- Describe your topic.
- Traumatic brain injury (TBI) is defined as “Cerebral edema [which] can result from a combination of several pathological mechanisms associated with primary and secondary injury patterns in traumatic brain injury (TBI).” As pressure within the skull increases, brain tissue displacement can lead to cerebral herniation, resulting in disability or death.1-3 Surgical removal of a portion of the skull, known as decompressive craniectomy (DC), has been performed for the purpose of relieving elevated intracranial pressure with outcome improvement in specific TBI patients.4,5 Most of the debate surrounding the role of decompressive craniectomy in the management of severe TBI results from a paucity of data coming from randomized controlled trials (RCTs) assessing this intervention.6-8 There have been variations in surgical techniques, timing, and patient populations in most of the observational studies published in the last 2 decades.7-10 Another key aspect of treatment for patients with TBI, with a significant potential to impact care and patient protocols is cerebrospinal fluid drainage. Management of external ventricular drainage (EVD) systems in patients with severe TBI remains a controversial topic and the 4th edition was the first edition of this guideline to include EVD management options. 11 The scope includes treatment interventions, monitoring, and TBI-specific treatment thresholds, focusing on TBI-specific risks or issues. Treatments include: 1. Decompressive Craniectomy 2. Prophylactic Hypothermia 3. Hyperosmolar Therapy 4. Cerebrospinal Fluid Drainage 5. Ventilation Therapies 6. Anesthetics, Analgesics, and Sedatives 7. Steroids 8. Nutrition 9. Infection Prophylaxis 10. Deep Vein Thrombosis Prophylaxis 11. Seizure Prophylaxis Key Questions for Treatment: Q1: Does the treatment affect clinical outcomes, defined as mortality and neurological function? Q2: Does the treatment cause harms? Q3: Does the treatment affect intermediate outcomes? Decompressive Craniectomy (DC) key questions: Q1: Does DC reduce mortality or improve neurological outcomes? Q2: Does DC cause harms? Q3: Does DC lower ICP (an intermediate outcome)? Prophylactic Hypothermia key questions: Q1: hypothermia versus normothermia, Q2: shorter versus longer periods of cooling, Q3: head-only versus systemic cooling. Hyperosmolar Therapy key questions: Q1: Hypertonic saline vs. mannitol Q2: Concentration (2% or 3% vs. 0.9%) Q3: Hypertonic saline vs. lactated ringers Q4: Mannitol vs. barbiturates Q5: Sodium lactate vs. mannitol Cerebrospinal Fluid Drainage key questions: Q1: Is continuous or intermittent CSF drainage superior at reducing ICP2? Q2: Is the use of CSF drainage associated with lower mortality? Ventilation Therapies key questions: Q1: Influence of hyperventilation on outcomes Q2: To compare normal ventilation to prolonged hyperventilation Anesthetics, Analgesics, and Sedatives key questions: Q1: Does the prophylactic use of barbiturates improve outcomes? Q2: Can barbiturates be used to reduce intracranial hypertension? Q3: Does the use of sedatives improve outcomes? Steroids key questions: Q1: Steroid efficacy vs. placebo Nutrition key questions: Q1: How many calories are required for optimal recovery? Q2: What is the optimal method of administering these calories (enterally/parenterally/both)? Q3: When should this support start? Q4: What should the composition of such support include with regard to carbohydrates, proteins, and lipids? Q5: Are there nutritional supplements that might play a role in improved recovery? Q6: What is the role of insulin in controlling serum glucose concentrations in this vulnerable patient population? Q7: Can specialized diets play a role in the care of the patient with severe TBI? Infection Prophylaxis key questions: Q1: Prevention of VAP Q2: Prevention of infection associated with EVD Deep Vein Thrombosis Prophylaxis key questions: Q1: Whether outcomes are better with or without prophylaxis? Q2: Prophylaxis protocol vs. no protocol? Q3: Early vs. late prophylaxis administration? Seizure Prophylaxis key questions: Q1: What is the effectiveness of seizure prophylaxis in preventing early and late seizures following TBI? Q2: Assess potential adverse effects Q3: Compare one agent to another or compare an agent to a placebo in seizure prevention and neuropsychological function Monitoring Includes: 12. Intracranial Pressure 13. Cerebral Perfusion Pressure 14. Advanced Cerebral Monitoring Key Questions for Monitoring: Q1: Does the monitoring affect treatment and ultimately impact clinical outcomes, defined as mortality and neurological function? Q2: Does monitoring lead to treatment that causes harms? Q3: Does monitoring affect the treatment that then affects intermediate outcomes? Q4: Is monitoring associated with changes in outcomes? In this case the impact on treatment is not measured, hence the “black box.” Q5: Does monitoring cause harms? Thresholds Include: 15. Blood Pressure 16. Intracranial Pressure 17. Cerebral Perfusion Pressure 18. Advanced Cerebral Monitoring Key Questions for Thresholds: In threshold studies the population is patients with TBI who are monitored. The questions are: Q1: What value is associated with better clinical outcomes? Q2: What value is associated with worse outcomes or harm? Q3: What value is associated with intermediate outcomes? REFERENCES: 1. Dunn LT. Raised intracranial pressure. J Neurol Neurosurg Psychiatry. 2002;73 Suppl 1:i23-27. 2. Farahvar A, Gerber LM, Chiu YL, et al. Response to intracranial hypertension treatment as a predictor of death in patients with severe traumatic brain injury. J Neurosurg. 2011;114(5):1471-1478. 3. Vik A, Nag T, Fredriksli OA, et al. Relationship of "dose" of intracranial hypertension to outcome in severe traumatic brain injury. J Neurosurg. 2008;109(4):678-684. 4. Bor-Seng-Shu E, Figueiredo EG, Amorim RL, et al. Decompressive craniectomy: a meta-analysis of influences on intracranial pressure and cerebral perfusion pressure in the treatment of traumatic brain injury. J Neurosurg. 2012;117(3):589-596. 5. Eberle BM, Schnuriger B, Inaba K, Gruen JP, Demetriades D, Belzberg H. Decompressive craniectomy: surgical control of traumatic intracranial hypertension may improve outcome. Injury. 2010;41(9):894-898. 6. Sahuquillo J, Arikan F. Decompressive craniectomy for the treatment of refractory high intracranial pressure in traumatic brain injury. The Cochrane database of systematic reviews. 2006(1):Cd003983. 7. Bohman LE, Schuster JM. Decompressive craniectomy for management of traumatic brain injury: an update. Curr Neurol Neurosci Rep. 2013;13(11):392. 8. Huang X, Wen L. Technical considerations in decompressive craniectomy in the treatment of traumatic brain injury. Int J Med Sci. 2010;7(6):385-390. 9. Ragel BT, Klimo P, Jr., Martin JE, Teff RJ, Bakken HE, Armonda RA. Wartime decompressive craniectomy: technique and lessons learned. Neurosurg Focus. 2010;28(5):E2. 10. Quinn TM, Taylor JJ, Magarik JA, Vought E, Kindy MS, Ellegala DB. Decompressive craniectomy: technical note. Acta Neurol Scand. 2011;123(4):239-244. 11. Carney N, Totten AM, O'Reilly C, et al. Guidelines for the management of severe traumatic brain injury, Fourth Edition. Neurosurgery. 2017;80(1):6-15. 12. Dewan MC, Rattani A, Fieggen G, et al. Global neurosurgery: the current capacity and deficit in the provision of essential neurosurgical care. Executive Summary of the Global Neurosurgery Initiative at the Program in Global Surgery and Social Change. J Neurosurg. 2018:1-10. 13. Hutchinson PJ, Kolias AG, Timofeev IS, et al. Trial of decompressive craniectomy for traumatic intracranial hypertension. N Engl J Med. 2016;375(12):1119-1130.
- Describe why this topic is important.
- According to the Centers for Disease Control and Prevention (CDC), about 69 million (95% CI 64–74 million) people worldwide sustain a traumatic brain injury per year.12 In one year, more than 2 million emergency department visits, 280,000 hospitalizations, and 50,000 deaths were attributed to TBIs. The rates of TBI have also increased in the past decade. In a report to Congress, the CDC stated: “The public health burden of TBI is substantial—affecting the lives of millions nationwide. While prevention of TBI is the key public health strategy for reducing the burden, it is imperative for those in public health, clinical practice, and research to design and evaluate effective rehabilitation strategies that reduce the negative health effects of TBI. However, access to services may be limited for those in need due to cost, geographic restrictions, and insurance.”
- Tell us why you are suggesting this topic.
- The Brain Trauma Foundation (BTF) previously led the development of the “Guidelines for the Management of Severe Traumatic Brain Injury, 4th Edition” for adults (and will also publish guidelines for pediatrics and prehospitalization later in 2018). However, the funding source (supported by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0086) used to conduct the systematic reviews and update the guidelines has expired, and the BTF is no longer able to support the updates and maintenance of these important guidelines. The BTF asked the Congress of Neurological Surgeons (CNS) to assume responsibility for its three TBI guidelines (adult, pediatrics, and prehospital). The CNS and BTF are currently in the process of signing a license agreement transitioning copyright of these guidelines to CNS (see Appendix A, attached). CNS will use this systematic review to update the “Guidelines for the Management of Severe Traumatic Brain Injury, 4th Edition” for adults.
