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. 2024 Jan 2;14(1):122.
doi: 10.1038/s41598-023-49299-4.

Use of smartphone-based remote assessments of multiple sclerosis in Floodlight Open, a global, prospective, open-access study

Affiliations

Use of smartphone-based remote assessments of multiple sclerosis in Floodlight Open, a global, prospective, open-access study

Jiwon Oh et al. Sci Rep. .

Abstract

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.

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Conflict of interest statement

The authors declare the following competing financial interests and no competing non-financial interests: J Oh has received personal compensation for consulting or speaking from EMD Serono, Sanofi-Genzyme, Biogen Idec., F. Hoffmann-La Roche Ltd., Celgene, and Novartis; and has received research funding from the MS Society of Canada, National MS Society, Brain Canada, Biogen Idec., and Sanofi-Genzyme. L Capezzuto is an employee of F. Hoffmann-La Roche Ltd. L Kriara is an employee of F. Hoffmann-La Roche Ltd. J Schjodt-Eriksen is an employee of and shareholder in F. Hoffmann-La Roche Ltd. J van Beek is an employee of Biogen Inc. C Bernasconi received consulting fees as a contractor for F. Hoffmann-La Roche Ltd. during the execution of this work. X Montalban has received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials, or participated in advisory boards of clinical trials in the past years with Actelion, Alexion, Bayer, Biogen, Celgene, EMD Serono, Genzyme, Immunic, MedDay, Merck, Mylan, Nervgen, Novartis, Roche, Sanofi-Genzyme, Teva Pharmaceuticals, TG Therapeutics, Excemed, MSIF, and NMSSH. H Butzkueven’s institution (Monash University) has received funding from Biogen, F. Hoffmann-La Roche Ltd., Merck, and Novartis; has carried out contracted research for Novartis, Merck, F. Hoffmann-La Roche Ltd., and Biogen; has taken part in speaker’s bureaus for Biogen, Genzyme, F. Hoffmann-La Roche Ltd., and Merck; and has received personal grants from Oxford Pharmagenesis and Biogen. L Kappos’ institutions (University Hospital Basel/Stiftung Neuroimmunology and Neuroscience Basel) have received and used exclusively for research support payments for steering committee and advisory board participation, consultancy services, and participation in educational activities from: Actelion, Aurigia Vision AG, Bayer, Bristol Myers Squibb, df-mp Molnia & Pohlmann, Celgene, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Japan Tobacco, Merck, MH Consulting, Minoryx, Novartis, Österreichische Gesellschaft für Neurologie, F. Hoffmann-La Roche Ltd., Senda Biosciences Inc., Sanofi, Santhera, Shionogi BV, TG Therapeutics, and Wellmera; and license fees for Neurostatus-UHB products; grants from Novartis, Innosuisse, and F. Hoffmann-La Roche Ltd. G Giovannoni received personal compensation in the past for serving as a consultant for AbbVie, Actelion, Atara Bio, Biogen, Celgene, Sanofi-Genzyme, Genentech, GlaxoSmithKline, Merck-Serono, Novartis, Roche, and Teva Pharmaceuticals; has received personal compensation from Elsevier for serving as an editor on MSARDs; and has received financial support for research activities from Biogen, Roche, Merck, Merck-Serono, Novartis, Sanofi-Genzyme, and Takeda. R Bove has received consultancy fees from Alexion, Biogen, EMD Serono, F. Hoffmann-La Roche Ltd., Genentech, Horizon, Janssen, Novartis, Sanofi-Genzyme, and TG Therapeutics; and is funded by the NMSS Harry Weaver Award, NIH, DOD, and NSF, as well as Biogen, Novartis, F. Hoffmann-La Roche Ltd. and Genentech. L Julian is an employee of Genentech, Inc., and a shareholder in F. Hoffmann-La Roche Ltd. M Baker is an employee of and shareholder in F. Hoffmann-La Roche Ltd. C Gossens is an employee of and shareholder in F. Hoffmann-La Roche Ltd. M Lindemann is a consultant for F. Hoffmann-La Roche Ltd. via Inovigate.

Figures

Figure 1
Figure 1
Overview of the Floodlight Open study workflow. Consent could be withdrawn at any time during the study, resulting in the termination of further data collection from the withdrawn participant. All data provided up to the withdrawal of consent were retained and used for study purposes. The Floodlight Open app was developed for iOS- and Android-based smartphones and made available for download in 17 countries (see Supplementary Table S1 for release dates in each country). ID identification, iOS iPhone operating system.
Figure 2
Figure 2
Funnel plot depicting the proportion of self-declared MS participants that progress from one active test (or PRO) to another active test, or drop out, during the fixed test sequence. Participants who never completed a full fixed test sequence were included. DaS Draw a Shape, DMQ Daily Mood Questionnaire, IPS Information Processing Speed, MS multiple sclerosis, PRO patient-reported outcome, SBT Static Balance Test, UTT U-Turn Test.
Figure 3
Figure 3
Persistence among participants. Persistence was defined as one of the following: at least any one test of the fixed sequence performed per week, at least one 2MWT performed per week, at least one full fixed test sequence performed per week, or having provided life-space measurement data in a given week. Participants are ordered along the x-axis starting with those with the highest persistence (self-declared MS, n = 1350; self-declared non-MS, n = 1133). The green shading indicates the exact number of days that the participant was adherent in the specific week. 2MWT Two-Minute Walk Test, MS multiple sclerosis.
Figure 4
Figure 4
Weekly persistence among self-declared MS and non-MS participants by country in the first 20 weeks. Persistence of self-declared (a) MS and (b) non-MS participants per week (at least one test of the fixed sequence performed per week) across countries with at least 20 participants; numbers of participants shown are those who performed at least one test of the fixed sequence. MS multiple sclerosis.
Figure 5
Figure 5
Distribution of test performance data for self-declared MS and non-MS participants. The distribution of performance data for each active test and life-space measurement is depicted with violin plots with low-degree smoothing applied. Note that for the DaS Test, the maximum average Hausdorff distance recorded for the non-MS population is 0.68. 2MWT Two-Minute Walk Test, DaS Draw a Shape, DMQ Daily Mood Questionnaire, IPS Information Processing Speed, MS multiple sclerosis, s seconds, SBT Static Balance Test, UTT U-Turn Test.

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