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Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.

ABSTRACT: 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.

SUBMITTER: Badawy R

PROVIDER: S-EPMC7046173 | biostudies-literature | 2019 Sep-Dec

REPOSITORIES: biostudies-literature

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Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.

Badawy Reham R Hameed Farhan F Bataille Lauren L Little Max A MA Claes Kasper K Saria Suchi S Cedarbaum Jesse M JM Stephenson Diane D Neville Jon J Maetzler Walter W Espay Alberto J AJ Bloem Bastiaan R BR Simuni Tanya T Karlin Daniel R DR

Digital biomarkers 20190901 3

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 utili ...[more]

PMID: 32175520

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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.

Project description:ImportanceDigital health technologies may expand organizational capacity to treat opioid use disorder (OUD). However, it remains unclear whether these technologies serve as substitutes for or complements to traditional substance use disorder (SUD) treatment resources in health care organizations.ObjectiveTo characterize the use of patient-facing digital health technologies for OUD by US organizations with accountable care organization (ACO) contracts.Design, setting, and participantsThis cross-sectional study analyzed responses to the 2022 National Survey of Accountable Care Organizations (NSACO), collected between October 1, 2021, and June 30, 2022, from US organizations with Medicare and Medicaid ACO contracts. Data analysis was performed between December 15, 2022, and January 6, 2023.ExposuresTreatment resources for SUD (eg, an addiction medicine specialist, sufficient staff to treat SUD, medications for OUD, a specialty SUD treatment facility, a registry to identify patients with OUD, or a registry to track mental health for patients with OUD) and organizational characteristics (eg, organization type, Medicaid ACO contract).Main outcomes and measuresThe main outcomes included survey-reported use of 3 categories of digital health technologies for OUD: remote mental health therapy and tracking, virtual peer recovery support programs, and digital recovery support for adjuvant cognitive behavior therapy (CBT). Statistical analysis was conducted using descriptive statistics and multivariable logistic regression models.ResultsOverall, 276 of 505 organizations responded to the NSACO (54.7% response rate), with a total of 304 respondents. Of these, 161 (53.1%) were from a hospital or health system, 74 (24.2%) were from a physician- or medical group-led organization, and 23 (7.8%) were from a safety-net organization. One-third of respondents (101 [33.5%]) reported that their organization used at least 1 of the 3 digital health technology categories, including remote mental health therapy and tracking (80 [26.5%]), virtual peer recovery support programs (46 [15.1%]), and digital recovery support for adjuvant CBT (27 [9.0%]). In an adjusted analysis, organizations with an addiction medicine specialist (average marginal effect [SE], 32.3 [4.7] percentage points; P < .001) or a registry to track mental health (average marginal effect [SE], 27.2 [3.8] percentage points; P < .001) were more likely to use at least 1 category of technology compared with otherwise similar organizations lacking these capabilities.Conclusions and relevanceIn this cross-sectional study of 276 organizations with ACO contracts, organizations used patient-facing digital health technologies for OUD as complements to available SUD treatment capabilities rather than as substitutes for unavailable resources. Future studies should examine implementation facilitators to realize the potential of emerging technologies to support organizations facing health care practitioner shortages and other barriers to OUD treatment delivery.

Project description:Digital technologies, especially if used in novel ways, provide a number of potential advantages to clinical research in trials related to human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and may greatly facilitate operations as well as data collection and analysis. These technologies may even allow answering questions that are not answerable with older technologies. However, they come with a variety of potential concerns for both the participants and the trial sponsors. The exact challenges and means for alleviation depend on the technology and on the population in which it is deployed, and the rapidly changing landscape of digital technologies presents a challenge for creating future-proof guidelines for technology application.The aim of this study was to identify and summarize some common themes that are frequently encountered by researchers in this context and highlight those that should be carefully considered before making a decision to include these technologies in their research.In April 2016, the Global HIV Vaccine Enterprise surveyed the field for research groups with recent experience in novel applications of digital technologies in HIV clinical research and convened these groups for a 1-day meeting. Real-world uses of various technologies were presented and discussed by 46 attendees, most of whom were researchers involved in the design and conduct of clinical trials of biomedical HIV prevention and treatment approaches. After the meeting, a small group of organizers reviewed the presentations and feedback obtained during the meeting and categorized various lessons-learned to identify common themes. A group of 9 experts developed a draft summary of the findings that was circulated via email to all 46 attendees for review. Taking into account the feedback received, the group finalized the considerations that are presented here.Meeting presenters and attendees discussed the many successful applications of digital technologies to improve research outcomes, such as those for recruitment and enrollment, participant identification, informed consent, data collection, data quality, and protocol or treatment adherence. These discussions also revealed unintended consequence of technology usage, including risks to study participants and risks to study integrity.Key lessons learned from these discussions included the need to thoroughly evaluate systems to be used, the idea that early success may not be sustained throughout the study, that some failures will occur, and considerations for study-provided devices. Additionally, taking these key lessons into account, the group generated recommendations on how to move forward with the use of technology in HIV vaccine and biomedical prevention trials.

Project description:BACKGROUND:A range of digital technologies are available to lay people to find, share, and generate health-related information. Few studies have directed attention specifically to how women are using these technologies from the diverse array available to them. Even fewer have focused on Australian women's use of digital health. OBJECTIVE:The Australian Women and Digital Health Project aimed to investigate which types of digital technologies women used regularly for health-related purposes and which they found most helpful and useful. Qualitative methods-semistructured interviews and focus groups-were employed to shed light on the situated complexities of the participants' enactments of digital health technologies. The project adopted a feminist new materialism theoretical perspective, focusing on the affordances, relational connections, and affective forces that came together to open up or close off the agential capacities generated with and through these enactments. METHODS:The project comprised two separate studies including a total of 66 women. In study 1, 36 women living in the city of Canberra took part in face-to-face interviews and focus groups, while study 2 involved telephone interviews with 30 women from other areas of Australia. RESULTS:The affordances of search engines to locate health information and websites and social media platforms for providing information and peer support were highly used and valued. Affective forces such as the desire for trust, motivation, empowerment, reassurance, control, care, and connection emerged in the participants' accounts. Agential capacities generated with and through digital health technologies included the capacity to seek and generate information and create a better sense of knowledge and expertise about bodies, illness, and health care, including the women's own bodies and health, that of their families and friends, and that of their often anonymous online social networks. The participants referred time and again to appreciating the feelings of agency and control that using digital health technologies afforded them. When the technologies failed to work as expected, these agential capacities were not realized. Women responded with feelings of frustration, disappointment, and annoyance, leading them to become disenchanted with the possibilities of the digital technologies they had tried. CONCLUSIONS:The findings demonstrate the nuanced and complex ways in which the participants were engaging with and contributing to online sources of information and using these sources together with face-to-face encounters with doctors and other health care professionals and friends and family members. They highlight the lay forms of expertise that the women had developed in finding, assessing, and creating health knowledges. The study also emphasized the key role that many women play in providing advice and health care for family members not only as digitally engaged patients but also as digitally engaged carers.

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Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.

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Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.

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