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

Free access

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.

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.

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.

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.

The authors have long been students, practitioners, and promoters of evidence-based medicine (EBM)—or as we prefer to call it, “evidence-based methodology”—in neurological surgery, one for 25 years (M.N.H.), and the other experienced and well-versed author (B.C.W.) for almost 40 years. We 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.41 We have twice led multiple author groups with varied backgrounds, specialties, and experiences to review the existing scientific literature, create evidentiary tables, and write summary guidelines based on well-defined principles of EBM for the management of acute cervical spine and spinal cord injuries, which were thoroughly reviewed and officially ratified by our national neurosurgical organizations (the Washington Committee, the American Association of Neurological Surgeons, and the Congress of Neurological Surgeons). They have now twice been published, first in 2002, and most recently in 2013.12,14,42 These guideline summaries, particularly the 2013 updated version, represent the current “official” stance of our specialty on these multiple and varied aspects of cervical spine fractures and spinal cord injuries (SCIs).

Topics reviewed and discussed in 2013 include prehospital immobilization of potentially injured patients;39 their transport,38 clinical assessment,13 and radiographic assessment;32 initial closed reduction of fracture-dislocation injuries;11 acute cardiopulmonary management;33 pharmacological therapy;18 cervical fracture classification schemes;1 individual fracture injuries and subtypes—from occipital condyle fracture injuries through fracture-dislocation injuries of the cervical vertebra through the cervical-thoracic junction (for both adult and pediatric patients);10,26–31,36,37 and related important topics of traumatic vertebral artery injuries15 and venous thromboembolism.7 In all, 21 topics were meticulously reviewed and 21 guidelines were generated offering 103 evidence-based recommendations including 18 level I (highest evidence) recommendations (Table 1), 17 level II recommendations, and 68 level III recommendations, using a clear, well-defined, science-based methodology and a supportive bibliography of 2565 citations.12 This undertaking inspired official praise in the United States Congress by Congressman James Langevin, himself a quadriplegic victim of SCI, along with fellow Congressmen and -women representing the home states of each of the guidelines’ authors, that can be found in the United States Congressional Record.20

TABLE 1.

Level I recommendations from the 2013 management guidelines for acute cervical spine injuries and SCIs42

TopicRecommendations
Clinical assessment13
 Functional outcome assessmentThe 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 SCIThe 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 patientIn 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 patientIn 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 patientIn 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 treatment18Administration of methylprednisolone for the treatment of acute SCI is not recommended. Clinicians considering 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 injuries36CT imaging to determine the condyle-C1 interval in pediatric patients with potential AOD is recommended.
Pediatric SCI26CT imaging to determine the condyle-C1 interval in pediatric patients with potential AOD is recommended.
VAI15CT 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 thromboembolism7Low-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.

There is inherent difficulty in attempting to apply EBM to identify ideal treatment strategies for individual cervical fracture injuries. First and foremost, there is almost no medical evidence reported in our literature for the management of specific isolated cervical fracture subtypes; simply stated, 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 SCI is the lack of study in comparative populations and scientific evidence on a given topic or fracture pattern providing level II evidence or higher. Second, many modest fracture injuries (i.e., isolated vertebral chip fractures or isolated laminar or transverse process fractures) are not associated with vascular or neural injury or spinal instability. These types of minor cervical vertebral injuries are stable and have not been subjected to evidence-based comparative scrutiny. They are managed expectantly, with or without a cervical orthosis (for patient comfort and modest motion limitation), many without recommended clinical or radiographic follow-up. These minor injuries and the patients who have them rarely require reassessment. Third, the complexity of many cervical fracture injuries that are associated with multiple injury variables, including malalignment, interspace or facet compromise, neural or vascular injury, and involvement of more than one cervical vertebra, makes characterization of the fracture injury problematic because several aspects of the injury pattern and its influence on neural structures and the remainder of the cervical spine may influence treatment. For the few randomized clinical trials that have been carried out in patients with SCI, these details have never been addressed, much less accounted for within the randomization scheme or statistical analysis process.

