Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial.

BACKGROUND: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one's own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. OBJECTIVE: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. METHODS: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). RESULTS: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=-7.08; t115=-5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=-0.61; t311=-2.73, P=.007), and fear of unplanned pregnancies (D̄=-0.22; t311=-2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=-1.67; t144=-2.49, P=.01). CONCLUSIONS: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. TRIAL REGISTRATION: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq.

Effects of stress on pain in females using a mobile health app in the Russia-Ukraine conflict.

The chronic and acute effects of stress can have divergent effects on health; long-term effects are associated with detrimental physical and mental health sequelae, while acute effects may be advantageous in the short-term. Stress-induced analgesia, the attenuation of pain perception due to stress, is a well-known phenomenon that has yet to be systematically investigated under ecological conditions. Using Flo, a women's health and wellbeing app and menstrual cycle tracker, with a world-wide monthly active usership of more than 57 million, women in Ukraine were monitored for their reporting of stress, pain and affective symptoms before, and immediately after, the onset of the Russian-Ukrainian conflict. To avoid potential selection (attrition) or collider bias, we rely on a sample of 87,315 users who were actively logging multiple symptoms before and after the start of the war. We found an inverse relationship between stress and pain, whereby higher reports of stress predicted lower rates of pain. Stress did not influence any other physiological symptoms with a similar magnitude, nor did any other symptom have a similar effect on pain. This relationship generally decreased in magnitude in countries neighbouring and surrounding Ukraine, with Ukraine serving as the epicentre. These findings help characterise the relationship between stress and health in a real-world setting.

Assessment of a Digital Symptom Checker Tool's Accuracy in Suggesting Reproductive Health Conditions: Clinical Vignettes Study.

BACKGROUND: Reproductive health conditions such as endometriosis, uterine fibroids, and polycystic ovary syndrome (PCOS) affect a large proportion of women and people who menstruate worldwide. Prevalence estimates for these conditions range from 5% to 40% of women of reproductive age. Long diagnostic delays, up to 12 years, are common and contribute to health complications and increased health care costs. Symptom checker apps provide users with information and tools to better understand their symptoms and thus have the potential to reduce the time to diagnosis for reproductive health conditions. OBJECTIVE: This study aimed to evaluate the agreement between clinicians and 3 symptom checkers (developed by Flo Health UK Limited) in assessing symptoms of endometriosis, uterine fibroids, and PCOS using vignettes. We also aimed to present a robust example of vignette case creation, review, and classification in the context of predeployment testing and validation of digital health symptom checker tools. METHODS: Independent general practitioners were recruited to create clinical case vignettes of simulated users for the purpose of testing each condition symptom checker; vignettes created for each condition contained a mixture of condition-positive and condition-negative outcomes. A second panel of general practitioners then reviewed, approved, and modified (if necessary) each vignette. A third group of general practitioners reviewed each vignette case and designated a final classification. Vignettes were then entered into the symptom checkers by a fourth, different group of general practitioners. The outcomes of each symptom checker were then compared with the final classification of each vignette to produce accuracy metrics including percent agreement, sensitivity, specificity, positive predictive value, and negative predictive value. RESULTS: A total of 24 cases were created per condition. Overall, exact matches between the vignette general practitioner classification and the symptom checker outcome were 83% (n=20) for endometriosis, 83% (n=20) for uterine fibroids, and 88% (n=21) for PCOS. For each symptom checker, sensitivity was reported as 81.8% for endometriosis, 84.6% for uterine fibroids, and 100% for PCOS; specificity was reported as 84.6% for endometriosis, 81.8% for uterine fibroids, and 75% for PCOS; positive predictive value was reported as 81.8% for endometriosis, 84.6% for uterine fibroids, 80% for PCOS; and negative predictive value was reported as 84.6% for endometriosis, 81.8% for uterine fibroids, and 100% for PCOS. CONCLUSIONS: The single-condition symptom checkers have high levels of agreement with general practitioner classification for endometriosis, uterine fibroids, and PCOS. Given long delays in diagnosis for many reproductive health conditions, which lead to increased medical costs and potential health complications for individuals and health care providers, innovative health apps and symptom checkers hold the potential to improve care pathways.

Characterization of Self-reported Improvements in Knowledge and Health Among Users of Flo Period Tracking App: Cross-sectional Survey.

