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Objective: To examine changes in children's albuterol use and out-of-pocket (OOP) costs in response to increased copayments after the Food and Drug Administration banned inhalers with chlorofluorocarbon (CFC) propellants., Setting: Four health maintenance organizations (HMOs), two that increased copayments for albuterol inhalers that went from generic CFC-containing to branded CFC-free versions, and two that retained generic copayments for CFC-free inhalers (controls). We included children with asthma aged 4-17 years with commercial coverage from 2007 to 2010., Design: Interrupted time series with comparison series., Data: We obtained enrollee and plan characteristics from enrollment files, and utilization data from pharmacy and medical claims; OOP expenditures were extracted from pharmacy claims for two HMOs with cost data available., Findings: There were no significant differences in albuterol use between the group with increased cost-sharing and controls with respect to changes after the policy change. There was a postpolicy increase of $6.11 OOP per month per child using albuterol among those with increased cost-sharing versus $0.36 in controls; the difference between groups was significant (p < .01)., Conclusions: Increased copayments for brand-name CFC-free albuterol after the CFC ban did not lead to a decrease in children's albuterol use, but it led to a modest increase in OOP costs., (© Health Research and Educational Trust.)

Purpose: In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts., Methods: We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions)., Findings: The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users., Implications: The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes., Competing Interests: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. M.G. Butler reports contracts with the FDA and Novartis outside the submitted work. V. Fung reports financial interest in Merck. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.)

Importance: Most patients with asthma take fewer than half of prescribed doses of controller medication. Interventions to improve adherence have typically been costly, impractical, and at best only minimally successful., Objective: To test a speech recognition (SR) intervention to improve adherence to pediatric asthma controller medication., Design, Setting, and Participants: The Breathe Well study was a 24-month pragmatic randomized clinical trial. The study was conducted within Kaiser Permanente Colorado, a large, group-model health maintenance organization. A total of 1187 children aged 3 to 12 years with a persistent asthma diagnosis and prescription for an inhaled corticosteroid were randomized to the computerized SR intervention or usual care condition and followed up for 24 months between October 2009 and February 2013., Interventions: Speech recognition telephone calls to parents in the intervention condition were triggered when an inhaled corticosteroid refill was due or overdue. Calls were automatically tailored with medical and demographic information from the electronic health record and from parent answers to questions in the call regarding recent refills or a desire to receive help refilling, learn more about asthma control, or speak with an asthma nurse or pharmacy staff member., Main Outcomes and Measures: Adherence to pediatric asthma controller medication, measured as the medication possession ratio over 24 months., Results: In the intention-to-treat analysis, inhaled corticosteroid adherence was 25.4% higher in the intervention group than in the usual care group (24-month mean [SE] adherence, 44.5% [1.2%] vs 35.5% [1.1%], respectively; P < .001). Asthma-related urgent care events did not differ between the 2 groups. The intervention effect was consistent in subgroups stratified by age, sex, race/ethnicity, body mass index, and disease-related characteristics., Conclusions and Relevance: The intervention's significant impact on adherence demonstrates strong potential for low-cost SR adherence programs integrated with an electronic health record. The absence of change in urgent care visits may be attributable to the already low number of asthma urgent care visits within Kaiser Permanente Colorado. Application of electronic health record-leveraged SR interventions may reduce health care utilization when applied in a population with less-controlled asthma., Trial Registration: clinicaltrials.gov Identifier: NCT00958932.

Rationale: Few previous studies have evaluated primary adherence (whether a new prescription is filled within 30 d) to controller medications in individuals with persistent asthma., Objective: To compare adherence to the major controller medication regimens for asthma., Methods: This was a retrospective cohort study of enrollees from five large health plans. We used electronic medical data on patients of all ages with asthma who had experienced an asthma-related exacerbation in the prior 12 months. We studied adherence measures including proportion of days covered and primary adherence (first prescription filled within 30 d)., Measurements and Main Results: Our population included 69,652 subjects who had probable persistent asthma and were prescribed inhaled corticosteroids (ICSs), leukotriene antagonists (LTRAs), or ICS/long-acting β-agonists (ICS/LABAs). The mean age was 37 years and 58% were female. We found that 14-20% of subjects who were prescribed controller medicines for the first time did not fill their prescriptions. The mean proportion of days covered was 19% for ICS, 30% for LTRA, and 25% for ICS/LABA over 12 months. Using multivariate logistic regression, subjects prescribed LTRA were less likely to be primary adherent than subjects prescribed ICS (odds ratio, 0.82; 95% confidence interval, 0.74-0.92) or ICS/LABA (odds ratio, 0.88; 95% confidence interval, 0.80-0.97). Black and Latino patients were less likely to fill the prescription compared with white patients., Conclusions: Adherence to controller medications for asthma is poor. In this insured population, primary adherence to ICSs was better than to LTRAs and ICS/LABAs. Adherence as measured by proportion of days covered was better for LTRAs and ICS/LABAs than for ICSs.

Background: Based on results of clinical trials, inhaled corticosteroids (ICS) are the most-effective controller medications for preventing asthma-related exacerbations, yet few studies in real-life populations have evaluated the comparative effectiveness of ICS., Objective: To determine the likelihood of asthma exacerbations among children with asthma after initiation of controller medications: ICS, leukotriene antagonists (LTRA), and ICS-long-acting β-agonist (LABA) combination therapy., Methods: This was a retrospective cohort study of subjects who were part of the Population-Based Effectiveness in Asthma and Lung Diseases Network. We conducted Cox regression analyses by adjusting for baseline covariates, adherence by using proportion of days covered, and high-dimensional propensity scores. The main outcome measurements were emergency department visits, hospitalizations, or oral corticosteroid use., Results: Our population included 15,567 health plan subjects and 10,624 TennCare Medicaid subjects with uncontrolled asthma. Overall adherence to controller medications was low, with no more than 50% of the subjects refilling the medication after the initial fill. For subjects with allergic rhinitis, the subjects in TennCare Medicaid treated with LTRAs were less likely to experience ED visits (hazard ratio 0.44 [95% CI, 0.21-0.93]) compared with the subjects treated with ICS. For all other groups, the subjects treated with LTRA or ICS-LABA were just as likely to experience ED visits or hospitalizations, or need oral corticosteroids as the subjects treated with ICS., Conclusion: Risks of asthma-related exacerbations did not differ between children who initiated LTRA and ICS. These findings may be explainable by LTRA, which has similar effectiveness as ICS in real-life usage by residual confounding by indication or other unmeasured factors., (Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Importance: The Patient Protection and Affordable Care Act (ACA) includes subsidies that reduce patient cost sharing for low-income families. Limited information on the effects of cost sharing among children is available to guide these efforts., Objective: To examine the associations between cost sharing, income, and care seeking and financial stress among children with asthma., Design, Setting, and Participants: A telephone survey in 2012 about experiences during the prior year within an integrated health care delivery system. Respondents included 769 parents of children aged 4 to 11 years with asthma. Of these, 25.9% of children received public subsidies; 21.7% were commercially insured with household incomes at or below 250% of the federal poverty level (FPL) and 18.2% had higher cost-sharing levels for all services (e.g., ≥$75 for emergency department visits). We classified children with asthma based on (1) current receipt of a subsidy (i.e., Medicaid or Children's Health Insurance Program) or potential eligibility for ACA low-income cost sharing or premium subsidies in 2014 (i.e., income ≤250%, 251%-400%, or >400% of the FPL) and (2) cost-sharing levels for prescription drugs, office visits, and emergency department visits. We examined the frequency of changes in care seeking and financial stress due to asthma care costs across these groups using logistic regression, adjusted for patient/family characteristics., Main Outcomes and Measures: Switching to cheaper asthma drugs, using less medication than prescribed, delaying/avoiding any office or emergency department visits, and financial stress (eg, cutting back on necessities) because of the costs of asthma care., Results: After adjustment, parents at or below 250% of the FPL with lower vs higher cost-sharing levels were less likely to delay or avoid taking their children to a physician's office visit (3.8% vs. 31.6%; odds ratio, 0.07 [95% CI, 0.01-0.39]) and the emergency department (1.2% vs. 19.4%; 0.05 [0.01-0.25]) because of cost; higher-income parents and those whose children were receiving public subsidies (eg, Medicaid) were also less likely to forego their children's care than parents at or below 250% of the FPL with higher cost-sharing levels. Overall, 15.6% of parents borrowed money or cut back on necessities to pay for their children's asthma care., Conclusions and Relevance: Cost-related barriers to care among children with asthma were concentrated among low-income families with higher cost-sharing levels. The ACA's low-income subsidies could reduce these barriers for many families, but millions of dependents for whom employer-sponsored family coverage is unaffordable could remain at risk for cost-related problems because of ACA subsidy eligibility rules.

We compared the impact of 3 confounding adjustment procedures-covariate-adjusted regression, propensity score regression, and high-dimensional propensity score regression-to assess the effects of selected asthma controller medication use (leukotriene antagonists and inhaled corticosteroids) on the following 4 asthma-related adverse outcomes: emergency department visits, hospitalizations, oral corticosteroid use, and the composite outcome of these. We examined a cohort of 24,680 new users who were 4-17 years of age at the incident dispensing from the Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network of 5 commercial health plans and TennCare, the Tennessee Medicaid program, during the period January 1, 2004, to December 31, 2010. The 3 methods yielded similar results, indicating that pediatric patients treated with leukotriene antagonists were no more likely than those treated with inhaled corticosteroids to experience adverse outcomes. Children in the TennCare population who had a diagnosis of allergic rhinitis and who then initiated the use of leukotriene antagonists were less likely to experience an asthma-related emergency department visit. A plausible explanation is that our data set is large enough that the 2 advanced propensity score-based analyses do not have advantages over the traditional covariate-adjusted regression approach. We provide important observations on how to correctly apply the methods in observational data analysis and suggest statistical research areas that need more work to guide implementation.

