title: Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure.
abstract: BACKGROUND
  This article describes the qualitative methods used to develop the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome (PRO) instrument for evaluating frequency, severity, and duration of exacerbations of chronic obstructive pulmonary disease (COPD).
  
  
  METHODS
  Focus groups and interviews were conducted in the United States with COPD patients treated for exacerbations during the past 6 months. Participants were asked to describe exacerbation attributes, care-seeking cues, and indications of progression and recovery. An iterative process was used to identify themes in the data to inform instrument content and structure. Cognitive debriefing interviews were performed to evaluate and revise the draft item pool. Experts in COPD, instrument development, and clinical research participated in the process.
  
  
  RESULTS
  Eighty-three subjects participated in elicitation focus groups or interviews (n=48); elicitation interviews with cognitive debriefing (n=23), or cognitive interviews alone (n=12). Mean age of the sample was 65 years (SD=10); 45% were male; mean FEV-1% predicted was 44% (SD=16). Participants characterized exacerbations as a persistent increase in the severity of respiratory symptoms and other systemic manifestations accompanied by a dramatic reduction in activity. Specific attributes included shortness of breath, chest congestion, cough, sputum, chest discomfort, feeling weak or tired, sleep disturbances, and concern or worry. The diary card of 23 candidate items was debriefed in booklet and electronic format.
  
  
  CONCLUSIONS
  Qualitative data from patients and input from experts formed the basis of the EXACT's structure and item pool, ready for empirically based item reduction and reliability and validity testing.
authors.affiliation: Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD 20814, USA. nancy.leidy@unitedbiosource.com
authors.forename: Nancy Kline
authors.initials: NK
authors.lastname: Leidy
authors.forename: Teresa K
authors.initials: TK
authors.lastname: Wilcox
authors.forename: Paul W
authors.initials: PW
authors.lastname: Jones
authors.forename: Lindsey
authors.initials: L
authors.lastname: Murray
authors.forename: Randall
authors.initials: R
authors.lastname: Winnette
authors.forename: Kellee
authors.initials: K
authors.lastname: Howard
authors.forename: Jennifer
authors.initials: J
authors.lastname: Petrillo
authors.forename: John
authors.initials: J
authors.lastname: Powers
authors.forename: Sanjay
authors.initials: S
authors.lastname: Sethi
mesh_terms: D000368:Aged; D018450:Disease Progression; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis*; D036301:Qualitative Research; D057566:Self Report; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires