Reducing inequities in maternal and child health in rural Guatemala through the CBIO+ Approach of Curamericas: 5. Mortality assessment.

BACKGROUND: The Curamericas/Guatemala Maternal and Child Health Project, 2011-2015, implemented the Census-Based, Impact-Oriented Approach, the Care Group Approach, and the Community Birthing Center Approach. Together, this expanded set of approaches is known as CBIO+. This is the fifth of 10 papers in our supplement describing the Project and the effectiveness of the CBIO+ Approach. This paper assesses causes, levels, and risk factors for mortality along with changes in mortality. METHODS: The Project maintained Vital Events Registers and conducted verbal autopsies for all deaths of women of reproductive age and under-5 children. Mortality rates and causes of death were derived from these data. To increase the robustness of our findings, we also indirectly estimated mortality decline using the Lives Saved Tool (LiST). FINDINGS: The leading causes of maternal and under-5 mortality were postpartum hemorrhage and pneumonia, respectively. Home births were associated with an eight-fold increased risk of both maternal (p = 0.01) and neonatal (p = 0.00) mortality. The analysis of vital events data indicated that maternal mortality declined from 632 deaths per 100,000 live births in Years 1 and 2 to 257 deaths per 100,000 live birth in Years 3 and 4, a decline of 59.1%. The vital events data revealed no observable decline in neonatal or under-5 mortality. However, the 12-59-month mortality rate declined from 9 deaths per 1000 live births in the first three years of the Project to 2 deaths per 1000 live births in the final year. The LiST model estimated a net decline of 12, 5, and 22% for maternal, neonatal and under-5 mortality, respectively. CONCLUSION: The baseline maternal mortality ratio is one of the highest in the Western hemisphere. There is strong evidence of a decline in maternal mortality in the Project Area. The evidence of a decline in neonatal and under-5 mortality is less robust. Childhood pneumonia and neonatal conditions were the leading causes of under-5 mortality. Expanding access to evidence-based community-based interventions for (1) prevention of postpartum hemorrhage, (2) home-based neonatal care, and (3) management of childhood pneumonia could help further reduce mortality in the Project Area and in similar areas of Guatemala and beyond.

Estimating the global impact of poor quality of care on maternal and neonatal outcomes in 81 low- and middle-income countries: A modeling study.

BACKGROUND: In low-resource settings where disease burdens remain high and many health facilities lack essentials such as drugs or commodities, functional equipment, and trained personnel, poor quality of care often results and the impact can be profound. In this paper, we systematically quantify the potential gain of addressing quality of care globally using country-level data about antenatal, childbirth, and postnatal care interventions. METHODS AND FINDINGS: In this study, we created deterministic models to project health outcomes if quality of care was addressed in a representative sample of 81 low- and middle-income countries (LMICs). First, available data from health facility surveys (e.g., Service Provision Assessment [SPA] and Service Availability and Readiness Assessment [SARA]) conducted 2007-2016 were linked to household surveys (e.g., Demographic and Health Surveys [DHS] and Multiple Indicator Cluster Surveys [MICS]) to estimate baseline coverage for a core subset of 19 maternal and newborn health interventions. Next, models were constructed with the Lives Saved Tool (LiST) using country-specific baseline levels in countries with a linked dataset (n = 17) and sample medians applied as a proxy in countries without linked data. Lastly, these 2016 starting baseline levels were raised to reach targets in 2020 as endline based upon country-specific utilization (e.g., proportion of women who attended 4+ antenatal visits, percentage of births delivered in a health facility) from the latest DHS or MICS population-based reports. Our findings indicate that if high-quality health systems could effectively deliver this subset of evidence-based interventions to mothers and their newborns who are already seeking care, there would be an estimated 28% decrease in maternal deaths, 28% decrease in neonatal deaths, and 22% fewer stillbirths compared to a scenario without any change or improvement in quality of care. Totals of 86,000 (range, 77,800-92,400) maternal and 0.67 million (range, 0.59 million-0.75 million) neonatal lives could be saved, and 0.52 million (range, 0.48 million-0.55 million) stillbirths could be prevented across the 81 countries in the calendar year 2020 when adequate quality care is provided at current levels of utilization. Limitations include the paucity of data to individually assess quality of care for each intervention in all LMICs and the necessary assumption that quality of care being provided among the subset of countries with linked datasets is comparable or representative of LMICs overall. CONCLUSIONS: Our findings suggest that efforts to close the quality gap would still produce substantial benefits at current levels of access or utilization. With estimated mortality rate declines of 21%-32% on average, gains from this first step would be significant if quality was improved for selected antenatal, intrapartum, and postnatal interventions to benefit pregnant women and newborns seeking care. Interventions provided at or around the time of childbirth are most critical and accounted for 64% of the impact overall estimated in this quality improvement analysis.

Linking household surveys and health facility assessments to estimate intervention coverage for the Lives Saved Tool (LiST).

BACKGROUND: Calls have been made for improved measurement of coverage for maternal, newborn and child health interventions. Recently, methods linking household and health facility surveys have been used to improve estimation of intervention coverage. However, linking methods rely the availability of household and health facility surveys which are temporally matched. Because nationally representative health facility assessments are not yet routinely conducted in many low and middle income countries, estimates of intervention coverage based on linking methods can be produced for only a subset of countries. Estimates of intervention coverage are a critical input for modelling the health impact of intervention scale-up in the Lives Saved Tool (LiST). The purpose of this study was to develop a data-driven approach to estimate coverage for a subset of antenatal care interventions modeled in LiST. METHODS: Using a five-step process, estimates of population level coverage for syphilis detection and treatment, case management of diabetes, malaria infection, hypertensive disorders, and pre-eclampsia, were computed by linking household and health facility surveys. Based on data characterizing antenatal care and estimates of coverage derived from the linking approach, predictive models for intervention coverage were developed. Updated estimates of coverage based on the predictive models were compared, first with current default proxies, then with estimates based on the linking approach. Model fit and accuracy were assessed using three measures: the coefficient of determination, Pearson's correlation coefficient, and the root mean square error (RMSE). RESULTS: The ability to predict intervention coverage was fairly accurate across all interventions considered. Predictive models accounted for 20-63% of the variance in intervention coverages, and correlation coefficients ranged from 0.5 to 0.83. The predictive model used to estimate coverage of management of pre-eclampsia performed relatively better (RMSE = 0.11) than the model estimating coverage of diabetes case management (RMSE = 0.19). CONCLUSIONS: The new approach to estimate coverage represents an improvement over current default proxies in LiST. As the availability of reliable coverage data improves, impact estimates generated by LiST will improve. This study underscores the need for continued efforts to improve coverage measurement, while bringing to the fore the importance of health facility assessments as complementary data sources.

Modelling stillbirth mortality reduction with the Lives Saved Tool.

BACKGROUND: The worldwide burden of stillbirths is large, with an estimated 2.6 million babies stillborn in 2015 including 1.3 million dying during labour. The Every Newborn Action Plan set a stillbirth target of ≤12 per 1000 in all countries by 2030. Planning tools will be essential as countries set policy and plan investment to scale up interventions to meet this target. This paper summarises the approach taken for modelling the impact of scaling-up health interventions on stillbirths in the Lives Saved tool (LiST), and potential future refinements. METHODS: The specific application to stillbirths of the general method for modelling the impact of interventions in LiST is described. The evidence for the effectiveness of potential interventions to reduce stillbirths are reviewed and the assumptions of the affected fraction of stillbirths who could potentially benefit from these interventions are presented. The current assumptions and their effects on stillbirth reduction are described and potential future improvements discussed. RESULTS: High quality evidence are not available for all parameters in the LiST stillbirth model. Cause-specific mortality data is not available for stillbirths, therefore stillbirths are modelled in LiST using an attributable fraction approach by timing of stillbirths (antepartum/ intrapartum). Of 35 potential interventions to reduce stillbirths identified, eight interventions are currently modelled in LiST. These include childbirth care, induction for prolonged pregnancy, multiple micronutrient and balanced energy supplementation, malaria prevention and detection and management of hypertensive disorders of pregnancy, diabetes and syphilis. For three of the interventions, childbirth care, detection and management of hypertensive disorders of pregnancy, and diabetes the estimate of effectiveness is based on expert opinion through a Delphi process. Only for malaria is coverage information available, with coverage estimated using expert opinion for all other interventions. Going forward, potential improvements identified include improving of effectiveness and coverage estimates for included interventions and addition of further interventions. CONCLUSIONS: Known effective interventions have the potential to reduce stillbirths and can be modelled using the LiST tool. Data for stillbirths are improving. Going forward the LiST tool should seek, where possible, to incorporate these improving data, and to continually be refined to provide an increasingly reliable tool for policy and programming purposes.

Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost?

Progress in newborn survival has been slow, and even more so for reductions in stillbirths. To meet Every Newborn targets of ten or fewer neonatal deaths and ten or fewer stillbirths per 1000 births in every country by 2035 will necessitate accelerated scale-up of the most effective care targeting major causes of newborn deaths. We have systematically reviewed interventions across the continuum of care and various delivery platforms, and then modelled the effect and cost of scale-up in the 75 high-burden Countdown countries. Closure of the quality gap through the provision of effective care for all women and newborn babies delivering in facilities could prevent an estimated 113,000 maternal deaths, 531,000 stillbirths, and 1·325 million neonatal deaths annually by 2020 at an estimated running cost of US$4·5 billion per year (US$0·9 per person). Increased coverage and quality of preconception, antenatal, intrapartum, and postnatal interventions by 2025 could avert 71% of neonatal deaths (1·9 million [range 1·6-2·1 million]), 33% of stillbirths (0·82 million [0·60-0·93 million]), and 54% of maternal deaths (0·16 million [0·14-0·17 million]) per year. These reductions can be achieved at an annual incremental running cost of US$5·65 billion (US$1·15 per person), which amounts to US$1928 for each life saved, including stillbirths, neonatal, and maternal deaths. Most (82%) of this effect is attributable to facility-based care which, although more expensive than community-based strategies, improves the likelihood of survival. Most of the running costs are also for facility-based care (US$3·66 billion or 64%), even without the cost of new hospitals and country-specific capital inputs being factored in. The maximum effect on neonatal deaths is through interventions delivered during labour and birth, including for obstetric complications (41%), followed by care of small and ill newborn babies (30%). To meet the unmet need for family planning with modern contraceptives would be synergistic, and would contribute to around a halving of births and therefore deaths. Our analysis also indicates that available interventions can reduce the three most common cause of neonatal mortality--preterm, intrapartum, and infection-related deaths--by 58%, 79%, and 84%, respectively.

Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial.

