Admin. Supplement to: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing

行政。

• 批准号: 10165356
• 负责人: Ruth Farrell
• 金额: $ 22.37万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165356
• 关键词: 2019-nCoV; Affect; Attention; Benefits and Risks; Blood; COVID-19; COVID-19 pandemic; Child; Client satisfaction; Clinic; Clinical; Columbidae; Data; Decision Making; Diagnostic tests; Ensure; Ethics; Exposure to; Family; First Pregnancy Trimester; Fright; Future; Genetic Screening; Gestational Age; Goals; Guidelines; Health; Health Personnel; Health care facility; Health system; Healthcare; Healthcare Systems; Informed Consent; Interview; Laboratories; Methods; Outcome; Outpatients; Parents; Patients; Pattern; Pregnancy; Pregnancy Outcome; Pregnant Women; Prenatal care; Procedures; Process; Provider; Public Health; Quality of Care; Registries; Resources; Risk; Safety; Screening Result; Second Pregnancy Trimester; Social Distance; System; Tail; Testing; Time; Ultrasonography; Visit; Woman; base; evidence base; genetic technology; genetic testing; health care delivery; healthcare community; obstetric outcomes; pandemic disease; pregnant; prenatal; prenatal testing; public health emergency; reproductive; risk perception; shared decision making; social implication

PROJECT ABSTRACT Prenatal genetic screening tests and diagnostic tests (referred to as prenatal genetic tests) are a fundamental component of the delivery of high-quality, evidence-based prenatal care. Current guidelines recommend that prenatal genetic tests should be offered to all pregnant patients to optimize obstetric outcomes, ideally offered early in pregnancy so that patients can make formative decisions about their prenatal care. Delay in access and utilization of prenatal genetic tests can have significant implications for pregnancy outcomes. The COVID- 19 pandemic is an urgent clinical problem that has emerged with the potential to jeopardize women's access to genetic tests. Currently, it is not known how COVID-19 may impact pregnant women's access to and utilization of these critical tests. This includes concern not just for those pregnant women who become severely ill with COVID-19 but also those who fear exposure to SARS-CoV-2 by presenting to a healthcare facility have genetic testing by means of a blood draw or ultrasound-based procedure. The goal of this study is to study the effect of COVID-19 on prenatal healthcare delivery, specifically patients' ability to access prenatal genetic screen- ing and diagnostic tests in an informed and evidence-based fashion. By doing so, we will identify serious short term health issues for women, children, and families resulting from this pandemic and readily- deployable and scalable solutions to ensure women's informed access to high-quality prenatal care during future public health crises. This study is significant as its findings will lead to system-level improvements to support pregnant patients' informed access to prenatal genetic tests for the duration of the pandemic and fu- ture public health emergencies of similar magnitude. Additionally, this study will increase the impact of the NEST R01, providing an in-depth understanding of how COVID-19 affects shared decision-making, informed consent, and patient satisfaction regarding prenatal genetic testing decisions. In doing so, this proposal dove- tails with the objectives of the parent R01 to ensure that patients have informed access to advances in prenatal genetic technologies as crucial metrics of prenatal healthcare safety, access, and quality.

项目摘要 产前基因筛查检测和诊断检测（简称产前基因检测）是一项基本的 这是提供高质量、循证产前护理的一个组成部分。现行准则建议， 应向所有怀孕患者提供产前基因检测，以优化产科结局， 在怀孕早期，这样病人就可以对他们的产前护理作出决定。访问延迟 产前基因检测的使用可能对妊娠结果产生重大影响。COVID- 19大流行病是一个紧迫的临床问题，已经出现，有可能危及妇女获得 基因测试目前，尚不清楚COVID-19可能如何影响孕妇获得和利用 这些关键的测试。这不仅包括对那些因怀孕而患重病的孕妇的关注， COVID-19以及那些担心通过向医疗机构提交而暴露于SARS-CoV-2的人， 通过抽血或基于超声的程序进行检测。本研究的目的是研究 COVID-19对产前保健的影响，特别是患者获得产前基因筛查的能力- 以知情和循证的方式进行检查和诊断测试。通过这样做，我们将确定严重的 妇女、儿童和家庭的短期健康问题， 可部署和可扩展的解决方案，以确保妇女在怀孕期间获得高质量的产前护理 未来的公共卫生危机。这项研究具有重要意义，因为其研究结果将导致系统层面的改进， 支持孕妇在大流行期间知情地接受产前基因检测， 类似规模的突发公共卫生事件。此外，这项研究将增加影响的 NEST R 01深入了解COVID-19如何影响共同决策， 同意，以及患者对产前基因检测决定的满意度。在这样做的时候，这个提议鸽子- 尾部与父R 01的目标一致，以确保患者能够知情地获得产前检查的进展， 遗传技术作为产前保健安全、可及性和质量的关键指标。