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Biomedical subjects

Robert S Zeiger

Publications and source records attributed to Robert S Zeiger.

At least 19 recordsLinked to original sources

Reliability and predictive validity of the Asthma Control Test administered by telephone calls using speech recognition technology.

BACKGROUND: The Asthma Control Test (ACT) has been validated in a paper and pencil version but has not been validated for use by telephone. OBJECTIVE: The purpose of this study was to provide validation data for the ACT administered by interactive telephone calls using speech recognition technology. METHODS: The ACT was administered to patients who confirmed a diagnosis of physician-diagnosed asthma, and information regarding race/ethnicity, smoking, and asthma course was also obtained during the call. Asthma emergency department visits, hospitalizations, and oral corticosteroid and beta-agonist canister dispensings were assessed for the 12 months after the date of each patient's call. Internal consistency reliability and predictive validity were assessed. RESULTS: Asthma Control Test scores (higher indicates better control) were completed by 2244 patients and were inversely related to black or Hispanic race/ethnicity and smoking. Reliability was 0.83. ACT scores were significantly related to emergency hospital care and oral corticosteroid and beta-agonist dispensings over the period of the subsequent 6 and 12 months. After adjusting for demographic characteristics, a score < or = 15 was associated significantly with an increased 12-month risk of emergency hospital care (odds ratio [OR], 2.5), oral corticosteroid dispensings (OR, 2.6) and dispensing of more than 6 beta-agonist canisters (OR, 6.8) compared with a score > or = 20. CONCLUSION: These data support the reliability and predictive validity of the ACT administered by interactive telephone calls using speech recognition technology. CLINICAL IMPLICATIONS: The ACT can be used for outreach or follow-up by means of interactive telephone calls using speech recognition technology.

Adrenal Cortex Hormones↗

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial.

BACKGROUND: More evidence is needed on which to base recommendations for treatment of mild-moderate persistent asthma in school-aged children. OBJECTIVE: The Pediatric Asthma Controller Trial (PACT) compared the effectiveness of 3 regimens in achieving asthma control. METHODS: A total of 285 children (ages 6-14 years) with mild-moderate persistent asthma on the basis of symptoms, and with FEV(1) >or= 80% predicted and methacholine FEV(1) PC(20) or= 80% predicted, confirming current guideline recommendations.

Acetates↗

Validation of the asthma impact survey, a brief asthma-specific quality of life tool.

BACKGROUND: The Asthma Impact Survey (AIS-6) is a new six question asthma outcome tool for which information on validity has not been published. OBJECTIVE: To provide validation for the AIS-6 as a brief asthma-specific quality of life tool. METHODS: Surveys were sent to a random sample of members of a large managed care organization who were at least 35 years of age and in the two-year period preceding the survey had either (1) at least one documented asthma-related medical encounter, or (2) at least a 6 months supply of asthma medication dispensed. In addition to the AIS-6, the survey included a validated quality of life tool [the mini-Asthma Quality of Life Questionnaire (AQLQ)]; a validated asthma control questionnaire [the Asthma Therapy Assessment Questionnaire (ATAQ)]; a validated symptom severity scale (AOMS); and information regarding demographics, co-morbidities, asthma severity, and asthma management. The results of the AIS-6 were compared to the results of the other tools by means of correlation and factor analysis. Independent predictors of AIS-6 and AQLQ scores were determined by multiple stepwise linear regression analyses. RESULTS: AIS-6 scores were significantly related to female sex, educational level, income, smoking, body mass index (BMI), COPD, steroid use, and hospitalization history in bivariate analyses. The AIS-6 score significantly correlated (r = - 0.84, p < 0.0001) with the AQLQ total score and loaded on the three factors (activity, symptoms, and concern/bother) reflected by the survey information and on which the AQLQ also loaded. Significant but somewhat smaller correlations were found between the AIS-6 and the ATAQ (r = 0.70, p < 0.0001) and the AOMS (r = 0.55, p < 0.0001). Independent predictors were the same for the AIS-6 and AQLQ and included oral steroid use, COPD history, BMI, female sex, educational level, and hospitalization in the past year. CONCLUSION: These data support the validity of the short six-question AIS-6 as an asthma-specific quality of life tool.

