The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia.
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.
Lamping
Donna L
DL
Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, UK. donna.lamping@lshtm.ac.uk
Schroter
Sara
S
Marquis
Patrick
P
Marrel
Alexia
A
Duprat-Lomon
Isabelle
I
Sagnier
Pierre-Philippe
PP
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
D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000658:Amoxicillin; D017291:Clarithromycin; D000077266:Moxifloxacin