Nerlekar 2006.
Clinical features and settings | People who received EVAR for AAA. Type of stents received: not reported. Aneurysm diameter: median: 52 (range 21‐75) mm using CT; 39 (38‐70) mm using US. Setting: department of surgery. |
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Participants | 121 participants enrolled; mean age: 73 years; median: 73 years; range: 52‐93 years. Comorbidities: not reported. Geography: Australia. Period of recruitment: 1995‐2003. |
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Study design | Retrospective review of prospectively collected data on people who received a stent for AAA. ("Between 1995 and 2003, 121 patients underwent EVR for an AAA. Their details regarding age, gender, and aneurysm morphology were entered into a prospective database. All patients were subjected to US and CT scan investigations. In addition, digital subtraction angiography was performed before surgery to assess vascular anatomy and to accurately determine aneurysm size." |
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Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: not provided. Endoleak (absolute n): 20. Prevalence of endoleak: 11.9% (29/243). Reference standard: CT scan. Image acquisition:
Type of CT scanner: high‐speed Advanced 2X spiral CT scanner (GE Medical Systems, Milwaukee, WI, USA). Use of contrast: yes, Ultravist 370 (Schering AC, Germany). |
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Index and comparator tests |
Index test: CDUS. Image production: not reported. Type of US: Sonoline Elegra Ultrasound lmaging System with colour flow Doppler (Siemens, New York, NY, USA). Use of contrast: no. Operator: 1 experienced ultrasonographer. |
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Follow‐up | People with modified device configurations (n = 5), pre‐existing grafts (n = 4), graft deployment failure (n = 1) and 3 participants who died before 1 month follow‐up from study. | |
Notes |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants represented average patients that after receiving EVAR are exposed to endoleak surveillance. |
Acceptable reference standard? All tests | Yes | Reference standard was CTA. |
Acceptable delay between tests? All tests | Yes | "There were 190 occasions in which US and CT were performed on the same day or within 1 month, and these results formed the basis of the study." |
Partial verification avoided? All tests | Yes | All study participants accounted for and results of reference standard reported for all. |
Differential verification avoided? All tests | Yes | All participants who received index test subjected to same reference standard. |
Incorporation avoided? All tests | Yes | Index test not part of reference standard. |
Reference standard results blinded? All tests | Yes | "For the purpose of the study, all US and CT scan films were reviewed by two blinded reviewers." |
Index test results blinded? All tests | Yes | "For the purpose of the study, all US and CT scan films were reviewed by two blinded reviewers." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | No uninterpretable results. |
Withdrawals explained? All tests | Yes | "Excluded were patients with modified device configurations (n = 5), preexisting grafts (n = 4), graft deployment failure (n = 1) and three patients who died before 1 month follow up from the study." |