MANAGEMENT OF PATIENTS WITH SUSPECTED PULMONARY EMBOLISH

这一成果研究项目的具体目标是获得必要的研究培训和经验，以成为临床研究的独立调查者。该培训将包括临床流行病学硕士学位的正式授课部分，以及由指定赞助商提供的个性化指导。通过实施一项前瞻性研究来评估疑似肺栓塞(PE)和非诊断性肺扫描患者的管理策略的有效性和安全性，可以完成在研究研究设计、执行和负责任的进行方面的培训和实践经验，这对社区医院是可行的，并且在大多数患者中避免了通过肺血管造影进行侵入性测试的需要。假设是，在临床怀疑PE、非诊断性肺扫描和足够的心肺储备的患者中，临床上重要的静脉血栓栓塞症(VTE)在随访时很少发生，前提是(A)D-二聚体和压缩超声(C-US)的结果在出现时正常，或(B)D-二聚体阳性，但C-US在系列测试中正常。那些进行了非诊断性肺部扫描，并且心肺储备充足的患者将符合条件，并进入三个实验队列中的一个：静脉血栓栓塞阴性队列包括C-US和D-二聚体结果阴性但未接受抗凝治疗的患者，系列检测队列包括接受连续C-US检测的D-二聚体阳性但C-US阴性的患者，静脉血栓栓塞组阳性队列包括C-US结果阳性且接受抗凝治疗的患者。主要的结果衡量标准将是在3个月的随访期内，客观检测证实的新的症状性静脉血栓栓塞症的发生率。该分析将比较每个VTE阴性和系列检测队列与VTE阳性队列的VTE在随访中的发生率。如果我们的假设是正确的，临床医生将有一种安全、实用的方法来管理临床怀疑为PE的患者，并进行非诊断性肺扫描，这些方法可以很容易地应用于社区医院或门诊。这项研究的完成将为提交独立的调查员补助金(R系列)做好准备，并使调查员成为静脉血栓栓塞病领域的专家顾问。

The specific aim of this outcomes research project is to obtain the research training and experience necessary to become an independent investigator in clinical research. This training will include both a formal didactic component leading to a Masters of Clinical Epidemiology, and individualized mentoring by the designated sponsor. Training and hands- on experience in research study design, execution, and the responsible conduct Of research win be accomplished by implementing a prospective study to evaluate the effectiveness and safety of a strategy for the management of patients with suspected pulmonary embolism (PE) and non-diagnostic lung scans, which is practical for community hospitals, and which avoids the need for invasive testing with pulmonary angiography in most patients. The hypothesis is that in patients with clinically suspected PE, non-diagnostic lung scans, and adequate cardiorespiratory reserve, clinically important venous thromboembolism (VTE) on follow-up is rare provided that (a) the results of D-dimer and compression ultrasound (C-US) are normal at presentation or (b) if D- dimer is positive, but C-US is normal on serial testing. Those patients with non-diagnostic lung scans, and adequate cardiorespiratory reserve defined by objective, reproducible and previously validated criteria will be eligible and entered into one of three experimental cohorts: VTE negative cohort includes patients with negative C-US and D-dimer results in whom anticoagulant therapy is withheld, Serial testing cohort includes patients with positive D-dimer but negative C-US who are managed by serial C-US testing, and VTE positive cohort includes patients with positive C-US results who are treated with anticoagulant therapy. The primary outcome measure will be the incidence of new symptomatic venous thromboembolism confirmed by objective testing, during a 3 month follow-up period. The analysis will compare the incidences of VTE on follow-up between each of the VTE negative and serial testing cohorts with the VTE positive cohort. If our hypothesis is correct, clinicians will have a safe, practical approach for the management of patients with clinically suspected PE, and non-diagnostic lung scans, which can be easily applied in community hospitals or the outpatient clinic. Completion of this research will be excellent preparation for the submission of an independent Investigator Grant (R-series), and establishment of the investigator as an expert consultant in the area of venous thromboembolic disease.