The document discusses the Common Data Elements project which aims to standardize data collection in traumatic brain injury (TBI) research. It describes why standardization is important for increasing study power and enabling data pooling across studies. An example is given of the International Mission on Prognosis and Clinical Trial Design in TBI study which established prognostic standards and improved trial design using standardized data. Working groups developed proposals for standardized elements in domains like demographics, biomarkers, imaging and outcomes. The goal is to facilitate high-quality comparative effectiveness research and clinical trials through consistent, electronic data collection.

1. The Common data elements project Standardization of data collection in TBI NNS 2011 Fort Lauderdale, Florida July 11-13, 2011 Andrew Maas On behalf of the WG demographics and clinical assessments Brain Injury TODAY The common data elements project

2. Why should we standardize data collection? Scientific: Increase comparability between studies “ my patients do better than others!” Individual patient analysis across studies Cost-efficiency: Simplify development of CRF Reduce costs

3. Standardizing data collection in Traumatic Brain Injury Maas et al, 2011, J Neurotrauma, Feb;28(2):177-87 . “ It seems unlikely that we will ever be able to mount adequately-powered trials to study all of the relevant treatment modalities” “ Pooling data from multiple studies (individual patient data analysis), and comparative effectiveness research (CER) utilizing prospective observational data collection, can provide alternative sources of evidence that can be obtained in a more cost-efficient way”

4. An example of the potential for individual patient data analysis: IMPACT I nternational M ission on P rognosis a nd C linical T rial Design in TBI 2003-2011 The problem: Vast heterogeneity of TBI populations Multicentre RCT’s have all failed to demonstrate benefit of promising treatments Database: A culture medium for exploring concepts to improve clinical trials in TBI Global aim: To optimize the design and analysis of clinical trials in TBI, to increase the likelihood of demonstrating benefit of a truly effective new therapy or therapeutic agent.

5. IMPACT results IMPACT: 43 + publications Prognostic standards Trial design and analysis Broad selection Covariate adjustment Ordinal analysis Increase of statistical power by 40-50% Standardisation of data collection www.tbi-impact.org

6. Potential for analysis of efficacy across studies Lipid peroxidation / free radical scavengers Targeting glutamate excitotoxicity Author, year Country Center N Agent Young et al, 1996 USA 29 463 (1562) PEG-SOD Marshall et al, 1998 INT 50 1120 Tirilazad US – Tirilazad, 1991-1994 USA 36 1155 Tirilazad Author, year Country Center N Agent Eliprodil, 1993-1995 EU 20+ 452 Eliprodril Morris et al, 1999 INT 95 693 Selfotel Saphir, 1995-1997 EU 51 924 D-CPP-ene Cerestat, 1996-1997 INT 38 532 Aptiganel Yurkewicz et al , 1998-2001 USA 40 404 CP-101606

7. TBI common data elements project – Interagency workshop March 2009 Working groups: - Demographics & Clinical Assessment - Biomarkers - Neuroimaging - Outcomes - Plus 4 PH groups Classification of data elements as core – supplemental - emerging 9 Publications in APMR in Fall 2010 describe process and results

8. Biospecimens and biomarkers Core elements: - DNA sample for genomic analysis - Acute plasma sample for proteomics/metabolomic analysis Supplemental / emerging: Serial sampling / CSF / Micro dialysis / PBMS’s Processing and handling - acquisition - local processing - local storage - shipping - central storage Note: no recommendations of safety parameters in RCT’s

9. Radiologic imaging Definitions Imaging protocol Flexible, electronic database Core elements: - All prognostic parameters Supplemental / Emerging : - Quantification - Advanced imaging

10. Outcome: recommendations for instruments Domain Instruments Global GOSE Neuropsych RAVLT, TMT, Processing speed Psych BSI-18 Symptoms RPQ Disability FIM: cognitive and motor subscales Social participation CHART-SF Qol SWLS

11. Aim WG: Demographics & Clinical Assessment To develop proposals on selection and coding of data elements for studies across the broad spectrum of TBI.

12. Members WG demographics & clinical assessment David Adelson Phoenix, USA Tom Balkin Washington DC, USA Ross Bullock Miami, USA Doortje Engel Heidelberg, Germany Wayne Gordon New York, USA Cynthia Harrison-Felix Englewood, US Jean Langlois-Orman Houston, USA Henry L. Lew Richmond, USA Andrew Maas Antwerp, Belgium David Menon Cambridge, UK Claudia Robertson Houston, USA Karen Schwab Washington DC, USA Nancy Temkin Seattle, USA Alex Valadka Austin, USA Mieke Verfaillie Boston, USA Mark Wainwright Chicago, USA David Wright Atlanta, USA

13. International experts Giuseppe Citerio Italy Peter Hutchinson UK Bertil Romner Denmark Juan Sahuquillo Spain Franco Servadei Italy Nino Stocchetti Italy

14. The Common Data Elements project Structure Categories Modules Data Elements Basic Intermediate Advanced www.tbi-impact.org Example Participants/subject characteristic Demographics Age/gender/race

15. CDE: 8 categories Participant/subject characteristics Participant and family history Injury/disease related events Assessment and examinations Treatments/interventions Protocol experience Adverse events and safety data

17. Elements and templates

18. Example of data elements for TIL Therapy intensity level (TIL): Basic

19. Therapy intensity level (TIL): Intermediate

20. Structure of templates CDE Variable CDE definition Recommended instrument for assessment Description of measure Permissible values Classification: Basic / Advanced / Extended Procedure Comments / special instructions Rationale /justification References

21. Example of template: age

22. Building a CRF for an acute phase study in severe TBI

23. CDE’s published

24. Current status CDE’s Published Available Work in progress www.tbi-impact.org www.commondataelements.ninds.nih.gov

25. CDE’s: a living organism Refinement: Validation study Track TBI (UCSF) (Inter)national feedback Development electronic format

26. Development electronic format Open source Agreement required on: Data field name Definition XML tag Time tag Downloadable as element with field name tag or available within database structure? “ Federated” database?

27. The case for a new beginning Standardisation essential Global approach Electronics standardisation Facilitates: RCT’s CER Systems biology The war on TBI