Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method.
Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method.
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DOI：
10.1002/hep.23577
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发表时间：
2010-06
期刊：
影响因子：
13.5
通讯作者：
Hayashi, Paul H.
中科院分区：
文献类型：
--
作者：
Rockey, Don C.;Seeff, Leonard B.;Rochon, James;Freston, James;Chalasani, Naga;Bonacini, Maurizio;Fontana, Robert J.;Hayashi, Paul H.
药物性肝损伤 (DILI) 在很大程度上是一种排除性诊断，因此具有挑战性。美国药物性肝损伤网络 (DILIN) 前瞻性研究使用两种方法来评估 DILI 因果关系：结构化专家意见流程和 Roussel-Uclaf 因果关系评估方法 (RUCAM)。因果关系评估侧重于疑似 DILI 患者的详细临床和实验室数据。裁决过程使用标准化的数字和描述性定义，并将案件分为明确的、极有可能的、可能的、可能的或不可能的。将结构化专家意见程序的结果与 RUCAM 方法得出的结果进行比较。在 250 名疑似 DILI 患者中，专家意见裁决过程将 78 名患者 (31%) 评为确定，102 名 (41%) 名患者为极有可能，37 名患者 (15%) 为可能，25 名患者 (10%) 为可能，8 名患者 (3%) 为不可能。在接受过单一相关药物的 187 名参与者中，50 名 (27%) 的参与者与专家意见流程达成初步完全一致，34 名 (19%) 的参与者与五类 RUCAM 量表达成初步完全一致 (P = 0.08)，并且这两种方法显示出彼此之间的适度相关性 (Spearman's r = 0.42，P = 0.0001)。重要的是，与 DILIN 专家意见流程相比，RUCAM 方法大大降低了因果关系的可能性。在评估因果关系方面，结构化的 DILIN 专家意见流程比 RUCAM 产生了更高的一致率和可能性分数，但两者仍然存在相当大的观察者间差异。因此，仍然需要一种更客观、可靠和可重复的方法来评估 DILI 因果关系。
Drug-induced liver injury (DILI) is largely a diagnosis of exclusion and is therefore challenging. The US Drug-Induced Liver Injury Network (DILIN) prospective study used two methods to assess DILI causality: a structured expert opinion process and the Roussel-Uclaf Causality Assessment Method (RUCAM). Causality assessment focused on detailed clinical and laboratory data from patients with suspected DILI. The adjudication process used standardized numerical and descriptive definitions and scored cases as definite, highly likely, probable, possible, or unlikely. Results of the structured expert opinion procedure were compared with those derived by the RUCAM approach. Among 250 patients with suspected DILI, the expert opinion adjudication process scored 78 patients (31%) as definite, 102 (41%) as highly likely, 37 (15%) as probable, 25 (10%) as possible, and 8 (3%) as unlikely. Among 187 enrollees who had received a single implicated drug, initial complete agreement was reached for 50 (27%) with the expert opinion process and for 34 (19%) with a five-category RUCAM scale (P = 0.08), and the two methods demonstrated a modest correlation with each other (Spearman's r = 0.42, P = 0.0001). Importantly, the RUCAM approach substantially shifted the causality likelihood toward lower probabilities in comparison with the DILIN expert opinion process. The structured DILIN expert opinion process produced higher agreement rates and likelihood scores than RUCAM in assessing causality, but there was still considerable interobserver variability in both. Accordingly, a more objective, reliable, and reproducible means of assessing DILI causality is still needed.
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影响因子：
9.8
作者：
Vuppalanchi, Raj;Liangpunsakul, Suthat;Chalasani, Naga
通讯作者：
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影响因子：
13.5
作者：
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作者：
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通讯作者：
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29.4
作者：
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