Study of Women's Health Across the Nation (SWAN): New Jersey

描述(由申请人提供)：这是全国妇女健康研究(SWAN)的修订竞争续展申请，这是1994年根据RFA AG-94-002发起的一项7站点纵向队列研究。斯旺的任务是“描述绝经转变(MT)的生物学和心理社会先兆和后遗症的年表，以及这种转变对随后的健康和年龄相关疾病风险因素的影响”，并将这一信息从白人女性扩展到“……其他种族/民族背景的女性的围绝经期经历范围(S)”。共有3302名黑人、中国人、日本人、西班牙裔和白人女性参加了调查，其中78%的人完成了从绝经前到绝经后早期(PM)的13次访问。到目前为止，斯旺已经描述了MT的自然历史--它的时间、激素变化的模式、与它们相关的症状和因素--以及它们与疾病风险指标的关系。在Swan V期间，我们将通过晚些时候的PM延长观察时间，这是评估MT对年龄相关疾病的影响的必要步骤。我们的具体目标是：1)通过PM晚期完成对生殖老龄化自然历史的描述；2)通过PM晚期评估生殖老龄化对临床上与60和70多岁女性相关的健康结果的影响，包括：认知和身体功能、心理健康、睡眠、骨骼和心脏代谢健康、泌尿生殖系统症状、性功能和阴道健康；以及3)通过评估炎症、止血和脂肪因子与生物学、功能和临床结果的发生和发展的关系，并描述身体大小和组成、种族/民族和社会经济状况与这些结果的相互关系，确定生殖衰老和健康之间的潜在机制。Swan V Core方案将在7个研究地点完成，其中4个地点进行骨骼和心血管研究，所有地点的一部分妇女进行活动成像研究。来自天鹅资料库的纵向标本将能够表征整个MT到PM的骨骼标志物、肾上腺激素、止血、炎症和脂肪因子协调中心将提供必要的组织基础设施、统计资源和及时传播高质量的天鹅数据。CLIA认证的中心实验室将执行或与其他实验室协调，以提供准确、高容量的分析，并根据需要采用新方法提供最先进的数据。在了解MT对60多岁和70多岁女性健康的影响方面，SWAN处于独特的地位，可以填补重要的科学空白，并促进将新知识应用于临床实践。通过1.5年的日历时间和“更年期”，Swan V可以分解老龄化和MT对女性健康的贡献，解决关于MT疾病关联的时间性的难题和关键问题，按种族/民族评估差异，并提供与老年女性创新预防和治疗计划设计相关的可修改因素的见解。

DESCRIPTION (provided by applicant): This is the amended competing renewal application of the Study of Women's Health Across the Nation (SWAN), a 7-site longitudinal cohort study initiated in 1994 in response to RFA AG-94-002. SWAN was mandated "to characterize the chronology of the biological and psychosocial antecedents and sequelae of the menopausal transition (MT) and the effect of this transition on subsequent health and risk factors for age- related disease", and to extend this information from White women to "...the range of peri-menopausal experiences in women of other racial/ethnic background(s)." A total of 3302 Black, Chinese, Japanese, Hispanic and White women were enrolled, with 78% completing up to 13 visits spanning the premenopause to early post-menopause (PM). Thus far, SWAN has described the natural history of the MT -- its timing, patterns of hormonal changes, and symptoms and factors related to them - and their relation to disease risk indicators. During SWAN V, we will extend observations through the late PM, a necessary step to assess the impact of the MT on age-related diseases. Our specific aims are to: 1) complete the characterization of the natural history of reproductive aging through the late PM; 2) evaluate the impact of reproductive aging through the late PM on health outcomes clinically relevant to women in their 60s and 70s, including: cognitive and physical function, psychological well-being, sleep, bone and cardiometabolic health, urogenital symptoms, sexual function and vaginal health; and 3) identify potential underlying mechanisms linking reproductive aging and health by assessing the relation of inflammation, hemostasis and adipokines to the occurrence and progression of biological, functional and clinical outcomes and delineating the interrelationships of body size and composition, race/ethnicity and socioeconomic status with these outcomes. The SWAN V Core protocol will be completed at 7 study sites, with bone and cardiovascular studies at 4 sites and actigraphy studies in a subset of women at all sites. Longitudinal specimens from the SWAN Repository will enable characterization of skeletal markers, adrenal hormones, hemostasis, inflammation, and adipokines across the MT into PM. The Coordinating Center will provide the necessary organizational infrastructure, statistical resources, and timely dissemination of high quality SWAN data. The CLIA-certified Central Laboratory will perform or coordinate with other laboratories to provide accurate, high volume assays, adopting new methods as needed to provide state- of-the-art data. SWAN is uniquely positioned to fill important scientific gaps in understanding of the impact of the MT on women's health in their 60s and 70s and to facilitate the application of new knowledge to clinical practice. With 1.5 decades of both calendar time and "menopause time", SWAN V can disaggregate the contributions of aging and the MT to women's health, address difficult and critical questions about the temporal nature of MT-disease associations, assess differences by race/ethnicity, and provide insights into modifiable factors relevant to the design of innovative prevention and treatment programs for aging women.