LMWH contra LMWH: superior, equivalent or non-inferior?
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Biomedical subjects
Publications and source records attributed to A Perrier.
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INTRODUCTION: Clinical prediction rules or scores are instruments that allow to quantify the respective contributions of medical history, clinical examination and laboratory tests to a diagnosis or a prognosis in a given patient. STATE OF THE ART: The development of clinical prediction rules requires three steps: 1) derivation of the rule from a population with known clinical characteristics and diagnosis or prognosis; 2) validation of the rule in a population distinct from the derivation sample; and 3) evaluation of the impact of the rule on clinician behavior and patient outcomes. PERSPECTIVES: This paper provides a guide for the critical appraisal of a prediction rule illustrated by two clinical scores for the assessment of the clinical probability of pulmonary embolism. CONCLUSIONS: Clinical prediction rules or scores have become indispensable components of the clinician's toolbox.
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This paper, first of a series devoted to evidence-based medicine, describes how to critically read an article on a randomised controlled intervention trial. This guide is applied to the common clinical question, whether or not to prescribe systemic glucocorticoids for patients with exacerbation of chronic obstructive pulmonary disease, through the analysis of two recently published series. It comprises a three-step evaluation: the assessment of the study methods to ensure that the results are valid, the analysis of the results of the larger of the two studies, and the evaluation of whether the results can be applied to a patient whose clinical case illustrates this article. Finally, a few limitations of randomised controlled trials are discussed.
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The case for endobronchial biopsy in the diagnosis of sarcoidosis: Faced with the continuous development of new diagnostic tests, the clinician needs to be able to critically assess their value and their clinical applicability. Using a practical example, the performance of endobronchial biopsy in diagnosing sarcoidosis, this review provides a guide for critically appraising a study evaluating a diagnostic test. The three main steps described are: 1) assessment of the validity of the results based on the scientific methods used; 2) analysis of the results with reference to sensitivity, specificity, predictive value, likelihood ratio, and precision of the diagnostic test in question; 3) determination of whether the results are applicable to an individual patient or to a specific patient population.
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BACKGROUND: Helical computed tomography (CT) is commonly used to diagnose pulmonary embolism, although its operating characteristics have been insufficiently evaluated. OBJECTIVE: To assess the sensitivity and specificity of helical CT in suspected pulmonary embolism. DESIGN: Observational study. SETTING: Emergency department of a teaching and community hospital. PATIENTS: 299 patients with clinically suspected pulmonary embolism and a plasma D -dimer level greater than 500 microgram/L. INTERVENTION: Pulmonary embolism was established by using a validated algorithm that included clinical assessment, lower-limb compression ultrasonography, lung scanning, and pulmonary angiography. MEASUREMENTS: Sensitivity, specificity, and likelihood ratios of helical CT and interobserver agreement. Helical CT scans were withheld from clinicians and were read 3 months after acquisition by radiologists blinded to all clinical data. RESULTS: 118 patients (39%) had pulmonary embolism. In 12 patients (4%), 2 of whom had pulmonary embolism, results of helical CT were inconclusive. For patients with conclusive results, sensitivity of helical CT was 70% (95% CI, 62% to 78%) and specificity was 91% (CI, 86% to 95%). Interobserver agreement was high (kappa = 0.823 to 0.902). The false-negative rate was lower for helical CT used after initial negative results on ultrasonography than for helical CT alone (21% vs. 30%). Use of helical CT after normal results on initial ultrasonography and nondiagnostic results on lung scanning had a false-negative rate of only 5% and a false-positive rate of only 7%. CONCLUSION: Helical CT should not be used alone for suspected pulmonary embolism but could replace angiography in combined strategies that include ultrasonography and lung scanning.
OBJECTIVE: To develop a simple standardized clinical score to stratify emergency ward patients with clinically suspected pulmonary embolism (PE) into groups with a high, intermediate, or low probability of PE to improve and simplify the diagnostic approach. METHODS: Analysis of a database of 1090 consecutive patients admitted to the emergency ward for suspected PE in whom diagnosis of PE was ruled in or out by a standard diagnostic algorithm. Logistic regression was used to predict clinical parameters associated with PE. RESULTS: A total of 296 (27%) of 1090 patients were found to have PE. The optimal estimate of clinical probability was based on 8 variables: recent surgery, previous thromboembolic event, older age, hypocapnia, hypoxemia, tachycardia, band atelectasis, or elevation of a hemidiaphragm on chest x-ray film. A probability score was calculated by adding points assigned to these variables. A cutoff score of 4 best identified patients with low probability of PE. A total of 486 patients (49%) had a low clinical probability of PE (score </=4), of which 50 (10.3%) had a proven PE. The prevalence of PE was 38% in the 437 patients with an intermediate probability (score of 5-8; n = 437) and 81% in the 63 patients with a high probability (score >/=9). CONCLUSIONS: This clinical score, based on easily available and objective variables, provides a standardized assessment of the clinical probability of PE. Applying this score to emergency ward patients suspected of having PE could allow a more effective diagnostic process.
