MODEL INFORMED CONSENT PROCESS FOR BRCA1 TESTING

描述：（来自申请人的摘要）很快就可以了 检测乳腺癌易感基因（BRCA1）， 约占乳腺癌病例的5%。 因为 预期高消费者和供应商的需求，初级保健医生 执业护士将被要求提供症状前检查 咨询和检测 很少有人注意到 知情同意应该是BRCA1检测的一部分。 的 拟议的研究将制定、实施和评估一个模型， 乳腺癌基因检测的同意过程， 消费者和供应商的看法。 知情同意书范本 流程将解决披露的内容和风格， 辅导 在当地提供者的四个焦点小组中（32名执业护士，遗传学 来自内科、家庭诊所、 妇科和普外科），我们将探讨评估 他们对BRCA1检测知情同意的期望，然后 编制一份反映他们答复的调查表。 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[居民（N=525）和非 来自上述专业的居民（N=400），我们将评估知识 乳腺癌遗传学，应该披露什么的期望， 应如何提供测试的指导性，风险认知， 在获得知情同意方面的作用， 描绘不同种族、风险和社会经济地位的妇女。 我们 还将研究影响供应商知识的因素， 预期，包括医疗期间可能发生的变化 社会化过程。 在之前的赠款的基础上，消费者焦点小组讨论了 BRCA1检测，我们将开发和管理一个消费者调查， 与供应商调查平行，评估他们对 BRCA1检测的知情同意程序。 本次调查将涉及 大约840名消费者，其中一半将是女性，男性优先 受影响的年轻妇女的直系亲属，一半将是妇女在 一般人口，通过妇科和医疗诊所确定 一家当地的健康维护组织 在审查了消费者群体之间的差异之后， 提供者，我们将为知情者建立示范教材， 同意过程反映了消费者和供应商的期望。 我们将实施一项BRCA1试验计划， 适合各类患者的披露内容，以及 随机分配140名合格且感兴趣的女性和男性患者 在BRAC 1测试中，有两种披露方式：个人或团体 考前教育和咨询。 我们将评估内容和 我们在患者方面的知情同意过程模型的风格 知识、满意度、知觉决策自主性和测试 决策 我们的研究结果将对提供和利用 乳腺癌和卵巢癌的基因检测， 知情同意指南。 结果还将指出， 在提供和培训方面对医疗培训进行必要的改进 同意进行预测性测试。

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.