PMID: 12777432Jun 5, 2003Paper

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

International Journal of Epidemiology
Shabbar JaffarB Greenwood

Abstract

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. Required sample sizes to achieve a study with specified power were calculated for all-cause and acute lower respiratory tract infection (ALRI) mortality for different levels of sensitivity and specificity of post-mortem questionnaires. Data from active community-based surveillance and post-mortem questionnaires collected 1989-1993 from the study area were used in the calculations. The mortality rate among children aged 6-29 months from all causes was 34.2 per 1000 child-years; 19% of deaths were attributable to ALRI. Assuming that pneumococci would be responsible for 50% of ALRI deaths and that the vaccine would cover 70% of disease serotypes and w...Continue Reading

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Citations

Mar 10, 2010·Biostatistics·Bart Van RompayeShabbar Jaffar
Mar 6, 2010·Epidemiologic Reviews·Edward Fottrell, Peter Byass
Aug 19, 2008·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Xinran XuJia Chen
Feb 27, 2013·Clinical Interventions in Aging·Jennifer K HarrisonTerence J Quinn
Jan 24, 2007·Bulletin of the World Health Organization·UNKNOWN SonLa Study Group
Sep 25, 2014·Tropical Parasitology·Lalit Kumar DasSudhansu Sekar Sahu
Feb 18, 2012·International Journal of Stroke : Official Journal of the International Stroke Society·Kate McArthurTerence J Quinn
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Sep 22, 2007·Stroke; a Journal of Cerebral Circulation·Terence J QuinnKennedy R Lees
Jan 10, 2009·Stroke; a Journal of Cerebral Circulation·Terence J QuinnKennedy R Lees

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