Staging Reproductive Aging in Five Cohort Studies

描述（由申请人提供）：更年期标志着妇女的生物学和健康状况发生关键变化的时期。与青春期不同，生殖老化的分期系统尚未建立。生殖老化的分期系统将促进健康干预措施的发展，使提供者能够更好地为妇女提供有关更年期症状和预防性治疗的咨询，并使研究人员能够更好地对妇女的生殖状况进行分类。2001年7月，NIA和其他组织举办了一个讲习班，提出了一个生殖老化分期系统。虽然ESTA的建议建立在中年妇女队列研究的新结果，并代表了专家的共识，他们不是数据库驱动。尽管在概念上与先前的定义一致，但ESTA的早期和晚期过渡期出血标准包括与当前临床和研究实践的重要偏离。此外，FDA没有为这些出血标准提供明确的操作定义。本申请的目的是根据经验评价5项建议的绝经早期过渡期开始的出血标准和4项建议的绝经晚期过渡期开始的出血标准，这些标准作为绝经后妇女建议的基础。我们将使用从五项关于绝经过渡期的大型综合性队列研究（Tremin Trust，墨尔本妇女中年健康项目，西雅图中年妇女健康研究，密歇根州骨骼健康研究和全国妇女健康的多地点，多种族研究）中积累的月经日历，激素和症状数据。我们建议评估1）每项标准定义明确的频率（即，我们是否能够使用该标准按生殖阶段对妇女进行分类？），2)过渡期年龄是否在队列内和队列间的标准中不同，3）过渡期年龄与绝经年龄之间的关系，以及4）是否通过包括预测因子如FSH或热潮红来改善绝经年龄的预测，以及它是否因种族、吸烟状况或体重指数而异。本研究将提供经验证据，说明哪些标准在人群和绝经年龄范围内具有广泛代表性，进一步努力建立绝经过渡期的分期标准。这些信息将有助于澄清我们对卵巢衰老的理解，允许研究人员更充分地控制绝经状态，并促进妇女及其提供者的决策。

DESCRIPTION (provided by applicant): The menopause marks a period of critical change in women's biology and health status. Unlike puberty, no staging system for reproductive aging has been established. A staging system for reproductive aging would facilitate development of health interventions, enable providers to better counsel women about menopausal symptoms and preventative therapy, and permit researchers to better classify women's reproductive status. In July 2001, NIA and other organizations held a workshop to propose a staging system for reproductive aging (STRAW). Although STRAW's recommendations built upon emerging results from cohort studies of midlife women and represent an expert consensus, they were not database driven. STRAW's bleeding criteria for the early and late transition stages, although conceptually consistent with prior definitions, include important departures from current clinical and research practice. Also, STRAW did not provide unambiguous operational definitions for these bleeding criteria. The goal of this application is to empirically evaluate 5 proposed bleeding criteria for onset of the early menopausal transition and 4 proposed bleeding criteria for onset of the late transition that served as the basis for the STRAW recommendations. We will use menstrual calendar, hormone and symptom data accumulated from five of the large and comprehensive cohort studies of the menopausal transition (the Tremin Trust, Melbourne Women's Midlife Health Project, Seattle Midlife Women's Health Study, Michigan Bone Health Study and the multi-site, multi-ethnic Study of Women's Health Across the Nation). We propose to assess 1) how frequently each criterion is well defined (i.e., are we able to categorize women by reproductive stage using the criterion?), 2) whether the age at transition differs among the criteria within and across cohorts, 3) the relationship between age at transition and age at menopause, and 4) whether prediction of age at menopause is improved by including predictors such as FSH, or hot flash, and whether it varies by ethnicity, smoking status or body mass index. This study will provide empirical evidence regarding which criteria are broadly representative across populations and across the range of menopausal ages, furthering efforts to establish staging criteria for the menopausal transition. This information will help clarify our understanding of ovarian aging, permit researchers to more adequately control for menopausal status, and facilitate decision-making among women and their providers.