Cosimo Bruni1,2,3, Tanaka Ngcozana4,5,6, Francesca Braschi4,5,6, Tiziana Pucci4,5,6, Guya Piemonte4,5,6, Laura Benelli4,5,6, Melissa Poli4,5,6, Yossra A Suliman4,5,6, Serena Guiducci4,5,6, Silvia Bellando-Randone4,5,6, Silvia Balduzzi4,5,6, Jonathan Grotts4,5,6, Christopher P Denton4,5,6, Laura Rasero4,5,6, CarloMaurizio Montecucco4,5,6, Daniel E Furst4,5,6, Marco Matucci-Cerinic4,5,6. 1. From the Department of Experimental and Clinical Medicine, and Department of Public Health, University of Florence; Department of Geriatric Medicine, Division of Rheumatology Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy; the Centre for Rheumatology and Connective Tissue Diseases, University College London (UCL), Division of Medicine, London, UK; Rheumatology and Rehabilitation Department, Assiut University Hospital, Assiut, Egypt; Department of Rheumatology, Institute for Research and Health Care (IRCCS) Policlinico San Matteo Foundation, Pavia, Italy; Department of Medicine Statistics Core, and Division of Rheumatology, Department of Medicine, University of California at Los Angeles, Los Angeles, California, USA. cosimobruni85@gmail.com. 2. Dr. Bruni has received a 6-month travel bursary grant from European League Against Rheumatism to undertake this project. Dr. Denton has been a consultant to Bayer, Roche, GSK, Actelion, Inventiva, CSL Behring, Takeda, Merck-Serono, MedImmune, and Biogen. He has received research grants from Actelion, GSK, Novartis, and CSL Behring. Dr. Furst has received grant/research support from AbbVie, Actelion, Amgen, BMS, the US National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, and consultancy fees from AbbVie, Actelion, Amgen, BMS, Cytori, Novartis, Pfizer, and Roche/Genentech. Dr. Matucci-Cerinic has acted as a consultant to and/or received speaker fees from Actelion, GSK, BMS, Pfizer, and Italfarmaco, and he has received research grants from Actelion. cosimobruni85@gmail.com. 3. C. Bruni, MD, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; T. Ngcozana, BNurs, Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine; F. Braschi, BNurs, Department of Experimental and Clinical Medicine, University of Florence and Department of Geriatric Medicine, Division of Rheumatology AOUC; T. Pucci, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; G. Piemonte, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; L. Benelli, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; M. Poli, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; Y.A. Suliman, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Guiducci, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Bellando-Randone, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Balduzzi, MD, Department of Rheumatology, IRCCS Policlinico San Matteo Foundation; J. Grotts, BStat, Department of Medicine Statistics Core, University of California at Los Angeles; C.P. Denton, MD, PhD, Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine; L. Rasero, BNurs, Department of Public Health, University of Florence; C. Montecucco, MD, PhD, Department of Rheumatology, IRCCS Policlinico San Matteo Foundation; D.E. Furst, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC, and Division of Rheumatology, Department of Medicine, University of California at Los Angeles; M. Matucci-Cerinic, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence and Department of Geriatric Medicine, Division of Rheumatology AOUC. Dr. Furst and Dr. Matucci-Cerinic made equal contributions as senior authors. cosimobruni85@gmail.com. 4. From the Department of Experimental and Clinical Medicine, and Department of Public Health, University of Florence; Department of Geriatric Medicine, Division of Rheumatology Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy; the Centre for Rheumatology and Connective Tissue Diseases, University College London (UCL), Division of Medicine, London, UK; Rheumatology and Rehabilitation Department, Assiut University Hospital, Assiut, Egypt; Department of Rheumatology, Institute for Research and Health Care (IRCCS) Policlinico San Matteo Foundation, Pavia, Italy; Department of Medicine Statistics Core, and Division of Rheumatology, Department of Medicine, University of California at Los Angeles, Los Angeles, California, USA. 5. Dr. Bruni has received a 6-month travel bursary grant from European League Against Rheumatism to undertake this project. Dr. Denton has been a consultant to Bayer, Roche, GSK, Actelion, Inventiva, CSL Behring, Takeda, Merck-Serono, MedImmune, and Biogen. He has received research grants from Actelion, GSK, Novartis, and CSL Behring. Dr. Furst has received grant/research support from AbbVie, Actelion, Amgen, BMS, the US National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, and consultancy fees from AbbVie, Actelion, Amgen, BMS, Cytori, Novartis, Pfizer, and Roche/Genentech. Dr. Matucci-Cerinic has acted as a consultant to and/or received speaker fees from Actelion, GSK, BMS, Pfizer, and Italfarmaco, and he has received research grants from Actelion. 6. C. Bruni, MD, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; T. Ngcozana, BNurs, Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine; F. Braschi, BNurs, Department of Experimental and Clinical Medicine, University of Florence and Department of Geriatric Medicine, Division of Rheumatology AOUC; T. Pucci, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; G. Piemonte, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; L. Benelli, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; M. Poli, BNurs, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC; Y.A. Suliman, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Guiducci, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Bellando-Randone, MD, PhD, Rheumatology and Rehabilitation Department, Assiut University Hospital; S. Balduzzi, MD, Department of Rheumatology, IRCCS Policlinico San Matteo Foundation; J. Grotts, BStat, Department of Medicine Statistics Core, University of California at Los Angeles; C.P. Denton, MD, PhD, Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine; L. Rasero, BNurs, Department of Public Health, University of Florence; C. Montecucco, MD, PhD, Department of Rheumatology, IRCCS Policlinico San Matteo Foundation; D.E. Furst, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology AOUC, and Division of Rheumatology, Department of Medicine, University of California at Los Angeles; M. Matucci-Cerinic, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence and Department of Geriatric Medicine, Division of Rheumatology AOUC. Dr. Furst and Dr. Matucci-Cerinic made equal contributions as senior authors.
