Quality, outcome, and cost of care provided to very low birth weight infants in California.

OBJECTIVE: To examine association of costs with quality of care and patient outcome across hospitals in California. METHODS: Retrospective study of very low birth weight (VLBW) births from 2014-2018 linking birth certificate, hospital discharge records and clinical data. Quality was measured using the Baby-MONITOR score. Clinical outcome was measured using survival without major morbidity (SWMM). Hierarchical generalized linear models, adjusting for clinical factors, were used to estimate risk-adjusted measures of costs, quality, and outcome for each hospital. Association between these measures was evaluated using Pearson correlation coefficient. RESULTS: In total, 15,415 infants from 104 NICUs were included. Risk-adjusted Baby-MONITOR score, SWMM rate, and costs varied substantially. There was no correlation between risk-adjusted cost and Baby-MONITOR score (r = 0, p = 0.998). Correlation between risk-adjusted cost and SWMM rate was inverse and not significant (r = -0.07, p = 0.48). CONCLUSIONS: With the metrics used, we found no correlation between cost, quality, and outcomes in the care of VLBW infants.

Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial.

Background: Racial inequities in maternal health outcomes, the result of systemic racism and social determinants of health, require maternity care systems to implement interventions that reduce disparities. One such approach may be support from a community doula, a health worker who provides emotional support, peer education, navigation, and advocacy for pregnant, birthing, and postpartum people who share similar racial identities, cultural backgrounds, and/or lived experiences. While community support during birth has a long tradition within communities of Black Indigenous and People of Color (BIPOC), the reframing of community doula support as a social intervention that reduces disparities in clinical outcomes is recent. Methods: We conducted a pragmatic randomized trial at an urban safety net hospital, comparing standard maternity care with standard care plus enhanced community doula support. We tested the effectiveness of a community doula program embedded in a safety net hospital in improving birth outcomes and explored the association between community doula support and health equity. Participants were nulliparous, insured by publicly funded health plans, and had lower risk pregnancies. The primary outcome was cesarean birth. Secondary outcomes included preterm birth and breastfeeding outcomes. Exploratory subgroup analysis was conducted by race-ethnicity. Results: Three hundred sixty-seven participants were included in the primary analysis. In the intent-to-treat analysis, outcomes were similar between groups. There was a trend toward increased breastfeeding initiation (p=0.08). There was a statistically nonsignificant 12% absolute reduction in cesarean birth and 11.5% increase in exclusive breastfeeding during delivery hospitalization among Black non-Hispanic participants. Discussion: While outcomes for the study sample were similar between randomization groups, health outcomes were improved for Black birthing people in cesarean and breastfeeding rates. Conclusion: This study demonstrates the need for larger studies of community doula support for Black birthing people. Clinicaltrials.gov ID: NCT02550730.

Knowledge, Attitudes, and Perceptions about Antibiotic Stewardship Programs among Neonatology Trainees.

OBJECTIVE: Antibiotic stewardship should be an essential component of neonatology training as neonatal intensive care units (NICU) have unique stewardship needs. Our aim was to assess neonatology fellowship trainees' knowledge, attitudes, and perceptions about antibiotic stewardship to inform sustainable curriculum development. STUDY DESIGN: We distributed an electronic survey to neonatology fellows in the United States over 4 months (January-April 2018) via Accreditation Council for Graduate Medical Education program directors. RESULTS: Of 99 programs in the United States with an estimated 700 fellows, 159 (23%) fellows from 52 training programs (53%) responded to the survey and 139 (87%) provided analyzed responses. Majority of respondents were training in southern (59; 42%) and northeastern (43; 31%) regions and were equally spread across all 3 years of training. One hundred (72%) respondents reported an antibiotic stewardship program (ASP) in their institution. While 86% (120/139) were able to identify the components of an ASP, 59% (82/139) either did not or were unsure if they had received antibiotic stewardship training during fellowship.Furthermore, while answering case studies, 124 (89%) respondents identified the optimal antibiotic for methicillin susceptible Staphylococcus aureus (MSSA) infection and 69 (50%) respondents chose appropriate empiric antibiotics for neonatal meningitis. Notably, fellowship training year was not significantly related to the proportion of incorrect knowledge responses (p = 0.40). Most survey respondents (81; 59%) identified small group sessions as the most useful teaching format, while others chose audit and feedback of individual prescribing behavior (52; 38%) and didactic lectures (52; 38%). Finally, ninety-five (69%) respondents preferred trainee-led ASP interventions targeting focal areas such as antifungal and surgical prophylaxis. CONCLUSION: Antibiotic stewardship is a critical part of neonatology training. Neonatology fellows report variation in access to ASP during their training. Fellows prefer dedicated trainee-led interventions and stewardship curriculum taught within small group settings to promote targeted NICU ASP. KEY POINTS: · Most neonatology programs expose trainees to internal or external antibiotic stewardship programs.. · Over half of fellow trainees are unsure about receiving targeted antibiotic stewardship training.. · Most neonatology fellows prefer a trainee-led antibiotic stewardship intervention..

