neu.2011.1952.pdf

8/10/2019 neu.2011.1952.pdf

1/15

Common Data Elements for Pediatric Traumatic Brain Injury:Recommendations from the Working Groupon Demographics and Clinical Assessment

P. David Adelson, 1 Jose Pineda, 2 Michael J. Bell, 3 Nicholas S. Abend, 4 Rachel P. Berger, 3

Christopher C. Giza, 5 Gillian Hotz, 6 and Mark S. Wainwright 7

Abstract

The Common Data Elements (CDEs) initiative is a National Institutes of Health (NIH) interagency effort tostandardize naming, denitions, and data structure for clinical research variables. Comparisons of the results of

clinical studies of neurological disorders have been hampered by variability in data coding, denitions, andprocedures for sample collection. The CDE project objective is to enable comparison of future clinical trialsresults in major neurological disorders, including traumatic brain injury (TBI), stroke, multiple sclerosis, andepilepsy. As part of this effort, recommendations for CDEs for research on TBI were developed through a 2009multi-agency initiative. Following the initial recommendations of the Working Group on Demographics andClinical Assessment, a separate workgroup developed recommendations on the coding of clinical and demo-graphic variables specic to pediatric TBI studies for subjects younger than 18 years. This article summarizes theselection of measures by the Pediatric TBI Demographics and Clinical Assessment Working Group. The variablesare grouped into modules which are grouped into categories. For consistency with other CDE working groups,each variable was classied by priority (core, supplemental, and emerging). Templates were produced tosummarize coding formats, guide selection of data points, and provide procedural recommendations. Thisproposed standardization, together with the products of the other pediatric TBI working groups in imaging, biomarkers, and outcome assessment, will facilitate multi-center studies, comparison of results across studies,and high-quality meta-analyses of individual patient data.

Key words: clinical studies; common data elements; data coding; data collection; pediatric; standardization;traumatic brain injury

Introduction

C hildhood traumatic brain injury (TBI) is the mostcommon cause of death for children over the age of 1year. While there are currently no specic therapies demon-strated to improve long-term outcome, aggressive intensiveprotocol-driven algorithms have been shown to improve

mortality. The International Mission on Prognosis and Clin-ical Design in TBI (IMPACT) studies highlighted the hurdlesand potential benets to meaningful comparisons betweenclinical TBI studies. Merging individual patient data fromeight randomized and three observational studies in prepa-ration for analyses took over 10 person-years of work (Maaset al., 2007; Marmarou et al., 2007). A prospective unied

1 Barrow Neurological Institute, Phoenix Childrens Hospital, Phoenix, Arizona.2 Departments of Pediatrics and Neurology, Division of Critical Care Medicine, Washington University School of Medicine, St. Louis,

Missouri.3 Safar Center for Resuscitation Research and Departments of Pediatrics and Critical Care Medicine, Childrens Hospital of Pittsburgh of

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.4 Division of Neurology, The Childrens Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia,

Pennsylvania.5 Division of Neurology, Department of Pediatrics, and Department of Neurosurgery, UCLA Brain Injury Research Center, Mattel

Childrens Hospital, David Geffen School of Medicine at UCLA, Los Angeles, California.6 DeWitt Daughtry Family and Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida.7 Department of Pediatrics, Divisions of Neurology and Critical Care, Northwestern University Feinberg School of Medicine, Chicago,

Illinois.

JOURNAL OF NEUROTRAUMA 29:639653 (March 1, 2012) Mary Ann Liebert, Inc.DOI: 10.1089/neu.2011.1952

639

8/10/2019 neu.2011.1952.pdf

2/15

approach to data collection and coding procedures wouldreduce variability in data collection and thereby facilitatecomparisons between studies and meta-analyses. Giventhe heterogeneity of TBI studies inherent to the multiplemechanisms of injury and patient populations, this approachis attractive both scientically and nancially because it fa-cilitates merging of data sets from small studies of specicpopulations.

Common Data Elements Overview

The Common Data Elements (CDE) is a National Institutesof Health (NIH) interagency effort to standardize naming,denitions, and data structure for clinical research variables.The goals of the overall CDE project are: (1) to disseminatestandards for the collection of data from participants enrolledin studies of neurological diseases; (2) to create accessibledata-collection tools for investigators that are ready to useoff-the-shelf; (3) to encourage focused and simplied datacollection to reduce the burden on investigators and practice- based clinicians to increase clinical research participation; (4)to improve study quality and reduce costs of data entry,

cleaning, and analysis, by providing uniform data descrip-tions and tools across National Institute of NeurologicalDisorders and Stroke (NINDS)-funded clinical studies of treatment for neurological diseases (National Institute of Neurological Disorders and Stroke; http://www.commondataelements.ninds.nih.gov/default.aspx).

The TBI Working Group (WG) sought to address these is-sues by prioritizing and standardizing data collection ele-ments for adult TBI patients to facilitate comparison of research ndings across studies and encourage high-qualitymeta-analyses of individual patient data (Maas et al.,2010,2011). The WG recognized that the types of data ele-ments and assignment of priority in children ( < 18 years old)differ from adults. The causes and mechanisms of injury, risk

factors in the medical history, contribution of birth injury, andimpact of socioeconomic factors on the childs developmentfollowing TBI are important pediatric considerations. Incontrast to adult TBI, there are limited data on age-dependentvalues for physiological variables used to guide therapy forchildren with severe TBI, including intracranial pressure (ICP)and cerebral perfusion pressure (CPP) (Chambers et al.,2005,2006; Adelson et al., 2005).

Overcoming such limitations will require structured datacollection that accommodates pediatric physiology and braindevelopment. Thus, the goal of this pediatric Demographicsand Clinical Assessment WG was to develop recommenda-tions on coding and terminology of demographicsand clinicalassessments forstudies acrossthe spectrum of pediatricTBIaspart of the larger multi-agency effort (Whyte et al., 2010) de-scribed by Thurmond and associates (2010). The primaryobjectives were to identify data elements specic to pediatricTBI, to prioritize these elements following the criteria estab-lished for adult TBI, to present the data elements in a clearformat, and to use a structure consistent with that establishedfor TBI by the original WG (Maas et al., 2010). Following thismethod, various elements and modules can be used as plug-inelements and used multiple times in clinical data collections.Forexample, the module on Glasgow Coma Scale (GCS) andpupils may be recorded only on admission, or also pre-hospital, as well as daily during the acute care phase.

This group followed the approach and structure of theprecedent established by the original Demographics andClinical Assessment WG for the broad spectrum of TBI, in-cluding adult, military, and pediatric cases (Maas et al.,2010,2011; Menon et al., 2010). This publication reports thegeneration of pediatric-specic CDE for TBI. This is the rststep in an iterative process of dening CDEs that harmonizethe denitions of key variables and the collection of data in

clinical studies of TBI. Other pediatric-specic WGs devel-oped data elements with recommendations for imaging, bio-markers, and outcomes assessment.

Process for selecting common data elements

Two members of the pediatric WG (P.D.A. and M.S.W.)participated in the development of CDEs for TBI that focusedon adult injury, but included limited recommendations forpediatric CDEs (Maas et al., 2010, referred to as the originalWG in this article). A larger pediatric WG was then formedand the progress and recommendations of the WG were dis-cussed during teleconferences in 20092010. In-depth dis-cussions were conducted during face-to-face meetings inSeptember 2009 and March 2010. The nal recommendationsof the WG were incorporated into a beta version of the pedi-atric TBI CDEs, reviewed by all WG members, and structuredto ensure compatibility with the NINDS broad CDE project.

