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

Multiple sclerosis; Outcomes researchEsclerosis múltiple; Resultados de la investigaciónEsclerosi múltiple; Recerca de resultatsFloodlight 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.The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: F. Hoffmann-La Roche Ltd., Basel, Switzerland provided financial support for the study and publication of this manuscript

Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device

Validación clínica; Salud digital; Salud participativaValidació clínica; Salut digital; Salut participativaClinical validation; Digital health; Participatory healthThere 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.The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: F. Hoffmann-La Roche Ltd., Basel, Switzerland provided financial support for the publication of this manuscript

The global patient-reported outcomes for multiple sclerosis initiative: bridging the gap between clinical research and care – updates at the 2023 plenary event

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. The initiative prioritizes the global integration of patient (For the purposes of the Global PROMS Initiative, the term “patient” refers to the people with the disease (aka People with Multiple Sclerosis – pwMS): any individual with lived experience of the disease. People affected by the disease/Multiple Sclerosis: any individual or group that is affected by the disease: E.g., family members, caregivers will be also engaged as the other stakeholders in the initiative). insights into the management of MS care. It merges subjective PROs with objective clinical metrics, thereby addressing the complex variability of disease presentation and progression. Following the completion of its second phase, the initiative aims to help increasing the uptake of eHealth tools and passive PROs within research and clinical settings, affirming its unwavering dedication to the progressive refinement of MS care. Looking forward, the initiative is poised to continue enhancing global surveys, rethinking to the relevant statistical approaches in clinical trials, and cultivating a unified stance among ‘industry’, regulatory bodies and health policy making regarding the application of PROs in MS healthcare strategies

Large-scale, dynamic and distributed multi-agent coordination for real-time systems

The Coalition Formation with Spatial and Temporal constraints Problem (CFSTP) is designed to characterise scenarios at the intersection between task allocation and coalition formation. In this model, tens of heterogeneous agents are deployed over kilometre-wide areas to carry out thousands of tasks, each with its deadline and workload. To maximise the number of tasks completed, the agents need to cooperate by forming, disbanding and reforming coalitions. In this thesis, we start with an in-depth analysis of Coalition Formation with Look-Ahead (CFLA), the state-of-the-art CFSTP algorithm. We outline its main limitations, based on which we derive an extension called CFLA2. We show that we cannot eliminate the limitations of CFLA in CFLA2, hence we also develop a novel algorithm called Cluster-based Task Scheduling (CTS), which is the first to be simultaneously anytime, efficient and with convergence guarantee. We empirically demonstrate the superiority of CTS over CFLA and CFLA2, and propose S-CTS, a simplified but parallel and more efficient variant. In problems generated by the RoboCup Rescue Simulation, S-CTS can compete with the high-performance Binary Max-Sum and DSA algorithms, while being up to two orders of magnitude faster. We then propose a minimal mathematical program of the CFSTP, and reduce it to a Dynamic and Distributed Constraint Optimisation Problem, based on which we design D-CTS, a distributed version of CTS. We create a test framework that simulates the mobilisation of firefighters, which we use to show the effectiveness of D-CTS in large-scale and dynamic environments. Finally, to characterise scenarios in which the faster the tasks are solved, the greater the benefits, we propose the Multi-Agent Routing and Scheduling through Coalition Formation problem (MARSC), a generalisation of both the CFSTP and the important Team Orienteering Problem with Time Windows. We formulate a binary integer program and propose Anytime, exact and parallel Node Traversal (ANT), the first algorithm of its kind for both the MARSC and the CFSTP. Moreover, we define an approximate variant called ANT-ε. Both algorithms are validated in our realistic test framework, using as baselines an extended version of CTS, and an implementation of the Earliest Deadline First technique, which is typically used in real-time systems

Large-scale, dynamic and distributed coalition formation with spatial and temporal constraints