The more complicated cervical fracture injuries are, the more likely they are to require treatment for initial immobilization and ultimately for surgical realignment; decompression of the spinal canal, cord, or root; and spinal stabilization and fusion. These types of cervical spine fractures and dislocation-malalignment injuries are heterogeneous in both pattern and pathogenesis and are difficult to discretely classify. Treatment strategies involving surgery when required are many, involving anterior approaches, posterior approaches, or both, and include a spectrum of potential internal fixation and fusion options and techniques that are variously used based on the fracture pattern and such associated characteristics as adjacent-level and neurological injury, spinal deformity, institutional resources, and individual surgeon preferences and experience. With so many injury pattern and treatment variables, rigorous comparative evidence-based studies of specific yet different treatment strategies of these complex, multifactorial fracture injuries have not been accomplished to date, and truthfully, may never be.

EBM has been applied to these types of injuries, not for a specific treatment or operation but to assess the need for surgical therapy rather than external immobilization and follow-up. Several subaxial cervical spine injury classification schemes have been developed to provide algorithms to help guide the management of these more complex injuries and to predict their outcome with or without surgery. These schemes incorporate fracture injury morphology, compromise of related disc and ligaments (disco-ligamentous complex) using contemporary imaging, and the patient’s neurological status. The Harris classification16 and the Allen classification2 systems of subaxial cervical spine injury have low reliability, demonstrated by low intraclass correlation coefficients, thereby providing level III evidence for class III recommendations. In contrast, the Subaxial Injury Classification (SLIC) System and Injury Severity Score40 provides level I evidence with excellent reliability and class I recommendations for a classification system that features graded instability and fracture patterns in patients with SCI after cervical spinal traumatic injury. Use of the SLIC for its intended purposes can assist clinicians in the management of patients with complex cervical fracture-dislocation injuries (i.e., the patient is likely to require decompression of the spinal canal and spinal cord followed by spinal realignment and stabilization with internal fixation and fusion), but does not offer specific recommendations for detailed surgical management.

There is one example in the scientific literature of the use of EBM investigative methods in the study of the treatment of an isolated fracture of the cervical spine—the C2 odontoid type II fracture. This unique isolated fracture subtype has been the topic of study and treatment for decades. Previous reports suggest nonoperative treatment versus operative treatment based on a variety of patient and fracture pattern characteristics. Previous studies—all case series publications—offered level III recommendations on this topic for this isolated fracture injury. In 2000, Lennarson et al. performed a comparative case-control analysis of 33 patients with type II odontoid fractures treated with halo ring-vest immobilization.22 The authors found that the only feature related to successful halo vest treatment as exemplified by fracture healing, compared to failed halo immobilization treatment of a type II odontoid fracture (nonunion), was patient age. Patients 50 years and older had a risk of nonunion 21 times greater than that found for patients younger than 50 years. Other medical comorbidities that included sex, degree of dens displacement, direction of displacement, length of hospital stay, or length of follow-up had no significant effect on outcome. Their study provides level II evidence for a class II recommendation for the treatment of type II odontoid fractures in adult patients. The only methodological improvement on this would be a randomized controlled trial—a very unlikely occurrence in any spinal specialty.

When higher-quality evidence provides a stronger, more definite recommendation, does it follow that this can be applied consistently? For example, an 83-year-old, frail, senile nursing home resident rolls out of bed and injures his/her neck with resultant neck pain and imaging revealing an isolated type II odontoid fracture. Based on the medical evidence concerning this fracture subtype, should he/she be treated operatively? Our answer would be “not necessarily.” Medical evidence does not dictate what a clinician/surgeon must do in any given situation; it provides the clinician with the best available data about union versus nonunion for these types of fracture injuries treated in a halo device. Consideration for surgical treatment is more than the available medical evidence. This patient is not likely to tolerate surgery and anesthesia. He/she has significantly increased risk of morbidity and mortality if treated in a halo immobilization device. Operative internal fixation is unlikely to endure and fusion is not likely to occur at that age; so perhaps this patient is best managed medically with nonnarcotic pain control and comfort care. So although the highest-quality available scientific evidence for best treatments may indicate a specific direction, it is understood that those treatments must be individualized in the care of the specific patient, as we continue to pursue precision medical care.

It is our optimistic view that the future application of the science of EBM to the management of cervical spine fracture injuries involves 3 comparative pathways.

