Expanded Prenatal Testing Options and Informed Choice

描述（由申请人提供）：我们建议确定向所有年龄段的女性提供有关染色体疾病的所有产前检查的完整信息的影响，并允许她们就接受哪些检查（如果有）做出明智的选择。具体来说，我们计划更新经过验证的产前检测决策辅助工具（“PT 工具”），以纳入所有新的筛查选项，并使识字率较低的人群更容易使用。然后，我们将进行一项随机对照试验，比较“知情自由选择”测试方法（包括提供有关所有产前测试选项的信息和获取所有产前测试选项的机会）与种族/民族、社会经济和年龄多样化孕妇群体中常规护理的效果。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替代目前仅使用基于风险的阈值进行侵入性检测的做法，并采取一种策略，使所有女性都能做出反映其自身价值观和偏好的明智选择。第二个目标是扩展 PT 工具，纳入新的筛查测试，并对其进行修改，以供识字率较低的女性使用。具体目标是： 1) 确定与接受常规护理的女性相比，获得所有测试选项完整信息并拥有所有可用选项的女性选择哪些测试策略； 2) 更新 PT Tool 的英语和西班牙语版本，以包含新筛查选项的信息，并对其进行修改以供识字率较低的女性使用； 3) 评估与常规护理相比，接收完整信息和访问所有测试选项以及拥有所有可用选项对知识、风险理解和决策冲突的影响； 4) 与常规护理相比，评估“知情自由选择”方法提供产前检测服务的成本效益。简而言之，这项研究将产生一个有用的决策辅助工具，并提供用于设计具有成本效益的测试计划的信息，以允许偏好的变化。

DESCRIPTION (provided by applicant): 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 information 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.