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Optimizing the initial evaluation and management of severe
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Saltzherr, T.P.
Publication date2011Document VersionFinal published version
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Optimizing the initial evaluation and management of severe
traumapatients.
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UITNODIGING
Voor het bijwonen van de openbare verdediging van
het proefschrift
OPTIMIZING THE INITIAL EVALUATION AND MANAGEMENT OF
SEVERE TRAUMA PATIENTS
van T.P. Saltzherr
op vrijdag 27 mei 2011
om 13.00u
in de aula van de Lutherse kerk Singel 411, hoek Spui 1012 WN
Amsterdam
Receptie na afloop van de promotie
Paranimfen Niels Molenaar 06-10158231
[email protected]
Mark van Heijl 06-41821900
[email protected]
T.P. Saltzherr Hemonystraat 70-2
1074 BT Amsterdam [email protected]
Optimizing the initial evaluation and management of severe
trauma patients
Teun Peter Saltzherr
Optim
izing the initial evaluation and managem
ent of severe trauma patients
T.P. Saltzherr
-
Optimizing the initial evaluation and management of severe
trauma patients
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2
The printing of this thesis was financially supported by:
Universiteit van Amsterdam, GlaxoSmithKline B.V., Philips
Healthcare Benelux, Siemens
Nederland B.V., Afdeling Chirurgie AMC, Bauerfeind Benelux B.V.,
Chipsoft B.V.,
Nederlandse Vereniging voor Traumatologie en Traumanet AMC.
The REACT trial was financially supported by a grant from ZonMw,
the Netherlands
organisation for health research and development (Grant number
3920.0005).
Optimizing the initial evaluation and management of severe
trauma patients
Thesis, University of Amsterdam, the Netherlands
Copyright © 2011 Teun Peter Saltzherr, the Netherlands
No part of this thesis may be reproduced, stored or transmitted
without prior permission of
the author.
Printed by: Gildeprint Drukkerijen - the Netherlands
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Optimizing the initial evaluation and
management of severe trauma patients
ACADEMISCH PROEFSCHRIFT
Ter verkrijging van de graad van doctor
aan de Universiteit van Amsterdam op gezag van
de Rector Magnificus Prof. Dr. D.C. van den Boom
ten overstaan van een door het college voor promoties
ingestelde
commissie, in het openbaar te verdedigen in de Aula der
Universiteit
op vrijdag 27 mei 2011, te 13:00 uur
door
Teun Peter Saltzherr
Geboren te de Bilt
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Promotiecommissie
Promotor: Prof. Dr. J.C. Goslings
Co-promotoren: Dr. K.J. Ponsen
Dr. J.B. Reitsma
Overige leden:
Dr. F.C. Bakker
Prof. Dr. P.M.M. Bossuyt
Prof. Dr. H.J.Ten Duis
Prof. Dr. M.W. Hollmann
Prof. Dr. C. van Kuijk
Prof. Dr. J.S. Lameris
Faculteit der Geneeskunde, Universiteit van Amsterdam
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Table of contents
Chapter 1: Introduction and outline 9
PART I Implementation of a modern trauma resuscitating room.
Chapter 2: An evaluation of a shockroom located CT scanner: a
17
randomized study of early assessment by CT scanning in
trauma patients in the bi-located trauma center North-
West Netherlands (REACT trial).
Chapter 3: Randomized trial comparing the value of a CT scanner
in 29
the trauma room with a CT scanner in the radiology
department; the REACT trial.
Chapter 4: A cost-effectiveness Analyses of a trauma
resuscitating 53
room with a sliding, multislice CT scanner.
PART II Radiographic imaging during the primary survey of
severe trauma patients.
Chapter 5: Clearing the cervical spine in Dutch trauma care; a
71
problem-analysis.
Chapter 6: Diagnostic imaging of cervical spine injuries
following 83
blunt trauma. A review of the literature and practical
guideline.
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Chapter 7: Frequent Computed Tomography scanning due to 101
incomplete three-view X-ray imaging of the cervical spine.
Chapter 8: Are routine repeat chest X-rays before leaving the
trauma 113
room useful?
PART III Sequelae of the initial evaluation and management
of
severe trauma patients.
Chapter 9: Complications in multitrauma patients in a Dutch
Level-1 125
trauma center.
Chapter 10: Missed injuries in Dutch Level-1 trauma patients.
139
Chapter 11: Preventability of trauma deaths in a Dutch Level-1
trauma 153
center.
Chapter 12: The value of post mortem Computed Tomography as a
165
reliable substitute for autopsy. A systematic review.
Chapter 13: Summary 184
Chapter 14: Samenvatting 191
Chapter 15: General discussion and future perspectives 199
Dankwoord 205
Curriculum vitae 209
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1 Introduction and outline
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Introduction and outline
Impact of trauma
Worldwide trauma is a major cause of morbidity and accounts for
10% of mortality,
especially in people younger than 50 years.1 The Netherlands has
5300 trauma
deaths every year, while 1500-2000 multitrauma patients are
presented at Level-1
trauma centers.2 Injury accounts for 14% of all
disability-adjusted life years
(DALY’s), especially because the trauma population consists of
young people
without pre-existent morbidity, making trauma an important
source of health-related
costs.2 The annual direct (medical) costs are approximately 1
billion Euros while
the indirect costs, as a result of decreased production
capacity, and immaterial
losses are 4 billion Euros.
More than 80% of those patients who die from injury succumb
within 6 hours after
injury. Most deaths in trauma victims are due to head injury
(40%), uncontrollable
bleeding (30%) and chest injuries (20%) as early causes of death
and sepsis,
multi-organ failure and pulmonary embolism as late causes of
death.3
Blunt trauma (i.e. motor vehicle accidents, fall from heights
etc.) is still the most
common mechanism of injury in the Netherlands although
penetrating injuries are
becoming more common due to the increasing violence.
Initial trauma evaluation
Time management, accuracy and specificity are of great essence
in trauma care.
The more rapid and accurate injuries are diagnosed and treated,
the better
patient’s short and long-term outcomes. Initial care for trauma
patients is globally
based on Advanced Trauma Life Support (ATLS®) guidelines, which
were first
introduced in 1980.4 ATLS dictates that the greatest threats to
life should be
treated first.4 Therefore, ALTS consists of a systematic
approach of clinical
examination and diagnostics in order of priority managed by a
multidisciplinary
team (i.e. trauma surgeons, radiologists and anesthesiologists).
The initial patient’s
assessment consists of a rapid primary evaluation and
resuscitation of vital
functions. When the patient demonstrates normal vital functions,
or normalizes
after acute interventions, the secondary survey is started with
a head to toe
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examination and the radiological evaluation. If an injury is
diagnosed, treatment
should be started immediately.
The radiological evaluation consists of conventional chest,
C-spine and pelvic
radiographs and abdominal ultrasonography. CT scanning is
advised to be
performed selectively (‘on indication’). After the initial
evaluation of the patient all
life-threatening injuries are known and if necessary the patient
is transported to the
destination where (definitive) treatment can be offered (OR,
ICU, Angiosuite,
ward). Less severe injuries can be diagnosed and/or treated in a
later phase when
necessary or after the secondary survey in the trauma room when
life-threatening
injuries are excluded or have been treated. After 24 hours,
assuming the patient
has stabilized or has regained consciousness, the patient is
checked once again
for potentially missed injuries (‘tertiary survey’) and when
necessary specific
radiological examinations are performed.4-6
Modern trauma room
Trauma care has changed drastically since the introduction of a
structured and
standardized initial evaluation of trauma patients. Appointing
designated trauma
centers for specialized trauma care all over the world decreased
trauma-related
mortality even further.7-9
As a result of the ongoing development of imaging
techniques and treatment protocols the outcomes of trauma care
are continuously
improving.
The influence of CT scanning as an early diagnostic tool is
increasing because it is
becoming faster and can give a more detailed overview of
sustained injuries than
conventional imaging (X-rays and ultrasonography). Furthermore,
CT scanners are
increasingly becoming available in the Emergency Departments
which facilitates
obtaining a very early CT scan.10-12
In the Academic Medical Center (AMC) a
concept was developed and implemented in January 2004 that
brought the CT
scanner to the patient instead of the patient to the scanner by
locating the CT
scanner within the trauma room itself. Its main feature is a
radiolucent trauma
resuscitation table and a multislice CT scanner placed on rails
which can slide over
the patient. When necessary it can also slide to a second
mirrored trauma room
which is separated by radiation shielded doors, to proceed with
an additional
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12
(trauma) patient In addition, facilities for conventional X-ray
imaging and
ultrasonography are also readily available. With this concept
the most important
diagnostic modalities for trauma evaluation are at hand in the
trauma room and CT
scanning is possible at any moment during the initial trauma
evaluation.