Abstract
OBJECTIVE: To date, "healed/non-healed" and clinical judgment are the only available assessment tools for digital ulcers (DU) in patients with systemic sclerosis (SSc). The aim of our study is to examine a preliminary composite DU clinical assessment score (DUCAS) for SSc for face, content, and construct validity. METHODS: Patients with SSc presenting at least 1 finger DU were enrolled and assessed with the Health Assessment Questionnaire-Disability Index, Cochin scale, visual analog scale (VAS) for DU-related pain, patient global DU status, and global assessment as patient-reported outcomes (PRO), and physician VAS for DU status (phyGDU) as an SSc-DU expert physician/nurse measure. The DUCAS included 7 DU-related variables selected by a committee of SSc DU experts and weighted on a clinical basis. Face validity was examined by consensus and partial construct validity was tested through convergent correlation with other measures of hand function, using Spearman's correlations. A range of patients with SSc was examined. A linear regression model with backward stepwise analysis was used to determine the relationship of individual variables with the primary clinical parameter, phyGDU. RESULTS: Forty-four patients with SSc (9 males, mean age 55 ± 15 yrs, mean disease duration 9.9 ± 5.8 yrs) were enrolled in the study. Overall DUCAS showed significant positive correlations with all abovementioned PRO (r > 0.4, p < 0.01). When all scores and scales were modeled, only DUCAS significantly predicted phyGDU (r = 0.59, R2 = 0.354, Akaike information criterion = 385.4). CONCLUSION: Preliminarily, we suggest that the DUCAS may be a new clinical score for SSc-related DU, having face and content validity and convergent/divergent correlations (construct validity). These early data suggest that this score deserves further evaluation.
OBJECTIVE: To date, "healed/non-healed" and clinical judgment are the only available assessment tools for digital ulcers (DU) in patients with systemic sclerosis (SSc). The aim of our study is to examine a preliminary composite DU clinical assessment score (DUCAS) for SSc for face, content, and construct validity. METHODS:Patients with SSc presenting at least 1 finger DU were enrolled and assessed with the Health Assessment Questionnaire-Disability Index, Cochin scale, visual analog scale (VAS) for DU-related pain, patient global DU status, and global assessment as patient-reported outcomes (PRO), and physician VAS for DU status (phyGDU) as an SSc-DU expert physician/nurse measure. The DUCAS included 7 DU-related variables selected by a committee of SSc DU experts and weighted on a clinical basis. Face validity was examined by consensus and partial construct validity was tested through convergent correlation with other measures of hand function, using Spearman's correlations. A range of patients with SSc was examined. A linear regression model with backward stepwise analysis was used to determine the relationship of individual variables with the primary clinical parameter, phyGDU. RESULTS: Forty-four patients with SSc (9 males, mean age 55 ± 15 yrs, mean disease duration 9.9 ± 5.8 yrs) were enrolled in the study. Overall DUCAS showed significant positive correlations with all abovementioned PRO (r > 0.4, p < 0.01). When all scores and scales were modeled, only DUCAS significantly predicted phyGDU (r = 0.59, R2 = 0.354, Akaike information criterion = 385.4). CONCLUSION: Preliminarily, we suggest that the DUCAS may be a new clinical score for SSc-related DU, having face and content validity and convergent/divergent correlations (construct validity). These early data suggest that this score deserves further evaluation.
Entities:
Keywords:
DIGITAL ULCER; DISEASE ACTIVITY SCORE; OUTCOME MEASURES; SYSTEMIC SCLEROSIS; WOUNDS AND INJURIES
Authors: Michael Hughes; Yannick Allanore; Lorinda Chung; John D Pauling; Christopher P Denton; Marco Matucci-Cerinic Journal: Nat Rev Rheumatol Date: 2020-02-25 Impact factor: 20.543