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

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

Data Coordinating Center (DCC) PI: Mike Dean PECARN Steering Committee Protocol Review and Development Quality Assurance, Safety and Regulatory Feasibility and Budget PECARN Subcommittees Grant Writing and Publication Pediatric Emergency Medicine Northeast, West and South

PEM-NEWS

PI: Peter Dayan Hospitals of the Midwest Emergency Research Node

HOMERUN

Great Lakes Emergency Medical Services for Children Research Network

GLEMSCRN

PI: Rachel Stanley

PRIDENET

Washington, Boston, Chicago Applied Research Node Pittsburgh, Rhode Island, Delaware Network

WBCARN

PI: Jim Chamberlain PI: Rich Ruddy PI: Bob Hickey Pediatric Research in Injuries and Medical Emergencies

PRIME

PI: Nathan Kuppermann HRSA/ MCHB/ EMSC Federal Project Officer: Tasmeen Weik

●

PECARN Sites

● ● ● ● ● ● ● ● ● ■ = Data Coordinating Center ● = PRIDENET Node ● = PRIME Node ● ● ● = GLEMSCRN Node = PEM-NEWS Node = WBCARN Node ● = HOMERUN Node ●

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  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

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

        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

Results

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

Inter-observer agreement 0.4

Kappa 0.6

0 0.2

0.8

m e c ha nis m o f injury m e c ha nis m o f injury ( lo w v s . high ris k ) dizzine s s a m ne s ia f o r e v e nt a ny LO C LO C dura t io n* s e izure a c t ing no rm a l pe r pa re nt he a da c he he a da c he s e v e rit y* v o m it ing v o m it ing f re que nc y* pa lpa ble f ra c t ure bulging f o nt a ne lle ( a ge <2 o nly) ba s ila r f ra c t ure he m a t o m a pre s e nt he m a t o m a lo c a t io n he m a t o m a s ize * he m a t o m a qua lit y a ny s ign o f t ra um a a bo v e c la v ic le s f o c a l ne uro lo gic de f ic it o t he r s ubs t a nt ia l injury int o xic a t io n G C S * G C S 15 v s <15 o t he r s igns o f a lt e re d m e nt a l s t a t us a git a t e d s lo w t o re s po nd s le e py re pe t it iv e ( a ge >=2 o nly) a ny s igns o f a lt e re d m e nt a l s t a t us 1

Kuppermann/Holmes, 2009

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:

Children < 2 years

Severe mechanism of injury History of LOC > 5 sec mental status Not acting normally per parent Palpable skull fracture Occipital/parietal/temporal scalp hematoma

Children 2-18 years

Severe mechanism of injury History of LOC mental status History of vomiting Severe headache in the ED Signs of basilar skull fracture

Under 2 years Over 2 years

Recommendations for children younger than 2 The Rule

Recommendations for children younger than 2 Suggestions

Recommendations for children 2 years and older The Rule

Recommendations for children 2 years and older Suggestions

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

Prediction Rule for IAI

AI

(n=12,044)

Abdominal Wall Trauma No GCS < 14

1,963 patients 112 (5.7%) IAI AI 826 patients 38 (4.6%) 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)

No Abdomen tender

2,532 patients 36 (1.4%) IAI AI

No Thoracic Trauma

955 patients 6 (0.6%) IAI AI

No

1,234 CT scans (25%)

Abdominal pain

305 patients 2 (0.7%) IAI AI

No ↓ Breath Sounds No No Emesis 5,034 patients

34 patients 1 (2.9%) IAI AI 395 patients 2 (0.5%) IAI AI 6 (0.1%) IAI AI

Holmes/Kuppermann, 2013

How to get clinicians to use the prediction rules?

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 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)

Decision Support: Patient < 2 years who meets rule

Methods – design

Interrupted 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

Selected References

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

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.