Assisted Reproductive Technology or Infertility: What underlies adverse outcomes? Lessons from the Massachusetts Outcome Study of Assisted Reproductive Technology.

Numerous studies have demonstrated that assisted reproductive technology (ART: defined here as including only in vitro fertilization and related technologies) is associated with increased adverse pregnancy, neonatal, and childhood developmental outcomes, even in singletons. The comparison group for many had often been a fertile population that conceived without assistance. The Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART) was initiated to define a subfertile population with which to compare ART outcomes. Over more than 10 years, we have used the MOSART database to study pregnancy abnormalities and delivery complications but also to evaluate ongoing health of women, infants, and children. This article will review studies from MOSART in the context of how they compare with those of other investigations. We will present MOSART studies that identified the influence of ART and subfertility/infertility on adverse pregnancy (pregnancy hypertensive disorder, gestational diabetes, placental abnormality) and delivery (preterm birth, low birthweight) outcomes as well as on maternal and child hospitalizations. We will provide evidence that although subfertility/infertility increases the risk of adverse outcomes, there is additional risk associated with the use of ART. Studies exploring the contribution of placental abnormalities as one factor adding to this increased ART-associated risk will be described.

Polycystic ovary syndrome and risk of adverse pregnancy outcomes: a registry linkage study from Massachusetts.

