Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trialBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38918.669317.4F (Published 31 August 2006) Cite this as: BMJ 2006;333:465
- Jean-Luc af Geijerstam, researcher ()1,
- Sven Oredsson, head of emergency department2,
- Mona Britton, senior medical adviser OCTOPUS Study Investigators3
- 1 Department of Medicine, Clinical Epidemiology Unit, Karolinska University Hospital, 171 76 Stockholm, Sweden
- 2 Emergency Department, Helsingborg Hospital, Helsingborg, Sweden
- 3 Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden
- Correspondence to: J-L af Geijerstam
- Accepted 22 June 2006
Objective To compare immediate computed tomography during triage for admission with observation in hospital in patients with mild head injury.
Design Multicentre, pragmatic, non-inferiority randomised trial.
Setting 39 acute hospitals in Sweden.
Participants 2602 patients (aged ≥ 6) with mild head injury.
Interventions Immediate computed tomography or admission for observation.
Main outcome measure Dichotomised extended Glasgow outcome scale (1-7 v 8). The non-inferiority margin was 5 percentage points.
Results At three months, 275 patients (21.4%) in the computed tomography group had not recovered completely compared with 300 (24.2%) admitted for observation. The difference was - 2.8 percentage points, non-significantly in favour of computed tomography (95% confidence interval - 6.1% to 0.6%). The worst outcomes (mortality and more severe loss of function) were similar between the groups. In the patients admitted for observation, there was a considerable delay in time to treatment in those who required surgery. None of the patients with normal findings on immediate computed tomography had complications later. Patients' satisfaction with the two strategies was similar.
Conclusions The use of computed tomography in the management of patients with mild head injury is feasible and leads to similar clinical outcomes compared with observation in hospital.
The details of investigators, committee members, and other study personnel are on bmj.com.
Contributors J-LG, SO, and MB designed and planned the trial, collected and analysed the data, and wrote the paper. MB and J-LG are the guarantors.
Funding County Council of Stockholm (Department of Research, Development, and Education); Thelma Zoéga Foundation; Apoteket; Swedish Research Council; Gorthon Foundation; Vårdal Foundation (the Swedish Foundation for Health Care Sciences and Allergy Research); Health Research Council of Southeast Sweden; Health and Medical Care Executive Board of the Region Västra Götaland; Swedish Society of Medicine; Region Skåne; and SBU (Swedish Council on Technology Assessment in Health Care).
Competing interests None declared.
Ethical approval The study was approved by all regional ethics committees in Sweden.