Neonatal morbidity and mortality in birth centers in the United States 2018-2021: An observational study of low-risk birthing individuals.

BACKGROUND: Many studies reporting neonatal outcomes in birth centers include births with risk factors not acceptable for birth center care using the evidence-based CABC criteria. Accurate comparisons of outcomes by birth setting for low-risk patients are needed. METHODS: Data from the public Natality Detailed File from 2018 to 2021 were used. Logistic regression, including adjusted and unadjusted odds ratios, compared neonatal outcomes (chorioamnionitis, Apgar scores, resuscitation, intensive care, seizures, and death) between centers and hospitals. Covariates included maternal diabetes, body mass index, age, parity, and demographic characteristics. RESULTS: The sample included 8,738,711 births (8,698,432 (99.53%) in hospitals and 40,279 (0.46%) in birth centers). There were no significant differences in neonatal deaths (aOR 1.037; 95% CI [0.515, 2.088]; p-value 0.918) or seizures (aOR 0.666; 95% CI [0.315, 1.411]; p-value 0.289). Measures of morbidity either not significantly different or less likely to occur in birth centers compared to hospitals included chorioamnionitis (aOR 0.032; 95% CI [0.020, 0.052]; p-value < 0.001), Apgar score < 4 (aOR 0.814, 95% CI [0.638, 1.039], p-value 0.099), Apgar score < 7 (aOR 1.075, 95% CI [0.979, 1.180], p-value 0.130), ventilation >6 h (aOR 0.349; [0.281,0.433], p-value < 0.001), and intensive care admission (aOR 0.356; 95% CI [0.328, 0.386], p-value < 0.001). Birth centers had higher odds of assisted neonatal ventilation for <6 h as compared to hospitals (aOR 1.373; 95% CI [1.293, 1.457], p-value < 0.001). CONCLUSION: Neonatal deaths and seizures were not significantly different between freestanding birth centers and hospitals. Chorioamnionitis, Apgar scores < 4, and intensive care admission were less likely to occur in birth centers.

Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir.

BACKGROUND: Elbasvir/grazoprevir is a once-daily fixed-dose combination therapy for the treatment of chronic HCV infection, including HCV/HIV coinfection. OBJECTIVES: To evaluate the pharmacokinetic interaction of elbasvir and grazoprevir with raltegravir or dolutegravir. METHODS: Three open-label trials in healthy adult participants were conducted. In the raltegravir trials, participants received a single dose of raltegravir 400 mg, a single dose of elbasvir 50 mg or grazoprevir 200 mg, and raltegravir with either elbasvir or grazoprevir. In the dolutegravir trial, participants received a single dose of dolutegravir 50 mg alone or co-administered with once-daily elbasvir 50 mg and grazoprevir 200 mg. RESULTS: The raltegravir AUC0-∞ geometric mean ratio (GMR) (90% CI) was 1.02 (0.81-1.27) with elbasvir and 1.43 (0.89-2.30) with grazoprevir. Dolutegravir AUC0-∞ GMR (90% CI) was 1.16 (1.00-1.34) with elbasvir and grazoprevir. The elbasvir AUC0-∞ GMR (90% CI) was 0.81 (0.57-1.17) with raltegravir and 0.98 (0.93-1.04) with dolutegravir. The grazoprevir AUC0-24 GMR (90% CI) was 0.89 (0.72-1.09) with raltegravir and 0.81 (0.67-0.97) with dolutegravir. CONCLUSIONS: Elbasvir or grazoprevir co-administered with raltegravir or dolutegravir resulted in no clinically meaningful drug-drug interactions and was generally well tolerated. These results support the assertion that no dose adjustments for elbasvir, grazoprevir, raltegravir or dolutegravir are needed for co-administration in HCV/HIV-coinfected people.

Similar neurocognitive outcomes after 48 weeks in HIV-1-infected participants randomized to continue tenofovir/emtricitabine + atazanavir/ritonavir or simplify to abacavir/lamivudine + atazanavir.

