Is Ambient Weather a Risk Factor for Acute Encephalopathy Outbreaks in Children in Muzaffarpur, Bihar, India? Insight from a 9-Year Analysis.

OBJECTIVES: Despite periodic outbreaks, the causes and risk factors of acute encephalitis syndrome (AES) in children of Muzaffarpur, Bihar, India, remain unknown. We explored the correlation between AES caseload and the climate parameters. METHODS: Data for 1318 hospitalized children with AES during 2012-20 were used. The correlation between AES cases and daily climate parameters (temperature, sunshine, rainfall, humidity and wind speed) for the previous 24, 48 and 72 h were examined using Pearson's and Spearman's rank-order correlation and Poisson regression or negative binomial regression analyses. RESULTS: Most (91.8%) of the AES cases occurred during the summer season (May-July months), especially June month. Pearson's and Spearman's rank-order correlation analyses revealed that AES caseload had positive correlations with maximum (r = 0.275, ρ = 0.293) and minimum (r = 0.306, ρ = 0.306) temperatures during past 24 h and heat index (r = 0.325, ρ = 0.325) and negative correlation with humidity (r = -0.222, ρ = -0.222) and rainfall (r = -0.183, ρ = -0.183) (all p < 0.05). The correlation was consistent for the climate parameters for the past 24, 48 and 72 h. Regression analysis also documented a significant association of AES cases with daily maximum (ß: 0.32-0.36) and minimum (ß: 0.53-0.62) temperatures and heat index (ß: 0.92-1.03) over past 24, 48 and 72 h (all p < 0.01). The number of AES cases exponentially increased when the daily maximum and minimum temperatures crossed 40°C and 31°C, respectively. CONCLUSIONS: The climate parameters, especially temperature appears to be a risk factor for AES in children. The definite aetiological role of heat for AES in children needs further exploration.

Repeated seasonal outbreaks of acute encephalitis syndrome (AES) in children have been observed in Muzaffarpur, Bihar (India), since 1995. These children mostly present during the summer months (May­June) of the year with sudden early morning onset of seizures, altered sensorium, hypoglycaemia, with or without fever. A high fatality (27­63%) or sequels among those who survive have been observed. Large outbreaks were observed in 2005, 2009, 2011, 2012, 2014 and 2019. The despite periodic outbreaks, the causes and risk factors of AES in these children remain mostly unknown. We explored the correlation between the AES caseload (data for 1318 hospitalized children with AES during 2012­2020) and the daily climate parameters (temperature, heat index, sunshine, rainfall, humidity and wind speed) for the previous 24, 48 and 72 h using various statistical tests. Most (91.8%) of the AES cases occurred during the summer season (May­July months), especially June month. The AES caseload had significant positive correlation with maximum and minimum temperatures and heat index and negative correlation with humidity and rainfall. The number of AES cases exponentially increased when the daily maximum and minimum temperatures crossed 40°C and 31°C, respectively.

Why parents agree or disagree for minimally invasive tissue sampling (MITS) to identify causes of death in under-five children and stillbirth in North India: a qualitative study.

BACKGROUND: Information on exact causes of death and stillbirth are limited in low and middle income countries. Minimally invasive tissue sampling (MITS) is increasingly practiced in place of autopsy across several settings. A formative research documented the experiences of counselling and consenting for MITS in north India. METHODS: This exploratory qualitative study was conducted at a tertiary care hospital in Delhi. During the early implementation of MITS, observations of the counselling and consenting process (n = 13) for under-five child death and stillbirths were conducted. In-depth interviews with MITS team members (n = 3) were also conducted. Observation and interview data were transcribed and inductively analysed using thematic content analysis to identify emerging themes and codes. RESULTS: The MITS team participated in daily ward rounds for familiarisation with parents/families. Following death declaration the counselling was done in counselling corner of the ward or adjacent corridor. Mostly the counselling was targeted at the father and family members present, using verbal explanation and the consent document in local language. The key concerns raised by parents/family were possible disfigurement, time needed and possible benefits. Most of the parents consulted family members before consent. Among those who consented, desire for next pregnancy, previous pregnancy or neonatal loss and participation of treating senior doctor were the key factors. The negative experience of hospital care, poor comprehension and distance from residence were the factors for consent refusal. Lesser number of parents of deceased children consented for MITS compared to the neonates and stillbirths. CONCLUSIONS: The initial experiences of obtaining consent for MITS were encouraging. Consent for MITS may be improved with active involvement of the treating doctors and nurses, better bereavement support, private counselling area along with improvement in quality of care and communication during hospitalisation. Special efforts and refinement in counselling are needed to improve consent for MITS in older children.

