Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in
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(2020) 20:76
RESEARCH ARTICLE
Open Access
Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial Insiyah Campwala1, Francis X. Guyette2, Joshua B. Brown1, Peter W. Adams1, Barbara J. Early1, Mark H. Yazer1, Matthew D. Neal1, Brian S. Zuckerbraun1 and Jason L. Sperry1*
Abstract Objectives: With increased focus on early resuscitation methods following injury to improve patient outcomes, studies are employing exception from informed consent (EFIC) enrollment. Few studies have assessed patients’ opinions following participation in an EFIC study, and none have been conducted within the realm of traumatic hemorrhage. We surveyed those patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research. Methods: Telephone calls were made between January–June 2019 to all patients who were enrolled under EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled, May 2014-Oct 2017) and their surrogates. Questions gauging approval of EFIC enrollment were asked before discussion of PAMPer trial outcomes, after disclosure of positive outcomes, and after a hypothetical negative trial outcome was proposed. Results: Of the total 647 telephone calls made, ninety-three interviews, reflecting 70 of 169 patient enrollments, were conducted. This included 13 in which only the patient was interviewed, 23 in which the patient and a surrogate were interviewed, and 34 in which only a surrogate was interviewed. Nearly half (48.4%) of respondents did not recall their personal or family member enrollment in the study. No patients or surrogates recalled hearing about the study through community consultation or being aware of opt out procedures. Patients and surrogates were glad they were enrolled (90.3%), agreed with EFIC use for their personal enrollment (88.17%), and agreed with the general use of EFIC for the PAMPer study (81.7%). Disclosure of the true positive PAMPer study outcome resulted in a significant increase in opinions regarding personal enrollment, EFIC for personal enrollment, and EFIC for general enrollment (all p < 0.001). Disclosure of a hypothetical neutral or negative study outcome resulted in significant decreases in opinions regarding EFIC for personal enrollment (p = 0.003) and EFIC for general enrollment (p < 0.001). (Continued on next page)
* Correspondence: [email protected] Presented at: Academic Surgical Congress, February 2020 1 Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh, 200 Lothrop St, Pittsburgh, PA 15213, USA Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate c
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