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

Hansen 1996.

Study characteristics
Patient Sampling Patients with a planned carotid endarterectomy sent to be examined with DUS and DSA; unclear where the patients were selected and exams performed previously
Exclusion criteria not described
Patient characteristics and setting 81 consecutive patients (22 women and 59 men), aged 49‐83 years (mean 68 years)
89% symptomatic patients: 28 patients (34.5%) had had minor strokes, 32 (39.5%) transient ischemic attacks (TIA), and 12 (15%) amaurosis fugax. 9 (11%); those previously undergoing an endarterectomy on the symptomatic side, were operated on because of a contralateral asymptomatic severe stenosis.
Index tests DUS
Image production: Acuson XP 10 (Acuson, Mountain View, CA, U.S.A.), using either a 7 MHz B‐mode real‐time linear scanner including a 5 MHz pulsed and color‐coded Doppler, or a 5 MHz B‐mode real‐time linear scanner including a 3.5 MHz pulsed and color‐coded Doppler
Contrast: No
Criteria used to determine grade of stenosis: ROC curve analysis
Target condition and reference standard(s) Reference standard: DSA
Target condition: internal carotid stenosis
Criteria used to determine grade of stenosis: quote "Diameter reduction in percent = (b ‐ a)/b * 100. Where a is the smallest diameter in the stenotic zone, and b is the diameter of the normal CCA proximal to the stenosis."
Complications: Not described
Flow and timing All exams were performed within 1 month
Comparative  
Methods Study design: Prospective, consecutive, accuracy cohort study
Study location: Sweden
Year and language of publication: Published in 1996 in English
Study period: Not described
Participants enrolled: 81 patients
Carotids included in analyses: 162 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? 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?     High
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
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? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Unclear 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? Unclear    
Could the patient flow have introduced bias?   Unclear risk