Information about exact cause of death and stillbirth are essential for appropriate care of children and pregnant women. Autopsy assists in establishing exact cause of death, but not preferred by the parents/families. Minimally invasive tissue sampling (MITS) is a suitable alternate to autopsy for establishing causes of death and stillbirth. A pilot project on MITS was initiated at a tertiary care hospital in north India (New Delhi). An exploratory formative research was conducted to document the experiences of counselling and consenting for MITS. Under this study, observation of the counselling and consenting process for conduct of MITS in under-five children (including neonates) and stillbirths were done. Additionally, in-depth interviews with MITS team members were also conducted. Counselling for MITS was done in one corner of the ward or adjacent corridor and mostly targeted at the father and family members present. Counselling was primarily verbal explanation in local language. The key concerns from parents/family were disfigurement, time needed and possible benefits. Most of the parents consulted family members before decision. Benefit during next pregnancy, past previous pregnancy or neonatal loss and senior treating doctor's involvement were key factors for consent. Poor quality of care and comprehension were the reasons for refusal.

Perceptions of family, community and religious leaders and acceptability for minimal invasive tissue sampling to identify the cause of death in under-five deaths and stillbirths in North India: a qualitative study.

BACKGROUND: Minimal invasive tissue sampling (MITS) has emerged as a suitable alternative to complete diagnostic autopsy (CDA) for determination of the cause of death (CoD), due to feasibility and acceptability issues. A formative research was conducted to document the perceptions of parents, community and religious leaders on acceptability of MITS. METHODS: This qualitative study was conducted at and around the Safdarjung Hospital, Delhi, India. Participants for in-depth interview included the parents who had either child or neonatal death or stillbirth and the key community and religious representatives. The focus group discussions (FGDs) involved community members. Process of obtaining consent for MITS was observed. Data were analyzed inductively manually for emerging themes and codes. RESULTS: A total of 104 interviews (parents of deceased children, neonates or stillbirths, n = 93; community members, n = 8 and religious leaders, n = 7), 8 FGDs (n = 72) were conducted and process of obtaining consent for MITS (n = 27) was observed. The participants were positive and expressed willingness to accept MITS. The key determinants for acceptance of MITS were: (1) understanding and willingness to know the cause of death or stillbirth, (2) experience of the healthcare received and trust, (3) the religious and sociocultural norms. Parents and community favored for MITS over CDA when needed, especially where in cases with past stillbirths and child deaths. The experience of treatment, attitude and communication from healthcare providers emerged as important for consent. The decision making process was collective involving the elders and family. No religious leader was against the procedure, as both, the respect for the deceased and need for medical care were satisfied. CONCLUSIONS: Largely, MITS appeared to be acceptable for identifying the causes of child deaths and stillbirths, if the parents and family are counseled appropriately considering the sociocultural and religious aspects. They perceived the quality of care, attitude and communication by the healthcare providers as critical factors for acceptance of MITS.

