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Routine follow up after head injury: a second randomised controlled trial
Wade DT, King NS, Wenden FJ, Crawford S, Caldwell FE
Journal of Neurology, Neurosurgery, and Psychiatry 1998 Aug;65(2):177-183
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To confirm that patients admitted to hospital with a head injury benefit from a routinely offered early intervention service. PATIENTS AND METHODS: A mixed rural and urban Health District of 560000 people with two accident and emergency departments provided the setting. Existing routine services for most patients with head injury are minimal. All patients aged 16-65 years admitted to hospital after a head injury of any severity, with or without other injuries entered the trial. Prospective randomisation, with a block randomisation procedure was used to allocate all eligible patients to either: a group offered an additional service by a specialist team; or a group receiving existing standard services. Patients were assessed at follow up six months after injury. The primary outcome measure was the Rivermead head injury follow up questionnaire, a validated and reliable measure of social disability. The Rivermead post-concussion symptoms questionnaire was used to estimate severity of post-concussion symptoms. Each patient in the trial group was contacted 7 to 10 days after injury, and offered assessment and interventions as needed. These initially focused on the provision of information, support, and advice. Forty six per cent of patients in the trial group also received further outpatient intervention or additional support by telephone. RESULTS: 314 patients were registered: 184 were randomised into the trial group, 130 into the control group. For prognostic data, the groups were comparable at randomisation, and remained comparable when assessed at six months. 132 trial and 86 control patients were followed up at six months after injury. Patients' posttraumatic amnesia ranged from mild (n = 79, 40%), and moderate (n = 62, 32%), to severe (n = 38, 19%) and very severe (n = 17, 9%). The trial group patients had significantly less social disability (p = 0.01) and significantly less severe post-concussion symptoms (p = 0.02) at follow up at six months after injury than the control group patients. CONCLUSIONS: The early interventions offered by a specialist service significantly reduced social morbidity and severity of post-concussion symptoms in trial group patients at six months after head injury. Recommendations about how specialist services should be targeted are made both in the light of these results and those from a previous randomised controlled trial.
Reproduced with permission from the BMJ Publishing Group.

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