The quality of the reported sample size calculation in clinical trials on COVID-19 patients indexed in PubMed
The quality of the reported sample size calculation in clinical trials on COVID-19 patients indexed in PubMed
Letter to the Editor: Given the utmost priority of COVID-19 research, many medical journals, especially the leading ones, expedited the review process of these papers. It was expected that the amount of submitted papers for peer review would raise sharply and the deadline of the review period at the COVID-19 outbreak will be tightened. Therefore, sample size calculation of these papers, a component that was being omitted in more than 40% of the published randomized controlled trials,1 might be neglected during the peer review process. Most importantly, authors of these papers were also rushing to conduct their COVID-19 research and they might not have seek necessary statistical consultation regarding sample size calculation. The CONsolidated Standards Of Reporting Trials (CONSORT) statement recommends trial reports to provide all essential information on the determination of sample size, including the level of statistical significance, the desired level of power, and the estimated effect size of the treatment. However, the degree of compliance to the CONSORT statement regarding sample size calculation of the newly-published COVID-19 trial papers is unknown. Therefore, we reviewed all clinical trials on COVID-19 patients published from 1st January 2020 to 4th April 2020 indexed in PubMed
Protocol, Sample size, SARS-CoV-2, Statistics, Trials
139-140
Lee, Paul H.
02620eab-ae7f-4a1c-bad1-8a50e7e48951
1 July 2020
Lee, Paul H.
02620eab-ae7f-4a1c-bad1-8a50e7e48951
Lee, Paul H.
(2020)
The quality of the reported sample size calculation in clinical trials on COVID-19 patients indexed in PubMed.
European Journal of Internal Medicine, 77 (7), .
(doi:10.1016/j.ejim.2020.04.057).
Abstract
Letter to the Editor: Given the utmost priority of COVID-19 research, many medical journals, especially the leading ones, expedited the review process of these papers. It was expected that the amount of submitted papers for peer review would raise sharply and the deadline of the review period at the COVID-19 outbreak will be tightened. Therefore, sample size calculation of these papers, a component that was being omitted in more than 40% of the published randomized controlled trials,1 might be neglected during the peer review process. Most importantly, authors of these papers were also rushing to conduct their COVID-19 research and they might not have seek necessary statistical consultation regarding sample size calculation. The CONsolidated Standards Of Reporting Trials (CONSORT) statement recommends trial reports to provide all essential information on the determination of sample size, including the level of statistical significance, the desired level of power, and the estimated effect size of the treatment. However, the degree of compliance to the CONSORT statement regarding sample size calculation of the newly-published COVID-19 trial papers is unknown. Therefore, we reviewed all clinical trials on COVID-19 patients published from 1st January 2020 to 4th April 2020 indexed in PubMed
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Accepted/In Press date: 27 April 2020
Published date: 1 July 2020
Keywords:
Protocol, Sample size, SARS-CoV-2, Statistics, Trials
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Local EPrints ID: 475048
URI: http://eprints.soton.ac.uk/id/eprint/475048
ISSN: 0953-6205
PURE UUID: 29b5f8cb-170f-4a7a-9447-acf563d59e32
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Date deposited: 09 Mar 2023 18:48
Last modified: 17 Mar 2024 04:16
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Author:
Paul H. Lee
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