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Efficacy and Evaluation of Clinical Case Definitions

William C. Blackwelder, PhD; Jann Storsaeter, MD; Patrick Olin, MD, PhD; Hans O. Hallander, MD, PhD

Am J Dis Child. 1991;145(11):1285-1289.

Abstract
• The efficacy of two acellular pertussis vaccines was estimated for various clinical case definitions, with and without the requirement of culture confirmation, from a randomized trial in Sweden. Efficacy increased with duration of coughing spasms and when the case definition included whoops or whoops plus at least nine coughing spasms a day. After deletion of clinical cases not believed to be caused by pertussis, efficacies were closer to the higher values for culture-confirmed disease. Nonspecificity of the clinical criterion "21 days of coughing spasms with whoops" resulted in estimates of predictive value for pertussis of 85% for placebo recipients and 56% for vaccinees. We conclude that laboratory confirmation of suspected cases is needed in pertussis vaccine trials. A suggested case definition is 21 days or more of coughing spasms with confirmation by culture, serologic study, or household exposure to culture-confirmed pertussis.

(AJDC. 1991;145:1285-1289)

Author Affiliations
From the National Institute of Allergy and Infectious Diseases, Bethesda, Md (Dr Blackwelder), and the Department of Pediatrics, Karolinska Institute, Sachs' Children's Hospital (Drs Storsaeter and Olin), and the National Bacteriological Laboratory (Dr Hallander), Stockholm, Sweden.

Footnotes
Accepted for publication June 24, 1991.

Reprint requests to BHV, Drakenbergsgatan 39, S-117 41 Stockholm, Sweden (Dr Storsaeter).

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