Abstract
BackgroundSince the introduction of non-invasive prenatal testing (NIPT) in 2011, mainly by commercial companies, a growing demand for NIPT from the public and healthcare professionals has been putting pressure on the healthcare systems of various countries. This study identifies the challenges of establishing a responsible implementation of NIPT for aneuploidy in prenatal healthcare, by looking at the Netherlands.MethodsA mixed methods approach involving 13 stakeholder interviews, document analysis and (participatory) observations of the Dutch NIPT Consortium meetings were used. The Diffusion of Innovation Theory and a Network of Actors model were used to interpret the findings.ResultsImplementation of NIPT was facilitated by several factors. The set-up of a national NIPT Consortium enabled discussion and collaboration between stakeholders. Moreover, it led to the plan to offer NIPT through a nationwide research setting (TRIDENT studies), which created a learning phase for careful implementation. The Dutch legal context was perceived as a delaying factor, but eventually gave room for the parties involved to organise themselves and their practices.ConclusionsThis study shows that implementing advanced technologies with profound effects on prenatal care benefit from a learning phase that allows time to carefully evaluate the technical performance and women’s experiences and to enable public debate. Such a coordinated learning phase, involving all stakeholders, will stimulate the process of responsible and sustainable implementation.
Highlights
Since the introduction of non-invasive prenatal testing (NIPT) in 2011, mainly by commercial companies, a growing demand for NIPT from the public and healthcare professionals has been putting pressure on the healthcare systems of various countries
NIPT is a revolutionary technique for testing for Down syndrome and other foetal aneuploidies using cell-free Deoxyribonucleic acid (DNA) in maternal blood [2]
In the Netherlands, NIPT became available in April 1, 2014 as part of the first TRIDENT study for pregnant women with an indication for invasive diagnostic testing based on an increased risk for aneuploidy (e.g. Down syndrome)(risk ≥1:200) at first trimester combined screening
Summary
Since the introduction of non-invasive prenatal testing (NIPT) in 2011, mainly by commercial companies, a growing demand for NIPT from the public and healthcare professionals has been putting pressure on the healthcare systems of various countries. NIPT can be performed as early as 9-week gestation [3], has a high sensitivity (>99% for Down syndrome), and a false positive rate of less than 0.1% [4]. These test characteristics make NIPT a suitable screening test for foetal anomalies, leading to a significant reduction in women referred for invasive testing and lowering the number of procedure-related miscarriages [5, 6]. In the Netherlands, NIPT became available in April 1, 2014 as part of the first TRIDENT study for pregnant women with an indication for invasive diagnostic testing based on an increased risk for aneuploidy (e.g. Down syndrome)(risk ≥1:200) at first trimester combined screening.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
