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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{
  "publisher": "Zenodo", 
  "DOI": "10.5281/zenodo.3928540", 
  "language": "eng", 
  "title": "Statistical review of  Effect of Dexamethasone in Hospitalized Patients with COVID-19 \u2013  Preliminary Report", 
  "issued": {
    "date-parts": [
      [
        2020, 
        7, 
        2
      ]
    ]
  }, 
  "abstract": "<p>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&nbsp; trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of COVID-19 treatments,&nbsp; independent of journal specific review processes. We aim to provide timely, constructive, focused, clear advice aimed at improving&nbsp; both the research outputs under review, as well as future studies. Given our collective expertise (clinical trial statistics) our reviews&nbsp; focus on the designs of the trials and other statistical content (methods, presentation and accuracy of results, inferences). This&nbsp; review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology&nbsp; Research Partnership, its wider membership, or any other organization. Here we review <em>Effect of Dexamethasone in Hospitalized Patients with COVID-19 &ndash;&nbsp; Preliminary Report </em>by Horby <em>et al</em>, published as a preprint on medRxiv on the 22nd of June, 2020.</p>\n\n<p><strong>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.&nbsp;</strong></p>", 
  "author": [
    {
      "family": "Morris, Tim"
    }, 
    {
      "family": "Dahly, Darren"
    }, 
    {
      "family": "Hood, Kerry"
    }, 
    {
      "family": "Gates, Simon"
    }
  ], 
  "version": "1.0", 
  "type": "article-journal", 
  "id": "3928540"
}
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