Cerebral Palsy

Listen to the Author Podcast, October 2023 of the Open Access paper: Cerebral palsy pain instruments: Recommended tools for clinical research studies by NINDS Cerebral Palsy CDE Project

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Cerebral Palsy Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Cerebral Palsy study start-up

Cerebral Palsy Highlight Summary: Overview of all Cerebral Palsy-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

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NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
Engagement and Quality of Life Assessments and Data Working Group Summary N/A
Health Growth Genetics Comorbidities and Labs Working Group Summary N/A
Neurocognitive Social Emotional Assessments Working Group Summary N/A
Neuroimaging Diagnostics Working Group Summary N/A
Neuromotor Skill Functional Assessments Working Group Summary N/A
Participant Characteristics and Disease and Injury Related Events Working Group Summary N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
Demographics CDE Details
General Core CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Behavioral History CDE Details
Family History CDE Details
Medical History CDE Details
Motor Development History CDE Details
Surgical and Hospitalization History CDE Details
Vaccination History CDE Details
Epidemiology/Environmental History
CRF Module/Guidance CDEs
Risk Factor Questionnaire (RFQ) - Physical Activity and Sleep CDE Details
Risk Factor Questionnaire (RFQ) - Residential History CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guidance CDEs
Bimanual Fine Motor Function (BFMF) N/A
Communication Function Classification System (CFCS) N/A
Eating and Drinking Classification System (EDACS) N/A
Gross Motor Function Classification System - Expanded & Revised (GMFCS - ER) N/A
Manual Ability Classification System (MACS) N/A
Participant Condition Characteristics CDE Details
Assessments and Examinations
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Gait Analysis CDE Details
Vital Signs CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Lower Extremity Passive Range of Motion Physical Exam CDE Details
Neurological Examination CDE Details
Physical Examination CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Mutation Analysis CDE Details
Imaging Diagnostics
CRF Module/Guidance CDEs
Neuroimaging Cerebral Palsy Magnetic Resonance Imaging CDE Details
Pelvic Radiographs CDE Details
Treatment/Intervention Data
Therapies
CRF Module/Guidance CDEs
External Devices - CP CDE Details
Occupational Therapy Treatment Session: Cerebral Palsy CDE Details
Physical Therapy Individual Session CDE Details
Rehabilitation Therapies - Episodes of care CDE Details
Speech and Language Therapy Treatment Session CDE Details
Surgeries and Other Procedures
CRF Module/Guidance CDEs
Lower Extremity Orthopedic Surgical Procedures - Ankle CDE Details
Lower Extremity Orthopedic Surgical Procedures - Hip CDE Details
Lower Extremity Orthopedic Surgical Procedures - Knee CDE Details
Outcomes and End Points
Functional Outcomes
CRF Module/Guidance CDEs
10 Meter Timed Walk N/A
6 Minute Walk Test N/A
Edinburgh Visual Gait Score (EGVS) N/A
Functional Independence Measure (FIM) N/A
Functional Independence Measure for Children (WeeFIM) N/A
Functional Mobility Scale N/A
Gait Deviation Index N/A
Gait Profile Score (GPS) N/A
Goal Attainment Scale (GAS) N/A
Instrumented Gait Analysis N/A
Observational Gait Scale N/A
Pediatric Evaluation of Disability Inventory (PEDI) N/A
Pediatric Orthopedic Society of North America Measure (PODCI) N/A
Stride Analysis and Gait Variability N/A
Timed Up and Go (TUG) N/A
Walking Speed CDE Details
Motor Function
CRF Module/Guidance CDEs
ABILHAND-Kids N/A
Alberta Infant Motor Scale N/A
Assisting Hand Assessment (AHA) N/A
Box and Blocks Test of Manual Dexterity N/A
Canadian Occupational Performance Measure (COPM) N/A
Gross Motor Function Measure (GMFM-88, GMFM-66) N/A
Jebsen-Taylor Hand Function Test N/A
Manual Muscle Testing-Using the Medical Research Council Muscle Grading Scale CDE Details
Maximum Voluntary Isometric Contraction (MVIC) N/A
Melbourne Assessment 2 (MA2) N/A
Nine Hole Peg Test N/A
Prechtl's Assessment of General Movements N/A
Purdue Pegboard N/A
Quality of Upper Extremity Skills Test (QUEST) N/A
Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) N/A
Test of Infant Motor Performance (TIMP) N/A
Participation
CRF Module/Guidance CDEs
Activities Scale for Kids (ASK) N/A
Assessment of Life Habits (Life-H) N/A
Assessment of Preschool Children's Participation (APCP) N/A
Child and Adolescent Scale of Participation (CASP) N/A
Child Engagement in Daily Life N/A
Children's Assessment of Participation and Enjoyment Scale (CAPE) / Preferences for Activities of Children (PAC) N/A
Evaluation of Social Interaction (ESI) N/A
Lifestyle Assessment Questionnaire for CP (LAQ-CP of LAQ-G) N/A
Participation and Environment Measure for Children and Youth (PEM-CY) N/A
Participation Assessment with Recombined Tools-Objective (PART-O)-17 N/A
School Function Assessment (SFA) N/A
Young Children's Participation and Environment Measure (YC-PEM) N/A
Cognitive and Emotional Status
CRF Module/Guidance CDEs
