Expanded Prenatal Testing Options and Informed Choice

我们建议确定提供所有产前检查的完整信息的影响 向所有年龄段的妇女提供染色体障碍，并允许她们在知情的情况下选择 如有测试，则须接受测试。具体地说，我们计划更新一个经过验证的产前测试决策辅助工具 (“PT工具”)纳入所有新的筛查选项，使识字率较低的人更容易获得 人口。然后我们将进行一项随机对照试验，比较“知情免费”的效果 选择“检测方法，包括提供关于所有产前检测的信息和获得这些信息 在不同种族/族裔、社会经济和年龄不同的人口中选择通常的护理 怀孕的女人。主要目标是产生所需的证据，以确定临床医生是否应该 考虑一种替代目前仅使用基于风险的阈值进行侵入性检测的做法 采取一项战略，使所有妇女都能做出反映她们自身情况的明智选择 值和首选项。第二个目标是扩展PT工具，以包括新的筛查测试并对其进行修改 文化程度较低的女性使用。具体目标是：1)确定哪些测试策略由 收到关于所有测试选项的完整信息并拥有所有可用选项的女性 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 工具，包括关于新的筛查选择的信息，并对其进行修改，以供识字率较低的妇女使用；3) 评估接收有关所有测试选项的完整信息和访问所有测试选项的影响 与通常的护理相比，在知识、风险理解和决策冲突方面提供的选项；4) 评估提供产前检测服务的“知情自由选择”方法的成本效益 与平时的护理相比。总之，这项研究将产生一个有用的决策辅助工具，并提供 用于设计经济高效的测试程序的信息，这些程序允许不同的偏好。

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.