Adult↗

Determinants of future long-term asthma control.

BACKGROUND: Asthma control has been hypothesized to be inversely related to asthma severity, directly related to effective management, and also related to other definable factors, but empiric data to support this construct are few. OBJECTIVE: We sought to identify independent prospective determinants of future long-term asthma control among asthma severity, management, demographic, and comorbidity predictors. METHODS: Surveys were completed by a random sample of 2250 health maintenance organization members aged 18 to 56 years with persistent asthma. Linked computerized pharmacy data provided baseline and follow-up year medication dispensings. The outcome was follow-up year long-term asthma control, as assessed by using a previously validated 4-level scale based on the number of short-acting beta-agonist canister dispensings. RESULTS: Oral corticosteroids (odds ratio [OR], 1.9) or unscheduled visits (OR, 1.2) in the prior year, any prior asthma hospitalizations (OR, 1.4), smoking (OR, 2.2), chronic obstructive pulmonary disease (OR, 1.9), male sex (OR, 1.5), black race (OR, 1.3), and lower educational level (OR, 1.1) were independently associated with poorer control in ordinal logistic regression analyses. Regular inhaled corticosteroids (OR, 0.7), long-acting beta-agonists (OR, 0.7) and asthma specialist care (OR, 0.6) were independently associated with better control. CONCLUSIONS: Markers of asthma severity and other patient characteristics are inversely related to future asthma control, but effective management strategies are associated with improved asthma control, even after accounting for these high-risk characteristics. CLINICAL IMPLICATIONS: Inhaled corticosteroids, long-acting beta-agonists, and asthma specialist care are associated with improved asthma control, even after accounting for markers of asthma severity.

Adolescent↗

Long-term inhaled corticosteroids in preschool children at high risk for asthma.

BACKGROUND: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma. METHODS: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 mug twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year. RESULTS: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively. CONCLUSIONS: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued. (ClinicalTrials.gov number, NCT00272441.).

Administration, Inhalation↗

Bronchodilation and bronchoconstriction: predictors of future lung function in childhood asthma.

BACKGROUND: Persistently low levels of lung function are associated with subsequent symptoms in patients with asthma as children. OBJECTIVES: We hypothesized that objective measures of baseline pulmonary function would be independently associated with future lung function in the Childhood Asthma Management Program and that these associations might vary with treatment. METHODS: We evaluated the association of FEV1, airway responsiveness, and bronchodilator response at randomization as predictors of longitudinal growth in FEV1 at the 48-month follow-up visit in the 1041 Childhood Asthma Management Program participants. RESULTS: Baseline levels of airway responsiveness and bronchodilator response were significantly associated with baseline level of lung function. In multivariate models, higher bronchodilator response (beta = 0.22; P < .0001), log PC20 (beta = 1.82; P < .0001), and FEV1 (beta = 0.58; P < .0001) at randomization were each associated with higher levels of prebronchodilator FEV1, as a percent of predicted, after 4 years. Similar associations were noted for prebronchodilator forced vital capacity and FEV1/forced vital capacity ratio. Baseline bronchodilator response was a particularly powerful predictor of lung function improvements while on inhaled corticosteroids, whereas airway responsiveness was a better predictor in subjects not randomized to any controller medications. CONCLUSION: We conclude that baseline bronchodilator response, airway responsiveness, and level of FEV1 are independent predictors of subsequent level of FEV1 in childhood asthma and may have treatment-specific prognostic significance for persistence of symptoms into early adulthood. CLINICAL IMPLICATIONS: In asthma, bronchodilator and bronchoconstrictor responses are independent predictors of future lung function and should not be used interchangeably; bronchodilator response may indicate good response to inhaled corticosteroids.

Asthma↗

Validation of a beta-agonist long-term asthma control scale derived from computerized pharmacy data.

BACKGROUND: Asthma control has been defined clinically by using validated tools, but an asthma control scale using administrative data has not been reported. OBJECTIVE: We sought to validate a beta-agonist asthma control scale derived from administrative data. METHODS: Surveys that included validated asthma symptom and control tools were completed by a random sample of 2250 health maintenance organization members aged 18 to 56 years with persistent asthma. Linked computerized pharmacy data provided beta-agonist canister and oral corticosteroid dispensings. The proposed 4-level asthma control scale was based on the number of short-acting beta-agonist canisters dispensed in 12 months. Construct validity and predictive validity were assessed. RESULTS: For construct validity, factor analysis showed significant loading of the beta-agonist scale on the symptom control factor, and the beta-agonist scale was significantly related to the validated asthma control and symptom scales (r = 0.31, P < .0001). For predictive validity, each progressive level of the proposed beta-agonist control scale was associated with an increased risk of subsequent asthma hospitalizations or emergency department visits and oral corticosteroid use, independent of prior use. CONCLUSION: A scale based on the number of beta-agonists dispensed in a 1-year period and derived from administrative data reflects asthma symptom control over that period of time. This scale can help identify patients who are at risk for future acute asthma health care use. CLINICAL IMPLICATIONS: This information can be used in population management and by clinicians to assess long-term asthma control and identify patients who need intervention to prevent future morbidity.

Adolescent↗

Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma.

BACKGROUND: Outcome data are needed to base recommendations for controller asthma medication use in school-aged children. OBJECTIVE: We sought to determine intraindividual and interindividual response profiles and predictors of response to an inhaled corticosteroid (ICS) and a leukotriene receptor antagonist (LTRA). METHODS: An ICS, fluticasone propionate (100 mug twice daily), and an LTRA, montelukast (5-10 mg nightly, age dependent), were administered to children ages 6 to 17 years with mild-to-moderate persistent asthma using only as-needed bronchodilators in a multicenter, double-masked, 2-sequence, 16-week crossover trial. Clinical, pulmonary, and inflammatory responses to these controllers were evaluated. RESULTS: Improvements in most clinical asthma control measures occurred with both controllers. However, clinical outcomes (asthma control days [ACDs], the validated Asthma Control Questionnaire, and albuterol use), pulmonary responses (FEV(1)/forced vital capacity, peak expiratory flow variability, morning peak expiratory flow, and measures of impedance), and inflammatory biomarkers (exhaled nitric oxide [eNO]) improved significantly more with fluticasone than with montelukast treatment. eNO was both a predictor of ACDs (P = .011) and a response indicator (P = .003) in discriminating the difference in ACD response between fluticasone and montelukast. CONCLUSIONS: The more favorable clinical, pulmonary, and inflammatory responses to an ICS than to an LTRA provide pediatric-based group evidence to support ICSs as the preferred first-line therapy for mild-to-moderate persistent asthma in children. eNO, as a predictor of response, might help to identify individual children not receiving controller medication who achieve a greater improvement in ACDs with an ICS compared with an LTRA.

Acetates↗

Mild to moderate asthma affects lung growth in children and adolescents.

BACKGROUND: The effect of childhood asthma on lung growth is unclear. OBJECTIVE: To show the effect of mild to moderate childhood asthma on lung growth. METHODS: A total of 1041 children with mild to moderate asthma from the Childhood Asthma Management Program (CAMP) were compared with 5415 children without asthma from the Harvard Six Cities Study (H6CS). Sex-age-specific comparisons of lung growth in CAMP with the H6CS were made by using repeated-measures multiple linear regression models. Sex-age-specific percentages of children with asthma with abnormal (<5th percentile of H6CS) pulmonary function values were calculated. RESULTS: In both boys and girls, the ratio of FEV(1) to forced vital capacity (FVC) was significantly lower for children with than without asthma (P < .001), with corresponding increases for children with asthma in FVC (P < .001). FEV(1) was lower for boys with asthma than for boys without asthma (P < .001), but not for girls (P = .14). Percentages of CAMP children with abnormal FEV(1)/FVC ratios increased with age for both sexes (P < .001). The patterns of lung growth for children with asthma compared with children without asthma did not differ among children treated for 4.3 years with budesonide or nedocromil and placebo during the CAMP trial. CONCLUSION: Mild to moderate asthma results in a pattern of airway obstruction that increases in magnitude from age 5 to 18 years. CLINICAL IMPLICATIONS: Periodic spirometry is needed to monitor children with asthma for signs of increasing airway obstruction with appropriate intervention following national guidelines.

Adolescent↗

Impact of a care manager on the outcomes of higher risk asthmatic patients: a randomized controlled trial.

Asthma care management programs may improve outcomes, but it is not clear which aspects of such management are responsible for the improvement. We performed a randomized controlled trial of a limited intervention (one visit with asthma self-management education and provision of inhaled budesonide) compared to this visit plus regular asthma care manager follow-up. Quality of life, symptom-free days, emergency hospital care, and beta-agonist dispensings did not differ between groups at 12 months. Patients who entered the study did receive significantly less beta-agonists in the follow-up year than patients who did not enter the study. These data suggest that the limited intervention in our setting improved outcomes but that regular care manager follow-up thereafter did not add significantly to this intervention.

Administration, Inhalation↗

The controller-to-total asthma medication ratio is associated with patient-centered as well as utilization outcomes.

BACKGROUND: The ratio of controller medication to total asthma medications has been related to asthma utilization outcomes, but its relationship to patient-centered outcomes has not been explored. METHODS: Surveys that included validated asthma quality-of-life, control, and symptom severity tools were completed by a random sample of 2,250 health maintenance organization members aged 18 to 56 years who had persistent asthma. Linked computerized pharmacy data provided dispensing information on beta-agonist canisters and asthma controller medication. The ratio was calculated as the number of controller medications dispensed during the year of the survey divided by the total number medications (ie, inhaled beta-agonist plus controller medications) dispensed. The relationships of the optimal ratio cutoff to patient-centered outcomes and to subsequent acute asthma exacerbations were determined. RESULTS: Mean asthma quality-of-life, asthma control, and symptom severity scale scores were significantly (p < 0.0001) more favorable in patients with ratios of > or = 0.5. After adjusting for demographic characteristics, patients with ratios of > or = 0.5 were significantly less likely to have adverse results regarding asthma quality of life (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.52 to 0.80), asthma control (OR, 0.62; 95% CI, 0.50 to 0.77), and symptom severity (OR, 0.53; 95% CI, 0.43 to 0.65), and were also less likely to experience subsequent asthma hospitalizations or emergency department visits (OR, 0.44; 95% CI, 0.26 to 0.74) than patients with lower ratios. CONCLUSION: A higher controller medication/total asthma medication ratio is associated with better patient-centered asthma outcomes as well as with reduced emergency hospital utilization. This adds further support to the use of the medication ratio as an asthma quality-of-care measure.

Adrenal Cortex Hormones↗

Development and validation of a medication intensity scale derived from computerized pharmacy data that predicts emergency hospital utilization for persistent asthma.

