Background: Assessment of symptoms should be the primary outcome measure in dyspepsia clinical trials. This requires a reliable, valid and responsive questionnaire that measures the frequency and severity of dyspepsia. The Leeds Dyspepsia Questionnaire fulfils these characteristics, but is long and was not designed for self-completion, so a shorter questionnaire was developed (the Short-Form Leeds Dyspepsia Questionnaire).
Aim: To assess the acceptability, interpretability, internal consistency, reliability, validity and responsiveness of the Short-Form Leeds Dyspepsia Questionnaire in primary and secondary care.
Methods: Unselected primary and secondary care patients completed the Short-Form Leeds Dyspepsia Questionnaire. Test-retest reliability was assessed after 2 days. Validity was measured by comparison with general practitioners' diagnosis. Sensitivity analysis and logistic regression were employed to determine the most valid scoring system. Responsiveness was determined before and after treatment for endoscopically proven disease.
Results: The Short-Form Leeds Dyspepsia Questionnaire was administered to 388 primary care and 204 secondary care patients. The Pearson coefficient for test-retest reliability was 0.93. The Short-Form Leeds Dyspepsia Questionnaire had a sensitivity of 77% and a specificity of 75%. A highly significant response to change was observed (P < 0.005).
Conclusions: The Short-Form Leeds Dyspepsia Questionnaire is a reliable, valid and responsive self-completed outcome measure for quantifying the frequency and severity of dyspepsia symptoms, which is shorter and more convenient than the Leeds Dyspepsia Questionnaire.