Coley 2000.
Study characteristics | |||
Patient sampling | Prospective study | ||
Patient characteristics and setting |
Study location: USA Study period: July 1997 to August 1998 Care setting: level I paediatric trauma centre Mass casualty: no Participants enrolled: 107: 68 boys and 38 girls Participants included in analysis: 97 Age: mean age 95 months ± 51 months (range 2 to 216 months) Type of injury: blunt abdominal trauma Injury severity: GCS 12.5 ± 4.2, PTS 8.0 ± 2.8 Haemodynamic stability: stable conditions Inclusion criteria: all children suffering blunt abdominal trauma who required a CT scan for evaluation of potential injury based on the surgical team leader’s clinical judgement Exclusion criteria: haemodynamically unstable, and required immediate operative intervention |
||
Index tests |
Index test: FAST US protocol: immediately before CT scan, the in‐house on‐call paediatric radiologist performed the FAST scan and rendered a decision regarding the absence or presence and location of any free fluid. If participants had a Foley catheter placed, this was clamped as soon as possible to allow the bladder to fill, facilitating detection of free fluid in the pelvis. Hardware used: Acuson 1283 P10 system (Mountain View, CA) by using 2‐ to 5‐MHz transducers, depending on participant body habitus Description of imaging technique: 4 specified locations were evaluated: the right upper quadrant, left upper quadrant, subxyphoid region, and pelvis |
||
Target condition and reference standard(s) |
Target condition: free fluid and air Reference standard: CECT, third‐generation spiral scanner (High Speed Advantage, General Electric, Milwaukee, WI) with IV but without oral contrast (more technical specifications were not reported) Description of technique: CT scans were evaluated for the absence or presence of fluid, its location, and the presence of any visceral injury |
||
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? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Low | Low | ||
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? | Yes | ||
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? | No | ||
Low | Low | ||
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 | ||
Did all participants receive a reference standard? (Risk of partial verification bias) | Yes | ||
Low |