The Case for the Future Role of Evidence-Based Medicine in the Management of Cervical Spine Injuries, with Or Without Fractures

LITERATURE REVIEW J Neurosurg Spine 31:457–463, 2019

The case for the future role of evidence-based medicine in the management of cervical spine injuries, with or without fractures

JNSPG 75th Anniversary Invited Review Article

Mark N. Hadley, MD,1 and Beverly C. Walters, MD, MSc, FRCSC1,2

1Department of Neurosurgery, University of Alabama at Birmingham, Alabama; and 2Department of Neurosurgery, Henry Ford Health System, Detroit, Michigan

The authors believe that the standardized and systematic study of immobilization techniques, diagnostic modalities, medical and surgical treatment strategies, and ultimately outcomes and outcome measurement after cervical spinal trauma and cervical spinal fracture injuries, if performed using well-designed medical evidence–based comparative investigations with meaningful follow-up, has both merit and the remarkable potential to identify optimal strategies for assessment, characterization, and clinical management. However, they recognize that there is inherent difficulty in attempting to apply evidence-based medicine (EBM) to identify ideal treatment strategies for individual cervical fracture injuries. First, there is almost no medical evidence reported in the literature for the management of specific isolated cervical fracture subtypes; specific treatment strategies for specific fracture injuries have not been routinely studied in a rigorous, comparative way. One of the vulnerabilities of an evidenced-based scientific review in spinal cord injury (SCI) is the lack of studies in comparative populations and scientific evidence on a given topic or fracture pattern providing level II evidence or higher. Second, many modest fracture injuries are not associated with vascular or neural injury or spinal instability. The application of the science of EBM to the care of patients with traumatic cervical spine injuries and SCIs is invaluable and necessary. The dedicated multispecialty author groups involved in the production and publication of the two iterations of evidence-based guidelines on the management of acute cervical spine and spinal cord injuries have provided strategic guidance in the care of patients with SCIs. This dedicated service to the specialty has been carried out to provide neurosurgical colleagues with a qualitative review of the evidence supporting various aspects of care of these patients. It is important to state and essential to understand that the science of EBM and its rigorous application is important to medicine and to the specialty of neurosurgery. It should be embraced and used to drive and shape investigations of the management and treatment strategies offered patients. It should not be abandoned because it is not convenient or it does not support popular practice bias or patterns. It is the authors’ view that the science of EBM is essential and necessary and, furthermore, that it has great potential as clinician scientists treat and study the many variations and complexities of patients who sustain acute cervical spine fracture injuries. https://thejns.org/doi/abs/10.3171/2019.6.SPINE19652 KEYWORDS evidence-based medicine; neurosurgery guidelines; cervical spine injury; spinal cord injury

he authors have long been students, practitioners, and ultimately outcomes and outcome measurement after cer- promoters of evidence-based medicine (EBM)—or vical spinal trauma and cervical spinal fracture injuries, as we prefer to call it, “evidence-based methodol- if performed using well-designed medical evidence–based Togy”—in neurological surgery, one for 25 years (M.N.H.), comparative investigations with meaningful follow-up, and the other experienced and well-versed author (B.C.W.) has both merit and the remarkable potential to identify for almost 40 years. We believe that the standardized and optimal strategies for assessment, characterization, and systematic study of immobilization techniques, diagnostic clinical management.41 We have twice led multiple author modalities, medical and surgical treatment strategies, and groups with varied backgrounds, specialties, and experi-

ABBREVIATIONS EBM = evidence-based medicine; NASCIS = National Acute Spinal Cord Injury Studies; SCI = spinal cord injury; SLIC = Subaxial Injury Classification; STASCIS = Surgical Timing in Acute Spinal Cord Injury Study. SUBMITTED June 2, 2019. ACCEPTED June 19, 2019. INCLUDE WHEN CITING DOI: 10.3171/2019.6.SPINE19652.

