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Table 5 Methodological considerations

From: Randomised controlled trials in pre-hospital trauma: a systematic mapping review

Intervention category Trial design Adaptive design Number of arms Method of randomisation Consent process Early stopping
Fluid therapy (n = 7) • Not reported (n = 7) • Yes (n = 4)
• Not reported (n = 3)
• 2 (n = 6)
• 3 (n = 1)
• Pre-randomised study packs (n = 5)
• Not reported (n = 2)
• Informed consent waived – consent for continued follow up (n = 5)
• Not required (n = 1)
• Not reported (n = 1)
- Futility (n = 1)
- Insufficient enrolment (n = 1)
Analgesia (n = 7) • Parallel (n = 3)
• Not reported (n = 4)
• Not reported (n = 7) • 2 (n = 5)
• 3 (n = 1)
• 4 (n = 1)
• Toss of a coin(n = 1)
• Use of sealed opaque envelopes (n = 3)
• Pre-randomised study packs (n = 1)
• Not reported (n = 2)
• Informed consent waived – consent for continued follow up (n = 1)
• Prospective verbal consent (n = 5)
• Not reported (n = 1)
• Insufficient enrolment (n = 1)
Blood product (n = 3) • Cluster (n = 1)
• Not reported (n = 2)
• Yes (n = 1)
• Unclear (n = 1)
• Not reported (n = 1)
• 2 (n = 3) • Service randomised (n = 1)
• Pre-randomised study packs (n = 1)
• Not reported (n = 1)
• Informed consent waived – consent for continued follow up (n = 3) • Futility (n = 1)
Temperature management (=3) • Not reported (n = 3) • Yes (n = 1)
• Not reported (n = 2)
• 2 (n = 3) • Use of sealed opaque envelopes (n = 3) • Prospective verbal consent (n = 2)
• Informed consent waived – consent for continued follow up (n = 1)
• No early stopping
Airway management/ventilation (n = 2) • Not reported (n = 2) • Yes (n = 1)
• Not reported (n = 1)
• 2 (n = 2) • Use of sealed opaque envelopes (n = 1)
• Not reported (n = 1)
• Informed consent waived – consent for continued follow up (n = 1)
• Not reported (n = 1)
• No early stopping
Model of care (n = 1) • Parallel (n = 1) • Unclear (n = 1) • 2 (n = 1) • Centrally automated system • Informed consent waived – consent for continued follow up (n = 1) • No early stopping