Measuring coverage and quality of supportive care for inpatient neonatal infections: EN-BIRTH multi-country validation study.

Background: An estimated 7 million episodes of severe newborn infections occur annually worldwide, with half a million newborn deaths, most occurring in low- and middle-income countries. Whilst injectable antibiotics are necessary to treat the infection, supportive care is also crucial in ending preventable mortality and morbidity. This study uses multi-country data to assess gaps in coverage, quality, and documentation of supportive care, considering implications for measurement. Methods: The EN-BIRTH study was conducted in five hospitals in Bangladesh, Nepal, and Tanzania (July 2017-July 2018). Newborns with an admission diagnosis of clinically-defined infection (sepsis, meningitis, and/or pneumonia) were included. Researchers extracted data from inpatient case notes and interviews with women (usually the mothers) as the primary family caretakers after discharge. The interviews were conducted using a structured survey questionnaire. We used descriptive statistics to report coverage of newborn supportive care components such as oxygen use, phototherapy, and appropriate feeding, and we assessed the validity of measurement through survey-reports using a random-effects model to generate pooled estimates. In this study, key supportive care components were assessment and correction of hypoxaemia, hyperbilirubinemia, and hypoglycaemia. Results: Among 1015 neonates who met the inclusion criteria, 89% had an admission clinical diagnosis of sepsis. Major gaps in documentation and care practices related to supportive care varied substantially across the participating hospitals. The pooled sensitivity was low for the survey-reported oxygen use (47%; 95% confidence interval (CI) = 30%-64%) and moderate for phototherapy (60%; 95% CI = 44%-75%). The pooled specificity was high for both the survey-reported oxygen use (85%; 95% CI = 80%-89%) and phototherapy (91%; 95% CI = 82%-97%). Conclusions: The women's reports during the exit survey consistently underestimated the coverage of supportive care components for managing infection. We have observed high variability in the inpatient documents across facilities. A standardised ward register for inpatient small and sick newborn care may capture selected supportive care data. However, tracking the detailed care will require standardised individual-level data sets linked to newborn case notes. We recommend investments in assessing the implementation aspects of a standardised inpatient register in resource-poor settings.

Birthweight: EN-BIRTH multi-country validation study.

BACKGROUND: Accurate birthweight is critical to inform clinical care at the individual level and tracking progress towards national/global targets at the population level. Low birthweight (LBW) < 2500 g affects over 20.5 million newborns annually. However, data are lacking and may be affected by heaping. This paper evaluates birthweight measurement within the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania (2017-2018). Clinical observers collected time-stamped data (gold standard) for weighing at birth. We compared accuracy for two data sources: routine hospital registers and women's report at exit interview survey. We calculated absolute differences and individual-level validation metrics. We analysed birthweight coverage and quality gaps including timing and heaping. Qualitative data explored barriers and enablers for routine register data recording. RESULTS: Among 23,471 observed births, 98.8% were weighed. Exit interview survey-reported weighing coverage was 94.3% (90.2-97.3%), sensitivity 95.0% (91.3-97.8%). Register-reported coverage was 96.6% (93.2-98.9%), sensitivity 97.1% (94.3-99%). Routine registers were complete (> 98% for four hospitals) and legible > 99.9%. Weighing of stillbirths varied by hospital, ranging from 12.5-89.0%. Observed LBW rate was 15.6%; survey-reported rate 14.3% (8.9-20.9%), sensitivity 82.9% (75.1-89.4%), specificity 96.1% (93.5-98.5%); register-recorded rate 14.9%, sensitivity 90.8% (85.9-94.8%), specificity 98.5% (98-99.0%). In surveys, "don't know" responses for birthweight measured were 4.7%, and 2.9% for knowing the actual weight. 95.9% of observed babies were weighed within 1 h of birth, only 14.7% with a digital scale. Weight heaping indices were around two-fold lower using digital scales compared to analogue. Observed heaping was almost 5% higher for births during the night than day. Survey-report further increased observed birthweight heaping, especially for LBW babies. Enablers to register birthweight measurement in qualitative interviews included digital scale availability and adequate staffing. CONCLUSIONS: Hospital registers captured birthweight and LBW prevalence more accurately than women's survey report. Even in large hospitals, digital scales were not always available and stillborn babies not always weighed. Birthweight data are being captured in hospitals and investment is required to further improve data quality, researching of data flow in routine systems and use of data at every level.

Stillbirths including intrapartum timing: EN-BIRTH multi-country validation study.

BACKGROUND: An estimated >2 million babies stillborn around the world each year lack visibility. Low- and middle-income countries carry 84% of the burden yet have the least data. Most births are now in facilities, hence routine register-recording presents an opportunity to improve counting of stillbirths, but research is limited, particularly regarding accuracy. This paper evaluates register-recorded measurement of hospital stillbirths, classification accuracy, and barriers and enablers to routine recording. METHODS: The EN-BIRTH mixed-methods, observational study took place in five hospitals in Bangladesh, Nepal and Tanzania (2017-2018). Clinical observers collected time-stamped data on perinatal care and birth outcomes as gold standard. To assess accuracy of routine register-recorded stillbirth rates, we compared birth outcomes recorded in labour ward registers to observation data. We calculated absolute rate differences and individual-level validation metrics (sensitivity, specificity, percent agreement). We assessed misclassification of stillbirths with neonatal deaths. To examine stillbirth appearance (fresh/macerated) as a proxy for timing of death, we compared appearance to observed timing of intrauterine death based on heart rate at admission. RESULTS: 23,072 births were observed including 550 stillbirths. Register-recorded completeness of birth outcomes was > 90%. The observed study stillbirth rate ranged from 3.8 (95%CI = 2.0,7.0) to 50.3 (95%CI = 43.6,58.0)/1000 total births and was under-estimated in routine registers by 1.1 to 7.3 /1000 total births (register: observed ratio 0.9-0.7). Specificity of register-recorded birth outcomes was > 99% and sensitivity varied between hospitals, ranging from 77.7-86.1%. Percent agreement between observer-assessed birth outcome and register-recorded birth outcome was very high across all hospitals and all modes of birth (> 98%). Fresh or macerated stillbirth appearance was a poor proxy for timing of stillbirth. While there were similar numbers of stillbirths misclassified as neonatal deaths (17/430) and neonatal deaths misclassified as stillbirths (21/36), neonatal deaths were proportionately more likely to be misclassified as stillbirths (58.3% vs 4.0%). Enablers to more accurate register-recording of birth outcome included supervision and data use. CONCLUSIONS: Our results show these routine registers accurately recorded stillbirths. Fresh/macerated appearance was a poor proxy for intrapartum stillbirths, hence more focus on measuring fetal heart rate is crucial to classification and importantly reduction in these preventable deaths.

Immediate newborn care and breastfeeding: EN-BIRTH multi-country validation study.

BACKGROUND: Immediate newborn care (INC) practices, notably early initiation of breastfeeding (EIBF), are fundamental for newborn health. However, coverage tracking currently relies on household survey data in many settings. "Every Newborn Birth Indicators Research Tracking in Hospitals" (EN-BIRTH) was an observational study validating selected maternal and newborn health indicators. This paper reports results for EIBF. METHODS: The EN-BIRTH study was conducted in five public hospitals in Bangladesh, Nepal, and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data on EIBF and INC practices (skin-to-skin within 1 h of birth, drying, and delayed cord clamping). To assess validity of EIBF measurement, we compared observation as gold standard to register records and women's exit-interview survey reports. Percent agreement was used to assess agreement between EIBF and INC practices. Kaplan Meier survival curves showed timing. Qualitative interviews were conducted to explore barriers/enablers to register recording. RESULTS: Coverage of EIBF among 7802 newborns observed for ≥1 h was low (10.9, 95% CI 3.8-21.0). Survey-reported (53.2, 95% CI 39.4-66.8) and register-recorded results (85.9, 95% CI 58.1-99.6) overestimated coverage compared to observed levels across all hospitals. Registers did not capture other INC practices apart from breastfeeding. Agreement of EIBF with other INC practices was high for skin-to-skin (69.5-93.9%) at four sites, but fair/poor for delayed cord-clamping (47.3-73.5%) and drying (7.3-29.0%). EIBF and skin-to-skin were the most delayed and EIBF rarely happened after caesarean section (0.5-3.6%). Qualitative findings suggested that focusing on accuracy, as well as completeness, contributes to higher quality with register reporting. CONCLUSIONS: Our study highlights the importance of tracking EIBF despite measurement challenges and found low coverage levels, particularly after caesarean births. Both survey-reported and register-recorded data over-estimated coverage. EIBF had a strong agreement with skin-to-skin but is not a simple tracer for other INC indicators. Other INC practices are challenging to measure in surveys, not included in registers, and are likely to require special studies or audits. Continued focus on EIBF is crucial to inform efforts to improve provider practices and increase coverage. Investment and innovation are required to improve measurement.

Antibiotic use for inpatient newborn care with suspected infection: EN-BIRTH multi-country validation study.

