Dissections INTERVENTIONAL

11 May 2009
Evidence-based Medicine for Surgeons

Effect of whole-body CT during trauma resuscitation on survival: a retrospective, multicentre

study
Authors: Huber-Wagner S, Lefering R, Qvick L-M, et al
Journal: Lancet 2009; 373: 1455–61
Centre: Working Group on Polytrauma of the German Trauma Society
Spiral CT scanning has been a big step forward in imaging the human body. Multislice, whole-
body CT scanning is faster than other imaging technologies available today. Many trauma centres
BACKGROUND are using it during the early resuscitation phase, even in haemodynamically unstable patients. As
yet, the direct benefit of whole body CT scanning on mortality is not established.
Authors' claim(s): “...Integration of whole-body CT into early trauma care
RESEARCH QUESTION significantly increased the probability of survival in patients with polytrauma.
Whole-body CT is recommended as a standard diagnostic method during the
Population
early resuscitation phase for patients with polytrauma.”
Patients culled from the records of
The German Trauma Registry
database for 2002–04, containing
IN SUMMARY
information on 9259 patients who Outcome of patients receiving CT scan and those who did not
sustained blunt trauma.
Whole body CT done Whole body CT not done
Indicator variable Number 1400 2713
Whole body CT scan. Predicted mortality (RISC score) 23.00% 21.00%
Outcome variable Actual recorded mortality  20.00% 21.00%
Standardised mortality ratio (SMR, Standardized mortality ratio 0.865 1.034
ratio of recorded to expected -SMR - (95%CI) (0.774 - 0.956) (0.959 -1.109)
mortality).

Comparison
Patients with blunt trauma who did
not receive a whole body CT scan.

THE TISSUE REPORT

There is a subtlety in this study that is easily missed. The CT, though seen as a diagnostic test, is offered here as an
intervention. The authors are claiming that the use of a whole body CT as an intervention in the injured patient, lowers
mortality (although their numbers don't support this). No explanation is offered for the mechanism of the benefit. The two
groups (CT vs no CT) are different in every aspect - hemodynamic parameters, injury severity, need for ventilation etc. -
and not comparable. For scientific validity, the study should have been designed as an RCT, not a retrospective comparison
of a poorly matched set of patients. Attributing survival benefits to CT in such a poorly matched comparison is not
acceptable. This paper, by virtue of its large numbers, distinguished pedigree and patronage, runs the risk of being quoted
as the justification for the performance of whole body CT in all patients with blunt abdominal injury. The data on which
this supportive recommendation is made, is suspect despite the industrial strength statistical analysis. Throw a large, flawed
database into a statistical package and impressive looking results will emerge that need not be the truth: "GIGO" redux.

EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interesting l | Novel l | Feasible l
Case series - retrospective  Ethical l | Resource saving l

The devil is in the details (more on the paper) ... 

© Dr Arjun Rajagopalan
 SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random Blunt trauma  Patients transferred CT done No CT
Injury Severity from other hospitals 
Stratified random Target ? ?
Score > 15  Penetrating trauma 
Cluster Accessible 9259
Consecutive Intended 4621
Convenience Drop outs 508 (no RISC data)
Judgmental Study 1400 2713

 = Reasonable | ? = Arguable |  = Questionable

Data was submitted to a central database hosted by the Institute for Research in Operative Medicine at the University
of Witten/Herdecke, Cologne, German
Sampling bias: The sample is large and culled from a multicentre database; still, sheer numbers are not the only
criteria for credibility. The study was carried out in Germany and the conclusions are, therefore, limited to trauma
systems that can match the efficiency and complexity.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details The registry accessed by the study records epidemiological, physiological, laboratory,
diagnostic, operative, interventional, and intensive-care medical data, and injury-severity
scores and outcome data. The specific parameter (whole-body CT) was recorded since 2002.
The authors analysed the database for 2002–04, containing information on 9259 patients.
Whole-body CT included an unenhanced CT of the head followed by contrast-enhanced CT of
the chest, abdomen, and pelvis, including the complete spine. The groups were not allocated
by any protocol: " Participating hospitals were free to choose their own diagnostic algorithms."
Comparability Only the ages and sex of the individuals in each group were similar.
Disparity The two groups were statistically significantly different on almost every major criterion: shock,
intubation, GCS, base excess, amount of blood tranfused, multiorgan failure, ventilation time,
days in ICU, hospital stay and injurity severity. The group that had CT was more seriously
injured than those that did not.

Comparison bias: It is surprising that for a study that attempts to show the difference in outcome from an
intervention, the two groups compared are almost entirely dissimilar. The decision to obtain a CT was done on an
individual basis; there was no protocol for random allocation, thus introducing a serious comparison bias.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.RISC score of trauma severity Y N ? - - - N

2. Whole body CT The study is entirely silent on the description of CT findings and
the mechanism of impact on survival

Measurement bias: The RISC score calculation was done retrospectively.

© Dr Arjun Rajagopalan