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    Anne Fuhlbrigge

    BACKGROUND Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these... more
    BACKGROUND Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).
    BACKGROUND Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite... more
    BACKGROUND Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients. METHODS In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations. FINDINGS At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size. INTERPRETATION COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.
    BACKGROUND FEV1 as a percentage of predicted (FEV1%pred) is commonly measured in asthma clinical studies; however, reports vary on its association with asthma control instruments evaluating symptoms. OBJECTIVE Assess the association... more
    BACKGROUND FEV1 as a percentage of predicted (FEV1%pred) is commonly measured in asthma clinical studies; however, reports vary on its association with asthma control instruments evaluating symptoms. OBJECTIVE Assess the association between FEV1%pred and Asthma Control Questionnaire (ACQ) scores in a managed-care population with persistent asthma. METHODS Retrospective analysis of survey responses and spirometry results of patients (aged ≥12 years) with persistent asthma from the Observational Study of Asthma Control and Outcomes was done. Eligible patients received 4 identical surveys including the 5-item ACQ (ACQ-5)/6-item ACQ (ACQ-6) and completed spirometry in parallel. Longitudinal analyses, comparisons of change over time, and fixed- and random-effects regression analyses were conducted, with/without adjustment for covariates. RESULTS There were 1748 survey responses with valid spirometry results. In unadjusted models, coefficients for ACQ-5/ACQ-6 scores were not statistically significant and coefficient of determination (R2) was low (0.03). When adjusted for covariates, ACQ-5 and ACQ-6 scores were significantly associated with FEV1%pred (P < .001) and R2 increased to 0.11 and 0.12, respectively. In adjusted models, every 1-point increase in ACQ-5 and ACQ-6 scores was associated with a 1.7% and 1.9% decrease, respectively, in FEV1%pred. Change in FEV1%pred and change in ACQ-5/ACQ-6 scores were not significantly associated in regressions with/without covariates. CONCLUSIONS The weak and statistically insignificant association between FEV1%pred and ACQ-5/ACQ-6 scores in unadjusted models suggests a high degree of unexplained variation between these measures. Results support the use of both symptoms and pulmonary function, rather than relying on one measure alone, to assess asthma control in clinical care and outcomes studies.
    Occurrence of severe asthma exacerbations are the cornerstone of the evaluation of asthma management, but severe asthma exacerbations are rare events. Therefore, trials that assess drug efficacy on exacerbations are done late in clinical... more
    Occurrence of severe asthma exacerbations are the cornerstone of the evaluation of asthma management, but severe asthma exacerbations are rare events. Therefore, trials that assess drug efficacy on exacerbations are done late in clinical development programmes. We aimed to establish an endpoint capturing clinically relevant deteriorations (diary events) that, when combined with severe exacerbations, create a composite outcome (CompEx). CompEx needs to strongly mirror results seen with the severe exacerbation-validated outcome, to allow the design of clinical trials of shorter duration and that include fewer patients than trials assessing severe exacerbations. Data from 12 asthma trials of 6 months or 12 months duration and, with standardised collection of exacerbations and diary card variables, were used to construct and test CompEx. The study populations had a mean age of 35-53 years, 59-69% were female, and had a mean FEV1 percentage of predicted normal of 63-84%. With data from f...
    The use of physician profiles in... more
    The use of physician profiles in "pay for performance" initiatives depend on their reliability and accuracy. To evaluate whether health care delivery units (practices) can be reliably differentiated using the Health Employers Data Information System (HEDIS) performance measure. Simulation was used to describe the relationship between practice size (number of children with persistent asthma) and precision of practice measures to estimate performance. Children enrolled in 1 of the 39 practice groups from 1 of 3 managed care organizations participating in the Pediatric Asthma Care Patient Outcomes Research Team (PAC PORT). The main outcome was reproducibility of 4 performance measures, the HEDIS measure and 3 additional measures available from automated claims data: the proportion of children with asthma related-hospitalization, emergency department visits and oral steroid dispensings for asthma. The ability to reproducibly rank a practice is dependent on the performance measure, practice size, and the reproducibility threshold chosen. Of measures evaluated, none achieved a reproducibility >85% for practice size of 50 or less. At a practice size of 100 subjects, the HEDIS measure reproducibly ranked practices 89% of the time, compared with 85% for emergency department visits and 83% for hospitalizations. Only at a practice size of 100 children with persistent asthma, was reproducibility of ranking greater than 85% with all performance measures evaluated. The reliability of ranking medical practices depends on practice size. Only at the level of the health care organization can asthma measures, available within claims data, be used to rank performance reliably.
