Cohort
Padayachee L, et al.Cervical Spine Clearance in Unconscious Traumatic Brain Injury Patients: Dynamic Flexion-Extension Fluoroscopy versus Computed Tomography with Three-Dimensional Reconstruction
Journal of Trauma
2006;60(2):341-345
- Submitted by:Amery Robinson - Emergency Physician
- Institution:Butterworth Hospital
- Date submitted:18th August 2009
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Whether cervical CT with three-dimensional (3D) reconstructions may obviate the need for flexion-extension radiology in the detection of occult ligamentous injury.
2
Design
2.1
Is the study design suitable for the objectives?
Yes - there have been no previous large series of unconscious TBI patients receiving both DF and fine-cut cervical CT (C0 to T2) with reconstructions in the same routine cervical screening protocol,
2.2
Who / what was studied?
Unconscious traumatic brain injury (TBI) patients admitted to the intensive care unit (ICU) at a Level 1 trauma center between July 1999 and November 2001 were included. At that time, cervical CT reconstructions and DF were both part of a routine cervical spine screening protocol for all of these patients. Patients were identified from a prospective intensive care unit database.
2.3
Was a control group used if appropriate?
Not appropriate
2.4
Were outcomes defined at the start of the study?
Yes - cervical fractures or instabilities seen on dynamic flexion-extension X-ray studies with fluoroscopy that were not identified by plain radiographs and CT. Table 1 in the study lists the definitions of positive and negative results.
2.5
Was this the right sample to answer the objectives?
Yes - data from all TBI patients in ICU were prospectively recorded in a departmental database, Some patients had not received DF either because their conscious state had allowed clinical clearance, or because injuries had been identified on earlier investigations.
2.6
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Sample size estimates were not performed - this is the largest study to date using dynamic flexion-extension fluoroscopy versus computed tomography with three-dimensional reconstruction
2.7
Were all subjects accounted for?
Yes - retrospective study.
2.8
Were all appropriate outcomes considered?
Yes - see Table 1
2.9
Has ethical approval been obtained if appropriate?
Not discussed
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes - Table 2
3.2
Was the assessment of outcomes blinded?
No
3.3
Was follow up sufficiently long and complete?
Yes
3.4
Are the measurements valid?
No - cervical radiology reports for these patients were reviewed by the authors and each was simply classified as negative, positive, inadequate, or “report missing.”
3.5
Are the measurements reliable?
Reliability was not measured
3.6
Are the measurements reproducible?
Unable to estimate based on methodology
4
Presentation of results
4.1
Are the basic data adequately described?
Yes - Table 2
4.2
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
No - subjective classification of radiology reports in a non-blinded study
4.3
How large are the effects within a specified time?
Dynamic flexion-extension was true-negative in 260 of 276 (94%) patients, falsely positive in six patients (2.2%) and falsely negative in one (0.4%) patient. In nine patients, dynamic flexion-extension was inadequate.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
5
Analysis
5.1
Are the data suitable for analysis?
Yes although two patients had abnormal DF without previous CT or subsequent MRI and thus were breaches of protocol.
5.2
Are the methods appropriate to the data?
Yes, although poorly described
5.3
Are any statistics correctly performed and interpreted?
Statistical analysis was not performed
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes, clearing the cervical spine in unconscious TBI patients remains controversial.
6.2
Is the discussion biased?
Yes, limitations was not addressed and study strengths were over-emphasized.
7
Interpretation
7.1
Are the author's conclusions justified by the data?
Yes, in this series of patients routine DF identified no new injuries and has therefore is not recommended as part of routine cervical spine clearance protocol for unconscious patients.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b
7.3
Does this paper help me to answer my problem?
Yes, routine DF is not recommended as part of routine cervical spine clearance protocol for unconscious patients.
8
Implementation
8.1
Can any necessary change be implemented in practice?
Routine DF identified should not be recommended as part of routine cervical spine clearance protocol for unconscious patients.
8.2
What aids to implementation exist?
N/A
8.3
What barriers to implementation exist?
Dynamic flexion-extension X-ray studies with fluoroscopy delayed cervical spine clearance and were almost always reported as normal. In a cervical spine clearance protocol for unconscious traumatic brain injury patients, dynamic flexion-extension X-ray studies with fluoroscopy did not identify any patients with cervical fracture or instability not already identified by plain radiographs and fine-cut CT (C0 to T2) with 3D reconstructions.
8.4
Are the study patients similar to your own?
Likely, but patient demographics were not described
8.5
Does the paper give any conclusions that will affect what you will offer or tell your patient?
Yes - routine DF identified should not be recommended as part of routine cervical spine clearance protocol for unconscious patients.