A multicentre prospective observational cohort study of incidence, acute care and recovery in the first year after moderate/severe traumatic brain injury in adults in the Netherlands.

The incidence of TBI is high, in the international literature varying between
100 and 300 per 100,000, with the highest incidence occurring in men, aged 15
to 24 years. The average age of patients with TBI is 30 years (1). Only one
study estimated the incidence of TBI, in the catchment area of the Academic
Hospital Maastricht, in the Netherlands. The incidence rate of traumatic head
or brain injury in 1997 was 836/100,000 and the incidence of admission
88/100,000 (1).
Recent data however indicate an increase in average age and a larger
contribution of elderly patients with TBI. Of all head injuries approximately
10% will be diagnosed with severe traumatic brain damage. Severe TBI is a life
threatening disease of predominantly young persons with a 30% case fatality
rate. Severe disabilities persist in over 50% of survivors. The young age at
which severe TBI occurs and the 50% overall poor outcome explain why the loss
of productive years is greater than that of subarachnoid haemorrhage and
comparable to ischemic stroke.

The main objective of this multicentre interdisciplinary study is to
systematically aggregate data on moderate and severe traumatic brain injury
patients in a national database. This database will serve to:
a. get an estimation of the incidence of moderate/severe traumatic brain injury
b. investigate variability in acute care management and identify areas for
improvement of acute care
c. assess variability in resource allocation for post acute care and
investigate determining factors.
d. quantify residual disability in survivors and provide an estimate of cost
burden
e. better target prevention campaigns

Secondary goals:

- to stimulate national network collaboration between researchers
- to increase awareness of the problem in the community
- to enable future extension of activities in the direction of translational
research in the Netherlands.
- initiate a network collaboration to permit long term longitudinal studies on
prevalence and impact of TBI related disability in the Netherlands.

Methods: Multicentre observational cohort study
Study population: Patients (age >= 16) with moderate to severe traumatic brain
injury.
Number of patients: Estimated 500.
Duration of the study: 2 years.
Inclusion criteria: Moderate and severe TBI. Moderate TBI is defined as a
hospital admission GCS 9- 12 (m/f). Severe TBI is defined as a hospital
admission GCS =< 8 (m/f). Admitted within 72 hours postinjury to one of the
participating centres.
Treating physicians (neurospecialist, traumatologist, intensive care physician)
involved in resuscitation of the patients at the emergency department will be
asked to fill out a short questionnaire at the time the patient leaves the
emergency department if they estimate that the patient will be dead or alive
after 6 months and if alive will be in a vegetative state, severly disabled
(GOSe 3-4) moderately disabled (GOSe 5-6) or recovered (GOSe 7-8)
For the purpose of this study the following data will be recorded in each
centre: age, sex, medical history, pre-injury working status, referral status,
GCS, pupillary reactions, overall injury severity (measured with the Injury
Severity Score (ISS)(4), the Trauma Coma Databank (TCDB) CT score (all initial
CT-scans will be send to the coordinating centre and read by one rater)(5),
intracranial and systemic operations, the occurrence of hypoxia (defined as a
PaO2 < 8kPa or a SaO2 < 90%) and hypotension (defined as a systolic blood
pressure < 90 mm Hg), duration of coma and post traumatic amnesia. During the
ICU registration of the occurrence of secondary complications: hypoxia,
hypotension and treatment approaches employed. Total hospitalization time (on
wards and ICU) will be registered.
At discharge: allocation of post acute care resource i.e home, rehabilitation
centre, nursing home.

Follow up: at 6 months and 12 months
Six and 12 months post injury a Glasgow Outcome Score-extended as well as an
employment and rehabilitation status will be obtained by personal or telephone
interview.
At these time points also postal questionnaires including an informed consent
letter will be send to all consecutive patients of the four centres who left
the hospital alive. Using pre-stamped return envelopes all questionaires can
be returned to the coordinating centre.
If no response can be obtained the general practitioner will be approached or a
specialist known to be involved in treating the patient to obtain the
information. If the patient has moved, the municipality register of the last
known residence will be contacted to trace the patient.

In addition to general questions about the patient*s demographics, education
and rehabilitation status, the questionnaire booklet contains the following
self-report scales:

a. General questions (eg. work, history)
b.SF36
c. Pain score list
d. VVV (Fatigue questionnaire)
e. RPQ (Rivermead)
f. SVL (post-traumatic stress)
g. BDI (depression)
h. GOSE
i PQOL (Quality of life)
j. ESS (sleep scale)
k. SCL-90 (Complaints list)
l. VOW (Well being)

In the period of half a year, the patient has to complete a postal
questionnaire. It will take 45 minutes to complete the questionnaire.