EXPERIMENTAL STUDY TO IMPROVE RISK/BENEFIT APPRAISAL

改进风险/效益评估的实验研究

• 批准号: 2889693
• 负责人: James R. Sorenson
• 金额: $ 7.8万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2889693
• 关键词: African American; behavioral /social science research tag; blood disorder diagnosis; caucasian American; decision making; family genetics; family structure /dynamics; female; hemophilia As; informed consent; interview; questionnaires; racial /ethnic difference; self concept

DESCRIPTION (Adapted from the Investigator's Abstract): The specific aims of this research are to develop, implement, and assess the effectiveness of a decision balance risk-benefit component as part of the informed consent process for women deciding to accept or reject free hemophilia A carrier testing. The decision balance risk-benefit procedure is derived from Decision Conflict Theory, and in particular the decision balance-sheet methodology for assisting decision making. This method increases pre-decisional scanning of utilitarian and nonutilitarian consequences of decision alternatives to compensate for common pre-decisional deficiencies in such assessments. If effective, women whose informed consent statement includes a decision balance risk-benefit component, in contrast to women whose informed consent statement includes the usual listing of potential risks and benefits should (a) be aware of more potential harms and benefits associated with their decision; (b) have a clearer assessment of the importance of these for themselves; (c) report they considered more potential harms and benefits prior to their decision; and (d) experience less post-decision regret. To accomplish the specific aims the investigators will randomly assign 414 women, by family membership, to receive either a standard or experimental informed consent statement. One month after their decision, all women both those who chose testing and those who did not, will complete a self administered questionnaire and six and twelve months later they will complete telephone interviews. Major outcome variables include (a) satisfaction with the testing decision; (b) level of post-decision regret; (c) post-decision assessments of the adequacy of pre decision risk/benefit considerations; (d) stability and change in assessed risks and benefits from before to 6 and 12 months post-decision; and (e) similarities and differences between black/white, as well as in carrier/noncarrier risk and benefit assessments at each data collection point as well as over the period of the study. The investigators will employ both quantitative methods (SUUDAN cluster analyses) and qualitative methods (in depth interviews, theme and cases analyses.) If demonstrated to be effective, the decision balance risk-benefit procedure could be widely used in research involving human subjects.

描述(改编自《调查者摘要》)：具体目标 这项研究的目的是开发、实施和评估 作为知情同意的一部分，决定平衡风险-利益部分 女性决定接受或拒绝自由血友病A携带者的程序 测试。决策平衡风险-收益程序是从 决策冲突理论，特别是决策资产负债表 辅助决策的方法论。这种方法增加了 功利性和非功利性后果的决策前扫描 弥补决策前常见缺陷的决策替代方案 在这样的评估中。如果有效，其知情同意声明的妇女 包括决策平衡风险-收益部分，与妇女形成对比 其知情同意声明包括通常的潜在客户名单 风险和收益应(A)意识到更多潜在的危害和收益 与他们的决定有关；(B)对 这些对自己的重要性；(C)报告说他们考虑了更多 在作出决定前的潜在危害和好处；以及(D)经验 减少决策后的后悔。为了实现特定的目标， 调查人员将按家庭成员随机分配414名女性 收到标准的或实验性的知情同意声明。一 在他们做出决定的一个月后，所有的女性，包括那些选择测试的人和那些 谁没有，将完成一份自我管理的问卷和六个和 12个月后，他们将完成电话采访。主要成果 变量包括(A)对测试决定的满意度；(B) 决定后后悔；(C)决定后评估 决策风险/效益考虑；(D)评估的稳定性和变化 从作出决定前到作出决定后6个月和12个月的风险和收益；和(E) 黑/白之间的异同，以及在 每次数据收集时的运营商/非运营商风险和收益评估 在研究期间也是如此。调查人员将 使用定量方法(SUUDAN聚类分析)和定性方法 方法(深度访谈、主题分析和案例分析)如果演示给 如果有效，风险-收益平衡决策程序可以广泛应用 用于涉及人类受试者的研究。

项目成果

Communication about carrier testing within hemophilia A families.

关于甲型血友病家族内携带者检测的沟通。

• DOI: 10.1002/ajmg.c.10001
• 发表时间: 2003
• 期刊: American journal of medical genetics. Part C, Seminars in medical genetics
• 作者: Sorenson,JamesR;Jennings-Grant,Tracey;Newman,Jamie
• 通讯作者: Newman,Jamie