Cost-Effectiveness Analysis of Maternal Respiratory Syncytial Virus Vaccine in Protecting Infants from RSV Infection in Japan.

INTRODUCTION: Respiratory syncytial virus (RSV) is one of the major causes of respiratory tract infections among children. Until recently, the monoclonal antibody palivizumab was the only RSV prophylaxis available in Japan. In 2024, the bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved for the prevention of RSV infection in infants by active immunization of pregnant women. In this study, we assessed the cost-effectiveness of a combined strategy of RSVpreF vaccine and palivizumab in Japanese setting. METHODS: Using a Markov model, we evaluated prevented cases and deaths of medically attended RSV infections from birth to age 11 months for each of the three healthcare settings: inpatient (hospitalization), emergency department visits, and outpatient visits. Incremental cost-effectiveness ratios (ICERs) were calculated from economic outcomes (intervention costs, medication costs, and productivity losses) and quality-adjusted life years (QALYs). Further, we calculated the maximum price of RSVpreF vaccine within which the program would be cost-effective. RESULTS: In comparison with the current prophylaxis (palivizumab alone), a combined prophylaxis of year-round RSVpreF vaccination of pregnant women and palivizumab prescription for premature infants born in < 32 weeks gestational age (wGA) and all infants with high risk prevented 14,382 medically attended cases of RSV (hospitalization, 7490 cases; emergency department, 2239 cases; outpatient, 4653 cases) and 7 deaths, respectively. From a healthcare payer perspective, when the price of RSVpreF vaccine was equal to or less than ¥23,948 (US $182), a combination prophylaxis was cost-effective under the ICER threshold of ¥5 million per QALY. The other combination prophylaxis of year-round RSVpreF vaccination and palivizumab prescription of premature born in < 32 wGA regardless of risk in infants was a dominant strategy (more effective and less costly). CONCLUSION: A combined prophylaxis of year-round RSVpreF vaccine and palivizumab could be a cost-effective strategy to protect neonates throughout the infant stage (< 1 years old) in Japan.

A latent class analysis of factors influencing preferences for infant respiratory syncytial virus (RSV) preventives among pregnant people in the United States.

A maternal vaccine and long-acting monoclonal antibody (mAb) were recently approved to protect infants against respiratory syncytial virus (RSV). We identified subgroups of pregnant people with different preferences for RSV preventives and respondent characteristics associated with subgroup membership. An online survey, including a discrete choice experiment (DCE), was conducted among US pregnant people. RSV preventive attributes included effectiveness, duration of protection during RSV season, injection recipient/timing, preventive type (vaccine or mAb), and type of visit required to receive injection. In DCE choice tasks, pregnant people selected between two hypothetical preventive profiles with varying attribute-levels and a no-preventive option. Logistic regression, including latent class analysis (LCA), was used to analyze the data. Of 992 pregnant people (mean age: 30.0 years), 60.3% were expecting their second/later birth. LCA identified three preference subgroups: 'Effectiveness' (preventive choice mostly driven by increases in effectiveness; 51.4% class membership probability), 'Season' (preventive choice mostly driven by improvement in duration of protection during the RSV season; 39.2% class membership probability), and 'No Preventive' (frequently chose no-preventive option; 9.4% class membership probability). 'Effectiveness' and 'Season' preferred maternal vaccine over mAb; mAb was preferred by 'No Preventive.' Perceiving RSV as serious for infants, higher health literacy, and lower household income were associated with 'Effectiveness.' Perceiving RSV as serious for pregnant people was associated with 'Season.' Perceiving RSV to not be serious for pregnant people and not being employed were associated with 'No Preventive.' Subgroups of pregnant people vary in preferences for RSV preventives. Most pregnant people preferred a maternal vaccine, although some may be more willing to accept alternative preventive options.

Cost-effectiveness Analysis of Maternal Immunization with RSVpreF Vaccine for the Prevention of Respiratory Syncytial Virus Among Infants in Spain.

