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1. Women’s Experience with Non-Invasive Prenatal Testing and Emotional Well-being and Satisfaction after Test-Results

Author

Schendel, R.V. van, Page-Christiaens, G.C.M.L., Beulen, L., Bilardo, C.M., Boer, M.A. de, Coumans, A.B.C., Faas, B.H.W., Langen, I.M. van, Lichtenbelt, K.D., Maarle, M.C. van, Macville, M.V.E., Oepkes, D., Pajkrt, E., Henneman, L., Dutch NIPT Consortium, Human genetics, Obstetrics and gynaecology, APH - Quality of Care, APH - Personalized Medicine, Amsterdam Reproduction & Development (AR&D), Other departments, Human Genetics, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, Reproductive Origins of Adult Health and Disease (ROAHD), Health Psychology Research (HPR), MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, and MUMC+: DA KG Lab Centraal Lab (9)

Subjects
DUTCH LABORATORIES, Satisfaction, Personal Satisfaction, Anxiety, 0302 clinical medicine, Pregnancy, Prenatal Diagnosis, Surveys and Questionnaires, Medicine, Genetics(clinical), 030212 general & internal medicine, Genetics (clinical), Original Research, Reassurance, media_common, 030219 obstetrics & reproductive medicine, Obstetrics, 3. Good health, Emotional well-being, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Feeling, Female, TRIAL, Prenatal Screening, medicine.symptom, MATERNAL ANXIETY, PREGNANT-WOMEN, Adult, medicine.medical_specialty, Genetic counseling, media_common.quotation_subject, Health literacy, 03 medical and health sciences, AGE, Humans, Medical history, ATTITUDES, Gynecology, ANEUPLOIDY, business.industry, Public health, Other Research Radboud Institute for Health Sciences [Radboudumc 0], Patient Acceptance of Health Care, medicine.disease, Health Literacy, Pregnancy Trimester, First, PERSPECTIVES, Down Syndrome, business, Trisomy, NIPT, Non-invasive Prenatal Testing
Abstract

Increasingly, high-risk pregnant women opt for non-invasive prenatal testing (NIPT) instead of invasive diagnostic testing. Since NIPT is less accurate than invasive testing, a normal NIPT result might leave women less reassured. A questionnaire study was performed among pregnant women with elevated risk for fetal aneuploidy based on first-trimester combined test (risk ≥1:200) or medical history, who were offered NIPT in the nationwide Dutch TRIDENT study. Pre- and post-test questionnaires (n = 682) included measures on: experiences with NIPT procedure, feelings of reassurance, anxiety (State-Trait Anxiety Inventory, STAI), child-related anxiety (PRAQ-R), and satisfaction. The majority (96.1%) were glad to have been offered NIPT. Most (68.5%) perceived the waiting time for NIPT results (mean: 15 days, range 5–32) as (much) too long. Most women with a normal NIPT result felt reassured (80.9%) or somewhat reassured (15.7%). Levels of anxiety and child-related anxiety were significantly lower after receiving a normal NIPT result as compared to the moment of intake (p

Published
2017
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2. TRIDENT-2: National Implementation of Genome-Wide Non-Invasive Prenatal Testing as a First-Tier Screening Test in the Netherlands

Author

Meij, K.R.M. van der, Sistermans, E.A., Macville, M.V.E., Stevens, S.J.C., Bax, C.J., Bekker, M.N., Bilardo, C.M., Boon, E.M.J., Boter, M., Diderich, K.E.M., Die-Smulders, C.E.M. de, Duin, L.K., Faas, B.H.W., Feenstra, I., Haak, M.C., Hoffer, M.J.V., Hollander, N.S. den, Hollink, I.H.I.M., Jehee, F.S., Knapen, M.F.C.M., Kooper, A.J.A., Langen, I.M. van, Lichtenbelt, K.D., Linskens, I.H., Maarle, M.C. van, Oepkes, D., Pieters, M.J., Schuring-Blom, G.H., Sikkel, E., Sikkema-Raddatz, B., Smeets, D.F.C.M., Srebniak, M.I., Suijkerbuijk, R.F., Tan-Sindhunata, G.M., Ven, A.J.E.M. van der, Zelderen-Bhola, S.L. van, Henneman, L., Galjaard, R.J.H., Opstal, D. van, Weiss, M.M., Dutch NIPT Consortium, Health Psychology Research (HPR), Reproductive Origins of Adult Health and Disease (ROAHD), Obstetrics and Gynaecology, Human Genetics, Clinical Genetics, MUMC+: DA KG Lab Centraal Lab (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, MUMC+: DA KG Polikliniek (9), Klinische Genetica, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Human genetics, Amsterdam Reproduction & Development (AR&D), Amsterdam Neuroscience - Complex Trait Genetics, Obstetrics and gynaecology, and APH - Quality of Care

Subjects
0301 basic medicine, Trisomy 13 Syndrome, IMPACT, 030105 genetics & heredity, genome-wide, 0302 clinical medicine, Pregnancy, Prenatal Diagnosis/methods, Prenatal Diagnosis, Down Syndrome/diagnosis, Genetics(clinical), DOWN-SYNDROME, Young adult, cfDNA, First, Genetics (clinical), Netherlands, Trisomy 13 Syndrome/diagnosis, Genome, 030219 obstetrics & reproductive medicine, Obstetrics, implementation study, Middle Aged, Prognosis, fetal trisomy, common trisomies, Parental anxiety, CELL-FREE DNA, Christian ministry, Female, Pregnancy Trimester, HEALTH, Genetic Testing/methods, PREGNANT-WOMEN, Human, rare autosomal trisomies, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], Adult, medicine.medical_specialty, Screening test, Adolescent, first tier test, Netherlands/epidemiology, Prenatal care, ORGANIZATION, Article, 03 medical and health sciences, Young Adult, All institutes and research themes of the Radboud University Medical Center, medicine, Genetics, Journal Article, Humans, Genetic Testing, Trisomy 18 Syndrome/diagnosis, Chromosome Aberrations, business.industry, Genome, Human, Non invasive, Other Research Radboud Institute for Health Sciences [Radboudumc 0], Health Plan Implementation, medicine.disease, NIPS, Pregnancy Trimester, First, prenatal screening, EXPERIENCE, Down Syndrome, Trisomy, business, NIPT, Trisomy 18 Syndrome, Follow-Up Studies
Abstract

The Netherlands launched a nationwide implementation study on non-invasive prenatal testing (NIPT) as a first-tier test offered to all pregnant women. This started on April 1, 2017 as the TRIDENT-2 study, licensed by the Dutch Ministry of Health. In the first year, NIPT was performed in 73,239 pregnancies (42% of all pregnancies), 7,239 (4%) chose first-trimester combined testing, and 54% did not participate. The number of trisomies 21 (239, 0.33%), 18 (49, 0.07%), and 13 (55, 0.08%) found in this study is comparable to earlier studies, but the Positive Predictive Values (PPV)—96% for trisomy 21, 98% for trisomy 18, and 53% for trisomy 13—were higher than expected. Findings other than trisomy 21, 18, or 13 were reported on request of the pregnant women; 78% of women chose to have these reported. The number of additional findings was 207 (0.36%); these included other trisomies (101, 0.18%, PPV 6%, many of the remaining 94% of cases are likely confined placental mosaics and possibly clinically significant), structural chromosomal aberrations (95, 0.16%, PPV 32%,) and complex abnormal profiles indicative of maternal malignancies (11, 0.02%, PPV 64%). The implementation of genome-wide NIPT is under debate because the benefits of detecting other fetal chromosomal aberrations must be balanced against the risks of discordant positives, parental anxiety, and a potential increase in (invasive) diagnostic procedures. Our first-year data, including clinical data and laboratory follow-up data, will fuel this debate. Furthermore, we describe how NIPT can successfully be embedded into a national screening program with a single chain for prenatal care including counseling, testing, and follow-up.

Published
2019
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3. The use of genotype-phenotype correlations in mutation analysis for the long QT syndrome. (Letter to JMG)

Author

Langen, I.M. Van, Birnie, E., Alders, M., Jongbloed, R.J., Marec, H. Le, and Wilde, A.A.M.

