BACKGROUND: Concerns have been raised about the enrollment of racial and ethnic minorities in research in the emergency setting when it is not possible to obtain informed consent. However, there is a paucity of data related to the validity of such claims. METHODS: Retrospective comparison of registry enrollment (4/1/2006-3/31/2007) and trial enrollment (4/1/2007-3/31/2008) from three sites in the Resuscitation Outcomes Consortium. Subjects compared met the following criteria: (1) shock, defined by blunt or penetrating force to the body with either systolic blood pressure (SBP) < or =70 mmHg or SBP 71-90 mmHg and heart rate > or =108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score < or =8. RESULTS: Overall, compared to a registry there were no differences in the percent of racial or ethnic groups enrolled in the clinical trial [odds ratio (OR) for Blacks versus Whites: 0.87, 95% confidence interval (CI) 0.65-1.16, p=.34; OR for Hispanics versus Whites 1.04; 95% CI 0.72-1.49, p=.85]. However, Blacks were less likely than Whites to be enrolled in the TBI cohort [OR 0.58 (0.34-0.97), p=.04]. CONCLUSIONS: Despite some discordance in subgroups, there was no overall difference in the racial and ethnic distribution of subjects enrolled in a multi-center clinical trial of severe trauma compared to a registry accounting for study entry criteria. These findings help address justice concerns about enrollment of racial and ethnic minorities in trauma research performed using an exception from informed consent under emergency circumstances.
BACKGROUND: Concerns have been raised about the enrollment of racial and ethnic minorities in research in the emergency setting when it is not possible to obtain informed consent. However, there is a paucity of data related to the validity of such claims. METHODS: Retrospective comparison of registry enrollment (4/1/2006-3/31/2007) and trial enrollment (4/1/2007-3/31/2008) from three sites in the Resuscitation Outcomes Consortium. Subjects compared met the following criteria: (1) shock, defined by blunt or penetrating force to the body with either systolic blood pressure (SBP) < or =70 mmHg or SBP 71-90 mmHg and heart rate > or =108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score < or =8. RESULTS: Overall, compared to a registry there were no differences in the percent of racial or ethnic groups enrolled in the clinical trial [odds ratio (OR) for Blacks versus Whites: 0.87, 95% confidence interval (CI) 0.65-1.16, p=.34; OR for Hispanics versus Whites 1.04; 95% CI 0.72-1.49, p=.85]. However, Blacks were less likely than Whites to be enrolled in the TBI cohort [OR 0.58 (0.34-0.97), p=.04]. CONCLUSIONS: Despite some discordance in subgroups, there was no overall difference in the racial and ethnic distribution of subjects enrolled in a multi-center clinical trial of severe trauma compared to a registry accounting for study entry criteria. These findings help address justice concerns about enrollment of racial and ethnic minorities in trauma research performed using an exception from informed consent under emergency circumstances.
Authors: Daniel P Davis; Lisa A Garberson; Douglas L Andrusiek; David Hostler; Mohamud Daya; Ronald Pirrallo; Alan Craig; Shannon Stephens; Jonathan Larsen; Alexander F Drum; Raymond Fowler Journal: Prehosp Emerg Care Date: 2007 Oct-Dec Impact factor: 3.077
Authors: Juan Carlos Arango-Lasprilla; Mitchell Rosenthal; John Deluca; Eugene Komaroff; Mark Sherer; David Cifu; Robin Hanks Journal: Brain Inj Date: 2007-06 Impact factor: 2.311
Authors: Shahzeer Karmali; Kevin Laupland; A Robert Harrop; Christi Findlay; Andrew W Kirkpatrick; Brent Winston; John Kortbeek; Lindsay Crowshoe; Morad Hameed Journal: CMAJ Date: 2005-04-12 Impact factor: 8.262
Authors: Graham Nichol; Judy Powell; Lois van Ottingham; Ron Maier; Tom Rea; Jim Christenson; Al Hallstrom Journal: Resuscitation Date: 2006-09 Impact factor: 5.262
Authors: David Wendler; Raynard Kington; Jennifer Madans; Gretchen Van Wye; Heidi Christ-Schmidt; Laura A Pratt; Otis W Brawley; Cary P Gross; Ezekiel Emanuel Journal: PLoS Med Date: 2005-12-06 Impact factor: 11.069
Authors: Jose-Miguel Yamal; Claudia S Robertson; M Laura Rubin; Julia S Benoit; H Julia Hannay; Barbara C Tilley Journal: Clin Trials Date: 2014-04 Impact factor: 2.486
Authors: Dorothy F Edwards; Ravi Menon; Ali Fokar; Christopher Gibbons; Jeffrey Wing; Brisa Sanchez; Chelsea S Kidwell Journal: J Health Care Poor Underserved Date: 2013-02
Authors: Neal W Dickert; Victoria A Mah; Michelle H Biros; Deneil M Harney; Robert Silbergleit; Jeremy Sugarman; Emir Veledar; Kevin P Weinfurt; David W Wright; Rebecca D Pentz Journal: Crit Care Med Date: 2014-02 Impact factor: 7.598
Authors: Audrey L Blewer; Shaun K McGovern; Robert H Schmicker; Susanne May; Laurie J Morrison; Tom P Aufderheide; Mohamud Daya; Ahamed H Idris; Clifton W Callaway; Peter J Kudenchuk; Gary M Vilke; Benjamin S Abella Journal: Circ Cardiovasc Qual Outcomes Date: 2018-08