STUDY QUESTION: Do women with polycystic ovary syndrome (PCOS) have a greater risk of adverse pregnancy complications (gestational diabetes, preeclampsia, cesarean section, placental abnormalities) and neonatal outcomes (preterm birth, small for gestational age, prolonged delivery hospitalization) compared to women without a PCOS diagnosis and does this risk vary by BMI, subfertility and fertility treatment utilization? SUMMARY ANSWER: Deliveries to women with a history of PCOS were at greater risk of complications associated with cardiometabolic function, including gestational diabetes and preeclampsia, as well as preterm birth and prolonged length of delivery hospitalization. WHAT IS KNOWN ALREADY: Prior research has suggested that women with PCOS may be at increased risk of adverse pregnancy outcomes. However, findings have been inconsistent possibly due to lack of consistent adjustment for confounding factors, small samples size and other sources of bias. STUDY DESIGN, SIZE, DURATION: Massachusetts deliveries among women ≥18 years old during 2013-2017 from state vital records linked to hospital discharges, observational stays and emergency department visits were linked to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) and the Massachusetts All-Payers Claims Database (APCD). PARTICIPANTS/MATERIALS, SETTING, METHODS: PCOS was identified by ICD9 and ICD10 codes in APCD prior to index delivery. Relative risks (RRs) and 95% CI for pregnancy and delivery complications were modeled using generalized estimating equations with a log link and a Poisson distribution to take multiple cycles into account and were adjusted a priori for maternal age, BMI, race/ethnicity, education, plurality, birth year, chronic hypertension and chronic diabetes. Tests for homogeneity investigated differences between maternal pre-pregnancy BMI categories (<30, ≥30, <25 and ≥25 kg/m2) and between non-infertile deliveries and deliveries that used ART or had a history of subfertility (defined by birth certificates, SART CORS records, APCD or hospital records). MAIN RESULTS AND THE ROLE OF CHANCE: Among 91 825 deliveries, 3.9% had a history of PCOS. Women with a history of PCOS had a 51% greater risk of gestational diabetes (CI: 1.38-1.65) and a 25% greater risk of preeclampsia (CI: 1.15-1.35) compared to women without a diagnosis of PCOS. Neonates born to women with a history of PCOS were more likely to be born preterm (RR: 1.17, CI: 1.06-1.29) and more likely to have a prolonged delivery hospitalization after additionally adjusting for gestational age (RR: 1.23, CI: 1.09-1.40) compared to those of women without a diagnosis of PCOS. The risk for gestational diabetes for women with PCOS was greater among women with a pre-pregnancy BMI <30 kg/m2. LIMITATIONS, REASONS FOR CAUTION: PCOS was defined by ICD documentation prior to delivery so there may be women with undiagnosed PCOS or PCOS diagnosed after delivery included in the unexposed group. The study population is limited to deliveries within Massachusetts among most private insurance payers and inpatient or observational hospitalization in Massachusetts during the follow-up window, therefore there may be diagnoses and or deliveries outside of the state or outside of our sample that were not captured. WIDER IMPLICATIONS OF THE FINDINGS: In this population-based study, women with a history of PCOS were at greater risk of pregnancy complications associated with cardiometabolic function and preterm birth. Obstetricians should be aware of patients' PCOS status and closely monitor for potential pregnancy complications to improve maternal and infant perinatal health outcomes. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by the NIH (R01HD067270). S.A.M. receives grant funding from NIH, AbbVie and the Marriot Family Foundation; payment/honoraria from the University of British Columbia, World Endometriosis Research Foundation and Huilun Shanghai; travel support for attending meetings for ESHRE 2019, IASP 2019, National Endometriosis Network UK meeting 2019; SRI 2022, ESHRE 2022; participates on the data safety monitoring board/advisory board for AbbVie, Roche, Frontiers in Reproductive Health; and has a leadership role in the Society for Women's Health Research, World Endometriosis Research Foundation, World Endometriosis Society, American Society for Reproductive Medicine and ESHRE. The other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

"All these people saved her life, but she needs me too": Understanding and responding to parental mental health in the NICU.

OBJECTIVE: To explore the mental health needs of parents of infants in a neonatal intensive care unit (NICU), as well as barriers and solutions to meeting these needs. DESIGN: Qualitative interviews conducted with parents and staff (n = 15) from a level IV NICU in the Northwestern United States. Thematic analysis completed using an inductive approach, at a semantic level. RESULTS: (1) Information and mental health needs change over time, (2) Staff-parent relationships buffer trauma and distress, (3) Lack of continuity of care impacts response to mental health concerns, (4) NICU has a critical role in addressing parental mental health. CONCLUSION: Mental health support should be embedded and tailored to the NICU trajectory, with special attention to the discharge transition, parents living in rural areas, and non-English-speaking parents. Research should address structural factors that may impact mental health such as integration of wholistic services, language barriers, and staff capacity.

The Clinical and Cost Utility of Cardiac Catheterizations in Infants with Bronchopulmonary Dysplasia.

