The Women's Health Study: Addition of New Data to Maximize its Research Impact

女性健康研究：添加新数据以最大限度地发挥其研究影响

• 批准号: 7810913
• 负责人: Julie E. Buring
• 金额: $ 49.98万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7810913
• 关键词: Address; Aging; American; Ancillary Study; Area; Aspirin; Biological Markers; Blood; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic Disease; Clinical; Clinical Research; Clinical Trials Design; Collaborations; Colon Carcinoma; Consent; Data; Data Sources; Evaluation; Event; Faculty; Follow-Up Studies; Funding; Genes; Genetic; Genetic Polymorphism; Goals; Gonadal Steroid Hormones; Grant; Health; Health Professional; Hormone Receptor; Hospitals; Individual; Investigation; Ischemic Stroke; Knowledge; Letters; Life Style; Mails; Malignant Neoplasms; Medical History; Medical Records; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Occupations; Outcome; Participant; Patient Self-Report; Physicians; Plasma; Population; Positioning Attribute; Preventive Medicine; Primary Prevention; Process; Publications; Questionnaires; Randomized Controlled Clinical Trials; Recovery; Research; Research Personnel; Research Support; Resources; Risk; Risk Factors; Schedule; Sex Hormone-Binding Globulin; Time; United States National Institutes of Health; Update; Validation; Vitamin E; Woman; Women' s Health; aged; base; biobank; cancer genomics; cancer prevention; cancer risk; cardiovascular disorder prevention; cardiovascular disorder risk; cohort; energy balance; follow-up; gene environment interaction; genetic analysis; genetic risk factor; genetic variant; genome wide association study; improved; inflammatory marker; interest; member; mortality; novel marker; research study; success; Address; Aging; American; Ancillary Study; Area; Aspirin; Biological Markers; Blood; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic Disease; Clinical; Clinical Research; Clinical Trials Design; Collaborations; Colon Carcinoma; Consent; Data; Data Sources; Evaluation; Event; Faculty; Follow-Up Studies; Funding; Genes; Genetic; Genetic Polymorphism; Goals; Gonadal Steroid Hormones; Grant; Health; Health Professional; Hormone Receptor; Hospitals; Individual; Investigation; Ischemic Stroke; Knowledge; Letters; Life Style; Mails; Malignant Neoplasms; Medical History; Medical Records; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Occupations; Outcome; Participant; Patient Self-Report; Physicians; Plasma; Population; Positioning Attribute; Preventive Medicine; Primary Prevention; Process; Publications; Questionnaires; Randomized Controlled Clinical Trials; Recovery; Research; Research Personnel; Research Support; Resources; Risk; Risk Factors; Schedule; Sex Hormone-Binding Globulin; Time; United States National Institutes of Health; Update; Validation; Vitamin E; Woman; Women' s Health; aged; base; biobank; cancer genomics; cancer prevention; cancer risk; cardiovascular disorder prevention; cardiovascular disorder risk; cohort; energy balance; follow-up; gene environment interaction; genetic analysis; genetic risk factor; genetic variant; genome wide association study; improved; inflammatory marker; interest; member; mortality; novel marker; research study; success

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (04) Clinical Research, and specific Challenge Topic 04-HL-104: Perform secondary analyses of existing data to answer important clinical and preventive medicine research questions. We request funding to support one additional cycle of observational follow-up of Women's Health Study (WHS) participants, to ascertain and validate cardiovascular disease (CVD) and cancer endpoints among cohort subjects, in order to retain jobs, support the research of junior faculty, and have increased power to both continue and initiate the evaluation of clinically important questions. The WHS began in 1992 as a randomized trial of aspirin and vitamin E in the primary prevention of CVD and cancer among 39,876 female health professionals aged e45 years. Completed in 2004 after an average of 10 years of treatment and follow-up, the participants are now followed observationally, returning yearly endpoint and risk factor questionnaires. Morbidity follow-up is well over 90%; mortality follow-up virtually 100%; and review completed of about 90% of medical records for self-reported CVD and cancer endpoints. Thus, the WHS is an extraordinary resource for research in women, in that not only does it have extensive demographic, lifestyle and medical history risk factor data as well as CVD and cancer outcome data for over 39,000 women collected yearly over an average of 15 years, but it also has comprehensive plasma-based biomarker and genetic data (including whole genome scans) available on over 28,000 participants. However, our current NIH funding supporting the ascertainment and validation of both the cardiovascular and cancer endpoints (Women's Health Study: Continued Follow-up - CA047988), ends on 6/30/09 (our current NHLBI funding (HL080467) provides support only for genetic analyses, not for any endpoint ascertainment). While this funding will allow us to mail out the 2009 follow-up questionnaires in May as scheduled, we have NO funding to process these questionnaires, obtain participant consent for medical record review of self-reported endpoints, obtain medical records, or validate through our Endpoints Committee of physicians. Our competing renewal application was positively reviewed but did not receive a fundable score, and we are resubmitting the application in July, 2009. However, because of the timing of this resubmission and subsequent start date, we will have no funding for the entire 2009 cycle of endpoints, and because of this gap, we will not be able to continue the current WHS staffing and functions. The financial impact of this gap is substantial: without additional funding, we will need to lay off 5 FTE WHS staff members (the study coordinator, programmer, data manager, and two research assistants) and FTE support for three WHS research faculty will be substantially reduced. Moreover, the research impact of the WHS is substantially driven by the number of validated endpoints available to power the studies which depend upon its resources. Without additional follow-up, the resultant decrease in the number of validated endpoints will critically adversely impact the success of many ongoing investigations by WHS investigators, as well as ancillary studies and NIH-sponsored collaborations with other CVD, cancer and genomic investigators. Because of the aging of the cohort, this one additional cycle of follow-up will add new data from medical record review for an estimated 171 validated CVD and 327 validated cancer endpoints, increasing the statistical power available for many investigators to adequately evaluate specific research hypotheses of particular relevance to women. There are currently over 29 currently funded ancillary grants and 10 grants submitted and under NIH review requiring these updated endpoints. Letters of Support from 12 representative investigators whose studies are dependent on these endpoints from the WHS are included. The impact of the ascertainment and validation of WHS endpoints to date has been substantial, with over 230 publications and 35 completed ancillary studies. In addition to furthering scientific knowledge, funding of this proposal will fulfill the goal of the American Recovery and Reinvestment Act (ARRA) to create and retain jobs and boost the economy. If funded, this proposal will retain 5 staff positions in the Division of Preventive Medicine, Brigham and Women's Hospital, as well as partial support for three WHS faculty. The data generated will support the research efforts of more than 40 research faculty whose funded, submitted or about to be submitted ancillary research studies are dependent on these WHS data. Additional follow-up (and the resulting increase in the endpoints of interest) will, without question, maximize the impact of the Women's Health Study in continuing to contribute to the state of knowledge concerning CVD and cancer prevention in the understudied population of women. The Women's Health Study is an ongoing (since 1992) observational follow-up study of almost 40,000 participants from a completed trial, designed to add knowledge concerning prevention of cardiovascular disease and cancer in women. Funding will allow the ascertainment and validation of one cycle of endpoints, allowing increased power to evaluate hypotheses, the ability to retain 5 staff members, and the ability for the study to continue to be a source of data for ongoing and planned research of over 40 faculty.

描述（由申请人提供）：此申请涉及广泛的挑战领域（04）临床研究以及特定挑战主题04-HL-104：对现有数据进行次要分析，以回答重要的临床和预防医学研究问题。我们要求资助以支持妇女健康研究（WHS）参与者的另一个观察性随访周期，以确定和验证心血管疾病（CVD）（CVD）和队列受试者之间的癌症终点，以保留工作，支持初级教师的研究，并具有更多的力量来继续并引发临床上重要问题的评估。 WHS始于1992年，是阿司匹林和维生素E的随机试验，在39,876名E45岁的女性卫生专业人员中，在CVD和癌症的主要预防中开始了。在平均进行10年的治疗和随访后，参与者于2004年完成，现在观察到参与者，返回的年度终点和风险因素问卷。发病率随访超过90％；死亡率随访实际上是100％；并审查了自我报告的CVD和癌症终点的约90％的医疗记录。因此，WHS是女性研究的非凡资源，因为它不仅具有广泛的人口统计，生活方式和病史风险因素数据以及CVD和CVD和癌症结果数据，超过39,000名女性在平均每年15年中收集到的39,000多名女性，而且还具有全面的基于Plasma的生物标志物和遗传数据（包括全基因扫描），包括全面的生物标志物和全基因扫描（包括全基因扫描）。但是，我们目前的NIH资金支持心血管和癌症终点的确定和验证（妇女健康研究：持续后续研究-CA047988），终止于6/30/09（我们当前的NHLBI资金（HL080467）仅提供遗传分析的支持，不提供任何遗传分析，而不是任何终点确定）。尽管这笔资金将使我们能够按计划在5月份邮寄2009年的后续调查表，但我们没有资金来处理这些问卷，获得参与者的同意，以对自我报告的终点的病历审查，获得医疗记录，或通过我们的医师终点委员会进行验证。我们的竞争续约应用程序得到了积极的审查，但没有获得可资金的分数，我们正在2009年7月重新提交该申请。但是，由于此重新提交和随后的开始日期的时机，我们将在整个2009年的端点周期中没有资金，并且由于这个空白，我们将无法继续当前的WHS工作人员和函数。这一差距的财务影响很大：如果没有额外的资金，我们将需要裁员5名FTE WHS员工（研究协调员，程序员，数据经理和两名研究助手）和FTE支持三个WHS研究学院的支持将大大减少。此外，WHS的研究影响基本上是由可用于依靠其资源的研究的验证终点的数量驱动的。没有额外的随访，验证端点数量的减少将严重影响WHS研究者进行的许多正在进行的研究的成功，以及与其他CVD，癌症和基因组研究人员的辅助研究和NIH赞助的合作。由于队列的老化，这是一个额外的随访周期，将为估计有171个经过验证的CVD和327个经过验证的癌症终点的新数据添加新数据，从而增加了许多研究人员可用的统计能力，以充分评估与女性特定相关性的特定研究假设。目前有29多个资助的辅助赠款，并提交了10笔赠款，并在NIH审查中需要这些更新的端点。包括12位代表研究人员的支持信，其研究依赖于WH的这些端点。迄今为止，确定和验证WHS端点的影响是很大的，有230多个出版物和35个完成的辅助研究。除了促进科学知识外，该提案的资金还将实现《美国恢复和再投资法》（ARRA）的目标，以创造和保留就业机会并促进经济。如果获得资助，该提案将保留预防医学，杨百翰和妇女医院的5个员工职位，并部分支持三个WHS教师。生成的数据将支持40多位研究学院的研究工作，这些研究学院的资助，提交或即将提交的辅助研究取决于这些WHS数据。毫无疑问，将最大程度地提高妇女健康研究的影响，以继续为研究妇女研究的妇女人群而言，对CVD和预防癌症的预防状态有助于最大程度地提高妇女健康研究的影响。妇女健康研究是一项持续的（自1992年以来）的观察性随访研究，对一项完整试验的近40,000名参与者进行了研究，旨在增加有关预防女性心血管疾病和癌症的知识。资金将允许确定和验证一个端点周期，从而增加了权力评估假设，保留5名员工的能力以及该研究的能力继续成为40多名教职员工的持续研究和计划研究的数据来源。