Standardizing measurement of chronic obstructive pulmonary disease exacerbations: Reliability and validity of a patient-reported diary

Nancy Kline Leidy, Teresa K. Wilcox, Paul W. Jones, Paul Jones, Laurie Roberts, John H. Powers, Sanjay Sethi, James Donohue, Sonya Eremenco, Penny Erickson, Fernando Martinez, Donald Patrick, Stephen Rennard, Roberto Rodriguez-Roisin, Holger Schünemann

Research output: Contribution to journalArticlepeer-review

149 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)323-329
Number of pages7
JournalAmerican Journal of Respiratory and Critical Care Medicine
Issue number3
StatePublished - Feb 1 2011


  • COPD
  • Diary
  • Exacerbation
  • Patient-reported outcomes
  • Symptoms

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine


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