SWAN NJ-Quantitative and Qualitative cohort Research

SWAN NJ-定量和定性队列研究

• 批准号: 8127757
• 负责人: CAROL A. DERBY
• 金额: $ 36.96万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8127757
• 关键词: Accounting; Address; Affect; African American; Aging; Alternative Medicine; Androstenedione; Area; Atherosclerosis; Blood; Body Weight; Calories; Caucasians; Caucasoid Race; Chinese People; Clinic Visits; Clinical; Clinical Research; Cognition; Communities; Complementary and alternative medicine; DNA; Data; Degenerative polyarthritis; Development; Diet; Disease; Distress; Employee; Energy Intake; Enrollment; Equilibrium; Estrone; Ethnic Origin; Ethnic group; Food; Fracture; Frequencies; Funding; Gait; Goals; Grant; Happiness; Health; Hispanics; Hormonal; Hormones; Interview; Japanese Population; Laboratories; Life; Longitudinal Studies; Major Depressive Disorder; Maps; Measurement; Medicine; Menopausal Symptom; Menopause; Metabolic; Metabolic syndrome; N-formylmethionylphenylalanine; National Institute of Nursing Research; National Institute on Aging; New Jersey; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Participant; Pattern; Performance; Physical Function; Physiological; Plasma; Population; Postmenopause; Prevalence; Protein Isoforms; Qualitative Methods; Qualitative Research; Quality of life; Questionnaires; Race; Recruitment Activity; Relative (related person); Reporting; Reproductive Periods; Research; Research Design; Resolution; Rest; Risk; Risk Factors; SHBG gene; Sampling; Schedule; Severities; Sex Functioning; Site; Sleep; Specimen; Stress; Surveys; Symptoms; Testing; Time; U-Series Cooperative Agreements; Urine; Vagina; Variant; Vasomotor; Visit; Weight Gain; Woman; Women' s Health; Work; age related; aged; base; bone; bone loss; cardiovascular risk factor; cohort; college; coping; design; diabetes risk; experience; healthy aging; hormone therapy; inflammatory marker; medical schools; member; operation; psychosocial; repository; reproductive hormone; response; satisfaction

DESCRIPTION (provided by applicant): The Study of Women's Health Across the Nation (SWAN) is a multi-center, multi-ethnic longitudinal study designed to characterize the physiological and psychosocial changes that occur during the menopausal transition and to observe their effects on subsequent health and risk factors for age-related diseases. The goals of the original RFA were to answer the following questions: How do hormones change with the menopausal transition? What factors affect the timing of the transition? What are the symptoms that accompany menopause and who is at risk? How do cardiovascular risk factors change with the transition and is there ethnic variation? What are the rates of bone loss with the transition? When does bone loss begin and what are the risk factors? What are the health consequences of menopause and who is at risk? SWAN is compiling the most comprehensive characterization to date of the health and the physiologic and psychosocial changes of women from pre- to postmenopause in community based samples. SWAN is now poised to study the effects of these menopause-related changes on subsequent healthy aging and on age-related diseases in the post-reproductive period. SWAN I was first funded in September 1994 by the National Institute on Aging (NIA), the National Institute of Nursing Research (NINR), and the Office of Research on Women's Health (ORWH) in response to RFA AG-94-002, Menopause and Health in Aging Women. The first competing continuation of SWAN (SWAN II) was funded in 1999 and the second (SWAN III) in 2004. SWAN I, II and III have been supported by a cooperative agreement mechanism, with 9 funded components: 7 clinical centers, a central reproductive hormone laboratory (CLASS), and a coordinating center. A second central laboratory (MRL) was originally funded as a subcontract to the Coordinating Center (CC). In addition, a Core Repository of serum, plasma, and urine specimens and a DNA Repository were established in June 2000 under separate funding (U01 AG 17719, PI: Dr. MaryFran Sowers). For non-study-related reasons, site operations at New Jersey Medical School stopped in April 2004. The basis of this action was allegations made by two study employees who resigned abruptly. The SWAN PI and study coordinator were subsequently exonerated from these allegations. Please see Appendix 12 for a more complete report. The grant was transferred to the Albert Einstein College of Medicine in 2005. Since that time, the New Jersey PI and project director have worked tirelessly to overcome the obstacles to re-implement the study. As of June 1, 2008, a total of 155 women have successfully completed their clinic visit and five more visits are scheduled. We project that by the end of SWAN III, data will be available for 250 women. This has been very encouraging and thus Nanette Santoro, PI of the New Jersey SWAN site has been approved by the NIA to prepare a U01 application to cover further contacts for the Hispanic women. Please note that the SWAN IVproject applications pertain to the remaining six sites only. Information relative to the New Jersey site is covered in the separate application submitted by Dr. Nanette Santoro. From over 16,000 women aged 40-55 years who were screened during 1995-1997, 3302 women aged 42-52 years were enrolled in SWAN's longitudinal cohort (approximately 450 at each of 7 clinical centers). They completed their baseline clinic visit during 1996-1997. Of the 3302 women enrolled, 1550 were Caucasian, 935 African American, 286 Hispanic, 250 Chinese, and 281 Japanese. A subset of 880 menstruating women was enrolled in the Daily Hormone Study (DHS) started in 1997, which is designed to examine cyclical daily hormone and symptom patterns during the menopausal transition.

