The DOI matches its Crossref record; 40 of the 40 references it cites were found in a registry or an index.
Prognosis and Clinical Trial Design in Traumatic Brain Injury: The IMPACT Study
Abstract
Traumatic brain injury (TBI) is a major health and socio-economic problem throughout the world. Many randomized controlled trials (RCTs) have been performed to investigate the effectiveness of new therapies, but none have convincingly demonstrated benefit. Clinical trials in TBI pose complex methodological challenges and meeting these requires new approaches. The challenges are related to the heterogeneity of head injuries, to optimum analysis of outcome and to aspects of the design of trials. To address these, we have created the IMPACT database on TBI through merging individual patient data from eight RCTs and three observational surveys. This database forms a culture medium in which innovative approaches to improving trial design and analysis are being explored. We hypothesize that the statistical power of TBI trials may be increased by adjusting for heterogeneity with covariate adjustment and/or prognostic targeting, by exploiting the ordinal nature of the Glasgow Outcome Scale and by relating the outcome obtained in individual patients to their baseline prognostic risk. Extensive prognostic analysis was required as a first step towards our aim of optimizing the chance of demonstrating benefit of new therapies in future trials. The fruits of this analysis are reported in detail in the subsequent reports in this issue of the Journal of Neurotrauma. The results will lead to the development and validation of new prognostic models, which will be applied to deal with heterogeneity. The findings will be synthesized into recommendations for the design and analysis of future RCTs, with the expectation of increasing the likelihood of demonstrating the benefit of a truly effective new therapy or therapeutic agent in victims of a head injury.
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Cites
Moderate and severe traumatic brain injury in adults
Maas, A. I., Stocchetti, N., & Bullock, R. (2008) · The Lancet Neurology · doi:10.1016/s1474-4422(08)70164-9 · Cited by 2,123
Self-citation(1999) · doi:10.1097/00001199-199912000-00009 · Cited by 1,387
Lack of Effect of Induction of Hypothermia after Acute Brain Injury
Clifton, G. L., Miller, E. R., Choi, S. C., Levin, H. S., McCauley, S., Smith, K. R., Muizelaar, J. P., Wagner, F. C., Marion, D. W., Luerssen, T. G., et al. (2001) · New England Journal of Medicine · doi:10.1056/nejm200102223440803 · Cited by 1,382
The epidemiology of traumatic brain injury: a review
Bruns, J., & Hauser, W. A. (2003) · Epilepsia · doi:10.1046/j.1528-1157.44.s10.3.x · Cited by 1,271
Classification of traumatic brain injury for targeted therapies
Saatman, K. E., Duhaime, A.-C., Bullock, R., Maas, A. I. R., Valadka, A., & Manley, G. T. (2008) · Journal of Neurotrauma · doi:10.1089/neu.2008.0586 · Cited by 1,141
Self-citationClinical trials in head injury
Narayan, R. K., Michel, M. E., Ansell, B., Baethmann, A., Biegon, A., Bracken, M. B., Bullock, M. R., Choi, S. C., Clifton, G. L., Contant, C. F., et al. (2002) · Journal of Neurotrauma · doi:10.1089/089771502753754037 · Cited by 913 · cited 2×
“Most involved pharmacologic agents; none have demonstrated a convincing benefit in the overall TBI population (Maas et al., 1999; Narayan et al., 2002).”
Self-citationPrevention of secondary ischemic insults after severe head injury
Robertson, C. S., Valadka, A. B., Hannay, H. J., Contant, C. F., Gopinath, S. P., Cormio, M., Uzura, M., & Grossman, R. G. (1999) · Critical Care Medicine · doi:10.1097/00003246-199910000-00002 · Cited by 748
Multivariable Prognostic Analysis in Traumatic Brain Injury: Results from The IMPACT Study
Murray, G. D., Butcher, I., McHugh, G. S., Lu, J., Mushkudiani, N. A., Maas, A. I. R., Marmarou, A., & Steyerberg, E. W. (2007) · Journal of Neurotrauma · doi:10.1089/neu.2006.0035 · Cited by 631
Self-citation
Cited by
Moderate and severe traumatic brain injury in adults
Maas, A. I., Stocchetti, N., & Bullock, R. (2008) · The Lancet Neurology · doi:10.1016/s1474-4422(08)70164-9 · Cited by 2,123
Self-citationClassification of traumatic brain injury for targeted therapies
Saatman, K. E., Duhaime, A.-C., Bullock, R., Maas, A. I. R., Valadka, A., & Manley, G. T. (2008) · Journal of Neurotrauma · doi:10.1089/neu.2008.0586 · Cited by 1,141
“These results provide an excellent basis for choosing classifiers (Maas et al., 2007; Mur-ray et al., 2007).”
Self-citationBlood–brain barrier breakdown as a therapeutic target in traumatic brain injury
Shlosberg, D., Benifla, M., Kaufer, D., & Friedman, A. (2010) · Nature Reviews Neurology · doi:10.1038/nrneurol.2010.74 · Cited by 897
Prognosis Research Strategy (PROGRESS) 2: Prognostic Factor Research
Riley, R. D., Hayden, J. A., Steyerberg, E. W., Moons, K. G. M., Abrams, K., Kyzas, P. A., Malats, N., Briggs, A., Schroter, S., Altman, D. G., et al. (2013) · PLoS Medicine · doi:10.1371/journal.pmed.1001380 · Cited by 823
Self-citationModulation of immune response by head injury
Morganti-Kossmann, M. C., Satgunaseelan, L., Bye, N., & Kossmann, T. (2007) · Injury · doi:10.1016/j.injury.2007.10.005 · Cited by 412
Metadata
- Authors
- Maas, A. I. R., Marmarou, A., Murray, G. D., Teasdale, S. G. M., & Steyerberg, E. W.
- Venue
- Journal of Neurotrauma
- Publisher
- SAGE Publications
- Published
- 2007-02
- Volume
- 24
- Issue
- 2
- Pages
- 232-238
- ISSN
- 0897-7151 (ISSN-L)
- 1557-9042
- OpenAlex
- W2092241603
- Cited by
- 355
- References
- 40
- FWCI
- 12.49
- Type
- journal article
- Language
- en
- Open access
- closed
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- Maas, A. I. R., Marmarou, A., Murray, G. D., Teasdale, S. G. M., & Steyerberg, E. W. (2007). Prognosis and Clinical Trial Design in Traumatic Brain Injury: The IMPACT Study. Journal of Neurotrauma. https://doi.org/10.1089/neu.2006.0024
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