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Background: Ending preventable newborn deaths is a global health priority, but efforts to improve coverage of maternal and newborn care have not yielded expected gains in infant survival in many settings. One possible explanation is poor quality of clinical care. We assess facility quality and estimate the association of facility quality with neonatal mortality in Malawi. Methods and Findings: Data on facility infrastructure as well as processes of routine and basic emergency obstetric care for all facilities in the country were obtained from 2013 Malawi Service Provision Assessment. Birth location and mortality for children born in the preceding two years were obtained from the 2013–2014 Millennium Development Goals Endline Survey. Facilities were classified as higher quality if they ranked in the top 25% of delivery facilities based on an index of 25 predefined quality indicators. To address risk selection (sicker mothers choosing or being referred to higher-quality facilities), we employed instrumental variable (IV) analysis to estimate the association of facility quality of care with neonatal mortality. We used the difference between distance to the nearest facility and distance to a higher-quality delivery facility as the instrument. Four hundred sixty-seven of the 540 delivery facilities in Malawi, including 134 rated as higher quality, were linked to births in the population survey. The difference between higher- and lower-quality facilities was most pronounced in indicators of basic emergency obstetric care procedures. Higher-quality facilities were located a median distance of 3.3 km further from women than the nearest delivery facility and were more likely to be in urban areas. Among the 6,686 neonates analyzed, the overall neonatal mortality rate was 17 per 1,000 live births. Delivery in a higher-quality facility (top 25%) was associated with a 2.3 percentage point lower newborn mortality (95% confidence interval [CI] -0.046, 0.000, p-value 0.047). These results imply a newborn mortality rate of 28 per 1,000 births at low-quality facilities and of 5 per 1,000 births at the top 25% of facilities, accounting for maternal and newborn characteristics. This estimate applies to newborns whose mothers would switch from a lower-quality to a higher-quality facility if one were more accessible. Although we did not find an indication of unmeasured associations between the instrument and outcome, this remains a potential limitation of IV analysis. Conclusions: Poor quality of delivery facilities is associated with higher risk of newborn mortality in Malawi. A shift in focus from increasing utilization of delivery facilities to improving their quality is needed if global targets for further reductions in newborn mortality are to be achieved.
The original survey implementers obtained ethical approvals for data collection; the Harvard University Human Research Protection Program deemed this analysis exempt from human subjects review. Data on health facilities were obtained from the 2013 Service Provision Assessment (SPA), a census of health facilities conducted by the DHS program. The SPA includes an audit of facility resources, surveys on clinical practices, and direct observation of delivery in larger facilities. Data on child survival were obtained from the 2013–2014 MDG Endline Survey (MES), a multiple indicator cluster survey (MICS) conducted in collaboration between the Malawi government and the United Nations Children’s Fund (UNICEF). The MES is a nationally representative household survey that employed a multi-stage stratified sampling strategy to identify households within enumeration areas (EAs) drawn from the 2008 census. Spatial locations of all EAs in the MES were obtained from the Malawi National Statistical Office. We grouped facilities based on type and management authority in the SPA survey to create categories matching response options to the MES question on delivery location. We linked all women delivering in institutions to the nearest facility of the type in which she delivered (e.g., government hospital) by direct distance from the geographic centroid of her EA. Based on prior studies suggesting women are unlikely to deliver far from home [18–20], we excluded women matching to facilities over 50 km away, as these women were likely in another area for childbirth. Neonatal mortality was defined as death within the first 28 days of life [2] among all children born in the two years prior to interview date. We reviewed the framework of quality of care for pregnant women and newborns endorsed by the World Health Organization (WHO) [21] and identified domains characterizing provision of care at the ultimate delivery facility: infrastructure, human resources, essential supplies, and evidence-based practices in routine and emergency care. We then used the WHO Safe Childbirth Checklist in combination with existing evidence on interventions most likely to avert maternal and neonatal death [11,15,22,23] to identify 25 quality criteria available in the SPA survey (listed in Fig 2). In keeping with prior research [24], the overall quality score was based on the proportion of criteria met, with missing items excluded from the calculation of the score for that facility. Facilities were missing data for only two items: staff training (15% missing) and partograph use (1.9%). We classified a facility as a “higher-quality facility” if it met more than 18 of 25 criteria, corresponding to the 75th percentile of the quality score distribution for all delivery facilities. Legend: BCG, Bacille Calmette-Guérin vaccine; LBW, low birth weight. Sixty-two facilities (13.3%) were missing data on staff training and eight (1.7%) were missing data on partograph use. Percentages shown are out of facilities with non-missing data per indicator. We created an alternative quality metric for sensitivity analyses. For the subset of facilities with clinical observations, we combined the 25-item quality index with a validated metric of quality of process of intrapartum and immediate postpartum care from direct observation of deliveries (45 items total) [25]. We obtained data on socioeconomic status (household wealth index, educational attainment above secondary), maternal demographics (age, marital status), and pregnancy characteristics (parity, maternal age under 18, receipt of any antenatal care [ANC], and receipt of the minimum recommended four ANC visits) for each mother from the MES [26]. We also included other variables that have been shown to be associated with increased mortality risk: male gender, multiple birth, and LBW (defined as ≤2.5 kilograms or very small by maternal report if weight not available). We identified the SPA survey and MES sample in Malawi as a unique combination of data that permitted us to directly link facility quality to a population-representative sample of births. To address likely biases resulting from the nonrandom and unmeasured selection of more complicated deliveries into referral facilities, we selected IV analysis as the appropriate empirical strategy. We chose relative distance to quality care as the instrument based on existing health systems research in high-income settings [27–30]. Key domains of maternal care quality were identified from global guidelines following prior analytic work [24]; we refined this index after receiving the data based on the specific indicators available in the Malawi SPA survey. We prespecified an additive summary measure, as is standard practice in this field [31], and focused on a binary quality indicator for simplicity in our main empirical model. Given that clear and objective thresholds for sufficient quality are not currently available, we classified the top 25% of all facilities in our sample as higher-quality in our initial model and then explored two alternative cutoffs as well as the continuous quality score. We conducted an exploratory assessment of the shape of the relationship between quality and mortality, defining higher quality as the top 75%, top 50%, and top 10% of facilities in turn. We present separate descriptive statistics for delivery facilities and births. Delivery facilities were defined as SPA facilities offering delivery services with at least one birth in the MES sample. Maternal and infant characteristics were weighted by the MES women’s sampling weight, rescaled to the analytic sample. We describe mortality by region and facility type and assess significance using an F-test corrected for clustering. We first modeled mortality against delivering in a higher-quality facility in unadjusted linear regression. As we anticipated unmeasured selection of complicated deliveries into referral facilities would bias the relationship between delivery in a higher-quality facility and newborn survival, we employed IV analysis using the difference between distance to the nearest delivery facility and distance to a higher-quality facility as the instrument. We selected this instrument on the assumption that, for a given level of remoteness from the health system, the relative location of a higher-quality facility is random. By using differential distance rather than direct distance to quality care, we explicitly account for systematically higher health risks related to living in areas with limited access to the health system. To be a valid instrument, differential distance must relate to mortality only through facility quality and not through a direct causal link or any shared common causes. Based on the distribution of measured confounders across contextual factors, we identified urban location and health system density as key control variables to eliminate other possible links between differential distance and neonatal outcomes. Health system density was defined as the natural log of one plus the number of health facilities within 20 km of the center of the EA. The IV analysis estimates a local average treatment effect (LATE), i.e., the effect of delivering in a higher-quality facility among women whose choice is affected by relative distance [32]. We present further details on the causal model, an assessment of the underlying assumptions, falsification tests [33], and estimation of bounds for the LATE estimate if assumptions do not hold in the Supporting Information (S1–S3 Texts). We plotted predicted probability of delivering in a higher-quality facility and of neonatal mortality against differential distance using a fractional polynomial plot to visualize the relationships among distance, quality, and mortality. We used two-stage least squares to fit a linear probability model of mortality on delivering in a higher-quality facility; linear probability models are standard in IV analysis [29]. In addition to urban residence and density of the health system, we controlled for maternal socioeconomic status and maternal and infant characteristics associated with mortality to increase precision in the estimate [33]. Observations with missing covariates (18, 0.3%) were excluded from the analysis. All analyses accounted for stratified sampling and clustering within EAs. We performed several robustness checks on the measurement of quality. To assess sensitivity to the threshold chosen for high quality, we (A) increased the threshold to an absolute standard of 0.80 of 1.00 score on the quality index, (B) lowered the threshold of high quality to include the top tertile of facilities, and (C) employed the continuous standardized quality index in place of the binary indicator of high quality. To check the measure construction, we applied principal components analysis (PCA) to create a weighted summary of the 25 items. To validate the content used to construct the quality metric, we employed the composite index described above that included direct observation of deliveries, the gold standard of clinical quality measurement. This analysis was limited to the facilities where observations occurred. We conducted two additional analyses to assess whether simpler measures of quality would show the same relationship as the facility quality index. We used hospital delivery as the exposure and differential distance to nearest hospital as an instrument. Secondly, we measured overall facility capacity using seven indicators of scope of services available [7] and used this index to define higher-quality facilities (top 25%) and to calculate differential distance to such facilities. We repeated all analyses using a probit model, which bounds the outcome between 0 and 1, to compare with the findings of the linear probability model.