OBJECTIVE: To validate a risk stratification scheme using computerized pharmacy data to predict emergency hospital utilization for persistent asthma. STUDY DESIGN: Retrospective cohort. METHODS: The development sample consisted of 1079 HMO members aged 18 to 56 years with persistent asthma. The scale used medication cut-points as predictors for next-year emergency hospital utilization in a stepwise logistic regression model. Prediction properties were evaluated in a validation sample of 24 370 patients aged 18 to 56 years in a separate persistent-asthma database. RESULTS: Increasing use of beta-agonists (odds ratio [OR] of 2.2 for 5-13 vs 0-4 canisters; OR of 2.4 for >13 vs 5-13 canisters) and oral corticosteroids (OR of 2.6 for >2 vs 0-2 dispensing events) in the first year independently predicted emergency hospital utilization in the second year. Assigning 1 point for exceeding each of the above 3 medication thresholds led to a 4-level medication intensity scale that was significantly (P <.0001) related to validated measures of asthma symptom severity, asthma control, and asthma quality of life in the development sample. In the validation sample, this scheme identified a high-risk group that was 6 times more likely than the low-risk group to require subsequent emergency hospital care, with overall sensitivity of 65% and specificity of 54%. This scale did not perform as well as a scale based on both baseline emergency hospital care and pharmacy data. CONCLUSION: This simple risk stratification scheme can be used for populations with persistent asthma for whom computerized pharmacy data, but not computerized prior utilization data, are available.

Adolescent↗

Improved asthma outcomes from allergy specialist care: a population-based cross-sectional analysis.

BACKGROUND: Prior studies suggest that allergist care improves asthma outcomes, but many of these studies have methodological shortcomings. OBJECTIVE: We sought to compare patient-based and medical utilization outcomes in randomly selected asthmatic patients cared for by allergists versus primary care providers. METHODS: A random sample of 3568 patients enrolled in a staff model health maintenance organization who were given diagnoses of persistent asthma completed surveys. Of these participants, 1679 (47.1%) identified a primary care provider as their regular source of asthma care, 884 (24.8%) identified an allergist, 693 (19.4%) reported no regular source of asthma care, and 195 (5.5%) identified a pulmonologist. Validated quality of life, control, severity, patient satisfaction, and self-management knowledge tools and linked administrative data that captured medication use were compared between groups, adjusting for demographics and baseline hospital and corticosteroid use. RESULTS: Compared with those followed by primary care providers, patients of allergists reported significantly higher (P < .001) generic physical and asthma-specific quality of life, less asthma control problems, less severe symptoms, higher satisfaction with care, and greater self-management knowledge. Patients of allergists were less likely than patients of primary care providers to require an asthma hospitalization (odds ratio, 0.45) or unscheduled visit (odds ratio, 0.71) and to overuse beta-agonists (odds ratio, 0.47) and were more likely to receive inhaled steroids (odds ratio, 1.81) during their past year. CONCLUSIONS: Allergist care is associated with a wide range of improved outcomes in asthmatic patients compared with care provided by primary care providers.

Adult↗

Short-term and long-term asthma control in patients with mild persistent asthma receiving montelukast or fluticasone: a randomized controlled trial.

PURPOSE: To determine whether montelukast is as effective as fluticasone in controlling mild persistent asthma as determined by rescue-free days. SUBJECTS AND METHODS: Participants aged 15 to 85 years with mild persistent asthma (n = 400) were randomized to oral montelukast (10 mg once nightly) or inhaled fluticasone (88 mug twice daily) in a year-long, parallel-group, multicenter study with a 12-week, double-blind period, followed by a 36-week, open-label period. RESULTS: The mean percentage of rescue-free days was similar between treatments after 12 weeks (fluticasone: 74.9%, montelukast: 73.1%; difference = 1.8%, 95% confidence interval [CI]: -3.2% to 6.8%) but not during the open-label period (fluticasone: 77.3%, montelukast: 71.1%; difference = 6.2%, 95% CI: 0.8% to 11.7%). Although both fluticasone and montelukast significantly improved symptoms, quality of life, and symptom-free days during both treatment periods, greater improvements occurred with fluticasone in lung function during both periods and in asthma control during open-label treatment. Post hoc analyses revealed a difference in rescue-free days favoring fluticasone in participants in the quartiles for lowest lung function and greatest albuterol use at baseline. CONCLUSION: In patients with mild persistent asthma, rescue-free days and most asthma control measures improved similarly with fluticasone or montelukast over the short term, but with prolonged open-label treatment, asthma control improved more with fluticasone. Improved asthma control with fluticasone appeared to occur in those with decreased lung function and greater albuterol use at baseline. In the remaining patients, the two treatments appeared to be comparable. These results suggest that classification criteria for mild persistent asthma may need to be re-evaluated.

