The extent to which recurrences of pericarditis episodes impact patients’ health-related quality of life (HRQOL) remains poorly understood. This study aimed to evaluate HRQOL and work productivity in ...patients with recurrent pericarditis (RP). Adult patients from a centralized recruitment database for the rilonacept Phase 2/3 clinical trials were invited to participate in a survey. Inclusion criteria were confirmed RP diagnosis and ≥1 recurrence within the previous 12 months. The 11-Point Pain Numeric Rating Scale, Patient Global Impression of Pericarditis Severity, Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2, PROMIS Short Form Sleep Disturbance 8b, Work Productivity and Activity Impairment v2.0, and customized questions about fear and economic impact were used. In total, 83 patients (55% female, average age = 49.3 years) completed the survey. The median time since pericarditis diagnosis was 3.0 years at the time of survey completion; 49% experienced ≥3 recurrences in the previous 12 months. Forty percent had an emergency room visit, and 25% were hospitalized for their most recent recurrence. Sixty-six percent of participants rated the symptoms of their last recurrence as severe. The mean value for worst pericarditis pain (0 to 10 scale) during the most recent recurrence was 6.1. The average T-scores for PROMIS physical and mental health were 37.6 and 42.8, respectively, compared with 50 in the general population. Participants reported 50% of overall work impairment and 62% of activity impairment due to RP. In conclusion, patients with RP experienced a high number of recurrences with severe symptoms that substantially reduced their HRQOL and work productivity.
To quantify the incidence of anemia and red blood cell (RBC) transfusion practice in critically ill patients and to examine the relationship of anemia and RBC transfusion to clinical outcomes.
...Prospective, multiple center, observational cohort study of intensive care unit (ICU) patients in the United States. Enrollment period was from August 2000 to April 2001. Patients were enrolled within 48 hrs of ICU admission. Patient follow-up was for 30 days, hospital discharge, or death, whichever occurred first.
A total of 284 ICUs (medical, surgical, or medical-surgical) in 213 hospitals participated in the study.
A total of 4,892 patients were enrolled in the study.
The mean hemoglobin level at baseline was 11.0 +/- 2.4 g/dL. Hemoglobin level decreased throughout the duration of the study. Overall, 44% of patients received one or more RBC units while in the ICU (mean, 4.6 +/- 4.9 units). The mean pretransfusion hemoglobin was 8.6 +/- 1.7 g/dL. The mean time to first ICU transfusion was 2.3 +/- 3.7 days. More RBC transfusions were given in study week 1; however, in subsequent weeks, subjects received one to two RBC units per week while in the ICU. The number of RBC transfusions a patient received during the study was independently associated with longer ICU and hospital lengths of stay and an increase in mortality. Patients who received transfusions also had more total complications and were more likely to experience a complication. Baseline hemoglobin was related to the number of RBC transfusions, but it was not an independent predictor of length of stay or mortality. However, a nadir hemoglobin level of <9 g/dL was a predictor of increased mortality and length of stay.
Anemia is common in the critically ill and results in a large number of RBC transfusions. Transfusion practice has changed little during the past decade. The number of RBC units transfused is an independent predictor of worse clinical outcome.
Background Many patients with severe asthma require maintenance treatment with systemic corticosteroids (SCSs) to control daily symptoms and prevent serious acute exacerbations, but chronic SCS use ...is associated with complications. Objective We sought to evaluate the risk of SCS-related complications by SCS exposure and quantify the associated health care costs and resource use in patients with severe asthma. Methods We performed a longitudinal, open-cohort, observational study using health insurance claims data (1997-2013: Medicaid) from Florida, Iowa, Kansas, Missouri, Mississippi, and New Jersey. Eligible patients were 12 years old or older with 2 or more asthma diagnoses and had more than 6 months of continuous SCS use. An open-cohort approach was used to classify patients' follow-up into low, medium, and high SCS exposure (≤6, >6-12, and >12 mg/d, respectively). Multivariate generalized estimating equation models were used to estimate the adjusted risk of SCS-related complications for patients with medium and high exposure compared with patients with low exposure and quantify the resulting health care resource use and costs. Results The study included 3628 patients (mean age, 57.6 years; 68% female). Patients with medium and high SCS exposure had significantly higher risks of SCS-related complications, including infections and cardiovascular, metabolic, psychiatric, ocular, gastrointestinal, and bone-related complications (odds ratio, 1.23-2.12 by complication; P < .05 for all but one) versus those with low (reference group) SCS exposure. Medium and high SCS exposure were also associated with significantly more emergency department visits (incidence rate ratios, 1.31 P = .0004 and 1.78 P < .0001) and inpatient visits (incidence rate ratios, 1.25 P < .0001 and 1.59 P < .0001) versus low SCS exposure. Conclusions A significant dose-response relationship was demonstrated between chronic SCS use and risk of SCS-related complications in patients with severe asthma. Effective SCS-sparing strategies might reduce the burden associated with SCS-related complications in patients with severe asthma.