    Asthma treatment guidelines recommend medications based on the level of asthma control. To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. Children (5-16... more
    Asthma treatment guidelines recommend medications based on the level of asthma control. To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. Children (5-16 years; n = 488) and adults (17-80 years; n = 530) with asthma and no controller therapy in the prior 6 months were included. Telephone surveys were conducted within 5 days of filling a new asthma controller prescription with either the caregiver of children or the adult patient. Demographics, asthma control before therapy, and asthma-related resource use were assessed for patients initiating monotherapy (filling one asthma controller prescription) and combination therapy (filling more than one controller medication or a fixed-dose combination). Mean pediatric age was 10 years; 53% were male. Mean adult age was 47 years; 25% were male. There were no significant differences in asthma control score between patients receiving monotherapy and combination therapy. Children on combination therapy did not have more nighttime awakening or short-acting β-agonist use but were more likely to have been hospitalized due to asthma attack (p = .05) and have more unscheduled (p = .0374) and scheduled (p = .009) physician visits. Adults on combination therapy were more likely to have been hospitalized due to asthma attack (p < .05) and have regular doctor visits for asthma (p < .01). Assessment of asthma control scores in the 4 weeks before index medication suggests that asthma severity during a treatment-free period did not differ significantly for patients initiating controller monotherapy versus combination therapy. From these findings, it appears that although physicians may not focus on asthma control when choosing the intensity of initial controller therapy, the intensity of health-care encounters may be an influence.
    ... 393–413. Tormo MJ, Navarro C, Chirlaque MD, Barber X. Validation of self diagnosis of high blood pressure in a sample of the Spanish EPIC cohort: overall agreement and predictive values. EPIC Group of Spain. J Epidemiol Community... more
    ... 393–413. Tormo MJ, Navarro C, Chirlaque MD, Barber X. Validation of self diagnosis of high blood pressure in a sample of the Spanish EPIC cohort: overall agreement and predictive values. EPIC Group of Spain. J Epidemiol Community Health 2000; 54: 221–226. Klungel OH ...
    The goal of asthma therapy is to maintain consistent control. We sought to examine the patterns of asthma control recorded over 3 years using administrative claims and resource utilization definition. We performed a retrospective... more
    The goal of asthma therapy is to maintain consistent control. We sought to examine the patterns of asthma control recorded over 3 years using administrative claims and resource utilization definition. We performed a retrospective observational study with a nationally representative patient-level database containing pharmacy and medical claims. Patients with asthma (International Classification of Diseases, Ninth Revision-Clinical Modification code 493.xx), patients undergoing treatment with at least 1 asthma medication, and patients with 36 months of continuous claims coverage during the calendar years 1996 through 2002 were identified. A total of 63,324 patients were included in the study. Patients were classified as having controlled asthma in year 1 if they had less than 4 claims for a short-acting beta 2 -agonist, no claims for an OCS, and no asthma-related emergency department visits or hospitalizations. Patients were then followed over the next 8 quarters (2 years) to observe whether control was maintained. Control during a quarter was defined with the same criteria, except the reliever threshold was adjusted to 2 or more claims per quarter. Thirty-nine thousand ninety-five (57%) patients were defined as having controlled asthma during year 1. During the 2-year follow-up period, a range of 10% to 14% of these patients with controlled asthma met the criteria of uncontrolled asthma during any given quarter. Overall, 46,227 (73%) patients identified met the criteria for uncontrolled asthma at least once during the 3-year period. This study demonstrates that almost 75% of asthmatic patients experience an uncontrolled asthma episode 1 or more times over a 3-year period. Furthermore, we found that significant fluctuations in asthma control exist, even in patients with prior controlled asthma.
