The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia
Abstract
STUDY OBJECTIVE: s: To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP).
DESIGN: 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.
SETTING: Sixty-four centers in 13 countries (France, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom).
PATIENTS: Five hundred fifty-six patients with CAP, recruited from outpatient clinics, general practice, and hospital centers.
INTERVENTIONS: 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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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