BACKGROUND: An estimated 30 million neonates require inpatient care annually, many with life-threatening infections. Appropriate antibiotic management is crucial, yet there is no routine measurement of coverage. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aimed to validate maternal and newborn indicators to inform measurement of coverage and quality of care. This paper reports validation of reported antibiotic coverage by exit survey of mothers for hospitalized newborns with clinically-defined infections, including sepsis, meningitis, and pneumonia. METHODS: EN-BIRTH study was conducted in five hospitals in Bangladesh, Nepal, and Tanzania (July 2017-July 2018). Neonates were included based on case definitions to focus on term/near-term, clinically-defined infection syndromes (sepsis, meningitis, and pneumonia), excluding major congenital abnormalities. Clinical management was abstracted from hospital inpatient case notes (verification) which was considered as the gold standard against which to validate accuracy of women's report. Exit surveys were conducted using questions similar to The Demographic and Health Surveys (DHS) approach for coverage of childhood pneumonia treatment. We compared survey-report to case note verified, pooled across the five sites using random effects meta-analysis. RESULTS: A total of 1015 inpatient neonates admitted in the five hospitals met inclusion criteria with clinically-defined infection syndromes. According to case note verification, 96.7% received an injectable antibiotic, although only 14.5% of them received the recommended course of at least 7 days. Among women surveyed (n = 910), 98.8% (95% CI: 97.8-99.5%) correctly reported their baby was admitted to a neonatal ward. Only 47.1% (30.1-64.5%) reported their baby's diagnosis in terms of sepsis, meningitis, or pneumonia. Around three-quarters of women reported their baby received an injection whilst in hospital, but 12.3% reported the correct antibiotic name. Only 10.6% of the babies had a blood culture and less than 1% had a lumbar puncture. CONCLUSIONS: Women's report during exit survey consistently underestimated the denominator (reporting the baby had an infection), and even more so the numerator (reporting known injectable antibiotics). Admission to the neonatal ward was accurately reported and may have potential as a contact point indicator for use in household surveys, similar to institutional births. Strengthening capacity and use of laboratory diagnostics including blood culture are essential to promote appropriate use of antibiotics. To track quality of neonatal infection management, we recommend using inpatient records to measure specifics, requiring more research on standardised inpatient records.

Chlorhexidine for facility-based umbilical cord care: EN-BIRTH multi-country validation study.

BACKGROUND: Umbilical cord hygiene prevents sepsis, a leading cause of neonatal mortality. The World Health Organization recommends 7.1% chlorhexidine digluconate (CHX) application to the umbilicus after home birth in high mortality contexts. In Bangladesh and Nepal, national policies recommend CHX use for all facility births. Population-based household surveys include optional questions on CHX use, but indicator validation studies are lacking. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study assessing measurement validity for maternal and newborn indicators. This paper reports results regarding CHX. METHODS: The EN-BIRTH study (July 2017-July 2018) included three public hospitals in Bangladesh and Nepal where CHX cord application is routine. Clinical-observers collected tablet-based, time-stamped data regarding cord care during admission to labour and delivery wards as the gold standard to assess accuracy of women's report at exit survey, and of routine-register data. We calculated validity ratios and individual-level validation metrics; analysed coverage, quality and measurement gaps. We conducted qualitative interviews to assess barriers and enablers to routine register-recording. RESULTS: Umbilical cord care was observed for 12,379 live births. Observer-assessed CHX coverage was very high at 89.3-99.4% in all 3 hospitals, although slightly lower after caesarean births in Azimpur (86.8%), Bangladesh. Exit survey-reported coverage (0.4-45.9%) underestimated the observed coverage with substantial "don't know" responses (55.5-79.4%). Survey-reported validity ratios were all poor (0.01 to 0.38). Register-recorded coverage in the specific column in Bangladesh was underestimated by 0.2% in Kushtia but overestimated by 9.0% in Azimpur. Register-recorded validity ratios were good (0.9 to 1.1) in Bangladesh, and poor (0.8) in Nepal. The non-specific register column in Pokhara, Nepal substantially underestimated coverage (20.7%). CONCLUSIONS: Exit survey-report highly underestimated observed CHX coverage in all three hospitals. Routine register-recorded coverage was closer to observer-assessed coverage than survey reports in all hospitals, including for caesarean births, and was more accurately captured in hospitals with a specific register column. Inclusion of CHX cord care into registers, and tallied into health management information system platforms, is justified in countries with national policies for facility-based use, but requires implementation research to assess register design and data flow within health information systems.

Kangaroo mother care: EN-BIRTH multi-country validation study.

BACKGROUND: Kangaroo mother care (KMC) reduces mortality among stable neonates ≤2000 g. Lack of data tracking coverage and quality of KMC in both surveys and routine information systems impedes scale-up. This paper evaluates KMC measurement as part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: The EN-BIRTH observational mixed-methods study was conducted in five hospitals in Bangladesh, Nepal and Tanzania from 2017 to 2018. Clinical observers collected time-stamped data as gold standard for mother-baby pairs in KMC wards/corners. To assess accuracy, we compared routine register-recorded and women's exit survey-reported coverage to observed data, using different recommended denominator options (≤2000 g and ≤ 2499 g). We analysed gaps in quality of provision and experience of KMC. In the Tanzanian hospitals, we assessed daily skin-to-skin duration/dose and feeding frequency. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine register design, filling and use. RESULTS: Among 840 mother-baby pairs, compared to observed 100% coverage, both exit-survey reported (99.9%) and register-recorded coverage (92.9%) were highly valid measures with high sensitivity. KMC specific registers outperformed general registers. Enablers to register recording included perceptions of data usefulness, while barriers included duplication of data elements and overburdened health workers. Gaps in KMC quality were identified for position components including wearing a hat. In Temeke Tanzania, 10.6% of babies received daily KMC skin-to-skin duration/dose of ≥20 h and a further 75.3% received 12-19 h. Regular feeding ≥8 times/day was observed for 36.5% babies in Temeke Tanzania and 14.6% in Muhimbili Tanzania. Cup-feeding was the predominant assisted feeding method. Family support during admission was variable, grandmothers co-provided KMC more often in Bangladesh. No facility arrangements for other family members were reported by 45% of women at exit survey. CONCLUSIONS: Routine hospital KMC register data have potential to track coverage from hospital KMC wards/corners. Women accurately reported KMC at exit survey and evaluation for population-based surveys could be considered. Measurement of content, quality and experience of KMC need consensus on definitions. Prioritising further KMC measurement research is important so that high quality data can be used to accelerate scale-up of high impact care for the most vulnerable.

Electronic data collection for multi-country, hospital-based, clinical observation of maternal and newborn care: EN-BIRTH study experiences.

BACKGROUND: Observation of care at birth is challenging with multiple, rapid and potentially concurrent events occurring for mother, newborn and placenta. Design of electronic data (E-data) collection needs to account for these challenges. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study to assess measurement of indicators for priority maternal and newborn interventions and took place in five hospitals in Bangladesh, Nepal and Tanzania (July 2017-July 2018). E-data tools were required to capture individually-linked, timed observation of care, data extraction from hospital register-records or case-notes, and exit-survey data from women. METHODS: To evaluate this process for EN-BIRTH, we employed a framework organised around five steps for E-data design, data collection and implementation. Using this framework, a mixed methods evaluation synthesised evidence from study documentation, standard operating procedures, stakeholder meetings and design workshops. We undertook focus group discussions with EN-BIRTH researchers to explore experiences from the three different country teams (November-December 2019). Results were organised according to the five a priori steps. RESULTS: In accordance with the five-step framework, we found: 1) Selection of data collection approach and software: user-centred design principles were applied to meet the challenges for observation of rapid, concurrent events around the time of birth with time-stamping. 2) Design of data collection tools and programming: required extensive pilot testing of tools to be user-focused and to include in-built error messages and data quality alerts. 3) Recruitment and training of data collectors: standardised with an interactive training package including pre/post-course assessment. 4) Data collection, quality assurance, and management: real-time quality assessments with a tracking dashboard and double observation/data extraction for a 5% case subset, were incorporated as part of quality assurance. Internet-based synchronisation during data collection posed intermittent challenges. 5) Data management, cleaning and analysis: E-data collection was perceived to improve data quality and reduce time cleaning. CONCLUSIONS: The E-Data system, custom-built for EN-BIRTH, was valued by the site teams, particularly for time-stamped clinical observation of complex multiple simultaneous events at birth, without which the study objectives could not have been met. However before selection of a custom-built E-data tool, the development time, higher training and IT support needs, and connectivity challenges need to be considered against the proposed study or programme's purpose, and currently available E-data tool options.

Survey of women's report for 33 maternal and newborn indicators: EN-BIRTH multi-country validation study.

BACKGROUND: Population-based household surveys, notably the Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys (MICS), remain the main source of maternal and newborn health data for many low- and middle-income countries. As part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study, this paper focuses on testing validity of measurement of maternal and newborn indicators around the time of birth (intrapartum and postnatal) in survey-report. METHODS: EN-BIRTH was an observational study testing the validity of measurement for selected maternal and newborn indicators in five secondary/tertiary hospitals in Bangladesh, Nepal and Tanzania, conducted from July 2017 to July 2018. We compared women's report at exit survey with the gold standard of direct observation or verification from clinical records for women with vaginal births. Population-level validity was assessed by validity ratios (survey-reported coverage: observer-assessed coverage). Individual-level accuracy was assessed by sensitivity, specificity and percent agreement. We tested indicators already in DHS/MICS as well as indicators with potential to be included in population-based surveys, notably the first validation for small and sick newborn care indicators. RESULTS: 33 maternal and newborn indicators were evaluated. Amongst nine indicators already present in DHS/MICS, validity ratios for baby dried or wiped, birthweight measured, low birthweight, and sex of baby (female) were between 0.90-1.10. Instrumental birth, skin-to-skin contact, and early initiation of breastfeeding were highly overestimated by survey-report (2.04-4.83) while umbilical cord care indicators were massively underestimated (0.14-0.22). Amongst 24 indicators not currently in DHS/MICS, two newborn contact indicators (kangaroo mother care 1.00, admission to neonatal unit 1.01) had high survey-reported coverage amongst admitted newborns and high sensitivity. The remaining indicators did not perform well and some had very high "don't know" responses. CONCLUSIONS: Our study revealed low validity for collecting many maternal and newborn indicators through an exit survey instrument, even with short recall periods among women with vaginal births. Household surveys are already at risk of overload, and some specific clinical care indicators do not perform well and may be under-powered. Given that approximately 80% of births worldwide occur in facilities, routine registers should also be explored to track coverage of key maternal and newborn health interventions, particularly for clinical care.