BACKGROUND: Research shows that poor knowledge and awareness of menstrual and pregnancy health among women are associated with adverse reproductive health and pregnancy outcomes. Menstrual cycle- and pregnancy-tracking mobile apps are promising tools for improving women's awareness of and attitudes toward their reproductive health; however, there is little information about subscribers' perceptions of app functionality and its impact on their knowledge and health. OBJECTIVE: This study aimed to explore knowledge and health improvements related to menstrual cycle and pregnancy, as well as improvements in general health among Flo app users. We also investigated what components of the Flo app were associated with the abovementioned improvements and evaluated whether those improvements differed based on education level, country of residence (low- and middle-income vs high-income countries), free or premium subscription to the app, short- or long-term use of the app, and frequency of use. METHODS: Flo subscribers who had been using the app for no less than 30 days, completed a web-based survey. A total of 2212 complete survey responses were collected. The survey included demographic questions and questions about motivations guiding the use of the Flo app and which components of the app improved their knowledge and health, as well as to what extent. RESULTS: Most study participants reported improvements in menstrual cycle (1292/1452, 88.98%) and pregnancy (698/824, 84.7%) knowledge from Flo app use. Participants with higher levels of education and those from high-income countries reported using the app predominantly for getting pregnant (χ21=4.2, P=.04; χ21=52.3, P<.001, respectively) and pregnancy tracking (χ21=19.3, P<.001; χ21=20.9, P=.001, respectively). Participants with less education reported using the app to avoid pregnancy (χ21=4.2; P=.04) and to learn more about their body (χ21=10.8; P=.001) and sexual health (χ21=6.3; P=.01), while participants from low- and middle-income countries intended to mainly learn more about their sexual health (χ21=18.2; P<.001). Importantly, the intended use of the app across education levels and country income levels matched areas in which they had gained knowledge and achieved their health goals upon use of the Flo app. Period, fertile days, and ovulation predictions as well as symptom tracking were consistently the top 3 components in the app that helped users with their cycle knowledge and general health. Reading articles or watching videos helped with users' education regarding their pregnancy. Finally, the strongest improvements in knowledge and health were observed in premium, frequent, and long-term users. CONCLUSIONS: This study suggests that menstrual health apps, such as Flo, could present revolutionary tools to promote consumer health education and empowerment on a global scale.

Menstrual cycle-associated symptoms and workplace productivity in US employees: A cross-sectional survey of users of the Flo mobile phone app.

Objective: Mood and physical symptoms related to the menstrual cycle affect women's productivity at work, often leading to absenteeism. However, employer-led initiatives to tackle these issues are lacking. Digital health interventions focused on women's health (such as the Flo app) could help fill this gap. Methods: 1867 users of the Flo app participated in a survey exploring the impact of their menstrual cycle on their workplace productivity and the role of Flo in mitigating some of the identified issues. Results: The majority reported a moderate to severe impact of their cycle on workplace productivity, with 45.2% reporting absenteeism (5.8 days on average in the previous 12 months). 48.4% reported not receiving any support from their manager and 94.6% said they were not provided with any specific benefit for issues related to their menstrual cycle, with 75.6% declaring wanting them. Users stated that the Flo app helped them with the management of menstrual cycle symptoms (68.7%), preparedness and bodily awareness (88.7%), openness with others (52.5%), and feeling supported (77.6%). Users who reported the most positive impact of the Flo app were 18-25% less likely to report an impact of their menstrual cycle on their productivity and 12-18% less likely to take days off work for issues related to their cycle. Conclusions: Apps such as Flo could equip individuals with tools to better cope with issues related to their menstrual cycle and facilitate discussions around menstrual health in the workplace.

Scaling up of safety and quality improvement interventions in perioperative care: a systematic scoping review of implementation strategies and effectiveness.

