Suliman, Yossra Atef, Bruni, Cosimo ORCID: 0000-0003-2813-2083, Johnson, Sindhu R., Praino, Emanuela, Alemam, Mohamed, Borazan, Nabeel, Cometi, Laura, Myers, Bethany ORCID: 0000-0002-4137-6245, Khanna, Dinesh, Allanore, Yannick, Baron, Murray, Krieg, Thomas, Herrick, Ariane, Afonso, Ana, Distler, Oliver ORCID: 0000-0002-0546-8310, Kafaja, Suzanne, Denton, Christopher P., Matucci-Cerinic, Marco and Furst, Daniel E. (2017). Defining skin ulcers in systemic sclerosis: systematic literature review and proposed World Scleroderma Foundation (WSF) definition. J. Scleroderma Relat. Disord., 2 (2). S. 115 - 121. LONDON: SAGE PUBLICATIONS LTD. ISSN 2397-1991

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Abstract

Purpose: There is a lack of a valid definition for skin ulcers in systemic sclerosis (SSc) to be used in clinical trials. Our aim was to develop a consensus definition for SSc skin ulcers based on the results of a systematic literature review (SLR) for skin ulcer definitions and expert opinion; and to evaluate its face validity, reliability and feasibility. Methods: SLR for skin ulcer definitions was conducted using PubMed, Web of Science, and Cochrane library for articles published from inception to January 1st, 2016. SSc experts were to discuss the definition categories and vote for the relevant terms. Reliability of the definition was tested in a second expert meeting, seven SSc experts evaluated 7 SSc patients with skin lesions twice. Face validity and feasibility were evaluated by sending out case report forms (CRFs) to four SSc experts, who were each asked to use the definition in five patients. Results: A total of 3464 abstracts and titles were screened, and 446 articles were fully evaluated. Of these, 66 met eligibility criteria and skin ulcer definitions were extracted. SSc experts discussed, refined, and voted on the consensus definition using nominal process. Kappa for inter-rater agreement was 0.51 and for intra-rater agreement was 0.90. The mean time to decide if the lesion is an ulcer was 7.4 seconds. All investigators endorsed the face validity of the new definition in the CRFs. Conclusions: Using an SLR and a nominal technique, we developed a preliminary consensus-based definition of SSc skin ulcers. Face validity, feasibility and reliability were demonstrated for the developed definition.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Suliman, Yossra AtefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruni, CosimoUNSPECIFIEDorcid.org/0000-0003-2813-2083UNSPECIFIED
Johnson, Sindhu R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Praino, EmanuelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alemam, MohamedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borazan, NabeelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cometi, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Myers, BethanyUNSPECIFIEDorcid.org/0000-0002-4137-6245UNSPECIFIED
Khanna, DineshUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allanore, YannickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baron, MurrayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krieg, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herrick, ArianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Afonso, AnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Distler, OliverUNSPECIFIEDorcid.org/0000-0002-0546-8310UNSPECIFIED
Kafaja, SuzanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Denton, Christopher P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Matucci-Cerinic, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Furst, Daniel E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-233361
DOI: 10.5301/jsrd.5000236
Journal or Publication Title: J. Scleroderma Relat. Disord.
Volume: 2
Number: 2
Page Range: S. 115 - 121
Date: 2017
Publisher: SAGE PUBLICATIONS LTD
Place of Publication: LONDON
ISSN: 2397-1991
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ISCHEMIC DIGITAL ULCERS; DUO REGISTRY; RHEUMATOID-ARTHRITIS; VASCULAR-DISEASE; CLINICAL-TRIALS; RHEUMATOLOGISTS; RELIABILITYMultiple languages
RheumatologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/23336

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