Diagnostic accuracy and predictive value of clinical symptoms for the diagnosis of mild COVID-19

  1. V. Popovych
  2. I. Koshel
  3. Y. Haman
  4. V. Leschak
  5. R. Duplikhin

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Abstract

To assess the diagnostic accuracy of clinical symptoms and their predictive values in patients with suspected mild COVID-19 and to identify target groups for self-isolation and outpatient treatment without additional testing in the primary health care system.

Methods

We conducted an open-label prospective study in both male and female patients aged 18 to 72 years with suspected mild COVID-19 who were sequentially enrolled in the study. The clinical diagnosis was performed in accordance with the WHO recommendations based on the acute onset of such symptoms as olfactory dysfunction, hyperthermia, myalgia, nasal congestion, nasal discharge, cough, rhinolalia, sore throat, without pneumonia or hypoxia in persons in contact with a confirmed case of COVID-19. The physician assessed clinical symptoms using a 4-point scale. The patient self-assessed clinical symptoms using a ten-point visual analogue scale (VAS). All enrolled patients underwent laboratory testing to confirm the diagnosis of COVID-19.

Results

Of the 120 patients underwent testing, the diagnosis of mild COVID-19 was confirmed in 96 patients and ruled out in 24 patients. When assessing symptoms by a physician according to the correlation analysis, hyperthermia, myalgia, nasal congestion and rhinolalia have a positive predictive value with a significance level of more than 0.6. When self-assessing symptoms by a patient, fever, myalgia and nasal congestion have a diagnostic accuracy with a significance level of more than 0.5. Nasal discharge, cough and sore throat have negative predictive values.

Discussion

The presence of these symptoms in patients with an acute onset of the disease can help to make a clinical diagnosis of coronavirus disease and identify target groups for self-isolation and outpatient treatment without additional testing. Highly suspect asymptomatic patients are not considered as those who have possible mild COVID-19 infection.

Registration

Ethics Committee of Ivano-Frankivsk National Medical University, Protocol No. 114/20 as of 21 May 2020.

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  1. ScreenIT

    SciScore for 10.1101/2021.03.05.21252963: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ethics Committee.
    Consent: Each study participant provided written consent to participate in the study.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variable120 male and female outpatients aged 18 to 72 years were included in the study.

    Table 2: Resources

    Antibodies
    SentencesResources
    The PCR test and tests for Ig M and Ig G antibodies were carried out.
    Ig G
    suggested: None

    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:
    The study objective was to assess the diagnostic accuracy of clinical symptoms and their predictive valuesin patients with suspected mild COVID-19, which very likely makes it possible to make a clinical diagnosis, but it has certain limitations. First, this preliminary study was retrospective with a relatively small sample size. In future, it will be needed to conduct studies with a larger sample of COVID- 19 patients. Second, the inclusion criteria included olfactory dysfunction as a mandatory marker. Therefore, it is needed to conduct future studies with a priori hypotheses regarding the role of hyposmia/anosmia in this population, since according to the literature data this symptom is not reliable, but according to our data, a number of patients with hyposmia had negative laboratory test results. Thirdly, the severity of olfactory dysfunction and its relationship with sinonasal or other symptoms remain incompletely characterized. Fourthly, all symptoms were statistically analysed only on the first day of this study without taking into account the change in condition during further follow-up. Fifthly, there were no predictive values or follow-up results for patients with disease worsening. In future, patients will be analysed over time. As a result, complex comparative studies can be conducted to study possible differences which could increase the risk of error in this study. Therefore, more data should be collected. This study demonstrated that there were more women than m...

    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

    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.

  2. Version published to 10.1101/2021.03.05.21252963v1 on medRxiv
  3. Version published to 10.4236/jbm.2021.96013