    RationaleA decision to implement innovative disease management interventions in health plans often requires evidence of clinical benefit and financial impact. The Pediatric Asthma Care PORT II trial evaluated the outcomes of two asthma... more
    RationaleA decision to implement innovative disease management interventions in health plans often requires evidence of clinical benefit and financial impact. The Pediatric Asthma Care PORT II trial evaluated the outcomes of two asthma care strategies in children (ages 3 – 17) – a peer leader based physician behavior change intervention (PLE) and a practice-based redesign (Planned Asthma Care Intervention (PACI)).
    ABSTRACT
    Although inhaled corticosteroids (ICSs) generally protect against severe exacerbations in asthma, they may result in elevated IgE levels, which are associated with exacerbations. To determine whether variation in the low-affinity IgE... more
    Although inhaled corticosteroids (ICSs) generally protect against severe exacerbations in asthma, they may result in elevated IgE levels, which are associated with exacerbations. To determine whether variation in the low-affinity IgE receptor gene, FCER2, is associated with severe exacerbations defined as emergency department visits and/or hospitalizations in patients with asthma on ICSs. We resequenced, then genotyped 10 FCER2 single nucleotide polymorphisms (SNPs) in 311 children randomized to inhaled budesonide as part of the Childhood Asthma Management Program. We evaluated the association of FCER2 variants with IgE levels and presence or absence of severe exacerbations over the 4-year clinical trial. We also evaluated differences in cellular expression of the novel FCER2 SNP, T2206C. In white subjects, 3 FCER2 SNPs were significantly associated (P < .05) with elevated 4-year IgE level; each was also associated with increased severe exacerbations. Final multivariable models demonstrated associations between T2206C and severe exacerbations in both white and African American children (hazard ratio, 3.95; 95% CI, 1.64-9.51; and hazard ratio, 3.08; 95% CI, 1.00-9.47), despite ICS use. Interaction models supported a true gene-environment effect in white subjects (interaction P = .004). T2206C was also associated with decreased FCER2 expression (P = .02). FCER2 predicts the likelihood of treatment protocol success in asthma. The associations of T2206C with IgE level, severe exacerbations, and FCER2 expression may provide a mechanistic basis for the observed findings. Genetic variation in FCER2 may help form a prognostic model for ICS response in asthma.
    ABSTRACT The evidence reviewed brings to light the complexity of the interactions that exist between the varied manifestations of sex and gender with the development of and morbidity associated with asthma. The effects of sex are manifest... more
    ABSTRACT The evidence reviewed brings to light the complexity of the interactions that exist between the varied manifestations of sex and gender with the development of and morbidity associated with asthma. The effects of sex are manifest throughout life, beginning during pregnancy. Although the effects of sex on asthma include hormonal differences between females and males, diverse effects have been noted, including influence on immune maturation, the balance of the immunologic response, amplification of the inflammatory state associated with obesity, and modification of the response to therapy through effects on the β2 AR. The complex interactions that occur between the effects of sex and gender (the socio-cultural effect of being female or male) are discussed. Th influence of psychosocial factors (eg, stress, cognitive factors, emotion, coping, identity) on the course and presentation of obstructive lung disease is examined compared between girls and women and boys and men. To understand the disparities in asthma risk, the potential role of the complex interactions between various determinants of health should be understood. Understanding these interactions promises to lead to more effective therapies, including interventions aimed at educating individuals with asthma and their social supports and at helping individuals make behavioral changes. Documenting these multilevel determinants of health can shape changes at the institutional level, including policies that influence environmental exposures, and can remediate social inequities in resources.
    Objective. To assess the practice‐level effects of (1) a physician peer leader intervention and (2) peer leaders in combination with the introduction of asthma education nurses to facilitate care improvement. And, to compare findings with... more
    Objective. To assess the practice‐level effects of (1) a physician peer leader intervention and (2) peer leaders in combination with the introduction of asthma education nurses to facilitate care improvement. And, to compare findings with previously reported patient‐level outcomes of trial enrollees.Study Setting. Data were included on children 5–17 years old with asthma in 40 primary care practices, affiliated with managed health care plans enrolled in the Pediatric Asthma Care Patient Outcomes Research Team (PORT) randomized trial.Study Design. Primary care practices were randomly assigned to one of two care improvement arms or to usual care. Automated claims data were analyzed for 12‐month periods using a repeated cross‐sectional design. The primary outcome was evidence of at least one controller medication dispensed among patients with persistent asthma. Secondary outcomes included controller dispensing among all identified asthmatics, evidence of chronic controller use, and the...