Methods for quality assessment
Trauma care is susceptible to medical errors or mismanagements
due to initial
unknown diagnoses, indicating the necessity of rapid diagnosis
and treatment in a
sometimes stressful environment.13,14
Therefore, continuous evaluation and
optimisation of the quality of trauma care is necessary. The
abovementioned
ongoing changes in imaging and treatment protocols make it even
more important
to monitor the outcomes and quality of the delivered care.
Several methods are
applied in evaluating trauma care, i.e. post-mortem examination
or discussion
panels to evaluate potential errors or preventable deaths.
Outline of the thesis
In this thesis several aspects for the optimization of the
initial evaluation and care
of trauma patients are discussed. This manuscript is divided in
three parts. In Part I
we describe the effects of a modern trauma room containing a
sliding, multislice
CT scanner on trauma care. Part 2 is focused on the evaluation
and optimization of
existing radiological imaging protocols. In Part 3 several
sequelae of trauma care in
a Dutch level-1 trauma center are analyzed and methods for
quality assessment of
trauma care are critically appraised.
Part I:
The first chapters of this thesis report on clinical outcomes,
logistics and costs
associated with a modern trauma room containing a sliding,
multislice CT scanner.
These outcomes have been assessed in the REACT study which is a
randomized
controlled trial comparing trauma care in a setting with a CT
scanner located in the
trauma room with a setting having the CT scanner at the
Radiology Department.
The design and rationale of the REACT study are described in
Chapter 2.
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In Chapter 3 we describe the results of this randomized
controlled trial on clinical
outcomes and logistics.
Chapter 4 provides an accurate overview and comparison of all
in-hospital and
trauma related healthcare costs involved up to one year after
the initial trauma for
both strategies.
Based on the outcomes of these studies, a well-considered
decision can be made
for which (category of) patients and hospitals early CT scanning
could be
beneficial. Furthermore, recommendations are formulated about
key issues to
address in future research.
Part II:
Most of the radiological imaging protocols used in Dutch
Emergency Departments
are based on the internationally accepted ATLS guidelines.
However, over the
years several adaptations and protocol changes have been carried
through.
Several evidence based decision rules exist for clearing the
cervical spine (C-
spine) in blunt trauma patients. However, there is still no
uniform policy for the use
of one of these decision rules in Dutch ED's. To investigate
which factors hinder
the implementation of such validated decision rules, we
performed a nationwide
problem analysis for clearing the C-spine with clinical decision
rules. The outcomes
of this problem analysis are described in Chapter 5.
Chapter 6 contains the results of a systematic review of
available studies on
radiological imaging for C-spine clearance. Based on the
findings from the review
two patient groups are described to facilitate decision making.
Finally, this chapter
provides two flowcharts which could help in decision making for
radiological
imaging in daily practice.
Subsequently, we were interested in the amount of CT scans
performed after
primary X-ray imaging of the C-spine. After assessing the
reasons for secondary
CT scanning we analyzed several clinically useful markers which
increase the risk
of inadequate C-spine X-ray imaging in Chapter 7.
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Another deviation from the ATLS guidelines is that many hospital
protocols include
a routine repeat chest X-ray during the secondary survey rather
than on indication
only. Because no real evidence exists for this historical habit,
we assessed the
utility and clinical impact of a routine repeat chest X-ray in
Chapter 8.
Part III:
Constant monitoring of current standards of trauma care is
required to provide
optimal trauma care. Critical appraisal of one’s own errors or
complications should
be part of this process. Therefore, the final part of the thesis
describes several
methods to monitor the quality of trauma care.
Trauma patients seem to be at high risk for developing
complications. This can be
due to the physiological and immunological impact of trauma or
due to specific
trauma patient or treatment characteristics such as long-lasting
ventilation or
immobilization. In Chapter 9 the amount, anatomical location and
consequences of
complications in multitrauma patients are described. With the
outcomes of this
study we want to emphasize that certain patients are more prone
for complications.
Chapter 10 describes the results of a study in which the
incidence of missed
injuries was assessed within the REACT study population. In this
analysis the
different phases in which the injuries were diagnosed were
distinguished, which
makes it possible to optimize both the initial trauma care as
well as the phase of
follow-up examination.
An assessment of preventability of trauma deaths and errors in
management is an
accepted method to evaluate the quality of trauma care.
Historically in the
Academic Medical Center Amsterdam this assessment is performed
during a
monthly Morbidity and Mortality meeting. Subsequently, to assess
the adequacy
and outcomes of this meeting an external and independent review
panel of trauma-
specialists was asked to review the evaluation and trauma care
of 62 trauma
victims in the AMC. Aim of this study was to optimize both
delivered trauma care
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as well as the internal evaluation system. The outcomes of this
external review
process are described in Chapter 11.
Post-mortem patient examination can be an important method to
evaluate the
outcome of the process of trauma management with the purpose to
further improve
the quality of trauma care. This is because this examination can
reveal missed
injuries or uncertain causes of deaths. This outcome can be
relevant for the
treatment of future trauma patients, if they lead to further
optimization of trauma
management. The current golden standard for this type of post
mortem
examination is autopsy. However, this method is time consuming,
labour intensive
and very invasive. Furthermore, the permission which is in
general required to
perform such an examination is often denied by the victim’s
family. In Chapter 12
the outcomes of a systematic review which assesses the value of
post-mortem CT
scanning as a potential substitute for autopsy are
described.
Finally, in Chapter 13 and 14 the findings of the preceding
chapters are
summarized and discussed. Brief recommendations for future
research and
guidelines are given.
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Reference list
1. World Health Organization: 2008
[http://www.who.int/topics/injuries/en/]. 2. World Health
Organization: Regional Office for Europe. 2008
[http://www.euro.who.int/violenceinjury]. 3. Acosta JA, Yang JC,
Winchell RJ, Simons RK, Fortlage DA, Hollingsworth-Fridlund P, Hoyt
DB.
Lethal injuries and time to death in a level I trauma center. J
Am Coll Surg. 1998 May;186(5):528-33.
4. Committee on Trauma: American College of Surgeons: Advanced
Trauma Life Support (ATLS®); for Physicians, 7th Edition Chicago;
1997.
5. Enderson BL, Reath DB, Meadors J, Dallas W, DeBoo JM, Maull
KI. The tertiary trauma survey: a prospective study of missed
injury. J Trauma. 1990 Jun;30(6):666-9; discussion 669-70
6. Biffl WL, Harrington DT, Cioffi WG. Implementation of a
tertiary trauma survey decreases missed injuries. J Trauma. 2003
Jan;54(1):38-43
7. Increased survival among severe trauma patients: the impact
of a national trauma system. Peleg K, Aharonson-Daniel L, Stein M,
Kluger Y, Michaelson M, Rivkind A, Boyko V; Israel Trauma Group.
Arch Surg. 2004 Nov;139(11):1231-6.
8. Champion HR, Sacco WJ, Copes WS. Improvement in outcome from
trauma centre care. Arch Surg. 1992; 127: 333–338.
9. Sampalis JS, Lavoie A, Boukas S, et al. Trauma center
designation: initial impact on trauma-related mortality. J Trauma.
1995; 39: 232–239.
10. Lee KL, Graham CA, Lam JM, Yeung JH, Ahuja AT, Rainer TH.
Impact on trauma patient management of installing a computed
tomography scanner in the emergency department. Injury. 2009
Aug;40(8):873-5.
11. Gralla J, Spycher F, Pignolet C, Ozdoba C, Vock P, Hoppe H.
Evaluation of a 16-MDCT scanner in an emergency department: initial
clinical experience and workflow analysis. AJR Am J Roentgenol.
2005 Jul;185(1):232-8.
12. Gross T, Messmer P, Amsler F, Füglistaler-Montali I, Zürcher
M, Hügli RW, Regazzoni P, Jacob AL. Impact of a multifunctional
image-guided therapy suite on emergency multiple trauma care. Br J
Surg. 2010 Jan;97(1):118-27.
13. Gruen RL, Jurkovich GJ, McIntyre LK, et al. Patterns of
errors contributing to trauma mortality: lessons learned from 2,594
deaths. Ann Surg 2006;244: 371–80.
14. MacLeod JB, Cohn SM, Johnson EW, McKenney MG. Trauma deaths
in the first hour: are they all unsalvageable injuries? Am J Surg
2007;193:195–9.
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2 An evaluation of a shockroom located CT scanner: a
randomized study of early assessment by CT scanning
in trauma patients in the bi-located trauma center
North-West Netherlands (REACT trial)
TP Saltzherr
PHP Fung Kon Jin
FC Bakker
KJ Ponsen
JSK Luitse
M Scholing
JF Giannakopoulos
LFM Beenen
CP Henny
GM Koole
JB Reitsma
MGW Dijkgraaf
PMM Bossuyt
JC Goslings
BMC Emerg Med. 2008 Aug 22;8:10
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Abstract
Background: For the evaluation of trauma patients CT scanning
has gained wide
acceptance in and provides detailed information on location and
severity of injuries.
