Pulmonary embolism risk stratification: external validation of the 4-level Clinical Pretest Probability Score (4PEPS)
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SUBMITTER: Chiang P
PROVIDER: S-EPMC10912690 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:ImportanceIn patients with suspected pulmonary embolism (PE), overuse of diagnostic imaging is an important point of concern.ObjectiveTo derive and validate a 4-level pretest probability rule (4-Level Pulmonary Embolism Clinical Probability Score [4PEPS]) that makes it possible to rule out PE solely on clinical criteria and optimized D-dimer measurement to safely decrease imaging testing for suspected PE.Design, setting, and participantsThis study included consecutive outpatients suspected of having PE from US and European emergency departments. Individual data from 3 merged management studies (n = 11 114; overall prevalence of PE, 11%) were used for the derivation cohort and internal validation cohort. The external validation cohorts were taken from 2 independent studies, the first with a high PE prevalence (n = 1548; prevalence, 21.5%) and the second with a moderate PE prevalence (n = 1669; prevalence, 11.7%). A prior definition of pretest probability target values to achieve a posttest probability less than 2% was used on the basis of the negative likelihood ratios of D-dimer. Data were collected from January 2003 to April 2016, and data were analyzed from June 2018 to August 2019.Main outcomes and measuresThe rate of PE diagnosed during the initial workup or during follow-up and the rate of imaging testing.ResultsOf the 5588 patients in the derivation cohort, 3441 (61.8%) were female, and the mean (SD) age was 52 (18.5) years. The 4PEPS comprises 13 clinical variables scored from -2 to 5. It results in the following strategy: (1) very low probability of PE if 4PEPS is less than 0: PE ruled out without testing; (2) low probability of PE if 4PEPS is 0 to 5: PE ruled out if D-dimer level is less than 1.0 μg/mL; (3) moderate probability of PE if 4PEPS is 6 to 12: PE ruled out if D-dimer level is less than the age-adjusted cutoff value; (4) high probability of PE if 4PEPS is greater than 12: PE ruled out by imaging without preceding D-dimer test. In the first and the second external validation cohorts, the area under the receiver operator characteristic curves were 0.79 (95% CI, 0.76 to 0.82) and 0.78 (95% CI, 0.74 to 0.81), respectively. The false-negative testing rates if the 4PEPS strategy had been applied were 0.71% (95% CI, 0.37 to 1.23) and 0.89% (95% CI, 0.53 to 1.49), respectively. The absolute reductions in imaging testing were -22% (95% CI, -26 to -19) and -19% (95% CI, -22 to -16) in the first and second external validation cohorts, respectively. The 4PEPS strategy compared favorably with all recent strategies in terms of imaging testing.Conclusions and relevanceThe 4PEPS strategy may lead to a substantial and safe reduction in imaging testing for patients with suspected PE. It should now be tested in a formal outcome study.
| S-EPMC7931139 | biostudies-literature
Project description:Introduction: Several strategies have been devised to safely limit the use of thoracic imaging in patients suspected of pulmonary embolism (PE). However, they are based on different rules for clinical probability (CP) assessment, rendering their combination difficult. The four-level pulmonary embolism probability score (4PEPS) allows the combination of all other strategies using a single CP assessment. Methods and analysis: Pragmatic cluster-randomized trial in 20 EDs. Patients with suspected PE will be included and followed for 90 days (number of patients to be included: 2560, 1280 in each arm). Ten centers will be allocated to the control group where physicians will be free to do as they see fit but they will be given the recommendation to apply a validated strategy. Ten centers will be allocated to the interventional group where the physicians will be given the recommendation to apply the 4PEPS strategy. The primary objective will be to demonstrate that the application of the 4PEPS strategy by the emergency physicians, in comparison to current practices, (i) does not increase the risk of serious events related to diagnostic strategies and (ii) significantly reduces the use of thoracic imaging. Ethics and dissemination: The study will be submitted for approval to an institutional ethics review board for all participating centers. If successful, the SPEED&PEPS trial will have an important impact for patients suspected of PE limiting their irradiation and for public health in substantial savings in terms of the direct cost of diagnostic investigations and the indirect cost of hospitalizations due to waiting times or delayed harmful effects. Funding: This work is funded by a French Public Health grant (PREPS-N 2019). The funding source plays no role in the study design, data collection, analysis, interpretation or the writing of the manuscript. Trial registration: ongoing. Trial status: not started.
