Objective: To evaluate the economic and organizational issues in the introduction of maternal serum screening (MSS) for Down syndrome (DS) in Quebec. Methods: A literature review and an economic analysis were performed. Relevant ethical and organizational questions were examined. Results: MSS could double the number of detected cases, reduce the number of amniocenteses per detected case and the number of procedure-related miscarriage per detected case. Even though MSS is cost-effective, prenatal screening and diagnosis would detect only 50% or less of expected DS cases. Conclusion: Effectiveness and cost-effectiveness of prenatal diagnosis of DS are improved using MSS. In spite of this performance, prenatal screening and diagnosis bring about unaffected fetal losses. Voluntary participation to MSS based on a good understanding of risks and advantages of prenatal screening appears essential for ethical reasons. Organizational issues influencing the quality of care have to be taken into account in the policy-making process along with the results of the economic analysis.

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