title: The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia.
abstract: OBJECTIVE
  s: To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP).
  
  
  METHODS
  A psychometric study within an international, prospective, randomized, double-blind study. The CAP-symptom questionnaire (CAP-Sym) is a new, 18-item, patient-reported outcome measure that evaluates the bothersomeness of CAP-related symptoms during the past 24 h using a 6-point Likert scale. We used "gold standard" psychometric methods to comprehensively evaluate the acceptability, reliability, validity, and responsiveness of the CAP-Sym.
  
  
  METHODS
  Sixty-four centers in 13 countries (France, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom).
  
  
  METHODS
  Five hundred fifty-six patients with CAP, recruited from outpatient clinics, general practice, and hospital centers.
  
  
  METHODS
  Randomization 1:1 to moxifloxacin (400 mg once daily), oral or standard oral treatment (amoxicillin, 1 g tid, or clarithromycin, 500 mg bid), alone or in combination, for up to 14 days.
  
  
  RESULTS
  Standard psychometric tests confirmed the acceptability (item nonresponse, item-endorsement frequencies, item/scale floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations, test-retest reliability), validity (content, construct, convergent, discriminant, known groups), and responsiveness of the CAP-Sym.
  
  
  CONCLUSIONS
  The CAP-Sym is a practical and scientifically sound patient-based outcome measure of CAP-related symptoms that has been developed using "gold standard" methods. As the only fully validated measure of symptoms in patients with CAP, which is quick and easy to administer and is more responsive than the generic Medical Outcomes Study 36-Item Short-Form Health Survey, the CAP-Sym provides a practical and rigorous method for improving the evaluation of outcomes in clinical trials and audit.
authors.affiliation: Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, UK. donna.lamping@lshtm.ac.uk
authors.forename: Donna L
authors.initials: DL
authors.lastname: Lamping
authors.forename: Sara
authors.initials: S
authors.lastname: Schroter
authors.forename: Patrick
authors.initials: P
authors.lastname: Marquis
authors.forename: Alexia
authors.initials: A
authors.lastname: Marrel
authors.forename: Isabelle
authors.initials: I
authors.lastname: Duprat-Lomon
authors.forename: Pierre-Philippe
authors.initials: PP
authors.lastname: Sagnier
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects; D001372:Aza Compounds; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D017714:Community-Acquired Infections / Q000175:diagnosis* / Q000188:drug therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D017063:Outcome Assessment, Health Care; D018410:Pneumonia, Bacterial / Q000175:diagnosis* / Q000188:drug therapy; D011594:Psychometrics; D011785:Quality Assurance, Health Care; D011804:Quinolines; D011795:Surveys and Questionnaires
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000658:Amoxicillin; D017291:Clarithromycin; D000077266:Moxifloxacin