Counting on birth registration: mixed-methods research in two EN-BIRTH study hospitals in Tanzania.

BACKGROUND: Birth registration marks a child's right to identity and is the first step to establishing citizenship and access to services. At the population level, birth registration data can inform effective programming and planning. In Tanzania, almost two-thirds of births are in health facilities, yet only 26% of children under 5 years have their births registered. Our mixed-methods research explores the gap between hospital birth and birth registration in Dar es Salaam, Tanzania. METHODS: The study was conducted in the two Tanzanian hospital sites of the Every Newborn-Birth Indicators Research Tracking in Hospitals (EN-BIRTH) multi-country study (July 2017-2018). We described the business processes for birth notification and registration and collected quantitative data from women's exit surveys after giving birth (n = 8038). We conducted in-depth interviews (n = 21) to identify barriers and enablers to birth registration among four groups of participants: women who recently gave birth, women waiting for a birth certificate at Temeke Hospital, hospital employees, and stakeholders involved in the national birth registration process. We synthesized findings to identify opportunities to improve birth registration. RESULTS: Standard national birth registration procedures were followed at Muhimbili Hospital; families received birth notification and were advised to obtain a birth certificate from the Registration, Insolvency, and Trusteeship Agency (RITA) after 2 months, for a fee. A pilot programme to improve birth registration coverage included Temeke Hospital; hand-written birth certificates were issued free of charge on a return hospital visit after 42 days. Among 2500 women exit-surveyed at Muhimbili Hospital, 96.3% reported receiving a birth notification form and nearly half misunderstood this to be a birth certificate. Of the 5538 women interviewed at Temeke Hospital, 33.0% reported receiving any documentation confirming the birth of their child. In-depth interview respondents perceived birth registration to be important but considered both the standard and pilot processes in Tanzania complex, burdensome and costly to both families and health workers. CONCLUSION: Birth registration coverage in Tanzania could be improved by further streamlining between health facilities, where most babies are born, and the civil registry. Families and health workers need support to navigate processes to register every child.

Neonatal resuscitation: EN-BIRTH multi-country validation study.

BACKGROUND: Annually, 14 million newborns require stimulation to initiate breathing at birth and 6 million require bag-mask-ventilation (BMV). Many countries have invested in facility-based neonatal resuscitation equipment and training. However, there is no consistent tracking for neonatal resuscitation coverage. METHODS: The EN-BIRTH study, in five hospitals in Bangladesh, Nepal, and Tanzania (2017-2018), collected time-stamped data for care around birth, including neonatal resuscitation. Researchers surveyed women and extracted data from routine labour ward registers. To assess accuracy, we compared gold standard observed coverage to survey-reported and register-recorded coverage, using absolute difference, validity ratios, and individual-level validation metrics (sensitivity, specificity, percent agreement). We analysed two resuscitation numerators (stimulation, BMV) and three denominators (live births and fresh stillbirths, non-crying, non-breathing). We also examined timeliness of BMV. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine recording of resuscitation. RESULTS: Among 22,752 observed births, 5330 (23.4%) babies did not cry and 3860 (17.0%) did not breathe in the first minute after birth. 16.2% (n = 3688) of babies were stimulated and 4.4% (n = 998) received BMV. Survey-report underestimated coverage of stimulation and BMV. Four of five labour ward registers captured resuscitation numerators. Stimulation had variable accuracy (sensitivity 7.5-40.8%, specificity 66.8-99.5%), BMV accuracy was higher (sensitivity 12.4-48.4%, specificity > 93%), with small absolute differences between observed and recorded BMV. Accuracy did not vary by denominator option. < 1% of BMV was initiated within 1 min of birth. Enablers to register recording included training and data use while barriers included register design, documentation burden, and time pressure. CONCLUSIONS: Population-based surveys are unlikely to be useful for measuring resuscitation coverage given low validity of exit-survey report. Routine labour ward registers have potential to accurately capture BMV as the numerator. Measuring the true denominator for clinical need is complex; newborns may require BMV if breathing ineffectively or experiencing apnoea after initial drying/stimulation or subsequently at any time. Further denominator research is required to evaluate non-crying as a potential alternative in the context of respectful care. Measuring quality gaps, notably timely provision of resuscitation, is crucial for programme improvement and impact, but unlikely to be feasible in routine systems, requiring audits and special studies.

Barriers and enablers to routine register data collection for newborns and mothers: EN-BIRTH multi-country validation study.

