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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., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Thomas SC et al.)

Purpose: Transatlantic guidelines endorse quality metrics for timely reperfusion in patients with ST-elevation myocardial infarction (STEMI). Compliance in low- and middle-income countries (LMICs) is largely unknown., Study Design: We prospectively evaluated 2928 STEMI patients in Kerala, India, across 16 PCI-capable hospitals who received reperfusion with either primary percutaneous coronary intervention (PPCI) or fibrinolysis. Primary endpoint was a major adverse cardiovascular event (MACE) composite of death, non-fatal myocardial infarction, stroke or readmission for heart failure at 1-year., Results: Among reperfused STEMI patients, 320 (10.9%) received timely reperfusion with either PPCI or fibrinolysis, 1985 (67.8%) received delayed PPCI, and 623 (21.3%) received delayed fibrinolysis. Timely reperfusion had lower unadjusted MACE rates than delayed PCI or fibrinolysis (timely reperfusion: 11.9%, delayed PPCI: 13.6%, delayed fibrinolysis: 23.9%, P < 0.001). Mortality was lowest in the timely reperfusion group (timely reperfusion: 6.3%, delayed PPCI: 7.8%, delayed fibrinolysis 18.8%, P < 0.001). After multivariate analysis, delayed fibrinolysis had a higher MACE rate (HR 1.52 95% CI 1.04-2.21) and mortality (HR 1.97, 95% CI 1.18-3.25) compared to timely reperfusion. Total ischemic time > 3 h and delayed first medical contact-to-needle time predicted MACE at 1 year., Conclusions: Among STEMI patients in Kerala, India, only one in 10 eligible patients received timely reperfusion. Longer total ischemic times and delayed fibrinolysis were associated with 1-year MACE. Improving timely reperfusion is critical to enhancing STEMI outcomes in LMICs. What is already known on this topic Given the established link between delay to reperfusion and worse major adverse cardiac events (MACE), global efforts have concentrated on minimizing different components of the total ischemic time to improve ST-elevation myocardial infarction (STEMI) outcomes. Compliance in low- and middle-income countries (LMICs) is largely unknown. What this study adds In this cohort of STEMI patients in Kerala, India, total ischemic time and first medical contact-to-needle time correlated with long-term MACE rates, whereas other timeliness indicators did not. How this study might affect research, practice or policy Our study highlights the significant barriers to accessing STEMI care that are prevalent in LMICs despite incremental growth in the number of PCI-capable hospitals. The pre-hospital phase within total ischemic time is the most important quality improvement metric of STEMI care in LMICs, especially for patients chosen for fibrinolysis., (© The Author(s) 2024. Published by Oxford University Press on behalf of Fellowship of Postgraduate Medicine.)

Background: Catalogues of pathogenic genetic mutations in hypertrophic cardiomyopathy (HCM) are disproportionately small when compared to that of the size of the population with South Asian ancestry and their collective increased risk of heart disease., Methods: We conducted clinical exome sequencing of 200 HCM patients to identified cardiomyopathy-associated genetic mutations. The clinical and echocardiographic characteristics of genotype-positive and genotype-negative patients were compared, and the likelihood of detecting a positive genetic test result was evaluated. Allelic burden analysis was done to compare the minor allele frequencies (MAF) of the pathogenic or likely pathogenic (P/LP) variants and variants of uncertain significance (VUSs) identified in the cohort against various population genomics databases., Results: The genetic yield was 40% for P/LP variants, with MYBPC3 and MYH7 as the predominant sarcomere genes. Younger age-at-diagnosis, family history of HCM, asymmetric hypertrophic (ASH) pattern, the ratio of the interventricular septum to posterior wall thickness (IVS/PW ratio), left atrial (LA) dimensions, severe mitral regurgitation grade (MR grade), late gadolinium enhancement (LGE) detected fibrosis and absence of hypertension were associated with an increased likelihood of HCM-associated variants. Patients who experienced ventricular tachycardia and premature cardiovascular death were significantly likely to carry MYBPC3 or loss-of-function variants. LA and interventricular septal (IVS) dimensions were associated with MYH7 variants. The rare variant burden for P/LP variants and VUSs was significantly enriched in HCM cases compared to population controls., Conclusion: Our study provides a comprehensive evaluation of HCM-associated genetic mutations from an Indian population. The identified genotype-phenotype associations could improve the yield of targeted genetic testing in HCM., Competing Interests: Declaration of competing interest The authors declare that there is no conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

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., (© 2024. The Author(s).)

Background: Cardiac rehabilitation (CR) remains greatly underutilized, especially in low- and middle-income countries (LMIC). It is therefore important to explore factors that contribute to this, as perceived by health-care professionals (HCPs)., Research Design and Methods: This was a qualitative study using in-depth interviews that enrolled 18 HCPs (i.e. six each of physicians, physiotherapists, and nurses; mean experience in CR: 17.9 ± 11.8 yrs) working in cardiovascular care, and CR across private and government hospitals (both teaching and non-teaching) in India., Results: The main challenges were related to lack of referrals, perceived lack of benefit from CR, poor infrastructure within hospitals and health systems, and differences in practice. The perceived inadequacies were lack of competencies in CR, limited task sharing strategies, and ineffective utilization of existing human resources. Devising strategies to improve awareness and competencies, facilitating task sharing, and remodeling holistic care with an active CR component may be beneficial to facilitate greater implementation of CR in India., Conclusions: Challenges, inadequacies, and solutions to implementing CR have been explored by involving various HCPs commonly involved in delivering CR across different health systems in a LMIC., Trial Registration: www.ctri.nic.in with identifier CTRI/2020/07/026807.

