RATIONALE: Although exacerbations are an important problem in chronic obstructive pulmonary disease (COPD) and a target of intervention, there is no valid, standardized tool for assessing their frequency, severity, and duration. OBJECTIVES: This study tested the properties of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome diary. METHODS: A prospective, two-group, observational study was conducted in patients with COPD. The acute group (n = 222) was enrolled during a clinic visit for exacerbation with follow-up visits on Days 10, 29, and 60. The stable group (n = 188), recruited by telephone or during routine visits, was exacerbation free for at least 60 days. MEASUREMENTS AND MAIN RESULTS: Acute patients completed the diary on Days 1-29 and 60-67; stable patients for 7 days. All patients provided stable-state spirometry and completed the St. George Respiratory Questionnaire-COPD (SGRQ-C). Acute patient assessments included clinician and patient global ratings of exacerbation severity and recovery. Mean age of the sample (n = 410) was 65 (± 10) years; 48% were male; stable FEV₁ was 51% predicted (± 20). Internal consistency (Pearson separation index) for the EXACT was 0.92, 1-week reproducibility (stable patients; intraclass correlation) was 0.77. EXACT scores correlated with SGRQ-C (r = 0.64; P < 0.0001) and differentiated acute and stable patients (P < 0.0001). In acute patients, scores improved over time (P < 0.0001) and differentiated between degrees of clinician-rated exacerbation severity (P < 0.05). EXACT change scores differentiated responders and nonresponders on Day 10, as judged by clinicians or patients (P < 0.0001). CONCLUSIONS: Results suggest the EXACT is reliable, valid, and sensitive to change with exacerbation recovery.
RATIONALE: Although exacerbations are an important problem in chronic obstructive pulmonary disease (COPD) and a target of intervention, there is no valid, standardized tool for assessing their frequency, severity, and duration. OBJECTIVES: This study tested the properties of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome diary. METHODS: A prospective, two-group, observational study was conducted in patients with COPD. The acute group (n = 222) was enrolled during a clinic visit for exacerbation with follow-up visits on Days 10, 29, and 60. The stable group (n = 188), recruited by telephone or during routine visits, was exacerbation free for at least 60 days. MEASUREMENTS AND MAIN RESULTS: Acute patients completed the diary on Days 1-29 and 60-67; stable patients for 7 days. All patients provided stable-state spirometry and completed the St. George Respiratory Questionnaire-COPD (SGRQ-C). Acute patient assessments included clinician and patient global ratings of exacerbation severity and recovery. Mean age of the sample (n = 410) was 65 (± 10) years; 48% were male; stable FEV₁ was 51% predicted (± 20). Internal consistency (Pearson separation index) for the EXACT was 0.92, 1-week reproducibility (stable patients; intraclass correlation) was 0.77. EXACT scores correlated with SGRQ-C (r = 0.64; P < 0.0001) and differentiated acute and stable patients (P < 0.0001). In acute patients, scores improved over time (P < 0.0001) and differentiated between degrees of clinician-rated exacerbation severity (P < 0.05). EXACT change scores differentiated responders and nonresponders on Day 10, as judged by clinicians or patients (P < 0.0001). CONCLUSIONS: Results suggest the EXACT is reliable, valid, and sensitive to change with exacerbation recovery.
Authors: John H Powers; Kellee Howard; Todd Saretsky; Sarah Clifford; Steve Hoffmann; Lily Llorens; George Talbot Journal: Clin Infect Dis Date: 2016-08-15 Impact factor: 9.079
Authors: Nancy K Leidy; Lindsey T Murray; Brigitta U Monz; Linda Nelsen; Mitchell Goldman; Paul W Jones; Elizabeth J Dansie; Sanjay Sethi Journal: Respir Res Date: 2014-10-07
Authors: Stefan M Frent; Kenneth R Chapman; Michael Larbig; Alexander Mackay; Robert Fogel; Florian S Gutzwiller; Steven Shen; Francesco Patalano; Donald Banerji; Konstantinos Kostikas; Jadwiga A Wedzicha Journal: Am J Respir Crit Care Med Date: 2019-01-01 Impact factor: 21.405