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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  <identifier identifierType="DOI">10.5281/zenodo.3928540</identifier>
      <creatorName>Morris, Tim</creatorName>
      <affiliation>MRC Clinical Trials Unit at University College London</affiliation>
      <creatorName>Dahly, Darren</creatorName>
      <affiliation>HRB Clinical Research Facility Cork. Senior Lecturer in Patient-Focused Research Methods, School of Public Health, University College Cork</affiliation>
      <creatorName>Hood, Kerry</creatorName>
      <affiliation>Centre for Trials Research, Cardiff University</affiliation>
      <creatorName>Gates, Simon</creatorName>
      <affiliation>Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, UK</affiliation>
    <title>Statistical review of  Effect of Dexamethasone in Hospitalized Patients with COVID-19 –  Preliminary Report</title>
    <subject>Cinical trial</subject>
    <subject>Randomized controlled trial</subject>
    <date dateType="Issued">2020-07-02</date>
  <resourceType resourceTypeGeneral="JournalArticle"/>
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    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsVersionOf">10.5281/zenodo.3928539</relatedIdentifier>
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    <rights rightsURI="">Creative Commons Attribution 4.0 International</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
    <description descriptionType="Abstract">&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;</description>
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