Development and validation of a measure of informed choice for women undergoing non-invasive prenatal testing for aneuploidy.

Development and validation of a measure of informed choice for women undergoing non-invasive prenatal testing for aneuploidy.
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DOI:
10.1038/ejhg.2015.207
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发表时间:
2016-06
期刊:
European journal of human genetics : EJHG
影响因子:
--
通讯作者:
Chitty LS
Chitty LS
中科院分区:
其他
文献类型:
--
作者:
Lewis C;Hill M;Skirton H;Chitty LS

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使用无细胞DNA进行非整倍体的无创产前检测(NIPT)是一种高度准确的筛查试验;然而,人们对检测常规化的可能性存在担忧。知情选择的多维测量(MMIC)是一种定量工具,用于评估唐氏综合征筛查(DSS)的知情选择。我们验证了NIPT的改进MMIC,并测量了在公共卫生服务中提供NIPT的妇女的知情选择。这项措施已分发给联合王国八个产科单位征聘的接受发展支助计划的妇女。通过同时进行定性访谈来评估结构效度。完成了585份调查问卷,并在抽血后进行了45次访谈(或拒绝NIPT的人)。测量结果具有良好的内部一致性和内部效度。结果表明,绝大多数女性(89%)做出了知情选择;95%的人被认为有良好的知识,88%的人有积极的态度,92%的人考虑过。11%的人被认为做出了不知情的选择,55%的人没有考虑过,41%的人知识不足,19%的人持消极态度。种族(OR=2.78, P=0.003)和接受NIPT (OR=16.05, P=0.021)是知情选择的显著预测因子。知情选择的高比率很可能反映了在本研究中提供测试前咨询的重要性。一旦NIPT在常规临床实践中提供,确保这一点是至关重要的。
Non-invasive prenatal testing (NIPT) using cell-free DNA for aneuploidy is a highly accurate screening test; however, concerns exist around the potential for routinisation of testing. The multidimensional measure of informed choice (MMIC) is a quantitative instrument developed to assess informed choice for Down syndrome screening (DSS). We have validated a modified MMIC for NIPT and measured informed choice among women offered NIPT in a public health service. The measure was distributed to women recruited across eight maternity units in the United Kingdom who had accepted DSS. Construct validity was assessed by simultaneously conducting qualitative interviews. Five hundred and eighty-five questionnaires were completed and 45 interviews conducted after blood-draw (or equivalent for those that declined NIPT). The measure demonstrated good internal consistency and internal validity. Results indicate the vast majority of women (89%) made an informed choice; 95% were judged to have good knowledge, 88% had a positive attitude and 92% had deliberated. Of the 11% judged to have made an uninformed choice, 55% had not deliberated, 41% had insufficient knowledge, and 19% had a negative attitude. Ethnicity (OR=2.78, P=0.003) and accepting NIPT (OR=16.05, P=0.021) were found to be significant predictors of informed choice. The high rate of informed choice is likely to reflect the importance placed on the provision of pre-test counselling in this study. It will be vital to ensure that this is maintained once NIPT is offered in routine clinical practice.