Development and validation of a simplified risk score for the prediction of critical COVID‐19 illness in newly diagnosed patients

  1. Stanislas Werfel
  2. Carolin E. M. Jakob
  3. Stefan Borgmann
  4. Jochen Schneider
  5. Christoph Spinner
  6. Maximilian Schons
  7. Martin Hower
  8. Kai Wille
  9. Martina Haselberger
  10. Hanno Heuzeroth
  11. Maria M. Rüthrich
  12. Sebastian Dolff
  13. Johanna Kessel
  14. Uwe Heemann
  15. Jörg J. Vehreschild
  16. Siegbert Rieg
  17. Christoph Schmaderer
  18. the LEOSS study group

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Abstract

Scores to identify patients at high risk of progression of coronavirus disease (COVID‐19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), may become instrumental for clinical decision‐making and patient management. We used patient data from the multicentre Lean European Open Survey on SARS‐CoV‐2‐Infected Patients (LEOSS) and applied variable selection to develop a simplified scoring system to identify patients at increased risk of critical illness or death. A total of 1946 patients who tested positive for SARS‐CoV‐2 were included in the initial analysis and assigned to derivation and validation cohorts ( n  = 1297 and n  = 649, respectively). Stability selection from over 100 baseline predictors for the combined endpoint of progression to the critical phase or COVID‐19‐related death enabled the development of a simplified score consisting of five predictors: C‐reactive protein (CRP), age, clinical disease phase (uncomplicated vs. complicated), serum urea, and D‐dimer (abbreviated as CAPS‐D score). This score yielded an area under the curve (AUC) of 0.81 (95% confidence interval [CI]: 0.77–0.85) in the validation cohort for predicting the combined endpoint within 7 days of diagnosis and 0.81 (95% CI: 0.77–0.85) during full follow‐up. We used an additional prospective cohort of 682 patients, diagnosed largely after the “first wave” of the pandemic to validate the predictive accuracy of the score and observed similar results (AUC for the event within 7 days: 0.83 [95% CI: 0.78–0.87]; for full follow‐up: 0.82 [95% CI: 0.78–0.86]). An easily applicable score to calculate the risk of COVID‐19 progression to critical illness or death was thus established and validated.

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  1. Version published to 10.1002/jmv.27252
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    SciScore for 10.1101/2021.02.07.21251260: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Written patient informed consent was waived.
    IRB: Approval for LEOSS was obtained by the applicable local ethics committees of all participating centers and the study was registered at the publicly accessible German Clinical Trails Register (DRKS, No. DRKS00021145).
    RandomizationTwo-sided p-values for binomial ridge penalized coefficients were obtained as suggested by Cule et al.10, by repeating the ridge regression procedure on a dataset with randomly permuted outcomes 1000 times (using equal amounts of the 20 imputed datasets).
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

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  3. Version published to 10.1101/2021.02.07.21251260v1 on medRxiv