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

Research output: Contribution to journalArticle

2 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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Cost-Benefit Analysis
Prospective Studies
High-Risk Pregnancy
Aneuploidy
Prenatal Diagnosis
Economics
Costs and Cost Analysis
Twin Pregnancy
Down Syndrome
Chromosome Aberrations
Observational Studies
Counseling
Delivery of Health Care
Physicians
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynaecology

Cite this

Kim, So Yeon ; Lee, Seung Mi ; Jun, Jong Kwan ; Han, You Jung ; Kim, Min Hyoung ; Shim, Jae Yoon ; Lee, Mi Young ; Oh, Soo young ; Lee, Joon Ho ; Kim, Soo Hyun ; Cha, Dong Hyun ; Cho, Geum Joon ; Kwon, Han Sung ; Kim, Byoung Jae ; Park, Mi Hye ; Cho, Hee Young ; Ko, Hyun Sun ; Ahn, Jeonghoon ; Ryu, Hyun Mee. / Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing. In: BMC Pregnancy and Childbirth. 2018 ; Vol. 18, No. 1.
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title = "Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing",
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.",
author = "Kim, {So Yeon} and Lee, {Seung Mi} and Jun, {Jong Kwan} and Han, {You Jung} and Kim, {Min Hyoung} and Shim, {Jae Yoon} and Lee, {Mi Young} and Oh, {Soo young} and Lee, {Joon Ho} and Kim, {Soo Hyun} and Cha, {Dong Hyun} and Cho, {Geum Joon} and Kwon, {Han Sung} and Kim, {Byoung Jae} and Park, {Mi Hye} and Cho, {Hee Young} and Ko, {Hyun Sun} and Jeonghoon Ahn and Ryu, {Hyun Mee}",
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Kim, SY, Lee, SM, Jun, JK, Han, YJ, Kim, MH, Shim, JY, Lee, MY, Oh, SY, Lee, JH, Kim, SH, Cha, DH, Cho, GJ, Kwon, HS, Kim, BJ, Park, MH, Cho, HY, Ko, HS, Ahn, J & Ryu, HM 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, vol. 18, no. 1, 307. https://doi.org/10.1186/s12884-018-1930-y

Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing. / Kim, So Yeon; Lee, Seung Mi; Jun, Jong Kwan; Han, You Jung; Kim, Min Hyoung; Shim, Jae Yoon; Lee, Mi Young; Oh, Soo young; Lee, Joon Ho; Kim, Soo Hyun; Cha, Dong Hyun; Cho, Geum Joon; Kwon, Han Sung; Kim, Byoung Jae; Park, Mi Hye; Cho, Hee Young; Ko, Hyun Sun; Ahn, Jeonghoon; Ryu, Hyun Mee.

In: BMC Pregnancy and Childbirth, Vol. 18, No. 1, 307, 24.07.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prospective observations study protocol to investigate cost-effectiveness of various prenatal test strategies after the introduction of noninvasive prenatal testing

AU - Kim, So Yeon

AU - Lee, Seung Mi

AU - Jun, Jong Kwan

AU - Han, You Jung

AU - Kim, Min Hyoung

AU - Shim, Jae Yoon

AU - Lee, Mi Young

AU - Oh, Soo young

AU - Lee, Joon Ho

AU - Kim, Soo Hyun

AU - Cha, Dong Hyun

AU - Cho, Geum Joon

AU - Kwon, Han Sung

AU - Kim, Byoung Jae

AU - Park, Mi Hye

AU - Cho, Hee Young

AU - Ko, Hyun Sun

AU - Ahn, Jeonghoon

AU - Ryu, Hyun Mee

PY - 2018/7/24

Y1 - 2018/7/24

N2 - 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.

AB - 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.

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