Abstract
Outcomes in Crohn's disease clinical trials are traditionally reported in terms of remission and response rates according to the Crohn's Disease Activity Index (CDAI), which was developed as part of the National Cooperative Crohn's Disease Study (1). However, it has been argued that the CDAI does not measure the overall burden of the illness experienced by patients. An alternative is to assess the impact of a particular therapy on health-related quality of life (HRQL). HRQL not only measures the benefits of the therapy on disease symptoms but also is probably better at evaluating the trade-off between therapeutic efficacy and potential adverse effects.