  1. Comparative assessment of the long-term outcome of specific isolated fracture injuries (much like the isolated type II odontoid fracture studied by Lennarson et al.) treated the same way (case-control study).22 What factor(s) resulted in successful treatment or failure of treatment? Fracture injuries potentially amenable to this type of study might include isolated atlas fractures, isolated hangman’s fractures of C2, isolated subaxial pillar fractures, isolated subaxial vertebral compression fractures, and perhaps others. This type of diligent comparative scientific evaluation of specific isolated vertebral injury subtypes has the potential to offer meaningful level II medical evidence on their management when we are not able to study these in the level I randomized controlled trials.
  2. Comparative assessment of the long-term outcome of specific isolated fracture injuries treated two different ways (nonrandomized cohort studies). Well-designed (especially prospective) comparative cohort scientific study of the outcomes of similar patients with similar isolated fracture injuries who are treated differently may offer data on long-term relative therapeutic effectiveness (level II medical evidence) of the distinctly different treatment strategies available.
  3. The use of the SLIC and Injury Severity Score in the assessment of more complex traumatic cervical spinal column injuries, especially in a well-designed comprehensive multiinstitutional neurosurgical and orthopedic registry, would provide a new and unique opportunity for detailed hypothesis generation leading to easier comparative studies. Properly designed, a registry of hundreds or perhaps thousands of similar SLIC injury severity patterns may provide real comparative scientific evaluation of and feedback on the surgical management of these more complex injury patterns. With sufficient numbers of patients with similar SLIC injuries and with adequate follow-up, investigators may be able to discern not just the potential merits of surgical decompression, stabilization, and fusion for those similar SLIC injuries, but also potentially the specific methods and techniques of surgery, including which type of internal fixation constructs may have the most merit, providing level II medical evidence by providing a population from whom to draw cases for case-control or cohort studies.

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 injuries and SCIs 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 patients with SCI. The benefits of the production of rigorous evidence-based guidelines are many.35 In particular:

  1. Guidelines serve to chronicle the multiple acceptable treatment options for individual patient pathology and can refute the scientific weakness of “How I do it!” proclamations.
  2. Guidelines development can be used to compare new technology and new techniques to established surgical procedures.
  3. Guidelines development, methodology, and process can help define standards of care or help refute false/inaccurate “standards of care.”
  4. Scientifically sound guidelines have the potential to modify existing assessment, management, and treatment strategies among clinicians worldwide, within institutions, and within healthcare systems to streamline and improve patient care by supporting efficient critical-care pathways.
  5. EBM guidelines production helps to define ideal, responsible, and effective strategies based on scientific evidence, offering scientific consensus based on defined, proven effects and outcomes.
  6. The process of guidelines formation helps to identify areas, issues, and strategies for which there are gaps in scientific evidence and identifies topics that need focused scientific investigation.
  7. The guidelines development process allows us the potential to educate ourselves and colleagues and to enhance our educational paradigms, thereby leading others to create EBM science for our specialty.

One of the most compelling and valuable examples of item 3 above is the systematic review and critique of the medical evidence published in our literature on the topic of methylprednisolone administration following acute traumatic SCI. Two National Acute Spinal Cord Injury Studies (NASCIS II3,4 and NASCIS III5,6) reported the potential benefits of the administration of methylprednisolone to patients who sustained acute SCIs. The lay press heralded this discovery21 and care providers for these patients with these devastating injuries. Trauma surgeons, orthopedic spine surgeons, and neurosurgeons became convinced that methylprednisolone improved neurological outcome among patients with SCI when administered within 8 hours after injury. By consensus this strategy was accepted as a new standard of care.

Our detailed, exhaustive, evidence-based critical appraisal of these studies (and many other published studies on this topic) revealed that the NASCIS II and III studies were negative studies. There were no significant differences in neurological outcome in all of the primary preplanned comparisons between patients in the treatment (methylprednisolone) and control groups. The 8-hour administration window was arbitrarily selected from post hoc analysis. The modest early improvements in motor change scores (not true motor scores) identified in the NASCIS II trial were based on 17 methylprednisolone and 22 control patients with incomplete SCIs (of a total trial size of 487 patients) and were based on motor change scores on the right side of the body only at 6-month follow-up. These modest motor change score improvements identified at 6-month follow-up did not endure at the 1-year follow-up. Neither study documented neurological improvement in patients with complete SCI.

