Staging Reproductive Aging in Four Cohorts: Issues of Hormone Use Spotting Bias

描述（由申请人提供）：更年期标志着女性生理和健康发生重大变化的时期。建立生殖衰老分期系统将使医疗服务提供者能够更好地向妇女提供有关更年期症状和预防治疗的咨询，并使研究人员能够准确地对妇女的生殖状况进行分类。生殖老龄化阶段研讨会（STRAW）提出了这样一个阶段系统。STRAW的建议虽然基于正在进行的队列研究的新结果，但不是数据驱动的，而且包括与临床和研究实践的重要背离。ReSTAGE是四个关于更年期过渡的大型队列研究（TREMIN，墨尔本妇女中年健康项目，西雅图中年妇女健康研究，全国妇女健康研究）的合作。我们的目标是根据经期日历、激素和症状数据，对绝经过渡期的出血标准进行实证评估，这些标准是STRAW推荐的基础。最初的拨款只关注更年期过渡的自然历史。这种竞争性更新解决了三个方法问题，这些问题对于确定广泛适用于异质妇女人群的包容性分期标准至关重要。它将扩大分期标准，包括中年期间使用激素（HT）的妇女，解决与月经间出血/出血（1MB）相关的错误分类，并描述绝经过渡研究中左截断和左审查偏差的问题。我们的目标首先是开发和比较两种方法来修改绝经过渡期的出血标准，以解释妇女使用激素治疗的情况，并评估在四项队列研究中纳入激素治疗者对绝经过渡期年龄和持续时间的影响。其次，由于1MB使出血标准的评估变得困难，我们的目标是开发一种算法来区分月经日历中的1MB和月经发作，并评估IMB对四个队列中年龄和过渡持续时间的估计的影响。第三，我们的目标是开发可能性方法来纠正与中年妇女队列研究中不同年龄进入标准相关的左删减和左截断偏差，并评估这些偏差对估计年龄和绝经过渡持续时间的影响。本研究将扩展生殖衰老分期系统，包括HT使用者，并为HT使用者和1MB妇女的生殖衰老分期标准提供明确的指导。研究结果将有助于妇女和医疗服务提供者在避孕、对症治疗和预防治疗方面的临床决策。

DESCRIPTION (provided by applicant): The menopause marks a period of critical change in women's biology and health. Establishing a staging system for reproductive aging would enable providers to better counsel women about menopausal symptoms and preventive therapy and permit researchers to accurately classify women's reproductive status. The Stages of Reproductive Aging Workshop (STRAW) proposed such a staging system. STRAW'S recommendations, although based on emerging results of ongoing cohort studies, were not data driven and included important departures from clinical and research practice. ReSTAGE is a collaboration among four large cohort studies of the menopausal transition (TREMIN, Melbourne Women's Midlife Health Project, Seattle Midlife Women's Health Study, Study of Women's Health Across the Nation). Our goal has been to empirically evaluate bleeding criteria for the menopausal transition that were the basis for STRAW'S recommendations using menstrual calendars, hormones and symptom data. The original grant focused only on the natural history of the menopausal transition. This competitive renewal addresses three methodological issues critical to specifying inclusive staging criteria broadly applicable to a heterogeneous population of women. It will extend staging criteria to include women who use hormones (HT) during the midlife, address misclassification associated with intermenstrual bleeding/spotting (1MB), and characterize the problem of left truncation and left censoring biases in studies of the menopausal transition. We aim first to develop and compare two approaches for modifying bleeding criteria for the menopausal transition to account for the case where women use HT and assess the effect of including HT users on estimates of age and duration of the menopausal transition in the four cohort studies. Second, as 1MB makes assessment of bleeding criteria difficult, we aim to develop an algorithm for distinguishing 1MB from menstrual episodes in menstrual calendars and to assess IMB's impact on estimates of age at and duration of the transition in the four cohorts. Third, we aim to develop likelihood methods to correct for left censoring and left truncation biases associated with the differential age at entry criteria in cohort studies of midlife women and assess the impact of these biases on estimates of age at and duration of the menopausal transition. This research will extend staging systems for reproductive aging to include HT users and provide definitive guidance regarding criteria for staging reproductive aging in HT users and women with 1MB. Results will facilitate clinical decision making for women and providers relevant to contraception, symptomatic treatment and preventive therapy.