COVID-19: underpowered randomised trials, or no randomised trials?
- PMID: 33781304
- PMCID: PMC8006114
- DOI: 10.1186/s13063-021-05209-5
COVID-19: underpowered randomised trials, or no randomised trials?
Abstract
A recently published trial of face mask use to protect against COVID-19 demonstrated a key barrier to carrying out randomised trials in public health: the need for unattainably large sample sizes. For many public health interventions, the choice is not between sufficiently powered trials and underpowered trials, but between underpowered trials and no trials at all. Underpowered trials should be viewed as contributions to the larger body of evidence, alongside other studies of various sizes and designs, collectively assessed and synthesized in systematic reviews. Overemphasis on sample size calculation is probably more of a hindrance than a help to scientific progress.
Conflict of interest statement
The author declares that he has no competing interests.
Comment on
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Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial.Ann Intern Med. 2021 Mar;174(3):335-343. doi: 10.7326/M20-6817. Epub 2020 Nov 18. Ann Intern Med. 2021. PMID: 33205991 Free PMC article. Clinical Trial.
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- Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, Pries-Heje MM, Vissing CR, Nielsen PB, Winslow UC, et al. Effectiveness of adding a mask recommendation to other public health measures to prevent SARS-CoV-2 infection in Danish mask wearers: a randomized controlled trial. Ann Intern Med. 2021;174(3):335–43. 10.7326/M20-6817. Epub 2020 Nov 18. - PMC - PubMed
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- Haber NA, Wieten SE, Smith ER. Letter of concern regarding “Reduction in COVID-19 infection using surgical facial masks outside the healthcare system”. Dan Med J. 2020;67(12):A205063. - PubMed
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