Ab0703 towards Treat-to-Target Patient Centred Care: Development of Multidimensional Disease Specific Patient Reported Outcome Measures Questionnaire for Giant Cell Arteritis

Abstract

BackgroundGiant Cell Arteritis (GCA) is the commonest form of systemic vasculitis in people over the age of 50. In 2017, the OMERACT Vasculitis Working Group published a core set of domains and outcome measures for use in clinical trials in large vessel vasculitis [1] and highlighted the lack of a disease-specific patient reported outcomes (PROMs) for GCA. The OMERACT group proposed a draft core set of domains for GCA, including disease specific domains, organ and arterial function, psychosocial impact and physical function biomarkers, fatigue, pain, as well as death.ObjectivesTo assess the validity, reliability and responsiveness to change of a patient self-reported questionnaire to assess for the construct outcome measures, co-morbidities and the impact of GCA and its treatment on health-related quality of life in GCA patients.MethodsThe PROMs-GCA was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the GCA specific physical and psychological symptoms, sense of self, symptoms severity using numerical visual analogue scale (0-10) in addition to assessment of functional disability, quality of life (QoL), review of the systems, glucocorticoids benefit:risks, comorbidities as well as motivation [2]. In addition, every patient completed HAQ and EQ-5D questionnaires.ResultsA total of 52 GCA patients completed the questionnaire. The PROMs-GCA questionnaire was reliable as demonstrated by a high standardized alpha (0.867-0.941). Content construct assessment of the PROMs-GCA/functional disability and QoL revealed significant correlation (p< 0.01) with both HAQ and EQ-5D. Changes in functional disability, QoL showed significant (p< 0.01) variation with diseases activity status in response to therapy.ConclusionThe developed PROMs-GCA questionnaire is a reliable and valid instrument for assessment of patients living with GCA. A phased treatment regimen depending on the severity of GCA as well as the patient’s preferences and comorbidities are the best approach to tailored patient management.References[1]Sreih AG, et al. Development of a core set of outcome measures for large-vessel vasculitis: report from OMERACT 2016. J Rheumatol. 2017;44(12):1933–7[2]El Miedany et al. Meaningful patient engagement in inflammatory arthritis: Development of the patient motivation questionnaire. Clin Rheumatol. 2017 doi: 10.1007/s10067-017-3605-x.Acknowledgements:NIL.Disclosure of InterestsNone Declared.