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• W1976823434 abstract "SummaryWe performed a prospective study to assess whether positive quantitative D-dimer (DD) levels could be integrated for a selected population in a defined strategy to accurately diagnose pulmonary embolism (PE). For this purpose, 1528 in- or outpatients with clinically suspected PE were investigated according to our prescription rules. Clinical probability was defined as low, intermediate or high. Patients in whom DD levels were measured met criteria defined by our previously described decision-making algorithm: in- and outpatients, < 80 years, without surgery in the previous 30 days or active cancer. Nine hundred and twenty-three patients (60.4%) had quantitative DD measurement using automated latex DD assay (STA-Liatest D-Di®). According to our decision-making algorithm, DD measurement was applied to 70.5% of out-, and 55.7% of inpatients, and PE diagnosis was ruled out in 49.5% of the 923 patients. This allowed us to confirm prospectively that our specific rules greatly improve the DD testing efficiency. PE was diagnosed in 115 (12.5%) patients. For a 0.5 mg L−1 cut-off, the test sensitivity was 97.4%, but its specificity was only 56.7%. However, PE prevalence increased gradually with DD levels. The true observed PE prevalence, according to the quantitative assessment of DD levels, differed from that predicted with pretest clinical probability only. Moreover, in this well-defined patient group, a quantitative DD level > 2 mg L−1 was predictive of PE occurrence independently of the clinical score (odds ratio 6.9, 95% confidence interval 3.7, 12.8). As part of a defined strategy, knowledge of positive DD quantitative value, together with the clinical probability score, improves the PE predictive model. A clinical validation of these results in a follow-up study would now be necessary before considering the implementation of this strategy into clinical practice. We performed a prospective study to assess whether positive quantitative D-dimer (DD) levels could be integrated for a selected population in a defined strategy to accurately diagnose pulmonary embolism (PE). For this purpose, 1528 in- or outpatients with clinically suspected PE were investigated according to our prescription rules. Clinical probability was defined as low, intermediate or high. Patients in whom DD levels were measured met criteria defined by our previously described decision-making algorithm: in- and outpatients, < 80 years, without surgery in the previous 30 days or active cancer. Nine hundred and twenty-three patients (60.4%) had quantitative DD measurement using automated latex DD assay (STA-Liatest D-Di®). According to our decision-making algorithm, DD measurement was applied to 70.5% of out-, and 55.7% of inpatients, and PE diagnosis was ruled out in 49.5% of the 923 patients. This allowed us to confirm prospectively that our specific rules greatly improve the DD testing efficiency. PE was diagnosed in 115 (12.5%) patients. For a 0.5 mg L−1 cut-off, the test sensitivity was 97.4%, but its specificity was only 56.7%. However, PE prevalence increased gradually with DD levels. The true observed PE prevalence, according to the quantitative assessment of DD levels, differed from that predicted with pretest clinical probability only. Moreover, in this well-defined patient group, a quantitative DD level > 2 mg L−1 was predictive of PE occurrence independently of the clinical score (odds ratio 6.9, 95% confidence interval 3.7, 12.8). As part of a defined strategy, knowledge of positive DD quantitative value, together with the clinical probability score, improves the PE predictive model. A clinical validation of these results in a follow-up study would now be necessary before considering the implementation of this strategy into clinical practice. Accurate and rapid pulmonary embolism (PE) diagnosis remains a difficult challenge for clinical practice [1Goldhaber S.Z. Visani L. De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER).Lancet. 