Burden of Crohn's disease: economics and quality of life aspects in Italy.

BACKGROUND: This was a prospective observational study designed to evaluate direct and indirect costs and quality of life for patients with Crohn's disease in Italy from the perspectives of the National Health System and of society. METHODS: A total of 162 male and female subjects aged 18-70 years with Crohn's disease in the active phase and a Crohn's Disease Activity Index score ≥150 were included in the study. Subjects were recruited from 25 Italian centers on a consecutive basis. The study consisted of four visits undertaken every 6 months with a follow-up period of 18 months. The study started on September 1, 2006 and was completed on April 12, 2010. Multivariate analyses were carried o…