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.

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.

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.

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.

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.

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.

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.

Promoting Family Integrated Early Childhood Development During the First 1000 Days in Urban Slums of Delhi: Feasibility and Early Implementation Experience.

The first 1000 days are critical for human development. Children residing in urban slums are at higher risk of suboptimal development. This article reports the feasibility and early implementation experiences of child stimulation directed counselling integrated with nutrition and health services by community functionaries in Delhi slums. This implementation research with cohort study design has two groups. The intervention group includes: pregnant women; infants and children in second year. The comparison group (without intervention) includes: recently delivered women, children aged 13-25 months. The feedback from the community functionaries and parents of children were also obtained. 44 videos with Hindi voiceover, demonstration of tools/toys/props, and 9 calendars depicting age-appropriate child stimulation activities were prepared and packaged with health and nutrition services for delivery by the frontline functionaries. These functionaries are coaching the families on child stimulation using these audio-visual messages using Tablets and demonstration tools/toys/props twice every three months. Monitoring and feedback data on service delivery are being collected. The data from the intervention cohort shall be compared with that from the comparison group to document the impact. From 63 anganwadi centres, 130 pregnant women, 142 infants and 136 children have been recruited for the intervention. 82.9% of the families received the intervention within 2 weeks and average time taken was 15 minutes. The initial feedback from the community functionaries and parents are very encouraging. The integrated child development package is acceptable and feasible for implementation through community functionaries and possible integration into the existing programs at scale.

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.

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.

Improving quality of care for pregnancy, perinatal and newborn care at district and sub-district public health facilities in three districts of Haryana, India: An Implementation study.

INTRODUCTION: Improving quality of care (QoC) for childbirth and sick newborns is critical for maternal and neonatal mortality reduction. Information on the process and impact of quality improvement at district and sub-district hospitals in India is limited. This implementation research was prioritized by the Haryana State (India) to improve the QoC for maternal and newborn care at the busy hospitals in districts. METHODS: This study at nine district and sub-district referral hospitals in three districts (Faridabad, Rewari and Jhajjar) during April 2017-March 2019 adopted pre-post, quasi-experimental study design and plan-do-study-act quality improvement method. During the six quarterly plan-do-study-act cycles, the facility and district quality improvement teams led the gap identification, solution planning and implementation with external facilitation. The external facilitators monitored and collected data on indicators related to maternal and newborn service availability, patient satisfaction, case record quality, provider's knowledge and skills during the cycles. These indicators were compared between baseline (pre-intervention) and endline (post-intervention) cycles for documenting impact. RESULTS: The interventions closed 50% of gaps identified, increased the number of deliveries (1562 to 1631 monthly), improved care of pregnant women in labour with hypertension (1.2% to 3.9%, p<0.01) and essential newborn care services at birth (achieved ≥90% at most facilities). Antenatal identification of high-risk pregnancies increased from 4.1% to 8.8% (p<0.01). Hand hygiene practices improved from 35.7% to 58.7% (p<0.01). The case record completeness improved from 66% to 87% (p<0.01). The time spent in antenatal clinics declined by 19-42 minutes (p<0.01). The pooled patient satisfaction scores improved from 82.5% to 95.5% (p<0.01). Key challenges included manpower shortage, staff transfers, leadership change and limited orientation for QoC. CONCLUSION: This multipronged quality improvement strategy improved the maternal and newborn services, case documentation and patient satisfaction at district and sub-district hospitals. The processes and lessons learned shall be useful for replicating and scaling up.

Association of meteorological parameters with intussusception in children aged under 2 years: results from a multisite bidirectional surveillance over 7 years in India.

OBJECTIVES: The study aimed to document the association between intussusception in Indian children and meteorological parameters and examine regional variations. DESIGN: A bidirectional (retrospective and prospective) surveillance between July 2010 and September 2017. SETTING: At 20 hospitals in India, retrospective case record review during July 2010 and March 2016 and prospective surveillance during April 2016 and September 2017 were performed. PARTICIPANTS: 2161 children aged 2-24 months with first intussusception episode were included. INTERVENTIONS: The monthly mean meteorological parameters (temperature, sunshine, rainfall, humidity and wind speed) for the study sites were collected. METHODS: The association between monthly intussusception cases and meteorological parameters was examined at pooled, regional and site levels using Pearson (r) and Spearman's rank-order (ρ) correlation, factorial analysis of variance, and Poisson regression or negative binomial regression analyses. RESULTS: The intussusception cases were highest in summer and lowest in autumn seasons. Pearson correlation analysis showed that temperature (r=0.056; p<0.05), wind speed (r=0.134; p<0.01) and humidity (r=0.075; p<0.01) were associated with monthly intussusception cases. Spearman's rank-order correlation analysis found that temperature (ρ=0.049; p<0.05), wind speed (ρ=0.096; p<0.01) and sunshine (ρ=0.051; p<0.05) were associated with monthly intussusception cases. Poisson regression analysis resulted that monthly intussusception case was associated with rising temperature (North region, p<0.01 and East region, p<0.05), sunshine (North region, p<0.01), humidity (East region, p<0.01) and wind speed (East region, p<0.01). Factorial analysis of variance revealed a significant seasonal difference in intussusception cases for pooled level (p<0.05), 2-6 months age group (p<0.05) and North region (p<0.01). Significant differences in intussusception cases between summer and autumn seasons were observed for pooled (p<0.01), children aged 2-6 months (p<0.05) and 7-12 months (p<0.05). CONCLUSIONS: Significant correlations between intussusception cases and temperature, humidity, and wind speed were observed at pooled and regional level in India. A peak in summer months was noted, which may be used for prediction, early detection and referral for appropriate management of intussusception.

Profile and Epidemiology of Intussusception in Children Under-Two Years of Age: A Prospective Surveillance.

OBJECTIVE: To report background intussusception epidemiology in children under-two years in Coimbatore district of Tamil Nadu state, India, prior to rotavirus vaccine (RVV) introduction. METHODS: Prospective sentinel surveillance was done at four hospitals in Coimbatore during April 2016 to September 2017. The children aged >1 mo and < 24 mo with diagnosed intussusception were recruited and data on clinical, treatment, diet, immunization, and sociodemography were collected. RESULTS: Sixty-eight children with intussusception were recruited. Among them 76.5% were infants with male predominance (57.4%) and 48.5% were 4-8 mo old. Vomiting (83.8%), pain in abdomen (including excessive crying) (72.1%), and bloody stools (45.6%) were the main symptoms. Reduction was tried in 92.6% cases with success in 83.8%. Surgery was needed by 16.2% children. No child died. Any RVV dose was received by 24.1% children and 2 children received RVV in 8-21 d and none within 1-7 d window. The incidence of intussusception requiring hospitalization was estimated to be 36.4 and 11.7 cases/100,000 children/y for the first and second years, respectively. CONCLUSION: Intussusception occurred in infants even without RVV exposure. Continued surveillance is needed to document the changes in intussusception epidemiology after RVV introduction.

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.

Perceptions of the parents of deceased children and of healthcare providers about end-of-life communication and breaking bad news at a tertiary care public hospital in India: A qualitative exploratory study.

BACKGROUND: Parents of dying children face unique challenge and expect compassionate support from health care providers (HCPs). This study explored the experiences of the parents and HCPs about the end-of-life care and breaking bad news and related positive and negative factors in Indian context. METHODS: This qualitative exploratory study was conducted at paediatrics department of a tertiary care hospital in Delhi. In-depth interviews with the parents (n = 49) and family members (n = 21) of the children died at the hospital and HCPs (6 doctors, 6 nurses and 4 support staffs) were conducted. Also events and communication around death of eight children were observed. Data were inductively analysed using thematic content analysis method to identify emerging themes and codes. RESULTS: Doctors were the lead communicators. Majority of parents perceived the attitude, communication and language used as by resident doctors as brief, insensitive and sometimes inappropriate or negative. They perceived that the attitude and communication by senior doctor's as empathetic, positive and complete. Parents recalled the death declaration by resident doctors as non-empathetic, blunt and cold. Most parents received no emotional support from HCPs during and after death of their child. All doctors expressed that death of their patients affected them and their emotions, which they coped through different activities. The overcrowded wards, high workload, infrastructural limitation and no formal communication training added to the emotional stress of the HCPs. CONCLUSIONS: Majority of the communication by the HCPs during the hospitalisation and end-of-life period were perceived as suboptimal by the parents. The HCPs were emotionally affected and faced end-of-life communication challenges. The study highlights the communication by HCPs and support for parents during the end-of-life communication and breaking bad news. It suggests adoption of context specific communication protocol and materials and training of HCPs in communication to improve the quality of care.

Grief reaction and psychosocial impacts of child death and stillbirth on bereaved North Indian parents: A qualitative study.

BACKGROUND: Grief following stillbirth and child death are one of the most traumatic experience for parents with psychosomatic, social and economic impacts. The grief profile, severity and its impacts in Indian context are not well documented. This study documented the grief and coping experiences of the Indian parents following stillbirth and child death. METHODS: This exploratory qualitative study in Delhi (India) included in-depth interviews with parents (50 mothers and 49 fathers), who had stillbirth or child death, their family members (n = 41) and community representatives (n = 12). Eight focus group discussions were done with community members (n = 72). Inductive data analysis included thematic content analysis. Perinatal Grief Scale was used to document the mother's grief severity after 6-9 months of loss. RESULTS: The four themes emerged were grief anticipation and expression, impact of the bereavement, coping mechanism, and sociocultural norms and practices. The parents suffered from disbelief, severe pain and helplessness. Mothers expressed severe grief openly and some fainted. Fathers also had severe grief, but didn't express openly. Some parents shared self-guilt and blamed the hospital/healthcare providers, themselves or family. Majority had no/positive change in couple relationship, but few faced marital disharmony. Majority experienced sleep, eating and psychological disturbances for several weeks. Mothers coped through engaging in household work, caring other child(ren) and spiritual activities. Fathers coped through avoiding discussion and work and professional engagement. Fathers resumed work after 5-20 days and mothers took 2-6 weeks to resume household chores. Unanticipated loss, limited family support and financial strain affected the severity and duration of grief. 57.5% of all mothers and 80% mothers with stillbirth had severe grief after 6-9 months. CONCLUSIONS: Stillbirth and child death have lasting psychosomatic, social and economic impacts on parents, which are usually ignored. Sociocultural and religion appropriate bereavement support for the parents are needed to reduce the impacts.

Harmonized One Health Trans-Species and Community Surveillance for Tackling Antibacterial Resistance in India: Protocol for a Mixed Methods Study.

BACKGROUND: India has the largest burden of drug­resistant organisms compared with other countries around the world, including multiresistant and extremely drug­resistant tuberculosis and resistant Gram­negative and Gram­positive bacteria. Antibiotic resistant bacteria are found in all living hosts and in the environment and move between hosts and ecosystems. An intricate interplay of infections, exposure to antibiotics, and disinfectants at individual and community levels among humans, animals, birds, and fishes triggers evolution and spread of resistance. The One Health framework proposes addressing antibiotic resistance as a complex multidisciplinary problem. However, the evidence base in the Indian context is limited. OBJECTIVE: This multisectoral, trans-species surveillance project aims to document the infection and resistance patterns of 7 resistant-priority bacteria and the risk factors for resistance following the One Health framework and geospatial epidemiology. METHODS: This hospital- and community-based surveillance adopts a cross-sectional design with mixed methodology (quantitative, qualitative, and spatial) data collection. This study is being conducted at 6 microbiology laboratories and communities in Khurda district, Odisha, India. The laboratory surveillance collects data on bacteria isolates from different hosts and their resistance patterns. The hosts for infection surveillance include humans, animals (livestock, food chain, and pet animals), birds (poultry), and freshwater fishes (not crustaceans). For eligible patients, animals, birds and fishes, detailed data from their households or farms on health care seeking (for animals, birds and fishes, the illness, and care seeking of the caretakers), antibiotic use, disinfection practices, and neighborhood exposure to infection risks will be collected. Antibiotic prescription and use patterns at hospitals and clinics, and therapeutic and nontherapeutic antibiotic and disinfectant use in farms will also be collected. Interviews with key informants from animal breeding, agriculture, and food processing will explore the perceptions, attitudes, and practices related to antibiotic use. The data analysis will follow quantitative (descriptive and analytical), qualitative, and geospatial epidemiology principles. RESULTS: The study was funded in May 2019 and approved by Institute Ethics Committees in March 2019. The data collection started in September 2019 and shall continue till March 2021. As of June 2020, data for 56 humans, 30 animals and birds, and fishes from 10 ponds have been collected. Data analysis is yet to be done. CONCLUSIONS: This study will inform about the bacterial infection and resistance epidemiology among different hosts, the risk factors for infection, and resistance transmission. In addition, it will identify the potential triggers and levers for further exploration and action. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23241.

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.