Eur Spine J. 2017 (Sep 22) [Epub] ~ FULL TEXT
N. Moser, N. Lemeunier, D. Southerst, H. Shearer, K. Murnaghan, D. Sutton, P. Cote
Division of Graduate Education and Research,
Canadian Memorial Chiropractic College (CMCC),
6100 Leslie Street,
Toronto, ON, Canada.
PURPOSE:   To update findings of the 2000-2010 Bone and Joint Decade Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) on the validity and reliability of clinical prediction rules used to screen for cervical spine injury in alert low-risk adult patients with blunt trauma to the neck.
METHODS:   We searched four databases from 2005 to 2015. Pairs of independent reviewers critically appraised eligible studies using the modified QUADAS-2 and QAREL criteria. We synthesized low risk of bias studies following best evidence synthesis principles.
RESULTS:   We screened 679 citations; five had a low risk of bias and were included in our synthesis. The sensitivity of the Canadian C-spine rule ranged from 0.90 to 1.00 with negative predictive values ranging from 99 to 100%. Inter-rater reliability of the Canadian C-spine rule varied from k = 0.60 between nurses and physicians to k = 0.93 among paramedics. The inter-rater reliability of the Nexus Low-Risk Criteria was k = 0.53 between resident physicians and faculty physicians.
CONCLUSIONS:   Our review adds new evidence to the Neck Pain Task Force and supports the use of clinical prediction rules in emergency care settings to screen for cervical spine injury in alert low-risk adult patients with blunt trauma to the neck. The Canadian C-spine rule consistently demonstrated excellent sensitivity and negative predictive values. Our review, however, suggests that the reproducibility of the clinical predictions rules varies depending on the examiners level of training and experience.
KEYWORDS:   Canadian C-spine rule; Clinical prediction rule; Neck pain; Nexus low-risk criteria; Reliability; Validity
From the FULL TEXT Article:
The incidence of a potentially serious cervical spine injury, including cervical spine fracture, dislocation, and ligamentous instability in the Norwegian population, is an estimated 16.5/100,000/year.  In the United States, more than a million patients are assessed each year.  Failure to diagnose these injuries in a timely manner may have significant consequences, including spinal cord injury and even death.  Thus, highly sensitive and reliable assessment methods are required to screen patients who are at risk of serious cervical spine injury.
The primary focus of an assessment for patients with acute neck pain following blunt trauma is to rule out the presence of major pathology, such as fractures and dislocations.  Assessment of the anatomical integrity of the cervical spine involves diagnostic imaging, such as plain radiography, computed tomography, or magnetic resonance imaging. However, relying on these procedures is an inefficient practice. [5–8] More than 98% of all cervical spine radiographs ordered following acute blunt trauma are negative for fracture. [6, 9–11] This low diagnostic yield is associated with significant costs and places a significant strain on health care resources]. [5, 12, 13] Furthermore, patients are exposed to potentially harmful radiation when imaging may not be clinically indicated. 
Clinical practice guidelines for the assessment of neck pain [15, 16] advocate for the use of clinical prediction rules to identify those at low risk of serious cervical spine injuries. Clinical prediction rules serve as a decision matrix, incorporating three or more variables from the patient’s history, physical examination, and/or simple diagnostic tests. Their intent is to guide the diagnostic and treatment decision-making process. [17, 18]
In 2008, The 2000–2010 Bone and Joint Decade Task
Force on Neck Pain and Its Associated Disorders (Neck Pain
Task Force) reported on the diagnostic accuracy of clinical
prediction rules used to screen alert low-risk adults with
blunt trauma to the neck.  They concluded that two clinical
prediction rules, The Nexus Low-Risk Criteria (NLC) and The Canadian C-spine rule (CCR), demonstrated high
sensitivity and negative predictive values. The Neck Pain
Task Force did not identify any low risk of bias studies
assessing their reliability. More recently, a systematic review
by Michaleff et al. reported that these clinical prediction
rules yielded consistently high sensitivity.  The emergence
of new evidence regarding the reliability and validity
of the NLC and CCR warrants an updated review of the
This systematic review aims to update the findings of
the Neck Pain Task Force on the validity and reliability of
clinical prediction rules used to screen for cervical spine
injury in alert low-risk adult patients, aged 16 and older,
with blunt trauma to the neck. This review is the second of
a series of five systematic reviews updating the NPTF on
the reliability and validity of clinical tests and tools used
to assess patients with NAD. Subsequent reviews focus on
screening for anatomical integrity of the cervical spine ,
measurement of pain and disability ; palpation and cervical
mobility , and functional tests of the cervical spine.  Together, the purpose of these reviews is to inform the
development of a clinical practice guideline for the clinical
assessment of the cervical spine.