Human immunodeficiency virus (HIV)-associated neurocognitive disorders can persist in many patients despite achieving viral suppression while on antiretroviral therapy (ART). Neurocognitive function over 48 weeks was evaluated using a Cogstate test battery assessing psychomotor function, attention, learning, and working memory in 293 HIV-1-infected, ART-experienced, and virologically suppressed adults. The ASSURE study randomized participants 1:2 to remain on tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV). Neurocognitive z-scores were computed using demographically adjusted normative data and were classified as "impaired" (defined as either a z-score ≤ - 2 or having 2 or more standardized individual test z-scores ≤ - 1); while higher scores (equaling better performance) were classified as "normal". By z-scores, 54.7% of participants had impaired neurocognition at baseline and 50.2% at week 48. There were no significant differences (p < 0.05) in the baseline-adjusted performance between treatment groups for any individual test or by z-score. Specific demographic and medical risk factors were evaluated by univariate analysis for impact on neurocognitive performance. Factors with p < 0.10 were evaluated by backwards regression analysis to identify neurocognition-correlated factors after accounting for treatment, assessment, and baseline. Four risk factors at baseline for impaired neurocognition were initially identified: lower CD4 nadir lymphocyte counts, higher Framingham risk scores, and interleukin-6 levels, and a history of psychiatric disorder not otherwise specified, however none were found to moderate the effect of treatment on neurocognition. In this aviremic, treatment-experienced population, baseline-adjusted neurocognitive function remained stable and equivalent over 48 weeks with both TDF/FTC + ATV/r-treated and in the ART-simplified ABC/3TC + ATV treatment groups.

Use of Tablet Devices in the Management of Agitation Among Inpatients with Dementia: An Open-Label Study.

OBJECTIVE: To investigate the feasibility, safety, and utility of tablet devices as novel nonpharmacologic tools in managing older psychiatric inpatients with agitation and dementia. METHODS: Thirty-six patients at a geriatric psychiatry inpatient unit were provided with tablets when agitated and used various apps on the tablet related to communication, games, music, web browser, and photography during their stay. Study staff documented the frequency, duration, and app usage history and rated the extent to which agitation improved after tablet use. RESULTS: All participants, regardless of dementia severity, were able to use apps and were rated by staff to have clinical benefit. Dementia severity was negatively associated with app complexity. Age was negatively associated with frequency and duration of tablet use. CONCLUSION: Tablet use as a nonpharmacologic intervention for agitation in older adults, including those with severe dementia, appears to be feasible, safe, and of potential utility.

HLA-B*57:01 allele prevalence in HIV-infected North American subjects and the impact of allele testing on the incidence of abacavir-associated hypersensitivity reaction in HLA-B*57:01-negative subjects.

BACKGROUND: The presence of the HLA-B*57:01 allele in HIV-infected subjects is associated with a higher risk of abacavir-associated hypersensitivity reaction (ABC HSR). HLA-B*57:01 allele prevalence varies in different populations, but HLA-B*57:01 testing with immunological confirmation has had a negative predictive value for ABC HSR between 97 and 100%. METHODS: In the ASSURE study (EPZ113734), the HLA-B*57:01 prevalence in virologically suppressed, antiretroviral treatment-experienced, HIV-infected subjects from the United States, including Puerto Rico, was assessed. RESULTS: Three hundred eighty-five subjects were screened; 13 were HLA-B*57:01 positive and 372 were negative. Only HLA-B*57:01-negative, abacavir-naive subjects were eligible to enroll into the ASSURE trial. Eleven of the 13 subjects who possessed the HLA-B*57:01 allele were white, the other 2 were African-American. There was no geographic clustering of HLA-B*57:01-positive subjects, and the incidence correlated roughly with those states with the greatest numbers of subjects screened. Similarly, there was no statistically significant correlation between subjects who possessed or lacked the allele and age, gender, ethnicity or CD4+ T-cell numbers. The incidence of ABC HSR following abacavir initiation was also evaluated. Only 1 of 199 HLA-B*57:01-negative subjects (an African-American male) randomized to receive abacavir-containing treatment developed symptoms consistent with suspected ABC HSR; ABC HSR was not immunologically confirmed. CONCLUSIONS: These findings confirm the utility of HLA-B*57:01 allele testing to reduce the frequency of ABC HSR. The prevalence of HLA-B*57:01 positivity was higher in white than in African-American subjects. In HLA-B*57:01-negative subjects, suspected ABC HSR is very rare, but should lead to discontinuation of abacavir when ABC HSR cannot be definitively excluded from the differential diagnosis. TRIAL REGISTRATION: The ASSURE (EPZ113734) study was registered on ClinicalTrials.gov registration on April 8th 2010 and the registration number is NCT01102972.

