Validation of DRAGON Versus a Simplified DRAGON/Machine Learning

Study Overview
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Brief Summary
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The CT-DRAGON score can predict long-term functional outcome after acute stroke treated by thrombolysis. However, implementation in clinical practice is hampered by a lack of validation in the broad spectrum of stroke patients undergoing thrombectomy, whether or not in combination with thrombolysis or conservative treatment. Furthermore, the CT-DRAGON score considers multiple items, which are not always readily available in every setting. This study aims to investigate whether either a simplified version of the CT-DRAGON score with only three clinical items or a machine learning technique could be as powerful and more feasible.

Detailed Description
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The investigators aim to validate the CT-DRAGON score in all ischaemic stroke localisations and for all treatment options, including a conservative treatment policy. The predictability will then be compared with on the one hand simplified prognostic models that include only a selective set of highly predictive parameters that have already been described in the literature, such as patient age, National Institutes of Health Stroke Scale (NIHSS) and pre-stroke modified Rankin Scale (mRS). On the other hand, machine learning techniques, that incorporate a large set of variables and have recently shown some promising results, will also be applied to predict long-term outcome after ischaemic stroke.

Official Title
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Prediction of Outcome After Acute Stroke: Validation of CT-DRAGON Versus a Simplified CT-DRAGON Score

Conditions
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Stroke, Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients diagnosed with a stroke Exclusion Criteria: -
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 |
| --- | --- |
| Stroke patients<br>All patients diagnosed with a stroke are collected in the database. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale at day 90 | The modified rankin scale will be assessed at 90 days at a consultation or by a telephonic interview which is standard of care in the hospital. The scale runs from 0-6, running from perfect health without symptoms to death. | 90 days after the onset of stroke | 
| Modified Rankin Scale at 7 days after discharge | The modified rankin scale will be assessed at 7 days after discharge by a telephonic interview which is standard of care in the hospital. he scale runs from 0-6, running from perfect health without symptoms to death. | 7 days after discharge at the hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS 10 questionnaire at 7 days after discharge | The Patient-Reported Outcomes Measurement Information System (PROMIS) is a publically available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life.The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health.The summed total is reported as 0 to 48 with higher scores reflecting less pain and better function. | 7 days after discharge | 
| PROMIS 10 questionnaire at 90 days after the onset of stroke | The Patient-Reported Outcomes Measurement Information System (PROMIS) is a publically available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life.The scoring system of the PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. The summed total is reported as 0 to 48 with higher scores reflecting less pain and better function. | 90 days after the onset of stroke | 
| NIHSS at 90 days after the onset of stroke | Change in NIHSS over time: baseline (diagnosis stroke), 3 months and one year follow-up. The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. | 90 days after the onset of stroke | 
| Analysis of the hospitalization cost after the onset of stroke | 90 days after the onset of stroke, all hospitalization costs will be analyzed per patient. All costs related to stroke in our hospital will be analyzed (surgery, clinical investigations, revalidation therapy etc) by our financial department. | 90 days after the onset of stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT-DRAGON score