1. The Pediatric Emergency Care Applied Research Network (PECARN) and Trauma Outcomes Research The PECARN is supported by cooperative agreements U03MC00001, U03MC00003, U03MC00006, U03MC00007, and U03MC00008 from the Emergency Medical Services for Children Program of the Maternal and Child Health Bureau, Health Resources and Services Administration, Department of Health and Human Services Surgical and Trauma Outcomes Research: Current Status and Future Directions Nathan Kuppermann, MD, MPH Departments of Emergency Medicine and Pediatrics UC Davis School of Medicine March 15 th, 2013

2. Disclosure ● No financial or other conflicts of interest

3. What is PECARN? u A collaborative research group of hospital EDs organized into nodes and coordinated by a Steering Committee u The infrastructure supported by funding from HRSA u PECARN works with the EMSC/MCHB/HRSA: multi-center randomized trials observational studies other issues related to emergency medical services for children u Highlighted in 2006 IOM reports on the future of EMSC

4. PECARN Structure PECARN Steering Committee Data Coordinating Center (DCC) Pediatric Emergency Medicine Northeast, West and South PEM-NEWS Hospitals of the Midwest Emergency Research Node HOMERUN Great Lakes Emergency Medical Services for Children Research Network GLEMSCRN Pittsburgh, Rhode Island, Delaware Network PRIDENET Washington, Boston, Chicago Applied Research Node WBCARN Pediatric Research in Injuries and Medical Emergencies PRIME PI: Peter Dayan PI: Rich Ruddy PI: Rachel Stanley PI: Bob Hickey PI: Jim Chamberlain PI: Nathan Kuppermann PECARN Subcommittees Protocol Review and Development Quality Assurance, Safety and Regulatory Feasibility and Budget Grant Writing and Publication HRSA/ MCHB/ EMSC Federal Project Officer: Tasmeen Weik PI: Mike Dean

5. PECARN Sites ● = PRIME Node ● = GLEMSCRN Node = PEM-NEWS Node = WBCARN Node ● ● ■ = Data Coordinating Center = HOMERUN Node ● = PRIDENET Node ● ● ● ● ■ ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

6. Ongoing PECARN Research Development  Patient safety and error reduction  Quality of PEM care  Evaluation of head trauma  C-Spine immobilization  Steroids in acute bronchiolitis  The burden of mental illness and psychiatric emergencies in PED  RCT of fluids for DKA  Magnesium for sickle cell pain  Therapeutic hypothermia in pediatric cardiopulmonary arrest cardiopulmonary arrest  Diagnostic categorization of illnesses and injuries in the PED and injuries in the PED  Management of status epilepticus  Evaluation of abdominal trauma  Progesterone for severe TBI  Knowledge translation of TBI rules  RNA transcription biosignatures to diagnose febrile infants febrile infants

7. Childhood Head Trauma: A Neuroimaging Decision Rule Supported by grant R40MC02461-01-00 from EMSC/MCHB/HRSA

8. The PECARN Head Injury Study Goal: to derive a clinical decision rule to accurately identify children at near zero risk of clinically important traumatic brain injury after blunt trauma with high accuracy and wide generalizability

9. Methods ● Design: –Prospective multicenter study over 28 mo. (6/04 – 9/06) in 25 sites in PECARN ● Inclusion Criteria: –Age < 18 years with head trauma evaluated in ED ● Exclusion Criteria: –Ground-level mechanisms and no symptoms or signs of TBI –Penetrating trauma –Injury > 24 hours old –Pre-existing neurological disease impeding assessment –Transfer with neuroimaging already performed

10. Outcome Definition Clinically-important TBI (ciTBI) –Death from TBI –Neurosurgical procedure –Intubation for > 24 hours for head injury –Positive CT in association with hospitalization > 2 nights

11. Variables Considered  Age in years  3-level mechanism severity  High risk  MVC - ejection, rollover, death  Ped or unhelmeted bicyclist struck by motorized vehicle  Fall > 5 feet (> 3 feet if < 2 yrs)  High impact / projectile  Amnesia (if > 2 yrs)  LOC (duration)  Seizure  Acting normal per parent  Headache (severity, location) if > 2 yrs  Emesis (number, timing)  GCS (14 vs. 15)  Other mental status  Agitated  Sleepy  Slow to respond  Repetitive  Palpable skull fx signs  Basilar skull fx signs  Bulging fontanelle  Scalp hematoma (location, size, quality)  Focal neurological deficit  Other system injuries  Evidence of intoxication

12. Results 57,030 eligible 42,412 (78.3%) 11,749 (21.7%) 88 ciTBI (1.0%) Enrolled Not enrolled 54,161 GCS 14-15 2,869 GCS <14 or other exclusion Validation 8,627 Derivation 33,785 288 ciTBI (0.9%)

13. Inter-observer agreement

14. Kuppermann/Holmes, 2009

15. The PECARN TBI Rules (derived and validated) Children < 2 yearsChildren 2-18 years Severe mechanism of injury History of LOC > 5 sec GCS = 14 or other signs of altered mental status Not acting normally per parent Palpable skull fracture Occipital/parietal/temporal scalp hematoma Severe mechanism of injury History of LOC GCS = 14 or other signs of altered mental status History of vomiting Severe headache in the ED Signs of basilar skull fracture Children are at very low risk of clinically-important traumatic brain injury (TBI) if they meet all criteria in age-specific rule:

