Author(s)
Laires P1, Carrilho M2, Tavares-Costa J3, Lucas P2, Machado P4, Cunha-Miranda L5, Pimentel-Santos F6, Santos H7, Vieira-Sousa E8, Santos MJ9
1Novartis Farma, Porto Salvo, Portugal, 2IQVIA, Porto Salvo, Portugal, 3ULSAM, Ponte de Lima, Portugal, 4University College London, London, UK, 5Portuguese Institute of Rheumatology, Lisbon, Portugal, 6NOVA University of Lisbon, Lisbon, Portugal, 7Instituto Português de Reumatologia, Lisbon, Portugal, 8Hospital de Santa Maria, Lisbon, Portugal, 9Hospital Garcia de Orta, Almada, Portugal
OBJECTIVES: Switching between biologics is a recommended strategy for Psoriatic Arthritis (PsA), with the target being remission or low disease activity, and improved disease management. Biologic switch assessment is therefore of utmost relevance in order to maximize outcomes. This study aims to validate an outcomes measurement tool named PASQAL (Psoriatic Arthritis Switch Quality Assessment tooL). METHODS: PASQAL was recently created to evaluate the quality of biologic switch in PsA patients with peripheral (pPASQAL) and axial (axPASQAL) phenotypes. For PASQAL’s validation, 12 experienced rheumatologists were asked to evaluate and classify the biologic switch of 80 clinical cases (40 with peripheral PsA and 40 with axial PsA). Clinical judgement was defined as the “gold standard” against which the tools’ output was compared. Each clinical case was evaluated by 3 experts and only those with consensual clinical judgement (agreement between at least 2 out of 3 rheumatologists) were included in the validation analysis. The results were used to assess its validity, through sensitivity/specificity analysis, and reliability, through the level of agreement between the tool and the clinical judgement measured by Cohen’s kappa. RESULTS: 75%(30/40) of peripheral PsA and 63%(25/40) of axial PsA switch scenarios reached agreement between rheumatologists and were, therefore, used for PASQAL’s validation. pPASQAL and axPASQAL were more sensitive upon “Good” quality level (92% and 100%), while more specific for the “Insufficient” quality level (97% and 100%). Concerning reliability, good agreement levels were obtained for both tools (k=0.87 pPASQAL;k=0.71 axPASQAL). PASQAL aims for higher standards of care, given that the likelihood of classifying a given switch as “Good” is lower than the rheumatologists’ classification (-25% to -33%). CONCLUSIONS: PASQAL’s validation provided evidence regarding tools’ validity and reliability for both phenotypes. These fully developed and validated tools may support rheumatologists in making more informed therapeutic decisions and be used on real-world research.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PMS64
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance, Clinical Outcomes Assessment, Clinician Reported Outcomes, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders
