Pos0823 Multi-Centre Validation of the Pastul Questionnaire for Self-Assessment of Skin Severity in Systemic Sclerosis

Background: The PASTUL (Patient self-Assessment of Skin Thickness in Upper Limb) questionnaire was developed during the COVID pandemic to allow self-assessment of skin remotely in systemic sclerosis (SSc) 1. Objectives: The aim of this study was to validate PASTUL, evaluate responsiveness and assess impact of skin on health related quality of life (HRQoL). Methods: SSc patients were included in four UK centres. The PASTUL questionnaire specifies a grading of skin (normal, mild, moderate, severe thickness) at eight sites corresponding to the modified Rodnan Skin Score (mRSS) with maximum score assigned to each site. Validity was assessed by comparing PASTUL scores with mRSS assessed by trained rheumatologists. HRQoL (EQ5D5L and Leeds SSc HRQoL) and Scleroderma Skin Patient reported Outcome (SSPRO) were collected for construct validity, using Pearson's correlation coefficient (0-0.19 = negligible, 0.2-0.39 = weak, 0.4-0.59 = moderate, 0.6-0.79 = strong, 0.8-1.0 = very strong). Test-retest reliability was estimated 2 weeks after baseline and using intraclass correlation coefficient (ICC). Patients were followed for 12 months to assess responsiveness of PASTUL to change in mRSS. Results: 200 patients were included, mean age 56.0 years (SD 14.0), 79% female (n=142), 90 (53%) had limited cutaneous SSc (lcSSc) and 79 (47%) diffuse cutaneous SSc (dcSSc). At baseline mean disease duration was 12.0 years (SD 9.7), mRSS was 8.2 (SD 8.0) and PASTUL score was 9.3 (SD 6.1). At baseline, 6 and 12 months follow-up, PASTUL and mRSS were strongly correlated (r=0.63, r=0.76, r=0.72, p 2, at 12 months this was 36%. Responsiveness of PASTUL at 6 and 12 months was r=0.17 and r=0.19. Conclusion: PASTUL is a valid and feasible outcome tool that adds a self-reported measure of skin severity to impact assessments like SSPRO. Skin thickening is associated with HRQoL in patients with early disease. PASTUL might be promising for clinical outcome assessment of skin thickening over time but needs further assessment in a larger cohort REFERENCES: 1 Spierings J, Ong, VH all outside the submitted work , Francesco Del Galdo has received research funding and/or consulting fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Actelion, Capella Bioscience, Chemomab, Kymab, Actelion, iqvia, and Mitsubishi Tanabe; all outside the submitted work, Ariane L. Herrick has received speaker fees from Janssen, consultancy fees from Arena, Boehringer Ingelheim, Camurus, CSL Behring Galderma and Gesynta Pharma., financial research grants from Gesynta Pharma; all outside the submitted work, Christopher P Denton has received speaker fees from Janssen and Boehringer Ingelheim, consultancy fees from Janssen, GlaxoSmithKline, Boehringer Ingelheim, Roche, CSL Behring, Corbus, Acceleron, Horizon, Arxx Therapeutics, Lilly, Novartis, Certa, research grants from GSK, Abbvie, Horizon, Arxx, Servier; all outside the submitted work.