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  • 1. NINDS Common Data Element (CDE) Project http://www.nindscommondataelements.org/
  • 2. What is the CDE Project?
    It is the identification and standardization by the scientific community of commonly used data elements (CDE) and case report forms (CRF).
    Then taking these CDEs and CRFs and putting them in a systematic format and posting them on a public website for all to use.
  • 3. Why is this needed?
    Reduces Time and Money
    Stop re-inventing the wheel
    • reduce the time needed to develop data collection elements and tools
    • 4. clinical trials take 6- 9 months to get up and going one reason is the development of the case report forms and the study database, the CDEs will reduce the time and money needed
  • Why?
    Data Quality
    Increase data quality
    • Less chance of data errors; because of the ability to have data in a standard format with data range check there is less likelihood of error thus quality will be higher and QA/QC may take less time
    • 5. Specific expertise (statistician and programmer) time requirement will be shortened
  • Why?
    Promotes Collaboration
    Investigators cannot make use of data from other studies if it is in a different format, the CDEs will:
    • promote data collection in a similar manner
    Even simple data collection elements such as gender can be coded differently (M/F or 1 /2 or 0/1) another example DOB (mm-dd-yyyy or dd-mm-yyyy); and the ability to look at different data sets with different definitions and codes is difficult and time consuming
    • facilitate data sharing and meta analysis
  • Why?
    Allows for FurtherResearch Opportunities for Investigators
    The ability to mine the data within and between studies is greater if the data is in standard format, this will allow the investigators to perform secondary analysis of associations, risk factors, etc.. – there is an unlimited opportunity
  • 6. Why?
    More Cost Savings
    Ability to reallocate resources from database and case report form activities to patient care and other clinical costs associated with clinical research
  • 7. Why?
    Help Investigators
    • CDEs can be used for planning clinical research projects
    • 8. Excel clinical research planning
    Use of data from other studies can be used to help design other studies and if it is in a common format the ability to use the data is made much easier (for example one can use placebo or historical data from one study to help define or estimate treatment effect for future studies)
  • 9. Why?
    Provide a Resource to the Community
    • Neurologic diseases are largely rare diseases and by having resources available for the community to use those who work with these groups will be able to spend time helping the patient and conducting research activities not developing forms
    • 10. Help new investigators in the development and design of their clinical research project
  • Significance?
    Scientific Community Buy-in
    Experts in the disease area are responsible for the development and vetting of the common data elements; NINDS facilitates and posts the recommendations but does not influence the process
  • 11. Why is this important to NINDS?
    Collaboration
    The CDEs have provided NINDS an opportunity to work with other NIH, DHHS, and federal agencies, not for profit organizations, foundations, and national/international organizations, as well as the scientific community. To date we have work collaboratively in the development and distribution of the CDEs by:
    • Expediting the process (e.g. taking the ASIA and ISCOS standards and data sets for spinal cord injury and mapping them into the CDEs; currently we have international buy-in for 6 data sets and working on 3 more)
    • 12. Not duplicate efforts (e.g. TBI collaboration with DOD, VA, NCRR, etc..)
    • 13. Work with other standardization projects such as CDISC and CaBIG to insure compatibility; discussions are underway regarding NINDS CDEs being added to these data standard projects. This may have a huge impact for studies under an FDA IND or IDE as data from these studies will need to be in CDISC HL7 format
  • Why NINDS ShouldDo This?
    • NIH Policy on Data Sharing
    All studies are responsible for sharing their data
    NINDS want to have the highest quality data and have it available for sharing; in clinical studies as in basic research, it is important that data is accurate and in a common language so that data can be shared
    • NINDS owes this to the public and study participants, a moral obligation, to ensure that NINDS data sets are compatible so that they are shared
  • What diseases/disorders are we working on?
    TBI
    (completed in Feb 2010)
    Epilepsy
    (completed in Feb 2010)
    Others
    (CMD, HD)
    “General” Core Common Data Elements
    SCI
    (6 domains completed in Feb/Mar 2010)
    FTD
    Stroke
    (completed in summer 2010)
    PD
    (completed in summer 2010)
  • 14. Guiding Principles for CDEs
    • Use of CDEs is not a requirement but compatibility is
    • 15. CDEs do not include all variables a clinical study will need to collect
    • 16. There are CDEs that apply to all studies no matter what neurologic disease or disorder and then there are CDEs for specific diseases
    • 17. CDE selection process should be as transparent as possible
    • 18. NINDS CDE project attempts to harmonize, or at least be compatible with, other important clinical data standards where feasible and prudent (CDISC, caBIG, etc.)
