Treatment patterns in US patients hospitalized with COVID-19 and pulmonary involvement.

This study describes the baseline characteristics and treatment patterns of US patients hospitalized with a diagnosis of coronavirus disease 2019 (COVID-19) and pulmonary involvement. Patients hospitalized with pulmonary involvement due to COVID-19 (first hospitalization) were identified in the IBM Explorys® electronic health records database. Demographics, baseline clinical characteristics, and in-hospital medications were assessed.

Baseline Demographics and Clinical Characteristics Among 3471 US Patients Hospitalized with COVID-19 and Pulmonary Involvement: A Retrospective Study.

Introduction: Coronavirus disease 2019 (COVID-19) can present as a range of symptoms, from mild to critical; lower pulmonary involvement, including pneumonia, is often associated with severe and critical cases. Understanding the baseline characteristics of patients hospitalized with COVID-19 illness is essential for effectively targeting clinical care and allocating resources. This study aimed to describe baseline demographics and clinical characteristics of US patients hospitalized with COVID-19 and pulmonary involvement.

The Added Burden of Allergen Sensitization Among Children with Severe or Poorly Controlled Asthma.

Background: Allergen sensitization (AS) may negatively affect asthma outcomes in children with severe or poorly controlled (SPC) asthma.

Objectives: To examine the impact of AS on asthma exacerbations, health care use, and costs among children with SPC asthma in private and public insurance settings.

Methods: This retrospective study analyzed children with SPC asthma aged 6 to 11 years from the MarketScan Commercial (private insurance) and Medicaid databases.

Validity and responsiveness of the Urticaria Activity and Impact Measure: A new patient-reported tool.

Background: Chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria, may produce hives, itch, and angioedema. The Urticaria Activity and Impact Measure (U-AIM) is a newly developed 9-item patient-reported measure designed for use in routine clinical practice to assess CSU activity and impact during the previous 7 days.

Objective: To evaluate validity, responsiveness, and clinically meaningful change of the U-AIM.

Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria.

Background: Chronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.

Objective: To assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.

Methods: A post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs.

Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies.

Background: Angioedema, present in some patients with chronic idiopathic/spontaneous urticaria (CIU/CSU), may have a negative effect on patient quality of life.

Objective: To describe patient-reported angioedema and its management in the pivotal omalizumab studies (ASTERIA I, ASTERIA II, GLACIAL).

Methods: Enrolled patients with CIU/CSU remained symptomatic despite treatment with histamine (H)-antihistamines at licensed doses (ASTERIA I, ASTERIA II) or H-antihistamines at up to 4 times the approved dose plus H-antihistamines and/or a leukotriene receptor antagonist (GLACIAL).

Clinical and economic burden of idiopathic pulmonary fibrosis: a retrospective cohort study.

Background: Idiopathic pulmonary fibrosis (IPF) is a devastating condition with a variable course. Not uncommonly, IPF patients are hospitalized for respiratory-related causes, including disease worsening. This study aimed to characterize the prevalence, and economic and health care burden of IPF.

Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria.

Background: Few data are available that describe response patterns in patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) treated with omalizumab.

Objective: We sought to describe response patterns by using data from the 3 pivotal omalizumab CIU/CSU trials.

Methods: Every 4 weeks, randomized patients received dosing with placebo or 75, 150, or 300 mg of omalizumab (ASTERIA I: n = 318, 24 weeks; ASTERIA II: n = 322, 12 weeks) or placebo or 300 mg of omalizumab (GLACIAL: n = 335, 24 weeks).

The minimal important difference for measures of urticaria disease activity: Updated findings.

Background: The Urticaria Patient Daily Diary (UPDD) is a validated patient-reported outcome that captures key measures of urticaria disease activity.

Objective: To update estimates of the minimal important difference (MID) for urticaria disease activity measures in the UPDD, including the weekly itch severity score, weekly number of hives score, weekly average size of largest hive score, and the composite measure of itch severity and number of hives over 7 days, or urticaria activity score 7 (UAS7).

Methods: A total of 975 subjects with chronic idiopathic urticaria from three randomized, double-blind, placebo-controlled studies completed the UPDD and other patient-reported outcome assessments (the Dermatology Life Quality Index, Medical Outcomes Study Sleep Scale, the Chronic Urticaria Quality-of-Life Questionnaire, the EuroQoL-5 Dimension Questionnaire) multiple times.

Changes in asthma control, work productivity, and impairment with omalizumab: 5-year EXCELS study results.

Background: Asthma poses a significant disease burden worldwide. Current guidelines emphasize achieving and maintaining asthma control.

Objective: To describe longitudinal changes of asthma control and asthma-related work, school, and activity impairment for patients with moderate-to-severe asthma treated with omalizumab and those who did not receive omalizumab in a real-world setting.

Risk of corticosteroid-related adverse events in asthma patients with high oral corticosteroid use.

