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

Zimmerman 2020.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to develop a data‐driven set of clinical indicators for COVID‐19 that would help to identify outpatient symptoms and those who most benefit from limited testing availability
Design: cross‐sectional cohort study, prospective data collection
Recruitment: symptomatic individuals who had either exposure to a case of COVID‐19 or a typical respiratory illness symptom were scheduled at a centralised outpatient COVID‐19 testing facility
Sample size: n = 736 (55 cases)
Inclusion criteria: either exposure to a case of COVID‐19 or a typical respiratory illness symptom
Exclusion criteria: asymptomatic individuals
Patient characteristics and setting Facility cases: adult patients testing positive for SARS‐CoV‐2 infection
Facility controls: adult patients testing negative for SARS‐CoV‐2 infection
Country: Pennsylvania, USA
Dates: 29 March 2020‐26 April 2020
Symptoms and severity: mild to moderate severity
Demographics: not specified
Exposure history: contact with COVID‐19 case: cases: 70%, controls: 21%
Index tests
  • Fever

  • Chills

  • Cough

  • Sore throat

  • Shortness of breath

  • Muscle aches

  • Abdominal pain

  • Nausea/vomiting

  • Diarrhoea

  • Headache

  • Decrease or loss of taste or smell

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

  • RS: PCR for SARS‐CoV‐2 (specimen not specified)

Flow and timing Not specified
Comparative  
Notes Funding: supported through a co‐operative agreement with the Centers for Disease Control and Prevention (CDC) through grant number U01 IP000467 and the National Institutes of Health grant number 1UL1 TR001857. The US Flu VE Network is supported through co‐operative agreements funded by CDC.
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? Yes    
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?     Unclear
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?   Unclear risk