Derivation of a Simple Clinical Model to Categorize Patients Probability of Pulmonary Embolism: Increasing the Models Utility with the SimpliRED D-dimer

Abstract

SummaryWe have previously demonstrated that a clinical model can be safely used in a management strategy in patients with suspected pulmonary embolism (PE). We sought to simplify the clinical model and determine a scoring system, that when combined with D-dimer results, would safely exclude PE without the need for other tests, in a large proportion of patients. We used a randomly selected sample of 80% of the patients that participated in a prospective cohort study of patients with suspected PE to perform a logistic regression analysis on 40 clinical variables to create a simple clinical prediction rule. Cut points on the new rule were determined to create two scoring systems. In the first scoring system patients were classified as having low, moderate and high probability of PE with the proportions being similar to those determined in our original study. The second system was designed to create two categories, PE likely and unlikely. The goal in the latter was that PE unlikely patients with a negative D-dimer result would have PE in less than 2% of cases. The proportion of patients with PE in each category was determined overall and according to a positive or negative SimpliRED D-dimer result. After these determinations we applied the models to the remaining 20% of patients as a validation of the results. The following seven variables and assigned scores (in brackets) were included in the clinical prediction rule: Clinical symptoms of DVT (3.0), no alternative diagnosis (3.0), heart rate >100 (1.5), immobilization or surgery in the previous four weeks (1.5), previous DVT/PE (1.5), hemoptysis (1.0) and malignancy (1.0). Patients were considered low probability if the score was <2.0, moderate of the score was 2.0 to 6.0 and high if the score was over 6.0. Pulmonary embolism unlikely was assigned to patients with scores <4.0 and PE likely if the score was >4.0. 7.8% of patients with scores of less than or equal to 4 had PE but if the D-dimer was negative in these patients the rate of PE was only 2.2% (95% CI = 1.0% to 4.0%) in the derivation set and 1.7% in the validation set.Importantly this combination occurred in 46% of our study patients. A score of <2.0 and a negative D-dimer results in a PE rate of 1.5% (95% CI = 0.4% to 3.7%) in the derivation set and 2.7% (95% CI = 0.3% to 9.0%) in the validation set and only occurred in 29% of patients. The combination of a score <4.0 by our simple clinical prediction rule and a negative SimpliRED D-Dimer result may safely exclude PE in a large proportion of patients with suspected PE.

Unenhanced multidetector computed tomography findings in acute central pulmonary embolism

“…Wells score was calculated based on seven variables are previously described [20]. The variables and their score were: 1) clinical symptoms of deep venous thrombosis (DVT) (score = 3.0); 2) no alternative diagnosis (score = 3.0); 3), heart rate > 100 (score = 1.5); 4) immobilization or surgery in the previous 4 weeks (score = 1.5); 5) previous DVT/PE (score = 1.5); 6) hemoptysis (score = 1.0); 7) malignancy (score = 1.0).…”

Calculating the sample size required for developing a clinical prediction model

“…Clinical prediction models are needed to inform diagnosis and prognosis in healthcare 123. Well known examples include the Wells score,45 QRISK,67 and the Nottingham prognostic index 89. Such models allow health professionals to predict an individual’s outcome value, or to predict an individual’s risk of an outcome being present (diagnostic prediction model) or developed in the future (prognostic prediction model).…”

Recurrent Venous Thromboembolism in a Patient with Klippel-Trenaunay Syndrome Despite Adequate Anticoagulation with Warfarin

“…This case highlights the difficulty that can be faced with patients with KTS in whom a high incidence of VTE exists owing to their anatomic abnormalities. In fact, it is well established that the incidence of VTE in KTS is between 14 and 22%, which is equal to or higher than the incidence associated with most other risk factors for VTE that have been integrated into clinical risk assessment scores such as the Wells score [5,7,8]. Although the importance of these clinical assessment scores cannot be undermined, their importance to at-risk patient populations, such as patients with KTS, may not be applicable.…”