Rationale: Statins, or HMG-CoA reductase inhibitors, may aid in the treatment of asthma through their pleiotropic antiinflammatory effects., Objectives: To examine the effect of statin therapy on asthma-related exacerbations using a large population-based cohort., Methods: Statin users aged 31 years or greater with asthma were identified from the Population-Based Effectiveness in Asthma and Lung population, which includes data from five health plans. Statin exposure and asthma exacerbations were assessed over a 24-month observation period. Statin users with a statin medication possession ratio greater than or equal to 80% were matched to non-statin users by age, baseline asthma therapy, site of enrollment, season at baseline, and propensity score, which was calculated based on patient demographics and Deyo-Charlson conditions. Asthma exacerbations were defined as two or more oral corticosteroid dispensings, asthma-related emergency department visits, or asthma-related hospitalizations. The association between statin exposure and each of the three outcome measures was assessed using conditional logistic regression., Measurements and Main Results: Of the 14,566 statin users, 8,349 statin users were matched to a nonuser. After adjusting for Deyo-Charlson conditions that remained unbalanced after matching, among statin users, statin exposure was associated with decreased odds of having asthma-related emergency department visits (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53-0.77; P < 0.0001) and two or more oral corticosteroid dispensings (OR, 0.90; 95% CI, 0.81-0.99; P = 0.04). There were no differences in asthma-related hospitalizations (OR, 0.91; 95% CI, 0.66-1.24; P = 0.52)., Conclusions: Among statin users with asthma, statin exposure was associated with decreased odds of asthma-related emergency department visits and oral corticosteroid dispensings.

Background: "Asthma-related quality of life" (QOL) refers to the perceived impact that asthma has on the patient's QOL., Objective: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures of the impact of asthma on QOL for use in future asthma clinical research., Methods: We reviewed published documentation regarding the development and psychometric evaluation; clinical research use since 2000; and extent to which the content of each existing QOL instrument provides a unique, reliable, and valid assessment of the intended construct. We classified instruments as core (required in future studies), supplemental (used according to the study's aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011., Results: Eleven instruments for adults and 6 for children were identified for review. None qualified as core instruments because they predominantly measured indicators of asthma control (symptoms and/or functional status); failed to provide a distinct, reliable score measuring all key dimensions of the intended construct; and/or lacked adequate psychometric data., Conclusions: In the absence of existing instruments that meet the stated criteria, currently available instruments are classified as either supplemental or emerging. Research is strongly recommended to develop and evaluate instruments that provide a distinct, reliable measure of the patient's perception of the impact of asthma on all of the key dimensions of QOL, an important outcome that is not captured in other outcome measures., (Published by Mosby, Inc.)

Background: Patient adherence, the level of asthma self-management skills, exposure to stress, and depression can have considerable influence on a wide range of asthma outcomes and thus are considered asthma outcome mediators., Objective: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures for 7 domains of asthma clinical research outcomes measures. Although the review of mediators of these outcomes was not within the scope of any specific outcome topic, a brief summary is presented so that researchers might consider potential mediators., Methods: We prepared a summary of key mediators of asthma outcomes based on expertise and knowledge of the literature., Results: The rationale for including measures of adherence, self-management skills, and exposures to stress in asthma clinical research is presented, along with a brief review of instruments for collecting this information from clinical research participants., Conclusions: Appropriate measurement of adherence, self-management skills, and exposures to stress will enhance characterization of study participants and provide information about the potential impact these factors can have on mediating the effects of treatment interventions., (Published by Mosby, Inc.)

Objectives: To evaluate the effectiveness of an intervention based on health information technology (HIT) that used speech recognition software to promote adherence to inhaled corticosteroids (ICS) among individuals with asthma who were members of a large health maintenance organization., Study Design: Pragmatic randomized clinical trial., Methods: Adults with asthma enrolled in a large managed care organization (N = 8517) were randomized to receive either usual care or an interactive voice recognition (IVR) intervention designed to prompt medication refills and improve ICS adherence. The primary outcome was ICS adherence as measured by modified medication possession ratio calculated from the electronic medical record (EMR). Secondary measures included survey- and EMR-based measures of asthma morbidity., Results: Our primary analyses found that ICS adherence increased modestly but significantly for participants in the intervention group relative to those in the usual care group ( Δ= 0.02, 95% confidence interval 0.01-0.03), with a baseline adherence of 0.42 in both groups. No difference was observed in asthma morbidity measures. In post hoc analyses of participants receiving 2 or more direct IVR contacts or detailed messages, the intervention effect was more marked. The overall effect was triple that observed in the primary analyses (0.06 vs 0.02), and significant differences were observed between groups in asthma control., Conclusions: An HIT-based adherence intervention shows potential for supporting medication adherence in patients with chronic diseases such as asthma. However, additional research is needed to determine how best to enhance the reach and effectiveness of such interventions.

