Colak, Seda Y;
Di Donato, Stephano;
Bixio, Riccardo;
Bissell, Lesley-Anne;
Barnes, Theresa;
Nisar, Muhammed;
Kakkar, Vishal;
... Del Galdo, Francesco; + view all
(2025)
Cross-validation and sensitivity to change of EULAR ScleroID as a measure of function and impact of disease in patients with systemic sclerosis.
RMD Open: Rheumatic and Musculoskeletal Diseases
, 11
(4)
, Article e005999. 10.1136/rmdopen-2025-005999.
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Cross-validation and sensitivity to change of EULAR ScleroID as a measure of function and impact of disease in patients with.pdf - Published Version Download (1MB) | Preview |
Abstract
OBJECTIVE: To determine the distribution of the EULAR SSc Impact of Disease (ScleroID) and its domain questions in very early (Ve), limited (lc) and diffuse cutaneous (dc) subsets, its value in reflecting clinical severity, and to assess its sensitivity to change and minimal clinically important difference (MCID) in a 12-month interval. // METHODS: Patients with ScleroID questionnaires from the observational cohort STRIKE were included in the study. Changes (Δ) were calculated as the difference between 12-month follow-up and compared MCIDs of the other measures. // RESULTS: Data were available for 271 patients, 69 with Ve, 139 lc and 63 dc systemic sclerosis (SSc). Median (IQR) ScleroID scores were progressively higher in the 3 subsets with 2.1 (3.6) for VeSSc, 3.4 (4.4) for lcSSc and 4.7 (4) for dcSSc (p<0.001). ScleroID showed strong content validity against clinical measures. Patients with high disease activity had significantly higher ScleroID scores than low ones (p=0.003). Presence of digital ulcers, pulmonary disease or small intestinal bacterial overgrowth was all reflected in higher scores in their relative domains (p<0.005 for all). Accordingly, ScleroID scores and its relative domains showed high correlations with all other patient-reported outcomes (PROs) (p<0.05). Changes in ScleroID strongly correlated with changes in clinical measures and other PROs with specific thresholds identified for MCID changes in Health Assessment Questionnaire Disability Index, the University of California Los Angeles Scleroderma Clinical Trials Consortium gastrointestinal tract 2.0 and Cochin Hand Function Scale. // CONCLUSION: ScleroID demonstrates strong correlation with validated clinical measures and responsiveness to changes in standard of care, supporting its use in both clinical practice and trials. ScleroID captures the multidimensional burden of SSc regardless of disease subsets.
| Type: | Article |
|---|---|
| Title: | Cross-validation and sensitivity to change of EULAR ScleroID as a measure of function and impact of disease in patients with systemic sclerosis |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1136/rmdopen-2025-005999 |
| Publisher version: | https://doi.org/10.1136/rmdopen-2025-005999 |
| Language: | English |
| Additional information: | © The Author(s), 2025. This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/ |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10216080 |
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