BACKGROUND: Globally, 5 billion people lack access to safe surgical care with more deaths due to lack of quality care rather than lack of access. While many proven quality improvement (QI) interventions exist in high-income countries, implementing them in low/middle-income countries (LMICs) faces further challenges. Currently, theory-driven, systematically articulated knowledge of the factors that support successful scale-up of QI in perioperative care in these settings is lacking. We aimed to identify all perioperative safety and QI interventions applied at scale in LMICs and evaluate their implementation mechanisms using implementation theory. METHODS: Systematic scoping review of perioperative QI interventions in LMICs from 1960 to 2020. Studies were identified through Medline, EMBASE and Google Scholar. Data were extracted in two phases: (1) abstract review to identify the range of QI interventions; (2) studies describing scale-up (three or more sites), had full texts retrieved and analysed for; implementation strategies and scale-up frameworks used; and implementation outcomes reported. RESULTS: We screened 45 128 articles, identifying 137 studies describing perioperative QI interventions across 47 countries. Only 31 of 137 (23%) articles reported scale-up with the most common intervention being the WHO Surgical Safety Checklist. The most common implementation strategies were training and educating stakeholders, developing stakeholder relationships, and using evaluative and iterative strategies. Reporting of implementation mechanisms was generally poor; and although the components of scale-up frameworks were reported, relevant frameworks were rarely referenced. CONCLUSION: Many studies report implementation of QI interventions, but few report successful scale-up from single to multiple-site implementation. Greater use of implementation science methodology may help determine what works, where and why, thereby aiding more widespread scale-up and dissemination of perioperative QI interventions.

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.

Use of Feedback Data to Reduce Surgical Site Infections and Optimize Antibiotic Use in Surgery: A Systematic Scoping Review.

OBJECTIVE: Surgical site infection (SSI) prevention remains significant, particularly in the era of antimicrobial resistance. Feedback on practices and outcomes is known to be key to reduce SSI rates and optimize antibiotic usage. However, the optimal method, format and frequency of feedback for surgical teams remains unclear. The objective of the study is to understand how data from surveillance and audit are fed back in routine surgical practice. METHODS: A systematic scoping review was conducted, using well-established implementation science frameworks to code the data. Two electronic health-oriented databases (MEDLINE, EMBASE) were searched to September 2019. We included studies that assessed the use of feedback as a strategy either in the prevention and management of SSI and/or in the use of antibiotics perioperatively. RESULTS: We identified 21 studies: 17 focused on SSI rates and outcomes and 10 studies described antimicrobial stewardship for SSI (with some overlap in focus). Several interventions were reported, mostly multimodal with feedback as a component. Feedback was often provided in written format (62%), either individualized (38%) or in group (48%). Only 25% of the studies reported that feedback cascaded down to the frontline perioperative staff. In 65% of the studies, 1 to 5 implementation strategies were used while only 5% of the studies reported to have utilized more than 15 implementation strategies. Among studies reporting antibiotic usage in surgery, most (71%) discussed compliance with surgical antibiotic prophylaxis. CONCLUSIONS: Our findings highlight the need to provide feedback to all levels of perioperative care providers involved in patient care. Future research in this area should report implementation parameters in more detail.

Household Survey Measurement of Newborn Postnatal Care: Coverage, Quality Gaps, and Internal Inconsistencies in Responses.

BACKGROUND: Reliable measurement of newborn postnatal care is essential to understand gaps in coverage and quality and thereby improve outcomes. This study examined gaps in coverage and measurement of newborn postnatal care in the first 2 days of life. METHODS: We analyzed Demographic and Health Survey data from 15 countries for 71,366 births to measure the gap between postnatal contact coverage and content coverage within 2 days of birth. Coverage was a contact with the health system in the first 2 days (postnatal check or newborn care intervention), and quality was defined as reported receipt of 5 health worker-provided interventions. We examined internal consistency between interrelated questions regarding examination of the umbilical cord. RESULTS: Reported coverage of postnatal check ranged from 13% in Ethiopia to 78% in Senegal. Report of specific newborn care interventions varied widely by intervention within and between countries. Quality-coverage gaps were high, ranging from 26% in Malawi to 89% in Burundi. We found some internally inconsistent reporting of newborn care. The percentage of women who reported that a health care provider checked their newborn's umbilical cord but responded "no" to the postnatal check question was as high as 16% in Malawi. CONCLUSION: Reliable measurement of coverage and content of early postnatal newborn care is essential to track progress in improving quality of care. Postnatal contact coverage is challenging to measure because it may be difficult for women to distinguish postnatal care from intrapartum care and it is a less recognizable concept than antenatal care. Co-coverage measures may provide a useful summary of contact and content, reflecting both coverage and an aspect of quality.

Distance to available services for newborns at facilities in Malawi: A secondary analysis of survey and health facility data.

