Floodlight Open was a global, open-access, digital-only study designed to understand the drivers and barriers in deployment and use of a smartphone app in a naturalistic setting and broad study population of people with and without multiple sclerosis (MS). The study utilised the Floodlight Open app: a ‘bring-your-own-device’ solution that remotely measures a user’s mood, cognition, hand motor function, and gait and postural stability via smartphone sensor-based tests requiring active user input (‘active tests’). Levels of mobility of study participants (‘life-space measurement’) were passively measured. Study data from these tests were made available via an open-access platform. Data from 1350 participants with self-declared MS and 1133 participants with self-declared non-MS from 17 countries across four continents were included in this report. Overall, MS participants provided active test data for a mean duration of 5.6 weeks or a mean duration of 19 non-consecutive days. This duration increased among MS participants who persisted beyond the first week to a mean of 10.3 weeks or 36.5 non-consecutive days. Passively collected life-space measurement data were generated by MS participants for a mean duration of 9.8 weeks or 50.6 non-consecutive days. This duration increased to 16.3 weeks/85.1 non-consecutive days among MS participants who persisted beyond the first week. Older age, self-declared MS disease status, and clinical supervision as part of concomitant clinical research were all significantly associated with higher persistence of the use of the Floodlight Open app. MS participants performed significantly worse than non-MS participants on four out of seven active tests. The findings from this multinational study inform future research to improve the dynamics of persistence of use of digital monitoring tools and further highlight challenges and opportunities in applying them to support MS clinical care.

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.

Background: Floodlight Open is a global, open-access, fully remote, digital-only study designed to understand the drivers and barriers in deployment and persistence of use of a smartphone app for measuring functional impairment in a naturalistic setting and broad study population. Objective: This study aims to assess measurement equivalence properties of the Floodlight Open app across operating system (OS) platforms, OS versions, and smartphone device models. Methods: Floodlight Open enrolled adult participants with and without self-declared multiple sclerosis (MS). The study used the Floodlight Open app, a “bring-your-own-device” (BYOD) solution that remotely measured MS-related functional ability via smartphone sensor–based active tests. Measurement equivalence was assessed in all evaluable participants by comparing the performance on the 6 active tests (ie, tests requiring active input from the user) included in the app across OS platforms (iOS vs Android), OS versions (iOS versions 11-15 and separately Android versions 8-10; comparing each OS version with the other OS versions pooled together), and device models (comparing each device model with all remaining device models pooled together). The tests in scope were Information Processing Speed, Information Processing Speed Digit-Digit (measuring reaction speed), Pinching Test (PT), Static Balance Test, U-Turn Test, and 2-Minute Walk Test. Group differences were assessed by permutation test for the mean difference after adjusting for age, sex, and self-declared MS disease status. Results: Overall, 1976 participants using 206 different device models were included in the analysis. Differences in test performance between subgroups were very small or small, with percent differences generally being ≤5% on the Information Processing Speed, Information Processing Speed Digit-Digit, U-Turn Test, and 2-Minute Walk Test; <20% on the PT; and <30% on the Static Balance Test. No statistically significant differences were observed between OS platforms other than on the PT (P<.001). Similarly, differences across iOS or Android versions were nonsignificant after correcting for multiple comparisons using false discovery rate correction (all adjusted P>.05). Comparing the different device models revealed a statistically significant difference only on the PT for 4 out of 17 models (adjusted P≤.001-.03). Conclusions: Consistent with the hypothesis that smartphone sensor–based measurements obtained with different devices are equivalent, this study showed no evidence of a systematic lack of measurement equivalence across OS platforms, OS versions, and device models on 6 active tests included in the Floodlight Open app. These results are compatible with the use of smartphone-based tests in a bring-your-own-device setting, but more formal tests of equivalence would be needed.

