A new method for assessing drug causation provided agreement with experts' judgment

Journal of Clinical Epidemiology

Volumn 59, Issue 3, 2006, Pages 308-314

  Arimone, Yannick ^a,b   Bégaud, Bernard ^a,b   Miremont Salamé, Ghada ^a,c   Fourrier Réglat, Annie ^a,b   Molimard, Mathieu ^a,b   Moore, Nicholas ^a,b   Haramburu, Françoise ^a,c  

^a INSERM U657   (France)

^b UNIVERSITÉ DE BORDEAUX   (France)

^c HÔPITAL PELLEGRIN   (France)

Author keywords

Adverse effects; Causality; Consensus; Drug safety; Epidemiology; Methods

Indexed keywords

DRUG;

ADVERSE DRUG REACTION; AGED; ALGORITHM; ARTICLE; CLINICAL ARTICLE; DATA BASE; DECISION MAKING; DRUG SURVEILLANCE PROGRAM; FEMALE; FRANCE; GOLD STANDARD; HUMAN; MODEL; MULTIVARIATE LOGISTIC REGRESSION ANALYSIS; PRIORITY JOURNAL; PROBABILITY; STATISTICAL ANALYSIS; TECHNIQUE;

EID: 32644441914     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2005.08.012     Document Type: Article

References (22)

1. M.S. Kramer Imputabilité des effets indésirables: individu (analyse du cas) versus groupe (épidémiologie) [in French] 3es entretiens Jacques Cartier 1989 Centre Jacques Cartier Lyon 31 44
2. S. Blanc, P. Leuenberger, J.P. Berger, E.M. Brooke, and J.L. Schelling Judgments of trained observers on adverse drug reactions Clin Pharmacol Ther 25 1979 493 498
3. F.E. Karch, C.L. Smith, B. Kerzner, J.M. Mazzullo, M. Weintraub, and L. Lasagna Adverse drug reactions-a matter of opinion Clin Pharmacol Ther 19 1976 489 492
4. M.S. Kramer Difficulties in assessing the adverse effects of drugs Br J Clin Pharmacol 11 Suppl 1 1981 105S 110S
5. J. Koch-Weser, E.M. Sellers, and R. Zacest The ambiguity of adverse drug reactions Eur J Clin Pharmacol 11 1977 75 78
6. A.R. Feinstein Clinical biostatistics: XXX. Biostatistical problems in 'compliance bias.' Clin Pharmacol Ther 16 1974 846 857
7. K.L. Lanctôt, and C.A. Naranjo Comparison of the Bayesian approach and a simple algorithm for assessment of adverse drug events Clin Pharmacol Ther 58 1995 692 698
8. M. Auriche Approche bayésienne de l'imputabilité des phénomènes indésirables aux médicaments [In French] Therapie 40 1985 301 306
9. B. Bégaud Dictionary of pharmacoepidemiology 2000 John Wiley & Sons Chichester, UK
10. T.A. Hutchinson, and D.A. Lane Assessing methods for causality assessment of suspected adverse drug reactions J Clin Epidemiol 42 1989 5 16
11. J.C. Péré, M.H. Godin, B. Bégaud, F. Haramburu, and H. Albin Sensibilité et spécificité des critères d'imputabilité: étude et comparaison de ces indices d'efficacité pour sept méthodes [in French] Therapie 40 1985 307 312
12. G. Danan, and C. Benichou Causality assessment of adverse reactions to drugs: I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries J Clin Epidemiol 46 1993 1323 1330
13. C. Benichou, G. Danan, and A. Flahault Causality assessment of adverse reactions to drugs: II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge J Clin Epidemiol 46 1993 1331 1336
14. F.E. Karch, and L. Lasagna Toward the operational identification of adverse drug reactions Clin Pharmacol Ther 21 1977 247 254
15. A. Emanueli, and G. Sacchetti An algorithm for the classification of untoward events in large scale clinical trials Agents Actions Suppl 7 1980 318 322
16. C.A. Naranjo, U. Busto, E.M. Sellers, P. Sandor, I. Ruiz, E.A. Roberts, E. Janecek, C. Domecq, and D.J. Greenblatt A method for estimating the probability of adverse drug reactions Clin Pharmacol Ther 30 1981 239 245
17. I.R. Edwards, and C. Biriell Harmonisation in pharmacovigilance Drug Saf 10 1994 93 102
18. N.S. Irey Teaching monograph: tissue reactions to drugs Am J Pathol 82 1976 613 647
19. J. Dangoumau, J.C. Evreux, and J. Jouglard Méthode d'imputabilité des effets indésirables des médicaments [in French] Therapie 33 1978 373 381
20. B. Bégaud, J.C. Evreux, J. Jouglard, and G. Lagier Imputabilité des effets inattendus ou toxiques des médicaments [in French] Therapie 40 1985 111 118
21. R. Salamon, and P. Peytour Recherche du poids des critères dans un algorithme d'imputabilité [in French] Therapie 36 1981 229 231
22. M.D. Rawlins, and J.W. Thompson Pathogenesis of adverse drug reactions D.M. Davies Textbook of adverse drug reactions 1977 Oxford University Press Oxford 10 31