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pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

Imelda GI Clinical Research Center · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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disabilityinflammatory-bowel-diseasepatient-reported-outcomesulcerative-colitis
Background and rationale: In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized. Objectives and design: To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.
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