title: Multicenter study comparing case definitions used to identify patients with chronic obstructive pulmonary disease.
abstract: BACKGROUND
  Clinical trials in chronic obstructive pulmonary disease (COPD) usually require evidence of airflow obstruction and clinical risk factors. International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes or patient-reported physician diagnoses are often used for epidemiologic studies and performance improvement programs.
  
  
  OBJECTIVE
  To evaluate agreement between these case definitions for COPD and to assess the comparability of study populations identified as having COPD not using the clinical trial reference standard.
  
  
  METHODS
  We recruited patients from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation multicenter clinical registry in a cross-sectional study. Demographics, clinical, and post-bronchodilator spirometry data were collected at an in-person study visit. The kappa statistic (κ) was used to evaluate agreement. A multivariable logistic regression model was used to identify patient characteristics associated with meeting the trial reference standard.
  
  
  RESULTS
  A total of 998 (82.8%) of 1,206 study participants met at least one case definition for COPD (of the 998: 91% using ICD-9 codes, 73% using patient-reported physician diagnosis, 56% using trial reference standard); agreement between case definitions was poor (κ = 0.20-0.26). Lack of airflow obstruction was the principal (89%) reason patients identified as having COPD did not meet the trial reference standard. Patients who were black (vs. white), obese (vs. normal weight), or had depression (vs. not) were less likely to meet the trial reference standard (odds ratio [95% CI], 0.37 [0.26-0.53], 0.51 [0.34-0.75], 0.53 [0.40-0.71], respectively).
  
  
  CONCLUSIONS
  Findings highlight concerns about the applicability of findings in clinical trials to patients meeting other case definitions for COPD.
authors.affiliation: 1 Division of Pulmonary, Critical Care, Sleep and Allergy and.
authors.forename: Valentin
authors.initials: V
authors.lastname: Prieto-Centurion
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Rolle
authors.forename: David H
authors.initials: DH
authors.lastname: Au
authors.forename: Shannon S
authors.initials: SS
authors.lastname: Carson
authors.forename: Ashley G
authors.initials: AG
authors.lastname: Henderson
authors.forename: Todd A
authors.initials: TA
authors.lastname: Lee
authors.forename: Peter K
authors.initials: PK
authors.lastname: Lindenauer
authors.forename: Mary A
authors.initials: MA
authors.lastname: McBurnie
authors.forename: Richard A
authors.initials: RA
authors.lastname: Mularski
authors.forename: Edward T
authors.initials: ET
authors.lastname: Naureckas
authors.forename: William M
authors.initials: WM
authors.lastname: Vollmer
authors.forename: Binoy J
authors.initials: BJ
authors.lastname: Joese
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Krishnan
mesh_terms: D000368:Aged; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D038801:International Classification of Diseases; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis*
keywords: COPD; ICD-9-CM; case definitions; comparative effectiveness; spirometry