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Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement

Periodic Reporting for period 3 - MOBILISE-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement)

Reporting period: 2021-04-01 to 2022-03-31

The ability to move is a key contributor to “physical, mental and social well-being”, however, the study of mobility has received little attention, except in diseases characterised by specific mobility dysfunction. The increasing longevity of the world’s population together with prolonged survival in many chronic diseases means that more people are suffering from loss of mobility, which in turn is a major determinant of loss of independence. This has a considerable and growing personal, societal and economic impact.
The objectives of MOBILISE-D are to: (i) deliver a robust, validated, technology independent solution, within a standards-based framework, for digital mobility assessment; (ii) provide evidence that the outcomes accurately measure and monitor disability and predict clinical outcomes in four of the most relevant mobility-limiting conditions and (iii) obtain regulatory, payer and health technology agencies approval of digital mobility outcomes. In addition, European Federation of Pharmaceutical Industries and Associations (EFPIA) partners will conduct exploratory studies in Congestive Heart Failure (CHF).
Mobilise-D’s ultimate goal is to provide a validated, robust set of algorithms to measure Digital Mobility Outcomes (DMOs) that informs therapeutic development, clinical practice, precision medicine, industrial development and stakeholder approval. Successful achievement of this goal will facilitate the development of drugs and other therapeutic interventions; provide a roadmap for clinical implementation.
Work Undertaken and Key Results
Within the first year of Mobilise-D, algorithms and specifications for DMO’s and datasets were identified and tested in preparation for the Technical Validation Study (TVS). Methodologies and protocols were developed to implement the TVS along with an assessment of confounding, human factors and statistical analysis requirements. In addition, gold standard tools for the TVS study have been developed, ethics approval for the study obtained, the data management platform was developed along with data ingestion tools and a specification for electronic Clinical Outcome Assessments (eCOAs). In addition changes to the pipeline to accept data from a new sensor type were needed for the Clinical Validation Study (CVS) as the foreseen sensor type was not available. Validating and incorporating this sensor into the study has shown the approach used by the project is sensor agnostic.
In year 3 the TVS has been completed with the algorithms and data analysis providing very good correlation to the Digital Mobility Outcomes of interest. The results are being prepared in a number of academic papers for publication. The results showed good to excellent performances for the top algorithms selected for each block (gait sequence detection, step detection, cadence, turning detection) both in the laboratory and real-world 2.5-hour assessments.

In preparation for the CVS cohorts for each of the 4 conditions of interest (Multiple Sclerosis (MS), Chronic Obstructive Pulmonary Disease (COPD), Parkinson's Disease (PD) and hip fracture) were identified, together with lead experts. An overarching literature search has been completed on DMO’s to understand the current state of the art in mobility assessment across the cohorts and to inform the choice of DMO and clinical outcome assessments for use in the CVS. The CVS started on time in April 2022, currently the PD and COPD cohorts have reached their recruitment targets with MS to follow shortly. Hip fracture is slightly behind this mainly due to COVID factors affecting recruitment.
A large amount of work has gone into mitigating the risks associated with COVID-19 and the unpredictable nature of lockdowns across Europe.
The project has requested 2 rounds of Qualification Advice from the EMA and two letters of support have been received. Mobilise-D is currently considering an approach to FDA and a strategic approach across both EFPIA and academic partners has been agreed. The project is also working on how to best to proceed with EMA Qualification Opinion.
Mobilise-D and another IMI project, IDEA-FAST have agreed to collaborate in non-confidential areas. A significant output of this is the Digital Health Catalyst (DHC) (www.digitalhealthcatalyst.org) which aims to provide a platform for the advancement of early career researchers in the field of digital health. During year 3 further work has been undertaken to extend the scope of the DHC to include data sharing after the end of the project and as a vehicle for sustainability.
Mobilise-D has developed a data sharing policy which will enable the data it generates to be more widely shared by actors in the field.
COVID mitigation in our dissemination activities has seen a move to online content including videos and blogs aimed at stakeholders as well as significant activity on social media and the website. A series of webinars have been produced and delivered to promulgate the results of the technical validation study. These have been well received and the project believes that the webinar approach has enabled a wider audience and larger impact than other more traditional conference or seminar approaches. To date 52 peer reviewed publications have been published. In addition to this significant work has been put into developing a clear and structured Public Patient Involvement and Engagement strategy and implementation plan.
MOBILISE-D is building an all-encompassing, clinically-valid digital mobility assessment system uniformly applicable across conditions where measures of mobility loss can be related to disease progression.
MOBILISE-D will contribute to the definition of mobility parameters that could be used as a new endpoint for clinical trials in drug development. It will also provide a better way to classify patients according to their disabilities, helping the process of patient stratification.
MOBILISE-D will extend the data management platform into mobility assessment, with systems developed to standards agreed with regulators and established as a new international basis for disease-specific and cross-condition endpoints
Algorithms have been identified and analysed against pre-existing data to look at functionality and performance against expected DMOs.
A bespoke data management platform has been implemented and tested. Significant work has also been undertaken to standardise data for input and storage. In addition, Gold Standard methods have been developed that enable sensors to be tested against this standard.
Significant advancement has been made in regulatory approach which will have a wider impact than just Mobilise-D and will form the basis of a regulatory approach for many other digital medicine methodologies.
Mobilise-D is part of the creation of a Digital Health Catalyst that will see the development of early career researchers into the experts of tomorrow in the field of Digital Medicine.
A Technical Validation Study has been completed, collecting data on MS, PD, COPD, CHF and hip fracture patients. The results of this provide high correlation for the data recorded, using the analysis and selected algorithms to the Digital Mobility Outcomes foreseen.
Mobilise-D Kick Off meeting