Maechler 2020.
Study characteristics | |||
Patient Sampling |
Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to describe epidemiological and clinical characteristics; to identify risk factors for SARS‐CoV‐2 infection Design: cross‐sectional cohort study, prospective data collection Recruitment: symptomatic patients presenting at the test site. Subgroups not by testing criteria at that time: (1) high‐risk contacts at a nightclub (26/94 positive). (2) Charité employees 125 asymptomatic. Sample size: n = 4333 (333 cases) Inclusion criteria: until 24 March 2020: symptomatic patients with high‐risk contacts or return from high‐risk area. From 24 March: also symptomatic people with risk factors and if the test capacity allowed also only symptomatic patients. Plus 2 subgroups of high‐risk patients in a nightclub and Charité employees Exclusion criteria: none specified |
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Patient characteristics and setting |
Facility cases: patients with a positive RT‐PCR for SARS‐CoV‐2 infection Facility controls: patients with a negative RT‐PCR for SARS‐CoV‐2 infection Country: Germany Dates: 03 March 2020‐13 April 2020 Symptoms and severity: mild to relatively more severe. Asymptomatic: 12 cases, 431 controls Demographics: age: controls median 34.0 years, cases mean 34.0 years M%/F%: cases 56.8/43.2, controls 48.5/51.5 Exposure history: high‐risk contact: cases 56.8%, controls 36.4% |
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Index tests |
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Target condition and reference standard(s) |
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Flow and timing | Index tests and reference standard both at presentation | ||
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? | 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? | 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? | Yes | ||
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 |