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 |
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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. |
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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 |
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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 |
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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 |
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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 |