PROMises Made, PROMises To Be Kept: Patient-Reported Outcome Measures in Inflammatory Bowel Diseases

With the Food and Drug Administration's (FDA) mandate to move from clinical disease activity indices to co-primary end points of patient-reported outcomes (PROs) and objective measures of disease for regulatory approval of inflammatory bowel disease (IBD) pharmacotherapy, and with the increasing emphasis on population health management and value-based care, PROs are the buzzword in IBD and other chronic gastrointestinal conditions.1–6 In contrast to conventional clinical disease activity indices such as the Crohn's disease activity index or the Mayo Clinic Score for ulcerative colitis, which includes a combination of patient-reported symptoms, physician interpretation of disease activity, and objective measures of disease activity, PROs are self-administered reports that comes directly from a patient about a health condition or its treatment, without interpretation of the patient's response by a clinician or anyone else.

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