The clonal relationships between pre-cancer and cancer revealed by ultra-deep sequencing.

The study of the relationships between pre-cancer and cancer and identification of early driver mutations is becoming increasingly important as the value of molecular markers of early disease and personalised drug targets is recognized, especially now the extent of clonal heterogeneity in fully invasive disease is being realized. It has been assumed that pre-cancerous lesions exhibit a fairly passive progression to invasive disease; the degree to which they, too, are heterogeneous is unknown. We performed ultra-deep sequencing of thousands of selected mutations, together with copy number analysis, from multiple, matched pre-invasive lesions, primary tumours and metastases from five patients with oral cancer, some with multiple primary tumours presenting either synchronously or metachronously, totalling 75 samples. This allowed the clonal relationships between the samples to be observed for each patient. We expose for the first time the unexpected variety and complexity of the relationships between this group of oral dysplasias and their associated carcinomas and, ultimately, the diversity of processes by which tumours are initiated, spread and metastasize. Instead of a series of genomic precursors of their adjacent invasive disease, we have shown dysplasia to be a distinct dynamic entity, refuting the belief that pre-cancer and invasive tumours with a close spatial relationship always have linearly related genomes. We show that oral pre-cancer exhibits considerable subclonal heterogeneity in its own right, that mutational changes in pre-cancer do not predict the onset of invasion, and that the genomic pathway to invasion is neither unified nor predictable. Sequence data from this study have been deposited in the European Nucleotide Archive, Accession No. PRJEB6588.

No clinically significant pharmacokinetic interactions between dolutegravir and daclatasvir in healthy adult subjects.

BACKGROUND: Daclatasvir (DCV) is an NS5A replication complex inhibitor recently approved for chronic hepatitis C virus treatment. METHODS: To assess drug interactions between the HIV integrase strand transfer inhibitor dolutegravir (DTG) and DCV, subjects were randomized into 1 of 2 sequences in an open-label, 3-period, crossover study. Subjects received either DTG 50 mg once daily or DCV 60 mg once daily for 5 days in periods 1 and 2 and DTG 50 mg plus DCV 60 mg once daily for 5 days in period 3, with no washout between periods 2 and 3. Between periods 1 and 2, there was a washout period of at least 7 days. RESULTS: The geometric least-squares mean ratios (90 % confidence intervals) of DCV area under the concentration-time curve over a dosing interval (AUC0-τ), maximum observed concentration (Cmax), and concentration at the end of the dosing interval (Cτ) were 0.978 (0.831-1.15), 1.03 (0.843-1.25), and 1.06 (0.876-1.29), respectively, when DCV was administered with DTG compared with DCV alone. Compared with DTG alone, coadministration of DTG with DCV increased DTG AUC0-τ, Cmax, and Cτ by approximately 33, 29, and 45 %, respectively. CONCLUSIONS: DCV plasma exposure was not meaningfully affected by DTG. Coadministration of DTG with DCV resulted in slight increases in DTG AUC0-τ, Cmax, and Cτ. Accumulated safety and tolerability data in humans receiving DTG to date suggests this effect is not considered clinically significant. DTG and DCV can be coadministered without dose adjustment. TRIAL REGISTRATION: Registered on March 6, 2014 with ClinicalTrials.gov; registration number: NCT02082808 and as Study ID: 201102 on the ViiV Clinical Study Registry.

A novel genomic signature reclassifies an oral cancer subtype.

Verrucous carcinoma of the oral cavity (OVC) is considered a subtype of classical oral squamous cell carcinoma (OSCC). Diagnosis is problematic, and additional biomarkers are needed to better stratify patients. To investigate their molecular signature, we performed low-coverage copy number (CN) sequencing on 57 OVC and exome and RNA sequencing on a subset of these and compared the data to the same OSCC parameters. CN results showed that OVC lacked any of the classical OSCC patterns such as gain of 3q and loss of 3p and demonstrated considerably fewer genomic rearrangements compared to the OSCC cohort. OVC and OSCC samples could be clearly differentiated. Exome sequencing showed that OVC samples lacked mutations in genes commonly associated with OSCC (TP53, NOTCH1, NOTCH2, CDKN2A and FAT1). RNA sequencing identified genes that were differentially expressed between the groups. In silico functional analysis showed that the mutated and differentially expressed genes in OVC samples were involved in cell adhesion and keratinocyte proliferation, while those in the OSCC cohort were enriched for cell death and apoptosis pathways. This is the largest and most detailed genomic and transcriptomic analysis yet performed on this tumour type, which, as an example of non-metastatic cancer, may shed light on the nature of metastases. These three independent investigations consistently show substantial differences between the cohorts. Taken together, they lead to the conclusion that OVC is not a subtype of OSCC, but should be classified as a distinct entity.

