Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis
Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis
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DOI：
10.1053/jhep.1997.v26.pm0009303497
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发表时间：
1997-09-01
期刊：
影响因子：
13.5
通讯作者：
Victorino, RMM
中科院分区：
文献类型：
--
作者：
Maria, VAJ;Victorino, RMM
本研究的目的是提出并验证药物性肝损伤（DILI）的临床诊断量表，该量表选择了五个组成部分：药物摄入与临床表现之间的时间关系、排除其他原因、肝外表现、再激发或意外再暴露以及既往医学文献中的报告。每个组成部分的相对重要性进行了权衡，并任意得分。DILI的诊断概率表示为最终评分，其范围为-6至20。本研究采用内容效度、效标效度、结构效度和评分者间信度进行分析。从我科120例疑似DILI病例中随机抽取50例进行信度和效度分析。以三位DILI专家对50例患者的分类为外部标准进行效标效度研究。用加权Kappa系数分析量表与标准的一致性和两个独立评定者之间的一致性（评定者间信度），42例（84%）量表与标准一致，加权Kappa系数为0.90。结构效度研究表明，该量表具有较好的区分能力。在86%的病例中观察到评分者之间的一致性，对应于0.93的加权kappa。总之，临床量表被证明具有较高的效度和评分者间信度，以及不同概率水平之间的良好区分能力。这些数据表明，该量表适用于临床实践，并可能有助于克服DILI因果关系评估过程中的困难。
The objective of this study is to present and validate a clinical scale for the diagnosis of drug-induced liver injury (DILI), Five components were selected to be included in the scale: temporal relationship between drug intake and the on-set of clinical picture, exclusion of alternative causes, extrahepatic manifestations, rechallenge or accidental re-exposure, and previous report in medical literature. The relative importance of each component was weighed, and arbitrary scores were attributed. The probability of the diagnosis of DILI was expressed as a final score, which could vary from -6 to 20. Content validity, criterion validity, construct validity, and inter-rater reliability were studied, To analyze validity and reliability, a random sample of 50 cases of suspected DILI was drawn from a series of 120 cases reported to our unit. The classification of the 50 cases by three experts in DILI was used as the external standard in the study of criterion validity. Agreement between the scale and the standard, and agreement between two independent raters (inter-rater reliability) was analyzed by weighted kappa coefficient, There was agreement between the scale and the standard in 42 cases (84%) with a weighted kappa coefficient of 0.90. A good discriminatory capacity of the scale was found when construct validity was studied. Agreement between raters was observed in 86% of the cases, corresponding to the weighted kappa of 0.93. In conclusion, the clinical scale was shown to have a high-level of validity and inter-rater reliability as well as a good discriminatory capacity between different levels of probability. These data suggest that the scale is suitable for use in clinical practice and may contribute to overcome the difficulties in the process of causality assessment in DILI.