Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Study Overview
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Brief Summary
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Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.

Official Title
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Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Conditions
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Pulmonary Vascular Disorder, Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Diagnostic Errors, Embolism

Intervention / Treatment
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* Other: Diagnostic error


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Episode of symptomatic acute pulmonary embolism objectively proven Exclusion Criteria: Below 18 years of age Patient chronically receiving therapeutic anticoagulation Pulmonary embolism complicating a current hospitalisation for another medical reason Asymptomatic pulmonary embolism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with a diagnostic error<br>Defined by one of : Absence of prescribed test included in an accepted pulmonary diagnosis algorithm in the next 48h00 after the firts contact with a physician Absence of prescribed test included in an accepted pulmonary diagnosis algorithm by the first contacted physician but the diagnostic is done before 48h00 because the patient went at the emergency room on his own initiative. More than one doctor consulted before the diagnostic of pulmonary embolism (excluding the emergency physician if the patient was referred by the 1st contact doctor) | Other: Diagnostic error<br>* There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.<br>|
| Patient without a diagnostic error<br>Any patient that did not meet the criteria to define the diagnostic error | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pulmonary embolism at the time of diagnosis | According to the 2014 Europe Society of Cardiology classification that combine clinical characteristics, signs of right ventricular dysfunction on imaging test and cardiac laboratory biomarkers | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication of pulmonary embolism | Composite of death, shock and recurrence | Day 30 and 180 | 
| Frequency of diagnostic errors | Frequency of diagnostic errors | Day 1 | 
| Characteristic of patient with diagnosis errors | Characteristic of patient with diagnosis errors | Day 30 |