Pivetta 2020.

Study characteristics
Patient Sampling	Purpose: diagnosis of COVID‐19 pneumonia; to explore whether the integration of lung ultrasound and clinical evaluation increases the sensitivity of the diagnosis of COVID‐19 pneumonia Design: cross‐sectional cohort study, prospective data collection Recruitment: all adult patients visiting an ED and screened positive for SARS‐CoV‐2‐associated symptoms Sample size: n = 228 (107 cases) Inclusion criteria: all adults (≥ 18 years) who screened positive for acute symptoms associated with SARS‐CoV‐2 infection at triage (= fever, dyspnoea, new or worsening cough, sore throat, diarrhoea, ageusia, anosmia and asthenia) Exclusion criteria: patients known to be infected by SARS‐CoV‐2, requiring an urgent psychiatric assessment, or already intubated at arrival, no attending physician with expertise in lung ultrasonography available
Patient characteristics and setting	Facility cases: positive RT‐PCR test for SARS‐CoV‐2, 1 test in patients with an initial positive PCR result, 2 tests in patients with an initial negative PCR result when clinical, sonographic, lab or imaging results were suggestive of COVID‐19 Facility controls: negative RT‐PCR test for SARS‐CoV‐2 and all other test results are concordant Country: Italy Dates: 01 April 2020‐20 April 2020 Symptoms and severity: ED outcome: home discharge 25.2% cases, 78.5% controls, ward admission 60.8% cases, 20.7% controls, ICU admission 7.5% cases, 0.8% controls, ED death 6.5% cases, 0% controls Demographics: age: controls median 50.3 years, cases median 62.8 years M%/F%: cases 54.1/45.9, controls 43.7/56.3 Exposure history: not specified
Index tests	Ageusia Anosmia Cough Diarrhoea Fatigue Fever Headache Shortness of breath Sore throat
Target condition and reference standard(s)	TC: SARS‐CoV‐2 infection RS: RT‐PCR (nasopharyngeal swabs), and in some cases other information including clinical, lab, imaging
Flow and timing	Maximum 72 h between index tests and RS
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?	Yes
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	No
Did the study avoid inappropriate inclusions?	Yes
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?			High
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?	No
Could the reference standard, its conduct, or its interpretation have introduced bias?		High risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			High
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?	No
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		High risk