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Table 1 Characteristics of included studies

From: Psychological and social consequences of non-invasive prenatal testing (NIPT): a scoping review

Study Aim of study Data collection Participants Outcome measures Limitations of the study (excerpt), conflicts of interest (COI)
Farrell, et al., 2014, USA [19] To determine how pregnant women conceptualize the utility of NIPT as compared to conventional screening and diagnostic tests. Focus groups. N = 53 women who received prenatal care at the study clinic; n = 10 women had NIPT.
Mean age (range) = 31.7 ys (21–43) (n = 53);
AMAa: n = 16.
Individual quotes. Limited sample size, women from only one community.
Authors declared to have no COI.
Lewis, et al. 2016, UK [20] To report on a number of psychosocial outcomes including decisional uncertainty, distress and anxiety, as well as motivations for undergoing or declining NIPT and clinical service preferences. Questionnaires at blood draw (Q1) and/or 1 month following receipt of results (Q2). N = 582 women with a Down syndrome screening (DSS) risk > 1:1000 accepted NIPT free of charge as part of an implementation study in the UK NHS. N = 263 responded to Q1 and Q2 and were included in the analysis.
Mean age (range):
35 ys (19–49) (n = 582).
DSSa risk distribution:
> 1:1000/medium (n = 417);
> 1:150/high (n = 165).
NIPT results:
Negative: n = 246;
Positive: n = 10;
Other: n = 7 (n = 4 test failed; n = 2 declined NIPT; n = 1 inconclusive results).
State-Trait Anxiety Inventory (STAI-6), short formb;
Decisional Regret Scale (DRS)c.
Only a small number of women declined NIPT, no control group that has not been offered NIPT, low response rate to Q2, absence of baseline anxiety testing.
Authors declared to have no COI.
Lo, et al., 2019, Hong Kong [21] To assess decision outcomes (decision conflict, decision regret and anxiety) of pregnant women who are offered NIPT for high-risk Down syndrome screening results. “first questionnaire” (Q1) and 4 weeks after Q1/after receiving NIPT results (Q2). N = 262 women with positive Down syndrome screening results whose informed decision making about NIPT had been analyzed in a previous cohort study.
Age distribution: < 35 years (n = 89); ≥35 years (n = 173).
DSSa risk distribution: 1:1–125 (n = 114); 1:126–250 (n = 91).
State-Trait Anxiety Inventory (STAI-6), short formb;
Decisional Regret Scale (DRS)c.
No limitations discussed.
Authors declared to have no COI.
Richmond, et al., 2017, Australia [22] To examine the psychological impact of NIPT in women with a high-risk and low-risk result on combined first trimester screening (cFTS) and to examine factors influencing anxiety and decision-making in both risk populations. Questionnaires at NIPT consultation and blood draw (point A) and 1 week post NIPT result (point B), then online after point B (point C). N = 115 women requesting NIPT after combined first trimester screening (cFTS) but prior to morphology ultrasound were recruited from a genetic counsellor-led clinic (n = 2 women excluded due to failed NIPT). All n = 113 women received a negative NIPT result.
Mean age (SD; range) = 36.4 ys (4.24; 27–44) (n = 113).
cFTS risk distribution: ≤1:301/low (n = 50); ≥1:300/ high (n = 63).
Both high-risk and low-risk cFTS groups had similar intrinsic trait anxiety levels at point A.
State-Trait Anxiety Inventory (STAI)b. Failure to record reasons for non-participation and declining follow-up; bias against those that experience pathological anxiety; artificially inflated anxiety scores (completing STAI in a clinic environment); no control group without NIPT; cohort may demonstrate
ascertainment bias towards those who both knew about and could afford NIPT; small study population.
Authors declared to have no COI.
Takeda, et al., 2018, Japan [23] To clarify the characteristics of psychological mental distress in postpartum women after non-invasive prenatal testing (NIPT) in Japan. Questionnaires pre-NIPT and approx. 1 month post-partum. N = 697 women that underwent NIPT at study hospital and had negative NIPT-results and low pre-NIPT psychological mental distress (K6) were included. Cases had high post-partum mental distress, controls had low post-partum mental distress (K6).
