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Abstract Details

Validation Process of NMOSDCopilotTM, a Software as a Medical Device (SaMD) for Patients Living with Neuromyelitis Optica Spectrum Disorder
Autoimmune Neurology
P10 - Poster Session 10 (11:45 AM-12:45 PM)
14-001
To describe the results of the validation process of NMOSDCopilotTM through an usability evaluation, and the design of the OPTIS clinical study.

Neuromyelitis Optica Spectrum Disorder (NMOSD) is characterised by severe and unpredictable relapses, from which recovery can be incomplete. Remote symptom monitoring could help inform patient symptomatology, raise evidence on disease burden and support treatment decisions.

NMOSDCopilotTM, a Software as a Medical Device (SaMD), includes a mobile application that enables patients to perform digital assessment of motor function, dexterity, cognition and vision, and patient-reported outcomes (PROs).

A usability validation evaluation (summative evaluation) was conducted via interviews with 12 French patients. Usability engineering techniques were used to identify and mitigate factors that could contribute to human errors and adverse events. Participants were asked to interact with the NMOSDCopilotTM interface (mobile application), including digital assessment modules and PROs (Pain Visual Analogue Scale and Patient Health Questionnaire-8). Success rate, ease and safety of use were analyzed by a specialized User Experience team.
The validation usability study revealed that NMOSDCopilotTM was perceived as being very easy to use (m=9.78/10 ; SD=0.44), with a success rate of 100% for all the tested features. Four major use errors, i.e errors likely to alter data measurement, were highlighted for the digital vision assessment and appropriate corrections were implemented (sound check for voice instructions, instructions relating to the smartphone’s position, read-out of numbers).

The usability of NMOSDCopilotTM interface was validated among French patients and is being tested in US patients. 

NMOSDCopilotTM will be validated in a larger study in 103 patients, the OPTIS study. This international, prospective, multicentre study will provide evidence of the clinical performance and safety of NMOSDCopilotTM by demonstrating the correlation between digital assessments and standard clinic assessments. It will also assess the accuracy, reliability and reproducibility of the device.
Authors/Disclosures
Michael Levy, MD, PhD, FAAN (Massachusetts General Hospital/Harvard Medical School)
PRESENTER 		Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Pharma. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Levy has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Various law firms. The institution of Dr. Levy has received research support from National Institutes Health.
Elias S. Sotirchos, MD (Johns Hopkins University) Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Sotirchos has received research support from National Institutes of Health. The institution of Dr. Sotirchos has received research support from National Multiple Sclerosis Society. The institution of Dr. Sotirchos has received research support from Sumaira Foundation. The institution of Dr. Sotirchos has received research support from Genentech. The institution of Dr. Sotirchos has received research support from UCB. The institution of Dr. Sotirchos has received research support from Astoria Biologica. The institution of Dr. Sotirchos has received research support from Ad Scientiam. The institution of Dr. Sotirchos has received research support from Alexion. The institution of Dr. Sotirchos has received research support from Corevitas. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving as a Ad Hoc Reviewer with National Institutes of Health.
Loic Carment (Ad Scientiam) Loic Carment has received personal compensation for serving as an employee of Ad Scientiam.
Clarissa Gorin, Other (Ad Scientiam) Dr. Gorin has received personal compensation for serving as an employee of Ad Scientiam.
Lissandra Klaeylé (Ad Scientiam) Lissandra Klaeylé has received personal compensation for serving as an employee of Ad Scientiam.
Dellini Ravindra (Ad Scientiam) Dellini Ravindra has received personal compensation for serving as an employee of Ad Scientiam.
Emma Touré Cuq (Ad Scientiam) No disclosure on file
Alizé Vives (Ad Scientiam) No disclosure on file
Sami Fam Sami Fam has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Sami Fam has or had stock in Astra Zeneca.
Adrian Kielhorn Adrian Kielhorn has received personal compensation for serving as an employee of Alexion. Adrian Kielhorn has stock in Alexion.
Emrah Aras (Alexion Pharmaceuticals Inc.) No disclosure on file
Saad Zinai Saad Zinai has received personal compensation for serving as an employee of AD Scientiam. Saad Zinai has stock in Ad Scientiam.
Jerome De Seze Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma. Jerome De Seze has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pharma.