India tops the chart of childhood deaths and stillbirths globally. The causes of many childhood deaths and stillbirths remain unknown or ill-defined in India. For planning the health policies, program and clinical practices, the cause of death (CoD) and stillbirth are primarily determined by verbal autopsy (VA) method, which has several inherent limitations. The acceptance and implementation of complete diagnostic autopsy (CDA) or full autopsy for CoD determination is limited. Minimally invasive tissue sampling (MITS) is a suitable alternative to full autopsy for CoD determination. MITS has been found to be acceptable and being implemented in some low and middle income countries. Considering the multi-religion and sociocultural contexts of India, an understanding about the perceptions, practices, acceptance and barriers among the parents, community members and religious leaders regarding MITS was necessary for designing appropriate communication strategies and materials for consent. A qualitative study was undertaken in New Delhi, India using in-depth interviews with the parents of deceased children and stillbirths, community leaders, community health workers and religious leaders and focus group discussions with the community members and observation of obtaining consent for MITS. The parents and community members were positive about MITS and expressed willingness to accept it over full autopsy to know the CoD and stillbirths. The factors like past stillbirths and child deaths, experience of the healthcare received and trust, the religious and sociocultural norms emerged as important determinants for acceptance of MITS. The religious leaders were also positive about MITS if needed for treatment and benefit of the family.

COVID-19 vaccine and the cold chain implications for global adoption.

The COVID-19 pandemic has spread globally with 190.8 million infected cases and 4.1 million deaths as of July 18, 2021. In absence of any definite antiviral agent availability and therapeutic armamentarium, vaccines are considered critical. While 20 vaccines are in use, about 295 vaccines are underdevelopment globally using eleven technological platforms. While the vaccines have >80% efficacy, the ultracold (-70°C and -20°C) storage and logistics requirements for some raise concerns for implementation, especially in developing countries. The Ebola vaccination in African countries, which required an ultracold chain provided lessons for these COVID-19 vaccines. The existing vaccine cold chain system suffers from temperature excursions at cold chain stores and during transportations in different countries suggests careful assessment and addressing the gaps for effective vaccine introduction. Appropriate attention for cold chain storage, logistics (especially the last mile), and vaccine management and upgradation is needed to achieve optimal vaccine effectiveness for curtailing the pandemic.

Documentation of vaccine wastage in two different geographic contexts under the universal immunization program in India.

BACKGROUND: Government of India is introducing new and relatively costly vaccines under immunization program. Monitoring of vaccine wastage is needed to guide the program implementation and forecasting. Under pilot introduction of rotavirus vaccine in two districts both 5- and 10-doses vials were used, which was considered as an opportunity for documenting the wastage. The wastage rates for other routine vaccines were also documented. METHODS: A survey conducted in two districts (Kangra, Himachal Pradesh and Pune, Maharashtra) covered 49 vaccine stores, 34 sub-centres and 34 outreach sessions collected vaccine receipt, distribution and usage data for two complete years 2016 and 2017. RESULTS: The overall wastage rates for almost all vaccines were higher in Kangra district (BCG 37.1%, DPT 32.1%, Measles 32.2%, OPV 50.8%, TT 34.1% and pentavalent 18.4%) than Pune district (BCG 35.1%, DPT 25.4%, Measles 21.7%, OPV 14.3%, TT 23.1% and pentavalent 13.2%). Wastage for pneumococcal conjugate and measles-rubella vaccines in Kangra district were 27 and 40.5%, respectively. With transition from 5- to 10-doses vials for rotavirus vaccine, wastage at stores levels increased in both Kangra (29 to 33.2%) and Pune (17.8 to 25.7%) districts. With transition from intramuscular to intradermal fractional inactivated polio vaccine, the wastage increased from 36.1 to 54.8% in Kangra and 18.4 to 26.9% in Pune district. CONCLUSIONS: The observed vaccine wastage rates for several vaccines were relatively higher than program assumption for forecasting. The observed variations in the vaccine wastage indicates need for state or region based documentation and monitoring in India for appropriate programmatic action.

Perceptions of the healthcare providers regarding acceptability and conduct of minimal invasive tissue sampling (MITS) to identify the cause of death in under-five deaths and stillbirths in North India: a qualitative study.

