Parkinson's Disease

Coming Soon! Parkinson's Disease Version 2.0 CDEs - September 2022

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)

Parkinson's Disease Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Parkinson's Disease study start-up

Parkinson's Disease Highlight Summary: Overview of all Parkinson's Disease-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.

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

Participant Characteristics

Demographics
CRF/Module Guidance	CDEs
General Core	CDE Details
Demographics	CDE Details

Participant History and Family History

Epidemiology/Environmental History
CRF/Module Guidance	CDEs
Epi/Envt Guidelines for CDE Use	N/A
Food Frequency Questionnaire (FFQ)	CDE Details
History of Early Exposure	CDE Details
Infection History	CDE Details
Non-prescribed Drug Use Questionnaire	CDE Details
Nurses' Health Study Questionnaire (NHQ)	N/A
Ohio State University TBI Identification Method Short Form	CDE Details
PD DOC Mini Environmental Risk Questionnaire for Parkinson's Disease Patients Baseline (PD DOC MERQ-PD-B)	CDE Details
Risk Factor Questionnaire (RFQ) - All	N/A
Risk Factor Questionnaire (RFQ) - NSAIDS and Calcium Channel Blockers (CCB)	CDE Details
Risk Factor Questionnaire (RFQ) - Occupation and Employment Status	CDE Details
Risk Factor Questionnaire (RFQ) - Physical Activity and Sleep	CDE Details
Risk Factor Questionnaire (RFQ) - Residential History	CDE Details
Risk Factor Questionnaire (RFQ) - Toxicants	CDE Details
Risk Factor Questionnaire (RFQ-U) - Height and Weight	CDE Details
Risk Factor Questionnaire (RFQ-U) - Pesticides (Home)	CDE Details
Risk Factor Questionnaire (RFQ-U) - Pesticides (Work)	CDE Details
Risk Factor Questionnaire (RFQ-U) - Smoking and Tobacco	CDE Details

General Health History
CRF/Module Guidance	CDEs
Family History	CDE Details

Disease/Injury Related Events

History of Disease/Injury Event
CRF/Module Guidance	CDEs
Medical History of Parkinson's Disease	CDE Details

Assessments and Examinations

Imaging Diagnostics
CRF/Module Guidance	CDEs
Imaging Guidelines for CDE Use	N/A
MR	CDE Details
MRI and Spectroscopy	CDE Details
PET-SPECT	CDE Details

Other Clinical Data
CRF/Module Guidance	CDEs
Neuropathology	CDE Details

Laboratory Tests and Biospecimens/Biomarkers
CRF/Module Guidance	CDEs
NINDS Repository Parkinsonism Data Elements	N/A

Treatment/Intervention Data

Surgeries and Other Procedures
CRF/Module Guidance	CDEs
Functional Neurosurgery	CDE Details

Drugs
CRF/Module Guidance	CDEs
Non-Parkinson's Disease Medication Log	CDE Details
Parkinson's Disease Medication Log	CDE Details

Outcomes and End Points

Cognitive
CRF/Module Guidance	CDEs
Cognitive Guidelines for CDE Use	N/A
Addenbrooke's Cognitive Examination-III (ACE-III)	N/A
Alzheimer's Disease Assessment Scale-Cognition (ADAS-cog)	N/A
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)	N/A
Cambridge Cognitive Assessment-Revised (CAMCOG-R)	N/A
Cambridge Neuropsychological Test Automated Battery (CANTAB)	N/A
CDR System	N/A
Lille Apathy Rating Scale (LARS)	N/A
Mattis Dementia Rating Scale (MDRS)	N/A
Mini-Mental State Examination (MMSE)	N/A
Montreal Cognitive Assessment (MoCA)	N/A
Parkinson Anxiety Scale (PAS)	N/A
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)	N/A
Questionnaire Impulsive-Compulsive Disorders Parkinson's Disease-Rating Scale (QUIP-RS)	N/A
Scale for the Assessment of Positive Symptoms-Parkinson's Disease (SAPS-PD)	N/A
Scales for Outcomes in Parkinson's Disease-Cognitive (SCOPA-COG)	CDE Details
Short Portable Mental Status Questionnaire (SPMSQ)	CDE Details

Other Non-Motor
CRF/Module Guidance	CDEs
Other Non-motor Guidelines for CDE Use	CDE Details
Berlin Questionnaire	CDE Details
Brief Index of Sexual Functioning for Women (BISF-W)	N/A
Brief Pain Inventory (Short Form)	CDE Details
Brief Smell Identification Test (Brief-SIT)	N/A
Cambridge-Hopkins Restless Legs Syndrome Diagnostic Questionnaire (CH-RLSQ)	CDE Details
Composite Autonomic Severity Scale (CASS)	N/A
Composite Autonomic Symptom Scale	N/A
Constipation Severity Scale (CSS)	N/A
Drooling Rating Scale (DRS)	N/A
Drooling Severity and Frequency Scale (DSFS)	CDE Details
Fatigue Severity Scale (FSS)	CDE Details
Haraldsson's Questionnaire	N/A
Insomnia Severity Index (ISI)	CDE Details
Instrument for the Assessment of Restless Legs Syndrome Severity (IRLSSG-Rating Scale)	N/A
International Consultation on Incontinence Modular Questionnaire-Overactive Bladder (ICIQ-OAB)	N/A
International Index of Erectile Function-5 (IIEF-5)	N/A
International Prostate Symptom Scale (IPSS)	N/A
Karolinska Sleepiness Scale (KSS)	N/A
Mini Nutritional Assessment (MNA)	CDE Details
Multiple Sleep Latency Test (MSLT) and Guidelines	N/A
Non-Motor Symptom assessment scale for Parkinson's Disease (NMSS)	CDE Details
Non-Motor Symptom Questionnaire (NMS-Quest) (PD-NMS)	CDE Details
Numeric Rating Scale (NRS)-Box 21 Scale	N/A
Parkinson's Disease Sleep Scale 2nd Version (PDSS-2)	CDE Details
Parkinson's Neuropsychometric Dementia Assessment (PANDA)	N/A
Pelli Robson Test	N/A
Pittsburgh Sleep Quality Index (PSQI)	CDE Details
Quality of Life in Swallowing Disorders (SWAL-QOL)	CDE Details
Quantitative Sudomotor Axon Reflex Test (QSART)	N/A
Rome III Constipation Module	CDE Details
Scale for Outcomes in Parkinson's Disease Autonomic (SCOPA-AUT)	CDE Details
Scale for Outcomes in Parkinson's Disease-Sleep (SCOPA-Sleep)	CDE Details
Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD)	CDE Details
Sleep Apnea Scale of Sleep Disorders Questionnaire (SA-SDQ)	CDE Details
Stanford Sleepiness Scale (SSS)	CDE Details
STOP Questionnaire	CDE Details
Survey Screen for Sleep Apnea (SSSA)	CDE Details
Swallowing Disturbance Questionnaire (SDQ)	CDE Details
The American Academy of Sleep Medicine (AASM): International Classification of Sleep Disorders (ICSD) Criteria	N/A
The International Association for the Study of Pain (IASP) Definitions for Pain	N/A
The International Restless Legs Syndrome Study Group Diagnostic Criteria	N/A
The REM Sleep Behavior Disorder (RBD) Screening Questionnaire (RBDSQ)	N/A
University of Pennsylvania Smell Identification Test (UPSIT)	N/A