Ages & Stages Questionnaires, Third Edition (ASQ-3) N/A
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Leiter International Performance Scale-3 (Leiter-3) N/A
NIH Toolbox Cognitive Battery CDE Details
Pediatric Sleep Questionnaire (PSQ) N/A
PROMIS Item Bank v1.0 - Sleep Disturbance CDE Details
Sleep Disorders Inventory for Students N/A
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) CDE Details
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) CDE Details
Wechsler Intelligence Scale for Children-V (WISC-V) N/A
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) N/A
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Assessment of Quality of Life (AQoL) N/A
Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) N/A
Cerebral Palsy Quality of Life (CP QOL) N/A
Child Health and Illness Profile (CHIP-CE) N/A
Child Health Assessment Questionnaire (CHAQ) N/A
Child Health Questionnaire (CHQ) N/A
EuroQoL-5 Dimension Questionnaire-Youth (EQ-5DY) N/A
Generic Children's Quality of Life Measure (GCQ) N/A
Health Related Quality of Life-14 (HRQOL-14) N/A
Health Utilities Index (HUI) N/A
KIDSCREEN-52 N/A
Multidimensional Students Life Satisfaction Scale (MSLSS) N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Pediatric Quality of Life Inventory (PEDSQL) N/A
Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL-CP) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Short Form 36-Item Health Survey (SF-36) CDE Details
The DISABKIDS Chronic Generic Module (DCGM-37) N/A
World Health Organization Quality of Life Assessment (WHOQOL-BREF) N/A
Spasticity/Movement
CRF Module/Guidance CDEs
Barry Albright Dystonia Scale (BADS) N/A
Dyskinesia Impairment Scale (DIS) N/A
Hypertonia Assessment Tool (HAT) N/A
Modified Ashworth Scale - Limb Tone Testing CDE Details
Selective Control Assessment of the Lower Extremity (SCALE) N/A
Tardieu Scale CDE Details
Pain
CRF Module/Guidance CDEs
Bath Adolescent Pain Questionnaire (BAPQ) N/A
Body Diagram N/A
Brief Pain Inventory (BPI) Long Form N/A
Brief Pain Inventory (BPI) Short Form CDE Details
Cerebral Palsy Pain Instrument Summary N/A
Child Activity Limitations Interview (CALI) N/A
Child Self-Efficacy Scale (CSES) N/A
Face, Legs, Activity, Cry, Consolability Scale (FLACC) N/A
Faces Pain Scale - Revised (FPS-R) N/A
Noncommunicating Children's Pain Checklist-Revised (NCCPC-R) N/A
Numeric Pain Rating Scale (NPRS) N/A
Pain Interference Index (PII) N/A
Pediatric Pain Profile (PPP) N/A
Pediatric Pain Questionnaire (PPQ) N/A
PROMIS Pain Behavior Short Form N/A
PROMIS Pain Interference Short Form N/A
Visual Analog Scale (VAS) N/A
Visual-Spatial Processing
CRF Module/Guidance CDEs
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) N/A
Executive Functioning
CRF Module/Guidance CDEs
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) CDE Details
Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2) N/A
Behavior Rating Inventory of Executive Function- Preschool Version (BRIEF-P) N/A
Conners Continuous Performance Test 3rd Edition (Conners CPT 3) N/A
Conners Kiddie Continuous Performance Test 2 (K-CPT 2) N/A
Corsi Block Wechsler Nonverbal Scale of Ability (WNV) N/A
Delis-Kaplan Executive Function System (D-KEFS) N/A
Kaufman Assessment Battery for Children N/A
Mullen Scales of Early Learning (MSEL) N/A
Test of Everyday Attention for Children (TEA-Ch) CDE Details
Test of Variables of Attention (TOVA) N/A
Symbol Digit Modalities Test N/A
Trunk Control/Balance
CRF Module/Guidance CDEs
Berg Balance Scale (BBS) CDE Details
Early Assessment of Balance (EAB) N/A
Functional Reach Test (FRT) N/A
Level of Sitting Scale (LSS) N/A
Segmental Assessment of Trunk Control (SATCo) N/A
Trunk Control Measurement Scale (TCMS) N/A
Social Emotional
CRF Module/Guidance CDEs
Brief Infant Toddler Social Emotional Assessment (BITSEA) N/A
Social Communication Questionnaire (SCQ) N/A
Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2) N/A
Wisconsin Card Sorting Test (WCST) N/A
Memory
CRF Module/Guidance CDEs
Brief Visuospatial Memory Test Revised (BVMT-R) N/A
California Verbal Learning Test - Children (CVLT-C) N/A
California Verbal Learning Test - Second Edition (CVLT-II) N/A
Rey Auditory Verbal Learning Test (RAVLT) N/A
Wechsler Memory Scale IV (WMS-IV) N/A
Family and Environment
CRF Module/Guidance CDEs
Child and Adolescent Scale of Environment (CASE) N/A
Family Assessment Device (FAD) N/A
Speech Language and Communication
CRF Module/Guidance CDEs
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5) N/A
Clinical Evaluation of Language Fundamentals-Preschool-2 (CELF-Preschool-2) N/A
Comprehensive Test of Phonological Processing (CTOPP) N/A
Dynamic Evaluation of Motor Speech Skills (DEMSS) N/A
Edinburgh Cognitive Behavioral ALS Screen (ECAS) N/A
Goldman Fristoe Test of Articulation 2 (GFTA-2) N/A
Language Sample Analysis N/A
Peabody Picture Vocabulary Test 4th Edition (PPVT-4) N/A
Percentage of Consonants Correct-Revised (PCC-R) N/A
Preschool Language Scales - Fifth Edition (PLS-5) N/A
Pure Tone Threshold Audiometry N/A
Speech Language Profile Groups (SLPG) N/A
Test of Children's Speech (TOCS) N/A
Verbal Motor Production Assessment for Children (VMPAC) N/A
Viking Speech Scale (VSS) N/A

