A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004

作者：Chapman Louisa E^*; Iskander John K; Chen Robert T; Neff John; Birkhead Guthrie S; Poland Gregory; Gray Gregory C; Siegel Jane; Sepkowitz Kent; Robertson Rose Marie; Yancy Clyde; Guerra Fernando A; Gardner Pierce; Modlin John F; Maurer Toby; Berger Tim; Flanders W Dana; Shope Robert

来源：Clinical Infectious Diseases, 2008, 46: S271-S293.

DOI：10.1086/524750

The US Department of Defense requested that the Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board joint Smallpox Vaccine Safety Working Group define the likelihood that smallpox vaccination played a causal role in the fatal illness of an Army reservist. Reported serious adverse events for which there was no a priori reason to discount the existence of a causal association with smallpox vaccine were reviewed to assess whether they were signals of constellations of vaccine-associated adverse events. A causal relationship between the immunization experience and the index patient's death was favored, but the implication of an individual vaccine was precluded. No new smallpox vaccine-associated clinical syndromes were identified. The data supported neutrality regarding the hypothesis that dilated cardiomyopathy was causally associated with smallpox vaccine-induced myocarditis. This review of sentinel cases augmented the ongoing safety review process and was transparent, but it shares limitations with other case-based causality-assessment methods.

• 出版日期2008-3-15