Psychiatric and Psychological Functions
CRF/Module Guidance	CDEs
Psychiatric and Psychological Function Guidelines for CDE Use	N/A
Apathy Scale (AS)	CDE Details
Beck Depression Inventory II (BDI-II)	CDE Details
Brief Psychiatric Rating Scale (BPRS)	CDE Details
Compulsive Eating Scale (CES)	N/A
Diagnostic and Statistical Manual of Mental Disorders (DSM-5)	N/A
Gambling Symptom Assessment Scale (G-SAS)	CDE Details
Geriatric Depression Scale (GDS)	CDE Details
Hamilton Anxiety Rating Scale (HAM-A)	CDE Details
Hamilton Depression Rating Scale (HDRS)	N/A
Hospital Anxiety and Depression Scale (HADS)	N/A
McElroy Diagnostic Criteria for Compulsive Buying	N/A
Montgomery-Asberg Depression Scale (MADRS)	N/A
Neuropsychiatric Inventory Questionnaire (NPI-Q)	N/A
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)	N/A
Proposed Criteria for Diagnosis of the Syndrome of Apathy	N/A
Questionnaire about Buying Behavior (QABB)	CDE Details
Questionnaire for Impulsive-Compulsive Behaviors in Parkinson's Disease (QUIP) (Short form)	CDE Details
Questionnaire for Impulsive-Compulsive Behaviors in Parkinson's Disease (QUIP) (Long form)	CDE Details
Scale for the Assessment of Positive Symptoms (SAPS)	CDE Details
Sexual Compulsivity Scale (SCS)	CDE Details
South Oaks Gambling Screen (SOGS)	CDE Details
Structured Clinical Interview for DSM-IV Axis Disorders-Patient Version (SCID-I/P)	N/A
Structured Clinical Interview for Pathological Gambling (SCI-PG)	CDE Details
Summary of Diagnostic Criteria and Assessments for Psychosis in Parkinson's Disease	N/A

Quality of Life/Patient Reported Outcomes
CRF/Module Guidance	CDEs
Quality of Life Guidelines for CDE Use	N/A
Belastungsfrageboge Parkinson kurzversion (BELA-P-k)	N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D)	CDE Details
Nottingham Health Profile (NHP)	N/A
Parkinson's Disease Quality of Life Questionnaire (PDQL)	N/A
Parkinson's Disease Quality of Life Scale (PDQUALIF)	CDE Details
Parkinson's Disease Questionnaire (PDQ-39)	N/A
Parkinson's Impact Scale (PIMS)	CDE Details
Quality of Life in Neurological Disorders (Neuro-QOL)	N/A
Questions on Life Satisfaction - Movement Disorder (QLS-MD) and Deep Brain Stimulation (QLS-DBS) Modules	N/A
Scales for Outcomes in Parkinson's Disease-Psychosocial (SCOPA-PS)	CDE Details
Schedule for the Evaluation of Individual Quality of Life (SEQOL)	N/A
Schedule for the Evaluation of Individual Quality of Life - Direct Weighting (SEIQoL-DW)	N/A
Short Form 36-Item Health Survey (SF-36)	CDE Details
Sickness Impact Profile (SIP)	N/A
World Health Organization Quality of Life Assessment (WHOQOL-BREF)	CDE Details

Motor Function
CRF/Module Guidance	CDEs
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	CDE Details
UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's Disease	N/A
Unified Parkinson's Disease Rating Scale (UPDRS)	CDE Details

Summary of All Outcome Recommendations
CRF/Module Guidance	CDEs
PD CDE Instrument Recommendations by Outcome Domain and Classification	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 National Institute of Neurological Disorders and Stroke (NINDS) convened the Parkinson's Disease (PD) v1.0 Common Data Elements (CDE) Working Group (WG) in 2009. The PD v1.0 CDE WG brought together over 50 experts from nine countries divided into 12 subgroups/specialty areas. The subgroups defined the CDEs for their domains and recommended standardized, validated instruments for PD research. The first set of CDEs for PD was completed in 2010.

The PD CDE Oversight Committee (OC) was created in 2016 to periodically review, direct the updating, and advance the development of PD CDEs.

In 2021, the PD v2.0 CDE WG was convened to perform a comprehensive review and update of the PD CDEs. The WG was divided into 11 domain-specific subgroups and a biostatistician serves as a consultant on scale metrics and statistics.

PD v2.0 CDE Subgroups:

Cognitive
Digital Technology
Epidemiology and Environment
Functional Neurosurgery
General and Motor
Genetics
Imaging
Neuropathology
Other Non-Motor
Psychiatry
Quality of Life

The public review period for the draft PD v2.0 CDEs was held April 6, 2022 - May 11, 2022. The final PD v2.0 CDE recommendations will be posted by September 2022.

Roster

Members of the Parkinson’s Disease v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, and the NINDS CDE Team are listed below. A roster spreadsheet can be downloaded from this link: Complete Version 2.0 Parkinson's Disease CDE Working Group Roster

Complete Version 1.0 Parkinson’s Disease CDE Working Group Roster – Lists members of the Parkinson’s Disease v1.0 CDE Working Group by subgroup, previous members of the Oversight Committee, and the NINDS CDE Team.

