Health Ministry's Screening Committee Research Articles

Using Digital Media to Improve Dementia Care in India: Protocol for a Randomized Controlled Trial.

BackgroundIndia is undergoing a demographic transition characterized by population aging and is witnessing a high dementia rate. Although nearly 7 million people live with dementia in India, dementia awareness is poor, and current resources addressing dementia care are basic and often incomplete, duplicated, or conflicting. To address this gap, this study aims to use digital media, which has had a massive technological uptake in India, to improve dementia care in India.ObjectiveThe objective of this paper is to describe an intervention study design that examines the feasibility and acceptability of Moving Pictures India, a digital media resource to improve dementia care in India.MethodsThis study employs a mixed methods design and is divided into 4 phases: (1) video interviews with Indian caregivers and health professionals; (2) coproduction of resources; (3) pilot randomized controlled trial (RCT); and (4) dissemination and analytics. The pilot RCT will follow an experimental parallel group design with 2 arms aiming to assess the impact, feasibility, and acceptability of the developed resources. The primary outcome measures for the pilot RCT will be feasibility and acceptability, while the secondary outcome measures will be caregiver burden, mood, and quality of life.ResultsThis study received funding from the Alzheimer’s Association in the United States in July 2021. In 2023, we will enroll 60 dementia caregivers (40 caregivers in the intervention arm and 20 in the control) for the pilot RCT. The study has been approved by the National Institute of Mental Health and Neuro Sciences Ethics Committee (26th IEC (BEH.SC.DIV.)/2020-21 dated November 11, 2020); the Health Ministry's Screening Committee, India (proposal ID 2020-10137); the Curtin University Human Research Ethics Committee (approval number HRE2020-0735); and the NARI Research Governance Office (site-specific approval dated March 17, 2021).ConclusionsThis protocol is designed to deliver unique, coproduced, and evidence-based media resources to support caregivers of persons with dementia in India and other countries aiming to utilize digital media for dementia care. If the intervention is found feasible and acceptable, postpiloting analytics and qualitative feedback will be used to develop an implementation trial to evaluate the effectiveness of the potential low-risk high-benefit intervention in practice.Trial RegistrationClinical Trials Registry-India CTRI/2021/01/030403; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50794International Registered Report Identifier (IRRID)DERR1-10.2196/38456

A Neurocognitive Investigation of Low-Level Arsenic Exposure Reveals Impaired Executive Function Mediated by Brain Anomalies

Background: Arsenic, a contaminant of groundwater and irrigated crops, is a global public health hazard. Exposure to low levels of arsenic through food extends well beyond the areas with high arsenic water content. While isolated impairments of cognitive function following chronic exposure to high arsenic levels have been described, a comprehensive assessment of the scope of such impairments and their underlying brain mechanisms does not exist, especially not in the case of the much more common low-level arsenic exposure. Methods: We analyse 1014 participants aged 6 to 23 years of the Indian Consortium-on-Vulnerability-to-Externalizing-Disorders-and-Addictions (cVEDA). Participants were characterised using deep phenotyping measures of behaviour, neuropsychology, psychopathology, brain neuroimaging and exposure to developmental adversities and environmental neurotoxins. Arsenic was measured in urine as an index of exposure. Findings: Using sparse-partial least square analysis (sPLS) we describe a correlation of arsenic exposure with impairments in executive function (r=-0.12, p=5.4x10-4), brain structure (r=-0·2, p=1·8x10-8) and functional connectivity (within-network: r=-0·12, p=7·5x10-4, between-network: r=-0·23, p=1·8x10-10). Impairments in executive function were partially mediated by localised changes in grey-matter volume (b=-0·004, CIs=-0·007 to -0·002) and within-network functional connectivity (b=-0·004, CIs=-0·008 to -0·002). Socio Economic Status (SES) and Body Mass Index (BMI) moderated the link between arsenic and changes in grey-matter volume, with the effect of arsenic being strongest in participants from lower SES and with low BMI. Interpretation: We describe a syndrome of impairments in executive function and their brain correlates associated with low-level arsenic exposure. Our results demonstrate detrimental consequences of arsenic exposure well below currently recommended guidelines that affects people beyond endemic risk areas. Precision medicine approaches to study global-mental-health vulnerabilities, highlight widespread but potentially modifiable risk factors and a mechanistic understanding of the impact of low-level arsenic exposure on brain development. Funding Information: Indian Council for Medical Research and Medical Research Council, United Kingdom. Declaration of Interests: All authors report no competing interests. Ethics Approval Statement: The cVEDA Study was approved by the Health Ministry Screening Committee, Ministry of Health and Family Welfare, Government of India. The study protocol was approved by the Institutional Ethics Review Boards of National Institute of Mental Health and Neurosciences (NIMHANS) Bangalore, India (Item No. VII, SI. No. 7·08, Behavioural Sciences) and all other regional collaborating institutions. Informed consent was obtained from participants over the age of 18 and from parents of participants under 18 years of age (along with assent from minor participants).

