Romero‐Gameros 2021.
Study characteristics | |||
Patient Sampling |
Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to evaluate and establish the diagnostic performance of symptoms and signs in patients with suspected COVID‐19 Design: cross‐sectional cohort study, prospective data collection Recruitment: patients who came to the ED for suspected COVID‐19. Patients were selected through a non probabilistic sampling of consecutive cases according to the order of arrival at the ED Sample size: n = 2137 (1148 cases) Inclusion criteria: > 17 years, high clinical probability of SARS‐CoV‐2, confirmatory RT‐PCR available Exclusion criteria: no RT‐PCR test done |
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Patient characteristics and setting |
Facility cases: positive RT‐PCR test for SARS‐CoV‐2 Facility controls: negative RT‐PCR test for SARS‐CoV‐2 Country: Mexico Dates: 14 April 2020‐21 July 2020 Symptoms and severity: mild to moderate severity, high prevalence (> 50%) of symptoms such as cough, asthenia, myalgia and headache; oxygen saturation < 93% in 11% of cases and 4% of controls Demographics: age: controls mean 42.8 years, cases mean 48.6 years M%/F%: cases 55.7/44.2, controls 46.8/53.1 Exposure history: not specified |
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Index tests |
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Target condition and reference standard(s) |
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Flow and timing | Timing not specified | ||
Comparative | |||
Notes | Funding: supported by the Mexican Institute of Social Security | ||
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? | 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? | 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? | Yes | ||
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 |