Clustering of health behaviors and their associations with cardiometabolic risk factors among adults at high risk for type 2 diabetes in India: A latent class analysis.

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 (ß = -3.70 mm Hg, 95% confidence interval [CI] -7.05, -0.36), diastolic blood pressure (ß = -2.45 mm Hg, 95% CI -4.74, -0.16), and triglycerides (ß = -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.

Identification of novel endogenous control miRNAs in heart failure for normalization of qPCR data.

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.

Demographic and clinical characteristics of primary lung cancer patients in Kerala: Analysis of data from six teaching centers.

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.

Stroke awareness among community health workers from rural health blocks of Thiruvananthapuram, 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.

Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial.

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.

Charting a roadmap for heart failure research in India: Insights from a qualitative survey.

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.

Sarcomeric gene variants among Indians with hypertrophic cardiomyopathy: A scoping review.

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.

Hypertension Diagnosis, Treatment, and Control in India.

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.

Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial.

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.

Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial.

Background: Delivery of proven structured lifestyle change education for reducing the burden of cardiometabolic diseases such as diabetes at worksites could overcome barriers to program adoption and improve sustainability and reach of these programs; 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 eleven 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, 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 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: Clinicaltrial.gov NCT02813668, registered June 27, 2016.

Development process of a clinical guideline to manage type 2 diabetes in adults by Ayurvedic practitioners.

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.

Development and validation of heart failure-specific quality-of-life measurement tool in India.

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.

Clinical profile and 90 day outcomes of 10 851 heart failure patients across India: National Heart Failure Registry.

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.

A multicentric, 2 × 2 factorial, randomised, open-label trial to evaluate the clinical effectiveness of structured physical activity training and cognitive behavioural therapy versus usual care in heart failure patients: a protocol for the PACT-HF trial.

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.

A systematic review of home-based records in maternal and child health for improving informational continuity, health outcomes, and perceived usefulness in low and middle-income countries.

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.

Language, intelligence, and educational outcomes of adolescents with antenatal exposure to antiseizure medications: Prospective data from the Kerala Registry of epilepsy and pregnancy.

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.

Determinants of very low birth weight in India: The National Family Health Survey - 4.

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.

Differential impact of antenatal exposure to antiseizure medications on motor and mental development in infants of women with epilepsy.

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.

Prevalence of multimorbidity and associated treatment burden in primary care settings in Kerala: a cross-sectional study in Malappuram District, Kerala, India.

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.