INTRODUCTION: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in children under one year of age. In high-income countries, RSV infections cause a significant overload of care every winter, imposing a significant burden to the healthcare system, which has made the development of prevention strategies a major global health priority. In this context, a new bivalent RSV prefusion F protein-based vaccine (RSVpreF) has recently been approved. The objective of this study was to evaluate the cost-effectiveness of vaccinating pregnant women with the RSVpreF vaccine to prevent RSV in infants from the Spanish National Healthcare System (NHS) perspective. METHODS: A hypothetical cohort framework and a Markov-type process were used to estimate clinical outcomes, costs, quality-adjusted life years (QALY) and cost-per-QALY gained (willingness-to-pay threshold: €25,000/QALY) for newborn infants born to RSV-vaccinated versus unvaccinated mothers over an RSV season. The base case analysis was performed from the NHS perspective including direct costs (€2023) and applying a discount of 3% to future costs and outcomes. To evaluate the robustness of the model, several scenarios, and deterministic and probabilistic analyses were carried out. All the parameters and assumptions were validated by a panel of experts. RESULTS: The results of the study showed that year-round maternal vaccination program with 70% coverage is a dominant option compared to no intervention, resulting in direct cost savings of €1.8 million each year, with an increase of 551 QALYs. Maternal vaccination could prevent 38% of hospital admissions, 23% of emergency room visits, 19% of primary care visits, and 34% of deaths due to RSV. All scenario analyses showed consistent results, and according to the probabilistic sensitivity analysis (PSA), the probability of maternal vaccination being cost-effective versus no intervention was 99%. CONCLUSIONS: From the Spanish NHS perspective, maternal vaccination with bivalent RSVpreF is a dominant alternative compared with a non-prevention strategy.

Healthcare Providers' and Pregnant People's Preferences for a Preventive to Protect Infants from Serious Illness Due to Respiratory Syncytial Virus.

We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were recruited via convenience sample from a general research panel to complete a cross-sectional, web-based survey, including a discrete choice experiment (DCE) wherein respondents chose between hypothetical RSV preventive profiles varying on five attributes (effectiveness, preventive type [maternal vaccine vs. mAb], injection recipient/timing, type of medical visit required to receive the injection, and duration of protection during RSV season) and a no-preventive option. A best-worst scaling (BWS) exercise was included to explore the impact of additional attributes on preventive preferences. Data were collected between October and November 2022. Attribute-level preference weights and relative importance (RI) were estimated. Overall, 992 pregnant people and 310 HCPs participated. A preventive (vs. none) was chosen 89.2% (pregnant people) and 96.0% (HCPs) of the time (DCE). Effectiveness was most important to preventive choice for pregnant people (RI = 48.0%) and HCPs (RI = 41.7%); all else equal, pregnant people (RI = 5.5%) and HCPs (RI = 7.2%) preferred the maternal vaccine over mAbs, although preventive type had limited influence on choice. Longer protection, protection starting at birth or the beginning of RSV season, and use for both pre-term and full-term babies were ranked highest in importance (BWS). Pregnant people and HCPs strongly preferred a preventive to protect infants against RSV (vs. none), underscoring the need to incorporate RSV preventives into routine care.

Protocol for a hybrid type 3 effectiveness-implementation trial of a pragmatic individual-level implementation strategy for supporting school-based prevention programming.

BACKGROUND: For approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children's SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement. METHODS: This project uses a blocked randomized cohort design with an active comparison control (ACC) condition. We will recruit and include approximately 276 teachers from 46 schools randomly assigned to BASIS-T or ACC conditions. Aim 1 will evaluate the main effects of BASIS-T on proximal implementation mechanisms (attitudes, subjective norms, self-efficacy, intentions to implement, and maintenance self-efficacy), implementation outcomes (adoption, reach, fidelity, and sustainment), and child outcomes (SEB, attendance, discipline, achievement). Aim 2 will examine how, for whom, under what conditions, and how efficiently BASIS-T works, specifically by testing whether the effects of BASIS-T on child outcomes are (a) mediated via its putative mechanisms of behavior change, (b) moderated by teacher factors or school contextual factors, and (c) cost-effective. DISCUSSION: This study will provide a rigorous test of BASIS-T-a pragmatic, theory-driven, and generalizable implementation strategy designed to target theoretically-derived motivational mechanisms-to increase the yield of standard EBPP training and support strategies. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05989568. Registered on May 30, 2023.

