Randomized Trial of a Decision Aid for BRCA1/BRCA2 Mutation Carriers: Impact on Measures of Decision Making and Satisfaction
Randomized Trial of a Decision Aid for BRCA1/BRCA2 Mutation Carriers: Impact on Measures of Decision Making and Satisfaction
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DOI：
10.1037/a0013147
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发表时间：
2009-01-01
影响因子：
4.2
通讯作者：
Komaridis, Kathryn
中科院分区：
文献类型：
--
作者：
Schwartz, Marc D.;Valdimarsdottir, Heiddis B.;Komaridis, Kathryn
目的：基因检测越来越多地成为有乳腺癌家族史妇女的常规临床护理的一部分。考虑到BRCA1/BRCA2突变携带者患乳腺癌的风险大大增加，他们必须做出艰难的决定，是否选择降低风险的乳房切除术。为了帮助BRCA1/2携带者做出决定，作者开发了一种基于计算机的交互式决策辅助工具，并在一项随机对照试验中对常规护理进行了测试。设计：完成遗传咨询后，214名女性（21-75岁）BRCA1/BRCA2突变携带者被随机分为常规护理组（UC, N = 114）或常规护理加决策辅助组（DA, N = 100）。UC参与者没有接受额外的干预。参加者可在家中观看光碟。主要结果测量：作者在随机分组后1个月、6个月和12个月测量了最终的管理决策、决策冲突、决策满意度和接受降低风险的乳房切除术。结果：纵向分析显示，DA在最初不确定如何控制乳腺癌风险的携带者中是有效的。在该组中，与UC相比，DA增加了达成管理决策的可能性（OR = 3.09, 95% CI = 1.62, 5.90; p < 0.001），减少了决策冲突（B = - 0.46, z = -3.1, p < 0.001），提高了满意度（B = 0.27, z = 3.1, p = 0.002）。在随机化时已经做出管理决策的携带者中，DA相对于UC没有益处。结论：这些结果表明，难以做出乳腺癌风险管理决策的BRCA1/BRCA2突变携带者可以从辅助决策支持中受益。
Objective: Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial. Design: After the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home. Main Outcome Measures: The authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization. Results: Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p < .001), decreased decisional conflict (B = -.46, z = -3.1, p < .002), and increased satisfaction (B = .27, z = 3.1, p = .002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC. Conclusion: These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.