BACKGROUND: IMPAACT 1077BF/FF (PROMISE) compared the safety/efficacy of two HIV antiretroviral therapy (ART) regimens to zidovudine (ZDV) alone during pregnancy for HIV prevention. PROMISE found an increased risk of preterm delivery (<37 weeks) with antepartum triple ART (TDF/FTC/LPV+r or ZDV/3TC/LPV+r) compared with ZDV alone. We assessed the impact of preterm birth, breastfeeding, and antepartum ART regimen on 24-month infant survival. METHODS: We compared HIV-free and overall survival at 24 months for liveborn infants by gestational age, time-varying breastfeeding status, and antepartum ART arm at 14 sites in Africa and India. Kaplan-Meier survival probabilities and Cox proportional hazards ratios were estimated. RESULTS: Three thousand four hundred and eighty-two live-born infants [568 (16.3%) preterm and 2914 (83.7%) term] were included. Preterm birth was significantly associated with lower HIV-free survival [0.85; 95% confidence interval (CI) 0.82-0.88] and lower overall survival (0.89; 95% CI 0.86-0.91) versus term birth (0.96; 95% CI 0.95-0.96). Very preterm birth (<34 weeks) was associated with low HIV-free survival (0.65; 95% CI 0.54-0.73) and low overall survival (0.66; 95% CI 0.56-0.74). Risk of HIV infection or death at 24 months was higher with TDF-ART than ZDV-ART (adjusted hazard ratio 2.37; 95% CI 1.21-4.64). Breastfeeding initiated near birth decreased risk of infection or death at 24 months (adjusted hazard ratio 0.05; 95% CI 0.03-0.08) compared with not breastfeeding. CONCLUSION: Preterm birth and antepartum TDF-ART were associated with lower 24-month HIV-free survival compared with term birth and ZDV-ART. Any breastfeeding strongly promoted HIV-free survival, especially if initiated close to birth. Reducing preterm birth and promoting infant feeding with breastmilk among HIV/antiretroviral drug-exposed infants remain global health priorities.

Factors influencing the prioritization of vaccines by policymakers in low- and middle-income countries: a scoping review.

Vaccination decision making in low- and middle-income countries (LMICs) has become increasingly complex, particularly in the context of numerous competing health challenges. LMICs have to make difficult choices on which vaccines to prioritize for introduction while considering a wide range of factors such as disease burden, vaccine impact, vaccine characteristics, financing and health care infrastructures, whilst adapting to each country's specific contexts. Our scoping review reviewed the factors that influence decision-making among policymakers for the introduction of new vaccines in LMICs. We identified the specific data points that are factored into the decision-making process for new vaccine introduction, whilst also documenting whether there have been any changes in decision-making criteria in new vaccine introduction over the last two decades. A comprehensive database search was conducted using a search strategy consisting of key terms and Medical Subject Headings (MeSH) phrases related to policy, decision-making, vaccine introduction, immunization programmes and LMICs. Articles were screened following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 843 articles were identified, with 34 articles retained after abstract screening, full-text screening and grading with the mixed methods appraisal tool (MMAT). The Burchett framework for new vaccine introduction was used to identify indicators for vaccine-decision making and guided data extraction. Articles in our study represented a diverse range of perspectives and methodologies. Across articles, the importance of the disease, which included disease burden, costs of disease and political prioritization, coupled with economic factors related to vaccine price, affordability and financing were the most common criteria considered for new vaccine introduction. Our review identified two additional criteria in the decision-making process for vaccine introduction that were not included in the Burchett framework: communication and sociocultural considerations. Data from this review can support informed decision-making for vaccine introduction amongst policymakers and stakeholders in LMICs.

Impacts of micronutrient intervention programs on effective coverage and lives saved: Modeled evidence from Cameroon.

Policymakers are committed to improving nutritional status and to saving lives. Some micronutrient intervention programs (MIPs) can do both, but not to the same degrees. We apply the Micronutrient Intervention Modeling tool to compare sets of MIPs for (1) achieving dietary adequacy separately for zinc, vitamin A (VA), and folate for children and women of reproductive age (WRA), and (2) saving children's lives via combinations of MIPs. We used 24-h dietary recall data from Cameroon to estimate usual intake distributions of zinc and VA for children 6-59 months and of folate for WRA. We simulated the effects on dietary inadequacy and lives saved of four fortified foods and two VA supplementation (VAS) platforms. We estimated program costs over 10 years. To promote micronutrient-specific dietary adequacy, the economic optimization model (EOM) selected zinc- and folic acid-fortified wheat flour, VA-fortified edible oils, and bouillon cubes, and VAS via Child Health Days in the North macroregion. A different set of cost-effective MIPs emerged for reducing child mortality, shifting away from VA and toward more zinc for children and more folic acid for WRA. The EOM identified more efficient sets of MIPs than the business-as-usual MIPs, especially among programs aiming to save lives.