Antibiotic Choice, Effectiveness, and Outcome Among Hospitalized Neonates with Gram-Negative Bloodstream Infection in India: A Prospective Cohort Study

Background: Neonatal sepsis is a leading cause of childhood mortality. Antimicrobial resistance complicates management in high burden countries, such as India. We sought to determine whether early use of microbiologically active antibiotics is associated with reduced mortality of neonatal Gram-negative (GN) bloodstream infections (BSI). Methods: Between May 2017 and July 2019, we recruited neonates with GN BSI admitted to three neonatal intensive care units in India. Antibiotic use, microbial data, and clinical outcomes were prospectively collected. We assessed the association between empiric therapy including an active agent, defined by in vitro susceptibility, and 30-day all-cause mortality using Cox proportional hazard models. Findings: Of 9303 neonates admitted over a 27-month period, 3107 (33%) had at least one blood culture; 263 (3%) had a GN BSI identified at a median 6 days of life (IQR 3-11). Among isolates, 196 were Enterobacterales with 73 (37%) identified as carbapenem-resistant Enterobacterales (CRE), and 46 were Acinetobacter species with 28 (61%) being carbapenem-resistant Acinetobacter species (CRAb). Overall, 52 infants received initial empiric therapy including colistin, which was active in most (169 of 263, 64%) instances, but a minority of patients with CRE (33 of 73, 45%) and CRAb (11 of 28, 39%) received an active agent. Initial use of active antibiotics was not associated with decreased 30-day mortality for CRE or CRAb infections. Interpretation: Early initiation of currently available, active antibiotics was not associated with lower mortality among neonates with GN BSI in a setting with a high burden of carbapenem-resistant organisms. Funding: U.S. Centers for Disease Control and Prevention Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: The study was approved by the ethics committees of each participating hospital, the Johns Hopkins School of Medicine Institutional Review Board, and the Government of India Health Ministry Screening Committee.

Conducting community-based pediatric research in rural India: Experience from vadu rural health program.

This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.

Prevalence of physical health conditions and health risk behaviours in people with severe mental illness in South Asia: protocol for a cross-sectional study (IMPACT SMI survey)

IntroductionPeople with severe mental illness (SMI) die on average 10–20 years earlier than the general population. Most of these deaths are due to physical health conditions. The aim of this...

Periconceptional surveillance for prevention of anaemia and birth defects in Southern India: protocol for a biomarker survey in women of reproductive age

IntroductionWomen of reproductive age (WRA) are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in...

Indian Council of Medical Research's International Collaboration & Partnerships; Health Ministry's Screening Committee: Facts, figures & procedures.

There is a great interest among various international agencies/countries in developing partnership with Indian research organizations, particularly with the Indian Council of Medical Research (ICMR) for biomedical research. The ICMR is actively involved in governance and co-ordination of partnerships with several international organizations and agencies. Various MoUs (Memorandum of Understanding)/agreements of ICMR with international partners bring together the researchers and resources towards progression through shared research and innovation agenda. Growing collaboration during recent years is reflected through increased number of internationally funded/technically coordinated research projects in health research. However, for any international collaborative research study to be undertaken in India, certain regulatory requirements are to be fulfilled. This article summarizes the international partnerships of ICMR as well as the details of guidelines regarding submission of international collaborative research projects for the Health Ministry's Screening Committee (HMSC), which is a mandatory requirement before undertaking such projects.