BACKGROUND: Policymakers need regular high-quality coverage data on care around the time of birth to accelerate progress for ending preventable maternal and newborn deaths and stillbirths. With increasing facility births, routine Health Management Information System (HMIS) data have potential to track coverage. Identifying barriers and enablers faced by frontline health workers recording HMIS source data in registers is important to improve data for use. METHODS: The EN-BIRTH study was a mixed-methods observational study in five hospitals in Bangladesh, Nepal and Tanzania to assess measurement validity for selected Every Newborn coverage indicators. We described data elements required in labour ward registers to track these indicators. To evaluate barriers and enablers for correct recording of data in registers, we designed three interview tools: a) semi-structured in-depth interview (IDI) guide b) semi-structured focus group discussion (FGD) guide, and c) checklist assessing care-to-documentation. We interviewed two groups of respondents (January 2018-March 2019): hospital nurse-midwives and doctors who fill ward registers after birth (n = 40 IDI and n = 5 FGD); and data collectors (n = 65). Qualitative data were analysed thematically by categorising pre-identified codes. Common emerging themes of barriers or enablers across all five hospitals were identified relating to three conceptual framework categories. RESULTS: Similar themes emerged as both barriers and enablers. First, register design was recognised as crucial, yet perceived as complex, and not always standardised for necessary data elements. Second, register filling was performed by over-stretched nurse-midwives with variable training, limited supervision, and availability of logistical resources. Documentation complexity across parallel documents was time-consuming and delayed because of low staff numbers. Complete data were valued more than correct data. Third, use of register data included clinical handover and monthly reporting, but little feedback was given from data users. CONCLUSION: Health workers invest major time recording register data for maternal and newborn core health indicators. Improving data quality requires standardised register designs streamlined to capture only necessary data elements. Consistent implementation processes are also needed. Two-way feedback between HMIS levels is critical to improve performance and accurately track progress towards agreed health goals.

Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of preventable maternal mortality worldwide. The World Health Organization (WHO) recommends uterotonic administration for every woman after birth to prevent PPH. There are no standardised data collected in large-scale measurement platforms. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) is an observational study to assess the validity of measurement of maternal and newborn indicators, and this paper reports findings regarding measurement of coverage and quality for uterotonics. METHODS: The EN-BIRTH study took place in five hospitals in Bangladesh, Nepal and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data. We compared observation data for uterotonics to routine hospital register-records and women's report at exit-interview survey. We analysed the coverage and quality gap for timing and dose of administration. The register design was evaluated against gap analyses and qualitative interview data assessing the barriers and enablers to data recording and use. RESULTS: Observed uterotonic coverage was high in all five hospitals (> 99%, 95% CI 98.7-99.8%). Survey-report underestimated coverage (79.5 to 91.7%). "Don't know" replies varied (2.1 to 14.4%) and were higher after caesarean (3.7 to 59.3%). Overall, there was low accuracy in survey data for details of uterotonic administration (type and timing). Register-recorded coverage varied in four hospitals capturing uterotonics in a specific column (21.6, 64.5, 97.6, 99.4%). The average coverage measurement gap was 18.1% for register-recorded and 6.0% for survey-reported coverage. Uterotonics were given to 15.9% of women within the "right time" (1 min) and 69.8% within 3 min. Women's report of knowing the purpose of uterotonics after birth ranged from 0.4 to 64.9% between hospitals. Enabling register design and adequate staffing were reported to improve routine recording. CONCLUSIONS: Routine registers have potential to track uterotonic coverage - register data were highly accurate in two EN-BIRTH hospitals, compared to consistently underestimated coverage by survey-report. Although uterotonic coverage was high, there were gaps in observed quality for timing and dose. Standardisation of register design and implementation could improve data quality and data flow from registers into health management information reporting systems, and requires further assessment.

Respectful maternal and newborn care: measurement in one EN-BIRTH study hospital in Nepal.

BACKGROUND: Respectful maternal and newborn care (RMNC) is an important component of high-quality care but progress is impeded by critical measurement gaps for women and newborns. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study was an observational study with mixed methods assessing measurement validity for coverage and quality of maternal and newborn indicators. This paper reports results regarding the measurement of respectful care for women and newborns. METHODS: At one EN-BIRTH study site in Pokhara, Nepal, we included additional questions during exit-survey interviews with women about their experiences (July 2017-July 2018). The questionnaire was based on seven mistreatment typologies: Physical; Sexual; or Verbal abuse; Stigma/discrimination; Failure to meet professional standards of care; Poor rapport between women and providers; and Health care denied due to inability to pay. We calculated associations between these typologies and potential determinants of health - ethnicity, age, sex, mode of birth - as possible predictors for reporting poor care. RESULTS: Among 4296 women interviewed, none reported physical, sexual, or verbal abuse. 15.7% of women were dissatisfied with privacy, and 13.0% of women reported their birth experience did not meet their religious and cultural needs. In descriptive analysis, adjusted odds ratios and multivariate analysis showed primiparous women were less likely to report respectful care (ß = 0.23, p-value < 0.0001). Women from Madeshi (a disadvantaged ethnic group) were more likely to report poor care (ß = - 0.34; p-value 0.037) than women identifying as Chettri/Brahmin. Women who had caesarean section were less likely to report poor care during childbirth (ß = - 0.42; p-value < 0.0001) than women with a vaginal birth. However, babies born by caesarean had a 98% decrease in the odds (aOR = 0.02, 95% CI, 0.01-0.05) of receiving skin-to-skin contact than those with vaginal births. CONCLUSIONS: Measurement of respectful care at exit interview after hospital birth is challenging, and women generally reported 100% respectful care for themselves and their baby. Specific questions, with stratification by mode of birth, women's age and ethnicity, are important to identify those mistreated during care and to prioritise action. More research is needed to develop evidence-based measures to track experience of care, including zero separation for the mother-newborn pair, and to improve monitoring.