OBJECTIVE: To evaluate the cost-utility of catheterization-obligate treatment in preterm infants with pulmonary hypertension, as compared with empiric initiation of sildenafil based on echocardiographic findings alone. STUDY DESIGN: A Markov state transition model was constructed to simulate the clinical scenario of a preterm infant with echocardiographic evidence of pulmonary hypertension associated with bronchopulmonary dysplasia (BPD) and without congenital heart disease under consideration for the initiation of pulmonary vasodilator therapy via one of two modeled treatment strategies-empiric or catheterization-obligate. Transitional probabilities, costs and utilities were extracted from the literature. Forecast quality-adjusted life-years was the metric for strategy effectiveness. Sensitivity analyses for each variable were performed. A 1000-patient Monte Carlo microsimulation was used to test the durability of our findings. RESULTS: The catheterization-obligate strategy resulted in an increased cost of $10 778 and 0.02 fewer quality-adjusted life-years compared with the empiric treatment strategy. Empiric treatment remained the more cost-effective paradigm across all scenarios modeled through one-way sensitivity analyses and the Monte Carlo microsimulation (cost-effective in 98% of cases). CONCLUSIONS: Empiric treatment with sildenafil in infants with pulmonary hypertension associated with BPD is a superior strategy with both decreased costs and increased effectiveness when compared with catheterization-obligate treatment. These findings suggest that foregoing catheterization before the initiation of sildenafil is a reasonable strategy in preterm infants with uncomplicated pulmonary hypertension associated with BPD.

Cost-effectiveness of Artificial Intelligence-Based Retinopathy of Prematurity Screening.

Importance: Artificial intelligence (AI)-based retinopathy of prematurity (ROP) screening may improve ROP care, but its cost-effectiveness is unknown. Objective: To evaluate the relative cost-effectiveness of autonomous and assistive AI-based ROP screening compared with telemedicine and ophthalmoscopic screening over a range of estimated probabilities, costs, and outcomes. Design, Setting, and Participants: A cost-effectiveness analysis of AI ROP screening compared with ophthalmoscopy and telemedicine via economic modeling was conducted. Decision trees created and analyzed modeled outcomes and costs of 4 possible ROP screening strategies: ophthalmoscopy, telemedicine, assistive AI with telemedicine review, and autonomous AI with only positive screen results reviewed. A theoretical cohort of infants requiring ROP screening in the United States each year was analyzed. Main Outcomes and Measures: Screening and treatment costs were based on Current Procedural Terminology codes and included estimated opportunity costs for physicians. Outcomes were based on the Early Treatment of ROP study, defined as timely treatment, late treatment, or correctly untreated. Incremental cost-effectiveness ratios were calculated at a willingness-to-pay threshold of $100 000. One-way and probabilistic sensitivity analyses were performed comparing AI strategies to telemedicine and ophthalmoscopy to evaluate the cost-effectiveness across a range of assumptions. In a secondary analysis, the modeling was repeated and assumed a higher sensitivity for detection of severe ROP using AI compared with ophthalmoscopy. Results: This theoretical cohort included 52 000 infants born 30 weeks' gestation or earlier or weighed 1500 g or less at birth. Autonomous AI was as effective and less costly than any other screening strategy. AI-based ROP screening was cost-effective up to $7 for assistive and $34 for autonomous screening compared with telemedicine and $64 and $91 compared with ophthalmoscopy in the primary analysis. In the probabilistic sensitivity analysis, autonomous AI screening was more than 60% likely to be cost-effective at all willingness-to-pay levels vs other modalities. In a second simulated cohort with 99% sensitivity for AI, the number of late treatments for ROP decreased from 265 when ROP screening was performed with ophthalmoscopy to 40 using autonomous AI. Conclusions and Relevance: AI-based screening for ROP may be more cost-effective than telemedicine and ophthalmoscopy, depending on the added cost of AI and the relative performance of AI vs human examiners detecting severe ROP. As AI-based screening for ROP is commercialized, care must be given to appropriately price the technology to ensure its benefits are fully realized.

Pregnancy outcomes among women with endometriosis and fibroids: registry linkage study in Massachusetts.

BACKGROUND: Endometriosis and uterine fibroids are common gynecologic conditions associated with a greater risk for infertility. Previous research has suggested that these conditions are associated with adverse pregnancy outcomes, potentially because of increased utilization of fertility treatments. OBJECTIVE: Our objective was to investigate whether women with a history of endometriosis or fibroids had a greater risk for adverse pregnancy outcomes and whether this risk varied by infertility history and fertility treatment utilization. STUDY DESIGN: Deliveries (2013-2017) recorded in Massachusetts' vital records were linked to assisted reproductive technology data, hospital stays, and all-payer claims database. We identified endometriosis and fibroids diagnoses via the all-payer claims database before index delivery. Adjusted relative risks for pregnancy complications were modeled using generalized estimating equations with a log link and Poisson distribution. The influence of subfertility or infertility and assisted reproductive technology was also investigated. RESULTS: Among 91,825 deliveries, 1560 women had endometriosis and 4212 had fibroids. Approximately 30% of women with endometriosis and 26% of women with fibroids experienced subfertility or infertility without utilizing assisted reproductive technology, and 34% of women with endometriosis and 21% of women with fibroids utilized assisted reproductive technology for the index delivery. Women with a history of endometriosis or fibroids were at a greater risk for pregnancy-induced hypertension, preeclampsia, or eclampsia (endometriosis relative risk, 1.17; fibroids relative risk, 1.08), placental abnormalities (endometriosis relative risk, 1.65; fibroids relative risk, 1.38), and cesarean delivery (endometriosis relative risk, 1.22; fibroids relative risk, 1.17) than women with no history of those conditions. Neonates born to women with a history of endometriosis or fibroids were also at a greater risk for preterm birth (endometriosis relative risk, 1.24; fibroids relative risk, 1.17). Associations between fibroids and low birthweight varied by fertility status or assisted reproductive technology (P homogeneity=.01) and were stronger among noninfertile women. CONCLUSION: Endometriosis or fibroids increased the risk for adverse pregnancy outcomes, possibly warranting differential screening or treatment.

The financial burden experienced by families of preterm infants after NICU discharge.

BACKGROUND AND OBJECTIVES: Describe the financial burden and worry that families of preterm infants experience after discharge from the neonatal intensive care unit (NICU). METHODS: We surveyed 365 parents of preterm infants in a cross-sectional study regarding socio-demographics, supplemental security income (SSI), and financial worry. We completed a multivariable logistic regression model to examine the adjusted association of financial worry with modifiable factors. RESULTS: We found that 53% of participants worried about healthcare costs after NICU discharge. After adjusting for socio-demographic and infant characteristics, we identified that, aOR (95% CI), out-of-pocket costs from the NICU index hospitalization, 3.51 (1.7, 7.26) and durable medical equipment use, 2.41 (1.11, 5.23) was associated with increased financial worry while enrollment in SSI, 0.38 (0.19, 0.76) was associated with decreased financial worry. CONCLUSIONS: We identified factors that could contribute to financial burden after NICU discharge that may advise future work to target financial support systems.

Neonates with mild hypoxic-ischaemic encephalopathy receiving supportive care versus therapeutic hypothermia in California.

OBJECTIVE: The use of therapeutic hypothermia (TH) for mild hypoxic-ischaemic encephalopathy (HIE) remains controversial and inconsistent. We analysed trends in TH and maternal and infant characteristics associated with short-term outcomes of infants with mild HIE. DESIGN: Retrospective cohort analysis of the California Perinatal Quality Care Collaborative database 2010-2018. E-value analysis was conducted to determine the potential impact of unmeasured confounding. SETTING: California neonatal intensive care units. PATIENTS: 1364 neonates with mild HIE. INTERVENTIONS: Supportive care versus TH. MAIN OUTCOME MEASURES: Factors associated with TH and mortality. RESULTS: The proportion of infants receiving TH increased from 46% in 2010 to 79% in 2018. TH was more likely in the setting of singleton birth (OR 2.69, 95% CI 1.21 to 5.39), no major birth defects (OR 2.18, 95% CI 1.42 to 3.30), operative vaginal delivery (OR 3.04, 95% CI 1.80 to 5.10) and 5-minute Apgar score ≤5 (OR 3.17, 95% CI 2.43 to 4.13). Mortality was associated with small for gestational age (OR 5.79, 95% CI 1.90 to 18.48), <38 weeks' gestation (OR 7.31 95% CI 2.39 to 24.93), major birth defects (OR 11.62, 95% CI 3.97 to 38.00), inhaled nitric oxide (OR 12.73, 95% CI 4.00 to 44.53) and nosocomial infection (OR 7.98, 95% CI 1.15 to 47.03). E-value analyses suggest that unmeasured confounding may have contributed to some of the observed effects. CONCLUSIONS: Variation in management of mild HIE persists, but therapeutic drift has become more prevalent over time. Further studies are needed to assess long-term outcomes alongside resource utilisation to inform evidence-based practice.

