PTU-100 Developing Swansea inflammatory bowel disease clinical severity index (SICSI)

Abstract

Introduction: Most of disease severity indices in IBD were not properly validated and did not go through robust methodology. Using different scoring systems makes it difficult to compare different trials especially when the end points are different. Therefore, there is a need to optimize and standardize methodology for assessing of disease activity in clinical trials. With the nationwide initiative to establish an IBD registry, a valid and easy to use activity measurement tool is needed. Our aim is to develop a single disease activity index that is suitable for all types and presentations of IBD. Methods: Literature search was conducted using MEDLINE and Google scholar database from January 1947 to 2011 to identify the clinical severity indeces commonly used in clinical trails. Seventeen indeces were identified for both Ulcerative coltis and Crohn's disease. We followed a clini-metric approach to develop the simple IBD clinical severity index. Few items were added to cover disease specific domains. The new index was examined by gastroenterologists and methodologists in Swansea University to ensure good face and content validity. The index was tested on 50 patients with different presentations of inflammatory bowel disease. Harvey Bradshaw index and Simple clinical colitis index were used for construct validity. Responsiveness was checked by repeating the test within 2 week period. Results: The new index, simple IBD clinical severity index, showed good face and content validity. It covers all presentations of IBD including Crohn's disease, ulcerative coltis and perianal disease. It has good reliability and construct validity. It is easy to use in daily practice. Conclusion: Simple IBD clinical severity index is a new tool to assess the clinical activity of IBD. It is valid, reliable, user friendly and non invasive index. Further studies are required to check how it perfoms on a wider range of patients.