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Table 4 Summary of findings by objective and Progression Criterion

From: Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study

Objectives [To assess:]

Relevant Progression Criteria

Relevant result

1. Willingness of both patients and paramedics to participate in the trial.

1. Recruit at least ten paramedics to conduct the trial

19 paramedics took part in the trial

2. At least 60% of recruited participants consent to follow up

80% of patients consented to follow up

2. Compliance with the FICB protocol by paramedics.

3. At least 50% of intervention participants receive FICB

55% of intervention participants received FICB

3. Which outcome measures and costs to use in a full RCT and when they should be collected

4. Retrieve primary outcomes for at least 70% of consented participants

We checked the mortality status for 100% of participants. 61% of 1 month questionnaires and 71% of 6 month questionnaires were returned

5. Clinicians are in equipoise about safety and effectiveness of paramedic-administered FICB

The only statistically significant difference between arms was the proportion receiving morphine

4. Acceptability of FICB as a method of providing pain relief in the prehospital care of patients with hip fracture.

6. Mean participant satisfaction in the experimental arm at least 80% of that in the usual care arm

Mean participant satisfaction in FICB was 97% of that in the usual care arm

7. Balance of SAEs between arms

SAEs occurred in three experimental participants and four in the usual care arm

5. Accuracy of recognition of hip fracture by paramedics.

8. Paramedics recognise hip fracture with sensitivity of 75% and positive predictive value of 85%

Paramedics recognised hip fracture with sensitivity 77% and positive predictive value of 81%

6. Sample size required for a fully-powered RCT and period required to recruit these

 

For example, ~ 1900 patients over 24 months.

7. Whether trial processes and outcomes achieve specified progression criteria for progress to fully-powered trial

We effectively met all progression criteria, with progression criterion four being met for two out of three proposed primary outcomes and progression criterion eight being within reasonable limits.