Economic considerations at the threshold of viability.

Neonatal intensive care for infants born at 22-24 weeks has become more prevalent in the past three decades, but outcomes remain highly variable between centers, in part due to different approaches in management. With this increased frequency of intervention, there has been concern for a concurrent increase in costs of care for survivors. This article reviews the direct medical, direct non-medical, and indirect costs of care for periviable infants and their families, as well as the current limitations of published data. In addition, we highlight the cost-effectiveness of neonatal intensive care and various therapies offered to extremely preterm infants, while also considering the ethical dilemmas inherently tied to periviable decision-making. Strategies to improve the gaps in knowledge on the economic impact of the smallest infants are discussed.

California and Oregon NICU Wildfire Disaster Preparedness Tools.

The 2020 wildfire season was devastating to the Western United States and affected the region's NICUs. In this study, we ask the question, "what tools/strategies do medical professionals deem as important and most helpful as they are preparing for wildfire disaster response?" It is a follow up to our previous study: Learning from Wildfire Disaster Experience in California NICUs. We reevaluated how California NICUs dealt with the 2020 wildfires and expanded to Oregon and Southwest (SW) Washington NICUs. We conducted a survey with eleven Oregon and SW Washington NICUs about their wildfire evacuation preparedness. We also interviewed two neonatologists about their wildfire disaster experience evacuating their NICU or preparing to evacuate. Our findings suggest there is more work needed to fully prepare NICUs for wildfire disasters. We hope that by bringing light to the strategies used by affected clinicians, we can educate and support future NICU disaster preparedness responses.

Influence of Placental Abnormalities and Pregnancy-Induced Hypertension in Prematurity Associated with Various Assisted Reproductive Technology Techniques.

OBJECTIVE: Assisted reproductive technology (ART)-treated women exhibit increased risk of premature delivery compared to fertile women. We evaluated whether ART treatment modalities increase prematurity and whether placental abnormalities and pregnancy-induced hypertensive (PIH) disorders mediate these risks. METHOD(S): This retrospective study of ART-treated and fertile deliveries (2004-2017) used an ART-cycle database linked to Massachusetts birth certificates and hospital discharges. Outcomes of late preterm birth (LPTB: 34-36 weeks gestation) and early preterm birth (EPTB: <34 weeks gestation) were compared with term deliveries (≥37 weeks gestation) in ART-treated (linked to the ART database) and fertile (no indicators of infertility or ART) deliveries. ART treatments with autologous oocyte, donor oocyte, fresh or frozen embryo transfer (FET), intracytoplasmic sperm injection (ICSI) and no-ICSI were separately compared to the fertile group. Adjusted odds ratios (AOR) were calculated with multivariable logistic regression: placental abnormalities or PIH were quantified in the pathway as mediators. RESULTS: There were 218,320 deliveries: 204,438 fertile and 13,882 ART-treated. All treatment types increased prematurity (AOR 1.31-1.58, LPTB; AOR 1.34-1.48, EPTB). Placental abnormalities mediated in approximately 22% and 38% of the association with LPTB and EPTB, respectively. PIH mediated 25% and 33% of the association with LPTB and EPTB in FET and donor oocyte cycles, more than other treatments (<10% LPTB and <13% EPTB). CONCLUSIONS: ART-treatment and all ART modalities increased LPTB and EPTB when compared with fertile deliveries. Placental abnormalities modestly mediated associations approximately equally, while PIH was a stronger mediator in FET and donor oocyte cycles. Reasons for differences require exploration.

