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pdfNINDS Common Data Elements (CDE) Survey
General information
OMB # 0925-0678
Expiration Date: 08/2016
Public reporting burden for this collection of information is estimated to average 10 minutes per
response, including the time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information. An
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burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-0678). Do not return the completed form to this
address.
Background
The NINDS Common Data Elements (CDE) Project was launched in 2005 with the primary goal to
develop data standards for clinical research involving neurological disorders so that data are
captured consistently across different studies. In addition to one set of general CDEs that are
applicable to all neurology studies, 18 disease-specific sets of CDEs have been developed through
the program. NINDS is interested in getting feedback from the community based on their experience
with CDEs so that we can assess how well the current program is meeting the needs of clinical
researchers.
Why you should participate
The information we collect from this survey will help give NINDS a clearer picture of the research
community’s perspectives on the current NINDS CDEs. This survey will help define future strategies
related to the development and maintenance of NINDS CDEs, and identify opportunities to enhance
the project’s impact on clinical research for neurological disorders. Participation in this survey is
voluntary and should only take 10 minutes to complete.
* 1. What neurological disease or condition best describes the primary focus of your clinical research?
1
* 2. Have you used any NINDS CDEs or served on any committees related to the development of NINDS
CDEs?
I have used NINDS CDEs and was involved in NINDS CDE development
I have used NINDS CDEs
I served on an NINDS CDE development working group
I have no experience with NINDS CDEs
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NINDS Common Data Elements (CDE) Survey
Participants with NINDS CDE experience & development
* 3. Below is a list of NINDS CDEs that are currently available to the research community. Please indicate
which set(s) are relevant to your area(s) of research, and which set(s) you have used. You do not need to
make a selection for those that are not relevant to your research area.
relevant, but have not used
relevant and have used
General
Amyotrophic Lateral
Sclerosis
Epilepsy
Friedreich's Ataxia
Headache
Huntington's Disease
Mitochondrial Disease
Multiple Sclerosis
Neuromuscular
Diseases
Congenital Muscular
Dystrophy
Myasthenia Gravis
Spinal Muscular
Atrophhy
Parkinson's Disease
Spinal Cord Injury
Stroke
Traumatic Brain Injury
3
* 4. What was your role in the research study or studies that used CDEs? Check all that apply.
Trial PI
Site PI
Co-investigator
Colleague/Collaborator
Project Coordinator
Data management role
Other (please specify)
* 5. What type of clinical study did you use NINDS CDEs with?
Observational / cohort study (including epidemiology, genetics, biomarkers, etc)
Human subjects basic research study (e.g. small hypothesis-generating studies not classified as clinical trials)
Exploratory clinical trials (including Phase I/II trials, or other early stage clinical trial)
Phase III clinical trial
Other (please specify)
* 6. How did you become aware of the NINDS CDEs?
Scientific meeting
NINDS staff/Program Director
NINDS website
NLM website
NINDS FOA
Other (please specify)
4
7. What were the primary reasons you chose to use CDEs for your study?
* 8. Were there any disadvantages to using the NINDS CDEs?
Yes
No
If yes, what were they? (e.g. difficulty incorporating necessary forms, lacked important data elements, increased effort to develop
databases...)
* 9. One goal of the CDE program is to provide data collection tools to facilitate efficient study start up. Did
access to the NINDS CDEs make it easier to set up the data collection processes for your study?
Yes
No
Please explain whether/how the CDE tools influenced efficiency of study start-up processes:
* 10. How would you rate the overall level of effort/burden associated with using the CDEs in your research
study, as compared to your previous experiences with non-CDE studies?
More effort, highly
burdensome
More effort, burdensome
More effort but
manageable
Similar amount of effort
Less effort
Comments:
5
* 11. Do you agree that NINDS CDEs are or could be a valuable resource for the neuroscience community?
Strongly Disagree
Disagree
Undecided
Agree
Strongly Agree
Comments:
* 12. The process of achieving community consensus on common data elements for a whole field of
research is challenging. Keeping in mind the complex nature of such an effort, how efficient do you feel the
process was for initial development of the CDEs for your research area?
Very inefficient
Inefficient
Neutral opinion
Efficient
Highly efficient
Comments:
13. Updating the CDEs is an important process for ensuring the CDEs are optimized and reflect the state
of the science. How frequently do you think the NINDS CDEs should be reviewed and what factors should
determine when a topic gets updated?
14. Do you have any additional suggestions for ways to improve the CDE development or review process?
15. Broad awareness and buy-in among the research community is key to realizing the long-term benefits
of common data elements. Do you believe there is broad awareness of the NINDS CDEs in your research
field, and do you believe there is wide buy-in of the concept? Why/why not?
6
NINDS Common Data Elements (CDE) Survey
Participants with NINDS CDE experience
* 16. Below is a list of NINDS CDEs that are currently available to the research community. Please indicate
which set(s) are relevant to your area(s) of research, and which set(s) you have used. You do not need to
make a selection for those that are not relevant to your research area.
relevant, but have not used
relevant and have used
General
Amyotrophic Lateral
Sclerosis
Epilepsy
Friedreich's Ataxia
Headache
Huntington's Disease
Mitochondrial Disease
Multiple Sclerosis
Neuromuscular
Diseases
Congenital Muscular
Dystrophy
Myasthenia Gravis
Spinal Muscular
Atrophhy
Parkinson's Disease
Spinal Cord Injury
Stroke
Traumatic Brain Injury
7
* 17. What was your role in the research study or studies that used CDEs? Check all that apply.