The objective was to describe the utility of mixed methods to inform the development of an automated telephone intervention to improve patients' compliance with asthma medication. As part of intervention development for a larger trial, we conducted 15 focus groups (n = 53) to design and develop calls, and to identify factors influencing intervention acceptability and usefulness. We piloted four call types and interviewed 64 participants to further improve call content and receptivity to the intervention. Feedback led to several changes to the intervention scripts and eventual calls, and an initial pilot led us to drop one of the calls. During the pilot, we reached 43 percent of target participants; 74 percent of those stayed on the call until it ended. This process provided key insights about automated calls, and may have broader applicability for the development of automated interventions designed to help patients manage a variety of chronic conditions., (© The Author(s) 2010.)

Rationale: Poor adherence to asthma controller medications results in poor treatment outcomes., Objectives: To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care., Methods: In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters., Measurements and Main Results: Refill adherence was measured using continuous medication acquisition (CMA) indices-the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures., Conclusions: Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes. Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).

Background: Inhaled corticosteroids (ICSs) are recommended as the first line of treatment in children with moderate-to-severe asthma. Exhaled nitric oxide (ENO) has been proposed as a clinically useful marker of control that might help identify patients in whom ICS dose may be safely reduced., Objective: To evaluate the ability of ENO to predict future asthma exacerbations in children with moderate-to-severe asthma undergoing ICS tapering., Methods: This is an observational study with no control group. ENO was measured biweekly for 14 weeks in 32 children with moderate-to-severe asthma who were undergoing ICS tapering. Clinical evaluations and spirometry were performed concomitantly, and families kept daily diaries to record symptoms between visits. We used generalized estimating equations to model the In (odds) of an asthma exacerbation in the subsequent 2-week interval as a function of ENO level at the start of the interval while adjusting for age, sex, asthma severity, and current medication use., Results: We were able to successfully lower ICS doses in 10 (56%) of the 18 children with moderate asthma and in 3 (21%) of the 14 children with severe asthma. In 83 of the 187 follow-up clinical evaluations, children were determined to have had an exacerbation during the preceding 2 weeks. ENO levels, whether expressed as a continuous variable or dichotomized, were not associated with future risk for exacerbations in either unadjusted or adjusted models., Conclusion: ENO was not a useful clinical predictor of future asthma exacerbations for children with moderate-to-severe asthma undergoing ICS tapering.

Objective: To identify an optimal cut-point score on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) to predict subsequent asthma exacerbations, and to determine the additional risk conferred by a prior history of acute episodes., Study Design: Cross-sectional survey linked to administrative records., Methods: A total of 1006 HMO patients with active asthma completed surveys that included the mini-AQLQ and prior-year history of acute episodes. Surveys were linked to administrative data that captured asthma emergency department and hospital care (emergency hospital care) for the year after the survey. Optimal mini-AQLQ cut-point scores were determined by stepwise logistic regression analyses using subsequentyear asthma emergency hospital care as the outcome and various mini-AQLQ cut-points as the predictors. Predictive properties of the 2 risk factors (mini-AQLQ cut-points and prior acute episodes) were determined., Results: A mini-AQLQ cut-point of 4.7 was most significantly associated with subsequent exacerbations in patients without a history of prior acute episodes. The presence of either a mini-AQLQ score <4.7 or a history of prior acute episodes provided high sensitivity (90.4%) and identified a group nearly 6 times more likely to require emergency hospital care than patients with neither risk factor. The presence of both risk factors provided high specificity (79.2%) and resulted in a risk ratio of 9.5 compared with the absence of both risk factors., Conclusion: Asthma-specific quality of life and a history of acute episodes can be used together to identify patients with clinically meaningful higher and lower risks of subsequent acute exacerbations.

Objective: To provide additional validity data for the Asthma Control TestTM (ACT) using a different criterion measure, setting, and population., Study Design: Cross-sectional survey., Methods: Questionnaires were completed at home by a random sample of 570 members of a large integrated healthcare organization who were 35 years or older with utilization suggestive of active asthma. The questionnaires included the ACT; another validated asthma control questionnaire (Asthma Therapy Assessment Questionnaire [ATAQ]), which was used as the criterion measure; a validated quality-of-life tool (Mini Asthma Quality of Life Questionnaire [Mini-AQLQ]); a validated symptom frequency scale (Asthma Outcomes Monitoring System); and information regarding demographics., Results: The ACT score was statistically significantly correlated with findings on the ATAQ (P = -0.73), Mini-AQLQ (P = 0.77), and symptom frequency scale (P = -0.69). The optimal ACT cutoff for well-controlled asthma (ATAQ level, 0) was confirmed to be 20 or higher (sensitivity, 78.1%; specificity, 83.8%), and the optimal ACT cutoff for poorly controlled asthma (ATAQ level, 3-4) was confirmed to be 15 or lower (sensitivity, 90.4%; specificity, 80.9%)., Conclusion: These data further support the validity of the ACT in the home setting among a random sample of patients with asthma.

Study Objectives: To develop simple clinical tools predictive of acute asthma care and to identify modifiable risk factors., Design: Prospective cohort study., Setting: A large health maintenance organization (430,000 members)., Patients/participants: Adult members (18 to 55 years old) with asthma., Interventions: Data from a questionnaire, skin-prick testing for inhalant allergens, and spirometry were collected at the baseline visit. Acute care utilization data were obtained from administrative databases for a subsequent 30-month period., Methods: This two-phase study first identified and performed a split-sample validation on three clinical tools to determine their predictive ability by employing data from a questionnaire, questionnaire plus spirometry, and questionnaire plus spirometry and skin-prick testing. Second, it identified modifiable independent risk factors., Measurements and Results: The 554 study participants generated 173 episodes of acute care over 1,258 person-years of follow-up (0.14 episodes per person per year). Of these, 101 participants had at least one episode, and one third of this group had two or more episodes. Clinical scoring into risk groups was done by reverse stepwise regression analyses. Using relative risks (RRs) as a guide, high-risk, moderate-risk, and low-risk groups were identified. The high-risk groups, 13 to 21% of the validation sample, had a 7- to 11-fold increased risk for hospital care compared to the low-risk groups. The moderate-risk groups, 46 to 50% of the validation sample, had a twofold- to fourfold-increased risk. FEV(1) was the most significant predictor (RR, 4.33). Of the four potentially modifiable risk factors identified, current cigarette smoke exposure (RR, 1.6) and ownership and skin-prick test positivity to cat or dog (RR, 1.5) were the most significant., Conclusions: These models stratify asthma patients at risk for acute care. Patients with lower FEV(1) values are at significantly higher risk, underscoring the importance of spirometry in asthma care.

Few studies have quantitatively addressed the relationship between asthma-specific quality of life and asthma control as assessed by validated tools. Questionnaires were completed at home by a random sample of 542 adult asthmatic patients. The correlations of the two asthma control tools (Asthma Control Test and Asthma Therapy Assessment Questionnaire) with the quality of life tool (mini-Asthma Quality of Life Questionnaire) were strongest with the symptoms and activity domains (r = 0.63-0.77); lower with the emotions domain (r = 0.57-0.64); and lowest with the environment domain (r = 0.38-0.43). Asthma control tools reflect the symptoms and activity themes of asthma quality of life well, but reflect the environmental domain less well.

The purpose of this study was to identify determinants of asthma control. Questionnaires were completed by a random sample of 570 members of a large managed care organization who were >or=35 years of age with utilization suggestive of active asthma. Asthma control was assessed buy the Asthma Control Test (ACT). Independent relationships were found between lower ACT scores and oral corticosteroid use (p < 0.0001), COPD (p < 0.0001), absence of regular specialist care (p = 0.006), higher BMI (p = 0.01), gastroesophageal reflux (p = 0.02), not being Caucasian (p = 0.04), and low income (p = 0.04).

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.

Objective: To test the ability of an automated telephone outreach intervention to reduce acute healthcare utilization and improve quality of life among adult asthma patients in a large managed care organization., Study Design: Randomized clinical trial., Methods: Patients with persistent asthma were randomly assigned to telephone outreach (automated = 3389, live caller = 192) or usual care (n = 3367). Intervention participants received 3 outreach calls over a 10-month period. The intervention provided brief, supportive information and flagged individuals with poor asthma control for follow-up by a provider. A survey was mailed to 792 intervention participants and 236 providers after the intervention. Additional feedback was obtained as part of the final intervention contact., Results: The intent-to-treat analysis found no significant differences between the intervention and usual-care groups for medication use, healthcare utilization, asthma control, or quality of life. Post hoc analyses found that, compared with the control group, individuals who actually participated in the intervention were significantly more likely to use inhaled steroids and to have had a routine medical visit for asthma during the follow-up period and less likely to use short-acting beta-agonists. They also reported higher satisfaction with their asthma care and better asthma-specific quality of life. Of surveyed providers, 59% stated the program helped them to clinically manage their asthma patients and 70% thought the program should be continued., Conclusions: This study did not find improved health outcomes in the primary analyses. The intervention was well accepted by providers, however, and the individuals who participated in the calls appeared to have benefited from them. These findings suggest that further studies of automated telephone outreach interventions seem warranted.

