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

描述(申请人提供)：更年期标志着女性生理和健康的关键变化时期。建立生殖老龄化分期系统将使提供者能够更好地就更年期症状和预防性治疗向妇女提供咨询，并使研究人员能够准确地对妇女的生殖状况进行分类。生殖老龄化研讨会(STRAW)提出了这样一种分期制度。尽管Straw的建议基于正在进行的队列研究的新结果，但并不是由数据驱动的，而且包括了与临床和研究实践的重要背离。ReStage是四项关于更年期转变的大型队列研究(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)之间的合作。我们的目标一直是经验性地评估绝经过渡的出血标准，这些标准是Straw使用月经日历、激素和症状数据提出建议的基础。最初的拨款只关注更年期过渡的自然历史。这一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不同种族妇女人口的包容性分期标准至关重要。它将扩大分期标准，将中年期间使用激素(HT)的女性包括在内，解决与月经间出血/斑点(1MB)相关的错误分类，并表征更年期过渡研究中的左截断和左审查偏差问题。我们的目标是首先开发和比较两种修改绝经过渡期出血标准的方法，以说明女性使用HT的情况，并在四个队列研究中评估包括HT使用者对绝经过渡期年龄和持续时间的估计的影响。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1MB与月经日历中的月经周期，并评估IMB对四个队列中过渡时年龄和持续时间的估计的影响。第三，我们的目标是开发似然方法来纠正与中年女性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，并评估这些偏差对绝经过渡年龄和持续时间的估计的影响。这项研究将扩大生殖老化的分期系统，包括HT使用者，并就HT使用者和具有1MB的妇女的生殖衰老分期标准提供明确的指导。结果将有助于妇女和提供者在避孕、对症治疗和预防性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.