A validation study of the Italian Short-Form Leeds Dyspepsia Questionnaire.

Assessment of symptoms should be one of the main outcome measures in dyspepsia clinical trials. This requires a reliable, valid and responsive questionnaire that measures the frequency and severity of dyspeptic symptoms. The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) has been proven to fulfil these criteria in its original version in the English language. The aim of the study was to assess the internal consistency, reliability, validity and responsiveness of the Italian version of the SF-LDQ in primary and secondary care. Unselected primary and secondary care patients completed the Italian version of the SF-LDQ. Test-retest reliability was assessed after 2 days. Validity was measured by comparison with diagnosis made by physicians. Responsiveness was determined before and after treatment for endoscopically proven disease. The SF-LDQ was administered to 311 patients in primary care and 179 in secondary care patients. Internal consistency, as judged by the Cronbach's α, was 0.90. Pearson's correlation coefficient for test-retest reliability was 0.92. The SF-LDQ had a sensitivity of 80% and a specificity of 82%. A highly significant response to change was also observed (p = 0.001). The Italian SF-LDQ is a reliable, valid and responsive self-completed outcome measure for quantifying the frequency and severity of dyspeptic symptoms.