We registered this review protocol with the International
Prospective Register of Systematic Reviews (PROSPERO)
on February 4, 2016 (CRD42016033896).
We included studies of alert low-risk adults (16 years of
age or older) with NAD (grades I–IV), including WAD
(grades I–IV) after blunt trauma to the neck. We defined
NAD according to the Neck Pain Task Force  and WAD
according to the Québec Task Force.  Alert low-risk
patients are defined as cooperative, non-intoxicated, conscious
patients that have scored 15 on the Glasgow Coma
Scale (GCS) and have no distracting injuries. [26–29] We
excluded studies targeting high-risk patients, defined as
those who are unconscious, sedated, intoxicated or noncooperative,
or those with distracting injuries or an altered
mental state (GCS < 15). [26, 27]
Evaluation of assessment
We restricted our review to studies assessing the validity
and reliability of clinical prediction rules used to screen for
cervical spine injury in alert low-risk patients with blunt
trauma to the neck. Validity is the degree to which the data
measure what they were intended to measure—that is, the
results of a measurement correspond to the true state of the
phenomenon being measured.  Reliability is the extent
to which repeated measurements of a stable phenomenon by
different people and instruments at different times and places
to produce similar results. 
We chose not to use the standard thresholds or cut-off
values for the kappa statistic to classify reliability findings
(i.e., weak, moderate, or strong). Since there is no standardized
interpretation for the kappa statistic, our judgement on
the reproducibility of the clinical prediction rules focused on
the importance of ruling out these injuries with little margin
To be included in our systematic review, studies had to fulfill the following inclusion criteria:
(1) English or French language;
(2) published from January 1, 2005 to November 5th, 2015 to ensure overlap with the NPTF literature search,
which ended in 2005 and was updated in 2007 ;
(3) published in a peer-reviewed journal;
(4) validity or reliability studies of clinical prediction rules used to screen alert lowrisk patients with blunt trauma to the neck;
(5) study population including alert low-risk adult patients (≥ 16 years of age) with grades I–IV neck pain (including non-traumatic neck pain and neck pain subsequent to a traffic collision) with or without its associated disorders;
(6) sample size of at least 20 per group; and
(7) if studies included a mixed population with individuals less than 16 years of age, results must be stratified for adults 16 years of age and older.
Studies fulfilling any of the following criteria were excluded:
(1) publication types including guidelines, letters, editorials, commentaries, unpublished manuscripts, dissertations, government reports, books and book chapters, conference proceedings, meeting abstracts, lectures and addresses, consensus development statements, and guideline statements;
(2) study designs including systematic and non-systematic reviews, and case studies;
(3) cadaveric or animal studies;
(4) studies solely targeting individuals with serious pathology (e.g., fractures, dislocations, myelopathy, neoplasms, infection), and systemic disease; and
(5) sample size less than 20 per group. The exclusion criteria replicate what was used by the NPTF except for publication types. 
A search strategy was developed in consultation with a
health sciences librarian and reviewed by a second librarian.
We systematically searched the following electronic
databases from January 1st, 2005 to November 5th, 2015:
MEDLINE, PubMed, Cochrane Central Register of Controlled
Trials, and CINAHL.
