Validity of Diabetes Self-Reports in the Women's Health Initiative

描述（由申请人提供）：以患者为导向和流行病学研究项目，特别是多中心项目，通常产生的数据具有潜在的效用，超出了他们设计的特定假设和问题。妇女健康倡议（WHI）临床试验招募了68,133名年龄在50-79岁之间的女性参加饮食和激素治疗试验。主要和次要结果（如乳腺癌、冠心病）的自我报告通过对医疗记录的审查得到证实。相比之下，自我报告的2型糖尿病事件没有通过医疗记录的审查独立证实，也没有进行常规诊断测试。确认WHI中参与者糖尿病自我报告的准确性将大大提高WHI数据的价值，作为进一步研究饮食、激素和其他因素对老年妇女糖尿病影响的无与伦比的资源。大约7%的WHI临床试验参与者在基线时报告患有糖尿病，WHI中自我报告的新发药物治疗糖尿病的发病率已接近每年1%。在以前的流行病学研究中，自我报告的糖尿病确诊率从64%到98%不等。来自明尼阿波利斯WHI现场中心医疗记录审查的初步数据显示，随访期间自我报告的糖尿病事件的阳性预测值为85%(74%- 94%)，而从未自我报告的糖尿病的阴性预测值为99%（92%-100%）。本研究的主要目的是通过将研究扩展到其他3个WHI领域中心，在WHI临床试验中获得WHI自我报告的糖尿病发病率的阳性和阴性预测值的更精确估计。这些额外的实地中心在糖尿病危险因素、人口统计、自我报告的糖尿病患病率和发病率方面共同密切代表世界卫生组织。我们将使用WHI数据库中的现有数据，并辅以新收集的问卷数据和一部分参与者的病历回顾，以实现研究目标。新的数据收集采用了与现有的用于判断其他自我报告的WHI主要结果的方法类似的方法，并将用于建立一个黄金标准，以比较WHI中糖尿病的自我报告。次要目的是比较试验中干预组和对照组之间自我报告糖尿病的确认率，并建立一个结合临床特征（如年龄、种族/民族、教育程度、体重指数）和自我报告糖尿病状况的糖尿病发生率预测模型。这是第一个检验糖尿病自我报告的负面预测价值的研究。从大量绝经后妇女队列中获得的一系列空腹血糖数据为估计该人群中未报告的糖尿病发生率提供了一个独特的机会。这项研究将根据标准诊断标准，检查在妇女健康倡议研究中自我报告患有糖尿病的绝经后妇女是否真的患有糖尿病。该研究的结果将有助于确定自我报告的糖尿病是否可以用于WHI数据的其他分析，以及其他研究中的绝经后妇女。

DESCRIPTION (provided by applicant): Patient oriented and epidemiologic research projects, particularly multi-center projects, typically generate data with potential utility beyond the specific hypotheses and questions for which they were designed. The Women's Health Initiative (WHI) Clinical Trials enrolled 68,133 female participants aged 50-79 in dietary and hormone therapy trials. Self-reports of the primary and secondary outcomes (e.g. breast cancer, coronary heart disease) were confirmed by reviews of medical records. In contrast, self-reported incident type 2 diabetes mellitus was not independently confirmed by review of medical records, nor was routine diagnostic testing performed. Confirming that participant self-report of diabetes in WHI is accurate would greatly enhance the value of the WHI data as an unparalleled resource for further investigation of the effects of dietary, hormonal and other influences on diabetes in older women. Approximately 7% of WHI Clinical Trial participants reported diabetes at baseline, and the self-reported incidence of new-onset medication-treated diabetes in WHI has been close to 1% per year. In previous epidemiologic studies, self-reports of diabetes were confirmed at widely ranging rates from 64% to 98%. Preliminary data from medical record reviews at the Minneapolis WHI Field Center showed that the positive predictive value of self-reported incident diabetes during follow-up was 85% (74%- 94%) and the negative predictive value of never self-reporting diabetes was 99% (92%-100%). The principal aim of the proposed study is to obtain more precise estimates of the positive and negative predictive values of WHI self-reports of incident diabetes in the WHI clinical trials by expanding the study to 3 other WHI Field Centers. These additional Field centers collectively represent WHI closely with regard to diabetes risk factors, demographics, prevalence and incidence of self-reported diabetes. We will use existing data in the WHI database, supplemented by newly collected data from a questionnaire and medical record reviews in a subset of participants to carry out the study's aims. The new data collection employs similar methods to those already in place for adjudication of other self-reported WHI primary outcomes, and will be used to establish a gold standard to which the self-reports of diabetes in WHI can be compared. Secondary aims are to compare the confirmation rates of self-reported diabetes between intervention and control arms within the trials, and develop a prediction model for incident diabetes that incorporates clinical characteristics (e.g., age, race/ethnicity, education, BMI) along with self-reported diabetes status. This is the first study to examine the negative predictive value of self-reports of diabetes. The availability of serial fasting serum glucose data from a large cohort of postmenopausal women provides a unique opportunity to estimate of the rate of under-reported incident diabetes in this population. This study will examine whether post-menopausal women who self-reported diabetes in the Women's Health Initiative study really had diabetes according to standard diagnostic criteria. The results of the study will help determine whether self-reported diabetes can be used for other analyses of the WHI data, and for post- menopausal women in other studies.