  • Data elements for a particular disease can be classified as:
    “General” Core Common Data Elements (CDEs)
    Disease-specific Core CDEs
    (should be used in all studies)
    Disease-specific CDEs
    (extended set that are “common” not “core”)
    Other Disease-specific Data Elements
    (Not part of the CDEs but may be in future)
    Coriell Forms
  • 19. General CDEs
    General CDE materials are available on the NINDS CDE Web site (www.nindscommondataelements.org):
    • Data dictionaries
    • 20. Template data collection forms
    • 21. Manuals of Procedures (MOPs)
    General CDEs include:
    • Demographic Information:
    • 22. Age
    • 23. Race
    • 24. Ethnicity
    • 25. Education level
    • 26. Modified Rankin Scale and Trail Making Test*
    • 27. Adverse events data
    • 28. Concomitant medications data
    • 29. Medical history data
  • 30. CDE Recommendations
    Basic Search
    Advanced Search
    Disease:
    Domain:
    Classification:
    Sub-Domain:
    Key word search:
    Location:
    Pediatrics?
    Search
    Reset
    Acknowledgements
    TBI -> Outcomes -> Global Outcomes -> Core/Basic -> Pediatrics = No
    10
    18
  • 31. Sample list of available elements: Adverse Events
  • 32. Common Data Element Case Report Form (CRF)
  • 33. General CDE Oversight Committee
    NINDS Staff Ad Hoc Members:
    Representation from the Disease Areas
    Brandy Fureman, PhD – Epilepsy
    Wendy Galpern, MD, PhD - Parkinson’s
    Ramona Hicks, PhD – TBI
    Scott Janis, PhD – Stroke
    Naomi Kleitman, PhD – SCI
    Laura Mamounas, PhD – Genetics Repository
    Marg Sutherland, PhD - FTD
    Steve Warach, MD, PhD - Stroke
    Petra Kaufmann, MD, MS – Associate Director, OCR
    Walter Koroshetz, MD – Deputy Director, NINDS
    Joanne Odenkirchen, MPH – CDE Project Director
    NINDS CDE Project Team:
    Joanne Odenkirchen, MPH – NINDS KAI Project Officer
    Kristy Miller, MPH – KAI
    Stacie Trollinger, MS – KAI
    Members:
    Rod Corriveau, PhD (Coriell)
    Gary Cutter, PhD (UAB)
    Yang Fann, PhD (NINDS Intramural)
    Irene Katzan, MD, MS (Cleveland Clinic)
    Chelsea Kidwell, MD (Georgetown)
    Karl Kieburtz, MD, MPH (Rochester)
    Roger Kurlan, MD (Rochester)
    Andrew Maas, MD, PhD (U. Antwerp)
    Yuko Palesch, PhD (MUSC)
    Ralph Sacco, MD, MS (U. Miami)
    Barbara Tilley, PhD (UTSPH)
  • 34. Disease Specific CDEs
    • Currently working with Program Directors and Working Groups of experts to develop CDEs for several disease areas
    • 35. Disease-specific CDEs will be added to the NINDS CDE Web site as they are developed and vetted through the working groups made up of community experts
  • CDE Project Timeline
  • 36. Epilepsy CDE Working GroupChairs: Drs. Nick Barbaro and Dan Lowenstein
    AEDs and other Anti Epileptic Treatments subgroup:
    Jackie French, MD – Chair
    Peggy Clark, RN, MSN
    Jim Cloyd, PharmD
    Tracy Glauser, MD
    Nina Graves, PharmD
    Dan Lowenstein, MD
    Gerry Nesbitt, MBA
    Seizures and Symptoms subgroup:
    Dale Hesdorffer, PhD – Chair
    Anne Berg, PhD
    Jackie French, MD
    W. Allen Hauser, MD
    Shlomo Shinnar, MD, PhD
    David Thurman, MD
    Electrophysiology subgroup:
    Anne Van Cott, MD – Chair
    Dennis Dlugos, MD
    William Gaillard, MD
    Gerry Nesbitt, MBA
    Imaging subgroup
    William Gaillard, MD – Chair
    Nick Barbaro, MD
    Greg Barkley, MD
    Robert Knowlton, MD, MSPH
    Ruben Kuzniecky, MD
    Neuropsychology subgroup:
    David Loring, PhD – Chair
    Avital Cnaan, PhD
    Marla Hamberger, PhD
    Bruce Hermann, PhD
    John Langfitt, PhD
  • 37. Epilepsy CDE Working GroupChairs: Drs. Nick Barbaro and Dan Lowenstein(continue)
    Neurological Exam subgroup:
    Dennis Dlugos, MD, MSCE - Chair
    Peggy Clark, RN, MSN
    Dan Lowenstein, MD
    Christine O’Dell, RN, MSN
    David Thurman, MD
    Mariann Ward, MS, NP
    Quality of Life subgroup:
    Joan Austin, DNS, RN, FAAN – Chair
    David Cella, PhD
    Avital Cnaan, PhD
    Kristen Fowler, MA
    Marla Hamberger, PhD
    John Langfitt, PhD
    Christine O’Dell, RN, MSN
    Surgery and Pathology subgroup:
    Steve Roper, MD- Chair
    Nick Barbaro, MD
    Robert Fisher, MD, PhD
    Sam Wiebe, MD
    Comorbidities subgroup:
    Bruce Hermann, PhD – Chair
    Joan Austin, DNS, RN, FAAN
    Anne Berg, PhD
    Kristen Fowler, MA
    Tracy Glauser, MD
    W. Allen Hauser, MD
    Dale Hesdorffer, PhD
    Curt LaFrance, MD
    Ruth Ottman, PhD
    Shlomo Shinnar, MD
  • 38. Stroke CDE Working GroupChair: Dr. Jeff Saver
    Stroke Presentation subgroup:
    Lee Schwamm, MD – Chair
    Mark Chimowitz, MD
    Lisa El-Hakam, MD
    Heather Fullerton, MD
    Judy Guzy, RN
    S. Clay Johnson, MD
    David Levy, MD
    James Meschia, MD
    Medical History and Prior Health Status subgroup:
    Oscar Benavente, MD – Chair
    Deborah Attix, PhD
    Richard Benson, MD
    Lisa Davis, RN, MSN, CCRC
    Mitchell Elkind, MD
    Heather Fullerton, MD
    Mary George, MD, MSPH, FACS
    George Howard, DrPH
    Irene Katzan, MD
    Warren Lo, MD
    Stroke Types and Subtypes subgroup:
    Joseph Broderick, MD – Chair
    Hakan Ay, MD
    Tim Bernard, MD
    Robert Brown, MD
    Louis Caplan, MD
    Rebecca Ichord, MD
    J.P. Mohr, MD
    Hospital Course and Acute Therapy subgroup:
    Karen Johnston, MD – Chair
    Kyra Becker, MD
    Joseph Broderick, MD
    Colin Derdeyn, MD
    Gabrielle deVeber, MD
    Mary George, MD, MSPH, FACS
    David Hanley, MD
    Kennedy Lees, MD
    Stephan Mayer, MD
    Lee Schwamm, MD
    Mark Wainwright, MD
  • 39. Stroke CDE Working GroupChair: Dr. Jeff Saver(continue)
    Long Term Therapies subgroup:
    Alexander Dromerick, MD - Chair
    Oscar Benavente, MD
    Robert Brown, MD
    Mark Chimowitz, MD
    Pamela Duncan, MD
    Neil Friedman, MD
    J.P. Mohr, MD
    Mubeen Rafay, MD
    Cathy Sila, MD
    Outcomes subgroup:
    Pamela Duncan, MD – Chair
    Deborah Attix, PhD
    Lisa Davis, RN, MSN, CCRC
    William Dunn, JR. MD
    Allen Heinemann, PhD
    George Howard, Dr PH
    Rebecca Ichord, MD
    Kennedy Lees, MD
    Mark MacKay, MD
    Yuko Palesch, PhD
    Cathy Sila, MD
    Michael Walker, MD