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Unauthenticated | Downloaded 10/02/21 02:23 AM UTC Hadley and Walters ences to review the existing scientific literature, create associated with multiple injury variables, including mal- evidentiary tables, and write summary guidelines based alignment, interspace or facet compromise, neural or vas- on well-defined principles of EBM for the management of cular injury, and involvement of more than one cervical acute cervical spine and spinal cord injuries, which were vertebra, makes characterization of the fracture injury thoroughly reviewed and officially ratified by our national problematic because several aspects of the injury pattern neurosurgical organizations (the Washington Committee, and its influence on neural structures and the remainder the American Association of Neurological Surgeons, and of the cervical spine may influence treatment. For the few the Congress of Neurological Surgeons). They have now randomized clinical trials that have been carried out in twice been published, first in 2002, and most recently in patients with SCI, these details have never been addressed, 2013.12,14,42 These guideline summaries, particularly the much less accounted for within the randomization scheme 2013 updated version, represent the current “official” or statistical analysis process. stance of our specialty on these multiple and varied as- The more complicated cervical fracture injuries are, pects of cervical spine fractures and spinal cord injuries the more likely they are to require treatment for initial (SCIs). immobilization and ultimately for surgical realignment; Topics reviewed and discussed in 2013 include prehos- decompression of the spinal canal, cord, or root; and pital immobilization of potentially injured patients;39 their spinal stabilization and fusion. These types of cervical transport,38 clinical assessment,13 and radiographic assess- spine fractures and dislocation-malalignment injuries are ment;32 initial closed reduction of fracture-dislocation in- heterogeneous in both pattern and pathogenesis and are juries;11 acute cardiopulmonary management;33 pharmaco- difficult to discretely classify. Treatment strategies involv- logical therapy;18 cervical fracture classification schemes;1 ing surgery when required are many, involving anterior individual fracture injuries and subtypes—from occipital approaches, posterior approaches, or both, and include a condyle fracture injuries through fracture-dislocation in- spectrum of potential internal fixation and fusion options juries of the cervical vertebra through the cervical-thorac- and techniques that are variously used based on the frac- ic junction (for both adult and pediatric patients);10,26–31,36,37 ture pattern and such associated characteristics as adja- and related important topics of traumatic vertebral artery cent-level and neurological injury, spinal deformity, insti- injuries15 and venous thromboembolism.7 In all, 21 top- tutional resources, and individual surgeon preferences and ics were meticulously reviewed and 21 guidelines were experience. With so many injury pattern and treatment generated offering 103 evidence-based recommendations variables, rigorous comparative evidence-based studies including 18 level I (highest evidence) recommendations of specific yet different treatment strategies of these com- (Table 1), 17 level II recommendations, and 68 level III plex, multifactorial fracture injuries have not been accom- recommendations, using a clear, well-defined, science- plished to date, and truthfully, may never be. based methodology and a supportive bibliography of 2565 EBM has been applied to these types of injuries, not citations.12 This undertaking inspired official praise in the for a specific treatment or operation but to assess the need United States Congress by Congressman James Langevin, for surgical therapy rather than external immobilization himself a quadriplegic victim of SCI, along with fellow and follow-up. Several subaxial cervical spine injury clas- Congressmen and -women representing the home states sification schemes have been developed to provide algo- of each of the guidelines’ authors, that can be found in the rithms to help guide the management of these more com- United States Congressional Record.20 plex injuries and to predict their outcome with or without There is inherent difficulty in attempting to apply surgery. These schemes incorporate fracture injury mor- EBM to identify ideal treatment strategies for individual phology, compromise of related disc and ligaments (disco- cervical fracture injuries. First and foremost, there is al- ligamentous complex) using contemporary imaging, and most no medical evidence reported in our literature for the patient’s neurological status. The Harris classification16 the management of specific isolated cervical fracture and the Allen classification2 systems of subaxial cervical subtypes; simply stated, specific treatment strategies for spine injury have low reliability, demonstrated by low in- specific fracture injuries have not been routinely studied traclass correlation coefficients, thereby providing level III in a rigorous, comparative way. One of the vulnerabili- evidence for class III recommendations. In contrast, the ties of an evidenced-based scientific review in SCI is the Subaxial Injury Classification (SLIC) System and Injury lack of study in comparative populations and scientific Severity Score40 provides level I evidence with excellent evidence on a given topic or fracture pattern providing reliability and class I recommendations for a classification level II evidence or higher. Second, many modest fracture system that features graded instability and fracture pat- injuries (i.e., isolated vertebral chip fractures or isolated terns in patients with SCI after cervical spinal traumatic laminar or transverse process fractures) are not associated injury. Use of the SLIC for its intended purposes can as- with vascular or neural injury or spinal instability. These sist clinicians in the management of patients with complex types of minor cervical vertebral injuries are stable and cervical fracture-dislocation injuries (i.e., the patient is have not been subjected to evidence-based comparative likely to require decompression of the spinal canal and scrutiny. They are managed expectantly, with or without spinal cord followed by spinal realignment and stabiliza- a cervical orthosis (for patient comfort and modest motion with internal fixation and fusion), but does not offer tion limitation), many without recommended clinical or specific recommendations for detailed surgical manage- radiographic follow-up. These minor injuries and the pa- ment. tients who have them rarely require reassessment. Third, There is one example in the scientific literature of the the complexity of many cervical fracture injuries that are use of EBM investigative methods in the study of the treat-

