Background Over time, a patient-centered evaluation of health status has become more important for systemic sclerosis (SSc), both in research and clinical setting. Patient-reported outcomes (PROs) are being increasingly used to measure various domains of disease status relevant to patients and physicians. The EULAR Outcome Measures Library (OML) is a freely available website with structured access to a growing database of validated PROs , but currently there are no PROs available on SSc at the EULAR OML.
Objectives To provide a comprehensive review of validated SSc-specific PROs and to critically appraise their validity.
Methods A sensitive search was developed in Medline and Embase (08/2015) to identify all validation studies, cohort studies, reviews or metaanalyses in which the objective were the development or validation of PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist.
Results From 13,140 articles captured, 74 met the predefined criteria. After excluding an instrument for the unavailability of an English version, the selected studies provided information on 6 SSc-specific PROs: the Scleroderma Assessment Questionnaire (SAQ), the scleroderma functional score (FS), the Raynaud's condition score (RCS), the Mouth Handicap in SSc (MHISS), the University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract (UCLA-SCTC-GIT 2.0), and the Skin Self-Assessment. The table summarizes the instruments and their measurement properties:
Conclusions Six SSc-specific PROs have a minimum validation and will be included in the EULAR OML. In general, the level of validation attained could be improved. Further development in the area of disease-specific PROs in SSc is warranted.
Castrejόn I, Gossec L, Carmona L. Ann Rheum Dis. 2015;74(2):475–6
Disclosure of Interest None declared