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Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries. Section on ... PDF

592 Pages·2002·3.13 MB·English
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TABLE OF CONTENTS I. Author Group II. Introduction III. Methodology 1. Pre-Hospital Cervical Spinal Immobilization Following Trauma 2. Transportation of Patients with Acute Traumatic Cervical Spine Injuries 3. Clinical Assessment Following Acute Spinal Cord Injury 4. Radiographic Assessment of the Cervical Spine in Asymptomatic Trauma Patients 5. Radiographic Assessment of the Cervical Spine in Symptomatic Trauma Patients 6. Initial Closed Reduction of Cervical Spinal Fracture-Dislocation Injuries Medical Management: 7. Management of Acute Spinal Cord Injuries in an Intensive Care Unit or Other Monitored Setting 8. Blood Pressure Management Following Acute Spinal Cord Injury 9. Pharmacological Therapy Following Acute Cervical Spinal Cord Injury 10. Deep Venous Thrombosis and Thromboembolism In Patients With Cervical Spinal Cord Injuries 11. Nutritional Support After Spinal Cord Injury Pediatric Injuries 12. Management of Pediatric Cervical Spine and Spinal Cord Injuries 13. Spinal Cord Injury Without Radiographic Abnormality (SCIWORA) Specific Injury Types 14. Diagnosis and Management of Traumatic Atlanto-Occipital Dislocation Injuries 15. Occipital Condyle Fractures 16. Isolated Fractures of the Atlas in Adults 17. Isolated Fractures of the Axis in Adults 18. Management of Combination Fractures of the Atlas and Axis in Adults 19. Os Odontoideum 20. Treatment of Subaxial Cervical Spinal Injuries 21. Management of Acute Central Cervical Spinal Cord Injuries 22. Management of Vertebral Artery Injuries Following Non-Penetrating Cervical Trauma IV. Bibliography Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons AUTHOR GROUP Co-Chairs Mark N. Hadley, MD, FACS Beverly C. Walters, MD, M.Sc. FRCSC, FACS Professor, University of Alabama at Birmingham Associate Professor, Brown Medical School Division of Neurological Surgery Department of Neurosurgery Paul A. Grabb, MD Associate Professor, University of Alabama at Birmingham Division of Neurological Surgery Children’s Hospital of Alabama Nelson M. Oyesiku, MD Associate Professor, Emory University Department of Neurosurgery Gregory J. Przybylski, MD Associate Professor, Northwestern University Medical School Department of Neurosurgery Daniel K. Resnick, MD Assistant Professor, University of Wisconsin – Madison Department of Neurosurgery Timothy C. Ryken, MD Assistant Professor, University of Iowa Department of Neurosurgery Secretarial Support Debbie H. Mielke Administrative Associate University of Alabama at Birmingham Division of Neurological Surgery INTRODUCTION Spinal cord injuries occur approximately 14,000 times per year in North America. The majority involves the cervical spinal region. Most patients, although not all, will have cervical spinal fracture-dislocation injuries as well. Patients who sustain cervical spinal cord injuries usually have lasting, often devastating neurological deficits and disability. Tens of thousands more patients per year will sustain traumatic cervical spinal injuries without spinal cord injury. The management of these patients and their injuries, cord and vertebral column, is typically not standardized or consistent within a single institution, from one center to another or among centers within geographic regions. Treatment strategies are usually based on institutional or personal provider experiences, physician training and the resources available at the treatment facility. Management can affect outcome in these patients; therefore, clinicians worldwide strive to provide the “best and most timely care”. Many times we may not be fully aware of what the “best care” may be or whether “timeliness” matters. In many circumstances “best care” likely encompasses a variety of treatment strategies, all with acceptable success rates and reasonable inherent risks. The Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons has long been interested in getting answers to some of the difficult management issues associated with acute spinal cord injuries. Identification of “best care” strategies is desired for all aspects of the care of acute cervical injury patients including pre-hospital care and transport, neurological and radiographic assessment, medical management of spinal cord injury, closed reduction of cervical fracture-dislocations and specific treatment options, both operative and non-operative, for each specific cervical injury type known to occur from the occiput through thoracic level one. The leadership of the Spine Section charged this committee to generate guideline documents on the management of patients with acute cervical spine and cervical spinal cord injuries. Our committee undertook this task in May 2000. Twenty-two topics were identified and multiple questions were generated around which recommendations would be formed. We followed a meticulous process founded in evidence-based medicine. We searched for and relied on published scientific evidence rather than expert opinion or traditional practices. The author group first convened in September 2000. One year later we have completed our task. Our hopes are that these guidelines will define the variety of assessment or treatment options available to a clinician in the management of an individual patient, provide direction within the broad scope of clinical practice, highlight what is known about specific issues and importantly, define what is not known, stimulating additional research. METHODOLOGY OF GUIDELINE DEVELOPMENT Introduction The evolution of medical evidence has occurred rapidly over the last fifty years. From initial reports, anecdotal in nature, to large-scale randomized controlled trials, medical evidence is variable. From the evidence, and influenced by personal experience, clinicians choose paths of disease management. The medical specialties have pioneered the use of evidence produced from experimental trials to support clinical practice decisions. The surgical specialties have lagged behind the development of large-scale studies of surgical procedures and perioperative management. However, the high cost of medical care along with practice variation from region to region has given rise to an interest in developing strategies for linking practice to underlying evidence. In the course of this endeavor it has become clear that the variability of the evidence must somehow be reflected in any recommendations derived from it. In the 1980s, criteria to be used in selecting evidence for developing treatment recommendations were developed. In a formal document, Clinical Practice Guidelines: Directions for a New Program, the Institute of Medicine addressed such guideline issues as “definition of terms, specification of key attributes of good guidelines, and certain aspects of planning for implementation and evaluation.” (1) The key intent of the document is to promote standardization and consistency in guideline development. In the course of the document, several key concepts in guideline development were espoused. They include: 1. A thorough review of the scientific literature should precede guideline development. 