BACKGROUND: Malawi has halved the neonatal mortality rate between 1990-2018, however, is not on track to achieve the Sustainable Development Goal 12 per 1,000 live births. Despite a high facility birth rate (91%), mother-newborn dyads may not remain in facilities long enough to receive recommended care and quality of care improvements are needed to reach global targets. Physical access and distance to health facilities remain barriers to quality postnatal care. METHODS: Using data We used individual data from the 2015-16 Malawi Demographic and Health Survey and facility data from the 2013-14 Malawi Service Provision Assessment, linking households to all health facilities within specified distances and travel times. We calculated service readiness scores for facilities to measure their capacity to provide birth/newborn care services. We fitted multi-level regression models to evaluate the association between the service readiness and appropriate newborn care (receiving at least five of six interventions). RESULTS: Households with recent births (n = 6010) linked to a median of two birth facilities within 5-10 km and one facility within a two-hour walk. The maximum service environment scores for linked facilities median was 77.5 for facilities within 5-10 km and 75.5 for facilities within a two-hour walk. While linking to one or more facilities within 5-10km or a two-hour walk was not associated with appropriate newborn care, higher levels of service readiness in nearby facilities was associated with an increased risk of appropriate newborn care. CONCLUSIONS: Women's choice of nearby facilities and quality facilities is limited. High quality newborn care is sub-optimal despite high coverage of facility birth and some newborn care interventions. While we did not find proximity to more facilities was associated with increased risk of appropriate care, high levels of service readiness was, showing facility birth and improved access to well-prepared facilities are important for improving newborn care.

Equity in newborn care, evidence from national surveys in low- and middle-income countries.

BACKGROUND: High coverage of care is essential to improving newborn survival; however, gaps exist in access to timely and appropriate newborn care between and within countries. In high mortality burden settings, health inequities due to social and economic factors may also impact on newborn outcomes. This study aimed to examine equity in co-coverage of newborn care interventions in low- and low middle-income countries in sub-Saharan Africa and South Asia. METHODS: We analysed secondary data from recent Demographic and Health Surveys in 16 countries. We created a co-coverage index of five newborn care interventions. We examined differences in coverage and co-coverage of newborn care interventions by country, place of birth, and wealth quintile. Using multilevel logistic regression, we examined the association between high co-coverage of newborn care (4 or 5 interventions) and social determinants of health. RESULTS: Coverage and co-coverage of newborn care showed large between- and within-country gaps for home and facility births, with important inequities based on individual, family, contextual, and structural factors. Wealth-based inequities were smaller amongst facility births compared to non-facility births. CONCLUSION: This analysis underlines the importance of facility birth for improved and more equitable newborn care. Shifting births to facilities, improving facility-based care, and community-based or pro-poor interventions are important to mitigate wealth-based inequities in newborn care, particularly in countries with large differences between the poorest and richest families and in countries with very low coverage of care.

How do reminder systems in follow-up screening for women with previous gestational diabetes work? - a realist review.

BACKGROUND: Women with previous gestational diabetes have an increased risk of developing type 2 diabetes later in life. Recommendations therefore urge these women to participate in follow-up screening, 4-12 weeks postpartum and every 1-3 years thereafter. We sought to theorize how reminder interventions to support early detection of diabetes work, for whom, and in what circumstances. METHODS: We used a method informed by realist review and synthesis. A systematic, iterative search in six electronic databases (PubMed, MEDLINE Ovid, The Cochrane Library, CINAHL, EMBASE) had a primary focus on experimental intervention studies and included additional information in relation to identified intervention studies. Analysis inductively identified context-mechanism-outcome configurations present in the evidence. RESULTS: We located 16 articles eligible for inclusion. A cross-case comparison identified seven grouped context-mechanism-outcome configurations leading to intervention mechanisms relating to changes in women's reasoning and behavior. Configurations were thematically ordered in relation to Systems Resources, Women's Circumstances, and Continuity of Care. These were mapped onto a socio-ecological model and discussed according to identified middle-range theories. CONCLUSION: Our findings adds to the body of evidence, that reminders have the potential to be effective in increasing participation in the recommended follow-up screening. Our study may assist researchers and policy and decision makers to analyze and judge if reminders are feasible and/or likely to succeed in their specific context. Further research into the perspective of socially disadvantaged and overweight women is needed to avoid unintended consequences such as social inequality in service use and stigmatization in future programs.

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.

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.