Evidence map›Paper›PMID 41073110›Full record

Observational studyRMD open2025

Cross-validation and sensitivity to change of EULAR ScleroID as a measure of function and impact of disease in patients with systemic sclerosis.

Seda Yurumez Colak, Stefano Di Donato, Riccardo Bixio, Lesley-Anne Bissell, Theresa Barnes, Muhammad Nisar, Vishal Kakkar, Chris Denton, Francesco Del Galdo

Abstract readObservational Study
In one paragraph

Observational study in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Seda Yurumez ColakLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK S.Colak@leeds.ac.uk.ORCID 0000-0002-5703-6739
Stefano Di DonatoLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK.
Riccardo BixioLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK.
Lesley-Anne BissellLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK.
Theresa BarnesDepartment of Rheumatology, Countess of Chester Hospital NHS Foundation Trust, Chester, UK.
Muhammad NisarDepartment of Rheumatology, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.
Vishal KakkarLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK.
Chris DentonDepartment of Rheumatology, Royal Free London NHS Foundation Trust, London, England, UK.
Francesco Del GaldoLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds Faculty of Medicine and Health, Leeds, UK.ORCID 0000-0002-8528-2283

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

methodsPatients 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.

resultsData 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.

conclusionScleroID 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.

Indexed as

Scleroderma, SystemicAdultAgedFemaleHumansMaleMiddle AgedMinimal Clinically Important DifferenceQuality of LifeReproducibility of ResultsSeverity of Illness IndexSurveys and QuestionnairesDisease ActivityPatient Reported Outcome MeasuresSystemic Sclerosis

Identifiers

PMID41073110
PMCPMC12516988

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.