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英国高通量非侵入性产前检测胎儿 RHD 基因型检测的实施:对妇产科单位的横断面调查和专家访谈结果。

Implementation of high-throughput non-invasive prenatal testing for fetal RHD genotype testing in England: Results of a cross-sectional survey of maternity units and expert interviews.

机构信息

Cedar, Cardiff and Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, UK.

出版信息

Transfus Med. 2020 Aug;30(4):287-294. doi: 10.1111/tme.12702. Epub 2020 Jun 11.

DOI:10.1111/tme.12702
PMID:32447792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7496714/
Abstract

BACKGROUND

Previously, routine antenatal anti-D prophylaxis (RAADP) was administered to all RhD-negative mothers to reduce the risk of sensitisation in the UK's National Health Service (NHS). If the baby is RhD-negative, RAADP is not required. In 2016, the UK National Institute for Health and Care Excellence (NICE) recommended non-invasive prenatal testing (NIPT) for fetal RHD genotype as a cost-effective option to guide RAADP.

OBJECTIVES

To evaluate the implementation of high-throughput NIPT for fetal RHD genotype in maternity units in England by addressing research recommendations from the NICE. These were to reduce uncertainty around the resource use and cost of staff training, management of samples and results and record-keeping, as well as resultant changes to antenatal or post-partum care and performance of NIPT.

METHODS

A cross-sectional survey was developed and sent to clinicians at 39 English NHS Trusts in May 2018. Qualitative interviews with seven individuals were conducted to explore missing or contraindicatory data. Qualitative findings were supplemented with NIPT test results (April 2017 to February 2019) from English hospitals.

RESULTS

Staff reported that training took up to 30 minutes. There were no extra costs associated with sample management or additional appointments. Extra time required for record-keeping and management of test results was balanced later in the patient pathway. The antenatal pathway was not changed in the Trusts surveyed. The survey revealed that four post-partum scenarios were being used within English NHS Trusts. The frequency of inconclusive NIPT results was 4.3%.

CONCLUSION

NIPT for fetal RHD genotype can be implemented without consuming substantial extra resources through incorporation into an existing patient pathway.

摘要

背景

先前,英国国民保健制度(NHS)常规进行产前抗-D 预防(RAADP),以降低 RhD 阴性母亲致敏的风险。如果婴儿是 RhD 阴性,则无需进行 RAADP。2016 年,英国国家卫生与临床优化研究所(NICE)建议采用非侵入性产前检测(NIPT)对胎儿 RHD 基因型进行检测,作为指导 RAADP 的一种具有成本效益的选择。

目的

通过解决 NICE 的研究建议,评估英国产科单位中高通量 NIPT 用于胎儿 RHD 基因型的实施情况。这些建议旨在减少人员培训、样本和结果管理以及记录保存方面资源使用和成本的不确定性,以及由此导致的产前或产后护理变化和 NIPT 的性能。

方法

2018 年 5 月,我们开发了一项横断面调查,并发送给了 39 家英国 NHS 信托机构的临床医生。对 7 名个人进行了定性访谈,以探讨缺失或禁忌数据。定性结果补充了英国医院的 NIPT 检测结果(2017 年 4 月至 2019 年 2 月)。

结果

工作人员报告说,培训需要长达 30 分钟。样本管理或额外预约没有额外费用。记录保存和测试结果管理所需的额外时间在患者流程的后期得到平衡。在所调查的信托机构中,产前流程没有改变。调查显示,英国 NHS 信托机构中正在使用四种产后方案。无法得出结论的 NIPT 结果的频率为 4.3%。

结论

通过纳入现有的患者流程,NIPT 用于胎儿 RHD 基因型可以在不消耗大量额外资源的情况下实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/f3e7b2610df1/TME-30-287-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/e0d070db00dc/TME-30-287-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/3ee406bc2f85/TME-30-287-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/ef1e9fd88672/TME-30-287-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/f3e7b2610df1/TME-30-287-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/e0d070db00dc/TME-30-287-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/3ee406bc2f85/TME-30-287-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/ef1e9fd88672/TME-30-287-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7613/7496714/f3e7b2610df1/TME-30-287-g004.jpg

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Diagnostic accuracy of routine antenatal determination of fetal RHD status across gestation: population based cohort study.孕期常规产前测定胎儿RHD状态的诊断准确性:基于人群的队列研究
BMJ. 2014 Sep 4;349:g5243. doi: 10.1136/bmj.g5243.
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Use of cffDNA to avoid administration of anti-D to pregnant women when the fetus is RhD-negative: implementation in the NHS.
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BJOG. 2015 Nov;122(12):1682-6. doi: 10.1111/1471-0528.13055. Epub 2014 Aug 21.
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