Mean age (SD; range):
‘case’ group (n = 29): 37.9 ys (±2.4; 34–43);
‘control’ group (n = 668): 37.0 ys (±2.3; 30–41).
Kessler Psychological Distress Scale (K6), Japanese versiond. No control group with women who did not undergo NIPT, inability to adjust for the variable of neonatal abnormality.
Authors declared to have no COI.
van Schendel, et al., 2017, Netherlands [24] To address the questions whether women feel reassured and less anxious after receiving a favorable NIPT result and whether women feel satisfied with their choice for NIPT. Questionnaires after NIPT counseling (Q1) and/or after NIPT or invasive test results were received (Q2). N = 682 women participating in a study on evaluation of NIPT with an elevated first-trimester combined test (FCT) risk for aneuploidy (≥1:200) or based on medical history.
Mean age (range): 35.8 years (22–45) (n = 682).
Negative NIPT result: n = 656; positive NIPT result: n = 26.
FCTa risk distribution: ≥1:10 (n = 30); 1:11–1:100 (n = 267); 1:101–1:200 (n = 267); missing (n = 24); NA (n = 92).
Spielberger State-Trait Anxiety Inventory (STAI-6), short form; Dutch versionb;
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R scale)e;
Survey on Reassurance/ Satisfaction/ Experience with NIPT.
Low response rate to post-test questionnaire, inability to perform subgroup analyses for positive NIPT results group, possible selection bias due to several reasons.
COI: One middle author had been employed and one middle author had participated in clinical research sponsored by companies that offer NIPT
Vanstone, et al., 2015, Candada [25] To examine how Ontario women have experienced the process of publicly funded NIPT in 2014, with the aim of identifying women’s values about this process to inform future formal policy making about this new health technology. Interviews and constructivist grounded theory. N = 38 women at ‘high risk’ of fetal aneuploidy, identified at prenatal diagnostics unit, via advertisements, snowball sampling and personal networks until theoretical saturation was reached.
Mean age at delivery = 35.4 ys (n = 38).
Age classes: 25–29 ys (n = 2); 30–34 ys (n = 14); 34–39 ys (n = 16); ≥40 ys (n = 6).
Grounded theory and individual quotes. Particular group of women, older and more educated than the average, with potentially more thorough understanding of NIPT and the available testing options.
Authors declared to have no COI.
  1. aAMA advanced maternal age (≥35 years at delivery), cFTS combined first trimester screening, DSS down syndrome screening, FCT first-trimester combined test, NIPT non-invasive prenatal testing, SD standard deviation
  2. bSpielberger State-Trait Anxiety Inventory (STAI): self-evaluation questionnaire to differentiate between “the temporary condition of ‘state anxiety’ and the more intrinsic quality of ‘trait anxiety’” [22], 2 × 20 items, range 20–80 (Richmond 2017: 20–90), higher scores indicate higher anxiety. Scores ≥50 indicate elevated state anxiety. Score ≥ 40 on the STAI trait scale are considered ‘highly anxious’. Van Schendel considered a score of 34–36 as normal anxiety. Lewis 2016, Lo 2019, van Schendel 2017 used a short version with 6 items (STAI-6) and considered a cut-off 31–49 as average anxiety
  3. cDecisional Regret Scale (DRS): measure of distress or remorse after a health care decision, range 0–100, higher scores indicate a higher level of regret, no formal cut-off, a score of ≥50 indicated decisional regret in Lo 2019
  4. dKessler Psychological Distress Scale (K6): assesses frequency of experienced symptoms during the past 30 days (six items), range: 0–24, K6 score ≥ 10 is defined as a high score in Takeda 2018
  5. ePregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R) Scale: Child-related anxiety measured by subscale ‘fear of bearing a handicapped child’ (four items), range 4–20, higher scores mean higher levels of child-related anxiety