Vamadevan S. Ajay

Chronic conditions cause notable health and economic burdens. While health insurance enables access to healthcare, its effects on chronic care outcomes remain under-explored. To examine the association between health insurance coverage and cardiometabolic risk factors among people with chronic conditions in India. Data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) and Solan studies, including 2,926 adults with chronic conditions were analyzed using propensity score weighting to evaluate the associations between health insurance and cardiometabolic risk factors (HbA1c, low-density lipoprotein cholesterol [LDLc], and blood pressure [BP]) and self-reported health status (measured using European Quality of Life Visual Analogue Scale [EQ-VAS]). Mediation analysis evaluated healthcare visits as a potential mediator. Among 2,926 respondents meeting criteria, mean (SD) age was 54.6 years (11.8), and 1630 (55.7%) were women. Health insurance coverage was low (6.5%) and more prevalent among men, higher-income groups, and rural vs urban residents. Insured participants had lower mean diastolic BP (84.8 vs 86.0 mmHg), mean LDLc (113.3 vs 117.2 mg/dl), mean HbA1c (6.9% vs 7.5%), and higher health status (EQ-VAS: 74.6 vs 69.1) than uninsured participants, respectively (p < 0.05). Mediation analysis showed healthcare visits strongly mediated the relationship between insurance and BP and partially mediated effects on LDLc, HbA1c, and self-rated health. Health insurance coverage was associated with better cardiometabolic risk profiles and health status, largely mediated by increased healthcare utilization. Expanding insurance coverage to include outpatient chronic care services should be prioritized to improve health outcomes in low- and middle-income countries.

Background: The growing burden of hypertension and diabetes is one of the major public health challenges being faced by the health system in India. Clinical Decision Support Systems (CDSS) that assist with tailoring evidence-based management approaches combined with task-shifting from more specialized to less specialized providers may together enhance the impact of a program. We sought to integrate a technology “CDSS” and a strategy “Task-shifting” within the Government of India’s (GoI) Non-Communicable Diseases (NCD) System under the Comprehensive Primary Health Care (CPHC) initiative to enhance the program’s impact to address the growing burden of hypertension and diabetes in India. Methods: We developed a model of care “I-TREC” entirely calibrated for implementation within the current health system across all facility types (Primary Health Centre, Community Health Centre, and District Hospital) in a block in Shaheed Bhagat Singh (SBS) Nagar district of Punjab, India. We undertook an academic-community partnership to incorporate the combination of a CDSS with task-shifting into the GoI CPHC-NCD system, a platform that assists healthcare providers to record patient information for routine NCD care. Academic partners developed clinical algorithms, a revised clinic workflow, and provider training modules with iterative collaboration and consultation with government and technology partners to incorporate CDSS within the existing system. Discussion: The CDSS-enabled GoI CPHC-NCD system provides evidence-based recommendations for hypertension and diabetes; threshold-based prompts to assure referral mechanism across health facilities; integrated patient database, and care coordination through workflow management and dashboard alerts. To enable efficient implementation, modifications were made in the patient workflow and the fulcrum of the use of technology shifted from physician to nurse. Conclusion: Designed to be applicable nationwide, the I-TREC model of care is being piloted in a block in the state of Punjab, India. Learnings from I-TREC will provide a roadmap to other public health experts to integrate and adapt their interventions at the national level. Trial registration: CTRI/2020/01/022723.

Introduction: Cardiovascular diseases (CVDs) are the leading cause of death in India. The CVD risk approach is a cost-effective way to identify those at high risk, especially in a low resource setting. As there is no validated prognostic model for an Indian urban population, we have re-calibrated the original Framingham model using data from two urban Indian studies. Methods: We have estimated three risk score equations using three different models. The first model was based on Framingham original model; the second and third are the recalibrated models using risk factor prevalence from CARRS (Centre for cArdiometabolic Risk Reduction in South-Asia) and ICMR (Indian Council of Medical Research) studies, and estimated survival from WHO 2012 data for India. We applied these three risk scores to the CARRS and ICMR participants and estimated the proportion of those at high-risk (>30% 10 years CVD risk) who would be eligible to receive preventive treatment such as statins. Results: In the CARRS study, the proportion of men with 10 years CVD risk > 30% (and therefore eligible for statin treatment) was 13.3%, 21%, and 13.6% using Framingham, CARRS and ICMR risk models, respectively. The corresponding proportions of women were 3.5%, 16.4%, and 11.6%. In the ICMR study the corresponding proportions of men were 16.3%, 24.2%, and 16.5% and for women, these were 5.6%, 20.5%, and 15.3%. Conclusion: Although the recalibrated model based on local population can improve the validity of CVD risk scores our study exemplifies the variation between recalibrated models using different data from the same country. Considering the growing burden of cardiovascular diseases in India, and the impact that the risk approach has on influencing cardiovascular prevention treatment, such as statins, it is essential to develop high quality and well powered local cohorts (with outcome data) to develop local prognostic models.