The multiple study design mistakes, post hoc determinations, arbitrary assignment of the 8-hour administration window, and multiple other data exclusions (e.g., left side of the body scores) and data analysis flaws led to the characterization of the medical evidence offered in these studies as flawed and without merit. Multiple studies—including NASCIS II and NASCIS III—reported increased complications and harm with the administration of methylprednisolone after acute SCI (level I medical evidence). To date the medical evidence on methylprednisolone is level I evidence against the use of methylprednisolone after acute traumatic SCI.18 A presumed standard of care was appropriately refuted and dismissed as a viable and effective treatment for acute SCI by applying the scientific rigor of EBM. Those few individuals who continue to embrace the belief that methylprednisolone has scientific merit may be biased by participation and investment in NASCIS studies, may not understand the practice of the science of EBM, or may just refuse to believe the published scientific facts. This latter potential cause of continued support of the use of this potentially harmful drug can be explored further.

Resistance to factual data is interesting. As clinician scientists, we need to depend on scientific facts—insofar as they are known—in clinical decision-making, albeit modified by patient details that deviate from those in the patients from whom the (usually published) facts were derived. But outside of this caveat, we need to proceed with the strength of the evidence behind our decision-making. The concept that, because high-quality clinical trials are so difficult—and expensive—to do, we need to look for alternatives is neither heretical nor outlandish. We have shown above that comparative case-control studies can elevate the strength of recommendations to class II. What is disturbing is that there appears to be an evolving belief that simpler prognosis-with-treatment case series, the weakest of all evidence, is a target methodology for consideration, as discussed below.

In addition, the denial of facts that we do not like, especially ones that challenge our beliefs in which treatments provide either adequate or the most desirable outcomes, seems entirely out of character for clinician scientists. But recent research into human behavior around fact-finding and translation of the “facts” into “beliefs” reflects a phenomenon that has been dubbed “myside bias”24 and explores the propensity that when “presented with someone else’s argument, we’re quite adept at spotting the weaknesses. Almost invariably, the positions we’re blind about are our own.”19

When our guidelines author groups reviewed the existing literature on early surgery for acute traumatic cervical spine injuries and SCIs both in 2002 and in 2013, we found very few publications and little scientific evidence on this important topic, the highest level of evidence being opinion derived from single or multiple case series. Thus, without scientific study and meaningful and reliable (reproducible) results, the topic could not be included in either iteration of our guidelines publications.

Trauma Section leaders cite the multicenter, multiinvestigator “Early Versus Delayed Decompression for Traumatic Cervical Spinal Cord Injury: Results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS),” published in PLoS One in 2012, as evidence that early decompression favorably impacts neurological morbidity following acute SCI in adults.9,34 The authors concluded that decompression prior to 24 hours after SCI is safe and is associated with improved neurological outcome at 6 months after surgery. Although we are supporters and admirers of the efforts of participants in this trial to attempt to provide helpful data in making this practice decision, the fact that it fails to do so cannot be ignored.25 An AOSpine author group generated a purported update to the 2013 “Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries” in 2017, advocating early surgery for traumatic cervical spine fracture-dislocation injuries based in large part on the results of the STASCIS trial.8 The problem is that the STASCIS trial, carried out over a number of years, is hampered by poor follow-up; multiple confounding factors; unbalanced, unequivalent treatment groups; and the uneven distribution of both pathologies and surgical treatments.25 It was rejected for publication in both of our national organization journals—Journal of Neurosurgery of the AANS and Neurosurgery of the CNS. The subsequent AOSpine-proposed updated guidelines publication was reviewed by the Washington Committee’s Guidelines Committee of the AANS and CNS and was rejected for lack of meaningful evidence to support the authors’ conclusions, and was therefore not carried out “under the auspices” of the national organizations as was stated.

It is important to recognize that, outside of the inherent value of scientific merit to us as clinician scientists, recommending treatments or management pathways that lack such scientific backup exposes practitioners to unfortunate and avoidable malpractice forays. Turning away from the highest quality of scientific evidence leaves us unprotected as to our therapeutic choices when treating patients, which may be completely opposed to those espoused by other “experts.” By jumping from the terrorization of the well-designed, thoughtfully implemented, randomized controlled trial back to the case series, or “prognosis with treatment” paradigm, without giving the middle-ground, easier-to-implement types of study a place in our scientific lives, we expose ourselves to the potential for the terrorization of the malpractice arena.

