Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Human Genetics, Radboud University Medical Center, Nijmegen, The Netherlands.
Health Expect. 2018 Jun;21(3):659-667. doi: 10.1111/hex.12661. Epub 2017 Dec 27.
BRCA1/2 mutation carriers' choice between risk-reducing salpingo-oophorectomy (RRSO) and salpingectomy with delayed oophorectomy is very complex. Aim was to develop a patient decision aid that combines evidence with patient preferences to facilitate decision making.
Systematic development of a patient decision aid in an iterative process of prototype development, alpha testing by patients and clinicians and revisions using International Patient Decision Aid Standards (IPDAS) quality criteria. Information was based on the available literature and current guidelines. A multidisciplinary steering group supervised the process.
Pre-menopausal BRCA1/2 mutation carriers choosing between RRSO and salpingectomy with delayed oophorectomy in Family Cancer Clinics in the Netherlands.
IPDAS quality criteria, relevance, usability, clarity.
The patient decision aid underwent four rounds of alpha testing and revisions. Finally, two paper decision aids were developed: one for BRCA1 and one for BRCA2. They both contained a general introduction, three chapters and a step-by-step plan containing a personal value clarification worksheet. During alpha testing, risk communication and information about premature menopause and hormone therapy were the most revised items. The patient decision aids fulfil 37 of 43 (86%) IPDAS criteria for content and development process.
Both BRCA1/2 mutation carriers and professionals are willing to use or offer the developed patient decision aids for risk-reducing surgery. The patient decision aids have been found clear, balanced and comprehensible. Future testing among patients facing the decision should point out its effectiveness in improving decision making.
BRCA1/2 基因突变携带者在选择预防性输卵管卵巢切除术（RRSO）和输卵管切除术加延迟卵巢切除术之间的决策非常复杂。目的是开发一种将证据与患者偏好相结合的患者决策辅助工具，以促进决策。
在迭代原型开发过程中系统地开发患者决策辅助工具，通过患者和临床医生进行 alpha 测试，并使用国际患者决策辅助标准（IPDAS）质量标准进行修订。信息基于现有文献和当前指南。一个多学科指导小组监督了这个过程。
在荷兰的家族癌症诊所中，选择 RRSO 和输卵管切除术加延迟卵巢切除术的绝经前 BRCA1/2 基因突变携带者。
IPDAS 质量标准、相关性、可用性、清晰度。
患者决策辅助工具经过四轮 alpha 测试和修订。最终，开发了两种纸质决策辅助工具：一种用于 BRCA1，另一种用于 BRCA2。它们都包含一个一般介绍、三个章节和一个逐步计划，其中包含一个个人价值澄清工作表。在 alpha 测试期间，风险沟通以及关于早发性绝经和激素治疗的信息是修订最多的项目。患者决策辅助工具满足了 43 项 IPDAS 标准中的 37 项（86%），内容和开发过程都得到了满足。
BRCA1/2 基因突变携带者和专业人员都愿意使用或提供为降低风险手术而开发的患者决策辅助工具。这些决策辅助工具被发现清晰、平衡且易于理解。未来在面临决策的患者中进行测试应该能够指出其在改善决策方面的有效性。
