Pretest probability assesment and D-dimer testing for PE

PE 的预测概率评估和 D-二聚体测试

• 批准号: 7082231
• 负责人: D. MARK COURTNEY
• 金额: $ 12.67万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7082231
• 关键词: blood tests; cardiovascular disorder diagnosis; clinical research; computer assisted diagnosis; diagnosis design /evaluation; diagnostic tests; dimer; emergency health services; fibrin; health care service utilization; human subject; informatics; longitudinal human study; lung imaging /visualization /scanning; mathematical model; patient oriented research; pulmonary circulation obstruction; respiratory disorder diagnosis

DESCRIPTION (provided by applicant): This proposal describes a 5 year mentored training program in patient oriented clinical research. The PI has completed a residency and research fellowship in Emergency Medicine and is seeking further training to study Bayesian probability, diagnostic test assessment, resource utilization, and classification tree analysis techniques to predict presence or absence of pulmonary embolism (PE). The most common symptoms of PE, chest pain and shortness of breath are included as the chief complaints of an estimated 10 million people in US emergency departments annually. Testing for PE must be done in conjunction with estimation of the pretest probability that the clinician believes to be existent at the time of patient presentation. There are no uniformly used or accepted means of estimating pretest probability. Two methods have been suggested in North American populations, the Wells score and the Charlotte criteria, but these give only ranges of probability estimates and include a series of questions, which must be memorized. They have been uncommonly used outside of their derivation populations. There has also been a recent proliferation of blood based screening tests for PE such as the quantitative D-dimer test. If normal, in low pretest probability patients, these rapid, highly sensitive, low specificity tests alone may be used to reduce the likelihood of PE to below a safe threshold. The ease of ordering a blood test to screen for PE may result in significant changes in overall test utilization, radiological test use, and overall disease diagnosis. This prospective observational study will quantify the effects of a new quantitative D-dimer on these three parameters, as well as test the hypothesis that low risk patients (Wells and Charlotte criteria) with a negative D-dimer have a very low prevalence of PE (<1.0%) as determined by imaging test results, and 3 month follow-up. To improve the safety, accuracy and efficiency of pretest probability assessment and D-dimer testing, a new model identifying low risk patients (goal: <5% pretest probability) will be derived from this data by non-linear modeling and classification tree analysis. Dr. Charles Bennett will be the mentor for this project and is a national leader in hematological and oncology research. He has significant experience in mentoring junior investigators and an emphasis in disease detection and outcome prediction to ensure development of the PI toward that of an independently funded investigator.

描述（由申请人提供）： 该提案描述了一个为期5年的指导培训计划，以患者为导向的临床研究。PI已完成急诊医学的住院医师和研究奖学金，并正在寻求进一步培训，以研究贝叶斯概率、诊断测试评估、资源利用和分类树分析技术，以预测是否存在肺栓塞（PE）。PE、胸痛和呼吸短促的最常见症状被列为美国急诊科每年估计1000万人的主要主诉。PE测试必须与临床医生认为在患者就诊时存在的预测试概率估计一起进行。没有统一使用或接受的方法来估计预试概率。在北美人群中，有两种方法被推荐，威尔斯评分和夏洛特标准，但这些方法只能给出概率估计的范围，并包括一系列必须记住的问题。它们在其衍生人群之外不常使用。最近还出现了基于血液的PE筛查试验的激增，例如定量D-二聚体试验。如果正常，在低预测概率患者中，这些快速、高灵敏度、低特异性的检测可单独用于将PE的可能性降低至安全阈值以下。订购血液检查筛查PE的容易程度可能会导致整体测试利用率，放射性测试使用和整体疾病诊断的显着变化。这项前瞻性观察性研究将量化一种新的定量D-二聚体对这三个参数的影响，并检验以下假设：D-二聚体阴性的低风险患者（威尔斯和夏洛特标准）的PE患病率非常低（<1.0%），这是通过成像检查结果和3个月随访确定的。为了提高预试验概率评估和D-二聚体检测的安全性、准确性和效率，将通过非线性建模和分类树分析从该数据中推导出识别低风险患者（目标：<5%预试验概率）的新模型。查尔斯班尼特博士将是这个项目的导师，是血液学和肿瘤学研究的国家领导人。他在指导初级研究者方面拥有丰富的经验，并强调疾病检测和结局预测，以确保PI向独立资助的研究者发展。