2. The available scientific literature should be searched using appropriate and comprehensive search terminology. © 2001 The Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons. All rights reserved. 3. The evidence should be evaluated and weighted, reflecting the scientific validity of the methodology used to generate the evidence. 4. There should be a link between the available evidence and the recommendations with the strength of the evidence being reflected in the strength of the recommendations, reflecting scientific certainty (or lack thereof). 5. Empirical evidence should take precedence over expert judgment in the development of guidelines. 6. Expert judgment should be used to evaluate the quality of the literature and to formulate guidelines when the evidence is weak or non-existent. 7. Guideline development should be a multidisciplinary process, involving key groups affected by the recommendations. The Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries were developed using the evidence-based approach reflected in the above recommendations, rather than a consensus-based approach using the input of experts in a given field who make recommendations based upon a literature review and their personal experience. The author group involved in the development of these guidelines for treatment of patients with acute cervical spinal injury employed a strict process of literature review, ranking the published papers by strength of study design. Every effort was made to avoid influence by personal or professional bias by being objective in following a methodology defined in advance. The methodology chosen for this Guideline is evidence-based and follows the recommendations of the Institute of Medicine (IOM) Committee to Advise the Public Health Service on Clinical Practice Guidelines (1) as outlined in detail in the development process description below. 2 GUIDELINE DEVELOPMENT METHODOLOGY Literature search Extensive literature searches were undertaken for each clinical question addressed. The searches involved the available English-language literature for the past twenty-five years, using the computerized database of the National Library of Medicine. Human studies were looked for, and the search terms employed reflected the clinical question in as much detail as relevant, as described in the individual sections. Abstracts were reviewed and clearly relevant articles were selected for evaluation. Evaluating strength of the therapy literature Each paper found by the above-mentioned techniques was evaluated as to study type (e.g., therapy, diagnosis, clinical assessment). For therapy, evidence can be generated by any number of study designs. The strongest study protocol, when well designed and executed, is by far the randomized controlled trial (RCT). The prospectivity, presence of contemporaneous comparison groups, and adherence to strict protocols observed in the RCT diminish sources of systematic error (called bias). The randomization process reduces the influence of unknown aspects of the patient population that might affect the outcome (random error). The next strongest study designs are the non-randomized cohort study and the case- control study, also comparing groups who received specific treatments, but in a non-randomized fashion. In the former study design, an established protocol for patient treatment is followed and groups are compared in a prospective manner, providing their allocation to treatment is not determined by characteristics that would not allow them to receive either treatment being studied. These groups would have a disorder of interest, e.g., spinal cord injury, and receive different interventions, and then the differences in outcome would be studied. In the case-control 3 study, the study is designed with the patients divided by outcome (e.g., functional ability) and their treatment (e.g., surgery vs. no surgery) would be evaluated for a relationship. These studies are more open to systematic and random error and thus are less compelling than an RCT. However, the RCT with significant design flaws that threaten its validity loses its strength and may be classified as a weaker study. Least strong evidence is generated by published series of patients all with the same or similar disorder followed for outcome, but not compared as to treatment. In this same category is the case report, expert opinion, and the RCT so significantly flawed that the conclusions are uncertain. All of these statements regarding study strength refer to studies on treatment. But patient management includes not only treatment, but also diagnosis and clinical assessment. These aspects of patient care require clinical studies that are different in design, generating evidence regarding choices of diagnostic tests and clinical measurement. Evaluating strength of the diagnostic test literature To be useful, diagnostic tests have to be reliable and valid. Reliability refers to the test’s stability in repeated use, in the same circumstance. Validity describes the extent to which the test reflects the “true” state of affairs, as measured by some “gold standard” reference test. Accuracy reflects the test’s ability to determine who does and does not have the suspected or potential disorder. Overall, the test must be accurate in picking out the true positives and true negatives, with the lowest possible false positive and false negative rate. These attributes are represented by sensitivity, specificity, positive predictive value, and negative predictive value. These may be calculated using a Bayesian 2 X 2 table as follows: 4 GOLD STANDARD Patient has injury Patient has no injury TEST Positive: TRUE FALSE RESULT Appears to have injury POSITIVE POSITIVE (a) (b) (a) + (b) C-SPINE FILM Negative: FALSE TRUE Appears to have no injury NEGATIVE NEGATIVE (c) (d) (c) + (d) (a) + (c) (b) + (d) (a) + (b) + (c) + (d) Using the above table, the components of accuracy can be expressed and calculated as follows: Sensitivity a/a+c If a patient has a positive X-ray, how likely is he to have a C-spine injury? Specificity d/b+d If a patient has a negative X-ray, how likely is he to not have a C- spine injury? Positive predictive a/a+b If a patient has a C-spine injury, how likely is he to have a positive value test? Negative predictive d/c+d If a patient does not have a C-spine injury, how likely is he to have a value negative test? Accuracy a+d/a+b+c+d It is the characteristic of diagnostic tests that these attributes do not always rise together, but generally speaking, these numbers should be greater than 70% to consider the test useful. The issue of reliability of the test will be discussed below when describing patient assessment. 5

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