Background: Multimorbidity or multiple long-term conditions (MLTCs), the coexistence of two or more chronic conditions within an individual, presents a growing concern for healthcare systems and individuals' well-being. However, we know little about the experiences of those living with MLTCs in low- and middle-income countries (LMICs) such as India. We explore how people living with MLTCs describe their illness, their engagements with healthcare services, and challenges they face within primary care settings in Kerala, India., Methods: We designed a qualitative descriptive study and conducted in-depth, semi-structured interviews with 31 people (16 males and 15 females) from family health centres (FHCs) in Kerala. Interview data were recorded, transcribed, and thematic analysis using the Framework Method was undertaken., Findings: Two main themes and three sub-themes each were identified; (1) Illness impacts on life (a)physical issues (b) psychological difficulties (c) challenges of self-management and (2) Care-coordination maze (a)fragmentation and poor continuity of care (b) medication management; an uphill battle and (c) primary care falling short. All participants reported physical and psychological challenges associated with their MLTCs. Younger participants reported difficulties in their professional lives, while older participants found household activities challenging. Emotional struggles encompassed feelings of hopelessness and fear rooted in concerns about chronic illness and physical limitations. Older participants, adhering to Kerala's familial support norms, often found themselves emotionally distressed by the notion of burdening their children. Challenges in self-management, such as dietary restrictions, medication adherence, and physical activity engagement, were common. The study highlighted difficulties in coordinating care, primarily related to traveling to multiple healthcare facilities, and patients' perceptions of FHCs as fit for diabetes and hypertension management rather than their multiple conditions. Additionally, participants struggled to manage the task of remembering and consistently taking multiple medications, which was compounded by confusion and memory-related issues., Conclusion: This study offers an in-depth view of the experiences of individuals living with MLTCs from Kerala, India. It emphasizes the need for tailored and patient-centred approaches that enhance continuity and coordination of care to manage complex MLTCs in India and similar LMICs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Joseph et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Diabetes 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., Methods: We 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., Results: The 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., Conclusion: The 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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ravindranath, Sarma, Sivasankaran, Thankappan and Jeemon.)

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 <5 servings of fruit and vegetables per day (0.70 for class 1; 0.63 for class 2). However, participants in class 1 had a lower probability of sitting for >=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., (© 2024 The Authors. Journal of Diabetes published by Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.)

MicroRNAs (miRNAs), a class of non-coding RNAs, are utilized as biomarkers for a wide range of disorders. Circulating miRNAs are proposed as potential markers in the clinical identification of heart failure (HF). However, identifying miRNA biomarkers in HF requires identification of robust endogenous control miRNAs for normalization in differential expression analysis. Hence, this study aimed to identify circulating miRNAs that can be utilized as endogenous controls in HF. We evaluated the expression of eight miRNAs, which were previously reported as endogenous controls in different pathological conditions. Total RNA, including miRNA, was extracted from the serum samples of 30 HF patients (15 HFrEF and 15 HFpEF) and their matched controls (n = 15). We used quantitative PCR to determine the miRNA expression. The stability of the selected endogenous miRNAs was assessed and compared using a standard set of criteria with the RefFinder software. Six of the eight miRNAs analyzed showed consistent expression among all sample groups. Stability analysis ranked hsa-let-7i-5p, hsa-miR-148b-3p, and hsa-miR-484 as the most stable miRNAs, indicating their potential as reliable endogenous controls., Competing Interests: Declaration of competing interest The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Elsevier B.V. All rights reserved.)

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., (© 2023. The Author(s).)

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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript., (© 2023 The Authors.)

Importance: Hypertension is a major cause of morbidity and mortality worldwide. Previous efforts to characterize gaps in the hypertension care continuum-including diagnosis, treatment, and control-in India did not assess district-level variation. Local data are critical for planning, implementation, and monitoring efforts to curb the burden of hypertension., Objective: To examine the hypertension care continuum in India among individuals aged 18 to 98 years., Design, Setting, and Participants: The nationally representative Fifth National Family Health Survey study was conducted in 2 phases from June 17, 2019, to March 21, 2020, and from November 21, 2020, to April 30, 2021, among 1 895 297 individuals in 28 states, 8 union territories, and 707 districts of India., Exposures: District and state of residence, urban classification, age (18-39, 40-64, and ≥65 years), sex, and household wealth quintile., Main Outcomes and Measures: Hypertension was defined as a self-reported diagnosis or a newly measured blood pressure of 140/90 mm Hg or more. The proportion of individuals diagnosed (self-reported), the proportion of individuals treated among those diagnosed (self-reported medication use), and the proportion of individuals with blood pressure control among those treated (blood pressure <140/90 mm Hg [aged 18-79 years] or <150/90 mm Hg [aged ≥80 years]) were calculated based on national guidelines. Age-standardized estimates of treatment and control were also provided among the total with hypertension. To assess differences in the care continuum between or within states (ie, between districts), the variance was partitioned using generalized linear mixed models., Results: Of the 1 691 036 adult respondents (52.6% women; mean [SD] age, 41.6 [16.5] years), 28.1% (95% CI, 27.9%-28.3%) had hypertension, of whom 36.9% (95% CI, 36.4%-37.3%) received a diagnosis. Among those who received a diagnosis, 44.7% (95% CI, 44.1%-45.3%) reported taking medication (corresponding to 17.7% [95% CI, 17.5%-17.9%] of the total with hypertension). Among those treated, 52.5% (95% CI, 51.7%-53.4%) had blood pressure control (corresponding to 8.5% [95% CI, 8.3%-8.6%] of the total with hypertension). There were substantial variations across districts in blood pressure diagnosis (range, 6.3%-77.5%), treatment (range, 8.7%-97.1%), and control (range, 2.7%-76.6%). Large proportions of the variation in hypertension diagnosis (94.7%), treatment (93.6%), and control (97.3%) were within states, not just between states., Conclusions and Relevance: In this cross-sectional survey study of Indian adults, more than 1 in 4 people had hypertension, and of these, only 1 in 3 received a diagnosis, less than 1 in 5 were treated, and only 1 in 12 had blood pressure control. National mean values hide considerable state-level and district-level variation in the care continuum, suggesting the need for targeted, decentralized solutions to improve the hypertension care continuum in India.

