Anzidei 2012.
Study characteristics | |||
Patient Sampling | 416 symptomatic patients (amaurosis fugax, stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit) and suspected carotid artery stenosis underwent DUS. Only patients with stenoses on DUS > 30% with irregular atheroma, were sent for combined evaluation with CTA and MRA and only those with an indication for treatment after theses studies underwent DSA Exclusion criteria: Patients that had contraindications to MR, CT or DSA or had already undergone surgical or endovascular treatment for carotid stenosis |
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Patient characteristics and setting | 170 patients (included in analysis), 108 male/62 female, mean age 69 ± 6.5 (range 62‐90 years) risk factors: 17 diabetes mellitus, 34 hypertension, 13 dyslipidemia, 18 current smoker, 11 former smoker Only patients with known disease |
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Index tests |
DUS Image production: Aplio XV or Mylab 70 with dedicated software for the vascular study and a 5‐12 MHz multiband linear transducer Contrast: No Criteria used to determine grade of stenosis: quoted "The degree of stenosis was determined. Measure of the residual lumen at the point of maximum narrowing and peak velocity (125–130 cm/s) were visualized at the level of the stenosis." |
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Target condition and reference standard(s) |
Reference standard: DSA Target condition: symptomatic carotid stenoses Criteria used to determine grade of stenosis: NASCET criteria Complications: There were 11 cases (6.5%) of complications following the DSA procedure (one cerebral ischemia, four pseudoaneurysms and six hematomas at the puncture site); eight (4%) patients suffered moderate‐to‐severe adverse reactions to the iodinated contrast agent. |
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Flow and timing | 416 with symptomatic carotid stenoses underwent DUS. 205 patients underwent CTA and MRA and 170 patients underwent DSA (only those that were treated). In two cases, MRA examination was not considered of diagnostic quality due to motion artefacts. Interval for performing all four techniques was 7 ± 3 days. |
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Comparative | |||
Methods |
Study design: Prospective accuracy cohort study. Unclear whether consecutive recruitment Study location: Italy Year and language of publication: Published in 2011 in English and Italian Study period: May 2006 and May 2010 Participants enrolled: 416 patients underwent DUS; 205 patients underwent CTA and MRA; 170 patients underwent DSA (underwent treatment). Carotids included in analyses: 335 |
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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? | Unclear | ||
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? | 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? | 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? | No | ||
Could the patient flow have introduced bias? | High risk |