POCON studie

Iain Haitsma

11-2-2009

POCON?

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

Multicentre

Dr. P.E. Vos, neuroloog, UMCN (Coordinating investigator/project leader)

Drs. T.M.J.C. Andriessen, Onderzoeker i.o. neurologie (Principal investigator)

Dr. J. van der Naalt, neuroloog, UMCG Groningen

Dr. J. Horn, Neuroloog-intensivist, AMC Amsterdam

Drs. G. Franschman, anesthesioloog, VU Amsterdam

Drs. I.K. Haitsma, neurochirurg, EMC, Rotterdam

Prospective observational cohort study

During a 12 months inclusion period all patients sustaining

moderate/severe TBI will be registered in a central database

Incidence

The incidence will be calculated from the total number of persons with

moderate/severe TBI divided by the total population from which they

were drawn i.e the total number of persons in the recruitment areas of

the participating centres

We will further analyse the cause of injury in relation to age and

gender. This analysis will provide a guide for better targeting of

prevention campaigns

Acute care

The institution of trauma centers aims for central coordination and concentration of care for severely injured patients.

Recently, Patel et al (2005) showed in the UK that mortality is doubled when severely and moderately injured patients are first seen and/or treated in regional hospitals. Our impression is that many patients are still secondarily referred from regional hospitals. It is uncertain whether international guidelines are followed in all causes and different approaches to medical therapy and surgical indications exist between centers.

We will investigate referral policy, adherence to guidelines, and explore differences in treatment approaches in relation to outcome. Results will serve to identify areas for further improvement in trauma organization and care.

Variability exists in post acute care facilities provided, some patients being transferred to specialized rehabilitation centers, and others to nursing homes.

For patients discharged home, structural follow-up and identification/intervention of problems manifesting late is often lacking.

We will assess which facilities are provided for individual patients, explore if differences exist between participating trauma centers and study whether allocation of post acute care resources is more dependent on initial baseline prognostic risk or on the condition of the patient upon discharge.

Recovery

Long term disability results in direct medical and non medical costs in terms of hospitalization, out patient care and rehabilitation and indirect costs due to loss of productivity as well as intangible costs due to reduced quality of life.

Traditionally, outcome is assessed by medical professionals, but the perception of patients and care takers may be different.

A recently developed disease specific quality of life scale for TBI (QOLIBRI) provides possibilities for comparing outcome as assessed by medical professionals to the perception of individual patients. (3)

First year after moderate/severe traumatic brain injury in adults

We will study the presence of chronic signs and symptoms associated with TBI during a follow-up period of 1 year.

The proportion of patients with a Glasgow Outcome Scale extended (GOSe) score 7 after 1 year will be taken as the denominator to calculate the prevalence of post traumatic morbidity.

In addition we will study the time course of recovery by determining the residual complaints and signs and health related quality of life in these patients 6 months and 1 year after the injury.

We will give estimates of the economic consequences of TBI using the data collected.

Validation and use of prognostic models

Prognostic models of varying complexity have recently been developed for severe and moderate TBI

The applicability and validity of these models which were developed of a large international merged dataset, on the Dutch population will be investigated

We will further explore with multivariate logistic regression whether addition of information on severity of extracranial injuries may improve performance of the models

We investigate whether these models are also predictive of quality of life as perceived by patients 6

and 12 months post injury

Application of these models towards a better classification of patients with TBI will be investigated

The performance of these models will be compared to clinical predictions of outcome determined by clinicians from different disciplines (e.g. neurospecialist, traumatologist, intensive care physician) upon admission to the ICU.

OBJECTIVES

Primary Objective: 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 Objective(s): - 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.

Study design

All patients with a moderate and severe Traumatic Brain Injury (GCS 3- 12 ) who are admitted within 72 hours postinjury to one of the participating centres are included in this study. The inclusion period is one year

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.

STUDY POPULATION

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 post injury to one of the participating centers

Exclusion criteria Aged below 16 years Mild TBI (GCS > 12)

Sample size calculation All patients who fulfil to the inclusion criteria will be included in this

study. We estimate a population size of 500 (1).

Study parameter/endpoints

Main The Extended Glasgow Outcome Scale (GOS-e)

Secondary The Rivermead Post-Concussion Questionnaire (RPCQ) Short Form-36 (SF-36, Dutch version) quality of life scale QOLIBRI. 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, severely disabled (GOSe 3-4) moderately disabled (GOSe 5-6) or recovered (GOSe 7-8)

Assessment of economic costs will be according to the “letsel last model“ developed by Consument en Veiligheid(7)

Other study parameters

recorded will be Age Sex medical history pre-injury working status referral status GCS pupillary reactions overall injury severity (ISS) Trauma Coma Databank (TCDB) CT score (all initial CT-scans will be send to

the coordinating centre and read by one rater) intracranial and systemic operations occurrence of hypoxia (defined as a PaO2 < 8kPa or a SaO2 < 90%) hypotension (defined as a systolic blood pressure < 90 mm Hg) duration of coma and post traumatic amnesia

Other study parameters

recorded will be

During the ICU registration of the occurrence of secondary

complications

Hypoxia

Hypotension

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.

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:

GOS-e The Rivermead Post-Concussion Questionnaire (RPCQ) Quality of life Short Form-36 (SF-36, Dutch version) QOLIBRI

Consent

In case of (early) death before consent could be obtained no informed consent will be asked but clinical data will be anonymised and send to the coordinating centre and be part of the study

At the ER or as soon as possible after hospital admission a short information letter will be given to the Patients (or legal representatives) that clinical data will be collected on behalf of the study and send to the coordinating centre

When patients are admitted to the hospital the patient (or legal representative) will be given an information letter that (anonymised) clinical data will be obtained on behalf of the POCON study and that they will be approached after 6 months.

Patients are invited if they do not agree with this procedure to inform the local investigator. In that case data will not be entered in the multicentre database. A letter with a questionnaire will be send from the local centre to the patient after 6 months. In this letter the patient will also be asked informed consent for participation in a telephone interview by the study coordinator at 6 months and a interview and postal questionnaire after 12 months.

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