Objectives: Secondary prevention of stroke largely depends on risk factor control and lifestyle modification. Optimal secondary prevention strategies are limited in rural settings due to the shortage of primary care physicians and neurologists. Awareness of community health workers (CHWs) regarding stroke and its management remains largely unexplored. The current cross-sectional study aimed at assessing the knowledge, attitude, and practice (KAP) of CHWs regarding stroke care., Materials and Methods: A structured KAP questionnaire was administered among 510 CHWs from randomly selected rural health blocks of Thiruvananthapuram, Kerala, India., Results: Knowledge assessment showed that the CHWs possessed an average knowledge of stroke care. The mean attitude and practice scores were higher, indicating a favorable attitude and good practice. The overall mean (standard deviation) KAP scores of CHWs were 13.54 (4.43) against a total score of 23. The KAP scores were highest among palliative care nurses. The stroke awareness of the accredited social health activists was comparatively lower than other CHWs. Factors such as age and years of work experience were not correlated to the KAP scores., Conclusion: Recurrent strokes remain a major challenge in primary care. Overall, the health workers demonstrated average knowledge, favorable attitudes, and positive practices. The study highlights the importance of training accredited social health activists (ASHAs) and other CHWs in stroke to improve secondary prevention strategies., Competing Interests: There are no conflicts of interest., (© 2023 Published by Scientific Scholar on behalf of Journal of Neurosciences in Rural Practice.)

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., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Journal of Family Medicine and Primary Care.)

Background & Objectives: Heart failure (HF) is emerging as a major health problem in India. The profile of HF in India is divergent from elsewhere in the world. While cardiologists must equip themselves with the requisite clinical management tools, scientists and health policymakers would need epidemiological data on HF and information on the resources required to meet the challenges ahead. The aim of this study was to identify the lacunae and to suggest recommendations to improve HF research., Methods: We surveyed a multidisciplinary group of HF experts using a two stage process. An email-based survey was conducted using a structured questionnaire, followed by an online discussion. The experts prioritized the major challenges in convergence research in India and inter-rater agreement values were calculated. In addition, they enlisted potential research gaps and barriers in the domains of epidemiology, diagnostics, management and technology and suggested recommendations to overcome those barriers., Results: The experts identified a paucity of data on HF burden, lack of state-of-the-art diagnostic facilities and trained personnel, overt dependence on imported devices/equipment/reagents, lack of interaction/awareness/information among stakeholders and lack of biobanks, as major barriers in HF research. Three fourths of the experts agreed that lack of interaction among stakeholders was the major challenge with the highest inter-rater agreement in both stages (19 out of 25 and 11 out of 17, respectively). The experts recommended the creation of multidisciplinary taskforces dedicated to population sciences, data sciences, technology development and patient management with short-, intermediate- and long-term strategies., Interpretation & Conclusions: The study generated a wish list for advances in HF research and management, and proposed recommendations for facilitating convergence research as a way forward to reduce the burden of HF in India.

Hypertrophic cardiomyopathy (HCM) is a genetic heart muscle disease that frequently causes sudden cardiac death (SCD) among young adults. Several pathogenic mutations in genes encoding the cardiac sarcomere have been identified as diagnostic factors for HCM and proposed as prognostic markers for SCD. The objective of this review was to determine the scope of available literature on the variants encoding sarcomere proteins associated with SCD reported among Indian patients with HCM. The eligibility criteria for the scoping review included full text articles that reported the results of genetic screening for sarcomeric gene mutations in HCM patients of Indian south Asian ancestry. We systematically reviewed studies from the databases of Medline, Scopus, Web of Science core collection and Google Scholar. The electronic search strategy included a combination of generic terms related to genetics, disease and population. The protocol of the study was registered with Open Science Framework (https://osf.io/53gde/). A total of 19 articles were identified that reported pathogenic or likely pathogenic (P/LP) variants within MYH7, MYBPC3, TNNT2, TNNI3 and TPM1 genes, that included 16 singletons, one de novo and one digenic mutation (MYH7/ TPM1) associated with SCD among Indian patients. Evidence from functional studies and familial segregation implied a plausible mechanistic role of these P/LP variants in HCM pathology. This scoping review has compiled all the P/LP variants reported to-date among Indian patients and summarized their association with SCD. Single homozygous, de novo and digenic mutations were observed to be associated with severe phenotypes compared to single heterozygous mutations. The abstracted genetic information was updated with reference sequence ID (rsIDs) and compiled into freely accessible HCMvar database, available at https://hcmvar.heartfailure.org.in/. This can be used as a population specific genetic database for reference by clinicians and researchers involved in the identification of diagnostic and prognostic markers for HCM.

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Jeemon P et al.)

Background: Type 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., Methods: The 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., Results: A 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., Conclusion: We systematically developed a clinical guideline for Ayurvedic practitioners to manage T2DM in adults., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Chattopadhyay, Kapoor, Heinrich, Mitra, Mittal, Lewis, Greenfield, Mukherjee, Pischel, Jeemon, Tandon, Kinra, Biswas and Leonardi-Bee.)

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 < 0.001) than those who received GDMT. Baseline educational class, body mass index, New York Heart Association functional class, ejection fraction, dependent oedema, serum creatinine, QRS > 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., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

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., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Harikrishnan S. and all authors has applied for a patent #Indian Patent No. 202141037246 for a related device pending to SCTIMST, Trivandrum and NIT, Calicut., (Copyright © 2022 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Jeemon P et al.)

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., Competing Interests: The authors have declared that no competing interests exist.

Objective: In a prospective cohort of children (13-21 years) of women with epilepsy (CWWE), we compared those exposed to antiseizure medications (ASM) in utero to those without exposure to ASM regarding their language proficiency and intelligence. We also compared their educational performance with state-wide averages., Methods: Research staff blinded to the ASM exposure of CWWE administered the Clinical Evaluation of Language Fundamentals IV and the Wechsler Intelligence Scale for Children IV to test their language proficiency and intelligence. We assessed their educational performance with a questionnaire. CWWE without antenatal exposure to ASM served as comparators for language and intelligence tests. The educational performance of CWWE (regardless of ASM exposure) was compared with the state-wide averages published by the government., Results: In total, 446 children (mean age 16.5 ± 2.2 years; 236 girls) participated in the study. Their ASM exposure involved monotherapy for 272 (61%), polytherapy for 133 (29.8%) and none for 41 (9.2%). The commonly used ASMs (mono & polytherapy) were carbamazepine (n = 192), valproate (n = 124), phenobarbitone (n = 95), and phenytoin (n = 73). The full-scale intelligence quotient of CWWE (n = 146) with antenatal exposure to ASM (89.2 ± 21.5) was significantly lower (p = 0.03) than that of CWWE (n = 11) unexposed to ASM (96.9 ± 8.8). The CELF core language scaled score for the exposed CWWE (n = 132) was significantly lower than that of unexposed children (n = 12; 99.2 ± 19.9). Compared with state-wide averages, CWWE (n = 386) had delayed initiation of education (2.6% vs. 0.1%), increased dropout rates (1% vs. 0.11%), increased usage of special assistance during examinations (4.4% vs. 0.1%) and a lower rate (19.9% vs. 37%) of enrolment in universities., Conclusion: The language and intelligence functions of CWWE with exposure to older ASMs were lower than those of unexposed CWWE. Compared to state-wide averages, a significantly higher proportion of CWWE had difficulties with education, and only a smaller proportion enrolled in higher education., (Copyright © 2022. Published by Elsevier Ltd.)

