Purpose of the Study A robust randomisation process reduces the risk of selection bias in randomised controlled trials. The time-critical nature of cardiac arrest interventions makes the use of some randomisation strategies challenging. We undertook a scoping review to summarise randomisation strategies used across cardiac arrest randomised controlled trials.
Materials and methods We searched Medline and Cochrane central from inception to November 2021 for human cardiac arrest randomised controlled, undertaken in both the out-of-hospital and in-hospital setting, which randomised participants during cardiac arrest or in the immediate post-arrest period. We excluded trials that were not published in English. We extracted data using a standardised form.
Results Our searches identified 5837 records, of which 167 were eligible for inclusion. Publication date ranged from 1978 to 2021. Most trials were undertaken solely in either North America (n=66, 11539.5%) or Europe (n=63, 37.7%). Across all studies, the median sample size was 221 (interquartile range 81-738). The majority were conducted solely in the out-of-hospital setting (n=129, 77.2%).
Randomisation methods were classified as individual parallel (n=115, 68.9%), individual crossover (n=4, 2.4%), cluster (n=29, 17.4%), quasi (n=14, 8.4%) or not stated (n=5, 3.0%)
Of the 119 individually randomised trials, the most common randomisation systems used were drug box (n=34, 28.6%) or an envelope system (n=30, 25.2%). The method was not stated in two trials (1.7%).
For the 29 cluster trials, the most common cluster level the EMS system/ base (n=11, 37.9%) or ambulance (n=8, 27.6%).
For the 156 trials where it could be assessed, 112 (71.8%) were judged as having adequate allocation concealment.
Conclusion
There is marked variability in randomisation strategies used across cardiac arrest randomised controlled trials, which likely reflects the specific setting, trial resources, and intervention. Key information about the randomisation strategy was not adequately reported in some studies.

Randomisation strategies in cardiac arrest randomised controlled trials: a scoping review

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