TY  - JOUR
UR  - https://doi.org/10.1136/rmdopen-2024-004653
PB  - BMJ
N2  - OBJECTIVE: Systemic sclerosis Impact of Disease (ScleroID) is the first comprehensive patient-reported outcome measure (PROM) specifically developed for systemic sclerosis (SSc). We investigated the performance of ScleroID in patients with diffuse cutaneous SSc (dcSSc), as a prerequisite for its use in randomised controlled trials (RCTs) testing potentially disease-modifying drugs. METHODS: All patients with dcSSc from the large, multicentric, ScleroID cohort were included. SSc-Health Assessment Questionnaire (HAQ), EuroQol-5 Dimensions and 36-item Short Form Health Survey (SF-36) were used as comparators. The study includes a longitudinal arm with a reliability visit at 7±3?days and a 12?months follow-up visit. The performance of ScleroID in dcSSc was assessed according to the Outcome Measures in Rheumatology filter. RESULTS: In total, 152 dcSSc patients were analysed (29% male, median age 54 years). ScleroID reflected well the disease impact of dcSSc, showing a good construct validity with high Spearman's correlation coefficients with comparators (SSc-HAQ, 0.79, 95% CI (0.69, 0.86); HAQ-Disability Index, 0.72 95% CI (0.60, 0.80); SF-36 physical score, -0.69 95% CI (-0.77, -0.60)). The internal consistency was strong (Cronbach's alpha 0.87, split-half reliability coefficient 0.88). In the longitudinal arm, 44 patients had a reliability visit and 113 had a follow-up visit, of whom 19/113 (17%) reported a significant change (11 improved, 8 worsened). ScleroID showed a good consistency and discriminative ability with excellent test-retest reliability (intraclass correlation coefficient 0.89, 95% CI (0.84, 0.92)) and moderate sensitivity to change (standardised response mean -0.63 in the improved subgroup and 0.48 in the worsened subgroup), but superior to the comparators. CONCLUSION: The European Alliance of Associations for Rheumatology (EULAR) ScleroID performs well for patients with dcSSc. This supports its inclusion and regular assessment as PROM in RCTs.
ID  - discovery10202580
A1  - Dobrota, R
A1  - Garaiman, A
A1  - Fligelstone, K
A1  - Tyrrell Kennedy, A
A1  - Roennow, A
A1  - Allanore, Y
A1  - Carreira, PE
A1  - Czirják, L
A1  - Denton, C
A1  - Hesselstrand, R
A1  - Sandqvist, G
A1  - Kowal-Bielecka, O
A1  - Bruni, C
A1  - Matucci-Cerinic, M
A1  - Mihai, C
A1  - Gherghe, AM
A1  - Mueller-Ladner, U
A1  - Kvien, T
A1  - Heiberg, T
A1  - Distler, O
A1  - Becker, MO
JF  - RMD open
AV  - public
Y1  - 2024///
VL  - 10
TI  - Performance of the EULAR Systemic sclerosis Impact of Disease (ScleroID) questionnaire as a patient-reported outcome measure for patients with diffuse systemic sclerosis
IS  - 4
N1  - © Author(s) (or their employer[s]) 2024. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license (http://creativecommons.org/licenses/by-nc/4.0/).
ER  -