Subjects
Diagnosis, Physiological aspects, Analysis, Genetic aspects, Case studies, Research, Methods, Health aspects, Chromosomes -- Genetic aspects -- Case studies -- Analysis -- Health aspects -- Physiological aspects -- Methods, Genotypes -- Research -- Case studies -- Health aspects -- Analysis -- Physiological aspects -- Methods, Medical genetics -- Research -- Case studies -- Health aspects -- Analysis -- Physiological aspects -- Methods, Genetic research -- Analysis -- Case studies -- Physiological aspects -- Methods -- Health aspects, Myocardial diseases -- Genetic aspects -- Research -- Diagnosis -- Case studies -- Physiological aspects -- Health aspects -- Analysis -- Methods, Heart diseases -- Diagnosis -- Research -- Case studies -- Genetic aspects -- Methods -- Physiological aspects -- Analysis -- Health aspects, Diagnosis -- Methods -- Case studies -- Health aspects -- Analysis -- Physiological aspects, Gene mutation -- Physiological aspects -- Case studies -- Methods -- Analysis -- Health aspects, Patients -- Health aspects -- Case studies -- Diagnosis -- Physiological aspects -- Methods -- Analysis, Genetic disorders -- Research -- Health aspects -- Diagnosis -- Case studies -- Genetic aspects -- Analysis -- Methods -- Physiological aspects, Gene mutations -- Physiological aspects -- Case studies -- Methods -- Analysis -- Health aspects, Genotype -- Research -- Case studies -- Health aspects -- Analysis -- Physiological aspects -- Methods, Cardiomyopathy -- Genetic aspects -- Research -- Diagnosis -- Case studies -- Physiological aspects -- Health aspects -- Analysis -- Methods
Abstract

The autosomal dominant form of the congenital long QT syndrome (LQTS or Romano-Ward syndrome) is a disease of disturbance of repolarisation of cardiac myocytes secondary to malfunctioning ion channels, potentially [...]

Published
2003

4. Trial by Dutch Laboratories for Evaluation of Non-Invasive Prenatal Testing.: Part II - Women's Perspectives

Author

Schendel, R.V. van, Page-Christiaens, G.C., Beulen, L., Bilardo, C.M., Boer, M.A. de, Coumans, A.B.C., Faas, B.H., Langen, I.M. van, Lichtenbelt, K.D., Maarle, M.C. van, Macville, M.V.E., Oepkes, D., Pajkrt, E., Henneman, L., Dutch NIPT Consortium, Reproductive Origins of Adult Health and Disease (ROAHD), Health Psychology Research (HPR), Genetica & Celbiologie, Klinische Genetica, RS: FHML non-thematic output, RS: GROW - School for Oncology and Reproduction, RS: GROW - R4 - Reproductive and Perinatal Medicine, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrie & Gynaecologie, MUMC+: DA KG Lab Centraal Lab (9), MUMC+: DA Pat Cytologie (9), Human Genetics, APH - Amsterdam Public Health, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, Human genetics, Obstetrics and gynaecology, ICaR - Ischemia and repair, and EMGO - Quality of care

Subjects
0301 basic medicine, Time Factors, Trisomy 13 Syndrome, Chromosome Disorders, Trisomy, Anxiety, 030105 genetics & heredity, DOWNS-SYNDROME, law.invention, Conflict, Psychological, Randomized controlled trial, Pregnancy, law, Surveys and Questionnaires, HEALTH LITERACY, INFORMED CHOICE, Genetics (clinical), Netherlands, Obstetrics, Obstetrics and Gynecology, Middle Aged, RANDOMIZED CONTROLLED-TRIAL, Test (assessment), Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], CELL-FREE DNA, Educational Status, Original Article, Female, medicine.symptom, Attitude to Health, PREGNANT-WOMEN, Adult, medicine.medical_specialty, Down syndrome, Decision Making, Health literacy, VALIDATION, DECISIONAL CONFLICT SCALE, Young Adult, 03 medical and health sciences, medicine, Journal Article, Humans, False Positive Reactions, Medical history, Gynecology, Chromosomes, Human, Pair 13, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], MULTIDIMENSIONAL MEASURE, Original Articles, DNA, Sequence Analysis, DNA, Odds ratio, medicine.disease, Pregnancy Trimester, First, Down Syndrome, Chromosomes, Human, Pair 18, business, Trisomy 18 Syndrome, NIPT, Follow-Up Studies
Abstract

Objective To evaluate preferences and decision‐making among high‐risk pregnant women offered a choice between Non‐Invasive Prenatal Testing (NIPT), invasive testing or no further testing. Methods Nationwide implementation study (TRIDENT) offering NIPT as contingent screening test for women at increased risk for fetal aneuploidy based on first‐trimester combined testing (>1:200) or medical history. A questionnaire was completed after counseling assessing knowledge, attitudes and participation following the Multidimensional Measure of Informed Choice. Results A total of 1091/1253 (87%) women completed the questionnaire. Of these, 1053 (96.5%) underwent NIPT, 37 (3.4%) invasive testing and 1 (0.1%) declined testing. 91.7% preferred NIPT because of test safety. Overall, 77.9% made an informed choice, 89.8% had sufficient knowledge and 90.5% had positive attitudes towards NIPT. Women with intermediate (odds ratio (OR) = 3.51[1.70–7.22], p, What's already known about this topic? NIPT is offered as alternative to invasive testing to screen pregnant women at high risk for fetal aneuploidy.Although NIPT has many advantages, concerns have been raised about the consequences for informed decision‐making. What does this study adds? Implementation of NIPT in a national healthcare‐funded prenatal screening program, accompanied by pre‐test counseling, results in most women having sufficient knowledge and making an informed choiceCompared to women choosing invasive testing, women undergoing NIPT have less intention to terminate the pregnancy for Down syndrome.

Published
2016
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5. Manifest disease, risk factors for sudden cardiac death, and cardiac events in a large nationwide cohort of predictively tested hypertrophic cardiomyopathy mutation carriers: determining the best cardiological screening strategy

Author

Christiaans, I., Birnie, E., Bonsel, G.J., Mannens, M.M.A.M., Michels, M., Majoor-Krakauer, D., Dooijes, D., Tintelen, J.P. van, Berg, M.P van den, Volders, P.G., Arens, Y.H., Wijngaard, A. van den, Atsma, D.E., Helderman-van den Enden, A.T., Houweling, A.C., Boer, K. de, Smagt, J.J. van der, Hauer, R.N.W., Marcelis, C.L.M., Timmermans, J., Langen, I.M. van, Wilde, A.A.M., Christiaans, I., Birnie, E., Bonsel, G.J., Mannens, M.M.A.M., Michels, M., Majoor-Krakauer, D., Dooijes, D., Tintelen, J.P. van, Berg, M.P van den, Volders, P.G., Arens, Y.H., Wijngaard, A. van den, Atsma, D.E., Helderman-van den Enden, A.T., Houweling, A.C., Boer, K. de, Smagt, J.J. van der, Hauer, R.N.W., Marcelis, C.L.M., Timmermans, J., Langen, I.M. van, and Wilde, A.A.M.

Abstract

Item does not contain fulltext, AIMS: We investigated the presence of a clinical diagnosis of hypertrophic cardiomyopathy (HCM), risk factors for sudden cardiac death (SCD), and cardiac events during follow-up in predictively tested-not known to have a clinical diagnosis of HCM before the DNA test-carriers of a sarcomeric gene mutation and associations with age and gender to determine the best cardiological screening strategy. METHODS AND RESULTS: One hundred and thirty-six (30%) of 446 mutation carriers were diagnosed with HCM at one or more cardiological evaluation(s). Male gender and higher age were associated with manifest disease. Incidence of newly diagnosed manifest HCM was <10% per person-year under the age of 40 years and >10% in older carriers, although numbers were small in carriers <15 years. Twenty-three percent of carriers, with and without manifest disease, had established risk factor(s) for SCD (no significant difference). During an average follow-up of 3.5 +/- 1.7 years two carriers, both with manifest disease, died suddenly (0.13% per person-year). A high-risk status for SCD (>/=2 risk factors and manifest HCM) was present in 17 carriers during follow-up (2.4% per person-year). Age but not gender was associated with a high-risk status for SCD. CONCLUSION: Thirty percent of carriers had or developed manifest HCM after predictive DNA testing and risk factors for SCD were frequently present. Our data suggest that the SCD risk is low and risk stratification for SCD can be omitted in carriers without manifest disease and that frequency of cardiological evaluations can possibly be decreased in carriers between 15 and 40 years as long as hypertrophy is absent.

Published
2011

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