The entwined circles of quality improvement & advocacy.

Health policy and quality improvement initiatives exist symbiotically. Quality projects can be spurred by policy decisions, such as the creation of financial incentives for high-value care. Then, advocacy can streamline high-value care, offering opportunities for quality improvement scholars to create projects consistent with evidenced-based care. Thirdly, as pediatrics and neonatology reconcile with value-based payment structures, successful quality initiatives may serve as demonstration projects, illustrating to policy-makers how best to allocate and incentivize resources that optimize newborn health. And finally, quality improvement (QI) can provide an essential link between broad reaching advocacy principles and boots-on-the-ground local or regional efforts to implement good ideas in ways that work practically in particular environments. In this paper, we provide examples of how national legislation elevated the importance of QI, by penalizing hospitals for low quality care. Using Medicaid coverage of pasteurized human donor milk as an example, we discuss how advocacy improved cost-effectiveness of treatments used as tools for quality projects related to reduction of necrotizing enterocolitis and improved growth. We discuss how the future of QI work will assist in informing the agenda as neonatology transitions to value-based care. Finally, we consider how important local and regional QI work is in bringing good ideas to the bedside and the community.

Prospective comparison of positron emission tomography (PET)/magnetic resonance and PET/computed tomography dosimetry in hepatic malignant neoplastic disease after 90Y radioembolization treatment.

Background: 90Y radioembolization is an established treatment modality for hepatic malignancies. Successful radioembolization requires optimal dose delivery to tumors while minimizing dosages to parenchyma. Post-treatment positron emission tomography (PET)/computed tomography (CT) dosimetry is the established benchmark, whereas PET/magnetic resonance (MR) is an emerging modality. The goal of this study was to assess the intermodality agreement between PET/MR and PET/CT 90Y dosimetry. Methods: In this single-institution study, 18 patients (20 treatment sessions) with a primary or metastatic hepatic malignancy underwent both PET/MR and PET/CT after 90Y radioembolization. Patients were randomized to undergo one modality first, followed by the other. The region of interest was delineated using MR images and tumor and liver dosimetry was calculated. Intermodality agreement was assessed using the Bland-Altman method. A generalized linear model was used to assess the effect of baseline variables on intermodality dose differences. Results: PET/MR underestimated tumor and liver absorbed doses when compared to PET/CT by -3.7% (P=0.042) and -5.8% (P=0.029), respectively. A coverage probability plot demonstrated that 80% and 90% of tumor dose measurements fell within intermodality differences of 11% and 18%, respectively. PET/MR underestimated tumor dose at both low (<1 GBq) and high (>3 GBq) injected activity levels (P<0.001) by -22.3 [standard deviation (SD) =13.5] and -24.3 (SD =18.7), respectively. Conclusions: Although PET/MR significantly underestimated the absorbed dose when compared to PET/CT, the intermodality agreement was high and the degree of underestimation was better than previously reported. Intermodality differences were more pronounced at low and high injected doses. Additional studies are required to assess the clinical implications of these findings.

Prediction of Mortality and Hepatic Encephalopathy after Transjugular Intrahepatic Portosystemic Shunt Placement: Baseline and Longitudinal Body Composition Measurement.

PURPOSE: To investigate effects of baseline and early longitudinal body composition changes on mortality and hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS). MATERIALS AND METHODS: This is a case-control study with analysis of a TIPS registry (1995-2020) including data from patients with cirrhosis with computed tomography (CT) scans obtained within 1 month before and 3 months after TIPS. Core muscle area (CMA), macroscopic subcutaneous adipose tissue (mSAT), macroscopic visceral adipose tissue (mVAT) area, and muscle adiposity index (MAI) on CT were obtained. Multipredictor Cox proportional hazards models were used to assess the effect of body composition variables on mortality or HE. RESULTS: In total, 280 patients (158 men; median age, 57.0 years; median Model for End-stage Liver Disease-sodium [MELD-Na] score, 14.0) were included. Thirty-four patients had post-TIPS imaging. Median baseline CMA was 68.3 cm2 (interquartile range, 57.7-83.5 cm2). Patients with higher baseline CMA had decreased risks of mortality (hazard ratio [HR]: 0.82; P = .04) and HE (HR: 0.82; P = .009). It improved prediction of mortality over MELD-Na and post-TIPS right atrial pressure alone (confidence interval = 0.729). An increase in CMA (HR: 0.60; P = .043) and mSAT (HR: 0.86; P = .022) or decrease in MAI (HR: 1.50; P = .049) from before to after TIPS was associated with a decreased risk of mortality. An increase in mSAT was associated with an increased risk of HE (HR: 1.11; P = .04). CONCLUSIONS: CMA on CT scan 1 month before TIPS placement predicts mortality and HE in patients with cirrhosis. Changes in body composition on CT measured 3 months after TIPS placement independently predict mortality and HE.

