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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  "conceptdoi": "10.5281/zenodo.3928539", 
  "created": "2020-07-02T15:11:04.011667+00:00", 
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    "doi": "10.5281/zenodo.3928540", 
    "description": "<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>", 
    "language": "eng", 
    "title": "Statistical review of  Effect of Dexamethasone in Hospitalized Patients with COVID-19 \u2013  Preliminary Report", 
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    "keywords": [
      "Cinical trial", 
      "Randomized controlled trial", 
    "publication_date": "2020-07-02", 
    "creators": [
        "affiliation": "MRC Clinical Trials Unit at University College London", 
        "name": "Morris, Tim"
        "affiliation": "HRB Clinical Research Facility Cork. Senior Lecturer in Patient-Focused Research Methods, School of Public Health, University College Cork", 
        "name": "Dahly, Darren"
        "affiliation": "Centre for Trials Research, Cardiff University", 
        "name": "Hood, Kerry"
        "affiliation": "Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, UK", 
        "name": "Gates, Simon"
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