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Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial

Merkel, Peter A; Silliman, Nancy P; Denton, Christopher P; Furst, Daniel E; Khanna, Dinesh; Emery, Paul; Hsu, Vivien M; Streisand, James B; Polisson, Richard P and Åkesson, Anita LU , et al. (2008) In Arthritis and Rheumatism 59(5). p.699-705
Abstract
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... (More)
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. (Less)
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Arthritis and Rheumatism
volume
59
issue
5
pages
699 - 705
publisher
John Wiley & Sons
external identifiers
  • wos:000255848000014
  • scopus:43549115057
ISSN
1529-0131
DOI
10.1002/art.23564
language
English
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yes
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baff2709-1546-462f-8964-c0312e0d1074 (old id 1204372)
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2008-09-17 13:06:22
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2017-09-03 03:44:39
@article{baff2709-1546-462f-8964-c0312e0d1074,
  abstract     = {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 &lt; 0.0001), patient self-assessments of skin disease (r = 0.69, P &lt; 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 &lt; 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.},
  author       = {Merkel, Peter A and Silliman, Nancy P and Denton, Christopher P and Furst, Daniel E and Khanna, Dinesh and Emery, Paul and Hsu, Vivien M and Streisand, James B and Polisson, Richard P and Åkesson, Anita and Coppock, John and van den Hoogen, Frank and Herrick, Ariane and Mayes, Maureen D and Veale, Douglas and Seibold, James R and Black, Carol M and Korn, Joseph H},
  issn         = {1529-0131},
  language     = {eng},
  number       = {5},
  pages        = {699--705},
  publisher    = {John Wiley & Sons},
  series       = {Arthritis and Rheumatism},
  title        = {Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial},
  url          = {http://dx.doi.org/10.1002/art.23564},
  volume       = {59},
  year         = {2008},
}