title: Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale.
abstract: This study examined the reliability and validity of a new measure for evaluating symptoms in patients with chronic obstructive pulmonary disease (COPD): the Breathlessness, Cough and Sputum Scale (BCSS). Designed as a daily diary, the BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Secondary analysis of data were from two multinational trials (n = 629; 765). The BCSS item and total scores exhibited evidence of internal consistency (alpha = 0.70 daily; 0.95 to 0.99 over time) and reproducibility (ICC = 0.77 to 0.88). Correlations (r) with pulmonary function (FEV1 % predicted, PEF) were -0.01 (n.s.) to -0.36 (P < 0.001). Correlations with the St George's Respiratory Questionnaire total and SF-36 Physical Functioning subscale were 0.44 to 0.59 (P < 0.0001). Breathlessness and total scores differentiated patients by disease severity (P < 0.01) and rescue medication use (P < 0.01). Cough, sputum, and total scores increased with sputum volume (r = 0.27, 0.30, 0.31; P < 0.001). Patients for whom treatment was moderately or highly effective reported significant improvements in BCSS scores (P < 0.0001). Results suggest that the BCSS is a reliable, valid, and responsive patient-reported outcome measure of symptom severity in patients with COPD.
authors.affiliation: Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA. leidy@medtap.com
authors.forename: N K
authors.initials: NK
authors.lastname: Leidy
authors.forename: J K
authors.initials: JK
authors.lastname: Schmier
authors.forename: M K C
authors.initials: MK
authors.lastname: Jones
authors.forename: J
authors.initials: J
authors.lastname: Lloyd
authors.forename: K
authors.initials: K
authors.lastname: Rocchiccioli
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use; D003371:Cough / Q000209:etiology*; D003625:Data Collection / Q000592:standards; D018492:Dopamine Antagonists / Q000627:therapeutic use; D004417:Dyspnea / Q000209:etiology*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000188:drug therapy; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013183:Sputum; D013844:Thiazoles / Q000627:therapeutic use
chemical_list: D000319:Adrenergic beta-Antagonists; D001993:Bronchodilator Agents; D018492:Dopamine Antagonists; D013844:Thiazoles; C116267:sibenadet