Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson's Disease.
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ABSTRACT:
SUBMITTER: Hill DL
PROVIDER: S-EPMC8954603 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
Publications
Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson's Disease.
Hill Derek L DL Stephenson Diane D Brayanov Jordan J Claes Kasper K Badawy Reham R Sardar Sakshi S Fisher Katherine K Lee Susan J SJ Bannon Anthony A Roussos George G Kangarloo Tairmae T Terebaite Viktorija V Müller Martijn L T M MLTM Bhatnagar Roopal R Adams Jamie L JL Dorsey E Ray ER Cosman Josh J
Sensors (Basel, Switzerland) 20220309 6
Sensor data from digital health technologies (DHTs) used in clinical trials provides a valuable source of information, because of the possibility to combine datasets from different studies, to combine it with other data types, and to reuse it multiple times for various purposes. To date, there exist no standards for capturing or storing DHT biosensor data applicable across modalities and disease areas, and which can also capture the clinical trial and environment-specific aspects, so-called meta ...[more]
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Project description:Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual's disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson's disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.
| S-EPMC7046173 | biostudies-literature
Project description:BackgroundDigital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste. But in order to develop sound e-waste management policies, it will be necessary to first estimate the current volume of e-waste that results from the use of DHTs in trials.Materials and methodsA Web Ontology Language (OWL)-compliant ontology of DHTs was created using a list of 500 DHT device names derived from a mixture of public and private sources. The U.S. clinical trials registry, ClinicalTrials.gov, was then queried to identify and classify trials using any of the devices in the ontology. The ClinicalTrials.gov records from this search were then analyzed to characterize the volume and properties of trials using DHTs, as well as estimating the total volume of individual DHT units that have been provisioned (or are planned to be provisioned) for clinical research.ResultsOur ontology-driven search identified 2326 unique clinical trials with a reported "actual" enrollment of 200,947 participants and a "planned" enrollment of an additional 4,094,748 participants. The most-used class of DHTs in our ontology was "wearables," (1852 trials), largely driven by the use of smart watches and other wrist-worn sensors (estimated to involve 149,391 provisioned devices). The most-used subtype of DHTs in trials was "subcutaneous" devices (367 trials), driven by the prevalent use and testing of glucose monitors (estimated to involve 17,666 provisioned devices).ConclusionThousands of trials, involving hundreds of thousands of devices, have already been completed, and many more trials (potentially involving millions more devices) are planned. Despite the great opportunities that are afforded by DHTs to the clinical trial enterprise, if the industry lacks the ability to track DHT use with sufficient resolution, the result is likely to be a great deal of e-waste. A new ontology of DHTs, combined with rigorous data science methods like those described in this paper, can be used to provide better information across the industry, and in turn, help create a more sustainable and equitable clinical trials enterprise.
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Project description:Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer's, and Parkinson's disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.
| S-EPMC9918454 | biostudies-literature
Project description:BackgroundDigital health services empower people to track, manage, and improve their own health and quality of life while delivering a more personalized and precise health care, at a lower cost and with higher efficiency and availability. Essential for the use of digital health services is that the treatment of any personal data is compatible with the Patient Data Act, Personal Data Act, and other applicable privacy laws.ObjectiveThe aim of this study was to develop a framework for legal challenges to support designers in development and assessment of digital health services.MethodsA purposive sampling, together with snowball recruitment, was used to identify stakeholders and information sources for organizing, extending, and prioritizing the different concepts, actors, and regulations in relation to digital health and health-promoting digital systems. The data were collected through structured interviewing and iteration, and 3 different cases were used for face validation of the framework.ResultsA framework for assessing the legal challenges in developing digital health services (Legal Challenges in Digital Health [LCDH] Framework) was created and consists of 6 key questions to be used to evaluate a digital health service according to current legislation.ConclusionsStructured discussion about legal challenges in relation to health-promoting digital services can be enabled by a constructive framework to investigate, assess, and verify the digital service according to current legislation. The LCDH Framework developed in this study proposes such a framework and can be used in prospective evaluation of the relationship of a potential health-promoting digital service with the existing laws and regulations.
| S-EPMC4909384 | biostudies-literature
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Project description: Not available
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| S-EPMC7851293 | biostudies-literature
Project description:Objectives:The objective of this study was to describe the conceptual and implementation approach of selected digital health technologies that were tailored in various resource-constrained countries. To provide insights from a donor-funded project implementer perspective on the practical aspects based on local context and recommendations on future directions. Methods:Drawing from our multi-year institutional experience in more than 20 high disease-burden countries that aspire to meet the 2030 United Nations Sustainable Development Goal 3, we screened internal project documentation on various digital health tools that provide clarity in the conceptual and implementation approach. Taking into account geographic diversity, we provide a descriptive review of five selected case studies from Bangladesh (Asia), Mali (Francophone Africa), Uganda (East Africa), Mozambique (Lusophone Africa), and Namibia (Southern Africa). Findings:A key lesson learned is to harness and build on existing governance structures. The use of data for decision-making at all levels needs to be cultivated and sustained through multi-stakeholder partnerships. The next phase of information management development is to build systems for triangulation of data from patients, commodities, geomapping, and other parameters of the pharmaceutical system. A well-defined research agenda must be developed to determine the effectiveness of the country- and regional-level dashboards as an early warning system to mitigate stock-outs and wastage of medicines and commodities. Conclusion:The level of engagement with users and stakeholders was resource-intensive and required an iterative process to ensure successful implementation. Ensuring user acceptance, ownership, and a culture of data use for decision-making takes time and effort to build human resource capacity. For future United Nations voluntary national reviews, countries and global stakeholders must establish appropriate measurement frameworks to enable the compilation of disaggregated data on Sustainable Development Goal 3 indicators as a precondition to fully realize the potential of digital health technologies.
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