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, MPHDepartments of Emergency Medicine and Pediatrics

UC Davis School of MedicineMarch 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

PECARNSteering 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

PECARN Sites

● = PRIME Node● = GLEMSCRN Node

= PEM-NEWS Node= WBCARN Node

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■= Data Coordinating Center

= HOMERUN Node●

= PRIDENET Node●

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Ongoing PECARN Research Development

Patient safety and error reductionPatient safety and error reduction

Quality of PEM careQuality 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 Therapeutic hypothermia in pediatric cardiopulmonary arrestcardiopulmonary arrest

Diagnostic categorization of illnesses Diagnostic categorization of illnesses and injuries in the PED and injuries in the PED

Management of status epilepticusManagement of status epilepticus

Evaluation of abdominal traumaEvaluation of abdominal trauma

Progesterone for severe TBIProgesterone for severe TBI

Knowledge translation of TBI rulesKnowledge translation of TBI rules

RNA transcription biosignatures to diagnoseRNA transcription biosignatures to diagnose febrile infantsfebrile infants

Childhood Head Trauma: A Neuroimaging Decision Rule

Supported by grant R40MC02461-01-00from 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

Results57,030 eligible

42,412(78.3%)

11,749 (21.7%)

88 ciTBI

(1.0%)

EnrolledNot enrolled

54,161 GCS 14-15

2,869 GCS <14 or other exclusion

Validation 8,627

Derivation 33,785

288 ciTBI

(0.9%)

Inter-observer agreement0 0.2 0.4 0.6 0.8 1

mechanism of injury

mechanism of injury (low vs. high risk)

dizziness

amnesia for event

any LOCLOC duration*

seizure

acting normal per parent

headache

headache severity*

vomiting

vomiting frequency*

palpable fracture

bulging fontanelle (age<2 only)

basilar fracturehematoma present

hematoma location

hematoma size*

hematoma quality

any sign of trauma above clavicles

focal neurologic deficit

other substantial injury

intoxication

GCS*

GCS 15 vs <15

other signs of altered mental statusagitated

slow to respond

sleepy

repetitive (age>=2 only)

any signs of altered mental status

Kappa

Kuppermann/Holmes, 2009

The PECARN TBI Rules (derived and validated)

Children < 2 years Children 2-18 years

Severe mechanism of injuryHistory of LOC > 5 secGCS = 14 or other signs of altered mental statusNot acting normally per parentPalpable skull fractureOccipital/parietal/temporal scalp hematoma  

Severe mechanism of injuryHistory of LOCGCS = 14 or other signs of altered mental statusHistory of vomitingSevere headache in the EDSigns 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:

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 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) 1,963 patients 112 (5.7%) IAIAI

No

GCS < 14826 patients 38 (4.6%) IAIAI

Abdomen tender 2,532 patients 36 (1.4%) IAIAI

Thoracic Trauma

Abdominal pain

↓ Breath Sounds

Emesis

Abdominal Wall Trauma

955 patients 6 (0.6%) IAIAI

305 patients 2 (0.7%) IAIAI

34 patients 1 (2.9%) IAIAI

395 patients 2 (0.5%) IAIAI

No

No

No

No

No

5,034 patients

No

6 (0.1%) 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)

1,234 CT scans (25%)

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

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

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.

Selected References