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Background: Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials. Materials and Methods: Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response for BRX versus PBO were assessed at hour 60 and as sustained through day 30 using relative risk. Associated number needed to treat (NNT) and number needed to harm (NNH) values were also estimated. Results: Two-hundred nine patients were included. The average HAMD-17 MID estimate was −2.1; the least-squared mean difference between BRX and PBO exceeded this at hour 60 and day 30. Minimal, moderate, and large MCTs were estimated to be −9, −15, and −20 points, respectively. Significantly more BRX-treated than PBO-treated patients achieved minimal, moderate, and large change (all ps < 0.05) at hour 60 and large meaningful response at day 30 (p < 0.05). BRX-treated patients were more likely to sustain HAMD-17 remission and CGI-I response through day 30 versus PBO. NNTs ranged from 4 to 8, with NNH of 97. Conclusions: BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017. [ABSTRACT FROM AUTHOR]

The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population. [ABSTRACT FROM AUTHOR]

In this letter to the editor, we present results of claims data analysis. This claims data analysis supports a hypothesis that in patients with hereditary angioedema due to C1-esterase inhibitor (C1-INH) deficiency, the occurrence and/or symptomatology of coexisting autoimmune disease may be positively influenced by a replacement therapy with plasma derived C1-INH. [ABSTRACT FROM AUTHOR]

Objectives. We examined trends in maternal comorbidities in California. Methods. We conducted a retrospective cohort study of 1 551 017 California births using state-linked vital statistics and hospital discharge cohort data for 1999, 2002, and 2005. We used International Classification of Diseases, Ninth Revision, Clinical Modification codes to identify the following conditions, some of which were preexisting: maternal hypertension, diabetes, asthma, thyroid disorders, obesity, mental health conditions, substance abuse, and tobacco use. We estimated prevalence rates with hierarchical logistic regression models, adjusting for demographic shifts, and also examined racial/ethnic disparities. Results. The prevalence of these comorbidities increased over time for hospital admissions associated with childbirth, suggesting that pregnant women are getting sicker. Racial/ethnic disparities were also significant. In 2005, maternal hypertension affected more than 10% of all births to non-Hispanic Black mothers; maternal diabetes affected nearly 10% of births to Asian/Pacific Islander mothers (10% and 43% increases, respectively, since 1999). Chronic hypertension, diabetes, obesity, mental health conditions, and tobacco use among Native American women showed the largest increases. Conclusions. The prevalence of maternal comorbidities before and during pregnancy has risen substantially in California and demonstrates racial/ethnic disparity independent of demographic shifts. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Predictive models for falls, injury falls, and restraint prevalence were explored within nursing unit structures and processes of care. BACKGROUND: The patient care team is responsible for patient safety, and improving practice models may prevent injuries and improve patient safety. METHODS: Using unit-level self-reported data from 215 hospitals, falls, injury falls, and restraint prevalence were modeled with significant covariates as predictors. RESULTS: Fewer falls/injury falls were predicted by populations with fewer frail and at-risk patients, more unlicensed care hours, and prevention protocol implementation, but not staffing per se, restraint use, or RN expertise. Lower restraint use was predicted by fewer frail patients, shorter length of stay, more RN hours, more certified RNs, and implementation of fall prevention protocols. CONCLUSION: In the presence of risk, patient injuries and safety were improved by optimizing staffing skill mix and use of prevention protocols. [ABSTRACT FROM AUTHOR]

The article discusses a study to determine the relationship between nurse staffing and adverse patient events at the shift level including falls, falls with injury and medication administration errors (MAE). The research team used a Military Nursing Outcomes Database (MilNOD) created from thirteen military hospitals to monitor nurse staffing, patient falls and medication errors, and other outcomes while using Bayesian hierarchical logistic regression modeling to determine associations between staffing and adverse events. Results indicated that the skill mix of registered nurses (RNs), total nursing care hours, and experience, measured by a proxy variable, were directly related to shift-level adverse events.