Computerized comparison of six adverse drug reaction assessment procedures

Clinical Pharmacology and Therapeutics
J C PéréH Albin

Abstract

Several standardized assessment procedures are currently used in the evaluation of adverse drug reactions (ADRs). Disagreement in rating ADRs can result from between-raters variability and between-methods differences in weighting the evidence. We eliminated between-raters variability by computer simulation of 1134 ADRs (including all the possible combinations of criteria currently used) and by automatic rating using different algorithms adapted from six published methods. Percentage agreement (Po) and weighted kappa test (kappa w) between pairs of methods are always better than with randomized scores, but the strength of agreement is only moderate (0.26 less than Po less than 0.59; 0.14 less than kappa w less than 0.51). The weightings of criteria are evaluated in terms of sensitivity, specificity, and predictive values. Criteria are neither sensitive (0.41 less than Se less than 0.70) nor specific (0.18 less than Sp less than 0.63) and have poor predictive values. Disagreements on weightings are considerable for three major criteria: timing of event, dechallenge, and alternative etiologic candidates. We discuss some ways of improving reliability of ADR diagnosis.

Citations

Jul 1, 1993·International Journal of Dermatology·G SacerdotiV Ruocco
Dec 22, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Taofikat B AgbabiakaEdzard Ernst
Feb 21, 2008·Alimentary Pharmacology & Therapeutics·M García-CortésUNKNOWN Spanish Group for the Study of Drug-induced Liver Disease (grupo de Estudio para las Hepatopatías Asociadas a Medicamentos,
Feb 1, 1997·The Annals of Pharmacotherapy·P A FrickJ P Rovers
May 10, 2013·European Journal of Clinical Pharmacology·Nicholas Moore
Aug 23, 2007·British Journal of Clinical Pharmacology·Yannick ArimoneBernard Bégaud
Apr 14, 2005·European Journal of Clinical Pharmacology·Yannick ArimoneFrançoise Haramburu
Nov 21, 2008·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Soo-Hee HwangYoon Kim
Jul 29, 2006·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ana F MacedoCarlos F Ribeiro
Sep 10, 2015·Pharmacoepidemiology and Drug Safety·Narumol JarernsiripornkulJanet Krska

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