Early prediction of level-of-care requirements in patients with COVID-19
- Boston University, United States
- Massachusetts General Hospital, Harvard Medical School, United States
Abstract
This study examined records of 2,566 consecutive COVID-19 patients at five Massachusetts hospitals and sought to predict level-of-care requirements based on clinical and laboratory data. Several classification methods were applied and compared against standard pneumonia severity scores. The need for hospitalization, ICU care, and mechanical ventilation were predicted with a validation accuracy of 88%, 87%, and 86%, respectively.ICU care and ventilation. When predictions are limited to patients with more complex disease, the accuracy of the ICU and ventilation prediction models achieved accuracy of 83% and 82%, respectively. Vital signs, age, BMI, dyspnea, and comorbidities were the most important predictors of hospitalization. Opacities on chest imaging, age, admission vital signs and symptoms, male gender, admission laboratory results, and diabetes were the most important risk factors for ICU admission and mechanical ventilation. The factors identified collectively form a signature of the novel COVID-19 disease.
Data availability
- Source code for processing patient data is provided together with the submission.- Due to HIPAA restrictions and Data Use Agreements we can not make the original patient data publicly available. Interested parties may submit a request to obtain access to de-identified data to the authors. The authors would request pertinent IRB approval to make available a de-identified version of the data, stripped of any protected health information as specified under HIPAA rules.-The IRB of the hospital system approved the study under Protocol #2020P001112 and the Boston University IRB found the study as being Not Human Subject Research under Protocol #5570X (the BU team worked with a de-identified limited dataset).
Article and author information
Author details
Shahabeddin Sotudian
Ioannis Ch Paschalidis
Funding
National Science Foundation (IIS-1914792)
- Ioannis Ch Paschalidis
National Science Foundation (DMS-1664644)
- Ioannis Ch Paschalidis
National Science Foundation (CNS-1645681)
- Ioannis Ch Paschalidis
National Institute of General Medical Sciences (R01 GM135930)
- Ioannis Ch Paschalidis
Office of Naval Research (N00014-19-1-2571)
- Ioannis Ch Paschalidis
National Institutes of Health (UL54 TR004130)
- Ioannis Ch Paschalidis
The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.
Ethics
Human subjects: The Institutional Review Board of Mass General Brigham reviewed and approved the study under Protocol #2020P001112. The Boston University IRB found the study as being Not Human Subject Research under Protocol #5570X (the BU team worked with a de-identified limited dataset).
Copyright
© 2020, Hao et al.
This article is distributed under the terms of the Creative Commons Attribution License permitting unrestricted use and redistribution provided that the original author and source are credited.
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Early prediction of level-of-care requirements in patients with COVID-19
eLife 9:e60519.
https://doi.org/10.7554/eLife.60519
Further reading
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- Medicine
- Microbiology and Infectious Disease
- Epidemiology and Global Health
- Immunology and Inflammation
eLife has published articles on a wide range of infectious diseases, including COVID-19, influenza, tuberculosis, HIV/AIDS, malaria and typhoid fever.
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- Medicine
Background:
Approximately one-third of patients with HER2-positive breast cancer experienced recurrence within 10 years after receiving 1 year of adjuvant trastuzumab. The ExteNET study showed that 1 year of extended adjuvant neratinib after trastuzumab-based adjuvant therapy could reduce invasive disease-free survival (iDFS) events compared with placebo. This study investigated the efficacy and safety of pyrotinib, an irreversible pan-HER receptor tyrosine kinase inhibitor, after trastuzumab-based adjuvant therapy in patients with high-risk, HER2-positive early or locally advanced breast cancer.
Methods:
This multicenter phase II trial was conducted at 23 centers in China. After enrollment, patients received 1 year of extended adjuvant pyrotinib (400 mg/day), which should be initiated within 6 months after the completion of 1-year adjuvant therapy (trastuzumab alone or plus pertuzumab). The primary endpoint was 2-year iDFS rate.
Results:
Between January 2019 and February 2022, 141 eligible women were enrolled and treated. As of October 10, 2022, the median follow-up was 24 (interquartile range, 18.0–34.0) months. The 2-year iDFS rate was 94.59% (95% confidence interval [CI]: 88.97–97.38) in all patients, 94.90% (95% CI: 86.97–98.06) in patients who completed 1-year treatment, 90.32% (95% CI: 72.93–96.77) in patients who completed only 6-month treatment, 96.74% (95% CI: 87.57–99.18) in the hormone receptor (HR)-positive subgroup, 92.77% (95% CI: 83.48–96.93) in the HR-negative subgroup, 96.88% (95% CI: 79.82–99.55) in the lymph node-negative subgroup, 93.85% (95% CI: 86.81–97.20) in the lymph node-positive subgroup, 97.30% (95% CI: 82.32–99.61) in patients with adjuvant trastuzumab plus pertuzumab, and 93.48% (95% CI: 86.06–97.02) in patients with adjuvant trastuzumab. The most common adverse events were diarrhea (79.4%), fatigue (36.9%), lymphocyte count decreased (36.9%), nausea (33.3%), and hand-foot syndrome (33.3%).
Conclusions:
Extended adjuvant pyrotinib administrated after trastuzumab-based adjuvant therapy showed promising efficacy in patients with high-risk HER2-positive breast cancer. The follow-up is ongoing to determine the long-term benefit.
Funding:
No external funding was received for this work.
Clinical trial number:
ClinicalTrials.gov: NCT05880927
