Pretest Probability Assessment for Pulmonary Embolism

肺栓塞的预测概率评估

• 批准号: 6950354
• 负责人: JEFFREY A KLINE
• 金额: $ 53.68万
• 依托单位: BREATHQUANT MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-03-17 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6950354
• 关键词: Internet; cardiovascular disorder epidemiology; cardiovascular disorder risk; clinical research; computer system design /evaluation; data collection methodology /evaluation; emergency care; health surveys; human data; human subject; interview; method development; pulmonary circulation obstruction; sign /symptom; statistics /biometry

DESCRIPTION (provided by applicant): Pretest probability assessment (PTP) plays a pivotal role in the evaluation of pulmonary embolism (PE) in the emergency department (ED) and accurate PTP assessment can modify defensive test-ordering behavior by physicians. However, current methods of PTP assessment produce broad categories of risk that tend to over fit individual patients and seldom obviate test-ordering. The primary hypothesis asserts that the PTP of a life-threatening process can be accurately estimated by using BreathQuant Medical System's patent-pending method of matching clinical attributes of an individual patient to an identical profile of attributes shared by patients drawn from a large, proprietary reference database. The reference database must contain detailed data from an appropriate spectrum of patients previously evaluated for that specific process, and for whom outcomes are encoded. Our attribute-matching(c) object code, launched from a personal digital assistant (PDA) or a personal computer, returns all patients matched to an identical clinical profile; the proportion of matched patients with an outcome of the disease in question equals the PTP; 95% confidence intervals can be computed. Validation data from a similar product, the ACS PREtest Consult TM, show merit of attribute-matching to estimate PTP of acute coronary syndrome. To accumulate a large database from ED patients undergoing objective testing for PE, Phase I of the present work developed the HIPAA-compliant, web-based, patent-pending Virtual Private Study TM platform to collect clinical data using PDAs and desktop computers in the ED setting using strict privacy-protection measures. In Phase II, we will deploy the phase I technology to collect clinical data on ED patients evaluated for PE in a multicenter study. The first aim is to disseminate the PE e-form to 10 US EDs. The second aim is to prospectively collect PE e-forms on a consecutive or random sample of 5000 patients evaluated for PE in the 10 EDs, and to complete 45-day follow-up on all patients. The third aim is to perform statistical analysis on the database using classification and regression tree analysis to determine the appropriate clinical attributes to use in the commercial product. BreathQuant Medical Systems will use the database to produce its second product, the PE PREtest ConsultTM to help physicians estimate a tailor-made pretest probability of PE. In phase III, we will test the validity of the PE PREtest Consult TM and determine if the use of the PE PREtest ConsultTM will decrease unnecessary testing for PE.

描述（由申请人提供）：预测试概率评估（PTP）在急诊科（ED）和准确的PTP评估中评估肺栓塞（PE）中起关键作用，可以修改医生的防御性测试命令行为。但是，当前的PTP评估方法会产生广泛的风险类别，这些风险往往过于拟合单个患者，并且很少消除测试顺序。主要假设断言，可以通过使用呼吸医学系统的申请专利的方法来准确估算生命危险过程的PTP，以使单个患者的临床属性与从大型专有参考数据库中得出的患者共享的属性相同的属性相同。参考数据库必须包含来自先前评估该特定过程的适当患者的详细数据，并为其编码结果。我们的属性匹配（C）对象代码是从个人数字助理（PDA）或个人计算机发行的，将所有与相同的临床状况相匹配的患者返回；相匹配的患者与有关疾病结果的匹配患者的比例等于PTP。可以计算95％的置信区间。来自类似产品的验证数据ACS预测咨询TM，表明属性匹配对急性冠状动脉综合征的PTP的优点。为了累积对PE进行客观测试的ED患者的大型数据库，本工作的第一阶段开发了符合HIPAA，基于Web的，申请专利的虚拟私人研究TM平台，使用严格的隐私保护度量使用ED设置中的PDA和台式计算机收集临床数据。在第二阶段，我们将部署I期技术，以在一项多中心研究中收集评估PE的ED患者的临床数据。第一个目的是将PE E-Form传播到10美国EDS。第二个目的是前瞻性地收集5000名在10 ED中评估的PE的患者的连续或随机样本，并对所有患者完成45天的随访。第三个目的是使用分类和回归树分析对数据库进行统计分析，以确定要在商业产品中使用的适当临床属性。呼吸的医疗系统将使用数据库生产其第二个产品PE Pretest Consulttm，以帮助医生估计PE的量身定制的预测试可能性。在第三阶段，我们将测试PE预测咨询TM的有效性，并确定PE Pretest Consulttm的使用是否会减少对PE的不必要测试。

项目成果

Frequency of thromboprophylaxis and incidence of in-hospital venous thromboembolism in a cohort of emergency department patients.

急诊科患者队列中血栓预防的频率和院内静脉血栓栓塞的发生率。

• DOI: 10.1007/s11239-007-0032-x
• 发表时间: 2008
• 期刊: Journal of thrombosis and thrombolysis
• 影响因子: 4
• 作者: Jones,AlanE;Fordham,Zachary;Yiannibas,Vasilios;Johnson,CharlesL;Kline,JeffreyA
• 通讯作者: Kline,JeffreyA

Systematic bias introduced by the informed consent process in a diagnostic research study.

诊断研究中知情同意过程引入的系统偏差。

• DOI: 10.1111/j.1553-2712.2008.00066.x
• 发表时间: 2008
• 期刊: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
• 作者: Mitchell,AliceM;Kline,JeffreyA
• 通讯作者: Kline,JeffreyA

Factors associated with positive D-dimer results in patients evaluated for pulmonary embolism.

• DOI: 10.1111/j.1553-2712.2010.00765.x
• 发表时间: 2010-06
• 期刊: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
• 作者: Kabrhel C;Mark Courtney D;Camargo CA Jr;Plewa MC;Nordenholz KE;Moore CL;Richman PB;Smithline HA;Beam DM;Kline JA
• 通讯作者: Kline JA