Background: Efforts are being made to integrate digital health technologies into clinical care for multiple sclerosis (MS) to improve patient monitoring. Efficiently probing how they might impact clinical care could streamline digital tool development. The Floodlight digital tool, comprising 5 smartphone sensor–based tests, was used to generate health-related data on patient function and symptoms in a clinical simulation. Objective: The study had 3 objectives: (1) assess the utility of simulated clinical encounters as a research methodology for exploring the introduction of digital health technologies into clinical practice in MS, (2) confirm the fidelity of the simulated environment and patient cases developed and understand what metrics (eg, workflow, comprehensive evaluation) could be generated, and (3) generate insights into the utility of digitally collected data, including usability, clinical decision contribution, and impact on workflows, in clinical practice. Methods: A total of 2 patient cases consisting of clinical, radiological, and digital health data were developed with clinician input. US-based neurologists prepared for and conducted 2 simulated teleconsultations each, with an actor briefed on case profiles. Floodlight data were available, via the Floodlight MS™ Health Care Professional Portal, for 1 of the 2 consultations. Participant neurologists completed interviews and surveys assessing the fidelity of the cases presented, user experience and workflow metrics, patient concerns identified, care decisions made, and confidence in making decisions. Results: All 10 neurologists indicated that the simulations were high-fidelity representations of real consultations. Using the Floodlight technology for the first time, median time taken to prepare for and conduct the consultation was ~1.7‐2 minutes longer, with slightly greater mental effort reported by participants, compared with not using the tool. The Floodlight MS Health Care Professional Portal scored an “above average” 79 on the System Usability Scale and an “acceptable” Net Promoter Score of 10. In total, 6 of the 10 neurologists “strongly agreed” that it was easier and quicker to identify patient concerns when they had access to the patient-generated Floodlight data to prepare for their encounters than when they did not. Overall, more care and management decisions were taken when the digital tool was used (37 vs 29). Of those 37 decisions, Floodlight data were reported as a trigger for 20 decisions, always in combination with other elements including patient history (20/20) and clinical exam findings (9/20). Conclusions: These findings advance our understanding of clinical simulation as a method for evaluating digital tools and other innovative technologies for MS care. High-fidelity patient cases could be provided for the mock teleconsultations, and the simulated clinical environment was useful for evaluating usability and utility of a new digital tool—yielding preliminary evidence on how digital data could be accessed and utilized by neurologists to support routine MS care.

BACKGROUND Floodlight Open is a global, open-access, fully remote, digital-only study designed to understand the drivers and barriers in deployment and persistence of use of a smartphone app for measuring functional impairment in a naturalistic setting and broad study population. OBJECTIVE This study aims to assess measurement equivalence properties of the Floodlight Open app across operating system (OS) platforms, OS versions, and smartphone device models. METHODS Floodlight Open enrolled adult participants with and without self-declared multiple sclerosis (MS). The study used the Floodlight Open app, a “bring-your-own-device” (BYOD) solution that remotely measured MS-related functional ability via smartphone sensor–based active tests. Measurement equivalence was assessed in all evaluable participants by comparing the performance on the 6 active tests (ie, tests requiring active input from the user) included in the app across OS platforms (iOS vs Android), OS versions (iOS versions 11-15 and separately Android versions 8-10; comparing each OS version with the other OS versions pooled together), and device models (comparing each device model with all remaining device models pooled together). The tests in scope were Information Processing Speed, Information Processing Speed Digit-Digit (measuring reaction speed), Pinching Test (PT), Static Balance Test, U-Turn Test, and 2-Minute Walk Test. Group differences were assessed by permutation test for the mean difference after adjusting for age, sex, and self-declared MS disease status. RESULTS Overall, 1976 participants using 206 different device models were included in the analysis. Differences in test performance between subgroups were very small or small, with percent differences generally being ≤5% on the Information Processing Speed, Information Processing Speed Digit-Digit, U-Turn Test, and 2-Minute Walk Test; <20% on the PT; and <30% on the Static Balance Test. No statistically significant differences were observed between OS platforms other than on the PT (P<.001). Similarly, differences across iOS or Android versions were nonsignificant after correcting for multiple comparisons using false discovery rate correction (all adjusted P>.05). Comparing the different device models revealed a statistically significant difference only on the PT for 4 out of 17 models (adjusted P≤.001-.03). CONCLUSIONS Consistent with the hypothesis that smartphone sensor–based measurements obtained with different devices are equivalent, this study showed no evidence of a systematic lack of measurement equivalence across OS platforms, OS versions, and device models on 6 active tests included in the Floodlight Open app. These results are compatible with the use of smartphone-based tests in a bring-your-own-device setting, but more formal tests of equivalence would be needed.