However, CT scanning is frequently time consuming due to
logistical (location of
CT scanner elsewhere in the hospital) and technical issues. An
innovative and
unique infrastructural change has been made in the AMC in which
the CT scanner
is transported to the patient instead of the patient to the CT
scanner. As a
consequence, early shockroom CT scanning provides an
all-inclusive multifocal
diagnostic modality that can detect (potentially
life-threatening) injuries in an earlier
stage, so that therapy can be directed based on these
findings.
Methods: The REACT-trial is a prospective, randomized trial,
comparing two
Dutch level-1 trauma centers, respectively the VUmc and AMC,
with the only
difference being the location of the CT scanner (respectively in
the Radiology
Department and in the shockroom). All trauma patients that are
transported to the
AMC or VUmc shockroom according to the current prehospital
triage system are
included. Patients younger than 16 years of age and patients who
die during
transport are excluded. Randomization will be performed
prehospitally.
Study parameters are the number of days outside the hospital
during the first year
following the trauma (primary outcome), general health at 6 and
12 months post
trauma, mortality and morbidity, and various time intervals
during initial evaluation.
In addition a cost-effectiveness analysis of this shockroom
concept will be
performed.
Regarding primary outcome it is estimated that the common
standard deviation of
days spent outside of the hospital during the first year
following trauma is a total of
12 days. To detect an overall difference of 2 days within the
first year between the
two strategies, 562 patients per group are needed. (alpha 0.95
and beta 0.80).
Discussion: The REACT-trial will provide evidence on the effects
of a strategy
involving early shockroom CT scanning compared with a standard
diagnostic
imaging strategy in trauma patients on both patient outcome and
operations
research.
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Background
Trauma is the most common cause of death in people younger than
50 years of
age and accounts for more years of life lost than cancer, heart
disease, and stroke
combined. Injuries cause 5 million deaths every year worldwide
(9% of global
mortality).1 In Europe alone injuries account for approximately
800,000 deaths
(10% of all deaths) and 14% of all disability-adjusted life
years (DALY).2 Injuries
are an important source of medical costs, economic losses, and
immaterial losses.
Trauma can therefore be regarded as a neglected epidemic.
For improving the trauma care specialized trauma centers are
designated and
specialized trauma care protocols, like the worldwide used ATLS®
guidelines, were
developed.[3] Because there is a narrow window of opportunity
between the
moment that a patient deteriorates and actually dies, the ATLS
guidelines prioritize
care and focus on (potentially) life-threatening injuries rather
than distracting but
less important injuries. As a consequence a systematic approach
of clinical
examination and diagnostics is developed to recognize the most
life-threatening
injuries first. These should be treated immediately and
preferably within ‘the golden
hour’.3
The imaging studies most frequently used in trauma patients
include conventional
X-rays, ultrasonography (FAST), and computed tomography scanning
(CT).
Although conventional X-rays and ultrasonography are widely used
and easily
accessible for many institutions, they have a limited
sensitivity for injuries such as
spine fractures,4 pulmonary contusion, rib fractures,
pneumothoraces or vascular
injuries to the mediastinum,5-8
and intra-abdominal, pelvic and retroperitoneal
injuries.9,10
Also, the amount of time necessary to obtain an overview of all
the
injuries is limited.
Recent improvements in CT technology with respect to image
quality and speed
have led to an increasingly important role of CT scanning in
management of
severely injured patients. However, the biggest problem with CT
scanning is that
this technique is frequently time-consuming due to logistical
(location of CT
scanner in other departments of the hospital) and technical
issues. This implies
that CT can only be used in hemodynamically stable patients
where time to OR for
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surgical stabilization is a less critical factor. Furthermore,
the fact that the same CT
scanner is scheduled for elective patients as well as trauma
patients means that an
unplanned, prioritized trauma patient will disrupt the scheduled
patient care and
logistics and will lead to increased waiting times.
In order to improve patient care and workflow in acute trauma
patients, the
Academic Medical Center (AMC) in Amsterdam, the Netherlands, has
initiated a
project together with Siemens Inc. A new and revolutionary
concept was developed
in which the CT scanner is transported to the patient instead of
the patient to the
CT scanner. Main feature is a radiolucent trauma resuscitation
table and a CT
scanner that slides over the patient in the trauma resuscitating
room. In addition
there are also possibilities for conventional X-ray imaging and
ultrasonography.
With this concept the most important diagnostic modalities for
trauma evaluation
are available in the shockroom and CT scanning is possible at
any moment during
initial trauma evaluation. Furthermore, no further transport and
patient transfers are
required which can endanger the patient itself during the
diagnostic phase
(potentially leading to dislodgement of tubes, lines, cables,
etc). Overall this
concept will likely result in a faster and improved workflow and
diagnostic imaging
of trauma patients.
Methods/design
Study objectives: The primary objective is to prove the
beneficial effects of early
shockroom CT scanning on trauma patients by comparing the
effects of a strategy
involving early shockroom CT scanning with a standard diagnostic
imaging
strategy on patient outcome. In the latter strategy the CT scan
is not located in the
shockroom, but elsewhere in the hospital. The secondary
objectives are to
document the impact of introducing shockroom CT-scanning on
logistics, capacity
utilization, waiting times, economies of scale, substitution
patterns, and
investments.
Study design: The REACT-trial is a prospective,
patient-randomized study that
will compare the clinical work-up of trauma patients in a
setting where the CT
scanner is located in the shockroom (AMC) with the standard
situation where CT
scanning takes place at the Radiology Department (VUmc).
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Setting/Participating centers: The Trauma Center North-West
Netherlands is
one of 10 designated Level-I trauma centers in the Netherlands.
It is constituted by
the ‘Vrije Universiteit’ medical center (VUmc) and the Academic
Medical Center
(AMC), which are both located approximately 8 kilometers apart
from each other in
Amsterdam. Each of these two hospitals, together with the
surrounding affiliated
hospitals, is responsible for the care of trauma victims in its
region (2.7 million
inhabitants in total) that are distributed over these hospitals.
In both hospitals,
patients are evaluated by a multidisciplinary team in the trauma
resuscitation room
('shockroom'), which is fully equipped for initial management of
trauma patients,
including conventional X-rays and ultrasonography.
The initial evaluation of trauma patients after arrival is
according to ATLS
guidelines and the same in both hospitals. After the primary
survey, standard X-
rays (i.e. thorax, pelvis and cervical spine) and sonography
will be done according
to the ATLS guidelines.
In the VUmc the CT scanner (64-slice) is located in the
Radiology Department on
the second floor. This requires transportation of the patient
with at least 4 patient
transfers from trolley to the CT table and vice versa.
In the AMC a concept was developed in which the CT scanner is
transported to the
patient instead of the patient to the CT scanner. Main feature
is a radiolucent
trauma resuscitation table and a 4-slice CT scanner (SOMATOTOM
Sensation 4,
Siemens) placed on a rail which enables the scanner to slide
over the patient.
Because of a mirrored design of a second shockroom that is
separated by radiation
shielded sliding doors the CT scanner can be transferred over
the rails into the
second room after the imaging is finished. The first advantage
of this design is that
no interference is experienced from the CT scanner during trauma
resuscitation.
Secondly, the design allows simultaneous use of the mirrored
trauma rooms, with
the sliding CT scanner accessible to both rooms.
Both trauma resuscitating settings are equipped with a
conventional X-ray
installation and ultrasound. As a result of the AMC concept no
further patient
transport or transfers are necessary for obtaining a CT scan and
all radiography
can be performed in the trauma room. In addition, at any time
during trauma
resuscitation CT imaging can be performed.
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Endpoints: The primary outcome criterion used is the number of
days spent
outside the hospital in the first year following the trauma.
This outcome is
responsive to differences in mortality (no additional days
outside hospital), to
differences in hospital stay for the initial admission and to
differences in
readmission rate.
The secondary outcome parameters include general health outcome
at 6 and 12
months after the shockroom admission (using the EuroQol and
HUI-3
questionnaires), morbidity and mortality during the first year
following the trauma
and various time intervals and process of care parameters of the
initial admission
(time to intervention, time to active bleed management, ICU and
total hospital stay,
etc.). Furthermore the radiation dosage is calculated in both
strategies based on
the actual number and type of radiological examinations related
to the initial trauma
performed in each patient during the first year.
Study group: All acute trauma patients are eligible for
inclusion for the REACT
trial when transported by the ambulance or helicopter to the AMC
or VUmc
shockroom according to the current pre-hospital triage system
based on: Injury
mechanism, Revised Trauma Score (RTS) and presence of traumatic
brain injury.
These factors determine the level of care that has to be present
in the facility to
which patients are transported.
