Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/04/2018
Date assigned
11/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical trauma is a healthcare problem all over the world and the main cause of death in young adults. Portugal is the leader among European countries concerning death related to accidents. The real dimension of the problem is not well known in Portugal as not enough studies have been performed on this subject. Therefore, our first and main objective is to know more about the frequency and types of physical trauma in Portugal as well as about its severity and consequences in terms of death and disease. Data from a Portuguese registry may help to understand this.
Death is the worst consequence of trauma but is not the only problem for those injured people. As technology improves, more people who suffer serious injuries during an accident can survive. And even the milder forms of trauma can result in significant problems that may affect people for a long time or might start after the injury.
From what we know, people who suffer some type of accident are often young and otherwise healthy. Many different types of physical disabilities can persist after the accident, as well as thought, behaviour or mood disturbances. All these problems can significantly affect patients, both in their immediate well-being, as well as by creating long-standing limits to their ability to live normally. Patients may appear physically recovered, but problems reintegrating into family, work, or school can appear. These can worsen quality of life. People who have had a traumatic injury should receive education on how they might feel about the injury and should be referred for physiotherapy or psychological treatment as soon as possible. People often receive excellent care for their injury in hospital, but don't get followed up once they are home. Many of these patients can achieve good recovery and reintegration into family and work life, but will require continuous and possibly life-long access to many different doctors. This means that their quality of life is a good as possible and is cost-effective in the long run. This process should start at the first contact with the patient and family. It should involve close collaboration between the family, patient, emergency physician, intensive care specialist, surgeons, psychiatrists, rehabilitation medicine and other therapists, rehabilitation facilities, the workplace and community groups.
This study had three aims:
1. To discover consequences of severe trauma in terms of death, development of disease and psychological limitations, disabilities and quality of life.
2. To determine whether there is a relationship between the initial accident and its treatment and the development of trauma-related disease.
3. To develop a way to predict quality of life after severe trauma.
The follow-up consultation developed for this project did an interview at 6 months after trauma. The main objectives were to ask for and diagnose problems in the patient as well as to serve as a base for data collection and research on late problems that can arise after trauma. Several questions and physical investigations were done to find out which problems are important at 6 months after the accident. We therefore asked patients to reply to some questionnaires, which include Mini Mental State; Glasgow Outcome Scale and Glasgow Outcome Scale Extended and EQ-5D).

Who can participate?
People who had a severe injury that required surgery to blood vessels, chest, brain or spinal cord.

What does the study involve?
The patients were interviewed 6 months after the injury. The main objectives were to ask for and diagnose problems in the patient as well as to serve as a base for data collection and research on late problems that can arise after trauma. Several questions and physical investigations were done to find out which problems were important at 6 months after the accident. Patients also filled in questionnaires, which included Mini Mental State; Glasgow Outcome Scale and Glasgow Outcome Scale Extended and EQ-5D.

What are the possible benefits and risks of participating?
There were no benefits or risks of participating.

Where is the study run from?
Hospital de Santo António, Porto, Portugal

When is the study starting and how long is it expected to run for?
January 2013 to December 2013.

Who is funding the study?
Fundação para a Ciência e a Tecnologia [Portuguese Science and Technology Foundation]

Who is the main contact?
Joana Berger-Estilita, joanamberger@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Joana Berger-Estilita

ORCID ID

Contact details

Freiburgstrasse 10
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PIC/IC/83120/2007

Study information

Scientific title

Outcome after severe trauma: Implications for the clinical approach

Acronym

Study hypothesis

1. To evaluate the consequences of severe trauma in terms of mortality, functional and psychological impairments, disabilities and quality of life
2. To determine whether a relationship between the initial event - namely epidemiological aspects, injury severity, types of injury and analytical, clinical markers of severity and presence or absence of the “Golden Hour” approach - and the outcome exists.
3. To discuss the “trimodal mortality” and the “Golden Hour” concepts and its implications in a Portuguese modern trauma system from the clinical and also organizational point of view.
4. Development of informatic systems and tools to support the registry as well as share and validation of data. This includes creating a predictive score called Global Outcome After Trauma (GOAT) to identify patients who may have worse outcomes after severe trauma.
5. To analyse the relationship between disability, cognitive impairment and health-related quality of life (HRQoL) in adult patients after trauma with and without traumatic brain injury (TBI).