Episodic Cost of Lower Respiratory Tract Illness Due to Respiratory Syncytial Virus Among US Infants During the First Year of Life.

A study using two healthcare claims databases (commercial, Medicaid) was undertaken to estimate episodic cost of lower respiratory tract illness due to respiratory syncytial virus (RSV-LRTI) among infants aged <12 months overall, by age, and by birth gestational age (weeks [wGA]). Among commercial-insured infants, mean costs were $28,812 for hospitalized episodes, $2,575 for emergency department episodes, and $336 for outpatient clinic episodes; costs were highest among infants aged <1 month and infants with wGA ≤32, and were comparable-albeit somewhat lower-among Medicaid-insured infants. Cost of RSV-LRTI during acute phase of illness is high, especially among youngest and premature infants.

Maternal Tdap and influenza vaccination uptake 2017-2021 in the United States: Implications for maternal RSV vaccine uptake in the future.

BACKGROUND: Assessment of maternal vaccine coverage is important for understanding and quantifying the impact of currently recommended vaccines as well as modeling the potential impact of future vaccines. However, existing data lack detail regarding uptake according to week of gestational age (wGA). Such granularity is valuable for more accurate estimation of vaccine impact. OBJECTIVE: To summarize contemporary maternal Tdap vaccination uptake, overall, yearly, and by wGA, and maternal influenza vaccination uptake, overall, by influenza observation year, immunization month, and delivery month, in the US. METHODS: Female patients 18-49 years of age with a pregnancy resulting in a live born infant (i.e., delivery) between 2017 and 2021 were selected from the Optum electronic health records (EHRs) database. Recently published gestational age algorithms were utilized to estimate wGA. RESULTS: Of 1,021,260 deliveries among 886,660 women between 2017-2021, 55.1% had Tdap vaccination during pregnancy; vaccine coverage varied slightly by year (2017: 56.6%; 2018: 55.2%; 2019: 55.2%; 2020: 54.7%; 2021: 52.1%). Most (64.4%) maternal Tdap vaccinations occurred 27-32 wGA; 79.5% occurred during the entire 10-week recommended vaccination window (27-36 wGA). In the evaluation of influenza vaccination uptake (n=798,113 deliveries; 714,841 women), 33.5% of deliveries had influenza vaccination during influenza observation years 2017-2021, most (73.0%) of which occurred during influenza peak activity months (October-January) with approximately one-quarter (27.0%) of vaccinations having occurred during the off-peak months, mostly in September. CONCLUSIONS: In this large contemporary analysis of EHR data, uptake of Tdap vaccination during pregnancy was consistent with previously published estimates; notably, most vaccination occurred early in the recommended 27-36 wGA window. Maternal influenza vaccination uptake largely correlated with peak influenza activity months and not gestational age. These study findings may have important implications for estimating the potential uptake and impact of future maternal vaccines.

Parent Preferences on Screening for Social Determinants of Health in Hospitalized Children.

BACKGROUND: Although there has been much research on screening families for social determinants of health (SDOH) at pediatric outpatient visits, there is little data on family preferences about SDOH screening during hospitalization. This is of critical importance because unmet SDOH, also known as social needs, are associated with poor health outcomes. OBJECTIVE: Our objective was to assess caregiver preferences for social needs screening in the inpatient pediatric setting. METHODS: We surveyed a sample of caregivers of admitted patients at our freestanding tertiary-care children's hospital between March 2021 and January 2022. Caregivers were surveyed with respect to the importance of screening, their comfort with screening, and which domains were felt to be acceptable for screening. RESULTS: We enrolled 160 caregivers. More than 60% of caregivers were comfortable being screened for each of the social needs listed. Between 40% and 50% found screening acceptable, even if resources were unavailable. Forty-five percent preferred to be screened in private, 9% preferred to be screened by a health care team member, and 37% were comfortable being screened either in private or with a health care team member. Electronic screening was the most preferred modality (44%), and if by a health care team member, social workers were preferred over others. CONCLUSIONS: Many caregivers reported the acceptance of and comfort with social needs screening in the inpatient setting. Our findings may help inform future hospital-wide social needs screening efforts.

