Real-world assessment of anaphylaxis and eosinophilic esophagitis with 12 SQ house dust mite SLIT-tablet sublingual immunotherapy.

Background: Sublingual immunotherapy (SLIT) with 12 SQ house dust mile SLIT-tablet (HDM SLIT-tablet) for dust mite-induced perennial allergic rhinitis is reported as effective and safe. Although serious allergic reactions (SARs) and eosinophilic esophagitis (EoE) have infrequently occurred under trial conditions, the safety of HDM SLIT-tablet challenge under real-world conditions is unknown. Objective: Our aim was to estimate the incidence of SARs and EoE due to HDM SLIT-tablet challenge. Methods: Through use of administrative data from Kaiser Permanente Southern California, this prospective observational study identified patients newly administered HDM SLIT-tablet with follow-up until SLIT discontinuation or end of study. Suspected cases of SARs and EoE were detected by using International Classification of Diseases, 10th Revision, diagnosis and Current Procedural Terminology procedure codes and medication dispensing records. A 3-member clinical review committee of allergists adjudicated suspected reactions. The incidence rate of confirmed SARs and EoE per 1000 person years of exposure were determined. Results: A total of 521 patients (93.9% adult and 6.1% pediatric) were exposed to HDM SLIT-tablet challenge from January 2018 through May 2023, for 440.4 person years of exposure. The patients' average age (SD) was 39.3 (14.1) years, 58.7% were female, 44.3% were non-Hispanic White, 40.3% had asthma, and 15.0% had gastroesophageal reflux disease. A SAR occurred in 1 adult patient, and during initial HDM SLIT-tablet challenge, SARs occurred in 2 pediatric adolescents, for an overall incidence of 6.8 SARs per 1000 patient years (95% CI = 2.2-21.1). EoE occurred in 1 adult patient, for an overall incidence of 2.3 cases of EoE per 1000 patient years (95% CI = 0.3-16.1). Conclusions: This real-world study demonstrated that SARs and EoE were infrequent events with HDM SLIT-tablet use, supporting the safety of HDM SLIT-tablets and need for physician supervision with initial challenge.

Advancing assessment of asthma control with a composite tool: The Asthma Impairment and Risk Questionnaire.

BACKGROUND: National and international asthma guidelines and reports do not include control tools that combine impairment assessment with exacerbation history in one instrument. OBJECTIVE: To analyze the performance of the composite Asthma Impairment and Risk Questionnaire (AIRQ) in assessing both domains of control and predicting exacerbation risk compared with the Global Initiative for Asthma (GINA) 4-question symptom control tool (GINA SCT), Asthma Control Test (ACT), and physician expert opinion (EO) informed by GINA SCT responses and appraisal of GINA-identified risk factors for poor asthma outcomes. METHODS: Multivariable logistic regressions evaluated AIRQ and GINA SCT as predictors of ACT. McNemar's test compared the proportion of patients categorized at baseline as completely or well-controlled by each assessment but with current impairment or previous-year and subsequent-year exacerbations. RESULTS: The analysis included 1064 patients aged 12 years or older; mean (SD) age 43.8 years (19.3); 70% female; 79% White; and 6% Hispanic or Latino. AIRQ and GINA SCT were highly predictive of ACT well-controlled vs not well-controlled and very poorly controlled (receiver operator characteristic area under curve AIRQ = 0.90, GINA SCT = 0.86, P = .03 AIRQ vs GINA SCT) and ACT very poorly controlled vs well-controlled and not well-controlled asthma (receiver operator characteristic area under curve AIRQ = 0.91, GINA SCT = 0.87, P = .01 AIRQ vs GINA SCT). AIRQ rated fewer patients as having completely or well-controlled asthma who had current impairment (P < .01) or with previous-year and subsequent-year exacerbations (P < .001) than did GINA SCT, ACT, and EO. CONCLUSION: AIRQ performs better in assessing both domains of current control and predicting exacerbation risk than do control tools and EO informed by GINA SCT and risk factors for poor asthma outcomes.

The Asthma Impairment and Risk Questionnaire enhances the assessment of asthma control.