    SummaryBackground An association between antibiotic use in early life and asthma in childhood has been reported in five retrospective studies and one longitudinal study.Objective To examine the relation between the use of oral antibiotics... more
    SummaryBackground An association between antibiotic use in early life and asthma in childhood has been reported in five retrospective studies and one longitudinal study.Objective To examine the relation between the use of oral antibiotics in the first year of life and asthma in early childhood.Methods Longitudinal follow‐up of 4408 children enrolled in a health maintenance organization (HMO) from birth to the age of 5 years.Results After adjusting for sex and illnesses of the lower respiratory tract (LRIs), we found a significant association between antibiotic use in the first year of life and asthma between the ages of 1 and 2 years (odds ratio (OR) for 1–2 vs. no courses of antibiotics=1.9, 95% confidence interval (CI)=1.3–2.7; OR for 3–4 vs. no courses of antibiotics=1.6, 95% CI=1.1–2.4; OR for at least 5 vs. no courses of antibiotics=2.1, 95% CI=1.5–3.2). After adjustment for sex and LRIs in the first year of life, there was no significant association between antibiotic use in t...
    ABSTRACT
    As the COVID-19 health crisis continues to reshape healthcare, systems across the country face increasing pressure to adapt their models of care to expand access to care, while also improving efficiency and quality in the face of limited... more
    As the COVID-19 health crisis continues to reshape healthcare, systems across the country face increasing pressure to adapt their models of care to expand access to care, while also improving efficiency and quality in the face of limited resources. Consequently, many have shown a growing interest and receptivity to the expansion of telehealth models to help meet these demands. Electronic consultations (eConsults) are a telehealth modality that allow for a non-face-to-face asynchronous consultation between a primary care provider (PCP) and a specialist aimed at facilitating specialist input without the need for a patient visit. The aim of this case study is to describe eConsults, how they differ from traditional in person models of care and other models of telemedicine and to review the evidence related to the effectiveness of eConsults by PCPs and clinicians from multiple specialties at the University of Colorado School of Medicine. We have worked to develop an infrastructure, deliv...
    BACKGROUND Discordance between physician and patient perceptions of asthma control may negatively impact symptom control, treatment, and outcomes. OBJECTIVE To evaluate concordance between physician and patient perception of overall... more
    BACKGROUND Discordance between physician and patient perceptions of asthma control may negatively impact symptom control, treatment, and outcomes. OBJECTIVE To evaluate concordance between physician and patient perception of overall asthma control and the association between perceived overall control and individual components of control. METHODS US survey data (Dec 2015-Feb 2016; Apr-Aug 2018) from the Respiratory Disease Specific Programme™ were analyzed. Physicians recorded patient disease characteristics and their perception of patients' asthma control. Patient perception of control was assessed using the Asthma Control Test (ACT); responses were compared with level of symptom control per the Global Initiative for Asthma (GINA) criteria and Work Productivity and Impairment questionnaire responses. Agreement and association were assessed by weighted Kappa (κ) and Spearman's Rho (r), respectively. RESULTS 1288 patients were included. Concordance between physician-perceived and patient-perceived asthma control in the prior 4 weeks was moderate (κ=0.4951). Association between physicians' overall perception of asthma control and patients' overall ACT score was also moderate (r=0.5450). However, 61.5% of patients with self-reported, well-controlled asthma had shortness of breath 1-2 times/week, 45.6% had 1-2 night-time awakenings/week, and patients reported a mean (SD) daily activity impairment of 17.5% (16.2%). Only 21.8% of patients with self-reported, well-controlled asthma were classified as such by GINA symptom criteria. CONCLUSION Patients' self-assessment of overall control does not accurately characterize true level of control, thus patients and physicians may benefit from working together to assess the individual components of asthma control to achieve better disease management, treatment decisions, and improved outcomes.
    BackgroundCompEx Asthma, a novel composite end-point combining severe exacerbations (SevEx) with asthma-worsening events, was recently developed. Further characterisation of CompEx Asthma is needed to illustrate the applicability of this... more
    BackgroundCompEx Asthma, a novel composite end-point combining severe exacerbations (SevEx) with asthma-worsening events, was recently developed. Further characterisation of CompEx Asthma is needed to illustrate the applicability of this end-point. The objective was to evaluate CompEx Asthma as a rate end-point to determine how seasonal and geographical factors impact this novel outcome.MethodsSeven 24–56-week randomised controlled trials of budesonide/formoterol (BUD/FORM) and benralizumab were analysed. Annualised event rates (AERs) and treatment effects (hazard ratio (HR)) were analysed with Poisson and Andersen–Gill models, respectively. Seasonality was analysed by month and five geographical regions were evaluated.ResultsThe studies included 10 815 patients (63% female, mean age 42–49 years). CompEx Asthma AER mirrored seasonal variations in SevEx AER. CompEx Asthma AERs were higherversusSevEx in BUD/FORM and benralizumab trials (range 2.7–4.5-fold and 1.3–2.0-fold increase, re...
    Tracking longitudinal measurements of growth and decline in lung function in patients with persistent childhood asthma may reveal links between asthma and subsequent chronic airflow obstruction. We classified children with asthma... more
    Tracking longitudinal measurements of growth and decline in lung function in patients with persistent childhood asthma may reveal links between asthma and subsequent chronic airflow obstruction. We classified children with asthma according to four characteristic patterns of lung-function growth and decline on the basis of graphs showing forced expiratory volume in 1 second (FEV1), representing spirometric measurements performed from childhood into adulthood. Risk factors associated with abnormal patterns were also examined. To define normal values, we used FEV1 values from participants in the National Health and Nutrition Examination Survey who did not have asthma. Of the 684 study participants, 170 (25%) had a normal pattern of lung-function growth without early decline, and 514 (75%) had abnormal patterns: 176 (26%) had reduced growth and an early decline, 160 (23%) had reduced growth only, and 178 (26%) had normal growth and an early decline. Lower baseline values for FEV1, small...
    Background: Severe exacerbations (SevEx) are rare events; hence, conventional exacerbation trials are large and lengthy to allow sufficient power. Aims & Objectives: Establish a composite endpoint of diary variables capturing... more
    Background: Severe exacerbations (SevEx) are rare events; hence, conventional exacerbation trials are large and lengthy to allow sufficient power. Aims & Objectives: Establish a composite endpoint of diary variables capturing clinically relevant deteriorations and SevEx that can guide decision making during early clinical development and allow trials to contain fewer patients and be of shorter duration. Methods: Data from eight 6–12 month trials (15524 patients) with budesonide/formoterol (Symbicort SMART ® ) or formoterol (Oxis ® ) using standardised collection of asthma exacerbations and diary card variables were investigated. From available diary variables, ie PEF, rescue SABA use, asthma symptoms, night-time awakenings, we identified a series of diary events based on predefined threshold values of deteriorations from baseline and slopes to assess trends. Random Forest methodology identified the most predictive variables. Composite Exacerbation (CompEx) was defined as first event of either diary event or SevEx. Performance was assessed by comparing treatment effects as hazard ratios relative to SevEx. Results: When censored at 3 months, 20% of patients experienced CompEx events vs 8% for SevEx with small variations between studies and CompEx algorithms. At least 50% of all SevEx were not captured by a diary event. CompEx defined by PEF and rescue SABA use alone was associated with best overall performance and statistical power. Treatment effects on CompEx at 3 months tracked the effect on SevEx. CompEx showed a similar effect profile as SevEx over time and in enriched populations. Conclusion: CompEx allows evaluation of exacerbation risk reduction in 3-month trials involving fewer patients compared with SevEx. Funding: AstraZeneca.
