Test-negative design: the best study design ever?

To kick off the 2018 Journal Club our PhD students discussed a bewildering new trial design* to determine vaccine effectiveness (VE) published in Lancet ID, from which Meri Varkila reports.  The classical approach to quantify VE was to spend the best 5 years of your life to find 2,000 general practitioners, to invite 600,000 elderly to randomize 85.000 and to find 139 primary endpoints in 57 hospitals while all involved remain blinded. This new approach, called the test-negative design (TND) study would give you that number in a year, by just studying a few hundred patients with community-acquired pneumonia. A true Quality-of-Life enhancer for many…., if reliable. Continue reading

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