Dr. Silliman owns stock and/or stock options in Genzyme. Dr. Denton has received consultant fees, speaking fees, and honoraria (less than $10,000 each) from Actelion and Encysive. Dr. Furst has received consultant fees (less than $10,000 each) from Genzyme, Actelion, and Gilead. Drs. Streisand and Polisson own stock and stock options in Genzyme. Dr. Mayes has received consultant fees (less than $10,000) from Novartis and honoraria (less than $10,000 each) from Actelion and Encysive. Dr. Veale has received consultant fees, speaking fees, and honoraria (less than $10,000 each) from Schering-Plough, Wyeth, and GlaxoSmithKline.
Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial
Article first published online: 25 APR 2008
Copyright © 2008 by the American College of Rheumatology
Arthritis Care & Research
Volume 59, Issue 5, pages 699–705, 15 May 2008
How to Cite
Merkel, P. A., Silliman, N. P., Denton, C. P., Furst, D. E., Khanna, D., Emery, P., Hsu, V. M., Streisand, J. B., Polisson, R. P., Åkesson, A., Coppock, J., van den Hoogen, F., Herrick, A., Mayes, M. D., Veale, D., Seibold, J. R., Black, C. M. and Korn, J. H. (2008), Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial. Arthritis & Rheumatism, 59: 699–705. doi: 10.1002/art.23564
- Issue published online: 25 APR 2008
- Article first published online: 25 APR 2008
- Manuscript Accepted: 1 NOV 2007
- Manuscript Received: 25 FEB 2007
- Scleroderma Foundation
- National Center for Research Resources (NIH) General Clinical Research Centers program at Boston University. Grant Number: M01-RR0-00533
- Mid-Career Clinical Investigator Award (National Institute of Arthritis and Musculoskeletal and Skin Diseases). Grant Number: K24-AR2224-01A1
- Scleroderma Foundation
- NIH BIRCWH Award. Grant Number: HD051953
To determine the validity, reliability, and feasibility of durometer measurements of skin hardness as an outcome measure in clinical trials of scleroderma.
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.
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.
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.