The exclusion criteria for subsequent follow-up and analysis are
patients younger
than 16 years of age and patients who die during transport to
the hospital.
The start of the study was scheduled for 1-11-2005.
Randomization: Randomization will be performed at the
“Meldkamer
Ambulancezorg Amsterdam” (MKA), the organization in charge of
the coordination
and distribution of ambulances and patients. Randomization will
be performed
using a computer program on a 1:1 basis with varying block sizes
of 8, 12, and 16.
Ambulance personnel will receive instructions according to the
outcome of the
randomization. Each eligible patient involved in a specific
accident will be
randomized. After each randomization, there is a pre-specified
time interval of 1
hour in which eligible patients will be automatically
transported to the other trauma
center in order to minimize peak pressure in the study centers
and guarantee
optimal utilization of the two trauma centers. These patients
are included in the
-
23
trial, but are not formally randomized. In extreme cases,
prehospital ambulance
personnel can decide to waive the outcome of randomization, if
they deem that the
status of the patient requires the immediate attention of the
closest hospital and
death is imminent.
Because the distance between the two hospitals is relatively
short (8 km) no
significant delay in treatment by patient transport is
encountered regardless of the
outcome of the randomization.
Sample size: Based on the primary outcome criterion for both
strategies, it is
estimated that the common standard deviation is a total of 12
days. To detect an
overall difference of 2 days in the number of days spent outside
the hospital within
the first year between the two strategies, 562 patients per
group are needed for a
two-sided significance level of 0.05 with a power of 0.80.
Based on historical data, we expect around 500 shockroom
patients to be admitted
on a yearly basis at each of the two participating centers.
Therefore, the total
number of eligible patients per year would be 1000 patients. We
expect that a
quarter of these patients will be excluded for various reasons
(age < 16 yrs, lost to
follow up, etc.) leading to a total of 750 inclusions per year.
Consequently, a 1½-
year period should be sufficient to include the necessary total
number of 1124 (2 x
562) patients.
Ethics and informed consent:
The research protocol was primarily submitted to both the local
Medical Ethics
Committee (MEC) of the AMC and the VUmc to be reviewed. Both
committees
have been accredited to judge studies for the Central Committee
on Research
Involving Human Subjects and determined that the proposed study
is not subject to
the Medical Research Involving Human Subjects Act (WMO) and that
therefore no
further judgment is required for the study. Informed consents
are not required from
patients.
Data analysis: The main Analyses of primary and secondary
outcomes will be
conducted for all randomized patients according to the result of
the randomization
(intention-to-treat). Additional Analyses include:
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24
(1) Per-protocol analysis excluding patients that are
transported to a different
hospital rather than the result of the assignment procedure.
(2) Analysis of included patients treated either in the AMC or
the VUmc
independent of the randomization through the assignment
procedure.
We will conduct both unadjusted and adjusted Analyses. We will
use gender,
mechanism of trauma (sharp / blunt), initial Glasgow Coma Scale
(GCS), RTS
score and the presence of intubation to adjust for possible
differences in severity of
trauma between the AMC and VUmc patients.
For subgroup analysis the following Analyses will be
performed:
Hemodynamically unstable patients (non-responders (SBP < 90)
vs. transient
responders (SBP > 90 with continuous fluid requirement));
Sharp vs. blunt trauma
patients; Patients prehospitally treated by Mobile Medical
Teams; Neurotrauma
patients; Presence or absence of a seatbelt sign; Torso trauma
vs. isolated
extremity trauma; Intubated vs. spontaneously breathing.
For final analysis standard statistical techniques will be used
to compare the
different outcomes between the two hospitals.
Discussion
The REACT trial is a multicentered, prospective randomized trial
that evaluates the
effect of the newly introduced Amsterdam Trauma Workflow concept
on trauma
care. The main goal of the Amsterdam Trauma Workflow concept is
to minimize
the total diagnostic work-up time of the initial trauma
evaluation by integrating all
diagnostic modalities in the trauma resuscitating room. This
concept makes it
possible to perform CT imaging earlier during the trauma
evaluation without the
need to transport the patient to the radiology department. This
adjustment will likely
result in a faster and improved workflow of trauma patients,
that leads to a more
complete diagnostic workup in the early phases of trauma
resuscitation. This could
potentially change therapeutic management options and eventually
lead to a better
outcome in severely injured trauma patients. The direct
availability of CT scanning
during the entire trauma resuscitation phase could mean that
this could become
available for even hemodynamically unstable patients
-
25
A second advantage of this concept is the reduction in the
number of patient
manipulations, patient transfers and transports. Generally,
these actions can have
the aforementioned, adverse effects, which could expose the
already critically ill
patients to extra dangers. However, the introduction of the
multifunctional
radiolucent patient treatment table, that is suitable for
resuscitation, conventional
diagnostic imaging and CT scanning, minimize these actions and
their additional
risks.
While the REACT study design enables us to describe the
diagnostic and
therapeutic procedures following initial CT scanning on an
individual patient level,
the REACT trial also gives us the opportunity to evaluate its
effect on an
institutional level.
Because of the additional CT scanning capacity that was created
by adding the
sliding CT scanner that services the two mirrored trauma rooms,
logistics for the
radiology department will be influenced for both acute (trauma)
patients and
elective CT scanning. By potentially eliminating the need to
reckon with unplanned
acute CT imaging, the regular elective CT scans can be planned
better and more
efficient, possibly leading to a reduction of waiting times and
waiting lists. Critically
ill patient groups (i.e. trauma patients and patients with
intracranial bleedings,
acute aneurysms or abdomens, ICU patients, etc.) who need CT
scanning can
have their total diagnostic work-up completed in the shockroom
before transport to
their destination of treatment. In some cases the diagnostic
work-up can even be
completed simultaneously for two patients because of the
mirrored shockroom
design.
Furthermore, the REACT study design enables us to describe in
detail the
diagnostic and therapeutic procedures following initial CT
scanning of trauma
patients in the shockroom or at the Radiology Department. We may
be able to
demonstrate a trade-off in the volume and cost of health care
use between early
detection of injuries and timely therapeutic management on one
hand and late
detection by additional diagnostic testing and subsequent
therapies on the other.
Another possible institutional effect might be that a shockroom
CT scan may be
used as an attractive alternative to other imaging procedures or
to sequential
diagnostic testing strategies in other patient groups (for
instance stroke patients,
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26
patients with acute abdominal pain, etc), since it remains an
all-inclusive multifocal
diagnostic modality. As a consequence substitution of diagnostic
modalities or
changes in patient groups presenting for CT scanning may occur
as a result of joint
production.
Finally, the total costs of realizing this concept are of
substantial amount and
therefore this shockroom design has to be assessed during the
study period in a
cost-effectiveness analysis.
Conclusion
The REACT trial is a prospective randomized multicenter trial
that compares the
effects of a new and revolutionary concept with a sliding CT
scanner located in the
trauma resuscitating room with a conventional setting,
respectively a CT scanner
located in the Radiology department.
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27
Abbreviations
REACT: Randomized study of Early Assessment by CT scanning in
Trauma
patients, AMC: Academic Medical Center, VUmc: ‘Vrije
Universiteit’ medical center
CT: Computed Tomography, FAST: Focused Assessment with
Sonography in
Trauma, SBP: systolic blood pressure, HUI-3: Health Utility
Index 3, MKA:
Meldkamer Ambulancezorg Amsterdam
Acknowledgment:
ZONMW, grant number 3920.0005
We would like to thank our Advisory board for their input and
efforts during the
design, preparation and implementation of the trial.
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28
Reference List
1. World Health Organization. WHO.
http://www.who.int/topics/injuries/en/ 2008. 2. World Health
Organization. Regional Office for Europe;
http://www.euro.who.int/violenceinjury 3. Committee on Trauma:
American College of Surgeons: Advanced Trauma Life Support
(ATLS
®);
for Physicians, 7th Edition. Chicago: 1997.
4. Holmes JF, Akkinepalli R: Computed tomography versus plain
radiography to screen for cervical spine injury: a meta-analysis. J
Trauma 2005, 58: 902-905.
5. Demetriades D, Gomez H, Velmahos GC, Asensio JA, Murray J,
Cornwell EE, III, Alo K, Berne TV: Routine helical computed
tomographic evaluation of the mediastinum in high-risk blunt trauma
patients. Arch Surg 1998, 133: 1084-1088.
6. Exadaktylos AK, Sclabas G, Schmid SW, Schaller B, Zimmermann
H: Do we really need routine computed tomographic scanning in the
primary evaluation of blunt chest trauma in patients with "normal"
chest radiograph? J Trauma 2001, 51: 1173-1176.
7. Omert L, Yeaney WW, Protetch J: Efficacy of thoracic
computerized tomography in blunt chest trauma. Am Surg 2001, 67:
660-664.
