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Ad Scientiam à l'ECTRIMS: European Committee for Treatment and Research In Multiple Sclerosis

Etude pilote comparant le score MSFC à l'application d'auto-évaluation de la SEP de Ad Scientiam. Présenté à l'ECTRIMS: European Committee for Treatment and Research In Multiple Sclerosis

Abstract Category: Clinical aspects of MS - Clinical assessment tools

Source: ECTRIMS Online Library

Poster available on slideshare

ClinicalTrials.gov Identifier: NCT02814487 


Background: Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation is not always optimal as it can prove to be very time consuming. Moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status. 

A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was developed in order to replicate each of MSFC tests available in order to assess MS progression in the patient environment.

Objective: To establish a correlation between application DAM and MSFC.

Methodology: DAM was created using the Apple open source Research Kit. An ongoing pilot study is currently recruiting 30 patients with an established diagnosis of MS. Patients are selected during a consultation at the Neurology department of the Pitié-Salpêtrière Hospital (France). Each patient is given access to DAM on their own or a provided iPhone. During the enrolment visit, patients have to complete a MSFC and DAM evaluation (V0). Through a push-notification on their phone, patients are reminded to perform two DAM evaluations at home at days 30 (V1) and 60 (V2). At day 90 (V3), they have to come back to hospital for a second MSFC and DAM evaluation. 

Interim analyses were performed in April 2016 using correlation tests after 24 V0 and 12 V1 were completed. A comparison between each test of DAM and MSFC was done in order to evaluate the reproducibility and robustness of DAM tests.

Results: Reproducibility of MSFC on smartphone seems to be excellent (correlation between MSFC V0 and DAM V0 Z-scores, r=0.79, p< 10-5). Timed 25-Foot Walk (T25-FW, r=0.68, p< 10-3) and Paced Auditory Serial Addition Test (PASAT, r=0.65, p< 10-3) have the best reproducibility. Robustness of DAM seems to be good (correlation between DAM V0 and V1 at day 30, r= 0.68, p< 0.05), particularly for the 9HPT (r=0.77, p< 10-2) and PASAT (r=0.67, p< 0.05).

Conclusions: These results reinforce the idea that a smartphone application would be a good self-assessment tool for patients with MS. A new version of the application taking into accounts these interim results is under development. Qualitative insights from patients and clinicians will also be used to enhance usability and clinical relevance with updated or new tests. Further validation will also be required using a larger sample size to improve the confidence level.

Disclosure

S Medjebar: affiliate of Ad Scientiam

C Louapre: travel grant from Genzyme and Novartis 

R Debs: nothing to disclose 

C Peczynski: affiliate of Ad Scientiam

E Maillart: conference fees from Teva, Biogen, Genzyme, Merck and Novartis / travel Grant from Teva, Biogen, Novartis and Genzyme 

Ad Scientiam: privately held research company which received a research grant from Roche France for the conduct of this study: Clinical aspects of MS - Clinical assessment tools

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