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  1. 1. NINDS Common Data Element (CDE) Project
  2. 2. 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. What is the CDE Project?
  3. 3. Stop re-inventing the wheel reduce the time needed to develop data collection elements and tools 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 is this needed? Reduces Time and Money
  4. 4. 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 Specific expertise (statistician and programmer) time requirement will be shortened Why? Data Quality
  5. 5. 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
  6. 6. Why? Allows for Further Research 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
  7. 7. 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
  8. 8. Why? Help Investigators CDEs can be used for planning clinical research projects 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. 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 Help new investigators in the development and design of their clinical research project
  10. 10. 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 Significance? Scientific Community Buy-in
  11. 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) Not duplicate efforts (e.g. TBI collaboration with DOD, VA, NCRR, etc..) 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
  12. 12. Why NINDS Should Do 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
  13. 13. What diseases/disorders are we working on? “General” Core Common Data Elements TBI (completed in Feb 2010) Stroke (completed in summer 2010) Epilepsy (completed in Feb 2010) Others (CMD, HD) FTD PD (completed in summer 2010) SCI (6 domains completed in Feb/Mar 2010)
  14. 14. Guiding Principles for CDEs  Use of CDEs is not a requirement but compatibility is  CDEs do not include all variables a clinical study will need to collect  There are CDEs that apply to all studies no matter what neurologic disease or disorder and then there are CDEs for specific diseases  CDE selection process should be as transparent as possible  NINDS CDE project attempts to harmonize, or at least be compatible with, other important clinical data standards where feasible and prudent (CDISC, caBIG, etc.)
  15. 15. “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) Data elements for a particular disease can be classified as: Coriell Forms
  16. 16. General CDEs General CDE materials are available on the NINDS CDE Web site ( Data dictionaries Template data collection forms Manuals of Procedures (MOPs) General CDEs include:  Demographic Information: Age Race Ethnicity Education level  Modified Rankin Scale and Trail Making Test*  Adverse events data  Concomitant medications data  Medical history data
  17. 17. Basic Search Advanced Search Acknowledgements 10 CDE Recommendations Domain Sub- Domain CDE Classifi- cation CDE Name CDE Location CDE Definition CDE Code List CDE Details Short Name: Data Type: Length: ….. Comments/Special Instructions: Short Name: Data Type: Length: ….. Comments/Special Instructions: Short Name: Data Type: Length: ….. Comments/Special Instructions: ….. ….. ….. ….. ….. ….. ….. ….. ….. 18
  18. 18. Sample list of available elements: Adverse Events
  19. 19. Common Data Element Case Report Form (CRF)
  20. 20. General CDE Oversight Committee 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) 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
  21. 21. Disease Specific CDEs  Currently working with Program Directors and Working Groups of experts to develop CDEs for several disease areas  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
  22. 22. CDE Project Timeline
  23. 23. Epilepsy CDE Working Group Chairs: 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
  24. 24. Epilepsy CDE Working Group Chairs: 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
  25. 25. Stroke CDE Working Group Chair: 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
  26. 26. Stroke CDE Working Group Chair: 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
  27. 27. Parkinson’s Disease (PD) CDE Working Group Chairs: 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
  28. 28. Parkinson’s Disease (PD) CDE Working Group Chairs: 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
  29. 29. Neuroimaging Gerald Riedy (Chair) Jeff Bazarian Dave Brody Tom DeGraba Tina Duhaime Tim Duncan Elie Elovic 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 Surreya Dikmen 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 Mieke Verfaellie M. Wainwright David Wright
  30. 30. 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
  31. 31. 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
  32. 32. What’s Next? / Future Plans Core “General” common Data Elements TBI Stroke Epilepsy Others HD, CMD FTD Parkinson’s SCI • Dissemination of information •NINDS Leadership and Program Directors •CDE working group members •Website •Flyers at meetings •Newsletter •E-blasts •Posters and presentations •Scientific publications • Collaboration with other NINDS staff, disease groups and outside organizations
  33. 33. NINDS CDE Web site: ( 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