Abstract 305: The Patients’ Experiences in Emergency Research (PEER) Study
Resuscitation research requires enrolling patients under an exception from informed consent (EFIC), but there remains ethical controversy and confusion about EFIC regulations. One concern is that patients may find enrollment unacceptable, but no study has systematically assessed views and experiences of patients enrolled in an EFIC study. The “Patients’ Experiences in Emergency Research (PEER)” study addresses this gap.
PEER was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) of pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees (or surrogates) from 5 sites. Interviewers used a structured interactive guide containing open and closed-ended questions focusing on views of personal and general acceptability of EFIC enrollment in RAMPART and existing regulatory protections. Closed-ended responses were directly coded. Simple descriptive and bivariate statistics were generated, consistent with our hypothesis-generating goals. Textual data were analyzed for common themes and to contextualize the data.
24 patients and 37 surrogates were interviewed. Two interviews were incomplete. 49 (82%) subjects were glad they (or family member) were included in RAMPART; 54 (92%) felt research on emergency seizure treatment is important. 43 (72%) found their inclusion in RAMPART under EFIC acceptable. 10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant demographic associations with enrollment attitudes. In textual analysis, 24 (41%) subjects expressed concern about absence of consent; 11 (19%) felt they were not told enough about the study. Positive responses mostly related to perceived medical benefits (53%) from RAMPART and trust in doctors/researchers (25%). More than a quarter had difficulty understanding concepts of clinical trials and EFIC.
Most subjects had positive views of their enrollment in RAMPART. A significant number were concerned about absence of consent, and many had difficulty understanding EFIC and clinical research. These approval rates cohere with data from other populations. They are largely reassuring but suggest the importance of post-enrollment communication.
- © 2012 by American Heart Association, Inc.