Safety and Clinical Utility of Four Clinical Decision Rules In the Diagnostic Management of Acute Pulmonary Embolism – the Prometheus Diagnosis Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3186-3186
Author(s):  
Inge CM Mos ◽  
Renée A Douma ◽  
Petra MG Erkens ◽  
Tessa AC Nizet ◽  
Marc F Durian ◽  
...  

Abstract Abstract 3186 Background Several clinical decision rules (CDRs) are available for the exclusion of acute pulmonary embolism (PE). This prospective multi-center study compared the safety and clinical utility of four CDRs (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score) in excluding PE in combination with D-dimer testing. Methods Clinical probability of patients with suspected acute PE was assessed using a computerized based “black box”, which calculated all CDRs and indicated the next diagnostic step. A “PE unlikely” result according to all CDRs in combination with a normal D-dimer result excluded PE, while patients with “PE likely” according to at least one of the CDRs or an abnormal D-dimer result underwent CT-scanning. Patients in whom PE was excluded were followed for three months. Results 807 consecutive patients were included and PE prevalence was 23%. The number of patients categorized as “PE unlikely” ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer level, the CDRs excluded PE in 22–24% of patients. The total failure rates of the CDR-D-dimer combinations were similar (1 failure, 0.5– 0.6%, upper 95% CI 2.9– 3.1%). Despite 30% of the patients had discordant CDR outcomes, PE was missed in none of the patients with discordant CDRs and a normal D-dimer result. Conclusions All four CDRs show similar safety and clinical utility for exclusion of acute PE in combination with a normal D-dimer level. With this prospective validation, the more straightforward simplified scores are ready for use in clinical practice. Disclosures: No relevant conflicts of interest to declare.

2011 ◽  
Vol 4 (4) ◽  
pp. 99-104
Author(s):  
John H Park ◽  
Cole R Spresser ◽  
Jorge A Valdivia ◽  
Michael J Khadavi ◽  
Saikat Das ◽  
...  

Background. Pulmonary embolism (PE) is clinically suspected in many patients who complain of shortness of breath or chest pain due to its nonspecific nature. The prevalence of PE, however, is low in this population. To assist physicians in diagnostic decision making, several clinical decision rules (CDR) have been developed. The appropriate use of these CDRs has been proven to decrease the need for expensive, time consuming, and invasive diagnostic imaging procedures. In this study, the appropriateness of D-dimer and CT usage was investigated to rule out pulmonary emboli based on the simplified Geneva score. Methods. A retrospective review was performed on 74 patients with a CT scan ordered through a pulmonary embolism (PE) protocol. Using clinical data, the patients were stratified into “unlikely” and “likely” groups for the presence of PE based on the simplification of the revised Geneva score. Scores of 0-2 were graded as “unlikely” and scores of 3 or greater were “likely.” Results. There were 45/74 (60.8%) patients in the “unlikely” group. Of these, 14/45 (31.1%) received a D-dimer; eight were normal and six elevated. Only one patient in the elevated group had evidence of a PE. Of the remaining 31(39.2%) patients in the “unlikely” group that did not receive a D-dimer, only one had a PE. The “likely” group consisted of 29 (39.2%) patients of whom six received a D-dimer. Three patients had a normal D-dimer and three had an elevated level. Neither of these two groups had a PE. Of the remaining 23 (60.8%) in the “likely” group who did not receive a D-dimer, six had a PE. Conclusions. Diagnosing pulmonary emboli using D-dimer levels and CT scans may be aided by clinical decision rules such as the simplified Geneva system. This process may lead to more effective use of medical resources.


2017 ◽  
Vol 117 (11) ◽  
pp. 2176-2185 ◽  
Author(s):  
Anne Bass ◽  
Kara Fields ◽  
Rie Goto ◽  
Gregory Turissini ◽  
Shirin Dey ◽  
...  

Background Clinical decision rules (CDRs) for pulmonary embolism (PE) have been validated in outpatients, but their performance in hospitalized patients is not well characterized. Objectives The goal of this systematic literature review was to assess the performance of CDRs for PE in hospitalized patients. Methods We performed a structured literature search using Medline, EMBASE and the Cochrane library for articles published on or before January 18, 2017. Two authors reviewed all titles, abstracts and full texts. We selected prospective studies of symptomatic hospitalized patients in which a CDR was used to estimate the likelihood of PE. The diagnosis of PE had to be confirmed using an accepted reference standard. Data on hospitalized patients were solicited from authors of studies in mixed populations of outpatients and hospitalized patients. Study characteristics, PE prevalence and CDR performance were extracted. The methodological quality of the studies was assessed using the QUADAS instrument. Results Twelve studies encompassing 3,942 hospitalized patients were included. Studies varied in methodology (randomized controlled trials and observational studies) and reference standards used. The pooled sensitivity of the modified Wells rule (cut-off ≤ 4) in hospitalized patients was 72.1% (95% confidence interval [CI], 63.7–79.2) and the pooled specificity was 62.2% (95% CI, 52.6–70.9). The modified Wells rule (cut-off ≤ 4) plus D-dimer testing had a pooled sensitivity 99.7% (95% CI, 96.7–100) and pooled specificity 10.8% (95% CI, 6.7–16.9). The efficiency (proportion of patients stratified into the ‘PE unlikely’ group) was 8.4% (95% CI, 4.1–16.5), and the failure rate (proportion of low likelihood patients who were diagnosed with PE during follow-up) was 0.1% (95% CI, 0–5.3). Conclusion In symptomatic hospitalized patients, use of the Wells rule plus D-dimer to rule out PE is safe, but allows very few patients to forgo imaging.


