Hépato-Gastro & Oncologie Digestive


Helping patients with inflammatory bowel disease to return to a normal life: the concept of patient-reported outcomes Volume 22, supplement 2, Octobre 2015

CHU de Nancy,
service d’hepato-gastroenterologie,
Université de Lorraine,
Allée de Morvan,
54511 Vandoeuvre-lès-Nancy,
* Tirés à part

Patient-reported outcomes (PROs) always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients’ experience with different therapies.