Acetates↗

Characterization of within-subject responses to fluticasone and montelukast in childhood asthma.

BACKGROUND: Responses to inhaled corticosteroids (ICSs) and leukotriene receptor antagonists (LTRAs) vary among asthmatic patients. OBJECTIVE: We sought to determine whether responses to ICSs and LTRAs are concordant for individuals or whether asthmatic patients who do not respond to one medication respond to the other. METHODS: Children 6 to 17 years of age with mild-to-moderate persistent asthma were randomized to one of 2 crossover sequences, including 8 weeks of an ICS, fluticasone propionate (100 microg twice daily), and 8 weeks of an LTRA, montelukast (5-10 mg nightly depending on age), in a multicenter, double-masked, 18-week trial. Response was assessed on the basis of improvement in FEV 1 and assessed for relationships to baseline asthma phenotype-associated biomarkers. RESULTS: Defining response as improvement in FEV 1 of 7.5% or greater, 17% of 126 participants responded to both medications, 23% responded to fluticasone alone, 5% responded to montelukast alone, and 55% responded to neither medication. Compared with those who responded to neither medication, favorable response to fluticasone alone was associated with higher levels of exhaled nitric oxide, total eosinophil counts, levels of serum IgE, and levels of serum eosinophil cationic protein and lower levels of methacholine PC(20) and pulmonary function; favorable response to montelukast alone was associated with younger age and shorter disease duration. Greater differential response to fluticasone over montelukast was associated with higher bronchodilator use, bronchodilator response, exhaled nitric oxide levels, and eosinophil cationic protein levels and lower methacholine PC(20) and pulmonary function values. CONCLUSIONS: Response to fluticasone and montelukast vary considerably. Children with low pulmonary function or high levels of markers associated with allergic inflammation should receive ICS therapy. Other children could receive either ICSs or LTRAs.

Acetates↗

Relationship of validated psychometric tools to subsequent medical utilization for asthma.

BACKGROUND: Risk stratification is used to identify patients with asthma at increased risk of experiencing morbidity and resource utilization. Validated psychometric tools are infrequently studied sources of data for this purpose. PURPOSE: To evaluate 4 types of validated psychometric tools as predictors for subsequent asthma utilization and determine their clinical usefulness. METHODS: Eleven hundred patients with active asthma from a Health Maintenance Organization completed surveys that included demographic information and validated psychometric tools measuring generic quality of life (physical and mental components), asthma-specific quality of life, asthma control, and asthma symptom severity. Survey records were linked to administrative data that captured emergency department and hospital care, short-acting beta-agonist, and oral corticosteroid utilization for the year of and the year following the survey. Relationships of survey variables with subsequent utilization were assessed, adjusting for both baseline demographic and asthma utilization factors. RESULTS: Scores of each psychometric tool were significantly related to subsequent utilization in univariate analyses and after adjusting for baseline utilization and demographic risk factors. Patients with higher scale-defined morbidity were as much as 4 times more likely to have subsequent utilization (sensitivity as high as 58%; specificity as high as 78%). Addition of an asthma-specific tool to either demographic or utilization prediction models added sensitivity (as much as 15%) but did not substantially improve the prediction properties of models containing both demographic and utilization predictors. CONCLUSION: Validated psychometric tools appear useful for asthma risk stratification in individuals and in populations in which both utilization and demographic predictors are not available.

Adolescent↗