The effect of a decision aid on informed decision-making in the era of non-invasive prenatal testing: a randomised controlled trial

Abstract

Early in pregnancy women and their partners face the complex decision on whether or not to participate in prenatal testing for fetal chromosomal abnormalities. Several studies show that the majority of pregnant women currently do not make informed decisions regarding prenatal testing. As the range of prenatal tests is expanding due to the development of new techniques such as non-invasive prenatal testing (NIPT), autonomous reproductive decision-making is increasingly challenging. In this study, a randomised controlled trial was conducted to evaluate the effect of a web-based multimedia decision aid on decision-making regarding prenatal testing. The decision aid provided both written and audiovisual information on prenatal tests currently available, that is, prenatal screening by first-trimester combined testing, NIPT and invasive diagnostic testing through chorionic villus sampling or amniocentesis. Furthermore, it contained values clarification exercises encouraging pregnant women to reflect on the potential harms and benefits of having prenatal tests performed. The use of the decision aid improved informed decision-making regarding prenatal testing. Of pregnant women allocated to the intervention group (n=130) 82.3% made an informed choice compared with 66.4% of women in the control group (n=131), P=0.004. As the vast majority of pregnant women made decisions consistent with their attitudes towards having prenatal testing performed, this improvement in informed decision-making could be attributed mainly to an increase in decision-relevant knowledge. This study shows that the implementation of a web-based multimedia decision aid directly facilitates the ultimate goal of prenatal testing for fetal chromosomal abnormalities, which is enabling informed autonomous reproductive choice.

Figure 1

Study participants and flow. Q1, questionnaire 1; Q2, questionnaire 2.

Figure 2

Prenatal test utilisation of study participants. Dashed lines indicate pathways outside the current programme for prenatal screening and diagnosis in the Netherlands. ^aPrenatal test utilisation based on self-report by participants during the process of decision making (prenatal test intended, n=5) or when the decisional process was completed and, where applicable, prenatal testing for chromosomal abnormalities was performed and the outcome was known (prenatal test confirmed, n=254). ^bCut-off risk FCT 1: ≤200. ^cOffering NIPT as primary screening test is currently prohibited in The Netherlands, but available in neighbouring countries. ^dTwo participants had invasive diagnostic testing performed after FCT had revealed a nuchal translucency ≥3.5 mm. One participant had invasive diagnostic testing performed after FCT had shown maternal serum markers (PAPP-A and free βhCG) to be suggestive for fetal triploidy. FCT, first-trimester combined test; NIPT, non-invasive prenatal test.