    Treatment guidelines recognize the importance of achieving and maintaining asthma control. This study was designed to assess the prevalence of asthma control in a representative U.S. population. A survey regarding asthma and associated... more
    Treatment guidelines recognize the importance of achieving and maintaining asthma control. This study was designed to assess the prevalence of asthma control in a representative U.S. population. A survey regarding asthma and associated symptoms was sent to a representative national sample of 134,401 households managed by the National Family Opinion WorldGroup from May to July 2007. Subjects >or=18 years with current asthma were identified and completed the Asthma Control Test (ACT), a brief validated self-administered survey that assesses asthma control. Subjects with an ACT score of >19 have been defined as having well-controlled asthma (WCA) and those with a score of <or=19 were defined as having not well-controlled asthma (NWCA). The prevalence of WCA was identified for the total population as well as subjects who currently were only using albuterol to control asthma symptoms. In addition, the frequency of past asthma exacerbations was studied and correlated with ACT. Su...
    Page 1. / Poster Discussion Session / Sunday, May 15/8:15 A24 IMPROVING OUTCOMES FOLLOWING LUNG TRANSPLANTATION AM-10:45 AM / Korbel Ballroom 4C-4D (Lower Level), Colorado Convention Center Interstitial ...
    Objective.Although the efficacy of inhaled antiinflammatory therapy in improving symptoms and lung function in childhood asthma has been shown in clinical trials, the effectiveness of these medications in real-world practice settings in... more
    Objective.Although the efficacy of inhaled antiinflammatory therapy in improving symptoms and lung function in childhood asthma has been shown in clinical trials, the effectiveness of these medications in real-world practice settings in reducing acute health care use has not been well-evaluated. This study examined the effect of inhaled antiinflammatory therapy on hospitalizations and emergency department (ED) visits by children for asthma.Design.Defined population cohort study over 1 year.Setting.Three managed care organizations (MCOs) in Seattle, Boston, and Chicago participating in the Pediatric Asthma Care–Patient Outcome Research and Treatment II trial.Participants.All 11 195 children, between 3 to 15 years old, with a diagnosis of asthma who were enrolled in the 3 MCOs between July 1996 and June 1997.Outcome Measures.We identified children with 1 or more asthma diagnoses using automated encounter data. Medication dispensings were identified from automated pharmacy data. Multiv...
    OBJECTIVE. The purpose of this work was to determine whether overweight in youth with mild-to-moderate asthma occurs with increased frequency and is accompanied by impaired psychological functioning. PATIENTS AND METHODS. The... more
    OBJECTIVE. The purpose of this work was to determine whether overweight in youth with mild-to-moderate asthma occurs with increased frequency and is accompanied by impaired psychological functioning. PATIENTS AND METHODS. The interrelationships among BMI and demographic and psychological characteristics were examined in 1005 children (aged 5–12 years) enrolled in the Childhood Asthma Management Program and seen for repeated visits over 4½ years. RESULTS. Baseline rates of overweight (BMI for age: ≥95th percentile) were comparable, but rates of overweight risk (BMI for age: 85th to <95th percentile) among children in the Childhood Asthma Management Program were elevated in comparison with the general population of children in the United States. Rates of overweight and overweight risk did not increase over the course of the longitudinal study. Overweight and overweight risk were more frequent among black and Hispanic than white children, although they were not higher relative to sa...
    Asthma exacerbations have well-established clinical and economic impact, yet lack consensus on characterization of an... more
    Asthma exacerbations have well-established clinical and economic impact, yet lack consensus on characterization of an episode's severity. Asthma treatment guidelines outline the concept of a moderate asthma exacerbation; however, a clear definition that can be operationalized has not been proposed, Adult asthma (ICD-9: 493.XX) patients, with at least 9 months of continuous enrolment in the Fallon Community Health Plan were included in the retrospective cohort study. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) or other lower respiratory tract conditions were excluded. The first reported asthma-related event following a 2-week symptom-free period was designated as the index event. Asthma-related events were categorized as (1) moderate exacerbations (symptom-based) or (2) severe exacerbations (claims-based). Timing between and temporal sequence of asthma-related events along with average costs were calculated, Of 3126 eligible patients, 55% reported an asthma-related event followed by a recurrent event(s). Moderate exacerbations followed by recurrent moderate exacerbations were most frequent (20%) with the shortest interval between exacerbations (mean: 83 days [SD 87]). Moderate exacerbations followed by severe exacerbations occurred in 16% of patients with an average of 176.74 (SD 176.94) days between events, Patient report of asthma bothersome enough to initiate contact with a clinician, but not requiring oral corticosteroid (OCS), is a definition for a moderate exacerbation that can be operationalized for research purposes. Further work is needed to demonstrate whether identification of moderate exacerbations will allow interventions that impact the frequency and timing of future exacerbations.
    Studies of the use of anti-inflammatory asthma therapy have been limited to selected populations or have been unable to assess the appropriateness of therapy for individuals. We sought to describe the current use of asthma medication in... more
    Studies of the use of anti-inflammatory asthma therapy have been limited to selected populations or have been unable to assess the appropriateness of therapy for individuals. We sought to describe the current use of asthma medication in the United States population and to examine the influence of symptoms and sociodemographics on medication use. This study was based on a cross-sectional, national, random-digit-dial household telephone survey in 1998 designed to identify adult patients and parents of children with current asthma. Respondents were classified as having current asthma if they had a physician's diagnosis of asthma and were either taking medication for asthma or had asthma symptoms during the past year. One or more persons met the study criteria for current asthma in 3273 (7.8%) households in which a screening questionnaire was completed. Of these, 2509 persons (721 children <16 years) with current asthma were interviewed. Current use of anti-inflammatory medication was reported by 507 (20.1%). Of these, most were using inhaled corticosteroids (72.5%), with use of antileukotrienes reported by 11.4% and use of cromolyn-nedocromil reported by 18.6%. Of persons with persistent asthma…
    Studies examining the influence of provider behavior and patterns of care delivery on the use of anti-inflammatory asthma therapy have been limited to selected populations or have been unable to assess the appropriateness of therapy for... more
    Studies examining the influence of provider behavior and patterns of care delivery on the use of anti-inflammatory asthma therapy have been limited to selected populations or have been unable to assess the appropriateness of therapy for individuals. We have previously reported the influence of sociodemographic variables and asthma severity on reported use of asthma medications in the United States. We sought to examine the influence of patterns of care delivery and clinician behavioral factors on the use of anti-inflammatory medication by patients with asthma. We performed a cross-sectional national random digit dial household telephone survey in 1998 of adult patients and parents of children with current asthma. Respondents were classified as having current asthma if they had a physician's diagnosis of asthma and were either taking medication for asthma or had asthma symptoms during the past year. One or more persons met the study criteria for current asthma in 3273 (7.8%) households in which a screening questionnaire was completed. Of the 2509 persons (721 children <16 years of age) with current asthma interviewed, 507 (20.1%) reported current use of anti-inflammatory medication. In a multiple logistic regression model controlling for asthma symptoms, reported anti-inflammatory use was significantly associated with patients reporting their physician having an excellent ability to explain asthma management (odds ratio [OR], 1.47; 95% CI, 1.09-1.98), scheduling regular visits to a physician for asthma (OR, 1.30; 95% CI, 1.02-1.64), having a written asthma action plan (OR, 1.63; 95% CI, 1.29-2.06), and being of white, non-Hispanic ethnicity (OR, 1.53; 95% CI, 1.19-1.98), along with markers of greater asthma morbidity, missing 6 or more days from work or school in the past year (OR, 1.29; 95% CI, 1.01-1.65), and hospitalization for asthma in the past year (OR, 1.74; 95% CI, 1.19-2.53). Anti-inflammatory use was less likely to be reported with younger age (OR, 0.82; 95% CI, 0.73-0.94), lower long-term asthma symptom burden (OR, 0.82; 95% CI, 0.71-0.94), use of 4 or fewer reliever inhaler canisters in the past year (OR, 0.50; 95% CI, 0.43-0.58), and smoking (OR, 0.50; 95% CI, 0.37-0.68). How asthma care is delivered influences the use of anti-inflammatory medication. Strategies to increase regular evaluation by a physician interested in asthma, particularly for minority patients, and to increase a physician's ability to communicate asthma management to patients might improve use of anti-inflammatory therapy among patients with asthma.

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