DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY REVIEW

A common data language for clinical research studies:

the National Institute of Neurological Disorders and
Stroke and American Academy for Cerebral Palsy and
Developmental Medicine Cerebral Palsy Common
Data Elements Version 1.0 recommendations

VER ONICA SCHIARITI 1,2 | EILEEN FOWLER 3 | JOLINE E BRANDENBURG 4 | ERIC LEVEY 5 | SARAH MCINTYRE 6 |
THERESA SUKAL-MOULTON 7 | SHARON L RAMEY 8 | JESSICA ROSE 9 | SUSAN SIENKO 10 |
ELAINE STASHINKO 11 | LAURA VOGTLE 12 | ROBIN S FELDMAN 13 | JAMES I KOENIG 14
1 Division of Medical Sciences, University of Victoria, Victoria, BC; 2 Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. 3 University of
California Los Angeles, Los Angeles, CA; 4 Department of Physical Medicine and Rehabilitation, Department of Pediatric and Adolescent Medicine, Mayo Clinic,
Rochester, MN; 5 Health Services for Children with Special Needs, Inc., Washington, DC, USA. 6 Cerebral Palsy Alliance, University of Sydney, Sydney, NSW,
Australia. 7 Department of Physical Therapy and Human Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL; 8 Virginia Tech
Carilion Research Institute, Virginia Polytechnic Institute, Roanoke, VA; 9 Stanford University School of Medicine, Stanford, CA; 10 Shriners Hospitals for Children,
Portland, OR; 11 Kennedy Krieger Institute, Baltimore, MD; 12 University of Alabama at Birmingham, Birmingham, AL; 13 The Emmes Corporation, Rockville, MD;
14 National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
Correspondence to Veronica Schiariti, Division of Medical Sciences, University of Victoria, PO Box 1700 STN CSC, BC V8W 2Y2, Canada. E-mail: vschiariti@cw.bc.ca

On behalf of the American Academy for Cerebral Palsy and Developmental Medicine Cerebral Palsy Common Data Elements working groups.
This article is commented on by Fairhurst on page 968 of this issue.

To increase the efficiency and effectiveness of clinical research studies, cerebral palsy (CP)
PUBLICATION DATA specific Common Data Elements (CDEs) were developed through a partnership between the
Accepted for publication 17th January National Institute of Neurological Disorders and Stroke (NINDS) and the American Academy
2018. of Cerebral Palsy and Developmental Medicine (AACPDM). International experts reviewed
Published online 15th March 2018. existing NINDS CDEs and tools used in studies of children and young people with CP. CDEs
were compiled, subjected to internal review, and posted online for external public comment
ABBREVIATIONS in September 2016. Guided by the International Classification of Functioning, Disability and
AACPDM American Academy of Cerebral Health framework, CDEs were categorized into six domains: (1) participant characteristics; (2)
Palsy and Developmental health, growth, and genetics; (3) neuroimaging; (4) neuromotor skills and functional assess-
Medicine ments; (5) neurocognitive, social, and emotional assessments; and (6) engagement and qual-
CDE Common Data Element ity of life. Version 1.0 of the NINDS/AACPDM CDEs for CP is publicly available on the NINDS
CRF Case report form CDE and AACPDM websites. Global use of CDEs for CP will standardize data collection,
ICF International Classification of improve data quality, and facilitate comparisons across studies. Ongoing collaboration with
Functioning, Disability and international colleagues, industry, and people with CP and their families will provide mean-
Health ingful feedback and updates as additional evidence is obtained. These CDEs are recom-
NINDS National Institute of mended for NINDS-funded research for CP.
Neurological Disorders and
Stroke

In this era of information, with a vast number of outcome
measures developed for complex neurological conditions,
clinicians and researchers find it increasingly challenging
to decide core concepts and how to most accurately mea-
sure important areas of health. To guide standardization
for data collection and outcome evaluation, the clinical and
research community recognized the need to develop Com-
mon Data Elements (CDEs). The overarching aim of
developing condition-specific CDEs is to accelerate
research, to enable prompt uptake of evidence into clinical
practice, and, ultimately, to deliver the best quality care to
individuals who require it.
In 2006, the National Institute of Neurological Disor-
ders and Stroke (NINDS) initiated the development of
CDEs to assist NINDS-funded investigators in collecting
neuroscience clinical trial research data in a standard and
consistent fashion.1,2 The CDEs are content standards that
can be applied to various data collection models, are
intended to be dynamic, and may evolve over time. The
CDE project is not a database, rather it is a collection of
metadata and data standards. The CDEs consist of identifi-
cation of common definitions, the standardization of case
report forms (CRFs), and tools. To date, the NINDS
CDE website contains metadata and data standards for 23