| S-EPMC9777430 | biostudies-literature
Project description:Acute pulmonary embolism (PE) is a frequently diagnosed condition. Prediction of in-hospital deterioration is challenging with current risk models. The Calgary Acute Pulmonary Embolism (CAPE) score was recently derived to predict in-hospital adverse PE outcomes but has not yet been externally validated. Retrospective cohort study of normotensive acute pulmonary embolism cases diagnosed in our emergency department between 2017 and 2019. An external validation of the CAPE score was performed in this population for prediction of in-hospital adverse outcomes and a secondary outcome of 30-day all-cause mortality. Performance of the simplified Pulmonary Embolism Severity Index (sPESI) and Bova score was also evaluated. 712 patients met inclusion and exclusion criteria, with 536 patients having a sPESI score of 1 or more. Among this population, the CAPE score had a weak discriminative power to predict in-hospital adverse outcomes, with a calculated c-statistic of 0.57. In this study population, an external validation study found weak discriminative power of the CAPE score to predict in-hospital adverse outcomes among normotensive PE patients. Further efforts are needed to define risk assessment models that can identify normotensive PE patients at risk for in hospital deterioration. Identification of such patients will better guide intensive care utilization and invasive procedural management of PE.
| S-EPMC10641891 | biostudies-literature
Project description:BackgroundIncreasing the threshold to define a positive D-dimer could reduce unnecessary computed tomographic pulmonary angiography (CTPA) for a suspected pulmonary embolism (PE) but might increase rates of a missed PE and missed pneumonia, the most common non-thromboembolic diagnosis seen on CTPA.ObjectiveMeasure the effect of doubling the standard D-dimer threshold for 'PE unlikely' Revised Geneva (RGS) or Wells' scores on the exclusion rate, frequency and size of a missed PE and missed pneumonia.MethodsPatients evaluated for a suspected PE with 64-channel CTPA were prospectively enrolled from emergency departments (EDs) and inpatient units of four hospitals. Pretest probability data were collected in real time and the D-dimer was measured in a central laboratory. Criterion standard was CPTA interpretation by two independent radiologists combined with clinical outcome at 30 days.ResultsOf 678 patients enrolled, 126 (19%) were PE+ and 93 (14%) had pneumonia. Use of either Wells' ≤ 4 or RGS ≤ 6 produced similar results. For example, with RGS ≤ 6 and standard threshold (< 500 ng mL(-1)), D-dimer was negative in 110/678 (16%), and 4/110 were PE+ (posterior probability 3.8%) and 9/110 (8.2%) had pneumonia. With RGS ≤ 6 and a threshold < 1000 ng mL(-1) , D-dimer was negative in 208/678 (31%) and 11/208 (5.3%) were PE+, but 10/11 missed PEs were subsegmental and none had concomitant DVT. Pneumonia was found in 12/208 (5.4%) with RGS ≤ 6 and D-dimer < 1000 ng mL(-1).ConclusionsDoubling the threshold for a positive D-dimer with a PE unlikely pretest probability could reduce CTPA scanning with a slightly increased risk of missed isolated subsegmental PE, and no increase in rate of missed pneumonia.
| S-EPMC3319270 | biostudies-literature
Project description:BackgroundRecent studies demonstrate an improved prognostic performance of the 2014 European Society of Cardiology (ESC) algorithm for risk stratification of patients with pulmonary embolism (PE) compared to the 2008 ESC algorithm. The modified FAST and Bova scores appear especially helpful to identify PE patients at intermediate-high risk.MethodsWe validated the prognostic performance of the modified FAST score compared to other scores for risk stratification in a post-hoc analysis of 868 normotensive PE patients included in the prospective Italian Pulmonary Embolism Registry. In-hospital adverse outcome was defined as PE-related death, mechanical ventilation, cardiopulmonary resuscitation or administration of catecholamines.ResultsOverall, 27 patients (3.1%) had an adverse outcome and 32 patients (3.7%) died. The rate of an adverse outcome was highest in the intermediate-high risk classes of the 2019 ESC algorithm (7.5%) and the modified FAST score (5.3%) while the Bova score failed to discriminate between intermediate-low and intermediate-high-risk patients. Patients classified as intermediate-high risk by the 2019 ESC algorithm (Odds Ratio [OR], 4.2 [95% CI, 1.9-9.0]) and modified FAST score (OR, 2.8 [1.3-6.2]) had a higher risk of an adverse outcome compared to patients classified by the Bova score (OR, 1.6 [0.7-3.7]). The c-index was higher for the 2019 ESC algorithm and the modified FAST score (AUC, 0.69 [0.58-0.79] and 0.67 [0.59-0.76]) compared to the Bova score (AUC, 0.64 [0.55-0.73]).ConclusionsThe 2019 ESC algorithm provided the best prognostic performance, but also the modified FAST score accurately stratified normotensive PE patients in different risk classes while the Bova score failed to identify patients at highest risk.