BACKGROUND: Asthma control is often overestimated in routine practice, and despite advances in the understanding of immunopathology and the availability of new precision therapies, the burden of disease remains unacceptably high. OBJECTIVE: To compare the performance of the Asthma Impairment and Risk Questionnaire (AIRQ) with patient and physician assessments and the Asthma Control Test (ACT) in identifying asthma control. METHODS: Baseline data from a longitudinal study of the AIRQ were analyzed. Patients with asthma in the United States aged 12 years and older followed in 24 specialty practices and 1 specialty-affiliated primary care clinic were enrolled between May and November 2019. At entry, participants completed AIRQ and ACT, and participants and physicians completed 5-point Likert scale assessments of control. RESULTS: A total of 1112 participants were enrolled (mean [SD] age = 43.9 [19.3] years, 70% of the female sex, 78% White). Overall, 62% of participants rated themselves as well- or completely controlled, and 54% were rated comparably by physicians. The ACT classified 49% of participants as well-controlled, with 35% similarly categorized by AIRQ. Previous-year exacerbations were experienced by 32% of participants who self-rated as well- or completely controlled, 30% who were rated as well- or completely controlled by physicians, and 29% assessed as well-controlled by ACT, but only 15% of those classified as well-controlled by AIRQ. CONCLUSION: The burden of asthma is substantial in patients cared for by asthma specialists, and asthma control is overestimated by patients, physicians, and the symptom-based ACT. The AIRQ assesses risk in addition to symptom control and may serve to improve asthma control determination by assessing previous exacerbations.

Systemic Corticosteroid-related Adverse Outcomes and Health Care Resource Utilization and Costs Among Patients with Chronic Rhinosinusitis with Nasal Polyposis.

PURPOSE: Nasal polyps (NPs) develop in 20% to 30% of patients with chronic rhinosinusitis. Severe forms of chronic rhinosinusitis with nasal polyposis (CRSwNP) may be treated with systemic corticosteroids (SCSs), which increase the risk for adverse clinical outcomes. This study compared the incidence of SCS-related adverse outcomes and health care resource utilization and costs between patients with CRSwNP who had SCS exposure and those who did not have SCS exposure. METHODS: This retrospective cohort study used health care claims data from adult patients with CRSwNP identified in the IBMⓇ MarketScanⓇ Databases between January 2003 and June 2019. The first SCS prescription date in SCS users or a matched date in SCS nonusers (controls) represented the index date. Enrollment for ≥1 year before and after the index date was required. SCS-related adverse outcomes and costs were compared between all SCS users and controls, and among subgroups of patients who had claims for 1-3 and ≥4 SCS prescriptions in the 12-month postindex period. Comparisons were also made among SCS users and controls who previously had and did not have NP surgery, and those with and without comorbid asthma. Inverse probability of treatment weights was applied to all comparisons, which were evaluated for a variable-length follow-up period. FINDINGS: SCS users (n = 37,740) had a greater risk for any adverse outcome than controls (n = 7032) (incidence rate ratio [IRR] = 1.10; 95% CI, 1.05-1.16). The risk for adverse outcomes was highest in the subgroups that did not have NP surgery and that had ≥4 SCS claims (n = 2993) versus controls who did not have NP surgery (n = 5078) (IRR = 1.30; 95% CI, 1.18-1.44). Similarly, patients with asthma and ≥4 SCS claims (n = 4195) had a greater risk for SCS-related outcomes versus controls with asthma (n = 1226) (IRR = 1.36; 95% CI, 1.19-1.55). SCS users incurred 60% higher all-cause costs versus non-SCS users (P < 0.001). IMPLICATIONS: In patients with CRSwNP, SCS use was associated with a higher risk for adverse outcomes and with increased health care costs compared with controls without SCS exposure. Alternative treatment strategies that avoid and/or reduce SCS use may decrease health care costs and the risk for adverse outcomes among patients with CRSwNP.

Prevalence and Burden of Chronic Cough in the United States.

