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) |
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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) |
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Index tests |
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Target condition and reference standard(s) |
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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 |