Objective: To determine whether peak flow monitoring has value above and beyond symptom monitoring when used as part of an asthma management plan., Methods: From a large managed-care organization, 296 adults, aged 50-92 yr, were recruited and randomly assigned in equal numbers to either use of symptoms or peak flow rate (twice daily or "as needed") for asthma monitoring, and monitored every 6 mo for 2 yr. Interventions were delivered in four 90-min small-group classes and included a personalized action plan and coaching in proper use of asthma inhalers., Results: We found no significant differences between peak flow rate and symptom monitoring, or between twice-daily and as-needed peak flow monitoring in the primary or secondary study outcomes: health care utilization (acute, nonacute, or total asthma visits), Asthma Quality-of-Life Questionnaire (AQLQ) scores, and lung function. AQLQ scores and prebronchodilator FEV1 increased significantly for both groups between baseline and 6 mo (AQLQ: mean, 0.4 units; 95% confidence interval, 0.3, 0.5; p < 0.0001; FEV1% predicted: mean, 4%). Inhaler technique improved substantially in both groups., Conclusions: Peak flow monitoring has no advantage over symptom monitoring as an asthma management strategy for older adults with moderate-severe asthma when used in a comprehensive asthma management program. Improved outcomes in both groups suggest that understanding proper medication use, regular monitoring of asthma status, and understanding how to respond to changes are of primary importance.

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.

We mailed a survey to a sample of adults with persistent asthma to assess gender differences in asthma management and quality of life. Women were more likely to regularly use a peak flow meter, have a regular clinician for their asthma care, and to have a written asthma management plan. No gender differences in self-reported asthma severity were observed, and men and women ranked their knowledge and confidence in their self-management skills similarly. Women reported significantly worse health status than men, but the differences observed were small and were attenuated after adjusting for socioeconomic status, smoking, body mass index, and comorbid illness.

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.

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.

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.

Objective: To examine the merits of the Asthma Therapy Assessment Questionnaire (ATAQ) control index together with prior asthma health-care utilization from administrative data in predicting future acute asthma health-care utilization., Design: Prospective cohort study., Population: A total of 4,788 adult asthma patients aged 17 to 93 years who completed a baseline evaluation and had at least 6 months of follow-up data., Statistical Methods: Classification and regression tree methodology to predict future risk of acute health-care utilization events., Results: These results show that the ATAQ control index and administrative data are jointly useful for predicting future health-care utilization. The utility of the ATAQ control index in the presence of information about prior health-care utilization is to further stratify risk among the subset of younger individuals who did not have any prior acute health-care utilization. While administrative health-care utilization data served as the strongest predictor of future health-care utilization, the ATAQ control index helped to identify 1% of individuals without recent acute care that had approximately a sixfold elevated risk (95% confidence interval, 4.2 to 8.4) of future acute health-care utilization. This is an important result since only a small fraction of individuals with acute events in a given year will have had acute events in the previous year., Conclusion: These findings should assist the practicing clinician and organizations interested in population-based asthma disease management.

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.

Objective: The objective of this study was to evaluate work-related asthma among health maintenance organization (HMO) members. Recent reports suggest that the incidence of work-related asthma may be much higher than Sentinel Event Notification Systems for Occupational Risks (SENSOR) data estimate., Methods: Using the HMO's electronic medical record, we identified 1,747 persons with evidence of new or recurrent asthma. Interviews with 352 of them elicited information about workplace exposures, symptoms, and home environment. Industrial hygienists rated the potential asthmagenicity of the respondents' work environments., Results: Based on the industrial hygienist ratings and self-reported work-relatedness of asthma symptoms, we classified 33% of those interviewed as having potentially work-related asthma, suggesting an overall work-related asthma incidence/recurrence rate of 28 cases per 10,000., Conclusions: The contribution of occupation to the occurrence of adult onset asthma may be much higher than typically suggested in the literature.

Objective: To estimate the incidence of Churg-Strauss syndrome (CSS) among a large population of asthma drug users., Methods: A retrospective study was conducted among patients who had been dispensed asthma drugs at 3 managed care organizations. Adults who received >or =3 dispensings of an asthma drug during any consecutive 12-month period between January 1, 1995 and June 30, 2000 were identified. Information on patient age, gender, enrollment status, asthma drugs dispensed, and inpatient and outpatient diagnoses and procedures was obtained from automated databases. Chart reviews were performed on persons identified by combinations of diagnostic and billing codes indicative of CSS. A rheumatologist reviewed abstracted information on all subjects; those who met >or =2 American College of Rheumatology criteria for CSS were reviewed by 2 clinical experts. Each clinical expert independently rated the cases; disagreements were resolved by consensus. Cases classified as having "probable/definite" CSS were included in these analyses. The incidence of CSS was estimated overall and according to patient gender, age, and calendar year., Results: From a population of 184,667 asthma drug users contributing 606,184 person-years of exposure, 21 incident cases of CSS were identified (overall incidence of 34.6 per million person-years; 95% confidence interval 21.4 to 53.0). Incidence rates did not differ by gender and age group. The incidence rates for 1995, 1996, 1997, 1998, 1999, and the first 6 months of 2000 were 0, 22, 52, 75, 14, and 14 per million person-years respectively., Conclusions: Results from this population-based study suggest a somewhat lower incidence of CSS in asthma drug users than previously reported and provides important information as to the risk of developing CSS from a population-based perspective.