1999; 353: 1386-9Abstract Full Text Full Text PDF PubMed Scopus (2409) Google Scholar]. PE diagnostic strategy typically follows the PIOPED study criteria [2The PIOPED investigators.Value of the ventilation/perfusion scan in acute pulmonary embolism; results of the prospective investigation pulmonary embolism diagnosis (PIOPED).JAMA. 1990; 263: 2573-9Google Scholar], including clinical probability, imaging tests such as lower limb ultrasonography, ventilation-perfusion lung scan and helical computed tomography (CT) [3Ferretti G. Bosson J.L. Buffaz P.D. Ayanian D. Pison C. Blanc F. Carpentier F. Carpentier P. Coulomb M. Acute pulmonary embolism: role of the helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs.Radiology. 1997; 205: 453-8Crossref PubMed Scopus (235) Google Scholar, 4Perrier A. Nendaz M.R. Sarasin F.P. Howarth N. Bounameaux H. Cost-effectiveness analysis of diagnostic strategies for suspected pulmonary embolism including helical computed tomography.Am J Respir Crit Care Med. 2003; 167: 39-44Crossref PubMed Scopus (81) Google Scholar] together with measurement of plasma D-dimer (DD) level [5Perrier A. Bounameaux H. Marabia A. De Moerloose P. Slosman D. Didier D. Unger P.-.F. Junod A. Diagnosis of pulmonary embolism by a decision analysis-based strategy including clinical probability, D-dimers levels and ultrasonography: a management study.Arch Intern Med. 1996; 156: 531-6Crossref PubMed Google Scholar, 6Perrier A. Desmarais S. Goehring C. De Moerloose P. Morabia A. Unger P.F. Slosman D. Junod A. Bounameaux H. D-Dimer testing for suspected pulmonary embolism in outpatients.Am J Respir Crit Care Med. 1997; 156: 492-6Crossref PubMed Scopus (261) Google Scholar, 7Kelly J. Hunt B.J. A clinical probability assessment and D-dimer measurement should be the initial step in the investigation of suspected venous thromboembolism.Chest. 2003; 124: 1116-9Abstract Full Text Full Text PDF PubMed Google Scholar]. Then, complex decision-making algorithms vary according to different combinations of the diagnosis methods used [5Perrier A. Bounameaux H. Marabia A. De Moerloose P. Slosman D. Didier D. Unger P.-.F. Junod A. Diagnosis of pulmonary embolism by a decision analysis-based strategy including clinical probability, D-dimers levels and ultrasonography: a management study.Arch Intern Med. 1996; 156: 531-6Crossref PubMed Google Scholar, 8Wells P. Anderson D. Bormanis J. Guy F. Mitchell M. Gray L. Clement C. Robinson K.S. Lewandowski B. Value of assessment of pre-test probability of deep-vein thrombosis in clinical management.Lancet. 1997; 350: 1795-8Abstract Full Text Full Text PDF PubMed Scopus (999) Google Scholar, 9Bernardi E. Prandoni P. Lensing A. Agnelli G. Guazzaloca G. Scannapieco G. Piovella F. Verlato F. Tomasi C. Moia M. Scarano L. Girolami A. D-Dimer testing as an adjunct to ultrasonography in patients with clinically suspected deep vein thrombosis: prospective cohort study.BMJ. 1998; 317: 1037-40Crossref PubMed Scopus (247) Google Scholar, 10Perrier A. Desmarais S. Miron M. De Moerloose P. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non-invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (774) Google Scholar, 11Fedullo P.F. Tapson V.F. The evaluation of suspected pulmonary embolism.N Engl J Med. 2003; 349: 1247-56Crossref PubMed Scopus (323) Google Scholar, 12Kruip M.J. Leclercq M.G. Van Der Heul C. Prins M.H. Buller H.R. Diagnostic strategies for excluding pulmonary embolism in clinical outcome studies. A systematic review.Ann Intern Med. 2003; 138: 941-51Crossref PubMed Scopus (189) Google Scholar]. In these different strategy approaches, it is now well established that DD determination is a useful diagnostic aid in suspected PE. Based on an accurate methodology [6Perrier A. Desmarais S. Goehring C. De Moerloose P. Morabia A. Unger P.F. Slosman D. Junod A. Bounameaux H. D-Dimer testing for suspected pulmonary embolism in outpatients.Am J Respir Crit Care Med. 1997; 156: 492-6Crossref PubMed Scopus (261) Google Scholar, 10Perrier A. Desmarais S. Miron M. De Moerloose P. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non-invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (774) Google Scholar, 13De Moerloose P. Minazio P. Reber G. Perrier A. Bounameaux H. D-Dimer determination to exclude pulmonary embolism: a two step approach using latex assay as a screening tool.Thromb Haemost. 