Outcomes
Anxiety, Down syndrome, anxiety
DOWN SYNDROME, ANEUPLOIDY
The primary outcome was the percentage of women who made an informed choice in the intervention group compared with control. The definition of informed choice was one that was made with good knowledge and value‐consistent behaviour. Secondary outcomes included informed choice with deliberation, knowledge, value‐consistent behaviour, anxiety and decisional conflict. Subgroup analyses were performed in women aged 35 years or older, those with a university degree, women who were religious, women who were parous, and women who had performed Down syndrome screening in their previous pregnancies.The assessment of informed choice was performed using a self‐administered questionnaire at the end of the clinic visit. A widely used measure of informed choice is the Multidimensional Measure of Informed Choice (MMIC), which was developed for women undergoing aneuploidy screening in pregnancy, assessing knowledge and attitudes towards the combined FTS.An informed choice was deemed to have been made if the subject had good knowledge and chose a testing option which was consistent with her attitude towards that test. Knowledge was assessed using the knowledge scale of the MMIC, which comprised 19 validated questions that covered important aspects of FTS, NIPS, and invasive testing that were deemed essential for an informed choice.A deliberation scale was added to the original MMIC in a previous study, as whether women deliberated their decision was thought to be an important component of informed decision making.Measures to assess decisional conflict and anxiety were included in a previous study by Beulen et al., which investigated the use of a decision‐making aid in a setting where NIPS was offered as part of contingent screening,Decisional conflict was measured using a validated Decisional Conflict Scale,Anxiety was assessed using the Spielberger State Trait Anxiety Inventory (STAI‐6) short form, which consisted of six items.