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

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          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.

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          Most cited references21

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          Practical statistics for medical researched

          DG ALTMAN, DG Altman, D Altman … (1991)
          Book 0 comments Cited 259 times – based on 0 reviews
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            High agreement but low kappa: II. Resolving the paradoxes.

            Jeffrey Feinstein, D Cicchetti (1989)
            An omnibus index offers a single summary expression for a fourfold table of binary concordance among two observers. Among the available other omnibus indexes, none offers a satisfactory solution for the paradoxes that occur with p0 and kappa. The problem can be avoided only by using ppos and pneg as two separate indexes of proportionate agreement in the observers' positive and negative decisions. These two indexes, which are analogous to sensitivity and specificity for concordance in a diagnostic marker test, create the paradoxes formed when the chance correction in kappa is calculated as a product of the increment in the two indexes and the increment in marginal totals. If only a single omnibus index is used to compared different performances in observer variability, the paradoxes of kappa are desirable since they appropriately "penalize" inequalities in ppos and pneg. For better understanding of results and for planning improvements in the observers' performance, however, the omnibus value of kappa should always be accompanied by separate individual values of ppos and pneg.
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              Methods for causality assessment of adverse drug reactions: a systematic review.

              Taofikat B Agbabiaka, Jelena Savović, Edzard Ernst (2008)
              Numerous methods for causality assessment of adverse drug reactions (ADRs) have been published. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. We conducted electronic searches in MEDLINE (via PubMed), EMBASE and the Cochrane databases to find all assessment methods. Thirty-four different methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods (Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. As a result of problems of reproducibility and validity, no single method is universally accepted. Different causality categories are adopted in each method, and the categories are assessed using different criteria. Because assessment methods are also not entirely devoid of individual judgements, inter-rater reliability can be low. In conclusion, there is still no method universally accepted for causality assessment of ADRs.
              Article 0 comments Cited 74 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                : Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Electronic): 1932-6203
                Publication date Collection: 2011
                Publication date (Electronic): 14 December 2011
                Volume: 6
                Issue: 12
                Electronic Location Identifier: e28096
                Affiliations
                [1 ]Institute of Child Health, Department of Women's and Children's Health, University of Liverpool, Liverpool, United Kingdom
                [2 ]Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom
                [3 ]Research and Development, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom
                [4 ]Pharmacy, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom
                [5 ]Department of Women's and Children's Health, University of Liverpool, Liverpool, United Kingdom
                [6 ]Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom
                Bremen Institute of Preventive Research and Social Medicine, Germany
                Author notes

                Conceived and designed the experiments: RMG JJK PRW RLS MP. Performed the experiments: RMG JRM KAB AJN MAT RLS MP. Analyzed the data: JJK RMG. Wrote the paper: RMG JJK PRW MAT RLS MP.

                Article
                Publisher ID: PONE-D-11-01930
                DOI: 10.1371/journal.pone.0028096
                PMC ID: 3237416
                PubMed ID: 22194808
                SO-VID: 2fc6939c-cffb-4fa6-9bcc-2daca291161d
                Copyright © Gallagher et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                History
                Date received : 20 January 2011
                Date accepted : 1 November 2011
                Page count
                Pages: 8
                Categories
                Subject: Research Article
                Subject: Biology
                Subject: Immunology
                Subject: Allergy and Hypersensitivity
                Subject: Population Biology
                Subject: Epidemiology
                Subject: Medicine
                Subject: Clinical Immunology
                Subject: Allergy and Hypersensitivity
                Subject: Clinical Research Design
                Subject: Epidemiology
                Subject: Drugs and Devices
                Subject: Adverse Reactions
                Subject: Clinical Pharmacology
                Subject: Epidemiology
                Subject: Pharmacoepidemiology
                Subject: Non-Clinical Medicine
                Subject: Health Care Policy
                Subject: Health Risk Analysis

                ScienceOpen disciplines: Uncategorized
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                ScienceOpen disciplines: Uncategorized

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