THE MULTIDIMENSIONAL HEALTH LOCUS OF CONTROL SCALE: PSYCHOMETRIC PROPERTIES AND FORM EQUIVALENCE.

This study examined the psychometric equivalence of Forms A and B of the Multidimensional Health Locus of Control Scale in a sample of college students (N = 370; M = 19.5 yr.; 318 Caucasians; 281 women). Given the dearth of studies that address the issue of form equivalence directly, this study sought to ascertain whether these forms could be used interchangeably by researchers. Subscales on the two forms had fairly high correlations (range of r = .77-.81), and similar alpha and omega reliability coefficients. Additionally, confirmatory factor analysis revealed both forms fit a three-factor model well. However, paired-sample t tests yielded significant mean differences for all three subscales. Furthermore, the two forms yielded inconsistent associations with relevant measures. Although the observed pattern of associations with social desirability and safe swimming behaviors were similar for Forms A and B, the pattern of differences was not identical for smoking groups and bicycle helmet use groups between forms. Overall, these results suggested that Forms A and B do not meet the strict criteria for parallel forms, but instead should be considered alternative forms.

The free will inventory: measuring beliefs about agency and responsibility.

In this paper, we present the results of the construction and validation of a new psychometric tool for measuring beliefs about free will and related concepts: The Free Will Inventory (FWI). In its final form, FWI is a 29-item instrument with two parts. Part 1 consists of three 5-item subscales designed to measure strength of belief in free will, determinism, and dualism. Part 2 consists of a series of fourteen statements designed to further explore the complex network of people's associated beliefs and attitudes about free will, determinism, choice, the soul, predictability, responsibility, and punishment. Having presented the construction and validation of FWI, we discuss several ways that it could be used in future research, highlight some as yet unanswered questions that are ripe for interdisciplinary investigation, and encourage researchers to join us in our efforts to answer these questions.

Parenting influences on bicycle helmet rules and estimations of children's helmet use.

The present study examined the potential relationship between parenting variables and estimations of children's bicycle helmet use. Parents (N = 121) completed surveys asking about parental monitoring and questions about their bicycle habits and attitudes, as well as their expectations for their children to wear a helmet and their estimation of how often their children wear a helmet. Parents reported stronger helmet rules for their children who are beginning cyclists rather than experienced cyclists, and rules for experienced cyclists were more strongly endorsed among parents who reported more parental monitoring as well. Parents who wear helmets themselves endorsed stronger helmet rules for their experienced riders, compared to parents who do not wear helmets. Parents without helmet rules reported more peer pressure in that they were more likely to agree that their friends do not make their kids wear helmets and that their child's friends do not wear helmets. In addition, believing other parents do not wear helmets and believing one's child's friends do not wear helmets were both associated with a lower likelihood that their children wear a helmet. This appears to be the first study linking perceptions of parental peer pressure with helmet rules and use. For public health reasons, it is imperative to examine parental factors that may establish children's helmet wearing.

Evaluation of cardiovascular biomarkers in a randomized trial of fosamprenavir/ritonavir vs. efavirenz with abacavir/lamivudine in underrepresented, antiretroviral-naïve, HIV-infected patients (SUPPORT): 96-week results.