Background: Validated psychometric tools measuring quality of life, asthma control, and asthma severity have been developed, but their relationships with each other and with other important patient-centered outcomes have not been rigorously assessed., Objective: To use factor analysis to evaluate the relationships of these validated tools with each other and with other patient-centered outcomes., Methods: Surveys were completed by a random sample of 2854 Health Maintenance Organization members age 18 to 56 years with persistent asthma. Surveys included demographic information; validated tools measuring generic (Short Form-12; SF-12) and asthma-specific (Juniper Mini Asthma Quality of Life Questionnaire; AQLQ) quality of life, asthma control (Asthma Therapy Assessment Questionnaire), and asthma symptom severity (Asthma Outcomes Monitoring System); self-described severity, control, and course over time; and history of acute exacerbations., Results: Principal component analysis suggested a 5-factor model that accounted for approximately 59% of the variability. The most prominent rotated factor reflected asthma symptom frequency (19.4% of variability), was measured by the symptom subscale of the AQLQ, and was the only factor significantly related to the Asthma Therapy Assessment Questionnaire, Asthma Outcomes Monitoring System, or the self-reported assessments of severity, control, or course. Other factors included symptom bother (12.1% of variability), reflected by the environment and emotion AQLQ subscales; activity limitation (13.9% of variability), reflected by the activity AQLQ subscale and the SF-12 physical component scale; mental health (8.3% of variability), reflected by the SF-12 mental component scale; and acute exacerbations (5.0% of variability), not measured by any of the validated scales., Conclusion: Distinct components of patient-reported asthma health status can be identified by factor analysis. Distinct constructs of severity versus control cannot be identified by the use of these tools alone.

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.

Objective: To provide a conceptual framework for defining severity and control in asthma, to describe recent advances in measuring asthma control, and to discuss the role of severity and control in asthma disease management., Data Sources: MEDLINE was searched for relevant English-language articles published between 1998 and July 2003. Additional sources included key references cited in these articles, national and international guidelines for the diagnosis and management of asthma, and the author's personal bibliography., Study Selection: All studies that reported on the development and validation of formal measures of asthma control, as well as the few editorials that focused on the distinction between asthma severity and control, were included. The author's professional judgment was used to select for illustrative purposes from among the many purported measures of asthma severity in the literature., Results: Although several standardized measures of asthma control exist, no direct comparisons of the performance and properties of these control measures have been published. The available instruments appear more similar than dissimilar. All share the common trait of assessing multiple aspects of asthma control, which is believed to provide better discrimination than a single measure., Conclusions: Asthma control is different from asthma severity and may be useful as a clinical vital sign for patients with asthma. Ultimately, no one measure may be better than any of the others or the optimal measure may depend on the intended use of the scale.

Objective: The development of a reliable asthma registry is an important first step for conducting population-based asthma disease management. This study developed a computerized algorithm for defining prevalent asthma, identified operational difficulties, and summarized data on asthma prevalence in the study population., Study Design and Setting: As part of a study of the incidence of occupational asthma, we used the electronic databases of a large health maintenance organization to develop a computerized algorithm for defining prevalent asthma and validated it against chart review. The predictive values of eight health care utilization profiles were validated by chart review to establish the algorithm., Results: The 1-year treated prevalence of asthma was 4.1% among members aged 15-55; the pharmacy database identified 61% of cases, and the outpatient care database 66%. Extending the outpatient care window from 1 year to 2 years increased estimated prevalence to 5.3%, with 81% now found in the outpatient care database., Conclusion: This analysis illustrates the benefit of using multiple databases for more accurate enumeration of cases and the impact of extending the search in time. These results are useful for researchers who can use such databases in selecting algorithms to define and identify asthma for their own purposes.

The preponderance of literature supports the efficacy of specialist care for asthma. Not every patient with asthma needs to be treated by a specialist, however. An optimal health care delivery model for asthma (i.e. one that provides high quality care that is cost effective) requires some mix of primary and specialty services. A tiered model of care in which the primary care physician acts as the first point of contact and decision-maker with regard to referral and that includes asthma specialists, including allergists, pulmonologists, and other health care professionals with expertise in asthma, appears to be a reasonable solution. The number of studies that compare various models for organizing asthma care is limited, however. Thus, further research is needed to determine how best to align the roles of primary care physicians, allied health professionals, and subspecialists in order to ensure seamless communication and cost-effective care that is targeted to individual patient needs.