Ethics approval

Approved by the Committee for Ethical Research at the Hospital de Santo António, Porto, Portugal, 26/03/2006, 08/CES/06

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Mortality, functional and psychological impairments, disabilities and quality of life in severe trauma patients

Intervention

We analysed prospectively collected data from a trauma database that included all trauma patients admitted to the Emergency Room of Hospital de Santo António (HGSA) for a period of 5 years. HGSA is a 700-bed tertiary hospital, equivalent to an American College of Surgeons classification of a level 1 trauma centre and serves an area of 2.5 million people.
For the purpose of this study we examined all severe trauma patients (ISS >15) registered between January 2003 and December 2007 and who were alive 6 months after the injury. Our institutional review board approved the study and informed consent was obtained from patients.
We performed a follow-up consultation that consisted of a structured interview and several self-administered tests. Data concerning disability, cognitive impairment and HRQoL was gathered and analysed.

Intervention type

Phase

Drug names

Primary outcome measures

1. Disability was assessed by the Glasgow Outcome Scale Extended (GOSE)
2. Cognitive impairment was assessed by the Mini Mental State (MMS) test
3. HRQoL was assessed with a modified EuroQol 5-Dimensions (EQ-5D-3L) questionnaire.

Secondary outcome measures

N/A

Overall trial start date

01/01/2003

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Need for specialized trauma care (vascular surgery, neurosurgery or thoracic surgery) and/or severe trauma (defined by an ISS >15).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Aged <13 years
2. Diagnosis of poisoning or overdose
3. Diagnosis of drowning or suffocation
4. Burns
5. Iatrogenic accidents
6. Isolated hip fractures in patients aged >65 years

Recruitment start date

01/01/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Portugal

Trial participating centre

Hospital Geral de Santo Antonio, Centro Hospitalar do Porto
Largo Professor Abel Salazar, 4099-001 Porto, Portugal
Porto
4099-001
Portugal

Sponsor information

Organisation

Fundacao para a Ciencia e Tecnologia

Sponsor details

Av. D. Carlos I
126
1249-074 Lisbon
Lisbon
1249-074
Portugal

Sponsor type

Government

Website

https://www.fct.pt

Funders

Funder type

Not defined

Funder name

Fundação para a Ciência e a Tecnologia

Alternative name(s)

Portuguese Science and Technology Foundation, Foundation for Science and Technology, FCT

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Portugal

Results and Publications

Publication and dissemination plan

Results to be published in Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

The results of our study show that:
1. A substantial proportion of injured patients have some form of measurable HRQoL impairment or disability 6 months after multiple trauma and ICU discharge
2. Female gender, older age and longer length of hospital stay are predicting factors for worse global outcome for trauma, as well as for individual scores for cognitive impairment, disability and HRQoL
3. The type of trauma (i.e. trauma with or without TBI and TBI alone) was not significantly associated with mortality, disability, cognitive impairment or HRQoL

During the study period a total of 688 patients were registered. 501 patients (73%) survived the stay at ICU and hospital, and 31 died within 6 months of hospital discharge. From the 470 patients alive at 6 months, 160 (34%) were lost to follow-up. 6 months after the injury, 310 (66% of survivors) were offered a follow-up consultation and of these, 262 (85%) agreed.
We found a statistically significant association of mortality with older age, road traffic accidents and blunt trauma, higher trauma severity scores and shorter ICU and hospital length of stay (LOS). There were no differences between survivors and non-survivors regarding sex, presence of TBI and presence of life-threatening events, whereas the non-survivors were significantly older.
The disability measured with GOSE was assessed for 262 patients (Table 2), where 167 (64%) scored a favourable outcome. Patients with unfavourable outcome were of female gender, older age, had higher injury severity scores (ISS), higher severity of trauma (TRISS), and longer ICU and hospital length of stay than those with favourable outcome.
Cognitive impairment was assessed for 208 patients. Moderate-to-severe cognitive impairment was present in 92 (44%) of the patients. Older age, higher severity of trauma (TRISS), and longer length of hospital stay were significantly associated with worse cognitive impairment outcomes.
HRQoL analysis included 262 patients. The median EQ-5D Index was 0.67 (0.45-0.85). 44% (n=114) of patients were in the low category and those patients were significantly older, had higher severity of trauma (TRISS), and longer length of ICU and hospital stay than the patients in the categories good or medium.
134 patients (51%) fell into the low global outcome category. Those patients were predominantly females, of older age, had higher injury severity scores (ISS), higher severity of trauma (TRISS) and longer ICU and hospital LOS than those in the other categories. Additionally, there was a significant association with the mechanism of trauma, with road traffic accidents and falls more frequent in the low and good categories, whilst the medium category had more stabbing accidents.
Data analyses lead to the best multiple logistic regression model, where we evaluated the effect of trauma, hospital, and demographic factors associated with the global outcome after trauma. The categories medium and low were merged and considered as reference. In this analysis, female sex, older age, higher injury severity scores (ISS), higher severity of trauma (TRISS) and longer ICU and hospital stay were risk factors for low global outcome in the univariate analysis. Female sex, older age and longer ICU stay remained significant in the multivariate analysis.

Publication summary

Publication citations

Additional files

Editorial Notes