MODEL INFORMED CONSENT PROCESS FOR BRCA1 TESTING

描述：(摘自申请者的摘要)很快就会实现 检测乳腺癌-卵巢癌易感基因(BRCA1) 约占乳腺癌病例的5%。因为. 预计消费者和提供者需求旺盛，初级保健医生 和护士从业者将被要求提供症状前 咨询和测试。人们很少注意到这些元素 知情同意应该是BRCA1测试的一部分。这个 拟议的研究将开发、实施和评估一个知情的模型 乳腺癌基因检测的同意程序，包括 消费者和供应商的看法。《知情同意范本》 流程将同时处理披露的内容和方式，并 心理咨询。 在当地提供者的四个重点小组中(32名执业护士、 来自内科、家庭诊所的咨询师和医生， 妇科和普通外科)，我们将探索评估 他们对BRCA1检测知情同意的期望，然后 制定一份问卷，反映他们的回答。 通过对一年级(N=240)和三年级(N=240)医学生的调查， 执业护士(N=200)和医生[住院医生(N=525)和非 来自上述专业的住院医生(N=400)，我们将评估知识 乳腺癌遗传学，对应该披露的内容的期望，以及 应提供测试的方向性、风险感知和 在获得知情同意方面的感知作用，使用以下情况 描绘不同种族、风险和社会经济地位的妇女。我们 还将审查影响提供商知识和 预期，包括在医疗过程中可能发生的变化 社会化进程。 建立在上一次拨款的基础上，在该拨款中，重点消费者小组讨论了 BRCA1测试，我们将开发和管理一项消费者调查， 与提供商调查平行的是，评估了他们对 BRCA1检测的知情同意程序。这项调查将涉及 大约840名消费者，其中一半将首先是女性和男性 受影响的年轻女性的学位亲属，其中一半将是 通过妇科和内科诊所确定的一般人口 在当地的一家医疗保健机构。 在检查了消费者群体之间和之间的差异之后， 供应商，我们将为有见识的人建立示范教材 反映消费者和供应商期望的同意过程。 我们将实施一项试点BRCA1测试计划，其中包括 适用于每一类患者的披露内容，以及 随机抽取140名符合条件和有兴趣的男性和女性患者 在BRAC1测试中选择以下两种披露方式之一：个人或团体 考试前的教育和咨询。我们将同时评估内容和 从患者的角度看我们模式的知情同意程序 知识、满意度、感知决策自主性和测试 决定。 我们的发现将对提供和利用 乳腺癌和卵巢癌的基因检测及其发展 知情同意准则。结果还将指向 在提供和提供医疗培训方面进行必要的改进 获得预测性测试的同意。

DESCRIPTION: (From the applicant's abstract) It will soon be possible to test for a breast-ovarian cancer susceptibility gene (BRCA1) that accounts for approximately 5% of breast cancer cases. Because of anticipated high consumer and provider demand, primary care physicians and nurse practitioners will be called upon to offer presymptomatic counseling and testing. Little attention has been paid to the elements of informed consent that ought to be part of BRCA1 testing. The proposed study will develop, implement and evaluate a model informed consent process for genetic testing for breast cancer that integrates the perceptions of consumers and providers. The model informed consent process will address both content and style of disclosure and counseling. In four focus groups of local providers (32 nurse practitioners, genetic counselors and physicians from internal medicine, family practice, gynecology, and general surgery), we will explore scenarios that assess their expectations of informed consent for BRCA1 testing, and then develop a questionnaire that reflects their responses. By surveys of first (N=240) and third year (N=240) medical students, nurse practitioners (N=200), and physicians [residents (N=525) and non- residents (N=400) from the above specialties, we will assess knowledge of breast cancer genetics, expectations of what should be disclosed and how directively the test should be offered, risk perception and perceived role in obtaining informed consent, using scenarios that depict women of different races, risks and socio-economic status. We also will examine factors influencing providers' knowledge and expectations, including changes that might occur during the medical socialization process. Building on a previous grant in which focus groups of consumers discussed BRCA1 testing, we will develop and administer a consumer survey, paralleling the provider survey, that assesses their expectations of the informed consent process for BRCA1 testing. This survey will involve approximately 840 consumers, half of whom will be female and male first degree relatives of young affected women, and half will be women in the general population, ascertained through gynecologic and medical clinics at a local HMO. After examining discrepancies between and among groups of consumers and providers, we will establish model educational materials for the informed consent process that reflect the expectations of consumers and providers. We will implement a pilot BRCA1 testing program that incorporates the content of disclosure appropriate for each category of patient, and randomize 140 female and male patients who are eligible and interested in BRAC1 testing to one of two disclosure styles: individual or group pre-test education and counseling. We will evaluate both the content and style of our model informed consent process in terms of patient knowledge, satisfaction, perceived decision-making autonomy and testing decisions. Our findings will have implications for the offering and utilization of genetic testing for breast and ovarian cancer, and for the development of informed consent guidelines. The results also will point to necessary improvements in medical training with regard to offering and obtaining consent for predictive testing.