BACKGROUND: India contributes the highest share of under-five and neonatal deaths and stillbirths globally. Diagnostic autopsy, although useful for cause of death identification, have limited acceptance. Minimally invasive tissue sampling (MITS) is an alternative to autopsy for identification of the cause of death (CoD). A formative research linked to pilot MITS implementation was conducted to document the perceptions and attitudes of the healthcare professionals and the barriers for implementation. METHODS: This exploratory qualitative study conducted at a tertiary care hospital in New Delhi, India included the hospital staffs. In-depth interviews were conducted with the doctors, nurses and support staffs from pediatrics, neonatology, obstetrics and forensic medicine departments. Inductive data analysis was done to identify the emerging themes and codes. RESULTS: A total of 26 interviews (doctors, n = 10; nurses, n = 9 and support staffs, n = 7) were conducted. Almost all professional and support staffs were positive about the MITS and its advantage for CoD identification including co-existing and underlying illnesses. Some opined conduct of MITS for the cases without clear diagnosis. All participants perceived that MITS would be acceptable for parents due to the non-disfigurement and preferred by those who had unexplained child deaths or stillbirths in past. The key factors for MITS acceptance were appropriate communication, trust building, involvement of senior doctors, and engagement of the counselor prior to deaths and training of the personnel. For implementation and sustenance of MITS, involvement of the institute authority and government stakeholders would be essential. CONCLUSIONS: MITS was acceptable for the doctors, nurses and support staffs and critical for better identification of the causes of death and stillbirths. The key facilitating factors and challenges for implementing MITS at the hospital in Indian context were identified. It emphasized on appropriate skill building, counseling, system organization and buy-in from institution and health authorities for sustenance of MITS.

Global research priorities for social, behavioural and community engagement interventions for maternal, newborn and child health.

BACKGROUND: Social, behavioural and community engagement (SBCE) interventions are essential for global maternal, newborn and child health (MNCH) strategies. Past efforts to synthesise research on SBCE interventions identified a need for clear priorities to guide future research. WHO led an exercise to identify global research priorities for SBCE interventions to improve MNCH. METHODS: We adapted the Child Health and Nutrition Research Initiative method and combined quantitative and qualitative methods to determine MNCH SBCE intervention research priorities applicable across different contexts. Using online surveys and meetings, researchers and programme experts proposed up to three research priorities and scored the compiled priorities against four criteria - health and social impact, equity, feasibility, and overall importance. Priorities were then ranked by score. A group of 29 experts finalised the top 10 research priorities for each of maternal, newborn or child health and a cross-cutting area. RESULTS: A total of 310 experts proposed 867 research priorities, which were consolidated into 444 priorities and scored by 280 experts. Top maternal and newborn health priorities focused on research to improve the delivery of SBCE interventions that strengthen self-care/family care practices and care-seeking behaviour. Child health priorities focused on the delivery of SBCE interventions, emphasising determinants of service utilisation and breastfeeding and nutrition practices. Cross-cutting MNCH priorities highlighted the need for better integration of SBCE into facility-based and community-based health services. CONCLUSIONS: Achieving global targets for MNCH requires increased investment in SBCE interventions that build capacities of individuals, families and communities as agents of their own health. Findings from this exercise provide guidance to prioritise investments and ensure that they are best directed to achieve global objectives. Stakeholders are encouraged to use these priorities to guide future research investments and to adapt them for country programmes by engaging with national level stakeholders.

Is Delaying Cord Clamping until Placenta Delivery Beneficial? Oxygen Saturation and Heart Rate Transition during the Initial 5 Minutes after Delivery in Indian Healthy Newborns.

OBJECTIVE: This study aimed to compare the preductal oxygen saturation (SpO2) and heart rate (HR) in newborns during the initial 5 minutes after birth with delayed cord clamping (DCC) and early cord clamping (ECC) practices at sea level. STUDY DESIGN: This prospective observational study included newborns born at >34 weeks vaginally (Dharampur, Gujarat) or through caesarean section (CS) (Kolkata, West Bengal). In Dharampur, the newborns received ECC practice (8 weeks) followed by DCC practice (10 weeks). In Kolkata, the newborns received ECC practice only (8 weeks). RESULTS: The newborns with DCC (n = 170) had significantly higher SpO2 (3-8%) throughout than those with ECC born either vaginally (n = 178) or through CS (n = 101). The newborns with DCC had slower rise in HR during the first 2 minutes than those with ECC. The 5th and 10th percentile values of SpO2 for newborns with DCC practice were higher than those with ECC practice. CONCLUSION: The trends of SpO2 and HR during the first 5 minutes after birth indicate a relatively smoother cardiopulmonary transition by delaying cord clamping till placental delivery compared with early clamping. The reference ranges can be used for Indian newborns born by uncomplicated vaginal delivery with DCC during the first 5 minutes.

