MENOPAUSE AND HEALTH IN AGING WOMEN

这项五年计划旨在协调一项前瞻性研究 老年妇女的更年期健康建立在独特的 私家侦探及其同事的经验和专长：12年 开展和分析最大规模的更年期前瞻性研究 在北美；以及协调多个站点的丰富经验 研究，包括8项当前研究，涉及80多项临床研究 站点，其中5个是前瞻性队列研究。 这项研究确定了两个主要的科学目标，基于 之前的工作。第一个目标是在一个具有代表性的队列中确定 最初绝经前的女性，这些变量表现出 与更年期相关的独特的变化模式。Aim Il是 要理清那些可以清楚地识别为 与更年期相关的(更年期的一个或两个拐点 变化率)以及那些与年龄相关的、独立的变化 更年期典型的内分泌变化 过渡。为了解决这些问题，以下核心变量 都是在一个研究模型中提出并联系起来的：生殖激素， 测量血压和血脂，血糖和胰岛素， 人体测量和症状(包括抑郁、潮热、 情绪波动)。 为了达到这些目标，在前3年来月经的女性 子宫和至少一个卵巢完整的月份年龄为40-47岁 (非吸烟者)和40-44(吸烟者)，不服用激素或其他 基线时的类固醇治疗以及可以从谁那里获得血液样本 获得的将被招募。分组分析的样本量和 提出了检测关键变量趋势变化的能力。 连续变量和分类变量的分析策略为 讨论以解决科学目标，包括讨论 丢失和截断的数据。分布式数据系统；广泛的 质量控制程序.临床现场的技术支持 用于队列抽样策略以及设计和 实施特定地点协议和一项关于 对传播成果进行了全面的描述。

This five year proposal to coordinate a prospective study of Menopausal Health in Aging Women builds on a unique combination of experience and expertise of the PI and her colleagues: 12 years conducting and analyzing the largest prospective study of menopause in North America; and extensive experience coordinating multi-site studies, including 8 current studies extending over 80 clinical sites, 5 of which are prospective, cohort studies. Two primary scientific aims are identified for this study, based on prior work. Aim I is to identify in a representative cohort of initially premenopausal women those variables that exhibit a distinctive pattern of change associated with menopause. Aim Il is to disentangle those changes that are clearly identifiable as associated with menopause (one or two points of inflexion in the rate of change) and those changes that are age-related, independent of the endocrinological changes that typify the menopause transition. To address these issues, the following core variables are proposed and linked in a research model: reproductive hormones, measures of blood pressure and lipids, blood glucose and insulin, anthropometry, and symptoms (including depression, hot flashes, mood swings). To address these aims, women who have menstruated in the prior 3 months with uterus and at least one ovary intact, are aged 40-47 (non-smokers) and 40-44 (smokers), are not taking hormone or other steroid therapies at baseline and from whom blood samples can be obtained will be recruited. Sample sizes for subgroup analyses and power to detect changes in trends for key variables are presented. Analytic strategies for continuous and categorical variables are discussed to address the scientific aims, including a discussion of missing and truncated data. A distributed data system; extensive quality control procedures; technical support to the clinical sites for cohort sampling strategies as well as for design and implementation of site-specific protocols and a proposal for disseminating results are fully described.