FDG-PET/MRI for the preoperative diagnosis and staging of peritoneal carcinomatosis: a prospective multireader pilot study.

PURPOSE: To assess the diagnostic performance of FDG-PET/MRI for the preoperative diagnosis and staging of peritoneal carcinomatosis (PC) using surgical Sugarbaker's PC index (PCI) as the reference in a multireader pilot study. METHODS: Fourteen adult patients (M/F: 3/11, mean age: 57 ± 12 year) with PC were prospectively included in this single-center study. Patients underwent FDG-PET/MRI prior to surgery (mean delay: 14 d, range: 1-63 d). Images were reviewed independently by 2 abdominal radiologists and 2 nuclear medicine physicians. The radiologists assessed contrast-enhanced abdominal MR images, while the nuclear medicine physicians assessed PET images fused with T2-weighted images. The abdomen was divided in 13 regions, scored from 0 to 3. A hybrid FDG-PET/MRI radiological PCI was created by combining the study data. Radiological PCI was compared to the surgical PCI on a per-patient and per-region basis. Inter-reader agreement was evaluated. RESULTS: Mean surgical PCI was 10 ± 8 (range: 0-24). Inter-reader agreement was almost perfect for all sets for radiologic PCI (Kappa: 0.81-0.98). PCI scores for all reading sets significantly correlated with the surgical PCI score (r range: 0.57-0.74, p range: < 0.001-0.003). Pooled per-patient sensitivity, specificity, and accuracy were 75%/50%/71.4% for MRI, 66.7%/50%/64.3% for FDG-PET, and 91.7%/50%/85.7% for FDG-PET/MRI, without significant difference (p value range 0.13-1). FDG-PET/MRI achieved 100% sensitivity and 100% specificity for a cutoff PCI of 20. Per-region sensitivity and accuracy were lower: 37%/61.8% for MRI, 17.8%/64.3% for FDG-PET, and 52.7%/60.4% for FDG-PET/MRI, with significantly higher sensitivity for FDG-PET/MRI. Per-region specificity was higher for FDG-PET (95%) compared to MRI (78.4%) and FDG-PET/MRI (66.5%). CONCLUSION: FDG-PET/MRI achieved an excellent diagnostic accuracy per-patient and weaker performance per-region for detection of PC. The added value of PET/MRI compared to MRI and FDG-PET remains to be determined.

How low can you go? Examining the effects of brief online training and post-training consultation dose on implementation mechanisms and outcomes for measurement-based care.

BACKGROUND: Initial training and ongoing post-training consultation (i.e., ongoing support following training, provided by an expert) are among the most common implementation strategies used to change clinician practice. However, extant research has not experimentally investigated the optimal dosages of consultation necessary to produce desired outcomes. Moreover, the degree to which training and consultation engage theoretical implementation mechanisms-such as provider knowledge, skills, and attitudes-is not well understood. This study examined the effects of a brief online training and varying dosages of post-training consultation (BOLT+PTC) on implementation mechanisms and outcomes for measurement-based care (MBC) practices delivered in the context of education sector mental health services. METHODS: A national sample of 75 clinicians who provide mental health interventions to children and adolescents in schools were randomly assigned to BOLT+PTC or control (services as usual). Those in BOLT+PTC were further randomized to 2-, 4-, or 8-week consultation conditions. Self-reported MBC knowledge, skills, attitudes, and use (including standardized assessment, individualized assessment, and assessment-informed treatment modification) were collected for 32 weeks. Multilevel models were used to examine main effects of BOLT+PTC versus control on MBC use at the end of consultation and over time, as well as comparisons among PTC dosage conditions and theorized mechanisms (skills, attitudes, knowledge). RESULTS: There was a significant linear effect of BOLT+PTC over time on standardized assessment use (b = .02, p < .01), and a significant quadratic effect of BOLT+PTC over time on individualized assessment use (b = .04, p < .001), but no significant effect on treatment modification. BOLT + any level of PTC resulted in higher MBC knowledge and larger growth in MBC skill over the intervention period as compared to control. PTC dosage levels were inconsistently predictive of outcomes, providing no clear evidence for added benefit of higher PTC dosage. CONCLUSIONS: Online training and consultation in MBC had effects on standardized and individualized assessment use among clinicians as compared to services as usual with no consistent benefit detected for increased consultation dosage. Continued research investigating optimal dosages and mechanisms of these established implementation strategies is needed to ensure training and consultation resources are deployed efficiently to impact clinician practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT05041517 . Retrospectively registered on 10 September 2021.

