Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Skin ulcers in SSc are a major clinical challenge and there are various un-validated definitions of skin ulcers utilized in SSc-related clinical trials. We wanted to better delineate a precise definition for skin ulcers in SSc to be used in clinical trials. Objective: To conduct a systematic literature review (SLR) regarding definitions of skin ulcers. The results were used to develop a consensus definition for SSc-skin ulcers.
Methods: A systematic literature search for SSc-skin ulcer definitions was conducted in PubMed, Web of Science, and Cochrane for articles published from inception to January 1st, 2016. For better generalizability we included related autoimmune diseases where skin ulcers are seen: SLE, RA and vasculitis. Diabetic ulcers were also included as more data is available when defining diabetic ulcers. Inclusion criteria were: studies reporting a definition of skin ulcer, adults, English language, skin ulcer as a study outcome, diseases as outlined above. Exclusions included: not in humans, pressure ulcers, reviews and case reports <10 pts. PRISMA recommendations were followed where applicable. The extracted definitions were categorized into relevant descriptive terms (Table 1) and formed the basis for a consensus definition. SSc experts discussed the definitions using a nominal process and voted for the pertinent definition terms, during the Scleroderma World Congress (SWC). A consensus was attained when agreement was > 70%. Photographs of 11 SSc skin lesions were evaluated before and after definition development to examine the face validity and general feasibility of the definition and to allow further refinement of the definition.
Results: A total of 3464 publications were screened in abstract and title and 446 articles were fully evaluated. Of these, 66 met eligibility criteria and skin ulcer definitions were extracted. Twelve SSc experts (11 rheumatologists, 1 dermatologist) from North America (n=6) and Europe (n=6) discussed, refined and voted on the consensus definition. Descriptive terms and mitigating factors (site, size etc.) were used to develop our new definition and exclusions were decided for its utilization in clinical trials. The preliminary SWC consensus-derived definition of SSc- skin ulcer for clinical trials is: “ Loss of epidermal covering with a break in the basement membrane (which separates dermis from epidermis). It appears clinically as visible blood vessels, fibrin, granulation tissue and/or underlying deeper structures (e.g. muscle, ligament, fat) or as it would appear on debridement"
Conclusion: Using an SLR and a modified nominal technique, a preliminary consensus-based definition of SSc-skin ulcers was developed. Further validation steps are warranted.
To cite this abstract in AMA style:Suliman YA, Bruni C, Johnson SR, Praino E, Alemam M, Borazan N, Cometi L, Myers B, Khanna D, Allanore Y, Baron M, Krieg T, Herrick AL, Kafaja S, Denton C, Matucci Cerinic M, Furst DE. Defining Skin Ulcers in Systemic Sclerosis: A Systematic Literature Review of Skin Ulcer Definitions and a Preliminary Consensus-Based New SSc Skin Ulcer Definition [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/defining-skin-ulcers-in-systemic-sclerosis-a-systematic-literature-review-of-skin-ulcer-definitions-and-a-preliminary-consensus-based-new-ssc-skin-ulcer-definition/. Accessed August 4, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/defining-skin-ulcers-in-systemic-sclerosis-a-systematic-literature-review-of-skin-ulcer-definitions-and-a-preliminary-consensus-based-new-ssc-skin-ulcer-definition/