Expanded Prenatal Testing Options and Informed Choice

扩大产前检测选项和知情选择

• 批准号: 7032858
• 负责人: MIRIAM KUPPERMANN
• 金额: $ 30万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7032858
• 关键词: Downs syndrome; behavioral /social science research tag; choice; chromosome disorders; clinical research; computer assisted medical decision making; cost effectiveness; female; focus groups; genetic counseling; genetic disorder diagnosis; health behavior; health care service availability; health care service evaluation; health services research tag; human pregnant subject; human subject; interview; nonEnglish language; prenatal care; prenatal diagnosis; socioeconomics; women' s health

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.

描述（由申请人提供）：我们建议确定提供有关所有年龄段女性染色体疾病的所有产前测试的完整信息的影响，并允许她们在哪些测试（如果有）进行哪些测试方面做出明智的选择。具体而言，我们计划更新经过验证的产前测试决策辅助工具（“ PT工具”），以合并所有新的筛选选项，并使较低的识字人群更容易获得。然后，我们将进行一项随机对照试验，将“知情自由选择”方法的效果进行比较，包括提供有关和获取所有产前测试选择的信息，以及在种族/种族/种族，社会经济和年龄多样性孕妇的孕妇中的常规护理中的信息。主要目标是生成所需的证据，以确定临床医生是否应该考虑仅使用基于风险的阈值进行入侵测试的替代方法，并采用一种策略，使所有妇女能够做出反映自己的价值观和偏好的明智选择。第二个目标是扩展PT工具，以包括新的筛选测试，并将其修改为较低的扫盲女性。具体目的是：1）确定妇女选择了哪些测试策略，这些妇女将获得有关所有测试选项的完整信息，并且与接受常规护理的妇女相比，所有可用的选择都可以使用； 2）更新PT工具的英语和西班牙语版本，以包括有关新筛选选项的信息，并修改它们以供较低的扫盲女性使用； 3）评估与常规护理相比，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以及具有有关知识，风险理解和决策冲突的所有选项； 4）评估“知情自由选择”方法的成本效益与通常的护理相比提供产前测试服务。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，以允许偏好变化。