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. 2022 May 20;2022(5):CD013665. doi: 10.1002/14651858.CD013665.pub3

Sonoda 2021.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to investigate the clinical symptoms to discriminate between COVID‐19 and non‐COVID‐19 cases among outpatients in GP clinics
Design: cross‐sectional cohort study, retrospective data collection
Recruitment: outpatients visiting the screening centre (GP clinic)
Sample size: n = 360 (17 cases)
Inclusion criteria: patients visiting the centre with suspicion of COVID‐19 (no definition of 'suspicion')
Exclusion criteria: patients who didn't receive a RT‐PCR test
Patient characteristics and setting Facility cases: positive RT‐PCR for SARS‐CoV‐2
Facility controls: negative RT‐PCR for SARS‐CoV‐2
Country: Japan
Dates: 01 August 2020‐14 August 2020
Symptoms and severity: clinical spectrum of cases (n = 17) was 14 moderate, 2 moderate and 1 severe illness
Demographics: mean age: cases 39.6 years, controls 41.2 years
M%/F%: cases 58.8/41.2, controls 50.7/49.2
Exposure history: close contact to patients with COVID‐19: cases 13.3%, controls 8.1%
Index tests
  • Body temperature

  • Headache

  • Sore throat

  • Dysgeusia

  • Anosmia

  • Nasal discharge

  • Cough

  • Sputum production

  • Nausea/vomiting

  • Diarrhoea

  • Stomach ache

  • Fatigue

  • Shortness of breath

  • Joint pain

  • Myalgia

  • Lack of appetite

Target condition and reference standard(s)
  • TC: SARS‐CoV‐2 infection

  • RS: SARS‐CoV‐2 RT‐PCR test (nasal swab or saliva specimen)

Flow and timing Timing not specified
Comparative  
Notes Funding: none declared
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
Did the study avoid inappropriate inclusions? Yes    
Could the selection of patients have introduced bias?   Unclear risk  
Are there concerns that the included patients and setting do not match the review question?     Low concern
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? No    
Could the conduct or interpretation of the index test have introduced bias?   High risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Unclear risk