THE CORRESPONDENCE BETWEEN PATIENT-REPORTED OUTCOME (PRO) INSTRUMENTS AND MEASURES OF DISEASE ACTIVITY IN ADULT PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS (UC) RECEIVING SHORT-TERM DAILY TREATMENT WITH MMX MESALAMINE

Author(s)

Yarlas A1, Willian MK2, Joshi AV3
1Optum, Lincoln, RI, USA, 2Shire, Wayne, PA, USA, 3Shire Development LLC, Wayne, PA, USA

OBJECTIVES: To examine correspondences between PROs with changes in disease activity and treatment in patients with UC.  PRO instruments assessed generic health-related quality of life (HRQL; 12-item Short Form v2 [SF-12v2]), disease-specific HRQL (Shortened Inflammatory Bowel Disease Questionnaire [SIBDQ]), and work-related outcomes (WROs; Work Productivity and Activity Impairment Questionnaire: UC [WPAI:UC]).  METHODS: Adults with mild-to-moderate UC received MMX mesalamine 4.8 mg/d for 8 weeks in an open-label, prospective study (NCT01124149).  PROs, and a modified UC-Disease Activity Index (UCDAI) that captured several symptoms, including stool frequency (SF) and rectal bleeding severity (RBS), were administered at baseline and Week 8.  Spearman coefficients examined associations between changes in PROs and disease activity.  Analysis of variance (ANOVA) models tested changes in scores over time, with Cohen’s d’s used to interpret effect sizes.  ANOVAs examined PRO change scores as a function of improvement (≥1-point reduction) in SF and RBS.  RESULTS:

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PGI28

Topic

Economic Evaluation, Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes, Work & Home Productivity - Indirect Costs

Disease

Gastrointestinal Disorders

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