BACKGROUND: Chronic cough is a common complaint but there are little population-based data on its burden in the United States. OBJECTIVE: To determine the prevalence of chronic cough and its burden on individuals and the health care system. METHODS: This was a survey of respondents who completed the 2018 National Health and Wellness Survey and questions about sleep and health care resource use. Chronic cough was defined as having a daily cough for 8 or more weeks. Respondents without chronic cough were selected through propensity score matching. Chronic cough prevalence was estimated using poststratification sampling weights calculated using U.S. Census data and post-data Horvitz-Thompson sampling weights to adjust for sampling bias. RESULTS: Of 74,977 National Health and Wellness Survey respondents, 3,654 had experienced chronic cough in the previous 12 months, for a weighted prevalence of 5.0%. Respondents with chronic cough were older and more predominantly female than respondents without chronic cough (both P < .001). Compared with matched respondents without chronic cough, those with chronic cough had lower mean scores on the Medical Outcomes Study 36-item Short Form Survey v2 physical (P < .001) and mental (P < .001) component summary scores. More respondents with chronic cough than matched controls experienced severe anxiety and severe depression in the past 2 weeks, work productivity impairment, impaired sleep quality and daytime sleepiness, as well as more emergency department visits and hospitalizations in the past 6 months (P < .001 for all comparisons). CONCLUSIONS: The burden of chronic cough manifests itself as reduced health-related quality of life, increased anxiety and depression, impaired sleep and work productivity, and greater health care utilization.

Patient-Reported Burden of Chronic Cough in a Managed Care Organization.

BACKGROUND: The burden of chronic cough (CC) requires better understanding. OBJECTIVE: To determine the severity, health status, and health care resource utilization among patients with CC identified by electronic health records on 2 visits separated by ≥1 year. METHODS: Information on cough-related burden was collected through survey from patients with CC, including validated questionnaires (the cough health status Leicester Cough Questionnaire [LCQ], the cough hypersensitivity Hull Airway Reflux Questionnaire [HARQ], and the Cough Quality of Life Questionnaire [CQLQ]), CC-associated respiratory and gastrointestinal comorbidities, and treatment responses. Spearman correlation coefficients were reported to examine the associations among the LCQ, HARQ, and CQLQ. Patient demographics and patient-reported CC features were compared between males and females, and among ethnic groups using Robust Poisson regression models. RESULTS: The survey was completed by 565 patients who were 64.8 ± 12.6 years, 75.8% female, and 60.4% white. CC duration was 8.6 ± 10.5 years with an average weekly severity of 5.3 ± 2.3 (maximum 10). The LCQ score was 11.3 ± 3.9 (maximum 21). The HARQ score was 33.3 ± 13.6 (normal ≤13). The CQLQ score was 56.9 ± 17.5 (maximum 112, worse with higher scores). The Spearman rank correlations were high between the LCQ and HARQ (-0.65), the LCQ and CQLQ (-0.80), and the HARQ and CQLQ (0.69). Patients with CC-associated respiratory and gastrointestinal comorbidities generally showed similar results regarding the above questionnaires. Treatment responses were suboptimal. Women compared with men and non-whites compared with whites reported significantly worse cough severity and poorer LCQ, HARQ, and CQLQ scores. CONCLUSIONS: CC is self-reported as a burdensome condition, particularly in women and non-white minorities, which markedly affects daily living with inadequate response to treatments.

Disease Burden and Long-Term Risk of Persistent Very Poorly Controlled Asthma: TENOR II.

BACKGROUND: Severe/difficult-to-treat disease occurs in 5% to 10% of patients with asthma, but accounts for more than 50% of related economic costs. Understanding factors associated with persistent very poorly controlled (VPC) asthma may improve outcomes. OBJECTIVE: To characterize persistent VPC asthma after more than 10 years of standard of care. METHODS: The Epidemiology and Natural history of asthma: Outcomes and treatment Regimens (TENOR) II (N = 341) was a multicenter, observational study of patients with severe/difficult-to-treat asthma with a single, cross-sectional visit more than 10 years after TENOR I. Persistent VPC asthma was defined as VPC asthma at TENOR I and TENOR II enrollment; without VPC asthma was defined as well- or not well-controlled asthma at either or both visits. Multivariable logistic regression assessed long-term predictors of persistent VPC asthma using TENOR I baseline variables. RESULTS: Of 327 patients, nearly half (48.0%, n = 157) had persistent VPC asthma. Comorbidities and asthma triggers were more frequent in patients with persistent VPC asthma than in patients without VPC asthma. Total geometric mean IgE was higher in patients with persistent VPC asthma (89.3 IU/mL vs 55.7 IU/mL); there was no difference in eosinophil levels. Lung function was lower in patients with persistent VPC asthma (mean % predicted pre- and postbronchodilator FEV1, 63.0% vs 82.8% and 69.6% vs 87.2%, respectively). Exacerbations in the previous year were more likely in patients with persistent VPC asthma (29.7% vs 9.0%, respectively). Predictors of persistent VPC asthma were black versus white race/ethnicity, allergic trigger count (4 vs 0), systemic corticosteroid use, and postbronchodilator FEV1 (per 10% decrease). CONCLUSIONS: The burden of persistent VPC asthma is high in severe/difficult-to-treat disease; management of modifiable risk factors, maximization of lung function, and trigger avoidance may improve outcomes.