976 DOI: 10.1111/dmcn.13723 © 2018 Mac Keith Press

neurological diseases for adult and paediatric populations
for NINDS-funded clinical studies. However, NINDS
CDEs were not available for children and young people
with cerebral palsy (CP). Moreover, the need to develop a
common data set of meaningful measurements for CP was
identified as a priority area of the 2013–2017 strategic plan
developed by the American Academy of Cerebral Palsy and
Developmental Medicine (AACPDM).
CP describes a group of disorders that affect the devel-
opment of movement and posture, causing activity limita-
tions, which are attributed to non-progressive disturbances
that occurred in the developing fetal or infant brain.3 The
motor disorders of CP are often accompanied by distur-
bances of sensation, cognition, communication, perception,
and/or behaviour and/or by a seizure disorder.3
Since the 2001 publication of the International Classifi-
cation of Functioning, Disability and Health (ICF)4 there
has been increased interest in not only standardizing data
collection, but also in understanding the functional abilities
of individuals living with CP and the challenges they face
in performing everyday activities. After the publication of
the ICF for children and young people in 2007,5 ICF-
based tools – entitled ICF Core Sets6 – were developed for
children and young people with CP worldwide. The ICF
Core Sets serve as useful tools to standardize the descrip-
tion of the functional abilities and challenges children and
young people with CP have in performing everyday activi-
ties, and the contextual factors that facilitate or hinder
functioning. Subsequently, an ICF-based toolbox of multi-
ple-item measures (e.g. questionnaires, standardized tests)
was proposed.7 This newly developed toolbox guides how
to measure the relevant areas of functioning, disability, and
health included in the ICF Core Sets for CP. Hence, inter-
national initiatives – such as the CDEs and ICF-based
tools – have recognized the importance of universal, stan-
dardized, and comprehensive data collection. Despite dif-
ferences in methodological approaches, the CDEs and
ICF-based tools put special emphasis on measures for
CP.6,7
Previous reviews have compared measures used in CP,
providing valuable information on measurement
characteristics and theoretical backgrounds of a range of
measures.8–14 A recent systematic review of outcome mea-
sures used in studies with children and young people with
CP showed that clinicians and researchers used different
measures to assess the same concept/construct.15 This find-
ing demonstrates the variability in practice and lack of con-
sensus on data collection, challenging the interpretation of
results. To address this issue, the AACPDM partnered
with the NINDS CDE team to create the paediatric CDEs
for CP. This paper reviews the process by which experts
gathered in working groups and developed the first version
of CDEs for children and young people with CP.
The goals of the NINDS CDE project are to: (1) dis-
seminate standards for data collected from participants
enrolled in studies of neurological diseases; (2) create easily
accessible tools for clinical study data collection – these
What this paper adds
• This is the first comprehensive Common Data Elements (CDEs) for children
and young people with CP for clinical research.
• The CDEs for children and young people with CP include common defini-
tions, the standardization of case report forms, and measures.
• The CDE guides the standardization for data collection and outcome evalua-
tion in all types of studies with children and young people with CP.
• The CDE ultimately improves data quality and data sharing.
tools should be especially helpful to new investigators and
others working with limited budgets; (3) encourage focused
and simplified data collection to reduce burden on investi-
gators and practice-based clinicians to facilitate their par-
ticipation in clinical research; (4) improve data quality
while controlling cost by providing uniform data descrip-
tions and tools across NINDS-funded clinical studies.1
The overall aim of this NINDS/AACPDM CDE project
was to standardize data collection and assessment in studies
of children and young people with CP by: (1) recommend-
ing a set of CDEs and tools that comprehensively repre-
sent functional profiles; (2) identifying valid and reliable
measures to be recommended for routine use across
NINDS-funded clinical studies and clinical practice; (3)
identifying CDEs/measurement gaps that could be
addressed in future research initiatives.
METHOD
Development of NINDS/AACPDM CDEs for children and
young people with CP
The CDE project for CP began in 2015. An organizing
committee with representatives from AACPDM and the
NINDS was convened at an international meeting.
AACPDM leadership created a Steering Committee and
worked with the AACPDM Research Committee to invite
experts in CP into working groups, each of which was
composed of five to seven members with knowledge and
experience relevant to CP-related health domains. These
experts included epidemiologists, clinicians, clinical
researchers, educators, and clinical trial experts. The work-
ing groups were organized into the following domains: (1)
participant characteristics; (2) health, growth, genetics,
comorbidities, and labs; (3) neuroimaging diagnostics; (4)
neuromotor skill and functional assessments; (5) neurocog-
nitive, social, and emotional assessments; (6) engagement
and quality of life assessments. Moreover, the integrated
across working group was created to oversee the data.
Composition of each working group is provided in
Appendix S1, online supporting information.
The Chair of each working group, together with their
Steering Committee liaison, constituted an advisory team
that communicated throughout the development phase to
coordinate goals and identify shared solutions. Each work-
ing group was tasked with identifying existing CDEs and/
or tools in the assigned domain and providing recommen-
dations for their use in clinical studies with children and
young people with CP. The working groups developed
CRFs by selecting the most relevant items from existing
NINDS CDEs and tools for other diagnoses, or identified
Review 977
and recommended the use of copyrighted tools for CP.
When necessary, they developed new CDEs and recom-
mendations de novo. Brief details of how this was accom-
plished in individual working groups are described later.
Assessment measures and/or outcome measures were
selected based on the reliability and validity of the tool in
children and young people with CP. Tools could be a sin-
gle question (single-item measure), a questionnaire (multi-
ple-item measure), a score obtained through physical
examination, a laboratory measurement, or a score
obtained through observation of an image.
Terminology of NINDS CDEs
Consistent with guidance across the NINDS CDE project,
the working groups were charged with classifying each rec-
ommended CDE and tools as ‘Core’, ‘Supplemental –
Highly Recommended’, ‘Supplemental’, or ‘Exploratory’
(Table I).
Conceptual framework
Managing the depth and breadth of data related to CP
required an organizational framework to help visualize the
essential data categories. Given the multidimensional
impact of having CP on developmental trajectories of chil-
dren and young people and their families,16–20 it was essen-
tial to use a comprehensive framework such as the ICF.4
Hence, NINDS domains were populated with the most
appropriate CDEs and measures incorporating the ICF
components (Fig. 1).
CDE revision process and selection criteria
Individual working groups met via teleconference
monthly for 6 to 9 months. As a starting point, all
working groups reviewed the existing list of CDEs and
tools previously defined from other diagnostic groups,
including Friedrich’s ataxia, stroke, epilepsy, Duchenne
muscular dystrophy/Becker muscular dystrophy, spinal
muscular atrophy, and traumatic brain injury, in the
NINDS CDE project.
Table I: National Institute of Neurological Disorders and Stroke (NINDS)
Common Data Elements (CDEs) classification criteria
CDE classification Definitions
Core A data element for recording essential
information applicable to any CP study,
including therapeutic areas and study
designs; consistent with all NINDS disease-
specific CDE sets
Supplemental – A data element recommended for use
Highly whenever applicable
Recommended
Supplemental A data element that has some evidence of
validity and is commonly collected in clinical
studies in CP; use depends upon study
design
Exploratory A data element that is emerging or that
requires further validation in CP
CP, cerebral palsy.
978 Developmental Medicine & Child Neurology 2018, 60: 976–986
The following selection criteria were applied by all
working groups: (1) applicable to children and young peo-
ple aged 0 to 18 years; (2) represents relevant areas of
study in CP; and (3) has documented validity and reliabil-
ity. Each of the working groups proceeded with slightly
different approaches that were largely dependent on the
status of existing data standards and elements (see ‘Individ-
ual methods of each of the working groups’). CDEs and
tools had to meet all selection criteria to be included in
the final set for CP.
After compiling the CDEs and definition tables, recom-
mendations, and CRFs from each of the working groups
representing the six CDE domains, the draft documents
were sent to the integrated across working group to look
for gaps, overlaps, and to make recommendations for the
inclusion of CDEs and tools. Descriptive analysis was con-
ducted to remove duplications and identify distribution of
CDEs by level of recommendation. Subsequently, all the
measures recommended as ‘Supplemental – Highly Recom-
mended’ were mapped into the ICF components and chap-
ters. Revised documents were then disseminated for
internal review by the full panel of working group experts,
the Steering Committee, and the NINDS CDE project
team (June 2016). The draft CDEs for CP were posted on
the NINDS CDE website for public review from Septem-
ber 2016 to October 2016. The final version, Version 1.0
NINDS CDEs for CP, was posted on the NINDS CDE
website on December 15th, 2016 after the incorporation of
comments received from the public review (Fig. 1).
Individual methods of each of the working groups
Participant characteristics
This working group conducted a review of common data
variables collected by CP registers from around the
world,21 most notably demographic and disease classifica-
tion data elements, to ensure that the CDEs for this initia-
tive were inclusive. All CDEs and tools selected were
reviewed and discussed by the members of the working
groups to determine the classification (core or supplement)
based on the NINDS classification criteria.
Health, growth, genetics, comorbidities, and labs
Each working group member independently reviewed 500
already established CDEs to determine if it applied to CP
and to the health, growth, genetics, comorbidities, or labs
topic areas. Each element was reviewed by two working
group members; in the case of disagreement, the element
was discussed by the working group and a resolution was
reached. Working group members independently drafted
modifications to existing CRFs for other diseases, or cre-
ated new CRFs if needed, and the draft was discussed by
the group during a teleconference to create updated ver-
sions of each CRF.
Engagement and quality of life assessments/data
The working group developed a list of measures for review
by surveying systematic reviews and reviewing the
 NINDS CDEs domains for CP

Health,
Neuromotor Neurocognitive, Engagement
growth,
Participant Neuroimaging skills and social, and and quality
genetics,
characteristics diagnostics functional emotional of Life
comorbidities,
assessmets assessments assessments
and labs

6 WGs proposed CDEs+1 WG compared CDEs across WGs

ICF framework
CDEs = CRFs Tools

CDEs for children and young people with CP – Version 0.0

Internal review Public feedback

CDEs for children and young people with CP – Version 1.0

Input from stakeholders Final revision

Figure 1: National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) for Cerebral Palsy (CP) Project: workflow and
conceptual framework. Tools include multiple-item measures, single-item measures, classifications systems, a score obtained through physical examina-
tion, a laboratory measurement, or a score obtained through observation of an image. Composition of each working group (WG) is provided in
Appendix S1, online supporting information. CRFs, case report forms; ICF, International Classification of Functioning, Disability and Health. [Colour figure
can be viewed at wileyonlinelibrary.com].

literature on engagement and quality of life tools used with
children with CP. The list of tools was distributed among
the working group members for review and additional
measures were added based on clinical expertise. A litera-
ture review was performed for each measure by a member
of the working group using the NINDS/AACPDM-
defined selection criteria. Preference was given to validated
measures that were developed for children with CP. Using
the tabulated information, all measures were reviewed and
discussed to determine the appropriate classification based
on the NINDS classification criteria.
Neuroimaging diagnostics
The working group searched for existing tools that were
developed for documenting or interpreting neuroimaging
findings in children with CP and infants and children at
risk of developing CP. While there were no commonly
accepted tools/tools for neuroimaging in CP, several neu-
roimaging assessment tools were identified and included.
Published reports of abnormal brain magnetic resonance
imaging (MRI) findings in children with CP were reviewed.
This working group focused on developing CDEs and a
CRF to document the characteristics and findings obtained
using conventional clinical MRI of the brain. The working
group decided to defer the development of CDEs or CRFs
for diffusion tensor imaging, although diffusion tensor
imaging is a promising neuroimaging tool for studying
brain microstructure in children with CP. The working
group did not specifically address use of ultrasound, com-
puted tomography, or functional MRI.
Neuromotor skills and functional assessments
The Chair of the working group reviewed CDEs and tools
related to physical and neurologic examination, neuromotor
skills, physical function assessments, rehabilitation thera-
pies, and adaptive equipment that were included for other
disease groups. The entire working group reviewed these
CDEs and tools, and narrowed this list to include those
that were applicable to CP. Working group members were
then assigned to CDE areas that matched their areas of
expertise and each member performed an electronic search
for systematic and narrative reviews to identify tools that

Review 979
were deemed most reliable and psychometrically sound.
Tools were selected that were psychometrically sound,
commonly used in CP research for children aged 0 to
18 years, filled gaps in outcome measures/functional assess-
ments, or were promising. Many CDEs that were already
in use for other disease groups were modified to fit the
accepted nomenclature for CP as determined through a
review of literature. When the working groups could not
identify a CDE that captured the important information, a
new CDE was created. When questions arose, consensus
was reached through discussion. A particularly critical focus
for this working group was to identify and collate occupa-
tional therapy, physical therapy, and speech and language
pathology CDEs and tools. Specifically, occupational ther-
apy, physical therapy, and speech and language pathology
CDEs were selected based on gaps and needs in rehabilita-
tion research (the need to determine the association
between frequency, intensity, timing, and type of rehabilita-
tion intervention and outcomes), published literature, and
clinical expertise. The CDEs and created CRFs were based
on three key articles,22–24 reviewed by three or more thera-
pists in each discipline, and modified to reflect CP practice.
Neurocognitive, social, and emotional assessments
This working group reviewed CDEs from other paediatric
diagnoses, including spinal cord injury – paediatrics, mito-
chondrial disease – paediatrics, Duchenne muscular dystro-
phy/Becker muscular dystrophy, epilepsy (diagnosis by age
included), and traumatic brain injury – including early
childhood. Like CP, these diagnoses are predominately
motor diseases often with some communicative and cogni-
tive impairment. The working group finalized specific
domains considered to be of central importance for CP.
Outcome measures for the domains: language – speech,
expressive, and receptive; cognitive and neurocognitive
executive function; intelligence and general cognition;
executive function and attention; adaptive behaviour; devel-
opmental milestones for the infant/toddler age range;
social–emotional development; and behavioural problems
were considered for inclusion/exclusion. In discussions, this
working group strongly advocated that clinical and longitu-
dinal studies of individuals with CP be considered, which
included several assessments that capture important aspects
of cognitive and social–emotional development.
RESULTS
The complete list of CDEs and tools and recommendation
for their use can be found on the NINDS CDEs (https://
www.commondataelements.ninds.nih.gov/#page=Default)
and AACPDM (http://www.aacpdm.org/) websites. Over-
all, few CDEs were classified as ‘Core’ and ‘Supplemental
– Highly Recommended’. None of the measures was classi-
fied as ‘Core’. A summary of CDEs classified as ‘Core and
Supplemental – Highly Recommended’ is available in
Appendix S2, online supporting information. A brief
description of the working group findings is provided in
the following subsections.
980 Developmental Medicine & Child Neurology 2018, 60: 976–986
Participant characteristics
The few CDEs classified as ‘Core’ included date of birth,
country of birth, country of residence, and sex. Only four
tools were specific to individuals with CP. CDEs classified
as ‘Supplemental – Highly Recommended’ were maternal
date of birth, level of education attained, health insurance,
postneonatal onset (exact cause), gestational age, birth-
weight, multiple birth, predominant, and secondary motor
type. Many CDEs identified by this working group were
classified as ‘Supplemental’.
Health, growth, genetics, comorbidities, and labs
The ‘Supplemental’ elements proposed are expected to be
used depending on the focus of a given clinical trial.
Efforts were made to give general and supporting addi-
tional levels of detail that may be appropriate for a given
study. Checklists and tables were used for the history
forms to facilitate efficient data collection. There are a few
‘Supplemental – Highly Recommended’ variables that
should be prioritized if collecting data related to those
constructs. In the review of existing CDEs, many relevant
CDEs were identified but were validated in diseases other
than CP; therefore, these were classified as ‘Exploratory’.
Engagement and quality of life assessments
No tools reviewed by the group were classified as ‘Core’.
Only three quality of life measures were classified as ‘Sup-
plemental – Highly Recommended (Disease Specific)’. The
remaining quality of life measures were classified as
‘Exploratory’ owing to their limited use in children with
CP and limited age range. For participation measures, only
three measures were classified as ‘Supplemental – Highly
Recommended’ as they have been widely used in the
assessment of participation in children with CP and have
demonstrated good psychometric properties in individuals
with CP. Many of the tools reviewed were not specific for,
or differentiated between, types or levels of CP motor
impairment.
Neuroimaging and diagnostics
This working group included a comprehensive list of
CDEs that would allow for coding and documentation of
lesions that would be found in any of the types of CP, i.e.
spastic CP (cortical lesions, periventricular white matter
injury, and diffuse white matter injury), dyskinetic CP
(basal ganglia lesions), ataxic CP (cerebellar lesions), or
mixed types. The CRF developed allows for documenta-
tion of both acute and chronic changes on a single form.
Future efforts should focus on classification of structural
MRI findings, interpretation, and prognostication based on
those findings.
Neuromotor skills and functional assessments
A total of 92 tools were included (Table II). No tools were
