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【Am J Respir Crit Care Med】Standardizing Measurement of C

Standardizing Measurement of Chronic Obstructive Pulmonary Disease Exacerbations
Reliability and Validity of a Patient-reported Diary
Nancy K. Leidy1, Teresa K. Wilcox1, Paul W. Jones2, Laurie Roberts1, John H. Powers3, Sanjay Sethi4 the EXACT-PRO Study Group

1 United BioSource Corporation, Bethesda, Maryland; 2 St. George's Hospital, University of London, London, United Kingdom; 3 George Washington University, Washington, District of Columbia; and 4 University at Buffalo, SUNY, Buffalo, New York

Correspondence and requests for reprints should be addressed to Nancy Kline Leidy, Ph.D., Center for Health Outcomes Research, UBC, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814. E-mail: Nancy.Leidy@unitedbiosource.com

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.

Key Words: exacerbation ? COPD ? symptoms ? diary ? patient-reported outcomes

AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject
The Exacerbations of Chronic Pulmonary Disease Tool is a patient-reported outcome measure designed to provide researchers with a single, standardized, reliable, and valid method for assessing frequency, severity, and duration of exacerbations of chronic obstructive pulmonary disease.

What This Study Adds to the Field
Prior work established the content validity of the instrument. Results of this first quantitative validation study indicate this 14-item daily diary is reliable, valid, and sensitive to changes during recovery from exacerbation. COPD guideline of ATS - docin.com豆丁网with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1995; 152:... 2.5. Assessment of sever ity: staging It is accepted that a single measurement of ...www.docin.com/p-47180044.html-2010-03-25-快照-of ATS - docin.com豆丁网" Early onset of effect of salmeterol and fluticasone propionaGiven the variation in the measurement of FEV1, a weak association was to be ... in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med ...journal.shouxi.net/...955.html-2006-11-10-快照-of effect of salmeterol and fluticasone propiona" Analysis of the Factors Related to Mortality in Chronic ObstClin Chest Med 2000;21:693704. Jones PW. Health status measurement in chronic ... of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care ...journal.shouxi.net/...906.html-2004-10-18-快照-of the Factors Related to Mortality in Chronic Obst"[标签:content2]

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