Rose 2001.
| Methods | RCT. Location: University Hospital, California, USA. Recruitment period: November 1997 to November 1998 Risk of bias assessment: A. Adequacy of concealment: 1 B. Intention‐to‐treat: 1 C. Blinding: 0 D. Comparability of treatment groups at entry: 2 E. Comparability of care programmes: 1 F. Definition of inclusion and exclusion criteria: 2 G. Description of interventions: 2 H. Definition of outcomes: 2 I. Duration of surveillance: 1 |
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| Participants | Inclusion criteria: patients 18 to 75 years old meeting critical trauma triage criteria after blunt injury, defined by the American College of Surgeons Subcommittee of trauma. 212 randomised (US 105, no US 107), 208 analysed (4 dropped because of incomplete data). US group: mean age 40.0 (SD 19.5) years, mean ISS 9.9 (SD 12.4), 61% males. No US group: mean age 39.0 (SD 16.8) years, mean ISS 9.8 (SD 8.8), 63% males | |
| Interventions | a. Standard trauma management plus focused ultrasound for free fluid (none, small, moderate, large) with 15 minutes of arrival by experienced doctors b. Standard trauma management | |
| Outcomes | 1. Difference in abdominal CT scan use (sample size calculations: 20% difference, 80% power, two‐tailed alpha 5%) 2. 30‐minute difference in time to laparotomy | |
| Notes | Trial was stopped at 215 participants because US was recognised as standard practice and did not allow for further patient recruitment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation in blocks of 30 |
| Allocation concealment (selection bias) | Unclear risk | Computer‐generated method, but unclear concealment |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding attempted |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding attempted |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding attempted |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
| Selective reporting (reporting bias) | Unclear risk | Unclear |
| Other bias | Unclear risk | Unclear |