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Background: The severity of asthma (SOA) score is based on a validated disease-specific questionnaire that addresses frequency of asthma symptoms, use of systemic corticosteroids, use of other asthma medications, and history of hospitalization/intubation for asthma. SOA does not require measurements of pulmonary function. This study compared the ability of SOA to predict clinical outcomes in the EXCELS (Epidemiological Study of Xolair [omalizumab]: Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma) patient population vs three other asthma assessment tools. EXCELS is a large, ongoing, observational study of patients with moderate to severe persistent asthma and reactivity to perennial aeroallergens., Methods: Baseline scores for SOA, asthma control test (ACT), work productivity and impairment index-asthma (WPAI-A), and FEV(1) % predicted were compared for their ability to predict five prespecified adverse clinical outcomes in asthma: serious adverse events (SAEs) reported as exacerbations, SAEs leading to hospitalizations, the incidence of unscheduled office visits, ED visits, and po or IV corticosteroid bursts related to asthma. Logistic regression analysis, area under receiver operating characteristic curves (AUCROCs), and classification and regression tree (CART) analysis were used to evaluate the ability of the four tools to predict adverse clinical outcomes using baseline and 1-year data from 2,878 patients enrolled in the non-omalizumab cohort of EXCELS., Results: SOA was the only assessment tool contributing significantly in all five statistical models of adverse clinical outcomes by logistic regression analysis (full model AUCROC range, 0.689-0.783). SOA appeared to be a stand-alone predictor for four of five outcomes (reduced model AUCROC range, 0.689-0.773). CART analysis showed that SOA had the greatest variable importance for all five outcomes., Conclusions: SOA score was a powerful predictor of adverse clinical outcomes in moderate to severe asthma, as evaluated by either logistic regression analysis or CART analysis., Trial Registry: ClinicalTrials.gov; No.: NCT00252135; URL: www.clinicaltrials.gov.

Background: A comprehensive survey-based COPD severity score has usefulness for epidemiologic and health outcomes research. We previously developed and validated the survey-based COPD Severity Score without using lung function or other physiologic measurements. In this study, we aimed to further validate the severity score in a different COPD cohort and using a combination of patient-reported and objective physiologic measurements., Methods: Using data from the Function, Living, Outcomes, and Work cohort study of COPD, we evaluated the concurrent and predictive validity of the COPD Severity Score among 1,202 subjects. The survey instrument is a 35-point score based on symptoms, medication and oxygen use, and prior hospitalization or intubation for COPD. Subjects were systemically assessed using structured telephone survey, spirometry, and 6-min walk testing., Results: We found evidence to support concurrent validity of the score. Higher COPD Severity Score values were associated with poorer FEV(1) (r = -0.38), FEV(1)% predicted (r = -0.40), Body mass, Obstruction, Dyspnea, Exercise Index (r = 0.57), and distance walked in 6 min (r = -0.43) (P < .0001 in all cases). Greater COPD severity was also related to poorer generic physical health status (r = -0.49) and disease-specific health-related quality of life (r = 0.57) (P < .0001). The score also demonstrated predictive validity. It was also associated with a greater prospective risk of acute exacerbation of COPD defined as ED visits (hazard ratio [HR], 1.31; 95% CI, 1.24-1.39), hospitalizations (HR, 1.59; 95% CI, 1.44-1.75), and either measure of hospital-based care for COPD (HR, 1.34; 95% CI, 1.26-1.41) (P < .0001 in all cases)., Conclusion: The COPD Severity Score is a valid survey-based measure of disease-specific severity, both in terms of concurrent and predictive validity. The score is a psychometrically sound instrument for use in epidemiologic and outcomes research in COPD.

Background: Both disability and depression are common in COPD, but limited information is available on the time-ordered relationship between increases in disability and depression onset., Methods: Subjects were members of a longitudinal cohort with self-reported physician-diagnosed COPD, emphysema, or chronic bronchitis. Data were collected through three annual structured telephone interviews (T1, T2, and T3). Depression was defined as a score >/= 4 on the Geriatric Depression Scale Short Form (S-GDS). Disability was measured with the Valued Life Activities (VLA) scale; three disability scores were calculated: percent of VLAs unable to perform, percent of VLAs affected (unable to perform or with some degree of difficulty), and mean VLA difficulty rating. Disability increases were defined as a 0.5 SD increase in disability score between T1 and T2. Multiple logistic regression analyses estimated the risk of T3 depression following a T1 to T2 disability increase for the total cohort and then excluding individuals who met the depression criterion at T1 or T2., Results: Approximately 30% of subjects met the depression criterion each year. Eight percent to 19% experienced a T1 to T2 disability increase, depending on the disability measure. Including all cohort members and controlling for baseline S-GDS scores, T1 to T2 increases in disability yielded a significantly elevated risk of T3 depression (% affected odds ratio [OR] =3.6; 95% CI, [1.7, 7.7]; % unable OR = 6.1 [17, 21.8]; mean difficulty OR= 3.6 [1.7, 8.0]). Omitting individuals depressed at T1 or T2 yielded even stronger risk estimates for % unable (OR = 13.4 [2.0, 91.4]) and mean difficulty (OR = 3.9 [1.3, 11.8])., Conclusions: Increases in VLA disability are strongly predictive of the onset of depression.

