The localized scleroderma skin severity index and physician global assessment of disease activity

A work in progress toward development of localized scleroderma outcome measures

Thaschawee Arkachaisri, Soamarat Vilaiyuk, Suzanne Li, Kathleen M. O'Neil, Elena Pope, Gloria C. Higgins, Marilynn Punaro, Egla C. Rabinovich, Margalit Rosenkranz, Daniel A. Kietz, Paul Rosen, Steven J. Spalding, Teresa R. Hennon, Kathryn S. Torok, Elaine Cassidy, Thomas A. Medsger

Research output: Contribution to journalArticle

90 Citations (Scopus)

Abstract

Objective. To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments' clinimetric property and effect on quality of life (QOL). Methods. A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children's Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined. Results. Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners' experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman's rho = 0.71-0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy. Conclusion. mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials. The Journal of Rheumatology

Original languageEnglish (US)
Pages (from-to)2819-2829
Number of pages11
JournalJournal of Rheumatology
Volume36
Issue number12
DOIs
StatePublished - Dec 2009

Fingerprint

Localized Scleroderma
Outcome Assessment (Health Care)
Physicians
Skin
Erythema
Quality of Life
Dermatology
Rheumatology
Reproducibility of Results
Clinical Trials

Keywords

  • Global assessment
  • Localized scleroderma
  • Outcome measure
  • Quality of life
  • Skin scores

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

The localized scleroderma skin severity index and physician global assessment of disease activity : A work in progress toward development of localized scleroderma outcome measures. / Arkachaisri, Thaschawee; Vilaiyuk, Soamarat; Li, Suzanne; O'Neil, Kathleen M.; Pope, Elena; Higgins, Gloria C.; Punaro, Marilynn; Rabinovich, Egla C.; Rosenkranz, Margalit; Kietz, Daniel A.; Rosen, Paul; Spalding, Steven J.; Hennon, Teresa R.; Torok, Kathryn S.; Cassidy, Elaine; Medsger, Thomas A.

In: Journal of Rheumatology, Vol. 36, No. 12, 12.2009, p. 2819-2829.

Research output: Contribution to journalArticle

Arkachaisri, T, Vilaiyuk, S, Li, S, O'Neil, KM, Pope, E, Higgins, GC, Punaro, M, Rabinovich, EC, Rosenkranz, M, Kietz, DA, Rosen, P, Spalding, SJ, Hennon, TR, Torok, KS, Cassidy, E & Medsger, TA 2009, 'The localized scleroderma skin severity index and physician global assessment of disease activity: A work in progress toward development of localized scleroderma outcome measures', Journal of Rheumatology, vol. 36, no. 12, pp. 2819-2829. https://doi.org/10.3899/jrheum.081284
Arkachaisri, Thaschawee ; Vilaiyuk, Soamarat ; Li, Suzanne ; O'Neil, Kathleen M. ; Pope, Elena ; Higgins, Gloria C. ; Punaro, Marilynn ; Rabinovich, Egla C. ; Rosenkranz, Margalit ; Kietz, Daniel A. ; Rosen, Paul ; Spalding, Steven J. ; Hennon, Teresa R. ; Torok, Kathryn S. ; Cassidy, Elaine ; Medsger, Thomas A. / The localized scleroderma skin severity index and physician global assessment of disease activity : A work in progress toward development of localized scleroderma outcome measures. In: Journal of Rheumatology. 2009 ; Vol. 36, No. 12. pp. 2819-2829.
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abstract = "Objective. To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments' clinimetric property and effect on quality of life (QOL). Methods. A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children's Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined. Results. Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners' experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman's rho = 0.71-0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy. Conclusion. mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials. The Journal of Rheumatology",
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AU - Li, Suzanne

AU - O'Neil, Kathleen M.

AU - Pope, Elena

AU - Higgins, Gloria C.

AU - Punaro, Marilynn

AU - Rabinovich, Egla C.

AU - Rosenkranz, Margalit

AU - Kietz, Daniel A.

AU - Rosen, Paul

AU - Spalding, Steven J.

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AU - Cassidy, Elaine

AU - Medsger, Thomas A.

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N2 - Objective. To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments' clinimetric property and effect on quality of life (QOL). Methods. A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children's Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined. Results. Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners' experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman's rho = 0.71-0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy. Conclusion. mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials. The Journal of Rheumatology

AB - Objective. To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments' clinimetric property and effect on quality of life (QOL). Methods. A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children's Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined. Results. Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners' experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman's rho = 0.71-0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy. Conclusion. mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials. The Journal of Rheumatology

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