The recent modifications of the French bioethics law, the therapeutic progress and the massive development of advanced genetic techniques (such Next-Generation Sequencing (NGS)) with a rapid decrease in costs imply to question the extension of Newborn Screening (NBS) to new actionable pathologies and the acceptable and relevant methods for its possible expansion. International studies are beginning to determine the potential place of NGS in NBS. In this perspective, the SeDeN project aims to fully assess the social acceptability of these issues by measuring the diversity and consistency of expectations of French health professionals, parents and public policy makers. The SeDeN-p3 Study focuses on the opinions of parents. It aims to analyze the perception of parents in different situations: birth, early childhood, child screened in the framework of the national neonatal screening program, etc. The objective of this part is to study the understanding and expectations of parents in France regarding the extension of newborn screening as well as their preferences regarding its conditions (information, types of pathologies, screening methods, etc.).
Study Type
OBSERVATIONAL
Enrollment
1,585
Online self-administered questionnaire to quantitatively mesure parental knowledge and expectations on current and expanded newborn screeing and parental acceptability of expanded newborn screening using genetic.
Semi-structured interview to explore parental representations on the extension of newborn screening and - if concerned - to retrace the screening/diagnosis/care management pathway
Hopital Antoine Beclere - Aphp
Clamart, France
Chu Dijon Bourgogne
Dijon, France
Hôpital Necker - Enfants Malades
Paris, France
Groupe Hospitalier de La Haute-Saône
Vesoul, France
Mixed matrix of parental acceptability dimensions of expanded newborn screening (Mixed-data matrix)
Mixed method design used to measure parental acceptability composed of quantitative and qualitative data
Time frame: November 2023
Parental acceptability scores for expanded newborn screening (Theorical Framework of Acceptability scores in self-administered questionnaire to measure parental acceptability)
Time frame: November 2023
Typology of parental acceptability scores for expanded newborn screening (Classification)
Time frame: November 2023
Measure of importance given to different modalities of information about newborn screening (by whom, when, how, etc.) (Multiple Choice Questions)
Time frame: November 2023
Parent opinion on newborn screening for Spinal Muscular Atrophy, Duchenne muscular dystrophy, BRCA-related breast and ovarian cancer predisposition syndrome and congenital long QT
(5-point Likert scale for agreement and thematic content analysis of the free comment areas)
Time frame: November 2023
Parent's views on the use of genetic testing in expanded newborn screening (Likert scales)
Time frame: November 2023
Description of acceptability of expanded newborn screening to parents of a sick child (Thematic content analysis)
Time frame: April 2024
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