Second week methyl-prednisolone pulses improve prognosis in patients with severe coronavirus disease 2019 pneumonia: An observational comparative study using routine care data

  1. Guillermo Ruiz-Irastorza
  2. Jose-Ignacio Pijoan
  3. Elena Bereciartua
  4. Susanna Dunder
  5. Jokin Dominguez
  6. Paula Garcia-Escudero
  7. Alejandro Rodrigo
  8. Carlota Gomez-Carballo
  9. Jimena Varona
  10. Laura Guio
  11. Marta Ibarrola
  12. Amaia Ugarte
  13. Agustin Martinez-Berriotxoa
  14. On behalf of the Cruces COVID Study Group

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Abstract

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  1. Version published to 10.1371/journal.pone.0239401
  2. ScreenIT

    SciScore for 10.1101/2020.07.16.20152868: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The protocol was approved by the Basque Country Research Ethics Committee (code EPA2020032) in accordance with the Declaration of Helsinki’s guidelines for research in humans.
    Consent: All data were fully anonymized before the analysis and the Basque Country Research Ethics Committee waived the requirement for informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    College Station, TX: StataCorp LLC.).
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations: The most important limitation of this study is the observational design with a high variability in the therapeutic schemes, a consequence of the rapidly changing situation during this highly stressing pandemic. Indeed, the actual number of patients treated with MP was lower than expected after the approval of the revised protocol. Patients receiving MP also had a more severe disease. Thus, although the analysis included a high number of potentially predictive variables in the initial multivariate Cox models, it is possible that some unidentified confounder may have influenced our results. We also had a low number of patients meeting the final endpoints compared with other studies (12-14,16). A possible explanation for this is that, despite the high pressure attained, our hospital did not collapse as many others in Spain. Despite the consequent limited statistical power, the risk reduction among patients receiving week-2-MP was consistently between 60-70% for both endpoints in all the models, which supports a clinically relevant effect. A critical point in the clinical application of our results is the correct identification of the point of disease onset, in order to make the correct evaluation and starting MP, if needed, early in the second week. This is not always easy, since non-specific symptoms may precede the fully symptomatic phase of the disease by several days and because some patients even with radiological features of severe pneumonia can be oligosympto...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.07.16.20152868 on medRxiv