Huang 2020.
Study characteristics | |||
Patient Sampling |
Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to explore a novel risk score to predict diagnosis with COVID‐19 among all suspected patients at admission Design: retrospective, multicentric observational study Recruitment: retrospective chart review of patients admitted into 26 COVID‐19 designated hospitals in Sichuan Province, China Sample size: n = 475 (336 cases) Inclusion criteria: patients with suspected COVID‐19 (suspected case is defined as having exposure history and 2 clinical manifestations. Patients without epidemiological exposure histories could also be seen as "suspected COVID‐19" only if 3 clinical manifestations were present. Exclusion criteria: none |
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Patient characteristics and setting |
Facility cases: suspected patients with a positive RT‐PCR test Facility controls: suspected patients with a negative RT‐PCR test. If the first test was negative, at least a second test was done, 24 h apart. Country: China Dates: 21 January 2020‐07 February 2020 Symptoms and severity: mild to moderate severity, all suspected patients included Demographics: mean age, cases: 43 years, controls: 34 years. Gender: % female cases 45.8%, controls: 41.0% Exposure history: epidemiological exposure history: cases: 69.6%, controls 12.9% |
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Index tests |
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Target condition and reference standard(s) |
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Flow and timing | RS and index tests both taken on admission | ||
Comparative | |||
Notes | Funding: Emergency Response Project for New Coronavirus of Science and Technology Department of Sichuan Provincial, Grant/Award Numbers: 2020YFS0005, 2020YFS0009; Special Funds for COVID‐19 Prevention and Control of West China Hospital of Sichuan University, Grant/Award Number: HX‐ 2019‐nCoV‐068; Science and Technology Benefit People Project of Chengdu Municipality, Grant/Award Number: 2016‐HM02‐00099‐SF | ||
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? | Unclear | ||
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? | 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? | 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 |