Purpose: Compulsory generic substitution of antiepileptic drugs (AEDs) may lead to adverse effects in epilepsy patients because of seizure recurrence or increased toxicity. The study objectives were ...(a) to quantify and compare the switchback rates from generic to brand‐name AEDs versus non‐AEDs, and (b) to assess clinical implications of switching from branded Lamictal to generic lamotrigine (LTG) and whether signals exist suggesting outcome worsening.
Methods: By using a public‐payer pharmacy‐claims database from Ontario, Canada, switchback rates from generic to branded AEDs Lamictal, Frisium (clobazam; CLB), and Depakene (VPA; divalproex) were calculated and compared with non‐AED long‐term therapies, antihyperlipidemics and antidepressants, in January 2002 through March 2006. We then assessed pharmacy utilization and AED dosage among LTG patients switching back to branded Lamictal compared with those staying on generic formulation.
Results: The 1,354 patients (403 monotherapy, 951 polytherapy) were prescribed generic LTG, of whom 12.9% switched back to Lamictal (11.7% monotherapy, 13.4% polytherapy). Switchback rates of other AEDs were ∼20% for CLB and VPA. The switchback rates for AEDs were substantially higher than for non‐AEDs (1.5–2.9%). Significant increases in LTG doses were observed after generic substitution for those who did not switch back (6.2%; p < 0.0001). The average number of codispensed AEDs and non‐AED drugs significantly increased (p < 0.0001) after LTG generic entry, especially in the generic group.
Conclusions: These results reflect poor acceptance of switching AEDs to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use.
Abstract Purpose Almost half of all patients diagnosed with schizophrenia have a history of substance abuse (SA). However, data on treatment of schizophrenia with paliperidone palmitate (PP) among ...patients with comorbid SA are limited. The objective of this study was to compare all-cause and SA-related health care resource utilization and costs in veterans with schizophrenia and co-occurring SA who were treated with PP versus oral atypical antipsychotics (OAAs). Methods Veterans Health Administration electronic health record data were used to conduct a retrospective longitudinal study in veterans with schizophrenia who initiated PP or OAA between January 1, 2010 and June 30, 2016, had ≥12 months of enrollment before treatment initiation (baseline), were diagnosed with SA, and had ≥1 Global Assessment of Functioning score during baseline. Differences in baseline characteristics were adjusted for using inverse probability of treatment weighting. Adjusted cost differences and incidence rate ratios (IRR) for the association between PP versus OAA and all-cause and SA-related health care costs and health care resource utilization in the 12 months after treatment initiation were estimated with corresponding 95% CIs using weighted linear and Poisson regression models, respectively. Findings Of 6872 veterans in the study, 1684 (25%) and 5188 (75%) were treated with PP and OAA, respectively. After adjustment, PP was associated with fewer all-cause inpatient (IRR = 0.88; 95% CI, 0.85 to 0.90), mental health-related inpatient (IRR = 0.88; 95% CI, 0.85 to 0.91), and long-term care stays (IRR = 0.53; 95% CI, 0.44 to 0.64), but more frequent mental health intensive case management visits (IRR = 1.51; 95% CI, 1.49 to 1.53) compared with OAA (all P < 0.001). Similarly, PP was associated with significantly lower rates of SA-related inpatient stays (IRR = 0.80; 95% CI, 0.77 to 0.83), mental health stays (IRR = 0.85; 95% CI, 0.82 to 0.88), long-term care stays (IRR = 0.22; 95% CI, 0.15 to 0.32), and outpatient visits (IRR = 0.78; 95% CI, 0.77 to 0.79) than OAA (all P < 0.001). Relative to OAA, patients treated with PP also had lower mean annual all-cause (cost difference = −$10,473; 95% CI, −$17,827 to −$3491) and SA-related (cost difference = −$8457; 95% CI, −$12,710 to −$3638) medical costs (all P < 0.001). Implications PP was associated with significant total medical cost savings resulting from fewer hospitalizations and lower rates of SA-related health care resource utilization compared with OAA in patients with schizophrenia and comorbid SA. Thus, PP appears to be a valuable treatment option for patients in this subpopulation.
Summary
Purpose: To study the impact of nonadherence to antiepileptic drugs (AEDs) on health care utilization and direct medical costs in a Medicaid population.
Methods: A retrospective cohort ...design was employed using state Medicaid claims data from Florida, Iowa, and New Jersey during the period from January 1997 to June 2006. Patients aged ≥18 years with one or more neurologist visit with an epilepsy diagnosis and two or more pharmacy claims for AEDs were included. Medication possession ratio (MPR) was used to evaluate AED adherence with MPR ≥ 0.80 considered adherent and <0.80 considered nonadherent. The association of nonadherence with utilization outcomes hospitalizations, inpatient days, emergency department (ED), and outpatient visits was assessed with univariate and multivariate Poisson regressions. Quarterly per‐patient inpatient, outpatient, ED, and pharmacy costs were calculated across nonadherent and adherent quarters for the younger than 65 population (under‐65) and cost differences were computed. Adjusted incremental costs of nonadherence were estimated with multivariate Tobit regression models.
