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Improving The Clinical Care of Children and Adolescents With Mild Traumatic Brain Injury

Improving The Clinical Care of Children and Adolescents With Mild Traumatic Brain Injury. Madeline Joseph , MD, FACEP, FAAP Professor of Emergency Medicine and Pediatrics Chief& Medical Director, Pediatric Emergency Medicine Division

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Improving The Clinical Care of Children and Adolescents With Mild Traumatic Brain Injury

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  1. Improving The Clinical Care of Children and Adolescents With Mild Traumatic Brain Injury Madeline Joseph, MD, FACEP, FAAP Professor of Emergency Medicine and Pediatrics Chief& Medical Director, Pediatric Emergency Medicine Division Chief & Medical Director, UF Health Pediatric Weight Management Center-Wolfson Children’s Hospital University of Florida College of Medicine, Jacksonville

  2. Pediatric Mild Traumatic Brain Injury • Appropriate diagnosis and management of children and teens with mild TBI, including concussion, can help safeguard the health of young Americans. • While clinical guidelines are available for adults with mild TBI, there is no current U.S. guideline to help clinicians care for children and teens with mild TBI. • With the numbers of children and teens in the U.S. seeking care for mild TBI continuing to increase markedly, this guideline is needed.

  3. CDC Takes the Lead to Develop Practice Guidelines to Assist Clinicians and Others Caring For : Children and Adolescents With Mild Traumatic Brain Injury Focus: Acute Diagnosis and Management

  4. Conceptual Framework Logistical Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  5. Patient population Intervention: The treatment Comparative intervention: (no treatment, placebo, alternative treatment) Outcome(s) Evidence-Answerable Questions PICO

  6. Instructions for Developing Questions The first step is to determine the type of question you are asking: Therapeutic: You are interested in the effect of an intervention designed to improve some outcome Diagnosticaccuracy: You are interested in determining the accuracy of a diagnostic test in identifying patients with a disease or condition compared to a reference standard. Prognostic accuracy: You want to determine if a patient characteristic or other factor increases the risk of an outcome. Screening (frequency): You are interested in determining how often something happens—most commonly how often a test of known diagnostic accuracy identifies an important abnormality.

  7. Therapeutic

  8. Diagnostic Accuracy

  9. Prognostic Accuracy

  10. Screening (Frequency)

  11. A total of 119 questions were submitted from over 40 experts on Pediatric Mild TBI.

  12. Question 1 • For children or adolescents (18 years of age and younger) with suspected mTBI, do specific tools as compared with a reference standard*, accurately diagnose mTBI? • Inclusion CriteriaStudies of children and adolescents (18 years of age and younger) with and without mild TBI. A putative diagnostic test is performed and is compared to a mild TBI reference standard in both populations.

  13. Question 2 • For children and adolescents (18 years of age and younger) presenting to the emergency department (or other acute care setting) with mild TBI, how often does routine head imaging identify important intracranial injury? • Inclusion CriteriaStudies of children and adolescents (18 years of age and younger) with mild TBI evaluated in an emergency room (or other acute care setting) undergo head imaging. The proportion of patients with traumatic intracranial abnormalities is reported.

  14. Question 3 (Dr. Joseph is the Lead) • For children and adolescents (18 years of age and younger) presenting to the emergency department (or other acute care setting) with mild TBI, which features identify patients at risk for important intracranial injury? • Inclusion CriteriaStudies of children and adolescents (18 years of age and younger) with mild TBI evaluated in an emergency room (or other acute care setting) with and without a putative risk factor. The proportion of patients with traumatic intracranial abnormalities are reported in both populations.

  15. Question 4 • For children and adolescents (18 years of age and younger) with mild TBI, what factors* identify patients at increased risk for ongoing impairment, more severe-symptoms, or delayed recovery? • Inclusion CriteriaStudies of children and adolescents (18 years of age and younger) with mild TBI with and without a putative risk factor. The study measures the strength of association between the risk factor and symptom severity or duration

  16. Question 5 • For children and adolescents (18 years of age and younger) with mild TBI, which factors identify patients at increased risk of long-term# (>1 year) sequelae? • Inclusion CriteriaStudies of children and adolescents (18 years of age and younger) with mild TBI with and without a putative risk factor. The study measures the strength of association between the risk factor and long-tem (>1 year) sequelae.

  17. Question 6 • For children and adolescents (18 years of age and younger) with mild TBI (with ongoing symptoms) which treatments* improve mild TBI-related outcomes? • Inclusion criteriaStudies of children and adolescents (18 years of age and younger) with mild TBI who receive and do not receive a treatment (randomization to treatment groups not required). The study measures the association between treatment and mild TBI-related outcomes.

  18. You can access the guideline protocol for review and comment at: http://www.aan.com/go/practice/publiccommentsThe Workgroup is using the American Academy of Neurology’s (AAN) guideline development process to develop a multidisciplinary, evidence-based guideline.Public comment on the guideline protocol is one of the first steps in the evidence-based clinical guideline development process Seeking Comments on the Pediatric mild TBI Guideline Protocol

  19. Conceptual Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  20. Complete Search Review Abstracts Review Full Text Select articles Relevant Literature Search Apriori inclusion criteria.

  21. To date the full workgroup reviewed over 11,000 abstractsAbstracts from initial search/ Articles for full text reviewQuestion 1:       5,012/  567Question 2:       4,381/ 67Question 3:       4,381/ 191Question 4: 5,199/ Not sure yetQuestion 5: 5,199/ 401Question 6: 2,882/ 385

  22. Conceptual Framework Logistical Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  23. Data Extraction

  24. Class I II III IV AAN: Decision rulesClassification of therapeutic evidence Controlled randomized matched comparative - Masked single single independent -

  25. Conceptual Framework Logistical Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  26. Summary Evidence TableModified GRADE Process

  27. Conclusion: Example Population In children and adolescents with disabling post MTBI headaches, an individualized graded plan for return to normal activity compared to no formal plan probably decreases the time to resolution of disabling headaches (HR time to resolution 1.7 95% CI 1.2 to 2.3). (Multiple Class II studies) Intervention Outcome Level of certainty Best Evidence

  28. Conceptual Framework Logistical Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  29. RecommendationsMuch more than evidence • Clinical context • The deductive logic supporting the recommendation • Three sources of premises: • Evidence reviewed • Axioms or principles of care • Strong evidence from related conditions • The recommendation: Must be actionable! • The level of obligation: Must, Should, Might

  30. Conceptual Framework Logistical Framework Form Balanced Author Panel  Develop Protocol & solicit public comment  Find, Select and Rate the Evidence  Synthesize the Evidence & Write the Systematic Review  Make Recs & Write Guideline  Peer Review & Publish Question Evidence Conclusion Recommendation

  31. Immediate Next Steps • Articles being retrieved and organized by the AAN • Author panel members will review full text, exclude those not meeting inclusion criteria

  32. Guidelines are coming soon……… Questions ?

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