Organized into domains often used in clinical studies, data standards
include:
- CDEs
- CRF Modules logically organize CDEs for data collection.
- Guidelines to provide further information about the CDEs.
Select a domain of interest below to find the related data standards.
Participant/Subject Characteristics
Participant/Subject Characteristics
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Demographics |
| PD Demographics |
66KB DOC |
HTML |
Back to top
Participant/Subject History and Family History
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Assessments and Examinations
Assessments and Examinations
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| General and Motor |
| General and Motor Recommended Instruments spreadsheet |
28KB XLS |
N/A |
| MDS-UPDRS |
353KB PDF |
HTML |
| Unified Parkinson's Disease Rating Scale (UPDRS) |
181KB PDF |
HTML |
| Psychiatry |
| Psychiatry Summary Statement |
58KB DOC |
N/A |
| Psychiatry Recommended Instruments spreadsheet |
82KB XLS |
N/A |
| Psychiatry Recommended CDEs table |
45KB DOC |
N/A |
| Geriatric Depression Scale (GDS) |
56KB DOC |
HTML |
| Hamilton Depression Rating Scale (HDRS) |
61KB PDF |
HTML |
| Hamilton Anxiety Rating Scale (HAM-A) |
56KB PDF |
HTML |
| Scale for the Assessment of Positive Symptoms (SAPS) |
66KB PDF |
HTML |
| Gambling Symptom Assessment Scale (G-SAS) |
29KB PDF |
HTML |
| Questionnaire about buying behavior |
59KB DOC |
HTML |
| Proposed Criteria for Diagnosis of the Syndrome of Apathy |
32KB DOC |
HTML |
| South Oaks Gambling Screen (SOGS) |
37KB DOC |
HTML |
| Brief Psychiatric Rating Scale (BPRS) |
16KB PDF |
HTML |
| Cognitive |
| Cognitive Summary Statement |
37KB DOC |
N/A |
| Cognitive Recommended Instruments spreadsheet |
55KB XLS |
N/A |
| Cognitive Recommended CDEs table |
52KB DOC |
N/A |
| Cognitive Psychometric Validation Scale |
34KB DOC |
N/A |
| Scales for Outcomes in PD-Cognitive (SCOPA-Cog) |
38KB PDF |
HTML |
| Short Portable Mental Status Questionnaire (SPMSQ) |
62KB DOC |
HTML |
| Imaging Diagnostics |
| Imaging Modality Summary Statement |
82KB DOC |
N/A |
| PET-SPECT |
90KB DOC |
HTML |
| MRI and Spectroscopy |
78KB DOC |
HTML |
| MR |
77KB DOC |
HTML |
| Other Non-Motor |
| Other Non-motor Summary Statement |
48KB DOC |
N/A |
| Other Non-motor Recommended Instruments spreadsheet |
166KB XLS |
HTML |
| Other Non-motor Recommended Instruments table |
44KB XLS |
N/A |
| MSLT and Guidelines |
2296KB PDF |
N/A |
| Stanford Sleepiness Scale (SSS) |
54KB DOC |
HTML |
| Scales for Outcomes in PD-Autonomic (SCOPA-Aut) |
42KB PDF |
HTML |
| Scales for Outcomes in PD-Sleep (SCOPA-Sleep) |
84KB PDF |
HTML |
| Berlin Questionnaire |
39KB PDF |
HTML |
| Insomnia Severity Index (ISI) |
25KB PDF |
HTML |
| Rome III Constipation Module |
226KB PDF |
HTML |
| Sleep Apnea Scale of Sleep Disorders Questionnaire (SDQ-SA) |
51KB DOC |
HTML |
| STOP Questionnaire |
58KB PDF |
HTML |
| Survey Screen for Sleep Apnea (SSSA) |
24KB DOC |
HTML |
| Cambridge-Hopkins Restless Legs Syndrome (CH-RLSQ) |
146KB PDF |
HTML |
| Composite Autonomic Scoring Scale (CASS) |
Coming Soon |
Coming Soon |
| Drooling Severity and Frequency Scale (DSFS) |
9KB PDF |
HTML |
| Fatigue Severity Scale (FSS) of Sleep Disorders |
92KB PDF |
HTML |
| Food Frequency Questionnaire (FFQ) |
321KB PDF |
HTML |
| Mini Nutritional Assessment (MNA) |
68KB PDF |
HTML |
