What about Informed Consent in First-Trimester Ultrasound Screening for Down Syndrome?

Abstract

Objectives: We evaluate the level of information and informed consent given for the screening of Down syndrome (DS) before the first-trimester ultrasound scan. We evaluate the nature of the medical information given and the patient’s understanding. This makes it possible to analyze the existence of the necessary elements (level of information and consent) for the patients to exercise their autonomy as to their decision making during the first-trimester ultrasound scan. Methods: A total of 350 patients were recruited prospectively in 2 hospitals. Patients were divided into 3 groups according to the results of maternal serum screening for DS. Group 1: Patients at high risk of having a child with DS with the second-trimester maternal serum screening (MSS) (risk >1/250). Group 2: Patients having a low risk (risk <1/250). Group 3: Patients who did not undergo maternal serum screening test. A questionnaire was completed before the medical consultation, to assess the quality of the medical consultation before the ultrasound, the level of prior knowledge and the maternal consent. Results: We excluded 45 of the 350 questionnaires from the analysis because they were incomplete (13.1%). We therefore analyzed a total of 305 questionnaires. The three groups analysed were: Group 1: 89 patients (29.2%) identified as at high risk after MSS. Group 2: 137 patients (44.9%) identified as at low risk accordingly to MSS. Group 3: 79 women (25.9%) who did not undergo maternal serum screening test for diverse reasons. The frequency of genuine informed consent was significantly (p < 0.001) higher in group 3 (56.9%) than in group 1 (52.8%) or group 2 (32.1%). Finally, the number of completely uninformed patients was significantly higher in group 2 (18%) than in the other two groups (7.8% for group 1 and 6.3% for group 3, p < 0.001). With multiple regression analysis, we found that maternal consent depended on 4 independent components: (1) Educational level (<baccalaureate, baccalaureate or at least 2 years of higher education after baccalaureate) (p < 0.03). (2) The location of consultations (hospital or private doctor’s practice) (p < 0.01). (3) History of medical termination (p < 0.001). (4) The score attributed to the doctor for information about early ultrasound scans (p < 0.001). The rate of consent increased with increasing educational level and was higher for women consulting at a hospital, for women with a history medical termination and for women whose doctors had a high score. Other criteria such as belonging to group 1, 2 or 3, age of the patient, first language, number of children, history of miscarriage, sex and age group of the professionals were not found significant. Conclusions: The response to the question ‘Is the level of medical information provided to patients concerning early screening by first-trimester ultrasound scans appropriate?’ is ‘no’. There is no difference in our result according to social-economic level. However, educational level (66% consent for patients with 2 years of higher education after the baccala...

Measuring informed choice in population-based reproductive genetic screening: a systematic review

“…11,13,26,[28][29][30][31][32][33][34][35] Twenty-two studies were prospective, 12,28,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55] including cross-sectional, 41,42,49 quasi-experimental, 53 pilot, 50 and longitudinal study designs. 52 Of the RCTs, five involved an information or educational intervention, 28,29,[32][33][34] five randomised the screening offer, 11,13,26,30,35 and there was one decision aid trial.…”

“…Three studies used the same cohort as in previous studies; 13,39,46 in subsequent studies the sample was stratified differently, 40 different measures were applied, 11 and additional validation data were reported. 45 Eight studies were conducted in continental Europe, 11,13,38,[43][44][45][46]53 and 14 were from the United Kingdom. 12,26,29,30,[32][33][34][35]37,[39][40][41]51,54 Seven studies were from Australia, 31,36,[48][49][50]52,55 three from the United States, 28,42,56 and one from Taiwan.…”

“…47 Prenatal screening for DS was the most common screening programme evaluated (27 studies). [11][12][13]28,29,[31][32][33][34][35][37][38][39][40][42][43][44][45][46][47][48][49][51][52][53]55,56 Three studies offering population carrier screening in prenatal settings included screening single gene disorders: sickle cell disease and thalassaemia (haemoglobinopathies (Hb)) 26,41 and cystic fibrosis (CF). 30 Of the 33 studies reviewed, only one included partners of the pregnant women, 30 and one offered CF carrier screening to men as well as women.…”

Increased nuchal translucency in euploid fetuses—what should we be telling the parents?

“…Not all women undergoing first trimester screening are aware of its possibilities and limitations (Favre et al, 2008). Women should also be properly informed that first trimester screening is not only for Down syndrome, but may reveal additional risk factors for the pregnancy requiring further investigations.…”

“…It is therefore mandatory that all pregnant women are properly counseled about prenatal screening (Layng, 1998;Müller et al, 2006;Chervenak et al, 2008;Favre et al, 2008Favre et al, , 2009 and that Health systems provide guidelines to allow parents to make an informed choice regarding first trimester screening (Seror et al, 2008).…”