Oxygen systems strengthening as an intervention to prevent childhood deaths due to pneumonia in low-resource settings: systematic review, meta-analysis and cost-effectiveness.

OBJECTIVES: Increasing access to oxygen services may improve outcomes among children with pneumonia living in low-resource settings. We conducted a systematic review to estimate the impact and cost-effectiveness of strengthening oxygen services in low-income and middle-income countries with the objective of including oxygen as an intervention in the Lives Saved Tool. DESIGN: We searched EMBASE and PubMed on 31 March 2021 using keywords and MeSH terms related to 'oxygen', 'pneumonia' and 'child' without restrictions on language or date. The risk of bias was assessed for all included studies using the quality assessment tool for quantitative studies, and we assessed the overall certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluations. Meta-analysis methods using random effects with inverse-variance weights was used to calculate a pooled OR and 95% CIs. Programme cost data were extracted from full study reports and correspondence with study authors, and we estimated cost-effectiveness in US dollar per disability-adjusted life-year (DALY) averted. RESULTS: Our search identified 665 studies. Four studies were included in the review involving 75 hospitals and 34 485 study participants. We calculated a pooled OR of 0.52 (95% CI 0.39 to 0.70) in favour of oxygen systems reducing childhood pneumonia mortality. The median cost-effectiveness of oxygen systems strengthening was $US62 per DALY averted (range: US$44-US$225). We graded the risk of bias as moderate and the overall certainty of the evidence as low due to the non-randomised design of the studies. CONCLUSION: Our findings suggest that strengthening oxygen systems is likely to reduce hospital-based pneumonia mortality and may be cost-effective in low-resource settings. Additional implementation trials using more rigorous designs are needed to strengthen the certainty in the effect estimate.

Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study.

BACKGROUND: While the COVID-19 pandemic will increase mortality due to the virus, it is also likely to increase mortality indirectly. In this study, we estimate the additional maternal and under-5 child deaths resulting from the potential disruption of health systems and decreased access to food. METHODS: We modelled three scenarios in which the coverage of essential maternal and child health interventions is reduced by 9·8-51·9% and the prevalence of wasting is increased by 10-50%. Although our scenarios are hypothetical, we sought to reflect real-world possibilities, given emerging reports of the supply-side and demand-side effects of the pandemic. We used the Lives Saved Tool to estimate the additional maternal and under-5 child deaths under each scenario, in 118 low-income and middle-income countries. We estimated additional deaths for a single month and extrapolated for 3 months, 6 months, and 12 months. FINDINGS: Our least severe scenario (coverage reductions of 9·8-18·5% and wasting increase of 10%) over 6 months would result in 253 500 additional child deaths and 12 200 additional maternal deaths. Our most severe scenario (coverage reductions of 39·3-51·9% and wasting increase of 50%) over 6 months would result in 1 157 000 additional child deaths and 56 700 additional maternal deaths. These additional deaths would represent an increase of 9·8-44·7% in under-5 child deaths per month, and an 8·3-38·6% increase in maternal deaths per month, across the 118 countries. Across our three scenarios, the reduced coverage of four childbirth interventions (parenteral administration of uterotonics, antibiotics, and anticonvulsants, and clean birth environments) would account for approximately 60% of additional maternal deaths. The increase in wasting prevalence would account for 18-23% of additional child deaths and reduced coverage of antibiotics for pneumonia and neonatal sepsis and of oral rehydration solution for diarrhoea would together account for around 41% of additional child deaths. INTERPRETATION: Our estimates are based on tentative assumptions and represent a wide range of outcomes. Nonetheless, they show that, if routine health care is disrupted and access to food is decreased (as a result of unavoidable shocks, health system collapse, or intentional choices made in responding to the pandemic), the increase in child and maternal deaths will be devastating. We hope these numbers add context as policy makers establish guidelines and allocate resources in the days and months to come. FUNDING: Bill & Melinda Gates Foundation, Global Affairs Canada.

