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REVIEW ARTICLE

Clinical Decision Rules for Adults With Minor Head Injury:


A Systematic Review
Sue E. Harnan, MSc, Alastair Pickering, MD, Abdullah Pandor, MSc, and Steve W. Goodacre, PhD

Background: There are many clinical decision rules for adults with minor
head injury, but it is unclear how they compare in terms of diagnostic I t is estimated that at least 1.7 million people sustain head
injury every year in the United States.1 Most head injuries
(90%) will be minor (Glasgow Coma Scale [GCS] score,
accuracy. This study aimed to systematically identify clinical decision rules
for adults with minor head injury and compare the estimated diagnostic 13–15) and do not require immediate neurosurgical interven-
accuracies for any intracranial injury and injury requiring neurosurgical tion or inpatient care. These patients have a small but important
intervention. risk of subsequent deterioration because of intracranial bleeding.
Methods: Several electronic bibliographic databases covering biomedical, If these cases are recognized and treated early, then a full
scientific, and gray literature were searched from inception to March 2010. recovery is likely; if not, severe disability or death may ensue.
At least two independent reviewers determined the eligibility of cohort Computed tomography (CT) of the head is the diagnos-
studies that described a clinical decision rule to identify adults with minor tic standard for identifying intracranial injury. Routine CT of
head injury (Glasgow Coma Scale score, 13–15) at risk of intracranial injury
all minor head injury patients would result in a large number
or injury requiring neurosurgical intervention.
Results: Twenty-two relevant studies were identified. Differences existed in
of normal CT scans being performed with associated risks of
patient selection, outcome definition, and reference standards used. Nine radiation exposure and waste of health care resources. There-
rules stratified patients into high- and moderate-risk categories (to identify fore, researchers have attempted to derive clinical decision
neurosurgical or nonsurgical intracranial lesions). The Canadian Computed rules to identify those at risk of intracranial injury based on
Tomography Head Rule (CCHR) high-risk criteria have sensitivity of 99% clinical characteristics at presentation to select them for
to 100% with specificity of 48% to 77% for injury requiring neurosurgical imaging. There are many such clinical decision rules for
intervention. Other rules such as New Orleans criteria, National Emer- adults with minor head injury, all of which vary in the
gency X-Radiography Utilization Study II, Neurotraumatology Commit- clinical criteria they use to identify those at risk of intra-
tee of the World Federation of Neurosurgical Societies, Scandinavian, cranial injury. Table 1 (see Table, Supplemental Digital
and Scottish Intercollegiate Guidelines Network produce similar sensi-
Content 1, http://links.lww.com/TA/A66) outlines some com-
tivities for injury requiring neurosurgical intervention but with lower and
more variable specificity values.
mon rules.
Discussion: The most widely researched decision rule is the CCHR, which It is currently unclear how existing rules compare in
has consistently shown high sensitivity for identifying injury requiring terms of diagnostic accuracy. This study aims to systemati-
neurosurgical intervention with an acceptable specificity to allow considered cally identify clinical decision rules for adults with minor
use of cranial computed tomography. No other decision rule has been as head injury and compare the decision or prediction rules in
widely validated or demonstrated as acceptable results, but its exclusion terms of estimated diagnostic accuracy for any intracranial
criteria make it difficult to apply universally. injury and injury requiring neurosurgical intervention.
Key Words: Craniocerebral trauma, Decision support techniques, System-
atic review, Clinical decision rules, Sensitivity and specificity. METHODS
(J Trauma. 2011;71: 245–251)
Search Strategy
Potentially relevant studies were identified through
Submitted for publication June 23, 2010. electronic searches of key databases including MEDLINE,
Accepted for publication December 23, 2010.
Copyright © 2011 by Lippincott Williams & Wilkins
EMBASE, CINAHL, and CENTRAL up to April 2009,
From the School of Health and Related Research, University of Sheffield, supplemented with an update from MEDLINE to March
Sheffield, South Yorkshire, United Kingdom. 2010. Search terms used free text and thesaurus terms (where
Supported by the NIHR Health Technology Assessment Programme (project available) with Boolean operators and database-specific syn-
number 07/37/08) and will be published in full in the monograph series Health
Technology Assessment. See the HTA programme website for further project tax. Manual searches of reference lists in key publications
information. were used to identify addition studies. Experts in the field
The views and opinions expressed therein are those of the authors and do not were contacted for any additional literature.
necessarily reflect those of the Department of Health.
Supplemental digital content is available for this article. Direct URL citations Inclusion Criteria
appear in the printed text, and links to the digital files are provided in the
HTML text of this article on the journal’s Web site (www.jtrauma.com). Studies were included if they met the following criteria:
Address for reprints: Sue E. Harnan, MSc, School of Health and Related Research, (a) a cohort study with minimum 20 patients at least half of
The University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 whom had GCS score of 1 to 15 at presentation, (b) they
4DA, United Kingdom; email: s.harnan@sheffield.ac.uk.
evaluated a decision rule that used three or more clinical
DOI: 10.1097/TA.0b013e31820d090f criteria (such as history, physical examination, or a simple

The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011 245
Harnan et al. The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011

diagnostic test) to determine the risk of any intracranial injury RESULTS


(defined as any intracranial abnormality detected on CT or A total of 8,003 citations were sifted from which 222
magnetic resonance imaging [MRI] scan because of trauma) articles were selected for full-text review and 22 articles3–24
or injury requiring neurosurgical intervention (defined as any met the inclusion criteria (Fig. 1).
intracranial injury seen on CT or MRI that required neuro-
surgical intervention), (c) some or all patients were assessed Study and Patient Characteristics
with CT scan or MRI for intracranial injury, or followed up Some 223–24 articles, representing 19 studies, were
to determine need for neurosurgical intervention, and (d) identified. Multiple publications from the same study were
provided data that allowed true positive, true negative, false found in two cases; an American publication23 which drew
positive, and false negative numbers to be extracted or on data from an Italian study,6 and three publications from
calculated. one study from the Netherlands.19 –21 Eight studies were
from the United States4,7–9,12,13,15; two each from Italy,3,6,23
Study Selection Canada,22,24 and Iran17,18; and one from each of The Nether-
Articles were considered for inclusion in three stages. lands,19 –21 Australia,16 Japan,14 Spain,10 and Denmark.5
First, titles were sifted to exclude obviously irrelevant articles Six were multicenter studies.13,17–22,24 Cohorts ranged in size
(A. Pandor and S.E.H.). Second, abstracts of the remaining from 16814 to 13,728.13 Fourteen studies derived a new
studies were split between two teams of reviewers (A. Pandor rule.3–5,8,10 –15,17,18,20,24 Four studies6,10,19 –23 reported validation
and A. Pickering, S.E.H. and S.W.G.) and assessed for results for more than one rule in the same cohort. Of the 19
relevance to produce a list of potentially relevant articles. studies, three reported both a derivation and a validation co-
Finally, all studies on this list were obtained and studied in hort.8,11,14 All studies reported intracranial injury as an outcome,
detail to generate a final list of included studies (S.E.H. and eight studies also reported need for neurosurgical intervention as
A. Pandor, checked by S.W.G. and A. Pickering). When an outcome.3,6,9,12,16,19 –24 Median prevalence of intracranial in-
discrepancies between reviewers occurred, these were re- jury was 7.2% (interquartile range, 6.3– 8.5%). Median preva-
solved through discussion. lence of injury requiring neurosurgical intervention was 0.95%
Assessment of Methodological Quality (interquartile range, 0.31–1.5%). Outcome definitions varied
The QUality Assessment of Diagnostic Accuracy Stud- across studies. The main difference for intracranial injury in-
ies checklist was used to assess study quality.2 Two questions volved the perception of clinical significance; four co-
were omitted; the disease progression bias item was ad- horts13,16,22,24 used a precise definition for significant injury,
dressed through definition of an adequate reference standard whereas the others defined this broadly as any acute lesion on
(CT within 24 hours), and the incorporation bias item was CT, often excluding isolated skull fracture. Definitions of surgi-
omitted, as the reference standard (CT/MRI scan or need for cal lesions also varied but most included hematoma evacuation,
neurosurgical intervention) was always independent of the elevation of depressed skull fracture, and intracranial pressure
index test. As a different reference standard was required for monitoring. Variations in reference standards are discussed below.
each outcome, items relating to the reference standard were Quality Assessment
included twice, once for each outcome. The methodological quality assessment of each in-
Data Abstraction cluded study is summarized in Figure 2. No study scored well
Data were extracted by one reviewer (S.E.H.) and on all the quality assessment criteria. However, studies were
checked by a second (A. Pandor). Data were extracted only usually reported well and satisfied the majority of the quality
from articles written in English. Variables relating to study assessment items, with notable exceptions.3– 6,23 The main
design, patient characteristics, study quality, and diagnostic source of variation was for patient spectrum, with only one
accuracy were extracted. When discrepancies occurred, these study17 reporting an unselected, prospective cohort of adults
were resolved through discussion. When differences were presenting within 48 hours of head injury. Studies used varied
unresolved, a third reviewer’s opinion was sought (S.W.G. or patient selection criteria. These included age restrictions
A. Pickering). When a study presented several different (inclusion ages ranged from older than 3 years,4 to adults
versions of a rule produced during derivation, all versions aged 17 and older,4 and to all ages5,12,13), recruitment only of
were extracted but only one version of the rule (either that those who had a CT scan4,9,11–13,15,16 and of those presenting
endorsed by the authors or that with the most appropriate to the ED with clinical characteristics.4,7–9,12,16,19 –22,24 Five
outcome definition) was considered in further analysis. studies defined minor head injury as GCS score of 14 to
156,7,10,14,23 and only included patients presenting within this
Data Synthesis range. Four studies included only those with GCS score of
A meta-analysis of any rule that had been indepen- 15,8,12,16,18 one study collected data on GCS score of 14 only,9
dently validated in multiple, relatively homogeneous cohorts two studies11,13 included data from all GCS categories and
was planned. During data extraction, it became clear that no two did not report GCS status.5,15 Only 10 stud-
rule had been evaluated to this extent. Instead, a narrative ies6,8,9,12,14,17–24 stated that they enrolled people who pre-
synthesis was performed, comparing diagnostic accuracy es- sented within 24 hours or 48 hours of injury. These variations
timates across cohorts to determine which (if any) of the in patient spectrum are likely to affect comparability across
decision rules were supported by consistent estimates of cohorts and application of conclusions with practice. They
sensitivity and specificity in multiple validation cohorts. may also affect estimates of sensitivity and specificity, as

