Challenges to effective research in acute trauma resuscitation: Consent and endpoints

John B. Holcomb, Richard Weiskopf, Howard Champion, Steven A. Gould, R. Michelle Sauer, Karen Brasel, Grant Bochicchio, Eileen Bulger, Bryan A. Cotton, Daniel Davis, Richard Dutton, Carl J. Hauser, John R. Hess, George A. Hides, Paula Knudson, Ellen MacKenzie, Robert L. McGinnis, Joel Michalek, Frederick A. Moore, Laurel OmertBradley H Pollock, Bartholomew Tortella, Jeremy Sugarman, Martin A. Schreiber, Charles E. Wade

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the group's concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.

Original languageEnglish (US)
Pages (from-to)107-113
Number of pages7
JournalShock
Volume35
Issue number2
DOIs
StatePublished - Feb 2011
Externally publishedYes

Fingerprint

Resuscitation
Wounds and Injuries
Research
Clinical Trials
Ethicists
National Heart, Lung, and Blood Institute (U.S.)
Hemorrhagic Shock
Drug Industry
Informed Consent
Multicenter Studies
Shock
Epidemiology
Emergencies
Referral and Consultation
Quality of Life
Research Personnel
Guidelines
Physicians
Mortality

Keywords

  • 21CFR50.24
  • composite
  • endpoint
  • surrogate
  • Trauma

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Emergency Medicine

Cite this

Holcomb, J. B., Weiskopf, R., Champion, H., Gould, S. A., Sauer, R. M., Brasel, K., ... Wade, C. E. (2011). Challenges to effective research in acute trauma resuscitation: Consent and endpoints. Shock, 35(2), 107-113. https://doi.org/10.1097/SHK.0b013e3181f7fd01

Challenges to effective research in acute trauma resuscitation : Consent and endpoints. / Holcomb, John B.; Weiskopf, Richard; Champion, Howard; Gould, Steven A.; Sauer, R. Michelle; Brasel, Karen; Bochicchio, Grant; Bulger, Eileen; Cotton, Bryan A.; Davis, Daniel; Dutton, Richard; Hauser, Carl J.; Hess, John R.; Hides, George A.; Knudson, Paula; MacKenzie, Ellen; McGinnis, Robert L.; Michalek, Joel; Moore, Frederick A.; Omert, Laurel; Pollock, Bradley H; Tortella, Bartholomew; Sugarman, Jeremy; Schreiber, Martin A.; Wade, Charles E.

In: Shock, Vol. 35, No. 2, 02.2011, p. 107-113.

Research output: Contribution to journalArticle

Holcomb, JB, Weiskopf, R, Champion, H, Gould, SA, Sauer, RM, Brasel, K, Bochicchio, G, Bulger, E, Cotton, BA, Davis, D, Dutton, R, Hauser, CJ, Hess, JR, Hides, GA, Knudson, P, MacKenzie, E, McGinnis, RL, Michalek, J, Moore, FA, Omert, L, Pollock, BH, Tortella, B, Sugarman, J, Schreiber, MA & Wade, CE 2011, 'Challenges to effective research in acute trauma resuscitation: Consent and endpoints', Shock, vol. 35, no. 2, pp. 107-113. https://doi.org/10.1097/SHK.0b013e3181f7fd01
Holcomb JB, Weiskopf R, Champion H, Gould SA, Sauer RM, Brasel K et al. Challenges to effective research in acute trauma resuscitation: Consent and endpoints. Shock. 2011 Feb;35(2):107-113. https://doi.org/10.1097/SHK.0b013e3181f7fd01
Holcomb, John B. ; Weiskopf, Richard ; Champion, Howard ; Gould, Steven A. ; Sauer, R. Michelle ; Brasel, Karen ; Bochicchio, Grant ; Bulger, Eileen ; Cotton, Bryan A. ; Davis, Daniel ; Dutton, Richard ; Hauser, Carl J. ; Hess, John R. ; Hides, George A. ; Knudson, Paula ; MacKenzie, Ellen ; McGinnis, Robert L. ; Michalek, Joel ; Moore, Frederick A. ; Omert, Laurel ; Pollock, Bradley H ; Tortella, Bartholomew ; Sugarman, Jeremy ; Schreiber, Martin A. ; Wade, Charles E. / Challenges to effective research in acute trauma resuscitation : Consent and endpoints. In: Shock. 2011 ; Vol. 35, No. 2. pp. 107-113.
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