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.
-
Recommended Instruments spreadsheets with details (descriptions,
scoring, references, etc.) for all recommended proprietary instruments/scales/tests.
If proprietary instruments/scales/tests are made available for use, they are populated
in the table below.
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/Subject Characteristics
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Participant/Subject Characteristics
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Demographics |
Demographics
|
66KB DOC |
HTML |
|
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Participant/Subject History and Family History
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Disease/Injury Related Events
Disease/Injury Related Events
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
History of Disease/Injury Event |
Medical History of Parkinson's Disease
|
97KB DOC |
HTML |
|
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Assessments and Examinations
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Assessments and Examinations
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Laboratory Tests and Biospecimens/Biomarkers |
Coriell's Parkinsonism Data Elements
|
Coriell  |
N/A |
|
Imaging Diagnostics |
Imaging Guidelines for CDE Use
|
82KB DOC |
N/A |
|
MR
|
76KB DOC |
HTML |
|
MRI and Spectroscopy
|
77KB DOC |
HTML |
|
PET-SPECT
|
91KB DOC |
HTML |
|
Other Clinical Data |
Neuropathology
|
253KB DOC |
HTML |
|
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Treatment/Intervention Data
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Treatment/Intervention Data
CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Drugs |
Non-Parkinson's Disease Medication Log
|
57KB DOC |
HTML |
|
Parkinson's Disease Medication Log
|
86KB DOC |
HTML |
|
Surgeries and Other Procedures |
Functional Neurosurgery
|
116KB DOC |
HTML |
|
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Protocol Experience
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Safety Data
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Outcomes and End Points
The CDEs from copyright-protected measures are intentionally excluded from this site unless permission was received from the copyright holder. If the measure is not included, 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 |
© or TM |
Summary of All Outcome Recommendations |
PD CDE Instrument Recommendations by Outcome Domain and Classification
|
470KB XLS |
N/A |
|
Cognitive |
Cognitive Guidelines for CDE Use
|
67KB DOC |
N/A |
|
Addenbrooke's Cognitive Examination (ACE-R)
|
308KB PDF |
HTML |
|
Scales for Outcomes in PD-Cognitive (SCOPA-Cog)
|
38KB PDF |
HTML |
|
Short Portable Mental Status Questionnaire (SPMSQ)
|
20KB PDF |
HTML |
|
Motor Function |
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
|
353KB PDF |
HTML |
|
Unified Parkinson's Disease Rating Scale (UPDRS)
|
1378KB PDF |
HTML |
|
Other Non-Motor |
Other Non-motor Guidelines for CDE Use
|
282KB DOC |
HTML |
|
Berlin Questionnaire
|
39KB PDF |
HTML |
|
Brief Pain Inventory (Short Form)
|
71KB PDF |
HTML |
|
Cambridge-Hopkins Restless Legs Syndrome (CH-RLSQ)
|
146KB PDF |
HTML |
|
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 |
|
Insomnia Severity Index (ISI)
|
25KB PDF |
HTML |
|
Mini Nutritional Assessment (MNA)
|
68KB PDF |
HTML |
|
Multiple Sleep Latency Test (MSLT) and Guidelines
|
2296KB PDF |
N/A |
|
NMS Questionnaire (NMS-Quest)
|
30KB PDF |
HTML |
|
Non-Motor Symptom assessment scale for Parkinson's Disease (NMSS)
|
12KB PDF |
HTML |
|
Parkinson's Disease Sleep Scale (PDSS)
|
17KB PDF |
HTML |
|
Quality of Life in Swallowing Disorders (SWAL-QOL)
|
124KB PDF |
HTML |
|
Rome III Constipation Module
|
226KB PDF |
HTML |
|
Scales for Outcomes in PD-Autonomic (SCOPA-Aut)
|
42KB PDF |
HTML |
|
Scales for Outcomes in PD-Sleep (SCOPA-Sleep)
|
84KB PDF |
HTML |
|
Sialorrhea Clinical Scale for PD (SCS-PD)
|
29KB DOC |
HTML |
|
Sleep Apnea Scale of Sleep Disorders Questionnaire (SA-SDQ)
|
52KB DOC |
HTML |
|
Stanford Sleepiness Scale (SSS)
|
20KB PDF |
HTML |
|
STOP Questionnaire
|
58KB PDF |
HTML |
|
Survey Screen for Sleep Apnea (SSSA)
|
55KB DOC |
HTML |
|
Swallowing Disturbance Questionnaire (SDQ)
|
73KB DOC |
HTML |
|
Psychiatric and Psychological Functions |
Psychiatric and Psychological Function Guidelines for CDE Use
|
72KB DOC |
N/A |
|
Apathy Scale (AS)
|
50KB DOC |
HTML |
|
Brief Psychiatric Rating Scale (BPRS)
|
16KB PDF |
HTML |
|
Gambling Symptom Assessment Scale (G-SAS)
|
29KB PDF |
HTML |
|
Geriatric Depression Scale (GDS)
|
23KB PDF |
HTML |
|
Hamilton Anxiety Rating Scale (HAM-A)
|
56KB PDF |
HTML |
|
Hamilton Depression Rating Scale (HDRS)
|
61KB PDF |
HTML |
|
Proposed Criteria for Diagnosis of the Syndrome of Apathy
|
32KB DOC |
N/A |
|
Questionnaire about Buying Behavior
|
59KB DOC |
HTML |
|
Questionnaire for Impulsive-Compulsive Behaviors in Parkinson's Disease (QUIP) (Long form)
|
73KB PDF |
HTML |
|
Questionnaire for Impulsive-Compulsive Behaviors in Parkinson's Disease (QUIP) (Short form)
|
69KB PDF |
HTML |
|
Scale for the Assessment of Positive Symptoms (SAPS)
|
66KB PDF |
HTML |
|
Sexual Compulsivity Scale (SCS)
|
77KB PDF |
HTML |
|
South Oaks Gambling Screen (SOGS)
|
37KB DOC |
HTML |
|
Structured Clinical Interview for Pathological Gambling (SCI-PG)
|
1194KB PDF |
HTML |
|
Quality of Life |
Quality of Life Guidelines for CDE Use
|
109KB DOC |
N/A |
|
36-Item Short Form Health Survey (SF-36)
|
127KB DOC |
HTML |
|
Parkinson's Impact Scale (PIMS)
|
39KB DOC |
HTML |
|
Parkinson's Disease Quality of Life Scale (PDQUALIF)
|
642KB PDF |
HTML |
|
Scales for Outcomes in PD-Psychological (SCOPA-PS)
|
81KB PDF |
HTML |
|
World Health Organization Quality of Life Assessment (WHOQOL-BREF)
|
66KB PDF |
HTML |
|
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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
|
- 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.
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
- Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA
- Wendy Galpern, MD, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joshua Hagel - The EMMES Corporation, Rockville, Maryland, USA
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Pamela West - The EMMES Corporation, 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 NINDSCDE@emmes.com.