| S-EPMC7376081 | biostudies-literature
Project description:ObjectiveAccording to the 2019 European Society of Cardiology (ESC) guidelines on pulmonary embolism (PE), prognosis is calculated using the Pulmonary Embolism Severity Index (PESI), a complex score with debated validity, or simplified PESI (sPESI). We have developed and validated a new risk score for in-hospital mortality (IHM) of patients with PE in the emergency department.MethodsThis retrospective, dual-center cohort study was conducted in the emergency departments of two third-level university hospitals. Patients aged >18 years with a contrast-enhanced computed tomography-confirmed PE were included. Clinical variables and laboratory tests were evaluated blindly to IHM. Multivariable logistic regression was performed to identify the new score's predictors, and the new score was compared with the PESI, sPESI, and shock index.ResultsA total of 1,358 patients were included in this study: 586 in the derivation cohort and 772 in the validation cohort, with a global 10.6% of IHM. The PATHOS scores were developed using independent variables to predict mortality: platelet count, age, troponin, heart rate, oxygenation, and systolic blood pressure. The PATHOS score showed good calibration and high discrimination, with an area under the receiver operating characteristics curve of 0.83 (95% confidence interval [CI], 0.77-0.89) in the derivation population and 0.74 (95% CI, 0.68-0.80) in the validation cohort, which is significantly higher than the PESI, sPESI, and shock index in both cohorts (P<0.01 for all comparisons).ConclusionPATHOS is a simple and effective prognostic score for predicting IHM in patients with PE in an emergency setting.
| S-EPMC10090728 | biostudies-literature
Project description:OBJECTIVE:Recently, a novel score for risk stratification of patients with pulmonary embolism (PE)-the HOPPE score-was derived. We aimed to externally validate the HOPPE score in emergency department-diagnosed PE, using SpO2 as a surrogate for PaO2-the modified HOPPE score. METHODS:Retrospective observational study of adult patients with an emergency department diagnosis of PE was performed. Data collected included demographics, co-morbidities, clinical features, electrocardiogram and test results, in-hospital mortality and non-fatal major adverse clinical events (MACE; survived cardiac arrest, cardiogenic shock or thrombolysis administration). The primary outcome of interest was clinical performance of the modified HOPPE score for inhospital mortality and the composite outcome of in-hospital death and MACE. A secondary outcome was comparison of predictive performance between the modified HOPPE score and the simplified Pulmonary Embolism Severity Index score. RESULTS:Two hundred and six patients were studied (median age 61, 55% female). There were no deaths or MACE in patients with a low risk modified HOPPE score of 0 to 6 (0%; 95% confidence interval, 0% to 1.8%). Negative predictive value of a low risk score was 100% (95% confidence interval, 92.2% to 100%) for in-hospital mortality and for the composite of in-hospital mortality or MACE. The modified HOPPE score had similar predictive performance to the simplified Pulmonary Embolism Severity Index score with an area under the curve of 0.88 vs. 0.80 for the composite outcome of in-hospital mortality or MACE (P=0.052). Twenty-eight percent of the patients were classified as low risk and potentially suitable for management as outpatients. CONCLUSION:The modified HOPPE score showed good clinical performance. Prospective validation is warranted.