Association of maternal fertility status and receipt of fertility treatment with healthcare utilization in infants up to age four.

OBJECTIVE: This study evaluates differences in child healthcare utilization by maternal fertility status in the first four years of life. STUDY DESIGN: The retrospective cohort evaluated Massachusetts (MA) live born infants using data linked from clinical assisted reproductive technology (ART) data, birth certificates, and hospital discharge records. Hospital records of infants born 2004-2017 to mothers of fertile (no infertility treatments or indicators of infertility), unassisted subfertile (UF, indicators of infertility but no fertility treatment), medically assisted reproduction (MAR, non-ART assistance with reproduction) and ART treatment were studied. Adjusted relative risk (aRR) was calculated using multivariable log binomial regression models. RESULTS: We included 339,426 singleton live-born infants discharged from birth hospitalization. Compared to children born to fertile mothers, those born to UF, MAR and ART-treated mothers were more likely to have hospital-based care (aRR 1.06-1.21) in their first 4 years. CONCLUSIONS: Maternal subfertility with and without treatment was associated with small increases in child healthcare utilization.

Perils and pitfalls for evaluating economic studies in neonatology.

Health care economics has become an essential topic for all clinicians. Rising health care costs and continued limited resources force hospitals, health networks, and payers to make difficult choices. Economic studies range from those that only focus on costs to those that include costs and outcomes in a single metric, allowing for an assessment of incremental benefit gained from the incremental investment made. This article takes a step by step approach to interpreting the results of an economic evaluation, allowing the reader to critically appraise the results and to understand the implications for their specific patient population.

Unbiasing costs? An appraisal of economic assessment alongside randomized trials in neonatology.

Economic evaluations performed alongside randomized controlled trials benefit from the protections against bias inherent in randomization. In this systematic review, we assessed the frequency and quality of economic assessments alongside randomized controlled trials of interventions in neonates published between 1990 and 2016. Over that period, 58 economic assessments were published, corresponding to approximately 2% of RCTs. We noted significant methodological limitations of these studies, including limitation of included costs to the health sector or payer rather than broader categories such as family or community expenditures (81%), short time horizon for cost measurement (less than one year in 60%), lack of reporting of uncertainty (26%), and infrequent analysis of costs and effects in a single metric (combined in 45%). Strategies for improving the quality and frequency of economic evaluations in neonatology are discussed, including selection of appropriate trials, funding, and peer review.

Optimizing the control group for evaluating ART outcomes: can outpatient claims data yield a better control group?

PURPOSE: We previously developed a subfertile comparison group with which to compare outcomes of assisted reproductive technology (ART) treatment. In this study, we evaluated whether insurance claims data in the Massachusetts All Payers Claims Database (APCD) defined a more appropriate comparison group. METHODS: We used Massachusetts vital records of women who delivered between 2013 and 2017 on whom APCD data were available. ART deliveries were those linked to a national ART database. Deliveries were subfertile if fertility treatment was marked on the birth certificate, had prior hospitalization with ICD code for infertility, or prior fertility treatment. An infertile group included women with an APCD outpatient or inpatient ICD 9/10 infertility code prior to delivery. Fertile deliveries were none of the above. Demographics, health risks, and obstetric outcomes were compared among groups. Multivariable generalized estimating equations were used to calculate adjusted relative risk (aRR) and 95% confidence intervals (CI). RESULTS: There were 70,726 fertile, 4,763 subfertile, 11,970 infertile, and 7,689 ART-treated deliveries. Only 3,297 deliveries were identified as both subfertile and infertile. Both subfertile and infertile were older, and had more education, chronic hypertension, and diabetes than the fertile group and less than the ART-treated group. Prematurity (aRR = 1.15-1.17) and birthweight (aRR = 1.10-1.21) were increased in all groups compared with the fertile group. CONCLUSION: Although the APCD allowed identification of more women than the previously defined subfertile categorization and allowed us to remove previously unidentified infertile women from the fertile group, it is not clear that it offered a clinically significantly improved comparison group.