Although we understand the disenchantment with pursuing the extraordinary difficulty of designing, organizing, funding, and implementing randomized controlled trials in surgical specialties,23 we do believe that the larger, less difficult questions should be addressed whenever possible in this manner. However, we also believe that we should be focusing on the less difficult comparative observational studies like case-control, cohort, or cross-sectional studies carried out in a careful, robust manner by using established, carefully worked out methodology.17

It is important to state and essential to understand that the science of EBM and its rigorous application is important to medicine and to our specialty of neurosurgery. It should be embraced and used to drive and shape our investigations of the management and treatment strategies we offer patients. It should not be abandoned because it is not convenient or it does not support popular practice bias or patterns. It is our view that the science of EBM is essential and necessary and, furthermore, that it has great potential as we treat and study the many variations and complexities of patients who sustain acute cervical spine fracture injuries.

Disclosures

The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

Author Contributions

Conception and design: both authors. Drafting the article: both authors. Critically revising the article: both authors. Reviewed submitted version of manuscript: both authors. Approved the final version of the manuscript on behalf of both authors: Hadley.

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  • 22

    Lennarson PJMostafavi HTraynelis VCWalters BC: Management of type II dens fractures: a case-control study. Spine (Phila Pa 1976) 25:123412372000

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    McLeod RSWright JGSolomon MJHu XWalters BCLossing A: Randomized controlled trials in surgery: issues and problems. Surgery 119:4834861996

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 24

    Mercier HSperber D: The Enigma of Reason. Cambridge, MA: Harvard University Press2019

  • 25

    O’Toole JE: Timing of surgery after cervical spinal cord injury. World Neurosurg 82:e389e3902014

  • 26

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Management of pediatric cervical spine and spinal cord injuries. Neurosurgery 72 (Suppl 2):2052262013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Os odontoideum. Neurosurgery 72 (Suppl 2):1591692013

  • 28

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Spinal cord injury without radiographic abnormality (SCIWORA). Neurosurgery 72 (Suppl 2):2272332013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Ryken TCAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Management of isolated fractures of the atlas in adults. Neurosurgery 72 (Suppl 2):1271312013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30

    Ryken TCHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Management of acute combination fractures of the atlas and axis in adults. Neurosurgery 72 (Suppl 2):1511582013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31

    Ryken TCHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Management of isolated fractures of the axis in adults. Neurosurgery 72 (Suppl 2):1321502013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32

    Ryken TCHadley MNWalters BCAarabi BDhall SSGelb DE: Radiographic assessment. Neurosurgery 72 (Suppl 2):54722013

  • 33

    Ryken TCHurlbert RJHadley MNAarabi BDhall SSGelb DE: The acute cardiopulmonary management of patients with cervical spinal cord injuries. Neurosurgery 72 (Suppl 2):84922013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 34

    Samadani U: Is the clock ticking on “Why don’t you hang some phenylephrine and call me in the morning?” Investigating evidence beyond the guidelines for acute management of spinal cord injury. Neurotrauma & Critical Care News. Spring 2019; 3–5 (www.neurotraumasection.org/LiteratureRetrieve.aspx?ID=244949) [Accessed June 26 2019]

    • Search Google Scholar
    • Export Citation
  • 35

    Shank CDLepard JRWalters BCHadley MN: Towards evidence-based guidelines in neurological surgery. Neurosurgery [epub ahead of print] 2018

  • 36

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: The diagnosis and management of traumatic atlanto-occipital dislocation injuries. Neurosurgery 72 (Suppl 2):1141262013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 37

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Occipital condyle fractures. Neurosurgery 72 (Suppl 2):1061132013

  • 38

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Transportation of patients with acute traumatic cervical spine injuries. Neurosurgery 72 (Suppl 2):35392013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 39

    Theodore NHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Prehospital cervical spinal immobilization after trauma. Neurosurgery 72 (Suppl 2):22342013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 40

    Vaccaro ARHulbert RJPatel AAFisher CDvorak MLehman RA Jr: The subaxial cervical spine injury classification system: a novel approach to recognize the importance of morphology, neurology, and integrity of the disco-ligamentous complex. Spine (Phila Pa 1976) 32:236523742007

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 41

    Walters BCHadley MN: Development of evidence-based guidelines for the management of acute spine and spinal cord injuries. Clin Neurosurg 50:2392482003

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42

    Walters BCHadley MNHurlbert RJAarabi BDhall SSGelb DE: Guidelines for the management of acute cervical spine and spinal cord injuries: 2013 update. Neurosurgery 60 (CN Suppl 1):82912013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation

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Article Information

Contributor Notes

Correspondence Mark N. Hadley: University of Alabama at Birmingham, Birmingham, AL. mnhadley@uabmc.edu.INCLUDE WHEN CITING DOI: 10.3171/2019.6.SPINE19652.Disclosures The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

© AANS, except where prohibited by US copyright law.

