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

doi:10.3899/jrheum.081284

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

Pediatrics

Research output: Contribution to journal › Article › peer-review

148 Scopus citations

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 language	English (US)
Pages (from-to)	2819-2829
Number of pages	11
Journal	Journal of Rheumatology
Volume	36
Issue number	12
DOIs	https://doi.org/10.3899/jrheum.081284
State	Published - Dec 2009

Keywords

Global assessment
Localized scleroderma
Outcome measure
Quality of life
Skin scores

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

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10.3899/jrheum.081284

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Arkachaisri, T., Vilaiyuk, S., Li, S., O'Neil, K. M., Pope, E., Higgins, G. C., Punaro, M., Rabinovich, E. C., Rosenkranz, M., Kietz, D. A., Rosen, P., Spalding, S. J., Hennon, T. R., Torok, K. S., Cassidy, E., & Medsger, T. A. (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, 36(12), 2819-2829. https://doi.org/10.3899/jrheum.081284

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

Research output: Contribution to journal › Article › peer-review

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

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title = "The localized scleroderma skin severity index and physician global assessment of disease activity: A work in progress toward development of localized scleroderma outcome measures",

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",

keywords = "Global assessment, Localized scleroderma, Outcome measure, Quality of life, Skin scores",

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

year = "2009",

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doi = "10.3899/jrheum.081284",

language = "English (US)",

volume = "36",

pages = "2819--2829",

journal = "Journal of Rheumatology",

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T1 - The localized scleroderma skin severity index and physician global assessment of disease activity

T2 - A work in progress toward development of localized scleroderma outcome measures

AU - Arkachaisri, Thaschawee

AU - Vilaiyuk, Soamarat

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.

AU - Hennon, Teresa R.

AU - Torok, Kathryn S.

AU - Cassidy, Elaine

AU - Medsger, Thomas A.

PY - 2009/12

Y1 - 2009/12

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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KW - Localized scleroderma

KW - Outcome measure

KW - Quality of life

KW - Skin scores

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The localized scleroderma skin severity index and physician global assessment of disease activity: A work in progress toward development of localized scleroderma outcome measures

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