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069 Assessing the impact of non-invasive prenatal screening (NIPS) on health-related quality of life: a comparative study using patient- reported outcome measures (PROMs) in prenatal screening among pregnant women
  1. Meryeme El Balqui1,2,3,
  2. François Rousseau2,4,
  3. Sylvie Langlois5,
  4. Souleymane Gadio3,
  5. Suélène-Georgina Dofara1,3,
  6. Sabrina Guay-Bélanger1,3,
  7. Denis Talbot2,4,
  8. France Légaré1,2,3
  1. 1Chaire de recherche du Canada sur la décision partagée et la mobilisation des connaissances, Québec, QC, Canada
  2. 2Université Laval, Québec, QC, Canada
  3. 3VITAM – Centre de recherche en santé durable, Centre intégré universitaire de santé et services sociaux (CIUSSS) de la Capitale-Nationale, Québec, QC, Canada
  4. 4Centre de Recherche du Centre Hospitalier Universitaire de Québec-Université Laval, Québec City, Québec, Canada
  5. 5Dept of Medical Genetics, University of British Columbia, Vancouver, BC, Canada

Abstract

Introduction The integration of Non-Invasive Prenatal Screening (NIPS) as a universal first-tier screening could provide an earlier screening and if needed, diagnostic result compared to standard screening. While the clinical performance of NIPS is well-documented, little research has documented its impact on pregnant women health-related quality of life (HRQoL) thus hampering informed decision- making about prenatal options. We compared the impact of NIPS on HRQoL to standard care.

Methods In a prospective multicentric randomized trial, pregnant women (≥19 years) undergoing foetal chromosomal anomaly screening (T13, T18, T21) were randomized 2:1 to first-tier NIPS or standard care. Randomization considered age and recruitment site. HRQOL was assessed using PROM Physical Health and Mental Health summary scores at 10, 16, and 22 weeks of gestation. Descriptive and multivariate analyses, mainly using a linear mixed model, were performed.

Results A total of 7815 pregnant women have been recruited with mean age of 32 years (Standard Deviation=4) and 64.7% of European origin in both groups. At 10, 16, and 22 weeks of gestation, physical Health and Mental Health summary scores were 47.2 to 53.0 (± 6 to 8) in both arms. The mean differences between first-tier NIPS group and standard care group were -0.77 (95% CI 2.06–0.52; P=0.12), for the physical health and 0.8034 (95% CI 0.42–2.02, P=0.10) for the mental health.

Discussion Trajectories of physical and mental health scores were similar between groups. No significant differences were detected between the two groups.

Conclusions The findings provide evidence that first-tier NIPS as an option for prenatal screening doesn’t worsen the HRQOL over 22 weeks of gestation compared to standard care. This evidence will be informing future decision aids about prenatal screening.

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