Emerging universality classes in thermally assisted activation of interacting diffusive systems: A perturbative hydrodynamic approach.

Thermal activation of a particle from a deep potential trap follows the Arrhenius law. Recently, this result has been generalized for interacting diffusive particles in the trap, revealing two universality classes-the Arrhenius class and the excluded volume class. The result was demonstrated with the aid of numerical analysis. Here, we present a perturbative hydrodynamic approach to analytically validate the existence and range of validity for the two universality classes.

A scalable health system model to achieve high coverage and quality of Kangaroo mother care in Uttar Pradesh, India.

AIM: To design a health system model for scaling-up Kangaroo mother care (KMC) and assess its impact on the population-level coverage and quality of KMC in Uttar Pradesh, India. METHODS: We co-developed the model with mothers and health system stakeholders using human-centred design over multiple cycles of implementation, learning and data-driven refinement. Infants with birthweight <2000 g in the study district were prospectively followed to assess the 'effective coverage' of KMC. Effective coverage referred to the proportion of eligible infants receiving ≥8 h of daily skin-to-skin contact and exclusive breastfeeding. RESULTS: High delivery load facilities were equipped with a KMC Lounge to ensure comfort, respectful care of mothers and high-quality KMC over prolonged periods. Systems to ensure weighing at birth, referral of infants with birthweight <2000 g to KMC facilities, initiation of KMC for all stable low birthweight infants, improving quality of care within KMC facilities and supporting families to continue KMC at home post discharge, were integrated into existing services. KMC was initiated in 93.3% of eligible infants with effective coverage of 52.7% and 64.8% at discharge and 7 days post discharge, respectively. CONCLUSION: The model addressed critical barriers to KMC implementation and adoption, contributing to its scale-up across the state.

Effect of sunflower seed oil emollient therapy on newborn infant survival in Uttar Pradesh, India: A community-based, cluster randomized, open-label controlled trial.

BACKGROUND: Hospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings. METHODS AND FINDINGS: This was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation. CONCLUSIONS: In this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function. TRIAL REGISTRATION: ISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.

Direct maternal morbidity and the risk of pregnancy-related deaths, stillbirths, and neonatal deaths in South Asia and sub-Saharan Africa: A population-based prospective cohort study in 8 countries.

BACKGROUND: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. METHODS AND FINDINGS: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman's self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. CONCLUSIONS: Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. TRIAL REGISTRATION: The study is not a clinical trial.

Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India.

BACKGROUND: The prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes. METHODS: We conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention. RESULTS: Of 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes. CONCLUSIONS: Birth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India.

OBJECTIVE: Evaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies. DESIGN: Matched pair, cluster-randomized controlled trial. SETTING: Uttar Pradesh, India. PARTICIPANTS: 120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites. INTERVENTIONS: Coaching targeting implementation of Checklist with data feedback and action planning. MAIN OUTCOME MEASURES: Mean supply availability by study arm; change in procurement sources for intervention sites. RESULTS: At baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2-21.5); 22.4 (95% CI: 21.8-22.9) and 22.1 (95% CI:21.4-22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3-21.3); 20.9 (95% CI: 20.3-21.5) and 21.7 (95% CI: 20.8-22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin). CONCLUSIONS: Implementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications. TRIAL REGISTRATION: ClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131-5647.

A shortened verbal autopsy instrument for use in routine mortality surveillance systems.

BACKGROUND: Verbal autopsy (VA) is recognized as the only feasible alternative to comprehensive medical certification of deaths in settings with no or unreliable vital registration systems. However, a barrier to its use by national registration systems has been the amount of time and cost needed for data collection. Therefore, a short VA instrument (VAI) is needed. In this paper we describe a shortened version of the VAI developed for the Population Health Metrics Research Consortium (PHMRC) Gold Standard Verbal Autopsy Validation Study using a systematic approach. METHODS: We used data from the PHMRC validation study. Using the Tariff 2.0 method, we first established a rank order of individual questions in the PHMRC VAI according to their importance in predicting causes of death. Second, we reduced the size of the instrument by dropping questions in reverse order of their importance. We assessed the predictive performance of the instrument as questions were removed at the individual level by calculating chance-corrected concordance and at the population level with cause-specific mortality fraction (CSMF) accuracy. Finally, the optimum size of the shortened instrument was determined using a first derivative analysis of the decline in performance as the size of the VA instrument decreased for adults, children, and neonates. RESULTS: The full PHMRC VAI had 183, 127, and 149 questions for adult, child, and neonatal deaths, respectively. The shortened instrument developed had 109, 69, and 67 questions, respectively, representing a decrease in the total number of questions of 40-55%. The shortened instrument, with text, showed non-significant declines in CSMF accuracy from the full instrument with text of 0.4%, 0.0%, and 0.6% for the adult, child, and neonatal modules, respectively. CONCLUSIONS: We developed a shortened VAI using a systematic approach, and assessed its performance when administered using hand-held electronic tablets and analyzed using Tariff 2.0. The length of a VA questionnaire was shortened by almost 50% without a significant drop in performance. The shortened VAI developed reduces the burden of time and resources required for data collection and analysis of cause of death data in civil registration systems.

Improving performance of the Tariff Method for assigning causes of death to verbal autopsies.

BACKGROUND: Reliable data on the distribution of causes of death (COD) in a population are fundamental to good public health practice. In the absence of comprehensive medical certification of deaths, the only feasible way to collect essential mortality data is verbal autopsy (VA). The Tariff Method was developed by the Population Health Metrics Research Consortium (PHMRC) to ascertain COD from VA information. Given its potential for improving information about COD, there is interest in refining the method. We describe the further development of the Tariff Method. METHODS: This study uses data from the PHMRC and the National Health and Medical Research Council (NHMRC) of Australia studies. Gold standard clinical diagnostic criteria for hospital deaths were specified for a target cause list. VAs were collected from families using the PHMRC verbal autopsy instrument including health care experience (HCE). The original Tariff Method (Tariff 1.0) was trained using the validated PHMRC database for which VAs had been collected for deaths with hospital records fulfilling the gold standard criteria (validated VAs). In this study, the performance of Tariff 1.0 was tested using VAs from household surveys (community VAs) collected for the PHMRC and NHMRC studies. We then corrected the model to account for the previous observed biases of the model, and Tariff 2.0 was developed. The performance of Tariff 2.0 was measured at individual and population levels using the validated PHMRC database. RESULTS: For median chance-corrected concordance (CCC) and mean cause-specific mortality fraction (CSMF) accuracy, and for each of three modules with and without HCE, Tariff 2.0 performs significantly better than the Tariff 1.0, especially in children and neonates. Improvement in CSMF accuracy with HCE was 2.5%, 7.4%, and 14.9% for adults, children, and neonates, respectively, and for median CCC with HCE it was 6.0%, 13.5%, and 21.2%, respectively. Similar levels of improvement are seen in analyses without HCE. CONCLUSIONS: Tariff 2.0 addresses the main shortcomings of the application of the Tariff Method to analyze data from VAs in community settings. It provides an estimation of COD from VAs with better performance at the individual and population level than the previous version of this method, and it is publicly available for use.

Aetiology of childhood viral gastroenteritis in Lucknow, north India.

BACKGROUND & OBJECTIVES: Due to limited availability of data on viral aetiology of acute gastroenteritis in north India, the present study was planned to detect rotavirus, norovirus, sapovirus and astrovirus in stool samples of both in hospitalized and non-hospitalized children less than five years of age presenting with acute gastroenteritis. METHODS: A total of 278 stool samples from equal number of children were tested for rotavirus antigen using ELISA and for norovirus, sapovirus and astroviruses by reverse transcription (RT)-PCR. RESULTS: Of the 169 samples from hospitalized patients, rotavirus, norovirus, sapovirus and astrovirus were detected in 19.5, 2.3, 3.5 and 2.9 per cent samples, respectively. Of the 109 samples collected from the non-hospitalized patients, frequency of rotavirus and sapovirus detection was 9.1 and 1.8 per cent, respectively while norovirus and astrovirus were not detected. INTERPRETATION & CONCLUSIONS: Rotavirus was the most frequent cause of viral gastroenteritis in both hospitalized and non-hospitalized children. Maximum positivity of the viruses was seen in children less than two years of age.

Women's political participation and health: a health capability study in rural India.

Understanding the relationship between women's political participation and health has eluded researchers and cannot be adequately studied using traditional epidemiological or social scientific methodologies. We employed a health capability framework to understand dimensions of health agency to illuminate how local political economies affect health. Exploiting a cluster-randomized controlled trial of a community-based behavior change management intervention in northern India, we conducted a qualitative study with semistructured, in-depth focus groups in both intervention and nonintervention villages. We presented scenarios to each group regarding the limitations and motivations involved in women's political participation and health. Thematic analysis focused on four domains of health agency -- participation, autonomy, self-efficacy, and health systems -- relevant for understanding the relationship between political participation and health. Elder women demonstrated the greatest sense of self-efficacy and as a group cited the largest number of successful health advocacy efforts. Participation in an associated community-based neonatal intervention had varying effects, showing some differences in self-efficacy, but only rare improvements in participation, autonomy, or health system functioning. Better understanding of cultural norms surrounding autonomy, the local infrastructure and health system, and male and female perceptions of political participation and self-efficacy are needed to improve women's health agency. For a community-based participatory health intervention to improve health capability effectively, explicit strategies focused on health agency should be as central as health indicators.

Using verbal autopsy to measure causes of death: the comparative performance of existing methods.

BACKGROUND: Monitoring progress with disease and injury reduction in many populations will require widespread use of verbal autopsy (VA). Multiple methods have been developed for assigning cause of death from a VA but their application is restricted by uncertainty about their reliability. METHODS: We investigated the validity of five automated VA methods for assigning cause of death: InterVA-4, Random Forest (RF), Simplified Symptom Pattern (SSP), Tariff method (Tariff), and King-Lu (KL), in addition to physician review of VA forms (PCVA), based on 12,535 cases from diverse populations for which the true cause of death had been reliably established. For adults, children, neonates and stillbirths, performance was assessed separately for individuals using sensitivity, specificity, Kappa, and chance-corrected concordance (CCC) and for populations using cause specific mortality fraction (CSMF) accuracy, with and without additional diagnostic information from prior contact with health services. A total of 500 train-test splits were used to ensure that results are robust to variation in the underlying cause of death distribution. RESULTS: Three automated diagnostic methods, Tariff, SSP, and RF, but not InterVA-4, performed better than physician review in all age groups, study sites, and for the majority of causes of death studied. For adults, CSMF accuracy ranged from 0.764 to 0.770, compared with 0.680 for PCVA and 0.625 for InterVA; CCC varied from 49.2% to 54.1%, compared with 42.2% for PCVA, and 23.8% for InterVA. For children, CSMF accuracy was 0.783 for Tariff, 0.678 for PCVA, and 0.520 for InterVA; CCC was 52.5% for Tariff, 44.5% for PCVA, and 30.3% for InterVA. For neonates, CSMF accuracy was 0.817 for Tariff, 0.719 for PCVA, and 0.629 for InterVA; CCC varied from 47.3% to 50.3% for the three automated methods, 29.3% for PCVA, and 19.4% for InterVA. The method with the highest sensitivity for a specific cause varied by cause. CONCLUSIONS: Physician review of verbal autopsy questionnaires is less accurate than automated methods in determining both individual and population causes of death. Overall, Tariff performs as well or better than other methods and should be widely applied in routine mortality surveillance systems with poor cause of death certification practices.

Are albumin and total lymphocyte count significant and reliable predictors of mortality in fractured neck of femur patients?

Hip fractures are a significant cause of mortality and morbidity in the elderly. It is important to identify factors that predict an increased mortality following hip fracture. The aim of this study was to identify significant predictors of mortality at 6 and 12 months following hip fractures. Three hundred patients above the age of 65 were identified who were admitted in to the hospital with fracture neck of femur. Two hundred and seventy-four patients were operated and were included into the study. Variables collected were age, gender, significant comorbidities, admission albumin level and admission total lymphocyte count (TLC). Admission time and subsequent time to surgery were also analysed. Our study showed that albumin and TLC were found to be the only clearly significant mortality predictors at 12 months and a delay of up to 4 days to surgery does not significantly increase the mortality at 12 months.

Arrhenius law for interacting diffusive systems.

Finding the mean time it takes for a particle to escape from a metastable state due to thermal fluctuations is a fundamental problem in physics, chemistry, and biology. Here, we consider the escape rate of interacting diffusive particles, from a deep potential trap within the framework of the macroscopic fluctuation theory-a nonequilibrium hydrodynamic theory. For systems without excluded volume, our investigation reveals adherence to the well-established Arrhenius law. However, in the presence of excluded volume, a universality class emerges, fundamentally altering the escape rate. Remarkably, the modified escape rate within this universality class is independent of the interactions at play. The universality class, demonstrating the importance of excluded volume effects, may bring insights to the interpretation of escape processes in the realm of chemical physics.

Prospective multi-centre sentinel surveillance for Haemophilus influenzae type b & other bacterial meningitis in Indian children.

BACKGROUND & OBJECTIVES: Haemophilus influenzae type b (Hib) is one of the leading bacterial causes of invasive disease in populations without access to Hib conjugate vaccines (Hib-CV). India has recently decided to introduce Hib-CV into the routine immunization programme in selected States. Longitudinal data quantifying the burden of bacterial meningitis and the proportion of disease caused by various bacteria are needed to track the impact of Hib-CV once introduced. A hospital-based sentinel surveillance network was established at four places in the country and this study reports the results of this ongoing surveillance. METHODS: Children aged 1 to 23 months with suspected bacterial meningitis were enrolled in Chennai, Lucknow, New Delhi, and Vellore between July 2008 and June 2010. All cerebrospinal fluid (CSF) samples were tested using cytological, biochemical, and culture methods. Samples with abnormal CSF (≥10 WBC per µl) were tested by latex agglutination test for common paediatric bacterial meningitis pathogens. RESULTS: A total of 708 patients with abnormal CSF were identified, 89 of whom had a bacterial pathogen confirmed. Hib accounted for the majority of bacteriologically confirmed cases, 62 (70%), while Streptococcus pneumoniae and group B Streptococcus were identified in 12 (13%) and seven (8%) cases, respectively. The other eight cases were a mix of other bacteria. The proportion of abnormal CSF and probable bacterial meningitis that was caused by Hib was 74 and 58 per cent lower at Christian Medical College (CMC), Vellore, which had a 41 per cent coverage of Hib-CV among all suspected meningitis cases, compared to the combined average proportion at the other three centres where a coverage between 1 and 8 per cent was seen (P<0.001 and P= 0.05, respectively). INTERPRETATION & CONCLUSIONS: Hib was found to be the predominant cause of bacterial meningitis in young children in diverse geographic locations in India. Possible indications of herd immunity was seen at CMC compared to sites with low immunization coverage with Hib-CV. As Hib is the most common pathogen in bacterial meningitis, Hib-CV would have a large impact on bacterial meningitis in Indian children.

Impact of community-based behaviour-change management on perceived neonatal morbidity: a cluster-randomized controlled trial in Shivgarh, Uttar Pradesh, India.

In the context of high neonatal mortality rate (NMR) in developing country settings, a promising strategy for enhancing newborn health is promotion of preventive newborn care practices. We measured the effect of a behaviour-change intervention on perceived neonatal illnesses in rural Uttar Pradesh, India. The study was nested in a cluster-randomized controlled trial of the impact of a package of essential newborn care on NMR. We prospectively enrolled 802 mothers and administered a questionnaire on perceived neonatal morbidities. Regression analysis showed that newborns in the intervention clusters had significantly lower risk of perceived diarrhoea [adjusted relative risk (aRR) 0.67, 95% confidence interval (CI) 0.49-0.90] and skin-related complications [aRR 0.67, 95% CI 0.45-1.00] compared to newborns in the comparison area. Assuming incidence of perceived illnesses is a proxy for actual morbidity rates, we conclude that promotion of preventive care practices through behaviour-change interventions was effective in reducing neonatal morbidities.

Advancing quality and safety of perinatal services in India: opportunities for effective midwifery integration.

India has made significant progress in improving maternal and child health. However, there are persistent disparities in maternal and child morbidity and mortality in many communities. Mistreatment of women in childbirth and gender-based violence are common and reduce women's sense of safety. Recently, the Government of India committed to establishing a specialized midwifery cadre: Nurse Practitioners in Midwifery (NPMs). Integration of NPMs into the current health system has the potential to increase respectful maternity care, reduce unnecessary interventions, and improve resource allocation, ultimately improving maternal-newborn outcomes. To synthesize the evidence on effective midwifery integration, we conducted a desk review of peer-reviewed articles, reports and regulatory documents describing models of practice, organization of health services and lessons learned from other countries. We also interviewed key informants in India who described the current state of the healthcare system, opportunities, and anticipated challenges to establishing a new cadre of midwives. Using an intersectional feminist theoretical framework, we triangulated the findings from the desk review with interview data to identify levers for change and recommendations. Findings from the desk review highlight that benefits of midwifery on outcomes and experience link to models of midwifery care, and limited scope of practice and prohibitive practice settings are threats to successful integration. Interviews with key informants affirm the importance of meeting global standards for practice, education, inter-professional collaboration and midwifery leadership. Key informants noted that the expansion of respectful maternity care and improved outcomes will depend on the scope and model of practice for the cadre. Domains needing attention include building professional identity; creating a robust, sustainable education system; addressing existing inter-professional issues and strengthening referral and quality monitoring systems. Public and professional education on midwifery roles and scope of practice, improved regulatory conditions and enabling practice environments will be key to successful integration of midwives in India.

Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial.

BACKGROUND: Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very-preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking. OBJECTIVES: We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at the population level. METHODS: We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis. RESULTS: We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight, by 0.94 g · kg-1 · d-1 (95% CI: 0.07, 1.82 g · kg-1 · d-1, P = 0.03), than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g · kg-1 · d-1) occurred in infants weighing <2000 g at birth. Weight gain in intervention infants was higher by 1.31 g · kg-1 · d-1 (95% CI: 0.17, 2.46 g · kg-1 · d-1; P = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% (OR: 0.64; 95% CI: 0.44, 0.94; P = 0.02) and 44% (OR: 0.56; 95% CI: 0.40, 0.77; P < 0.001), respectively, in treated infants. CONCLUSIONS: SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at the population level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings.This trial was registered at www.isrctn.com as ISRCTN38965585 and http://ctri.nic.in as CTRI/2014/12/005282.

Population Health Metrics Research Consortium gold standard verbal autopsy validation study: design, implementation, and development of analysis datasets.

BACKGROUND: Verbal autopsy methods are critically important for evaluating the leading causes of death in populations without adequate vital registration systems. With a myriad of analytical and data collection approaches, it is essential to create a high quality validation dataset from different populations to evaluate comparative method performance and make recommendations for future verbal autopsy implementation. This study was undertaken to compile a set of strictly defined gold standard deaths for which verbal autopsies were collected to validate the accuracy of different methods of verbal autopsy cause of death assignment. METHODS: Data collection was implemented in six sites in four countries: Andhra Pradesh, India; Bohol, Philippines; Dar es Salaam, Tanzania; Mexico City, Mexico; Pemba Island, Tanzania; and Uttar Pradesh, India. The Population Health Metrics Research Consortium (PHMRC) developed stringent diagnostic criteria including laboratory, pathology, and medical imaging findings to identify gold standard deaths in health facilities as well as an enhanced verbal autopsy instrument based on World Health Organization (WHO) standards. A cause list was constructed based on the WHO Global Burden of Disease estimates of the leading causes of death, potential to identify unique signs and symptoms, and the likely existence of sufficient medical technology to ascertain gold standard cases. Blinded verbal autopsies were collected on all gold standard deaths. RESULTS: Over 12,000 verbal autopsies on deaths with gold standard diagnoses were collected (7,836 adults, 2,075 children, 1,629 neonates, and 1,002 stillbirths). Difficulties in finding sufficient cases to meet gold standard criteria as well as problems with misclassification for certain causes meant that the target list of causes for analysis was reduced to 34 for adults, 21 for children, and 10 for neonates, excluding stillbirths. To ensure strict independence for the validation of methods and assessment of comparative performance, 500 test-train datasets were created from the universe of cases, covering a range of cause-specific compositions. CONCLUSIONS: This unique, robust validation dataset will allow scholars to evaluate the performance of different verbal autopsy analytic methods as well as instrument design. This dataset can be used to inform the implementation of verbal autopsies to more reliably ascertain cause of death in national health information systems.