Linking household and health facility surveys to assess obstetric service availability, readiness and coverage: evidence from 17 low- and middle-income countries.

BACKGROUND: Improving access and quality of obstetric service has the potential to avert preventable maternal, neonatal and stillborn deaths, yet little is known about the quality of care received. This study sought to assess obstetric service availability, readiness and coverage within and between 17 low- and middle-income countries. METHODS: We linked health facility data from the Service Provision Assessments and Service Availability and Readiness Assessments, with corresponding household survey data obtained from the Demographic and Health Surveys and Multiple Indicator Cluster Surveys. Based on performance of obstetric signal functions, we defined four levels of facility emergency obstetric care (EmOC) functionality: comprehensive (CEmOC), basic (BEmOC), BEmOC-2, and low/substandard. Facility readiness was evaluated based on the direct observation of 23 essential items; facilities "ready to provide obstetric services" had ≥20 of 23 items available. Across countries, we used medians to characterize service availability and readiness, overall and by urban-rural location; analyses also adjusted for care-seeking patterns to estimate population-level coverage of obstetric services. RESULTS: Of the 111 500 health facilities surveyed, 7545 offered obstetric services and were included in the analysis. The median percentages of facilities offering EmOC and "ready to provide obstetric services" were 19% and 10%, respectively. There were considerable urban-rural differences, with absolute differences of 19% and 29% in the availability of facilities offering EmOC and "ready to provide obstetric services", respectively. Adjusting for care-seeking patterns, results from the linking approach indicated that among women delivering in a facility, a median of 40% delivered in facilities offering EmOC, and 28% delivered in facilities "ready to provide obstetric services". Relatively higher coverage of facility deliveries (≥65%) and coverage of deliveries in facilities "ready to provide obstetric services" (≥30% of facility deliveries) were only found in three countries. CONCLUSIONS: The low levels of availability, readiness and coverage of obstetric services documented represent substantial missed opportunities within health systems. Global and national efforts need to prioritize upgrading EmOC functionality and improving readiness to deliver obstetric service, particularly in rural areas. The approach of linking health facility and household surveys described here could facilitate the tracking of progress towards quality obstetric care.

Pushing the envelope through the Global Financing Facility: potential impact of mobilising additional support to scale-up life-saving interventions for women, children and adolescents in 50 high-burden countries.

INTRODUCTION: The Global Financing Facility (GFF) was launched to accelerate progress towards the Sustainable Development Goals (SDGs) through scaled and sustainable financing for Reproductive, Maternal, Newborn, Child and Adolescent Health and Nutrition (RMNCAH-N) outcomes. Our objective was to estimate the potential impact of increased resources available to improve RMNCAH-N outcomes, from expanding and scaling up GFF support in 50 high-burden countries. METHODS: The potential impact of GFF was estimated for the period 2017-2030. First, two scenarios were constructed to reflect conservative and ambitious assumptions around resources that could be mobilised by the GFF model, based on GFF Trust Fund resources of US$2.6 billion. Next, GFF impact was estimated by scaling up coverage of prioritised RMNCAH-N interventions under these resource scenarios. Resource availability was projected using an Excel-based model and health impacts and costs were estimated using the Lives Saved Tool (V.5.69 b9). RESULTS: We estimate that the GFF partnership could collectively mobilise US$50-75 billion of additional funds for expanding delivery of life-saving health and nutrition interventions to reach coverage of at least 70% for most interventions by 2030. This could avert 34.7 million deaths-including preventable deaths of mothers, newborns, children and stillbirths-compared with flatlined coverage, or 12.4 million deaths compared with continuation of historic trends. Under-five and neonatal mortality rates are estimated to decrease by 35% and 34%, respectively, and stillbirths by 33%. CONCLUSION: The GFF partnership through country- contextualised prioritisation and innovative financing could go a long way in increasing spending on RMNCAH-N and closing the existing resource gap. Although not all countries will reach the SDGs by relying on gains from the GFF platform alone, the GFF provides countries with an opportunity to significantly improve RMNCAH-N outcomes through achievable, well-directed changes in resource allocation.

