Risk factors for severity on admission and the disease progression during hospitalisation in a large cohort of patients with COVID-19 in Japan
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Abstract
To investigate the risk factors contributing to severity on admission. Additionally, risk factors of worst severity and fatality were studied. Moreover, factors were compared based on three points: early severity, worst severity and fatality.
Design
An observational cohort study using data entered in a Japan nationwide COVID-19 inpatient registry, COVIREGI-JP.
Setting
As of 28 September 2020, 10480 cases from 802 facilities have been registered. Participating facilities cover a wide range of hospitals where patients with COVID-19 are admitted in Japan.
Participants
Participants who had a positive test result on any applicable SARS-CoV-2 diagnostic tests were admitted to participating healthcare facilities. A total of 3829 cases were identified from 16 January to 31 May 2020, of which 3376 cases were included in this study.
Primary and secondary outcome measures
Primary outcome was severe or nonsevere on admission, determined by the requirement of mechanical ventilation or oxygen therapy, SpO2 or respiratory rate. Secondary outcome was the worst severity during hospitalisation, judged by the requirement of oxygen and/orinvasive mechanical ventilation/extracorporeal membrane oxygenation.
Results
Risk factors for severity on admission were older age, men, cardiovascular disease, chronic respiratory disease, diabetes, obesity and hypertension. Cerebrovascular disease, liver disease, renal disease or dialysis, solid tumour and hyperlipidaemia did not influence severity on admission; however, it influenced worst severity. Fatality rates for obesity, hypertension and hyperlipidaemia were relatively lower.
Conclusions
This study segregated the comorbidities influencing severity and death. It is possible that risk factors for severity on admission, worst severity and fatality are not consistent and may be propelled by different factors. Specifically, while hypertension, hyperlipidaemia and obesity had major effect on worst severity, their impact was mild on fatality in the Japanese population. Some studies contradict our results; therefore, detailed analyses, considering in-hospital treatments, are needed for validation.
Trial registration number
UMIN000039873. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045453
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SciScore for 10.1101/2021.04.02.21254809: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: The National Center for Global Health and Medicine ethics board approved this study (referral number NCGM-G-003494-08), and waived the need for informed consent from individual patients owing to the non-invasive, non-interventional nature of this observational study according to the local Ethical Guidelines20.
Consent: Ethics: The National Center for Global Health and Medicine ethics board approved this study (referral number NCGM-G-003494-08), and waived the need for informed consent from individual patients owing to the non-invasive, non-interventional nature of this observational study according to the local Ethical Guidelines20.Randomization not … SciScore for 10.1101/2021.04.02.21254809: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: The National Center for Global Health and Medicine ethics board approved this study (referral number NCGM-G-003494-08), and waived the need for informed consent from individual patients owing to the non-invasive, non-interventional nature of this observational study according to the local Ethical Guidelines20.
Consent: Ethics: The National Center for Global Health and Medicine ethics board approved this study (referral number NCGM-G-003494-08), and waived the need for informed consent from individual patients owing to the non-invasive, non-interventional nature of this observational study according to the local Ethical Guidelines20.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources (REDCap) electronic data capture tools13, 14, hosted at the datacenter in National Center for Global Health and Medicine. REDCapsuggested: (REDCap, RRID:SCR_003445)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 several limitations. In some of our analyses, confounders were not eliminated. We did not consider treatments prior to and during hospitalization. As our data were collected from hundreds of healthcare facilities, treatment type, dosage, duration, and combination varied immensely. We plan to deliberate the analytical methodology further to evaluate the outcomes which are prone to be affected by in-hospital treatments. Data were collected from numerous facilities; therefore, accuracy may be questionable. Additionally, hotels were utilized as isolation facilities from April 2020, and participant selection might have altered thereafter. COVIREGI-JP is continuously open for new entry; the number of registrations is increasing, and subsequent results may vary from ours.
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.
- No funding statement was detected.
- No protocol registration statement was detected.
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