained health system in India. Additionally, the adverse impact of HF on the economic well-being of affected individuals and their families has been narrated in various anecdotal reports, with affected individuals and their dependents pushed into poverty. However, there is limited research quantifying how HF impacts the economic well-being of households from low- and middle-income countries. Methods: We describe the methods of a detailed economic impact assessment of HF at the household level in India. The study will be initiated across 20 hospitals in India. The selected centres represent different regions in India stratified based on the prevailing stages of epidemiological transition levels (ETLs). We will collect data from 1800 patients with acute decompensated HF and within 6-15 months follow-up from the time of initial admission. The data that we intend to collect will consist of a) household healthcare expenditure including out-of-pocket expenditure, b) financing mechanisms used by households and (c) the impoverishing effects of health expenditures including distress financing and catastrophic health expenditure. Trained staff at each centre will collect relevant data by using a validated and structured interview schedule. The study will have 80% power to detect an 8% difference in the proportion of households experiencing catastrophic health expenditures between two ETL groups. After considering a non-response rate of 5%, the target sample size is approximately 600 patients from each group and the total sample size is 1800 patients with heart failure. Impact: The results from our study will help policy makers in understanding the micro-economic impact of HF in India and aid in allocation of appropriate resources for prevention and control of HF.

Objective: Heart failure (HF) has emerged as a global public health problem that affects both low and high-income countries. The high HF burden and the need for resource-intensive treatments often lead to health system crisis in resource-poor settings. Data on prevailing practice patterns and long-term clinical outcomes of HF are scarce from the low and middle-income countries. Nationally representative HF data from India are not available. Methods: The National Heart Failure Registry (NHFR) is a multicentric, hospital-based registry of HF patients from 53 centers across India. Consecutive patients admitted with the diagnosis of acute decompensated HF satisfying the European Society of Cardiology (ESC) 2016 criteria will be enrolled into the registry from January 2019 to December 2019. Each participating center is expected to contribute 200 patients into the registry (i.e., more than 10,000 HF patients from India). We are collecting demographics, clinical, laboratory, imaging, and other diagnostic data at baseline from all registered patients in the registry by using a structured document. Additionally, we are collecting the details of treatment practices and the usage of guideline-directed therapy from all participants. We intend to obtain the in-hospital, 3-months, 6-months and one-year outcome data on mortality, cause of death, and repeated hospitalization events. Conclusions: In summary, NFHR will be the first nationally representative HF registry aimed at providing crucial information on prevailing etiology, distribution and current practices in the management of HF. Keywords: Heart failure, Registry, India