Randomized Trial of a Mammography Decision Aid for Women Aged 75 and Older

描述（由申请人提供）：75岁及以上的女性是美国人口中增长最快的部分。然而，没有一项乳房x光检查筛查试验包括75岁以上的女性，也不清楚乳房x光检查是否会降低这些女性的死亡率。虽然乳房x光检查的益处尚不确定，特别是对于预期寿命较短的老年妇女，但筛查有一些重要的危害，包括：与检查有关的疼痛和焦虑，乳房x光检查假阳性后额外检查（例如乳房活检）的并发症，以及过度诊断（诊断出对一生没有威胁的肿瘤）。过度诊断尤其令人担忧，因为乳腺癌治疗的风险随着年龄的增长而增加。指南指出，没有足够的证据推荐75岁以上的妇女进行乳房x光检查，并建议告知老年妇女益处和潜在危害的不确定性。他们进一步鼓励临床医生在提供筛查之前考虑患者的健康和预期寿命。与此同时，医疗保险为所有65岁以上的女性提供年度乳房x光检查，许多老年女性无论其预期寿命如何都要接受筛查。因此，很少有老年妇女被告知乳房x光检查的危害，大多数人高估了它的好处。为了提高老年妇女在乳房x线摄影筛查方面的决策能力，我们开发并试点测试了一种乳房x线摄影筛查决策辅助（DA），适用于年龄在75岁以上的妇女。DA是一份自我管理、易于阅读的小册子，其中包括关于筛查结果、乳腺癌风险、健康和预期寿命、相互竞争的死亡率风险的信息，以及一项价值观澄清工作。我们对来自波士顿一家大型学术初级保健诊所的49名年龄在75岁（75-86岁）的女性进行了DA的试验前/试验后试验，发现DA提高了知识水平，减少了决策冲突，降低了筛查的意愿，并导致与医生进行更平衡的乳房x光检查讨论。我们，一个由内科医生、老年病专家和心理学家组成的团队，现在提议对DA进行一项大型随机对照试验（RCT），以明确评估其疗效。我们的目的是表明DA提高了老年妇女对乳房x光检查利弊的认识，减少了决策冲突，降低了筛查意图，特别是对于预期寿命<7年的妇女。我们还旨在表明DA导致平衡乳房x光检查讨论的图表文件增加，并减少筛查，特别是对于预期寿命<7年的妇女。我们将从波士顿的一家学术初级保健和老年医学诊所、波士顿地区的3家社区诊所和北卡罗来纳州的一家学术和社区诊所招募人员。我们计划将520名年龄在75-89岁之间的妇女随机分配到DA组（干预组）或老年人家庭安全教育小册子组（对照组）。我们必须在大型随机对照试验中测试我们的DA，以了解它是否真正有效。这种令人信服的RCT数据需要支持二级翻译（研究到临床实践）的DA全国初级保健。我们的DA有可能改善老年妇女的乳房x光检查决策，从而改善她们的护理和生活质量。

DESCRIPTION (provided by applicant): Women aged 75 and older are the fastest growing segment of the US population. Yet, none of the mammography screening trials included women over age 75, and it is not clear whether mammography results in a mortality benefit for these women. While the benefits of mammography are uncertain, particularly for older women with short life expectancies, there are important harms to screening including: pain and anxiety related to the test, complications from additional tests after a false positive mammogram (e.g., breast biopsy), and overdiagnosis (diagnosis of tumors that are no threat in one's lifetime). Overdiagnosis is particularly concerning since risks of breast cancer treatment increase with age. Guidelines state that there is insufficient evidence to recommend mammography for women >75 years and recommend that older women be informed of the uncertainty of benefit and potential for harm. They further encourage clinicians to consider patient health and life expectancy before offering screening. Meanwhile, Medicare covers annual mammograms for all women >65 years and many older women are screened regardless of their life expectancy. Thus, few older women are informed of harms of mammography and most overestimate the benefits. To improve older women's decision- making around mammography screening, we developed and pilot tested a mammography screening decision aid (DA) for women >75 years. The DA, a self-administered, easy-to-read, pamphlet, includes information on outcomes of screening, breast cancer risk, health and life expectancy, competing mortality risks, and a values clarification exercise. Our pilot pretest/posttest trial of the DA included 49 women >75 years (range 75-86 years) from a large Boston academic primary care practice and found that the DA improved knowledge, decreased decisional conflict, reduced intentions to be screened, and led to more balanced mammography discussions with their physician. We, a team of internists, geriatricians, and a psychologist, now propose a large randomized controlled trial (RCT) of the DA to definitively evaluate its efficacy. We aim to show that the DA improves older women's knowledge of the pros and cons of mammography, decreases decisional conflict, and reduces screening intentions, particularly for women with <7 year life expectancy. We also aim to show that the DA leads to increased chart documentation of balanced mammography discussions and reduces screening, particularly for women with <7 year life expectancy. We will recruit from an academic primary care and geriatrics practice in Boston, 3 Boston area community practices, and an academic and community practice in North Carolina. We plan to randomize 520 women ages 75-89 years to the DA (intervention arm) or an educational pamphlet on home safety for older adults (control arm). It is essential that we test our DA in a large RCT to know if it is truly effective. Such compelling RCT data are needed to support second-order translation (research to clinical practice) of the DA nationally within primary care. Our DA has the potential to improve older women's mammography screening decisions, thereby improving their care and quality of life.