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TABLE 1. Level I recommendations from the 2013 management guidelines for acute cervical spine injuries and SCIs42 Topic Recommendations Clinical assessment13 Functional outcome assessment The Spinal Cord Independence Measure III is recommended as the preferred functional outcome assessment tool for clinicians involved in the assessment, care, and follow-up of patients with SCIs. Pain associated with SCI The International Spinal Cord Injury Basic Pain Data Set is recommended as the preferred means to assess pain, including pain severity, physical functioning, and emotional functioning, among SCI patients. Radiographic assessment32 Awake, asymptomatic patient In the awake, asymptomatic patient who is without neck pain or tenderness, who has a normal neurological examination, is without an injury detracting from an accurate evaluation, and who is able to complete a functional range of motion examination, radiographic evaluation of the cervical spine is not recommended. Discontinuance of cervical immobilization for these patients is recommended without cervical spinal imaging. Awake, symptomatic patient In the awake, symptomatic patient, high-quality CT imaging of the cervical spine is recommended. If high-quality CT imaging is available, routine 3-view cervical spine radiographs are not recommended. If high-quality CT imaging is not available, a 3-view cervical spine series (anteroposterior, lateral, and odontoid views) is recommended. This should be supplemented with CT (when it becomes available) if necessary to further define areas that are suspicious or not well visualized on the plain cervical x-rays. Obtunded or unevaluable patient In the obtunded or unevaluable patient, high-quality CT imaging is recommended as the initial imaging modality of choice. If CT imaging is available, routine 3-view cervical spine radiographs are not recommended. If high-quality CT imaging is not available, a 3-view cervical spine series (anteroposterior, lateral, and odontoid views) is recommended. This should be supplemented with CT (when it becomes available) if necessary to further define areas that are suspicious or not well visualized on the plain cervical x-rays. Pharmacological treatment18 Administration of methylprednisolone for the treatment of acute SCI is not recommended. Clinicians consider- ing methylprednisolone therapy should bear in mind that the drug is not approved by the Food and Drug Administration for this application. There is no class I or class II medical evidence supporting the clinical benefit of methylprednisolone in the treatment of acute SCI. Scattered reports of class III evidence claim inconsistent effects likely related to random chance or selection bias. However, class I, II, and III evidence exists that high-dose steroids are associated with harmful side effects, including death. Administration of GM-1 ganglioside (Sygen) for the treatment of acute SCI is not recommended. AOD injuries36 CT imaging to determine the condyle-C1 interval in pediatric patients with potential AOD is recommended. Pediatric SCI26 CT imaging to determine the condyle-C1 interval in pediatric patients with potential AOD is recommended. VAI15 CT angiography is recommended as a screening tool in selected patients after blunt cervical trauma who meet the modified Denver Screening Criteria for suspected VAI. DVT and thromboembolism7 Low-dose heparin therapy alone is not recommended as a prophylactic treatment strategy. Oral anticoagulation alone is not recommended as a prophylactic treatment strategy. Early administration of venous thromboembolism prophylaxis (within 72 h) is recommended. A 3-month duration of prophylactic treatment for DVT and PE is recommended. AOD = atlanto-occipital dislocation; DVT = deep venous thrombosis; PE = pulmonary embolism; VAI = vertebral artery injury. These recommendations were previously published in Walters BC, Hadley MN, Hurlbert RJ, Aarabi B, Dhall SS, Gelb DE, et al: Guidelines for the management of acute cervical spine and spinal cord injuries: 2013 update. Neurosurgery 60 (Suppl 1):82–91, 2013. Modified from Walters et al. with the permission of Oxford University Press on behalf of the Congress of Neurological Surgeons. ment of an isolated fracture of the cervical spine—the fracture (nonunion), was patient age. Patients 50 years and C2 odontoid type II fracture. This unique isolated frac- older had a risk of nonunion 21 times greater than that ture subtype has been the topic of study and treatment for found for patients younger than 50 years. Other medical decades. Previous reports suggest nonoperative treatment comorbidities that included sex, degree of dens displace- versus operative treatment based on a variety of patient ment, direction of displacement, length of hospital stay, or and fracture pattern characteristics. Previous studies—all length of follow-up had no significant effect on outcome. case series publications—offered level III recommenda- Their study provides level II evidence for a class II recom- tions on this topic for this isolated fracture injury. In 2000, mendation for the treatment of type II odontoid fractures Lennarson et al. performed a comparative case-control in adult patients. The only methodological improvement analysis of 33 patients with type II odontoid fractures on this would be a randomized controlled trial—a very treated with halo ring-vest immobilization.22 The authors unlikely occurrence in any spinal specialty. found that the only feature related to successful halo vest When higher-quality evidence provides a stronger, treatment as exemplified by fracture healing, compared to more definite recommendation, does it follow that this can failed halo immobilization treatment of a type II odontoid be applied consistently? For example, an 83-year-old, frail,

