Y A Suliman1,2, C Bruni3, S R Johnson4, E Praino3,5, M Alemam6, N Borazan1, L Cometi3, B Meyers7, D Khanna8, Y Allanore9, M Baron10, T Krieg11, A Herrick12, A Afonso13, O Distler14, S Kafaja1, C P Denton15, M Matucci-Cerinic3, D E Furst1. 1. Division of Rheumatology, David Geffen School of Medicine, University of California Los Angeles, 1000 Veterans Avenue, Los Angeles, California 90025, USA. 2. Rheumatology and Rehabilitation Department, Assiut University Hospital, Assiut, Egypt. 3. Dept Clinical & Experimental Medicine, University and Division of Rheumatology & Scleroderma Unit, AOUC, University of Florence, Florence,Italy. 4. Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada. 5. Rheumatology Unit, University of Bari, Italy. 6. Clinical pathology department, South valley university, Qena, Egypt. 7. Louise M. Darling Biomedical Library, University of California, Los Angeles, USA. 8. University of Michigan, Ann Arbor, USA. 9. Paris Descartes University and Cochin Hospital, AP-HP, Paris, France. 10. Jewish General Hospital and McGill University, Montreal, Quebec, Canada. 11. Department of Dermatology, University of Cologne, Cologne, Germany; Center for Molecular Medicine Cologne, University of Cologne, Cologne, Germany. 12. University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. 13. University of Oporto, Portugal. 14. Division of Rheumatology, University Hospital Zurich, Switzerland. 15. Centre for Rheumatology, Royal Free Hospital, London, UK.
Abstract
PURPOSE: There is a lack of a valid, definition for skin ulcers in 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 definitions' categories and vote for the relevant terms. Reliability of the definition were tested in a second expert meeting, seven SSc experts evaluated 7 SSc pts with skin lesions twice. Face validity and feasibility evaluated by sending out case report forms(CRFs) to 4 SSc experts, they were asked to use the definition in 5 pts each. 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-, intra-rater rater agreement was 0.51, 0.90 respectively. The mean time to decide if the lesion is an ulcer was 7.4 sec. All investigators endorsed the face validity of the new definition in the CRFs. CONCLUSION: Using a 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.
PURPOSE: There is a lack of a valid, definition for skin ulcers in 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 definitions' categories and vote for the relevant terms. Reliability of the definition were tested in a second expert meeting, seven SSc experts evaluated 7 SSc pts with skin lesions twice. Face validity and feasibility evaluated by sending out case report forms(CRFs) to 4 SSc experts, they were asked to use the definition in 5 pts each. 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-, intra-rater rater agreement was 0.51, 0.90 respectively. The mean time to decide if the lesion is an ulcer was 7.4 sec. All investigators endorsed the face validity of the new definition in the CRFs. CONCLUSION: Using a 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.
Entities:
Keywords:
amputation; digital loss; gangrene; skin ulcers; systemic sclerosis
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