Development and initial validation of the Localized Scleroderma Skin Damage Index and Physician Global Assessment of disease Damage: a proof-of-concept study

Development and initial validation of the Localized Scleroderma Skin Damage Index and Physician Global Assessment of disease Damage: a proof-of-concept study
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DOI:
10.1093/rheumatology/kep361
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发表时间:
2010-02-01
期刊:
影响因子:
5.5
通讯作者:
Medsger, Thomas A., Jr.
Medsger, Thomas A., Jr.
中科院分区:
医学1区
文献类型:
--
作者:
Arkachaisri, Thaschawee;Vilaiyuk, Soamarat;Medsger, Thomas A., Jr.

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目标。目的:建立和评估局限性硬皮病(LS)皮肤损伤指数(LoSDI)和医师疾病损伤整体评估(PGA-D)的心理测量学特性。损害被定义为由于先前的活动性疾病/治疗并发症而导致的不可逆/持续变化(bbb6个月)。8位风湿病学家评估了17个变量在制定PGA-D/LoSDI中的重要性。LS患者由两名风湿病学家使用这两种工具评估其心理测量特性。LoSDI是通过将18个解剖部位测量的皮肤损伤特征[真皮萎缩(DAT)、皮下萎缩(SAT)和色素沉着(DP)]的三个分数相加来计算的。记录每次检查时患者疾病严重程度GA (PtGA-S)、儿童皮肤病生活质量指数(CDLQI)和PGA-D。本研究纳入30例LS患者(112个病变)和9对患者访视对(18个病变)进行评分间和评分内可靠性研究。LoSDI及其域DAT、SAT、DP和PGA-D表现出良好的域间信度和域内信度(信度系数分别为0.86 ~ 0.99和0.74 ~ 0.96)。LoSDI与PGA-D的相关性中等,与pga - s和CDLQI的相关性较差。PGA-D与pga - s相关性中等,但与cdlqi相关性较差。为了完成LS皮肤评估工具(LoSCAT),我们开发并评估了LoSDI和PGA-D以及LS皮肤严重程度指数(LoSSI)的心理测量特性。这些仪器将有助于评估LS患者的个体患者管理和临床试验。LoSDI和PGA-D具有良好的信度和高效度。LoSCAT提供了对LS自然历史的更好理解。需要在更大的患者群体中进行进一步的研究来证实这些初步发现。
Objective. To develop and assess the psychometric properties of the Localized Scleroderma (LS) Skin Damage Index (LoSDI) and Physician Global Assessment of disease Damage (PGA-D).Methods. Damage was defined as irreversible/persistent changes (>6 months) due to previous active disease/complications of therapy. Eight rheumatologists assessed the importance of 17 variables in formulating the PGA-D/LoSDI. LS patients were evaluated by two rheumatologists using both tools to assess their psychometric properties. LoSDI was calculated by summing three scores for cutaneous features of damage [dermal atrophy (DAT), subcutaneous atrophy (SAT) and dyspigmentation (DP)] measured at 18 anatomic sites. Patient GA of disease severity (PtGA-S), Children's Dermatology Life Quality Index (CDLQI) and PGA-D were recorded at the time of each examination.Results. Thirty LS patients (112 lesions) and nine patient-visit pairs (18 lesions) were included for inter-and intra-rater reliability study. LoSDI and its domains DAT, SAT, DP and PGA-D demonstrated excellent inter-and intra-rater reliability (reliability coefficients 0.86-0.99 and 0.74-0.96, respectively). LoSDI correlated moderately with PGA-D and poorly with PtGA-S and CDLQI. PGA-D correlated moderately with PtGA-S, but poorly with CDLQI.Conclusions. To complete the LS Cutaneous Assessment Tool (LoSCAT), we developed and evaluated the psychometric properties of the LoSDI and PGA-D in addition to the LS Skin Severity Index (LoSSI). These instruments will facilitate evaluation of LS patients for individual patient management and clinical trials. LoSDI and PGA-D demonstrated excellent reliability and high validity. LoSCAT provides an improved understanding of LS natural history. Further study in a larger group of patients is needed to confirm these preliminary findings.