Search terms consisted of subject headings specific to
each database (e.g., MeSH in MEDLINE and PubMed) and
free text words relevant to NAD, diagnosis, validity, reliability,
blunt trauma, spinal fracture, and clinical prediction
rules (Appendix I). In addition, the reference lists of
included studies and related systematic reviews [4, 19] were
screened to identify any studies that we may have missed
using our search strategy.
Pairs of independent reviewers (NM, NL, and DS) screened
articles in two phases. The first phase involved screening
titles and abstracts for relevant and possibly relevant citations
based on the inclusion and exclusion criteria. Possibly,
relevant citations from the first phase were reviewed in the
second phase using the full text. Disagreements between
paired reviewers were resolved by discussion to reach consensus.
If consensus could not be reached, a third reviewer
independently screened the citation and discussed with the
other two reviewers to reach consensus.
Pairs of reviewers (NM, NL, and DS) independently critically
appraised all relevant studies. We assessed internal
validity using the modified Quality Assessment of Diagnostic
Accuracy Studies-2 (QUADAS-2)  criteria
for diagnostic accuracy studies and the modified Quality
Appraisal Tool for Studies of Diagnostic Reliability
(QAREL)  criteria for diagnostic reliability studies.
We modified the original QUADAS-2 and QAREL instruments
1) a question on whether the study objective was clear;
2) ‘not applicable’ options for some items; and
3) the Sackett and Haynes classification for validity studies (in the QUADAS-2 instrument). 
between reviewers was reached through discussion. Following
appraisal, we considered studies with adequate
internal validity as low risk of bias and included them in
our best evidence synthesis (Tables 1, 2).
Classification of diagnostic studies
We classified each low risk of bias study according to the
classification system by Sackett and Haynes based on the
type of research question being addressed.  Studies
classified as phases I and II are exploratory in nature;
therefore, they cannot confirm validity and require further
evaluation. In phase III studies, the ability of the test
to distinguish between patients with and without the target
disorder is assessed and may be compared to a gold
standard. Due to their design, the results from phase III
studies are hypothesis confirming and form the basis for
widespread adoption. Phase IV studies measure utility by
assessing whether patients undergoing a test have better
health outcomes than patients who do not receive the test.
Data extraction and synthesis of results
The lead author (NM) extracted data from low risk of bias
studies to build evidence tables (Tables 3, 4) and a second
reviewer (DS) independently checked the data extraction.
Meta-analysis was not performed due to heterogeneity of
studies with low risk of bias regarding patient population,
clinical setting, clinical prediction rules being evaluated,
and the background and experience of assessors. We,
therefore, performed a qualitative synthesis of findings
from low risk of bias studies according to principles of
best evidence synthesis.  Finally, we interpreted our
findings in the context of findings from admissible studies
summarized by the Neck Pain Task Force. 
We computed the inter-rater reliability for the screening of
articles using the kappa coefficient (κ) and 95% confidence
intervals (CI).  We calculated the percent agreement for
classifying studies into high or low risk of bias following
independent critical appraisal.
Our review complies with the Reporting Items for Systematic
Reviews and Meta-Analyses (PRISMA) statement 
and Statement for Reporting Studies of Diagnostic Accuracy
Our search identified 679 citations (Figure 1); six articles met
our eligibility criteria and were critically appraised. Five of
six critically appraised articles had a low risk of bias and
were included in our synthesis.
Identification and selection
of articles for clinical prediction rules
The inter-rater agreement for screening citations and
selection of relevant studies was k = 0.91 (95% CI: 0.83,
1.00). The percent agreement for the independent critical
appraisal of studies was 83% (5/6). Disagreements were
resolved through discussions between assigned reviewers
without the need to involve a third reviewer. We contacted
authors from one study during critical appraisal to
request additional information; however, we did not receive
a response. 
Validity and reliability studies included in our synthesis are
summarized in Tables 2 and 3. The prevalence of clinically
important cervical spine injury ranged between 0.40% 
and 1.15%  with a median of 0.55%.
Of the five low-risk bias studies, four assessed validity
[39–42] and four assessed reliability. [40–43] Three of the
five studies evaluated the Canadian C-spine rule (CCR). [39–41] One study evaluated
a modified version of the CCR for field use by paramedics.  In this modified version, the criterion related
to ‘delayed onset of neck pain’ was removed. One study
evaluated the Nexus Low-Risk Criteria (NLC).  Among all the studies, physicians
were instructed to use the clinical prediction rules to decide
whether or not to image. However, nurses [40, 41] and paramedics  were asked to record their decision regarding
the need for cervical spine immobilization.
Three of the five studies [39–41] included alert (GCS 15)
adult patients with potential cervical spine injury presenting
to emergency departments within 48 h of injury. In another
study, paramedics examined alert (GCS 15), stable adult
patients transported by ambulance to local hospitals within
8 h of sustaining acute blunt trauma with potential injury to
the neck.  One study applied a clinical prediction rule in
active duty military personnel, family members, and retirees
(aged at least 18 years), who suffered blunt trauma and
presented to a military hospital emergency department with
complaints of cervical spine pain. 
All four validity studies [39–42] were phase III cohorts
comparing the CCR to a reference standard. The reference
standard that was selected included radiographic imaging
and a follow-up via telephone or mail to confirm the absence
of clinically important cervical spine injury. All four reliability
studies examined inter-rater reliability:
(1) between nurses and physicians [40, 41];
(2) within a single group of practitioners: nurses  and paramedics ; and
(3) among physicians of varying experience levels.  The background and experience levels of the assessors applying the clinical prediction rules varied among studies (Tables 2, 3).
Risk of bias
All four low-risk bias studies used a clear research question,
appropriate reference standard, appropriate index reviewer
blinding methods, and valid and reliable outcome measures
(Table 1a). However, these studies had the following limitations:
(1) utilization of a convenience sample [39, 40, 42];
(2) unclear information on whether interpretation of the reference standard was done without knowledge of the index test [39, 40]; and
(3) participants received different reference standards. [39–42]
All four reliability studies with low risk of bias used a clear
research question, appropriate reference standard, appropriate
index reviewer blinding methods, and valid and reliable
outcome measures (Table 1b). Included studies had the following
limitations: (1) unclear inter-rater blinding methods  and (2) unclear methods for concealment of clinical
Summary of evidence
Validity of the Canadian C–spine rule
Three low-risk bias studies (Table 2) assessed the validity
of the Canadian C-spine rule (CCR) for screening alert, stable patients presenting
to emergency departments. [39–41] Stiell et al. reported
a sensitivity of 1.00 (95% CI: 0.91, 1.00), a specificity of
0.43 (95% CI: 0.42, 0.45), and a negative predictive value
of 100% when physicians applied the CCR.  When triage
nurses applied the CCR, the sensitivity was 0.90 (95%
CI: 0.76, 0.95).  Miller et al. also investigated the CCR
when administered by emergency nursing staff and reported
a sensitivity of 1.00 (95% CI: 0.91, 1.00), a specificity of
0.51 (95% CI: 0.42, 0.45), and a negative predictive value of
100%.  Coffey et al. reported a sensitivity of 1.00 (95%
CI: 0.91, 1.00), specificity of 0.43 (95% CI: 0.39, 0.54), and
negative predictive value of 100% when emergency department
physicians applied the CCR. 
One low-risk bias study investigated the validity using
two different applications of the CCR: 1) CCR applied in
the field by paramedics and 2) CCR applied by investigators
reviewing paramedic care reports (Table 2). When applied
in the field by paramedics, the CCR had a sensitivity of
1.00 (95% CI: 0.74, 1.00), specificity of 0.38 (95% CI: 0.36,
0.40), and negative predictive value of 100% (95% CI: 99,
100). When applied by investigators using the paramedics’
care reports, the CCR had a sensitivity of 1.00 (95% CI:
0.74, 1.00), specificity of 0.43 (95% CI: 0.40, 0.45), and
negative predictive value of 100% (95% CI: 0.99, 1.00).