COVID-19 vaccine development and the way forward.

The whole globe is reeling under the COVID-19 pandemic now. With the scale and severity of infection, number of deaths and lack of any definite therapeutic armamentarium, the vaccine development has been accelerated at a never-before pace. A wide variety of vaccine technologies and platforms are being attempted. Out of the over 108 efforts, 100 are in preclinical and eight in Phase 1 or 2 trial stage. While the availability of newer technologies has facilitated development, there are several challenges on the way including limited understanding of the pathophysiology, targeting humoral or mucosal immunity, lack of suitable animal model, poor success of human severe acute respiratory syndrome/Middle East Respiratory Syndrome vaccines, limited efficacy of influenza vaccines, and immune exaggeration with animal coronavirus vaccines. With the current scenario with political, funding, research, and regulatory supports, if everything sails through smoothly, the successful vaccine is expected in 12-18 months. Modestly efficacious vaccine may be also a good achievement.

Exploring family, community and healthcare provider perceptions and acceptability for minimal invasive tissue sampling to identify the cause of death in under-five deaths and stillbirths in North India: a qualitative study protocol.

BACKGROUND: Around 5.4 million under-five deaths occur globally annually. Over 2.5 million neonatal deaths and an equivalent stillbirths also occur annually worldwide. India is largest contributor to these under-five deaths and stillbirths. To meet the National Health Policy goals aligned with sustainable development targets, adoption of specific strategy and interventions based on exact causes of death and stillbirths are essential. The current cause of death (CoD) labelling process is verbal autopsy based and subject to related limitations. In view of rare diagnostic autopsies, the minimally invasive tissue sampling (MITS) has emerged as a suitable alternate with comparable efficiency to determine CoD. But there is no experience on perception and acceptance for MITS in north Indian context. This formative research is exploring the perceptions and view of families, communities and healthcare providers regarding MITS to determine the acceptability and feasibility. METHODS: The cross-sectional study adopts exploratory qualitative research design. The study will be conducted in New Delhi linked to deaths and stillbirths occurring at a tertiary care hospital. The data from multiple stakeholders will be collected through 53-60 key-informant in-depth interviews (IDIs), 8 focus group discussions (FGDs) and 8-10 death or stillbirth event observations. The IDIs will be done with the parents, family members, community representatives, religious priests, burial site representatives and different health care providers. The FGDs will be conducted with the fathers, mothers, and elderly family members in the community. The data collection will focus on death, post-death rituals, religious practices, willingness to know CoD, acceptability of MITS and decision making dynamics. Data will be analysed following free listing, open coding, selective coding and theme identification. Subsequently 8-10 parents will be approached for consent to conduct MITS using the communication package to be developed using the findings. DISCUSSION: The study will provide in-depth understanding of the cultural, social, religious practices related to child death and stillbirth and factors that potentially determine acceptance of MITS. The findings will guide development of communication and counselling package and strategies for obtaining consent for MITS. The pilot experience on obtaining consent for MITS will inform suitable refinement and future practice.

Ethics committee registration and re-registration with the regulatory authority in India.

Background: All ethics committees (ECs) that review and monitor clinical trials in India must be registered with the regulatory authority. We ascertained the status of registration and re-registration of ECs till December 2017. Methods: The ECs registered and re-registered with the Indian regulatory authority till December 2017 were extracted. The status of ECs was analysed according to the state, institute category and registration. Results: A total of 1260 ECs were registered, of which 14% were based in medical colleges, 2% in dental colleges, 61.2% in hospitals other than medical colleges and 8% as independent ECs. Of the recognized medical and dental colleges, only 37.3% and 10.9%, respectively, and 45.9% of ECs from teaching hospitals (other than medical and dental colleges) had registered with the regulatory authority. Of the 911 ECs eligible for re-registration, 516 (56.5%) had reregistered. Conclusion: A low proportion of registrations ofECs from eligible academic health institutions raises concern about adherence to regulatory guidelines and conduct of clinical trials in India. The lower re-registration of ECs helps in the identification of factors which should be addressed to facilitate clinical research in India.

Temperature integrity and exposure to freezing temperature during vaccine transfer under the universal immunization program in Three States of India.

Temperature excursion and exposure to sub-zero temperatures may reduce the potency of the freeze-sensitive vaccines. This study assessed temperature during vaccine transfers at various levels under the Universal Immunization Program. This cross-sectional study undertaken in 21 districts of three states of India - Bihar (n = 8), Kerala (n = 8), and Gujarat (n = 5). We documented temperature inside the cold boxes and vaccine carriers using LogTag-Trix8 data loggers. In total, 110 vaccine transportation episodes were observed; 55 inter-facility transfers and 55 outreach sessions. Sizable proportions of inter-facility (9% to 35%) and outreach vaccine transfers (18%) were exposed to sub-zero temperature. The proportions of exposure to temperature to >8°C were in the range of 0.8%-11.3% for inter-facility transfers and 2.3% for outreach sessions. The vaccines were exposed to freezing temperatures for significant durations during transportation across the cold chain. Rigorous monitoring of temperature integrity is essential to ensure the delivery of potent vaccines and to avoid vaccine failure.

Improving quality of care for perinatal and newborn care at district and subdistrict hospitals in Haryana, India: Implementation research protocol.

AIM: This implementation research aims to improve quality of care for mothers and newborns in three districts of Haryana, India at different public health facilities. BACKGROUND: The decline in key maternal and newborn health indicators in India is relatively slower than expected and missed the millennium development goals. The multifold rise in institutional delivery in last decade has limited impact on neonatal and maternal mortality. Despite investments in infrastructure, equipment, supplies, monitoring tools, and also manpower, suboptimal gains in indicators point towards potential challenge in quality of care. DESIGN: This study adopts pre-post, quasi-experimental study design with repeated observations using mixed research methods to document the impact of the plan-do-study-act implementation cycles. METHODS: The quality improvement interventions shall be implemented at three district hospitals and six-first referral unit hospitals in three districts of Haryana targeting the antenatal, delivery, newborn care services with nurses as the key partners. Formative research, situational analysis, and root-cause analysis shall inform the contextualization, prioritization of interventions. Incremental plan-do-study-act cycles over 15 months shall be implemented. The changes in adherence to protocols, appropriate documentation, reduction in delays, and client satisfaction shall be documented for 16 indicators across delivery, antenatal, and sick newborn care domains. DISCUSSION: The successful implementation of the quality improvement processes has the potential of improving the pregnancy outcomes in terms of stillbirths, maternal, and newborn mortality and sick newborn outcomes. The feasibility and learning of coimplementation in the public health system shall inform integration into standards and scaling up.

Geospatial methodology for determining the regional prevalence of hospital-reported childhood intussusception in patients from India.

Both developed and developing countries carry a large burden of pediatric intussusception. Sentinel site surveillance-based studies have highlighted the difference in the regional incidence of intussusception. The objectives of this manuscript were to geospatially map the locations of hospital-confirmed childhood intussusception cases reported from sentinel hospitals, identify clustering and dispersion, and reveal the potential causes of the underlying pattern. Geospatial analysis revealed positive clustering patterns, i.e., a Moran's I of 0.071 at a statistically significant (p value < 0.0010) Z score of 16.14 for the intussusception cases across India (cases mapped n = 2221), with 14 hotspots in two states (Kerala = 6 and Tamil Nadu = 8) at the 95% CI. Granular analysis indicated that 67% of the reported cases resided < 50 km from the sentinel hospitals, and the average travel distance to the sentinel hospital from the patient residence was calculated as 47 km (CI 95% min 1 km-max 378 km). Easy access and facility referral preferences were identified as the main causes of the existing clustering pattern of the disease. We recommend designing community-based surveillance studies to improve the understanding of the prevalence and regional epidemiological burden of the disease.

Adverse Events Following Immunization- The Known Unknowns and Black Box : Based on 10th Dr. I. C. Verma Excellence Award for Young Pediatricians Delivered as Oration on 9th Oct. 2022.

Although vaccines are one of the most rigorously tested biological products, the safety concerns persist globally. The vaccine safety concerns linked to measles, pentavalent and human papillomavirus (HPV) vaccines have affected the vaccine coverage significantly in past. While surveillance of adverse events following immunization (AEFI) is part of the national immunization program mandate, it suffers from challenges and biases related to reporting, completeness, and quality. Some conditions of concern, termed as adverse events of special interest (AESI) following vaccination, mandated specialised studies to prove/disprove the association. The AEFIs/AESIs are usually caused by one of the four pathophysiologic mechanisms, but for several AEFIs/AESIs, the exact pathophysiology remains elusive. For the causality assessment of AEFIs, a systematic process with checklists and algorithm are followed to classify into one of the four causal association categories. While the causal association primarily banks on epidemiological observations for several AEFIs, the emerging evidences indicate roles of underlying genetic, gender, age and other pro-inflammatory risk factors for AEFIs and AESIs. The emerging evidences suggest role of antigenic mimicry, autoantibody(ies) and underlying genetic susceptibility for the AEFIs/AESIs. The uncertainty about the frequency, profile, interval, and severity of AEFIs/AESIs and variations across the population, ambiguity about the exact pathophysiology mechanism, absence of definite markers, suggest a possible black box effect of the vaccines. Unless these unanswered questions concerning the AEFIs/AESIs are addressed appropriately and communicated to the stakeholders (professionals, care providers, beneficiaries, general public and media), the anti-vaccine movement shall keep challenging the vaccine and vaccination program.

An Introduction to Qualitative and Mixed Methods Study Designs in Health Research.

With the recognition of different population behavior and relevance of socio-cultural factors in health, health services and public health program contexts, qualitative research is increasingly being used in health research, including clinical trials. Qualitative research follows an inductive framework to explore and gain an in-depth understanding of the phenomena, especially why and how aspects, through techniques including interviews, focus groups and observations. It analyzes the textual data collected following one of the common analysis approaches: grounded theory, phenomenology, ethnography or participatory action research. Despite the divergence in principles, mixed methods research designs systematically combine the quantitative and qualitative methods for a comprehensive understanding on the issue. The commonly used mixed methods designs variably combine the purpose, priority, sequence, embedding and data integration. Mixed methods analysis requires strategic synthesis of the results to gain comprehensive knowledge for appropriate clinical or public health action.

Multicenter Studies: Relevance, Design and Implementation.

Multicenter studies are essential in clinical and public health research with several advantages compared to single-center studies. Multicenter studies are attractive and advantageous, allowing quicker recruitment, diverse population coverage and increased generalizability. However, these studies often suffer from methodological, implementation and statistical challenges that can compromise the validity of the study. To meet the technical and interpretative integrity, a multicenter study must be conducted with sound study design, uniform implementation methodology, assured standardization, high-quality data and appropriate statistical considerations. A systematic site selection, rigorous study protocols, stringent quality assurance measures and appropriate analytical approach are indispensable to ensure high internal validity and minimize inter-site variability. For effective implementation of multicenter study, a well-organized coordination center and functional governance mechanism are critical. Transparent and effective network communication among the investigators with cultural sensitivities assists in building productive collaboration. This manuscript summarizes the design, organization, implementation and governance aspects of multicenter studies.

Nurses and Midwives Human Resource for Health and Their Education in India: A Situational Analysis.