Comparison of birth outcomes of mothers covered by Medicaid versus those privately insured when accounting for social determinants of health.

OBJECTIVES: To determine the association between maternal health insurance type and birth outcomes [prematurity, small for gestational age (SGA), Term/Appropriate for gestational age NICU admission (Term/AGA-NICU) & composite birth outcomes (CBO)] accounting for social determinants of health. DESIGN/METHODS: A cross-sectional study of maternal surveys and birth certificate data of singleton live births in NY born to mothers with Medicaid (M) or Private Insurance (PI). RESULTS: 1015 mothers [M = 631, PI = 384) included. Individual birth outcomes did not differ between groups. Adjusting for social, demographic and clinical covariates, M mothers had similar odds of preterm birth, SGA, Term/AGA-NICU admission and CBO compared to PI. CONCLUSIONS: M mothers were as likely as PI mothers to deliver a preterm, SGA or a Term/AGA-NICU infant after controlling for social determinants of health. Despite more social adversity among enrollees, our study suggests NY Medicaid recipients have similar birth outcomes to privately insured, socially advantaged women.

Selective Use of Neoadjuvant Targeted Therapy Is Associated with Greater Achievement of Partial Nephrectomy for High-complexity Renal Masses in a Solitary Kidney.

Background: Partial nephrectomy (PN) is preferred for a renal mass in a solitary kidney (RMSK), although tumors with high complexity can be challenging. Objective: To evaluate the evolution of RMSK management with a focus on achievement of PN. Design setting and participants: Patients with nonmetastatic RMSK (n = 499) were retrospectively reviewed; 133 had high tumor complexity, including 80 in the pre-tyrosine kinase inhibitor (TKI) era (1999-2008) and 53 in the TKI era (2009-2022). After 2009, 23/53 patients received neoadjuvant TKI and 30/53 had immediate-surgery. Outcome measurements and statistical analysis: Functional outcomes, adverse events and complications, dialysis-free survival, and recurrence-free survival (RFS) were the measures evaluated. Mann-Whitney and χ2 tests were used to compare cohorts, and the log-rank test was applied for survival analyses. Results and limitations: Overall, the median RENAL score was 10 and the median tumor diameter was 5.2 cm. Demographic characteristics, tumor diameter, and RENAL scores were similar between the pre-TKI-era and TKI-era groups. In the TKI era, 23/53 patients (43%) with clear-cell histology were selected for neoadjuvant TKI. These 23 patients had a greater median tumor diameter (7.1 vs 4.4 cm; p = 0.02) and RENAL score (11 vs 10; p = 0.07). After TKI treatment, the median tumor diameter decreased to 5.6 cm and the RENAL score to 9, and tumor volume was reduced by 59% (all p < 0.05). PN was accomplished in 21/23 (91%) the TKI-treated cases and in 27/30 (90%) of the immediate-surgery cases (2009-2022). PN was only accomplished in 52/80 (65%) of the patients from the pre-TKI era (p < 0.01). The 5-yr dialysis-free survival rate was 59% in the pre-TKI-era group and 91% in the TKI-era group. The 5-yr RFS rate was lower in the TKI-era group (59% vs 74%; p = 0.21), which was mostly related to more aggressive tumor biology, as reflected by a predominance of systemic rather than local recurrences. Conclusions: Management of RMSK with high tumor complexity is challenging. Selective use of TKI therapy was associated with greater use of PN, although a randomized study is needed. RFS mostly reflected aggressive tumor biology rather than failure of local management. Patient summary: For complex kidney tumors in patients with a single kidney, management is challenging. Use of drugs called tyrosine kinase inhibitors before surgery was associated with reductions in tumor size and greater ability to achieve partial kidney removal for cancer control. Most recurrences were metastatic, which reflects aggressive tumor biology rather than failure of surgery.