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Unauthenticated | Downloaded 10/02/21 02:23 AM UTC Hadley and Walters senile nursing home resident rolls out of bed and injures ries and with adequate follow-up, investigators may be his/her neck with resultant neck pain and imaging reveal- able to discern not just the potential merits of surgi- ing an isolated type II odontoid fracture. Based on the cal decompression, stabilization, and fusion for those medical evidence concerning this fracture subtype, should similar SLIC injuries, but also potentially the specific he/she be treated operatively? Our answer would be “not methods and techniques of surgery, including which necessarily.” Medical evidence does not dictate what a cli- type of internal fixation constructs may have the most nician/surgeon must do in any given situation; it provides merit, providing level II medical evidence by providing the clinician with the best available data about union ver- a population from whom to draw cases for case-control sus nonunion for these types of fracture injuries treated in or cohort studies. a halo device. Consideration for surgical treatment is more The application of the science of EBM to the care of than the available medical evidence. This patient is not patients with traumatic cervical spine injuries and SCIs likely to tolerate surgery and anesthesia. He/she has signif- is invaluable and necessary. The dedicated multispecialty icantly increased risk of morbidity and mortality if treated author groups involved in the production and publica- in a halo immobilization device. Operative internal fixation of the two iterations of evidence-based guidelines tion is unlikely to endure and fusion is not likely to occur on the management of acute cervical spine injuries and at that age; so perhaps this patient is best managed medi- SCIs have provided strategic guidance in the care of pa- cally with nonnarcotic pain control and comfort care. So tients with SCIs. This dedicated service to the specialty although the highest-quality available scientific evidence has been carried out to provide neurosurgical colleagues for best treatments may indicate a specific direction, it is with a qualitative review of the evidence supporting vari- understood that those treatments must be individualized ous aspects of care of patients with SCI. The benefits of in the care of the specific patient, as we continue to pursue the production of rigorous evidence-based guidelines are precision medical care. many. 35 In particular: It is our optimistic view that the future application of the science of EBM to the management of cervical spine 1. Guidelines serve to chronicle the multiple acceptable fracture injuries involves 3 comparative pathways. treatment options for individual patient pathology and can refute the scientific weakness of “How I do it!” 1. Comparative assessment of the long-term outcome of proclamations. specific isolated fracture injuries (much like the iso- 2. Guidelines development can be used to compare new lated type II odontoid fracture studied by Lennarson et technology and new techniques to established surgical al.) treated the same way (case-control study).22 What procedures. factor(s) resulted in successful treatment or failure of 3. Guidelines development, methodology, and process can treatment? Fracture injuries potentially amenable to help define standards of care or help refute false/inac- this type of study might include isolated atlas fractures, curate “standards of care.” isolated hangman’s fractures of C2, isolated subaxial 4. Scientifically sound guidelines have the potential to pillar fractures, isolated subaxial vertebral compres- modify existing assessment, management, and treat- sion fractures, and perhaps others. This type of dili- ment strategies among clinicians worldwide, within gent comparative scientific evaluation of specific iso- institutions, and within healthcare systems to stream- lated vertebral injury subtypes has the potential to offer line and improve patient care by supporting efficient meaningful level II medical evidence on their manage- critical-care pathways. ment when we are not able to study these in the level I 5. EBM guidelines production helps to define ideal, re- randomized controlled trials. sponsible, and effective strategies based on scientific 2. Comparative assessment of the long-term outcome of evidence, offering scientific consensus based on de- specific isolated fracture injuries treated two different fined, proven effects and outcomes. ways (nonrandomized cohort studies). Well-designed 6. The process of guidelines formation helps to identify (especially prospective) comparative cohort scientific areas, issues, and strategies for which there are gaps study of the outcomes of similar patients with similar isolated fracture injuries who are treated differently in scientific evidence and identifies topics that need fo- may offer data on long-term relative therapeutic effec- cused scientific investigation. tiveness (level II medical evidence) of the distinctly dif- 7. The guidelines development process allows us the po- ferent treatment strategies available. tential to educate ourselves and colleagues and to en- 3. The use of the SLIC and Injury Severity Score in the hance our educational paradigms, thereby leading oth- assessment of more complex traumatic cervical spinal ers to create EBM science for our specialty. column injuries, especially in a well-designed compre- One of the most compelling and valuable examples of hensive multiinstitutional neurosurgical and orthopedic item 3 above is the systematic review and critique of the registry, would provide a new and unique opportunity medical evidence published in our literature on the topic for detailed hypothesis generation leading to easier of methylprednisolone administration following acute comparative studies. Properly designed, a registry of traumatic SCI. Two National Acute Spinal Cord Injury hundreds or perhaps thousands of similar SLIC injury Studies (NASCIS II3,4 and NASCIS III5,6) reported the po- severity patterns may provide real comparative scien- tential benefits of the administration of methylpredniso- tific evaluation of and feedback on the surgical man- lone to patients who sustained acute SCIs. The lay press agement of these more complex injury patterns. With heralded this discovery21 and care providers for these pa- sufficient numbers of patients with similar SLIC inju- tients with these devastating injuries. Trauma surgeons,