Assessment of HCC response to Yttrium-90 radioembolization with gadoxetate disodium MRI: correlation with histopathology.

BACKGROUND AND AIMS: Transarterial 90Y radioembolization (TARE) is increasingly being used for hepatocellular carcinoma (HCC) treatment. However, tumor response assessment after TARE may be challenging. We aimed to assess the diagnostic performance of gadoxetate disodium MRI for predicting complete pathologic necrosis (CPN) of HCC treated with TARE, using histopathology as the reference standard. METHODS: This retrospective study included 48 patients (M/F: 36/12, mean age: 62 years) with HCC treated by TARE followed by surgery with gadoxetate disodium MRI within 90 days of surgery. Two radiologists evaluated tumor response using RECIST1.1, mRECIST, EASL, and LI-RADS-TR criteria and evaluated the percentage of necrosis on subtraction during late arterial, portal venous, and hepatobiliary phases (AP/PVP/HBP). Statistical analysis included inter-reader agreement, correlation between radiologic and pathologic percentage of necrosis, and prediction of CPN using logistic regression and ROC analyses. RESULTS: Histopathology demonstrated 71 HCCs (2.8 ± 1.7 cm, range: 0.5-7.5 cm) including 42 with CPN, 22 with partial necrosis, and 7 without necrosis. EASL and percentage of tumor necrosis on subtraction at the AP/PVP were independent predictors of CPN (p = 0.02-0.03). Percentage of necrosis, mRECIST, EASL, and LI-RADS-TR had fair to good performance for diagnosing CPN (AUCs: 0.78 - 0.83), with a significant difference between subtraction and LI-RADS-TR for reader 2, and in specificity between subtraction and other criteria for both readers (p-range: 0.01-0.04). Radiologic percentage of necrosis was significantly correlated to histopathologic degree of tumor necrosis (r = 0.66 - 0.8, p < 0.001). CONCLUSIONS: Percentage of tumor necrosis on subtraction and EASL criteria were significant independent predictors of CPN in HCC treated with TARE. Image subtraction should be considered for assessing HCC response to TARE when using MRI. KEY POINTS: • Percentage of tumor necrosis on image subtraction and EASL criteria are significant independent predictors of complete pathologic necrosis in hepatocellular carcinoma treated with90Y radioembolization. • Subtraction, mRECIST, EASL, and LI-RADS-TR have fair to good performance for diagnosing complete pathologic necrosis in hepatocellular carcinoma treated with90Y radioembolization.

Brothers and sisters sharing in the care of a parent with dementia.

Brothers' and sisters' experiences providing care to a parent with dementia differ, but little is known about how mixed-gender siblings share their caregiving responsibilities or how sharing affects their relationship. This study aimed to explore mixed-gender siblings processes for distributing caregiving tasks when caring for a parent with dementia and the impact of sharing care on their relationship. This descriptive qualitative study recruited fourteen English-speaking mixed-gender sibling pairs caring for a parent with dementia. Online open-ended surveys and individual semi-structured interviews were completed. Interviews and surveys explored division of caregiving responsibilities, conflict resolution, and the effects of sharing care on sibling relationships. Thematic analysis was used to analyze the qualitative data. Five themes were identified: goal of shared caregiving is to meet parents' needs, sisters often take the lead, practical issues affect sharing of caregiving activities, personal resources or skills affect division of responsibilities, and shared caregiving influences relationship quality. Understanding how siblings share caregiving responsibilities can inform the practices of healthcare professionals who care for people with dementia and their family caregivers.

