BetaEntity Annotation Prototype
← Back to drugs

Annotated abstract

P.319 Comparative sensitivity to change of ScleroId and UCLA GIT score in a lower GI predominant SSC cohort

jsrd · 2026-06-05 · canonical JSON source

4 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Introduction Systemic sclerosis (SSc) is a heterogeneous autoimmune disease frequently affecting multiple organs, including the gastrointestinal tract (GIT). Several patient-reported outcome measures (PROMs) exist, but few cover the full spectrum of symptoms relevant to patients. The recently developed and validated EULAR ScleroID is a disease-specific, patient-derived tool with demonstrated reliability and responsiveness. However, it has not yet been evaluated in clinical trial settings or compared directly with established GIT-specific tools such as the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA GIT 2.0).Material and Methods This study evaluated the sensitivity to change of ScleroID compared with UCLA GIT 2.0 and explored correlations between upper and lower GI symptom domains using data from the randomized ReSScue clinical trial. The trial enrolled SSc patients with moderate to severe bloating and/or diarrhea, as defined by UCLA GIT scores.Participants completed both PROMs at baseline and after 20 weeks. ScleroID includes six domains: Raynaud’s phenomenon, hand function, upper and lower GI symptoms, mobility, and life impact, each scored on a 0–10 Likert scale, with higher scores indicating greater impairment. UCLA GIT 2.0 consists of seven subscales—reflux, bloating/distention, diarrhea, constipation, fecal soilage, emotional well-being, and social functioning—scored from 0 to 3 based on symptom frequency and severity. Changes over time were analyzed using paired t-tests. Standardized response means (SRMs) assessed sensitivity to change, with SRM approximately 0.20 indicating low, 0.50 indicating moderate, and approximately 0.80 indicating high sensitivity. Spearman’s correlations evaluated relationships between domains.Results The cohort included 67 SSc patients (mean age 60.5 years, mean disease duration 10 years). Using ScleroID, 54% reported improvement in upper GIT symptoms and 51% in lower GIT symptoms. Using UCLA GIT 2.0, 56%, 59%, and 33% reported improvement in reflux, bloating, and diarrhea, respectively. Both tools showed low-to-moderate sensitivity to change: ScleroID SRM = 0.42 (95% CI: 0.10–0.68); UCLA GIT 2.0 SRM = 0.45 (95% CI: 0.18–0.77). Strong correlations existed between ScleroID upper GIT and UCLA reflux (r = 0.799, p < 0.001). Moderate correlations appeared between ScleroID lower GIT and UCLA constipation (r = 0.306, p = 0.031) and bloating (r = 0.444, p < 0.001).Conclusions ScleroID and UCLA GIT 2.0 demonstrated comparable low-to-moderate sensitivity to change and strong domain-specific correlations, supporting their utility as outcome measures in clinical trials of SSc patients with GI manifestations.Abstract P.319 Figure 1SRM in both questionnairesAbstract P.319 Table 1Demographics