1994; 72: 89-91Crossref PubMed Scopus (34) Google Scholar, 14De Moerloose P. Desmarais S. Bounameaux H. Reber G. Perrier A. Dupuy G. Pittet J.L. Contribution of a new, rapid, individual and quantitative automated D-dimer ELISA to exclude pulmonary embolism.Thromb Haemost. 1996; 75: 11-3Crossref PubMed Scopus (189) Google Scholar, 15Meyer G. Fischer A.M. Collignon M.A. et al.Diagnostic value of two rapid and individual D-dimer assays in patients with clinically suspected pulmonary embolism: comparison with microplate enzyme-linked immunosorbent assay.Blood Coagul Fibrinolysis. 1998; 9: 603-8Crossref PubMed Scopus (22) Google Scholar, 16Tardy B. Tardy-Poncet B. Viallon A. Lafond P. Page Y. Venet C. Bertrand J.C. Evaluation of D-dimer ELISA test in elderly patients with suspected pulmonary embolism.Thromb Haemost. 1998; 79: 38-41Crossref PubMed Scopus (117) Google Scholar, 17Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimers: comparison of ELISA with a new, rapid, quantitative latex assay.Clin Lab Haem. 1999; 21: 363-4Crossref PubMed Scopus (7) Google Scholar, 18Heit J.A. Minor T.A. Andrews J.C. Larson D.R. Li H. Nichols W.L. Determinants of plasma fibrin D-dimer sensitivity for acute pulmonary embolism as defined by pulmonary angiography.Arch Pathol Lab Med. 1999; 123: 235-40Crossref PubMed Google Scholar], DD tests are characterized by a remarkable 94% sensitivity [95% confidence interval (CI) 88, 97) [19Brown M.D. Rowe B.H. Reeves M.J. Bermingham J.M. Goldhaber S.Z. The accuracy of the enzyme-linked immunosorbent assay D-dimer test in the diagnosis of pulmonary embolism: a meta-analysis.Ann Emerg Med. 2002; 40: 133-44Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar]. In patients with low clinical probability, the DD negative predictive value (NPV) (> 98%) is thus clearly established and PE diagnosis can be ruled out in symptomatic outpatients [19Brown M.D. Rowe B.H. Reeves M.J. Bermingham J.M. Goldhaber S.Z. The accuracy of the enzyme-linked immunosorbent assay D-dimer test in the diagnosis of pulmonary embolism: a meta-analysis.Ann Emerg Med. 2002; 40: 133-44Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 20Wells P.S. Anderson D.R. Rodger M. Stiell I. Dreyer J.F. Barnes D. Forgie M. Kovacs G. Ward J. Kovacs M.J. Excluding pulmonary embolism at the bedside without diagnostic imaging: management of patients with suspected pulmonary embolism presenting to the emergency department by using a simple clinical model and D-dimer.Ann Intern Med. 2001; 135: 98-107Crossref PubMed Scopus (1136) Google Scholar, 21Kelly J. Hunt B.J. The utility of pre-test probability assessment in patients with clinically suspected venous thromboembolism.J Thromb Haemost. 2003; 1: 1888-96Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 22Leclerc M.G.L. Lutisan J.G. Van Marwijk Kooy M. Kuipers B.F. Oostdijk A.H.J. Van Der Leur J.J.C.M. Büller H.R. Ruling out clinically suspected pulmonary embolism by assessment of clinical probability and D-dimer levels: a management study.Thromb Haemost. 2003; 89: 97-103Crossref Scopus (62) Google Scholar, 23Schutgens R.E. Ackermark P. Haas F.J. Nieuwenhuis H.K. Peltenburg H.G. Pijlman A.H. Pruijm M. Oltmans R. Kelder J.C. Biesma D.H. Combination of a normal D-dimer concentration and a non-high pre-test clinical probability score is a safe strategy to exclude deep venous thrombosis.Circulation. 2003; 107: 593-7Crossref PubMed Scopus (163) Google Scholar, 24British Committe for Standards in Haematology.The diagnosis of deep vein thrombosis in symptomatic outpatients and the potential for clinical assessment and D-dimer assays to reduce the need for diagnostic imaging.Br J Haematol. 