| Non-Motor Symptom assessment scale for Parkinson's Disease (NMSS) |
12KB PDF |
HTML |
| Brief Pain Inventory (Short Form) |
71KB PDF |
HTML |
| Quality of Life in Swallowing Disorders (SWAL-QOL) |
124KB PDF |
HTML |
| Sialorrhea Clinical Scale for PD (SCS-PD) |
29KB DOC |
HTML |
| Other Clinical Data |
| Neuropathology Data Form |
151KB DOC |
HTML |
Back to top
Treatment/Intervention Data
Treatment/Intervention Data
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Drugs |
| Non-Parkinson's Disease Medication Log |
68KB DOC |
HTML |
| Parkinson's Disease Medication Log |
81KB DOC |
HTML |
| Surgeries and Other Procedures |
| Functional Neurosurgery |
114KB DOC |
HTML |
Back to top
Protocol Experience
The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Safety Data
The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Outcomes and End Points
NOTE: The CDEs from copyright-protected measures are intentionally excluded from this site. Please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Outcomes and End Points
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
| Quality of Life |
| Parkinson's Impact Scale (PIMS) |
39KB DOC |
HTML |
| Quality of Life Summary Statement |
59KB DOC |
N/A |
| Quality of Life Recommended Instruments spreadsheet |
89KB XLS |
N/A |
| Quality of Life Recommended Instruments table |
84KB DOC |
N/A |
| 36-Item Short Form Health Survey (SF-36) |
127KB DOC |
HTML |
| World Health Organization Quality of Life Assessment (WHOQOL-BREF) |
66KB PDF |
HTML |
| Scales for Outcomes in PD-Psycological (SCOPA-PS) |
81KB PDF |
HTML |
Back to top
Prospective Assessments for Suicidality
Investigators should use the Columbia Suicide Severity Rating Scale (C-SSRS) (available
at
http://www.cssrs.columbia.edu, see additional C-SSRS information for
background materials provided to the NINDS CDE project by Dr. Posner) or another
instrument that maps to the Columbia Classification Algorithm for Suicide Assessment
(C-CASA) (Posner et al. 2007).
Posner, K, MA Oquendo, M Gould, B Stanley, and M Davies, 2007, Columbia Classification
Algorithm of Suicide Assessment
(C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk
Analysis of Antidepressants, Am J Psychiatry, 164:1035-1043.
Accessibility Statement
The NINDS CDE Team has requested, and in many cases received, permission to post
proprietary instruments/scales recommended by the CDE Working Groups to this site.
When permission is granted, the documents are posted in the exact format they were
received in order to maintain the validity of the instrument. If approval is not
granted for the instrument to be reproduced on this site, with the author/copyright
holder’s permission, a link is posted to an external Web site where users can get
more information about the instrument. If you have difficulty accessing either the
proprietary instruments/scales or the external links, please contact the
NINDS CDE Project Officer, Joanne Odenkirchen.
Download readers:
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
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- Epidemiology/Environment
- Psychiatry
- Functional Neurosurgery
- Other Non-Motor
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- Quality of Life
- Operations
- Cognitive
- Scale Metrics and Statistics
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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.
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.
Working Group Co-Chairs
- Karl Kieburtz, MD, MPH - University of Rochester
- Caroline Tanner, MD - The Parkinson’s Institute
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Cognitive Subgroup
- Karen Marder, MD, MPH - Columbia University Medical Center, Chair
- David Burn, MD - Newcastle University
- Irene Litvan, MD - University of Louisville
- Laurie Ryan, PhD - National Institute on Aging, Ad hoc member
- Nina Silverberg, PhD - National Institute on Aging, Ad hoc member
- Glenn Stebbins, PhD - Rush University Medical Center
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Epidemiology and Environment Subgroup
- Webster Ross, MD - Pacific Health Research Institute, Chair
- Alberto Ascherio, MD, DrPh - Harvard School of Public Health
- Yoav Ben-Shlomo, MD, PhD - University of Bristol
- Cindy Lawler, PhD - National Institute of Environmental Health Sciences, Ad hoc member
- Connie Marras, MD, PhD - University of Toronto
- David Thurman, MD, MPH - Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion
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Functional Neurosurgery Subgroup
- Mahlon DeLong, MD - Emory University, Chair
- Guenther Deuschl, MD - University of Hospital Kiel
- Jaimie Henderson, MD - Stanford University School of Medicine
- Andres Lozano, MD, PhD - University of Toronto
- Kelly Lyons, PhD - University of Kansas Medical Center
- Philip Starr, MD - University of California, San Francisco
- Jerrold Vitek, MD, PhD - Cleveland Clinic
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General and Motor Subgroup
- Tony Lang, MD - University of Toronto, Chair
- Piu (Bill) Chan, MD - Capital Medical University
- Stanley Fahn, MD - Columbia University Medical Center
- Christopher Goetz, MD - Rush University Medical Center
- Werner Poewe, MD - Medical University of Innsbruck
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Genetics Subgroup
- Tatiana Foroud, PhD - Indiana University School of Medicine, Chair
- Susan Bressman, MD - Albert Einstein College of Medicine
- Rod Corriveau, PhD - Coriell Institute for Medical Research, Ad hoc member
- Matt Farrer, PhD - Mayo Clinic
- Andy Singleton, PhD - National Institutes for Aging
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Imaging Subgroup
- Ken Marek, MD - Institute for Neurodegenerative Disorders, Chair
- David Brooks, MD, DSc - Imperial College
- Andrew Feigin, MD - New York University School of Medicine
- Wayne Martin, MD - University of Alberta
- Joel Perlmutter, MD - Washington University
- Michael Schocke, MD - Medical University Innsbruck
- Klaus Seppi, MD - Medical University Innsbruck
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Neuropathology Subgroup
- Dennis Dickson, MD - Mayo Clinic Florida, Chair
- Irina Alafuzoff, MD, PhD - Uppsala University
- John Duda, MD - Philadelphia VA Medical Center
- Jean-Paul Vonsattel, MD - Columbia University
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Operations Subgroup
- Cornelia Kamp, MBA - University of Rochester, Chair
- Cynthia Casaceli, MBA - University of Rochester
- Donald Grosset, MD - University of Glasgow
- Christine Hunter, RN, CCRC - Baylor College of Medicine
- Walter Kukull, PhD - National Alzheimer's Coordinating Center
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Other Non-Motor Subgroup
- Ron Pfeiffer, MD - University of Tennessee, Chair
- Marian Evatt, MD - Emory University School of Medicine
- Hubert Fernandez, MD - University of Florida
- Bob van Hilten, MD, PhD - Leiden University Medical Center
- Ron Postuma, MD - Montreal General Hospital
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Psychiatry Subgroup
- Daniel Weintraub, MD - University of Pennsylvania, Chair
- Laura Marsh, MD - Baylor College of Medicine
- William McDonald, MD - Emory University School of Medicine
- Matthew Menza, MD - Robert Wood Johnson Medical School
- Bernard Ravina, MD - University of Rochester
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Scale Metrics and Statistics Subgroup
- Jordan Elm, PhD - Medical University of South Carolina, Chair
- Gary Cutter, PhD - University of Alabama Birmingham
- Bruce Levin, PhD - Columbia University
- Pablo Martinez-Martin, MD, PhD - National Center for Epidemiology, ISCIII
- David Oakes, PhD - University of Rochester
- Patrick Shrout, PhD - New York University
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Quality of Life Subgroup
- Andrew Siderowf, MD - University of Pennsylvania, Chair
- Cindy Nowinski, MD, PhD - NorthShore University
- Annette Schrag, MD - Royal Free and University College
- Lisa Shulman, MD - University of Maryland
- Mickie Welsh, RN, DNSc - University of Southern California
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NINDS CDE Team
- Tiffany Abushaikha - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
- Wendy Galpern, MD, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Lisa Hunegs, MSW, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Kristy Miller, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Christina You, MSPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
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Note: Institutions for all individuals acknowledged in this section
were those they belonged to when they joined the Working Group. All Working Group
members were asked to voluntarily disclose all potential sources of bias in their
involvement with the NINDS CDE Project. The summary disclosure information is available
upon request by contacting NINDSCommonData@kai-research.com.
|
The NINDS Common Data Element Project is committed to creating useful tools for
the neurological research community. To send questions, comments, or concerns regarding
the Project, please fill out the form below.
Thank you in advance for your feedback!
Required fields are marked with
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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.
No updates have been made at this time.