OBJECTIVE: To determine the validity, reliability, and feasibility of durometer measurements of skin hardness as an outcome measure in clinical trials of scleroderma. METHODS:Skin hardness was measured during a multicenter treatment trial for scleroderma using handheld digital durometers with a continuous scale. Skin thickness was measured by modified Rodnan skin score (MRSS). Other outcome data collected included the Scleroderma Health Assessment Questionnaire. In a reliability exercise in advance of the trial, 9 investigators examined the same 5 scleroderma patients by MRSS and durometry. RESULTS:Forty-three patients with early diffuse cutaneous systemic sclerosis were studied at 11 international centers (mean age 49 years [range 24-76], median disease duration 6.4 months [range 0.3-23], and median baseline MRSS 22 [range 11-38]). The reliability of durometer measurements was excellent, with high interobserver intraclass correlation coefficients (ICCs) (0.82-0.92), and each result was greater than the corresponding skin site ICCs for MRSS (0.54-0.85). Baseline durometer scores correlated well with MRSS (r = 0.69, P < 0.0001), patient self-assessments of skin disease (r = 0.69, P < 0.0001), and Health Assessment Questionnaire (HAQ) disability scores (r = 0.34, P = 0.03). Change in durometer scores correlated with change in MRSS (r = 0.70, P < 0.0001), change in patient self-assessments of skin disease (r = 0.52, P = 0.003), and change in HAQ disability scores (r = 0.42, P = 0.017). The effect size was greater for durometry than for MRSS or patient self-assessment. CONCLUSION: Durometer measurements of skin hardness in patients with scleroderma are reliable, simple, accurate, demonstrate good sensitivity to change compared with traditional skin scoring, and reflect patients' self-assessments of their disease. Durometer measurements are valid, objective, and scalable, and should be considered for use as a complementary outcome measure to skin scoring in clinical trials of scleroderma.
RCT Entities:
OBJECTIVE: To determine the validity, reliability, and feasibility of durometer measurements of skin hardness as an outcome measure in clinical trials of scleroderma. METHODS:Skin hardness was measured during a multicenter treatment trial for scleroderma using handheld digital durometers with a continuous scale. Skin thickness was measured by modified Rodnan skin score (MRSS). Other outcome data collected included the Scleroderma Health Assessment Questionnaire. In a reliability exercise in advance of the trial, 9 investigators examined the same 5 sclerodermapatients by MRSS and durometry. RESULTS: Forty-three patients with early diffuse cutaneous systemic sclerosis were studied at 11 international centers (mean age 49 years [range 24-76], median disease duration 6.4 months [range 0.3-23], and median baseline MRSS 22 [range 11-38]). The reliability of durometer measurements was excellent, with high interobserver intraclass correlation coefficients (ICCs) (0.82-0.92), and each result was greater than the corresponding skin site ICCs for MRSS (0.54-0.85). Baseline durometer scores correlated well with MRSS (r = 0.69, P < 0.0001), patient self-assessments of skin disease (r = 0.69, P < 0.0001), and Health Assessment Questionnaire (HAQ) disability scores (r = 0.34, P = 0.03). Change in durometer scores correlated with change in MRSS (r = 0.70, P < 0.0001), change in patient self-assessments of skin disease (r = 0.52, P = 0.003), and change in HAQ disability scores (r = 0.42, P = 0.017). The effect size was greater for durometry than for MRSS or patient self-assessment. CONCLUSION: Durometer measurements of skin hardness in patients with scleroderma are reliable, simple, accurate, demonstrate good sensitivity to change compared with traditional skin scoring, and reflect patients' self-assessments of their disease. Durometer measurements are valid, objective, and scalable, and should be considered for use as a complementary outcome measure to skin scoring in clinical trials of scleroderma.
Authors: Christopher P Denton; Peter A Merkel; Daniel E Furst; Dinesh Khanna; Paul Emery; Vivien M Hsu; Nancy Silliman; James Streisand; John Powell; Anita Akesson; John Coppock; Frank van den Hoogen; Ariane Herrick; Maureen D Mayes; Douglas Veale; Joanna Haas; Stephen Ledbetter; Joseph H Korn; Carol M Black; James R Seibold Journal: Arthritis Rheum Date: 2007-01
Authors: Peter A Merkel; Philip J Clements; John D Reveille; Maria E Suarez-Almazor; Gabriele Valentini; Daniel E Furst Journal: J Rheumatol Date: 2003-07 Impact factor: 4.666
Authors: Peter A Merkel; Karen Herlyn; Richard W Martin; Jennifer J Anderson; Maureen D Mayes; Patrice Bell; Joseph H Korn; Robert W Simms; Mary Ellen Csuka; Thomas A Medsger; Naomi F Rothfield; Michael H Ellman; David H Collier; Arthur Weinstein; Daniel E Furst; Sergio A Jiménez; Barbara White; James R Seibold; Fredrick M Wigley Journal: Arthritis Rheum Date: 2002-09
Authors: P Clements; P Lachenbruch; J Siebold; B White; S Weiner; R Martin; A Weinstein; M Weisman; M Mayes; D Collier Journal: J Rheumatol Date: 1995-07 Impact factor: 4.666
Authors: D Khanna; D J Lovell; E Giannini; P J Clements; P A Merkel; J R Seibold; M Matucci-Cerinic; C P Denton; M D Mayes; V D Steen; J Varga; D E Furst Journal: Ann Rheum Dis Date: 2007-09-24 Impact factor: 19.103
Authors: Ki Won Moon; Ran Song; Jin Hyun Kim; Eun Young Lee; Eun Bong Lee; Yeong Wook Song Journal: Rheumatol Int Date: 2011-07-19 Impact factor: 2.631
Authors: Laura E Dellalana; Fuyao Chen; Arved Vain; Jocelyn S Gandelman; Mihkel Põldemaa; Heidi Chen; Eric R Tkaczyk Journal: Skin Res Technol Date: 2018-11-10 Impact factor: 2.365
Authors: Dinesh Khanna; Daniel E Furst; Philip J Clements; Yannick Allanore; Murray Baron; Lazlo Czirjak; Oliver Distler; Ivan Foeldvari; Masataka Kuwana; Marco Matucci-Cerinic; Maureen Mayes; Thomas Medsger; Peter A Merkel; Janet E Pope; James R Seibold; Virginia Steen; Wendy Stevens; Christopher P Denton Journal: J Scleroderma Relat Disord Date: 2017 Jan-Apr