| S-EPMC7348671 | biostudies-literature
Project description:ObjectiveDevelop and validate a prognostic model for clinical deterioration or death within days of pulmonary embolism (PE) diagnosis using point-of-care criteria.MethodsWe used prospective registry data from six emergency departments. The primary composite outcome was death or deterioration (respiratory failure, cardiac arrest, new dysrhythmia, sustained hypotension, and rescue reperfusion intervention) within 5 days. Candidate predictors included laboratory and imaging right ventricle (RV) assessments. The prognostic model was developed from 935 PE patients. Univariable analysis of 138 candidate variables was followed by penalized and standard logistic regression on 26 retained variables, and then tested with a validation database (N = 801).ResultsLogistic regression yielded a nine-variable model, then simplified to a nine-point tool (PE-SCORE): one point each for abnormal RV by echocardiography, abnormal RV by computed tomography, systolic blood pressure < 100 mmHg, dysrhythmia, suspected/confirmed systemic infection, syncope, medico-social admission reason, abnormal heart rate, and two points for creatinine greater than 2.0 mg/dL. In the development database, 22.4% had the primary outcome. Prognostic accuracy of logistic regression model versus PE-SCORE model: 0.83 (0.80, 0.86) vs. 0.78 (0.75, 0.82) using area under the curve (AUC) and 0.61 (0.57, 0.64) vs. 0.50 (0.39, 0.60) using precision-recall curve (AUCpr). In the validation database, 26.6% had the primary outcome. PE-SCORE had AUC 0.77 (0.73, 0.81) and AUCpr 0.63 (0.43, 0.81). As points increased, outcome proportions increased: a score of zero had 2% outcome, whereas scores of six and above had ≥ 69.6% outcomes. In the validation dataset, PE-SCORE zero had 8% outcome [no deaths], whereas all patients with PE-SCORE of six and above had the primary outcome.ConclusionsPE-SCORE model identifies PE patients at low- and high-risk for deterioration and may help guide decisions about early outpatient management versus need for hospital-based monitoring.
| S-EPMC8601564 | biostudies-literature
Project description:BackgroundPulmonary embolism (PE) in children carries a significant morbidity and mortality. We examined previously described factors in 2 cohorts of children tested for PE and identified novel factors.MethodsWe combined data from 2 retrospective cohorts. Patients up to age 21 years were included who underwent imaging or D-dimer testing for PE, with positive radiologic testing being the gold standard. Combined predictor variables were examined by univariate analysis and then forward stepwise multivariable logistic regression.ResultsThe combined data set yielded 1103 patients with 42 unique predictor variables, and 93 PE-positive patients (8.4%), with a median age of 16 years. Univariate analysis retained 17 variables, and multivariable logistic regression found 9 significant variables with increased probability of PE diagnosis: age-adjusted tachycardia, tachypnea, hypoxia, unilateral limb swelling, trauma/surgery requiring hospitalization in previous 4 weeks, prior thromboembolism, cancer, anemia, and leukocytosis.ConclusionThis combined data set of children with suspected PE discovered factors that may contribute to a diagnosis of PE: hypoxia, unilateral limb swelling, trauma/surgery requiring hospitalization in previous 4 weeks, prior thromboembolism, and cancer, age-adjusted tachycardia, tachypnea, anemia, and leukocytosis. Prospective testing is needed to determine which criteria should be used to initiate diagnostic testing for PE in children.
| S-EPMC6971320 | biostudies-literature
Project description:ObjectivesExisting pulmonary embolism (PE) risk scores were developed to predict death within weeks, but not more proximate adverse events. We determined the ability of 3 PE risk stratification tools (simplified pulmonary embolism severity index [sPESI], 2019 European Society of Cardiology guidelines [ESC], and PE short-term clinical outcomes risk estimation [PE-SCORE]) to predict 5-day clinical deterioration after emergency department (ED) diagnosis of PE.MethodsWe analyzed data from six EDs on ED patients with confirmed PE. Clinical deterioration was defined as death, respiratory failure, cardiac arrest, new dysrhythmia, sustained hypotension requiring vasopressors or volume resuscitation, or escalated intervention within 5 days of PE diagnosis. We determined sensitivity and specificity of sPESI, ESC, and PE-SCORE for predicting clinical deterioration.ResultsOf 1569 patients, 24.5% had clinical deterioration within 5 days. sPESI, ESC, and PE-SCORE classifications were low-risk in 558 (35.6%), 167 (10.6%), and 309 (19.6%), respectively. Sensitivities of sPESI, ESC, and PE-SCORE for clinical deterioration were 81.8 (78, 85.7), 98.7 (97.6, 99.8), and 96.1 (94.2, 98), respectively. Specificities of sPESI, ESC, and PE-SCORE for clinical deterioration were 41.2 (38.4, 44), 13.7 (11.7, 15.6), and 24.8 (22.4, 27.3). Areas under the curve were 61.5 (59.1, 63.9), 56.2 (55.1, 57.3), and 60.5 (58.9, 62.0). Negative predictive values were 87.5 (84.7, 90.2), 97 (94.4, 99.6), and 95.1 (92.7, 97.5).ConclusionsESC and PE-SCORE were better than sPESI for detecting clinical deterioration within 5 days after PE diagnosis.
| S-EPMC10214857 | biostudies-literature