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This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.
Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Cognitive Evaluation (CCE) | Diagnostic Test | The Linus Health Core Cognitive Evaluation (CCE) is an easy-to-use but powerful tool to augment and facilitate cognitive health assessment during a patient's visit to their PCP. As a digital assessment solution, the CCE combines objective insights into cognitive ability with patient-reported insights to detect early signs of cognitive impairment and reveal specific modifiable risk factors earlier than the existing status quo assessments. The CCE is an FDA-listed Class II 510k exempt software as a medical device. The CCE has two components: The Digital Clock and Recall (DCR™) test and the Life and Health Questionnaire (LHQ). |
| Measure | Description | Time Frame |
|---|---|---|
| Median rating of each CDS recommendation | Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE. | 2-3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intraclass correlation coefficient (ICC) of each rating | ICC of each rating of clinical appropriateness to evaluate the inter-rater variability. | 2-3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 55 and above, with or without cognitive symptoms, across all the healthcare organizations that Linus Health has been deployed in.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Jannati, MD, PhD | Contact | 6174173002 | ajannati@linus.health | |
| William I Morrow, B.S. | Contact | imorrow@linus.health |
| Name | Affiliation | Role |
|---|---|---|
| Ali Jannati, MD, PhD | Linus Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linus Health, Inc. | Boston | Massachusetts | 02210 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000068079 | Motor Disorders |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |