Disparities in access to reproductive genetic services associated with geographic location of residence and maternal race and ethnicity.

PURPOSE: To describe the association between geographic location of residence and use of aneuploidy screening or prenatal genetic counseling and how it is modified by maternal race and ethnicity. METHODS: Retrospective cohort of individuals at a tertiary care center between 2017-2019. County of residence was classified as rural or metropolitan based in US Office of Management and Budget 2019 definitions. Maternal race and ethnicity were self-identified. Our composite outcome was defined as use of aneuploidy screening or genetic counseling visit. The composite outcome was compared by geographic location and ethnicity. Logistic regression was used to model the relationship between geographic location and the composite outcome. RESULTS: A total of 8774 pregnancies were included. Of these, 4770 (54%) had genetic screening, and 3781 (43%) had at least 1 genetic counseling visit. Rural patients were significantly less likely to have the composite outcome compared with metropolitan peers (37.1% vs 47.2%, P < .001). In addition, we identified differences in the composite outcome between White rural patients and LatinX rural patients (37.7% vs 35.6%, P < .001) and between Asian rural patients and LatinX and Black rural patients (41.0% vs 35.6%, P < .001; 41.0% vs 36.8%, P < .001). Logistic regression demonstrated that rural patients were significantly less likely to have the composite outcome compared with metropolitan peers, after adjusting for LatinX ethnicity and gestational age at first prenatal visit (OR 0.72, [0.55, 0.95], P = .002). CONCLUSION: Rural, minority patients were significantly less likely to receive reproductive genetic services compared with metropolitan peers extending our knowledge of disparities in maternity care.

Use of Postpartum Hemorrhage Checklist during Vaginal Deliveries: A Quality Improvement Study.

OBJECTIVE: Postpartum hemorrhage (PPH) protocols improve patient safety and reduce utilization of blood products; however, few data exist on sustainability of PPH checklist use, how use affects care delivery, and variation of use among patient subgroups. This study aimed to (1) examine compliance with PPH checklist use during vaginal deliveries, (2) evaluate whether checklist use varied by patient and/or care team characteristics, and (3) evaluate whether checklist use was associated with increased use of recommended medications/interventions. STUDY DESIGN: This was a quality improvement study performed from April 2021 through June 2023. A multidisciplinary team developed a revised PPH checklist and used quality improvement methodology to increase checklist use following vaginal birth. Data were collected from medical records and clinician survey. Control charts were generated to track checklist use and evaluate special cause variation. Chi-square tests and logistic regression were used to evaluate variation in medications/interventions and across subgroups. RESULTS: During the study period, there were 342 cases of PPH at the time of vaginal birth. The checklist was used in 67% of PPH cases during the 20-month period after implementation in a setting where no checklist was previously being used. We found no statistically significant differences in checklist use by patient or health care team characteristics. Use of tranexamic acid, carboprost, and misoprostol were significantly associated with checklist use. CONCLUSION: This study demonstrated successful implementation of a checklist protocol where no checklist was previously being used, with sustained use in an average of 67% of PPH cases over 20 months. Checklist use was consistent across subgroups and was associated with higher use of interventions shown to lower blood loss. KEY POINTS: · Our study showed sustainability of PPH checklist use over a 20-month period.. · PPH checklist use was associated with increased use of interventions known to reduce blood loss.. · Checklist was used consistently across patient subgroups; may help address inequities in obstetric outcomes..

Twin Vaginal Deliveries in Labor Rooms: A Cost-Effectiveness Analysis.

OBJECTIVE: Twin vaginal deliveries (VDs) are often performed in the operating room (OR) given the theoretical risk of conversion to cesarean delivery (CD) for the aftercoming twin. We aim to evaluate the cost-effectiveness of performing VDs for twin gestations in the labor and delivery room (LDR) versus OR. STUDY DESIGN: We conducted a cost-effectiveness analysis using a decision-analysis model that compared the costs and effectiveness of two strategies of twin deliveries undergoing a trial of labor: (1) intended delivery in the LDR and 2) delivery in the OR. Sensitivity analyses were performed to assess strength and validity of the model. Primary outcome was incremental cost-effectiveness ratio (ICER) defined as cost needed to gain 1 quality-adjusted life year (QALY). RESULTS: In the base-case scenario, where 7% of deliveries resulted in conversion to CD for twin B, attempting to deliver twins in the LDR was the most cost-effective strategy. For every QALY gained by delivering in the OR, 243,335 USD would need to be spent (ICER). In univariate sensitivity analyses, the most cost-effective strategy shifted to delivering in the OR when the following was true: (1) probability of successful VD was less than 86%, (2) probability of neonatal morbidity after emergent CD exceeded 3.5%, (3) cost of VD in an LDR exceeded 10,500 USD, (4) cost of CD was less than 10,000 USD, or (5) probability of neonatal death from emergent CD exceeded 2.8%. Assuming a willingness to pay of 100,000 USD per neonatal QALY gained, attempted VD in the LDR was cost effective in 51% of simulations in the Monte Carlo analysis. CONCLUSION: Twin VDs in the LDR are cost effective based on current neonatal outcome data, taking into account gestational age and associated morbidity. Further investigation is needed to elucidate impact of cost and outcomes on optimal utilization of resources. KEY POINTS: · Cost effectiveness of twin VDs in the LDR versus OR was assessed.. · Twin VDs in the LDR are cost effective based on current neonatal outcome data.. · Attempted VD in the LDR was cost effective in 51% of simulations in the Monte Carlo analysis..

Racial and Rural-Urban Disparities in Maternal Cardiac Disease Care in North Carolina: A Call to Action.

Background: Cardiac disease is a leading cause of severe maternal morbidity (SMM). We sought to estimate the effects of race and rural-urban status on cardiac-specific severe maternal morbidity ("cardiac SMM") in North Carolina. Methods: This retrospective study used the 2019 North Carolina State Inpatient Database (SID). Diagnosis codes were used to identify births, comorbidities, modified World Health Organization (mWHO) cardiac category, and outcomes. Hospital-level data were obtained from publicly available sources and the SID datasets. The primary outcome was a composite of cardiac SMM. Results: Of 106,778 births, 369 had mWHO category I-II disease, and 366 had mWHO category II/III-IV disease. Individuals with cardiac disease had higher rates of cardiac SMM (10.4% versus 0.27% versus 0.13% for mWHO II/III-IV, mWHO I/II, and no disease, respectively). Among patients with mWHO II/III-IV disease, 60.0% of rural residents delivered at hospitals with advanced cardiac capabilities versus 80.8% of urban residents; there were no statistically significant differences in cardiac SMM rates (11.3% versus 10.1% for rural versus urban individuals, P = NS). In contrast, there were pronounced disparities in cardiac SMM among Black individuals compared with White individuals (0.28% versus 0.13%, P < .001), especially among individuals with mWHO II/III-IV disease (23.71% versus 5.41%, P < .001). Limitations: Cardiac disease and outcomes were identified based on diagnosis and procedure codes. Identifying complications subsequent to the delivery hospitalization was not possible. Conclusions: In North Carolina, there is a pronounced racial disparity in cardiac SMM during delivery hospitalizations, which is driven by patients with mWHO II/III-IV disease.

The association between care management and neonatal outcomes: the role of a Medicaid-managed pregnancy medical home in North Carolina.