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at https://cssrs.columbia.edu/).

Instrument Notice of Copyright Information

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

Overview

The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team developed Version 1.0 of the CP CDEs in 2015 through a partnership between NINDS and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM).

To develop the Cerebral Palsy CDEs, the Cerebral Palsy CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Engagement and Quality of Life Assessments/Data
  • Health, Growth, Genetics, Comorbidities and Labs
  • Neurocognitive, Social, and Emotional Assessments
  • Neuroimaging Diagnostics
  • Neuromotor Skills and Functional Assessments
  • Participant Characteristics and Disease/Injury Related Events

Data standards include CDEs as well as case report form (CRF) Modules, Guidance documents and Instrument Notice of Copyright (NOC) documents. The CRF Modules logically organize the CDEs for data collection, the Guidance documents provide further information about the CDE, and the NOC documents include perinent information on recommended instruments. The CDE, CRF Modules, Guidance documents and NOCs presented are organized into domains which are intuitive and common in clinical research studies. Version 1.0 of the Cerebral Palsy CDEs were released in 2016.

The Cerebral Palsy CDE Oversight Committee (OC) was created in 2017 to periodically review, direct the updating, and advance the development of the CP CDEs.

Since 2017 the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018 the CP OC developed and posted the External Device – CP CRF, and in 2020 developed and posted the Participant Condition Characteristics CRF on the Cerebral Palsy data standards page.

In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process, the CP OC formed two subgroups. The CP Pain subgroup recommended 15 Pain Instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.

