This study emphasizes the importance of including the perception of bother associated with urinary symptoms in addition to urinary severity and provides information useful for inclusion in education programmes on urinary symptoms.

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OBJECTIVES: To develop a practical and scientifically rigorous, patient‐based outcome questionnaire to evaluate symptoms in community‐acquired pneumonia (CAP). METHODS: The CAP‐Symptom questionnaire (CAP‐Sym) is an 18‐item, interviewer‐administered questionnaire that measures the bothersomeness of 18 symptoms during the past 24 hours 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 in field testing involving 556 patients in 13 countries. The development and validation of the CAP‐Sym were carried out as part of the CAP 2000 study, a multicentre, multinational, prospective, randomised, double‐blind study to compare the effectiveness of moxifloxacin oral tablets to standard oral treatment regimes in patients with CAP. RESULTS: Field testing in all countries confirmed the acceptability (item non‐response, 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 that can be used to evaluate CAP‐related symptoms in clinical trials or clinical audit. The disease‐specific CAP‐Sym shows preliminary evidence of being more responsive than the generic SF‐36 as a measure of outcome in CAP.

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