The Physical Health of People With Severe Mental Illness in South Asia: A Cross-Sectional Multi-Country Survey

Background: People with severe mental illness (SMI) die earlier than the general population, primarily due to physical disorders. There is little information on the prevalence of physical illnesses and health-risk behaviours in people with SMI in low and middle-income countries.Methods: We recruited adults with SMI attending specialist mental health service in Bangladesh, India, and Pakistan to a cross-sectional survey. Data were collected on non-communicable diseases (NCDs), risk factors and health-risk behaviours using the WHO STEPwise approach to Surveillance of NCDs. We also investigated chronic infections, health-related quality of life and healthcare utilisation.Findings: Before halting recruitment due to the COVID-19 pandemic, we assessed 3,229 patients for eligibility, we recruited 2,506 participants with bipolar disorder (36·7%), non-affective psychosis (42·2%), and depression with psychotic symptoms (21·1%). Nine percent had diabetes, 3·8% cardiovascular diseases, 3% tuberculosis and 2·4% chronic hepatitis. Forty-four percent were overweight/obese, 24·3% had hypertension, 48·9% hypercholesterolemia, and 38·0% anaemia. An important incidental finding of this research is that most participants with diabetes, hypertension and hypercholesterolemia were previously undiagnosed. Fifty-two percent of men and 16·4% of women used tobacco; 53·0% engaged in recommended levels of physical activity and 12·5% consumed recommended portions of fruit and vegetables. Only 45·0% with NCDs, 42·4% with hypertension and 26·6% of tobacco users received any treatment or health advice.Interpretation: A third of people with SMI reported physical disorders. We found significant gaps reported in screening, prevention and treatment, physical health in people with SMI may be grossly neglected in South Asia.Trial Registration: ISRCTN88485933; https://doi.org/10.1186/ISRCTN88485933.Funding Statement: This research was funded by the National Institute for Health Research (NIHR) (Grant: GHRG 17/63/130:) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care.Declaration of Interests: The authors declare that they have no conflicts of interest.Ethics Approval Statement: The study was approved by the ethics committees of the Department of Health Sciences, University of York, UK; Centre for Injury Prevention and Research, Bangladesh; NIMHANS and Health Ministry Screening Committee, India; and the National Bioethics Committee, Pakistan. All study procedures complied with legislation and guidance for good practice governing the participation in research of people who may lack capacity (Mental Capacity Act (UK) 2005).

Understanding intersections of social determinants of maternal healthcare utilization in Uttar Pradesh, India.

ObjectiveTo explore intersections of social determinants of maternal healthcare utilization using the Classification and Regression Trees (CART) algorithm which is a machine-learning method used to construct prediction models.MethodsInstitutional review board approval for this study was granted from Public Health Service—Ethical Review Board (PHS-ERB) and from the Health Ministry Screening Committee (HMSC) facilitated by Indian Council for Medical Research (ICMR). IRB review and approval for the current analyses was obtained from University of California, San Diego. Cross-sectional data were collected from women with children aged 0–11 months (n = 5,565) from rural households in 25 districts of Uttar Pradesh, India. Participants were surveyed on maternal healthcare utilization including registration of pregnancy (model-1), receipt of antenatal care (ANC) during pregnancy (model-2), and delivery at health facilities (model -3). Social determinants of health including wealth, social group, literacy, religion, and early age at marriage were captured during the survey. The Classification and Regression Tree (CART) algorithm was used to explore intersections of social determinants of healthcare utilization.ResultsCART analyses highlight the intersections, particularly of wealth and literacy, in maternal healthcare utilization in Uttar Pradesh. Model-1 documents that women who are poorer, illiterate and Muslim are less likely to have their pregnancies registered (71.4% vs. 86.0% in the overall sample). Model-2 documents that poorer, illiterate women had the lowest ANC coverage (37.7% vs 45% in the overall sample). Model-3, developed for deliveries at health facilities, highlighted that illiterate and poor women have the lowest representation among facility deliveries (59.6% vs. 69% in the overall sample).ConclusionThis paper explores the interactions between determinants of maternal healthcare utilization indicators. The findings in this paper highlights that the interaction of wealth and literacy can play a very strong role in accentuating or diminishing healthcare utilization among women. The study also reveals that religion and women’s age at marriage also interact with wealth and literacy to create substantial disparities in utilization. The study provides insights into the effect of intersections of determinants, and highlights the importance of using a more nuanced understanding of the impact of co-occurring forms of marginalization to effectively tackle inequities in healthcare utilization.

