Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)

Study Overview
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Brief Summary
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This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated against the review of a stroke subject expert. The study hypothesis is that Clinical Decision Support Tool used by neurology residents will have an agreement of >0.77 when compared to Stroke Expert (gold standard) in diagnosing type of ischemic stroke.

Detailed Description
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Overall Objective: To adapt, develop and validate the clinical decision support tool, an information technology application to assist acute stroke diagnosis for use among neurology graduate trainees compared to stroke expert (gold standard). Specific Aims: 1. To validate the adapted clinical decision support tool, an information technology application to assist acute ischemic stroke diagnosis for use among neurology residents compared to stroke expert (Gold standard) in the adult population presenting at a tertiary care hospital in Pakistan. The study will be conducted in Emergency department and the Neurology ward at Aga Khan University Hospital. The data collector will enroll the patients meeting the eligibility criteria and providing informed consent. Neurology residents will use the Clinical Decision Support Tool application to assist in acute stroke diagnosis. In the second part, the Stroke Expert will independently assess all diagnosis. The purpose of this would be to validate the Clinical Decision Support Tool application to assist in acute stroke diagnosis.

Official Title
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Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis

Conditions
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Stroke, Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women, >18 years of age. Patients admitted with neurological deficit consistent with stroke. Confirmation of stroke by objective modality of CT scan and MRI. Consenting to participate in the study. Exclusion Criteria: Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others. Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection. Patients signing LAMA (left against Medical Advice) and leaving undiagnosed

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 |
| --- | --- |
| Pakistani adult<br>Men and women aged 18 years or above,presenting with neurological deficit consistent with stroke in the Emergency Department at Aga Khan University Hospital Consenting to participate in the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation_Primary Outcome Measure_ Sensitivity | Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert | Day 1 | 
| Validation_ Primary Outcome Measure_Specificity | Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert | Day 1 | 
| Validation_Primary Outcome Measure_Positive and Negative Predictive Values | Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Qualitative assessments by focus group discussion will be performed to incorporate user feedback | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, Validation, Clinical decision support tool