Personalized Evidence-based Medicine in Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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A retrospective analysis

Detailed Description
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4200 EMR of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (CDSS MedicBK) utilizing a core laboratory.

Official Title
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Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation

Conditions
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Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke

Intervention / Treatment
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* Drug: anticoagulation treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EMR only if an ECG diagnosis (12-lead ECG, 24-h Holter, or other electrocardiographic documentation) confirming AF was made in patients at high risk for stroke by CHA2DS2-VASc (≥2 in men and ≥3 in women). Exclusion Criteria: No
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 |
| --- | --- |
| CDSS (MedicBK) Analysis<br> | Drug: anticoagulation treatment<br>* Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation<br>|
| Core Laboratory Analysis<br> | Drug: anticoagulation treatment<br>* Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of guideline-based and personalized EBM recommendations | The percentage of guideline-based and personalized EBM recommendations acted on by clinicians for anticoagulant therapy in patients with AF. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory. | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the performance of the CDSS (MedicBK) algorithm | Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV | 1-year | 
| 1-year FU outcomes | Outcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoint of any thromboembolism, cardiovascular death, or bleeding in relation to whether they were guideline-based treatment or personalized EBM treatment. Thromboembolism refers to stroke, transient ischemic attack, acute coronary syndrome, coronary intervention, cardiac arrest, peripheral embolism, and pulmonary embolism | 1-year | 
| Predictors | Predictors of guideline-based and personalized EBM adherence | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Personalized evidence-based medicine, Clinical decision support systems, Anticoagulation, Guidelines, Atrial fibrillation