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Validity, reliabili...
Validity, reliability, and feasibility of durometer measurements of scleroderma skin disease in a multicenter treatment trial
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Merkel, Peter A (author)
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Silliman, Nancy P (author)
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Denton, Christopher P (author)
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Furst, Daniel E (author)
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Khanna, Dinesh (author)
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Emery, Paul (author)
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Hsu, Vivien M (author)
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Streisand, James B (author)
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Polisson, Richard P (author)
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- Åkesson, Anita (author)
- Lund University,Lunds universitet,Reumatologi och molekylär skelettbiologi,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Rheumatology,Section III,Department of Clinical Sciences, Lund,Faculty of Medicine
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Coppock, John (author)
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van den Hoogen, Frank (author)
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Herrick, Ariane (author)
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Mayes, Maureen D (author)
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Veale, Douglas (author)
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Seibold, James R (author)
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Black, Carol M (author)
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Korn, Joseph H (author)
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(creator_code:org_t)
- 2008
- 2008
- English.
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In: Arthritis and Rheumatism. - : Wiley. - 1529-0131 .- 0004-3591. ; 59:5, s. 699-705
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
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- By the author/editor
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Merkel, Peter A
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Silliman, Nancy ...
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Denton, Christop ...
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Furst, Daniel E
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Khanna, Dinesh
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Emery, Paul
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show more...
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Hsu, Vivien M
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Streisand, James ...
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Polisson, Richar ...
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Åkesson, Anita
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Coppock, John
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van den Hoogen, ...
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Herrick, Ariane
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Mayes, Maureen D
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Veale, Douglas
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Seibold, James R
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Black, Carol M
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Korn, Joseph H
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show less...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Rheumatology and ...
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Arthritis and Rh ...
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Lund University