Validation Process of NMOSDCopilotTM, a Software as a Medical Device (SaMD) for Patients Living with Neuromyelitis Optica Spectrum Disorder
Michael Levy1, Elias Sotirchos2, Loic Carment3, Clarissa Gorin3, Lissandra Klaeyle3, Dellini Ravindra3, Emma Touré Cuq3, Alizé Vivès3, Sami Fam4, Adrian Kielhorn4, Emrah Aras4, Saad Zinaï3, Jerome De Seze5
1Department of Neurology, Massachusetts General Hospital/Harvard Medical School, Boston, USA, 2Department of Neurology, Johns Hopkins University, Baltimore, USA, 3Ad Scientiam, Paris, France, 4Alexion, AstraZeneca Rare Disease, Boston, MA, 5Department of Neurology, Hôpital Civil, Strasbourg University, Strasbourg, France
Objective:
To describe the results of the validation process of NMOSDCopilotTM through an usability evaluation, and the design of the OPTIS clinical study.
Background:

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).
Design/Methods:

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.

Results:
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).
Conclusions:

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.
10.1212/WNL.0000000000205132