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 |
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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 |
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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 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 |