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Assessment of Patient Understanding of Non-Invasive Prenatal Testing Following Introduction of Three Systematic Patient Counselling Models Kelly Chen1, Thomas Lee2, Liza Kunz1, Maximilian Schmid1
1Ariosa Diagnostics Inc., San Jose, CA, United States 2Northwest Perinatal Center, Portland, OR , United States Objectives Non-invasive prenatal testing/screening (NIPT) is now widely available for clinical use. NIPT has detection rates for fetal trisomy 21 of >99% and false positive rates of <0.1%, an improved performance compared to combined testing in all pregnant patients, which has increased its utilization and consequently the need for genetic counseling, a standard for pre- and post-test management. The main objective was to evaluate patient understanding of NIPT before and after their participation in three different systematic patient counseling programs as alternatives for one-on-one pre-test genetic counseling. Methods Quasi-experimental, multi-center design pilot study. Participants had a singleton pregnancy, provided informed consent and were >18 years of age. After receiving genetic prenatal screening education via one of four methods (group flip book –GFB-, one-on-one video –OOOV-, group video –GV- and a control site –C-), participants were administered a survey exploring pre- and post-training knowledge of NIPT and common aneuploidies. Four sites participated with one intervention per site. All interventions included the same content. Quorum IRB approved the protocol. Results A total of 1026 women participated in the 4 sites/intervention groups (GFB, OOOV, GV, C) with 283, 104, 214 and 425 participants respectively. All groups had good recognition of trisomy 21 (>90% all sites, p 0.12) as opposed to other trisomies (18, 13 or sex chromosomes aneuploidies –SCA-), which ranged from 28% to 52%. Less than 25% of participants identified all four conditions. Nearly 60% of participants demonstrated recognition of amniocentesis, while only 21% recognized nuchal translucency (p 0.001). GFB were best change in knowledge (25 to 75 inter quartile range –IQR- p<0.001) followed by GV (50 to 75IQR p<0.01) Conclusions GFB was the most effective method, followed by GV. OOOVs do not provide good results in this study. Although limited by its quasi-experimental design, this pilot study suggests that alternative delivery methods of counseling may be considered useful in light of increasing patient volume expected to undergo NIPT in the near future