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

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
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%
Index tests
  • Fever

  • Headache

  • Rhinorrhea

  • Dyspnoea

  • Wheeze

  • Dry cough

  • Haemoptysis

  • Diarrhoea

  • Earache

  • Rash

  • Enlargement of lymph nodes

  • Weakness/fatigue

  • Myalgia

  • Stuffy nose

  • Sore throat

  • Chest pain

  • Productive cough

  • Stomach ache

  • Nausea/vomiting

  • Arthralgia

  • Skin ulcer

  • Unconsciousness

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

  • RS: RT‐PCR (if negative, a second test taken at least 24 h apart), sample type not specified

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