Skip to main content
. 2022 May 20;2022(5):CD013665. doi: 10.1002/14651858.CD013665.pub3

Bhattacharya 2021.

Study characteristics
Patient Sampling Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to evaluate the clinical symptoms among patients with suspected COVID‐19 presenting to screening outpatient clinics to develop and validate a clinical symptom‐based scoring system
Design: cross‐sectional cohort study, prospective data collection
Recruitment: patients presenting to an outpatient clinic at a tertiary care hospital
Sample size: n = 378 (125)
Inclusion criteria: patients who were suspected of having COVID‐19 and tested, provided informed consent and were contacted successfully by phone, from 1066 suspected patients who were tested during this period, 384 patients were enrolled in the study based on the availability of informed consent and successful telephonic communication). Suspicion was based on the testing advisory developed by the Indian Council of Medical Research (ICMR), Version 5, dated 18 May 2020. "ILI symptoms", defined as acute respiratory infection with fever ≥ 38 °C AND cough.
Exclusion criteria: no PCR test result
Patient characteristics and setting Facility cases: positive SARS‐CoV‐2 test
Facility controls: negative SARS‐CoV‐2 test
Country: India
Dates: 17 June 2020‐1 July 2020
Symptoms and severity: not specified, mostly mild to moderate severity
Demographics: mean age overall 35.6 years
M%/F% overall: 65.1/34.9
Exposure history: not specified
Index tests
  • Body temperature (cutoff fever >37.8°C)

  • Sore throat

  • Cough

  • Headache

  • Myalgia

  • Breathlessness

  • Nausea

  • Vomiting

  • Diarrhoea

  • Loss of smell

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

  • RS: RT‐PCR for SARS‐CoV‐2 (nasal + throat swab)

Flow and timing Index tests and RS both at presentation, phone interview after test was taken but before result was generated
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? No    
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? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Unclear risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Unclear
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? No    
Could the patient flow have introduced bias?   Unclear risk