Cost/Utility Ratio in the Management of Patients With Acquired Severe Brain Injury: Comparison Between a Programme of In-hospital Graded Intensity Rehabilitation and Usual Care.

Materials and methods Study design This study was an organizational assessment of an integrated system of care (GIR) for patients with SBI and was designed as a prospective, randomised trial. An individual record was created for each patient with SBI; this record contained the patient's personal data, information prior to admission to intensive care or neurosurgery, clinical characteristics, the presence of devices, complications, time of hospitalisation in an Intensive Care Unit, and cognitive conditions. Once it had been determined that the study entry criteria were met, the patients were entered in the register and prospectively in parallel-group randomised to two different management strategies.

The concealment of allocation was guaranteed by the availability of beds in the ward. Patients and health care providers and assessors were blinded to the study designed to compare the strategies management. Data analysts were blinded to treatment.

Sample size The sample size requirements for this study are intended to provide adequate power for the analysis of the primary objective ( decrease event-related mortality). The simulation were run in statsoft six sigma software according to the following hypotheses: the mortality of severe brain injury used as a Null hypothesis was 58%. This percent value is expected to decrease at 40% in the study arm. The target type-I error(α) was 0.05. A sample size of 119 patients per group would allow a power of 80% to detect an individual risk score ratio of 0.70 with a type -I error of 0.05.

Based on the availability of beds in the ward, two groups were formed:

(i) the UC patients who, while meeting the criteria for access into the Graded Intensity of Rehabilitation Unit for patients with SBI (SBI-GIRU), did not enter the department because no beds were free and were, therefore, discharged from the Intensive Care Unit into the management models available, such as acute care, Intensive Brain Injury rehabilitation ( cod 75) brain injury rehabilitation (code 56) ( hospital admission, lasting on average 60 days, in which intensive rehabilitation care is delivered prior to transfer to another structure), long-term care, home.