The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
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.
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.