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. 2022 Jul 11;2022(7):CD013172. doi: 10.1002/14651858.CD013172.pub2

Knudsen 2002.

Study characteristics
Patient Sampling Included patients with suspected symptomatic high‐grade ICA stenosis but did not specify how they suspected it was high‐grade stenosis
Patient characteristics and setting 65 symptomatic patients
Characteristics not described
Unclear if there were previous exams performed
Index tests DUS
Image production: Siemens Sonoline Elegra, Siemens Medical System, Washington
Contrast: No
Criteria used to determine grade of stenosis:stenosis ≥ 70% stenosis was characterized by an ICA PSV ≥ 150 cm/s, an ICA end diastolic velocity ≥ 90 cm/s, and a PSV ratio ≥ 2.8. No flow indicated occlusion.
Target condition and reference standard(s) Reference standard: DSA
Target condition: symptomatic high‐grade ICA stenosis
Criteria used to determine grade of stenosis: NASCET
Complications: Not described
Flow and timing DSA and DUS performed within 2 days
65 patients and 129 arteries were included in analysis; unclear why 1 artery was excluded
Comparative  
Methods Study design: Prospective, consecutive, accuracy cohort study
Study location: Denmark
Year and language of publication: Published in 2002 in English
Study period: a 12‐month period 1998 to 1999
Participants enrolled: 65 patients
Carotids included in analyses: 129 arteries
Notes  
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? Unclear    
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?     Unclear
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?   Low 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? Yes    
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? No    
Could the patient flow have introduced bias?   High risk