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.

Development and evaluation of training resources to prepare health professionals for counselling pregnant women about non-invasive prenatal testing for Down syndrome: a mixed methods study

“…It will also be important that women are aware of the current turnaround time for the test results (which in the RAPID study was 7–10 working days) as this may impact on decisions around whether to have NIPT or invasive testing for very high risk women, or those with ultrasound abnormalities. Consideration should also be given to knowledge gaps identified in pregnant women, such as the meaning of a negative NIPT result [42]. Future training should emphasise these areas and the knowledge could be reinforced through access to e-learning and/or further mandatory training.…”

Talking Points: Women's Information Needs for Informed Decision‐Making About Noninvasive Prenatal Testing for Down Syndrome

“…However, the way in which women ought to be provided with this information (i.e., through discussion or adjunct decision support tools) remains unclear. This is highlighted by Piechan et al (2016) who stress that health professionals must balance the need to provide sufficient information with the need to provide this information at a pace that allows the woman to process the information. Consequently, future research to understand what types of information should be prioritized in a discussion with a health professional and what information is better presented in decision support tools may be helpful.…”

“…Knowledge estimates in these studies are likely to be inflated due to the studies' emphasis on pre-test counseling. By contrast, a study with higher ecological validity found that only 44% of women had sufficient knowledge following Busual care^pre-test counseling for NIPT as a first-tier, non-contingent test (Piechan et al 2016). Given the context-dependency of knowledge assimilation following pre-test counseling, it is important that we understand what information women value in decision-making about NIPT so that we can maximize the relevancy of the information provided and in turn aim to maximize knowledge assimilation.…”

Prenatal Diagnosis

“…23 Previous studies have shown that patients’ misunderstanding of this test is significant despite pretest counseling. 24 Notably, in the aforementioned cohort, 9 patients underwent termination of pregnancy without diagnostic confirmation of a chromosomal abnormality. 23 Any results should be interpreted with the aid of a genetic counselor in order to provide further guidance as to patients’ individual risk.…”