Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool.

Louise E Bracken,Anthony J Nunn,Matthew Peak,Janine Arnott,Mark A Turner,Rosalind L Smyth,Jamie J Kirkham,Munir Pirmohamed,Zheng Li

doi:10.1371/journal.pone.0169393

Abstract

AimTo develop and test a new tool to assess the avoidability of adverse drug reactions that is suitable for use in paediatrics but which is also applicable to a variety of other settings.MethodsThe study involved multiple phases. Preliminary work involved using the Hallas scale and a modification of the existing Hallas scale, to assess two different sets of adverse drug reaction (ADR) case reports. Phase 1 defined, modified and refined a new tool using multidisciplinary teams. Phase 2 involved the assessment of 50 ADR case reports from a prospective study of paediatric inpatients by individual assessors. Phase 3 compared assessments with the new tool for individuals and groups in comparison to the ‘gold standard’ (the avoidability outcome set by a panel of senior investigators: an experienced clinical pharmacologist, paediatrician and pharmacist).Main Outcome MeasuresInter-rater reliability (IRR), measure of disagreement and utilization of avoidability categories.ResultsPreliminary work—Pilot phase: results for the original Hallas cases were fair and pairwise kappa scores ranged from 0.21 to 0.36. Results for the modified Hallas cases were poor, pairwise kappa scores ranged from 0.06 to 0.16.Phase 1: on initial use of the new tool, agreement between the two multidisciplinary groups was found on 13/20 cases with a kappa score of 0.29 (95% CI -0.04 to 0.62).Phase 2: the assessment of 50 ADR case reports by six individual reviewers yielded pairwise kappa scores ranging from poor to good 0.12 to 0.75 and percentage exact agreement (%EA) ranged from 52–90%.Phase 3: Percentage exact agreement ranged from 35–70%. Overall, individuals had better agreement with the ‘gold standard’.ConclusionAvoidability assessment is feasible but needs careful attention to methods. The Liverpool ADR avoidability assessment tool showed mixed IRR. We have developed and validated a method for assessing the avoidability of ADRs that is transparent, more objective than previous methods and that can be used by individuals or groups.

Highlights

Adverse drug reactions (ADRs) contribute significantly to patient morbidity, mortality and hospitalisation costs
Phase 1: on initial use of the new tool, agreement between the two multidisciplinary groups was found on 13/20 cases with a kappa score of 0.29
We have developed and validated a method for assessing the avoidability of ADRs that is transparent, more objective than previous methods and that can be used by individuals or groups

Summary

Introduction

Adverse drug reactions (ADRs) contribute significantly to patient morbidity, mortality and hospitalisation costs. A recent systematic review of ADRs in children reported incidences of ADRs in hospitalised children ranging from 0.6 to 16.8% among studies [2]. This is similar to the incidence rate in hospitalised adults of 14.7% [3]. The annual cost of drug related morbidity and mortality has been estimated in the United States at more than $136 billion and ADRs contribute significantly to these costs [4]. Children are considered to be susceptible to ADRs [5,6]

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