Making Sense of Non-Randomized Comparative Treatment Studies in Times of Covid-19: A Case Study of Tocilizumab

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Abstract

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  1. SciScore for 10.1101/2021.04.06.21254612: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This study was approved by the ethics committee of HM Hospitales (approval number 20.05.1627-GHM).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using Stata v16.1 (StataCorp LP College Station, TX, USA).
    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:
    Our study has some limitations. Only death was analysed and other endpoints such as use of ICU and mechanical ventilation are important for hospital resource utilization in times of a pandemic. However, all-cause death is the outcome with least scope for misclassification and no missing data. We adjusted for competing risk. With sufficient data, if this endpoint cannot provide a valid finding other endpoints used in observational studies (16-18) are open to greater difficulties in analysis. Other repurposed drugs which were used in the hospitals of the dataset were not included with the exception of corticosteroids but there is no good evidence for their beneficial effect (SOLIDARITY). We did not use propensity scores for adjustment but our statistical models using multivariable adjustment were appropriate and there is little evidence that propensity score adjustments would give different results (21). The quality of the data did not allow accurate analyses of the timing of administration of TCZ in relation to mechanical ventilation or date of ICU admission. Clinical severity was not always recorded or assessable at baseline or the time of administration of TCZ, however, the analysis used laboratory markers of severity such as CRP and D-dimer and LDH. During the worst weeks of the pandemic from which this dataset arises, comorbidities at admission were not comprehensively collected, with some chronic conditions being recorded after admission. While many of the chronic conditi...

    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.