MENOPAUSE AND HEALTH IN AGING WOMEN

这份为期五年的提案旨在协调一项前瞻性研究， 老年妇女的月经健康建立在以下独特的组合之上： PI及其同事的经验和专业知识：12年 进行和分析最大的绝经期前瞻性研究 以及协调多个地点的丰富经验 研究，包括8项目前的研究，涉及80多个临床 研究中心，其中5项为前瞻性队列研究。 本研究确定了两个主要科学目标， 以前的工作。目的I是在一个代表性队列中确定 最初绝经前妇女，这些变量表现出 与更年期有关的独特的变化模式。Aim II是 去理清那些可以清晰识别的变化， 与绝经期相关（绝经期的一个或两个点） 变化率）以及与年龄相关的、独立的 更年期的典型内分泌变化 过渡为了解决这些问题，以下核心变量 在一个研究模型中被提出并联系在一起：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）。 为了实现这些目标，在过去3年中， 年龄在40 - 47岁之间，子宫和至少一个卵巢完整 （非吸烟者）和40 - 44（吸烟者），不服用激素或其他 基线时接受类固醇治疗， 将被招募。亚组分析的样本量， 提供了检测关键变量趋势变化的功效。 连续变量和分类变量的分析策略是 讨论的科学目标，包括讨论 缺失和截断的数据。分布式数据系统;广泛的 质量控制程序;对临床研究中心的技术支持 队列抽样策略以及设计和 执行具体地点的议定书，并建议 传播结果得到充分说明。

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.