2004; 124: 15-25Crossref Scopus (82) Google Scholar]. Most of the studies published on the use of DD were restricted to outpatients, preselected in emergency rooms, in which NPV is the highest. However, restricting DD use to outpatients only is debatable. Indeed, PE incidence increases with the presence of risk factors or comorbidity, which accounts for the high PE prevalence in hospitalized patients. Unfortunately, such comorbidity or risk factors usually make DD inefficient among hospitalized patients [25Brotman D.J. Segal J.B. Jani J.T. Petty B.G. Kickler T.S. Limitations of D-dimer testing in unselected inpatients with suspected venous thromboembolism.Am J Med. 2003; 114: 276-82Abstract Full Text Full Text PDF PubMed Scopus (104) Google Scholar], leading to PE exclusion in < 14–17% of cases [26Van Beek E.J. Schenk B.E. Michel B.C. Van Den Ende B. Brandjes D.P. Van Der Heide Y.T. Bossugt P.M. Buller H.R. The role of plasma D-dimers concentration in the exclusion of pulmonary embolism.Br J Haematol. 1996; 92: 725-32Crossref PubMed Scopus (73) Google Scholar, 27Schrecengost J.E. Legallo R.D. Boyd J.C. Moons K.G.M. Gonias S.L. Rose C.E. Bruns D.E. Comparison of diagnostic accuracies in outpatients and hospitalised patients of D-dimer testing for the evaluation of suspected pulmonary embolism.Clin Chem. 2003; 49: 1483-90Crossref PubMed Scopus (90) Google Scholar]. To circumvent this problem, we validated, in a case–control study, an efficient use of DD testing for clinicians in charge of PE diagnosis in hospitalized patients [28Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalised patients.Thromb Res. 1999; 95: 263-9Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar]. In this strategy, we demonstrated that DD testing was useful for all patients in hospital who are under 80, with neither cancer nor previous surgery, regardless of whether they were outpatients or not. However, the pretest clinical probability might be affected by excluding these major risk factors. Therefore, the decisional impact of the clinical-based diagnostic probability might be evaluated in this low PE risk group. So in the present study, our aim was first to validate prospectively our DD prescription rules. Because of its low specificity (varying from 28% to 68%) [24British Committe for Standards in Haematology.The diagnosis of deep vein thrombosis in symptomatic outpatients and the potential for clinical assessment and D-dimer assays to reduce the need for diagnostic imaging.Br J Haematol. 2004; 124: 15-25Crossref Scopus (82) Google Scholar] due to a high proportion of false-positive results, the DD test is not currently suited for PE positive diagnosis, although elevated levels are present in nearly all patients with thromboembolism. Restricting its use to a low-risk-factor group would increase the NPV of the DD test [29Propp D.A. Kumar A.M. D-Dimer in venous thromboembolism.N Engl J Med. 2004; 350: 192-3Crossref PubMed Scopus (10) Google Scholar], and the percentage of false positives might fall. So, secondly, we assessed whether high positive quantitative DD levels could be integrated in this low-risk group in a defined PE diagnostic strategy to allow a more accurate PE positive diagnosis. A prospective monocentric clinical study was conducted on 1528 non-selected patients clinically suspected of PE, in the absence of life-threatening symptoms. This study protocol was approved by the local Ethics Committee. Outpatients were characterized by an interval of < 48 h between hospital admission and the onset of PE clinical suspicion. The management of all clinical suspicion of PE was centralized and effected by the Emergency Angiology Unit, where all patients are referred for this pathology. PE diagnostic strategy was based on the pretest clinical probability, DD assay as initial diagnostic test, followed by lower limb ultrasonography and ventilation-perfusion lung scan in patients without prior cardiopulmonary disease or abnormal chest radiography [30Task force on pulmonary embolism, European Society of Cardiololy.Guidelines on diagnosis and management of acute pulmonary embolism.Eur Heart J. 2000; 21: 1301-36Crossref Scopus (680) Google Scholar]. A helical CT (HiSpeed Advantage; GE Medical Systems, Milwaukee, WI, USA, performed at 120 kVp and 150–250 mA with 3 mm-thick section and a pitch of 1.6 : 1) was performed in cases of non-diagnostic scintigraphy as previously reported [3Ferretti G. Bosson J.L. Buffaz P.D. Ayanian D. Pison C. Blanc F. Carpentier F. Carpentier P. Coulomb M. Acute pulmonary embolism: role of the helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs.Radiology. 