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Unauthenticated | Downloaded 10/02/21 02:23 AM UTC Hadley and Walters orthopedic spine surgeons, and neurosurgeons became In addition, the denial of facts that we do not like, espe- convinced that methylprednisolone improved neurologi- cially ones that challenge our beliefs in which treatments cal outcome among patients with SCI when administered provide either adequate or the most desirable outcomes, within 8 hours after injury. By consensus this strategy was seems entirely out of character for clinician scientists. But accepted as a new standard of care. recent research into human behavior around fact-finding Our detailed, exhaustive, evidence-based critical ap- and translation of the “facts” into “beliefs” reflects a phe- praisal of these studies (and many other published studies nomenon that has been dubbed “myside bias”24 and ex- on this topic) revealed that the NASCIS II and III stud- plores the propensity that when “presented with someone ies were negative studies. There were no significant dif- else’s argument, we’re quite adept at spotting the weak- ferences in neurological outcome in all of the primary nesses. Almost invariably, the positions we’re blind about preplanned comparisons between patients in the treatment are our own.”19 (methylprednisolone) and control groups. The 8-hour ad- When our guidelines author groups reviewed the exist- ministration window was arbitrarily selected from post hoc ing literature on early surgery for acute traumatic cervi- analysis. The modest early improvements in motor change cal spine injuries and SCIs both in 2002 and in 2013, we scores (not true motor scores) identified in the NASCIS II found very few publications and little scientific evidence trial were based on 17 methylprednisolone and 22 control on this important topic, the highest level of evidence be- patients with incomplete SCIs (of a total trial size of 487 ing opinion derived from single or multiple case series. patients) and were based on motor change scores on the Thus, without scientific study and meaningful and reliable right side of the body only at 6-month follow-up. These (reproducible) results, the topic could not be included in modest motor change score improvements identified at either iteration of our guidelines publications. 6-month follow-up did not endure at the 1-year follow-up. Trauma Section leaders cite the multicenter, multiinves- Neither study documented neurological improvement in tigator “Early Versus Delayed Decompression for Trau- patients with complete SCI. matic Cervical Spinal Cord Injury: Results of the Surgical The multiple study design mistakes, post hoc determi- Timing in Acute Spinal Cord Injury Study (STASCIS),” nations, arbitrary assignment of the 8-hour administra- published in PLoS One in 2012, as evidence that early tion window, and multiple other data exclusions (e.g., left decompression favorably impacts neurological morbidity side of the body scores) and data analysis flaws led to the following acute SCI in adults.9,34 The authors concluded characterization of the medical evidence offered in these that decompression prior to 24 hours after SCI is safe studies as flawed and without merit. Multiple studies—in- and is associated with improved neurological outcome at cluding NASCIS II and NASCIS III—reported increased 6 months after surgery. Although we are supporters and complications and harm with the administration of meth- admirers of the efforts of participants in this trial to at- ylprednisolone after acute SCI (level I medical evidence). tempt to provide helpful data in making this practice deci- To date the medical evidence on methylprednisolone is sion, the fact that it fails to do so cannot be ignored.25 An level I evidence against the use of methylprednisolone AOSpine author group generated a purported update to the after acute traumatic SCI.18 A presumed standard of care 2013 “Guidelines for the Management of Acute Cervical was appropriately refuted and dismissed as a viable and Spine and Spinal Cord Injuries” in 2017, advocating early effective treatment for acute SCI by applying the scien- surgery for traumatic cervical spine fracture-dislocation tific rigor of EBM. Those few individuals who continue to injuries based in large part on the results of the STASCIS embrace the belief that methylprednisolone has scientific trial.8 The problem is that the STASCIS trial, carried out merit may be biased by participation and investment in over a number of years, is hampered by poor follow-up; NASCIS studies, may not understand the practice of the multiple confounding factors; unbalanced, unequivalent science of EBM, or may just refuse to believe the pub- treatment groups; and the uneven distribution of both lished scientific facts. This latter potential cause of contin- pathologies and surgical treatments.25 It was rejected for ued support of the use of this potentially harmful drug can publication in both of our national organization journals— be explored further. Journal of Neurosurgery of the AANS and Neurosurgery Resistance to factual data is interesting. As clinician of the CNS. The subsequent AOSpine-proposed updated scientists, we need to depend on scientific facts—insofar guidelines publication was reviewed by the Washington as they are known—in clinical decision-making, albeit Committee’s Guidelines Committee of the AANS and modified by patient details that deviate from those in the CNS and was rejected for lack of meaningful evidence patients from whom the (usually published) facts were de- to support the authors’ conclusions, and was therefore not rived. But outside of this caveat, we need to proceed with carried out “under the auspices” of the national organiza- the strength of the evidence behind our decision-making. tions as was stated. The concept that, because high-quality clinical trials are It is important to recognize that, outside of the inherent so difficult—and expensive—to do, we need to look for value of scientific merit to us as clinician scientists, rec- alternatives is neither heretical nor outlandish. We have ommending treatments or management pathways that lack shown above that comparative case-control studies can el- such scientific backup exposes practitioners to unfortunate evate the strength of recommendations to class II. What and avoidable malpractice forays. Turning away from the is disturbing is that there appears to be an evolving be- highest quality of scientific evidence leaves us unprotect- lief that simpler prognosis-with-treatment case series, the ed as to our therapeutic choices when treating patients, weakest of all evidence, is a target methodology for con- which may be completely opposed to those espoused by sideration, as discussed below. other “experts.” By jumping from the terrorization of the

