Chesnut 2012.
| Methods | Randomised controlled trial (multicentre: Ecuador and Bolivia) | |
| Participants | 324 patients aged ≥ 13 years with severe traumatic brain injury (mean age 29, range 22 to 44). The median GCS motor score at randomisation was 4.0. Traffic incidents accounted for the majority of injuries. Most patients were admitted to the study hospitals via another centre. Median time from injury to arrival at hospital for all participants was 3.1 hours Inclusion criteria: GCS < 8 on admission or within first 48 hours after injury; admission to study hospital within 24 hours of injury Exclusion criteria: GCS 3 and fixed dilated pupils on admission; age ≤ 12 years |
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| Interventions | Guidelines based management protocol Active group: invasive ICP monitoring with protocol‐based clinical care to maintain measured ICP < 20 mmHg Control group: protocol based general clinical care with intervention for raised ICP as indicated by clinical examination or radiological data |
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| Outcomes |
Primary outcomes:
Secondary outcomes: severe disability at the end of the follow‐up period. As part of the multi‐domain outcome, data investigators provided GOS‐E data at six months. Frequency of complications such as focal haemorrhage and local infection: adverse effect data were collected Additional outcomes: investigators also reported on the number of days spent in the ICU and the duration and intensity of medical treatments for raised ICP (e.g. administration of hyperosmolar fluids, use of hyperventilation) |
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| Notes | The authors of the paper concluded that for patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at less than 20 mmHg was not shown to be superior to care based on imaging and clinical examination | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequences performed remotely by a data‐centre biostatistician at the University of Washington (USA) and stratified according to site, severity of injury and age, such that numbers of participants on each site were balanced after every two to four allocations. Investigators report that the two groups were similar at baseline with regard to all characteristics assessed at that point. |
| Allocation concealment (selection bias) | Low risk | Allocation concealment according to protocol; the local coordinator logged onto a secure database and entered each patient's details after consent was obtained from a legally authorised representative. Once confirmation of eligibility was made and stratum determined (by the programme), the programme itself entered "the subject information on the randomisation log, retrieve[d] the next assignment for that center and stratum, enter[ed] that on the randomisation log, and sen[t] the assignment to the study co‐ordinator". |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Treating personnel cannot be blinded to the placement of an ICP monitor. Arguably, (unconscious) participants could be blinded although monitor placement leaves a surgical scar. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded to assigned treatment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data was analysed on an intention‐to‐treat basis (model not described) |
| Selective reporting (reporting bias) | Low risk | Reporting was consistent with the pre‐published protocol |
| Other bias | Low risk | Integra Life Sciences donated catheters used in monitoring and provided other support to the trial, but investigators reported that the firm had "no role in the design or conduct of the study, the data analysis, or the writing of the manuscript" (Chesnut 2012). |
GCS: Glasgow Coma Score; GOS‐E: extended Glasgow Outcome Score; ICP: intracranial pressure; ICU: intensive care unit.