An Investigation of Disagreement in Causality Assessment of Adverse Drug Reactions

  title={An Investigation of Disagreement in Causality Assessment of Adverse Drug Reactions},
  author={Emma C. Davies and Philip H. Rowe and Sally James and Gareth Nickless and Amitava Ganguli and Mohammed Ibn-Mas’ud Danjuma and Lynn Owens and Elizabeth Odgers and Christopher F. Green and David R. Mottram and Munir Pirmohamed},
  journal={Pharmaceutical Medicine},
AbstractBackground: Causality assessment is used to determine the likelihood that a drug caused a particular adverse event. There are multiple methods for assessing the causality of suspected adverse drug reactions (ADRs). Undertaking some form of causality assessment of suspected ADRs is part of pharmacovigilance practice, but potentially without value if reproducibility of the results is consistently poor, and may vary with the background and experience of the assessor. Objective: The aim of… 
Comparison of different methods for causality assessment of adverse drug reactions
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Imputation of adverse drug reactions: Causality assessment in hospitals
Although the ADR causality assessment algorithms were poorly reproducible, the data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report.
Interrater agreement of two adverse drug reaction causality assessment methods: A randomised comparison of the Liverpool Adverse Drug Reaction Causality Assessment Tool and the World Health Organization-Uppsala Monitoring Centre system
It is found that the high interrater agreement achieved by the Liverpool Adverse Drug Reaction Causality Assessment Tool is lower than that achieved when using the World Health Organization-Uppsala Monitoring Centre system for standardised case causality assessment (WHO-UMC system).
Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions☆
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Causality or Relatedness Assessment in Adverse Drug Reaction and Its Relevance in Dermatology
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  • Medicine
    Indian journal of dermatology
  • 2018
The present study reviews some of the established or commonly used causality assessment tools (CATs) and its implications or relevance to dermatology in clinical practice.
Precedence of Cognizant Adverse Drug Reactions (ADRs) Reporting in a South Indian Tertiary Care Hospital: A Prospective Study
This study is indicative of ‘poor’ agreement between the two widely used criteria of WHO-UMC scale and Naranjo Algorithm.
Validation of a novel causality assessment scale for adverse events in non-small cell lung carcinoma patients treated with platinum and pemetrexed doublet chemotherapy
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Methods for Causality Assessment of Adverse Drug Reactions
There is still no method universally accepted for causality assessment of ADRs, and different causality categories are adopted in each method, and the categories are assessed using different criteria.
Adverse drug reactions: physicians' opinions versus a causality assessment method
Since spontaneous reporting of adverse drug reactions depends on the physician's opinion of the relationship between the drug and the adverse event, we compared physicians' opinions with the scores
A method for estimating the probability of adverse drug reactions
It was shown that the ADR probability scale has consensual, content, and concurrent validity and may be applicable to postmarketing drug surveillance.
Agreement of expert judgment in causality assessment of adverse drug reactions
This study confirms that experts express marked disagreements when assessing drug causality independently, and in a decision-making context, a step-by-step consensual approach such as the Delphi method seems necessary to make the assessment of such cases more reliable.
Role and place of causality assessment
Nowadays, causality assessment is understood as one of the signaling and sorting parameters and the many drug regulatory agencies assess causality, although rarely using a standardized assessment.
Algorithms Used in Adverse Drug Event Reports: A Comparative Study
The Karch and Kramer algorithms may disagree in how they assign a probability of risk to a potential ADE, due to how algorithms are applied, as well as to structural differences.
Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes
It is concluded that approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode.
Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability
Objectives:  To evaluate agreement between causality assessments of reported adverse drug reactions (ADRs) obtained from decisional algorithms, with those obtained from an expert panel using the WHO
Comparison of three algorithms used to evaluate adverse drug reactions.
The simpler and less time-consuming Naranjo algorithm compared favorably with the Kramer algorithm in scoring ADRs; more data are needed to support the use of the Jones algorithm.
Guidelines for submitting adverse event reports for publication
These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites and widespread distribution is encouraged.