Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

The increasing miniaturization and affordability of sensors and circuitry has led to the current level of innovation in the area of wearable and microsensor solutions for health monitoring. This facilitates the development of solutions that can be used to measure complex health outcomes in nonspecialist and remote settings. In this article, we review a number of innovations related to brain monitoring including portable and wearable solutions to directly measure brain electrical activity, and solutions measuring aspects related to brain function such as sleep patterns, gait, cognition, voice acoustics, and gaze analysis. Despite the need for more scientific validation work, we conclude that there is enough understanding of how to implement these approaches as exploratory tools that may provide additional valuable insights due to the rich and frequent data they produce, to justify their inclusion in clinical study protocols.

Background:Sedentary behaviour (SB) is an important risk factor for a number of chronic diseases. Although gaps remain in our knowledge of the elements of SB most associated with reduced health outcomes, measuring SB is important, especially in less active patient populations where treatment-related changes may be seen first in changes in SB.Methods:We review current published work in the measurement of SB to make recommendations for SB measurement in clinical studies.Results:To help move our understanding of the area forward, we propose a set of derived measures of SB that can be easily understood and interpreted.Conclusion:Although there is more work required to determine and validate the most clinically relevant and sensitive measures of SB, there is enough understanding of how to measure SB to enable its inclusion in study protocols.

Background Parkinson’s disease is the second most common long-term chronic, progressive, neurodegenerative disease, affecting more than 10 million people worldwide. There has been a rising interest in wearable devices for evaluation of movement disorder diseases such as Parkinson’s disease due to the limitations in current clinic assessment methods such as Unified Parkinson’s Disease Rating Scale (UPDRS) and the Hoehn and Yahr (HY) scale. However, there are only a few commercial wearable devices available, which, in addition, have had very limited adoption and implementation. This inconsistency may be due to a lack of users’ perspectives in terms of device design and implementation. This study aims to identify the perspectives of healthcare professionals and patients linked to current assessment methods and to identify preferences, and requirements of wearable devices. Methods This was a qualitative study using semi-structured interviews followed by focus groups. Transcripts from sessions were analysed using an inductive thematic approach. Results It was noted that the well-known assessment process such as Unified Parkinson’s Disease Rating Scale (UPDRS) was not used routinely in clinics since it is time consuming, subjective, inaccurate, infrequent and dependent on patients’ memories. Participants suggested that objective assessment methods are needed to increase the chance of effective treatment. The participants’ perspectives were positive toward using wearable devices, particularly if they were involved in early design stages. Patients emphasized that the devices should be comfortable, but they did not have any concerns regarding device visibility or data privacy transmitted over the internet when it comes to their health. In terms of wearing a monitor, the preferable part of the body for all participants was the wrist. Healthcare professionals stated a need for an economical solution that is easy to interpret. Some design aspects identified by patients included clasps, material choice, and form factor. Conclusion The study concluded that current assessment methods are limited. Patients’ and healthcare professionals’ involvement in wearable devices design process has a pivotal role in terms of ultimate user acceptance. This includes the provision of additional functions to the wearable device, such as fall detection and medication reminders, which could be attractive features for patients.

Using this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance.