Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Suliman, Yossra Atef UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruni, Cosimo UNSPECIFIED orcid.org/0000-0003-2813-2083 UNSPECIFIED Johnson, Sindhu R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Praino, Emanuela UNSPECIFIED UNSPECIFIED UNSPECIFIED Alemam, Mohamed UNSPECIFIED UNSPECIFIED UNSPECIFIED Borazan, Nabeel UNSPECIFIED UNSPECIFIED UNSPECIFIED Cometi, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Myers, Bethany UNSPECIFIED orcid.org/0000-0002-4137-6245 UNSPECIFIED Khanna, Dinesh UNSPECIFIED UNSPECIFIED UNSPECIFIED Allanore, Yannick UNSPECIFIED UNSPECIFIED UNSPECIFIED Baron, Murray UNSPECIFIED UNSPECIFIED UNSPECIFIED Krieg, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Herrick, Ariane UNSPECIFIED UNSPECIFIED UNSPECIFIED Afonso, Ana UNSPECIFIED UNSPECIFIED UNSPECIFIED Distler, Oliver UNSPECIFIED orcid.org/0000-0002-0546-8310 UNSPECIFIED Kafaja, Suzanne UNSPECIFIED UNSPECIFIED UNSPECIFIED Denton, Christopher P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Matucci-Cerinic, Marco UNSPECIFIED UNSPECIFIED UNSPECIFIED Furst, Daniel E. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language ISCHEMIC DIGITAL ULCERS; DUO REGISTRY; RHEUMATOID-ARTHRITIS; VASCULAR-DISEASE; CLINICAL-TRIALS; RHEUMATOLOGISTS; RELIABILITY Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23336