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Unauthenticated | Downloaded 10/02/21 02:23 AM UTC Hadley and Walters well-designed, thoughtfully implemented, randomized 8. Fehlings MG, Tetreault LA, Wilson JR, Aarabi B, Anderson controlled trial back to the case series, or “prognosis with P, Arnold PM, et al: A clinical practice guideline for the treatment” paradigm, without giving the middle-ground, management of patients with acute spinal cord injury and central cord syndrome: recommendations on the timing (≤24 easier-to-implement types of study a place in our scientific hours versus >24 hours) of decompressive surgery. Global lives, we expose ourselves to the potential for the terroriza- Spine J 7 (3 Suppl):195S–202S, 2017 tion of the malpractice arena. 9. Fehlings MG, Vaccaro A, Wilson JR, Singh A, W Cadotte Although we understand the disenchantment with pur- D, Harrop JS, et al: Early versus delayed decompression for suing the extraordinary difficulty of designing, organizing, traumatic cervical spinal cord injury: results of the Surgical funding, and implementing randomized controlled trials Timing in Acute Spinal Cord Injury Study (STASCIS). PLoS in surgical specialties,23 we do believe that the larger, less One 7:e32037, 2012 difficult questions should be addressed whenever possible 10. Gelb DE, Aarabi B, Dhall SS, Hurlbert RJ, Rozzelle CJ, in this manner. However, we also believe that we should Ryken TC, et al: Treatment of subaxial cervical spinal injuries. Neurosurgery 72 (Suppl 2):187–194, 2013 be focusing on the less difficult comparative observational 11. Gelb DE, Hadley MN, Aarabi B, Dhall SS, Hurlbert RJ, studies like case-control, cohort, or cross-sectional stud- Rozzelle CJ, et al: Initial closed reduction of cervical spinal ies carried out in a careful, robust manner by using estab- fracture-dislocation injuries. Neurosurgery 72 (Suppl lished, carefully worked out methodology.17 2):73–83, 2013 It is important to state and essential to understand that 12. Hadley MN, Walters BC: Introduction to the Guidelines for the science of EBM and its rigorous application is impor- the Management of Acute Cervical Spine and Spinal Cord tant to medicine and to our specialty of neurosurgery. It Injuries. Neurosurgery 72 (Suppl 2):5–16, 2013 should be embraced and used to drive and shape our in- 13. Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, et al: Clinical assessment following acute vestigations of the management and treatment strategies cervical spinal cord injury. Neurosurgery 72 (Suppl 2):40– we offer patients. It should not be abandoned because it 53, 2013 is not convenient or it does not support popular practice 14. Hadley MN, Walters BC, Grabb PA, Oyesiku NM, Przybylski bias or patterns. It is our view that the science of EBM is GJ, Resnick DK, et al: Guidelines for the management of essential and necessary and, furthermore, that it has great acute cervical spine and spinal cord injuries. Clin Neurosurg potential as we treat and study the many variations and 49:407–498, 2002 complexities of patients who sustain acute cervical spine 15. Harrigan MR, Hadley MN, Dhall SS, Walters BC, Aarabi fracture injuries. B, Gelb DE, et al: Management of vertebral artery injuries following non-penetrating cervical trauma. Neurosurgery 72 (Suppl 2):234–243, 2013 References 16. Harris JHJ Jr, Edeiken-Monroe B, Kopaniky DR: A practical 1. Aarabi B, Walters BC, Dhall SS, Gelb DE, Hurlbert classification of acute cervical spine