Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing

So Yeon Kim, Seung Mi Lee, Jong Kwan Jun, You Jung Han, Min Hyoung Kim, Jae Yoon Shim, Mi Young Lee, Soo young Oh, Joon Ho Lee, Soo Hyun Kim, Dong Hyun Cha, Geum-Joon Cho, Han Sung Kwon, Byoung Jae Kim, Mi Hye Park, Hee Young Cho, Hyun Sun Ko, Jeonghoon Ahn, Hyun Mee Ryu

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3 Citations (Scopus)

Abstract

Background: Among the non-invasive screening methods for the identification of fetal aneuploidy, NIPT (non-invasive prenatal testing) shows the highest sensitivity and specificity in high-risk pregnancies. Due to the low false positive rate of NIPT, it is assumed that the implementation of NIPT as a primary screening method may reduce the number of invasive fetal tests and result in a similar or lowered cost in the overall detection of Down syndrome. However, most previous studies are based on theoretical economic analysis. This study aims to determine the cost effectiveness of various prenatal test strategies, including NIPT, in real clinical settings in both low risk and high risk pregnancies. Methods/design: In this prospective observational study, women (<24weeks) with singleton or twin pregnancies will be enrolled in 12 different healthcare institutions. The participants will be grouped based on the risks of fetal chromosomal abnormalities and will be counseled on the various screening or diagnostic methods, including NIPT, according to the aneuploidy risk. The final decision on screening or diagnostic methods will be made by patients after counseling. Questionnaires regarding factors affecting the decision on prenatal test will be answered by the participants and physicians. The economic analysis on final total costs will be compared according to the various prenatal test strategies. Discussion: The results of present study are expected to have a significant impact on national policies in determining Korean prenatal screening test strategies and to help in developing novel and effective prenatal screening tests in the future.

Original languageEnglish
Article number307
JournalBMC Pregnancy and Childbirth
Volume18
Issue number1
DOIs
Publication statusPublished - 2018 Jul 24

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Keywords

  • Clinical practice guidelines
  • NIPT
  • Prenatal diagnosis
  • Prenatal genetic counseling
  • Prenatal screening test

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Kim, S. Y., Lee, S. M., Jun, J. K., Han, Y. J., Kim, M. H., Shim, J. Y., Lee, M. Y., Oh, S. Y., Lee, J. H., Kim, S. H., Cha, D. H., Cho, G-J., Kwon, H. S., Kim, B. J., Park, M. H., Cho, H. Y., Ko, H. S., Ahn, J., & Ryu, H. M. (2018). Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing. BMC Pregnancy and Childbirth, 18(1), [307]. https://doi.org/10.1186/s12884-018-1930-y