Background: Psychologic factors affect how patients with COPD respond to attempts to improve their self-management skills. Learned helplessness may be one such factor, but there is no validated measure of helplessness in COPD., Methods: We administered a new COPD Helplessness Index (CHI) to 1,202 patients with COPD. Concurrent validity was assessed through association of the CHI with established psychosocial measures and COPD severity. The association of helplessness with incident COPD exacerbations was then examined by following subjects over a median 2.1 years, defining COPD exacerbations as COPD-related hospitalizations or ED visits., Results: The CHI demonstrated internal consistency (Cronbach alpha = 0.75); factor analysis was consistent with the CHI representing a single construct. Greater CHI-measured helplessness correlated with greater COPD severity assessed by the BODE (Body-mass, Obstruction, Dyspnea, Exercise) Index (r = 0.34; P < .001). Higher CHI scores were associated with worse generic (Short Form-12, Physical Component Summary Score) and respiratory-specific (Airways Questionnaire 20) health-related quality of life, greater depressive symptoms, and higher anxiety (all P < .001). Controlling for sociodemographics and smoking status, helplessness was prospectively associated with incident COPD exacerbations (hazard ratio = 1.31; P < .001). After also controlling for the BODE Index, helplessness remained predictive of COPD exacerbations among subjects with BODE Index

Background: Psychosocial factors play an important role in outcomes of asthma. Perceived control, a measure of patients' beliefs about their ability to control their disease, has not been studied in association with asthma health outcomes, Methods: We used data from a prospective cohort study of patients who were hospitalized for asthma (n = 865). After hospital discharge, we conducted structured telephone interviews to obtain demographic characteristics, asthma history, and psychological variables. Interviews included administration of the Perceived Control of Asthma Questionnaire (PCAQ). We then prospectively measured emergency department (ED) visits and hospitalizations for asthma over time, with a median follow-up time of 1.9 years, Results: Greater perceived control was associated with better physical health status (mean score increment per 2-point change in PCAQ score, 1.13; 95% confidence interval [CI], 0.79 to 1.47), better asthma-related quality of life (mean score increment, -2.24; 95% CI, -2.6 to -1.83), fewer days of restricted activity due to asthma (mean increment, -1.23; 95% CI, -1.62 to -0.83), and lower asthma severity scores (mean score increment, -0.40; 95% CI, -0.53 to -0.27). In a multivariate model, greater perceived control was associated with a significantly decreased prospective risk of ED visits (hazard ratio [HR], 0.92; 95% CI, 0.86 to 0.98; p = 0.008) and hospitalizations for asthma (HR, 0.84; 95% CI, 0.78 to 0.90; p < 0.0001). There was no association found between perceived control and most aspects of preventive care or self-management, Conclusions: Greater perceived control is associated with improved asthma-related health status as well as with a decreased prospective risk of severe asthma attacks resulting in emergency health-care utilization. This difference does not appear to be mediated by changes in preventive care or asthma self-management practices.

Background: The Airways Questionnaire 20 (AQ20) is a concise measure of health-related quality of life (HRQL) in obstructive airway disease; however, its original format may underestimate impairment due to the complete cessation of certain activities., Methods: We revised seven items of the original AQ20 (revised AQ20 [AQ20-R]), adding response options for inability to perform certain activities. We assessed the performance of the AQ20-R among 352 adults with various airway conditions identified through a random telephone sample. Concurrent validity of the AQ20-R was assessed relative to the Short Form-12 (SF-12) physical component summary (PCS), FEV(1), and medication use. Predictive validity was assessed relative to health-care utilization among 278 subjects studied longitudinally., Results: Twenty-one of 352 subjects were unable to perform at least one activity. These subjects demonstrated higher AQ20-R scores (p < 0.001) indicating worse HRQL. Mean (+/- SD) AQ20-R scores differed significantly (p < 0.001) among subjects with COPD (8.9 +/- 5.2), asthma (6.7 +/- 5.0), and chronic bronchitis (4.7 +/- 4.2). At baseline, the AQ20-R correlated with the SF-12 PCS (r = - 0.55, p < 0.001) and FEV(1) (r = - 0.43, p < 0.001), and was associated with the use of respiratory-specific therapies (p

