Abstract
BackgroundClinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates.In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol.MethodsAll aspects of the pilot phase of the trial were conducted as for the main trial. The pilot phase had oversight by independent Steering and Data Monitoring committees.ResultsForty sites across 12 countries gained ethical approval. Thirty seven of 40 sites were initiated for recruitment. Of these, 29 had screened patients and 21 randomized at least one patient. Lead times to ethics approval (6.8 weeks), hospital approval (18 weeks), interest to set up (61 weeks), set up to screening (11 weeks), and set up to randomization (31.6 weeks) are comparable with other international trials. Sixteen per cent of screened patients were eligible. We found 88% compliance rate with trial protocol.ConclusionThe pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered.Trial registrationCurrent Controlled Trials: ISRCTN34555414.
Highlights
Clinical trials in traumatic brain injury (TBI) are challenging
In this report we evaluate data collected during the internal pilot phase (January 2009 to August 2011) to assess the following criteria: design and implementation of an online electronic case report form for screening, randomisation and data collection; feasibility of recruitment; patient eligibility
Trial size As a result of the internal pilot the sample size for the full trial was reduced to 600 patients. Two factors underpinned this decision: the homogeneity of the patient group - unlike most previous trials all patients had evidence of brain swelling; and we showed an optimised cooling intervention could be delivered, which meant that the meta-analysis by Peterson and colleagues [10] was the most relevant for the power calculation, rather than the median estimate of effect of six metaanalyses on which our original power calculation was based [12]
Summary
Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates. In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol. The pattern of severe traumatic brain injury (TBI) is changing globally with the incidence increasing rapidly in low- and middle-income countries as a result of increased motor vehicle use [1]. Previous trials of complex interventions in TBI patients have been conducted in high-income countries such as Europe and the US. The increasing cost and administrative burden of conducting large clinical trials has forced researchers. Previous trials of TBI patients have reported long lead times for site setup/approvals and low screenedto-recruitment rates [4]. A balance must be achieved between our current understanding of the mechanisms of action of the intervention being evaluated and maximizing recruitment by using broad inclusion criteria
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