Objective: We aimed to determine a possible association between motor and mental development in infants of women with epilepsy and antenatal exposure to antiseizure medication (ASM)., Methods: Developmental paediatricians who were blinded to antenatal ASM exposure evaluated motor and mental development of infants (>12 months) using the Developmental Assessment Scale for Indian Infants (an Indian adaptation of the Bayley Scale of Infant Development). Motor (MODQ) and mental development quotients (MEDQ) were computed as ratios of respective developmental age to the chronological age of the child. We employed linear mixed models to study the relationship between antenatal exposure to ASM and the development quotients after adjustment for malformation status and age of the baby, maternal education and seizure type., Results: We studied 1,357 infants with mean age of 15.3±4.0 months (71.2% of all eligible infants). Infants were classified as having monotherapy or polytherapy, or unexposed in 840, 407 and 110 participants, respectively. The MEDQ of the polytherapy (92.9±14.9) and monotherapy (96.9±13.9) groups was lower than that of unexposed infants (99.8 12.5). Similarly, the MODQ of polytherapy (91.1±19.3) and monotherapy (96.6±17.5) groups was lower than that of unexposed infants (97.6 16.6). The differences in adjusted mean MEDQ were -7.4 (-11.4 to -4.3, p=0.001), -9.6 (-11.3 to -6.0, p=0.001) and -6.4 (-9.2 to -3.7, p=0.001) for valproate monotherapy, polytherapy with valproate and polytherapy without valproate, respectively. The adjusted mean MODQ also showed a similar trend. Those exposed to levetiracetam (n=62) had higher or similar adjusted MODQ (110.4±14.3; p=0.001) and MEDQ (104.3±9.1; p=0.09), compared to unexposed infants. A dose-dependent decrease in developmental indicators was observed for valproate and phenobarbitone., Significance: Antenatal exposure to ASM, especially valproate and phenobarbitone, adversely affects motor and mental development of exposed infants. Early developmental screening of high-risk infants is desirable.

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<1500 g) or LBW  (birth weight: 1500-2499 g). Results Of the 147,762 children included in the study, VLBW and LBW were observed in 1.2% and 15.8% of children, respectively. The odds of VLBW were higher in female children (aOR: 1.36, 95% CI: 1.15-1.60), among mothers aged 13-19 years (aOR: 1.58, 95% CI: 1.22-2.07), mothers with severe or moderate anaemia (aOR: 1.61, 95% CI: 1.34-1.94), mothers without recommended antenatal care (aOR: 1.47, 95% CI: 1.31-1.90), maternal height less than 150 cm (aOR: 1.54, 95% CI: 1.29-1.85) and among mothers with multiple pregnancy (aOR: 21.34, 95% CI: 14.70-30.96) in comparison to their corresponding counterparts. In addition to the variables associated with VLBW, educational status of mothers (no education; aOR: 1.08, 95% CI: 1.02-1.15 and primary education; aOR: 1.16, 95% CI: 1.08-1.25), caste of the children (scheduled tribe; aOR: 1.13, 95% CI: 1.03-1.24), and wealthiness of the family (poorest wealth quintiles; aOR: 1.11, 95% CI: 1.03-1.19) were associated with LBW. Conclusions Interventions targeting improvements in antenatal care access, maternal health, and nutritional status may reduce the number of VLBW infants. Social determinants of LBW require further detailed study to understand the high propensity of low birth-weight phenotypes in the disadvantaged communities in India., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Scaria L et al.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Ismail S et al.)

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, I 2  = 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; I 2  = 79.8%); and advanced clinical tasks (-4.5 mmHg, 95%CI: -6.1, -3.3; I 2  = 81%). Systolic BP was reduced most by team-based care involving pharmacists (-7.3 mm Hg, 95% CI: -9.2, -5.4; I 2  = 67.2%); followed by nurses (-5.1 mm Hg, 95% CI: -8.0, -2.2; I 2  = 72.7%), dieticians (-4.7 mmHg, 95%CI: -7.1, -2.3; I 2  = 0.0%), then community health workers (-3.3 mm Hg, 95% CI: -4.8, -1.8; I 2  = 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., Competing Interests: The authors declare no conflict of interest., (© 2022 The Authors.)

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.

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 multi-morbidity was 39.8% (35.7 - 44.1). The prevalence of multi-morbidity 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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Ismail S et al.)

The association between dietary patterns and cardiometabolic risk factors is not well understood among adults in India, particularly among those at high risk for diabetes. For this study, we analyzed the data of 1007 participants (age 30-60 years) from baseline and year one and two follow-ups from the Kerala Diabetes Prevention Program using multi-level mixed effects modelling. Dietary intake was measured using a quantitative food frequency questionnaire, and dietary patterns were identified using principal component analysis. Two dietary patterns were identified: a "snack-fruit" pattern (highly loaded with fats and oils, snacks, and fruits) and a "rice-meat-refined wheat" pattern (highly loaded with meat, rice, and refined wheat). The "snack-fruit" pattern was associated with increased triglycerides (mg/dL) (β = 6.76, 95% CI 2.63-10.89), while the "rice-meat-refined wheat" pattern was associated with elevated Hb1Ac (percentage) (β = 0.04, 95% CI 0.01, 0.07) and central obesity (OR 1.16, 95% CI 1.01, 1.34). These findings may help inform designing dietary interventions for the prevention of diabetes and improving cardiometabolic risk factors in high-diabetes-risk individuals in the Indian setting.

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 )., (© 2022. The Author(s).)