Study Objectives: To determine the relationship between diagnosed and treated COPD and the incidence of cardiovascular disease (CVD) hospitalization and mortality., Design: Retrospective matched cohort study., Setting: Northern California Kaiser Permanente Medical Care Program (KPNC), a comprehensive prepaid integrated health-care system., Patients or Participants: Case patients (n = 45,966) were all KPNC members with COPD who were identified during a 4-year period from January 1996 through December 1999. An equal number of control subjects without COPD were selected from KPNC membership and were matched for gender, year of birth, and length of KPNC membership., Measurements and Results: Follow-up conducted for hospitalization and mortality from CVD end points through December 31, 2000. CVD study end points included cardiac arrhythmias, angina pectoris, acute myocardial infarction, congestive heart failure (CHF), stroke, pulmonary embolism, all of the aforementioned study end points combined, other CVD, and all CVD end points. The mean follow-up time was 2.75 years for case patients and 2.99 years for control subjects. The risk of hospitalization was higher in COPD case patients than in control subjects for all CVD hospitalization and mortality end points. The relative risk (RR) for hospitalization for the composite measure of all study end points was 2.09 (95% confidence interval [CI], 1.99 to 2.20) after adjustment for gender, preexisting CVD study end points, hypertension, hyperlipidemia, and diabetes, and ranged from 1.33 (stroke) to 3.75 (CHF). The adjusted RR for mortality for the composite measure of all study end points was 1.68 (95% CI, 1.50 to 1.88), ranging from 1.25 (stroke) to 3.53 (CHF). Younger patients (ie, age < 65 years) and female patients had higher risks than older and male participants., Conclusions: COPD was a predictor of CVD hospitalization and mortality over an average follow-up time of nearly 3 years. The finding of a stronger relationship of COPD to CVD outcomes in patients < 65 years of age suggests that CVD risk should be monitored and treated with particular care in younger adults with COPD.

Objective: To develop a comprehensive disease-specific COPD severity instrument for survey-based epidemiologic research., Study Design and Setting: Using a population-based sample of 383 US adults with self-reported physician-diagnosed COPD, we developed a disease-specific COPD severity instrument. The severity score was based on structured telephone interview responses and included five overall aspects of COPD severity: respiratory symptoms, systemic corticosteroid use, other COPD medication use, previous hospitalization or intubation, and home oxygen use. We evaluated concurrent validity by examining the association between the COPD severity score and three health status domains: pulmonary function, physical health-related quality of life (HRQL), and physical disability. Pulmonary function was available for a subgroup of the sample (FEV1, n = 49; peak expiratory flow rate [PEFR], n = 93)., Results: The COPD severity score had high internal consistency reliability (Cronbach alpha = 0.80). Among the 49 subjects with FEV1 data, higher COPD severity scores were associated with poorer percentage of predicted FEV1 (r = - 0.40, p = 0.005). In the 93 subjects with available PEFR measurements, greater COPD severity was also related to worse percentage of predicted PEFR (r = - 0.35, p < 0.001). Higher COPD severity scores were strongly associated with poorer physical HRQL (r = - 0.58, p < 0.0001) and greater restricted activity attributed to a respiratory condition (r = 0.59, p < 0.0001). Higher COPD severity scores were also associated with a greater risk of difficulty with activities of daily living (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.8 to 3.0) and inability to work (OR, 4.2; 95% CI, 3.0 to 5.8)., Conclusion: The COPD severity score is a reliable and valid measure of disease severity, making it a useful research tool. The severity score, which does not require pulmonary function measurement, can be used as a study outcome or to adjust for disease severity.

