Safety and Compliance among Newly Qualified Paramedics in a Pre-hospital Clinical Trial of an Investigational Medicinal Product: A Post-Hoc analysis of the PACKMaN Randomised Controlled Trial
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Background
Pre-hospital research has unique challenges. Ambulance clinicians are required to enrol patients in emergency situations, often remote from the research team at time of recruitment. With Newly Qualified Paramedics (NQPs) representing a significant and growing proportion of ambulance staff, it is important to establish if they can safely and effectively recruit patients to clinical trials. This paper reports a post-hoc analysis of the PACKMaN trial, a large, double-blind Randomised Controlled Trial of an Investigational Medicinal Product (CTIMP), of ketamine versus morphine in the pre-hospital setting.
Methods
Adverse Events (AEs) and Serious Adverse Events (SAEs) experienced by patients recruited to the PACKMaN trial, and protocol Non-Compliances (NCs) by paramedics during the trial were retrospectively analysed. We compared recruitment, incidence and type of AEs, as well as incidence of SAEs and NCs dichotomised by paramedic experience.
Results
Of the 458 patients, 259 (56.6%) and 199 (43.4%) were recruited by experienced paramedics and NQPs respectively. Incidence of AEs was similar regardless of experience: experienced paramedics reported 128/259 (49.8%) and NQPs reported 91/199 (45.7%) OR 0.86 95% CI [0.60 to 1.25]. SAEs slightly increased, but not statistically significantly, in the NQP group: experienced paramedics 4/259 (1.5%), NQPs 8/199 (4.0%) OR 2.67 95% CI [0.79 to 9.00]. NC was similar amongst both groups, experienced paramedics 3/259 (1.2%), NQPs 6/199 (3.0%), OR 2.65 95% CI [0.66 to 10.74].
Conclusion
In a double-blind CTIMP, there was no statistical difference in the incidence of AEs or NCs between NQPs and experienced paramedics. NQPs made an important contribution to patient recruitment in this study, improving the generalisability. SAEs and NCs were rare, and patients received analgesics safely. There was no correlation between experience and AE likelihood, and no safety concerns identified arising from NQP participation. Our findings demonstrate that NQPs can safely recruit patients to clinical trials.
