Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool
Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool
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DOI：
10.1371/journal.pone.0028096
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发表时间：
2011-12-14
期刊：
影响因子：
3.7
通讯作者：
Pirmohamed, Munir
中科院分区：
文献类型：
--
作者：
Gallagher, Ruairi M.;Kirkham, Jamie J.;Pirmohamed, Munir
目的：目的：开发和测试一种新的药物不良反应因果关系评估工具（CAT）。方法：对80例前瞻性观察性研究和37例已发表的ADR病例报告，由专家焦点小组制定的新CAT的7名评估员与Naranjo CAT进行比较（共819个因果关系评估）。主要结果测量：因果关系类别的利用，分歧的测量，评估者间的可靠性（IRR）。利物浦ADR CAT使用来自一项观察性研究的40例病例，显示因果关系分类为1个不太可能，62个可能，92个很可能和125个明确（1，62，92，125）和“中度”IRR（kappa 0.48），相比之下，纳兰霍（0，100，172，8）与“中度”IRR（kappa 0.45）。在另外40例病例中，利物浦工具（0，66，81，133）显示“良好”IRR（kappa 0.6），而Naranjo（1，90，185，4）保持“中度”。结论：利物浦工具分配了全部因果关系类别，并显示良好的IRR。需要不同研究人员在不同环境下进行进一步评估，以充分评估该工具的实用性。
Aim: To develop and test a new adverse drug reaction (ADR) causality assessment tool (CAT).Methods: A comparison between seven assessors of a new CAT, formulated by an expert focus group, compared with the Naranjo CAT in 80 cases from a prospective observational study and 37 published ADR case reports (819 causality assessments in total).Main Outcome Measures: Utilisation of causality categories, measure of disagreements, inter-rater reliability (IRR).Results: The Liverpool ADR CAT, using 40 cases from an observational study, showed causality categories of 1 unlikely, 62 possible, 92 probable and 125 definite (1, 62, 92, 125) and 'moderate' IRR (kappa 0.48), compared to Naranjo (0, 100, 172, 8) with 'moderate' IRR (kappa 0.45). In a further 40 cases, the Liverpool tool (0, 66, 81, 133) showed 'good' IRR (kappa 0.6) while Naranjo (1, 90, 185, 4) remained 'moderate'.Conclusion: The Liverpool tool assigns the full range of causality categories and shows good IRR. Further assessment by different investigators in different settings is needed to fully assess the utility of this tool.