Factors associated with neonatal pneumonia in India: protocol for a systematic review and planned meta-analysis

IntroductionIndia accounts for more neonatal deaths than any other country. There is a lack of consolidated evidence from India regarding the determining factors of pneumonia in neonates. This systematic review...

Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12–18 months in India: study protocol for a randomised controlled trial

IntroductionBiofortified crops represent a sustainable agricultural solution for the widespread micronutrient malnutrition in India and other resource-limited settings. This study aims to investigate the effect of the consumption of foods...

Risk factors and barriers to case management of neonatal pneumonia: protocol for a pan-India qualitative study of stakeholder perceptions

IntroductionIndia accounted for more neonatal deaths (estimated at 696 000) than any other country, as of 2015. Of these , most neonatal deaths due to infections can be attributed to...

Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol.

IntroductionHypertension is emerging in rural populations of India. Barriers to diagnosis and treatment of hypertension may differ regionally according to economic development. Our main objectives are to estimate the prevalence, awareness, treatment and control of hypertension in 3 diverse regions of rural India; identify barriers to diagnosis and treatment in each setting and evaluate the feasibility of a community-based intervention to improve control of hypertension.Methods and analysisThis study includes 4 main activities: (1) assessment of risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours in ∼14 500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an intervention provided by Accredited Social Health Activists (ASHAs), comprising group-based education and support for individuals with hypertension to self-manage blood pressure. Wards/villages/hamlets of a larger Mandal are identified as the primary sampling unit (PSU). PSUs are then randomly selected for inclusion in the cross-sectional survey, with further randomisation to intervention or control. Changes in knowledge of hypertension and risk factors, and clinical and anthropometric measures, are assessed. Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs.Ethics and disseminationApproval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health and Family Welfare (India), institutional review boards at each site and Monash University. In addition to publication in peer-reviewed articles, results will be shared with federal, state and local government health officers, local healthcare providers and communities.Trial registration numberCTRI/2016/02/006678; Pre-results.

Health Ministry's Screening Committee (Indian Council of Medical Research)

The Health Ministry's Screening Committee (Indian Council of Medical Research) takes decisions on the international research proposals in the field of health research, requiring foreign collaboration and assistance from foreign funding agencies.

Protocol for developing the evidence base for a national salt reduction programme for India

IntroductionThe scientific evidence base in support of salt reduction is strong but the data required to translate these insights into reduced population salt intake are mostly absent. The aim of...

Immune Activation Is Associated With Increased Gut Microbial Translocation in Treatment-Naive, HIV-Infected Children in a Resource-Limited Setting

Gut damage resulting in microbial translocation (MT) is considered a major cause of immune activation (IA) in HIV infection, but data in children are limited, particularly in the absence of antiretroviral therapy. Sixty perinatally HIV-infected, antiretroviral therapy-naive children, aged 2-12 years, were evaluated for plasma levels of lipopolysaccharide, DNA sequences encoding bacterial 16 second ribosomal DNA (16S rDNA) and soluble CD14 concurrently with markers of CD4 and CD8 T-cell IA and immune exhaustion (IE), CD4 counts, and plasma viral load. At study entry, participants were classified into immune categories (ICs): IC1 (CD4% > 25), IC2 (CD4% 15-25), and IC3 (CD4% < 15). Age-matched HIV-uninfected children served as controls. Data were evaluated at study entry and at 12 months. Levels of MT, IA, and IE were increased in patients as compared with controls, were highest in patients in IC3 group, and did not change over 12 months. MT products lipopolysaccharide and 16S rDNA correlated with each other and each correlated with plasma viral load, soluble CD14, and T-cell IA and IE. There was a correlation of IA with IE. CD4 counts and percentage were inversely correlated with MT products and underlying CD4 activation. In a natural history cohort of HIV-infected children not on therapy, MT was more pronounced in the most severely immunocompromised patients and was associated with IA. Strategies to reduce MT may help to reduce IA and prevent CD4 depletion.