246 © 2011 Lippincott Williams & Wilkins


The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011 Decision Rules for Adults With Minor Head Injury

Identification
Records identified through database Additional records identified
searching through other sources
(n = 7987) (n =16)

Records screened by title


(n = 8003)
Screening

Excluded by title
(n = 4578)

Record screened by
abstract
(n = 3425)
Excluded by abstract
(n = 3203)

Full-text articles assessed


Eligibility

for eligibility
(n = 222)
Full-text articles excluded,
with reasons
(n =200)

Full text articles included (review or not cohort study


(n =22) n=11; not all or
predominantly minor head
injury n=9; foreign
language n=18; no data on,
or new or usable
Studies included in narrative
diagnostic data for adult
synthesis
Included

decision rules n=129;


patients selected on basis
22 articles representing 19 of prior imaging or
studies outcome n=25; inadequate
reference standard n=1;
cohort <20 n=1; unable to
obtain n=3; wrong
outcome n=3)

Figure 1. PRISMA flow chart (adapted from www.prisma-statement.org).

selection of patients on these criteria may result in a cohort dard for injuries requiring neurosurgical intervention were
with more severe injury. usually because not all patients were followed-up or the
Only three studies scored well for the intracranial length of follow-up was sooner than 30 days after injury.
injury reference standard.12,17,19 Problems with the refer- Both of these factors are likely to affect estimates of
ence standard for intracranial injury included variation in diagnostic accuracy. For intracranial injury, partial verifi-
methods, a lack of clarity about whether CT was per- cation bias and differential verification bias were generally
formed within 24 hours (rather than CT not being used at avoided but may be a problem in two large cohorts6,23 as
all),4,7–11,13–16,18 and use of telephone follow-up and/or participants received different reference standards depen-
review of hospital records where CT was not performed for dent on their initial presentation. Less than half the studies
all. It is unlikely that follow-up would accurately identify scored well for blinding, and studies were of mixed quality
all intracranial injuries and could affect estimates of sen- for clinical review bias, which may limit external validity
sitivity and specificity.25 Problems with the reference stan- of results.

© 2011 Lippincott Williams & Wilkins 247


Harnan et al. The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011

Figure 2. Methodological quality graph: review authors’ judgements about each quality item presented as percentages across
all included studies.

