A novel haemocytometric COVID-19 prognostic score developed and validated in an observational multicentre European hospital-based study

  1. Joachim Linssen
  2. Anthony Ermens
  3. Marvin Berrevoets
  4. Michela Seghezzi
  5. Giulia Previtali
  6. Simone van der Sar-van der Brugge
  7. Henk Russcher
  8. Annelies Verbon
  9. Judith Gillis
  10. Jürgen Riedl
  11. Eva de Jongh
  12. Jarob Saker
  13. Marion Münster
  14. Imke CA Munnix
  15. Anthonius Dofferhof
  16. Volkher Scharnhorst
  17. Heidi Ammerlaan
  18. Kathleen Deiteren
  19. Stephan JL Bakker
  20. Lucas Joost Van Pelt
  21. Yvette Kluiters-de Hingh
  22. Mathie PG Leers
  23. Andre J van der Ven

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Abstract

COVID-19 induces haemocytometric changes. Complete blood count changes, including new cell activation parameters, from 982 confirmed COVID-19 adult patients from 11 European hospitals were retrospectively analysed for distinctive patterns based on age, gender, clinical severity, symptom duration, and hospital days. The observed haemocytometric patterns formed the basis to develop a multi-haemocytometric-parameter prognostic score to predict, during the first three days after presentation, which patients will recover without ventilation or deteriorate within a two-week timeframe, needing intensive care or with fatal outcome. The prognostic score, with ROC curve AUC at baseline of 0.753 (95% CI 0.723–0.781) increasing to 0.875 (95% CI 0.806–0.926) on day 3, was superior to any individual parameter at distinguishing between clinical severity. Findings were confirmed in a validation cohort. Aim is that the score and haemocytometry results are simultaneously provided by analyser software, enabling wide applicability of the score as haemocytometry is commonly requested in COVID-19 patients.

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  1. Version published to 10.7554/elife.63195 on eLife
  2. ScreenIT

    SciScore for 10.1101/2020.09.27.20202168: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethics: The study was reviewed by all participating centre ethics committees with approval granted in Italy (Registration Number 54/20) and Belgium (Registration Number 3002020000105) and exemption in the Netherlands, with need for informed consent waived by all.
    Consent: Ethics: The study was reviewed by all participating centre ethics committees with approval granted in Italy (Registration Number 54/20) and Belgium (Registration Number 3002020000105) and exemption in the Netherlands, with need for informed consent waived by all.
    Randomizationnot detected.
    BlindingAs these data are genearted from automated haematology analysers, and do not rely on interpretation, predictors for the prognostic score were automatocally blinded.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    (MedCalc Software Ltd, Ostend, Belgium; https://www.medcalc.org; 2020) was used.
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)

    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:
    A limitation of our study is its retrospective nature, as data retrieved from hospital records were sometimes incomplete. Our study was performed at a time that COVID-19 was a new disease entity that constrained the health care in many of the participating centers which may have affected management decisions and therefore study outcome parameters. Data from out-patient settings including more mild cases, and from nursing homes that usually accommodate high risk patients, are needed. Furthermore, clinical data collection was limited, including comorbidity affecting COVID-19 susceptibility and ICU admission decisions, notably as the demand for ICU beds was greater than the availability at the time of our study. Importantly, the conditions of our fast-tracked ethics clearance to facilitate rapid study initiation, did not permit data collection. about bacterial superinfections and medication (antibiotics, corticosteroids), while these factors may affect outcome and haemocytometric parameters. Finally, our prognostic score includes Sysmex unique parameters. This is a limitation as the score is not universally applicable to all haematology analysers, although the concept is transferable (see Table S1 for parameters available on other manufacturer haematology platforms). However, it is the very ability to quantify blood cell activation, a reflection of the general immune response status of an individual, that has rendered our prognostic score (which incorporates cell activation para...

    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

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  3. Version published to 10.1101/2020.09.27.20202168v1 on medRxiv