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 |
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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). |
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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. |
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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 |
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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 |
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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