Narrative Synthesis and medium-risk criteria had corresponding values of 99% to


The 19 included studies reported test accuracy data 100% and 37% to 48%,16,19,23 whereas NOC had similar sensi-
for a total of 25 decision rules3–5,7,8,10 –15,17,18,20,24,26 –35 tivity of 99% to 100% but generally poorer specificity, ranging
(see Table, Supplemental Digital Content 2, from 3% to 31%.16,19,22,23 For the identification of those with
http://links.lww.com/TA/A67). Nine of the rules21,24,26,27,31–34 intracranial injury, the estimates of sensitivity range from 80% to
were reported as existing in two forms. These were often 100%10,16,19,22–24 for CCHR high- and medium-risk criteria,
intended to identify those at risk of injury requiring neurosurgi- whereas for NOC, they range from 95% to 100%,8,10,16,19,22,23
cal intervention (high risk) and those at risk of intracranial injury which suggests NOC may have superior sensitivity. However,
(medium risk). Eleven rules3,8,11,13,14,24,26,27,29 –31,34 were evalu- this would seem to be at the expense of specificity, as CCHR
ated in more than one data set, and one further rule12 was achieves specificities in the range 39% to 50%, whereas NOC
evaluated in two cohorts: one of GCS score of 15 (derivation specificity ranges from 3% to 33%. In most cohorts, application
cohort)12 and one of GCS score of 14.9 Figure 3 shows of NOC would have resulted in nearly all patients having a CT
the diagnostic accuracy for identifying neurosurgical in- scan, whereas for CCHR, specificity is adequate to allow a
jury by rules that have been evaluated in multiple cohorts. meaningful proportion of patients to avoid a CT scan. CCHR
Figure 4 (see Figure, Supplemental Digital Content 3, sensitivity for any intracranial injury is probably more modest
http://links.lww.com/TA/A68) shows the corresponding but the missed cases are unlikely to be clinically significant.
parameters for identifying intracranial injury. Further data The National Institute for Health and Clinical Excel-
relating to rules that were evaluated in only one data set lence guidelines29,30 were developed from the CCHR high-
are reported elsewhere.36 and medium-risk criteria. However, sensitivity and specificity
The Canadian CT Head Rule (CCHR) and the New for injuries requiring neurosurgical intervention seemed
Orleans Criteria (NOC) have been most extensively tested. The poorer generally, ranging from 88% to 98%6,21,23 and 29% to
CCHR was developed for use in patients with GCS score of 13 67%, respectively. For intracranial injury, sensitivity seemed
to 15, with some specific exclusions, whereas the NOC were poorer, and ranged from 67% to 99%,6,21,23 whereas speci-
developed for use in patients with GCS score of 15 only. Five ficity may be superior with a range from 31% to 70%. It
studies evaluated both rules,10,16,19,22,23 allowing direct compar- should be noted that two of these studies6,23 report data from
ison. The CCHR24 high-risk criteria has sensitivity ranging from the same cohort but with different outcome definitions.
99% to 100% and specificity from 48% to 77% for injuries The National Emergency X-Radiography Utilization
requiring neurosurgical intervention,16,22–24 and the CCHR high- Study II13 rule seems to have high sensitivity for both injuries

248 © 2011 Lippincott Williams & Wilkins


The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011 Decision Rules for Adults With Minor Head Injury

Figure 3. Sensitivity and specificity of decision rules for identifying injuries that require neurosurgical intervention: rules with
multiple cohorts of data.

requiring neurosurgical intervention and any injury but variable intervention (94 –99%)20,32 and specificity for injuries requir-
specificity and limited validation. The Neurotraumatology Com- ing neurosurgical intervention (20 –50%) or any injury (21–
mittee of the World Federation of Neurosurgical Societies31 60%). Other rules have not been validated in sufficient
guidelines and Scottish Intercollegiate Guidelines Network cohorts and settings to draw meaningful conclusions.
guidelines both have sensitivities in a similar range to the CCHR
when lenient criteria are used, but results for specificity are
variable and generally much lower. The Scandinavian lenient DISCUSSION
criteria27 have diagnostic parameters in the same range but with There are many clinical decision rules for minor head
more variation in sensitivity for injuries requiring neurosurgical injury but few have been adequately validated. The CCHR

