Control without separate controls: evaluation of vaccine safety using case-only methods

Epidemiological methods involving only cases are reviewed in the context of vaccine safety studies. These methods include some ecological methods, case-coverage methods, case-crossover and self-controlled case series methods. The properties of the methods are described using examples from the literature. It is argued that such methods, and in particular the self-controlled case series method, are powerful epidemiologic tools meriting the same attention as more traditional cohort and case-control methods. (C) 2004 Elsevier Ltd. All rights reserved.