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- Title
Accuracy of composite diagnostic standards for pneumococcal pneumonia in vaccine trials.
- Authors
Suzuki, M.; Katoh, S.; Miyahara, R.; Ariyoshi, K.; Morimoto, K.
- Abstract
Because of a lack of gold standard diagnostics, a combination of multiple diagnostic tests, or composite diagnostic standard, has been used to measure pneumococcal pneumonia (PP) in pneumococcal vaccine trials. We estimated the accuracy of composite diagnostic standards for PP used in previous randomised controlled trials by simple formulas. A systematic literature review identified five eligible trials and all trials had used different combinations of diagnostic tests for PP. The estimated values of sensitivity and minimum specificity of composite diagnostic standards varied substantially between trials: 48.4% to 98.1% and 71.0% to 97.3%, respectively. Without standardizing the outcome measurements, pneumococcal vaccine efficacy estimates against PP are not comparable between trials and their pooled estimates are biased.
- Subjects
PNEUMOCOCCAL pneumonia; ROUTINE diagnostic tests; DRUG formularies; CLINICAL trials; DIAGNOSIS; VACCINATION
- Publication
Epidemiology & Infection, 2018, Vol 146, Issue 6, p712
- ISSN
0950-2688
- Publication type
Article
- DOI
10.1017/S0950268818000651