Validation and impact of a simplified clinical decision rule for diagnosing pulmonary embolism in primary care: design of the PECAN prospective diagnostic cohort management study

Validation and impact of a simplified clinical decision rule for diagnosing pulmonary embolism in primary care: design of the PECAN prospective diagnostic cohort management study
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DOI:
10.1136/bmjopen-2019-031639
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发表时间:
2019-10-01
期刊:
影响因子:
2.9
通讯作者:
Geersing, Geert-Jan
Geersing, Geert-Jan
中科院分区:
医学3区
文献类型:
--
作者:
van Maanen, Rosanne;Rutten, Frans H.;Geersing, Geert-Jan

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结合病史和体格检查,D-二聚体阴性可以安全地排除肺栓塞(PE)。然而,D-二聚体测试经常是假阳性,导致许多(事后诸葛亮)“不必要的”转介到二级保健。最近,新的年算法,结合灵活的D-二聚体阈值取决于预测试的风险,被开发和验证,显示其能够安全地排除PE在医院环境中。重要的是,这伴随着14%的计算机断层肺血管造影比标准的,固定的D-二聚体阈值。虽然有前途的,在初级保健这个算法还没有得到验证you.Methods和分析PECAN(诊断肺栓塞的背景下,常见的替代diagNoses在初级保健)研究是一个前瞻性的诊断研究,在荷兰初级保健。入选的疑似急性PE患者将由其全科医生根据YEARS诊断算法进行管理,并在初级保健中随访3个月以确定最终诊断。为了研究使用YEARS算法的影响,主要终点是YEARS算法在初级保健中的安全性和有效性。安全性定义为假阴性检测结果在未提及的检测结果中所占的比例。效率是指被归类为非转诊类别的患者比例。此外,我们量化C反应蛋白测量是否增加了诊断价值的年算法,使用多变量逻辑和多分类回归模型。此外,我们将调查哪些因素有助于主观年项目“PE最可能的诊断”。
Introduction Combined with patient history and physical examination, a negative D-dimer can safely rule-out pulmonary embolism (PE). However, the D-dimer test is frequently false positive, leading to many (with hindsight) 'unneeded' referrals to secondary care. Recently, the novel YEARS algorithm, incorporating flexible D-dimer thresholds depending on pretest risk, was developed and validated, showing its ability to safely exclude PE in the hospital environment. Importantly, this was accompanied with 14% fewer computed tomographic pulmonary angiography than the standard, fixed D-dimer threshold. Although promising, in primary care this algorithm has not been validated yet.Methods and analysis The PECAN (Diagnosing Pulmonary Embolism in the context of Common Alternative diagNoses in primary care) study is a prospective diagnostic study performed in Dutch primary care. Included patients with suspected acute PE will be managed by their general practitioner according to the YEARS diagnostic algorithm and followed up in primary care for 3 months to establish the final diagnosis. To study the impact of the use of the YEARS algorithm, the primary endpoints are the safety and efficiency of the YEARS algorithm in primary care. Safety is defined as the proportion of false-negative test results in those not referred. Efficiency denotes the proportion of patients classified in this non-referred category. Additionally, we quantify whether C reactive protein measurement has added diagnostic value to the YEARS algorithm, using multivariable logistic and polytomous regression modelling. Furthermore, we will investigate which factors contribute to the subjective YEARS item 'PE most likely diagnosis'.