期刊
CLINICAL INFECTIOUS DISEASES
卷 72, 期 9, 页码 1669-1675出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1453
关键词
influenza; vaccine effectiveness; test-negative design; real-time test-negative design; clinical testing
资金
- Centers for Disease Control and Prevention [75D301-19-C-05670]
- National Institutes of Health [R37 AI032042]
The real-time test-negative design (rtTND) utilizes real-time viral testing and respiratory infection eligibility criteria to identify influenza cases and test-negative controls prior to enrollment, potentially improving study efficiency, accuracy, and power to estimate influenza vaccine effectiveness. Key considerations for minimizing biases in the rtTND include comprehensive clinical testing at study sites and accurate influenza tests.
With rapid and accurate molecular influenza testing now widely available in clinical settings, influenza vaccine effectiveness (VE) studies can prospectively select participants for enrollment based on real-time results rather than enrolling all eligible patients regardless of influenza status, as in the traditional test-negative design (TND). Thus, we explore advantages and disadvantages of modifying the TND for estimating VE by using real-time, clinically available viral testing results paired with acute respiratory infection eligibility criteria for identifying influenza cases and test-negative controls prior to enrollment. This modification, which we have called the real-time test-negative design (rtTND), has the potential to improve influenza VE studies by optimizing the case-to-test-negative control ratio, more accurately classifying influenza status, improving study efficiency, reducing study cost, and increasing study power to adequately estimate VE. Important considerations for limiting biases in the rtTND include the need for comprehensive clinical influenza testing at study sites and accurate influenza tests.
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