16. Under 2 yearsOver 2 years

19. Recommendations for children younger than 2 The Rule

20. Recommendations for children younger than 2 Suggestions

21. Recommendations for children 2 years and older The Rule

22. Recommendations for children 2 years and older Suggestions

23. PECARN Clinical Prediction Rule for Abdominal CT in Pediatric Trauma ● Prospective multicenter study 2007 - 2010 –< 18 years with blunt abdominal trauma –Clinical data recorded before abd CT (if done) –Follow-up obtained on all patients:  Discharged patient: telephone follow-up  Admitted patients: medical record review ● Primary outcome: IAI requiring therapy (IAI AI ) –Recursive partitioning analysis –761 (6.3%) with IAI and 203 (1.7%) with IAI AI

24. Prediction Rule for IAI AI (n=12,044) 1,963 patients 112 (5.7%) IAI AI No GCS < 14 826 patients 38 (4.6%) IAI AI Abdomen tender 2,532 patients 36 (1.4%) IAI AI Thoracic Trauma Abdominal pain ↓ Breath Sounds Emesis Abdominal Wall Trauma 955 patients 6 (0.6%) IAI AI 305 patients 2 (0.7%) IAI AI 34 patients 1 (2.9%) IAI AI 395 patients 2 (0.5%) IAI AI No 5,034 patients No 6 (0.1%) IAI AI Sensitivity = 197/203 (97.0%; 95% CI 93.7, 98.9%) Specificity = 5028/11841 (42.5%; 95% CI 41.6, 43.4%) NPV = 5028/5034 (99.9%; 95% CI 99.7, 100%) LR- = 0.07 (95% CI 0.03, 0.15) 1,234 CT scans (25%)

25. Holmes/Kuppermann, 2013

26. How to get clinicians to use the prediction rules?

27. Knowledge Translation Pipeline ● EBM – continuum here Glasziou/Haynes, 2005

28. Translating Research into Practice What works Clinical decision support more successful when: ● Automatic provision of support in workflow ● Recommendations given rather than risks ● Support given at the time and location of decision-making ● Support is computer based Kawamoto, 2005

29. Implementation of the PECARN Traumatic Brain Injury Prediction Rules Using Electronic Health Record-Based Clinical Decision Support: An Interrupted Time Series Trial Funded by the American Recovery and Reinvestment Act – Office of the Secretary: Grant #S02MC19289-01-00

30. Data Completion by Nursing If Triage RN enters “Yes-less than 24 hours ago” items for risk assessment will be cascade

31. Blunt Head Trauma Assessment Courtesy: Peter S. Dayan, MD, PECARN

32. Clinical Decision Support Clinician receives a statement no matter what is entered Formatted similarly across statements 1. Recommendation 2. Risk estimate of clinically-important TBI based on PECARN data 3. Details regarding recommendations/risks 4. List of predictors and responses 5. Links to useful information (e.g. the prediction rules)

33. Decision Support: Patient < 2 years who meets rule

34. Month of Trial 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Pre-intervention phase Intervention Intervention maintained Main Comparisons: implemented (post-intervention phase) Pre to post int. Intervention Group Measurement (receives CDS) Baseline rate of CT use Post-intervention rate of CT use Control Group Measurement (standard of care) Rate of CT use measured throughout the study period Methods – design Interrupted Time Series Trial with Concurrent Controls

35. 1.Glasziou P, Haynes B. The paths from research to improved health outcomes. ACP J Club 2005;142:A8-10. 2.Graham ID, Stiell IG, Laupacis A, O’Connor AM, Wells GA. Emergency physicians’ attitudes toward and use of clinical decision rules for radiography. Acad Emerg Med 1998;5:134-40. 3.Holmes JF, Lillis K, Monroe D, Borgialli D, Kerrey BT, Mahajan P et al and PECARN. Identifying children at very low risk of clinically-important blunt abdominal. Ann Emerg Med 2013 [Epub ahead of print]. 4.Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ 2005;330:765 [Epub]. 5.Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R et al and PECARN. Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet 2009;374:1160-70. 6.Laupacis A, Sekar N, Stiell IG. Clinical prediction rules: a review and suggested modifications of methodological standards. JAMA 1997;277:488-494. Selected References

36. 7.Maguire JL, Kulik DM, Laupacis A, Kuppermann N, Uleryk EM, Parkin PC.Clinical prediction rules for children: a systematic review. Pediatrics 2011;128:e666-77. 8.Palchak MJ, Holmes JF, Vance CW, et al. A decision rule for identifying children at low risk for brain injuries after blunt head trauma. Ann Emerg Med 2003;42:492-506. 9.Stiell IG, Wells GA. Methodologic standards for the development of clinical decision rules in emergency medicine. Ann Emerg Med 1999;33:437-447. 10.The Pediatric Emergency Care Applied Research Network. The Pediatric Emergency Care Applied Research Network (PECARN): Rationale, development, and first steps. Acad Emerg Med 2003;10:661-668. Selected References