Utilization and Costs of Severe Uncontrolled Asthma in a Managed-Care Setting.

BACKGROUND: Clinical and economic burden of patients with severe uncontrolled asthma (SUA) in a real-world managed-care setting required further documentation. OBJECTIVE: The objective of this study was to determine the characteristics, clinical, and economic burden of SUA in a managed-care setting. METHODS: This observational study identified patients with persistent asthma aged 12 years or more (N = 25,935) using the International Classification of Diseases, 9th Revision asthma codes and Healthcare Effectiveness Data and Information Set administrative criteria. An SUA subgroup was identified when all of the following 3 criteria were met in 2012: (1) 2 or more asthma exacerbations; (2) 6 or more medium- or high-dose dispensed canisters of inhaled corticosteroid (ICS) as monotherapy or with long-acting ß2-agonist; and (3) 3 or more dispensed non-ICS controllers. Health care utilization and direct costs (all-cause and asthma-related) in 2013 were compared between SUA and non-SUA subgroups using multivariable regression. RESULTS: Compared with the non-SUA subgroup (N = 25,350, 97.7%), the SUA subgroup (N = 585, 2.3%) at baseline was significantly older and had more comorbidities, asthma specialist care, controller medication dispensed, and asthma exacerbations. During follow-up, patients with SUA exhibited significantly more asthma exacerbations and short-acting ß2-agonist use, and higher all-cause and asthma-related costs than patients with non-SUA. The adjusted asthma-related average direct cost per patient at follow-up was significantly higher for SUA (mean ± SE) ($2325 ± $75) than non-SUA ($1261 ± $9) with an incremental cost of $1056 (95% CI, $907-$1205). Asthma drugs accounted for the major difference (incremental cost of $848/patient; 95% CI, $737-$959). CONCLUSION: Increases and disparities in health care utilization and direct cost by SUA status suggest that patients with SUA require more intensive therapy, greater attention to adherence and comorbidities, more specialist care, and, possibly, personalized treatment approaches including novel biologic treatments.

Comparative safety and costs of stepping down asthma medications in patients with controlled asthma.

BACKGROUND: Limited data exist regarding outcomes after stepping down asthma medication. OBJECTIVE: We sought to compare the safety and costs of stepping down asthma controller medications with maintaining current treatment levels in patients with controlled asthma. METHODS: Patients with persistent asthma were identified from the US Medical Expenditure Panel Survey years 2000-2010. Each patient had Medical Expenditure Panel Survey data for 2 years, and measurement was divided into 5 periods of 4 to 5 months each. Eligibility for stepping down asthma controller medications included no hospitalizations or emergency department visits for asthma in periods 1 to 3 and no systemic corticosteroid and 3 or less rescue inhalers dispensed in periods 2 and 3. Steps were defined by type and dose of chronic asthma medication based on current guidelines when comparing period 4 with period 3. The primary outcome of complete asthma control in period 5 was defined as no asthma hospitalizations, emergency department visits, and dispensed systemic corticosteroids and 2 or fewer dispensed rescue inhalers. Multivariable analyses were conducted to assess safety and costs after step down compared with those who maintained the treatment level. RESULTS: Overall, 29.9% of patients meeting the inclusion criteria (n = 4235) were eligible for step down; 89.4% (95% CI, 86.4% to 92.4%) of those who stepped down had preserved asthma control compared with 83.5% (95% CI, 79.9% to 87.0%) of those who were similarly eligible for step down but maintained their treatment level. The average monthly asthma-related cost savings was $34.02/mo (95% CI, $5.42/mo to $61.24/mo) with step down compared with maintenance of the treatment level. CONCLUSION: Stepping down asthma medications in those whose symptoms were controlled led to similar clinical outcomes at reduced cost compared with those who maintained their current treatment level.

High blood eosinophil count is a risk factor for future asthma exacerbations in adult persistent asthma.