Trial PI
Site PI
Co-investigator
Colleague/Collaborator
Project Coordinator
Data management role
Other (please specify)
* 18. What type of clinical study did you use NINDS CDEs with?
Observational / cohort study (including epidemiology, genetics, biomarkers, etc)
Human subjects basic research study (e.g. small hypothesis-generating studies not classified as clinical trials)
Exploratory clinical trials (including Phase I/II trials, or other early stage clinical trial)
Phase III clinical trial
Other (please specify)
* 19. How did you become aware of the NINDS CDEs?
Scientific meeting
NINDS staff/Program Director
NINDS website
NLM website
NINDS FOA
Other (please specify)
8
20. What were the primary reasons you chose to use CDEs for your study?
* 21. Were there any disadvantages to using the NINDS CDEs?
Yes
No
If yes, what were they? (e.g. difficulty incorporating necessary forms, lacked important data elements, increased effort to develop
databases...)
* 22. One goal of the CDE program is to provide data collection tools to facilitate efficient study start up. Did
access to the NINDS CDEs make it easier to set up the data collection processes for your study?
Yes
No
Please explain whether/how the CDE tools influenced efficiency of study start-up processes:
* 23. How would you rate the overall level of effort/burden associated with using the CDEs in your research
study, as compared to your previous experiences with non-CDE studies?
More effort, highly
burdensome
More effort, burdensome
More effort but
manageable
Similar amount of effort
Less effort
Comments:
9
* 24. Do you agree that NINDS CDEs are or could be a valuable resource for the neuroscience community?
Strongly Disagree
Disagree
Undecided
Agree
Strongly Agree
Comments:
10
NINDS Common Data Elements (CDE) Survey
Participants involved in NINDS CDE development
* 25. The process of achieving community consensus on common data elements for a whole field of
research is challenging. Keeping in mind the complex nature of such an effort, how efficient do you feel the
process was for initial development of the CDEs for your research area?
Very inefficient
Inefficient
Neutral opinion
Efficient
Highly efficient
Comments:
26. Updating the CDEs is an important process for ensuring the CDEs are optimized and reflect the state
of the science. How frequently do you think the NINDS CDEs should be reviewed and what factors should
determine when a topic gets updated?
27. Do you have any additional suggestions for ways to improve the CDE development or review process?
28. Broad awareness and buy-in among the research community is key to realizing the long-term benefits
of common data elements. Do you believe there is broad awareness of the NINDS CDEs in your research
field, and do you believe there is wide buy-in of the concept? Why/why not?
11
NINDS Common Data Elements (CDE) Survey
Experience with non-NINDS CDEs
* 29. Have you used any other (non-NINDS) CDEs? Examples include topic-specific CDEs from other NIH
Institutes, or data elements that are required for specific research activities (e.g. FDA CDISC). Please
mark all that you have used.
I have not used other CDEs
Asthma CDEs
cLBP
EDRN
eyeGENE
GRDR
Neuro-QOL
NIDA EHR
NIH Toolbox
PhenX
PROMIS
CDEs provided by a society or foundation
Other (please specify)
* 30. Are you likely to use NINDS CDEs in future studies (if available for the particular topic under study)?
Yes
No
NINDS-funded studies:
Non-NINDS funded
studies:
Why or why not?
12
* 31. In general, do you think CDEs have the potential to (check all that apply):
improve data quality
enable data sharing
facilitate more meta-analyses
lead to improved quality or validity in systematic reviews
none of the above
Other (please specify)
32. Are there any comments or suggestions you would like to provide to help NINDS improve the CDE
program’s processes, products, or overall impact on the research community?
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NINDS Common Data Elements (CDE) Survey
No experience with NINDS CDEs
* 33. What was your reason for not using NINDS CDEs? Check all that apply.
not aware of them
no disease specific CDEs available for field of study
inconvenient
did not capture data needed
Other (please specify)
* 34. Have you used any other (non-NINDS) CDEs? Examples include topic-specific CDEs from other NIH
Institutes, or data elements that are required for specific research activities (e.g. FDA CDISC). Please
mark all that you have used.
I have not used other CDEs
Asthma CDEs
cLBP
EDRN
eyeGENE
GRDR
Neuro-QOL
NIDA EHR
NIH Toolbox
PhenX
PROMIS
CDEs provided by a society or foundation
Other (please specify)
14
* 35. Are you likely to use NINDS CDEs in future studies (if available for the particular topic under study)?
Yes
No
NINDS-funded studies:
Non-NINDS funded
studies:
Why or why not?
* 36. In general, do you think CDEs have the potential to (check all that apply):
improve data quality
enable data sharing
facilitate more meta-analyses
lead to improved quality or validity in systematic reviews
none of the above
Other (please specify)
37. Are there any comments or suggestions you would like to provide to help NINDS improve the CDE
program’s processes, products, or overall impact on the research community?
15
| File Type | application/pdf |
| File Title | View Survey |
| File Modified | 0000-00-00 |
| File Created | 2016-04-11 |