EXPERIMENTAL STUDY TO IMPROVE RISK/BENEFIT APPRAISAL

改进风险/效益评估的实验研究

• 批准号: 2546138
• 负责人: James R. Sorenson
• 金额: $ 7.23万
• 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 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2546138
• 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（改编自研究者摘要）：具体目标 这项研究的目的是开发，实施和评估有效性， 作为知情同意书一部分的决策风险-获益平衡部分 妇女决定接受或拒绝游离血友病A携带者的过程 试验. 决策平衡风险-收益程序源自 决策冲突理论，特别是决策资产负债表 协助决策的方法。 该方法提高 决策前扫描的功利和非功利的后果 弥补常见决策前缺陷的决策替代方案 在这样的评估中。 如果有效，知情同意声明 包括一个决策平衡风险-收益组成部分，与女性相比， 其知情同意声明包括潜在的 风险和收益应（a）意识到更多的潜在危害和收益 （B）对其决定作出更明确的评估; （c）他们审议更多报告 决定前的潜在危害和益处;以及（d）经验 更少的事后后悔 为了实现具体目标， 研究人员将根据家庭成员随机分配414名妇女， 获得标准或实验性知情同意声明。 一 在他们做出决定后一个月，所有选择测试的女性和 谁没有，将完成一个自我管理的问卷和六个， 12个月后，他们将完成电话面试。 主要成果 变量包括（a）对测试决定的满意度;（B） 决策后后悔;（c）决策后对决策前的充分性的评估 决策风险/效益考虑因素;（d）评估的稳定性和变化 从决策前到决策后6个月和12个月的风险和收益;以及（e） 黑/白色之间的异同，以及 每次数据收集时的携带者/非携带者风险和获益评估 以及在研究期间。 调查人员将 采用定量方法（SUUDAN聚类分析）和定性方法 方法（深入访谈、主题分析和案例分析）如果证明 有效，决策平衡风险-收益程序可以广泛应用于 用于涉及人体的研究。