2012 ◽  
Vol 107 (01) ◽  
pp. 167-171 ◽  
Author(s):  
Inge Mos ◽  
Renée Douma ◽  
Petra Erkens ◽  
Marc Durian ◽  
Tessa Nizet ◽  
...  

SummaryFour clinical decision rules (CDRs) (Wells score, Revised Geneva Score (RGS), simplified Wells score and simplified RGS) safely exclude pulmonary embolism (PE), when combined with a normal D-dimer test. Recently, an age-adjusted cut-off of the D-dimer (patient’s age x 10 μg/l) safely increased the number of patients above 50 years in whom PE could safely be excluded. We validated the age-adjusted D-dimer test and assessed its performance in combination with the four CDRs in patients with suspected PE. A total of 414 consecutive patients with suspected PE who were older than 50 years were included. The proportion of patients in whom PE could be excluded with an ‘unlikely’ clinical probability combined with a normal age-adjusted D-dimer test was calculated and compared with the proportion using the conventional D-dimer cut-off. We assessed venous thromboembolism (VTE) failure rates during three months follow-up. In patients above 50 years, a normal age-adjusted D-dimer level in combination with an ‘unlikely’ CDR substantially increased the number of patients in whom PE could be safely excluded: from 13–14% to 19–22% in all CDRs similarly. In patients over 70 years, the number of exclusions was nearly four-fold higher, and the original Wells score excluded most patients, with an increase from 6% to 21% combined with the conventional and age-adjusted D-dimer cut-off, respectively. The number of VTE failures was also comparable in all CDRs. In conclusion, irrespective of which CDR is used, the age-adjusted D-dimer substantially increases the number of patients above 50 years in whom PE can be safely excluded.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Jacob Ortiz ◽  
Rabia Saeed ◽  
Christopher Little ◽  
Saul Schaefer

Risk assessment for pulmonary embolism (PE) currently relies on physician judgment, clinical decision rules (CDR), and D-dimer testing. There is still controversy regarding the role of D-dimer testing in low or intermediate risk patients. The objective of the study was to define the role of clinical decision rules and D-dimer testing in patients suspected of having a PE. Records of 894 patients referred for computed tomography pulmonary angiography (CTPA) at a University medical center were analyzed. The clinical decision rules overall had an ROC of approximately 0.70, while signs of DVT had the highest ROC (0.80). A low probability CDR coupled with a negative age-adjusted D-dimer largely excluded PE. The negative predictive value (NPV) of an intermediate CDR was 86–89%, while the addition of a negative D-dimer resulted in NPVs of 94%. Thus, in patients suspected of having a PE, a low or intermediate CDR does not exclude PE; however, in patients with an intermediate CDR, a normal age-adjusted D-dimer increases the NPV.


2010 ◽  
Vol 104 (10) ◽  
pp. 831-836 ◽  
Author(s):  
Geerte van Sluis ◽  
Pieter Kamphuisen ◽  
Maaike Söhne ◽  
Frank Leebeek ◽  
Patrick Bossuyt ◽  
...  

SummaryPatients with malignancy frequently present with clinically suspected pulmonary embolism (PE). However, the safe and efficient combination of a clinical decision rule (CDR) and D-dimer test to rule out PE performs less well in patients with malignancy. We examined potential explanations and analysed whether elevating the D-dimer cut-off could improve the clinical utility. We used data on consecutive patients with suspected PE included in a multicenter management study. The performance of the Wells CDR and the D-dimer test was compared between patients with and without malignancy and multivariable analysis was used to compare the weights of the CDR variables. Furthermore, we combined the CDR (cut-off ≤4) with different D-dimer cut-off levels for the exclusion of PE. Of 3,306 patients with suspected PE, 475 (14%) had cancer. The Wells rule variables were less diagnostic in cancer patients. Increasing the D-dimer cut-off level to 700 μg/l for all ages or using an age-dependent cut-off resulted in an increase in the proportion of patients in whom PE could be excluded from 8.4% to 13% and 12%, respectively. The corresponding false-negative rates were 1.6% (95% confidence interval 0.3–8.7%) and 0.0% (0.0–6.3%). The Wells CDR and D-dimer perform less well in patients with suspected PE if they have cancer. Individual variables in the Wells rule are less diagnostic in cancer patients than in non-cancer patients with suspected PE. A CDR combined with an age-dependent D-dimer cut-off shows a modest improvement of the strategy in cancer patients.


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