injuries. Orthop Clin RJ, Rozzelle CJ, et al: Subaxial cervical spine injury North Am 17:15–30, 1986 classification systems. Neurosurgery 72 (Suppl 2):170–186, 17. Hu X, Wright JG, McLeod RS, Lossing A, Walters BC: 2013 Observational studies as alternatives to randomized clinical 2. Allen BLJ Jr, Ferguson RL, Lehmann TR, O’Brien RP: A trials in surgical clinical research. Surgery 119:473–475, mechanistic classification of closed, indirect fractures and 1996 dislocations of the lower cervical spine. Spine (Phila Pa 18. Hurlbert RJ, Hadley MN, Walters BC, Aarabi B, Dhall SS, 1976) 7:1–27, 1982 Gelb DE, et al: Pharmacological therapy for acute spinal cord 3. Bracken MB, Shepard MJ, Collins WF, Holford TR, Young injury. Neurosurgery 72 (Suppl 2):93–105, 2013 W, Baskin DS, et al: A randomized, controlled trial of 19. Kolbert E: Why facts don’t change our minds. New methylprednisolone or naloxone in the treatment of acute discoveries about the human mind show the limitations of spinal-cord injury. Results of the Second National Acute reason. The New Yorker. February 19, 2017 (https://www. Spinal Cord Injury Study. N Engl J Med 322:1405–1411, 1990 newyorker.com/magazine/2017/02/27/why-facts-dont-change- 4. Bracken MB, Shepard MJ, Collins WF Jr, Holford TR, our-minds) [Accessed June 26, 2019] Baskin DS, Eisenberg HM, et al: Methylprednisolone or 20. Langevin J: Recognizing the contributors to the updated naloxone treatment after acute spinal cord injury: 1-year guidelines for the management of acute cervical spine and follow-up data. Results of the second National Acute Spinal spinal cord injuries. Congr Rec 159:E1394, 2013 Cord Injury Study. J Neurosurg 76:23–31, 1992 21. Leary WE: Treatment is said to reduce disability from spinal 5. Bracken MB, Shepard MJ, Holford TR, Leo-Summers injury. New York Times. March 31, 1990 (https://www. L, Aldrich EF, Fazl M, et al: Administration of nytimes.com/1990/03/31/us/treatment-is-said-to-reduce- methylprednisolone for 24 or 48 hours or tirilazad mesylate disability-from-spinal-injury.html) [Accessed June 26, 2019] for 48 hours in the treatment of acute spinal cord injury. 22. Lennarson PJ, Mostafavi H, Traynelis VC, Walters BC: Results of the Third National Acute Spinal Cord Injury Management of type II dens fractures: a case-control study. Randomized Controlled Trial. National Acute Spinal Cord Spine (Phila Pa 1976) 25:1234–1237, 2000 Injury Study. JAMA 277:1597–1604, 1997 23. McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, 6. Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Lossing A: Randomized controlled trials in surgery: issues Aldrich EF, Fazl M, et al: Methylprednisolone or tirilazad and problems. Surgery 119:483–486, 1996 mesylate administration after acute spinal cord injury: 1-year 24. Mercier H, Sperber D: The Enigma of Reason. Cambridge, follow up. Results of the third National Acute Spinal Cord MA: Harvard University Press, 2019 Injury randomized controlled trial. J Neurosurg 89:699– 25. O’Toole JE: Timing of surgery after cervical spinal cord 706, 1998 injury. World Neurosurg 82:e389–e390, 2014 7. Dhall SS, Hadley MN, Aarabi B, Gelb DE, Hurlbert 26. Rozzelle CJ, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, RJ, Rozzelle CJ, et al: Deep venous thrombosis and Ryken TC, et al: Management of pediatric cervical spine and thromboembolism in patients with cervical spinal cord spinal cord injuries. Neurosurgery 72 (Suppl 2):205–226, injuries. Neurosurgery 72 (Suppl 2):244–254, 2013 2013