BACKGROUND: Exacerbation-associated uncontrolled asthma represents a major public health problem. The relationship of elevated blood eosinophils to this process needs study. OBJECTIVE: To determine whether a high blood eosinophil count is a risk factor for future asthma exacerbations in adult persistent asthma. METHODS: By using electronic pharmacy and health care data from Kaiser Permanente Southern California, 2392 patients, ages 18 to 64 years, were identified who met the Health Effectiveness Data and Information Set 2-year criteria for persistent asthma, did not manifest chronic obstructive pulmonary disease and other major illnesses, and had a blood eosinophil determination in 2010. Exacerbations (primary outcome) were defined as asthma outpatient visits that required systemic corticosteroid dispensing within ±7 days or asthma emergency department visits or hospitalizations. A period of ≥8 days defined a new exacerbation. Multivariate modelling used negative binomial and Poisson regression to examine the association between a blood eosinophil count determined in 2010 and risk of exacerbations, and ≥7 short-acting ß2-agonist (SABA) canisters dispensed (secondary outcome) in 2011 by adjusting for demographics, comorbidities, and asthma burden. RESULTS: The rate of asthma exacerbations in 2011 was 0.41 events per person year (95% CI, 0.37-0.45). Eosinophil count ≥400/mm(3) in 2010 was a risk factor for asthma exacerbations in 2011 (adjusted rate ratio 1.31 [95% CI, 1.07-1.60]; P = .009) and ≥7 SABA dispensed (adjusted risk ratio 1.17 [95% CI, 1.03-1.1.33]; P = .015). CONCLUSION: A high blood eosinophil count is a risk factor for increased future asthma exacerbations and excessive short-acting ß2-agonist use after adjustment of potential confounders in adults with persistent asthma, which suggests a higher disease burden in patients with asthma and with high blood eosinophil counts.

Clinical burden and predictors of asthma exacerbations in patients on guideline-based steps 4-6 asthma therapy in the TENOR cohort.

BACKGROUND: Patients with severe or difficult-to-treat asthma on guideline-recommended Steps 4/5/6 therapy have not previously been described. OBJECTIVE: To characterize patients with severe or difficult-to-treat asthma on Steps 4/5/6 therapy and assess predictors of future asthma exacerbations. METHODS: Patients ages ≥12 years with baseline and month 12 medication data were assigned to Steps 4/5/6 care levels from the 2007 National Heart, Lung, and Blood Institute guidelines. Demographic, atopic, and clinical characteristics at baseline and month 12 were assessed by using descriptive statistics. Asthma-related quality of life was assessed by using the Mini Asthma Quality of Life Questionnaire, and work and activity impairment was assessed by the Work Productivity and Activity Impairment Questionnaire-Asthma. Odds ratios (OR) and 95% CI for asthma exacerbation risk at month 12 were generated by using multivariable logistic regression. RESULTS: A total of 1186 patients were included. More than two-thirds of the patients (67.4%) were on ≥3 long-term controllers, and 55.1% were considered difficult to treat due to frequent exacerbations. Patients reported low asthma-related quality of life scores and considerable impairment in overall work and daily activity (21.4% and 32.1%, respectively). After adjustment for covariates, exacerbation history (hospitalization, OR 6.27 [95% CI, 3.61-10.88]; emergency department visit, OR 3.84 [95% CI, 2.50-5.91]; corticosteroid burst, OR 2.89 [95% CI, 2.18-3.82]) and very poorly controlled asthma (OR 1.95 [95% CI, 1.41-2.71] vs not well controlled) were independently associated with risk of a future exacerbation (all P < .001). CONCLUSION: Despite multiple long-term controller medications, patients with severe or difficult-to-treat asthma on Steps 4/5/6 therapy present with significant clinical burden and risk of future asthma exacerbations.

Change in asthma control over time: predictors and outcomes.

BACKGROUND: Maintenance of asthma control over time is a clear goal of national asthma guidelines, but few studies have addressed the natural history of asthma control over time. OBJECTIVE: To assess the impairment domain of asthma control over time in patients with persistent asthma and to determine predictors and consequences of controlled and uncontrolled asthma over time. METHODS: Patients 18-56 years old with persistent asthma who completed baseline (November 2007) and follow-up asthma surveys (April, July, October 2008) were included in the study. The survey included the Asthma Control Test as well as questions regarding other patient and asthma characteristics. Health care utilization (pharmacy and exacerbations) for 2008 was obtained from administrative data. RESULTS: The baseline and first follow-up surveys were completed by 1267 patients, and all 4 surveys were completed by 782 patients. Patients with well-controlled asthma at baseline were significantly more likely (P < .0001) to have well-controlled asthma over the following year (76.2%-80.4%) than patients with uncontrolled asthma at baseline (33.5%-36.9%). Patients whose asthma control improved over the first several months of follow-up experienced significantly (P < .05) fewer exacerbations over the subsequent year than patients with initially uncontrolled asthma who did not improve. CONCLUSION: Degree of asthma control at one point in time is strongly related to the achievement or maintenance of control and to asthma exacerbations over time. Patients with uncontrolled asthma, especially very poorly controlled asthma, should receive intensive management and follow-up in an attempt to achieve well-controlled asthma over time.

Development and preliminary validation of the Adult Asthma Adherence Questionnaire™.

BACKGROUND: Asthma medication adherence is related to better asthma outcomes, but identification of suboptimal patient adherence behavior is not standardized in clinical settings. OBJECTIVE: [corrected] The purpose of this study was to develop a practical questionnaire that reflects nonadherence risk and identifies potential adherence barriers. METHODS: A questionnaire that included 20 potential adherence questions was completed by 420 adult patients with asthma who filled a prescription for an inhaled corticosteroid (ICS) and a short-acting beta agonist (SABA) in the previous 6 months. Questions without substantial floor or ceiling effects that were significantly related to self-reported low adherence or previous ICS canister dispensings were identified. Internal consistency reliability was tested by Cronbach α. Relationships of these questions to Asthma Control Test scores, future percent of days covered for ICS dispensings, and future asthma exacerbations and SABA dispensings were determined. RESULTS: Five final questions were identified: following "my medication plan," forgetting, not "needing" the medications, side effects, and cost. Low internal consistency reliability (<0.50) suggested items should not be summarized by a single score. All five questions were related to Asthma Control Test scores. Following the medication plan, forgetting, and not needing medication were significantly related to prospective percent of days covered. Side effects were related to subsequent SABA and oral corticosteroid dispensings, and cost was significantly related to oral corticosteroid dispensings. CONCLUSIONS: We identified five questions related to other measures of adherence and to asthma control that can be used clinically to identify patients at risk of nonadherence and the specific adherence barriers involved.

Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort.

Patients with severe or difficult-to-treat asthma account for substantial asthma morbidity, mortality, and healthcare burden despite comprising only a small proportion of the total asthma population. TENOR, a multicenter, observational, prospective cohort study was initiated in 2001. It enrolled 4,756 adults, adolescents and children with severe or difficult-to-treat asthma who were followed semi-annually and annually for three years, enabling insight to be gained into this understudied population. A broad range of demographic, clinical, and patient self-reported assessments were completed during the follow-up period. Here, we present key findings from the TENOR registry in relation to asthma control and exacerbations, including the identification of specific subgroups found to be at particularly high-risk. Identification of the factors and subgroups associated with poor asthma control and increased risk of exacerbations can help physicians design individual asthma management, and improve asthma-related health outcomes for these patients.

Telephone-based environmental control interventions in asthmatic patients: what are patients willing to do?

BACKGROUND: Environmental control education is recommended for allergic patients with persistent asthma, but patients may not be willing to comply with recommendations. In a prior study from our group, only 24% of patients reported making any recommended environmental changes. OBJECTIVE: To determine what environmental changes allergic asthmatic patients say they would be willing to make and what changes they actually make. METHODS: Asthmatic patients with known perennial aeroallergen sensitization were asked by telephone to rate on a 1- to 5-point Likert scale their willingness to make specific environmental changes. Items with mean scores of 3 or higher were used to formulate a practical set of recommendations to be given to patients in stage 2 of the study. Stage 2 patients were given the advice formulated in stage 1 and then telephoned 2 months later to see what changes they actually made. RESULTS: Stage 1 patients (n = 60) were willing to institute 14 of the 18 proposed allergen-specific recommendations. Of 36 stage 2 patients who were allergic to mite, mold, and/or dander, 29 (80.6%) reported that they complied with at least 1 of the recommendations made in this study. Patients who owned their own home were significantly (P < .05) more likely (91.3%) to make at least 1 change than patients who rented their home (63.6%). CONCLUSION: Pending additional information, we suggest that environmental control recommendations for mite, mold, and dander emphasize those used in this study because they appear to be practical for a substantial proportion of patients, especially if they own their home.

