Parkinson's Disease

Data Standards

The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. The first set of Common Data Elements (CDEs) for Parkinson’s Disease was developed in 2010. The Core data elements to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

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

An overview of all Parkinson’s Disease (PD) CDE recommendations can be found in the PD CDE Highlight Summary document. For your reference, a zip file containing all the current PD CDE template CRF modules can be downloaded below.

Download PD CDE Recommendations

Participant Characteristics
Demographics
CRF/Module Guideline CDEs
General Core CDE Details
Demographics CDE Details
Disease/Injury Related Events
History of Disease/Injury Event
CRF/Module Guideline CDEs
Medical History of Parkinson's Disease CDE Details
Assessments and Examinations
Other Clinical Data
CRF/Module Guideline CDEs
Neuropathology CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF/Module Guideline CDEs
NINDS Repository Parkinsonism Data Elements N/A
Treatment/Intervention Data
Surgeries and Other Procedures
CRF/Module Guideline CDEs
Functional Neurosurgery CDE Details
Outcomes and End Points
Other Non-Motor
CRF/Module Guideline 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 Guideline 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
Summary of All Outcome Recommendations
CRF/Module Guideline CDEs
PD CDE Instrument Recommendations by Outcome Domain and Classification N/A

Overview

The Parkinson’s disease (PD) CDEs will follow the recommendations of the PD CDE Working Group (WG), a committee of experts in the field (see History and Acknowledgements).

The Parkinson’s Disease CDE WG brings together over fifty experts from nine countries that are divided into twelve 
Subgroups / Specialty areas. These specialty areas include:

  • General and Motor
  • Imaging
  • Neuropathology
  • Genetics
  • Epidemiology/Environment
  • Psychiatry
  • Functional Neurosurgery
  • Other Non-Motor
  • Quality of Life
  • Operations
  • Cognitive
  • Scale Metrics and Statistics

These subgroups tabulate the data elements commonly utilized in PD clinical studies in order to standardize the collection of the most relevant and useful data.

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.

History and Acknowledgements

The Parkinson’s Disease CDE Working Group is currently comprised of twelve different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively develop the CDEs for their specific subgroups and also have an opportunity to review and comment on the recommendations of the other subgroups. The PD CDE Working Group is supported by the NINDS CDE Team. The complete PD CDE Working Group roster and the rosters by Subgroup are shown below.

Complete Parkinson's Disease CDE Working Group Roster

 

The Parkinson’s Disease CDE WG meetings commenced in October 2009 and the Working Group plans to release Version 1.0 of their PD CDEs in the fall of 2010. The PD CDE WG holds meetings throughout the year to review materials drafted by the Subgroups and incorporate them into the CDE recommendations. The Parkinson’s Disease CDE Oversight Committee was created in 2016.

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
  • Kevin Biglan, MD, MPH
    University of Rochester, Rochester, New York (2016-2019)
  • Helen Bronte-Stewart, MD, MS
    Stanford University School of Medicine, Stanford, California
  • Jesse Cedarbaum, MD
    Coeruleus Clinical Sciences LLC, Woodbridge, Connecticut
  • Jordan Elm, PhD
    Medical University of South Carolina, Charleston, South Carolina (2016-2019)
  • Stanley Fahn, MD
    Columbia University Medical Center, New York, New York
  • Tatiana Foroud, PhD
    Indiana University School of Medicine, Indianapolis, Indiana (2016-2019)
  • Christopher Goetz, MD
    Rush University Medical Center, Chicago, Illinois
  • Karen Marder, MD, MPH
    Columbia University Medical Center, New York, New York (2016-2019)
  • Michael Okun, MD
    University of Florida, Gainesville, Florida
  • Ronald Pfeiffer, MD
    Oregon Health and Science University, Portland, Oregon (2016-2019)
  • Paul Rohrlich, PhD
    Parkinson?s Foundation, Falls Church, Virginia
  • Kathleen Shannon, MD, FAAN, FANA
    University of Wisconsin, Madison, Wisconsin
  • Andrew Siderowf, MD
    Avid Radiopharmaceuticals, Inc., Philadelphia, Pennsylvania (2016-2019)
  • Caroline Tanner, MD, PhD
    University of California, San Francisco, San Francisco, California (2016-2019)
  • Daniel Weintraub, MD
    University of Pennsylvania, Philadelphia, Pennsylvania (2016-2019)

Working Group Co-Chairs

  • Caroline Tanner, MD, PhD
    University of California, San Francisco, San Francisco, California
  • Karl Kieburtz, MD, MPH
    University of Rochester, Rochester, New York

Cognitive Subgroup

  • Karen Marder, MD, MPH
    Columbia University Medical Center, New York, New York
    Chair
  • David Burn, MD
    Newcastle University, Newcastle upon Tyne, United Kingdom
  • Irene Litvan, MD
    University of Louisville, Louisville, Kentucky
  • Laurie Ryan, PhD
    National Institute on Aging (NIA), National Institutes of Health (NIH), Bethesda, Maryland
  • Nina Silverberg, PhD
    National Institute on Aging (NIA), National Institutes of Health (NIH), Bethesda, Maryland Ad hoc member
  • Glenn Stebbins, PhD
    Rush University Medical Center, Chicago, Illinois

Epidemiology and Environment Subgroup

  • Webster Ross, MD
    Pacific Health Research Institute, Honolulu, Hawaii
    Chair
  • Alberto Ascherio, MD, DrPh
    Harvard School of Public Health, Boston, Massachusetts
  • Yoav Ben-Shlomo, MD, PhD
    University of Bristol, Bristol, United Kingdom
  • Cindy Lawler, PhD
    National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Bethesda, Maryland hoc member
  • Connie Marras, MD, PhD
    University of Toronto, Toronto, Canada
  • David Thurman, MD, MPH
    Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, Georgia

