PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

Study Overview
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Brief Summary
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PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule. PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.

Official Title
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Performance of the Pulmonary Embolism Rule-out Criteria (the PERC Rule) Combined With Implicit Low Clinical Probability (Gestalt) to Rule-out PE Without Further Exams

Conditions
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Pulmonary Embolism, Dyspnea, Thoracic Pain

Intervention / Treatment
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* Other: Gestalt estimation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients admitted to the emergency department for one of the following criteria : Dyspnea and/or Thoracic pain without another obvious cause Pulmonary embolism suspicion whatever the reason Exclusion Criteria: Age lower than 18 Patients hospitalized for more than 48h Ongoing curative anticoagulant therapy for more than 48h before admission Patients with thromboembolic disease diagnosed before the admission Unavailability for follow-up (short life expectancy, no phone number…) Patient refusing to be contacted by phone at 3 month Patient refusing that medical data were collected Secondary exclusion criteria : curative anticoagulant therapy for more than 5 days during the 3 month follow-up for another reason than thromboembolic disease.

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

| Intervention/Treatment |
| --- |
|Other: Gestalt estimation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents) | Rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule. Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams | Mean number of further exams performed per diagnostic strategy | During emergency managment | 
| To assess the accuracy of PERC and low clinical probability combination depending of clinical probability assessment method (implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score) | For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared. | 3 months | 
| To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score | For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PERC, Pulmonary Embolism, Diagnostic strategy, Exclusion, Clinical probability, Implicit Judgment (Gestalt)