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.  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. Pediatric Mild Traumatic Brain Injury

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 Question Evidence Conclusion Recommendation 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 Logistical Framework

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

6. Instructions for Developing Questions The first step is to determine the type of question you are asking: 1.Therapeutic: You are interested in the effect of an intervention designed to improve some outcome 2.Diagnostic accuracy: You are interested in determining the accuracy of a diagnostic test in identifying patients with a disease or condition compared to a reference standard. 3.Prognostic accuracy: You want to determine if a patient characteristic or other factor increases the risk of an outcome. 4.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 ElementExample Patient population For children with mTBI and post- traumatic headaches Intervention: The treatment Does a preplanned-strategy for a gradual return to normal activity Comparative intervention: (no treatment, placebo, alternative treatment) As compared to no plan Outcome(s)Decrease the severity and duration of headaches

8. Diagnostic Accuracy ElementExample Patient population For children with suspected mTBI with concussion Intervention: The test of interest Does a symptom checklist administered by first responders Comparative intervention: The reference standard As compared to a neurologists evaluation Outcome: The diagnosisAccurately diagnose concussion.

9. Prognostic Accuracy ElementExample Patient population For children with mTBI and a normal neurological examination Intervention: The diagnostic test of known accuracy How often does routine head neuroimaging (MRI or CT) Comparative intervention (Not doing the procedure) (As compared to not doing head neuroimaging) Outcome(s) A condition or complication Identify patients with unsuspected severe mTBI related complications (e.g., subdural hematoma)

10. Screening (Frequency) ElementExample Patient population For children with mTBI and a normal neurological examination Intervention: The diagnostic test of known accuracy How often does routine head neuroimaging (MRI or CT) Comparative intervention (Not doing the procedure) (As compared to not doing head neuroimaging) Outcome(s) A condition or complication Identify patients with unsuspected severe mTBI related complications (e.g., subdural hematoma)

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 Criteria Studies 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 Criteria Studies 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 Criteria Studies 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 Criteria Studies 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 Criteria Studies 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 criteria Studies 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/publiccomments The 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 http://www.aan.com/go/practice/publiccomments 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. Literature Search Search Review Abstracts Review Full Text Select articles Relevant Complete Apriori inclusion criteria.

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

22. 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 Logistical Framework Question Evidence Conclusion Recommendation

23. Data Extraction

24. ClassIIIIIIIV AAN: Decision rules Classification of therapeutic evidence Masked single independent - Controlled randomized matched comparative -

25. 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 Logistical Framework Question Evidence Conclusion Recommendation

26. Summary Evidence Table Modified GRADE Process

27. Conclusion: Example 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) Population Intervention Outcome Level of certainty Best Evidence

28. 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 Logistical Framework Question Evidence Conclusion Recommendation

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

30. 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 Logistical Framework 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 ?