The Coalition Formation with Spatial and Temporal constraints Problem (CFSTP) is a multi-agent task allocation problem in which few agents have to perform many tasks, each with its deadline and workload. To maximize the number of completed tasks, the agents need to cooperate by forming, disbanding and reforming coalitions. The original mathematical programming formulation of the CFSTP is difficult to implement, since it is lengthy and based on the problematic Big-M method. In this paper, we propose a compact and easy-to-implement formulation. Moreover, we design D-CTS, a distributed version of the state-of-the-art CFSTP algorithm. Using public London Fire Brigade records, we create a dataset with 347588 tasks and a test framework that simulates the mobilization of firefighters in dynamic environments. In problems with up to 150 agents and 3000 tasks, compared to DSA-SDP, a state-of-the-art distributed algorithm, D-CTS completes 3.79%±[42.22%,1.96%] more tasks, and is one order of magnitude more efficient in terms of communication overhead and time complexity. D-CTS sets the first large-scale, dynamic and distributed CFSTP benchmark.<br/

Anytime and efficient multi-agent coordination for disaster response

The Coalition Formation with Spatial and Temporal constraints Problem (CFSTP) is a multi-agent task allocation problem where the tasks are spatially distributed, with deadlines and workloads, and the number of agents is typically much smaller than the number of tasks. To maximise the number of completed tasks, the agents may have to schedule coalitions. The state-of-the-art CFSTP solver, the Coalition Formation with Look-Ahead (CFLA) algorithm, has two main limitations. First, its time complexity is exponential with the number of agents. Second, as we show, its look-ahead technique is not effective in real-world scenarios, such as open multi-agent systems, where new tasks can appear at any time. In this work, we study its design and define a variant, called Coalition Formation with Improved Look-Ahead (CFLA2), which achieves better performance. Since we cannot eliminate the limitations of CFLA in CFLA2, we also develop a novel algorithm to solve the CFSTP, the first to be simultaneously anytime, efficient and with convergence guarantee, called Cluster-based Task Scheduling (CTS). In tests where the look-ahead technique is highly effective, CTS completes up to 30% (resp. 10%) more tasks than CFLA (resp. CFLA2) while being up to 4 orders of magnitude faster. We also propose S-CTS, a simplified but parallel variant of CTS with even lower time complexity. Using scenarios generated by the RoboCup Rescue Simulation, we show that S-CTS is at most 10% less performing than high-performance algorithms such as Binary Max-Sum and DSA, but up to 2 orders of magnitude faster. Our results affirm CTS as the new state-of-the-art algorithm to solve the CFSTP

Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device

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

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

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 users 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&nbsp;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&nbsp;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&nbsp;weeks or 50.6 non-consecutive days. This duration increased to 16.3&nbsp;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

The “dica” endoscopic classification for diverticular disease of the colon shows a significant interobserver agreement among community endoscopists

BACKGROUND AND AIM: An endoscopic classification of Diverticular Disease (DD), called DICA (Diverticular Inflammation and Complication Assessment) is currently available. It scores severity of the disease as DICA 1, DICA 2 and DICA 3. Our aim was to assess the agreement levels for this classification among an endoscopist community setting. METHODS: A total of 66 endoscopists independently scored a set of DD endoscopic videos. The percentages of overall agreement on the DICA score and a free-marginal multirater kappa (κ) coefficient were reported as statistical measures of the inter-rater agreement. RESULTS: The overall agreement levels were: 70.2% for DICA 1, 70.5% for DICA 2, 81.3% for DICA 3. The free marginal κ was: 0.553 for DICA 1, 0.558 for DICA 2, 0.719 for DICA 3. The agreement levels among the expert group were: 78.8% for DICA 1, 80.2% for DICA 2, 88.5% for DICA 3. The free marginal κ among the expert group were: 0.682 for DICA 1, 0.712 for DICA 2, 0.828 for DICA 3. The agreement of expert raters on the single item of the DICA classification was superior to the agreement of the overall group. CONCLUSIONS: The overall inter-rater agreement for DICA score in this study ranges from moderate to good, with a significant improvement in the expert subgroup of raters. Diverticular Inflammation and Complication Assessment is a simple and reproducible endoscopic scoring system