CORE--DATA AND CLINICAL PREDICTION

核心——数据和临床预测

• 批准号: 6272278
• 负责人: Roberta B. Ness
• 金额: $ 18.15万
• 依托单位: MAGEE-WOMEN'S HOSPITAL OF UPMC
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-01 至 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6272278
• 关键词: biomedical facility; case history; clinical research; data collection; data management; female; human data; human subject; interview; preeclampsia; statistics /biometry

The purposes of the Data and Clinical Prediction Core are twofold. First, the Core will centralize recruitment, baseline data collection, data management and statistical consultation for clinical projects in the PERC. Second, efficient analysis of data collected by the Core will allow the development of the first multivariate clinical prediction rule to predict the occurrence of preeclampsia. Until now, limited success has been achieved using indicidual tests proposed to distinguish women who will develop preeclampsia from those who will not. The core will recruit an estimated 550 eligible women per year from Magee Womens Hospital for whom baseline clinical, anthropometric, and laboratory data will be obtained. Longitudinal clinical data and biologic samples iwll also be collected and stored. Data will be organized and maintained using expertise within the Department of Epidemiology. Statistical consultation will be ongoing. The Clinical Prediction study will be a nested case-control design. One hundred ten preeclamptic patients will be compared to 220 non-preeclamptic controls in formulating the rule; 60 cases will be compared to 120 controls in validating the rule. All formulation subjects will have been enrooled in the Core's longitudinal follow-up activities. To be included as cases, women must meet a rigorous case definition as reviewed by a panel of experts. Potential predictors that will be analyzed include baseline interview data, weight, body fatness, and laboratory tests. The clinical and test findings of cases and controls will be compared in order to identify women at high risk for the development of preeclampsia. From univariate tests and multivariate logistic regression models, prediction capabilities will be evaluated using Receiver Operating Curves; the simplified rule with the best test characteristics iwll be identified. Preeclampsia is a major contributor to maternal and perinatal morbidity and mortality. Prevention of this disease requires both an understanding of pathophysiology as well as a clinical characterization of women fated to develop in the disease. The core will assist in both pursuits.

数据和临床预测核心的目的是 双重。 首先，核心将集中招聘、基线数据 临床数据采集、数据管理和统计咨询 PERC 中的项目。 二、高效分析收集到的数据 由核心将允许开发第一个多元 临床预测子痫前期发生的规律。 到目前为止，通过单独的测试取得了有限的成功 提议区分将患先兆子痫的女性 来自那些不会的人。 该核心每年将招募约 550 名符合条件的女性 来自 Magee 妇女医院的基线临床， 将获得人体测量和实验室数据。 纵向临床数据和生物样本也将 收集并保存。 数据将使用以下方式组织和维护 流行病学系的专业知识。 统计 磋商将持续进行。 临床预测研究将采用巢式病例对照设计。 将 110 名先兆子痫患者与 220 名患者进行比较 制定规则时的非先兆子痫控制； 60 例将 与验证规则时的 120 个控件相比。 所有配方 受试者将被纳入核心纵向 后续活动。 要纳入案例，女性必须满足 经过专家小组审查的严格案例定义。 将分析的潜在预测因素包括基线访谈 数据、体重、体脂和实验室测试。 临床和 将比较病例和对照的测试结果，以便 识别患有先兆子痫的高风险女性。 根据单变量检验和多变量逻辑回归模型， 预测能力将使用接收器操作进行评估 曲线；具有最佳测试特性的简化规则将是 确定。 先兆子痫是孕产妇和围产儿的主要诱因 发病率和死亡率。 预防这种疾病需要两方面 对病理生理学和临床的理解 女性注定会患上这种疾病的特征。 这 core 将有助于这两种追求。