Population-based disease management should be enhanced by good risk assessment models and instruments. We prospectively evaluated the ability of a simple measure of short-term asthma control (scored 0 to 4) to predict asthma 12-mo health care utilization (HCU). A total of 5,172 adult asthma patients completed a brief questionnaire in fall 1997 to assess current level of asthma control. We then evaluated HCU for calendar year 1998. Ninety-three percent had health plan eligibility in 1998 and were included in this analysis. Both acute and routine asthma utilization increased with increasing numbers of asthma control problems. Rates of acute care episodes were 3.5 (95% confidence interval [CI] = 2.9, 4.3) times more likely for those with 3 to 4 control problems versus those with no control problems. Lesser, but statistically significant, increases were seen for those with two (relative risk [RR] = 1.7, 95% CI = 1.4, 2.2) or one (RR = 1.4, 95% CI = 1.1, 1.8) control problems. These patterns were similar for men and women, and diminished with increasing age. The asthma control index contributed significantly to prospective prediction models even after adjusting for administrative data such as medication use and prior HCU. These data reinforce the usefulness of measures of short-term asthma control both for the individual clinician and for those interested in population-based asthma management.

Abstract Background Pharmacy databases are commonly used to assess medication usage, and a number of measures have been developed to measure patients’ adherence to medication. An extensive literature now supports these measures, although few studies have systematically compared the properties of different adherence measures. Methods As part of an 18-month randomized clinical trial to assess the impact of automated telephone reminders on adherence to inhaled corticosteroids (ICS) among 6903 adult members of a managed care organization, we computed eight pharmacy-based measures of ICS adherence using outpatient pharmacy dispensing records obtained from the health plan’s electronic medical record. We used simple descriptive statistics to compare the relative performance characteristics of these measures. Results Comparative analysis found a relative upward bias in adherence estimates for those measures that require at least one dispensing event to be calculated. Measurement strategies that require a second dispensing event evidence even greater upward bias. These biases are greatest with shorter observation times. Furthermore, requiring a dispensing to be calculated meant that these measures could not be defined for large numbers of individuals (17-32 % of participants in this study). Measurement strategies that do not require a dispensing event to be calculated appear least vulnerable to these biases and can be calculated for everyone. However they do require additional assumptions and data (e.g., pre-intervention dispensing data) to support their validity. Conclusions Many adherence measures require one, or sometimes two, dispensings in order to be defined. Since such measures assume all dispensed medication is used as directed, they have a built in upward bias that is especially pronounced when they are calculated over relatively short timeframes (< 9 months). Less biased measurement strategies that do not require a dispensing event are available, but require additional data to support their validity. Trial registration The study was funded by grant R01HL83433 from the National Heart, Lung and Blood Institute (NHLBI) and is filed as study NCT00414817 in the clinicaltrials.gov database.

The article discusses evidence confirming that non-smokers or never smokers comprise a significant proportion of individuals with chronic obstructive pulmonary disease (COPD). The study analyzed data from 14 countries that participated in the Burden of Obstructive Lung Disease (BOLD) program where participants completed questionnaires about health status, respiratory symptoms and exposure to COPD risk factors. It is suggested that increased age, a prior diagnosis of asthma and lower education levels in women are associated with increased COPD risk.

Inhaled corticosteroids are often used to manage chronic obstructive pulmonary disease, although the evidence regarding their long-term efficacy in preventing or reducing adverse health outcomes is not definitive. This retrospective cohort study analyzed whether regular inhaled corticosteroid use is associated with reduced health care utilization and all-cause mortality related to chronic obstructive pulmonary disease. Subjects were 2,902 health maintenance organization members aged 50 and over who met criteria for chronic obstructive pulmonary disease. The study used a composite endpoint of time to (1) death or (2) hospitalization or emergency room care related to chronic obstructive pulmonary disease, whichever occurred first, during a 4-year follow-up. Among the 42% of chronic obstructive pulmonary disease patients with an indication of co-morbid asthma, inhaled corticosteroid use was associated with significantly reduced risk for both all-cause mortality and the composite outcome. The reduction in risk was greatest in never- and ex-smokers. Among chronic obstructive pulmonary disease patients with no indication of asthma, inhaled corticosteroid use was associated with reduced risk only in never smokers. These findings generally persisted in separate analyses stratified by asthma status and in sensitivity analyses using four alternative definitions of regular medication use, with comparable results when regular medication use was treated as a fixed covariate defined at the start of follow-up. We conclude that use of inhaled corticosteroids was associated with reduced risk of chronic obstructive pulmonary disease exacerbations and all-cause mortality. This benefit was most pronounced among never-smokers and in those with evidence of co-morbid asthma. [ABSTRACT FROM AUTHOR]

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 β-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 β-agonist canister and oral corticosteroid dispensings. The proposed 4-level asthma control scale was based on the number of short-acting β-agonist canisters dispensed in 12 months. Construct validity and predictive validity were assessed. Results: For construct validity, factor analysis showed significant loading of the β-agonist scale on the symptom control factor, and the β-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 β-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 β-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. [Copyright &y& Elsevier]

Editorial. Discusses the morbidity and mortality for asthma. Decline in asthma mortality rates in the U.S. and Canada from 1965 through 1978; Role of urban environment in asthma mortality; Contribution of health care access, availability and utilization to the increase in asthma morbidity and mortality.