Headings
References
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    Lennarson PJMostafavi HTraynelis VCWalters BC: Management of type II dens fractures: a case-control study. Spine (Phila Pa 1976) 25:123412372000

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    McLeod RSWright JGSolomon MJHu XWalters BCLossing A: Randomized controlled trials in surgery: issues and problems. Surgery 119:4834861996

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 24

    Mercier HSperber D: The Enigma of Reason. Cambridge, MA: Harvard University Press2019

  • 25

    O’Toole JE: Timing of surgery after cervical spinal cord injury. World Neurosurg 82:e389e3902014

  • 26

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Management of pediatric cervical spine and spinal cord injuries. Neurosurgery 72 (Suppl 2):2052262013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Os odontoideum. Neurosurgery 72 (Suppl 2):1591692013

  • 28

    Rozzelle CJAarabi BDhall SSGelb DEHurlbert RJRyken TC: Spinal cord injury without radiographic abnormality (SCIWORA). Neurosurgery 72 (Suppl 2):2272332013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Ryken TCAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Management of isolated fractures of the atlas in adults. Neurosurgery 72 (Suppl 2):1271312013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30

    Ryken TCHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Management of acute combination fractures of the atlas and axis in adults. Neurosurgery 72 (Suppl 2):1511582013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31

    Ryken TCHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Management of isolated fractures of the axis in adults. Neurosurgery 72 (Suppl 2):1321502013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32

    Ryken TCHadley MNWalters BCAarabi BDhall SSGelb DE: Radiographic assessment. Neurosurgery 72 (Suppl 2):54722013

  • 33

    Ryken TCHurlbert RJHadley MNAarabi BDhall SSGelb DE: The acute cardiopulmonary management of patients with cervical spinal cord injuries. Neurosurgery 72 (Suppl 2):84922013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 34

    Samadani U: Is the clock ticking on “Why don’t you hang some phenylephrine and call me in the morning?” Investigating evidence beyond the guidelines for acute management of spinal cord injury. Neurotrauma & Critical Care News. Spring 2019; 3–5 (www.neurotraumasection.org/LiteratureRetrieve.aspx?ID=244949) [Accessed June 26 2019]

    • Search Google Scholar
    • Export Citation
  • 35

    Shank CDLepard JRWalters BCHadley MN: Towards evidence-based guidelines in neurological surgery. Neurosurgery [epub ahead of print] 2018

  • 36

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: The diagnosis and management of traumatic atlanto-occipital dislocation injuries. Neurosurgery 72 (Suppl 2):1141262013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 37

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Occipital condyle fractures. Neurosurgery 72 (Suppl 2):1061132013

  • 38

    Theodore NAarabi BDhall SSGelb DEHurlbert RJRozzelle CJ: Transportation of patients with acute traumatic cervical spine injuries. Neurosurgery 72 (Suppl 2):35392013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 39

    Theodore NHadley MNAarabi BDhall SSGelb DEHurlbert RJ: Prehospital cervical spinal immobilization after trauma. Neurosurgery 72 (Suppl 2):22342013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 40

    Vaccaro ARHulbert RJPatel AAFisher CDvorak MLehman RA Jr: The subaxial cervical spine injury classification system: a novel approach to recognize the importance of morphology, neurology, and integrity of the disco-ligamentous complex. Spine (Phila Pa 1976) 32:236523742007

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 41

    Walters BCHadley MN: Development of evidence-based guidelines for the management of acute spine and spinal cord injuries. Clin Neurosurg 50:2392482003

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42

    Walters BCHadley MNHurlbert RJAarabi BDhall SSGelb DE: Guidelines for the management of acute cervical spine and spinal cord injuries: 2013 update. Neurosurgery 60 (CN Suppl 1):82912013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
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