Search

To evaluate the health-related quality of life (HRQoL) burden associated with postpartum depression (PPD), determine the extent to which clinical response impacts HRQoL, and estimate the impact of PPD and clinical response on healthcare resource utilization (HRU) and productivity. Patient data (n = 127) from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials evaluating the safety and efficacy of brexanolone injection in adults with PPD were employed for these posthoc analyses. HRQoL and health utility was assessed with the SF-36-v2 Health Survey (SF-36v2) acute version. The 17-item Hamilton Rating Scale for Depression (HAMD-17) total score was used to identify clinical response (≥50% reduction in HAMD-17 total score). Baseline HRQoL burden was assessed by comparison to age- and gender-adjusted population normative data from the 2009 QualityMetric PRO Norming study. The impact of clinical response was evaluated by comparing day 7 and day 30 SF-36v2 scores between clinical responders and non-responders. Interpretations of the meaningfulness of clinical response were indirectly estimated via 2017 National Health and Wellness Survey data linking SF-36v2 mental component summary (MCS) scores to (HRU) and productivity. Baseline HRQoL of patients with PPD was significantly below normative values. Day 7 and day 30 clinical response were associated with large and statistically significant improvements in HRQoL, greater likelihood of meeting SF-36v2 responder definitions, and reduced impairment. MCS levels corresponding to those observed in clinical responders were linked to lower HRU and productivity loss relative to non-responders. PPD places a substantial burden on HRQoL. Achievement of rapid clinical response (at day 7) and clinical response sustained several weeks following the end of treatment (day 30) led to significant improvement in HRQoL, suggesting the importance of identifying women with PPD and providing effective treatment options. [ABSTRACT FROM AUTHOR]

Objective. To examine the relationship between prolonged second stage and postpartum hemorrhage (PPH). Methods. We conducted a retrospective case-control study of all cases of PPH which occurred at four Southern California hospitals in 2003. Cases were identified by ICD-9 codes and confirmed by chart reviews, and non-cases were randomly selected as controls. The relationship between PPH and prolonged second-stage was examined using bivariate and multivariate analyses. Results. The sample consisted of 91 cases and 323 controls. Cases were significantly more likely than controls to have had a prolonged second stage of labor, over a range of definitions for PPH and prolonged second stage. In multivariable analyses, prolonged second stage was associated with greater than three-fold (OR = 3.35; 95% CI 1.22-9.19) increased risk for PPH. Conclusion. Prolonged second stage is an important risk factor for PPH. Close supervision is warranted for women with a prolonged second stage. [ABSTRACT FROM AUTHOR]

Chemotherapy used to treat lymphoma can cause severe neutropenia. Risk models have identified factors that predict neutropenia across all chemotherapy cycles. We used clinical information obtained during pretreatment evaluation to develop a predictive model for severe neutropenia in the first cycle of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy. This case series study included lymphoma patients receiving CHOP chemotherapy with or without rituximab who did not receive pre-emptive hematopoietic growth factor. Risk factors for neutropenia were identified from previously published models and included age ≥65 years, hypoalbuminemia, renal/cardiovascular disease, anemia, abnormal bone marrow and increased lactate dehydrogenase (LDH). A composite score equal to the number of pretreatment risk factors was used to predict severe neutropenia in cycle 1. Fifty-three percent of patients (47 of 89) had severe neutropenia, with 70% of first episodes occurring during cycle 1. Eighty-two percent of first-cycle, severe neutropenia events occurred in patients ≥65-years-old. In univariate analysis, age ≥65 years and increased baseline LDH were significantly associated with increased risk for severe neutropenia in cycle 1. In logistic regression modeling, the probability of severe neutropenia in cycle 1 increased as the number of pretreatment risk factors increased, with a one-unit increase in risk score resulting in a 2.3-fold increase in severe neutropenia. The study results suggest that data obtained before initiating CHOP-based chemotherapy can be used to identify those patients who are at risk for severe neutropenia in cycle 1. If validated, our model could be used to identify patients who would benefit from early use of growth factors. [ABSTRACT FROM AUTHOR]