Functional Neurosurgery Subgroup

  • Mahlon DeLong, MD
    Emory University, Atlanta, Georgia
    Chair
  • Guenther Deuschl, MD
    University of Hospital Kiel, Kiel, Germany
  • Jaimie Henderson, MD
    Stanford University School of Medicine, Palo Alto, California
  • Andres Lozano, MD, PhD
    University of Toronto, Toronto, Canada
  • Kelly Lyons, PhD
    University of Kansas Medical Center, Kansas City, Kansas
  • Philip Starr, MD
    University of California, San Francisco, San Francisco, California
  • Jerrold Vitek, MD, PhD
    Cleveland Clinic, Cleveland, Ohio

General and Motor Subgroup

  • Tony Lang, MD
    University of Toronto, Toronto, Canada
    Chair
  • Piu (Bill) Chan, MD
    Capital Medical University, Beijing, China
  • Stanley Fahn, MD
    Columbia University Medical Center, New York, New York
  • Christopher Goetz, MD
    Rush University Medical Center, Chicago, Illinois
  • Werner Poewe, MD
    Medical University of Innsbruck, Innsbruck, Austria

Genetics Subgroup

  • Tatiana Foroud, PhD
    Indiana University School of Medicine, Indianapolis, Indiana
    Chair
  • Susan Bressman, MD
    Albert Einstein College of Medicine, New York, New York
  • Rod Corriveau, PhD
    Coriell Institute for Medical Research, Camden, New JerseyAd hoc member
  • Matt Farrer, PhD
    Mayo Clinic, Rochester, Minnesota
  • Andy Singleton, PhD
    National Institute on Aging (NIA), National Institutes of Health (NIH), Bethesda, Maryland

Imaging Subgroup

  • Ken Marek, MD
    Institute for Neurodegenerative Disorders, New Haven, Conneticut
    Chair
  • David Brooks, MD, DSc
    Imperial College, London, United Kingdom
  • Andrew Feigin, MD
    New York University School of Medicine, New York, New York
  • Wayne Martin, MD
    University of Alberta, Edmonton, Canada
  • Joel Perlmutter, MD
    Washington University, St Louis, Missouri
  • Michael Schocke, MD
    Medical University Innsbruck, Innsbruck, Austria
  • Klaus Seppi, MD
    Medical University Innsbruck, Innsbruck, Austria

Neuropathology Subgroup

  • 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
  • Jean-Paul Vonsattel, MD
    Columbia University, New York, New York

Operations Subgroup

  • Cornelia Kamp, MBA
    University of Rochester, Rochester, New York
    Chair
  • Cynthia Casaceli, MBA
    University of Rochester, Rochseter, New York
  • Donald Grosset, MD
    University of Glasgow, Glasgow, United Kingdom
  • Christine Hunter, RN, CCRC
    Baylor College of Medicine, Houston, Texas
  • Walter Kukull, PhD
    National Alzheimer's Coordinating Center, Bethesda, Maryland

Other Non-Motor Subgroup

  • Ron Pfeiffer, MD
    University of Tennessee, Knoxville, Tennessee
    Chair
  • Marian Evatt, MD
    Emory University School of Medicine, Atlanta, Georgia
  • Hubert Fernandez, MD
    University of Florida, Gainesville, Florida
  • Bob van Hilten, MD, PhD
    Leiden University Medical Center, Leiden, Netherlands
  • Ron Postuma, MD
    Montreal General Hospital, Montreal, Canada

Psychiatry Subgroup

  • Daniel Weintraub, MD
    University of Pennsylvania, Philadelphia, Pennsylvania
    Chair
  • Laura Marsh, MD
    Baylor College of Medicine, Houston, Texas
  • William McDonald, MD
    Emory University School of Medicine, Atlanta, Georgia
  • Matthew Menza, MD
    Robert Wood Johnson Medical School, New Brunswick, New Jersey
  • Bernard Ravina, MD
    University of Rochester, Rochester, New York

Scale Metrics and Statistics Subgroup

  • Jordan Elm, PhD
    Medical University of South Carolina, Charleston, South Carolina
    Chair
  • Gary Cutter, PhD
    University of Alabama Birmingham, Birmingham, Alabama
  • Bruce Levin, PhD
    Columbia University, New York, New York
  • Pablo Martinez-Martin, MD, PhD
    National Center for Epidemiology, ISCIII, Madrid, Spain
  • David Oakes, PhD
    University of Rochester, Rochester, New York
  • Patrick Shrout, PhD
    New York University, New York, New York

Quality of Life Subgroup

  • Andrew Siderowf, MD
    University of Pennsylvania, Philadelphia, Pennsylvania
    Chair
  • Cindy Nowinski, MD, PhD
    NorthShore University, Evanston, Illinois
  • Annette Schrag, MD
    Royal Free and University College, London, United Kingdom
  • Lisa Shulman, MD
    University of Maryland, College Park, Maryland
  • Mickie Welsh, RN, DNSc
    University of Southern California, Los Angeles, California

NINDS CDE Team

  • Wendy Galpern, MD, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Codrin Lungu, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Robin Feldman, BS, MBA
    The Emmes Corporation
  • Muniza Sheikh, MS/MBA
    The Emmes Corporation
  • Tiffany Abushaikha
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Lisa Hunegs, MSW, MPH
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Kristy Miller, MPH
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Christina You, MSPH
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland

References

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