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）：更年期标志着女性生物学和健康发生重大变化的时期。建立生殖衰老分期系统将使提供者能够更好地向妇女提供有关更年期症状和预防性治疗的咨询，并使研究人员能够准确地对妇女的生殖状况进行分类。生殖衰老阶段研讨会（STRAW）提出了这样一个分期系统。 STRAW 的建议虽然基于正在进行的队列研究的新结果，但并非数据驱动，并且包含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）的合作项目。我们的目标是利用月经日历、激素和症状数据对绝经过渡期的出血标准进行实证评估，这是 STRAW'S 建议的基础。最初的资助仅关注更年期过渡的自然史。这一竞争性更新解决了三个方法问题，这些问题对于制定广泛适用于异质女性群体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) 的女性纳入其中，解决与经间期出血/点滴出血 (1MB) 相关的错误分类问题，并描述更年期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修改绝经过渡出血标准的方法，以考虑女性使用 HT 的情况，并评估在四项队列研究中纳入 HT 使用者对年龄和绝经过渡持续时间估计的影响。其次，由于 1MB 使得评估出血标准变得困难，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事件，并评估 IMB 对四个队列中年龄和过渡持续时间估计的影响。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的进入标准年龄相关的左删失和左截断偏差，并评估这些偏差对绝经过渡年龄和持续时间估计的影响。这项研究将扩展生殖衰老的分期系统，将 HT 用户纳入其中，并为 HT 用户和拥有 1MB 的女性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做出与避孕、对症治疗和预防治疗相关的临床决策。