BACKGROUND: Preterm birth is a significant clinical and public health issue in the United States. Rates of preterm birth have remained unchanged, and racial disparities persist. Although a causal pathway has not yet been defined, it is likely that a multitude of clinical and social risk factors contribute to a pregnant person's risk. State-based public health and provider programmatic partnerships have the potential to improve care during pregnancy and reduce complications, such as preterm birth. In North Carolina, a state-based Medicaid-managed Pregnancy Medical Home Program screens pregnant individuals for psychosocial and medical risk factors and utilizes community-based care management, to offer support to those at highest risk. OBJECTIVE: This study aimed to examine the association between care-management and birth outcomes (low birthweight and preterm birth rates) among high-risk non-Hispanic White and Black pregnant people enrolled in the North Carolina Pregnancy Medical Home. STUDY DESIGN: This was a quasi-experimental study of people in the Medicaid-managed North Carolina Pregnancy Medical Home who had singleton pregnancies and who enrolled in the program between January 2016 and December 2017. Black and White pregnant people were included in the analysis if they had singleton pregnancies, were enrolled in the Pregnancy Medical Home, and for whom there were data regarding care management involvement. Preterm birth and low birthweight were chosen as the outcomes of interest. Two different methodologies were used to test the effect of care management on outcomes: Method 1 evaluated the effect of intensive care management (≥5 face-to-face visits from a care manager) and Method 2 evaluated the effect of the implementation of a specific risk-stratification system. Chi-squared and multivariate logistic regressions were performed as appropriate. RESULTS: From January 1, 2016 to December 31, 2017, a total of 3564 singleton pregnancies occurred among non-Hispanic Black and White pregnant Medicaid beneficiaries, who were a part of the Pregnancy Medical Home in North Carolina. White pregnant people comprised 57% and Black pregnant people comprised 43% of the sample. In the Method 1 analysis, intensive care management was significantly associated with reductions in preterm birth and low birthweight among Black and White pregnant people whereas in the Method 2 analysis, the implementation of a risk-stratification score only resulted in a significant reduction among Black pregnant people. In multivariable logistic modeling, race, number of prenatal visits, and intensive care management were all significantly associated with the outcomes of interest. CONCLUSION: Care management is associated with reductions in preterm birth and low birthweight in the Medicaid-managed Pregnancy Medical Home in North Carolina. This study contributes to a growing body of literature on the role of state-based initiatives in reducing perinatal morbidity. These results are significant as it demonstrates the importance of care coordination and management, in identifying and providing resources for high-risk pregnant people. In the United States, where pregnancy-related outcomes are poor, programs that address the multitude of economic, social, and clinical complexities are becoming increasingly crucial and necessary.

The value of confirmatory testing in early infant HIV diagnosis programmes in South Africa: A cost-effectiveness analysis.

BACKGROUND: The specificity of nucleic acid amplification tests (NAATs) used for early infant diagnosis (EID) of HIV infection is <100%, leading some HIV-uninfected infants to be incorrectly identified as HIV-infected. The World Health Organization recommends that infants undergo a second NAAT to confirm any positive test result, but implementation is limited. Our objective was to determine the impact and cost-effectiveness of confirmatory HIV testing for EID programmes in South Africa. METHOD AND FINDINGS: Using the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model, we simulated EID testing at age 6 weeks for HIV-exposed infants without and with confirmatory testing. We assumed a NAAT cost of US$25, NAAT specificity of 99.6%, NAAT sensitivity of 100% for infants infected in pregnancy or at least 4 weeks prior to testing, and a mother-to-child transmission (MTCT) rate at 12 months of 4.9%; we simulated guideline-concordant rates of testing uptake, result return, and antiretroviral therapy (ART) initiation (100%). After diagnosis, infants were linked to and retained in care for 10 years (false-positive) or lifelong (true-positive). All parameters were varied widely in sensitivity analyses. Outcomes included number of infants with false-positive diagnoses linked to ART per 1,000 ART initiations, life expectancy (LE, in years) and per-person lifetime HIV-related healthcare costs. Both without and with confirmatory testing, LE was 26.2 years for HIV-infected infants and 61.4 years for all HIV-exposed infants; clinical outcomes for truly infected infants did not differ by strategy. Without confirmatory testing, 128/1,000 ART initiations were false-positive diagnoses; with confirmatory testing, 1/1,000 ART initiations were false-positive diagnoses. Because confirmatory testing averted costly HIV care and ART in truly HIV-uninfected infants, it was cost-saving: total cost US$1,790/infant tested, compared to US$1,830/infant tested without confirmatory testing. Confirmatory testing remained cost-saving unless NAAT cost exceeded US$400 or the HIV-uninfected status of infants incorrectly identified as infected was ascertained and ART stopped within 3 months of starting. Limitations include uncertainty in the data used in the model, which we examined with sensitivity and uncertainty analyses. We also excluded clinical harms to HIV-uninfected infants incorrectly treated with ART after false-positive diagnosis (e.g., medication toxicities); including these outcomes would further increase the value of confirmatory testing. CONCLUSIONS: Without confirmatory testing, in settings with MTCT rates similar to that of South Africa, more than 10% of infants who initiate ART may reflect false-positive diagnoses. Confirmatory testing prevents inappropriate HIV diagnosis, is cost-saving, and should be adopted in all EID programmes.

Postpartum Emergency Care Visits Among North Carolina Medicaid Beneficiaries, 2013-2019.

Objective: To describe the rate, timing, and primary diagnosis codes for emergency care visits up to 8 weeks (56 days) after live birth among Medicaid beneficiaries in North Carolina (NC). Materials and Methods: Using a linked dataset of Medicaid hospital claims and certificates of live birth, which included Medicaid beneficiaries who had a live-born infant in NC between January 1, 2013, and November 4, 2019, and met inclusion criteria (n = 321,879), we estimated week-specific visit rates for emergency care visits that did not result in hospital admission (outpatient) and those that did (inpatient). We assessed the 10 leading diagnosis code categories for emergency care visits and described the characteristics of people with 0, 1, or ≥2 outpatient emergency care visits. Results: One in eight (12.4%) Medicaid beneficiaries had an emergency care visit that did not result in inpatient hospital admission during the first 8 weeks postpartum. Visit rates peaked in postpartum week 2. Diagnosis codes for nonspecific symptoms and substance use were the two leading diagnosis code categories for outpatient emergency care visits. Respiratory concerns and gastrointestinal concerns were the two leading diagnosis code categories for inpatient emergency care visits. Compared with those with zero outpatient emergency care visits, a greater proportion of people with ≥2 visits had less than a high school education, used tobacco during pregnancy, had Medicaid insurance outside of pregnancy, had mental health as a medical comorbidity, and/or had ≥2 medical comorbidities. Conclusions: These findings support scheduling health care visits early in the postpartum period, when emergency care visits are most frequent, and point to unmet needs for substance use support.

Hospital Discharge Codes and Overestimating Severe Maternal Morbidity During Delivery Hospitalization.

Our objective was to identify birth hospitalization severe maternal morbidity (SMM) diagnoses that were also coded during prior encounters and, thus, potentially falsely carried forward as de novo SMM events. This retrospective cohort study included pregnant patients with births between 2016 and 2020. We applied the SMM algorithm to the birth hospitalization and encounters occurring prepregnancy, antepartum, and postpartum. The primary outcome was the rate of SMM diagnoses recorded during the birth hospitalization that were also coded on previous encounters. There were 1,380 (1.8%) birthing patients with SMM. Of patients with SMM codes at the birth hospitalization, 19.0% had the same SMM code during a prior encounter. Certain SMM events may be prone to carry-forward errors and may not signify a de novo birth hospitalization event.

Statewide assessment of telehealth use for obstetrical care during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic started a period of rapid transition to telehealth in obstetrical care delivery to maintain social distancing and curb the spread of the virus. The use of telehealth, such as telephone and video visits, remote imaging interpretation, and provider-to-provider consultations, increased in the early months of the pandemic to maintain access to prenatal and postpartum care. Although there is considerable literature on the use of telehealth in obstetrical care, there are limited data on widespread telehealth use among different practice types and patient populations during the pandemic and whether these are preferred technologies. OBJECTIVE: This study aimed to describe variations in telehealth use for obstetrical care among practices in North Carolina during the COVID-19 pandemic and to outline future preferences and needs for continued telehealth use. This study also aimed to delineate telehealth use among rural and micropolitan and metropolitan practices to better understand if telehealth use varied by practice location. STUDY DESIGN: A web-based survey was distributed to practice managers of obstetrical practices in North Carolina from June 14, 2020 to September 14, 2020. Practice managers were contacted through assistance of the Community Care of North Carolina Pregnancy Medical Home program. Practice location was defined as rural, micropolitan, or metropolitan based on the county population. The survey assessed telehealth use before and during the COVID-19 pandemic, types of modalities used, and preferences for future use. Descriptive statistics were performed to describe survey responses and compare them by practice location. RESULTS: A total of 295 practice managers were sent a web-based survey and 98 practice managers responded. Responding practices represented 66 of 100 counties in North Carolina with 50 practices from rural and micropolitan counties and 48 practices from metropolitan counties. The most common type of provider reported by practice managers were general obstetrician and gynecologists (85%), and the most common practice type was county health departments (38%). Overall, 9% of practices reported telehealth use before the pandemic and 60% reported telehealth use during the pandemic. The most common type of telehealth modality was telephone visits. There were no significant differences in the uptake of telehealth or in the modalities used by practice location. A total of 40% of practices endorsed a preference for continued telehealth use beyond the COVID-19 pandemic. The most commonly reported need for continuation of telehealth use was assistance with patient access to telehealth technologies (54%). There were no significant differences in the preferences for telehealth continuation or future needs by practice location. CONCLUSION: Telehealth use increased among a variety of practice types during the pandemic with no variation observed by practice location in terms of modalities used, future preferences, or needs. This study assessed statewide uptake of and differences in obstetrical telehealth use during the early COVID-19 pandemic. With telehealth becoming an integral part of obstetrical care delivery, this survey has implications for anticipating the needs of practices and designing innovative solutions for providers and pregnant people beyond the COVID-19 pandemic.

For better care we need better data: towards a national obstetrics registry.

Unacceptably high rates of severe maternal morbidity and mortality in the United States and stark racial disparities in outcomes are generating efforts to improve both research capacity and quality improvement in obstetrical care. Comprehensive, high-quality datasets on which to build these efforts are crucial to the success of obstetrical quality improvement efforts. However, existing data sources in obstetrics have notable limitations. Other medical and surgical specialties have addressed similar challenges through the creation of national registries, and we argue that obstetrics must take the same approach to improve outcomes. In this article, we summarized the current availability and limitations of large-scale data in obstetrics research and compared the data with registries developed in other specialties. Moreover, we have outlined the guiding principles for the development of a national obstetrics registry and have proposed future directions.

Association between social vulnerability and COVID-19 vaccination hesitancy and vaccination in pregnant and postpartum individuals.

OBJECTIVE: To evaluate the association of community-level social vulnerability with COVID-19 vaccine hesitancy and vaccination among pregnant and postpartum individuals. METHODS: Prospective cohort study assessing COVID-19 vaccine hesitancy among pregnant and postpartum individuals. We performed a baseline survey on COVID-19 vaccine hesitancy from 03/22/21 to 04/02/21, and a follow-up survey on COVD-19 vaccination status 3- to 6-months later. The primary exposure was the Centers for Disease Control and Prevention SVI (Social Vulnerability Index), measured in quartiles. Higher SVI quartiles indicated greater community-level social vulnerability with the lowest quartile (quartile 1) as the referent group. The primary outcome was COVID-19 vaccine hesitancy on the baseline survey (uncertainty or refusal of the vaccine), and the secondary outcome was self-report of not being vaccinated (unvaccinated) for COVID-19 on the follow-up survey. RESULTS: Of 456 assessed individuals, 46% reported COVID-19 vaccine hesitancy on the baseline survey; and of 290 individuals (290/456, 64%) who completed the follow-up survey, 48% (140/290) were unvaccinated. The frequency of baseline vaccine hesitancy ranged from 25% in quartile 1 (low SVI) to 68% in quartile 4 (high SVI), and being unvaccinated at follow-up ranged from 29% in quartile 1 to 77% in quartile 4. As social vulnerability increased, the risk of COVID-19 vaccine hesitancy at baseline increased (quartile 2 aRR (adjusted relative risk): 1.46; 95% CI:0.98 to 2.19; quartile 3 aRR: 1.86; 95% CI:1.28 to 2.71; and quartile 4 aRR: 2.24; 95% CI:1.56 to 3.21), as did the risk of being unvaccinated at follow-up (quartile 2 aRR: 1.00; 95% CI:0.66 to 1.51; quartile 3 aRR: 1.68; 95% CI:1.17 to 2.41; and quartile 4 aRR: 1.82; 95% CI:1.30 to 2.56). CONCLUSIONS: Pregnant and postpartum individuals living in an area with higher community-level social vulnerability were more likely to report COVID-19 vaccine hesitancy and subsequently to be unvaccinated at follow-up.

Association between social vulnerability and influenza and tetanus-diphtheria-acellular pertussis vaccination in pregnant and postpartum individuals.

