Operationalising health systems thinking: a pathway to high effective coverage.

BACKGROUND: The global health community has recognised the importance of defining and measuring the effective coverage of health interventions and their implementation strength to monitor progress towards global mortality and morbidity targets. Existing health system models and frameworks guide thinking around these measurement areas; however, they fall short of adequately capturing the dynamic and multi-level relationships between different components of the health system. These relationships must be articulated for measurement and managed to effectively deliver health interventions of sufficient quality to achieve health impacts. Save the Children's Saving Newborn Lives programme and EnCompass LLC, its evaluation partner, developed and applied the Pathway to High Effective Coverage as a health systems thinking framework (hereafter referred to as the Pathway) in its strategic planning, monitoring and evaluation. METHODS: We used an iterative approach to develop, test and refine thinking around the Pathway. The initial framework was developed based on existing literature, then shared and vetted during consultations with global health thought leaders in maternal and newborn health. RESULTS: The Pathway is a robust health systems thinking framework that unpacks system, policy and point of intervention delivery factors, thus encouraging specific actions to address gaps in implementation and facilitate the achievement of high effective coverage. The Pathway includes six main components - (1) national readiness; (2) system structures; (3) management capacity; (4) implementation strength; (5) effective coverage; and (6) impact. Each component is comprised of specific elements reflecting the range of facility-, community- and home-based interventions. We describe applications of the Pathway and results for in-country strategic planning, monitoring of progress and implementation strength, and evaluation. CONCLUSIONS: The Pathway provides a cohesive health systems thinking framework that facilitates assessment and coordinated action to achieve high coverage and impact. Experiences of its application show its utility in guiding strategic planning and in more comprehensive and effective monitoring and evaluation as well as its potential adaptability for use in other health areas and sectors.

Neonatal resuscitation and immediate newborn assessment and stimulation for the prevention of neonatal deaths: a systematic review, meta-analysis and Delphi estimation of mortality effect.

BACKGROUND: Of 136 million babies born annually, around 10 million require assistance to breathe. Each year 814,000 neonatal deaths result from intrapartum-related events in term babies (previously "birth asphyxia") and 1.03 million from complications of prematurity. No systematic assessment of mortality reduction from tactile stimulation or resuscitation has been published. OBJECTIVE: To estimate the mortality effect of immediate newborn assessment and stimulation, and basic resuscitation on neonatal deaths due to term intrapartum-related events or preterm birth, for facility and home births. METHODS: We conducted systematic reviews for studies reporting relevant mortality or morbidity outcomes. Evidence was assessed using GRADE criteria adapted to provide a systematic approach to mortality effect estimates for the Lives Saved Tool (LiST). Meta-analysis was performed if appropriate. For interventions with low quality evidence but strong recommendation for implementation, a Delphi panel was convened to estimate effect size. RESULTS: We identified 24 studies of neonatal resuscitation reporting mortality outcomes (20 observational, 2 quasi-experimental, 2 cluster randomized controlled trials), but none of immediate newborn assessment and stimulation alone. A meta-analysis of three facility-based studies examined the effect of resuscitation training on intrapartum-related neonatal deaths (RR= 0.70, 95%CI 0.59-0.84); this estimate was used for the effect of facility-based basic neonatal resuscitation (additional to stimulation). The evidence for preterm mortality effect was low quality and thus expert opinion was sought. In community-based studies, resuscitation training was part of packages with multiple concurrent interventions, and/or studies did not distinguish term intrapartum-related from preterm deaths, hence no meta-analysis was conducted. Our Delphi panel of 18 experts estimated that immediate newborn assessment and stimulation would reduce both intrapartum-related and preterm deaths by 10%, facility-based resuscitation would prevent a further 10% of preterm deaths, and community-based resuscitation would prevent further 20% of intrapartum-related and 5% of preterm deaths. CONCLUSION: Neonatal resuscitation training in facilities reduces term intrapartum-related deaths by 30%. Yet, coverage of this intervention remains low in countries where most neonatal deaths occur and is a missed opportunity to save lives. Expert opinion supports smaller effects of neonatal resuscitation on preterm mortality in facilities and of basic resuscitation and newborn assessment and stimulation at community level. Further evaluation is required for impact, cost and implementation strategies in various contexts. FUNDING: This work was supported by the Bill & Melinda Gates Foundation through a grant to the US Fund for UNICEF, and to the Saving Newborn Lives program of Save the Children, through Save the Children US.

Managing possible serious bacterial infection of young infants where referral is not possible: Lessons from the early implementation experience in Kushtia District learning laboratory, Bangladesh.

BACKGROUND: Serious infections account for 25% of global newborn deaths annually, most in low-resource settings where hospital-based treatment is not accessible or feasible. In Bangladesh, one-third of neonatal deaths are attributable to serious infection; in 2014, the government adopted new policy for outpatient management of danger signs indicating possible serious bacterial infections (PSBI) when referral was not possible. We conducted implementation research to understand what it takes for a district health team to implement quality outpatient PSBI management per national guidelines. METHODS: PSBI management was introduced as part of the Comprehensive Newborn Care Package in 2015. The study piloted this package through government health systems with limited partner support to inform scale-up efforts. Data collection included facility register reviews for cases seen at primary level facilities; facility readiness and provider knowledge and skills assessments; household surveys capturing caregiver knowledge of newborn danger signs and care-seeking for newborn illness; and follow-up case tracking, capturing treatment adherence and outcomes. Analysis consisted of descriptive statistics. RESULTS: Over the 15-month implementation period, 1432 young infants received care, of which 649 (45%) were classified as PSBI. Estimated coverage of care-seeking increased from 22% to 42% during the implementation period. Although facility readiness and providers' skills increased, providers' adherence to guidelines was not optimal. Among locally managed PSBI cases, 75% completed the oral antibiotic course and 15% received the fourth day follow-up. Care-seeking remained high among private providers (95%), predominantly village health doctors (over 80%). CONCLUSIONS: Facility readiness, including health care provider knowledge and skills were strengthened; future efforts should focus on improving provider adherence to guidelines. Social and behavior change strategies targeting families and communities should explore shifting care-seeking from private, possibly less-qualified providers. Strategies to improve private sector management of PSBI cases and improved linkages between private and public sector providers could be explored.

The use of chlorhexidine to reduce maternal and neonatal mortality and morbidity in low-resource settings.

Of the 4 million neonatal deaths and 500,000 maternal deaths that occur annually worldwide, almost 99% are in developing countries and one-third are associated with infections. Implementation of proven interventions and targeted research on a select number of promising high-impact preventative and curative interventions are essential to achieve Millennium Development Goals for reduction of child and maternal mortality. Feasible, simple, low-cost interventions have the potential to significantly reduce the mortality and severe morbidity associated with infection in these settings. Studies of chlorhexidine in developing countries have focused on three primary uses: 1) intrapartum vaginal and neonatal wiping, 2) neonatal wiping alone, and 3) umbilical cord cleansing. A study of vaginal wiping and neonatal skin cleansing with chlorhexidine, conducted in Malawi in the 1990s suggested that chlorhexidine has potential to reduce neonatal infectious morbidity and mortality. A recent trial of cord cleansing conducted in Nepal also demonstrated benefit. Although studies have shown promise, widespread acceptance and implementation of chlorhexidine use has not yet occurred. This paper is derived in part from data presented at a conference on the use of chlorhexidine in developing countries and reviews the available evidence related to chlorhexidine use to reduce mortality and severe morbidity due to infections in mothers and neonates in low-resource settings. It also summarizes issues related to programmatic implementation.

Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.

Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all disability-adjusted life-years. Despite this burden, few data are available on incidence, aetiology, and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational neonatal infection studies, to increase comparability and to strengthen research in this area. This checklist, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE- NI), is an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. STROBE-NI was developed following systematic reviews of published literature (1996-2015), compilation of more than 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology, and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines.

Racial disparity in meconium-stained amniotic fluid and meconium aspiration syndrome in the United States, 1989-2000.

OBJECTIVE: To estimate the prevalence of meconium-stained amniotic fluid and meconium aspiration syndrome, as well as the differences in case fatality from meconium aspiration syndrome, between non-Hispanic black and non-Hispanic white infants. METHODS: We studied non-Hispanic black and non-Hispanic white live births with weights greater than 2.5 kg and gestational ages greater than 35 weeks, using the linked US birth and infant death cohorts for three periods: 1989-1991, 1995-1997, and 1998-2000. We used logistic regression to estimate the risks of meconium-stained amniotic fluid and meconium aspiration syndrome and to estimate the case fatality of meconium aspiration syndrome by maternal race, birth weight, period, and pregnancy complications. RESULTS: Risk of meconium-stained amniotic fluid was 80% higher in non-Hispanic blacks when compared with non-Hispanic whites (birth weight-adjusted odds ratio [OR], 1.81, 95% confidence interval [CI] 1.80, 1.82). The prevalence of pregnancy complications did not explain this racial disparity. Risk of meconium aspiration syndrome in non-Hispanic blacks was 67% higher when compared with non-Hispanic whites (birth weight-adjusted OR 1.67, 95% CI 1.64, 1.70). The case fatality rate of meconium aspiration syndrome was similar between non-Hispanic blacks and non-Hispanic whites in the three periods, with rates of 15.5, 15.2, and 11.2 per 1000 in non-Hispanic blacks and 13.5, 11.2, and 10.1 per 1000 in non-Hispanic whites in 1989-1991, 1995-1997, and 1998-2000, respectively. CONCLUSION: Our results suggest that when compared with non-Hispanic whites, non-Hispanic blacks are at significantly greater risk for meconium-stained amniotic fluid and meconium aspiration syndrome but not for meconium aspiration syndrome case fatality.

Hospital factors and nontransfer of small babies: a marker of deregionalized perinatal care?

OBJECTIVES: Our purpose was to examine the contribution of hospital factors (e.g., reimbursement sources, teaching status) to the rate of nontransfer of <1250 g infants born in nontertiary hospitals in Illinois. We chose nontransfer as a marker of the extent to which there have been structural changes in the regionalized perinatal care system in Illinois. STUDY DESIGN: Using data from live birth certificates (1989-1996), from the American Hospital Association's Annual Survey of Hospitals (1990 to 1996), and Illinois hospital discharge records (1992 to 1996), we simultaneously assessed the effect of hospital and individual factors on nontransfer of infants <1250 g (n=2904). RESULTS: When adjusted for individual risk factors, several hospital factors were associated with nontransfer. These include birth in a Level II+hospital (odds ratios(OR) 3.75; 95% CI 2.29, 5.29), high Medicaid revenues (OR 1.97; 95% CI 1.58, 2.47), high HMO revenues (OR 1.39; 95% CI 1.11, 2.28), and status as a teaching hospital (OR 1.63; 95% CI 1.30, 2.09). CONCLUSIONS: This study suggests that there should be careful consideration of the role of hospital factors in perinatal deregionalization in order to preserve the improvements in maternal and infant outcomes associated with regionalized perinatal care.

Maternal support in the delivery room and birthweight among African-American women.

OBJECTIVES: We performed a hospital-based case control study of African-American mothers to explore the relationship between maternal support by a significant other in the delivery room and very low birthweight (VLBW). METHODS: We administered a structured questionnaire to mothers of VLBW (less than 1,500 g; N=104) and normal birthweight (greater or equal to 2,500 g; N=208) infants. RESULTS: The odds ratio for VLBW comparing women without social support in the delivery room to those with a companion was 3.5 (2.1-5.8). Several traditional risk factors were not associated with VLBW, but older maternal age and perceived racial discrimination were. CONCLUSIONS: Maternal support in the delivery room or factors closely associated with it significantly decreases the odds of delivering a VLBW infant for African-American women.

Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring.

BACKGROUND: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. METHODS: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. CONCLUSIONS: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials' results.

Newborn survival in Bangladesh: a decade of change and future implications.

