ReviewBrain sciences2021
Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device.
Review in Brain sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07664865 (Digitalization of Procedures for Neuropsychological Assessment for Neurocognitive Disorders), which is not on this map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Digitalization of Procedures for Neuropsychological Assessment for Neurocognitive Disorders: Standardization and Clinical Validation of the Teleneuropsychology Platform Tenèpsia®
Who cites it
22 citing papers in PubMed, 34 citations in OpenAlex.
- Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Trial
- Delivering high-quality multiple sclerosis care in Germany: challenges and regional models.Neurological research and practice · 2026Review
- Detecting progressing events in multiple sclerosis clinics in real-time is possible: Yes.Multiple sclerosis (Houndmills, Basingstoke, England) · 2026Article
- Simulation of Clinical Visits as a Novel Approach to Evaluate Digital Health in Multiple Sclerosis: Simulation Study.JMIR medical informatics · 2025Article
- Performance of machine learning models for predicting high-severity symptoms in multiple sclerosis.Scientific reports · 2025Observational
- Investigating Measurement Equivalence of Smartphone Sensor-Based Assessments: Remote, Digital, Bring-Your-Own-Device Study.Journal of medical Internet research · 2025Article
- Longitudinal Trajectories of Digital Cognitive Biomarkers for Multiple Sclerosis.Annals of clinical and translational neurology · 2025Observational
- Application of telemedicine in fatigue management for patients with multiple sclerosis: A scoping review.PloS one · 2025Article
- Integration of the expanded disability status scale with ambulation, visual and cognitive tests.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Article
- User Experience of a Large-Scale Smartphone-Based Observational Study in Multiple Sclerosis: Global, Open-Access, Digital-Only Study.JMIR human factors · 2024Observational
- A digital teleneuropsychology platform for the diagnosis of mild cognitive impairment: from concept to certification as a medical device.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Article
- Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study.JMIR formative research · 2024Article
- The administration of the paper and electronic versions of the Manual Ability Measure-36 (MAM-36) and Fatigue Severity Scale (FSS) is equivalent in people with multiple sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Article
- Use of smartphone-based remote assessments of multiple sclerosis in Floodlight Open, a global, prospective, open-access study.Scientific reports · 2024Article
- An Exploratory Study on the Utility of Patient-Generated Health Data as a Tool for Health Care Professionals in Multiple Sclerosis Care.Methods of information in medicine · 2023Article
- Assessment of Upper Extremity Function in Multiple Sclerosis: Feasibility of a Digital Pinching Test.JMIR formative research · 2023Article
- Progression events defined by home-based assessment of motor function in multiple sclerosis: protocol of a prospective study.Frontiers in neurology · 2023Article
- Management of multiple sclerosis fatigue in the digital age: from assessment to treatment.Frontiers in neuroscience · 2023Review
- Digital Innovation in Multiple Sclerosis Management.Brain sciences · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
Abstract
There is increasing interest in the development and deployment of digital solutions to improve patient care and facilitate monitoring in medical practice, e.g., by remote observation of disease symptoms in the patients' home environment. Digital health solutions today range from non-regulated wellness applications and research-grade exploratory instruments to regulated software as a medical device (SaMD). This paper discusses the considerations and complexities in developing innovative, effective, and validated SaMD for multiple sclerosis (MS). The development of SaMD requires a formalised approach (design control), inclusive of technical verification and analytical validation to ensure reliability. SaMD must be clinically evaluated, characterised for benefit and risk, and must conform to regulatory requirements associated with device classification. Cybersecurity and data privacy are also critical. Careful consideration of patient and provider needs throughout the design and testing process help developers overcome challenges of adoption in medical practice. Here, we explore the development pathway for SaMD in MS, leveraging experiences from the development of Floodlight™ MS, a continually evolving bundled solution of SaMD for remote functional assessment of MS. The development process will be charted while reflecting on common challenges in the digital space, with a view to providing insights for future developers.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.