BACKGROUND: Rates of cardiovascular disease are higher among HIV-infected patients as a result of the complex interplay between traditional risk factors, HIV-related inflammatory and immunologic changes, and effects of antiretroviral therapy (ART). This study prospectively evaluated changes in cardiovascular biomarkers in an underrepresented, racially diverse, HIV-1-infected population receiving abacavir/lamivudine as backbone therapy. METHODS: This 96-week, open-label, randomized, multicenter study compared once-daily fosamprenavir/ritonavir 1400/100 mg and efavirenz 600 mg, both with ABC/3TC 600 mg/300 mg, in antiretroviral-naïve, HLA-B*5701-negative adults without major resistance mutations to study drugs. We evaluated changes from baseline to weeks 4, 12, 24, 48, and 96 in interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), soluble vascular adhesion molecule-1 (sVCAM-1), d-dimer, plasminogen, and fibrinogen. Biomarker data were log-transformed before analysis, and changes from baseline were described using geometric mean ratios. RESULTS: This study enrolled 101 patients (51 receiving fosamprenavir/ritonavir; 50 receiving efavirenz): 32% female, 60% African American, and 38% Hispanic/Latino; 66% (67/101) completed 96 weeks on study. At week 96, levels of IL-6, sVCAM-1, d-dimer, fibrinogen, and plasminogen were lower than baseline in both treatment groups, and the decrease was statistically significant for sVCAM-1 (fosamprenavir/ritonavir and efavirenz), d-dimer (fosamprenavir/ritonavir and efavirenz), fibrinogen (efavirenz), and plasminogen (efavirenz). Values of hs-CRP varied over time in both groups, with a significant increase over baseline at Weeks 4 and 24 in the efavirenz group. At week 96, there was no difference between the groups in the percentage of patients with HIV-1 RNA <50 copies/mL (fosamprenavir/ritonavir 63%; efavirenz 66%) by ITT missing-equals-failure analysis. Treatment-related grade 2-4 adverse events were more common with efavirenz (32%) compared with fosamprenavir/ritonavir (20%), and median lipid concentrations increased in both groups over 96 weeks of treatment. CONCLUSIONS: In this study of underrepresented patients, treatment with abacavir/lamivudine combined with either fosamprenavir/ritonavir or efavirenz over 96 weeks, produced stable or declining biomarker levels except for hs-CRP, including significant and favorable decreases in thrombotic activity (reflected by d-dimer) and endothelial activation (reflected by sVCAM-1). Our study adds to the emerging data that some cardiovascular biomarkers are decreased with initiation of ART and control of HIV viremia. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00727597.

Reducing imaging waiting times: enhanced roles and service-redesign.

PURPOSE: The aim of this paper is to explain how University Hospitals of Leicester's Nuclear Medicine service managers needed to reduce waiting times to comply with internal clinical requirements and with external local primary care trust (PCT) and national Department of Health targets. DESIGN/METHODOLOGY/APPROACH: The team undertook a comprehensive service review to identify problem areas and potential improvements, including: process mapping; data gathering (activity and demand, equipment and staff availability/utilisation); external practice reviews, searching evidence bases; and financial implications. This case study describes how an inter-disciplinary team redesigned the service and used new working methods to reduce waiting times. Their aim was to discuss a service's practical elements and show how innovation leading to sustainable change can be implemented effectively. FINDINGS: The review highlighted service delivery bottlenecks for myocardial perfusion imaging, which were linked to medical staff shortages, staff use and equipment between hospital sites, and a silo approach to referrals rather than a coordinated organisation-wide approach. PRACTICAL IMPLICATIONS: Introducing enhanced roles allowed nurses, radiographers and technologists to undertake work previously performed by medical staff thus removing a key service bottleneck. Modifications to service delivery and a cultural change in nuclear medicine resulted in a service that was more efficient, flexible and able to cope with increased demand. ORIGINALITY/VALUE: These changes meant that minimum waiting-time targets were achieved, in particular waiting for myocardial perfusion imaging (reduced from 42 weeks in 2005 to two weeks by 2009). Changes allowed service managers to maintain short waiting times in the current, challenging healthcare climate.

Humility, Personality, and Psychological Functioning.

As part of the shift to a more positive psychology, researchers have demonstrated a relatively new and intense fascination with humility. Following a discussion of this construct and its correlates, we investigate how humility relates to personality dimensions, anxiety and depression, love of life and happiness, and self-efficacy in two samples-college students and adult Mturk workers. In both studies, we used the Dual Dimension Humility Scale, a measure that does not conflate the construct with honesty. Among students (N = 399), aspects humility correlated with dimensions of personality (more conscientiousness and openness, and less agreeableness and neuroticism), less depression, more love of life and happiness, and stronger social self-efficacy. Although fewer associations were found, overall, among adults (N = 509), aspects of humility correlated with dimensions of personality, less anxiety, and some dimensions of psychological well-being. The most unique contributions of this study include linking humility with college students' love of life and self-efficacy, and with adults' well-being. We conclude with a discussion of ideas for future research and potential applications to boost humility.

Distress, Social Support, and Self-Compassion: Relationships With Mental Health Among College Students.

This study investigated how distress, conceptualized as an interaction between hassles and stress perceptions, related to mental health, whether the type of distress (social or nonsocial) was consequential, and whether perceived support and self-compassion attenuated these relationships. Students (N = 185) from a mid-sized university in the southeast completed a survey. Survey questions pertained to hassles and stress perceptions, mental health (i.e., anxiety, depression, happiness, and love of life), perceived social support, and self-compassion. As predicted, students reporting more hassles and stress (both social and nonsocial) as well as those reporting less support and self-compassion, were worse off regarding mental illness and mental wellness. This was observed for both social and nonsocial distress. Although we did not support our hypotheses regarding buffering effects, we found perceived support and self-compassion are beneficial, regardless of hassles and stress levels. We discuss implications for students' mental health and ideas for future research.

Family Unpredictability and Sense of Coherence: Relationships With Anxiety and Depression in Two Samples.

Sense of coherence (SOC) refers to beliefs about how comprehensible, manageable, and meaningful one's life is. We investigated how SOC relates to family of origin unpredictability and psychological functioning in two samples. College students (N=172, 78% female; M=18.9 years old; 78% white/Caucasian) who recalled more family unpredictability while growing up also reported weaker SOC beliefs and poorer mental health. Furthermore, SOC mediated the negative impact of family unpredictability on anxiety but not on depression. Among adults (N=220, 47% female, 50% male, 3% gender nonconforming; M=40.2 years old; 60% Caucasian), correlations among family chaos, SOC, and psychological functioning were even stronger, overall. One mediation was detected: the relationship between family unpredictability and anxiety was partially explained by adults' perceptions regarding the manageability of their life. This is the first study to explore the relationships among SOC, family chaos, and psychological functioning.

ARIES 144 week results: durable virologic suppression in HIV-infected patients simplified to unboosted atazanavir/abacavir/lamivudine.

BACKGROUND: The open-label study ARIES (ClinicalTrials.gov NCT00440947) utilized a ritonavir (/r)-boosted protease inhibitor treatment simplification strategy. Antiretroviral-naïve subjects received abacavir/lamivudine (ABC/3TC) + atazanavir/ ritonavir (ATV/r) from baseline through randomization at week 36, then maintained or discontinued ritonavir for an additional 108 weeks. Non-inferiority of the unboosted regimen was demonstrated at week 84. In this optional extension phase, virologic suppression and adverse events were assessed through week 144. METHODS: Patients were randomized at week 36 if they had confirmed HIV RNA <50 copies/mL by week 30 and no previous virologic failure (VF; defined as failure to achieve HIV RNA <400 copies/mL or confirmed rebound after achieving HIV RNA ≥400 copies/mL). Three hundred sixty-nine subjects who completed 84 weeks in ARIES participated in the extension phase and maintained their randomized regimen for an additional 60 weeks post randomization. RESULTS: At week 144, 146/189 (77%) versus 132/180 (73%) subjects in the unboosted ATV and ATV/r groups, respectively, maintained HIV RNA <50 copies/mL. Post randomization (weeks 36-144), treatment-related grade 2-4 adverse events were more common in the ATV/r-treated (23%) compared to the ATV-treated (13%) group; the most frequently reported was increased serum bilirubin (6% of ATV-treated subjects vs 14 % of ATV/r-treated subjects). During the extension phase, 3% (11/369) of subjects met protocol-defined VF (5 ATV-treated and 6 ATV/ r-treated subjects); one ATV/r-treated subject had treatment-emergent major viral resistance-associated mutations. The median change in fasting triglycerides from baseline to week 144 was significantly different (P=.001) in the ATV-treated (-8.5 mg/dL) compared to the ATV/r-treated (28.5 mg/dL) groups. CONCLUSIONS: These long-term study results demonstrate that ATV in combination with ABC/3TC is a potent, well-tolerated regimen in patients who have achieved initial suppression on a ritonavir-boosted regimen.

Using next-generation sequencing for high resolution multiplex analysis of copy number variation from nanogram quantities of DNA from formalin-fixed paraffin-embedded specimens.