We sought to identify risk factors associated with the time to febrile neutropenia in patients with intermediate-grade, non-Hodgkin's lymphoma (NHL) who were receiving treatment with CHOP chemotherapy. Data were collected from 12 community and academic oncology practices participating in the Oncology Practice Pattern Study between 1991 and 1999. We reviewed the medical records of 577 intermediate-grade NHL patients who received initial CHOP chemotherapy and evaluated risk factors associated with time to first febrile neutropenic event. A febrile neutropenic event was defined as a body temperature of >100.6°F and an ANC nadir <1000/mm 3 . A total of 160 patients experienced 224 febrile neutropenic events. The risk of febrile neutropenia was significantly associated with age ≥65 years ( p =0.001), cardiovascular disease ( p =0.020), renal disease ( p =0.006), baseline hemoglobin <12 g/dl ( p =0.018), >80% planned average relative dose intensity (ARDI; p =0.018 ), and no prophylactic colony-stimulating factor (CSF) use ( p =0.046). First febrile neutropenic events occurred by day 14 of cycle 1 in one-half of patients experiencing febrile neutropenia. In multivariate analysis, the risk of febrile neutropenia remained significantly associated with age ≥65 years ( HR=1.65, 95% CI: 1.18-2.32), renal disease ( HR=1.91, 95% CI: 1.10-3.30), cardiovascular disease ( HR=1.54, 95% CI: 1.02-2.33), baseline hemoglobin <12 g/dl ( HR=1.44, 95% CI: 1.04-2.00), >80% planned CHOP ARDI ( HR=2.41, 95% CI: 1.30-4.47), and no CSF prophylaxis ( HR=2.13, 95% CI: 1.20-3.76). Such a model may permit the identification of patients at greatest risk of febrile neutropenia and, therefore, candidates for the selective prophylactic use of the hematopoietic growth factors. [ABSTRACT FROM AUTHOR]

Focuses on the development of a maximum likelihood approach for the analysis of stochastic volatility models. Utilization of a recursive numerical integration procedure to calculate the marginal likelihood; Introduction of innovative stochastic volatility models; Characterization of model by a non-Gaussian stochastic volatility innovation distribution.

Background: Autoimmune diseases are a leading cause of morbidity and mortality in the US (estimated prevalence: 4.5%) and often associated with dysregulation of the complement system (innate and adaptive immune response). The classic complement pathway is regulated by the C1-inhibitor (C1-INH), which binds to C1 to prevent its activation. Hereditary angioedema with C1-INH deficiency (C1-INH-HAE) may be linked to increased autoimmunity due to secondary deficiency of C1r, C1s, and other components. Aims: It was hypothesized that increased regulation of the complement system via C1-INH replacement therapy may reduce autoimmunity in patients with C1-INH-HAE. The coexisting autoimmune disease claims frequency was compared between C1-INH-HAE patients treated with plasma-derived (pd) C1-INH vs "other (non-C1-INH)" treatments. Methods: C1-INH-HAE patients were identified in the IMS Health PharMetrics Plus claims database between January 2012 and December 2015 by International Classification of Diseases 9/10 diagnosis code, and classified based on the use of pdC1-INH or "other (non-C1-INH)" treatments for HAE. Index date was the first claim for HAE treatment. For patients using pdC1-INH, the first fill was the index date, even if other HAE medications were used previously. Frequency of visit claims for autoimmune conditions was identified by diagnostic codes (primary or secondary). Mean visits per patient per year by treatment group, gender, and age (<50 vs ≥50 years) were summarized for autoimmune conditions. Results: Of 589 patients with HAE identified (69% female, 38% aged ≥50 years), 276 (729 patient-years) received pdC1-INH and 313 (860 patient-years) received "other (non-C1-INH)" treatments. In this cohort, 12.9% of patients had ≥1 visit associated with a coexisting autoimmune disorder – the most common were lupus, alopecia, rheumatoid arthritis, sicca (Sjogren) syndrome, and connective tissue disorders. The mean (95% CI) number of visits for autoimmune diagnoses per patient per year was numerically lower for patients treated with pdC1-INH compared to those receiving "other (non-C1-INH)" treatments (1.37 [0.56–2.19] vs 2.28 [0.83–3.73]). Conclusions: Based on these findings, it is concluded that treatment of C1-INH-HAE with pdC1-INH may have a positive impact on coexisting autoimmune conditions by normalizing complement. Further research is needed on this important issue. There may be implications for healthcare resource utilization among patients with HAE and coexisting autoimmune disorders. [ABSTRACT FROM AUTHOR]