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What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?
  1. P-A Abboud1,*,
  2. K Heard2,*,
  3. A A Al-Marshad3,
  4. S R Lowenstein2
  1. 1Department of Emergency Medicine, Kaiser Permanente Oakland Medical Center, Oakland, California, USA
  2. 2Division of Emergency Medicine, University of Colorado School of Medicine, The Denver Health Residency in Emergency Medicine, Denver, Colorado, USA
  3. 3George Washington University School of Medicine, Washington DC, USA
  1. Correspondence to:
 Dr Kennon Heard
 Division of Emergency Medicine, University of Colorado School of Medicine, The Denver Health Residency in Emergency Medicine, 4200 E 9th Ave B215, Denver, CO 80262, USA; Kennon.heard{at}uchsc.edu

Abstract

Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.

Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to (1) receive a new drug outside of a study, (2) receive a new drug as part of a study and (3) participate in a randomised controlled trial (RCT) for a new drug. Patients were also asked about participation in studies of invasive procedures.

Results: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug (χ2 test for trend, p<0.001 for both settings). Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter (p = 0.008 for the geriatric clinic, p = 0.01 for the emergency department). Willingness to participate was not associated with trust in the doctors.

Conclusions: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent.

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Footnotes

  • * PAA and KH share first authorship on this manuscript.

  • Funding: This work was supported in part by the 2002 American Geriatric Society/Society for Academic Emergency Medicine Geriatric Resident Research Grant (PAA). KH was supported by a Jahnigen Career Development Scholars Award from the American Geriatric Society.

  • Competing interests: None declared.

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