1997; 205: 453-8Crossref PubMed Scopus (235) Google Scholar, 28Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalised patients.Thromb Res. 1999; 95: 263-9Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar], and in patients with cardiopulmonary disease [4Perrier A. Nendaz M.R. Sarasin F.P. Howarth N. Bounameaux H. Cost-effectiveness analysis of diagnostic strategies for suspected pulmonary embolism including helical computed tomography.Am J Respir Crit Care Med. 2003; 167: 39-44Crossref PubMed Scopus (81) Google Scholar, 31Perrier A. Howarth N. Didier D. Loubeyre P. Unger P.F. De Moerloose P. Slosman D. Junod A. Bounameaux H. Performance of helical computed tomography in unselected outpatients with suspected pulmonary embolism.Ann Intern Med. 2001; 135: 88-97Crossref PubMed Scopus (301) Google Scholar, 32Musset D. Parent F. Meyer G. Maitre S. Girard P. Leroyer C. Reve Carette M.F. Laurent M. Charbonnier B. Laurent F. Mal H. Nonen Lancar R. Grenier P. Simonneau G. Evaluation du scanner spirale, l'Embolie Pulmonaire Study Group.Lancet. 2002; 360: 1914-20Abstract Full Text Full Text PDF PubMed Scopus (382) Google Scholar] Initial pretest clinical probability was estimated according to Wells, and scored as low (< 2), intermediate (2–6) or high (> 6) initial pretest PE clinical probability [33Wells P.S. Anderson D.R. Rodger M. Ginsberg J.S. Kearon C. Gent M. Turpie A.G.G. Bormanis J. Weitz J. Chamberlain M. Bowie D. Barnes D. Hirsh J. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimplyRED D-dimer.Thromb Haemost. 2000; 83: 416-20Crossref PubMed Scopus (1342) Google Scholar] for each patient. Patients for whom DD levels were measured met the criteria of our previously described decision-making algorithm: in- or outpatients, < 80 years old, without surgery in the previous 30 days or active cancer [28Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalised patients.Thromb Res. 1999; 95: 263-9Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar]. A normal DD level ruled out PE. In contrast, patients with normal DD associated with high clinical probability, patients with DD level > 0.5 mg L−1, and patients who did not have DD determination according to our prescription rules underwent lower limb venous compression ultrasonography as a first imaging investigation (Fig. 1). PE diagnosis was made when one of the following criteria was present: (i) presence of proximal deep vein thrombosis, (ii) high-probability lung scan, (iii) positive helical tomodensitometry. PE diagnosis was excluded in case of (i) negative DD levels, (ii) normal lung scan, (iii) non-diagnostic lung scan associated with low clinical probability or (iv) normal CT scan associated with normal ultrasonography. In case of high clinical probability and negative helical tomodensitometry, pulmonary angiography was indicated, but this was left to the discretion of clinicians. Qualitative plasma DD determination was realized in real time, whereas quantitative plasma DD levels were assessed retrospectively by a quantitative automated latex agglutination assay (STA-Liatest D-Di®; Diagnostica Stago, Asnières, France, cut-off 0.5 mg L−1) [17Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimers: comparison of ELISA with a new, rapid, quantitative latex assay.Clin Lab Haem. 1999; 21: 363-4Crossref PubMed Scopus (7) Google Scholar, 28Barro C. Bosson J.L. Pernod G. Carpentier P.H. Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalised patients.Thromb Res. 1999; 95: 263-9Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar]. STA-Liatest D-Di® is an immunoturbidimetric assay using a suspension of latex microparticles coated by covalent bonding with monoclonal antibodies specific for DD. This assay allows the quantitative determination of D-dimers in plasma by the immunoturbidimetric method. The assay working range is 0.22–4 mg L−1, up to 20 mg L−1 in case of use of automatic dilution, and the coefficient of variation is 4.1% for the cut-off value 0.5 mg L−1. Working on STA-automated analyzers, this assay takes 7 min, allowing its use especially in emergency units. In this study, quantitative results of high plasma DD were therefore not taken into account in