A Brief Online Implicit Bias Intervention for School Mental Health Clinicians.

Clinician bias has been identified as a potential contributor to persistent healthcare disparities across many medical specialties and service settings. Few studies have examined strategies to reduce clinician bias, especially in mental healthcare, despite decades of research evidencing service and outcome disparities in adult and pediatric populations. This manuscript describes an intervention development study and a pilot feasibility trial of the Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) for mental health clinicians in schools-where most youth in the U.S. access mental healthcare. Clinicians (N = 12) in the feasibility study-a non-randomized open trial-rated VIBRANT as highly usable, appropriate, acceptable, and feasible for their school-based practice. Preliminarily, clinicians appeared to demonstrate improvements in implicit bias knowledge, use of bias-management strategies, and implicit biases (as measured by the Implicit Association Test [IAT]) post-training. Moreover, putative mediators (e.g., clinicians' VIBRANT strategies use, IAT D scores) and outcome variables (e.g., clinician-rated quality of rapport) generally demonstrated correlations in the expected directions. These pilot results suggest that brief and highly scalable online interventions such as VIBRANT are feasible and promising for addressing implicit bias among healthcare providers (e.g., mental health clinicians) and can have potential downstream impacts on minoritized youth's care experience.

Hospital Readmissions and Mortality Among Intubated and Mechanically Ventilated Adult Subjects With Pneumonia Due to Gram-Negative Bacteria.

BACKGROUND: Ventilator-associated pneumonia (VAP) is one of the most common hospital-acquired infections in ICUs and is associated with significant morbidity and mortality. Gram-negative bacteria cause 55-85% of hospital-acquired pneumonia and are associated with increased mortality. METHODS: This study sought to describe mortality rates and 30-d readmission rates among intubated and mechanically ventilated subjects with Gram-negative pneumonia and to explore associated risk factors for mortality and rehospitalization using data from the 2013 Healthcare Cost and Utilization Project (HCUP) National Readmission Database. The study sample included adults age ≥ 18 y who were hospitalized with invasive, continuous mechanical ventilation; were discharged between February 1, 2013, and November 30, 2013; and had a primary or secondary diagnosis of Gram-negative bacterial pneumonia. Logistic regression was used to identify subject characteristics significantly associated with mortality and readmissions. RESULTS: Using the HCUP projected sample of 32,683 intubated and mechanically ventilated subjects with Gram-negative pneumonia, the mortality rate during the index hospitalization was 24.3%. More than one fifth of subjects (22.9%) who survived the index hospitalization were readmitted within 30 d of discharge. Among subjects with readmissions, 18% occurred within 3 d of discharge, 39% occurred within 7 d of discharge, and 65% occurred within 14 d of discharge. Subjects with prior hospitalization within 30 d of the index hospitalization had a higher risk of readmission with an odds ratio of 1.70 (95% CI 1.48-1.94). CONCLUSIONS: Mortality was high and readmissions were substantial among intubated and mechanically ventilated subjects with Gram-negative pneumonia.

Comparison of Healthcare Costs Associated With Patients Receiving Traditional Negative Pressure Wound Therapies in the Post-Acute Setting.

Objective A retrospective national insurance claims database analysis evaluated total and wound-related costs for acute and chronic wound patients treated with negative pressure wound therapy (NPWT), comparing a product specific NPWT (NPWT-K) to other NPWT systems (NPWT-O). Methods Patients with one or more NPWT claims between January 2016 and September 2018 in an outpatient setting with continuous medical and pharmacy benefits for six months before the initial (index) NPWT claims and 12 months post index were assessed. The cohorts were propensity score matched based on age, gender, comorbidities, and payer type. Each cohort included 3,368 patients after matching. Costs were evaluated at 30 days, three months, and 12 months after initial NPWT placement. Hospital admission rates, emergency room (ER) visits, and NPWT device switching were evaluated at 30 days. Differences were analyzed by t-test and chi-square test. Results At 30 days, wound-related costs were $8,583 and $11,334, and total cost to treat was $17,809 and $24,405 for NPWT-K and NPWT-O, respectively (p < 0.0001). NPWT-O patients had higher NPWT, wound-related, and total costs across all time periods, as well as a longer average length of therapy (p = .0039). There was no statistical difference in 30-day hospital admissions (p = 0.089); although 30-day ER visits were higher for NPWT-K (4.9% vs. 3.3%, p = 0.0007). A higher degree of switching from NPWT-O to NPWT-K occurred at 30 days (NPWT-O 2.5% vs. 0.4%, p < 0.0001). Conclusions This comparative effectiveness analysis indicates differences remain across NPWT suppliers in wound-related and total cost to treat for patients who receive durable NPWT in the outpatient setting.

Twelve-month discontinuation rates of levonorgestrel intrauterine system 13.5 mg and subdermal etonogestrel implant in women aged 18-44: A retrospective claims database analysis.

OBJECTIVE: To investigate the 12-month discontinuation rates of levonorgestrel intrauterine system 13.5 mg (LNG-IUS 13.5) and subdermal etonogestrel (ENG) implant in the US. STUDY DESIGN: We identified women aged 18-44 who had an insertion of LNG-IUS 13.5 or ENG implant from the MarketScan Commercial claims database (7/1/2013-9/30/2014). Women were required to have 12 months of continuous insurance coverage prior to the insertion (baseline) and at least 12-months after (follow-up). Discontinuation was defined as presence of an insurance claim for pregnancy-related services, hysterectomy, female sterilization, a claim for another contraceptive method, or removal of the index contraceptive without re-insertion within 30 days. Using Cox regression we examined the potential impact of ENG implant vs. LNG-IUS 13.5 on the likelihood for discontinuation after controlling for patient characteristics. RESULTS: A total of 3680 (mean age: 25.4 years) LNG-IUS 13.5 and 23,770 (mean age: 24.6 years) ENG implant users met the selection criteria. Prior to insertion, 56.6% of LNG-IUS 13.5 and 42.1% of ENG implant users had used contraceptives, with oral contraceptives being most common (LNG-IUS 13.5: 42.1%; ENG implant: 28.5%). Among users of LNG-IUS 13.5 and ENG implant, rates of discontinuation were similar during the 12-month follow-up (LNG-IUS 13.5: 24.9%; ENG implant: 24.0%). Regression results showed that women using LNG-IUS 13.5 vs. ENG implant had similar likelihood for discontinuation (hazard ratio: 0.97, 95% confidence interval: 0.90-1.05, p=.41). CONCLUSION: In the real-world US setting, women aged 18-44 using LNG-IUS 13.5 and ENG implant have similar discontinuation rates after 12 months. IMPLICATIONS: In the United States, women aged 18-44 using levonorgestrel intrauterine system (13.5 mg) and subdermal etonogestrel implant have similar discontinuation rates after 12 months.

Liver Imaging Reporting and Data System: Discordance Between Computed Tomography and Gadoxetate-Enhanced Magnetic Resonance Imaging for Detection of Hepatocellular Carcinoma Major Features.

