Abstract 178: Patients’ Experiences in Emergency Research- ProTECT Phase (PEER-ProTECT)
Background: Resuscitation research often requires an exception from informed consent (EFIC). Concerns exist regarding patients’ experiences when enrolled in EFIC studies, and it is unclear whether community consultation participants’ views reflect views of enrollees.
Methods: The Patients’ Experiences in Emergency Research- ProTECT (PEER-ProTECT) study was nested within the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) Trial, a placebo-controlled trial of progesterone in traumatic brain injury (TBI). ProTECT III patients or surrogates (if the patient died or could not be interviewed) were enrolled from 12 hub sites. Structured interviews used open and closed-ended questions to explore views and acceptance of EFIC enrollment in ProTECT III. Closed-ended responses were analyzed using simple descriptive and bivariate statistics. Text data were analyzed thematically.
Results: 31 patients and 54 surrogates were interviewed. 71 (84%) subjects were glad they (or their family member) were included in ProTECT III. 66 (78%) found their personal EFIC inclusion acceptable; 4 (5%) found it unacceptable, and 15 (18%) were neutral or uncertain. Female subjects were more likely to agree with their EFIC enrollment (87% vs. 67%, p=0.025). Black subjects were less likely to agree with their EFIC enrollment than white or Hispanic subjects (55% vs. 83% and 100% respectively, p=0.029). There were no significant differences between patients and surrogates. In textual analysis, 26% expressed some concern about EFIC. Positive responses mostly related to potential direct medical benefits (88%), recognition that consent was impractical (39%), low study risks (35%), and desire to contribute to science (32%). Subjects generally accepted placebo use (79%) and randomization (91%).
Conclusions: Most enrollees and surrogates in a placebo-controlled EFIC trial for TBI had positive views of enrollment; approval rates were higher than in a prior study in a prehospital seizure trial and in community consultation reports from ProTECT III. The latter finding suggests that community consultation may underestimate enrollee acceptance. Male and black subjects’ lower acceptance, however, demonstrates some heterogeneity within this population.
- © 2013 by American Heart Association, Inc.