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 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<1500 g) or LBW (birth weight <2500 g). Results Of the 147,762 children included in the study, VLBW and LBW were observed in 1.2% and 15.8% of children, respectively. The odds of VLBW were higher in female children (aOR: 1.36, 95% CI: 1.15-1.60), among mothers aged 13-19 years (aOR: 1.58, 95% CI: 1.22-2.07), mothers with severe or moderate anaemia (aOR: 1.61, 95% CI: 1.34-1.94), mothers without recommended antenatal care (aOR: 1.47, 95% CI: 1.31-1.90), maternal height less than 150 cm (aOR: 1.54, 95% CI: 1.29-1.85) and among mothers with multiple pregnancy (aOR: 21.34, 95% CI: 14.70-30.96) in comparison to their corresponding counterparts. In addition to the variables associated with VLBW, educational status of mothers (no education; aOR: 1.08, 95% CI: 1.02-1.15 and primary education; aOR: 1.16, 95% CI: 1.08-1.25), caste of the children (scheduled tribe; aOR: 1.13, 95% CI: 1.03-1.24), and wealthiness of the family (poorest wealth quintiles; aOR: 1.11, 95% CI: 1.03-1.19) were associated with LBW. Conclusions Interventions targeting improvements in antenatal care access, maternal health, and nutritional status may reduce the number of VLBW infants. Social determinants of LBW require further detailed study to understand the high propensity of low birth-weight phenotypes in the disadvantaged communities in India., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Scaria L et al.)

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 < 0.05)., Conclusion: In the PROKERALA registry, annual mortality rate was 4%. More than half of the patients reported re-hospitalisation events on follow up. Uptake of guideline directed therapies were suboptimal in the study population. Quality improvement programmes to improve guideline directed therapy may improve clinical outcomes of PH patients in India., Competing Interests: Declaration of competing interest None of the authors have any conflict of Interests to declare., (Copyright © 2021 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

Objectives: We aim to report the major congenital malformation (MCM) rates for new and old anti-epileptic drugs (AED) exposures during the first trimester of pregnancy in women with epilepsy (WWE)., Methods: We extracted relevant data on drug exposure and malformation rate from the records of a prospective observational registry (Kerala Registry of Epilepsy and Pregnancy) for all completed pregnancies between 1998 and 2019. A comprehensive and uniform criterion with detailed guideline was used for assessment of malformations. We employed generalised linear model to generate adjusted incidence rate ratios (aIRR) of MCM in AED exposed group as compared to AED unexposed group, after adjustment for age and educational status of mothers' and epilepsy classification., Results: The unadjusted MCM rate was 6.2% for all the infants included in the study (148/2328); 4.7% for the unexposed group (16/340), and 6.6% for the exposed group (132/1988). The aIRR of MCM as compared to unexposed group was similar for all monotherapies; lamotrigine (0.50; 95% CI 0.07-3.68), levetiracetam (1.16; 0.43-3.11), oxcarbazepine (1.61; 0.62-4.21) valproate (1.71, 0.93-3.19), phenytoin (1.21, 0.51-2.90), carbamazepine (0.99, 0.54-1.82), and phenobarbitone (1.20, 0.52-2.74). However, the point estimates suggest least risk with lamotrigine and highest risk with valproate. Polytherapy with high-dose valproate carried significantly higher risk of MCM as compared to the unexposed group (aIRR=4.12; 2.18-7.79, p<0.001). The aIRR of GTCS during pregnancy was 1.63 (95% CI 1.12-2.37, p = 0.011) for monotherapy with new AEDs (lamotrigine, levetiracetam or oxcarbazepine) as compared to old AEDs (phenobarbitone, phenytoin, carbamazepine, or valproate)., Conclusion: The MCM risk was significantly higher for polytherapy with high dose valproate. It did not differ substantially between different AED monotherapies although point estimate was lowest with lamotrigine. Pregnant women on new AEDs report higher likelihood of GTCS than women on old AEDs during pregnancy., (Copyright © 2021. Published by Elsevier Ltd.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Harikrishnan S et al.)