Reliability of the Canadian C–spine rule
Miller et al. found an inter-rater reliability of k = 0.60 (95%
CI 0.50, 0.62) between physicians and nurses. Stiell
et al. found inter-rater reliability of k = 0.75 (95% CI 0.67,
0.84) between physicians and nurses and k = 0.78 (95% CI
0.72, 0.84) among nurses only.  One additional study
investigated the reliability of a modified version of the Canadian C-spine rule (CCR). They reported an inter-rater reliability among paramedics
of k = 0.93 (95% CI 0.87, 0.99) (Table 3).
Reliability of the NEXUS low–risk criteria
Matteucci et al. reported an inter-rater reliability of k = 0.53
(95% CI 0.35, 0.72).  The items of the tool with the
lowest agreement were altered mental status (k = 0.22 95%
CI: 0.11, 0.55), focal neurological deficit (k = 0.21 95% CI:
0.19, 0.62), and distracting injury (k = 0.13 95% CI: -0.19,
Summary of evidence
Our systematic review examined the validity and reliability
of clinical prediction rules used to screen for cervical spine
injury in alert low-risk adult patients with blunt trauma to
the neck. We summarized the findings from five low-risk
bias studies on the diagnostic accuracy and reproducibility
of the Canadian C-spine rule (CCR) and Nexus Low-Risk Criteria (NLC).
Evidence from four studies [39–42] reported consistently
high sensitivity and negative predictive values for the CCR,
suggesting that a negative test result is highly informative to
clinicians for excluding a clinically significant cervical spine
injury. Conversely, and as expected, the specificity of the
CCR was lower in all four studies. [39–42] Therefore, using
the CCR results is associated with an important number of
In three studies, triage nurses and paramedics demonstrated
acceptable agreement using the CCR to determine
the necessity for immobilization. [40–42] Only one study
evaluated the NLC and found unacceptable levels of agreement
between emergency medicine (EM) physicians and
EM residents.  The findings suggest that there may be
subjectivity in how NLC criteria are interpreted. Furthermore,
examiners of different expertise, backgrounds, and
levels of experience may interpret the NLC differently. A
recent study by Tran et al. examined the improved diagnostic
accuracy of a modified version of the NLC, which included
two changes, modified definition of distracting injury and
the definition of normal mentation.  They reported a
sensitivity of 1.00 (95% CI: 0.68, 1.00), a specificity of 0.48
(95% CI: 0.44, 0.51), and a negative predictive value of 1.00
(95% CI: 0.99, 1.00). They suggest that the modifications to
the NLC may improve the tool’s accuracy.  Clarifying
the definitions of distracting injuries and mental status may
also positively impact the reliability of the tool.
Previous systematic reviews
The Neck Pain Task Force summarized evidence from 11
studies on the validity of clinical prediction rules for screening
alert low-risk patients with blunt trauma to the neck.  The CCR and the NLC demonstrated high sensitivity
and negative predictive values for ruling out significant
cervical spine injury. In one of the articles included, CCR
was reported superior to the NLC with respect to sensitivity
[99.4% (95% CI: 96–100) vs. 90.7% (95% CI: 85–94),
respectively] and specificity [45.1% (95% CI: 44–46) vs.
36.8% (95% CI: 36–38), respectively] for cervical spine
injury, and its use would result in reduced rates of radiography.  The NPTF concluded that these instruments
effectively inform clinicians on the necessity of further diagnostic
imaging. Another systematic review reported on the
accuracy of the CCR and the NLC. Michaleff et al. reported
evidence from 15 studies and noted that both rules demonstrated
consistently high sensitivity.  They concluded
that a negative prediction is highly informative in the exclusion
of clinically significant cervical spine injury and the
necessity for radiographic examination.
