Article Text

SAT0219 Correlation between Patient-Reported Outcomes and Changes in Digital Ulcer Status in Systemic Sclerosis Patients
  1. C. Bruni1,
  2. T. Ngcozana2,
  3. F. Braschi1,
  4. S. Guiducci1,
  5. S. Bellando-Randone1,
  6. L. Tofani3,
  7. C.P. Denton2,
  8. D.E. Furst4,
  9. M. Matucci-Cerinic1
  1. 1Department of experimental and clinical medicine, division of Rheumatology, University of Firenze, Firenze, Italy
  2. 2Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine, London, United Kingdom
  3. 3Department of Neurosciences, Psychology, Drug Research and Child Health, University of Firenze, Firenze, Italy
  4. 4Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, United States


Background Among various measures used to evaluate patients with systemic sclerosis (SSc), the Health Assessment Questionnaire (HAQ-DI) for disability, the UK scleroderma Functional Score (UKFS) and the Cochin Scale for hand functionality, the Visual Analogic Scale (VAS) to estimate pain, general disease activity and digital ulcers status are among the more frequently used [1]. Digital Ulcers (DU) are a major clinical complication in patients with Systemic Sclerosis (SSc), leading to a severe impairment of the quality of life and possibly determining important complication (from infections to amputation).

Objectives this study aimed at evaluating the correlation between Clinician-Reported outcomes (CROs) and patient-reported outcome (PROs) and how changes in different parameters related to DU status in SSc patients may reflect changes in the above mentioned outcome measures.

Methods SSc patients presenting at least one DU and attending the Rheumatology Wound Care Clinic of the Florence University Hospital or the London Royal Free Hospital were eligible for the study. Patients were assessed with HAD-DI, UKFS, Cochin scale, VAS for pain, DU status and general disease status (as PROs) and VAS for DU status (as CROs) at baseline and then every 4 weeks for a total of 16 weeks (or until DU healing, if occurred before). Number of DU, appearance of new DU, presence of gangrene, infection, need for hospitalization or surgery procedures, painkillers use were recorded at each visit. Correlations were tested through Spearman test.

Results forty-four SSc patients were enrolled in the study. At baseline, all the PROs and CROs were positively correlated to each other, with most of the scales being also correlated with baseline DU number, presence of infection, need for hospitalization and painkillers use. When investigating baseline to mean follow-up changes, significant correlations were confirmed between CROs and PROs (except for VAS for general disease status), as well as between changes in PROs/CROs and changes of DU parameters being already significant at baseline.

Conclusions PROs are useful outcome measures paralleling changes in clinical evaluation of DU status, which is influenced by changes in DU number, presence of infection, need for hospitalization and painkillers use.

  1. Pope J. Measures of systemic sclerosis (scleroderma): Health AssessmentQuestionnaire (HAQ) and Scleroderma HAQ (SHAQ), physician- and patient-ratedglobal assessments, Symptom Burden Index (SBI), University of California, LosAngeles, Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTCGIT) 2.0, Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) (Mahler's Index), Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), and Raynaud's Condition Score (RCS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S98–111.

Disclosure of Interest None declared

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