8. Trupka A, Kierse R, Waydhas C, Nast-Kolb D, Blahs U,
Schweiberer L, Pfeifer KJ: [Shock room diagnosis in polytrauma.
Value of thoracic CT]. Unfallchirurg 1997, 100: 469-476.
9. Fang JF, Wong YC, Lin BC, Hsu YP, Chen MF: Usefulness of
multidetector computed tomography for the initial assessment of
blunt abdominal trauma patients. World J Surg 2006, 30:
176-182.
10. Korner M, Krotz MM, Degenhart C, Pfeifer KJ, Reiser MF,
Linsenmaier U: Current Role of Emergency US in Patients with Major
Trauma. Radiographics 2008, 28: 225-242.
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29
3 Randomized trial comparing the value of a CT scanner
in the trauma room with a CT scanner in the radiology
department; the REACT trial.
TP Saltzherr
PHP Fung Kon Jin
FC Bakker
KJ Ponsen
JSK Luitse
JF Giannakopoulos
LFM Beenen
CP Henny
PMM Bossuyt
MGW Dijkgraaf
JB Reitsma
JC Goslings
Submitted
-
30
Abstract
Background: CT scanning of trauma patients when the scanner is
located in the
Radiology Department requires potentially dangerous and
time-consuming patient
transports and transfers. We hypothesised that a CT scanner
located in the trauma
room would improve patient outcome and workflow.
Methods: In a randomized controlled trial with 1338 eligible
patients we compared
two infrastructural settings with regard to the CT scanner. In
the intervention
hospital the CT scanner was located in the trauma room. In the
control hospital the
scanner was located in the Radiology Department. Both hospitals
are Level-1
trauma centers, geographically close, and responsible for the
same area. Patients
≥16 years old triaged for evaluation in a Level-1 trauma center
were randomly
assigned to one of these hospitals at the time of transport. The
primary outcome
measure was the number of non-institutionalised days within the
first year after
randomization. Secondary measures were time from arrival to
first CT image and
number of patient transfers and transports. In preplanned
subgroup analyses we
evaluated the effects in multitrauma patients and in severe
traumatic brain injury
(TBI) patients.
Results: In total, 1124 patients were included, of which 264
were multitrauma
patients and 121 were TBI patients. The time from arrival to the
first CT image was
13 minutes shorter in the intervention group (median 36.00 vs.
49.00, 95% CI:
10.05 to 15.44; p
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31
Introduction
Trauma is a major cause of morbidity and mortality. Injuries
account for 9% of
global mortality and for 14% of all disability-adjusted life
years.1 The impact and
cost of trauma are high as injured patients are often young
(under the age of 50)
and without pre-existing co-morbidity.
In most regions, the initial care for trauma patients is highly
protocollised. The
globally acknowledged Advanced Trauma Life Support (ATLS®)
guidelines,
developed by the American College of Surgeons, specify a
systematic approach to
physical examination and diagnostic imaging based on clinical
priorities.2 Diagnosis
and treatment are focused on recognizing and treating
potentially life-threatening
injuries, preferably within the 'golden hour'.
Although conventional radiographs and ultrasonography are widely
used and easily
accessed during primary evaluation, their sensitivity in
recognising a number of
injuries is limited.3-6
Obtaining a complete overview of all injuries using
conventional
imaging can be time-consuming. Computed Tomography (CT) has
become the
gold standard for the definitive diagnostic imaging of most
injuries in severely and
potentially-severely injured patients. Recent technical
improvements include better
image quality, multiplanar reformatting, and increased speed.
While rapid
diagnosis and treatment are of paramount importance, obtaining a
CT scan often
requires multiple patient transfers and transports. In most
hospitals the CT scanner
is not located in the trauma room, but elsewhere in the
Emergency or Radiology
departments.7 Transfers and transports are time-consuming and
laborious; they
endanger adequate monitoring of the patients’ condition and
frequently lead to vital
equipment becoming disconnected.8,9
To improve patient care and workflow in acute trauma patients,
in 2004 the
Academic Medical Center implemented a policy of transporting the
CT scanner to
the patient rather than the other way around. This is
facilitated by a radiolucent
trauma resuscitation table and a multislice CT scanner that
slides over the patient
in the trauma room (TR).7 This ‘one-stop-shop’ approach
transforms a sequential
and stepwise diagnostic workup into an all-inclusive diagnostic
modality without the
need to transfer or transport the patient. It is likely that
this concept will increase
the flexibility of the sequence in which diagnostic procedures
can take place.
-
32
Taking the potential benefits such as a reduction of adverse
events during
transfers and transport and time saved during initial trauma
evaluation and care
into account, it seems self-evident that it will improve
clinical outcome. Worldwide
several centers are planning to implement this idea or have
already adapted
comparable infrastructures in their institutions. Several
studies have analyzed early
CT scanning in trauma patients but solid evidence provided by
randomized trials is
lacking. Before general acceptance and implementation of a CT
scanner in or near
the trauma room, we wanted to provide high-level evidence to
support the
hypothetical benefits.
The aim of this randomized controlled trial was to compare the
clinical outcome of
trauma patients evaluated in a setting where CT scanning was
performed in the
trauma room with patients evaluated in a setting where CT
scanning was
performed in the Radiology Department. Second, we aimed to
assess the potential
improvements or changes in logistics and management that this
infrastructure
would imply for daily practice.
Methods
Study setting
This randomized controlled trial was performed between November
2005 and
November 2007 in Amsterdam, the Netherlands. During the study
period, two
designated Level-1 urban trauma centers, the Academic Medical
Center
(intervention hospital) and the VU University Medical Center
(control hospital),
were jointly responsible for the care of severely-injured trauma
patients in a region
with approximately three million inhabitants. The geographical
distance between
the two centers is approximately 8 kilometres. The decision to
present patients in a
Level-1 trauma center is made on-scene by the ambulance
personnel and is based
on high energy trauma mechanisms, abnormal vital parameters, or
high suspicion
on severe injuries such as traumatic brain injury or severe
hemorrhage.
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33
Randomization
Randomization was done by the regional ambulance dispatch center
on receiving
notification from an ambulance crew that a patient required
transport to one of the
two Level-1 trauma centers. A computer programme with a 1:1
allocation ratio with
varying block sizes (4, 8 and 16) was used. Immediately after
randomization the
dispatch center instructed the ambulance to which destination
center the patient
should be taken.
Inclusion criteria
All trauma patients who fulfilled the pre-hospital triage
criteria for transport to a
Level-1 trauma center were eligible for inclusion. Triage
criteria included trauma
mechanism, Revised Trauma Score (RTS)10
, and suspicion of traumatic brain
injury. Exclusion criteria were age
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34
two floors up, where a multislice CT scanner (SOMATOM Sensation
64, Siemens)
was available. If subsequent additional radiological evaluation
with secondary
conventional radiographic imaging was indicated, the patient had
to be transported
back to the trauma room.
At both trauma centers every patient was evaluated by a
multidisciplinary trauma
team and in accordance with current best practice on trauma care
and diagnostics.
Efforts were made to minimize differences in diagnostic imaging
protocols between
centers. This was done by protocol comparison, discussion
meetings with involved
trauma care givers, etc. To promote inclusion, prehospital
trauma care providers
were informed about the study prior to the start of the
trial.
Outcome measures
The primary outcome measure was the number of
non-institutionalised days during
the first year after the trauma. This outcome was chosen as it
reflects differences in
mortality (no additional days outside hospital), to differences
in length of initial
hospital stay, and to differences in length of hospital
readmission and stay in
rehabilitation centers. Maximum is therefore 365 days outside of
the hospital for
patients discharged on the first day and 0 for the patients that
did not leave the
hospital or rehabilitation center because of long rehabilitation
or mortality. To
increase the quality of data on primary outcome, information was
obtained by
contacting the study participants and their general
practitioners, both by telephone
and using questionnaires, and through the National Information
System on Hospital
Care, which collects and Analyses medical data from
approximately 98% of all
Dutch hospitals. Institutionalised days were defined as stay in
one of the two
trauma centers, hospitals elsewhere, nursing homes or
rehabilitation centers.
Secondary outcome measures were 30-day and 1-year mortality,
length of stay of
initial hospital admission, Intensive Care Unit stay, the number
and type of
radiology examinations performed during complete diagnostic
work-up, transfusion
requirements administered over the first 24 hours after trauma,
number of
emergency interventions (immediate operation or angiography),
time from arrival to
the first CT image and the number of in-hospital patient
transports (i.e. from trauma
room to CT room) and transfers (i.e. from CT gantry to transport
gurney). The first
-
35
CT image time was the time of acquisition of the first CT image
as registered in the
picture archiving and communication systems (minutes). We
additionally collected
data on health-related Quality of Life at 6 and 12 months after
trauma using the
EuroQoL 5-D+ questionnaire.12
The local Institutional Review Board determined that the
proposed study was not
subject to the Dutch Medical Research Involving Human Subjects
Act (WMO), and
that informed consent prior to intervention was not
required.