Assessment of the validity of the measurement of newborn and maternal health-care coverage in hospitals (EN-BIRTH): an observational study.

BACKGROUND: Progress in reducing maternal and neonatal deaths and stillbirths is impeded by data gaps, especially regarding coverage and quality of care in hospitals. We aimed to assess the validity of indicators of maternal and newborn health-care coverage around the time of birth in survey data and routine facility register data. METHODS: Every Newborn-BIRTH Indicators Research Tracking in Hospitals was an observational study in five hospitals in Bangladesh, Nepal, and Tanzania. We included women and their newborn babies who consented on admission to hospital. Exclusion critiera at admission were no fetal heartbeat heard or imminent birth. For coverage of uterotonics to prevent post-partum haemorrhage, early initiation of breastfeeding (within 1 h), neonatal bag-mask ventilation, kangaroo mother care (KMC), and antibiotics for clinically defined neonatal infection (sepsis, pneumonia, or meningitis), we collected time-stamped, direct observation or case note verification data as gold standard. We compared data reported via hospital exit surveys and via hospital registers to the gold standard, pooled using random effects meta-analysis. We calculated population-level validity ratios (measured coverage to observed coverage) plus individual-level validity metrics. FINDINGS: We observed 23 471 births and 840 mother-baby KMC pairs, and verified the case notes of 1015 admitted newborn babies regarding antibiotic treatment. Exit-survey-reported coverage for KMC was 99·9% (95% CI 98·3-100) compared with observed coverage of 100% (99·9-100), but exit surveys underestimated coverage for uterotonics (84·7% [79·1-89·5]) vs 99·4% [98·7-99·8] observed), bag-mask ventilation (0·8% [0·4-1·4]) vs 4·4% [1·9-8·1]), and antibiotics for neonatal infection (74·7% [55·3-90·1] vs 96·4% [94·0-98·6] observed). Early breastfeeding coverage was overestimated in exit surveys (53·2% [39·4-66·8) vs 10·9% [3·8-21·0] observed). "Don't know" responses concerning clinical interventions were more common in the exit survey after caesarean birth. Register data underestimated coverage of uterotonics (77·9% [37·8-99·5] vs 99·2% [98·6-99·7] observed), bag-mask ventilation (4·3% [2·1-7·3] vs 5·1% [2·0-9·6] observed), KMC (92·9% [84·2-98·5] vs 100% [99·9-100] observed), and overestimated early breastfeeding (85·9% (58·1-99·6) vs 12·5% [4·6-23·6] observed). Inter-hospital heterogeneity was higher for register-recorded coverage than for exit survey report. Even with the same register design, accuracy varied between hospitals. INTERPRETATION: Coverage indicators for newborn and maternal health care in exit surveys had low accuracy for specific clinical interventions, except for self-report of KMC, which had high sensitivity after admission to a KMC ward or corner and could be considered for further assessment. Hospital register design and completion are less standardised than surveys, resulting in variable data quality, with good validity for the best performing sites. Because approximately 80% of births worldwide take place in facilities, standardising register design and information systems has the potential to sustainably improve the quality of data on care at birth. FUNDING: Children's Investment Fund Foundation and Swedish Research Council.

Labour and delivery ward register data availability, quality, and utility - Every Newborn - birth indicators research tracking in hospitals (EN-BIRTH) study baseline analysis in three countries.

BACKGROUND: Countries with the highest burden of maternal and newborn deaths and stillbirths often have little information on these deaths. Since over 81% of births worldwide now occur in facilities, using routine facility data could reduce this data gap. We assessed the availability, quality, and utility of routine labour and delivery ward register data in five hospitals in Bangladesh, Nepal, and Tanzania. This paper forms the baseline register assessment for the Every Newborn-Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: We extracted 21 data elements from routine hospital labour ward registers, useful to calculate selected maternal and newborn health (MNH) indicators. The study sites were five public hospitals during a one-year period (2016-17). We measured 1) availability: completeness of data elements by register design, 2) data quality: implausibility, internal consistency, and heaping of birthweight and explored 3) utility by calculating selected MNH indicators using the available data. RESULTS: Data were extracted for 20,075 births. Register design was different between the five hospitals with 10-17 of the 21 selected MNH data elements available. More data were available for health outcomes than interventions. Nearly all available data elements were > 95% complete in four of the five hospitals and implausible values were rare. Data elements captured in specific columns were 85.2% highly complete compared to 25.0% captured in non-specific columns. Birthweight data were less complete for stillbirths than live births at two hospitals, and significant heaping was found in all sites, especially at 2500g and 3000g. All five hospitals recorded count data required to calculate impact indicators including; stillbirth rate, low birthweight rate, Caesarean section rate, and mortality rates. CONCLUSIONS: Data needed to calculate MNH indicators are mostly available and highly complete in EN-BIRTH study hospital routine labour ward registers in Bangladesh, Nepal and Tanzania. Register designs need to include interventions for coverage measurement. There is potential to improve data quality if Health Management Information Systems utilization with feedback loops can be strengthened. Routine health facility data could contribute to reduce the coverage and impact data gap around the time of birth.

