What question did this study set out to answer?

To validate the core assumptions, accuracy, and precision of the test-negative design for estimating vaccine efficacy compared with the gold standard of per-protocol randomized placebo-controlled trial analyses.

September 12, 2013EurosurveillanceOpen Access

The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials

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Authors

GSGaston De SerresCentre hospitalier universitaire de Québec DSDanuta M. SkowronskiUniversity of British Columbia XWXionghua WuHalozyme Therapeutics (United States)

Discussion

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Implication

Randomized placebo-controlled trial analysis reveals identical efficacy estimates between test-negative designs and per-protocol methods in patient cohorts, indicating robust validity.

Key Points

To validate the core assumptions, accuracy, and precision of the test-negative design for estimating vaccine efficacy compared with the gold standard of per-protocol randomized placebo-controlled trial analyses.
Analyzed four randomized placebo-controlled trial datasets evaluating live attenuated influenza vaccine (LAIV) in children aged ≤7 years and older adults aged ≥60 years.
Evaluated generalizability across two additional randomized placebo-controlled trial datasets assessing monoclonal antibodies for preventing respiratory syncytial virus (RSV) hospitalization.
Compared efficacy estimates and confidence intervals between test-negative design and classic per-protocol analyses, while checking for off-target effects on non-targeted respiratory pathogens.
Efficacy estimates and confidence intervals derived from test-negative design analyses were virtually identical to classic per-protocol randomized trial results for both LAIV and RSV monoclonal antibodies.
Neither LAIV nor monoclonal antibodies influenced the risk of disease from non-targeted pathogens, confirming the core methodological assumption of the test-negative design.

Cite This Study

Serres et al. (2013) studied this question.

synapsesocial.com/papers/6a6f711afebe604dd7085bf5 https://doi.org/10.2807/1560-7917.es2013.18.37.20585

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Implication

Randomized placebo-controlled trial analysis reveals identical efficacy estimates between test-negative designs and per-protocol methods in patient cohorts, indicating robust validity.

The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials

Discussion

Member takes

Implication

Key Points

Cite This Study

The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials

Discussion

Member takes

Implication

Key Points

Cite This Study

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