Friese 2007.
Study characteristics | |||
Patient sampling | Retrospective study | ||
Patient characteristics and setting |
Study location: Texas, USA Study period: November 2003 to February 2005 Care setting: level I trauma centre Mass casualty: no Participants enrolled: 126 Participants included in analysis: 96: 47 men and 49 women Age: mean age 42.3 ± 22.5 years Type of injury: pelvic trauma Injury severity: not reported Haemodynamic stability: increased risk for haemorrhage Inclusion criteria: "the trauma registry was queried for all patients admitted to the trauma service through our emergency department during the study period with the diagnosis of pelvic fracture and the presence of at least one of the following risk factors for haemorrhage: age 55 years, the presence of haemorrhagic shock (systolic blood pressure 100 mm Hg), or an unstable fracture pattern. Additional inclusion criteria were the use of the FAST examination to evaluate the peritoneal space for the presence of haemoperitoneum on arrival to the emergency department and a confirmation of the presence or absence of haemoperitoneum by laparotomy or abdominopelvic computed tomography (CT) scan." Exclusion criteria: "DPL performed before confirmatory evaluation and treatment at an outside facility before arrival at our emergency department." |
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Index tests |
Index test: FAST US protocol: all FAST examinations were performed by surgery residents (postgraduate year 3 or higher) who were required to complete the American College of Surgeons course on the use of ultrasound in the acute setting. The trauma bay protocol specifies that all FAST examinations were performed as an adjunct to the primary trauma survey, which meant that the FAST examination was completed within 5 to 10 minutes of participant arrival in the emergency department. A true‐positive FAST examination was defined as free intraperitoneal fluid detected on US and haemoperitoneum confirmed at laparotomy or abdominopelvic CT scan. A true‐negative FAST examination was defined as no free fluid noted on abdominal US and the absence of haemoperitoneum noted at laparotomy or abdominopelvic CT scan. A false‐positive FAST examination was defined as free intraperitoneal fluid detected on US and the absence of haemoperitoneum on laparotomy or abdominopelvic CT scan. A false‐negative FAST examination was defined as no free intraperitoneal fluid detected on abdominal US and haemoperitoneum found at laparotomy or abdominopelvic CT scan. Hardware used: portable 2102 HAWK ultrasound unit (B&K Medical, Willmington, MA) with a low‐frequency (3.5‐MHz) transducer and a curvilinear array Description of imaging technique: standard 4‐view FAST examination |
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Target condition and reference standard(s) |
Target condition: free fluid and air Reference standard: CT (technical specifications not reported), laparotomy Description of technique: all operative and abdominopelvic CT scan reports were also reviewed for documentation of the presence of haemoperitoneum. CT scan and operative findings were based on the final dictated and transcribed reports placed in the permanent medical record from the attending radiologist and attending surgeon. Special information about the technique of the reference standard was not reported. |
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Flow and timing | Time between US and reference standard: not reported | ||
Comparative | |||
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 | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Unclear | High | ||
DOMAIN 2: Index Test All tests | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Was the qualification of the US operator appropriate? | Yes | ||
Was the US hardware (i.e. generation, manufacturer, probe, etc.) up to date? | Yes | ||
Was the US protocol (i.e. 'classic' FAST) appropriate? | Yes | ||
Are there concerns that the definition or performance of the index test (i.e. POC US of trauma) do not match generally accepted, established, or practiced rules or recommendations? | No | ||
Low | Low | ||
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 | ||
Was the qualification of the doctors (i.e. radiologists, surgeons, etc.) determining the reference standard appropriate? | Yes | ||
Was the reference imaging standard (i.e. MDCT‐rows (4 to ≥ 256 slices), contrast‐imaging, etc.) up to date? | Unclear | ||
Are there concerns that the definition or performance of the reference tests (e.g. CT, MRI, laparatomy, thoracotomy, autopsy, etc.) do not match generally accepted, established, or practiced rules or recommendations? | Yes | ||
Unclear | High | ||
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? | No | ||
Were all patients included in the analysis? | Yes | ||
Did all participants receive a reference standard? (Risk of partial verification bias) | Yes | ||
Low |