"Every Newborn-BIRTH" protocol: observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania.

BACKGROUND: To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The Every Newborn - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels. METHODS: EN-BIRTH is an observational study including >20 000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses. CONCLUSIONS: To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.

Saving Lives at Birth; development of a retrospective theory of change, impact framework and prioritised metrics.

BACKGROUND: Grand Challenges for international health and development initiatives have received substantial funding to tackle unsolved problems; however, evidence of their effectiveness in achieving change is lacking. A theory of change may provide a useful tool to track progress towards desired outcomes. The Saving Lives at Birth partnership aims to address inequities in maternal-newborn survival through the provision of strategic investments for the development, testing and transition-to-scale of ground-breaking prevention and treatment approaches with the potential to leapfrog conventional healthcare approaches in low resource settings. We aimed to develop a theory of change and impact framework with prioritised metrics to map the initiative's contribution towards overall goals, and to measure progress towards improved outcomes around the time of birth. METHODS: A theory of change and impact framework was developed retrospectively, drawing on expertise across the partnership and stakeholders. This included a document and literature review, and wide consultation, with feedback from stakeholders at all stages. Possible indicators were reviewed from global maternal-newborn health-related partner initiatives, priority indicator lists, and project indicators from current innovators. These indicators were scored across five domains to prioritise those most relevant and feasible for Saving Lives at Birth. These results informed the identification of the prioritised metrics for the initiative. RESULTS: The pathway to scale through Saving Lives at Birth is articulated through a theory of change and impact framework, which also highlight the roles of different actors involved in the programme. A prioritised metrics toolkit, including ten core impact indicators and five additional process indicators, complement the theory of change. The retrospective nature of this development enabled structured reflection of the program mechanics, allowing for inclusion of learning from the first four rounds of the program to inform implementation of subsequent rounds. CONCLUSIONS: While theories of change are more traditionally developed before program implementation, retrospective development can still be a useful exercise for multi-round programs like Saving Lives at Birth, where outputs from the development can be used to strengthen subsequent rounds. However, identifying a uniform set of prioritised metrics for use across the portfolio proved more challenging. Lessons learnt from this exercise will be relevant to the development of pathways to change across other Grand Challenges and global health platforms.

Count every newborn; a measurement improvement roadmap for coverage data.

BACKGROUND: The Every Newborn Action Plan (ENAP), launched in 2014, aims to end preventable newborn deaths and stillbirths, with national targets of ≤12 neonatal deaths per 1000 live births and ≤12 stillbirths per 1000 total births by 2030. This requires ambitious improvement of the data on care at birth and of small and sick newborns, particularly to track coverage, quality and equity. METHODS: In a multistage process, a matrix of 70 indicators were assessed by the Every Newborn steering group. Indicators were graded based on their availability and importance to ENAP, resulting in 10 core and 10 additional indicators. A consultation process was undertaken to assess the status of each ENAP core indicator definition, data availability and measurement feasibility. Coverage indicators for the specific ENAP treatment interventions were assigned task teams and given priority as they were identified as requiring the most technical work. Consultations were held throughout. RESULTS: ENAP published 10 core indicators plus 10 additional indicators. Three core impact indicators (neonatal mortality rate, maternal mortality ratio, stillbirth rate) are well defined, with future efforts needed to focus on improving data quantity and quality. Three core indicators on coverage of care for all mothers and newborns (intrapartum/skilled birth attendance, early postnatal care, essential newborn care) have defined contact points, but gaps exist in measuring content and quality of the interventions. Four core (antenatal corticosteroids, neonatal resuscitation, treatment of serious neonatal infections, kangaroo mother care) and one additional coverage indicator for newborns at risk or with complications (chlorhexidine cord cleansing) lack indicator definitions or data, especially for denominators (population in need). To address these gaps, feasible coverage indicator definitions are presented for validity testing. Measurable process indicators to help monitor health service readiness are also presented. A major measurement gap exists to monitor care of small and sick babies, yet signal functions could be tracked similarly to emergency obstetric care. CONCLUSIONS: The ENAP Measurement Improvement Roadmap (2015-2020) outlines tools to be developed (e.g., improved birth and death registration, audit, and minimum perinatal dataset) and actions to test, validate and institutionalise proposed coverage indicators. The roadmap presents a unique opportunity to strengthen routine health information systems, crosslinking these data with civil registration and vital statistics and population-based surveys. Real measurement change requires intentional transfer of leadership to countries with the greatest disease burden and will be achieved by working with centres of excellence and existing networks.