RT Journal Article
SR Electronic
T1 A Comparative Study Using Patient-Reported Outcome Measures (PROMs) in Prenatal Screening among pregnant women in Canada
JF The Annals of Family Medicine
JO Ann Fam Med
FD American Academy of Family Physicians
SP 6534
DO 10.1370/afm.22.s1.6534
VO 22
IS Supplement 1
A1 El Balqui, Meryeme
A1 Rousseau, Francois
A1 Langlois, Sylvie
A1 Dofara, Georgina Suélène
A1 Gadio, Souleymane
A1 Talbot, Denis
A1 Legare, France
YR 2024
UL http://www.annfammed.org/content/22/Supplement_1/6534.abstract
AB Context: 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, to our knowledge, no research has documented its impact on pregnant women’s health-related quality of life (HRQoL), thus hampering informed decision-making about prenatal options.Objective: We compared the impact of NIPS on HRQoL with that to standard care.Study Design and Analysis: In a prospective multicentric randomized 2:1 clinical trial, descriptive and multivariable analyses, mainly linear mixed models, were performed.Setting: Randomization considered age and recruitment site in Quebec and British-Columbia.Population Studied: Pregnant women (≥19 years) undergoing foetal chromosomal anomaly screening (T13, T18, T21).Intervention/Instrument: First-tier NIPS compared to standard care.Outcome Measures: HRQoL was assessed using the PROMIS-29 v2.1 at 10, 16, and 22 weeks of gestation.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, the PROMIS-29 T-Scores of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain were 47.2 to 53.0 (± 6 to 8) in both arms and the majority falls within the normal limits category of the T-score across all PROMIS-29 domains. The mean differences between first-tier NIPS group and standard care group were -0.27 (95% CI -0.87;0.33, P=0.2) for physical function, 0.21 (95% CI -0.55;0.98, P=0.35) for anxiety,0.28 (95% CI -0.41;0.96, P=0.28) for depression,0.55 (95% CI -0.19;1.30, P=0.08) for fatigue, 0.15 (95% CI -0.35;0.95, P=0.18) for sleep disturbance, -0.50 (95% CI -1.25;0.22, P=0.09) for ability to participate in social roles, and 0.12 (95% CI -0.50;0.74 P=0.48) for pain.Conclusions: Trajectories of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference T-Scores were similar between groups. No significant differences were detected between the two groups. Our findings offer initial evidence that choosing first-tier NIPS for prenatal screening maintains HRQOL through 22 weeks of gestation, similar to standard care. This evidence will inform future decision aids about prenatal screening.