patient management. Statistical analysis were realized with Stata™ (Stata Corporation, College Station, TX, USA). Continuous variables were described by median, with minima and maxima. Qualitative variables were compared with χ2 test with a P-value = 0.05. A logistic regression model was used to predict PE. We compared a model with clinical probability alone as an independent variable and a model with both clinical probability and D-dimer value, using the likelihood ratio test and calculating odds ratio and 95% confidence interval. Sensibility and specificity were estimated on the current diagnosis established during the study. Therefore, receiver operating characteristic (ROC) curve analysis was constructed for different cut-off values. During the study period, 1528 in- and outpatients (Table 1) were suspected of PE. According to Wells, these patients were scored as low (43.6%), intermediate (45.6%), or high (10.8%) pretest clinical probability. The global prevalence of PE was 19.9%, respectively 5.5%, 26.7% and 49.6% in the low, intermediate and high clinical probability groups. The difference in the prevalence of PE among the three pretest probability groups was statistically significant (P < 0.01).Table 1Main demographic and clinical characteristics of the patients (n = 1528).Age, mean years (range)67 (13–96)SexFemale (%)54.1Male (%)45.9Main clinical symptoms (%)Dyspnea63Thoracic pain53.7Clinical signs of DVT20.1Risk factors (%)Cancer12.7Recent surgery (< 30 days)11.3Previous DVT/PE16DVT, Deep vein thrombosis; PE, pulmonary embolism. Open table in a new tab DVT, Deep vein thrombosis; PE, pulmonary embolism. Based on our previously described decision-making algorithm (Fig. 1), 605 patients did not have DD testing and were directly investigated by imaging techniques. According to Wells, these patients were scored as low (21.5%), intermediate (60.5%), or high (18%) pretest clinical probability. The global prevalence of PE was 25%, respectively 6.9%, 32.8% and 56% in the low, intermediate and high clinical probability groups. Therefore, DD was determined in 923 patients (DD patients) (491 men and 432 women, mean age 57 ± 16 years) of whom 46% were inpatients and 54% outpatients. Five hundred and thirty-six patients (58%) were characterized as having a low, 331 (35.8%) an intermediate and 56 (6.1%) a high initial clinical probability (Table 2a). Thus based on the exclusion of defined risk factors, most of the patients having DD testing were classified as having a low clinical probability. PE diagnosis was made in 114 patients (12.3%). PE was recorded in 5%, 19.9% and 37.5% in the low, intermediate and high pretest clinical probability groups, respectively (Table 2a). Although PE prevalence was lower in these DD patients (12.3% vs. 19.9% for global prevalence), this PE prevalence increased gradually and remains statistically different among the pretest clinical probability score groups (P < 0.01). This indicated that the Well's clinical score was efficient even in this low risk factor group of patients.Table 2Distribution of clinical probability and pulmonary embolism (PE) prevalence in the main groups of D-dimer (DD) (a) and DD+ (b) patientsa. DD patients: n (%) (n = 923)PE Prevalence: n (%) (12.3%)Pretest clinical probability (score)Low (< 2)536 (58%)27 (5%)Intermediate (2–6)331 (35.8%)66 (19.9%)High (> 6)56 (6.1%)21 (37.5%)b. DD+ patients: n (%) (n = 465)PE prevalence: n (%) (23.8%)Pretest clinical probability (score)Low (< 2)233 (50.1%)27 (11.6%)Intermediate (2–6)197 (42.4%)66 (33.5%)High (> 6)35 (7.5%)18 (51.4%) Open table in a new tab A negative DD result was recorded in 457 of the 923 patients (49.6%) tested (39.1% inpatients, 60.9% outpatients). Among the patients with DD < 0.5 mg L−1, three had PE (false negatives). Four hundred and sixty-five DD were > 0.5 mg L−1 (DD+ patients); 233 patients (50.1%) were scored as low, 197 (42.4%) as intermediate and 35 (7.5%) as high pretest clinical probability (Table 2b). PE prevalence (n = 111, 23.8%) in these groups (11.6%, 33.5% and 51.4% in the different pretest clinical probability groups, respectively) (Table 2b) was very similar to the prevalence observed in high risk factor patients who did not have DD testing (25%). For a 0.5 mg L−1 cut-off, the test sensitivity was estimated as 97.4% (95% CI 94.9, 99.9), while its specificity was 56.2% (95% CI 52.8,59.6), as determined by the ROC curve analysis (data not shown). PE prevalence increased gradually with the DD level; the increase was 2-fold for DD levels between 1 and 2 mg L−1, and 4-fold for levels > 2 mg L−1 compared with 0.5–1 mg L−1 (P < 0.01) (Fig. 2). So in this particular DD+ patient group, we wondered whether the quantitative positive DD value would be helpful in the estimation of PE risk. To this end, true observed PE prevalence was recorded for each pretest initially estimated clinical probability group and for each defined interval of measured DD quantitative values (Table 3). Therefore we tested whether the initial PE diagnostic probability, established initially only on a clinical basis, might be influenced by this quantitative DD value.Table 3Observed pulmonary embolism (PE) prevalence for each interval of D-dimer (DD) levels (mg L−1) and for each level of initial clinical PE probabilityN = 465Initial estimated Well's clinical PE probabilityLow (n = 232)Intermediate (n = 197)High (n = 35)Observed PE prevalence, %11.633.551.4DD 0.5–1 (n = 170)N = 97N = 62N = 113*The number of observed PE./97†The number of patients clinically suspected of PE.11/624/11(3.1%)(17.7%)(36.4%)DD 1–2 (n = 155)N = 77N = 68N = 108/7718/683/10(10.4%)(26.5%)(30%)DD > 2 (n = 140)N = 59N = 67N = 1416/5937/6711/14(27.1%)(55.2%)(78.6%)Initial estimated clinical probability was recorded at the beginning and scored as low, intermediate or high according to Wells. Observed PE prevalence among the group of DD+ patients was recorded for each pretest initially estimated clinical probability group regarding each defined interval of measured quantitative DD values.* The number of observed PE.† The number of patients clinically suspected of PE. Open table in a new tab Initial estimated clinical probability was recorded at the beginning and scored as low, intermediate or high according to Wells. Observed PE prevalence among the group of DD+ patients was recorded for each pretest initially estimated clinical probability group regarding each defined interval of measured quantitative DD values. When DD levels were between 0.5 and 1 mg L−1, observed PE prevalence was very low in the low initial estimated clinical probability group (3.1%). In contrast, in the high initial estimated clinical probability group, PE prevalence was close to that observed in the overall intermediate pretest clinical probability group (36.4% vs. 33.5%). For DD levels between 1 and 2 mg L−1, PE prevalence observed within the intermediate (26.5%) and high (30%) initial clinical probability groups was close to the prevalence observed in the overall intermediate pretest clinical probability group (33.5%). More interestingly, when DD levels were above 2 mg L−1, the observed prevalence in each initial pretest clinical probability group was systematically higher than expected. In the low probability group, PE prevalence was twice as high, and close to that observed in the overall intermediate pretest clinical probability group (27.1% vs. 33.5%). In the intermediate probability group, PE observed prevalence was close to that in the high pretest clinical PE probability group (55.2% vs. 51.4%). In the high estimated clinical probability group, PE observed was very high (78.6%). Among patients with DD levels higher than 2 mg L−1, 59 were initially judged at low and 67 at intermediary estimated clinical PE probability. These 126 patients moved from a low or intermediate clinical-based diagnostic probability towards a group at higher PE prevalence corresponding to intermediate or high diagnostic probability. For patients with" @default.
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• W1976823434 date "2005-01-01" @default.
• W1976823434 modified "2023-09-30" @default.
• W1976823434 title "Quantitative high D-dimer value is predictive of pulmonary embolism occurrence independently of clinical score in a well-defined low risk factor population" @default.
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