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The out-of-hospital validation of the CCR rule by paramedics
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The out-of-hospital validation of the CCR rule by paramedics
Ref: Vaillancourt C et al. The Out-of- Hospital Validation of the Canadian C-Spine Rule by Paramedics. Ann of Emerg Med Nov 2009;54(5):663-671
CRITICAL APPRAISAL Dineo Moiloa Nov 2009
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Introduction
• > 1 million trauma pts w suspected C-spine injuries• 2 % significant injuries• Problems w immobilisation, methods not
evidence-based• No improvement in pt outcome (Cochrane)• Validation study for CCR in pre-hospital setting• NOTE: Follows on landmark article (CCR vs NEXUS
in hospital)
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Method of study
• Prospective cohort study: 2002-2006• 7 locations in 3 Canadian locations• 1949 enrolled patients : Neck trauma• Inclusion and exclusion criteria• Median age=39 (26-52)• 50.8% females, 49% males• 62.5 % MVA• Trained EMS vs Investigators (CCR)• Primary oucome : ID of acute cervical spine injury AND performance
characteristics of the interpretation of CCR by paramedics• Effect of CCR in clinical practise : Less Xrays
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Canadian C-Spine Rule
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Flow of patients recruited in study
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Results 320 ‘indeterminate’cases
Investigators (95% CI) Paramedics (95% CI)
Results of assessment
Injury No Injury Injury No Injury
Positive no. 12 924 12 1204
Negative no. 0 693 0 731
Sensitivity % 100 (74-100) 100 (74-100)
Specificity % 42.9 (40-45) 37.7 (36-40)
NPV % 100 (99-100) 100 (99-100)
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Results
• Performance characteristics of the interpretation of the rule by paramedics
- 5 point Likert scale : k value 0f 0.93- Very uncomfortable/uncomfortable :9.5%- Comfortable/ V comfortable : 81.7%
• Effect of rule : CCR- 62% of pts would have been immobilised (vs 100% acc to local EMS protocol)
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What is the clinical question?
Can paramedics apply the Canadian C-Spine Rule in alert, stable, cooperative, blunt trauma patients to reserve spinal immobilisation for high risk patients while avoiding immobilisation for low risk patients?
Well addressed by the paper
Validation study for CCR in the pre-hospital setting
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What type of study?
• Prospective cohort study• ‘Gold standard’?• Comparing CCR with local protocol- which the
researchers already regard as ‘unfounded’ and ‘not evidence-based’.
• Would results have been different if another clinical decision rule was used?
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What do we know about CCR already?
Which clinical decision rule is better at recognising cervical spine injury, the Canadian C-spine rule or the NEXUS low-risk criteria rule?
Reference : Stiell IG et al. The Canadian C-spine rule vs the NEXUS Low-Risk Criteria in Patients with Trauma. N Engl J Med Dec 25, 2003; 349:250-8
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Results(7438 patients)Assessment results
Injury (CCR) No Injury (CCR) Injury (Nexus) No Injury (Nexus)
Positive (no.) 161 3995 147 4599
Negative (no.) 1 3281 15 2677
Sensitivity (%) 99.4 (95% CI,96-100)
90.7 (95% CI, 85-94)
Specificity (%) 45.1 (95% CI, 44-46)
36.8 (95% CI, 36-38)
NPV (%) 100 99.4
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Methodological quality of study
• Was the study original?• Who is the study about?• Was the design of the study sensible?• Was systematic bias avoided or minimised?• Was the study large enough, and continued
long enough, to make results credible?
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Was the study original
• Original research• Reference : previous similar studies Up to date refs (Last 5 yrs)• Primary research- validation of clinical
decision rule in pre-hospital setting
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Was the study design sensible?
• Specific intervention :CCR • Compared with? Current gold standard
already deemed inadequate• Outcome measured?- Identification of clinically-significant C-spine
injuries- Paramedics interpretation and application of
the rule- % of immobilisations potentially avoided
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Flow of patients recruited in study
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Bias
• Canadian researchers and most medics in Canada comfortable w CCR
• No control group• Selection of participants (at discretion of
paramedics)- Paramedics unlikely to recruit severely injured
patients into study• ED doctors widely used CCR in hospital to
‘clear’ C-spine- Would they have immoblsd more patients had they used other clinical decisions
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Duration and size of study
• 2002-2006 : Long enough?• Could have continued longer to get a larger
sample size• Could the paramedics have missed more
injuries if the sample was larger? (Ref other prehospital studies)
• Lots of ‘indeterminate’ cases= 320-Misinterpretation of the rule?• Adequacy and completeness of follow up?
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Flow of patients recruited in study
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Results 320 ‘indeterminate’cases
Investigators (95% CI) Paramedics (95% CI)
Results of assessment
Injury No Injury Injury No Injury
Positive no. 12 924 12 1204
Negative no. 0 693 0 731
Sensitivity % 100 (74-100) 100 (74-100)
Specificity % 42.9 (40-45) 37.7 (36-40)
NPV % 100 (99-100) 100 (99-100)
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Results• 100% sensitivity and NPV- Very wide confidence intervals - Researchers attribute it to small sample size- Could the paramedics have missed more injuries if the
sample was larger• 320 indeterminate cases- Paramedics uncomfortable rotating the neck- All those revealed no significant injuries- Would there have been more false positives if they were
included in the analysis
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Reliability of Paramedic’s interpretation of the rule
• 5-point Likert scale : widely used and acceptable as a tool
-Mostly comfortable/very comfortable using the rule
BUT 320 ‘indeterminate’ cases- paramedics failed to rotate the neck in cases where it was safe to do so
NOTE: Same issue w ED doctors in landmark study
• k value=0.93 ( interobserver agreement)- Paramedics’interpretation of the rule good- Difficulty w ‘dangerous mechanisms’ part of
the rule
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Effect of CCR
• Reduce no. of immobilisation required to 62%• CCR vs NLR study : Redn to 56% by CCR (Xrays)
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Does the paper validate the test?
• Utility of test in our practise• Comparison w true ‘gold standard’• Appropriate spectrum of patients?• Bias• Test reproducibility- In other places outside Canada?- In our SA setting?- Level of EMS training in SA?• Confidence intervals : very wide
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Discussion
• 100% sensitivity and NPV using CCR (both paramedic and investigators)
• Good interpretation of the rule by paramedics after a 2-hour tutorial
• Clinical decision rule is reliable : v high k value• Mostly comfortable applying the rule• Application of CCR can potentially reduce no.
Of immobisations by 40%----less ED crowding, less unnecessary labour, reduce pt discomfort en-route to hosp
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South Africa
Would you be ‘comfortable’ with your EMS providers ‘clearing’ C-spines?