Background: Coronary heart disease, a leading cause of death globally, is amenable to lifestyle interventions. The family environment can affect the ability or willingness of individuals to make lifestyle changes. We aimed to investigate the efficacy of a targeted family-based intervention for reduction of total cardiovascular risk in individuals with a family history of premature coronary heart disease., Methods: We did an open-label, cluster randomised controlled trial (PROLIFIC) in the families (first-degree relatives and spouses, older than age 18 years) of individuals with coronary heart disease who had been diagnosed before age 55 years. Patients with coronary heart disease diagnosed within the past year were selected from a tertiary care speciality hospital that provides care for patients from Kerala, India. Family members of selected patients who were bedridden or terminally ill, and individuals with a history of established cardiovascular heart disease and stroke were excluded, as were families with fewer than two eligible family members. Simple randomisation with computer-generated random numbers was used to randomly assign families to intervention and usual care groups (1:1). Participants in the intervention group received a comprehensive package of interventions facilitated by non-physician health workers, consisting of: screening for cardiovascular risk factors; structured lifestyle interventions; linkage to a primary health-care facility for individuals with established chronic disease risk factors or conditions; and active follow-up for adherence. The usual care group received one-time counselling and annual screening for risk factors. We obtained data on lifestyle, clinical, and biochemical characteristics at baseline and annually during the 2-year follow-up. The primary outcome was achievement or maintenance of any three of the following: blood pressure lower than 140/90 mm Hg, fasting plasma glucose lower than 110 mg/dL, low-density lipoprotein cholesterol lower than 100 mg/dL, and abstinence from tobacco. The primary outcome was analysed in all participants available for follow-up at the relevant timepoint. This trial is registered with Clinicaltrials.gov, NCT02771873., Findings: From Jan 1, 2015, to April 30, 2017, 980 patients with coronary heart disease were assessed for eligibility and 230 were excluded primarily due to lack of evidence of coronary artery disease (n=199), or a diagnosis of coronary heart disease more than 1 year previously (n=29). Of the 750 remaining families, 368 (with 825 participants) were assigned to the intervention group and 382 (with 846 participants) were assigned to the usual care group. At the 2-year follow-up, data from 803 (97%) of 825 participants in the intervention group and 819 (97%) of 846 participants in the usual care group were available. Of the 1671 participants, 1111 (66·5%) were women, and 560 (33·5%) were men. The mean age of the study population was 40·8 years (SD 14·2). At the 2-year follow-up, the primary outcome was achieved by 514 (64%) of 803 participants in the intervention group and 379 (46%) of 819 in the usual care group. After adjustment for clustering and baseline risk factors, the odds of achieving the primary outcome at the 2-year timepoint was two times higher in the intervention group than in the usual care group (odds ratio 2·2, 95% CI 1·7-2·7; p<0·0001)., Interpretation: The reduction of total cardiovascular risk observed after the intervention could have a substantial public health impact by preventing future cardiovascular events., Funding: The Wellcome Trust and Department of Biotechnology, Government of India, and India Alliance., Competing Interests: Declaration of interests DP and PJ received research grants from the US National Heart Lung and Blood Institute for a work-site-based cardiovascular risk reduction initiative (5R01HL125442-05). PJ also received research grants from the Australian National Health and Medical Research Council (1160283 and 1169766), the World Diabetes Federation (WDF-15-959), and the Indian Council of Medical Research for diabetes and hypertension risk reduction interventions. All other authors declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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, evidence-based, inexpensive BP-lowering agents., Competing Interests: Panniyammakal Jeemon is supported by the Wellcome Trust through a Wellcome Trust/DBT India Alliance Clinical and Public Health Intermediate Fellowship [IA/CPHI/14/1/501497]. Neil Poulter has received financial support from several pharmaceutical companies which manufacture BP-lowering agents, for consultancy fees (Servier), research projects, and staff (Servier, Pfizer) and for arranging and speaking at educational meetings (AstraZeneca, Lri Therapharma, Napi, Servier, Sanofi, Eva Pharma and Pfizer). He holds no stocks and shares in any such companies. Norman Campbell reports personal fees from Resolve to Save Lives (RTSL) outside the submitted work and is an unpaid member of World Action on Salt, Sugar and Health and an unpaid consultant on dietary sodium and hypertension control to numerous governmental and non-governmental organizations. Kazuomi Kario received research grant from A &D Co., Omron Helthcare Co., Fukuda Denshi Co., MSD K.K., Astellas Pharma Inc., Eisai Co., Otsuka Pharmaceutical Co., Otsuka Holdings Co., Sanofi K.K., Shionogi & Co., Sanwa Kagaku Kenkyusho Co., Daiichi Sankyo Co., Taisho Pharmaceutical Co., Ltd, Sumitomo Dainippon Pharma Co., Takeda Pharmaceutical Co., Mitsubishi Tanabe Pharma Co., Teijin Pharma, Boehringer Ingelheim Japan Inc., Pfizer Japan Inc., Fukuda Lifetec Co., Fukuda Lifetec Kanto Co., Bristol-Myers Squibb K.K., Mylan Co., Mochida Pharmaceutical Co., Roche Diagnostics K.K. and honoraria from Idorsia Pharmaceuticals Japan, Omron Healthcare Co., Daiichi Sankyo Company, Limited, Takeda Pharmaceutical Co., Terumo Corporation, Mylan EPD. Taskeen Khan is a staff member of the World Health Organization. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent those of the World Health Organization. Pedro Ordunez is a staff member of the Pan American Health Organization. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent those of the Pan American Health Organization. Aletta E Schutte has received speaker honoraria from Omron Healthcare, Servier, Takeda, Novartis and advisory board fees from Abbott, outside the submitted work., (Copyright: © 2021 The Author(s).)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 (<5 gm/day) across participants divided into four strata, and the probabilities were also estimated using the fitted multiple binary logistic regression models., Results: Overall, 13.9% (95%CI: 12.2%-15.9%) and 29.4% (95%CI: 28%-30.8%) of participants consumed the recommended level of fruit and vegetable, and salt, respectively. Adjusted odds ratios were not significantly different across the four strata based on the status of treatment and control of diabetes or hypertension. The likelihood of following the recommended fruit and vegetable intake was highest for 50-69-year-old females with above high school education, obese, under treatment for diabetes or hypertension, and had normal values of FBS and BP (0.28). The likelihood for recommended salt intake was highest for 50-69-year-old males with above high school education and had normal BMI, under treatment for diabetes or hypertension, and had normal values of FBS and BP (0.69)., Conclusion: The status of diabetes or hypertension did not show considerable influence in the fruit, vegetable, and salt intake of adults in general. A detailed exploration of the accessibility and acceptability of such recommended intakes in the Kerala context is warranted., Competing Interests: There are no conflicts of interest., (Copyright: © 2021 Journal of Family Medicine and Primary Care.)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Harikrishnan S et al.)

Background: Deficits in quality of care for patients with heart failure (HF) contribute to high mortality in this population. This qualitative study aimed to understand the barriers and facilitators to high-quality HF care in Kerala, India. Methods: Semi-structured, in-depth interviews were conducted with a purposive sample of health care providers (n=13), patients and caregivers (n=14). Additionally, focus group discussions (n=3) were conducted with patients and their caregivers. All interviews and focus group discussions were transcribed verbatim. Textual data were analysed using thematic analysis. Results: Patients' motivation to change their lifestyle behaviours after HF diagnosis and active follow-up calls from health care providers to check on patients' health status were important enablers of high-quality care. Health care providers' advice on substance use often motivated patients to stop smoking and consuming alcohol. Although patients expected support from their family members, the level of caregiver support for patients varied, with some patients receiving strong support from caregivers and others receiving minimal support. Emotional stress and lack of structured care plans for patients hindered patients' self-management of their condition. Further, high patient loads often limited the time health care providers had to provide advice on self-management options. Nevertheless, the availability of experienced nursing staff to support patients improved care within health care facilities. Finally, initiation of guideline-directed medical therapy was perceived as complex by health care providers due to multiple coexisting chronic conditions in HF patients. Conclusions: Structured plans for self-management of HF and more time for patients and health care providers to interact during clinical visits may enable better clinical handover with patients and family members, and thereby improve adherence to self-care options. Quality improvement interventions should also address the stress and emotional concerns of HF patients., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Jose P et al.)