Study Objectives: Homelessness is a growing problem in the United States that may significantly impair physical health. The homeless have a high prevalence of cigarette smoking, poor nutrition, and adverse environmental exposures, which could contribute to obstructive lung disease (OLD). Despite this risk, the prevalence of OLD among the homeless remains unknown. We aimed to systematically assess the prevalence of OLD among the urban homeless., Design, Setting, and Participants: We conducted a cross-sectional study of the prevalence of OLD among homeless individuals in San Francisco. By random sampling, we recruited 68 adults living in one homeless shelter to participate in a structured interview survey and spirometry assessment. We used a multifaceted approach to assess OLD, including respiratory symptoms, self-reported physician diagnosis of asthma, chronic bronchitis, emphysema, or COPD, and spirometry (defined as FEV1 < 80% predicted and FEV1/FVC ratio < 0.70)., Results: Sixty-eight adults completed the survey, and 67 adults completed the spirometry. Homeless adults were likely to be homeless < 1 year and homeless for the first time. There was a high prevalence of cigarette smoking (75% ever smokers, 68% current smokers). The prevalence of symptoms suggestive of OLD was high, including cough (29%), wheezing (40%), chronic bronchitis symptoms (21%), and dyspnea on exertion (29%). A substantial proportion of homeless subjects indicated a prior diagnosis of asthma (24%), chronic bronchitis (19%), and COPD (4%). Based on spirometry, the prevalence of OLD was 15% (95% confidence interval, 8 to 26%), which was more than double the expected prevalence in the general US population., Conclusions: As OLD is a leading cause of death in the United States, it is important to identify it early for treatment. Homeless individuals have a higher-than-expected prevalence of OLD. Public health interventions should target the homeless population for prevention and treatment of OLD.

Objectives: In California, state law now prohibits smoking in most public places. We examined the prevalence and short-term health impact of environmental tobacco smoke (ETS) exposure during travel among adults with asthma., Design, Setting, and Participants: A cohort of 374 nonsmoking adults with asthma recruited from a random sample of allergy, pulmonary, and family practice physicians in northern California underwent structured telephone interviews., Measurements and Results: The prevalence of self-reported ETS exposure during travel in the past 12 months was substantial (30%; 95% confidence interval, 25 to 35%). Of the exposed subjects, approximately one third (34%) indicated no other regular source of ETS exposure. ETS-related cough, wheezing, or chest tightness during travel was the most common complaint (66%), followed by eye irritation (46%) and nose irritation (43%). After ETS exposure, many subjects indicated extra inhaled asthma medication use (55%). Subjects with no other regular ETS exposure reported a greater likelihood of eye irritation (58% vs 40%; p = 0.068) and nose irritation (58% vs 36%; p = 0.025) than persons with regular exposure. In contrast, there were no differences in respiratory symptoms, asthma medication use, or asthma exacerbation by regular ETS exposure status., Conclusions: In adults with asthma, ETS exposure is common during travel. For many subjects, travel is their principal source of exposure.

Background: Asthma and rhinosinusitis are common medical conditions among adults. Alternative treatments could have important impacts on health status among those individuals with these conditions, but specific prevalence data for these treatments are limited., Objective: To estimate the prevalence of specific alternative treatment modalities, including herbal agents, ingestion of caffeinated beverages, homeopathy, acupuncture, and massage therapies., Design: Random population telephone sample., Setting: Northern California., Participants: Three hundred adults aged 18 to 50 years with self-report of a physician diagnosis of asthma (n = 125) or rhinosinusitis without concomitant asthma (n = 175)., Measurements: Structured telephone interviews covering demographics and clinical variables, including the following alternative treatments used in the previous 12 months: herbal agents; caffeine-containing products; homeopathy; acupuncture; aromatherapy; reflexology; and massage., Results: Any alternative practice was reported by 127 subjects (42%; 95% confidence interval [CI], 36 to 48%). Of these, 33 subjects (26%; 95% CI, 21 to 31%) were not current prescription medication users. Herbal use was reported by 72 subjects (24%), caffeine treatment by 54 subjects (18%), and other alternative treatments by 66 subjects (22%). Taking into account demographic variables, subjects with asthma were more likely than those with rhinitis alone to report caffeine self-treatment for their condition (odds ratio, 2.5; 95% CI, 1.4 to 4.8%), but herbal use and other alternative treatments did not differ significantly by condition group., Conclusion: Alternative treatments are frequent among adults with asthma or rhinosinusitis and should be taken into account by health-care providers and public health and policy analysts.

Study Objective: To examine the association of cigarette smoking and alcohol consumption with hospital presentation of ARDS in a well-defined, multiethnic population., Design: Retrospective cohort study., Setting: Health maintenance organization in Northern California., Participants: A total of 121,012 health plan subscribers (54.2% women), aged 25 to 89 years., Outcome Measure: Hospital presentation of ARDS (validated by medical chart review) from baseline in 1979 to 1985 through the end of 1993 (median, 9.9 years)., Results: There were 56 cases of ARDS (33 in men, 23 in women). The case fatality rate was 39% in both genders. ARDS was independently related to increasing age (rate ratio of 10 years, 1.38; 95% confidence interval [CI], 1.12 to 1.71), to current smoking of < 20 cigarettes/d (rate ratio vs never cigarette smokers, 2.85; 95% CI, 1. 23 to 6.60), and to current cigarette smoking of > or = 20 cigarettes/d (rate ratio vs never smokers, 4.59; 95% CI, 2.13 to 9.88). No association was observed between alcohol consumption and ARDS., Conclusions: The results of this study suggest a relationship (with evidence of dose-response effect) between cigarette smoking and ARDS. Assuming a causal relationship, approximately 50% of ARDS cases were attributable to cigarette smoking.

Background: In general practice settings, the proportion of adult asthma attributable to occupational factors is not known., Objective: The goal of this study was to estimate the proportion of adult asthma cases that can be attributed to occupational factors initiating new disease onset and exacerbating preexisting disease., Methods: We performed a cross-sectional analysis of interview data for 150 adults with asthma recruited from a random sample of family practice specialists. We ascertained the asthma and work histories of the subjects and estimated the proportion with likely work-initiated asthma and work-related asthma recrudescence., Results: Seventy-four subjects (49%) reported adult-onset asthma while employed; an additional 25 (17%) reported recrudescence of previously quiescent childhood-onset asthma during employment. Of those with new-onset asthma while employed, 15 (10% of the study group; 95% confidence interval, 5 to 15%) were employed in occupations at increased risk of occupational asthma initiation on the basis of an independent job scoring matrix. Of those with asthma recrudescence in adulthood, seven (5% of the study group; 95% confidence interval, 2 to 8%) were employed in occupations at increased risk of exposures aggravating asthma., Conclusions: Among adults with asthma treated in general practice settings, > 1 in 10 patients has a work history strongly suggestive of a potential relationship between exposure and disease.

Study Objective: To determine whether expandable metal stent placement for benign airway lesions improves pulmonary function., Design: Case series., Setting: University medical center., Patients: Nine patients who underwent balloon-mediated expandable metal stent deployment for airway obstruction due to benign etiologies., Results: All nine patients had expandable stents deployed for benign airway lesions using fiberoptic bronchoscopy and fluoroscopic guidance. Pulmonary function improved after stent placement. The mean FVC increased by 388 mL (95% confidence interval [CI], 30 to 740 mL), the mean peak expiratory flow (PEF) increased by 1,288 mL (95% CI, 730 to 1,840 mL), the mean FEV1 increased by 550 mL (95% CI, 240 to 860 mL), and the mean forced expiratory flow between 25% and 50% of vital capacity (FEF25-75%) increased by 600 mL (95% CI, 110 to 1,090 mL). Corresponding relative measurements included increases in FVC (12%), PEF (95%), FEV1 (38%), and FEF25-75% (87%). The complete characterization of a benign airway obstruction generally required a multimodal approach., Conclusions: Expandable metal stent placement appears to be an effective therapy for benign airway obstruction.

Study Objective: To describe the clinical, radiographic, and autopsy features of AIDS-related non-Hodgkin's Iymphoma (NHL) with pulmonary involvement., Design: Retrospective series of patients with HIV infection and NHL with pathologically documented lung or pleural involvement., Setting: A university and a county hospital in San Francisco., Patients: Thirty-eight patients with HIV infection and NHL involving the lungs or pleura., Results: Most patients had respiratory symptoms (87%) and signs (84%). The majority of patients had advanced HIV infection, with a mean CD4 count of 67 (+/- 65). The most common laboratory abnormalities were elevated lactate dehydrogenase value (89%), elevated erythrocyte sedimentation rate (94%), hematologic abnormalities (95%), and widened alveolar-arterial gradient (89%). Thoracic CT revealed pulmonary nodules (50%), lobar infiltrates (27%), and lung mass (19%) as the most common parenchymal abnormalities. Pleural effusion (68%) and thoracic lymphadenopathy (54%) were unexpectedly common. Autopsy confirmed the high prevalence of pulmonary nodules (30%), airspace disease (35%), and lung mass (25%). Pleural effusions (65%) and thoracic lymphadenopathy (60%) were also common at autopsy. The respiratory system was the most common extranodal site (71%) in patients with AIDS-related NHL undergoing autopsy. Of the bronchoscopic procedures performed, transbronchial biopsy had the highest diagnostic yield (58%) for lymphoma. BAL and bronchial brushing were never diagnostic. Pleural fluid cytologic study and open lung biopsy specimens also had high diagnostic yields (75% each)., Conclusions: The lung is a common extranodal site in AIDS-related NHL. NHL with pulmonary involvement occurs primarily in patients with advanced HIV infection. Most patients have nodules, infiltrates, or masses by thoracic imaging and autopsy. Thoracic lymphadenopathy is much more common than previously believed. Transbronchial biopsy, pleural fluid cytologic study, and open lung biopsy are the most useful diagnostic procedures.