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Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report.慢性移植物抗宿主病治疗反应的评估。美国国立卫生研究院慢性移植物抗宿主病临床试验标准共识发展项目:IV。2014年反应标准工作组报告。
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National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report.美国国立卫生研究院慢性移植物抗宿主病临床试验标准共识发展项目:I. 2014年诊断与分期工作组报告
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Blood. 2013 Jun 20;121(25):5098-103. doi: 10.1182/blood-2012-10-464198. Epub 2013 Apr 1.
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National Institutes of Health chronic graft-versus-host disease staging in severely affected patients: organ and global scoring correlate with established indicators of disease severity and prognosis.美国国立卫生研究院严重移植物抗宿主病分期:器官和全球评分与既定疾病严重程度和预后指标相关。
Biol Blood Marrow Transplant. 2013 Apr;19(4):632-9. doi: 10.1016/j.bbmt.2013.01.013. Epub 2013 Jan 20.
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Correlation between NIH composite skin score, patient-reported skin score, and outcome: results from the Chronic GVHD Consortium.NIH 综合皮肤评分、患者报告皮肤评分与结局的相关性:慢性移植物抗宿主病联盟研究结果。
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Interrater agreement and interrater reliability: key concepts, approaches, and applications.评定者间一致性和评定者间信度:关键概念、方法和应用。
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Biol Blood Marrow Transplant. 2011 Nov;17(11):1619-29. doi: 10.1016/j.bbmt.2011.04.002. Epub 2011 Apr 12.
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Repeated teaching courses of the modified Rodnan skin score in systemic sclerosis.系统性硬化症改良 Rodnan 皮肤评分的重复教学课程。
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A single-center pilot validation study of a new chronic GVHD skin scoring system.一项关于新型慢性移植物抗宿主病皮肤评分系统的单中心试点验证研究。
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皮肤慢性移植物抗宿主病临床分级测量的评分者间信度。

Interrater Reliability of Clinical Grading Measures for Cutaneous Chronic Graft-vs-Host Disease.

机构信息

Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.

Department of Dermatology, Duke University, Durham, North Carolina.

出版信息

JAMA Dermatol. 2019 Jul 1;155(7):833-837. doi: 10.1001/jamadermatol.2018.5459.

DOI:10.1001/jamadermatol.2018.5459
PMID:30994873
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6583829/
Abstract

IMPORTANCE

Cutaneous chronic graft-vs-host disease (cGVHD) is common after allogeneic hematopoietic stem cell transplant and is often associated with poor patient outcomes. A reliable and practical method for assessing disease severity and response to therapy among these patients is urgently needed.

OBJECTIVE

To evaluate the interrater agreement and reliability of skin-specific and range of motion (ROM) variables of the 2014 National Institutes of Health (NIH) response criteria for cGVHD and a skin sclerosis grading scale (SSG).

DESIGN, SETTING, AND PARTICIPANTS: In this observational study performed at a single tertiary academic center, 6 academic blood and marrow transplant specialists and 4 medical dermatologists examined 8 patients with diagnosed cutaneous cGVHD on July 10, 2015. The patient cohort was enriched for patients with sclerotic features. Each patient was evaluated by using the skin-specific and ROM criteria of the 2014 NIH response criteria for cGVHD and an SSG ranging from 0 to 3. Each patient was also asked to complete quality-of-life scoring instruments. Interrater agreement and reliability were estimated by calculating the Krippendorff α and Cohen κ statistics. Data were analyzed from September 29, 2015, through November 22, 2018.

MAIN OUTCOMES AND MEASURES

Estimation of interrater agreement by interclass coefficient (Krippendorff α and Cohen κ statistics) for the skin-specific and ROM components of the 2014 NIH Response Criteria for Chronic GVHD and for the SSG.

RESULTS

The median age of the patients evaluated was 54 years (range, 46-58 years). Patients were predominantly male (6 [75%]). Six of the 8 patients had a predominantly sclerotic cutaneous phenotype. Interrater agreement among our experts was acceptable for NIH skin feature score (0.68; 95% CI, 0.30-0.86) and good for NIH ROM scoring (0.80; 95% CI, 0.68-0.86). Dermatologists had acceptable agreement for NIH skin GVHD score (0.69; 95% CI, 0.25-0.82) and skin feature score (0.78; 95% CI, 0.17-0.98), good agreement in ROM grading (0.85; 95% CI, 0.69-0.90), and near perfect agreement in identifying sclerosis (0.82; 95% CI, 0.27-0.97).

CONCLUSIONS AND RELEVANCE

Although dermatologists had acceptable agreement in NIH skin GVHD score and skin features score, near perfect agreement in identifying cutaneous sclerosis, better agreement in grading severity of cutaneous cGVHD, especially in the intermediate grades, appears to be needed.

摘要

重要性

异基因造血干细胞移植后常发生慢性移植物抗宿主病(cGVHD),且常与患者预后不良相关。目前迫切需要一种可靠且实用的方法来评估此类患者的疾病严重程度和对治疗的反应。

目的

评估 2014 年美国国立卫生研究院(NIH)cGVHD 反应标准的皮肤特异性和运动范围(ROM)变量以及皮肤硬化分级量表(SSG)的观察者间一致性和可靠性。

设计、地点和参与者:在单中心三级学术中心进行的这项观察性研究中,于 2015 年 7 月 10 日,6 位血液和骨髓移植领域的学术专家和 4 位皮肤科医生检查了 8 例确诊为皮肤 cGVHD 的患者。该患者队列中富含有硬化特征的患者。每位患者均接受了 2014 年 NIH cGVHD 反应标准的皮肤特异性和 ROM 标准以及 0 至 3 分的 SSG 评估。每位患者还完成了生活质量评分量表。观察者间一致性和可靠性通过计算 Krippendorff α 和 Cohen κ 统计量来估计。数据于 2015 年 9 月 29 日至 2018 年 11 月 22 日进行分析。

主要结局和测量

通过组内系数(Krippendorff α 和 Cohen κ 统计量)估计 2014 年 NIH 慢性 GVHD 反应标准的皮肤特异性和 ROM 成分以及 SSG 的观察者间一致性。

结果

接受评估的患者中位年龄为 54 岁(范围,46-58 岁)。患者主要为男性(6 [75%])。8 例患者中有 6 例(75%)主要表现为硬化性皮肤表型。我们的专家之间的观察者间一致性对于 NIH 皮肤特征评分是可接受的(0.68;95%CI,0.30-0.86),对于 NIH ROM 评分是良好的(0.80;95%CI,0.68-0.86)。皮肤科医生对于 NIH 皮肤 GVHD 评分(0.69;95%CI,0.25-0.82)和皮肤特征评分(0.78;95%CI,0.17-0.98)具有可接受的一致性,对于 ROM 分级具有良好的一致性(0.85;95%CI,0.69-0.90),对于识别硬化具有近乎完美的一致性(0.82;95%CI,0.27-0.97)。

结论和相关性

尽管皮肤科医生对于 NIH 皮肤 GVHD 评分和皮肤特征评分具有可接受的一致性,对于识别皮肤硬化具有近乎完美的一致性,但在评估皮肤 cGVHD 的严重程度,尤其是在中间等级时,似乎需要更好的一致性。