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

四个群体的生殖衰老分期：激素使用发现偏差问题

基本信息

批准号：
7500194
负责人：
Sioban D Harlow
金额：
$ 41.2万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-30 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7500194
关键词：
Accounting Address Age Age Distribution Aging Algorithms Amenorrhea Biology Calendar Characteristics Clinical Clinical Research Clinical assessments Cohort Studies Collaborations Complex Contraceptive methods Counseling Data Decision Making Educational workshop Enrollment Environment Exogenous Hormone Therapy Follicle Stimulating Hormone Goals Grant Health Health Personnel Hemorrhage Hormonal Hormones Intervention Left Length Menopausal Symptom Menopause Menstrual cycle Methods Natural History Ovarian Population Heterogeneity Preventive Provider Puberty Range Recommendation Research Research Personnel Scientific Advances and Accomplishments Serum Site Spottings Staging Staging System Symptoms Time To specify Truncation Bias Woman Women&apos s Health base cohort critical developmental period day disorder risk improved interest middle age prospective rat Ran 2 protein reproductive

项目摘要

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.

描述（由申请人提供）：更年期标志着妇女生物学和健康的重大变化时期。建立用于生殖衰老的分期系统将使提供者能够更好地为妇女提供关于绝经症状和预防疗法的咨询，并允许研究人员准确地对妇女的生殖状况进行分类。生殖老化研讨会（Straw）的阶段提出了这样的分期系统。 Straw的建议虽然基于正在进行的队列研究的新兴结果，但并不是数据驱动的，并且包括与临床和研究实践的重要不同。 RESTAGE是对更年期过渡的四项大型队列研究（Tremin，墨尔本女性中年健康项目，西雅图中年生活妇女健康研究，全国妇女健康研究）。我们的目标是通过经验评估更年期过渡的出血标准，这是使用月经日历，激素和症状数据提出稻草建议的基础。最初的赠款仅着眼于更年期过渡的自然历史。这种竞争性更新解决了三个方法论问题，对于指定包容性分期标准至关重要，广泛适用于异类妇女人群。它将扩展分期标准，包括中期期间使用激素（HT）的女性，解决与月经间出血/斑点（1MB）相关的错误分类，并表征了左截断的问题，并在对绝经过渡的研究中剩下的左截断偏见。我们首先要开发和比较两种方法，以修改更年期过渡的出血标准，以说明妇女使用HT并评估在四个队列研究中将HT用户对更年期过渡的年龄和更年期过渡期估计的影响。其次，由于1MB对出血标准的评估变得难以评估，因此我们旨在开发一种算法，以将1MB与月经日历中的月经发作区分开，并评估IMB对四个同类产品中过渡时期和过渡期限的估计的影响。第三，我们旨在开发可能性方法，以纠正与中年妇女队列研究中与差异年龄相关的左审查和左截断偏见，并评估这些偏见对绝经过渡年龄和期限的估计值的影响。这项研究将扩展用于生殖衰老的分期系统，以包括HT用户，并提供有关在HT用户和1MB女性中分期生殖老化标准的明确指导。结果将促进与避孕，症状治疗和预防治疗有关的妇女和提供者的临床决策。