After a public review period of the draft CP CDEs, from April 27, 2022 to June 1, 2022, the CP OC recommended 15 Pain Instruments and six Orthopedic Surgical CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022. In September 2022, the CP Pain and CP Orthopedic Surgery subgroups presented the development of their respective CDEs and recommendations for pain instruments at the 76th Annual AACPDM Meeting in Las Vegas, NV.

Roster

The Cerebral Palsy (CP) CDE Working Group was comprised of seven different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The CP CDE Working Group was supported by the NINDS CDE Team. The complete CP CDE Working Group roster and the rosters by Subgroup are shown below:

Complete Cerebral Palsy CDE Roster

Oversight Committee

Oversight Committee

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
    Chair
  • Krister P. Freese, MD
    Shriners Hospital for Children, Portland, Oregon
  • Theresa Moulton, PT, PhD
    Northwestern University, Chicago, Illinois
  • Terence Sanger, MD, PhD (Until 2023)
    University of Southern California, Los Angeles, California
  • Veronica Schiariti, MD, PhD
    University of Victoria, Victoria, British Columbia, Canada
  • Angela Shierk, PhD, OTR
    Texas Woman's University, Denton, Texas
  • M. Wade Shrader, MD
    Nemours/Alfred I. duPont Hospital, Wilmington, Delaware
  • Susan Sienko, PhD
    Shriners Hospital for Children, Portland, Oregon
  • Wendy Sullivan
    Cerebral Palsy Foundation, Alpharetta, Georgia
  • Joyce Trost, PhD, PT
    Cerebral Palsy Research Network, Goodhue, Minnesota
  • Lisa Wagner DHS, OTR/L
    Shriners Hospital for Children, Greenville, South Carolina

Previous Cerebral Palsy Oversight Committee Members

Previous Cerebral Palsy Oversight Committee Members

  • Brian Carlson, PhD
    Ipsen Biopharmaceuticals, Inc., Basking Ridge, New Jersey
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Paul Gross
    Cerebral Palsy Research Network, Woodinville, Washington
  • Deborah Gordon Hirtz, MD
    University of Vermont College of Medicine, Burlington, Vermont
  • Sandra E. Juul, MD, PhD
    University of Washington, Seattle, Washington
  • Sarah McIntyre, PhD
    Cerebral Palsy Alliance, University of Sydney, Sydney NSW, Australia
  • Elaine Stashinko, PhD, RN
    Johns Hopkins University, Baltimore, Maryland

AACPDM CDE Steering Committee

AACPDM CDE Steering Committee

  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
    Co-Chair
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Laura Prosser, PT, PhD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Sharon Ramey, PT, PhD
    Virginia Polytechnic Institute, Roanoke, Virginia
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama

Engagement and Quality of Life Assessments/Data

Engagement and Quality of Life Assessments/Data

  • Susan Sienko, PhD
    Shriners Hospitals for Children, Portland, Oregon
    Chair
  • Kristie Bjornson, PT, PhD
    Seattle Children's, Seattle, Washington
  • Stephanie DeLuca, PhD
    Virginia Polytechnic Institute, Blacksburg, Virginia
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Margaret Wallen, OT, PhD
    University of Sydney, Sydney, Australia

Health, Growth, Genetics, Co-Morbidities and Labs

Health, Growth, Genetics, Co-Morbidities and Labs

  • Theresa Moulton, DPT, PhD
    Northwestern University, Chicago, Illinois
    Chair
  • Kathleen M. Kolaski, MD
    Wake Forest Baptist Health, Winston-Salem, North Carolina
  • Sebastian Schroeder, MD
    Ludwig-Maximilians-University of Munich, Munich, Bavaria, Germany
  • Benjamin J. Shore, MD
    Harvard Medical School, Boston, Massachusetts
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
  • Gordon Worley, MD
    Duke University School of Medicine, Durham, North Carolina

Integrated Across Working Groups

Integrated Across Working Groups

  • Veronica Schiariti, MD, PhD
    Children's & Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada
    Chair
  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
  • Mary Gannotti, PT, PhD
    University of Hartford, Hartford, Connecticut
  • Bernadette Gillick, PT, PhD
    University of Minnesota, Minneapolis, Minnesota
  • Sylvia Ounpuu, MSc
    University of Connecticut, Farmington, Connecticut