PURPOSE: The goal of this study was to compare agreement between computed tomography (CT) and magnetic resonance imaging (MRI) in the evaluation of the major Liver Imaging Reporting and Data System (LI-RADS) features used in assessment of hepatocellular carcinoma: arterial phase hyperenhancement (APHE), portal venous phase washout (WO), capsule appearance (capsule), and largest diameter (diameter). METHODS: Patients with liver protocol CT and gadoxetate-enhanced MRI within 1 month of each other and at least 1 discrete untreated liver lesion were included. Two readers independently reviewed hepatic arterial phase and portal venous phase of each lesion on both CT and MRI, presented at random. The APHE, WO, capsule, and diameter were assessed for each lesion on CT and MRI. The LI-RADS category was assigned based on the recorded major features. Interobserver agreements between the readers for both imaging modalities and for each of the major features were assessed using κ statistics. Agreement between CT and MRI for each reader and for each feature was assessed using κ statistics. Agreement was interpreted based on κ as follows: 0.20 or less, slight agreement; 0.21 to 0.40, fair agreement; 0.41 to 0.60, moderate agreement; 0.61 to 0.80, substantial agreement; and 0.81 to 1.00, almost perfect agreement. Intraclass correlation coefficient was used to assess concordance of diameter measurements. RESULTS: There were 42 patients (mean age, 62.2 ± 7.0 years; 33 men [78.6%]) with 50 lesions. On CT, the interobserver agreement between the readers was almost perfect for APHE (κ = 0.85), WO (κ = 0.83), and capsule (κ = 0.86). On MRI, the interobserver agreement between the readers was almost perfect for APHE (κ = 0.86) and WO (κ = 0.83) and moderate for capsule (κ = 0.59). Intraclass correlation coefficient for diameter measurement was 0.99 for CT and 0.98 for MRI. For reader 1, the agreement between CT and MRI was fair for APHE (κ = 0.39) and capsule (κ = 0.26) and moderate for WO (κ = 0.49). For reader 2, the agreement between CT and MRI was moderate for APHE (κ = 0.43) and capsule (κ = 0.43) and fair (κ = 0.38) for WO. Agreement between readers for final LI-RADS category was substantial for CT (κ = 0.79) and moderate for MRI (κ = 0.60). Agreement for final LI-RADS categories between MRI and CT was fair for both reader 1 (κ = 0.33) and reader 2 (κ = 0.39). CONCLUSIONS: Interobserver agreement for the major LI-RADS features varies from moderate to almost perfect, for both CT and MRI. However, the agreement between CT and MRI for each of the major LI-RADS features is poor, ranging from fair to moderate. This poor agreement contributes to substantial differences between final LI-RADS category assigned on CT versus MRI.

Long-term outcomes after elective sterilization procedures - a comparative retrospective cohort study of Medicaid patients.

OBJECTIVES: The objectives were to compare the long-term outcomes, including hysterectomy, chronic pelvic pain (CPP) and abnormal uterine bleeding (AUB), in women post hysteroscopic sterilization (HS) and laparoscopic tubal ligation (TL) in the Medicaid population. STUDY DESIGN: This was a retrospective observational cohort analysis using data from the US Medicaid Analytic Extracts Encounters database. Women aged 18 to 49years with at least one claim for HS (n=3929) or TL (n=10,875) between July 1, 2009, through December 31, 2010, were included. Main outcome measures were hysterectomy, CPP or AUB in the 24months poststerilization. Propensity score matching was used to control for patient demographics and baseline characteristics. Logistic regression analysis investigated the variables associated with a 24-month rate of each outcome in the HS versus laparoscopic TL cohorts. RESULTS: Postmatching analyses were performed at 6, 12 and 24months post index procedure. At 24months, hysterectomy was more common in the laparoscopic TL than the HS group (3.5% vs. 2.1%; p=.0023), as was diagnosis of CPP (26.8% vs. 23.5%; p=.0050). No significant differences in AUB diagnoses were observed. Logistic regression identified HS as being associated with lower risk of hysterectomy (odds ratio [OR] 0.77 [95% confidence interval {CI} 0.60-0.97]; p=.0274) and lower risk of CPP diagnosis (OR 0.91 [95% CI 0.83-0.99]; p=.0336) at 24months poststerilization. CONCLUSION: In Medicaid patients, HS is associated with a significantly lower risk of hysterectomy or CPP diagnosis 24months poststerilization versus laparoscopic TL. Incidence of AUB poststerilization is not significantly different. While some differences in outcomes were statistically significant, the effect sizes were small, and the conclusion is one of equivalence and not clinical superiority. IMPLICATIONS STATEMENT: This propensity score matching analysis confirms that pelvic pain and AUB are common in women before and after sterilization regardless of whether the procedure is performed hysteroscopically or laparoscopically. Moreover, HS is associated with a significantly lower risk of hysterectomy or a CPP diagnosis in the 24months poststerilization when compared to TL.