A comparison of the psychometric properties of the Mini-Rhinitis Quality of Life Questionnaire and the Rhinitis Control Assessment Test.

BACKGROUND: The relationships between validated quality of life tools and control tools have not been explored for rhinitis. This study was designed to determine relationships of the Mini-Rhinitis Quality of Life Questionnaire (MiniRQLQ) and the Rhinitis Control Assessment Test (RCAT) to each other regarding content and predictive abilities. METHODS: Participants were adult members of a large integrated care organization with an encounter diagnosis of rhinitis in the prior 2 years. Patients completed mailed questionnaires at baseline that contained the MiniRQLQ and the RCAT and three follow-up questionnaires that contained those tools as well as questions regarding missed work or school because of rhinitis and frequency and effectiveness of medications used for rhinitis. Medications dispensed during the follow-up year were obtained from computerized pharmacy records. Results of allergy tests were retrieved for patients seen in the Allergy Department. RESULTS: The final cohort included 1051 patients. Baseline RCAT scores were strongly correlated with baseline MiniRQLQ scores in both allergic (r = -0.80) and nonallergic (r = -0.84) patients. Baseline MiniRQLQ and RCAT scores were significantly related to patient reports of missed school/work, medication use, and effectiveness over the next 3 months and to dispensing during the following year of total and some individual rhinitis medications. Test-retest reliability, responsiveness, and a preliminary minimal important difference (>2.5) were shown for the RCAT, using the MiniRQLQ as an anchor. CONCLUSION: The MiniRQLQ and RCAT are strongly related to each other and both predict subsequent rhinitis outcomes. Determining the comparative usefulness of these tools will require further study.

Economic burden of impairment in children with severe or difficult-to-treat asthma.

BACKGROUND: The cost associated with asthma impairment in children with severe asthma has not been determined. OBJECTIVE: To assess the asthma cost burden in children with severe or difficult-to-treat asthma based on asthma impairment. METHODS: Children aged 6 to 12 years in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study with available data at baseline (n = 628), month 12 (n = 385), and month 24 (n = 280) corresponding to the National Heart, Lung, and Blood Institute asthma guidelines' impairment domain were included. Children were categorized as either very poorly controlled (VPC), not well controlled (NWC), or well controlled (WC) and assessed cross-sectionally and longitudinally. Mean total asthma costs based on direct (medication usage, unscheduled office visits, emergency department visits, hospitalizations) and indirect (school/work days lost) asthma costs were assessed. RESULTS: Mean annual total asthma costs were more than twice as high in the VPC group compared with NWC and WC groups (baseline: $7,846, $3,526, $3,766.44, respectively; month 12: $7,326, $2,959, $2,043, respectively; month 24: $8,879, $3,308, $1,861, respectively (all P < .001). Indirect costs accounted for approximately half the total asthma costs for VPC asthma patients at each time point. Significantly lower costs were observed for patients whose impairment status improved or temporarily improved from VPC after baseline. CONCLUSION: The economic burden of severe or difficult-to-treat asthma in children is associated with VPC asthma and improvement in asthma control and is associated with reducing cost. Further attention to patients with poorly controlled asthma, through better management strategies or more effective medications, may significantly reduce this burden of illness.

Improving asthma outcomes in large populations.

This article summarizes our experience using administrative, survey, and telephone information to define asthma severity, impairment, risk, and quality of care in our large Kaiser Permanente population. Our data suggest that the 2-year Healthcare Effectiveness Data and Information Set definition of persistent asthma is a good surrogate for survey-defined persistent asthma, and thus it would be reasonable to direct asthma population management and quality-of-care assessments at patients with Healthcare Effectiveness Data and Information Set-defined persistent asthma for 2 years in a row. For population management, the numbers of short-acting ß-agonist (SABA) canisters dispensed and validated tools on mail or telephone surveys have been used to assess asthma impairment. Algorithms based on pharmacy data (SABA canister and oral corticosteroid dispensings and prior emergency hospital care) have been used to assess the risk domain of asthma control. The asthma medication ratio (controllers divided by controllers plus SABAs) has been shown to be related to improved outcomes and is recommended as an asthma quality-of-care marker. It is hoped that outreach to patients and providers based on these indicators will improve asthma outcomes in patients cared for in individual practices, as well as in large health plans.