Document Detail


Standardizing measurement of chronic obstructive pulmonary disease exacerbations: reliability and validity of a patient-reported diary.
MedLine Citation:
PMID:  20813886     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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:
Nancy K Leidy; Teresa K Wilcox; Paul W Jones; Laurie Roberts; John H Powers; Sanjay Sethi;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-09-02
Journal Detail:
Title:  American journal of respiratory and critical care medicine     Volume:  183     ISSN:  1535-4970     ISO Abbreviation:  Am. J. Respir. Crit. Care Med.     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-03     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9421642     Medline TA:  Am J Respir Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  323-9     Citation Subset:  AIM; IM    
Affiliation:
Center for Health Outcomes Research, Bethesda, MD 20814, USA. Nancy.Leidy@unitedbiosource.com
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MeSH Terms
Descriptor/Qualifier:
Investigator
Investigator/Affiliation:
Paul Jones / ; Sanjay Sethi / ; James Donohue / ; Sonya Eremenco / ; Penny Erickson / ; Fernando Martinez / ; Donald Patrick / ; John Powers / ; Stephen Rennard / ; Roberto Rodriguez-Roisin / ; Holger Schünemann /
Comments/Corrections
Comment In:
Am J Respir Crit Care Med. 2011 Feb 1;183(3):287-8   [PMID:  21288860 ]

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