Please see the Overview tab for additional project background and timeline information.

Oversight Committee Members

Mark Hallett, MD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

Co-Chair
Irene Litvan, MD

University of California, San Diego, La Jolla, California

Co-Chair
James Beck, PhD

Parkinson's Foundation, New York, New York
Helen Bronte-Stewart, MD, MS

Stanford University School of Medicine, Stanford, California
Jesse Cedarbaum, MD

Coeruleus Clinical Sciences LLC, Woodbridge, Connecticut
Stanley Fahn, MD

Columbia University Medical Center, New York, New York
Christopher Goetz, MD

Rush University Medical Center, Chicago, Illinois
Michael Okun, MD

University of Florida, Gainesville, Florida
Paul Rohrlich, PhD

Parkinson's Foundation, Falls Church, Virginia
Kathleen Shannon, MD, FAAN, FANA

University of Wisconsin, Madison, Wisconsin
Daniel Weintraub, MD

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

Working Group Co-Chairs Version 2.0

Tanya Simuni, MD

Northwestern University Feinberg School of Medicine, Chicago, Illinois
Caroline Tanner, MD, PhD

University of California, San Francisco, San Francisco, California

Cognitive Subgroup Version 2.0

Irene Litvan, MD

University of California, San Diego, La Jolla, California

Co-Chair
Daniel Weintraub, MD

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

Co-Chair
Dag Aarsland, MD, PhD

King's College, London, United Kingdom
Sule Tinaz, MD, PhD

Yale School of Medicine, New Haven, Connecticut
Alexander Troster, PhD

Barrow Neurological Institute, Phoenix, Arizona

Digital Technology Subgroup Version 2.0

Fay Horak, PhD, PT

Oregon Health and Science University, Portland, Oregon

Chair
Jamie Adams, MD

University of Rochester, Rochester, New York
Paolo Bonato, PhD

Harvard Medical School, Boston, Massachusetts
Jean-Francois Daneault, PhD

Rutgers University, Newark, New Jersey
Kelley Erb, PhD

Biogen Digital Health, Cambridge, Massachusetts
Jennifer Goldsack, MChem, MA, MBA, OLY

Digital Medicine Society (DiMe), Boston, Massachusetts (ad hoc)
Dina Katabi, PhD

MIT Computer Science & Artificial Intelligence Lab, Cambridge, Massachusetts
Larsson Omberg, PhD

Sage Bionetworks, Seattle, Washington

Epidemiology and Environment Subgroup Version 2.0

Yoav Ben-Shlomo, MBBS, PhD

University of Bristol, Bristol, United Kingdom

Co-Chair
Webster Ross, MD

Pacific Health Research Institute, Honolulu, Hawaii

Co-Chair
Alberto Ascherio, MD, DrPh

Harvard School of Public Health, Boston, Massachusetts
Caroline Tanner, MD, PhD

University of California, San Francisco, San Francisco, California
Allison Willis, MD, MS

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

Functional Neurosurgery Subgroup Version 2.0

Philip Starr, MD

University of California, San Francisco, San Francisco, California

Chair
Helen Bronte-Stewart, MD, MS

Stanford University School of Medicine, Stanford, California
Svjetlana Miocinovic, MD, PhD

Emory University School of Medicine, Atlanta, Georgia
Sameer Sheth, MD, PhD

Baylor College of Medicine, Houston, Texas

General and Motor Subgroup Version 2.0

Christopher Goetz, MD

Rush University Medical Center, Chicago, Illinois

Chair
Piu (Bill) Chan, MD

Capital Medical University, Beijing, China
Michael Schwarzschild, MD, PhD

Massachusetts General Hospital, Boston, Massachusetts
Holly Shill, MD

Barrow Neurological Institute, Phoenix, Arizona
Tanya Simuni, MD

Northwestern University Feinberg School of Medicine, Chicago, Illinois
Glenn Stebbins, PhD

Rush University Medical Center, Chicago, Illinois (ad hoc)

