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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), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs.ObjectiveThis study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework.MethodsWe used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions.ResultsThirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity.ConclusionsThe CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care.International registered report identifier (irrid)RR2-10.1136/bmjopen-2021-057430.

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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Project description:Undergraduate subject pools are prevalent across disciplines in the United States. The Health Education Research Experience (HERE) Program was the first known course-based subject pool entirely managed and conducted online for online students enrolled in an introductory health education/health promotion course. The program was conducted within five semesters from Spring 2012 through Summer 2013. The HERE Program encompassed 13 studies embedded in two sections of an undergraduate online course at the University of Florida. The studies were all related to course topics and current research topics in health education/promotion (as identified through the Healthy People 2020 Framework). The topics ranged from the relatively less sensitive health aspects of college life (i.e., technology use) to studies assessing more sensitive health topics (i.e., intimate partner violence and sexual assault). In alignment with a best practice in survey design, the HERE Program's survey instruments included one metadata item embedded in each survey to identify which devices students used to complete the surveys. Understanding which devices students used for survey completion has ramifications for survey designers and survey researchers. In contrast to the relative uniformity of pen and paper surveys and control of the survey completion environment, online surveys may not look identical across personal devices and may be completed in increasingly varied environments. All studies, study procedures and protocols, and metadata collection procedures were approved by the university's Institutional Review Board. The data presented here were extracted from each survey's data files and aggregated. The aggregated metadata are available through Mendeley Data in a.csv file for widespread access. Descriptive statistics are presented in tables. The data provided in this article will benefit researchers interested in survey methodology, questionnaire design, modes of survey collection, and survey metadata. The data are hosted in the following Mendeley Data repository: https://data.mendeley.com/datasets/ht9jmd3cdt/2.

Dataset Information

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

Publications

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

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