Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis

Journal of Scleroderma and Related Disorders

Volumn 2, Issue 1, 2017, Pages 11-18

  Khanna, Dinesh ^a   Furst, Daniel E ^b   Clements, Philip J ^b   Allanore, Yannick ^c   Baron, Murray ^d   Czirjak, Lazlo ^e   Distler, Oliver ^f   Foeldvari, Ivan ^g   Kuwana, Masataka ^h   Matucci Cerinic, Marco ⁱ   Mayes, Maureen ^j   Medsger, Thomas ^k   Merkel, Peter A ^l   Pope, Janet E ^m   Seibold, James R ⁿ   Steen, Virginia ^o   Stevens, Wendy ^p   Denton, Christopher P ^q  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d MCGILL UNIVERSITY   (Canada)

^e UNIVERSITY OF PÉCS   (Hungary)

^f UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^g Hamburger Zentrum fur Kinder und Jugendrheumatologie   (Germany)

^h NIPPON MEDICAL SCHOOL GRADUATE SCHOOL OF MEDICINE   (Japan)

ⁱ UNIVERSITY OF FLORENCE   (Italy)

^j UNIVERSITY OF TEXAS   (United States)

^k UNIVERSITY OF PITTSBURGH   (United States)

^l UNIVERSITY OF PENNSYLVANIA   (United States)

^m UNIVERSITY OF WESTERN ONTARIO   (Canada)

ⁿ Scleroderma Research Consultants LLC   (United States)

^o GEORGETOWN UNIVERSITY   (United States)

^p ST VINCENT S HOSPITAL   (Australia)

^q ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

more..

Author keywords

Clinical trials; Modified Rodnan skin score; Skin thickness; Standardization

Indexed keywords

AUTOANTIBODY; DNA TOPOISOMERASE;

BODY MASS; CERTIFICATION; CONSTRUCT VALIDITY; CONTENT VALIDITY; CRITERION RELATED VALIDITY; DISEASE EXACERBATION; DISEASE SEVERITY; ETHNICITY; HUMAN; MODIFIED RODNAN SKIN SCORE; MORTALITY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRAM FEASIBILITY; PUNCH BIOPSY; REVIEW; SCLERODERMA; SCORING SYSTEM; SENSITIVITY ANALYSIS; SKIN PIGMENTATION; SKINFOLD THICKNESS; STANDARDIZATION; STUDENT; SYSTEMIC SCLEROSIS;

EID: 85036502547     PISSN: 23971983     EISSN: 23971991     Source Type: Journal    
DOI: 10.5301/jsrd.5000231     Document Type: Review

References (32)

1. LeRoy EC, Medsger TA Jr. Criteria for the classification of early systemic sclerosis. J Rheumatol. 2001;28(7):1573-1576. Published online July 27, 2001.
2. Perera A, Fertig N, Lucas M, et al. Clinical subsets, skin thickness progression rate, and serum antibody levels in systemic sclerosis patients with anti-topoisomerase I antibody. Arthritis Rheumatol. 2007;56(8):2740-2746.
3. Shand L, Lunt M, Nihtyanova S, et al. Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: application of a latent linear trajectory model. Arthritis Rheumatol. 2007;56(7):2422-2431.
4. Clements PJ, Wong WK, Hurwitz EL, et al. The Disability Index of the Health Assessment Questionnaire is a predictor and correlate of outcome in the high-dose versus low-dose penicillamine in systemic sclerosis trial. Arthritis Rheum. 2001;44(3): 653-661.
5. Clements PJ, Hurwitz EL, Wong WK, et al. Skin thickness score as a predictor and correlate of outcome in systemic sclerosis: high-dose versus low-dose penicillamine trial. Arthritis Rheum. 2000;43(11):2445-2454.
6. Domsic RT, Rodriguez-Reyna T, Lucas M, Fertig N, Medsger TA Jr. Skin thickness progression rate: a predictor of mortality and early internal organ involvement in diffuse scleroderma. Ann Rheum Dis. 2011;70(1):104-109.
7. Steen VD, Medsger TA Jr. Improvement in skin thickening in systemic sclerosis associated with improved survival. Arthritis Rheum. 2001;44(12):2828-2835.
8. Dobrota R, Maurer B, Graf N, et al; EUSTAR coauthors. Prediction of improvement in skin fibrosis in diffuse cutaneous systemic sclerosis: a EUSTAR analysis. Ann Rheum Dis. 2016; 75(10):1743-1748.
9. Maurer B, Graf N, Michel BA, et al; EUSTAR co-authors. Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database. Ann Rheum Dis. 2015;74(6):1124-1131.
10. Rodnan GP, Lipinski E, Luksick J. Skin thickness and collagen content in progressive systemic sclerosis and localized scleroderma. Arthritis Rheum. 1979;22(2):130-140.
11. Steen VD, Medsger TA Jr, Rodnan GP. D-Penicillamine therapy in progressive systemic sclerosis (scleroderma): a retrospective analysis. Ann Intern Med. 1982;97(5):652-659.
12. Clements PJ, Lachenbruch PA, Seibold JR, et al. Skin thickness score in systemic sclerosis: an assessment of interobserver variability in 3 independent studies. J Rheumatol. 1993;20(11): 1892-1896.
13. Clements PJ, Furst DE, Wong WK, et al. High-dose versus lowdose D-penicillamine in early diffuse systemic sclerosis: analysis of a two-year, double-blind, randomized, controlled clinical trial. Arthritis Rheum. 1999;42(6):1194-1203.
14. Kahaleh MB, Sultany GL, Smith EA, Huffstutter JE, Loadholt CB, LeRoy EC. A modified scleroderma skin scoring method. Clin Exp Rheumatol. 1986;4(4):367-369.
15. Clements PJ, Lachenbruch PA, Ng SC, Simmons M, Sterz M, Furst DE. Skin score. A semiquantitative measure of cutaneous involvement that improves prediction of prognosis in systemic sclerosis. Arthritis Rheum. 1990;33(8):1256-1263.
16. Mendoza FA, Nagle SJ, Lee JB, Jimenez SA. A prospective observational study of mycophenolate mofetil treatment in progressive diffuse cutaneous systemic sclerosis of recent onset. J Rheumatol. 2012;39(6):1241-1247.
17. Clements PJ. Measuring disease activity and severity in scleroderma. Curr Opin Rheumatol. 1995;7(6):517-521.
18. Merkel PA, Aydin SZ, Boers M, et al. The OMERACT core set of outcome measures for use in clinical trials of ANCA-associated vasculitis. J Rheumatol. 2011;38(7):1480-1486.
19. Merkel PA, Silliman NP, Denton CP, et al; CAT-192 Research Group; Scleroderma Clinical Trials Consortium. Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial. Arthritis Rheum. 2008;59(5):699-705.
20. Wiese AB, Berrocal VJ, Furst DE, et al. Correlates and responsiveness to change of measures of skin and musculoskeletal disease in early diffuse systemic sclerosis. Arthritis Care Res (Hoboken). 2014;66(11):1731-1739.
21. Kaloudi O, Bandinelli F, Filippucci E, et al. High frequency ultrasound measurement of digital dermal thickness in systemic sclerosis. Ann Rheum Dis. 2010;69(6):1140-1143.
22. Furst DE, Clements PJ, Steen VD, et al. The modified Rodnan skin score is an accurate reflection of skin biopsy thickness in systemic sclerosis. J Rheumatol. 1998;25(1):84-88.
23. Kissin EY, Merkel PA, Lafyatis R. Myofibroblasts and hyalinized collagen as markers of skin disease in systemic sclerosis. Arthritis Rheum. 2006;54(11):3655-3660.
24. Tashkin DP, Elashoff R, Clements PJ, et al; Scleroderma Lung Study Research Group. Cyclophosphamide versus placebo in scleroderma lung disease. N Engl J Med. 2006;354(25):2655-2666.
25. van Laar JM, Farge D, Sont JK, et al; EBMT/EULAR Scleroderma Study Group. Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomized clinical trial. JAMA. 2014;311(24):2490-2498.
26. Khanna D, Denton CP, Jahreis A, et al. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet. 2016; 387(10038):2630-2640.
27. Khanna D, Furst DE, Hays RD, et al. Minimally important difference in diffuse systemic sclerosis: results from the D-penicillamine study. Ann Rheum Dis. 2006;65(10):1325-1329.
28. Scott DL, Choy EH, Greeves A, et al. Standardising joint assessment in rheumatoid arthritis. Clin Rheumatol. 1996;15(6): 579-582.
29. Pope JE, Baron M, Bellamy N, et al. Variability of skin scores and clinical measurements in scleroderma. J Rheumatol. 1995;22(7):1271-1276.
30. Czirják L, Nagy Z, Aringer M, Riemekasten G, Matucci-Cerinic M, Furst DE; EUSTAR. The EUSTAR model for teaching and implementing the modified Rodnan skin score in systemic sclerosis. Ann Rheum Dis. 2007;66(7):966-969.
31. Foeldvari I, Wierk A. Healthy children have a significantly increased skin score assessed with the modified Rodnan skin score. Rheumatology (Oxford). 2006;45(1):76-78.
32. Sobanski V, Dauchet L, Lefevre G, et al. Prevalence of anti-RNA polymerase III antibodies in systemic sclerosis: new data from a French cohort and a systematic review and meta-analysis. Arthritis Rheum. 2014;66(2):407-417.