Evidence map›Paper›PMID 28046035›Full record

ArticlePloS one2017

Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool.

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

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
7.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

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  17. Adverse Drug Reactions in Norway: A Systematic Review.Pharmacy (Basel, Switzerland) · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Louise E BrackenPaediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.
Anthony J NunnDepartment of Women's & Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
Jamie J KirkhamDepartment of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
Matthew PeakPaediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.
Janine ArnottPaediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.
Rosalind L SmythInstitute of Child Health, University College London, London, United Kingdom.
Munir PirmohamedDepartment of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
Mark A TurnerPaediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom.
Alder Hey Children's NHS Foundation Trust · GBUniversity of Liverpool · GBUniversity College London · GBUniversity of Central Lancashire · GB

Funding

Medical Research Council MR/L006758/1
6 · The paper itself

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.

Indexed as

Adverse Drug Reaction Reporting SystemsAlgorithmsCausalityChildData CollectionDecision MakingDrug-Related Side Effects and Adverse ReactionsHumansObserver VariationPediatricsPharmacologyPilot ProjectsProspective StudiesReproducibility of ResultsSoftwareUnited Kingdom

Identifiers

PMID28046035
PMCPMC5207751
OpenAlexW2568209022

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.