© 2011 Lippincott Williams & Wilkins 249


Harnan et al. The Journal of TRAUMA® Injury, Infection, and Critical Care • Volume 71, Number 1, July 2011

has been shown to be consistent across a number of studies scanning and missed intracranial injury, as reflected in the
and to have diagnostic parameters that would allow CT sensitivity and specificity estimates reported. The substantial
scanning to be avoided in a worthwhile proportion of patients benefit of neurosurgical interventions for certain lesions
without an excessive risk of significant intracranial injury means that specificity should be sacrificed to optimize sensi-
being missed. The NOC seems to have higher sensitivity for tivity for injuries requiring neurosurgical intervention. How-
intracranial injury but at the expense of specificity. Other ever, the benefit of identifying and treating injuries that do
rules may have comparable diagnostic performance with the not require surgical intervention is less certain, and the
CCHR, when applied appropriately but have not been as balance between unnecessary investigation and missed pa-
widely validated. thology is less clear. This uncertainty is reflected in variations
The CCHR has high sensitivity for detecting injuries in the definition of what constitutes a clinically significant
requiring neurosurgical intervention, whether high-risk or intracranial lesion; most studies considered any acute lesion
high-and medium-risk criteria are used. This is a consistent as a positive outcome. Consistently listed injuries include
finding in the available data, and so clinicians can be reason- extradural, subdural, subarachnoid, intracerebral, and intra-
ably assured that selecting patients for CT scanning on the parenchymal hemorrhage as well as cerebral contusion. Only
basis of the CCHR will carry a low risk of missing injuries two authors13,24 predefined their clinically significant findings
that require neurosurgical intervention. The sensitivity of the on CT (which have been adopted for other cohorts). Stiell et
CCHR medium-risk criteria for detecting any intracranial al.,24 more specifically, defines what was considered not
lesion is less consistent, although the lower reported sensi- significant, after extensive consultation with expert contrib-
tivity in some studies may reflect failure to detect injuries that utors, but disagreement still exists between these definitions.
are of little clinical significance. Clinicians using the CCHR Further research is required to validate existing rules
should be aware that it may miss some nonneurosurgical and compare the performance of different rules in the same
lesions of questionable clinical significance. population. Decision analysis and economic modeling is
Some limitations of the available data should be con- required to explore the trade-off between sensitivity and
sidered when using the CCHR in practice. Patients with specificity in terms of the costs and benefits of missed
coagulopathy, age ⬍16 years, pregnancy, seizure postinjury, pathology and unnecessary investigation. Research into the
focal neurologic deficit, or injuries considered minimal were prognosis of nonneurosurgical intracranial injuries and the
excluded from developmental work, and so the rule may not effect of identification and treatment on prognosis is required
be applicable to these patients. However, diagnostic accuracy to allow better definition of what constitutes a clinically
significant injury and what benefits can be derived from
was maintained in subsequent studies that included these
accurate identification. In addition, researchers should con-
patients (see CCHR high and medium risk adapted to cohort,
sider how best to minimize bias and sources of inaccuracy in
Figs. 3 and 4).19 Whenever rules have been directly compared
their study design. In the face of practical and ethical diffi-
in the same patient cohort, only marginal differences in
culties, researchers have to choose between a selected cohort
sensitivity have been identified, translating to little clinical
where all patients have CT (with the attendant risk of spec-
difference in injury detection. The primary advantage of the
trum bias) and a relatively unselected cohort that uses
CCHR over other decision rules is in its improved specificity, follow-up without CT in the reference standard (with the
leading to a reduction in the number of scans required to attendant risk of verification bias). Where follow-up is used,
identify the same number of injuries. careful consideration of adequacy should be made.
To the best of our knowledge, this study constitutes the The heterogeneity of these rules has highlighted the dif-
most extensive search of diagnostic test accuracy data relat- ficulties that exist with any research into minor head injury.
ing to minor head injury decision rules performed to date. Definitions of injury and outcomes vary while patient selection
However, as with all systematic reviews, our search strategy and reference standards are not uniform. To take minor head
may have missed some eligible cohorts and others may have injury research forward, agreed definitions and standard out-
been excluded on the basis of non-English language. There is come assessments must be adopted, along the lines of the
a high degree of heterogeneity in minor head injury defini- approach by Utstein37 in cardiopulmonary resuscitation re-
tion, patient spectrum, outcome definition (for both intracra- search. The call for unification of mild brain injury definitions
nial injuries and injuries requiring neurosurgical intervention) for the future development of patient management is not new.38
and reference standards used. These variations lead to signif- The current evidence base suggests that the CCHR has the
icant differences in prevalence, selection bias, and quality most consistent and acceptable sensitivity and specificity when
assessment and, as such, limited direct comparability of rules compared with other decision rules for adults with minor head
with each other, and precluded meta-analysis. However, the injury.
main purpose of data synthesis is to increase the precision of
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