Journal article Open Access

Statistical review of Effect of Dexamethasone in Hospitalized Patients with COVID-19 – Preliminary Report

Morris, Tim; Dahly, Darren; Hood, Kerry; Gates, Simon


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    <subfield code="a">&lt;p&gt;The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with experience in clinical&amp;nbsp; trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments,&amp;nbsp; independent of journal specific review processes. We aim to provide timely, constructive, focused, clear advice aimed at improving&amp;nbsp; both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews&amp;nbsp; focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences). This&amp;nbsp; review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology&amp;nbsp; Research Partnership, its wider membership, or any other organization. Here we review &lt;em&gt;Effect of Dexamethasone in Hospitalized Patients with COVID-19 &amp;ndash;&amp;nbsp; Preliminary Report &lt;/em&gt;by Horby &lt;em&gt;et al&lt;/em&gt;, published as a preprint on medRxiv on the 22nd of June, 2020.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Overall, this was a well-conducted, well-designed, practice-changing clinical trial providing the most convincing evidence to date of an efficacious treatment in hospitalised COVID-19 patients. However, there are a number of issues, primarily around the reporting of the trial, that should ideally be resolved prior to final publication. We also urge caution against over-interpreting the estimated subgroup-specific effects based on level of respiratory support, especially the suggestion of harm in the group not on oxygen or mechanical ventilation.&amp;nbsp;&lt;/strong&gt;&lt;/p&gt;</subfield>
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