Our findings expand on the conclusions of the previous
reviews by summarizing findings regarding the reliability
of the CCR and NLC. Although these instruments demonstrate
consistent performance in terms of high sensitivity and
negative predictive values, the inter-examiner reliability of
the NLC may vary depending on the expertise, background,
experience, and training of the health professional. Specifically,
a lack of reproducibility when the NLC is applied by
multiple examiners of varied experience levels may jeopardize
In addition to being valid and reliable, the Canadian C-spine
rule appears to improve the efficiency of health care resource
use in practice. Coffey et al. reported that a reduction in
cervical spine radiographs of 17.4% (95% CI 15 to 19%)
would have been achieved without compromising patient
safety.  Furthermore, two studies reported a reduction
in the rate of cervical spine immobilization by triage nurses
of 25% (95% CI: 21, 29%)  and 40%  when the CCR
was followed. Similarly, Vaillancourt et al. reported that if
paramedics had instituted their findings from the modified
CCR, only 62.2% (95% CI 60 to 64%) of recruited patients
would have required immobilization in the field. 
In addition, evidence suggests that the majority of professionals
reported feeling comfortable (‘comfortable’ or ‘very
comfortable’) using the clinical prediction rules, with values
ranging among professionals from 82 to 90%. [39–42] Comfort
with use of the NLC was not reported.
Recommendations for future studies
Our review found only one article with a low risk of bias
that evaluated the reliability of the Nexus Low-Risk Criteria (NLC). Future studies may
focus on the validity and reliability of this clinical prediction
rule among health care professionals with varied expertise,
backgrounds, and levels of experience and in multiple health
Clinical relevance and implications
There is strong consistent evidence that using clinical prediction
rules for adult patients with blunt trauma to the neck
effectively clears the cervical spine without the need for
imaging. The clinical prediction rules have the potential,
if globally adopted, to standardize practice and improve
efficiency in the use of cervical spine radiography without
compromising patient safety.
Strengths and limitations
Our review has a number of strengths. We utilized an extensive
and rigorous search strategy. We pre-defined explicit
inclusion and exclusion criteria to identify possibly relevant
studies. We utilized two pairs of independent reviewers to
minimize error and potential bias. Furthermore, we used the
QUADAS-2 and QAREL tools to standardize the critical
appraisal process and inform our scientific judgement on
study admissibility. Finally, we utilized principles of best
evidence synthesis, excluding studies with high risk of bias.
Our review also has limitations. First, we limited our
search to the English and French language literature. Second,
the critical appraisal process entailed judgement by the
reviewers, which may be subjective. This potential bias was
limited by training the reviewers and using standardized
critical appraisal methods.
When synthesized with the Neck Pain Task Force, the evidence
consistently demonstrates that the Canadian C-spine rule (CCR) has excellent
sensitivity and negative predictive values, indicating
strong clinical value in ruling out serious cervical spine
injury and informing the need for further diagnostic imaging.
Furthermore, our review adds new information regarding
the tools’ reproducibility. We identified that the CCR
has acceptable inter-examiner reliability. We found only
one study evaluating the reliability of the NLC demonstrating
underwhelming levels of reproducibility. Therefore,
there is insufficient evidence to conclude on the
validity or reliability of the Nexus Low-Risk Criteria (NLC).
The authors acknowledge and thank Mrs. Sophie
Despeyroux, librarian at the Haute Autorité de Santé, for her suggestions
and review of the search strategy. The authors also acknowledge
Dr. Jessica Wong, who provided methodological guidance and training
for several co-authors. This research was undertaken, in part, thanks to
funding and supervision from the Canada Research Chairs program to
Dr. Pierre Cote, Canada Research Chair in Disability Prevention and
Rehabilitation at the University of Ontario Institute of Technology.
This study was funded by the Institut Franco-Européen de
Chiropraxie, the Association Française de Chiropraxie and the Fondation
de recherche en chiropraxie in France. None of these associations
was involved in the collection of data, data analysis, interpretation of
data, or drafting of the manuscript.
Conflict of interest
We have no potential conflict of interest.
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