<p><strong>BACKGROUND: </strong>The goal of regionalized perinatal care, specifically levels of maternal care, is to improve maternal outcomes through risk-appropriate obstetric care. Studies of levels of maternal care are limited by current approaches to identify a hospital's level of care, often relying on hospital self-reported data, which is expensive and challenging to collect and validate. The study objective was to develop an empiric approach to determine a hospital's level of maternal care using administrative data reflective of the patient care provided and apply this approach to describe the levels of maternal care available over time.</p>

<p><strong>METHODS: </strong>Retrospective cohort study of mother-infant dyads who delivered in California, Missouri, and Pennsylvania hospitals from 2000 to 2009. Linked mother-infant administrative records with an infant born at 24-44 weeks' gestation and a birth weight of 400-8000 g were included. Using the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine descriptions of levels of maternal care, four levels were classified based on the appropriate location of care for patients with specific medical or pregnancy conditions. Individual hospitals were assigned a level of maternal care annually based on the volume of patients who delivered reflective of the four classified levels as determined by International Classification of Diseases and Current Procedural Terminology.</p>

<p><strong>RESULTS: </strong>Based on the included 6,895,000 mother-infant dyads, the obstetric hospital levels of maternal care I, II, III and IV were identified. High-risk patients more frequently delivered in hospitals with higher level maternal care, accounting for 8.9, 10.9, 13.8, and 16.9% of deliveries in level I, II, III and IV hospitals, respectively. The total number of obstetric hospitals decreased over the study period, while the proportion of hospitals with high-level (level III or IV) maternal care increased. High-level hospitals were located in more densely populated areas.</p>

<p><strong>CONCLUSION: </strong>Identification of the level of maternal care, independent of hospital self-reported variables, is feasible using administrative data. This empiric approach, which accounts for changes in hospitals over time, is a valuable framework for perinatal researchers and other stakeholders to inexpensively identify measurable benefits of levels of maternal care and characterize where specific patient populations receive care.</p>

<p><strong>BACKGROUND: </strong>Maternal mortality is higher among Black compared to White people in the United States. Whether Black-White disparities in maternal in-hospital mortality during the delivery hospitalization vary across hospital types (Black-serving vs. non-Black-serving and teaching vs. non-teaching) and whether overall maternal mortality differs across hospital types is not known.</p>

<p><strong>OBJECTIVES: </strong>1) Determine whether risk-adjusted Black-White disparities in maternal mortality during the delivery hospitalization vary by hospital types - this is analysis of disparities in mortality within hospital types. 2) Compare risk-adjusted in-hospital maternal mortality among Black-serving and non-Black-serving teaching and non-teaching hospitals regardless of race - this is an analysis of overall mortality across hospital types.</p>

<p><strong>STUDY DESIGN: </strong>We performed a population-based, retrospective cohort study of 5,679,044 deliveries among Black (14.2%) and White (85.8%) patients in three states (CA, MO, PA) from 1995-2009. A hospital discharge disposition of "death" defined maternal in-hospital mortality. Black-serving hospitals had at least 7% Black obstetric patients (top quartile). We performed risk adjustment by calculating expected death rates using predictions from logistic regression models incorporating sociodemographics, rurality, comorbidities, multiple gestations, gestational age at delivery, year, state, and mode of delivery. We calculated risk-adjusted risk ratios of mortality by comparing observed:expected ratios among Black and White patients within hospital types and then examined mortality across hospital types, regardless of patient race. We quantified the proportion of Black-White disparities in mortality attributable to delivering in Black-serving hospitals using causal mediation analysis.</p>

<p><strong>RESULTS: </strong>There were 330 maternal deaths among 5,679,044 patients (5.8 per 100,000). Black patients died more often (11.5 per 100,000) than White patients (4.8 per 100,000) (RR 2.38, 95% CI: 1.89-2.98). Examination of Black-White disparities revealed that after risk adjustment, Black patients had significantly greater risk of death (adjusted RR 1.44, 95% CI 1.17-1.79) and that the disparity was similar within each of the hospital types. Comparison of mortality, regardless of race, across hospital types, revealed that among teaching hospitals, mortality was similar in Black-serving and non-Black-serving hospitals. However, among non-teaching hospitals, mortality was significantly higher in Black-serving versus non-Black-serving hospitals (adjusted RR 1.47, 95% CI: 1.15-1.87). Notably, 53% of Black patients delivered in non-teaching, Black-serving hospitals, compared with just 19% of White patients. Among non-teaching hospitals, 47% of Black-White disparities in maternal in-hospital mortality attributable to delivering at Black-serving hospitals.</p>

<p><strong>CONCLUSION: </strong>Maternal in-hospital mortality during the delivery hospitalization among Black patients is more than double that of White patients. Our data suggest this disparity is due to both excess mortality among Black patients within each hospital type, in addition to excess mortality in non-teaching, Black-serving hospitals where most Black patients deliver. Addressing downstream effects of racism to achieve equity in maternal in-hospital mortality will require transparent reporting of quality metrics by race to reduce differential care and outcomes within hospital types, improvements in care delivery at Black-serving hospitals, overcoming barriers to accessing high-quality care among Black patients, and eventually desegregation of healthcare.</p>

<p><strong>BACKGROUND/AIMS: </strong>Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation.</p>

<p><strong>METHODS: </strong>We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.</p>

<p><strong>RESULTS: </strong>Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively; = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3), &lt; 0.001.</p>

<p><strong>CONCLUSION: </strong>Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.</p>

<p><strong>OBJECTIVE: </strong>Examine the adoption and presence of preterm, neuro-centric care practices across neonatal intensive care units (NICUs).</p>

<p><strong>STUDY DESIGN: </strong>Statewide, cross-sectional survey of California NICUs. Data were collected surrounding the timing of adoption and presence of delivery room practices, nursing protocols, provider management practices and quality improvement initiatives.</p>

<p><strong>RESULT: </strong>Among the 95 NICUs completing the survey (65%), adoption of all surveyed practices increased between 2005 and 2016, though rates of uptake changed over time and varied by practice. Adoption of indomethacin prophylaxis increased 1.8-fold, whereas delayed cord clamping increased 78-fold. Adoption of premedication for intubation and a patent ductus arteriosus management algorithm differed by unit level. Additionally, two underlying practice domains were identified; adoption of delivery room practices and adoption of any preterm practice.</p>

<p><strong>CONCLUSION: </strong>Adoption of preterm, neuro-centric care practices across California NICUs has increased, though uptake patterns vary by practice and level.</p>