I. Campwala1, M. D. Neal1, B. S. Zuckerbraun1, J. Brown1, F. X. Guyette2, J. L. Sperry1 1University Of Pittsburg,Surgery,Pittsburgh, PA, USA 2University Of Pittsburg,Emergency Medicine,Pittsburgh, PA, USA
Introduction: With the increased focus on prehospital intervention and early resuscitation methods, more studies are employing trials that utilize exception from informed consent (EFIC). Few studies have assessed opinions of patients following participation in an EFIC study, and none have assessed patients following traumatic injury and hemorrhagic shock. We surveyed patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research.
Methods: A total of 647 telephone calls were made from January through June 2019 to patients enrolled via EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled) and their surrogates. A survey of opinions regarding consent and research was conducted. A series of questions gauging approval of personal and general EFIC enrollment was asked before outcomes of PAMPer were disclosed, after positive outcomes were disclosed, and after a hypothetical negative outcome was proposed.
Results: Ninety-three interviews were conducted, including 36 patients and 57 surrogates. Figure 1 displays key responses to survey questions regarding community consultation and EFIC. Without disclosure of study outcome, patients and surrogates were glad they were enrolled (90.3%, n=84), agreed with EFIC use for their personal enrollment (88.17%, n=82), and agreed with the general use of EFIC for the PAMPer study (81.7%, n=76). Disclosure of the true positive PAMPer study outcome resulted in significant increases 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). Responses from patients and surrogates were not statistically different, and responses from surrogates for patients who were alive at 30 days post initial injury (n=49) versus surrogates for patients who died (n=8) were not statistically different. These results were independent of age, gender, and respondent type.
Conclusion: Although EFIC is becoming more common, the community knows little about the process. Despite this, patients and surrogates previously enrolled via EFIC are generally accepting of this type of trial. Patients' and surrogates’ responses were similar, suggesting that surrogates may be excellent proxies for these types of inquiries. The outcomes of the trial in which EFIC was utilized significantly affected agreement with personal and general EFIC enrollment, with positive outcomes increasing acceptability and negative outcomes decreasing acceptability.