Expanding Medicaid Payment for Pasteurized Donor Human Milk in High-Risk Neonates.

Pasteurized donor human milk (PDHM) is associated with a reduced incidence of necrotizing enterocolitis in very low birth weight (VLBW) infants. Absence of Medicaid and private insurance payment for PDHM use in neonatal intensive care units contributes to disparities based on state of birth and socioeconomic level. Before 2017, 5 states had policies for PDHM coverage, incorporating less than 30% of VLBW infants born nationally. In this case study, we outline the partnership of local American Academy of Pediatrics (AAP) chapters with the national AAP Section on Neonatal-Perinatal Medicine to create a PDHM Advocacy Toolkit to facilitate Medicaid PDHM coverage. Over 5 years, neonatologist-led advocacy, incentivized via AAP funds, contributed to 5 additional states providing Medicaid payment for PDHM, resulting in over 55% of VLBW infants born nationally in states with funded coverage. Partnerships with state AAP chapters, pilot grant funding with deliverables, emphasis on advocacy coaching, and modification of the generalized toolkit to suit local needs were essential in engineering Medicaid PDHM payment. Together these actions provide a template for other pediatric subspecialists to help advance niche-focused advocacy issues at the state level.

Advocacy in neonatology: current issues and introduction to the series.

Advocacy is an increasingly important skill for neonatologists. As social factors play a greater influence on short & long-term newborn outcomes, neonatal physicians must be attentive to policy factors and work to ensure they benefit the health of both patients and the specialty. In this article, we review advocacy issues of current relevance to neonatal practice, including the "Born Alive Executive Order," the "Newborn Screening Saves Lives Act," subspecialty loan repayment and legislation related to donor human milk, as well as introduce topics further discussed as part of the American Academy of Pediatrics Section on Neonatal-Perinatal Medicine Advocacy Series.

Gastrointestinal malignancies in pregnancy.

Gastrointestinal malignancies, though uncommon in pregnancy, present several unique challenges with regards to diagnosis, staging, and treatment. Imaging the pregnant patient with a suspected or confirmed GI malignancy requires modifications to the radiologic modality of choice and protocol in order to minimize harm to the fetus, ensure accuracy in diagnosis and staging and guide treatment decisions. In this review article, we discuss the imaging approach to the pregnant patient with GI cancer, including safe radiologic modalities and modifications to imaging protocols. We also review the most common GI cancers encountered in pregnancy, including colorectal, pancreatic, gastric, and small bowel tumors, with emphasis to imaging findings, staging, and treatment considerations.

Association between CT-based body composition assessment and patient outcomes during neoadjuvant chemotherapy for epithelial ovarian cancer.