Statistical analysis
For dichotomous outcomes (mortality), we calculated absolute
risk differences
between the intervention and the control group together with 95%
confidence
intervals. Several continuous outcomes, including the number of
days alive and not
institutionalised, were heavily skewed. Therefore we used median
and interquartile
values to describe these data, and used bootstrap methods to
calculate 95%
confidence intervals around the difference in medians between
the two study
groups.13
A total of 1,000 bootstrap samples were used to calculate
95%
confidence intervals.
Preplanned subgroup Analyses were performed for multitrauma
patients, defined
as having an Injury Severity Score of ≥16, and severe traumatic
brain injury (TBI)
patients, defined as having a Glasgow Coma Score ≤8 on
admission. A two-sided
0.05 level was used for all statistical significance tests. Data
Analyses were
performed by the corresponding author and supervised by the
trial statistician
(JBR). In reporting we followed the CONSORT guidelines.
Sample size
To detect an overall difference between the two strategies of
two days in the
number of days spent outside hospital within the first year and
assuming a
common standard deviation of 12 days, 562 patients in each group
were necessary
to achieve a power of 80%. Compensating for 25% of patients that
would be non-
evaluable or lost to follow-up and on the basis of historical
data, we aimed to enroll
the required patients in a two-year period.
-
36
Role of the funding source
This trial was sponsored by an unrestricted grant from ZonMw,
the Netherlands
Organization for Health Research and Development (Grant number
3920.0005).
The corresponding author had full access to all data in the
trial. The steering
committee of the REACT study group reviewed and approved the
final version and
had final responsibility for the decision to submit for
publication.
Results
Patient characteristics
Figure 1 shows the flow of patients in the trial. In total, 54
patients (8%) who had
been allocated to the intervention group and 51 patients (8%)
allocated to the
control group were presented at the other trauma center. They
were excluded from
Analyses. The median age of the 1124 included patients was 34,
803 patients
(72%) were male, and 1079 (96%) had sustained blunt trauma.
Median ISS was 6
(2-14), 265 (24%) were multitrauma patients and 121 patients
(11%) had sustained
severe traumatic brain injury (TBI). Ninety-five of the 265
multitrauma patients had
sustained severe TBI. Table 1 shows the baseline characteristics
per study group.
Except for the proportion of multitrauma patients which was
higher in the
intervention group, baseline characteristics were comparable
between the two
study groups. Median ISS in the multitrauma population was 22
(17-29) in the
intervention group and 25 (17-29) in the control group. For the
severe TBI patients
these numbers were respectively 25 (17-33) and 25 (13-34).
Radiological examinations
Table 2 shows the number of conventional radiological
examinations during
primary survey and the number of body regions evaluated with CT.
Overall, 822
patients (73%) underwent a CT scan of one or more body regions
and 610 patients
(54%) two or more body regions. Table 3 shows the number of
additional CT scans
performed to complete radiographic imaging on admission
following initial
radiological work-up.
-
37
Figure 1 Flowchart showing inclusion of patients
-
38
Table 1. Baseline characteristics
IQR = interquartile ranges ISS = Injury Severity Score GCS =
Glasgow Coma Scale
Trial population
intervention group (n=562)
Control group
(n=562) male gender
72 %
71 %
median age (IQR)
39 (27-53)
37 (26-50)
trauma mechanism:
- blunt - penetrating - burn injury - drowning
95.7 % 3.4 % 0.2 % 0.7 %
96.3 % 2.8 % 0.4 % 0.5 %
prehospital intubation
8.4 %
7.8 %
initial GCS 14-15 9-13 ≤ 8
420 (81%) 34 (7%)
64 (11%)
453 (83%) 32 (6%)
57 (11%) median ISS (IQR)
8 (2-16)
5 (2-13)
ISS category: ≤ 15 16-24 25-49 49-75
413 (73.5 %) 82 (14.6 %) 62 (11.0 %) 5 (0.9 %)
446 (79.4 %) 58 (10.3 %) 54 (9.6 %) 4 (0.7 %)
multitrauma patients
149 (26.5 %)
116 (20.6 %)
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39
Table 2. Radiological examinations during initial assessment in
the trauma room
radiological examination
intervention group
(n=562)
control group
(n=562) standard X-ray diagnostics (ATLS)
• Chest • Pelvis
• Cervical spine series
• 2nd
Chest
abdominal Sonography (FAST)
557 (99%) 525 (93%) 336 (60%) 479 (85%)
526 (94%)
552 (98%) 432 (77%) 483 (86%) 95 (17%)
463 (82%)
patients evaluated with CT
397 (71%)
416 (74%)
body regions evaluated with CT
• brain
• cervical spine • maxillofacial skeleton
• chest
• thoracic spine
• abdomen
• lumbar spine
• pelvis
• extremities
254 336 42
67 104
66 99 77
28
369 282 53
60 128
49 84 68
28 patients undergoing additional X-rays after CT
191 (48%)
73 (18%)
Time intervals
Table 4 shows the time interval from arrival in the trauma room
to the time of
acquisition of the first CT image. Median time between arrival
at the trauma room
and first CT image for all patients in whom CT scanning was
performed was 13
minutes shorter in the intervention group than in the control
group (95% CI: 10.05
to 15.44; p
-
40
minutes (IQR: 35.00 to 52.00) in the control group (95% CI: 7.70
to 16.74 p
-
42
Table 4. Time between arrival and first CT image, patient
transfers, and transports during initial assessment
time interval (minutes)
trial population
intervention
group
control group
no. of patients with CT (%)
397
(71%)
416
(74%) time from arrival to first CT image median; IQR
36 (26-48)
49 (40-62) no. of patient transfers till destination of
treatment: total mean
794 2.0
1810 4.4
no. of patient transports until destination of treatment
397
905
Table 5. Blood products administered in the first 24 hours to
the transfused patients
trial population
multitrauma patients
TBI patients
interv. group
(n= 77)
control group
(n= 49)
interv. group
(n=62)
control group
(n= 32)
interv. group
(n= 26)
control group
(n= 17) packed red blood cells
4
(2-9)
5
(2-13)
4
(2-10)
7
(4-19)
5
(2-12)
9
(5-20) fresh frozen plasma
2
(0-4)
2
(0-6)
2
(0-6)
3
(0-8)
2
(1-4)
2
(0-8) thrombocyte concentrate
0
(0-1)
0
(0-1)
0
(0-1)
0
(0-1)
0
(0-1)
1
(0-1) median; IQR interv.= intervention
-
43
Subgroup Analyses showed that clinical outcomes were better in
the intervention
group for both multitrauma patients and severe TBI patients,
although not
statistically significant.
Figure 2 shows the cumulative percentage of patients related to
the primary
outcome of the trial population and predefined subgroups. The
distribution of non-
institutionalised days for both trauma centers are almost
identical in the trial
population but favour the intervention group in both multitrauma
and severe TBI
patients.
Figure 2. Number of days alive and spent outside the hospital
during the first year after trauma
number of days
4003002001000
cu
mu
lati
ve %
100
80
60
40
20
0
center B
center A
trauma center
total population
-
44
number of days
4003002001000
cu
mu
lati
ve
%100
80
60
40
20
0
center B
center A
trauma center
multitrauma patients
number of days
4003002001000
cu
mu
lati
ve %
100
80
60
40
20
0
center B
center A
trauma center
severe TBI patients
-
45
-
46
Quality of life outcomes
Quality of life as measured by the EuroQoL 5-D+, 6 months
posttrauma is shown in
Figure 3. Two hundred patients from the control group completed
the
questionnaires after 6 months and 125 after 12 months. In the
intervention group
169 patients completed the questionnaire after 6 months and 87
after 12 months.
Intervention group patients who completed the questionnaire had
sustained
significantly more severe injuries than patients in the control
group, at an ISS of 8
versus 5 (p=0.045). No significant differences in quality of
life were found at 6 and
12 months posttrauma in these groups. Second, there were also no
significant
differences in scores on quality of life subscales after 6 and
12 months at each
trauma center.
Figure 3. Quality of Life after 6 months (EQ-5D+)
mob
ility
A
mob
ility
B
self-
care
A
self-
care
B
usua
l act
iviti
es A
usua
l act
iviti
es B
pain
/dis
com
fort A
pain
/disco
mfo
rt B
anxi
ety/de
pres
sion
A
anxi
ety/
depr
ession
B
cogn
ition
A
cogn
ition
B
0
10
20
30
40
50
60
70
80
90
100
no problems
moderate problems
severe problems
cum
ula
tive %
-
47
Discussion
We carried out a large randomized trial in a broad trauma
population to document
the changes in care brought about by having a CT scanner
available in the trauma
room and to examine whether this situation would improve patient
outcomes. As
hypothesized, having a CT scanner in the trauma room did lower
the number of
patient transfers and transports and it reduced the time to
start CT scanning by an
average of 13 minutes. The proportion of patients in whom a CT
was performed
was comparable in both strategies. However, a CT scanner in the
emergency room
did not lead to statistically significantly better clinical
outcomes (days alive and
outside the hospital, mortality, health-related quality of life)
in this study population.