Distinguishing core, supplemental, and emerging data elements

In accordance with the criteria used by the other CDE WGs,the elements should be applicable across the spectrum of mildto severe TBI, for acute to long-term studies, and for studiesincluding patients early after injury and those enrolling pa-tients at later time periods. Following the nomenclatureadopted by the CDE project, CDEs were classied by priorityas core, supplemental, and emerging. Core elements are in-

tended to encompass the minimal set of measures to charac-terize the broad spectrum of subjects. Core data elementsare data considered essential for every study, and follow-ing the consensus of the CDE Steering Committee, arelimited in number. Supplemental elements provide greaterdepth/breadth of exploration and/or may be useful formore specialized subpopulations. Emerging elements mayrequire further validation, but they may ll gaps in currentlyvalidated measures, and/or substitute for recommendedmeasures once validation is complete. Supplemental andemerging elements are specic to a research hypothesis or TBIsubpopulations (i.e., children with concussion or abusivehead trauma). Both may include a higher number of dataelements because of the need for high data granularity and

high resolution. As supplemental and emerging elements arerened and validated, some may need reclassication as coredata elements, as well as future grouping of core data ele-ments for particular types of studies (i.e., acute care clinicaltrials).

Categorizing elements as core/supplemental/emerging asproposed by the planning committee (Thurmond et al., 2010)is an unresolved issue for the CDE project, including pediatricTBI.. The denition of a core element for an acute phase studymay differ from what is considered a core element for anepidemiological or rehabilitation-oriented study. The broadrange of settings and types of studies within TBI, including

640 ADELSON ET AL.

8/10/2019 neu.2011.1952.pdf

3/15

pediatric TBI, therefore precludes a large number of coreclinical data elements that would be appropriate to all studies.Consensus did exist that as a minimum, the most relevantmeasures of injuryseverity andpredictors foroutcome should be collected in studies of severe and moderate TBI in the acutesetting. Consistent with the consensus of the CDE SteeringCommittee, the number of core elements is small. Supple-mental and emerging data elements can be selected appro-

priate to the aims of each study.The level of detail required can vary greatly with the designand aim of a specic study. Observational studies or largepragmatic clinical trials would require less detail than highly-focused Phase II or Phase III trials. It is therefore necessary toincorporate exibility into the supplemental recommenda-tions so that data elements can be selected to accommodatedifferent levels of complexity and research questions. Thisapproach is consistent with objectives of the CDE initiative tofacilitate comparisons of results or merging of data acrossmultiple studies, in this case, pooling results from small pe-diatric studies or comparing pediatric to adult studies.

The product: Pediatric TBI demographics and clinical evaluation common data elements

The structure of the adult CDEs (Maas et al., 2010) wasmodied to accommodate the CDEs specic to pediatric TBIas summarized in Figure 1. Importantly, these initial recom-mendations of the WG represent a beta version. The longer-term intent is to make this CDE a global initiative (Maas,2009). The recommendations should be eld tested in studiesof pediatric TBI prior to general acceptance. This eld testingmay also serve to provide evidence for categorizing elementsas core/supplemental/emerging.

The data elements presented here were considered to bespecic to pediatric TBI. For data elements not discussed here(e.g., gender, race, and ethnicity; Bhopal et al., 1998; Wyniaet al., 2010), the elements and their classication did not differ between the adult and pediatric set, and therefore no changeswere made to those already assigned (Maas et al., 2010). Inmany instances there were no differences between the adultand pediatric CDEs and no changes were made to the CDEs

created for the adult studies. The intent was to keep the rel-evance of the CDEs as broad as necessary for the differenttypes of investigators likely to use them (i.e., epidemiologi-cal/observational studies and acute/rehabilitation clinicaltrials). Different formats for data collection may, however, beappropriate in different circumstances. As an example, theWG proposes different formats for coding early details of injury and referral details for patients presenting acutelyversus those presenting late. For patients who present early,referral policy and time of arrival, as well as mode of transportand emergency services provision, are relevant. For patientspresenting late, the main reason for presentation and moregeneral information on delivery of initial care and the specicsof such care are more appropriate. Capturing information on

the reason for presentation is important also for later charac-terization of the population captured. For example, mild TBImay be overreported by individuals or families with possiblenancial gain, but underreported by individuals highly mo-tivated to return to team play.

A consensus on the coding of CDEs for use in pediatric TBIwas achieved. The CDEs are grouped into modules which aregrouped into categories. For example, the data elements age,gender, and race are contained in the module demograph-ics, under the category subject characteristics. The fourmain categories relevant to this manuscript are: (1) Participant

FIG. 1. Schema of sequential approach to selection of common data elements for pediatric studies (TBI, traumatic braininjury; ICP, intracranial pressure; ED, emergency department; CT, computed tomography; PTSD, post-traumatic stressdisorder; HC, head circumference).

CDES FOR PEDIATRIC TBI DEMOGRAPHICS AND CLINICAL ASSESSMENT 641

8/10/2019 neu.2011.1952.pdf

4/15

or Subject Characteristics(Table 1), (2)Participant History andFamily History (Table 2), (3) Injury- and Disease-RelatedEvents (Table 3), and (4) Assessments and Examinations(Table 4). A complete overview of the data elements anddenitions together with the templates may be found at theNINDS website www.commondataelements.ninds.nih.gov,and additional information is available at www.tbi-impact.org.

1. Subject Characteristics (Demographicsand Pre-Injury Baseline)

Core data elements

Age. Recording age in TBI studies is of great importance.Causes of injury differ by age group and lead to differenttypes of injury. Age is one of the strongest predictors of out-come in TBI, and younger patients may be at greater risk forpoor outcome (Anderson et al., 2005).

Age is a core element and should be collected for all pedi-atric studies. Accurate recording of the date of birth (DOB)provides the most detailed and source-veriable information, but collection of such data could lead to privacy concerns.Age should be calculated on the nominal scale. For childrenyounger than 1 year, age should be expressed to three decimalplaces to allow calculation of age in days if needed. In addi-tion, for those born at less than 36 weeks gestation, ageshould be adjusted for gestational age. For children above1 year, age should be expressed to two decimal places.When reporting the relationship between age and outcome, acontinuous analysis is recommended over theuseof thresholdvalues.

Date of injury. Date of injury is recommended as a coreelement. This should be specically recorded as veried, es-timated, or unknown.

Age at injury. Again reecting the importance of age-dependent responses to injury, and changes in key physio-logical variables including blood pressure and cerebral blood ow, the WG considered the age at injury to be a corevariable.This should also be expressed on the nominal scale tothree decimal places below 1 year of age, and one place above1 year.

Head circumference. Head circumference (occipito-frontal circumference: OFC) is a quantiable measure of braindevelopment (Pryor and Thelander, 1968). The WG deter-mined that OFCwould serve as a core variable.Abnormalitiesin OFC may identify children who were not neurologicallynormal at the time of injury in acute injury studies, or serve asa baseline for following developmental outcome in studieswith longer follow-up. To enable interpretation of the OFC,the percentile, height. and weight should also be recorded ascore variables. TheWG did not specify a source forcalculatingpercentiles, but recommended that the source of the norma-tive percentile data be included.

Supplemental data elements

Time of injury. Timing of injury may be a critical deter-minant of response to a given therapy. As discussed above,this consideration may not be relevant to all studies, and the

WG therefore determined this to be a supplemental element.When recorded, it should be classied as veried by a witness,estimated, or unknown. In addition, the data should differ-entiate between times when the child was injured, becamesymptomatic, the time of trauma activation, and/or the timeof presentation to the emergency department.

Language. The primary language of the child at the time

of injury was determined to be a supplemental element. Formultilingual children, recording the specic secondary lan-guage is recommended.

Educational level. For adults and children, educationallevel is a basic descriptor and an important component of socioeconomic status. Educational attainment is a strongcorrelate of income level and highly relevant to outcome.Educational level is associated with outcome following TBI(Mushkudiani et al., 2007). The WG agreed that documentingat least some information on education prior to injury is rel-evant. Various approaches exist for documenting educationallevel, and the WG recognized that attendance and achieve-ment are not identical aspects. Achievement is probably the

more relevant as a descriptor or predictor of outcome. Forthese reasons, the WG recommended that both the number of years of education completed as well as the highest level of education at the time of injury be recorded. If the child re-quired special education services prior to injury, this should be specied. As an additional measure of pre-injury intellec-tual abilities, whether the child is behind, ahead of, or in thecorrect grade for age may also be recorded.

Handedness. Early selection of a dominant hand orchange in dominant hand may reect prior or new brain injury, respectively, and may be a sequela of brain trauma. Insome studies, these data may be useful and this element wasconsidered supplemental by the WG.

2. Subject and Family Medical History

Core data elements

No recommendations for core data elements were made forthis module. Details on medical history, family history, anduse of medications are collected in nearly every TBI study.However, medical history data are typically the least reliabledata collected and are almost universally collected in a freetext format, thus prohibiting any meaningful analysis.Nevertheless, pre-existing conditions may inuence the dis-ease course and chances of recovery, and information onmedical history is essential for interpretation of adverseevents occurring during clinical trials. It is therefore highly

relevant to accurately record medical history and medica-tions. In order to facilitate better use of such data, the WGagreed with the approach of the original WG and recom-mends pre-specied categories. Consistent with these rec-ommendations, these data are supplemental.


Past medical and family history. To accommodate med-ical disorders that are more relevant to children, the WG ad-ded categories that included type and timing of disorders(e.g., prenatal, antenatal, and post-natal; acquired or con-genital disorders; and other specic types, such as epilepsy,

642 ADELSON ET AL.

8/10/2019 neu.2011.1952.pdf

5/15

T a b l e 1 .

P a r t i c i p a n t o r S u b j e c t C h a r a c t e r

i s t i c s

C D E v a r i a b l e

C D E d e n i t i o n

R e c o m m e n d e d i n s t r u m e n t

D e s c r i p t i o n o f m e a s u r e

C o d e l i s t / p e r m i s s i b l e v a r i a b l e

C l a s s i c a t i o n : c o r e

s u p p l e m e n t a l /

e m e r g i n g

M o d u l e a n d d a t a

e l e m e n t n a m e

P h r a s e

o r s e n t e n c e t o d e n e t h e

c o n c e p t b e i n g m e a s u r e d

N a m e o r a c r o n y m f o r t h e

s e l e c t e d m e a s u r e

N u m b e r a n d d e s c r i p t i o n o f t e r m s

a n d s u b s c a l e s t r u c t u r e

T o t a l r a n g e o f s c o r e s

I n d i c a t e c o r e /


e m e r g i n g

D e m o g r a p h i c s

A g e a t p r e s e n t a t i o n

A g e

A g e

_ P r e s e n t a t i o n_

0 0 . 0

0 0 1 y

0 0 . 0

> 1 y

A d j u s t a g e t o g e s t a t i o n a l

a g e u p t o 1 y

0 t o < 1 8 y

C o r e

D a t e o f i n j u r y

D a t e o f i n j u r y

D O I

D a t e t h a t i n j u r y o c c u r r e d ;

m m - d

d - y y y y

V e r i e d / U n v e r i e d / U n k n o w n

C o r e

D a t e o f a d m i s s i o n

D a t e o f a d m i s s i o n

D O A

m m - d

d - y y y y

D a t e o f e n r o l l m e n t t o t h e s t u d y

C o r e

T i m e o f i n j u r y

T i m e o f i n j u r y

T O I

H H : M M

V e r i e d / E s t i m a t e d / U n k n o w n

V e r i e d - a c t u a l l y w i t n e s s e d a n d

t i m e p r o v i d e d

E s t i m a t e d : I t n e e d s t o b e d e n e d

f o r e a c h s t u d y : T i m e t h a t t h e

c h i l d b e c a m e s y m p t o m a t i c ;

t i m e o f r s t t r a u m a a c t i v a t i o n ;

t i m e o f p r e s e n t a t i o n t o E D

U n k n o w n

S u p p l e m e n t a l

A g e a t i n j u r y



0 0 . 0

0 0 1 y

0 1 . 0

> 1 y

A d j u s t a g e t o g e s t a t i o n a l

a g e u p t o 1 y

0 t o < 1 8 y e a r s

C o r e

H e a d c i r c u m f e r e n c e

H e a d c i r c u m f e r e n c e

O c c i p i t o f r o n t a l

c i r c u m f e r e n c e

C m

P e r c e n t i l e

C o r e

H e i g h t

W e i g h t

L a n g u a g e

H e i g h t

W e i g h t

P r i m a r y a n d s e c o n d a r y l a n g u a g e s

o f c h i l d a t t i m e o f i n j u r y

H e i g h t

W e i g h t

L a n g u a g e

c m k g E n g l i s h

S p a n i s h

O t h e r

C o r e

C o r e


E d u c a t i o n a l l e v e l ,

c u r r e n t o r h i g h e s t

c o m p l e t e d

P r e s e n t g r a d e l e v e l o r

c o m p l e t e d a t t i m e o f i n j u r y

S c h o o l l e v e l

P r e - s c h o o l , K 1

2 , c o l l e g e 1 3 1

6

E a r l y i n t e r v e n t i o n / S p e c i a l

E d / R e g u l a r E d


A g e - a p p r o p r i a t e

g r a d e l e v e l

G r a d e l e v e l f o r a g e

C o r r e c t g r a d e

B e h i n d f o r a g e

C o r r e c t f o r a g e

A h e a d f o r a g e


H a n d e d n e s s

H a n d p r e f e r e n c e b y c h i l d a t

t i m e o f i n j u r y

H a n d e d n e s s

R i g h t

L e f t

E q u a l L e f t & R i g h t

U n k n o w n


E D , e

m e r g e n c y d e p a r t m e n t .

643

8/10/2019 neu.2011.1952.pdf

6/15

T a b l e 2 . P a r t i c i p a n t H i s t o r y a n d F a m i l y H i s t o r y



R e c o m m e n d e d

i n s t r u m e n t


C o d e l i s t / p e r m i s s i b l e

v a r i a b l e

C l a s s i c a t i o n : c o r e /


e m e r g i n g

M o d u l e a n d d a t a e l e m e n t n a m e

P h r a s e o r s e n t e n c e

t o d e n e t h e c o n c e p t

b e i n g m e a s u r e d

N a m e o r a c r o n y m

f o r t h e s e l e c t e d

m e a s u r e

N u m b e r a n d d e s c r i p t i o n

o f t e r m s a n d

s u b s c a l e s t r u c t u r e

T o t a l r a n g e

o f s c o r e s



e m e r g i n g

P a s t M e d i c a l a n d F a m i l y H i s t o r y

P r e m a t u r i t y / p r e n a t a l / a n t e n a t a l o r

p o s t n a t a l d i s o r d e r s

P r e n a t a l / A n t e n a t a l / P o s t n a t a l


C o n g e n i t a l o r a c q u i r e d

C o n g e n i t a l / A c q u i r e d


P e r i n a t a l b r a i n i n j u r y



H I E

I C H

P R O M

A b r u p t i o n

C e p h a l o h e m a t o m a

O t h e r

E m e r g i n g

E p i l e p s y , c o n g e n i t a l h e a r t d i s e a s e .

s i c k l e c e l l d i s e a s e , m e t a b o l i c ,

l e a r n i n g d i s a b i l i t y , b e h a v i o r a l

d i s o r d e r s , c e r e b r a l p a l s y ;

f a m i l i a l m a c r o c e p h a l y ;

f a m i l i a l m i c r o c e p h a l y


P r e v i o u s b r a i n i n j u r y

S p e c i f y p e r i n a t a l o r p o s t n a t a l :

E n c e p h a l i t i s o r m e n i n g i t i s

S t r o k e

I C H

C a r d i a c a r r e s t

P e r i n a t a l a s p h y x i a

N e a r - d r o w n i n g

N o n e


H I E

, h y p o x i c - i s c h e m i c e n c e p h a l o p a t h y ; I C E , i n t r a c e r e b r a l h e m o r r h a g e ; P R O M

, p r e m a t u r e r u p t u r e o f m e m b r a n e s ; I C H , i n t r a c e r e b r a l h e m o r r h a g e .