    Imaging subgroup:
    Chelsea Kidwell, MD – Chair
    Rand Askalan, MD
    Hakan Ay, MD
    Colin Derdeyn, MD
    Michael Dowling, MD
    Edward Feldmann, MD
    Daniel Hanley, MD
    Pooja Khatri, MD
    Stephan Mayer, MD
    Biospecimens/Biomarkers subgroup:
    James Meschia, MD – Chair
    Jennifer Armstrong- Wells, MD
    Rod Corriveau, PhD*
    Bruce Coull, MD
    Mitchel Elkind, MD
    Karen Furie, MD
    Edward Jauch, MD
    Kate Lefond, MD
    Alex Rai, PhD
    Laboratory Tests and Vital Signs subgroup:
    Kyra Becker, MD – Chair
    Rod Corriveau, PhD*
    Judy Guzy, RN
    S. Clay Johnson, MD
    Steve Pavlakis, MD
    John Strouse, MD
    Mark Wainwright, MD
    * Ad hoc member
  • 40. Parkinson’s Disease (PD) CDE Working GroupChairs: Drs. Karl Kieburtz and Caroline Tanner
    General and Motor subgroup:
    Tony Lang, MD - Chair
    Stan Fahn, MD
    Chris Goetz, MD
    Piu (Bill) Chan, MD
    Werner Poewe, MD
    Psychiatry:
    Dan Weintraub, MD - Chair
    Laura Marsh, MD
    William McDonald, MD
    Matt Menza, MD
    Bernard Ravina, MD
    Imaging subgroup:
    Ken Marek, MD - Chair
    David Brooks, MD, DSc
    Andrew Feigin, MD
    Joel Perlmutter, MD
    Cognitive subgroup:
    Karen Marder, MD, MPH - Chair
    David Burn, MD
    Irene Litvan, MD
    Laurie Ryan, PhD*
    Nina Silverberg, PhD*
    Glenn Stebbins, PhD
    Neuropathology subgroup:
    Dennis Dickson, MD – Chair
    Irina Alafuzoff, MD, PhD
    John Duda, MD
    Jean-Paul Vonsattel, MD
    Genetics subgroup:
    Tatiana Foroud, PhD – Chair
    Susan Bressman, MD
    Rod Corriveau, PhD*
    Matt Farrer, PhD
    Andy Singleton, PhD
    * Ad hoc member
  • 41. Parkinson’s Disease (PD) CDE Working GroupChairs: Drs. Karl Kieburtz and Caroline Tanner(continued)
    Epidemiology/Environment subgroup:
    Web Ross, MD – Chair
    Alberto Ascherio, MD, DrPH
    Yoav Ben-Shlomo, MD, PhD
    Cindy Lawler, PhD*
    Connie Marras, MD, PhD
    David Thurman, MD, MPH
    Functional Neurosurgery subgroup:
    Jerrold Vitek, MD, PhD - Chair
    Mahlon Delong, MD
    Guenther Deuschl, MD
    Jaimie Henderson, MD
    Phil Starr, MD
    Andres Lozano, MD, PhD
    Other Non-motor subgroup:
    Ron Pfieffer, MD – Chair
    Hubert Fernandez, MD
    Marian Evatt, MD
    Bob Van Hilten, MD, PhD
    Ron Postuma, MD
    Quality of Life subgroup:
    Andrew Siderowf, MD – Chair
    Cindy Nowinski, MD, PhD
    Annette Schrag, MD
    Lisa Shulman, MD
    Mickie Welsh, RN, DNSc
    Operations subgroup:
    Cornelia Kamp, MBA - Chair
    Cynthia Casaceli, MBA
    Donald Grosset, MD
    Christine Hunter, RN, CCRC
    Walter Kukull, PhD
    Scale Metrics and Statistics subgroup:
    Jordan Elm, PhD - Chair
    Gary Cutter, PhD
    Bruce Levin, PhD
    Pablo Martinez-Martin, MD, PhD
    David Oakes, PhD
    * Ad hoc member
  • 42. TBI CDE Workshop
    March 2009
     
    Neuroimaging
    Gerald Riedy (Chair)
    Jeff Bazarian
    Dave Brody
    Tom DeGraba
    Tina Duhaime
    Tim Duncan
    ElieElovic
    Alisa Gean
    Mark Haacke
    Robin Hurley
    Larry Latour
    David Moore
    P. Mukherjee