This study showed that the ‘one-stop-shop’ approach has a number
of beneficial
effects on the process of care. By having a CT scanner in the
trauma room the
average time to the start of CT scanning was reduced by 13
minutes (from 49 to
36). This reduction was also achieved in specific patient
groups, including multi-
trauma and TBI groups. This reduction is comparable with or
larger than those
described in the current literature.14,15
This reduction in time can be critical in
severely injured patients as life-threatening injuries can be
detected earlier which in
turn facilitates earlier critical decision making.
A second benefit to the process of care was the reduction in the
number of patient
transfers and transports by more than half. As described in the
literature, transports
and transfers of critically ill patients do not only increase
the risk of accidents (8;9)
but they also impact costs and logistics such as additional
equipment and the
involvement of extra staff.
A third effect on the process of care was that the intervention
group underwent
three times more conventional radiographic imaging after CT
scanning than the
control group. This finding supports the hypothesis of increased
flexibility of the
‘one-stop-shop’ approach in the choice and order of diagnostics.
Consequently, the
decision to perform specific diagnostic tests in a particular
order can be based on
priorities and the clinical condition of the patient instead of
choices based on
logistic options.
Despite the time advantage to start of CT scanning, we did not
observe statistically
significant improvements in patient outcomes (days alive and
outside the hospital,
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48
30-day mortality, health-related quality of life) in the
intervention group. Nor did we
observe significant effects in patient outcomes in the
predefined subgroup
populations.
Several factors may explain our findings. First, we included a
broad population of
trauma patients in order to document all possible changes in the
process of care
related to having a CT scanner in the trauma room. In addition,
the decision to
include patients was made “on scene” (pre-hospital) in order to
randomize patients
on an individual basis to a setting with or without a CT scanner
in the trauma room.
A relative drawback of this approach was that a substantial
number of patients with
minor trauma, respectively a low ISS, who did not need CT
scanning (28%) during
initial evaluation were included in our trial. This reduced the
power of our trial to
identify relevant differences in patient outcomes. Power became
even smaller in
the pre-specified subgroups because the prevalence of severe
trauma was
relatively low in the trial population. This is reflected in our
results where we
observed differences in patient outcomes favouring the
intervention group,
especially in subgroups, but these results are not statistically
significant. Future
studies, therefore, should focus on more severely injured trauma
populations to
demonstrate if early CT scanning improves outcome.
Second, in our trial patients were individually randomized, but
each intervention
was confined to a specific hospital. The ideal design would be
to randomize
individual patients within a single hospital to either care with
CT in the trauma room
or to a setting with CT in the radiology department. Because the
concept of having
a CT in the emergency department requires large investments and
numerous
changes in both housing, personal and training, it is nearly
impossible for a hospital
to have both settings operational at the same time. Therefore,
we took advantage
of having two closely related, very similar trauma centers in
close proximity of each
other where CT in the trauma room was introduced in one of these
hospitals.
Because of this geographical situation we were able to avoid a
before-after study
with its associated problems, but instead could still randomize
the destination of
the ambulance for individual patients on-scene.
The strength of our design is that clinical and demographical
characteristics
between groups are comparable and only differ because of chance.
This is in
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49
contrast with a cluster randomized trial where each hospital
would receive their
usual trauma population and a broader case mix can be expected,
requiring
adjustment for confounding in the analysis. Adjustment in the
analysis always
raises the issue whether residual confounding is still present.
Our design produces
the problem that there is a one-to-one relationship between the
individual
intervention and the hospital of admission. This means that
systematic differences
in care between the hospitals other than the location of the CT
scanner could have
influenced the results. Despite our efforts to harmonize the
imaging and
management protocols and the fact that for some disciplines,
such as
neurosurgery, there is only one neurosurgical team covering both
centers, we still
encountered differences in radiological investigations and
trauma care between the
two centers. These differences were mostly the result of
variations in clinical
judgment and instant decision making in care for severely
injured patients, and
ongoing research in both individual trauma centers which caused
some changes in
radiology protocols. This may also affect other protocols, such
as treatment or
discharge protocols, which were not assessed in this study.
Therefore, the impact
of such differences on our final results remains difficult to
judge.
The total inclusion period was 2 years which was slightly longer
than anticipated.
Reason for this was that the complex of prehospital trauma care
was not always
suitable for randomization procedures. As a result, not all
eligible patients were
actually randomized or randomized patients were transported to
the non-assigned
hospital because of communication problems. Because this
decision took place
outside the hospital (on-scene or in the ambulance), such
patients had had no
contact with the intervention whatsoever, and therefore we
excluded these patients
from the analysis in order to avoid problems with interpreting
the outcomes of
these patients. The reason that we included 1045 patients for
analysis on primary
outcome and not the 1124 intended patients was because
eligibility for analysis on
primary outcome only became clear after one year.
Most of the abovementioned problems can be avoided by having
both interventions
available in each of the hospitals participating in a future
trial. It remains debatable
whether having two such different and complex interventions
available and running
parallel would be feasible in day-to-day practice.
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50
Conclusion
The findings of our large randomized trial demonstrated that
having a CT scanner
in the trauma room reduced the time to the start of CT scanning
and streamlined
workflow and patient logistics. We did not find statistically
significant differences in
clinical outcomes in the overall trauma population. Although the
power to
demonstrate differences in subgroups was limited in the
intervention setting there
was a tendency towards some beneficial effects on clinical
outcomes in
multitrauma and severe traumatic brain injury patients.
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51
Contributors
All members of the writing committee helped with the design of
the study, data
interpretation and with manuscript preparation. JC Goslings and
FC Bakker helped
with the organisation of data collection. GF Giannakopoulos and
TP Saltzherr
collected the data. JB Reitsma, MGW Dijkgraaf and TP Saltzherr
analyzed the
data. JB Reitsma provided statistical expertise. JC Goslings
supervised the study
and obtained funding.
Acknowledgements
This trial was funded by ZonMw, the Netherlands organisation for
health research
and development (Grant number 3920.0005). We would like to thank
the REACT
Trial Advisory Committee for their input and efforts during the
design, preparation
and conduction of the trial. The authors wish to express their
thanks to M.
Scholing, M. Olff and J. Mouthaan for their extensive efforts in
data collection and
management. We thank all prehospital personnel and trauma care
organizations
for their cooperation and efforts in enabling the carrying out
of this study.
Abbreviations
CT= Computed Tomography
TR= trauma room
TBI= traumatic brain injury
RD= Radiology Department
AMC= Academic Medical Center, Amsterdam
VUmc= VU University Medical Center, Amsterdam
RTS= Revised Trauma Score
ISS= Injury Severity Score
GCS= Glasgow Coma Scale
LOS= length of stay
C-spine= cervical spine
EQ-5D+= EuroQol-5D+
CXR= chest X-ray
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52
Reference List
1. World Health Organization;
http://www.who.int/whosis/whostat/2009/en/index.html. 2009. 2.
Committee on Trauma: American College of Surgeons. Advanced Trauma
Life Support (ATLS®);
for Physicians, 8th Edition. Chicago: 2009. 3. Gaarder C,
Kroepelien CF, Loekke R, Hestnes M, Dormage JB, Naess PA.
Ultrasound performed
by radiologists-confirming the truth about FAST in trauma. J
Trauma 2009 August;67(2):323-7. 4. Korner M, Krotz MM, Degenhart C,
Pfeifer KJ, Reiser MF, Linsenmaier U. Current Role of
Emergency US in Patients with Major Trauma. Radiographics 2008
January;28(1):225-42. 5. Exadaktylos AK, Sclabas G, Schmid SW,
Schaller B, Zimmermann H. Do we really need routine
computed tomographic scanning in the primary evaluation of blunt
chest trauma in patients with "normal" chest radiograph? J Trauma
2001 December;51(6):1173-6.
6. Holmes JF, Akkinepalli R. Computed tomography versus plain
radiography to screen for cervical spine injury: a meta-analysis. J
Trauma 2005 May;58(5):902-5.
7. Fung Kon Jin PH, Goslings JC, Ponsen KJ, van KC, Hoogerwerf
N, Luitse JS. Assessment of a new trauma workflow concept
implementing a sliding CT scanner in the trauma room: the effect on
workup times. J Trauma 2008 May;64(5):1320-6.
