title: Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes.
abstract: The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML.
  
  
  
  A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific 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.
  
  
  
  From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements.
  
  
  
  Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted.
authors.affiliation: Department of Clinical Sciences and Community Health, Università degli Studi di Milano, P.zza Cardinal Ferrari 1, 20122 Milano, Italy. Electronic address: francesca.ingegnoli@unimi.it.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ingegnoli
authors.affiliation: Instituto de Salud Musculoesquelética, InMusc, Madrid, Spain.
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona
authors.affiliation: Division of Rheumatology, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy.
authors.forename: Isabel
authors.initials: I
authors.lastname: Castrejon
mesh_terms: D003430:Cross-Sectional Studies; D016208:Databases, Factual; D006801:Humans; D008137:Longitudinal Studies; D015201:Meta-Analysis as Topic; D000071066:Patient Reported Outcome Measures; D016032:Randomized Controlled Trials as Topic; D011928:Raynaud Disease / Q000503:physiopathology; D012196:Review Literature as Topic; D012595:Scleroderma, Systemic / Q000503:physiopathology*; D057566:Self Report; D012720:Severity of Illness Index; D054928:Validation Studies as Topic
keywords: Functional status; Mouth Handicap in Systemic Sclerosis; Patient-reported outcomes; Questionnaire; Raynaud’s condition score; Scleroderma; Scleroderma Assessment Questionnaire; Scleroderma Functional Score; Self-assessment; Skin self-assessment; Symptom burden index; Systemic sclerosis; University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0