Background: The safety of long-acting b-agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial. Objective: We sought to determine whether administering formoterol in combination with mometasone furoate increases the risk of serious asthma outcomes (SAOs) compared with mometasone furoate alone. This clinical trial is registered as NCT01471340. Methods: We conducted a 26-week, randomized, double-blind trial in adolescent and adult patients (> _12 years) with persistent asthma in 35 countries with the primary objective of evaluating whether mometasone furoate-formoterol increases the risk of SAOs (adjudicated hospitalization, intubation, or death) compared with mometasone furoate alone. The key efficacy end point was asthma exacerbation (composite of hospitalization of > _24 hours, emergency department visits of <24 hours requiring systemic corticosteroids, or use of systemic corticosteroids for > _3 consecutive days). Results: Among 11,729 patients (mometasone furoateformoterol, n 5 5,868; mometasone furoate, n 5 5,861), a total of 81 SAOs, all asthma-related hospitalizations, were observed in 71 patients: 45 events from 39 patients receiving mometasone furoate-formoterol and 36 events from 32 patients receiving mometasone furoate. The hazard ratio for the first SAO in the mometasone furoate-formoterol versus mometasone furoate group was 1.22 (95% CI, 0.76-1.94; P 5 .411). Asthma exacerbation occurred in 1,487 patients: 708 receiving mometasone furoate-formoterol and 779 receiving mometasone furoate. The hazard ratio for the first asthma exacerbation in the mometasone furoate-formoterol versus mometasone furoate group was 0.89 (95% CI, 0.80-0.98; P 5 .021). Conclusions: The addition of formoterol to mometasone furoate maintenance therapy did not increase the risk of serious asthma-related events and reduced the risk of asthma exacerbation.
To develop a model to predict risk of intravenous immunoglobulin (IVIg) nonresponse in patients with Kawasaki disease (KD) to assist in early discharge decision-making. METHODS: Retrospective cohort study of 430 patients 0 to 18 years old discharged from a US children's hospital January 1, 2010, through July 31, 2017 with a diagnosis of KD. IVIg nonresponse was defined as at least 1 of the following: temperature $38.0°C between 36 hours and 7 days after initial IVIg dose, receipt of a second IVIg dose after a temperature $38.0°C at least 20 hours after initial IVIg dose, or readmission within 7 days with administration of a second IVIg dose. Backward stepwise logistic regression was used to select a predictive model. RESULTS: IVIg nonresponse occurred in 19% (81 of 430) of patients. We identified a multivariate model (which included white blood cell count, hemoglobin level, platelet count, aspartate aminotransferase level, sodium level, albumin level, temperature within 6 hours of first IVIg dose, and incomplete KD) with good predictive ability (optimism-adjusted concordance index: 0.700) for IVIg nonresponse. Stratifying into 2 groups by a predictive probability cutoff of 0.10, we identified 26% of patients at low risk for IVIg nonresponse, with a sensitivity and specificity of 90% and 30%, respectively, and a negative predictive value of 93%. CONCLUSIONS: We developed a model with good predictive value for identifying risk of IVIg nonresponse in patients with KD at a US children's hospital. Patients at lower risk may be considered for early discharge by using shared decision-making. Our model may be used to inform implementation of electronic health record tools and future risk prediction research.
BackgroundIdentifying asymptomatic individuals with hepatitis C virus (HCV) infection is challenging. Pregnancy presents a unique opportunity to screen women for HCV and then link those positive to care. Universal screening in pregnant women, however, is not recommended by CDC or ACOG. Further, treatment with direct antiviral agents (DAAs) are not currently approved for pregnant women but are warranted following delivery and breastfeeding. We sought to compare treatment uptake before and after universal screening in pregnant women was implemented as the standard of care in our institution and then determine if universal screening leads to increased treatment after pregnancy.MethodsA retrospective analysis of risk-based HCV screening in pregnant women was used for the first period (2014–2015) and a prospective design was used following 18 months of universal screening (2016–2017). Prenatal data were collected from all pregnant women that sought care at our institution in the prospective part of the study. We tested for differences in relevant outcomes (e.g., screening rates, rate of those eligible for treatment, and those who actually received treatment) between the two periods. Finally, we performed a cost-effective analysis of universal screening considering treatment rates.ResultsDuring the universal screening period, more women were screened for HCV and diagnosed with chronic infection. Universal screening was not associated with a significant increase in the odds of women receiving treatment after pregnancy. The increased cost for universal screening was $1060 per patient, resulting in an ICER of $219,391 per additional treatment received or $57,734 per quality-adjusted life-year (QALY) gained, which is below the willingness-to-pay threshold to be cost-effective. Universal screening, however, is cost-effective with an ICER well below the established willingness-to-pay threshold of $100,000 per QALY gained, if all women eligible for treatment receive therapy.ConclusionUniversal screening may not lead to a significant increase in the odds that pregnant women receive DAAs therapy after pregnancy. Barriers to linkage to care should be addressed in an effort to increase antiviral therapy for these women and universal screening should be implemented within this patient population. Disclosures All authors: No reported disclosures.
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