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

Clemency 2020.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to develop symptom‐based criteria for screening of HCW for SARS‐CoV‐2
Design: prospective observational cohort
Recruitment: HCW with symptoms concerning for COVID‐19 infection were evaluated for potential testing through a centralised nurse call centre and referred to outpatient drive‐through testing sites if any suspicion of infection
Sample size: n = 961 (225 cases)
Inclusion criteria: all HCW tested for SARS‐CoV‐2, based on symptom‐based triage ("symptoms concerning for COVID‐19 infection"
Exclusion criteria: none specified (141 excluded because symptoms were not documented, 12 excluded because test results not available)
Patient characteristics and setting Facility cases: all consecutive HCW with a single positive RT‐PCR test for SARS‐CoV‐2
Facility controls: all consecutive HCW with a single negative RT‐PCR test for SARS‐CoV‐2
Country: New York, USA
Dates: 26 March 2020‐16 April 2020
Symptoms and severity: mild to moderate severity, inclusion based on presenting symptoms
Demographics: mean age not presented; gender not presented
Exposure history: not presented (likely a high rate of exposure, because HCW)
Index tests
  • Fever

  • Fatigue

  • Dry cough

  • Loss of appetite

  • Myalgia

  • Difficulty breathing

  • Coughing up phlegm

  • Sore throat

  • Diarrhoea

  • Loss of taste or smell

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

  • RS: (single) RT‐PCR, nasopharyngeal or oropharyngeal swabs

Flow and timing HCW referred for reference test after index test, but exact time interval not specified
Comparative  
Notes Funding: supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award UL1TR001412 to the University at Buffalo
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Did the study avoid inappropriate inclusions? Yes    
Could the selection of patients have introduced bias?   Low 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? Unclear    
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