Background: Oral corticosteroids (OCS) are a mainstay of asthma treatment. Their use increases the risk of various corticosteroid-related adverse events, but the extent of risk is poorly characterized.

Objective: To determine the incremental risk of possible corticosteroid-related adverse events (AE) in asthma among patients with high OCS use compared with patients who do not use OCS.

Omalizumab adherence in an observational study of patients with moderate to severe allergic asthma.

Background: Adherence to omalizumab is not well characterized and its association with asthma control has not been well established.

Objective: To evaluate adherence in patients initiating omalizumab in the Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma (EXCELS) observational study.

Methods: Adherence was assessed over 5 years using the proportion of patients who missed any dose, rates of doses missed, and proportions of patients with good (<10% doses missed) or poor (≥30% doses missed) adherence.

Validation of an ICD-9-based claims algorithm for identifying patients with chronic idiopathic/spontaneous urticaria.

Background: There is no specific International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for chronic idiopathic urticaria or spontaneous urticaria (CIU/CSU), a skin condition characterized by hives and angioedema lasting at least 6 weeks with no known cause.

Objective: To validate an ICD-9-CM-based algorithm for identification of patients with CIU/CSU and thus facilitate claims-based research.

Methods: Patient records were reviewed at 4 US practices.

Real-time asthma outreach reduces excessive short-acting β2-agonist use: a randomized study.

Background: Excessive use of short-acting β2-agonists (SABA) indicates impaired asthma control.

Objective: To determine whether real-time outreach to excessive SABA users reduces SABA canister dispensings.

Methods: After real-time determination of a seventh SABA canister dispensing in the prior 12 months by using informational pharmacy technology, 12 to 56 year old patients with physician-coded asthma and inhaled corticosteroid dispensing were block randomized by prior asthma specialist care and medication step-care level into intervention (n = 1001) and control groups (n = 998).

Demonstrating measurement equivalence of the electronic and paper formats of the Urticaria Patient Daily Diary in patients with chronic idiopathic urticaria.

Background: The Urticaria Patient Daily Diary (UPDD), originally developed on paper, is a measure of key symptoms of chronic idiopathic urticaria (CIU). The development of the electronic version (eUPDD) involved moderate modifications to the appearance of the paper version.

Objective: This study assessed the measurement equivalence of the electronic and paper versions of the UPDD in a sample of patients with CIU.

Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy.

Background: Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies.

Objectives: We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H₁-antihistamines at up to 4 times the approved dose plus H₂-antihistamines, leukotriene receptor antagonists, or both.

Methods: In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period.

Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS Study.

Background: Asthma guidelines emphasize the importance of achieving and maintaining asthma control; however, many patients with moderate to severe asthma fail to achieve adequate control.

Objective: This 2-year interim analysis evaluated the longitudinal effects of omalizumab on asthma control in patients treated in real-world clinical practice settings.

Methods: EXCELS is an ongoing observational cohort study of approximately 5000 omalizumab-treated and 2500 non-omalizumab-treated patients aged ≥12 years with moderate to severe asthma.

Concomitant asthma medication use by patients receiving omalizumab 2003-2008.

Objective: To examine patterns of omalizumab use in the first 5 years of its availability.

Methods: Our study comprised a series of descriptive retrospective cohort analyses using healthcare claims data. The study population comprised patients of any age who had omalizumab claims in the 5 years after 1 July 2003, and we created five 1-year cohorts from this population.

Neurocognitive function in patients with recurrent glioblastoma treated with bevacizumab.

Neurocognitive decline is a frequent adverse effect of glioblastoma. Antitumor therapies that are efficacious, as measured by traditional endpoints such as objective response (OR) and progression-free survival (PFS), and have beneficial effects on neurocognitive function (NCF) are of clinical benefit to these patients. We evaluated neurocognitive changes across time in 167 patients with recurrent glioblastoma treated with bevacizumab-based therapy in BRAIN, a phase II, randomized, multicenter trial.

Prioritizing "psychological" consequences for disaster preparedness and response: a framework for addressing the emotional, behavioral, and cognitive effects of patient surge in large-scale disasters.

While information for the medical aspects of disaster surge is increasingly available, there is little guidance for health care facilities on how to manage the psychological aspects of large-scale disasters that might involve a surge of psychological casualties. In addition, no models are available to guide the development of training curricula to address these needs. This article describes 2 conceptual frameworks to guide hospitals and clinics in managing such consequences.

Psychological effects of patient surge in large-scale emergencies: a quality improvement tool for hospital and clinic capacity planning and response.

Although information is available to guide hospitals and clinics on the medical aspects of disaster surge, there is little guidance on how to manage the expected surge of persons needing psychological assessment and response after a catastrophic event. This neglected area of disaster medicine is addressed by presenting a novel and practical quality improvement tool for hospitals and clinics to use in planning for and responding to the psychological consequences of catastrophic events that create a surge of psychological casualties presenting for health care. Industrial quality improvement processes, already widely adopted in the healthcare sector, translate well when applied to disaster medicine and public health preparedness.