The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent

Joshua G. Salzman, Ralph J. Frascone, Nathan Burkhart, Richard Holcomb, Sandi S. Wewerka, Robert A. Swor, Brian D. Mahoney, Marvin A. Wayne, Robert M. Domeier, Michael Olinger, Tom P. Aufderheide, Keith G. Lurie

Research output: Contribution to journalArticle

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Abstract

Objectives Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. Methods This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group. Results Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95% confidence interval [CI] = 1.73 to 5.75; OR = 7.64, 95% CI = 2.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent (OR = 1.86, 95% CI = 1.17 to 2.95; OR = 4.52, 95% CI = 2.21 to 9.26, respectively). Conclusions Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.

Original languageEnglish (US)
Pages (from-to)347-353
Number of pages7
JournalAcademic Emergency Medicine
Volume22
Issue number3
DOIs
StatePublished - Mar 1 2015

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Out-of-Hospital Cardiac Arrest
Heart Arrest
Informed Consent
Nervous System
Health Status
Odds Ratio
Survival
Confidence Intervals
Medical Records
Ventricular Fibrillation
Ventricular Tachycardia
Demography
Patient Advocacy
Research Ethics Committees
Documentation
Biomedical Research
Emergencies
Multivariate Analysis
Logistic Models
Research Personnel

ASJC Scopus subject areas

  • Emergency Medicine
  • Medicine(all)

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The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent. / Salzman, Joshua G.; Frascone, Ralph J.; Burkhart, Nathan; Holcomb, Richard; Wewerka, Sandi S.; Swor, Robert A.; Mahoney, Brian D.; Wayne, Marvin A.; Domeier, Robert M.; Olinger, Michael; Aufderheide, Tom P.; Lurie, Keith G.

In: Academic Emergency Medicine, Vol. 22, No. 3, 01.03.2015, p. 347-353.

Research output: Contribution to journalArticle

Salzman, JG, Frascone, RJ, Burkhart, N, Holcomb, R, Wewerka, SS, Swor, RA, Mahoney, BD, Wayne, MA, Domeier, RM, Olinger, M, Aufderheide, TP & Lurie, KG 2015, 'The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent', Academic Emergency Medicine, vol. 22, no. 3, pp. 347-353. https://doi.org/10.1111/acem.12613
Salzman, Joshua G. ; Frascone, Ralph J. ; Burkhart, Nathan ; Holcomb, Richard ; Wewerka, Sandi S. ; Swor, Robert A. ; Mahoney, Brian D. ; Wayne, Marvin A. ; Domeier, Robert M. ; Olinger, Michael ; Aufderheide, Tom P. ; Lurie, Keith G. / The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent. In: Academic Emergency Medicine. 2015 ; Vol. 22, No. 3. pp. 347-353.
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abstract = "Objectives Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. Methods This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group. Results Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6{\%}). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96{\%}) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95{\%} confidence interval [CI] = 1.73 to 5.75; OR = 7.64, 95{\%} CI = 2.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent (OR = 1.86, 95{\%} CI = 1.17 to 2.95; OR = 4.52, 95{\%} CI = 2.21 to 9.26, respectively). Conclusions Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.",
author = "Salzman, {Joshua G.} and Frascone, {Ralph J.} and Nathan Burkhart and Richard Holcomb and Wewerka, {Sandi S.} and Swor, {Robert A.} and Mahoney, {Brian D.} and Wayne, {Marvin A.} and Domeier, {Robert M.} and Michael Olinger and Aufderheide, {Tom P.} and Lurie, {Keith G.}",
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T1 - The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent

AU - Salzman, Joshua G.

AU - Frascone, Ralph J.

AU - Burkhart, Nathan

AU - Holcomb, Richard

AU - Wewerka, Sandi S.

AU - Swor, Robert A.

AU - Mahoney, Brian D.

AU - Wayne, Marvin A.

AU - Domeier, Robert M.

AU - Olinger, Michael

AU - Aufderheide, Tom P.

AU - Lurie, Keith G.

PY - 2015/3/1

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N2 - Objectives Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. Methods This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group. Results Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95% confidence interval [CI] = 1.73 to 5.75; OR = 7.64, 95% CI = 2.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent (OR = 1.86, 95% CI = 1.17 to 2.95; OR = 4.52, 95% CI = 2.21 to 9.26, respectively). Conclusions Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.

AB - Objectives Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. Methods This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group. Results Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95% confidence interval [CI] = 1.73 to 5.75; OR = 7.64, 95% CI = 2.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent (OR = 1.86, 95% CI = 1.17 to 2.95; OR = 4.52, 95% CI = 2.21 to 9.26, respectively). Conclusions Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.

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