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A reduction in cause-specific mortality may be the most important public health measure of the efficacy of a new vaccine. However, in developing countries, assignment of causes of deaths occurring outside hospitals can be assessed often only through the questioning of relatives about the signs and symptoms leading to death ('post-mortem questionnaire'). Causes assigned in this way have poor sensitivity and specificity. We illustrate the effects of this misclassification on the power of a large trial of a pneumococcal polysaccharide/protein conjugate vaccine with a mortality endpoint.

Effects of misclassification of causes of death on the power of a trial to assess the efficacy of a pneumococcal conjugate vaccine in The Gambia