Introduction: Heart failure (HF) has emerged as an important and increasing disease burden in India. We present the 5-year outcomes of patients hospitalized for HF in India., Methods: The Trivandrum Heart Failure Registry (THFR) recruited consecutive patients admitted for acute HF among 16 hospitals in Trivandrum, Kerala in 2013. Guideline-directed medical therapy (GDMT) was defined as the combination of beta-blockers (BB), renin angiotensin system blockers (RAS), and mineralocorticoid receptor antagonists (MRA) in patients with HF with reduced ejection fraction (HFrEF, EF < 40%) at discharge. We used Cox proportional hazards models and Kaplan-Meier survival plots for analysis. The MAGGIC risk score variables were included as exposure variables., Results: Among 1205 patients [69% male, mean (SD) age = 61.2 (13.7) years], HFrEF constituted 62% of patients and among them, 25% received GDMT. The 5-year mortality rate was 59% (n = 709 deaths), and median survival was 3.1 years. Sudden cardiac death and pump failure caused 46% and 49% of the deaths, respectively. In the multivariate Cox model, components of GDMT associated with lower 5-year mortality risks were discharge prescription of BB, RAS blocker, and MRA. Older age, lower systolic blood pressure, NYHA class III or IV, and higher serum creatinine were also associated with higher 5-year mortality., Conclusions: Three out of every 5 patients had died during 5-years of follow-up with a median survival of approximately 3 years. Lack of GDMT in patients with HFrEF and frequent readmissions were associated with higher 5-year mortality. Quality improvement programmes with strategies to improve adherence to GDMT and reduction in readmissions may improve HF outcomes in this region., (Copyright © 2020. Published by Elsevier B.V.)

Background: Task-sharing interventions using non-physician health-care workers might be a potential diabetes management strategy in health systems that are constrained by physician shortages, such as those in low-income and middle-income countries (LMICs)., Methods: We did a systematic review and meta-analysis of task-sharing intervention strategies for managing type 2 diabetes in LMICs. We searched PubMed, Embase, and CINAHL from database inception to Sept 25, 2019, for studies that were randomised control trials or cluster randomised trials with task-shifted or task-shared interventions delivered to adults (≥18 years) by non-physician health workers versus usual care, done in LMICs with glycated haemoglobin (HbA 1c ) or fasting blood sugar (FBS) as outcome measures. The methodological quality of included studies was assessed using the Cochrane risk of bias tool. Random-effects model meta-analysis was used to estimate the population average pooled mean difference for HbA 1c and FBS with 95% CIs. Our study protocol was registered in the PROSPERO database (CRD42018081015)., Findings: We found 4213 studies from the literature search, of which 46 (1·1%) were eligible for the narrative synthesis, including a total of 16 973 participants. 16 of these studies were excluded from the meta-analysis due to high risk of bias. 24 studies with a total of 5345 participants were included in the meta-analysis of HbA 1c and 18 studies with a total of 3287 participants for FBS. Interventions led to an average reduction in HbA 1c when tasks were delivered by nurses (averaged pooled mean difference -0·54% [95% CI -0·89 to -0·18]; I 2 =80%) and pharmacists (-0·91% [-1·15 to -0·68]; I 2 =58%), but not when they were delivered by dietitians (-0·50% [-1·10 to 0·09]; I 2 =54%) or community health workers (0·05% [0·03 to 0·07]; I 2 =0%). A reduction in average FBS was also observed when interventions were delivered by pharmacists (average pooled mean difference -36·26 mg/dL [-52·60 to -19·92]; I 2 =78%) but not nurses (-7·46 mg/dL [-18·44 to 3·52]; I 2 =79%) or community health workers (-5·41 [-12·74 to 1·92]; I 2 =71%). Only one study reported on FBS when tasks were delivered by dietitians, with a mean difference of -35·00 mg/dL (-65·96 to -4·04)., Interpretation: Task sharing interventions with non-physician healthcare workers show moderate effectiveness in diabetes management in LMIC settings. Although relatively high heterogeneity limits the interpretation of the overall findings, interventions led by pharmacists and nurses in LMICs with relatively high physician density are effective strategies in the management of diabetes., Funding: Wellcome Trust-Department of Biotechnology India Alliance., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background and Aim: Increasing stroke burden in developing countries necessitates measures to strengthen health systems. We aimed to evaluate whether a Community Health Worker (CHW) based educational intervention will improve risk factor control among stroke survivors and enhance behavior change communication., Method: An open-label, cluster-randomized trial was conducted in rural area of Thiruvananthapuram district, Kerala from December 2017 to December 2018. A CHW-based educational intervention in addition to standard of care was provided in intervention arm and compared to standard clinical care in the control arm with follow-up at three and six months. The primary outcome measures were risk factor control and quality of behavior change communication provided by CHWs., Results: Of the 234 Stroke/TIA survivors enrolled, the mean age (SD) was 59.43 (11.07) years. At 6-month follow up, all patients with smokeless tobacco consumption had quit in the intervention arm (5 at baseline and 0 at six months) and no relapse in smoking was found (as compared to control arm wherein 9 at baseline and one at 6 months). The control of hypertension and diabetes was not significant at 3 months and 6 months in both intervention and control groups. Home visits as well as health education on risk factors by CHWs in the intervention arm were significantly higher., Conclusion: Community health worker-based intervention is feasible in resource constrained settings for secondary stroke prevention. Training of CHW on risk factor control and lifestyle modifications for stroke survivors enhances quality of health education provided by health services., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background : Multi-morbidity is the coexistence of multiple chronic conditions in individuals. With advancing epidemiological and demographic transitions, the burden of multi-morbidity is expected to increase India. Methods : A cross-sectional representative survey was conducted among 410 participants aged 30-69 years in Pathanamthitta District, Kerala to assess the prevalence of multi-morbidity. A multi-stage cluster sampling method was employed to identify households for the survey. We interviewed all eligible participants in the selected households. A structured interview schedule was used to assess socio-demographic variables, behavioral risk factors and prevailing clinical conditions. We used the PHQ-9 questionnaire for depression screening. Further, we conducted active measurements of both blood sugar and blood pressure. Multiple logistic regression was used to identify variables associated with multi-morbidity. Results : Overall, the prevalence of multi-morbidity was 45.4% (95% CI: 40.5-50.3%). Nearly a quarter of the study participants (25.4%) reported only one chronic condition (21.3-29.9%). Further, 30.7% (26.3-35.5), 10.7% (7.9-14.2), 3.7% (2.1-6.0) and 0.2% reported two, three, four and five chronic conditions, respectively. At least one person with multi-morbidity was present in around seven out of ten households (72%, 95% CI: 65-78%). Further, one in five households (22%, 95% CI: 16.7-28.9%) reported more than one person with multi-morbidity. Diabetes and hypertension was the most frequent dyad (30.9%, 95% CI: 26.5-35.7%), followed by hypertension and depression (7.8%, 95% CI: 5.5-10.9%). Diabetes, hypertension and ischemic heart disease was the common triad in males (8.5%, 95% CI: 4.8-14.1%), while it was diabetes, hypertension and depression (6.9%, 95% CI: 4.2-11.1%) in females. Age, sex, and employment status were associated with multi-morbidity. Conclusion : Multi-morbidity is prevalent in one of two participants in the productive age group of 30-69 years. Further, seven of ten households have at least one person with multi-morbidity. The high burden of multi-morbidity calls for integrated management strategies for multiple chronic conditions., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 C R and Jeemon P.)