Remarkable progress over the last decade has put Bangladesh on track for Millennium Development Goal (MDG) 4 for child survival and achieved a 40% decline in maternal mortality. However, since neonatal deaths make up 57% of under-five mortality in the country, increased scale up and equity in programmes for neonatal survival are critical to sustain progress. We examined change for newborn survival from 2000 to 2010 considering mortality, coverage and funding indicators, as well as contextual factors. The national neonatal mortality rate has undergone an annual decline of 4.0% since 2000, reflecting greater progress than both the regional and global averages, but the mortality reduction for children 1-59 months was double this rate, at 8.6%. Examining policy and programme change, and national and donor funding for health, we identified various factors which contributed to an environment favourable to newborn survival. Locally-generated evidence combined with re-packaged global evidence, notably The Lancet Neonatal Series, has played a role, although pathways between research and policies and programme change are often complex. Several high-profile champions have had major influence. Attention for community initiatives and considerable donor funding also appear to have contributed. There have been some increases in coverage of key interventions, such as skilled attendance at birth and postnatal care, however these are low and reach less than one-third of families. Major reductions in total fertility, some change in gross national income and other contextual factors are likely to also have had an influence in mortality reduction. However, other factors such as socio-economic and geographic inequalities, frequent changes in government and pluralistic implementation structures have provided challenges. As coverage of health services increases, a notable gap remains in quality of facility-based care. Future gains for newborn survival in Bangladesh rest upon increased implementation at scale and greater consistency in content and quality of programmes and services.

Newborn survival in Pakistan: a decade of change and future implications.

Pakistan has the world's third highest national number of newborn deaths (194 000 in 2010). Major national challenges over the past decade have affected health and development including several large humanitarian disasters, destabilizing political insurgency, high levels of poverty and an often hard-to-reach predominately rural population with diverse practices. As part of a multi-country analysis, we examined changes for newborn survival between 2000 and 2010 in terms of mortality, coverage and health system indicators as well as national and donor funding. Neonatal mortality declined by only 0.9% per annum between 2000 and 2010; less than the global average (2.1%) and less than national maternal and child mortality declines. Coverage of newborn care interventions increased marginally, with wide socio-economic variations. There was little focus on newborn health until 2000 when considerable policy change occurred, including integration of newborn care into existing community-based maternal and child packages delivered by the Lady Health Worker Programme and national behaviour change communications strategies and programmes. The National Maternal, Newborn and Child Health Programme catalyzed newborn services at both facility and community levels. Civil society and academics have linked with government and several research studies have been highly influential. Since 2005, donor funding mentioning the term 'newborn' has increased more for Pakistan than for other countries. The country faces ongoing challenges in reducing neonatal mortality, and in much of Pakistan, societal norms discourage care-seeking and many women are unable to access care for themselves or their children. The policy advances and existing delivery platforms offer the potential to substantially accelerate progress in reducing neonatal deaths. The recent decision to dismantle the national Ministry of Health and devolve responsibility for health sector management to the provincial level presents both challenges and opportunities for newborn health.

Newborn survival in Nepal: a decade of change and future implications.

Nepal is on target to meet the Millennium Development Goals for maternal and child health despite high levels of poverty, poor infrastructure, difficult terrain and recent conflict. Each year, nearly 35,000 Nepali children die before their fifth birthday, with almost two-thirds of these deaths occurring in the first month of life, the neonatal period. As part of a multi-country analysis, we examined changes for newborn survival between 2000 and 2010 in terms of mortality, coverage and health system indicators as well as national and donor funding. Over the decade, Nepal's neonatal mortality rate reduced by 3.6% per year, which is faster than the regional average (2.0%) but slower than national annual progress for mortality of children aged 1-59 months (7.7%) and maternal mortality (7.5%). A dramatic reduction in the total fertility rate, improvements in female education and increasing change in skilled birth attendance, as well as increased coverage of community-based child health interventions, are likely to have contributed to these mortality declines. Political commitment and support for newborn survival has been generated through strategic use of global and national data and effective partnerships using primarily a selective newborn-focused approach for advocacy and planning. Nepal was the first low-income country to have a national newborn strategy, influencing similar strategies in other countries. The Community-Based Newborn Care Package is delivered through the nationally available Female Community Health Volunteers and was piloted in 10 of 75 districts, with plans to increase to 35 districts in mid-2013. Innovation and scale up, especially of community-based packages, and public health interventions and commodities appear to move relatively rapidly in Nepal compared with some other countries. Much remains to be done to achieve high rates of effective coverage of community care, and especially to improve the quality of facility-based care given the rapid shift to births in facilities.

