Pediatric anesthesia & critical care
Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent
Authors' conclusion
Personal public disclosure supports patient/family autonomy within an EFIC trial; however, this approach is limited by low cost-effectiveness, feasibility and appropriateness in many circumstances.
Study context
- Population
- Families of children and young adults <26 years receiving care in medical and medical/surgical PICUs at an academic children's hospitalcontacted over 16 months
- Participants
- 1,577 families
- Outcome
- Opt-out after personal public disclosure, and enrolment among patients with the emergent event
- Follow-up
- 16-month period
Methodological detailssingle-centre
- Single-centre
Main finding
As reported in the abstract
- Potentially eligible patients/families contacted for personal public disclosure
- 1577
- Opted out of future participation
- 473 (30%)
- Patients developing the emergent event of interest
- 64
- Enrolled among those with the event
- 9 (14%)
- Agreed to continue in data collection after notification of enrolment
- 9 (100%)
- Missed enrolments due to event before personal public disclosure completed
- 38 (69%) of 55
Original publication
Personal Public Disclosure: A New Paradigm for Meeting Regulatory Requirements Under Exception From Informed Consent. Crit Care Med. Published 12 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →