DOI: 10.1161/circ.148.suppl_1.342 ISSN: 0009-7322

Abstract 342: Willingness to Participate in an Active Pediatric Critical Care Interventional Trial Using Exception From Informed Consent

Catherine E Ross, Muhammad Asad, Robert A Berg, Monica E Kleinman, Michael Donnino
  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Introduction: Emergency interventional trials using Exception From Informed Consent (EFIC) are rare, but pooled survey data preceding 27 EFIC studies show that 73% of respondents were willing to be enrolled in the associated trial. However, given the hypothetical nature of these surveys, the actual rate of willingness to participate in an active EFIC trial and any associations with demographic characteristics are unknown.

Aims: To 1) compare the actual rate of willingness to participate in an EFIC trial with that from previously published hypothetical surveys for the same trial; and 2) describe demographic characteristics associated with actual willingness rates.

Hypothesis: We hypothesized that the actual rate of willingness to participate in an EFIC trial would be lower than the hypothetical survey rate.

Methods: From April 13 to June 5, 2023, we attempted to notify all eligible patients/families of an active EFIC trial enrolling in our PICU and gave them the option to opt out from enrollment. Responses were recorded, and patient demographics were abstracted from the medical record. Major exclusion criteria were age over 25 years and state custody. Surveys were performed prior to trial initiation with a similar screening process. Likert scale responses for willingness to participate were dichotomized.

Results: Of 207 families contacted, 149 (72%) were willing to participate in the trial which was similar to our pre-trial survey data (43/58 [74%]; p = 0.87). Willingness rates varied by race category (Asian 5/5, 100%; Black 8/18, 44%; Hispanic 22/33, 67%; White 66/84, 79%; Other 12/20 60%; Unknown 36/47, 77%; p = 0.03) but not patient age (willing, median 5 years [IQR 1, 13] vs not willing, median 7 years [IQR 1,4]; p=0.84).

Conclusion: The actual rate of willingness to participate in an EFIC trial in the PICU was similar to the hypothetical rate reported in pre-trial survey data, suggesting surveys may reasonably reflect attitudes of potential participants. Willingness rates varied by race, though a significant proportion of data was missing. Reasons for racial differences in research engagement should be explored to better understand the consequences of long-standing structural racism in the US and the impact on future trial participation for these groups.

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