La prise de décisions éclairée sur le dépistage prénatal cfDNA : une évaluation des documents écrits

Translated title of the contribution: Informed decision-making about prenatal cfDNA screening: An assessment of written materials

M. Michie, S. A. Kraft, M. A. Minear, R. R. Ryan, Megan Allyse

Research output: Contribution to journalShort survey

3 Citations (Scopus)

Abstract

Objectives The introduction of prenatal cfDNA screening for fetal aneuploidy and other genetic conditions has exacerbated concerns about informed decision-making in clinical prenatal testing. To assess the information provided to patients to facilitate decisions about cfDNA screening, we collected written patient education and consent documents created by laboratories and clinics. Methods Informed consent documents (IC) were coded by two independent coders. Each IC was assessed for readability, attention to elements of informed consent, and completeness of information about the test and the screened conditions. Results We found variance between IC produced by commercial laboratories versus those provided by local clinics or health care systems, and considerable variance among materials from all sources. “Commercial” IC were longer and written at a more difficult reading level than “non-commercial” IC, and were less likely to state explicitly that cfDNA only screens for certain conditions. About one-third of IC were combined with laboratory order forms. Though most IC recommended confirmatory testing for positive results, only about half clearly stated that results could be incorrect — including mentions of false positives or false negatives. About one-third of IC explicitly stated that cfDNA screening was optional. While nearly all IC from any source listed the conditions screened by the test, only about half of the IC included any phenotypic descriptions of these conditions. Few IC mentioned psychosocial considerations, and only one IC mentioned the availability of support groups for families of children with genetic conditions. Conclusions Based on our findings, we recommend that written and well-informed consent be sought before performing cfDNA screening, and we offer minimal and recommended standards for patient education and consent materials.

Original languageFrench
Pages (from-to)362-371
Number of pages10
JournalEthics, Medicine and Public Health
Volume2
Issue number3
DOIs
StatePublished - Jul 1 2016

Fingerprint

Consent Forms
Prenatal Diagnosis
Decision Making
Patient Education
Informed Consent
Self-Help Groups
Aneuploidy

Keywords

  • cfDNA
  • Informed consent
  • NIPT
  • Prenatal screening
  • Reproductive health

ASJC Scopus subject areas

  • Health Policy

Cite this

La prise de décisions éclairée sur le dépistage prénatal cfDNA  : une évaluation des documents écrits. / Michie, M.; Kraft, S. A.; Minear, M. A.; Ryan, R. R.; Allyse, Megan.

In: Ethics, Medicine and Public Health, Vol. 2, No. 3, 01.07.2016, p. 362-371.

Research output: Contribution to journalShort survey

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abstract = "Objectives The introduction of prenatal cfDNA screening for fetal aneuploidy and other genetic conditions has exacerbated concerns about informed decision-making in clinical prenatal testing. To assess the information provided to patients to facilitate decisions about cfDNA screening, we collected written patient education and consent documents created by laboratories and clinics. Methods Informed consent documents (IC) were coded by two independent coders. Each IC was assessed for readability, attention to elements of informed consent, and completeness of information about the test and the screened conditions. Results We found variance between IC produced by commercial laboratories versus those provided by local clinics or health care systems, and considerable variance among materials from all sources. “Commercial” IC were longer and written at a more difficult reading level than “non-commercial” IC, and were less likely to state explicitly that cfDNA only screens for certain conditions. About one-third of IC were combined with laboratory order forms. Though most IC recommended confirmatory testing for positive results, only about half clearly stated that results could be incorrect — including mentions of false positives or false negatives. About one-third of IC explicitly stated that cfDNA screening was optional. While nearly all IC from any source listed the conditions screened by the test, only about half of the IC included any phenotypic descriptions of these conditions. Few IC mentioned psychosocial considerations, and only one IC mentioned the availability of support groups for families of children with genetic conditions. Conclusions Based on our findings, we recommend that written and well-informed consent be sought before performing cfDNA screening, and we offer minimal and recommended standards for patient education and consent materials.",
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N2 - Objectives The introduction of prenatal cfDNA screening for fetal aneuploidy and other genetic conditions has exacerbated concerns about informed decision-making in clinical prenatal testing. To assess the information provided to patients to facilitate decisions about cfDNA screening, we collected written patient education and consent documents created by laboratories and clinics. Methods Informed consent documents (IC) were coded by two independent coders. Each IC was assessed for readability, attention to elements of informed consent, and completeness of information about the test and the screened conditions. Results We found variance between IC produced by commercial laboratories versus those provided by local clinics or health care systems, and considerable variance among materials from all sources. “Commercial” IC were longer and written at a more difficult reading level than “non-commercial” IC, and were less likely to state explicitly that cfDNA only screens for certain conditions. About one-third of IC were combined with laboratory order forms. Though most IC recommended confirmatory testing for positive results, only about half clearly stated that results could be incorrect — including mentions of false positives or false negatives. About one-third of IC explicitly stated that cfDNA screening was optional. While nearly all IC from any source listed the conditions screened by the test, only about half of the IC included any phenotypic descriptions of these conditions. Few IC mentioned psychosocial considerations, and only one IC mentioned the availability of support groups for families of children with genetic conditions. Conclusions Based on our findings, we recommend that written and well-informed consent be sought before performing cfDNA screening, and we offer minimal and recommended standards for patient education and consent materials.

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