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IMPACT: International Mission for Prognosis and Analysis of Clinical Trials in TBI

A project focused on advancing knowledge of prognosis, trial-design and treatment in TBI. IMPACT has * developed and validated prognostic models for classification and characterization of TBI series * participated in the development of standardization of data collection in TBI studies (common data elements). * provided evidence based recommendations for improving sensitivity and efficiency of trials in TBI IMPACT will * Continue its research efforts towards provision of further evidence in support of efforts to improve treatment. * Advise and assist in the development of clinical research programs, investigating new treatments for TBI which could lead to better patients outcomes. IMPACT was initially funded from 2003-2006 (IMPACT I) and focused on methodology to deal with the heterogeneity of the population and included extensive prognostic analyses. IMPACT I established the IMPACT database and development of prognostic models necessary for relating final outcome to initial prognostic risk. We found that a relative trial size reduction of up to 50% can be achieved with covariate adjustment and by applying innovative statistical approaches, which exploit the ordinal nature of the Glasgow Outcome Scale (GOS). These include proportional odds analysis and applying the concept of the sliding dichotomy, in which the split for dichotomizing the GOS is differentiated according to baseline prognostic risk (Murray et al 2005). Continuation funding (IMPACT II) was obtained for the period 2007-2011. In IMPACT II, we expanded the IMPACT database, including data from a mega trial and from more recent studies which contain the Extended GOS (GOSE), an endpoint of presumed increased sensitivity. Impact II focuses on: * center effects and variations in patient management (specific aim 2) * sensitivity of outcome measures (specific aim 3) as related to statistical power * the choice (specific aim 4) between a mega trial (with large numbers of patients, substantial heterogeneity, and simple outcome measures) and a conventional trial (with fewer patients, less heterogeneity among centers, and more complex outcome measures) Access to the IMPACT database will be limited to use via on site facilities in the participating institutes in order to guarantee confidentiality to the original stakeholders. Relatively simple analyses, requested by other investigators, will be run by our research staff. For more complex analyses, we will provide on site access to the database and will provide appropriate support where required. Full documentation on the content and structure of the IMPACT database will be made available. If significant time and effort is required from our research staff, costs will have to be charged to investigators requesting analyses with the IMPACT database. These procedures will become operational following completion of the expanded IMPACT database on TBI, which is foreseen by the end of 2008. The procedures outlined above are consistent with the NIH-concept of a data enclave, and are in our opinion, best suited for encouraging and facilitating further scientific work, whilst maintaining appropriate confidentiality for the original stakeholders. All data contained within the IMPACT database on TBI are anonymized, and thus aspects of patient confidentiality are maintained.

URL: http://www.tbi-impact.org/

Resource ID: nlx_143883     Resource Type: Resource     Version: Latest Version

Keywords

traumatic brain injury, common data element, clinical research, treatment, head injury, data set, randomized controlled trial, one mind tbi, brain, clinical trial

Additional Resource Types

topical portal, international standard specification, database

Species

human

Publication Link

http://www.tbi-impact.org/documents/design.pdf

Abbreviation

IMPACT

Synonyms

TBI-IMPACT, International Mission for Prognosis and Analysis of Clinical Trials in TBI

Parent Organization

Funding Information

NIH, NINDS, NS 042691

Related Disease

Traumatic brain injury

Supercategory

Resource

Original Submitter

Anonymous

Version Status

Curated

Submitted On

12:00am December 22, 2011

Originated From

SciCrunch

Changes from Previous Version

First Version

Version 1

Created 3 years ago by Anonymous