Development and Inter-Rater Reliability of the Liverpool Adverse Drug Reaction Causality Assessment Tool

被引：154

作者：

Gallagher, Ruairi M. ^{[1
]}

Kirkham, Jamie J. ^{[2
]}

Mason, Jennifer R. ^{[3
]}

Bird, Kim A. ^{[3
]}

Williamson, Paula R. ^{[2
]}

Nunn, Anthony J. ^{[3
]}

Turner, Mark A.

Smyth, Rosalind L. ^{[1
]}

Pirmohamed, Munir ^{[4
]}

机构：

[1] Univ Liverpool, Inst Child Hlth, Dept Womens & Childrens Hlth, Liverpool L69 3BX, Merseyside, England

[2] Univ Liverpool, Dept Biostat, Liverpool L69 3BX, Merseyside, England

[3] Alder Hey Childrens NHS Fdn Trust, Liverpool, Merseyside, England

[4] Univ Liverpool, Dept Mol & Clin Pharmacol, Inst Translat Med, Liverpool L69 3BX, Merseyside, England

来源：

PLOS ONE | 2011年 / 6卷 / 12期

基金：

美国国家卫生研究院;

关键词：

HIGH AGREEMENT; LOW KAPPA; PROBABILITY;

D O I：

10.1371/journal.pone.0028096

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：8

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