Results: A total of 33,658 patients were included (28,470 under‐65), together contributing 388,564 treated quarters (26% nonadherent). In multivariate analyses, AED nonadherence was associated with significantly higher incidence of hospitalizations incident rate ratio (IRR) = 1.39, 95% confidence interval (CI) = 1.37–1.41, inpatient days (IRR = 1.76, 95% CI = 1.75–1.78), and ED visits (IRR = 1.19, 95% CI = 1.18–1.21). Nonadherence was associated with cost increases related to serious outcomes, including inpatient ($4,320 additional cost per quarter, 95% CI = $4,077–$4,564) and ED services ($303 additional cost per quarter, 95% CI = $273–$334), but lower costs for outpatient and pharmacy services, likely because of nonadherent behavior.
Discussion: Nonadherence to AEDs appears to be associated with serious outcomes, as evidenced by increased utilization and costs of inpatient and ED services.
The goal of this study was to compare health care costs, health care resource utilization, and adverse events associated with sustained oral corticosteroid (OCS) use versus no OCS use in systemic ...lupus erythematosus.
This retrospective cohort study used claims data (January 1, 2006–July 31, 2019) from patients with systemic lupus erythematosus aged ≥5 years with ≥24 months of continuous enrollment. Health care costs, health care resource utilization, and OCS-related adverse events were assessed. The sustained OCS cohort (defined as ≥12 months of continuous OCS use) was divided into exposure categories based on the number of 6-month classification periods with >5 mg/d OCS (0, 1–2, or 3–4).
Of the 6234 patients in the sustained OCS use cohort, there were 1587 (25.5%) patients with 0 periods of >5 mg/d OCS use, 2087 (33.5%) patients with 1 to 2 periods of >5 mg/d OCS use, and 2560 (41.1%) patients with 3 to 4 periods of >5 mg/d OCS use; the no OCS use cohort included 7828 patients. Adjusted health care cost differences (95% CIs) were significantly greater for patients with 0, 1 to 2, and 3 to 4 periods of OCS use >5 mg/d versus the no OCS use cohort ($7774 5426–10,223, $21,738 18,898–25,321, and $30,119 26,492–33,774, respectively). A higher proportion of patients in all OCS exposure categories required health care resource utilization (≥99.7% vs 93.4%) and experienced OCS-related adverse events (94.3%–96.8% vs 82.6%) versus the no OCS use cohort, with more periods of OCS use >5 mg/d associated with increased health care resource utilization and adverse events.
Sustained OCS use in systemic lupus erythematosus was associated with high economic burden, health care resource utilization, and OCS-related adverse events. These data highlight the need for health care providers to carefully consider OCS use in systemic lupus erythematosus.
To estimate incremental costs and healthcare resource utilization (HRU) associated with select severe adverse events (AEs) and AEs of any severity in patients with metastatic urothelial carcinoma ...receiving first-line (1L) therapy.
Adults treated with 1L systemic therapy between January 2012 and September 2017 with ≥1 urothelial cancer diagnosis were identified using claims data. Per-patient-per-month cost differences and HRU rate ratios comparing patients with and without select AEs were estimated.
Patients with any severe select AEs had higher costs than those without (cost difference = $6130 per-patient-per-month; p < 0.001). Healthcare costs and HRU for patients with select AEs were significantly higher versus those without.
Select AEs during 1L therapy for metastatic urothelial carcinoma can result in significant burden to patients and healthcare systems.
Concurrent chemoradiotherapy (cCRT) was the standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC) prior to the PACIFIC trial, however, patients also received ...single modality therapy. This study identified predictors of therapy and differences in overall survival (OS).
This retrospective study included stage III NSCLC patients aged ≥65 years, with ≥1 claim for systemic therapy (ST) or radiotherapy (RT) within 90 days of diagnosis, identified in SEER-Medicare data (2009-2014). Patients who had overlapping claims for chemotherapy and RT ≤90 days from start of therapy were classified as having received cCRT. Patients who received sequential CRT or surgical resection of tumor were excluded. Predictors of cCRT were analyzed using logistic regression. OS was compared between therapies using adjusted Cox proportional hazards models.
Of 3,799 patients identified, 21.7% received ST; 26.3% received RT; and 52.0% received cCRT. cCRT patients tended to be younger (p <0.001), White (p = 0.002), and have a good predicted performance status (p<0.001). Patients who saw all three specialist types (medical oncologist, radiation oncologist, and surgeon) had increased odds of receiving cCRT (p<0.001). ST and RT patients had higher mortality risk versus cCRT patients (hazard ratio 95% CI: ST: 1.38 1.26-1.51; RT: 1.75 1.61, 1.91); p<0.001).
Several factors contributed to treatment selection, including patient age and health status, and whether the patient received multidisciplinary care. Given the survival benefit of receiving cCRT over single-modality therapy, physicians should discuss treatment within a multidisciplinary team, and be encouraged to pursue cCRT for patients with unresectable stage III NSCLC.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK