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 |