studies provides evidence for a causal relation that outweighs the evidence against such a relation. Demonstrated biologic plausibility was considered supportive of a decision to accept a causal relation but insufficient on its own to shift the balance of evidence from other sources.

5. The evidence establishes a causal relation.

Epidemiologic studies and/or case reports provide unequivocal evidence for a causal relation, and biologic plausibility has been demonstrated.

REFERENCES

Dickersin K, Berlin JA. Meta-analysis: state-of-the-science. Epidemiological Reviews 1992; 14:154-176.


Faich GA. Adverse drug reaction monitoring. New England Journal of Medicine 1986;314:1589-1592.


Hill AB. The environment and disease: association or causation. Proceedings of the Royal Society of Medicine 1965;58:295-300.

Hutchinson TA, Lane DA. Assessing methods for causality assessment of suspected adverse drug reactions. Journal of Clinical Epidemiology 1989;42:5-16.


Institute of Medicine. Adverse Effects of Pertussis and Rubella Vaccines. Washington. DC: National Academy Press; 1991.


Kramer MS. Difficulties in assessing the adverse effects of drugs. British Journal of Clinical Pharmacology 1981;11:105S-110S.

Kramer MS. Assessing causality of adverse drug reactions: global introspection and its limitations. Drug Information Journal 1986;20:433-437.

Kramer MS, Lane DA. Causal propositions in clinical research and practice. Journal of Clinical Epidemiology 1992;45:639-649.


Lane D. A probabilist's view of causality assessment. Drug Information Journal 1984;18:323-330.

Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a Bayesian approach. Journal of Pharmaceutical Medicine 1987;2:265-268.


Péré J-C. Estimation du numérateur en notification spontanée. In: Bégaud B, ed. Analyse d'Incidence en Pharmacovigilance: Application à la Notification Spontanée. Bordeaux, France: ARME-Pharmacovigilance Editions; 1991.


Stolley PD. How to interpret studies of adverse drug reactions. Clinical Pharmacology and Therapeutics 1990;48:337-339.

Susser M. Causal Thinking in the Health Sciences. New York: Oxford; 1973.


Tubert P, Bégaud B, Péré JC, Haramburu F, Lellouch J. Power and weakness of spontaneous reporting: a probabilistic approach. Journal of Clinical Epidemiology 1992;45:283-286.


U.S. Department of Health, Education, and Welfare. Smoking and Health: Report of the Advisory Committee to the Surgeon General. PHS Publication No. 1103. Washington, DC: U.S. Public Health Service, U.S. Department of Health, Education, and Welfare; 1964.


Venulet J, ed. Assessing Causes of Adverse Drug Reactions with Special Reference to Standardized Methods. London: Academic Press; 1982.



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