Genetics Subgroup Version 2.0

Sonja Scholz, MD, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

Chair
Susan Bressman, MD

Mount Sinai Hospital, New York, New York
Mark Fraiser, PhD

The Michael J. Fox Foundation, New York, New York
Christine Klein, MD, PhD

University of Luebeck, Luebeck, Germany
Ignacio Mata, PhD

Cleveland Clinic, Cleveland, Ohio
Marta San Luciano, MD, MS

University of California, San Francisco, San Francisco, California

Imaging Subgroup Version 2.0

Kenneth Marek, MD

Institute for Neurodegenerative Disorders, New Haven, Connecticut

Chair
Andrew Feigin, MD

NYU Langone Health, New York, New York
Silvina Horovitz, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Joel Perlmutter, MD

Washington University, St Louis, Missouri
Kathleen Poston, MD, MS

Stanford University, Stanford, California
Klaus Seppi, MD

Medical University Innsbruck, Innsbruck, Austria

Neuropathology Subgroup Version 2.0

Dennis Dickson, MD

Mayo Clinic Florida, Jacksonville, Florida

Chair
Irina Alafuzoff, MD, PhD

Uppsala University, Uppsala, Sweden
John Duda, MD

Philadelphia VA Medical Center, Philadelphia, Pennsylvania
Glenda Halliday, PhD

University of Sydney, Sydney, Australia

Other Non-Motor Subgroup Version 2.0

Horacio Kaufmann, MD

NYU Langone Health, New York, New York

Chair
Leslie Cloud, MD, MSc

Virginia Commonwealth University, Richmond, Virginia (ad hoc)
David Goldstein, MD, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland (ad hoc)
Samantha Holden, MD

University of Colorado Anschutz Medical Center, Aurora, Colorado
Alex Iranzo, MD, PhD

Hospital Clinic de Barcelona/Universitat de Barcelona, Barcelona, Spain
Jalesh Panicker, MD

The National Hospital for Neurology and Neurosurgery, Queen Square, London, United Kingdom (ad hoc)
Ronald Pfeiffer, MD

Oregon Health & Science University Parkinson Center of Oregon and Movement Disorder Clinic, Portland, Oregon (ad hoc)
Wolfgang Singer, MD

Mayo Clinic, Rochester, Minnesota (ad hoc)
Aleksandar Videnovic, MD, MSc

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts

Psychiatry Subgroup Version 2.0

Gregory Pontone, MD

Johns Hopkins University School of Medicine, Baltimore, Maryland

Chair
Laura Marsh, MD

Baylor College of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
William McDonald, MD

Emory University School of Medicine, Atlanta, Georgia
Laura Rowland, PhD

National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Bethesda, Maryland

Quality of Life Subgroup Version 2.0

Anette Schrag, MD, PhD

UCL Queen Square Institute of Neurology, London, United Kingdom

Chair
Cindy Nowinski, MD, PhD

Northwestern University, Chicago, Illinois
Lisa Shulman, MD

University of Maryland Medical Center, Baltimore, Maryland
Elizabeth Stegemoller, PhD, MT-BC

Iowa State University, Ames, Iowa

Scale Metrics and Statistics Consultant Version 2.0

Sharon Xie, PhD

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

NINDS CDE Team

Codrin Lungu, MD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
M. Carolina Mendoza-Puccini, MD

NINDS CDE Program Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Beth-Anne Sieber, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Sherita Ala'i Hansen, MS (Until 2018)

The Emmes Company, LLC, Rockville, Maryland
Clare Aman, BS

The Emmes Company, LLC, Rockville, Maryland
Damon Collie, MSHS

The Emmes Company, LLC, Rockville, Maryland
Joy Esterlitz, MS (Until 2020)

The Emmes Company, LLC, Rockville, Maryland
Robin 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
Cameron Meis, BA

The Emmes Company, LLC, Rockville, Maryland
Muniza Sheikh, MS, MBA

The Emmes Company, LLC, Rockville, Maryland

Publications

A publication related to the Parkinson’s disease CDE initiative is in development. The citation for this publication will be included on this site as soon as it is available.

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.

Parkinson’s Disease CDEs Revision History