Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?

Jeremy Sugarman, Colleen Sitlani, Dug Andrusiek, Tom Aufderheide, Eileen M. Bulger, Daniel P. Davis, David B. Hoyt, Ahamed Idris, Jeffrey D. Kerby, Judy Powell, Terri Schmidt, Arthur S. Slutsky, George Sopko, Shannon Stephens, Carolyn Williams, Graham Nichol

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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) ≤70 mmHg or SBP 71-90 mmHg and heart rate ≥108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score ≤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.

Original languageEnglish (US)
Pages (from-to)644-649
Number of pages6
JournalResuscitation
Volume80
Issue number6
DOIs
StatePublished - Jun 2009

Fingerprint

Emergencies
Blood Pressure
Registries
Odds Ratio
Informed Consent
Research
Clinical Trials
Confidence Intervals
Wounds and Injuries
Social Justice
Coma
Hispanic Americans
Ethnic Groups
Resuscitation
Shock
Heart Rate
Head
Traumatic Brain Injury

Keywords

  • Clinical trials
  • Exemption from consent
  • Race and ethnicity
  • Research ethics
  • Research in the emergency setting
  • Subject selection
  • Trauma

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Emergency
  • Emergency Medicine

Cite this

Sugarman, J., Sitlani, C., Andrusiek, D., Aufderheide, T., Bulger, E. M., Davis, D. P., ... Nichol, G. (2009). Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable? Resuscitation, 80(6), 644-649. https://doi.org/10.1016/j.resuscitation.2009.03.015

Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable? / Sugarman, Jeremy; Sitlani, Colleen; Andrusiek, Dug; Aufderheide, Tom; Bulger, Eileen M.; Davis, Daniel P.; Hoyt, David B.; Idris, Ahamed; Kerby, Jeffrey D.; Powell, Judy; Schmidt, Terri; Slutsky, Arthur S.; Sopko, George; Stephens, Shannon; Williams, Carolyn; Nichol, Graham.

In: Resuscitation, Vol. 80, No. 6, 06.2009, p. 644-649.

Research output: Contribution to journalArticle

Sugarman, J, Sitlani, C, Andrusiek, D, Aufderheide, T, Bulger, EM, Davis, DP, Hoyt, DB, Idris, A, Kerby, JD, Powell, J, Schmidt, T, Slutsky, AS, Sopko, G, Stephens, S, Williams, C & Nichol, G 2009, 'Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?', Resuscitation, vol. 80, no. 6, pp. 644-649. https://doi.org/10.1016/j.resuscitation.2009.03.015
Sugarman, Jeremy ; Sitlani, Colleen ; Andrusiek, Dug ; Aufderheide, Tom ; Bulger, Eileen M. ; Davis, Daniel P. ; Hoyt, David B. ; Idris, Ahamed ; Kerby, Jeffrey D. ; Powell, Judy ; Schmidt, Terri ; Slutsky, Arthur S. ; Sopko, George ; Stephens, Shannon ; Williams, Carolyn ; Nichol, Graham. / Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?. In: Resuscitation. 2009 ; Vol. 80, No. 6. pp. 644-649.
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abstract = "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) ≤70 mmHg or SBP 71-90 mmHg and heart rate ≥108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score ≤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.",
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AU - Sitlani, Colleen

AU - Andrusiek, Dug

AU - Aufderheide, Tom

AU - Bulger, Eileen M.

AU - Davis, Daniel P.

AU - Hoyt, David B.

AU - Idris, Ahamed

AU - Kerby, Jeffrey D.

AU - Powell, Judy

AU - Schmidt, Terri

AU - Slutsky, Arthur S.

AU - Sopko, George

AU - Stephens, Shannon

AU - Williams, Carolyn

AU - Nichol, Graham

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N2 - 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) ≤70 mmHg or SBP 71-90 mmHg and heart rate ≥108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score ≤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.

AB - 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) ≤70 mmHg or SBP 71-90 mmHg and heart rate ≥108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score ≤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.

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KW - Research ethics

KW - Research in the emergency setting

KW - Subject selection

KW - Trauma

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