title: NIPT and Informed Consent: an Assessment of Patient Understanding of a Negative NIPT Result.
abstract: Since becoming clinically available in 2011, the use of noninvasive prenatal testing (NIPT) to screen for fetal aneuploidy has continued to increase. However, it has been questioned whether the education of patients undergoing NIPT consistently meets informed consent standards. We sought to evaluate patients' basic understanding of NIPT, such as conditions assessed and accuracy. In addition, we investigated patient self-assessment of NIPT knowledge and satisfaction with the testing process. We distributed an anonymous paper survey to pregnant women during prenatal visits following a negative NIPT result. The survey assessed patient NIPT knowledge, gathered pregnancy-specific and demographic information, and allowed respondents to rank their basic understanding of NIPT and provide written feedback about the testing process. A total of 95 completed and 3 partially completed surveys were returned. Participants scored lowest on knowledge questions involving whether a negative NIPT result ensures a healthy baby or eliminates the possibility of Down syndrome. Most perceived themselves to have a good basic understanding of NIPT and two-thirds of the written feedback proposed no changes to NIPT administration. Overall, most patients appear satisfied with their understanding of NIPT and the testing process, yet they may not fully appreciate the limitations of this screening method.
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Medical Research and Library Building, Room IB-130, 975 West Walnut Street, Indianapolis, IN, 46202-5251, USA. jpiechan@iu.edu.
authors.forename: Julie L
authors.initials: JL
authors.lastname: Piechan
authors.affiliation: Division of Maternal Fetal Medicine, Indiana University Health, Indianapolis, IN, USA.
authors.forename: Karrie A
authors.initials: KA
authors.lastname: Hines
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Koller
authors.affiliation: Division of Maternal Fetal Medicine, Indiana University Health, Indianapolis, IN, USA.
authors.forename: Kristyne
authors.initials: K
authors.lastname: Stone
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Quaid
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Wilfredo
authors.initials: W
authors.lastname: Torres-Martinez
authors.affiliation: Maternal-Fetal Medicine and Genetics Center, St. Vincent Hospital and Health Services, Indianapolis, IN, USA.
authors.forename: Divya
authors.initials: D
authors.lastname: Wilson Mathews
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Foroud
authors.affiliation: Maternal-Fetal Medicine and Genetics Center, St. Vincent Hospital and Health Services, Indianapolis, IN, USA.
authors.forename: Lola
authors.initials: L
authors.lastname: Cook
mesh_terms: D000328:Adult; D000782:Aneuploidy; D032882:Comprehension; D004314:Down Syndrome / Q000175:diagnosis* / Q000235:genetics; D005260:Female; D005333:Fetus; D006801:Humans; D007258:Informed Consent; D008297:Male; D010290:Parents / Q000523:psychology*; D011247:Pregnancy; D011296:Prenatal Diagnosis; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Cell-free fetal DNA; Informed consent; Noninvasive prenatal screening; Noninvasive prenatal testing; Patient education; Patient knowledge; cffDNA