Expanded Prenatal Testing Options and Informed Choice

扩大产前检测选项和知情选择

• 批准号: 7933158
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 6.03万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2010-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7933158
• 关键词: Adopted; Affect; Age; Benefits and Risks; Clinic; Clinical; Complex; Comprehension; Conflict (Psychology); Congenital chromosomal disease; Cultural Backgrounds; Diagnostic tests; Down Syndrome; Fetus; Goals; Guidelines; Individual; Knowledge; Language; Low Literacy Population; Outcome; Policy Maker; Population Heterogeneity; Pregnant Women; Prenatal care; Provider; Randomized Controlled Trials; Risk; Screening procedure; Services; Target Populations; Testing; United States; Update; Variant; Woman; aged; base; cost; cost effectiveness; design; improved; literacy; preference; prenatal; prenatal testing; programs; socioeconomics; tool; treatment as usual; trial comparing

We propose to determine the impact of providing complete information about all prenatal tests for chromosomal disorders to women of all ages and allowing them to make informed choices regarding which tests, if any, to undergo. Specifically, we plan to update a validated prenatal testing decision-assisting tool ("PT Tool") to incorporate all new screening options and make it more accessible to a lower literacy population. We then will conduct a randomized controlled trial comparing the effect of an "informed free choice" approach to testing, consisting of providing information regarding and access to all prenatal testing options, to that of usual care among a racially/ethnically, socioeconomically and age-diverse population of pregnant women. The primary goal is to generate evidence needed to determine whether clinicians should consider an alternative to the current practice of using only risk-based thresholds for invasive testing and adopt a strategy that would enable all women to make informed choices that are reflective of their own values and preferences. A second goal is to expand PT Tool to include new screening tests and modify it for use by lower literacy women. Specific aims are to: 1) determine which testing strategies are selected by women who receive complete information on all testing options and have all the options available to them compared to women receiving usual care; 2) update both the English- and Spanish-language versions of PT Tool to include infromation on new screening options and modify them for use by lower literacy women; 3) assess the impact of receiving complete information on and access to all testing options and having all options available on knowledge, risk comprehension, and decisional conflict compared to usual care; 4) evaluate the cost effectiveness of an"informed free choice" approach to providing prenatal testing services compared to usual care. In short, this study will generate a useful decision-assisting tool and provide information for use in designing cost-effective testing programs that allow for variation in preferences.

我们建议确定提供有关所有产前测试的完整信息的影响 染色体疾病对各个年龄段的妇女，并允许她们做出明智的选择 测试（如果有的话）进行。具体而言，我们计划更新经过验证的产前测试决策工具 （“ PT工具”）合并所有新的筛选选项并使其更容易获得较低的识字能力 人口。然后，我们将进行一项随机对照试验，比较“无知的免费” 选择“测试方法，包括提供有关和访问所有产前测试的信息 在种族/种族，社会经济和年龄多元化的种族，社会经济和年龄人口中，选择的选择 孕妇。主要目标是生成所需的证据，以确定临床医生是否应 考虑仅使用基于风险的阈值进行侵入性测试的当前做法的替代方法 采用一种策略，使所有妇女能够做出反映自己的明智选择 价值和偏好。第二个目标是扩展PT工具以包括新的筛选测试并将其修改为 低识字妇女的使用。具体目的是：1）确定由 获得有关所有测试选项并拥有所有可用选项的妇女 与接受常规护理的妇女相比； 2）更新PT的英语和西班牙语版本 包括在新筛选方案上包括不适的工具，并将其修改为低识字妇女使用； 3） 评估接收有关所有测试选项的完整信息并拥有所有信息的影响 与通常的护理相比，有关知识，风险理解和决策冲突的选择； 4） 评估提供产前测试服务的“知情自由选择”方法的成本效益 与通常的护理相比。简而言之，这项研究将生成一个有用的决策工具，并提供 用于设计具有成本效益的测试程序的信息，允许偏好变化。