644

8/10/2019 neu.2011.1952.pdf

7/15

T a b l e 3 . I n j u r y - a n d D i s e a s e - R

e l a t e d E v e n t s



R e c o m m e n d e d

i n s t r u m e n t


C o d e l i s t /

p e r m i s s i b l e v a r i a b l e



e m e r g i n g

M o d u l e a n d d a t a e l e m e n t n a m e

P h r a s e o r s e n t e n c e

t o d e n e t h e c o n c e p t

b e i n g m e a s u r e d

N a m e o r a c r o n y m

f o r t h e s e l e c t e d

m e a s u r e

N u m b e r a n d d e s c r i p t i o n o f t e r m s

a n d s u b s c a l e s t r u c t u r e




e m e r g i n g

S c e n e o f I n j u r y a n d P r e - H o s p i t a l A s s e s s m e n t

T y p e a n d M e c h a n i s m o f I n j u r y

T y p e o f i n j u r y

T y p e o f i n j u r y

I n j u r y t y p e

C l o s e d / p e n e t r a t i n g / b l a s t / c r u s h

C o r e

M e c h a n i s m

M e c h a n i s m

M e c h a n i s m

A c c i d e n t a l / a b u s i v e i n i c t e d /

n o n - i n i c t e d

C o r e

A b u s i v e h e a d t r a u m a

A b u s i v e h e a d t r a u m a

I n c i d e n t a l t r a u m a

N e g l e c t

A H T

D e n i t e / s u s p e c t e d

C o r e



R a d i o g r a p h i c

S i g n s / s y m p t o m s

E m e r g i n g

C o r e

R e p o r t e d o n s e t o f s y m p t o m s

D a t e o f o n s e t o f s y m p t o m s

D O S

m m - d

d - y y y y

H H : m m

E v i d e n c e o f p r i o r i n j u r y

E v i d e n c e o f p r i o r i n j u r y f o u n d

e i t h e r h i s t o r i c a l l y

, a t p r e v i o u s

E D v i s i t s

, r a d i o g r a p h i c

n d i n g s , o r s i g n s o r

s y m p t o m s a t t i m e o f

p r e s e n t a t i o n

P r i o r i n j u r y

Y e s / n o

B r a i n i n j u r y

E x t r a c r a n i a l i n j u r y

B o t h

S p i n e i n j u r y

H i s t o r i c a l

r a d i o g r a p h i c

s i g n s / s y m p t o m

s

H i s t o r i c a l

R a d i o g r a p h i c s i g n s /

s y m p t o m s

C o r e

P r o t e c t i v e d e v i c e s

P r o t e c t i v e d e v i c e s u t i l i z e d a t

t i m e o f p r i m a r y i n j u r y

m e c h a n i s m

P r o t e c t i v e d e v i c e s

Y e s / n o

T y p e :

H e l m e t / c a r s e a t / b o o s t e r /

s e a t b e l t


E D , e

m e r g e n c y d e p a r t m e n t .

645

8/10/2019 neu.2011.1952.pdf

8/15

T a b l e 4 . A s s e s s m e n t s a n d E x a m i n a t i o n s








e m e r g i n g



P h r a s e o r s e n t e n c e t o d e n e

t h e c o n c e p t b e i n g m e a s u r e d

N a m e o r a c r o n y m f o r

t h e s e l e c t e d m e a s u r e


o f t e r m s a n d s u b s c a l e

s t r u c t u r e




e m e r g i n g

C l i n i c a l S e v e r i t y

C l a s s i c a t i o n

G l a s g o w C o m a S c o r e

( p o s t - r e s u s c i t a t i o n )

p e d i a t r i c p r e f e r r e d

G l a s g o w C o m a S c o r e , b e s t

G C S o b t a i n e d f o l l o w i n g

r e s u s c i t a t i o n i n t h e E D

G C S - I

3 1 5

P o s t - r e s u s c i t a t i o n

C o r e

G l a s g o w C o m a S c o r e ( d a i l y )

G l a s g o w C o m a S c o r e

o b t a i n e d o n a d a i l y

b a s i s d u r i n g h o s p i t a l

s t a y . I

t s h o u l d b e b e s t

G C S o n a n y g i v e n d a y

G C S - D

3 1 5

B e s t G C S d u r i n g t h e l a s t 2 4 h


E x t r a c r a n i a l i n j u r i e s

E x t r a c r a n i a l i n j u r i e s b a s e d

o n t h e A b b r e v i a t e d

I n j u r y S e v e r i t y S c o r e

E x t r a c r a n i a l i n j u r y

A I S

I S S

A I S a n d c a l c u l a t e d I S S o n a d m

i s s i o n


S p i n e / s p i n a l c o r d i n j u r y

P e d i a t r i c R i s k o f

M o r t a l i t y ( P R I S M ) s c o r e

S p i n a l c o l u m n a n d o r

s p i n a l c o r d i n j u r y

P e d i a t r i c

S p i n a l i n j u r y

P R I S M

R a d i o g r a p h i c

s i g n s / s y m p t o m s



S e c o n d I n s u l t s

( S e l f - p o p u l a t i n g )

H y p o x i a

H y p o x i a

H y p o x i a

Y e s / n o / u n k n o w n

P a o

2

m m H g

O 2

S a t u r a t i o n O x y g e n p e r c e n t a g e

T i m e o f m e a s u r e

F i r s t a s s e s s e d v s . h

o u r l y

C o r e

H y p o t e n s i o n




S B P m m H g

C o r e

H y p e r t h e r m i a




o C

C o r e

H y p o t h e r m i a




o C

C o r e

H y p e r v e n t i l a t i o n




P a c o

2

m m H g

C o r e


r e q u i r i n g C P R




C o r e

S e i z u r e s

S e i z u r e s

S e i z u r e s


C o r e

C l i n i c a l s e i z u r e s

S t a t u s e p i l e p t i c u s

C l i n i c a l

C l i n i c a l / N o n - c o n v u l s i v e


S t a t u s

e p i l e p t i c u s



I n f e c t i o n

I n f e c t i o n

I n f e c t i o n

C u l t u r e p o s i t i v e /

s u s p e c t e d / u n k n o w n


( c o n t i n u e d )

646

8/10/2019 neu.2011.1952.pdf

9/15

T a b l e 4 . ( C o n t i n u e d )








e m e r g i n g



P h r a s e o r s e n t e n c e t o d e n e

t h e c o n c e p t b e i n g m e a s u r e d

N a m e o r a c r o n y m f o r

t h e s e l e c t e d m e a s u r e


o f t e r m s a n d s u b s c a l e

s t r u c t u r e




e m e r g i n g

L a b o r a t o r y D a t a

G l u c o s e

G l u c o s e

G l u c o s e

S e r u m v a l u e s

m g / d L

T h r e s h o l d s :

H y p e r g l y c e m i a 1 8 0 m g / d L

H y p o g l y c e m i a 8 0 m g / d L

C r i t i c a l 4 0 m g / d L

T i m e o f a s s e s s m e n t :

F i r s t

L o w e s t


H e m o g l o b i n

H e m o g l o b i n

H g b

S e r u m v a l u e s

g / d L

F i r s t

T i m e o f a s s e s s m e n t :

F i r s t

L o w e s t


V i t a l S i g n s

B l o o d p r e s s u r e

B l o o d p r e s s u r e

M A P

M A P

H i g h e s t a n d l o w e s t p r e s s u r e o v e r a

g i v e n p e r i o d ; h o u r l y r e c o m m e n d e d

C o r e

I n t r a c r a n i a l p r e s s u r e

I n t r a c r a n i a l p r e s s u r e

I C P

I C P

H i g h e s t a n d l o w e s t p r e s s u r e o v e r a

g i v e n p e r i o d ; h o u r l y r e c o m m e n d e d

C o r e

C e r e b r a l p e r f u s i o n p r e s s u r e

C P P

C P P

M A P , I C P

C o r e

B r a i n o x y g e n a t i o n ,

b r a i n t e m p e r a t u r e ,

j u g u l a r v e n o u s o x y g e n

H o u r l y r e c o r d i n g o r h i g h - f r e q u e n c y

d a t a c a p t u r e

E m e r g i n g

T r e a t m e n t

H o s p i t a l t r e a t m e n t

A m o u n t o f t h e r a p y a n d

t r e a t m e n t n e c e s s a r y

f o r c o n t r o l o f I C P

P e d i a t r i c I n t e n s i t y

L e v e l o f T h e r a p y

S c a l e ( P I L O T )

P I L O T

S c a l e 0 3 8

, d a i l y r e c o r d i n g

C o r e

A I S

, A b b r e v i a t e d I n j u r y S c a l e ; I S S , I n j u r y S e v e r i t y S c o r e ; S B P , s y s t o l i c b l o o d p r e s s u r e ; P a c o

2 , p

a r t i a l a r t e r i a l c a r b o n d i o x i d e p r e s s u r e ; M A P , m e a n a r t e r i a l p r e s s u r e .

647

8/10/2019 neu.2011.1952.pdf

10/15

congenital heart disease, sickle cell disease, metabolic, learningdisabilities, familial macro- or microcephaly, and behavioraldisorders). The WG also classied specic prior brain injuries.

Emerging data elements

Recognizing that the denition of perinatal brain injuryis controversial ( vide infra), a history of such injury is alsoincluded in this category as an emerging data element.

3. Injury-Related Elements and Pre-HospitalAssessment and Treatment

Core data elements

Type and mechanism of injury. Recording details on thetype, place, nature, and mechanism of injury is highly rele-vant, both from an epidemiologic perspective (with implica-tions for prevention programs), and because differentpathophysiologic mechanisms occur in different types of injury. The WG followed the consensus of the original WG andagreed with classifying the type of injury into four categories:closed, penetrating, blast, and crush. Blast injuries (any form

of TBI occurring in association with a blast explosion) are anegligible cause of pediatric TBI outside of combat theatres(Ling et al., 2009; Wolfet al.,2009). In combat theatres, up to 50%of civilian hospitalizations due to blast injury may be pediatric(Dr. C. Giza, personal communication). The WG considered itimportant to maintain a consistent classication systemwith theoriginal WG, and to distinguish between data related to theplace and cause of injury. The place of injury is intended tocapture information on the location of injury, such as street,home/domestic, work/school, or sports/recreation. In distinc-tion, causeof injury is directed towards causative factors suchas road or trafc incident or fall. Indirectly, these imply a certainelement of mechanism, but more detailed information on themechanism of injury can be recorded separately.

Abusive head trauma (AHT). The WG discussed at lengththe issues of classication related to AHT. This is a signicantcause of head injury in infants and young children (Barlowet al., 2005; Berger et al., 2002; Keenan et al., 2004; Maguireet al., 2009). Accordingly this mechanism was added to thepediatric data elements. When identied as a potentialmechanism, other relevant information including evidence of prior trauma, timing of the insult, and whether the insult wasconrmed as inicted (non-accidental), or classied as sus-pected, should be recorded.

Evidence of prior brain injury. In distinction to the pastmedical and family data (Table 2), which may be unreliable,the WG recommended that evidence of prior brain injury berecorded as a core data element.


Pediatric protective devices. The use of protective de-vices (car seats or helmets) may affect outcome after pediatricTBI. The WG considered such data supplemental.


Perinatal brain injury. Brain injury as a result of the birthprocess is a common and well-described phenomenon (Hol-

den et al., 1999; Pollina et al., 2001; Looney et al.,2007; Towneret al., 1999; Whitby et al., 2004). Birth-related brain injuries/abnormalities are most frequently characterized by intracra-nial hemorrhages (ICH)of multiple types, including subdural,subarachnoid, intraparenchymal, and intraventricular hem-orrhages. Unlike TBI due to other causes, the locations of theICH associated with birth are almost exclusively posteriorfossa/occipital lobes (Looney et al., 2007; Whitby et al., 2004).

Presenting symptoms due to birth-related injury can rangefrom none to severe, and include apnea, bradycardia, and/orseizures (Looney et al., 2007). Furthermore, whether suchimaging ndings are related to neurologic injury is contro-versial, since they may occur in asymptomatic infants withnormal developmental outcomes (Rooks et al., 2008).

The unique features of birth-related brain injury lead to therecommendation for inclusion as an emerging data element.This injury occurs only in neonates at the time of birth. Thefact that the majority of neonates with such injury areasymptomatic, that the location of ICH is most commonly theposterior fossa, and the fact that there appears to be no effectof the injury on long-term development (Holden et al., 1999),also make this type of injury unique. The clinical scenario

during which the possibility of undiagnosed birth trauma isinvariably discussed is during the evaluation of possible in-icted childhood neurotrauma (e.g., AHT).

4. Assessments and Examinations

4.1 Classication of Clinical Severity

Core data elements

Traditionally, TBI hasbeen classied by mechanism(closedversus penetrating), by clinical severity (GCS score, length of loss of consciousness, and/or length of post-traumatic am-nesia), or by assessment of structural damage (neuroimaging).A substantial limitation of all these approaches is that they

categorize patients articially. For example, in classifyingpatients by clinical severity, patients are somewhat arbitrarilygrouped into three distinct categories: severe (GCS score 38),moderate (GCS score 912), or mild (GCS score 1315). Thisapproach insufciently recognizes that the severity of TBI liesalong a continuum, the GCS score may uctuate, and thereexist additional reliability issues for using GCS in the young/preverbal/developmentally-delayed pediatric population.Furthermore, classication of TBI by clinical severity is in-creasingly limited in the acute setting by confounders, such asmedical sedation, neuromuscular blockade, or intoxication,and does not account for anatomical features that may greatlyinuence outcome, such as brainstem injury. In addition, theextent of injury, treatment, prognosis, and outcome of patients

at the same injury level differs markedly due to differences inthe actual pathology. Finally, inaccurate or incomplete clinicalclassication of injury severity in the medical record is com-mon. Advances in modern neuroimaging techniques and theemerging technology of biomarkers offer new opportunitiestowards development of a multidimensional classication forTBI. We agree with the original WG regarding the priority forfurther research in this eld. Classication of injury severity inpediatric TBIstudieswillbenetfrom careful documentation of factors that may inuence the GCS, timing of the evaluation(i.e., scene of the accident or post-resuscitation), and neurora-diological classication of the injury (computed tomography

648 ADELSON ET AL.

8/10/2019 neu.2011.1952.pdf

11/15

[CT] or magnetic resonance imaging [MRI] scan in severe TBIpatients). It is important to acknowledge that methods forneuroradiological classication of TBI in children havenot beenvalidated. A GCS score (daily) was added as a supplementalelement to provide for clinical severity assessment during thehospital stay, and is best GCS score on any given day.

Neurological assessment. The GCS score is widely usedin clinical practice, and research and has evolved into a uni-versal classication system for the severity of TBI. It consistsof the sum score (range 315) of three components (eye, mo-tor, and verbalscales).TheGCS hasgood inter-rater reliabilityin adults, and in the acute phase can identify children withintracranial pathology who are at risk of needing signicantinterventions with acceptable levels of accuracy (Holmeset al., 2005). In patients with severe TBI, the GCS is frequencyinuenced by the presence of sedatives and neuromuscular blocking agents, and adult studies show that the GCS mayoverestimate severity of injury in this group of patients(Stocchetti et al., 2004). Documentation of these confoundersis considered a core data element. Strategies to overcome thislimitation include reporting the evolution of GCS scores in therst 24 h post-injury (Pineda et al., 2007).

In light of these limitations, the WG recommends thatstandardized assessments of severity of injury be performedusing the pediatric GCS (Marcin and Pollack, 2002). Whilealternative scores for children younger than age 2 have beendescribed, such methods have not been widely adopted atpresent (Durham et al., 2000). For assessment of injury se-verity in individual patients, the three components of thepediatric GCS should be reported separately. For intubatedpatients, nomenclature such as the use of the letter T is notrecommended, as it cannot be statistically analyzed and mayintroduce variability in the assessment of the verbal responsecomponent of the GGS.


Classifying extracranial injuries. In the past, relativelylittle attention has been paid in TBI to assessment of the oc-currence and severity of extracranial injuries. Nevertheless,extracranial injuries occur frequently in combination with TBIand may affect short and long-term outcome. Practicality dic-tates that any scoring system used to quantify systemic injurymust be widely disseminated and easily understood. For thesereasons, the Abbreviated Injury Scale (AIS) is the most logicalcandidate. The AIS is dened as an anatomically-based, con-sensus-driven, global severity scoring system that classieseach injury by body region according to its relative importanceon a six-point ordinal scale (Gennarelli and Wozdin, 2006).

For expressing the overall severity of injuries, the InjurySeverity Score (ISS) can be calculated from the AIS (Bakeret al., 1974). The spine is not considered separately in theoriginal ISS classication, but given the association betweenTBI and in particular cervical spine injuries, the WG considersit important to record spinal injuries separately.

4.2 Second Insults

Core data elements

Second insults may aggravate processes of secondarydamagein a brain already rendered vulnerable by theprimary

injury. The main physiologic insults relevant to TBI are hy-potension, hyperthermia, hypoxia, seizures, and hypocapniadue to hyperventilation. The adverse effects of the occurrenceof such insults both pre- and in-hospital is well established(Chesnut et al., 1993; McHugh et al., 2007; Signorini et al.,1999; Bullock et al., 2000). Second insults are commonly de-ned by threshold values, but these values are not well es-tablished in pediatrics, and when applied arebased on limited

data (Adelson et al., 2003a). However, given the consistentassociation between second insults and signicantly worseoutcome, the WG considered these to be core elements. Thegroup recognized that these elements may not be available forstudies performed late after injury. Similar considerationsfor biochemical second insults may also apply in the futurefor glucose, sodium [hyponatremia], and hemoglobin.


The WG concluded that there is insufcient evidence tomake recommendations on the frequency of recording andformat for analysis (mean values versus min/max values, orpresent versus not present). Again, the WG recognizedthat denitions of normal or abnormal based on a thresholdvalue were not satisfactory.

If seizures arepresent, theWG recommended recordingtheclassication as (1) clinical versus non-convulsive, and (2)status epilepticus versus not status epilepticus. Some studiesmay need to classify the type of electroencephalography(EEG) monitoring used.


The WG recognized that the use of thresholds was unsatis-factory in the long-term. The approach of different groups todene the severity of insult based on the duration and devia-tion from the norm is clearly preferable (Barlow et al., 2005,Chambers et al., 2005, 2006; Jones et al., 2003). The WG sees a

great need for further development and implementation of dedicated software to this purpose in existing monitoringsystems, similarly to the approach taken for applying infor-matics to multivariate data in adult TBI (Cohen et al., 2010).Whether current methods (such as data extraction of docu-mented vital signs) or emerging methods are used (high-resolutionautomated datacollection), careful attention must begiven to denitions such as frequency of data collection, use of averagevalues versus timespent under a critical threshold,useof highest/lowest documented values, and the denition of adequate lters for non-physiological values. As the technol-ogy becomes available, the WG viewed high-resolution datacollection and area under thecurve (AUC) analysis as the mostpromising emerging methods, but agreed that it is premature

to recommend collection of data in this format at present.

4.3 Laboratory Data


Based on the available data for pediatric TBI, thresholds of 80180mg/dL for glucose are recommended (Adelson et al.,2003b). A threshold for hemoglobin is more difcult to denegiven emerging data on the lower limit of hemoglobin safelytolerated by critically ill children in general, and the variableeffect of blood transfusion in children with severe TBI spe-cically. Considering the complexity of data collection, the


8/10/2019 neu.2011.1952.pdf

12/15

WG concluded that these data elements would more com-monly be included in supplemental datasets and should bewell dened in each study using this element as to how thedata element was utilized.

4.4 Recording and Documentation of Vital Signs

Core data elements

In the analysis phase, the WG recommended that allphysiologic data are referenced to date and time of injury,since this represents the only xed time event that is commonto all patients.

Documentation of blood pressure, heart rate, temperature,and oxygen saturation is recommended for all TBI patientsadmitted to hospital directly after injury. This is important fortwo reasons. First, therapeutic interventions in a trial mayincrease the incidence of abnormal physiology, and such ad-verse effects need to be recorded on safety grounds. Second,regardless of whether or not physiological insults are due totrial interventions, systemic hypotension, low cerebral per-fusion pressure (CPP), hypoxia, or hyperthermia may aggra-vate damage to the injured brain. Conversely, a high blood

pressure maylead to a protracted courseof increasedICP, andtherapeutically induced hypertension carries an increasedrisk of cardiopulmonary complications.

As a minimum, vital signs should be recorded on admis-sion, and also on a daily basis during the acute phase afterinjury. For the core datasets, the WG recommends recordingthe average and lowest blood pressure over a given period. Inthe intensive care unit (ICU) environment, recording bloodpressure on an hourly basis is recommended, especially whenICP is monitored in order to permit determination of CPP,calculated as mean arterial pressure (MAP) ICP (supple-mental data set). As the technology and corresponding dataanalysis methods become available, high-resolution datacollection of vital signs (every minute or even every second)

will allow trend analysis and accurate AUC calculations (es-timation of secondary insult dose).

Systolic blood pressure (SBP) was selected in addition toMAP asa data element for a numberof reasons.First, there arewell-established age-based normative values of SBP for chil-dren. Second, a single study in pediatrics of the effect of bloodpressure on outcome from pediatric TBI (White et al., 2001)demonstrated that SBP greater than a given threshold was in-dependently associated with survival in 136 subjects. To ourknowledge there is only one published report of age-relatednormativeMAP values (Haque and Zaritsky, 2007). Last,in theinitial phase of care (pre-hospital and emergency department),measurements of MAP are also subject to signicant error sincediastolic blood pressure is only estimated by commonly usednon-invasive blood pressure measuring devices.

Intracranial pressure. Monitoring of ICP is recommendedin pediatric patients with severe TBI (Adelson et al., 2003a).For the supplemental data set, hourly documentation of ICPvalues is recommended at a minimum, because it allows asummary measure and the highest value on a daily basis. Theemerging data set includes high-resolution data collection atfrequencies that are not routinely documented and requirespecialized equipment and software. For both the supple-mental and emerging data sets, periods of artifactually highICP (for example, during calibration of the monitor), or short-

duration ICP increases due to patient care interventions,coughing, and/or straining should be excluded when deter-mining the highest ICP.

For valid comparison of results between patients and acrossstudies, a common approach towards zeroing the ICP monitorshould be agreed upon. For uid-coupled systems, the WGsuggests that the ICP monitor be zeroed to the level of the fo-ramen of Monro. The format recommended for recording ICP

can also be applied for other monitoring modalities andemerging pediatric data elements, such as brain tissue oxygentension,brain temperature,or jugular venous oxygen saturation.

The WG realizes that the current approaches to analysis of hourly values is often rather crude. Therefore, the WGstrongly advocates further development of software aimed atcapturing the frequency distribution and AUC calculations of measured values during continuous monitoring, and furtherresearch into the benets of such an approach relative tocalculation of mean values, or the percentage of time mea-sured hourly values are above or below a certain threshold(e.g., for ICP above or below 20 or 15 mm Hg).

The module on ICP monitoring includes capturing infor-mation on procedures and problems encountered. Recording

the duration of ICP monitoring is essential. Documentation of the reason for stopping monitoring (e.g., clinically no longerrequired, device failure, or for reasons of futility) is relevantwhen interpreting measured values and their relation totherapy intensity. Identication of possible device malfunc-tion (e.g., partial blockage of a ventricular catheter), and re-visions of the monitoring device are highly relevant foraccurate interpretation of values.

4.5 Treatment

Core data elements

To record in-hospital treatment of pediatric TBI, the WGrecommended the use of the Pediatric Intensity Level of Therapy Scale (PILOT; Shore et al., 2006).


For children with mild TBI the WG recommended collect-ing data specic to the signs and symptoms most commonlyassociated with this insult (Comper et al., 2005; Halstead et al.,2010;). Documentation of the method used to obtain vitalsigns is also important. In particular, temperature recordingmethods are important. The correlation of different temper-ature recording methods and brain temperature is just be-ginning to be explored in children. This relationship appearsto be temperature-dependent, and is likely also inuenced byage and brain hemodynamics. Depending on the purpose of

the study, additional details may be required on the proce-dures and medications employed.


No recommendations were made for this module.

Next Steps

A number of gaps in knowledge specic to pediatricTBI may serve to focus future research. While this createssignicant challenges to the development of CDEs for pedi-atric TBI research, the recommended structure of core,

650 ADELSON ET AL.

8/10/2019 neu.2011.1952.pdf

13/15

supplemental, and emerging data elements addresses theselimitations. A number of valuable data elements can be cur-rently recommended for the supplemental data sets. Theemerging data sets can be used to address current limitations, but will require carefully designed studies for validation. Forexample, research is needed to better dene mild to moderateTBI in newborns and infants, since assessments of level of consciousness are not reliable. This is related to the current

lack of consensus on the measures to assess and classify theinitial level of neurologic injury in infants and children. Thereare limited data on normal values for, and age-dependence of,key physiologic parameters including ICP and CPP. There is aneed for long-term outcome studies to assess the impact of thesequelae of TBI on school performance, self-esteem, ability toenter the work force, and the impact of this injury on thechilds family (Hoge et al., 2008). Longitudinal studies arecomplex and expensive, emphasizing the need for consensuson the measures needed to assess long-term functional out-come. Consideration is also given to the fact that consent must be obtained from parents or from a proxy. Validation of futuredata elements will require large prospective data sets, andconsideration could be given to exempt consent in pediatric

TBI studies that do not involve patient interventions (for ex-ample, a prospective registry that further evaluates the va-lidity of core, supplemental, and emerging data elements).

This approach to dening CDEs for pediatric TBI is the rststep in an iterative process. The elements selected here andpriorities assigned represent the consensus of broad and ex-pert input with representation from different disciplines andstakeholder organizations. In addition, they were selectedsince there wasa basis for their use in clinical trialsin pediatricTBI to date. Nevertheless, these currently recommended ele-ments will require further renement and validation. Theprocesses for feedback from users and modication of CDEsare not yet fully dened. The expectation of the CDE project isthat these rst tools will be rened based on recommenda-

tions from researchers who make use of them in clinical trialsand epidemiologic studies. There are clearly issues to resolveand gaps in the current CDE versions, including varyingdenitions of core variables, and the need for better integra-tion between adult and pediatric CDEs. The next generationof CDEs will also need to be integrated with the electronicmedical record. The current version of the pediatric CDEs will be successful if they: (1) are widely adopted by the pediatricTBI community as a standard of care, (2) enable efcientpooling of harmonized data from multiple studies, registries,and databases, and (3) yield aggregated patient samplespowered to answer questions that could otherwise be studiedonly by large clinical studies.

The WG would like to see this initiative evolve as an in-ternational effort that has the potential to set global standardsfor data collection in TBI. To accomplish this goal, the fol-lowing steps are proposed:

Renement and validation of recommendations in col-laboration with international partners and ratication by stakeholders and international scientic bodies. Translation of the modules into a web-based data entryformat with pull-down menus and automated datachecks.

Use of relational database architecture to minimize du-plicate data entry across research projects.

Software development for direct data entry and coor-dinated time stamping of the data to improve analysisand cross-study comparisons.

Acknowledgments

The meetings and activities of the pediatric WG Demo-graphics and Clinical Assessment group were supported byfunding in the context of the interagency initiative towards anintegrated approach to Research in Psychological Health andTraumatic Brain Injury (NIH-NINDS; the National Instituteon Disability and Rehabilitation Research; the Department of Veterans Affairs; the Defense and Veterans Brain InjuryCenter, and the Defense Centers of Excellence). The devel-opment of CDEs was further supported by a supplementalgrant from NIH-NINDS (NS 042691).

The views expressed are those of the authors and do notnecessarily reect those of the agencies or institutions withwhich they are afliated, including the U.S. Department of Veterans Affairs, the U.S. Department of Education, and theNIH. This work is not an ofcial document, guidance, orpolicy of the U.S. government, nor should any ofcial en-dorsement be inferred.

Note: With the exception of the rst through the third au-thors and the last (corresponding) author, all other workinggroup members have been listed in alphabetical order, andeach has contributed signicantly to the preparation of thismanuscript.

This project was jointly supported by the NIH/NINDS andthe U.S. Department of Education/National Institute onDisability and Rehabilitation Research (DOE/NIDRR).

Author Disclosure Statement

No competing nancial interests exist.

ReferencesAdelson, P., Bratton, S., Carney, N., Chesnut, R., du Coudray,

H., Goldstein, B., Kochanek, P., Miller, H., Partington, M.,Selden, N., Warden, C., and Wright, D. (2003b). Guidelines forthe acute medical management of severe traumatic brain injury in infants, children, and adolescents. Resuscitation of blood pressure and oxygenation and prehospital brain-specictherapies for the severe pediatric traumatic brain injury pa-tient. Pediatr. Crit. Care Med. 4, S12S18.

Adelson, P., Bratton, S., Carney, N., Chesnut, R., du Coudray,H., Goldstein, B., Kochanek, P., Miller, H., Partington, M.,Selden, N., Warden, C., and Wright, D. (2003a). Guidelines forthe acute medical management of severe traumatic brain injury in infants, children, and adolescents. Threshold for

treatment of intracranial hypertension. Pediatr. Crit. CareMed. 4, S25S27.Adelson, P., Ragheb, J., Muizelaar, J., Kanev, P., Brockmeyer, D.,

Beers, S., Brown, S., Cassidy, L., Chang, Y., and Levin, H.(2005). Phase II clinical trial of moderate hypothermia aftersevere traumatic brain injury in children. Neurosurgery 56,740754.

American Congress of Rehabilitation Medicine; Mild TraumaticBrain Injury Committee. (1993). Denition of mild traumatic brain injury. J. Head Trauma Rehabil. 8, 8687.

Anderson, V., Catroppa, C., Morse, S., Haritou, F., and Ro-senfeld, J. (2005). Functional plasticity or vulnerability afterearly brain injury. Pediatrics 116, 13741382.


8/10/2019 neu.2011.1952.pdf

14/15

Baker, S., ONeill, B., Haddon, W., and Long, W. (1974). Theinjury severity score: a method for describing patients withmultiple injuries and evaluating emergency care. J. Trauma 14,187196.

Barlow, K., Thomson, E., Johnson, D., and Minns, R. (2005). Lateneurologic and cognitive sequelae of inicted traumatic braininjury in infancy. Pediatrics 116, e174e185.

Berger, R., Pierce, M., Wisniewski, S., Adelson, P., Clark, R.,Ruppel, R., and Kochanek, P. (2002). Neuron-specic enolaseand S100B in cerebrospinal uid after severe traumatic braininjury in infants and children. Pediatrics 109, e31.

Bhopal, R., and Donaldson, L. (1998). White, European, Western,Caucasian, or What? Inappropriate labelling in research onrace, ethnicity, and health. Am. J. Publ. Health. 88, 13031307

Bullock, R., Chesnut, R., Clifton, G., Ghajar, J., Marion, D.,Narayan, R., Newell, D., Pitts, L., Rosner, M., Walters, B., andWilberger, J. (2000). Management and prognosis of severetraumatic brain injury. Guidelines for the management of se-vere traumatic brain injury. J. Neurotrauma 17, 451627.

Chambers, I., Jones, P., Lo, T., Forsyth, R., Fulton, B., Andrews,P., Mendelow, A., and Minns, R. (2006). Critical thresholds of intracranial pressure and cerebral perfusion pressure relatedto age in paediatric head injury. J. Neurol. Neurosurg. Psych.

77, 234240.Chambers, I,. Stobbart, L., Jones, P., Kirkham, F., Marsh, M.,Mendelow, A., Minns, R., Struthers, S., and Tasker, R. (2005).Age-related differences in intracranial pressure and cerebralperfusion pressure in the rst 6 hours of monitoring afterchildrens head injury: association with outcome. Childs Nerv.Syst. 21, 195199.

Chesnut, R., Marshall, L., Klauber, M., Blunt, B., Baldwin, N.,Eisenberg, H., Jane, J., Marmarou, A., and Foulkes, M. (1993).The role of secondary brain injury in determining outcomefrom severe head injury. J. Trauma 34, 216222.

Cohen, M., Grossman, A., Morabito, D., Knudson, M., Butte, A.,and Manley, G. (2010). Identication of complex metabolicstates in critically injured patients using bioinformatic clusteranalysis. Critical Care 14, R10.

Comper, P., Bisschop, S., Carnide, N., and Tricco, A. (2005). Asystematic review of treatments for mild traumatic brain injury. Brain Inj. 19, 863880.

Durham, S., Clancy, R., Leuthardt, E., Sun, P., Kamerling, S.,Dominguez, T., and Duhaime, A. (2000). CHOP infant comascale (Infant Face Scale) a novel coma scale for children lessthan two years of age. J. Neurotrauma 17, 729737.

Gennarelli, T., and Wodzin, A. (2006). AIS 2005: A contemporaryinjury scale. Injury 37, 10831091.

Halstead, M., and Walter, K., for The Council on Sports Medi-cine and Fitness. (2010). Clinical reportsport-related con-cussion in children and adolescents. Pediatrics 126, 587615.

Haque, I., and Zaritsky, A. (2007). Analysis of the evidence forthe lower limit of systolic and mean arterial pressure in chil-

dren. Pediatr. Crit. Care Med. 8, 138144.Hoge, C., McGurk, D., Thomas, J., Cox, A., Engel, C., and Castro,C. (2008). Mild traumatic brain injury in U.S. soldiers return-ing from Iraq. N. Engl. J. Med. 358, 453463.

Holden, K., Titus, M., and Van Tassel, P. (1999). Cranial mag-netic resonance imaging examination of normal term neona-tes: a pilot study. J. Child Neurol. 14, 708710.

Holmes, J.,Palchak, M.,MacFarlane,T., andKupperman,N. (2005).Performance of the pediatric Glasgow Coma Scale in childrenwith blunt head trauma. Acad. Emerg. Med. 12, 814819.

Jones, P., Andrews, P., Easton, V., and Minns, R. (2003). Trau-matic brain injury in childhood: Intensive care time series dataand outcome. Br. J. Neurosurg. 17, 2939.

Keenan, H., Runyan, D., Marshall, S., and Nocera, M. (2004). Apopulation-based comparison of clinical and outcome char-acteristics of young children with serious inicted and non-inicted traumatic brain injury. Pediatrics 114, 633639.

Kennedy, J., Jaffee, M., Leskin, G., Stokes, J., Leal, F., and Fitz-patrick, P. (2009). Posttraumatic stress disorder and post-traumatic stress disorder-like symptoms and mild traumatic brain injury. J. Rehabil. Res. Dev. 44, 895920.

Ling, G., Bandak, F., Armonda, R., Grant, G., and Ecklund, J.(2009). Explosive blast neurotrauma. J. Neurotrauma 26,815825.

Looney, C., Smith, J., Merck, L., Wolfe, H., Chescheir, N., Hamer,R., and Gilmore, J. (2007). Intracranial hemorrhage inasymptomatic neonates: prevalence on MR images and rela-tionship to obstetric and neonatal risk factors. Radiology 242,535541.

Maas, A., Marmarou, A., Murray, G., Teasdale, S., and Steyer- berg, E. (2007). Prognosis and clinical trial design in traumatic brain injury: the IMPACT study. J. Neurotrauma 24, 232238.

Maas, A. (2009). Standardisation of data collection in traumatic

brain injury: key to the future? Critical Care 13, 1016.Maas, A., Harrison-Felix, C., Menon, D., Adelson, P., Balkin, T.,Bullock, R., Engel, D., Gordon, W., Langlois-Orman, J., Lew,H., Robertson, C., Temkin, N., Valadka, A., Verfaellie,M., Wainwright, M., Wright, D., and Schwab, K. (2010a).Common data elements for traumatic brain injury: Re-commendations from the Interagency Working Group onDemographics and Clinical Assessment. Arch. Phys. Med.Rehabil. 91, 16411649.

Maas, A., Harrison-Felix, C., Menon, D., Adelson, P., Balkin, T.,Bullock, R., Engel, D., Gordon, W., Langlois-Orman, J., Lew,H., Robertson, C., Temkin, N., Valadka, A., Verfaellie, M.,Wainwright, M., Wright, D., and Schwab, K. (2011). Standar-dizing data collection in traumatic brain injury. J. Neuro-trauma 28, 177187.

Maguire, S., Pickerd, N., Farewell, D., Mann, M., Tempest, V.,and Kemp, A. (2009). Which clinical features distinguish in-icted from non-inicted brain injury? A systematic review.Arch. Dis. Child 94, 860867.

Marcin, J., and Pollack, M. (2002). Triage scoring systems, se-verity of illness measures, and mortality prediction models inpediatric trauma. Crit. Care. Med. 30, S457S467.

Marmarou, A., Lu, J., Butcher, I., McHugh, G., Mushkudiani, N.,Murray, G., Steyerberg, E., and Maas, A. (2007). IMPACTdatabase of traumatic brain injury: design and description. J.Neurotrauma 24, 239250.

McHugh, G., Engel, D., Butcher, I., Steyerberg, E., Lu, J.,Mushkudiani, N., Herna ndez, A., Marmarou, A., Maas, A.,and Murray, G. (2007). Prognostic value of secondary insults

in traumatic brain injury: results from the IMPACT study. J.Neurotrauma 24, 287293.Menon, D., Schwab, K., Wright, D., and Maas, A. (2010). Position

statement: denition of traumatic brain injury. Arch. Phys.Med. Rehabil. 91, 16371640.

Mushkudiani, N., Engel, D., Steyerberg, E., Butcher, I., Lu, J.,Marmarou, A., Slieker, F., McHugh, G., Murray, G., and Maas,A. (2007). Prognostic value of demographic characteristics intraumatic brain injury: results from the IMPACT study. J.Neurotrauma 24, 259269.

652 ADELSON ET AL.

8/10/2019 neu.2011.1952.pdf

15/15

National Institute of Neurological Disorders and Stroke,NINDS Common Data Elements. Available from: http://www.commondataelements.ninds.nih.gov/default.aspx

Pineda, J., Lewis, S., Valadka, A., Papa, L., Hannay, H., Heaton,S., Demery, J., Liu, M., Aikman, J., Akle, V., Brophy, G., Tepas, J., Wang, K., Robertson, C., and Hayes, R. (2007). Clinicalsignicance of II-spectrin breakdown products in cerebrospi-nal uid after severe traumatic brain injury. J. Neurotrauma24, 354366.

Pollina. J., Diasm M., Li, V., Kachurek, D., and Arbesman, M.(2001). Cranial birth injuries in term newborn infants. Pediatr.Neurosurg. 35, 113119.

Pryor, H., and Thelander, H. (1968). Abnormally small head sizeand intellect in children. J. Pediatr. 73, 593598.

Rooks, V., Eaton, J., Ruess, L., Petermann, G., Keck-Wherley, J.,and Pedersen, R. (2008). Prevalence and evolution of intra-cranial hemorrhage in asymptomatic term infants. Am. J.Neuroradiol. 29, 10821089.

Shore, P., Adelson, P., Kochanek, P., Hand, L., and Roy, L.(2006). Reliability and validity of the Pediatric IntensityLevel of Therapy (PILOT) Scale: A measure of the use of intracranial pressure-directed therapies. Crit. Care Med. 34,19811987.

Signorini, D., Andrews, P., Jones, P., Wardlaw, J., and Miller, J.(1999). Adding insult to injury: the prognostic value of earlysecondary insults for survival after traumatic brain injury. J.Neurol. Neurosurg. Psychiatry 66, 2631.

Steyerberg, E., Mushkudiani, N., Perel, P., Butcher, I., Lu, J.,McHugh, G., Murray, G., Marmarou, A., Roberts, I., Habbe-ma, J., and Maas, A. (2008). Pre

neu.2011.1952.pdf

Documents