Clinical decision rule and D-dimer have lower clinical utility to exclude pulmonary embolism in cancer patients

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

Blood ◽

10.1182/blood.v116.21.3186.3186 ◽

2010 ◽

Vol 116 (21) ◽

pp. 3186-3186

Author(s):

Inge CM Mos ◽

Renée A Douma ◽

Petra MG Erkens ◽

Tessa AC Nizet ◽

Marc F Durian ◽

...

Keyword(s):

Pulmonary Embolism ◽

Clinical Utility ◽

Acute Pulmonary Embolism ◽

Decision Rules ◽

Clinical Decision ◽

Clinical Decision Rules ◽

Wells Rule ◽

Revised Geneva Score ◽

Acute Pe ◽

D Dimer

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.

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Further validation and simplification of the Wells clinical decision rule in pulmonary embolism

Thrombosis and Haemostasis ◽

10.1160/th07-05-0321 ◽

2008 ◽

Vol 99 (01) ◽

pp. 229-234 ◽

Cited By ~ 110

Author(s):

Maaike Sohne ◽

Marieke J. H. A Kruip ◽

Lidwine W Tick ◽

Victor E Gerdes ◽

Patrick M Bossuyt ◽

...

Keyword(s):

Pulmonary Embolism ◽

Venous Thromboembolism ◽

Decision Rule ◽

Clinical Decision ◽

Clinical Decision Rule ◽

Odds Ratios ◽

Wells Score ◽

Individual Variables ◽

Diagnostic Work ◽

Wells Rule

SummaryThe Wells rule is a widely applied clinical decision rule in the diagnostic work-up of patients with suspected pulmonary embolism (PE).The objective of this study was to replicate, validate and possibly simplify this rule. We used data collected in 3,306 consecutive patients with clinically suspected PE to recalculate the odds ratios for the variables in the rule, to calculate the proportion of patients with PE in the probability categories, the area under the ROC curve and the incidence of venous thromboembolism during follow-up. We compared these measures with those for a modified and a simplified version of the decision rule. In the replication, the odds ratios in the logistic regression model were found to be lower for each of the seven individual variables (p=0.02) but the proportion of patients with PE in the probability categories in our study group were comparable to those in the original derivation and validation groups. The area under the ROC of the original, modified and simplified decision rule was similar: 0.74 (p=0.99; p=0.07).The venous thromboembolism incidence at three months in the group of patients with a Wells score ≤ 4 and a normal D-dimer was 0.5%, versus 0.3% with a modified rule and 0.5% with a simplified rule. The proportion of patients safely excluded for PE was 32%, versus 31% and 30%, respectively. This study further validates the diagnostic utility of theWells rule and indicates that the scoring system can be simplified to one point for each variable.

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Use of a Clinical Decision Rule in Combination With D-Dimer Concentration in Diagnostic Workup of Patients With Suspected Pulmonary Embolism

Archives of Internal Medicine ◽

10.1001/archinte.162.14.1631 ◽

2002 ◽

Vol 162 (14) ◽

pp. 1631 ◽

Cited By ~ 129

Author(s):

Marieke J. H. A. Kruip ◽

Marjan J. Slob ◽

Joost H. E. M. Schijen ◽

Cees van der Heul ◽

Harry R. Büller

Keyword(s):

Pulmonary Embolism ◽

Decision Rule ◽

Clinical Decision ◽

Diagnostic Workup ◽

Clinical Decision Rule ◽

Suspected Pulmonary Embolism ◽

D Dimer

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Impact of a Clinical Decision Rule and a D-dimer plus Alveolar Deadspace Measurement to Rule Out Pulmonary Embolism in an Urban Emergency Department

Academic Emergency Medicine ◽

10.1197/aemj.10.5.502-a ◽

2003 ◽

Vol 10 (5) ◽

pp. 502-a-502 ◽

Cited By ~ 3

Author(s):

J. A Kline

Keyword(s):

Emergency Department ◽

Pulmonary Embolism ◽

Decision Rule ◽

Clinical Decision ◽

Clinical Decision Rule ◽

D Dimer ◽

Urban Emergency Department ◽

Rule Out

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The Christopher Study: effective management of pulmonary embolism by clinical decision rule (CDR), D-dimer test and helical computed tomography (CT)

http://isrctn.org/> ◽

10.1186/isrctn56430379 ◽

2012 ◽

Author(s):

M V Huisman

Keyword(s):

Computed Tomography ◽

Pulmonary Embolism ◽

Decision Rule ◽

Clinical Decision ◽

Helical Computed Tomography ◽

Effective Management ◽

Clinical Decision Rule ◽

D Dimer

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Simple and safe exclusion of pulmonary embolism in outpatients using quantitative D-dimer and Wells’ simplified decision rule

Thrombosis and Haemostasis ◽

10.1160/th06-09-0529 ◽

2007 ◽

Vol 97 (01) ◽

pp. 146-150 ◽

Cited By ~ 29

Author(s):

Neeltje Steeghs ◽

Rene Niessen ◽

Gé Jonkers ◽

Hans Dik ◽

Ad Castel ◽

...

Keyword(s):

Pulmonary Embolism ◽

Decision Rule ◽

Clinical Decision ◽

Clinical Decision Rule ◽

Non Invasive ◽

Highly Efficient ◽

Venous Thromboembolic Events ◽

Venous Thromboembolic ◽

D Dimer

SummaryA safe and effective management strategy is pivotal in excluding pulmonary embolism (PE). The combination of Wells’ simplified dichotomous clinical decision rule and D-dimer test is non-invasive and could be highly efficient, though its safety has not been widely studied. We evaluated safety and efficiency of this combination in excluding PE. Wells clinical decision rule was performed in 941 consecutive patients with suspected PE and, if patients had a score ≤ 4.0 points, a VIDAS D-dimer test followed. Patients with a normal D-dimer concentration had no further tests, PE was considered excluded, and patients did not receive anticoagulant treatment. Patients, in whom PE was excluded, were followed up for three months. Four hundred fifty patients (51.2%) had a clinical decision score ≤ 4.0 points and a normal D-dimer concentration. In 45 of these patients, during the initial diagnostic period additional objective testing, although not indicated, was performed, and PE was established in two patients. During three months of follow up no venous thromboembolic events (VTE) occurred. Therefore, the overall VTE failure rate was two of 450 (0.4% [95%CI 0–1.1]); the overall prevalence of PE was 12.3%. The diagnostic protocol could be completed and allowed a decision to be made in 90% of the study patients. This study has prospectively established the safety of a combination of a dichotomized clinical decision rule and D-dimer test in ruling out PE. The strategy proved highly efficient, since more than 50% of patients could be managed without the need for more invasive and expensive tests.

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