RT Journal Article
T1 Pharmacogenomics decision support in the U-PGx project: Results and advice from clinical implementation across seven European countries.
A1 Blagec, Kathrin
A1 Swen, Jesse J
A1 Koopmann, Rudolf
A1 Cheung, Ka-Chun
A1 Crommentuijn-van Rhenen, Mandy
A1 Holsappel, Inge
A1 Konta, Lidija
A1 Ott, Simon
A1 Steinberger, Daniela
A1 Xu, Hong
A1 Cecchin, Erika
A1 Dolžan, Vita
A1 Davila-Fajardo, Cristina Lucia
A1 Patrinos, George P
A1 Sunder-Plassmann, Gere
A1 Turner, Richard M
A1 Pirmohamed, Munir
A1 Guchelaar, Henk-Jan
A1 Samwald, Matthias
K1 Decision Support Systems, Clinical
K1 Pharmacogenetics
K1 Precision Medicine
K1 Retrospective Studies
K1 Software
AB The clinical implementation of pharmacogenomics (PGx) could be one of the first milestones towards realizing personalized medicine in routine care. However, its widespread adoption requires the availability of suitable clinical decision support (CDS) systems, which is often impeded by the fragmentation or absence of adequate health IT infrastructures. We report results of CDS implementation in the large-scale European research project Ubiquitous Pharmacogenomics (U-PGx), in which PGx CDS was rolled out and evaluated across more than 15 clinical sites in the Netherlands, Spain, Slovenia, Italy, Greece, United Kingdom and Austria, covering a wide variety of healthcare settings. We evaluated the CDS implementation process through qualitative and quantitative process indicators. Quantitative indicators included statistics on generated PGx reports, median time from sampled upload until report delivery and statistics on report retrievals via the mobile-based CDS tool. Adoption of different CDS tools, uptake and usability were further investigated through a user survey among healthcare providers. Results of a risk assessment conducted prior to the implementation process were retrospectively analyzed and compared to actual encountered difficulties and their impact. As of March 2021, personalized PGx reports were produced from 6884 genotyped samples with a median delivery time of twenty minutes. Out of 131 invited healthcare providers, 65 completed the questionnaire (response rate: 49.6%). Overall satisfaction rates with the different CDS tools varied between 63.6% and 85.2% per tool. Delays in implementation were caused by challenges including institutional factors and complexities in the development of required tools and reference data resources, such as genotype-phenotype mappings. We demonstrated the feasibility of implementing a standardized PGx decision support solution in a multinational, multi-language and multi-center setting. Remaining challenges for future wide-scale roll-out include the harmonization of existing PGx information in guidelines and drug labels, the need for strategies to lower the barrier of PGx CDS adoption for healthcare institutions and providers, and easier compliance with regulatory and legal frameworks.
PB Public Library of Science
YR 2022
FD 2022-04-26
LK http://hdl.handle.net/10668/20428
UL http://hdl.handle.net/10668/20428
LA en
NO Blagec K, Swen JJ, Koopmann R, Cheung KC, Crommentuijn-van Rhenen M, Holsappel I, et al. Ubiquitous Pharmacogenomics Consortium. Pharmacogenomics decision support in the U-PGx project: Results and advice from clinical implementation across seven European countries. PLoS One. 2022 Jun 8;17(6):e0268534.
DS RISalud
RD Apr 18, 2025