Neurocognitive, Social, and Emotional Assessments/Data

Neurocognitive, Social, and Emotional Assessments/Data

  • Sharon Ramey, PT, PhD
    PhD, Virginia Polytechnic Institute, Roanoke, Virginia
    Chair
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Michael Msall, MD
    University of Chicago, Chicago, Illinois
  • Seth A. Warschausky, PhD
    University of Michigan, Ann Arbor, Michigan
  • Kathi Zebracki, PhD
    Loyola University Chicago, Chicago, Illinois

Neuroimaging Diagnostics

Neuroimaging Diagnostics

  • Eric Levey, MD
    Kennedy Krieger Institute, Baltimore, Maryland
    Chair
  • Patrick Barnes, MD
    Stanford University, Palo Alto, California
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Hannah Glass, MD
    University of California San Francisco, San Francisco, California
  • Andrea Poretti, MD
    Johns Hopkins University, Baltimore, Maryland
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California

Neuromotor Skill and Functional Assessments

Neuromotor Skill and Functional Assessments

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
    Chair
  • Michael Aiona, MD
    Shriners Hospitals for Children, Portland, Oregon
  • Mary Jo Cooley Hidecker, PhD MS MA CCC-A/SLP
    University of Wyoming, Laramie, Wyoming
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Christopher Joseph, MS PT
    Kennedy Krieger Institute, Baltimore, Maryland
  • Claire Morress, OT, PhD
    Cincinnati Children's Perlman Center, Cincinnati, Ohio
  • Laura Prosser, PT, PhD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington

Participant Characteristics and Disease/Injury Related Events

  • Sarah McIntyre, PhD
    University of Sydney, Sydney, Australia
    Chair
  • Katherine Alter, MD
    NIH Clinical Center, Bethesda, Maryland
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Deborah Thorpe, PT, PhD
    University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

NINDS CDE Team

NINDS CDE Team

  • James I. Koenig, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH (Until 2016)
    National Institute for Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Clara Aman, MPH (Until 2023)
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Robin S. Feldman, BS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Andy Franklin, BA
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Cerebral Palsy CDEs Revision History

The need to develop a common data set of meaningful measurements for Cerebral Palsy (CP) was identified as a priority area of the American Academy of Cerebral Palsy and Developmental Medicine’s (AACPDM) 2013–2017 strategic plan. In 2015, the CP specific Common Data Elements (CDEs) were developed through a partnership between the National Institute of Neurological Disorders and Stroke (NINDS) and the AACPDM. Version 1.0 of the CP CDEs was posted on the CP Data Standards page in 2016.

In 2017, the CP CDE Oversight Committee (OC) was created to periodically review, direct the updating, and advance the development of the CP CDEs. Since 2017, the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018, the CP OC developed and posted the External Devices – CP case report form (CRF) and in 2020 developed the Participant Condition Characteristics CRF.

In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process the CP OC formed two subgroups. The CP Pain subgroup recommended 15 pain instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.

The CP Pain subgroup reviewed a total of 184 assessments: 22 NINDS CDE CRFs across disorders; 23 NINDS CDEs across disorders related to pain; 101 pain measures from the NIH HEAL Initiative; and 38 from a literature review. These assessments were reviewed using the following criteria to recommend the selected 15 pain instruments:

  • Assessment was developed specifically for chronic pain
  • Assessment was developed for pediatric populations (children 0 to 18 years)
  • Main focus of the assessment is pain
    • more than 3 questions
  • Assessment fits within one of the pain categories
    • intensity, interference, behavior, quality, or location
  • Assessment is available in English

The CP Orthopedic Surgery subgroup assessed the Cerebral Palsy Research Network’s (CPRN) Orthopedic Registry Elements to develop CP orthopedic surgery CDEs. The CPRN Orthopedic Registry Elements and Data Forms were chosen as a basis for these CDEs because these elements have been vetted by CPRN’s Orthopedic Registry Task Force of renowned orthopedic surgeons allowing the subgroup to select, organize and augment the registry elements more quickly to develop the NINDS Orthopedic Surgery CDEs.

The CP Pain Instruments and Orthopedic Surgery CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022.

A complete listing of the Pain Instruments and Orthopedic Surgery CRFs and CDE data dictionaries may be found in the CP CDEs Revision History document linked above.