BACKGROUND: Despite current guidelines recommending universal vaccination, the frequency of vaccination in pregnancy for influenza and tetanus-diphtheria-acellular pertussis remains low. OBJECTIVE: This study aimed to evaluate the association between community-level social vulnerability and influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations among pregnant and postpartum individuals. STUDY DESIGN: We conducted a cross-sectional survey of vaccine hesitancy in the peripartum period among pregnant and postpartum participants enrolled in prenatal care at a single tertiary care center from March 22, 2021, to April 02, 2021. Participant addresses were geocoded using ArcGIS and linked at the census tract level. The primary exposure was community-level social vulnerability as measured by the US Centers for Disease Control and Prevention's Social Vulnerability Index. This index incorporates 15 census variables to produce a composite score and subscores across 4 major thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). The scores range from 0 to 1, with higher values indicating greater social vulnerability. The primary outcomes were self-reported influenza vaccination during the current influenza season and having received or planning to receive the tetanus-diphtheria-acellular pertussis vaccination in pregnancy. We used multivariable logistic regression and adjusted for age, self-reported race and ethnicity, parity, trimester of pregnancy, and chronic comorbid conditions. RESULTS: Of 456 assessed individuals (95% pregnant individuals and 5% postpartum individuals), the frequency of influenza vaccination was 58% (95% confidence interval, 53-62), and the anticipated tetanus-diphtheria-acellular pertussis vaccination was 72% (95% confidence interval, 68-76). Individuals from communities with a higher Social Vulnerability Index were less likely to report vaccination in pregnancy than those from communities with a lower Social Vulnerability Index. Specifically, for each 0.1-unit increase in the Social Vulnerability Index, the odds of influenza vaccination (adjusted odds ratio, 0.23; 95% confidence interval, 0.11-0.46) and anticipated tetanus-diphtheria-acellular pertussis vaccination (adjusted odds ratio, 0.24; 95% confidence interval, 0.11-0.53) decreased by >70%. By domain, the Social Vulnerability Index subscores of socioeconomic status (influenza adjusted odds ratio, 0.20 [95% confidence interval, 0.10-0.40]; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.25 [95% confidence interval, 0.12-0.53]) and housing type and transportation (influenza adjusted odds ratio, 0.41 [95% confidence interval, 0.19-0.84; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.39 [95% confidence interval, 0.18-0.87) were inversely associated with a lower odds of influenza and tetanus-diphtheria-acellular pertussis vaccinations. CONCLUSION: Pregnant and postpartum individuals living in areas with higher social vulnerability were less likely to report influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations in pregnancy. The Social Vulnerability Index could be used as a tool to improve vaccine equity and address disparities in vaccination in pregnancy.

Gottesfeld-Hohler Memorial Foundation Risk Assessment for Early-Onset Preeclampsia in the United States: Think Tank Summary.

Preeclampsia is responsible for significant maternal and neonatal morbidity and is associated with a substantial economic burden. Aspirin has been shown to be effective in decreasing the risk of preterm preeclampsia; however, there is no consensus on the target population for aspirin prophylaxis. In May 2018, the Gottesfeld-Hohler Memorial Foundation organized a working group meeting with the goal of identifying the optimal preeclampsia risk-assessment strategy and consequent intervention in the United States. The meeting brought together experts from the leading professional societies. We discussed available literature and trends in preeclampsia risk assessment, current professional guidelines for identifying women at risk for preeclampsia, prophylactic use of aspirin in the United States and Europe, cost-effectiveness data, and feasibility of implementation of different assessment tools and preventive strategies in the United States. We identified specific knowledge gaps and future research directions in preeclampsia risk assessment and prevention that need to be addressed before practice change.

Strategies for Prescribing Aspirin to Prevent Preeclampsia: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost effectiveness of various preeclampsia screening and aspirin prophylaxis strategies, including a strategy based on biomarker and ultrasound measures. METHODS: We designed a decision analysis to compare preeclampsia-related costs and effects of four strategies for aspirin use in pregnancy initiated before 16 weeks of gestation to prevent preeclampsia. The four strategies were: 1) no aspirin use, 2) biomarker and ultrasound measure-predicated use, 3) use based on the U.S. Preventive Services Task Force guidelines, and 4) universal aspirin use. Our outcomes were preeclampsia-related costs and number of cases per 100,000 pregnant women. Using a threshold of $90,843 per case of preeclampsia, one-way, two-way, and Monte-Carlo sensitivity analyses incorporating varying probabilities of risk reduction due to aspirin use, aspirin-related side effects, and costs were performed to identify ranges at which costs and risks of aspirin-related complications shifted the preferred strategy. RESULTS: Compared with universal aspirin administration, the use of U.S. Preventive Services Task Force guidelines is associated with $8,011,725 higher health care costs and 346 additional cases of preeclampsia per 100,000 pregnant women; biomarker and ultrasound screening is associated with an additional $19,216,551 and 308 additional cases. Similarly, no aspirin use is associated with an increased cost of $18,750,381 and 762 additional cases. Thus, universal aspirin use dominated all three other strategies. In a Monte Carlo simulation of 10,000 pregnant women, universal aspirin was the preferred strategy in 91% of simulations. The U.S. Preventive Task Force screen was preferred in 8.5% of simulations, and biomarker and ultrasound screening and no aspirin were preferred in 0% and 0.5% of simulations, respectively. CONCLUSION: Over a broad range of assumptions, universal aspirin administration is associated with fewer cases of preeclampsia and fewer costs relative to no aspirin administration and aspirin administration based on serum and ultrasound measures or clinical risk factors.

Optimal breastfeeding durations for HIV-exposed infants: the impact of maternal ART use, infant mortality and replacement feeding risk.

INTRODUCTION: In 2010, the WHO recommended women living with HIV breastfeed for 12 months while taking antiretroviral therapy (ART) to balance breastfeeding benefits against HIV transmission risks. To inform the 2016 WHO guidelines, we updated prior research on the impact of breastfeeding duration on HIV-free infant survival (HFS) by incorporating maternal ART duration, infant/child mortality and mother-to-child transmission data. METHODS: Using the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Infant model, we simulated the impact of breastfeeding duration on 24-month HFS among HIV-exposed, uninfected infants. We defined "optimal" breastfeeding durations as those maximizing 24-month HFS. We varied maternal ART duration, mortality rates among breastfed infants/children, and relative risk of mortality associated with replacement feeding ("RRRF"), modelled as a multiplier on all-cause mortality for replacement-fed infants/children (range: 1 [no additional risk] to 6). The base-case simulated RRRF = 3, median infant mortality, and 24-month maternal ART duration. RESULTS: In the base-case, HFS ranged from 83.1% (no breastfeeding) to 90.2% (12-months breastfeeding). Optimal breastfeeding durations increased with higher RRRF values and longer maternal ART durations, but did not change substantially with variation in infant mortality rates. Optimal breastfeeding durations often exceeded the previous WHO recommendation of 12 months. CONCLUSIONS: In settings with high RRRF and long maternal ART durations, HFS is maximized when mothers breastfeed longer than the previously-recommended 12 months. In settings with low RRRF or short maternal ART durations, shorter breastfeeding durations optimize HFS. If mothers are supported to use ART for longer periods of time, it is possible to reduce transmission risks and gain the benefits of longer breastfeeding durations.

Performance of Virological Testing for Early Infant Diagnosis: A Systematic Review.

BACKGROUND: Improved access to both maternal antiretroviral therapy and infant prophylaxis may have an impact on the performance of virological assays for diagnosis of HIV infection in infants. This systematic review was performed to assess the diagnostic accuracy of virological testing at birth as well as the performance of virological testing on dried blood spots at 6 weeks among HIV- and antiretroviral (ARV)-exposed infants. METHODS: A systematic review was performed for studies published between January 1, 2009 and January 30, 2015. The search strategy included studies related to HIV, nucleic acid amplification tests, and newborns/infants and queried PubMed, Embase, the Cochrane Library, LILACS as well as several conference proceedings. Two independent reviewers collected studies and extracted data. The final analysis includes summary estimates of the sensitivities and specificities of the virological assays assessed. The GRADE approach was used to assess the overall quality of evidence and Quality Assessment of Diagnostic Accuracy Studies was used to evaluate the risk of bias in the studies. RESULTS: A total of 2243 records were screened with a final selection of 5 manuscripts. To assess the test characteristics of virological testing at birth, 2 studies were used to calculate a pooled sensitivity of 69.3% (95% confidence interval: 61.1 to 77.4) and a specificity of 99.9% (98.6-100%). The quality of evidence to support the sensitivity of assays at birth was low, whereas the quality of evidence for the specificity of such tests was intermediate-high. In terms of the performance of virological testing on dried blood spots for HIV- and ARV-exposed infants, 3 studies were used to calculate a pooled sensitivity of 99.4% (98.3-100.00%) and specificity of 99.6% (99.1-100.00%). The quality of evidence for both outcomes was low. CONCLUSION: The performance of polymerase chain reaction at birth demonstrates low sensitivity and high specificity, reflecting the difficulty of detecting intrapartum infections at birth and transmission dynamics. In addition, there is no evidence to suggest poor performance of virological testing on dried blood spots for ARV-exposed infants. Overall, given the very limited and low-quality evidence, further research is needed to assess the accuracy of polymerase chain reaction at different time points and in the context of more effective prevention of mother-to-child transmission interventions.