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. 2020 Jul 7;2020(7):CD013665. doi: 10.1002/14651858.CD013665

Ai 2020a.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 pneumonia
Design: cross‐sectional multicentre prospective study
Recruitment: hospitalised pneumonia patients
Sample size: n = 53 (20 cases)
Inclusion criteria: suspected SARS‐COV‐2 pneumonia patients, defined as having pneumonia after chest CT (with 1 of the 2 following criteria met: fever or respiratory symptoms, normal or decreased WBC counts/decreased
Exclusion criteria: not defined
Patient characteristics and setting Facility cases: confirmed case: a positive SARS‐COV‐2 nucleotides result either by metagenomic sequencing or RT‐PCR assay for nasopharyngeal swab specimens
Facility controls: pneumonia patients confirmed not to be infected by SARS‐Cov2 (2 PCR tests, 2 days in between)
Country: China
Dates: 22 January 2020‐19 February 2020
Symptoms and severity: suspected SARS‐COV‐2 pneumonia (NCP): having pneumonia after chest CT with 1 of the 2 following criteria met: fever or respiratory symptoms, normal or decreased WBC counts/decreased lymphocyte counts, and a travel history or contact with patients with fever or respiratory symptoms from Hubei Province or confirmed cases within 2 weeks
Demographics: median age cases 37 years, controls 39 years, gender distribution cases (M/F: 50/50), controls (M/F: 48.5/51.5)
Exposure history: not specified
Index tests
  • Fever

  • Dry cough

  • Diarrhoea

  • Fatigue

  • Headache

  • Vomiting

  • Abdominal pain

Target condition and reference standard(s)
  • TC: COVID‐19 pneumonia

  • RS: a positive SARS‐COV‐2 nucleotides result either by metagenomic sequencing or RT‐PCR assay for nasopharyngeal swab specimens, repeated after 2 days if negative on day 0

Flow and timing Time interval not specified. Reference standard at day 0 and day 2, index tests from electronic medical records but stated at pneumonia onset
Comparative  
Notes  
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? No    
Could the selection of patients have introduced bias?   High risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
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?   Low risk