AB0357 LANDSCAPE REVIEW OF PATIENT-REPORTED OUTCOME MEASURES IN GIANT CELL ARTERITIS

Background: Giant cell arteritis (GCA) is a systemic large vessel vasculitis that results in symptoms (e.g., headaches, jaw claudication, fatigue, pain, etc.) can have multiple negative impacts on an individual’s health-related quality of life. Objectives: To identify important and experienced by individuals with GCA, develop conceptual model, evaluate available patient reported outcome (PRO) measures for appropriateness inclusion GCA clinical studies. Methods: Published literature disease experience from databases, conference abstracts, Guidance/OMERACT documents were reviewed. A model was developed based the identified this supplemented input. detailed review selected PROs then conducted to assess concept coverage gaps population. Results: Of 245 citations, 24 abstracts 18 articles Key affecting patients ischemic constitutional symptoms) lives reduced physical, social emotional functioning) formed basis (see Figure 1). No GCA-specific identified. Therefore, used most frequently studies reviewed evaluated. These included SF-36, FACIT-Fatigue, Patient Global Assessment (PtGA), Multidimensional Fatigue Inventory (MFI), EQ-5D, Health Questionnaire (HAQ), Brief Illness Perception (BIPQ), Visual Functioning Questionnaire-25 (VFQ-25). some key but did not fever, etc.). input there has been limited evaluation measurement properties these patients. The PtGA, which administered published studies, measure concepts such as functioning, impact daily activities status. (reliability, validity, sensitivity change) documented several other rheumatologic diseases (Table Conclusion: In absence PRO, FACIT- Fatigue, PtGA are recommended use assessment literature. Qualitative quantitative research should be content validity Table 1. Summary Recommended Measures Description SF-36 FACIT-Fatigue Type Generic, health status function/daily Measure activity Method Administration Self/Interviewer Self # Items 36 13 1 Recall period Past 4 weeks/past week 7 days Varies Scoring 8 domain scores; 2 component summary scores Total score Measurement demonstrated (SLE, RA, SpA, chronic knee pain); construct single study populations including SLE, PsA, RA Select (RA, TAK, RP) Concept (emotional, activities), bodily fatigue Overall Administered recent YES SLE= lupus erythematosus, SpA = spondyloarthritis, PsA=psoriatic arthritis, RA=rheumatoid GCA= giant arteritis, TAK=Takayasu’s RP=relapsing polychondritis Disclosure Interests: Hilary H Colwell Consultant of: Janssen Pharmaceutical Companies Johnson & Johnson, Susan Mathias Kelly Kato Employee Catherine E Najem Shareholder Amy M Archer