classified as ‘Core’. Twelve tools inclusive of ICF domains
of body structures and functions and activities and partici-
pation were categorized as ‘Supplemental – Highly
Table II: Number of tools and case report forms (CRFs) reviewed and
recommended by working groups
Number
Working group of tools
Participant characteristics 8 3
Health, growth, genetics, comorbidities, 28
and labs
Neuromotor skill and functional 92
assessments
Neurocognitive, social, and emotional 66
assessments
Engagement and quality of life 32
assessments
Neuroimaging NA
Total 226
NA, not applicable.
Recommended’ (Table III). Specific tolls included in the
‘Supplemental – Highly Recommended’ group included
Gross Motor Function Classification System – Expanded
and Revised, Manual Ability Classification System, Eating
and Drinking Ability Classification System, and Communi-
cation Function Classification System. Sixty-nine tools
were classified as ‘Supplemental’. Eleven tools were catego-
rized as ‘Exploratory’.
Neurocognitive, social, and emotional assessments
This working group included standardized assessments of
neurocognitive and social–emotional development that cap-
ture the full developmental potential of children with CP,
from the youngest ages through to and including adult-
hood. The working group identified many standardized
tools designed originally for children who are typically
developing that are included in studies of children with CP
but have not necessarily been subjected to formal psycho-
metric inquiry. Further, tests for younger children have
often been used with older children with CP when their
developmental stage seems matched to the research ques-
tion (e.g. children who are age-delayed in language acquisi-
tion). In many but not all study samples, the assessors
make reasonable accommodations as to how they adminis-
ter the test or the timing of the items, adjusting to the
individual profile of a child with CP. To what extent this
alters the reported reliability and validity estimates is sel-
dom known with high levels of confidence.
Integrated across working group
The integrated across working group compiled and
reviewed all the tools that the six other working groups
recommended (Table II). As expected, a vast number of
measures were identified by the working groups (n=226).
Of the initial 226 tools reviewed by the working groups,
122 (54%) were proposed for inclusion in Version 1.0 CP
CDEs. Of these, 34 were classified as ‘Supplemental –
Highly Recommended’; 61 as ‘Supplemental’; and 31 as
‘Exploratory’. Of note, some valuable classification systems
specific for CP – Gross Motor Function Classification
System, Manual Ability Classification System, and Com-
munication Function Classification System – were included
within the list of ‘Supplemental – Highly Recommended’
tools by different working groups. In addition, 11 CRFs
CRFs
were recommended by the working groups (Table II). An
example of a recommended CRF can be found in
11
Appendix S3, online supporting information.
6 Table III shows the tools recommended as ‘Supplemen-
tal – Highly Recommended’ by the working groups. In
NA
addition, tools are organized by NINDS domains, ICF
NA components, and ICF chapters. The tools highly repre-
sented the ICF component body functions followed by the
1
component activities and participation; many measures
20
covered areas of neuromusculoskeletal and movement-
related functions, intellectual functions, general tasks and
demands, and mobility.
DISCUSSION
The NINDS/AACPDM CDEs for children and young
people with CP (Version 1.0) are now available for clinical
practice and research. The proposed CDEs for CP are the
starting point to achieving standardization and universal
data collection across NINDS-funded clinical studies. Ben-
efits of the widespread use of these CDEs include facilitat-
ing data sharing across a wide range of study types.
Importantly, sharing CDEs and cross-referencing with
other international measurement initiatives for CP will
enable a common language across the full spectrum of
clinical research studies worldwide. While many of the
CDEs for CP are used across other domains and diseases,
some of the CDEs were created de novo and will require
further scrutiny regarding use for CP research. In addition,
measures for CP continue to be developed and others
improved upon. With the creation of the CDEs for chil-
dren and young people with CP (Version 1.0), we hope
that this will encourage researchers to continue this pro-
cess along with creating and validating measures to fill
gaps in research for children and young people with CP.
Following the CDE recommendations for CP, research-
ers and clinicians can select the most appropriate set of
CDEs to best design and conduct their research or clinical
study. Tutorials demonstrating how to access and apply
the CDEs are available on the NINDS CDE website. In
addition, a demonstration video was created to illustrate
how to access, select, and apply the CDEs for CP (https://
www.youtube.com/watch?v=C9CqmFAHtvE).
Challenges creating CDEs for CP
The biggest challenge when creating the CDEs for CP
was the heterogeneity of the condition, with regards to
both clinical presentation and aetiology.
Health, growth, genetics, comorbidities, and labs
There is no genetic or other test to biologically confirm
the diagnosis, and laboratory tests that may be related to
comorbidities were thought to be more extensive than rea-
sonable for the first iteration of CDE recommendations.
Review 981
Table III: List of ‘Supplemental – Highly Recommended’ tools (including measures and classifications) by National Institute of Neurological Disorders
and Stroke (NINDS) domains and International Classification of Functioning, Disability and Health (ICF) components/chapters

Speech,
Spasticity/ language, and
NINDS domain ICF component/chapters Classification Motor function movement communication
25,26
Neuromotor skill Body functions: neuromusculoskeletal EDACS AIMS27,28 BADS29 PPVT-430
and functional and movement-related functions GMFCS-ER31 COPM32,33 Tardieu Scale34
assessments Mental functions MACS35 GMFM-88, GMFM-6636–38
Functions of digestive system CFCS39 Prechtl’s Assessment of
Activities and participation: mobility General Movements
communication (General Movement
Assessments)40,41
TIMP42

Speech,
language, and Cognitive and Executive Social–
NINDS domain ICF component/chapters communication emotional status functioning Memory emotional

Neurocognitive, Body functions: mental functions PPVT-430 ASQ-343 BRIEF-P44 CVLT-C45 BITSEA46
social, and Neuromusculoskeletal and movement- BRIEF-247 SCQ48,49
emotional related functions Bayley III, BSID50,51 BRIEF-A52
assessments Voice and speech functions MSEL53
Activities and participation: general tasks WAIS-IV54 Conners CPT 355
and demands D-KEFS56
Learning and applying knowledge WISC-V57
Communication

NINDS domain ICF component/chapters QoLa Participation

58
Engagement and Activities and participation: general CPCHILD LIFE-H59
quality of life tasks and demands CP QOL60 Child Engagement
assessments Mobility in Daily Life61
Self-care Interpersonal interactions PedsQL62, 63 PEM-CY64–66
and relationships PedsQL-CP67 YC-PEM68,69
Learning and Applying knowledge
Environmental factors: Attitudes
and supports
a
Not included in the ICF. EDACS, Eating and Drinking Ability Classification System; AIMS, Alberta Infant Motor Scale; BADS, Barry-Albright
Dystonia Scale; PPVT-4, Peabody Picture Vocabulary Test, Fourth Edition; GMFCS-ER, Gross Motor Function Classification System –
Expanded and Revised; COPM, Canadian Occupational Performance Measure; MACS, Manual Ability Classification System; GMFM, Gross
Motor Function Measure; CFCS, Communication Function Classification System; TIMP, Test of Infant Motor Performance; ASQ-3, Ages &
Stages Questionnaire 3; BRIEF-P, Brief Rating Inventory of Executive Function – Preschool version; CVLT-C, California Verbal Learning Test
for Children; BITSEA, Brief Infant Toddler Social Emotional Assessment; BRIEF-2, Behavior Rating Inventory of Executive Function – Sec-
ond edition; SCQ, Social Communication Questionnaire; BSID, Bayley Scale of Infant Development; BRIEF-A, Behavior Rating Inventory of
Executive Function – Adult version; MSEL, Mullen Scales of Early Learning; WAIS-IV, Wechsler Adult Intelligence Scale – Fourth edition;
Conners CPT 3, Conners Continuous Performance Test, Third Edition; D-KEFS, Delis–Kaplan Executive Function System; WISC-V, Wechsler
Intelligence Scale for Children – Fifth Edition; QoL, quality of life; CPCHILD, Caregiver Priorities and Child Health Index of Life with Disabili-
ties; LIFE-H, Assessment of Life Habits; CP QOL, Cerebral Palsy Quality of Life; PedsQL, Pediatric Quality of Life Inventory; PEM-CY, Partici-
pation and Environment Measure for Children and Youth; PedsQL-CP, Pediatric Quality of Life Inventory Cerebral Palsy Module; YC-PEM,
Young Children’s Participation and Environment Measure.

Engagement and quality of life assessments/data
Identifying one engagement or quality of life tool was diffi-
cult. Many of the tools reviewed were not specific for chil-
dren with CP. For individuals with CP who are non-verbal
or who have cognitive impairments as a component of
their CP, assessment of quality of life is a difficult con-
struct to measure, and validated proxy and self-report
options are limited.
Neuroimaging diagnostics
In contrast to CP, CRFs developed for other neurological
disorders and populations are more homogeneous and the
types of findings are narrower. CP has many aetiologies
and there can be a wide range of findings; therefore, it is
important that a neuroimaging CRF allows for data
collection of any relevant findings. Comprehensive evalua-
tion is important for analysis and meta-analysis in future
studies to better understand the neural structure function
relations vital to improving function in CP. Also, it is chal-
lenging to allow for documentation of both acute findings
(recent injury) and chronic findings that would be relevant
to development of CP. This working group developed a
useful CRF that can be utilized for documenting both
acute and chronic findings among the different types of
CP.
Neuromotor skills and functional assessments
CP is a heterogeneous disorder in aetiology and pheno-
type. Therefore, identifying tools that (1) spanned the CP
type and functional ability; (2) were psychometrically

982 Developmental Medicine & Child Neurology 2018, 60: 976–986

sound; and (3) were specific to individuals with CP was
challenging. Furthermore, while therapies are key interven-
tions in CP, there has not been a standardized method for
documenting and reporting on therapy interventions.
Therefore, this working group created CRFs for therapies
(physical, occupational, speech/language) to facilitate sys-
tematic reporting on specific therapeutic interventions,
duration, and intensity of interventions.
Comparison to other international CP standards
CP registers throughout the world were used as a starting
point.21 Where there was full agreement amongst registers,
those items were included and measured in the same way.
Medical, surgical, and family history forms are consistent
with the type of information collected by CP registries
around the world.
In terms of CDEs related to neuroimaging, conventional
MRI of the brain is the imaging modality of choice for
clinical diagnostic evaluation of children with CP and is
consistent with the practice parameter ‘Diagnostic Assess-
ment of the Child with CP’ of the American Academy of
Neurology,70 as well as the practice parameters of other
international groups. Moreover, the Surveillance of Cere-
bral Palsy in Europe group published a classification sys-
tem for standardizing the abnormal findings of brain MRI
in children with CP.71 Their approach was different from
the NINDS CDE project in that they tried to define cate-
gories of patterns of involvement for research studies. The
NINDS CDE for CP approach was to promote coding
and documentation of all abnormal findings in a consistent
manner but with less focus on interpretation and categoriz-
ing patterns of involvement. The tool developed by
Surveillance of Cerebral Palsy in Europe would be useful
for research and complementary to the CRF developed for
this project, and both could be used together.
The NINDS CDEs for CP are comparable to CDEs for
other medical conditions, including Friedrich’s ataxia,
stroke, epilepsy, Duchenne muscular dystrophy/Becker
muscular dystrophy, spinal muscular atrophy, and trau-
matic brain injury. However, terminology used for these
other diagnoses is not consistent with currently accepted
terminology based on published consensus statements of
experts.72 For example, while hemiplegia, diplegia, and
quadriplegia are frequently used in other disorders, there
can be imprecision with this classification in CP.73 Thus,
we sought to also encourage the use of ‘unilateral’ and ‘bi-
lateral’ CP, as recommended by expert consensus.72 Tools
were reviewed from systematic and narrative reviews in the
CP literature, when those existed.15,74–82 Occupational
therapy, physical therapy, and speech and language pathol-
ogy recommendations are based on published data ele-
ments (modified to reflect CP practice) and are aligned
with discipline-specific standards of practice and current
research.22,24,83
When we compared the what and the how to measure
common information proposed by the NINDS/AACPDM
CDEs for CP (Version 1.0) to other newly developed
international standards, specifically the ICF Core Sets for
children and young people with CP,6 which highlight what
areas of functioning, disability, and health should be mea-
sured in this population, we found commonalities and dif-
ferences. The landmark characteristics of CP are captured
by both standards, including movement and posture disor-
ders, communication, cognition, and musculoskeletal chal-
lenges, among others. However, some relevant areas are
under-represented by the current version of the CDEs, for
example sensation of pain, sensory functions, sleep func-
tions, support and attitude of peers, role of products and
technology – including assistive devices for daily living,
education, and recreation. When we compared the how to
measure relevant areas in CP – proposed by the NINDS/
AACPDM set of tools – to the recently developed ICF-
based toolbox of measures for CP,7 we found that the
NINDS/AACPDM includes a much more comprehensive
set of tools, including single-item and multiple-item mea-
sures. However, the NINDS/AACPDM recommended
tools highly represent the ICF component body functions,
whereas the ICF-based toolbox of measures focuses mainly
on the ICF component activities and participation.
Considerations for future CDE revisions
There is currently no definitive ‘classification of aetiology’
of CP owing to the heterogeneous nature of the disorder
and because there is very rarely one definitive cause, rather
a causal pathway that contains any number of risk factors.
If classifications for aetiology are developed, they should
be incorporated into the CP CDEs. In addition, further
expansion of commonly used laboratory tests should be
considered in future revisions.
Coding systems for evaluating different structures in the
brain by neuroimaging will gradually become more refined.
The various aetiologies of CP will be increasingly corre-
lated with specific neuroimaging findings. This research
will need to be incorporated into the CDE framework for
neuroimaging in CP. CDEs for newer neuroimaging
modalities (e.g. diffusion tensor imaging and functional
MRI) relevant to CP will need to be developed.
Owing to the wide spectrum of abilities and limitations
of individuals with CP, the development of tools specific
to anatomical distribution, unilateral or bilateral, or the
functional level of individuals with CP would be beneficial.
While there are well-known tools for spasticity and dys-
tonia assessments in CP, there are as yet no tools to clas-
sify hypotonia. Furthermore, tools to assess a child’s
engagement in therapy and measure the impact that partic-
ipation has on the outcomes of therapy are needed. Finally,
given the breadth of the CDEs and instruments, the work-
ing groups did not explore CDEs or tools to assess surgical
interventions and surgical outcomes in CP. Creation of an
interdisciplinary surgical working group for the next ver-
sion of the CDEs for CP is recommended.
From an ICF perspective, future revisions should include
all relevant areas of functioning, disability, and health
highlighted in the ICF Core Sets for children and young
Review 983
people with CP, incorporating measures addressing func-
tional impact of chronic pain and sleep disturbances in
day-to-day functioning. Further expansion of self-report
measures capturing activities and participation constructs
should be considered in future revisions.
Finally, although CP is a life-long disability, many mea-
sures for CP are focused on paediatrics. Measures for chil-
dren and young people with CP have been used to
evaluate adults with CP, but the psychometric properties
have not been studied. In addition, measures developed for
adults with other types of disability may be useful but have
not been validated for adults with CP. The development of
a working group to examine this need is recommended.
Future directions
Of note, Version 1.0 of NINDS CDEs for CP is the start-
ing point; CDEs are dynamic and will evolve over time. It
is expected that future revisions will incorporate the valu-
able perspective of parents of children with CP, as well as
adults with CP. Furthermore, NINDS has created an over-
sight committee to continuously review the NINDS CDEs
for CP.
CONCLUSION
The global adoption of standardized data collection,
whenever feasible, will increase opportunities for con-
ducting secondary data analyses and meta-analyses that
could advance knowledge about how brain behaviour,
functional abilities, and genetics–biology–environment
interact dynamically across ages and stages of develop-
ment of children and young people with CP. Ongoing
international collaboration will help ensure that the
CDEs are updated and reviewed as additional evidence is
obtained.
A CK N O W L E D G E M E N T S
The views expressed here are those of the authors and do not rep-
resent those of the National Institutes of Health, the National
Institute of Neurological Disorders and Stroke (NINDS), or the
US Government. Logistics support for this project was provided,
in part, through National Institutes of Health contract
HHSN271201200034C. The development of the NINDS CP
CDEs was made possible thanks to the great investment of time
and effort of working group members and the members of the
NINDS Common Data Elements Project team participating from
2015 to present. Dr. Ver onica Schiariti was the recipient of a
NeuroDevNet & Child and Family Research Institute Postdoc-
toral Fellowship Award (2014-2016), supporting this study
SUPPORTING INFORMATION
The following additional material may be found online:
Appendix S1: National Institute of Neurological Disorders
and Stroke/American Academy of Cerebral Palsy and Develop-
mental Medicine Common Data Element Project working
groups.
Appendix S2: Cerebral palsy start-up resource document.
Appendix S3: Cerebral palsy motor developmental history case
report form.

