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

2007 ◽  
Vol 97 (01) ◽  
pp. 146-150 ◽  
Author(s):  
Neeltje Steeghs ◽  
Rene Niessen ◽  
Gé Jonkers ◽  
Hans Dik ◽  
Ad Castel ◽  
...  

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.

2002 ◽  
Vol 162 (14) ◽  
pp. 1631 ◽  
Author(s):  
Marieke J. H. A. Kruip ◽  
Marjan J. Slob ◽  
Joost H. E. M. Schijen ◽  
Cees van der Heul ◽  
Harry R. Büller

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 967-967
Author(s):  
Arina ten Cate-Hoek ◽  
Diane Toll ◽  
Eit Frits van der Velde ◽  
Arno Hoes ◽  
Harry Buller ◽  
...  

Abstract Prior studies have evaluated the safety and effectiveness of a diagnostic work up based on combined use of a clinical decision rule and a D-dimer laboratory test in patients with suspected deep vein thrombosis in secondary care facilities. The overall outcome of these studies show that approximately 30% of additional objective evaluation can be avoided without compromising the safety, resulting in failure rates of less than 1%. The objective of our study was to assess the effectiveness of a modified algorithm using a dichotomized clinical decision rule including a point of care D-dimer test in patients suspected of deep vein thrombosis in primary care. The AMUSE study is a prospective cohort study of consecutive patients with clinically suspected acute deep vein thrombosis conducted in 400 general practices coordinated by 3 university affiliated centers in the Netherlands from March 2004 through January 2007. The study population of 1029 patients included 63% women. Patients were categorized as “deep vein thrombosis unlikely” or “deep vein thrombosis likely” using a dichotomized version of a for general practice adapted clinical decision rule based on the Wells rule. Patients classified as unlikely were excluded from further testing. All other patients underwent ultrasonography. Anticoagulants were withheld from patients classified as unlikely. All patients were followed up for 3 months. The main outcome measure was symptomatic or fatal venous thromboembolism (VTE) during 3 months follow-up. Deep vein thrombosis was classified as unlikely in 500 patients (48.6%), all of whom were not treated with anticoagulants; subsequent non fatal VTE occurred in 8 patients (1.6% [95 CI 0.7–3.1%]). In 500 patients categorized as likely, deep vein thrombosis was confirmed in 124 patients (24.8%), 3 patients did not receive objective testing (0.6%) and 373 patients were tested negative (74.6%). Two out of 4 patients not receiving objective testing had confirmed deep vein thrombosis in the 3 month follow-up period. In patients that tested negative 4 non fatal events occurred during the 3 month follow-up (1.1%). The algorithm was completed and allowed a management decision in 97.2% of patients. We conclude that this management strategy is both safe and highly effective in patients with suspected deep vein thrombosis in general practice. Its use is associated with low risk for subsequent fatal and nonfatal VTE and a further increase in the yield of objective diagnostic tests.


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.


2008 ◽  
Vol 99 (01) ◽  
pp. 229-234 ◽  
Author(s):  
Maaike Sohne ◽  
Marieke J. H. A Kruip ◽  
Lidwine W Tick ◽  
Victor E Gerdes ◽  
Patrick M Bossuyt ◽  
...  

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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