Abstract
ObjectivesWith 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.MethodsTelephone 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.ResultsOf 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).ConclusionsClinical trial participants with traumatic hemorrhagic shock enrolled with EFIC, and surrogates of such participants, are generally accepting of EFIC. The results of the trial in which EFIC was utilized significantly affected patient and surrogate agreement with personal and general EFIC enrollment.
Highlights
Recent studies have found that deaths following traumatic injury occur quickly—often within the first few hours following arrival to definitive care
Clinical trial participants with traumatic hemorrhagic shock enrolled with exception from informed consent (EFIC), and surrogates of such participants, are generally accepting of EFIC
Study population A total of 647 telephone calls were made between January 2019 and June 2019 to all patients who were enrolled under EFIC in the Prehospital Air Medical Plasma Trial (PAMPer) study at the University of Pittsburgh site and their surrogates
Summary
Recent studies have found that deaths following traumatic injury occur quickly—often within the first few hours following arrival to definitive care. Management of severe injury has changed over the last decade, and improvements have occurred primarily in the in-hospital setting. In clinical trials that focus on emergency interventions, most patients are unresponsive or incapable of making informed consent decisions related to their treatment, and legally authorized representatives are often not immediately available to make decisions on their behalf. This has led to increasing use of exception from informed consent (EFIC) for such trials [3, 4]. Surrogates are notified as soon as feasible and patients and/or surrogates are consented for continued participation after patients are medically stabilized and are capable of informed decision-making
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