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 DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY REVIEW

RESUMEN
UN LENGUAJE DE DATOS COMUNES PARA ESTUDIOS DE INVESTIGACION
CL
INICA PARA PARALISIS

CEREBRAL:
RECOMENDACIONES DEL NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE Y LA AMERICAN ACADEMY FOR

1.0
CEREBRAL PALSY AND DEVELOPMENTAL MEDICINE - ELEMENTOS DE DATOS COMUNES VERSION
Para aumentar la eficiencia y la efectividad de los estudios de investigacio
n cl
ınica, se desarrollaron elementos de datos comunes
(CDEs sigla en ingle
s) espec
ıficos para la para
lisis cerebral (PC), mediante una colaboracio
n entre la Academia Estadounidense de
Para
lisis Cerebral y Medicina del Desarrollo (AACPDM) y el Instituto Nacional de Trastornos Neurolo
gicos y Accidentes
Cerebrovasculares (NINDS). Expertos internacionales revisaron los CDEs existentes y las herramientas de medicio
n del NINDS
utilizadas en estudios de nin ~ os y jo
venes con PC. Los CDEs se compilaron, se sometieron a una revisio
n interna y se publicaron
en l
ınea para recibir comentarios pu
blicos externos en septiembre de 2016. Guiados por el marco teo
rico de la Clasificacio
n
Internacional del Funcionamiento, de la Discapacidad y de la Salud, los CDE se categorizaron en seis dominios: (1) caracter
ısticas
de los participantes; (2) salud, crecimiento y gene
tica; (3) neuroimagen; (4) habilidades neuromotoras y evaluaciones funcionales;
(5) evaluaciones neurocognitivas, sociales y emocionales; y (6) compromiso y calidad de vida. La versio
n 1.0 de los CDE del
NINDS / AACPDM para PC esta
pu
blicamente disponible en los sitios web del NINDS CDE y AACPDM. El uso global de CDE para
PC estandarizara
la recopilacio
n de datos, mejorara
la calidad de los datos, y facilitara
las comparaciones entre los estudios. La
colaboracio
n continua con colegas internacionales, la industria, y las personas con PC y sus familias proporcionara

retroalimentacio
n y actualizaciones significativas a medida que se obtenga evidencia adicional. Por el momento, la aplicacio
n de
estos CDEs se recomienda para estudios cl
ınicos y de investigacio
n - financiados por el NINDS - en individuos con PC.

RESUMO
UMA LINGUAGEM DE DADOS COMUNS PARA ESTUDOS DE PESQUISA CL
INICA: VERSAO
~ 1.0 DAS RECOMENDAC ~
ß OES DOS
ELEMENTOS DE DADOS COMUNS DO NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE E DA AMERICAN
ACADEMY FOR CEREBRAL PALSY AND DEVELOPMENTAL MEDICINE
Para aumentar a eficie ^ncia e efetividade dos estudos de pesquisas cl
ınicas, Elementos de dados comuns (EDC) espec
ıficos para
paralisia cerebral (PC) foram desenvolvidos por meio de parceria com a Academia Americana de Paralisia Cerebral e Medicina do
Desenvolvimento (AACPDM) e do Instituto Nacional de Desordens Neurolo
gicas e Derrame (NINDS). Especialistas internacionais
revisaram os EDCs do NINDS e os instrumentos usados em estudos de criancßas e jovens com PC. EDCs foram compilados,
submetidos a revisa ~o interna, e postados online para comenta
rio do pu
blico externo em setembro de 2016. Guiados pela
estrutura da Classificacßa~ o internacional de funcionalidade, incapacidade e sau
de, os EDC foram categorizados em seis dom
ınios:
1) caracter
ısticas dos participantes; 2) sau
de, crescimento e gene
tica; 3) neuroimagem; 4) habilidades neuromotoras e avaliacßo ~ es
funcionais; 5) avaliacßo~ es neurocognitivas, sociais e emocionais; e 6) engajamento e qualidade de vida. A versa ~o 1.0 dos EDC
NINDS/AACPDM para PC esta
dispon
ıvel para o pu
blico nos websites do NINDS EDC e da AACPDM. O uso global de EDCs para

padronizar a coleta de dados, melhorar a qualidade dos dados, e facilitar comparacßo
PC ira ~ es entre estudos. Colaboracßo~ es em
andamento com colegas internacionais, indu
stria e pessoas com PC e suas fam
ılias ira ~o fornecer informacßo~ es significativas e
~ es conforme evide
atualizacßo ^ncias adicionais forem obtidas. Estes EDCs sa ~o recomentados para pesquisas em PC financiadas pelo
NINDS.