Spaite, D. W., Spaite, D. W., Bobrow, B. J., Bobrow, B. J., Keim, S. M., Keim, S. M., Smith, J. J., Smith, J. J., Mhayamaguru, K., Mhayamaguru, K., Rice, A., Rice, A., Mullins, T., Mullins, T., Barnhart, B., Barnhart, B., Denninghoff, K. R., Denninghoff, K. R., Viscusi, C. D., , Viscusi, C. D., et al. (2017). Body Temperature after EMS Transport: Association with Traumatic Brain Injury Outcomes. Prehospital Emergency Care, 21(5), 575-582. doi:10.1080/10903127.2017.1308609
Gaither JB, Chikani V, Stolz U, Viscusi C, Denninghoff K, Barnhart B, Mullins T, Rice AD, Mhayamaguru M, Smith JJ, Keim SM, Bobrow BJ, Spaite DW: Body Temperature after EMS Transport: Association with Traumatic Brain Injury Outcomes. Prehosp Emerg Care. 2017 Sep-Oct;21(5):575-582. doi: 10.1080/10903127.2017.1308609. Epub 2017 May 8. PubMed PMID: 28481163; NIH Manuscript System ID: NIHMS910946; PubMed Central PMCID: PMC5638643.
Spaite, D. W., Hu, C., Bobrow, B. J., Chikani, V., Gaither, J. B., Barnhart, B. J., Adelson, P. D., Denninghoff, K. R., Rice, A. D., Mullins, T., Sherrill, D., & Keim, S. M. (2017). Evaluation of the Combined Prehospital Hypoxia-Hypotension “Depth-Duration Dose” and Mortality in Major Traumatic Brain Injury. Circulation.
Spaite DW, Hu C, Bobrow BJ, Chikani V, Gaither JB, Barnhart B, Adelson PD, Denninghoff KR, Rice AD, Mullins T, Sherrill D, Keim SM: Evaluation of the Combined Prehospital Hypoxia-Hypotension “Depth-Duration Dose” and Mortality in Major Traumatic Brain Injury. Circulation 2017
Biros, M. H., Dickert, N. W., Wright, D. W., Scicluna, V. M., Harney, D., Silbergleit, R., Denninghoff, K., & Pentz, R. D. (2015). Balancing ethical goals in challenging individual participant scenarios occurring in a trial conducted with exception from informed consent. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 22(3), 340-6.
In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.
Spaite, D. W., Hu, C., Bobrow, B. J., Chikani, V., Barnhart, B., Gaither, J. B., Denninghoff, K. R., Adelson, P. D., Keim, S. M., Viscusi, C., Mullins, T., & Sherrill, D. (2017). The Effect of Combined Out-of-Hospital Hypotension and Hypoxia on Mortality in Major Traumatic Brain Injury. ANNALS OF EMERGENCY MEDICINE, 69(1), 62-72.
BIO5 Collaborators
Kurt R Denninghoff, Chengcheng Hu
Chikani, V., Spaite, D. W., Smith, J. J., Curry, M., Mhayamagru, M., Barnhart, B. J., Adelson, P. D., Viscusi, C. D., Denninghoff, K. R., Bobrow, B. J., & Gaither, J. B. (2016). Elevated Initial Trauma Center Body Temperatures Are Associated With Poor Non-Mortality Outcomes Following Major Traumatic Brain Injury. Prehospital Emergency Care.