Cerebral Venous Sinus Thrombosis is not Significantly Linked to COVID-19 Vaccines or Non-COVID Vaccines in a Large Multi-State Health System

  1. Colin Pawlowski
  2. John Rincón-Hekking
  3. Samir Awasthi
  4. Viral Pandey
  5. Patrick Lenehan
  6. AJ Venkatakrishnan
  7. Sairam Bade
  8. John C. O'Horo
  9. Abinash Virk
  10. Melanie D. Swift
  11. Amy W. Williams
  12. Gregory J. Gores
  13. Andrew D. Badley
  14. John Halamka
  15. Venky Soundararajan

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Abstract

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  1. Version published to 10.1016/j.jstrokecerebrovasdis.2021.105923
  2. ScreenIT

    SciScore for 10.1101/2021.04.20.21255806: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Institutional Review Board (IRB): This is a retrospective study of individuals who underwent polymerase chain reaction (PCR) testing for suspected SARS-CoV-2 infection at the Mayo Clinic and hospitals affiliated with the Mayo Clinic Health System.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Analyses were conducted in the Python programming language.
    Python
    suggested: (IPython, RRID:SCR_001658)

    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:
    This study has several limitations. First, we analyzed data from a single health system which is demographically distinct from the broader United States population. In addition, the study population was restricted to individuals who have received at least one PCR test for SARS-CoV-2 at the Mayo Clinic, which is different from the overall vaccinated population. Second, as a retrospective study our analyses are inherently limited to only the data which was deemed necessary for collection during the clinical care of each patient. For example, platelet counts are not available for most individuals within 30 days of any vaccination and quantification of anti-PF4 antibodies are even more sparse. Other clinical covariates not included in the analysis such as oral contraceptives and smoking status may be potential confounding factors. Finally, our cohort contains 1,745 individuals who received the Johnson & Johnson (Janssen) COVID-19 vaccine. Given that VITT has only been reported in 6 of approximately 7 million recipients of this vaccine2, we are unlikely to detect a signal for it in this cohort. Despite these limitations, the estimation of the baseline incidence rate for CVST, as well as for CVST with thrombocytopenia, in a cohort of over 600,000 individuals is useful to contextualize the reported frequencies of CVST and VITT in patients receiving all authorized COVID-19 vaccines. It also highlights the fact that CVST is likely an under-reported entity in the VAERS database, and th...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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 10.1101/2021.04.20.21255806v1 on medRxiv