Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool



Bracken, L, Nunn, A, Kirkham, JJ ORCID: 0000-0003-2579-9325, Peak, M ORCID: 0000-0003-1909-3211, Arnott, J, Smyth, RL, Pirmohamed, M ORCID: 0000-0002-7534-7266 and Turner, M ORCID: 0000-0002-5299-8656
(2017) Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool. PLoS ONE, 12 (1). e0169393-.

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Abstract

Aim To 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. Methods The 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 Measures Inter-rater reliability (IRR), measure of disagreement and utilization of avoidability categories. Results Preliminary 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’. Conclusion Avoidability 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.

Item Type: Article
Uncontrolled Keywords: Humans, Observer Variation, Data Collection, Prospective Studies, Pilot Projects, Reproducibility of Results, Adverse Drug Reaction Reporting Systems, Decision Making, Pharmacology, Pediatrics, Causality, Algorithms, Software, Child, Drug-Related Side Effects and Adverse Reactions, United Kingdom
Depositing User: Symplectic Admin
Date Deposited: 04 Jan 2017 13:10
Last Modified: 19 Jan 2023 07:20
DOI: 10.1371/journal.pone.0169393
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3005095