Simulation Training to Improve Informed Consent and Pharmacokinetic/Pharmacodynamic Sampling in Pediatric Trials
Burckhardt, Bjoern B.; Ciplea, Agnes Maria; Laven, Anna; Ablonczy, László; Klingmann, Ingrid; Läer, Stephanie; Kleine, Karl; Dalinghaus, Michiel; Đukić, Milan; Breur, Johannes M.P.J.; van der Meulen, Marijke; Swoboda, Vanessa; Schwender, Holger; Lagler, Florian B.
(2020) Frontiers in Pharmacology, volume 11
(Article)
Abstract
Background: Pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success
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by optimizing the preparedness of the study staff shift. Method: An interdisciplinary faculty developed a simulation training focusing on the communication within the informed consent procedure and the conduct of the complex pharmacokinetic/pharmacodynamic (PK/PD) sampling within a simulation facility. Scenarios were video-debriefed by an audio-video system and manikins with artificial blood simulating patients were used. The training was evaluated by participants' self-assessment before and during trial recruitment. Results: The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded “LENA” project (grant agreement no. 602295). Self-perceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5–3.5) to four points (4.0–4.5), and from 2 (1.5–2.5) to five points (4.0–5.0). Conclusion: An innovative training concept to optimize the informed consent process and study conduct was successfully developed and enabled high-quality conduct of the pediatric trials as of the very first patient visit.
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Keywords: clinical study, communication, patient recruitment, pediatrics, pharmacokinetic/pharmacodynamic, simulation training, study conduct, Pharmacology, Pharmacology (medical)
ISSN: 1663-9812
Publisher: Frontiers Media S. A.
Note: Funding Information: The activities within the simulation training has received funding from the European Union Seventh Framework Programme (FP7/ 2007-2013) under grant agreement n 602295 (LENA). Funding Information: Results: The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded “LENA” project (grant agreement no. 602295). Self-perceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5–3.5) to four points (4.0–4.5), and from 2 (1.5–2.5) to five points (4.0–5.0). Publisher Copyright: © Copyright © 2020 Burckhardt, Ciplea, Laven, Ablonczy, Klingmann, Läer, Kleine, Dalinghaus, Đukić, Breur, van der Meulen, Swoboda, Schwender and Lagler.
(Peer reviewed)