Core 3: Data Collection & Data Management Core

SWAN-Aging旨在确定中年健康和更年期过渡（MT）特征对女性成功衰老的影响程度，包括认知能力下降的速度以及痴呆和残疾的风险。这项申请建议建立在全国妇女健康研究（SWAN）的丰富资源的基础上，这是一项于1994年启动的纵向队列研究，旨在描述MT期间发生的生理和心理变化。在SWAN-Aging中，我们将SWAN队列的随访扩展到老年早期（66-75岁），并扩大数据收集范围，以包括其他认知领域，以检测认知障碍（执行和视觉空间功能，语言流畅性）和认知缺陷的功能影响（认知要求工具性日常生活活动），心脏健康和久坐行为。这是为数不多的几项研究之一，可以量化中年和老年早期认知能力的下降率，并确定可改变的风险因素对轻度认知障碍发生率的贡献。SWAN-Aging包括三个综合项目：项目1将评估MT特征和中年健康指标对认知功能保护的影响（避免认知能力下降和轻度认知障碍的发生）、睡眠、泌尿生殖和性功能以及老年早期的生活质量;项目2将测试MT如何与老年早期女性的心脏健康和心血管疾病（CVD）事件相关，并测试心脏健康如何与身体损伤的早期标志物相关，项目3将探讨MT和中年特征对肌肉骨骼健康和身体功能的作用。数据收集和数据管理核心（核心3）的具体目标是：1）在所有临床研究中心保持研究参与者的良好保留; 2）最终确定参与者访视方案，并确保从临床研究中心和阅读中心收集高质量数据; 3）实施有效的质量控制措施，并向研究者提供分析数据集;和4）存档和共享SWAN-Aging数据。核心3将与临床研究中心合作，采用有效的策略来维持SWAN的高受试者留存率，并制定明确、详细的方案、现场人员培训和质量控制措施，以监测数据和标本的收集。核心3将利用现有SWAN数据管理结构的优势，并采用改进的技术来提高质量控制流程的效率。核心3将构建数据集，以促进各种分析策略，全面评估MT和中年因素对认知能力下降，心脏健康和身体功能的作用，并将存档去识别数据集供公众使用。核心3将通过支持保留和数据收集并确保研究数据的高质量，并用于识别与避免轻度认知障碍、功能保留和优化老年早期生活质量相关的可修改因素，在开展项目中发挥至关重要的作用。

SWAN-Aging is designed to determine the extent to which midlife health and characteristics of the menopause transition (MT) affect successful aging in women, including the rate of cognitive decline and the risk of dementia and disability. This application proposes to build upon the rich resources of the Study of Women’s Health Across the Nation (SWAN), a longitudinal cohort study initiated in 1994 to characterize the physiological and psychosocial changes that occur during the MT. In SWAN-Aging, we will extend follow-up of the SWAN cohort into early old age (66-75 years) and expand data collection to include additional domains of cognition to detect cognitive impairment (executive and visual-spatial function, language fluency) and the functional impact of cognitive deficits (cognitively demanding instrumental activities of daily living), cardiac health, and sedentary behavior. It is one of a few studies that can quantify the rate of decline in cognitive performance during midlife and early old age and determine the contribution of modifiable risk factors to the incidence of mild cognitive impairment. SWAN-Aging includes three integrated Projects: Project 1 will evaluate the impact of MT characteristics and midlife health indicators on preservation of cognitive function (avoiding cognitive decline and onset of mild cognitive impairment), sleep, genitourinary and sexual function, and quality of life in early old age; Project 2 will test how the MT relates to cardiac health and cardiovascular disease (CVD) events in women in early old age and test how cardiac health relates to early markers of physical impairment, Alzheimer’s disease, and vascular dementia at a critical period in the lifespan; and Project 3 will examine the role of MT and midlife characteristics on musculoskeletal health and physical functioning. The specific aims of Data Collection and Data Management Core (Core 3) are to: 1) Maintain excellent retention of study participants at all clinical sites; 2) Finalize the participant visit protocol and ensure the collection of high quality data from the clinical sites and reading centers; 3) Implement effective quality control measures and provide analytic datasets to study investigators; and 4) Archive and share the SWAN-Aging data. Core 3 will work with the clinical sites to employ effective strategies to maintain SWAN’s high participant retention rate and develop clear, detailed protocols, on-site personnel trainings and quality control measures to monitor the collection of data and specimens. Core 3 will build on the strengths of the existing SWAN data management structure and incorporate improved technology to improve the efficiency of quality control processes. Core 3 will construct datasets to facilitate a variety of analytic strategies to comprehensively assess the role of MT and midlife factors on cognitive decline, cardiac health and physical functioning and will archive de-identified datasets for public use. Core 3 will play a vital role in conducting the Projects by supporting retention and data collection and ensuring that study data will be high quality and used to identify modifiable factors linked to avoidance of mild cognitive impairment, preservation of functioning, and optimization of quality of life in early old age.