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

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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局部的硬皮病皮肤严重程度指数和医师全球疾病活动评估:旨在发展局部硬皮病预后指标的工作。

DOI:
10.3899/jrheum.081284
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发表时间:
2009-12
期刊:
The Journal of rheumatology
影响因子:
--
通讯作者:
Localized Scleroderma Clinical and Ultrasound Study Group
Localized Scleroderma Clinical and Ultrasound Study Group
中科院分区:
其他
文献类型:
--
作者:
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 Jr;Localized Scleroderma Clinical and Ultrasound Study Group

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开发和评价局部硬皮病(LS)皮肤严重程度指数(LoSSI)和整体评估的临床特征和对生活质量(QOL)的影响。进行了3期研究。第一阶段涉及15例LS患者和14名检查员,他们评估了LoSSI [表面积(SA)、红斑(ER)、皮肤厚度(ST)和新病变/扩展(N/E)]两次,以评估间/内可靠性。收集患者疾病严重程度总体评估(PtGA-S)和儿童皮肤病生活质量指数(CDLQI)进行内部信度评价。第二阶段的目的是开发临床决定因素的医生全球评估疾病活动性(PhysGA-A),并评估其内容效度。第三阶段涉及2名检查员评估27名患者的LoSSI和PhysGA-A。确定培训对提高LoSSI和PhysGA-A的信度/效度和变化敏感性的影响。ER [组内相关系数(ICC)0.71]、ST(ICC 0.70)、LoSSI(ICC 0.80)和PhysGA-A(ICC 0.90)的评估者间可靠性极佳,但SA(ICC 0.35)的评估者间可靠性较差;因此,将LoSSI修改为mLoSSI。考官的经验并不影响分数,但培训/实践提高了可靠性。ER、ST和LoSSI的内部可靠性极好(斯皮尔曼rho = 0.71-0.89),SA的内部可靠性中等。PtGA-S和CDLQI具有良好的内部一致性(ICC 0.63和0.80)。mLoSSI与PhysGA-A和PtGA-S中度相关。mLoSSI和PhysGA-A均对治疗后的变化敏感。mLoSSI和PhysGA-A是评估LS疾病严重程度的可靠有效工具,并显示出检测随时间变化的高灵敏度。这些工具可用于常规临床实践。应考虑将其纳入临床试验的LS结局指标核心集。
To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments’ clinimetric property and effect on quality of life (QOL). 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. 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. 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.
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发表时间: 2007-08-01
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影响因子: 5.5
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发表时间: 1977-01-01
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