Expanding the population coverage of evidence-based interventions with community health workers to save the lives of mothers and children: an analysis of potential global impact using the Lives Saved Tool (LiST).

BACKGROUND: Evidence has been accumulating that community health workers (CHWs) providing evidence-based interventions as part of community-based primary health care (CBPHC) can lead to reductions in maternal, neonatal and child mortality. However, investments to strengthen and scale-up CHW programs still remain modest. METHODS: We used the Lives Saved Tool (LiST) to estimate the number of maternal, neonatal and child deaths and stillbirths that could be prevented if 73 countries effectively scaled up the population coverage of 30 evidence-based interventions that CHWs can deliver in these high-burden countries. We set population coverage targets at 50%, 70%, and 90% and summed the country-level results by region and by all 73 high-burden countries combined. We also estimated which specific interventions would save the most lives. FINDINGS: LiST estimates that a total of 3.0 (sensitivity bounds 1.8-4.0), 4.9 (3.1-6.3) and 6.9 (3.7-8.7) million deaths would be prevented between 2016 and 2020 if CBPHC is gradually scaled up during this period and if coverage of key interventions reaches 50%, 70%, and 90% respectively. There would be 14%, 23%, and 32% fewer deaths in the final year compared to a scenario assuming no intervention coverage scale up. The Africa Region would receive the most benefit by far: 58% of the lives saved at 90% coverage would be in this region. The interventions contributing the greatest impact are nutritional interventions during pregnancy, treatment of malaria with artemisinin compounds, oral rehydration solution for childhood diarrhea, hand washing with soap, and oral antibiotics for pneumonia. CONCLUSIONS: Scaling up CHW programming to increase population-level coverage of life-saving interventions represents a very promising strategy to achieve universal health coverage and end preventable maternal and child deaths by 2030. Numerous practical challenges must be overcome, but there is no better alternative at present. Expanding the coverage of key interventions for maternal nutrition and treatment of childhood illnesses, in particular, may produce the greatest gains. Recognizing the millions of lives of mothers and their young offspring that could be achieved by expanding coverage of evidence-based interventions provided by CHWs and strengthening the CBPHC systems that support them underscores the pressing need for commitment from governments and donors over the next 15 years to prioritize funding, so that robust CHW platforms can be refined, strengthened, and expanded.

Clearing the Cervical Spine in a War Zone: What Other Injuries Matter?

BACKGROUND: Cervical spine clearance requires clinicians to assess the reliability of physical examination based on a patient's mental status and distracting injuries. Distracting injuries have never been clearly defined in military casualties. METHODS: Retrospective review was conducted of patients entered into Department of Defense Trauma Registry January 2008 to August 2013, identifying blunt trauma patients with cervical spine injury and Glasgow Coma Score ≥ 14. Physical examination and radiology results were abstracted from medical records and injury diagnoses were obtained from Department of Defense Trauma Registry. Groups were compared, p-value of < 0.05 was considered significant. RESULTS: A total of 149 patients met study criteria; 20 patients (13%) had a negative clinical examination of the cervical spine. Coexisting injuries identified in patients with negative physical examination included injuries in proximity to the neck (head, thoracic spine, chest, or humerus) in 17 (85%) patients. In 3 patients (15%), coexisting injuries were not in proximity to the neck and included pelvic, femur, and tibia fractures. All patients without coexisting injury (n = 37) had a positive physical examination. CONCLUSION: Physical examination of multitrauma casualties with neck injury may be unreliable when distracting injuries are present. When no distracting injuries were present, the physical examination was accurate in all patients.

The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.

OBJECTIVE: To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting. METHODS: The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification. RESULTS: In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery. CONCLUSIONS: Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.