Improving Research Enrollment of Severe Burn Patients

Abstract

Objective Enrolling severely burn injured patients into prospective research studies poses specific challenges to investigators. Methods We describe our experience of recruiting adults with ≥20% total body surface area burns or inhalation injury admitted to a single academic burn unit into observational research with minimally invasive specimen collection. We outline iterative changes that we made to our recruitment processes in response to perceived weaknesses leading to delays in enrollment. Our primary outcome was the change in days to consent for enrolled patients or cessation of recruitment for non-enrolled patients before and after the interventional modifications. We assessed change in overall enrollment as a secondary outcome. Results Study enrollment was ~70% in both 4-month study periods before and after the intervention. Following the intervention, time to consent by surrogate decision maker decreased from a median of 26.5 days (IQR 14–41) to 3 days (IRQ 3–6) (p=0.004). Time to initial consent by patient changed from a median of 15 days (IQR 2–30) to 3 days (IQR 2–6) (p=0.27). Time to decline for non-enrolled patients decreased from a median of 12 days (IQR 6.5–27) to 1.5 days (IQR 1–3.5) (p=0.026). Conclusions Both the findings of our study and our brief literature review suggest that careful design of the recruitment protocol, increased experience of the study team, and broad time windows for both approach and enrollment improve the efficiency of recruiting critically ill burn patients into research.

In Silico Simulation of the Systemic Drug Exposure Following the Topical Application of Opioid Analgesics in Patients with Cutaneous Lesions

“…Clinical evaluation of drug pharmacokinetics in patients with severe skin lesions is substantially hindered due to unstable patient conditions and dramatically altered biochemical pathways [ 9 ]. Animal models, on the other hand, were shown to be irrelevant due to significant differences in the composition of dermal layers, the density of hair follicles, and skin thickness.…”