Phenomenological study exploring ethics in prehospital research from the paramedic’s perspective: experiences from the Paramedic-2 trial in a UK ambulance service

Abstract

ObjectivesWe set out to investigate paramedics’ views of ethics and research, drawing on experiences from Paramedic-2, a randomised controlled trial comparing epinephrine and placebo in out-of-hospital cardiac arrest (OHCA).MethodsAn interpretative phenomenological approach was adopted. A purposive sample of paramedics (n=6) from North East Ambulance Service NHS Foundation Trust were invited to a semi-structured, in-depth interview.ResultsThree superordinate themes emerged: (1) morality, (2) emotion and (3) equipoise. Some viewed Paramedic-2 as an opportunity to improve OHCA outcomes for the many, viewing participation as a moral obligation; others viewed the study as unethical, equating participation with immoral behaviour. Morality was a motivator to drive individual action. Positive and negative emotions were exhibited by the paramedics involved reflecting the wider view each paramedic held about trial participation. Those morally driven to participate in Paramedic-2 discussed their pride in being associated with the trial, while those who found participation unethical, discussed feelings of guilt and regret. Individual experience and perceptions of epinephrine guided each paramedic’s willingness to accept or reject equipoise. Some questioned the role of epinephrine in OHCA; others believed withholding epinephrine was synonymous to denying patient care.ConclusionA paucity of evidence exists to support any beneficial role of epinephrine in OHCA. Despite this, some paramedics were reluctant to participate in Paramedic-2 and relied on their personal perceptions and experiences of epinephrine to guide their decision regarding participation. Failure to acknowledge the importance of individual perspectives may jeopardise the success of future out-of-hospital trials.

Defibrillation trials: POSED a challenge

“…Cluster RCTs require high levels of protocol compliance, which can only be achieved through the engagement and education of frontline staff. Paramedic and healthcare provider involvement in clinical trials can often be challenging, particularly when the intervention seeks to withhold or reduce a standard of care, 19 as may be the case with defibrillation dosing. Although POSED investigators achieved a good adherence rate to the protocol (86%), achieving high rates of compliance in larger trials involving thousands of front-life staff may be more challenging.…”