The Short-Form Leeds Dyspepsia Questionnaire validation study A. FRASER*, B. C. DELANEY*, A. C. FORD  , M. QUME* & P. MOAYYEDI* *Department of Primary Care and General Practice, Primary Care Clin- ical Sciences Building, University of Birmingham, Edgbaston, Birming- ham;  Centre for Digestive Diseases, Leeds General Infirmary, Leeds, West Yorkshire, UK Correspondence to: Dr B. C. Delaney, Department of Primary Care and General Practice, Primary Care Clinical Sciences Building, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. E-mail: a.a.fraser@bham.ac.uk Publication data Submitted 9 August 2006 First decision 24 August 2006 Resubmitted 9 December 2006 Accepted 13 December 2006 SUMMARY 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 question- naire was developed (the Short-Form Leeds Dyspepsia Questionnaire). Aim To assess the acceptability, interpretability, internal consistency, reliab- ility, 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 practi- tioners’ 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 fre- quency and severity of dyspepsia symptoms, which is shorter and more convenient than the Leeds Dyspepsia Questionnaire. Aliment Pharmacol Ther 25, 477–486 Alimentary Pharmacology & Therapeutics ª 2007 The Authors 477 Journal compilation ª 2007 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2006.03233.x