title: Validation of the Clinical COPD questionnaire in Italian language.
abstract: BACKGROUND
  The development and validation study of the Clinical Chronic Obstructive Disease (COPD) Questionnaire (CCQ) has recently been published in this journal. The CCQ is the first questionnaire that incorporates both clinician and patient guideline goals in the clinical control evaluation of patients with COPD in general clinical practice. The aim of this study is the validation of the CCQ questionnaire in Italian, in specific pulmonary disease clinical practice.
  
  
  METHODS
  Validity was tested on a population of healthy subjects and patients with COPD, using the Italian validated version of the Short Form Health Survey (SF-36) and guideline recommended routine measurement in COPD patients (FEV1, FVC, BMI and functional dyspnoea). Test-retest reliability was tested by re-administering the CCQ after 2 weeks. Responsiveness was tested by re-administering the CCQ after three weeks of hospital pulmonary rehabilitation. Distance walked and Borg breathlessness rating were measured at the end of the six-minute walking test (6 MWT), before and after rehabilitation.
  
  
  RESULTS
  Cross-sectional data were collected from 175 subjects (55 healthy; 40 mild-moderate, 50 severe and 25 very severe COPD). Cronbach's alpha was high (0.89). The CCQ scores in patients were significantly worse than in healthy subjects. The CCQ total score in patients with COPD was significantly worse in those with BMI < or = 21. Significant correlations were found between the CCQ total score and domains of the SF-36 (rho = -0.43 to rho = -0.72). The correlation between the CCQ and FEV1 % predicted was rho = -0.57. The correlation between the CCQ and MRC was rho = 0.63. Test-retest reliability was determined in 112 subjects over a period of two weeks (Intra Class Coefficient = 0.99). Forty-six patients with COPD showed significant improvement in CCQ scores, distance-walked and Borg breathlessness rating after 3 weeks of pulmonary rehabilitation, indicating CCQ responsiveness.
  
  
  CONCLUSIONS
  The CCQ is self-administered and has been specially developed to measure clinical control in patients with COPD. Data support its validity, reliability and responsiveness in Italian and in specific pulmonary disease clinical practice.
authors.affiliation: Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Via Cadore 48, 20052 Monza, MI, Italy. salvatore.damato@unimib.it
authors.forename: Salvatore
authors.initials: S
authors.lastname: Damato
authors.forename: Chiara
authors.initials: C
authors.lastname: Bonatti
authors.forename: Vinicio
authors.initials: V
authors.lastname: Frigo
authors.forename: Silvana
authors.initials: S
authors.lastname: Pappagallo
authors.forename: Rita
authors.initials: R
authors.lastname: Raccanelli
authors.forename: Claudio
authors.initials: C
authors.lastname: Rampoldi
authors.forename: Francesco
authors.initials: F
authors.lastname: Rodi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D003627:Data Interpretation, Statistical; D005080:Exercise Test; D005260:Female; D006801:Humans; D007558:Italy; D007802:Language; D008137:Longitudinal Studies; D008173:Lung Diseases, Obstructive / Q000503:physiopathology* / Q000534:rehabilitation; D008297:Male; D008875:Middle Aged; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life; D012129:Respiratory Function Tests; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires / Q000592:standards*; D014177:Translations