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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
Journal of Rheumatology, 10/21/09
Arkachaisri T et al. – 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.
Methods- 3-phase study
- 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) collected for intrarater reliability evaluation
- Second phase aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity
- 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 LoSSI and PhysGA-A determined
- Interrater reliability 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 modified to mLoSSI
- Examiners’ experience did not affect the scores, but training/practice improved reliability
- Intrarater reliability 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
- mLoSSI and PhysGA-A sensitive to change following therapy
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