Background: Widespread access to good quality antihypertensive medicines is a critical component for reducing premature cardiovascular disease (CVD) mortality. Poor-quality medicines pose serious health concerns; however, there remains a knowledge gap about the quality of cardiovascular medicines available in low- and middle-income countries. Objectives: The aim of this study was to determine the quality of generic antihypertensive medicines available in the retail market of a developing country. Methods: Samples of the 2 most commonly prescribed classes of antihypertensive medicines were collected from 3 states in 3 different geopolitical zones in Nigeria following a semirandom sampling framework. Medicine samples were purchased by mystery shoppers from 22 pharmacy outlets from 6 local government areas across the 3 states. Medicine quality was determined by measuring the amount of stated active pharmaceutical ingredient using high-performance liquid chromatography with photodiode array detection and classified according to their compliance to the specified pharmacopeia tolerance limits for each antihypertensive drug. Results: Amlodipine and lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 361 samples from 22 pharmacies were collected and tested. In total, 24.6% of amlodipine and 31.9% of lisinopril samples were of substandard quality and significantly more samples purchased in rural (59 of 161, 36.7%) compared with urban (32 of 200, 16%) outlets were found to be of substandard quality (p < 0.001). No falsified samples of either amlodipine or lisinopril were detected. There was large variation in price paid for the antihypertensive medicines (range ₦150 to ₦9,750). Of the 24 pharmacy outlets surveyed, 46% stated that patients did not always require a prescription and 21% had previously reported a medicine as falsified or substandard. Conclusions: More than one-quarter of some commonly prescribed antihypertensive medicines available in Nigeria may be of substandard quality. Enhanced quality assurance processes in low- and middle-income countries, such as Nigeria, are needed to support optimum management.

Studies in high-income countries have reported associations between oral health and diabetes. There is however a lack of evidence on this association from low and middle-income countries, especially India. The current study aimed to assess the prevalence of common oral diseases and their association with diabetes. This cross-sectional study was nested within the second Cardiometabolic Risk Reduction in South Asia Surveillance Study. A subset of study participants residing in Delhi were administered the World Health Organization’s Oral Health Assessment Questionnaire and underwent oral examination for caries experience and periodontal health assessment using standard indices. Diabetes status was ascertained by fasting blood glucose, glycosylated hemoglobin values or self-reported medication use. Information was captured on co-variates of interest. The association between oral health and diabetes was investigated using Multivariable Zero-Inflated Poisson (ZIP) regression analysis. Out of 2045 participants, 47% were women and the mean age of study participants was 42.17 (12.8) years. The age-standardised prevalence (95% confidence interval) estimates were 78.9% (75.6–81.7) for dental caries, 35.9% (32.3–39.6) for periodontitis. Nearly 85% participants suffered from at least one oral disease. Compared to diabetes-free counterparts, participants with diabetes had more severe caries experience [Mean Count Ratio (MCR) = 1.07 (1.03–1.12)] and attachment loss [MCR = 1.10 (1.04–1.17)]. Also, the adjusted prevalence of periodontitis was significantly higher among participants with diabetes [42.3%(40.0–45.0)] compared to those without diabetes [31.3%(30.3–32.2)]. We found that eight out of ten participants in urban Delhi suffered from some form of oral disease and participants with diabetes had worse oral health. This highlights the need for public health strategies to integrate oral health within the existing Non-Communicable Disease control programs.

Although most Indians live in rural settings, data on cardiovascular disease risk factors in these groups are limited. We describe the association between socioeconomic position and cardiovascular disease risk factors in a large rural population in north India. We performed representative, community-based sampling from 2013 to 2014 of Solan district in Himachal Pradesh. We used education, occupation, household income, and household assets as indicators of socioeconomic position. We used tobacco use, alcohol use, low physical activity, obesity, hypertension, and diabetes as risk factors for cardiovascular disease. We performed hierarchical multivariable logistic regression, adjusting for age, sex and clustering of the health sub-centers, to evaluate the cross-sectional association of socioeconomic position indicators and cardiovascular disease risk factors. Among 38,457 participants, mean (SD) age was 42.7 (15.9) years, and 57% were women. The odds of tobacco use was lowest in participants with graduate school and above education (adjusted OR 0.11, 95% CI 0.09, 0.13), household income >15,000 INR (adjusted OR 0.35, 95% CI 0.29, 0.43), and highest quartile of assets (adjusted OR 0.28, 95% CI 0.24, 0.34) compared with other groups but not occupation (skilled worker adjusted OR 0.93, 95% CI 0.74, 1.16). Alcohol use was lower among individuals in the higher quartile of income (adjusted OR 0.75, 95% CI 0.64, 0.88) and assets (adjusted OR 0.70, 95% CI 0.59, 0.82). The odds of obesity was highest in participants with graduate school and above education (adjusted OR 2.33, 95% CI 1.85, 2.94), household income > 15,000 Indian rupees (adjusted OR 1.89, 95% CI 1.63, 2.19), and highest quartile of household assets (adjusted OR 2.87, 95% CI 2.39, 3.45). The odds of prevalent hypertension and diabetes were also generally higher among individuals with higher socioeconomic position. Individuals with lower socioeconomic position in Himachal Pradesh were more likely to have abnormal behavioral risk factors, and individuals with higher socioeconomic position were more likely to have abnormal clinical risk factors.

Background: Appropriate strategies and key stakeholder engagement are the keys to successful implementation of new health care interventions. Objectives: The study sought to articulate the key strategies used for scaling up a research-based intervention, mPower Heart electronic Clinical Decision Support System (e-CDSS), for state-wide implementation at health facilities in Tripura. Methods: Multiple strategies were used for statewide implementation of mPower Heart e-CDSS at noncommunicable diseases clinics across the government health facilities in Tripura: formation of a technical coordination-cum-support unit, change management, enabling environment, adapting the intervention with user focus, and strengthening the Health Information System. Results: The effective delivery of a new health system intervention requires engagement at multiple levels including political leadership, health administrators, and health professionals, which can be achieved by forming a technical coordination-cum-support unit. It is important to specify the role and responsibilities of existing manpower and provide a structured training program. Enabling environment at health facilities (providing essential equipment, space and time, etc.) is also crucial. Successful implementation also requires that patients, health care providers, the health system, and leadership recognize the immediate and long-term benefits of the new intervention and have a buy-in in the intervention. With constant encouragement and nudge from administrative authorities and by using multiple strategies, 40 government health facilities adopted the mPower Heart e-CDSS. From its launch in May 2017 until November 20, 2018, a total of 100,810 eligible individuals were screened and enrolled, with 35,884 treated for hypertension, 9,698 for diabetes, and 5,527 for both hypertension and diabetes. Conclusions: Multiple strategies, based on implementation principles, are required for successful scaling up of research-based interventions.

Introduction: India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research. Methods and analysis: The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al ’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. Ethics and dissemination: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations. Trial registration number: NCT03164317 ; Pre-results.

Cardiac rehabilitation (CR) after myocardial infarction is highly effective. It is unavailable in public hospitals in India due to limited resources. Our objective was to develop a scalable model of CR for India based on yoga, which could also appeal to some groups with low uptake of CR (e.g., ethnic minorities, women, and older people) globally. The intervention was developed using a structured process. A literature review and consultations with yoga experts, CR experts, and postmyocardial infarction patients were conducted to systematically identify and shortlist appropriate yoga exercises and postures, breathing exercises, meditation and relaxation practices, and lifestyle changes, which were incorporated into a conventional CR framework. The draft intervention was further refined based on the feedback from an internal stakeholder group and an external panel of international experts, before being piloted with yoga instructors and patients with myocardial infarction. A four-phase yoga-based CR (Yoga-CaRe) programme was developed for delivery by a single yoga instructor with basic training. The programme consists of a total of 13 instructor-led sessions (2 individual and 11 group) over a 3-month period. Group sessions include guided practice of yoga exercises and postures, breathing exercises, and meditation and relaxation practices, and support for the lifestyle change and coping through a moderated discussion. Patients are encouraged to self-practice daily at home and continue long-term with the help of a booklet and digital video disc (DVD). Family members/carers are encouraged to join throughout. In conclusion, a novel yoga-based CR programme has been developed, which promises to provide a scalable CR solution for India and an alternative choice for CR globally. It is currently being evaluated in a large multicentre randomised controlled trial across India.