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- The literature base is continually increasing, and it is of paramount importance that the guideline is updated according to new findings. During the 7 years between the third and fourth editions of this guideline, there were 94 new studies included as evidence. Since the literature search from the “Guidelines for the Management of Severe Traumatic Brain Injury, 4th Edition” was completed in 2014, the CNS performed an update of some of the searches included in the most recent iteration of this guideline. For example, re-running the Decompressive Craniectomy search for the period of 2014 through May 2018 brought back an additional 93 studies, which included the RESCUEicp Trial13, which will likely provide further nuance to the current recommendations. Other areas that the update should prioritize include hyperosmolar therapy. There were no specific recommendation made in the 4th Edition, but re-running the search for the period of 2014 through June 2018 yielded 121 new studies, which could potentially support new recommendations. Seizure prophylaxis is also an area in which clinical practice seems to differ from the evidence-based recommendations. The 4th Edition also did not include significant new findings regarding hypothermia. Finally, intracranial pressure monitoring is an area of practice in which there has been variation in practice regarding invasive monitoring and threshold for treatment. Re-running the invasive monitoring search from the 4th Edition for the period of 2014 through June 2018 yielded 200 new studies, which could potentially provide more evidence to inform recommendations for this controversial area of clinical practice to help clinicians improve outcomes for their patients. Evidence gaps do exist in many of these areas, but there seems to be emerging literature continually being published (as literature scans cited above have indicated) that warrant this update.
- How will you or your group use the information from a new evidence report?
- As a leader in education and innovation, the CNS recognizes high-quality, evidence-based guidelines as a critical tool to confront a rapidly changing health care environment. The CNS supports an infrastructure, including robust, methodological processes to produce high-quality evidence-based clinical practice guidelines. Endorsement of these guidelines is achieved in partnership with the American Association of Neurological Surgeons (AANS) and CNS Joint Subspecialty Sections, which will continue to provide the scientific content experts fundamental to quality guidelines formulation. Failure to follow the guidelines can be lethal for the approximately 2.5 million Americans with traumatic brain injury every year and expensive for the health care system. A 2007 study by the Centers for Disease Control and Prevention estimated an annual reduction in mortality of 3,607 lives with closer adherence to the guidelines, and an annual reduction of lifetime societal costs of $3.84 billion. “Severe TBIs contribute to 30 percent of all injury-related deaths in the U.S. TBIs that are fatal or require hospitalization account for 90 percent of the $76.5 billion in annual costs for TBI.”11
- How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?
- The CNS has developed an infrastructure in which it will publish executive summaries of guidelines in peer-reviewed journals (Neurosurgery), the full-text guideline on the CNS webpage, and also offer ancillary educational products, such as a free mobile app, and webinars and live courses (for CME). CNS also proactively markets newly published guidelines to its members, other clinicians, patients and the public via social media, email, press releases, and other mechanisms for dissemination. The CNS has also successfully submitted guidelines to the National Guidelines Clearinghouse, and will continue to do so for all future guidelines if NGC is operational in the future. The CNS has also successfully engaged partner societies for the peer review, endorsement or dissemination of its guidelines, including the American Society for Radiation Oncology, American Society of Clinical Oncology, Cancer Care Ontario, Society of Neuro-oncology, American Academy of Pediatrics, American Academy of Neurology, American Epilepsy Society, Child Neurology Society and the Spina Bifida Association.
- Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?
- The CNS plans to develop a robust, high quality, clinical practice guideline, using a multidisciplinary panel of experts, based on the research findings of this evidence report, in order to update the “Guidelines for the Management of Severe Traumatic Brain Injury, 4th Edition” for adults, which was published in January, 2017. In addition to developing clinical practice guidelines, BTF also developed the Brain Trauma Evidence-Based Consortium (B-TEC) to actively promote the generation of new, strong evidence that addresses critical questions identified in BTF’s guideline documents. B-TEC, which was also supported by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0086, was a multi-center program with a contract to Stanford University in collaboration with the Brain Trauma Foundation, and with subcontracts to Oregon Health & Science University, Portland State University, and other institutions. The main purpose of B-TEC was to prioritize research topics, develop a clinically useful classification system for TBI, update TBI clinical practice guidelines, and provide an infrastructure for conducting clinical trials that will include specific research project coordination, investigator training and education, data management, and data analytics. CNS is committed to continuing to work with B-TEC stakeholders with respect to guideline development (engaging these partners for peer review) and dissemination, continuing the spirit of collaboration.
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- Congress of Neurological Surgeons
