Development and Pilot Test of an Elective BSO Decision Support Guide

描述(由申请者提供)：卵巢癌是一种常见且往往致命的疾病。每年有60多万妇女接受子宫切除术，其中90%是在非癌症情况下进行的。历史上，这些妇女中的许多人接受了双侧输卵管卵巢切除术(BSO)，以降低卵巢癌的风险和/或避免可能的并发症和未来与良性卵巢肿瘤、子宫内膜异位症和盆腔疼痛相关的手术。然而，BSO会导致卵巢雌激素和雄激素的永久性丢失，这些激素被认为与维持心血管健康、骨骼健康、性功能和总体健康相关的生活质量有关。因此，对于没有卵巢癌遗传风险增加的绝经前妇女，建议考虑保留卵巢，尽管对于如何决定是否进行择期BSO和良性情况下的子宫切除时间还没有明确的指导方针。已经开发了决策辅助工具，并鼓励在许多领域使用它们，以帮助患者和提供者分享做出知情决定的机会，特别是在包括一种以上护理方法、不确定结果以及人们不同评价的益处和危害的情况下。显然，围绕BSO的决策是一个符合这些标准的领域。因此，我们建议进行形成性研究，并利用它来开发和试行BSO决策支持指南，以帮助患者与他们的提供者分享关于是否在子宫切除术的同时接受BSO以预防卵巢癌的知情的、基于偏好的决定。为了实现这些目标，我们将进行一系列焦点小组和一对一定性访谈，以评估即将接受或最近因非癌症疾病接受子宫切除术的女性如何看待可选的BSO，并评估她们在这一背景下关于共同决策的信息需求和愿望。然后，我们将使用从文献中获得的信息，从我们的形成性研究中获得的信息，以及咨询过女性这一选择的提供者的经验，创建BSO决策支持指南草案。在对62名计划接受良性子宫切除术的妇女进行BSO决策支持指南试点测试后，我们将评估其对患者及其提供者的有用性和可用性，之后我们将生成最终版本，供将来研究干预对BSO决策质量和使用的影响时使用。公共卫生相关性：这项研究的结果将有助于关于妇女对BSO的偏好和态度的小型文献。这项研究将产生一份临床上有用的BSO决策支持指南，不同识字水平和不同文化背景的妇女可以使用该指南来帮助她们参与关于使用BSO的共同决策。它还将生成调查问卷和数据，用于规划未来对指南对中等风险妇女子宫切除所伴随的BSO的知情决策的影响以及对BSO的使用和满意度的影响的评估。

DESCRIPTION (provided by applicant): Ovarian cancer is a common and often fatal condition. Over 600,000 women undergo hysterectomy each year, 90% of which are done for non-cancerous conditions. Historically, many of these women have undergone bilateral salpingo-oophorectomy (BSO) to decrease the risk of ovarian cancer and/or to avoid possible morbidities and future surgery related to benign ovarian neoplasms, endometriosis, and pelvic pain. However, BSO results in a permanent loss of ovarian estrogen and androgens that are known to be associated with maintenance of cardiovascular health, bone health, sexual functioning, and overall health-related quality-of-life. As a result, consideration of ovarian retention for premenopausal women who are not at increased genetic risk of ovarian cancer has been advocated, although no clear guidelines have been established regarding how decisions should be made regarding whether or not to perform elective BSO and the time of hysterectomy for benign condition. Decision aids have been developed and their use has been encouraged, in a number of areas to help patients and providers share in making informed decisions, particularly in situations that include more than one approach to care, uncertain outcomes, and benefits and harms that people value differently. Clearly, decision making around BSO is an area the meets these criteria. We therefore propose to conductive formative research and use it to develop and pilot test a BSO Decision Support Guide, to help patients share with their providers in making informed, preference-based decisions regarding whether or not to undergo BSO concomitant to hysterectomy to prevent ovarian cancer. To accomplish these goals, we will conduct a series of focus groups and one-on-one qualitative interviews to assess how women who will be undergoing, or who have recently undergone, hysterectomy for non-cancerous conditions view elective BSO and to assess their information needs and desires regarding shared decision making in this context. We will then create a draft BSO Decision Support Guide using information obtained from the literature, from our formative research, and the experience of providers who have counseled women about this choice. After pilot testing the BSO Decision Support Guide among 62 women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and usability for patients and their providers, we will generate a final version that will be ready for use in future studies of the impact of the intervention on decision quality and use of BSO. PUBLIC HEALTH RELEVANCE: Results of this study will contribute to the small literature on women's preferences and attitudes toward BSO. This study will generate a clinically useful BSO Decision Support Guide that women of varying literacy levels and diverse cultural backgrounds can use to help them participate in shared decisions about use of BSO. It will also generate questionnaires and data to be used in planning future evaluations of the impact of the guide on informed decision making regarding and use of and satisfaction with BSO concomitant to hysterectomy among average risk women.