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

Wolfle 2002.

Study characteristics
Patient Sampling 47 patients were included with suspected severe (≥ 70%) carotid stenosis; unclear how patients were selected
Exclusion criteria: patients with claustrophobia or contraindications for MRA
Patient characteristics and setting 47 patients included; 34 (72%) were symptomatic and 13 (28%) were asymptomatic
37 (79%) male and 10 (21%) female
The median age was 68 years (ranging from 46‐84 years).
Index tests DUS
Image production: Siemens (Elegra) with a 7,5MHz linear scan
Contrast: No
Criteria used to determine stenosis: Carotid stenosis was classified as severe (70‐99%) when PSV was greater than 230 cm/s and EDV was greater than 70 cm/s.
Target condition and reference standard(s) Reference standard: DSA
Target condition: ≥ 70% carotid artery stenosis
Criteria used to determine grade of stenosis: NASCET criteria
Complications: 2.1% stroke rate
Flow and timing Median time between exams was 2.8 days (SD 2.17)
Comparative  
Methods Study design: Prospective, not consecutive, accuracy study
Study location: Germany
Year and language of publication: Published in 2002 in German
Study period: Not described
Participants enrolled: 47 patients
Carotids included in analyses: 94 arteries
Notes Patients were only included with proven carotid stenosis.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
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? Yes    
Could the patient flow have introduced bias?   Low risk  

CCA: common carotid artery
CDUS: color duplex ultrasound
CE: contrast enhanced
CTA: computed tomography angiography
DEGUM: The German Society of Ultrasound in Medicine
DSA: digital subtraction angiography
DUS: duplex ultrasound
EDV: end diastolic velocity
ICA: internal carotid artery
IQR: interquartile range
MRA: magnetic resonance angiography
MR: magnetic resonance
NASCET: North American Symptomatic Carotid Endaterectomy Trial
PSV: peak systolic velocity
PTA: percutaneous transluminal angioplasty
ROC:receiver operating curve
SD: standard deviation
TIA: transient ischemic attack
US: ultrasound