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Methods Inf Med 1984; 23(04): 183-188
DOI: 10.1055/s-0038-1635341
Original Article
Schattauer GmbH

Adverse Drug Reactions— A Computer-assisted Application of Correspondence Analysis for Automatic Causality Assessment

Arzneimittelnebenwirkungen – Computerunterstützte Anwendung der Korrespondenzanalyse für die automatische Kausalitätsbeurteilung
Ch. Bastin
1   (From the Université de Paris VI, Laboratoire de Statistique, Paris, France and Ciba-Geigy Ltd., Medical Department, Basle, Switzerland)
,
P. Wertheimer
1   (From the Université de Paris VI, Laboratoire de Statistique, Paris, France and Ciba-Geigy Ltd., Medical Department, Basle, Switzerland)
,
J. Venulet   *
1   (From the Université de Paris VI, Laboratoire de Statistique, Paris, France and Ciba-Geigy Ltd., Medical Department, Basle, Switzerland)
› Author Affiliations
Further Information

Publication History

Publication Date:
20 February 2018 (online)

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Summary

An assessment forra comprising 27 questions relating to adverse drug reactions and causal relationship was completed for 204 subjects. Questions providing no information were disregarded and answers to the remaining questions recorded and subjected to a correspondence analysis.

The correspondence analysis returned a set of mappings together with new quantitative variables to which discriminant analysis was applied aiming at a future allocation of individuals to causality groups.

Results of the analysis, based on data from the 204 subjects, demonstrated that in 61.3% of cases assessment of causality obtained with discriminant analysis was identical with the assessment made by a medical evaluator.

The allocation rule was subsequently applied to data from 100 new case reports and, in a similar percentage (60%) of cases, allocation to the causality groups coincided with the evaluator’s assessment.

Für 204 Patienten wurde ein Beurteilungsbogen mit 27 Fragen zu unerwünschten Arzneimittelwirkungen und ihrem kausalen Zusammenhang ausgefüllt. Für die Auswertung wurden alle Fragen ohne Informationscharakter weggelassen. Die Antworten auf die übrigen Fragen wurden aufgelistet und einer Korrespondenzanalyse unterzogen.

Die Korrespondenzanalyse resultierte in einer Datenreduktion mit neuen quantitativen Variablen, die ihrerseits einer Diskriminanzanalyse unterzogen wurden mit der Absicht, die einzelnen Patienten anschließend Kausalitätsgruppen zuzuordnen.

Die Ergebnisse der Datenanalyse der 204 Patienten zeigten, daß 61,3% der mit der Diskriminanzanalyse erhaltenen Kausalitätsbeurteilungen mit jenen des klinischen Prüfers übereinstimmten.

Anschließend wurde diese Zuteilungsregel auch auf 100 neue Fallberichte angewandt; hierbei entsprachen 60% der Kausalitätszuordnungen jenen des klinischen Prüfers.

Key-Words:

Adverse Drug Reactions - Causality Assessment - Computer-assisted Approach - Correspondence Analysis

Schlüssel-Wörter:

Unerwünschte Arzneimittelwirkungen - Kausalitätsbeurteilung - Computerunterstützte Auswertung - Korrespondenzanalyse

* Address for correspondence: Prof. Jan Venulet, Medical Department Ciba-Geigy A. G., CH-4002 Basel, Switzerland


 

  • References

  • 1 Benzecri J. P.. L’Analyse des Correspondances. Paris: Dunod; 1976
    Google Scholar
  • 2 Dangamou J., Evereux J.-C , Jouglard J.. Méthode d’imputabilité des effets indésirables des médicaments. Thérapie 1978; 33: 373-381.
    PubMedGoogle Scholar
  • 3 Emanueli A., Sacchetti G.. An algorithm for the classification of untoward events in large scale clinical trials. In Velo G. G.. (Edit.) Trends in Inflammation Research 1, pp 318-322. (Agents and Actions Suppl., Vol.7). (Basel: Birkhäuser 1980;
    PubMedGoogle Scholar
  • 4 Greenacre M. J.. Theory and Application of Correspondence Analysis. London: Academic Press 1984
    PubMedGoogle Scholar
  • 5 James D., Haller E., Rosselet G., Brooke E. M., Schelling J. L.. Fréquence des prescriptions dé médicaments et de leurs effets indésirables dans un départment de médecine. Schweiz. med. Wschr 1978; 108: 1270-1277.
    PubMedGoogle Scholar
  • 6 Jones J. K.. Adverse drug reactions in the community health setting: Approaches to recognizing, counseling and reporting. Fam. Commun. Hlth J 1982; 58-67.
    PubMedGoogle Scholar
  • 7 Joyce C. R. B.. Identifying causes of disagreement in assessment of causality. In Venulet J., Berneker G.-C, Ciucci A. G.. (Eds) Assessing Causes of Adverse Drug Reactions, pp. 95-103. London: Academic Press; 1982
    Google Scholar
  • 8 Karch F. E., Lasagna L.. Toward the operational identification of adverse drug reactions. Clin. Pharmacol. Ther 1977; 21: 247-254.
    CrossrefPubMedGoogle Scholar
  • 9 Karch F. E., Smith C. L., Kerzner B., Mazzullo J., Weintraub M., Lasagna L.. Adverse drug reactions—a matter of opinion. Clin. Pharmacol. Ther 1976; 19: 489-492.
    CrossrefPubMedGoogle Scholar
  • 10 Koch-Weser J., Sellers E. M., Zacest R.. The ambiguity of adverse drug reactions. Europ. J. clin. Pharmacol 1977; 11: 75-78.
    CrossrefPubMedGoogle Scholar
  • 11 Kramer M. S., Leventhal J. M., Hutchinson T. A., Feinstein A. R.. An.Algorithm for the operational assessment of adverse drug reactions. I. Background, description and instructions for use. J. Amer. med. Ass 1979; 242: 623-632.
    PubMedGoogle Scholar
  • 12 Rainisio M.. Statistical and other non-empirical approaches. In Venulet J., Berneker G.-C, Ciucci A. G.. (Eds) Assessing Causes of Adverse Drug Reactions, pp. 105-116. London: Academic Press; 1982
    Google Scholar
  • 13 Venulet J., Ciucci A., Berneker G.-C. Standardized assessment of drug-adverse reaction relationship. Int. J. clin. Pharmacol 1980; 18: 381-188.
    PubMedGoogle Scholar