AIM: This study aimed to the status of the nurses and midwives human resource and training institutes in India and variations across states. METHOD: This cross-sectional study collected information available from open sources (all data for the states) and supplemented with grey literature, as of 2019. The census population data were used for estimating the nurses and midwives dentistry. There was no sample selection. All the available information for the 30 states and six Union Territories were included. RESULTS: The auxiliary nurses and midwives (ANMs) density varied from 0.7 (Bihar and Telangana) to 26.6 (Andhra Pradesh) in states and 6.6 per 10,000 population at a national level. The registered nurses and midwives (RN/RM) density varied from 0.8 (Bihar) and 0.9 (Jharkhand) to 78.7 (Kerala) in states and 16.1 per 10,000 population at a national level. In 2019, there were 1890 ANM training schools, 3155 general nurses and midwives (GNM) training colleges, and 1958 Bachelor of Science (BSc) nursing training colleges in India. These institutions had 54,948 ANM, 227,370 GNM/BSc and 40,795 postgraduate nursing seats. With the current capacity, the nurses and midwives deficit can only be met in a 6-12 years period. CONCLUSION: India suffers from severe nurses and midwives shortage compared to the global norms with wide variations across the states. Increasing the training institution's number and seats are needed to meet the norms.

Barriers in reaching new-borns and infants through home visits: A qualitative study using nexus planning framework.

Background: Home visitation has emerged as an effective model to provide high-quality care during pregnancy, childbirth, and post-natal period and improve the health outcomes of mother- new born dyad. This 3600 assessment documented the constraints faced by the community health workers (known as the Accredited Social Health Activists, ASHAs) to accomplish home visitation and deliver quality services in a poor-performing district and co-created the strategies to overcome these using a nexus planning approach. Methods: The study was conducted in the Raisen district of Madhya Pradesh, India. The grounded theory approach was applied for data collection and analysis using in-depth interviews, and focus group discussions with stakeholders representing from health system (including the ASHAs) and the community (rural population). A key group of diverse stakeholders were convened to utilize the nexus planning five domain framework (social-cultural, educational, organizational, economic, and physical) to prioritize the challenges and co-create solutions for improving the home visitation program performance and quality. The nexus framework provides a systemic lens for evaluating the success of the ASHAs home visitation program. Results: The societal (caste and economic discrimination), and personal (domestic responsibilities and cultural constraints of working in the village milieu) issues emerged as the key constraints for completing home visits. The programmatic gaps in imparting technical knowledge and skills, mentoring system, communication abilities, and unsatisfactory remuneration system were the other barriers to the credibility of the services. The nexus planning framework emphasized that each of the above factors/domains is intertwined and affects or depends on each other for home-based maternal and newborn care services delivered with quality through the ASHAs. Conclusion: The home visitation program services, quality and impact can be enhanced by addressing the social-cultural, organizational, educational, economic, and physical nexus domains with concurrent efforts for skill and confidence enhancement of the ASHAs and their credibility.

Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies.

OBJECTIVES: To document and share the process of establishing the nationally representative multisite surveillance network for intussusception in India, coordination, data management and lessons learnt from the implementation. DESIGN: This study combined both retrospective and prospective surveillance approaches. SETTING: 19 tertiary care institutions were selected in India considering the geographic representation and public and private mix PARTICIPANTS: All children under-2 years of age with intussusception PRIMARY AND SECONDARY OUTCOME MEASURES: The experience of site selection, regulatory approvals, data collection, quality assurance and network coordination were documented. RESULTS: The site selection process involved systematic and objective four steps including shortlisting of potential institutions, information seeking and telephonic interaction, site visits and site selection using objective criteria. Out of over 400 hospitals screened across India, 40 potential institutions were shortlisted and information was sought by questionnaire and interaction with investigators. Out of these, 25 institutes were visited and 19 sites were finally selected to participate in the study. The multistep selection process allowed filtering and identification of sites with adequate capacity and motivated investigators. The retrospective surveillance documented 1588 cases (range: 14-652 cases/site) and prospective surveillance recruited 621 cases (range: 5-191 cases/site). The multilayer quality assurance measures monitored and ensured protocol adherence, complete record retrieval and data completeness. The key challenges experienced included time taken for obtaining regulatory and ethical approvals, which delayed completion of the study. Ten sites continued with another multisite vaccine safety surveillance study. CONCLUSION: The experience and results of this systematic and objective site selection method in India are promising. The systematic multistep site selection and data quality assurance methods presented here are feasible and practical. The lessons from the establishment and coordination of this surveillance network can be useful in planning, selecting the sites and conducting multisite and surveillance studies in India and developing countries.