8. Papson JP, Russell KL, Taylor DM. Unexpected events during
the intrahospital transport of critically ill patients. Acad Emerg
Med 2007 June;14(6):574-7.
9. Waydhas C. Intrahospital transport of critically ill
patients. Crit Care 1999;3(5):R83-R89. 10. Champion HR, Sacco WJ,
Copes WS, Gann DS, Gennarelli TA, Flanagan ME. A revision of
the
Trauma Score. J Trauma 1989 May;29(5):623-9. 11. Saltzherr TP,
Luitse JS, Hoogerwerf N, Vernooij AS, Goslings JC. Facilitating
in-hospital transport
of trauma patients: design of a trauma life support trolley.
Injury 2008 July;39(7):809-12. 12. Hoeymans N, van LH, Westert GP.
The health status of the Dutch population as assessed by the
EQ-6D. Qual Life Res 2005 April;14(3):655-63. 13. Carpenter J,
Bithell J. Bootstrap confidence intervals: when, which, what? A
practical guide for
medical statisticians. Stat Med 2000 May 15;19(9):1141-64. 14.
Gross T, Messmer P, Amsler F, Fuglistaler-Montali I, Zurcher M,
Hugli RW et al. Impact of a
multifunctional image-guided therapy suite on emergency multiple
trauma care. Br J Surg 2010 January;97(1):118-27.
15. Lee KL, Graham CA, Lam JM, Yeung JH, Ahuja AT, Rainer TH.
Impact on trauma patient management of installing a computed
tomography scanner in the emergency department. Injury 2009
August;40(8):873-5.
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4 A comparison of cost-effectiveness and cost-utility for
Trauma CT scanning in the trauma room versus at the
Radiology Department; the REACT trial
TP Saltzherr
JC Goslings
FC Bakker
LFM Beenen
M Olff
K Meijssen
FF Asselman
JB Reitsma
MGW Dijkgraaf
Submitted
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54
Abstract
Background: Little is known about costs associated with CT
scanning in the
trauma room. Aim of this study was to determine its
cost-effectiveness and cost-
utility from a health care provider perspective compared with
the conventional
setting of a CT scanner at the Radiology Department.
Methods: This study was part in the randomized controlled REACT
trial. Costs
were calculated for direct and indirect medical costs of
institutionalized stay,
diagnostic and therapeutic procedures. Unit costs were used from
hospital-bound
costing systems and from the Dutch manual for costing in health
care. Volumes of
institutional stay were retrieved from patients, hospital
information systems and the
National Information System on Hospital Care. To derive Quality
Adjusted Life
Years (QALYs) we used the EuroQol-5D (EQ-5D) measured at 6 and
12 months
posttrauma. Preplanned subgroup analyses were performed for
severe traumatic
brain injury (TBI) patients and multitrauma patients.
Results: 1124 patients were randomized to two groups with
comparable
demographic and clinical characteristics. The mean number of
non-institutionalized
days alive was 322.5 in the intervention group (95% CI: 314 to
331) and 320.7 in
the control group (95% CI: 312.1 to 329.2). Mean costs of
diagnostic and
therapeutic procedures per hospital inpatient day were €554 for
the intervention
group and €468 for the control group, based on national unit
costs. Total mean
costs for patients in the intervention group were €16,002 (95%
CI: 13,075-18,929)
and €16,635 (95% CI: 13,528-19,743) for the control group based
on national costs
(p=0.77) No significant differences in mean costs were detected
for severe TBI or
multitrauma patients. QALYs could be calculated for 269 patients
in the control and
218 patients in the intervention group. Applying the UK time
trade-off based health
valuation algorithm, the mean number of QALYs were 0.66 for the
control group
and 0.60 for the intervention group (p=0.10).
Conclusion: The present study showed that in trauma patients the
setting with a
CT scanner located in the trauma room did not provide any
advantages or
disadvantages from a health economic perspective compared with a
setting with
the CT scanner in the Radiology Department.
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Background
Early and accurate diagnosis of injuries is crucial for treating
trauma patients. CT
scanning has become of vital importance during the evaluation of
trauma patients.
The scanner’s location in the Radiology Department in many
trauma centers
however, makes this time-consuming due to technical and logistic
reasons. The
required patient transfers and in-hospital transports to obtain
a CT scan in these
centers also increases the risk of (potentially) dangerous
adverse events.1
In 2004 the Academic Medical Center developed a concept to
improve trauma care
and workflow in which the CT scanner is transported to the
patient instead of the
patient to the CT scanner. Its main feature is a radiolucent
trauma resuscitation
table and a multislice CT scanner that slides over the patient
in the trauma room
(TR).2 With this ‘one-stop-shop’ concept, a sequential and
stepwise diagnostic
workup is modified into an all-inclusive diagnostic modality
without the need for any
transports of the patient.
To assess the effects on clinical outcomes, time management and
logistics, the
REACT trial (Randomized study of Early Assessment by CT scanning
in Trauma
patients) was conducted in which trauma patients were randomized
to CT scanning
in a trauma room or at a Radiology Department.3 This study
showed a trend in
better clinical outcomes in severely injured subgroups as well
as a large reduction
in time to CT, and also diminishes patient transfers and
transports in general.
Because CT scanning in the trauma room is a relative modern
concept, little is
known about its effects on costs. Because an increasing number
of trauma centers
are planning to implement such an infrastructure, we will
provide an overview of
these costs in the present study in support of
decision-making.
We hypothesized that as a result of time saving, improved
workflow and better
outcomes, trauma care in a setting with a CT scanner located in
the trauma room
would be cost-effective compared to a setting having the CT
scanner in the
Radiology Department.
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56
Methods
Setting and population
Between November 2005 and November 2007 all trauma patients in
the
Amsterdam region that fulfilled pre-hospital triage criteria for
Level-1 trauma care
were randomized to one of the two participating university
trauma centers,
respectively the Academic Medical Center (Center A) and the VU
University
Medical Center (Center B). Both centers are geographically close
and responsible
for trauma care in the same region. Triage criteria included
trauma mechanism,
Revised Trauma Score (RTS),4 and suspicion of traumatic brain
injury.
Randomization was performed by the central dispatch center the
moment
ambulance personnel requested transport to a Level 1 trauma
center. Exclusion
criteria were age below 16 years and patients that died before
arrival in the trauma
center.
The intervention group consisted of trauma patients evaluated in
Center A where a
moveable multislice CT scanner was available in the trauma room
(TR). The
control group consisted of patients evaluated in the Center B
where CT scanning
was performed at the Radiology Department on the first floor. In
both trauma
centers patients were evaluated by multidisciplinary trauma
teams using the same
protocol and according to the current knowledge on trauma care
and diagnostics
with the only difference being the location of the CT scanner.
Attention was paid to
minimize differences in diagnostic and treatment protocols. The
REACT study
protocol was published in 2008.3
Economic evaluation
The cost-effectiveness and cost-utility analyses were both
performed from a health
care provider perspective with provider costs,
non-institutionalized days alive and
Quality Adjusted Life Years (QALYs) during the first year
posttrauma as outcome
parameters. Incremental cost-effectiveness and cost-utility
analyses were
assessed for the extra costs per additional
non-institutionalized day alive or per
additional QALY. Because the follow-up period was one year, no
discounting of
costs or effects was done.
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57
Sensitivity analyses were performed for local unit costing of
diagnostic and
therapeutic procedures and for the health utility scoring
algorithm.
Cost components
Direct and indirect medical costs of institutionalized stay,
diagnostic and
therapeutic procedures were included. Center A and B were
considered as index
hospitals. Institutional stay consisted of ICU and general ward
(re)admissions at
the index hospitals, (re)admissions in other hospitals than the
index hospitals, stay
in rehabilitation centers and in nursing homes. Hospital day
care treatment was
counted as a single general ward day. Diagnostic procedures
encompassed
imaging procedures and laboratory examinations. Therapeutic
procedures included
operations, transfusion of blood products, (para)medical
support, devices (e.g.
prosthesis, pacemaker), and non-operative procedures (e.g. chest
tube insertion,
cast treatment).
Out-of-hospital medication, general practitioner care, as well
as psychological
support and physiotherapy other than provided during intramural
rehabilitation
were discarded.
Volume data
Volumes of institutional stay were gathered from both index
hospital information
systems and by paper and telephone survey among patients as well
as general
practitioners. For verification, data were retrieved from the
National Information
System on Hospital Care (NISHC), managed by the Dutch Hospital
Data agency,
which collects and analyses medical data of approximately 98% of
all Dutch
hospitals. Volume data on diagnostic and therapeutic procedures
too were
retrieved from the index hospitals’ information systems. No
volume data on
diagnostic examinations and therapeutic procedures from
hospitals elsewhere
were retrieved.
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Unit costing
Unit costs of ICU day (€1,782), index hospital general ward day
(€504), other
hospital gener
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