描述（由申请人提供）：全国妇女健康（SWAN）的研究是一项多中心的，多种族的纵向研究，旨在表征绝经期期间发生的生理和社会心理变化，并观察其对年龄相关疾病的后续健康和风险因素的影响。原始RFA的目标是回答以下问题：激素如何随年过渡而变化？ 哪些因素会影响过渡的时机？ 更年期伴随的症状是什么？ 心血管危险因素如何随着过渡而变化，并且存在种族差异吗？ 过渡的骨质流失率是多少？ 骨质流失何时开始，风险因素是什么？ 更年期的健康后果是什么？天鹅正在汇编迄今为止健康的最全面的特征，以及在基于社区的样本中，从绝经前到绝经后的妇女的生理和社会心理变化。现在，天鹅有望研究这些更年期相关的变化对随后的健康衰老和与年龄相关的疾病的影响。天鹅一世于1994年9月由美国国家老龄研究所（NIA），美国国家护理研究所（NINR）和妇女健康研究办公室（ORWH）授予RFA AG-94-002，更年期和健康妇女的健康。天鹅（天鹅II）的第一次竞争延续于1999年资助，第二次（天鹅III）于2004年进行。SWANI，II和III得到了合作协议机制的支持，其中9个资助的组件：7个临床中心，一个中央生殖激素实验室（班级）和一个协调中心。第二个中央实验室（MRL）最初是作为分包合同（CC）资助的。此外，2000年6月，在单独的资金（U01 AG 17719，PI：Maryfran Sowers博士）下建立了血清，血浆和尿液标本和DNA存储库的核心存储库。出于无关的原因，新泽西医学院的现场运营于2004年4月停止。此行动的基础是两名突然辞职的研究员工的指控。 Swan Pi和研究协调员随后从这些指控中免除了。请参阅附录12以获取更完整的报告。该赠款于2005年转移到爱因斯坦医学院。从那时起，新泽西PI和项目总监不懈地努力克服重新实施这项研究的障碍。截至2008年6月1日，共有155名妇女成功完成了诊所的访问，并计划又进行了5次访问。我们预测，到天鹅三世结束时，将为250名妇女提供数据。这是非常令人鼓舞的，因此，新泽西天鹅遗址的PI NANETTE SANTORO已获得NIA批准，以准备U01申请，以涵盖西班牙裔妇女的进一步联系。请注意，Swan Ivproject应用程序仅与其余六个站点有关。 Nanette Santoro博士提交的单独申请中涵盖了有关新泽西网站的信息。从1995 - 1997年期间筛查的40-55岁以上的16,000名妇女中，有3302名42-52岁的女性在Swan的纵向队列中招募了（在7个临床中心中的每个中心约为450名）。他们在1996 - 1997年完成了基线诊所就诊。在入学的3302名妇女中，有1550名是高加索人，935名非裔美国人，286名西班牙裔，250名中国人和281个日语。每日激素研究（DHS）的一部分始于1997年，旨在检查绝经期间的周期性日常激素和症状模式。