Neuroimaging and Decisionmaking in Adult Mild

TRAUMA/CLINICAL POLICY C d D y i From the American College of Emergency Physicians (ACEP)/Centers for Disease Control and Prevention (CDC) Panel An Jeffre John Steph Alisa Patric Jamshid Ghajar, MD, PhD Silvana Riggio, MD Da Ro Ar Pa National Center for Injury Prevention and Control, Ma Rh Ap Su Th 01 Co doi AB rec 71 4 Annals of Emergency Medicine Volume , .  : December  Centers for Disease Control and Prevention rlena M. Wald, MLS, MPH, Epidemiologist, Division of Injury Response, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention onda R. Whitson, RHIA, Clinical Practice Manager, ACEP proved by the ACEP Board of Directors, August 13, 2008 pported by the Emergency Nurses Association, September 23, 2008 is 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. Policy statements and clinical policies are the official policies of the American College of Emergency Physicians and, as such, are not subject to the same peer review process as articles appearing in the print journal. Policy statements and clinical policies of ACEP do not necessarily reflect the policies and beliefs of Annals of Emergency Medicine and its editors. 96-0644/$-see front matter pyright © 2008 by the American College of Emergency Physicians. :10.1016/j.annemergmed.2008.08.021 [Ann Emerg Med. 2008;52:714-748.] STRACT This clinical policy provides evidence-based ommendations on select issues in the management of adult patients with mild traumatic brain injury (TBI) in the acute setting. It is the result of joint efforts between the American College of Emergency Physicians and the Centers for Disease Control and Prevention and was developed by a multidisciplinary panel. The critical questions addressed in this vid W. Wright, MD bert L. Wears, MD, MS, Methodologist ic Bakshy, MD ula Burgess, MD, MPH, Division of Injury Response, y J. Bazarian, MD, MPH J. Bruns, Jr, MD en V. Cantrill, MD D. Gean, MD ia Kunz Howard, PhD, RN, CEN, ENA Representative to Revise the 2002 Clinical Policy: Neuroimaging and Decisionmaking in Adult Mild Traumatic Brain Injury in the Acute Setting: dy S. Jagoda, MD, Chair linical Policy: Neuroimaging an Traumatic Brain Injur ecisionmaking in Adult Mild n the Acute Setting clinical policy are: (1) Which patients with mild TBI should ha the ma eva mi acu iso saf sho ap no wi 15 Th pre sca oc IN vis Sta are no in wo to Gl les the int 15 fun wh int Th an the be TB thi im of ha inj fro Un Terms used have included “concussion,” “mild TBI,” “minor TB ris int are de exa lac tra its res de wh 1. 2. 3. de Oc or fol sur ● ● ● ● int of ap ha fro gro ne int ide of ab sco pe pa 9 t *Ac inc sub Clinical Policy Vo ve a noncontrast head computed tomography (CT) scan in emergency department (ED)? (2) Is there a role for head gnetic resonance imaging over noncontrast CT in the ED luation of a patient with acute mild TBI? (3) In patients with ld TBI, are brain specific serum biomarkers predictive of an te traumatic intracranial injury? (4) Can a patient with an lated mild TBI and a normal neurologic evaluation result be ely discharged from the ED if a noncontrast head CT scan ws no evidence of intracranial injury? Inclusion criteria for plication of this clinical policy’s recommendations are npenetrating trauma to the head, presentation to the ED thin 24 hours of injury, a Glasgow Coma Scale score of 14 or on initial evaluation in the ED, and aged 16 years or greater. e primary outcome measure for questions 1, 2, and 3 is the sence of an acute intracranial injury on noncontrast head CT n; the primary outcome measure for question 4 is the currence of neurologic deterioration. TRODUCTION There are more than 1 million emergency department (ED) its annually for traumatic brain injury (TBI) in the United tes.1,2 The majority of these visits are for “mild” injuries that primarily the result of falls and motor vehicle crashes.1,2 In npediatric patients, the highest incidence of mild TBI is seen males between the ages of 15 and 24 years and in men and men 65 years of age and older.3 It has been reported that up 15% of patients with head trauma evaluated in the ED with a asgow Coma Scale (GCS) score of 15 will have an acute ion on head computed tomography (CT); less than 1% of se patients will have a lesion requiring a neurosurgical ervention.4-9 Depending on how disability is defined, 5% to % of patients with mild TBI may have compromised ction 1 year after their injury.10,11 The challenge to the emergency physician is identifying ich patients with a head injury have an acute traumatic racranial injury,* and which patients can be safely sent home. e initial version of this clinical policy was published in 2002 d designed to provide the best evidence available to answer se questions.12 Since then, several well-designed studies have en published that have added to our understanding of mild I and assist in clinical decisionmaking.5,6,8,9,13 Consequently, s clinical policy provides an update of the 2002 document. The question of how best to define a mild TBI is of great portance and has been a source of confusion.14 A small subset these patients will harbor a life-threatening injury; some will ve neurocognitive sequelae for days to months after the ury.15,16 In fact, it is difficult to convince a patient disabled m the postconcussive syndrome that their injury was “mild.” fortunately, there exists no consensus regarding classification. ute traumatic intracranial injuries include the spectrum of injuries luding isolated fractures of the cranium, subarachnoid hemorrhage, durals, epidurals, hemorrhagic, and bland contusions. lume , .  : December  I,” “minimal TBI,” “grade I TBI,” “class I TBI,” and “low- k TBI.” Even the terms “head” and “brain” have been used erchangeably. Head injury and TBI are 2 distinct entities that often, but not necessarily, related. A head injury is best fined as an injury that is clinically evident on physical mination and is recognized by the presence of ecchymoses, erations, deformities, or cerebrospinal fluid leakage. A umatic brain injury refers specifically to an injury to the brain elf and is not always clinically evident; if unrecognized, it may ult in an adverse outcome. The American Congress of Rehabilitation Medicine lineated inclusion criteria for a diagnosis of mild TBI, of ich at least 1 of the following must be met17: Any period of loss of consciousness of less than 30 minutes and GCS score of 13 to 15 after this period of loss of consciousness; Any loss of memory of the event immediately before or after the accident, with posttraumatic amnesia of less than 24 hours; or Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented, or confused). The Centers for Disease Control and Prevention has veloped a similar conceptual definition for mild TBI18: currence of injury to the head, resulting from blunt trauma acceleration or deceleration forces, with one or more of the lowing conditions attributable to the head injury during the veillance period: Any period of observed or self-reported transient confusion, disorientation, or impaired consciousness Any period of observed or self-reported dysfunction of memory (amnesia) around the time of injury Observed signs of other neurologic or neuropsychological dysfunction Any period of observed or self-reported loss of consciousness lasting 30 minutes or less. Both definitions are broad and contribute to the difficulty of erpreting the mild TBI literature. Historically, the system most often used for grading severity brain injury is the GCS. The phrase “mild TBI” is usually plied to patients with a score of 13 or greater. Some authors ve suggested that patients with a GCS score of 13 be excluded m the “mild” category and placed into the “moderate” risk up because of their high incidence of lesions requiring urosurgical intervention.19-21 Lesions requiring neurosurgical ervention may not be the only injuries that require ntification. In a prospective study, patients with a GCS score 13 or greater were grouped according to the presence or sence of acute intracranial injury.20 Despite having GCS res of 13 to 15, those patients with intraparenchymal lesions rformed on neuropsychological testing similar to those tients categorized as having moderate TBI (GCS scores o 12). Annals of Emergency Medicine 715 Created by Teasdale and Jennett22 in 1974, the GCS was de int he too lea pa sup de eva fac shi no qu pri mi is i aft val rem po low em usi de sco req pla Ho sin mi the be ap po foc tho sym ord ch of an an fro pre pri co exp red co ha Definitions has app hav an po ou GC the po CT to sug pa ha po los the pa of 61 pu de co sen stu eli Be be Ac Ph pa rec ● ● ● ● rec ● ● ● ● qu ide qu 1. 2. Clinical Policy 71 veloped as a standardized clinical scale to facilitate reliable erobserver neurologic assessments of comatose patients with ad injury. The original studies applying the GCS score as a l for assessing outcome required that coma be present for at st 6 hours.22-24 The scale was not designed to diagnose tients with mild or even moderate TBI, nor was it intended to plant a neurologic examination. Instead, the GCS was signed to provide an easy-to-use assessment tool for serial luations by relatively inexperienced care providers and to ilitate communication between care providers on rotating fts.22 This need was especially great because CT scanning was t yet available. Since its introduction, the GCS has become ite useful for diagnosing severe and moderate TBI and for oritizing interventions in these patients. Nevertheless, for ld TBI, a single GCS score is of limited prognostic value and nsufficient to determine the degree of parenchymal injury er trauma.22 On the other hand, serial GCS scores are quite uable in patients with mild TBI. A low GCS score that ains low or a high GCS score that decreases predicts a orer outcome than a high GCS score that remains high or a GCS score that progressively improves.24,25 From an ergency medical services’ and ED perspective, the key to ng the GCS in patients with mild TBI is in serial terminations. When head CT is not available, serial GCS res clearly are the best method for detecting patients who uire a neurosurgical procedure. The GCS score continues to y this role and to provide important prognostic information. wever, the previous discussion makes it clear that the use of a gle GCS determination cannot be used solely in diagnosing ld TBI. In one of the original multicenter studies validating scale in the pre-CT era, approximately 13% of patients who came comatose had an initial GCS of 15.24 The immediate challenge in the ED lies in identifying the parently well, neurologically intact patient who has a tentially significant intracranial injury. These patients are the us of this clinical policy. A second challenge is to identify se patients at risk for having prolonged postconcussive ptoms and those at risk for the postconcussive syndrome in er to ensure proper discharge planning. Meeting the second allenge has proven to be elusive and remains an area in need research. Increased attention has been brought to bear on concussions d postconcussive issues as a result of the wars in Afghanistan d Iraq. TBI has been labeled the “signature injury” resulting m these conflicts. The proportion of military personnel senting with a blunt TBI has increased dramatically, marily because of an increase in survival after exposure to ncussive weapons (primarily a result of lower-yield improvised losive devices, coupled with modern body armor that uces fatal penetrating injuries). In the Afghanistan/Iraq nflicts, approximately 20% of returning combat personnel ve experienced a TBI in theater.26 6 Annals of Emergency Medicine Since the initial 2002 clinical policy, an analysis of the literature driven a change in the working definition of mild TBI as it lies to this document. The majority of patients classified as ing mild TBI have a GCS score of 15 when they are in the ED, d consequently this group was the focus of the first clinical licy.12 The Canadian CTHead Rule, which has a primary tcome measure of a neurosurgical lesion, includes patients with a S of 14 and allows for a period of 2 hours for normalization of GCS score before deciding on imaging.27 Since this clinical licy was first published, several studies have used the Canadian Head Rule criteria, and therefore the panel members decided use a GCS of 14 or 15 as inclusion criteria. In the 2002 edition of this clinical policy, the literature gested that the absence of loss of consciousness or amnesia in tients with blunt head injury were negative predictors of ving an intracranial injury; therefore, in the 2002 clinical licy, inclusion criteria for application required the presence of s of consciousness or posttraumatic amnesia and implied that absence of loss of consciousness or posttraumatic amnesia in tients with a nonfocal neurologic examination and GCS score 15 precluded the need to obtain a head CT (if age less than years and patient was not on anticoagulants).12 Since the blication of the first edition of this clinical policy, 2 well- signed studies have demonstrated that neither loss of nsciousness nor posttraumatic amnesia are sufficiently sitive to identify all patients at risk.8,28 After a review of these dies, the panel decided to change the inclusion criteria by minating these factors as criteria for this clinical policy. cause mild TBI management in the pediatric population has en presented in a clinical policy developed by the American ademy of Pediatrics and the American Academy of Family ysicians, this clinical policy specifically addresses mild TBI in tients aged 16 years or older.29 Inclusion criteria for application of this clinical policy’s ommendations are: Nonpenetrating trauma to the head Presentation to the ED within 24 hours of injury A GCS score of 14 or 15 on initial evaluation in the ED and Age 16 years or greater Exclusion criteria for application of this clinical policy’s ommendations include: Penetrating trauma Patients with multisystem trauma GCS score less than 14 on initial evaluation in the ED and Age less than 16 years Evidence-based practice guidelines require that a focused estion be asked and that a clear outcome measure be ntified. The 2002 clinical policy12 identified 3 critical estions relevant to clinical practice: Is there a role for plain film radiographs in the assessment of acute mild TBI in the ED? Which patients with acute mild TBI should have a noncontrast head CT scan in the ED? Volume , .  : December  3. Can a patient with mild TBI be safely discharged from the rad tha ma 1. 2. 3. 4. de ab ne po inj ou ne for pri Th of ap are (su ne pro ava an M cri Co Jan the were limited to English-language sources, human studies, and age rev be Ad art So inc Ph be lite use an the ne to gra evi cla de rep an Ar rel ver all val val rec pre of “X po da rev acc rec are fou po pa cri pa cer ov stu ma ma (ie Clinical Policy Vo ED if a noncontrast head CT scan shows no evidence of acute injury? In this revision, the first question about the role of plain film iographs was not readdressed because the panel concluded t there is no new evidence that changes the recommendation de in 2002: Recommendation B: Skull film radiographs are not recommended in the evaluation of mild TBI. Although the presence of a skull fracture increases the likelihood of an intracranial lesion, its sensitivity is not sufficient to be a useful screening test. Indeed, negative findings on skull films may mislead the clinician. The questions addressed in this clinical policy update are: Which patients with mild TBI should have a noncontrast head CT scan in the ED? Is there a role for head magnetic resonance imaging (MRI) over noncontrast CT in the ED evaluation of a patient with acute mild TBI? In patients with mild TBI, are brain-specific serum biomarkers predictive of an acute traumatic intracranial injury? 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? The panel considered several outcome measures in veloping this clinical policy, including presence of an acute normality on noncontrast CT scan, clinical deterioration, ed for neurosurgical intervention, and the development of stconcussive symptoms. Presence of an acute intracranial ury on noncontrast head CT scan was chosen as the primary tcome measure; development of a lesion requiring urosurgical intervention was the secondary outcome measure questions 1, 2, and 3. Neurologic deterioration was the mary outcome measure for question 4. The limitations of these outcome measures were discussed. ere is a paucity of literature that discusses the natural course acute traumatic intracranial lesions in patients who initially pear intact. The Canadian CT Head Rule suggests that there inconsequential traumatic lesions, such as “smear” subdurals bdurals less than 4 mm thick), for which detection is not cessary27; however, this is based on survey data and not on spective studies. Unfortunately, there is insufficient evidence ilable to use the development of postconcussive symptoms as outcome measure at this time. ETHODOLOGY This clinical policy was created after careful review and tical analysis of the medical literature. MEDLINE and the chrane Database were searched for articles published from uary 2000 through 2007. Specific key words/phrases used in searches are identified under each critical question. Searches lume , .  : December  d 16 years or older. References obtained on the searches were iewed by panel members (title and abstract) for relevance fore inclusion in the pool of studies to be reviewed. ditional articles were reviewed from the bibliographies of icles cited and from hand searches of published literature. me literature from the 2002 policy12 (1980 to 2001) is also luded in this current policy. The panel used the American College of Emergency ysicians clinical policy development process as described low. This policy is based on the existing literature; where rature was not available, consensus of panel members was d. Outside review comments were received from physicians d individuals with expertise in the topic area and practicing in fields of emergency medicine, neurology, neuroradiology, urosurgery, and neuropsychology. Their responses were used further refine and enhance this policy. All articles used in the formulation of this clinical policy were ded by at least 2 subcommittee members for strength of dence and classified by the subcommittee members into 3 sses of evidence on the basis of the design of the study, with sign 1 representing the strongest evidence and design 3 resenting the weakest evidence for therapeutic, diagnostic, d prognostic clinical reports, respectively (Appendix A). ticles were then graded on 6 dimensions thought to be most evant to the development of a clinical guideline: blinded sus nonblinded outcome assessment, blinded or randomized ocation, direct or indirect outcome measures (reliability and idity), biases (eg, selection, detection, transfer), external idity (ie, generalizability), and sufficient sample size. Articles eived a final grade (Class I, II, III) on the basis of a determined formula, taking into account design and quality study (Appendix B). Articles with fatal flaws were given an ” grade and not used in formulating recommendations in this licy. Evidence grading was done with respect to the specific ta being extracted and the specific crit