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The Pediatric Emergency Care Applied Research Network (PECARN) and Trauma Outcomes Research.
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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 15th, 2013
Disclosure • No financial or other conflicts of interest
What is PECARN? • A collaborative research group of hospital EDs organized into nodes and coordinated by a Steering Committee • The infrastructure supported by funding from HRSA • PECARN works with the EMSC/MCHB/HRSA: • multi-center randomized trials • observational studies • other issues related to emergency medical services for children • Highlighted in 2006 IOM reports on the future of EMSC
PECARN Structure PECARN Steering Committee Data Coordinating Center (DCC) HRSA/ MCHB/ EMSC Grant Writing and Publication Quality Assurance, Safety and Regulatory Protocol Review and Development Feasibility and Budget PI: Mike Dean Federal Project Officer: Tasmeen Weik PECARN Subcommittees Great Lakes Emergency Medical Services for Children Research Network GLEMSCRN Washington, Boston, Chicago Applied Research Node WBCARN Pediatric Emergency Medicine Northeast, West and South PEM-NEWS PI: Peter Dayan PI: Rachel Stanley PI: Jim Chamberlain Hospitals of the Midwest Emergency Research Node HOMERUN Pittsburgh, Rhode Island, Delaware Network PRIDENET Pediatric Research in Injuries and Medical Emergencies PRIME PI: Nathan Kuppermann PI: Bob Hickey PI: Rich Ruddy
PECARN Sites ● ● ● ● ● ● ● ● ● ■ ● ● ● ● ● ● ● ● = Data Coordinating Center ■ ● ● = PRIDENET Node = PRIME Node ● ● = GLEMSCRN Node ● = PEM-NEWS Node = WBCARN Node ● = HOMERUN Node ●
Ongoing PECARN Research Development • Therapeutic hypothermia in pediatric cardiopulmonary arrest • Diagnostic categorization of illnesses 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 • 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
Childhood Head Trauma:A Neuroimaging Decision Rule Supported by grant R40MC02461-01-00 from EMSC/MCHB/HRSA
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
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
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
Variables Considered • 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 • 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)
Results 57,030 eligible 2,869 GCS <14 or other exclusion 54,161 GCS 14-15 Not enrolled Enrolled 42,412(78.3%) 11,749 (21.7%) Validation 8,627 Derivation 33,785 288 ciTBI (0.9%) 88 ciTBI (1.0%)
The PECARN TBI Rules (derived and validated) Children are at very low risk of clinically-important traumatic brain injury (TBI) if they meet all criteria in age-specific rule:
Under 2 years Over 2 years
Recommendations for children younger than 2 Suggestions
Recommendations for children 2 years and older Suggestions
PECARN Clinical Prediction Rulefor 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 (IAIAI) • Recursive partitioning analysis • 761 (6.3%) with IAI and 203 (1.7%) with IAIAI
Prediction Rule for IAIAI (n=12,044) Abdominal Wall Trauma 1,963 patients 112 (5.7%) IAIAI 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) No 826 patients 38 (4.6%) IAIAI GCS < 14 No 2,532 patients 36 (1.4%) IAIAI Abdomen tender No 955 patients 6 (0.6%) IAIAI Thoracic Trauma No Abdominal pain 305 patients 2 (0.7%) IAIAI No ↓ Breath Sounds 34 patients 1 (2.9%) IAIAI No Emesis 395 patients 2 (0.5%) IAIAI No 1,234 CT scans (25%) 5,034 patients 6 (0.1%) IAIAI
Knowledge Translation Pipeline • EBM – continuum here Glasziou/Haynes, 2005
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
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
Data Completion by Nursing If Triage RN enters “Yes-less than 24 hours ago” items for risk assessment will be cascade
Blunt Head Trauma Assessment Courtesy: Peter S. Dayan, MD, PECARN
Clinical Decision Support • Clinician receives a statement no matter what is entered • Formatted similarly across statements • Recommendation • Risk estimate of clinically-important TBI based on PECARN data • Details regarding recommendations/risks • List of predictors and responses • Links to useful information(e.g. the prediction rules)
Methods – designInterrupted Time Series Trial with Concurrent Controls 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
Glasziou P, Haynes B. The paths from research to improved health outcomes. ACP J Club 2005;142:A8-10. • 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. • 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]. • 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]. • 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. • Laupacis A, Sekar N, Stiell IG. Clinical prediction rules: a review and suggested modifications of methodological standards. JAMA 1997;277:488-494. Selected References
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. • 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. • Stiell IG, Wells GA. Methodologic standards for the development of clinical decision rules in emergency medicine. Ann Emerg Med 1999;33:437-447. • 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