The use of next-generation sequencing technologies to produce genomic copy number data has recently been described. Most approaches, however, reply on optimal starting DNA, and are therefore unsuitable for the analysis of formalin-fixed paraffin-embedded (FFPE) samples, which largely precludes the analysis of many tumour series. We have sought to challenge the limits of this technique with regards to quality and quantity of starting material and the depth of sequencing required. We confirm that the technique can be used to interrogate DNA from cell lines, fresh frozen material and FFPE samples to assess copy number variation. We show that as little as 5 ng of DNA is needed to generate a copy number karyogram, and follow this up with data from a series of FFPE biopsies and surgical samples. We have used various levels of sample multiplexing to demonstrate the adjustable resolution of the methodology, depending on the number of samples and available resources. We also demonstrate reproducibility by use of replicate samples and comparison with microarray-based comparative genomic hybridization (aCGH) and digital PCR. This technique can be valuable in both the analysis of routine diagnostic samples and in examining large repositories of fixed archival material.

Salary and Workload of Midwives Across Birth Center Practice Types and State Regulatory Structures.

INTRODUCTION: Expansion of the midwifery-led birth center model of care is one pathway to improving maternal and newborn health. There are a variety of practice types among birth centers and a range of state regulatory structures of midwifery practice across the United States. This study investigated how those variations relate to pay and workload for midwives at birth centers. METHODS: Data from the American Association of Birth Centers Practice Survey and the Bureau of Labor Statistics' report on occupational employment and wage statistics were analyzed to explore how midwife salaries and workload at birth centers compare within and beyond the birth center model. RESULTS: Survey results from 161 birth centers across the United States demonstrate wide variation in nurse-midwife salaries and are inconsistent with nurse-midwife salaries across all settings as reported by the Bureau of Labor Statistics. The reported number of hours worked by midwives within the birth center model is high. Salaries of midwives who work in birth center-only practices were consistently lower than salaries of midwives who worked in blended birth center and hospital practices, independent of the midwife's level of experience, geographic region of the country, and state regulatory structure. DISCUSSION: Further research is needed to understand how to bring salaries and workload for midwives at birth centers into alignment with national averages.

Strong Start Innovation: Equitable Outcomes Across Public and Privately Insured Clients Receiving Birth Center Care.

INTRODUCTION: The Birth Center model of care is a health care delivery innovation in its fourth decade of demonstration across the United States. The purpose of this research was to evaluate the model's potential for decreasing poverty-related health disparities among childbearing families. METHODS: Between 2013 and 2017, 26,259 childbearing people received care within the 45 Center for Medicare and Medicaid Innovation Strong Start birth center sites. Secondary analysis of the prospective American Association of Birth Centers Perinatal Data Registry was conducted. Descriptive statistics described sociobehavioral, medical risk factors, and core clinical outcomes to inform the logistic regression model. Privately insured consumers were independently compared with 2 subgroups of Medicaid beneficiaries: Strong Start enrollees (midwifery-led care with peer counselors) and non-Strong Start Medicaid beneficiaries (midwifery-led care without peer counselors). RESULTS: After controlling for medical risk factors, Strong Start Medicaid beneficiaries achieved similar outcomes to privately insured consumers with no significant differences in maternal or newborn outcomes between groups. Perinatal outcomes included induction of labor (adjusted odds ratio [aOR], 0.86; 95% CI 0.61-1.13), epidural analgesia use (aOR, 1.00; 95% CI, 0.68-1.48), cesarean birth (aOR, 1.16; 95% CI, 0.87-1.53), exclusive breastfeeding on discharge (aOR, 1.11; 95% CI, 0.48-2.56), low Apgar score at 5 minutes (aOR, 1.23; 95% CI, 0.86-1.83), low birth weight (aOR, 1.12; 95% CI, 0.77-1.64), and antepartum transfer of care after the first prenatal appointment (aOR, 1.53; 95% CI, 0.97-2.40). Medicaid beneficiaries who were not enrolled in the Strong Start midwifery-led, peer counselor program demonstrated similar results except for having higher epidural analgesia use (aOR, 1.30; 95% CI, 1.10-1.53) and significantly lower exclusive breastfeeding on discharge (aOR, 0.57; 95% CI, 0.40-0.81) than their privately insured counterparts. DISCUSSION: The midwifery-led birth center model of care complemented by peer counselors demonstrated a pathway to achieve health equity.