Objective: Exposure to certain intrauterine antiepileptic drugs (AEDs) can negatively influence the language skills and intelligence of young children. It remains unanswered whether these deficits are transient or persist as children grow up. This study aims to evaluate the language function of children of women with epilepsy (CWE) aged 9-13 years in comparison with their peers, and its relationship with intrauterine AED exposure., Methods: We included 191 CWE in our study from the Kerala Registry of Epilepsy and Pregnancy. Children in the same age group (n = 144) and without maternal epilepsy or antenatal AED exposure served as controls. We used Clinical Examination for Language Function version IV to assess language in both groups. Relevant data related to maternal epilepsy and AED use were obtained from the registry records., Results: The average Core Language Scaled Score (CLSS) was significantly lower in CWE as compared to controls (83.19 vs 90.18, P = .001). Similarly, the mean scaled scores in other language parameters were also significantly lower in CWE. In the multivariate analysis, compared to control children, the average CLSS in CWE was 4.5 units lower (95% confidence interval [CI] = -8.8 to -0.2, P = .04) with AED monotherapy exposure and 7.3 units lower with exposure to AED polytherapy (95% CI = -13.8 to -0.8, P = .03). Intrauterine exposure to phenobarbitone (n = 61) and valproate (n = 55) as either monotherapy or polytherapy showed a negative effect on CLSS in CWE as compared to control children. However, carbamazepine (n = 75) and phenytoin (n = 37) use was not associated with significant variation of CLSS. In head-to-head comparisons between AED monotherapies in CWE, phenobarbitone showed a negative effect on CLSS (-14.7, 95% CI = -23.1 to -6.4, P = .001) as compared to carbamazepine., Significance: Intrauterine exposure to phenobarbitone and valproate impairs language development in CWE, with effects persisting into the second decade., (© 2020 International League Against Epilepsy.)

Background: Deficits in quality of care for patients with heart failure (HF) contribute to high mortality in this population. This qualitative study aims to understand the barriers and facilitators to high-quality HF care in Kerala, India. Methods: Semi-structured, in-depth interviews were conducted with a purposive sample of health care providers (n=13), patients and caregivers (n=14). Additionally, focus group discussions (n=3) were conducted with patients and their caregivers. All interviews and focus group discussions were transcribed verbatim. Textual data were analysed using thematic analysis. Results: Patients' motivation to change their lifestyle behaviours after HF diagnosis and active follow-up calls from health care providers to check on patients' health status were important enablers of high-quality care. Health care providers' advice on substance use often motivated patients to stop smoking and consuming alcohol. Although patients expected support from their family members, the level of caregiver support for patients varied, with some patients receiving strong support from caregivers and others receiving minimal support. Emotional stress and lack of structured care plans for patients hindered patients' self-management of their condition. Further, high patient loads often limited the time health care providers had to provide advice on self-management options. Nevertheless, the availability of experienced nursing staff to support patients improved care within health care facilities. Finally, initiation of guideline-directed medical therapy was perceived as complex by health care providers due to multiple coexisting chronic conditions in HF patients. Conclusions: Structured plans for self-management of HF and more time for patients and health care providers to interact during clinical visits may enable better clinical handover with patients and family members, and thereby improve adherence to self-care options. Quality improvement interventions should also address the stress and emotional concerns of HF patients., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Jose P et al.)

Background : Multi-morbidity is the coexistence of multiple chronic conditions in individuals and families. With advancing epidemiological and demographic transitions, the burden of multi-morbidity is expected to increase India. Methods : A cross-sectional representative survey was conducted among 410 participants aged 30-69 years in Pathanamthitta District, Kerala. A multi-stage cluster sampling method was employed to identify households for the survey. We interviewed all eligible participants in the selected households. A structured interview schedule was used to assess socio-demographic variables, behavioral risk factors and prevailing clinical conditions. We used the PHQ-9 questionnaire for depression screening. Further, we conducted active measurements of both blood sugar and blood pressure. Multiple logistic regression was used to identify variables associated with multi-morbidity. Results : Overall, the prevalence of multi-morbidity was 45.4% (95% CI: 40.5-50.3%). Nearly a quarter of the study participants (25.4%) reported only one chronic condition (21.3-29.9%). Further, 30.7% (26.3-35.5), 10.7% (7.9-14.2), 3.7% (2.1-6.0) and 0.2% reported two, three, four and five chronic conditions, respectively. At least one person with multi-morbidity was present in around seven out of ten households (72%, 95% CI: 65-78%). Further, one in five households (22%, 95% CI: 16.7-28.9%) reported more than one person with multi-morbidity. Diabetes and hypertension was the most frequent dyad (30.9%, 95% CI: 26.5-35.7%), followed by hypertension and depression (7.8%, 95% CI: 5.5-10.9%). Diabetes, hypertension and ischemic heart disease was the common triad in males (8.5%, 95% CI: 4.8-14.1%), while it was diabetes, hypertension and depression (6.9%, 95% CI: 4.2-11.1%) in females. Age, sex, and employment status were associated with multi-morbidity. Conclusion : Multi-morbidity is prevalent in one of two participants in the productive age group of 30-69 years. Further, seven of ten households have at least one person with multi-morbidity. The high burden of multi-morbidity calls for integrated preventive and management strategies for multiple chronic conditions., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 C R and Jeemon P.)