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27. Rozzelle CJ, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, 38. Theodore N, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Ryken TC, et al: Os odontoideum. Neurosurgery 72 (Suppl Rozzelle CJ, et al: Transportation of patients with acute 2):159–169, 2013 traumatic cervical spine injuries. Neurosurgery 72 (Suppl 28. Rozzelle CJ, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, 2):35–39, 2013 Ryken TC, et al: Spinal cord injury without radiographic 39. Theodore N, Hadley MN, Aarabi B, Dhall SS, Gelb DE, abnormality (SCIWORA). Neurosurgery 72 (Suppl 2):227– Hurlbert RJ, et al: Prehospital cervical spinal immobilization 233, 2013 after trauma. Neurosurgery 72 (Suppl 2):22–34, 2013 29. Ryken TC, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, 40. Vaccaro AR, Hulbert RJ, Patel AA, Fisher C, Dvorak M, Rozzelle CJ, et al: Management of isolated fractures of the Lehman RA Jr, et al: The subaxial cervical spine injury atlas in adults. Neurosurgery 72 (Suppl 2):127–131, 2013 classification system: a novel approach to recognize the 30. Ryken TC, Hadley MN, Aarabi B, Dhall SS, Gelb DE, importance of morphology, neurology, and integrity of the Hurlbert RJ, et al: Management of acute combination disco-ligamentous complex. Spine (Phila Pa 1976) 32:2365– fractures of the atlas and axis in adults. Neurosurgery 72 2374, 2007 (Suppl 2):151–158, 2013 41. Walters BC, Hadley MN: Development of evidence-based 31. Ryken TC, Hadley MN, Aarabi B, Dhall SS, Gelb DE, guidelines for the management of acute spine and spinal cord Hurlbert RJ, et al: Management of isolated fractures of the injuries. Clin Neurosurg 50:239–248, 2003 axis in adults. Neurosurgery 72 (Suppl 2):132–150, 2013 42. Walters BC, Hadley MN, Hurlbert RJ, Aarabi B, Dhall 32. Ryken TC, Hadley MN, Walters BC, Aarabi B, Dhall SS, SS, Gelb DE, et al: Guidelines for the management of Gelb DE, et al: Radiographic assessment. Neurosurgery 72 acute cervical spine and spinal cord injuries: 2013 update. (Suppl 2):54–72, 2013 Neurosurgery 60 (CN Suppl 1):82–91, 2013 33. Ryken TC, Hurlbert RJ, Hadley MN, Aarabi B, Dhall SS, Gelb DE, et al: The acute cardiopulmonary management of patients with cervical spinal cord injuries. Neurosurgery 72 Disclosures (Suppl 2):84–92, 2013 34. Samadani U: Is the clock ticking on “Why don’t you The authors report no conflict of interest concerning the materi- hang some phenylephrine and call me in the morning?” als or methods used in this study or the findings specified in this Investigating evidence beyond the guidelines for acute paper. management of spinal cord injury. Neurotrauma & Critical Care News. Spring 2019; 3–5 (www.neurotraumasection. Author Contributions org/LiteratureRetrieve.aspx?ID=244949) [Accessed June 26, Conception and design: both authors. Drafting the article: both 2019] authors. Critically revising the article: both authors. Reviewed 35. Shank CD, Lepard JR, Walters BC, Hadley MN: Towards submitted version of manuscript: both authors. Approved the final evidence-based guidelines in neurological surgery. version of the manuscript on behalf of both authors: Hadley. Neurosurgery [epub ahead of print], 2018 36. Theodore N, Aarabi B, Dhall SS, Gelb DE, Hurlbert Correspondence RJ, Rozzelle CJ, et al: The diagnosis and management Mark N. Hadley: University of Alabama at Birmingham, Bir- of traumatic atlanto-occipital dislocation injuries. mingham, AL. [email protected]. Neurosurgery 72 (Suppl 2):114–126, 2013 37. Theodore N, Aarabi B, Dhall SS, Gelb DE, Hurlbert RJ, Rozzelle CJ, et al: Occipital condyle fractures. Neurosurgery 72 (Suppl 2):106–113, 2013

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