    J. Smirniotopoulos
    Doug Smith
    M. Wintermark
     
      
     
    Biomarkers
    Geoff Manley (Chair)
    Mary Brophy
    R. Diaz-Arrastia
    Doortje Engel
    Clay Goodman
    K. Gwinn-Hardy
    Ron Hayes
    Geoff Ling
    Andrew Ottens
    Frank Tortella
    Tim Veenstra
    Interagency
    Ramona Hicks (Chair)
    Theresa Gleason
    Jean Langlois
    Cate Miller
    Karen Schwab
    Nick Szuflita
    V. Thurmond
     
      
    Outcomes
    Gale Whiteneck (Chair)
    Jennifer Bogner
    Tamara Bushnik
    David Cifu
    SurreyaDikmen
    Lou French
    Joe Giacino
    Tessa Hart
    James Malec
    Scott Millis
    Tom Novack
    Alex Ommaya
    Mark Sherer
    David Tulsky
    R. Vanderploeg
    N. Von Steinbuechel
    Demographics
    Andrew Maas (Chair)
    Dave Adelson
    Tom Balkin
    Wayne Gordon
    C.Harrison-Felix
    Jean Langlois
    Henry Lew
    David Menon
    C. Robertson
    Karen Schwab
    Nancy Temkin
    Alex Valadka
    MiekeVerfaellie
    M. Wainwright
    David Wright
     
  • 43. TBI Interagency CDE Planning Committee
    Leighton Chan, MD – NIH
    Tom DeGraba, MD- VA (Navy)
    Ann-Christine Duhaime, MD- Dartmouth- Hitchcock
    Howard Eisenberg, MD- UMD
    Yang Fann, PhD- NINDS
    Theresa Gleason, PhD- VA
    Ramona Hicks, PhD – NINDS
    Petra Kaufmann, MD, MS - NINDS
    Walter Koroshetz, MD- NINDS
    Larry Latour, PhD- NIH
    Geoff Manley, MD, PhD- UCSF
    Matthew McAuliffe, PhD- NIH
    Cate Miller, PhD- NIDRR
    Joanne Odenkirchen, MPH - NINDS
    Jean Orman, ScD, MPH- VA
    Paul Pasquina, MD- WRAMC
    Gerard Riedy, MD, PhD- WRAMC
    Karen Schwab, PhD- DCoE
    Sunil Sen-Gupta, PhD- VA
  • 44. SCI CDE Working Group
    Core Working Group Membership:
    Executive Committee for the International Spinal Cord Injury Standards and Data Sets:
    Fin Biering-Sorensen, MD
    Susie Charlifue, PhD
    Michael Devivo, DrPH
    Naomi Kleitman, PhD – NINDS
    Joanne Odenkirchen, MPH – NINDS
    Stacie Trollinger, MS – KAI
    Yun Lu, PhD – KAI
    SCI – CDE meeting that was held September 23, 2009 at the ASIA Annual Meeting:
    Volker Dietz, MD
    Robert Grossman, MD
    Ralph Marino, MD
    Vanessa Noonan, MSc, PT
    Marcel Post, PhD
    Marca Sipski, MD
    Thomas Stripling
    Larry Vogel, MD
    Peter Wing, MD
  • 45. What’s Next? / Future Plans
    • Dissemination of information
    • 46. NINDS Leadership and Program Directors
    • 47. CDE working group members
    • 48. Website
    • 49. Flyers at meetings
    • 50. Newsletter
    • 51. E-blasts
    • 52. Posters and presentations
    • 53. Scientific publications
    • 54. Collaboration with other NINDS staff, disease groups and outside organizations
  • CDE Project Team
    Joanne Odenkirchen, MPH – NINDS CDE Project Officer
    Stacie Grinnon, MS* Co-Project Manager for CDE Project
    Kristy Miller, MPH* – Co-Project Manager for CDE Project
    Yun Lu, PhD* – Technical Lead for CDE Project
    * From KAI Research, Inc., NINDS contractor assisting with the CDE Project
    NINDS CDE Web site: (www.nindscommondataelements.org)
  • 55. Questions?