Reducing intrapartum-related neonatal deaths in low- and middle-income countries-what works?

Each year, 814,000 neonatal deaths and 1.02 million stillbirths result from intrapartum-related causes, such as intrauterine hypoxia. Almost all of these deaths are in low- and middle-income countries, where women frequently lack access to quality perinatal care and may delay care-seeking. Approximately 60 million annual births occur outside of health facilities, and most of these childbirths are without a skilled birth attendant. Conditions that increase the risk of intrauterine hypoxia--such as pre-eclampsia/eclampsia, obstructed labor, and low birth weight--are often more prevalent in low resource settings. Intrapartum-related neonatal deaths can be averted by a range of interventions that prevent intrapartum complications (eg, prevention and management of pre-eclampsia), detect and manage intrapartum problems (eg, monitoring progress of labor with access to emergency obstetrical care), and identify and assist the nonbreathing newborn (eg, stimulation and bag-mask ventilation). Simple, affordable, and effective approaches are available for low-resource settings, including community-based strategies to increase skilled birth attendance, partograph use by frontline health workers linked to emergency obstetrical care services, task shifting to increase access to Cesarean delivery, and simplified neonatal resuscitation training (Helping Babies Breathe(SM)). Coverage of effective interventions is low, however, and many opportunities are missed to provide quality care within existing health systems. In sub-Saharan Africa, recent health services assessments found only 15% of hospitals equipped to provide basic neonatal resuscitation. In the short term, intrapartum-related neonatal deaths can be substantially reduced by improving the quality of services for all childbirths that occur in health facilities, identifying and addressing the missed opportunities to provide effective interventions to those who seek facility-based care. For example, providing neonatal resuscitation for 90% of deliveries currently taking place in health facilities would save more than 93,000 newborn lives each year. Longer-term strategies must address the gaps in coverage of institutional delivery, skilled birth attendance, and quality by strengthening health systems, increasing demand for care, and improving community-based services. Both short- and long-term strategies to reduce intrapartum-related mortality should focus on reducing inequities in coverage and quality of obstetrical and perinatal care.

Neonatal resuscitation in low-resource settings: what, who, and how to overcome challenges to scale up?

BACKGROUND: Each year approximately 10 million babies do not breathe immediately at birth, of which about 6 million require basic neonatal resuscitation. The major burden is in low-income settings, where health system capacity to provide neonatal resuscitation is inadequate. OBJECTIVE: To systematically review the evidence for neonatal resuscitation content, training and competency, equipment and supplies, cost, and key program considerations, specifically for resource-constrained settings. RESULTS: Evidence from several observational studies shows that facility-based basic neonatal resuscitation may avert 30% of intrapartum-related neonatal deaths. Very few babies require advanced resuscitation (endotracheal intubation and drugs) and these newborns may not survive without ongoing ventilation; hence, advanced neonatal resuscitation is not a priority in settings without neonatal intensive care. Of the 60 million nonfacility births, most do not have access to resuscitation. Several trials have shown that a range of community health workers can perform neonatal resuscitation with an estimated effect of a 20% reduction in intrapartum-related neonatal deaths, based on expert opinion. Case studies illustrate key considerations for scale up. CONCLUSION: Basic resuscitation would substantially reduce intrapartum-related neonatal deaths. Where births occur in facilities, it is a priority to ensure that all birth attendants are competent in resuscitation. Strategies to address the gap for home births are urgently required. More data are required to determine the impact of neonatal resuscitation, particularly on long-term outcomes in low-income settings.