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Complete Summary

GUIDELINE TITLE

Clinical policy: neuroimaging and decisionmaking in adult mild traumatic brain injury in the acute setting.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Mild traumatic brain injury

GUIDELINE CATEGORY

Diagnosis
Evaluation
Management

CLINICAL SPECIALTY

Emergency Medicine
Family Practice
Geriatrics
Internal Medicine
Neurology
Radiology
Sports Medicine

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

  • To provide evidence-based recommendations on select issues in the management of adult patients with mild traumatic brain injury (TBI) in the acute setting
  • To address the following critical questions:
    1. Which patients with mild TBI should have a noncontrast head computed tomography (CT) scan in the emergency department (ED)?
    2. Is there a role for head magnetic resonance imaging over noncontrast CT in the ED evaluation of a patient with acute mild TBI?
    3. In patients with mild TBI, are brain-specific serum biomarkers predictive of an acute traumatic intracranial injury?
    4. Can a patient with an isolated mild TBI and a normal neurologic evaluation result be safely discharged from the ED if a noncontrast head CT scan shows no evidence of intracranial injury?

TARGET POPULATION

Adult patients (16 years of age or older) with blunt trauma to the head who present to the emergency department (ED) within 24 hours of injury and who have a Glasgow Coma Scale (GCS) score of 14 or 15 on initial evaluation in the ED

Note: This guideline is not intended for patients with penetrating trauma or multisystem trauma, who are younger than 16 years, or who have a GCS score of less than 14 on initial evaluation in the ED.

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Identification of patients with mild traumatic brain injury who should have noncontrast head computer tomography (CT) scan
    • Use of Glasgow Coma Scale (GCS) score
    • Use of other clinical criteria
  2. Use of head magnetic resonance imaging (MRI) (no recommendation specified)
  3. Use of brain-specific serum biomarkers (e.g., serum S-100 B level) and timing of measurement
  4. Establishing criteria for safe discharge from the emergency department and informing discharged patients about post-concussive symptoms

MAJOR OUTCOMES CONSIDERED

  • Presence of an acute intracranial injury on noncontrast head computed tomography (CT) scan (primary outcome measure)
  • Development of a lesion requiring neurosurgical intervention (secondary outcome measure for questions 1, 2, and 3)
  • Neurologic deterioration (primary outcome measure for question 4)
  • Sensitivity and specificity of diagnostic tests
  • Incidence and persistence of postconcussive symptoms

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

This clinical policy was created after careful review and critical analysis of the medical literature. MEDLINE and the Cochrane Database were searched for articles published from January 2000 through 2007. Specific key words/phrases used in the searches are identified under each critical question. Searches were limited to English-language sources, human studies, and aged 16 years or older. References obtained on the searches were reviewed by panel members (title and abstract) for relevance before inclusion in the pool of studies to be reviewed. Additional articles were reviewed from the bibliographies of articles cited and from hand searches of published literature. Some literature from the 2002 policy (1980 to 2001) is also included in this current policy.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Strength of Evidence

Literature Classification Schema^

Design/
Class
Therapy* Diagnosis** Prognosis***
1 Randomized, controlled trial or meta-analyses of randomized trials Prospective cohort using a criterion standard Population prospective cohort
2 Nonrandomized trial Retrospective observational Retrospective cohort
Case control
3 Case series
Case report
Other (e.g., consensus, review)
Case series
Case report
Other (e.g., consensus, review)
Case series
Case report
Other (e.g., consensus, review)

^Some designs (e.g., surveys) will not fit this schema and should be assessed individually.

*Objective is to measure therapeutic efficacy comparing >2 interventions.

**Objective is to determine the sensitivity and specificity of diagnostic tests.

***Objective is to predict outcome including mortality and morbidity.

Approach to Downgrading Strength of Evidence*

  Design/Class
Downgrading 1 2 3
None I II III
1 level II III X
2 levels III X X
Fatally flawed X X X

*See "Description of Methods Used to Analyze the Evidence" field for more information.

METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

This clinical policy was created after careful review and critical analysis of the medical literature.

All articles used in the formulation of this clinical policy were graded by at least 2 subcommittee members for strength of evidence and classified by the subcommittee members into 3 classes of evidence on the basis of the design of the study, with design 1 representing the strongest evidence and design 3 representing the weakest evidence for therapeutic, diagnostic, and prognostic clinical reports, respectively (see the "Rating Scheme for the Strength of Evidence" field). Articles were then graded on 6 dimensions thought to be most relevant to the development of a clinical guideline: blinded versus nonblinded outcome assessment, blinded or randomized allocation, direct or indirect outcome measures (reliability and validity), biases (e.g., selection, detection, transfer), external validity (i.e., generalizability), and sufficient sample size. Articles received a final grade (Class I, II, III) on the basis of a predetermined formula, taking into account design and quality of study (see the "Rating Scheme for the Strength of Evidence" field). Articles with fatal flaws were given an "X" grade and not used in formulating recommendations in this policy. Evidence grading was done with respect to the specific data being extracted and the specific critical question being reviewed. Thus, the level of evidence for any one study may vary according to the question, and it is possible for a single article to receive different levels of grading as different critical questions are answered. Question-specific level of evidence grading may be found in the Evidentiary Table included at the end of original guideline document.

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The panel used the American College of Emergency Physicians clinical policy development process. This policy is a product of the American College of Emergency Physicians (ACEP) clinical policy development process, including expert review, and is based on the existing literature; where literature was not available, consensus of emergency physicians was used.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Clinical findings and strength of recommendations regarding patient management were made according to the following criteria:

Strength of Recommendations

Level A recommendations. Generally accepted principles for patient management that reflect a high degree of clinical certainty (i.e., based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues).

Level B recommendations. Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (i.e., based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies).

Level C recommendations. Other strategies for patient management that are based on preliminary, inconclusive, or conflicting evidence, or, in the absence of any published literature, based on panel consensus.

There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, strength of prior beliefs, and publication bias, among others, might lead to such a downgrading of recommendations.

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

External Peer Review
Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Outside review comments were received from physicians and individuals with expertise in the topic area and practicing in the fields of emergency medicine, neurology, neuroradiology, neurosurgery, and neuropsychology. Their responses were used to further refine and enhance this policy.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions for the strength of evidence (Class I-III) and strength of recommendations (Level A-C) are repeated at the end of the "Major Recommendations" field.

  1. Which patients with mild traumatic brain injury (TBI) should have a noncontrast head computed tomography (CT) scan in the emergency department (ED)?

    Recommendations

    Level A recommendations. A noncontrast head CT is indicated in head trauma patients with loss of consciousness or posttraumatic amnesia only if one or more of the following is present: headache, vomiting, age greater than 60 years, drug or alcohol intoxication, deficits in short-term memory, physical evidence of trauma above the clavicle, posttraumatic seizure, Glasgow Coma Scale (GCS) score less than 15, focal neurologic deficit, or coagulopathy.

    Level B recommendations. A noncontrast head CT should be considered in head trauma patients with no loss of consciousness or posttraumatic amnesia if there is a focal neurologic deficit, vomiting, severe headache, age 65 years or greater, physical signs of a basilar skull fracture, GCS score less than 15, coagulopathy, or a dangerous mechanism of injury.*

    *Dangerous mechanism of injury includes ejection from a motor vehicle, a pedestrian struck, and a fall from a height of more than 3 feet or 5 stairs.

    Level C recommendations. None specified.

  1. Is there a role for head magnetic resonance imaging (MRI) over noncontrast CT in the ED evaluation of a patient with acute mild TBI?

    Recommendations

    Level A recommendations. None specified.

    Level B recommendations. None specified.

    Level C recommendations. None specified.

  1. In patients with mild TBI, are brain-specific serum biomarkers predictive of an acute traumatic intracranial injury?

    Recommendations

    Level A recommendations. None specified.

    Level B recommendations. None specified.

    Level C recommendations. In mild TBI patients without significant extracranial injuries and a serum S-100B level less than 0.1 micrograms/L measured within 4 hours of injury, consideration can be given to not performing a CT.*

    *This test has not yet received Food and Drug Administration approval for clinical use in the United States.

  1. Can a patient with an isolated mild TBI and a normal neurologic evaluation result be safely discharged from the ED if a noncontrast head CT scan shows no evidence of intracranial injury?

    Recommendations

    Level A recommendations. None specified.

    Level B recommendations. Patients with an isolated mild TBI who have a negative head CT scan result are at minimal risk for developing an intracranial lesion and therefore may be safely discharged from the ED.*

    *There are inadequate data to include patients with a bleeding disorder; who are receiving anticoagulation therapy or antiplatelet therapy; or who have had a previous neurosurgical procedure in this population.

    Level C recommendations. Mild TBI patients discharged from the ED should be informed about postconcussive symptoms.

Definitions:

Strength of Evidence

Literature Classification Schema^

Design/
Class
Therapy* Diagnosis** Prognosis***
1 Randomized, controlled trial or meta-analyses of randomized trials Prospective cohort using a criterion standard Population prospective cohort
2 Nonrandomized trial Retrospective observational Retrospective cohort
Case control
3 Case series
Case report
Other (e.g., consensus, review)
Case series
Case report
Other (e.g., consensus, review)
Case series
Case report
Other (e.g., consensus, review)

^Some designs (e.g., surveys) will not fit this schema and should be assessed individually.

*Objective is to measure therapeutic efficacy comparing >2 interventions.

**Objective is to determine the sensitivity and specificity of diagnostic tests.

***Objective is to predict outcome including mortality and morbidity.

Approach to Downgrading Strength of Evidence*

  Design/Class
Downgrading 1 2 3
None I II III
1 level II III X
2 levels III X X
Fatally flawed X X X

*See "Description of Methods Used to Analyze the Evidence" field for more information.

Strength of Recommendations

Level A recommendations. Generally accepted principles for patient management that reflect a high degree of clinical certainty (i.e., based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues).

Level B recommendations. Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (i.e., based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies).

Level C recommendations. Other strategies for patient management that are based on preliminary, inconclusive, or conflicting evidence, or, in the absence of any published literature, based on panel consensus.

There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, strength of prior beliefs, and publication bias, among others, might lead to such a downgrading of recommendations.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Guideline recommendations can assist clinicians with appropriate and safe evaluation and management of patients presenting to the emergency department (ED) with mild traumatic brain injury in the acute setting.

POTENTIAL HARMS

Risk of possible delayed complications (postconcussive symptoms) in patients discharged from the emergency department after a negative computed tomography (CT) scan

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

  • It is the goal of the panel to provide an evidence-based recommendation when the medical literature provides enough quality information to answer a critical question. When the medical literature does not contain enough quality information to answer a critical question, the members of the panel believe that it is equally important to alert emergency physicians to this fact.
  • Recommendations offered in this policy are not intended to represent the only diagnostic and management options that the emergency physician should consider. The American College of Emergency Physicians clearly recognizes the importance of the individual physician's judgment. Rather, this guideline defines for the physician those strategies for which medical literature exists to provide support for answers to the crucial questions addressed in this policy.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better

IOM DOMAIN

Effectiveness
Safety
Timeliness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2008 Nov 25

GUIDELINE DEVELOPER(S)

American College of Emergency Physicians - Medical Specialty Society

SOURCE(S) OF FUNDING

This clinical policy was developed by a multidisciplinary panel and funded under contract 200-2007-21367, Centers for Disease Control and Prevention, Coordinating Center for Environmental Health and Injury Prevention, National Center for Injury Prevention and Control, Division of Injury Response.

GUIDELINE COMMITTEE

American College of Emergency Physicians(ACEP)/Centers for Disease Control and Prevention (CDC) Panel to Revise the 2002 Clinical Policy

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Panel Members: Andy S. Jagoda, MD, Chair; Jeffrey J. Bazarian, MD, MPH; John J. Bruns, Jr, MD; Stephen V. Cantrill, MD; Alisa D. Gean, MD; Patricia Kunz Howard, PhD, RN, CEN, ENA Representative; Jamshid Ghajar, MD, PhD; Silvana Riggio, MD; David W. Wright, MD; Robert L. Wears, MD, MS, Methodologist; Aric Bakshy, MD; Paula Burgess, MD, MPH, Division of Injury Response, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; Marlena M. Wald, MLS, MPH, Epidemiologist, Division of Injury Response, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; Rhonda R. Whitson, RHIA, Clinical Practice Manager, ACEP

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Relevant industry relationships of panel members: There were no relevant industry relationships disclosed by panel members.

Relevant industry relationships are those relationships with companies associated with products or services that significantly impact the specific aspect of disease addressed in the critical question.

ENDORSER(S)

Emergency Nurses Association - Medical Specialty Society

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on November 13, 2008. The information was verified by the guideline developer on January 14, 2009.

COPYRIGHT STATEMENT

DISCLAIMER

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