Wells P S, Anderson D R, Rodger M, Stiell I, Dreyer J F, Barnes D, Forgie M, Kovacs G, Ward J, Kovacs M J
Division of Hematology, The Ottawa Hospital, Civic Campus, Suite 452, 737 Parkdale Avenue, Ottawa, Ontario K1Y 1J8, Canada.
Ann Intern Med. 2001 Jul 17;135(2):98-107. doi: 10.7326/0003-4819-135-2-200107170-00010.
The limitations of the current diagnostic standard, ventilation-perfusion lung scanning, complicate the management of patients with suspected pulmonary embolism. We previously demonstrated that determining the pretest probability can assist with management and that the high negative predictive value of certain D -dimer assays may simplify the diagnostic process.
To determine the safety of using a simple clinical model combined with D -dimer assay to manage patients presenting to the emergency department with suspected pulmonary embolism.
Prospective cohort study.
Emergency departments at four tertiary care hospitals in Canada.
930 consecutive patients with suspected pulmonary embolism.
Physicians first used a clinical model to determine patients' pretest probability of pulmonary embolism and then performed a D -dimer test. Patients with low pretest probability and a negative D -dimer result had no further tests and were considered to have a diagnosis of pulmonary embolism excluded. All other patients underwent ventilation-perfusion lung scanning. If the scan was nondiagnostic, bilateral deep venous ultrasonography was done. Whether further testing (by serial ultrasonography or angiography) was done depended on the patients' pretest probability and the lung scanning results.
Patients received a diagnosis of pulmonary embolism if they had a high-probability ventilation-perfusion scan, an abnormal result on ultrasonography or pulmonary angiography, or a venous thromboembolic event during follow-up. Patients for whom the diagnosis was considered excluded were followed up for 3 months for the development of thromboembolic events.
The pretest probability of pulmonary embolism was low, moderate, and high in 527, 339, and 64 patients (1.3%, 16.2%, and 37.5% had pulmonary embolism), respectively. Of 849 patients in whom a diagnosis of pulmonary-embolism had initially been excluded, 5 (0.6% [95% CI, 0.2% to 1.4%]) developed pulmonary embolism or deep venous thrombosis during follow-up. However, 4 of these patients had not undergone the proper diagnostic testing protocol. In 7 of the patients who received a diagnosis of pulmonary embolism, the physician had performed more diagnostic tests than were called for by the algorithm. In 759 of the 849 patients in whom pulmonary embolism was not found on initial evaluation, the diagnostic protocol was followed correctly. Only 1 (0.1% [CI, 0.0% to 0.7%]) of these 759 patients developed thromboembolic events during follow-up. Of the 437 patients with a negative D -dimer result and low clinical probability, only 1 developed pulmonary embolism during follow-up; thus, the negative predictive value for the combined strategy of using the clinical model with D -dimer testing in these patients was 99.5% (CI, 99.1% to 100%).
Managing patients for suspected pulmonary embolism on the basis of pretest probability and D -dimer result is safe and decreases the need for diagnostic imaging.
当前的诊断标准——通气灌注肺扫描存在局限性,这使得疑似肺栓塞患者的管理变得复杂。我们之前证明,确定验前概率有助于管理,并且某些D -二聚体检测的高阴性预测值可能会简化诊断过程。
确定使用简单临床模型结合D -二聚体检测来管理急诊科疑似肺栓塞患者的安全性。
前瞻性队列研究。
加拿大四家三级护理医院的急诊科。
930例连续的疑似肺栓塞患者。
医生首先使用临床模型确定患者肺栓塞的验前概率,然后进行D -二聚体检测。验前概率低且D -二聚体结果为阴性的患者不再进行进一步检测,并被认为排除了肺栓塞诊断。所有其他患者接受通气灌注肺扫描。如果扫描结果不具有诊断意义,则进行双侧下肢深静脉超声检查。是否进行进一步检测(通过连续超声检查或血管造影)取决于患者的验前概率和肺扫描结果。
如果患者通气灌注扫描为高概率、超声检查或肺血管造影结果异常,或在随访期间发生静脉血栓栓塞事件,则诊断为肺栓塞。被认为排除诊断的患者随访3个月,观察是否发生血栓栓塞事件。
肺栓塞的验前概率低、中、高的患者分别有527例、339例和64例(肺栓塞发生率分别为1.3%、16.2%和37.5%)。在最初被排除肺栓塞诊断的849例患者中,5例(0.6% [95% CI,0.2%至1.4%])在随访期间发生了肺栓塞或深静脉血栓形成。然而,这些患者中有4例未遵循正确的诊断检测方案。在诊断为肺栓塞的7例患者中,医生进行的诊断检测比算法要求的更多。在849例初始评估未发现肺栓塞的患者中,759例正确遵循了诊断方案。这759例患者中只有1例(0.1% [CI,0.0%至0.7%])在随访期间发生了血栓栓塞事件。在437例D -二聚体结果为阴性且临床概率低的患者中,随访期间只有1例发生了肺栓塞;因此,在这些患者中使用临床模型与D -二聚体检测相结合策略的阴性预测值为99.5%(CI,99.1%至100%)。
根据验前概率和D -二聚体结果管理疑似肺栓塞患者是安全的,并减少了诊断性影像学检查的需求。