Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1-14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were determined (St Mark's ,3.5, ulcerative colitis disease activity index ,2.5, simple clinical colitis activity index (SCCAI) ,2.5, Seo ,120, and inflammatory bowel disease quality of life index (IBDQ) .205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease .1.5, Seo decrease .30, IBDQ increase .20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.

Endoscopy items contribute little additional information to indices of disease activity in ulcerative colitis. The clinical practice of treating patients based on reported symptoms is appropriate. The use of noninvasive indices in clinical trials could lower study costs and may increase subjects' willingness to participate.

Summary Background Ulcerative colitis disease activity indices have not been formally validated. Aim To analise quantitatively the psychometric and performance validity of two non‐endoscopic indices for ulcerative colitis, the Simple Clinical Colitis Activity Index and the Seo Index. Methods In 66 patients with ulcerative colitis, the measurement of disease activity was repeated with the two non‐endoscopic indices, St Mark's Index, and the Inflammatory Bowel Disease Questionnaire. Psychometric validity was evaluated by measuring the content, construct, criterion‐convergent and criterion‐predictive validity on a 0–1 scale. Performance validity was evaluated by measuring the reproducibility and responsiveness on a 0–1 scale. Results The Simple Clinical Colitis Activity Index had good to excellent psychometric and performance validity, while the Seo Index had moderate to excellent psychometric validity and moderate to good performance validity. The Simple Clinical Colitis Activity Index had weaknesses in content validity and in responsiveness. The Seo Index had weaknesses in content validity, construct validity and responsiveness. Conclusions These two non‐endoscopic indices for ulcerative colitis have good psychometric and performance validity, and are now the most rigorously validated disease activity indices for ulcerative colitis. The Simple Clinical Colitis Activity Index appears to have better overall validity. Quantitative evaluation identifies weaknesses in disease activity indices, and can lead to better disease activity indices for ulcerative colitis.

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We conclude that intestinal epithelial cells from IBD patients are more readily transfected by standard adenoviral vectors than are those from control patients. These results suggest that targeting genes to inflamed intestine through the luminal route may be possible.