PURPOSE: Four strategies for the diagnosis of deep vein thrombosis have been validated recently. The strategies use various combinations of assessment of a patient's clinical probability of having deep venous thrombosis, serial lower limb venous compression ultrasonography, and measurement of plasma D-dimer levels. We compared the cost-effectiveness of these diagnostic strategies. MATERIALS AND METHODS: We performed a formal cost-effectiveness analysis using a decision-analysis model. Outcomes considered were costs per patient, 3-month quality-adjusted survival, number of lives saved per 1,000 patients, and incremental costs per quality-adjusted life-year (QALY) gained. RESULTS: Under baseline conditions, with a 24% prevalence of deep vein thrombosis in tested patients, the effectiveness of all strategies was similar (4.6 to 4.8 lives saved per 1,000 patients managed). The most expensive strategy was serial ultrasound (repeat ultrasound on day 7 in all patients with a normal initial ultrasound) at a cost-effectiveness of $10,716 per additional QALY. Performing a repeat ultrasound only in patients with an elevated D-dimer level (serial ultrasound with D-dimer) was somewhat less expensive at $10,281 per additional QALY. Taking clinical probability into account by repeating ultrasound only in patients with an intermediate clinical probability of deep vein thrombosis (risk-based serial ultrasound) yielded further savings and cost $10,090 per additional QALY. The least expensive and most cost-effective option was to perform D-dimer as the initial test, followed by a single ultrasound if the D-dimer level was abnormal, and by phlebography in patients with a normal ultrasound and a high clinical probability of deep vein thrombosis (D-dimer with risk-based single ultrasound) at $8,897 per additional QALY. This strategy allowed a 17% reduction in incremental costs compared with the most expensive algorithm and reduced resource consumption (70 ultrasound procedures per 100 patients managed vs 130 to 170 with the other diagnostic strategies). CONCLUSIONS: Combining clinical probability and D-dimer with a single ultrasound in the diagnostic workup of patients with possible deep vein thrombosis is highly cost-effective, allowing a reduction in costs and resource use without any substantial increase in mortality. Serial ultrasonography is less cost-effective.
Considerable progress has been made in pulmonary embolism (PE) diagnosis during the last 10 years. New, noninvasive tools such as D-dimer measurement and lower limb venous compression ultrasonography have been introduced as diagnostic strategies. Clinical evaluation of the likelihood of PE has been rehabilitated and has proven to be accurate and useful. The interpretation of lung scan results has become more standardized and clear to clinicians. Finally, two diagnostic strategies have been validated in large scale outcome studies. Both rely on a sequential combination of the aforementioned instruments and have safely treated more than 90% of patients without use of pulmonary angiography. The 3-month venous thromboembolic risk in patients in whom PE was ruled out and, hence, who did not undergo anticoagulation was less than 1% in both studies. In the absence of a formal comparison of their respective cost-effectiveness, choosing between these strategies rests on local preferences or logistics. Finally, spiral computed tomography (CT) seems promising and might modify the diagnostic work-up of PE in the near future. However, it is insufficiently validated, and its place in a rational diagnostic algorithm is not defined.
The performance of a new latex-enhanced turbidimetric assay, D-Dimer PLUS, has been evaluated with two analyzers performing various coagulation assays: the BCS Analyzer and the BCT Analyzer. A precision study showed total coefficients of variation ranging from 2.7 to 11.1% with the BCS Analyzer and from 2.5 to 6.6% with the BCT Analyzer. We investigated the ability of D-Dimer PLUS to exclude venous thromboembolism in 312 outpatients suspected of either pulmonary embolism or deep venous thrombosis. Three months follow-up was available for all patients. With the BCS Analyzer, we determined a cut-off value of 190 ng/ml, which gave a sensitivity of 97.9% [95% confidence interval (CI), 92.6-99.7%], a specificity of 37.9% (95% CI, 30.9-43.8%) and a negative predictive value of 97.6% (95% CI, 91.7-99.7%). With the BCT Analyzer, at a cut-off value of 130 ng/ml, sensitivity was 96.8% (95% CI, 91.0-99.3%), specificity was 45.2% (95% CI, 38.5-51.2%) and the negative predictive value was 97% (95% CI, 91.6-99.4). This new assay is fast and fully automated, and its performance is suitable to exclude venous thromboembolism. Management studies should be performed to assess its utility.
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The clinical assessment of the probability of pulmonary embolism is a key step in proposed diagnostic strategies for pulmonary embolism, because the interpretation of noninvasive test results is conditional on the pretest probability derived from the presence or absence of clinical factors. The past year has brought important progress in the general area of clinical prediction of pulmonary embolism with the publication of two new simple clinical prediction rules. Each of the prediction rules includes a total of seven clinical variables that, when combined, allow for the categorization of patients into categories of low, intermediate, or high pretest probability of pulmonary embolism. Although these clinical prediction rules are perhaps only slightly better than the estimates of experienced clinicians, they provide an explicit method for estimating the probability of PE as an adjunct to diagnostic testing. Further validation work is now needed to assess how well these new prediction rules perform in settings other than the derivation sites.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
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