OBJECTIVE: The aim of this study was to characterize the body composition of patients undergoing neoadjuvant chemotherapy (NACT) for epithelial ovarian cancer (EOC), identify factors associated with sarcopenia at diagnosis, and evaluate the impact of pretreatment sarcopenia and changes in body composition parameters during therapy on perioperative and disease-related outcomes. METHODS: Patients undergoing NACT for EOC between 2008 and 2020 were identified. Pre-treatment and post-treatment contrast-enhanced CT scans were reviewed to determine skeletal muscle index (SMI) and visceral adipose tissue (VAT) area at the mid-fourth lumbar vertebral level. SMI and VAT were analyzed for association with clinical and treatment variables. RESULTS: 174 patients were identified. Mean pretreatment SMI and VAT were 38.3 cm2/m2 ± 7.9 and 51.2 cm2/m2 ± 34.3, respectively. Comparatively, mean post-treatment SMI and VAT were 37.8 cm2/m2 ± 7.9 and 43.7 cm2/m2 ± 29.7, respectively. Most patients exhibited an overall decrease in SMI from pretreatment to posttreatment scans. Caucasian race, older age, and lower body mass index at diagnosis were associated with lower pretreatment SMI. Lower pre-treatment SMI was associated with lower surgical complexity scores (p < 0.001) and estimated blood loss (p = 0.029). Decrease in SMI after NACT was associated with increased rates of ICU admissions and length of stay. While there was no association between SMI and overall survival (OS) or progression-free survival (PFS), >2% decrease per 100 days in VAT was significantly associated with worse OS. CONCLUSIONS: Patients with lower pretreatment SMI tend to undergo less complex surgery than those with higher SMI despite NACT. Decrease in VAT may be a potential indicator of worse OS. Information on body composition can aid in clinical decision making in patients with EOC.

Changes in abdominal adipose tissue depots assessed by MRI correlate with hepatic histologic improvement in non-alcoholic steatohepatitis.

BACKGROUND & AIMS: Non-alcoholic steatohepatitis (NASH) is prevalent in adults with obesity and can progress to cirrhosis. In a secondary analysis of prospectively acquired data from the multicenter, randomized, placebo-controlled FLINT trial, we investigated the relationship between reduction in adipose tissue compartment volumes and hepatic histologic improvement. METHODS: Adult participants in the FLINT trial with paired liver biopsies and abdominal MRI exams at baseline and end-of-treatment (72 weeks) were included (n = 76). Adipose tissue compartment volumes were obtained using MRI. RESULTS: Treatment and placebo groups did not differ in baseline adipose tissue volumes, or in change in adipose tissue volumes longitudinally (p = 0.107 to 0.745). Deep subcutaneous adipose tissue (dSAT) and visceral adipose tissue volume reductions were associated with histologic improvement in NASH (i.e., NAS [non-alcoholic fatty liver disease activity score] reductions of ≥2 points, at least 1 point from lobular inflammation and hepatocellular ballooning, and no worsening of fibrosis) (p = 0.031, and 0.030, respectively). In a stepwise logistic regression procedure, which included demographics, treatment group, baseline histology, baseline and changes in adipose tissue volumes, MRI hepatic proton density fat fraction (PDFF), and serum aminotransferases as potential predictors, reductions in dSAT and PDFF were associated with histologic improvement in NASH (regression coefficient = -2.001 and -0.083, p = 0.044 and 0.033, respectively). CONCLUSIONS: In adults with NASH in the FLINT trial, those with greater longitudinal reductions in dSAT and potentially visceral adipose tissue volumes showed greater hepatic histologic improvements, independent of reductions in hepatic PDFF. CLINICAL TRIAL NUMBER: NCT01265498. IMPACT AND IMPLICATIONS: Although central obesity has been identified as a risk factor for obesity-related disorders including insulin resistance and cardiovascular disease, the role of central obesity in non-alcoholic steatohepatitis (NASH) warrants further clarification. Our results highlight that a reduction in central obesity, specifically deep subcutaneous adipose tissue and visceral adipose tissue, may be related to histologic improvement in NASH. The findings from this analysis should increase awareness of the importance of lifestyle intervention in NASH for clinical researchers and clinicians. Future studies and clinical practice may design interventions that assess the reduction of deep subcutaneous adipose tissue and visceral adipose tissue as outcome measures, rather than simply weight reduction.

Going Farther by Going Together: Collaboration as a Tool in Advocacy.

With greater understanding of the impact of social determinants on child health, advocacy has become essential to promoting children's health, particularly at the population level. Successful advocacy requires coalition building. Steps on how to create a productive coalition, including the selection of partner organizations, understanding how these groups enhance your activities, and strict definition of assigned roles is reviewed. Examples of successful coalitions are reviewed. A list of potential partners, who focus on various aspects of child health, is provided.

Before the first breath: why ambient air pollution and climate change should matter to neonatal-perinatal providers.

Common outdoor air pollutants present threats to fetal and neonatal health, placing neonatal-perinatal clinical specialists in an important role for harm reduction through patient counseling and advocacy. Climate change is intertwined with air pollution and influences air quality. There is increasing evidence demonstrating the unique vulnerability in the development of adverse health consequences from exposures during the preconception, prenatal, and early postnatal periods, as well as promising indications that policies aimed at addressing these toxicants have improved birth outcomes. Advocacy by neonatal-perinatal providers articulating the potential impact of pollutants on newborns and mothers is essential to promoting improvements in air quality and reducing exposures. The goal of this review is to update neonatal-perinatal clinical specialists on the key ambient air pollutants of concern, their sources and health effects, and to outline strategies for protecting patients and communities from documented adverse health consequences.

Intention to Breastfeed and Paternal Influence on Pregnant Mothers Exclusively Using Marijuana Compared with Other Substances.

Objective: To determine intention to breastfeed (ITBF) rates among mothers exclusively using marijuana (eMJ) compared with electronic cigarettes (eEcig), tobacco products (eTob), or multisubstances (MS), nonusers (NU), and the influence of paternal presence and paternal substance use. Study Design: Cross-sectional study of parental survey responses merged with electronic birth certificates. Accounting for clinical and social determinants of health, analyses of ITBF included (1) all mothers, (2) single mothers, and (3) mothers with fathers. Results: Among all mothers (n = 1,073), eMJ, eTob, and MS users had lower odds of ITBF compared with NU. Only eMJ users had lower odds of ITBF for those without paternal presence. However, in those mothers with a paternal presence, odds of ITBF were similar to NU for eMJ, eTob, and MS users when accounting for paternal factors, including paternal substance use. Conclusion: Women exclusively using MJ have lower ITBF compared with NU. However, paternal presence mitigated this effect, independent of parental MJ use. The presence of fathers may represent a unique predictor for increased ITBF in MJ using mothers.

Infant Outcomes among Teenage and Young Mothers: Racial Inequities and the Role of Educational Attainment.

OBJECTIVE: To examine the association of age-appropriate maternal educational attainment in teenage and young mothers on infant health outcomes across racial/ethnic groups. STUDY DESIGN: In this retrospective, cross-sectional study using Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research Natality data (2016-2017), we included live births comparing 14- to 19- year-old mothers with 20- to 24-year-old mothers. To analyze the association of maternal age-appropriate education (≥8th grade for 15-18 years of age, 9th-12th grade/completed high school for 19-24 years of age), we conducted multivariable regression adjusting for mothers' demographics, reporting adjusted incidence rate ratios with 95% CI for infant mortality rate, and logistic regression for extreme prematurity and low birth weight, reporting aORs with 95% CI. RESULTS: From 2016 to 2017, there were 1 976 334 live births among women 14-24 years of age; 407 576 (20.6%) were in 14- to 19-year-olds. In the multivariable model, increased term infant mortality rate was associated with age 14-19 years (adjusted incidence rate ratio 1.18, 95% 1.10, 1.27), age-inappropriate education (adjusted incidence rate ratio 1.38, 95% CI 1.28, 1.48), and non-Hispanic Black mothers (adjusted incidence rate ratio 1.21, 95% CI 1.12, 1.30). Extreme prematurity was associated with women age 14-19 years (aOR 1.35, 95% CI 1.30, 1.40), non-Hispanic Black (aOR 2.50, 95% CI 2.39, 2.61), and Hispanic mothers (aOR 1.09, 95% CI 1.04, 1.15). Term infant low birth weight was associated with age 14-19 years (aOR 1.14, 95% CI 1.12, 1.16), age-inappropriate education for non-Hispanic White (aOR 1.16, 95% CI 1.11, 1.21), and non-Hispanic Black (aOR 1.08, 1.04, 1.12) mothers. CONCLUSIONS: Inadequate maternal educational attainment, which is influenced by modifiable social policies, is associated with increased adverse infant outcomes in mothers 14-24 years of age.