MSCOPILOT ®: results of a comparative study versus standards tests.
Introduction: Assessing patients' disability in multiple sclerosis (MS) requires to perform time-consuming and expensive batteries of tests at the hospital. MSCopilot® is a software medical device designed for the self-assessment of patients with MS (PwMS), combining 4 tests: walking, dexterity, cognition, and low contrast vision.
Objectives: To compare MSCopilot® sensitivity, specificity and reliability versus Multiple Sclerosis Functional Composite (MSFC).
Methods: This multicentre, open-label, randomized, controlled, crossover study, enrolled 141 PwMS and 76 healthy controls (HC). All participants performed MSCopilot® and MSFC tests at day 0, and 46 PwMS performed the same tests at day 30±3 to assess their reproducibility. The primary endpoint was the performance of MSCopilot® versus MSFC for the identification of PwMS against HCs, quantified using area under the curve (AUC).
This biomedical research was approved by an Independent Ethic Committee (CPP Ile de France XI) on 02/06/2017. The trial is registered on ClinicalTrials.gov (NCT03148938) and the French National Agency for Medicines and Health Products Safety (RCB ID: 2017-A00504-49).
Results: 116 PwMS and 69 HC were analyzed. The primary endpoint was reached: MSCopilot® performance was non-inferior to that of MSFC (AUC 0.92 and 0.89 respectively; p = 0.3). MSCopilot® and MSFC discriminated PwMS and HC with 81% and 76% sensitivity and 82% and 88% specificity respectively. Digital and standard test scores were highly correlated (r = 0.81; p< 0.001). The test-retest study demonstrated the good reproducibility of MSCopilot®. Results of the satisfaction questionnaire showed that the majority of patients preferred the use of the mobile application over traditional tests.
Conclusion: This multicentre, controlled, randomized study demonstrated that the performance of MSCopilot-3tests for the discrimination of patients with MS against healthy controls was non-inferior to that of MSFC. Additionally, this study demonstrated the reliability of MSCopilot and its strong correlation with the z-scores obtained with the various versions of MSFC.
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