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Publication Name
Link to Publication
DiMe Resources used (expand to view all)
DiMe Resource(s) in Action: Implementation Story
Extra resources (if available)
Indication/Tx area
Digital tool
51 Flavors: Regional Resource Configurations and Foreign Multinational Market Entry in the US Biopharmaceutical Industry
https://www.mdpi.com/2071-1050/13/17/9763
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Authors reference DiMe's resource when discussing the biopharmaceutical industry's dependence highly specialized workforce. They reference DiMe's study, noticing it sheds light on the "growing shortage of properly skilled employees available to work in this industry." Authors conclude that, "given the necessity and growing scarcity of talent needed in this industry, we include a measure of the biopharmaceutical industry’s skilled workforce by state," ultimately measuring skilled workforce as a state's "Location Quotient (LQ), which is the ratio of an industry’s share of total state employment relative to its share of total national employment." This is used in the author's overall evaluation of resources.
Agnostic
DHTs
A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial
https://www.sciencedirect.com/science/article/pii/S1551714422002282
DiMe Library of Digital Endpoints
The authors, who describe a protocol for the Asthma Digital Study, accessed DiMe's Library of Digital Endpoints to ascertain the use of digital endpoints for Asthma. Using the library, among other sources, they found that "fluctuations in asthma control can correlate with changes in respiratory rate, heart rate, physical activity level, sleep disturbances, and oxygen saturation, all of which can be measured using consumer-grade devices." Consumer-grade devices deployed with smartphone applications (“apps”) may be one promising approach to advance digital health technologies for asthma.
Respiratory
DHTs
Digital Health Applications
A digital health service for elderly people with balance disorders and risk of falling: a design science approach
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8835704/
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Through a mixed methods study, authors identified and explored the "dissatisfaction with electronic medical records and the opportunity for using digital health solutions." They drew on concepts from DiMe's resource to improve the success of DHTs, noting that the "involvement of patients, caregivers and healthcare professionals is one key point for the success of digital interactive solutions." The authors drew similar conclusions to DiMe authors, finding that "caregivers’ deep involvement and training were essential" and that the "lack of investment in long-term care services, including digital solutions, and of alignment with public health policies, were constraints."
Agnostic
Musculoskeletal Disorders
DHTs
EHR
A learning health systems approach to integrating electronic patient‐reported outcomes across the health care organization
https://pubmed.ncbi.nlm.nih.gov/34667879/
mHealth and patient generated health data
Authors used the DiMe resource to identify a gap in their study's methodology (e.g., the involvement of patients on the the research team), and course-corrected to involve patients in their "local planning and development efforts for ePROs and, more broadly, patient‐generated health data."
Agnostic
EHR
DHTs
PGHD
A novel digital approach to describe real world outcomes among patients with constipation
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887258/
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
The authors cited the use of the DiMe resource in their methodology, noting that "the Achievement study platform is available as a mobile application for both Android and iOS operating systems, with functionality to connect consumer mobile devices and third-party digital diary apps, as well as enable users to participate and engage in clinical research efforts."
Gastrointestinal
DHTs
A pilot study of the Earable device to measure facial muscle and eye movement tasks among healthy volunteers
https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000061
V3
"The steps taken in this study reflect the analytical validation steps of the V3 framework for the development of digital assessments. Taken together, the results from the authors' study highlight the utility of the Earable device and similar devices that collect bio-signal data as potential measurement tools in a clinical trial setting for evaluating facial and eye movement tasks, and enable further clinical development with this and similar devices."
Agnostic
Wearables
A Smartphone Application as an Exploratory Endpoint in a Phase 3 Parkinson’s Disease Clinical Trial: A Pilot Study
https://www.karger.com/Article/Abstract/521232
DiMe Library of Digital Endpoints
Authors use DiMe's Endpoints Library to illustrate the growth in use of digital endpoints in clinical trials, while highlighting that while digital tools have been "increasingly studied in observational studies, the incorporation of smartphones into clinical trials in Parkinson’s has been rare."
Parkinson's Disease
Neurological Disorders
Digital Health Applications
Advancing digital health applications: priorities for innovation in real-world evidence generation
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(21)00292-2/fulltext
Digital measures that matter to patients
DiMe Library of Digital Endpoints
The article is the result of a roundtable convened by DiMe and the Health Innovation Hub of the German Federal Ministry of Health (hih) to bring together experienced international experts in evidence generation for digital medicine products. This article highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonization of best evidentiary practices. In the discussion focused on study design, the article notes that for the selection, definition, establishment, and collection of endpoints, "it is and will remain vital to consider the patient's perspective," as concluded in DiMe's measures that matter work. Further, the authors reference DiMe's library of digital endpoints in the discussion around growth in the use of digital endpoints, "with 225 unique digital endpoints currently in use in medical product development at the time of writing" and note that the "expansion of open-access tools like this will create important public goods for RWE researchers in the context of app evaluation and beyond." Finally, in the author's "Future Outlook," they highlight the importance of pre-competitive collaboratives like the DiMe–hih partnership. They note that these partnerships "will be key to convening experts, addressing evidence and trust gaps, and subsequently driving the dissemination of best practices and examples. All of these efforts will be bolstered by new, RWE-based public funding models for clinical studies that engage broad-ranging stakeholder groups."
Agnostic
DHTs
Advancing Digital Medicine with Wearables in the Wild
https://www.mdpi.com/1424-8220/22/12/4576/pdf?version=1655451589
V3
Authors leverage the V3 framework to outline the opportunities and challenges to adopting wearables. For example, the authors discuss "future opportunities for further evaluation of technologies [e.g., V3] and in clinical areas that would benefit from objective assessment of symptoms... and remote patient monitoring for the delivery of personalized therapeutics when and where they are most needed." Excerpt from the text: "A compelling evaluation framework is emerging, through the efforts of the Digital Medicine Society [7] and others, that aims to identify digital medicine technologies that are fit for purpose (e.g., see [5,6]). The comprehensive framework incorporates Measurement Verification, Analytical Validation, Clinical Validation, and Clinical Utility testing to help foster the development of digital medicine technologies that function as designed and markedly improve human health."
Agnostic
Wearables
An Aging Focused Unobtrusive and Privacy-Preserving Digital Behaviorome
https://www.medrxiv.org/content/10.1101/2021.12.23.21267929v1
It takes a village: development of digital measures for computer scientists
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
The authors use the terminology outlined in DiMe publications to standardize their work among the other bodies of work that have also adopted this language. Additionally, in the discussion of their results, authors consider the best practices laid out in 'It takes a village: development of digital measures for computer scientists' (e.g., the discouraging of sensor-symptoms mapping, "which is to some degree what a digital behaviorome-based approach is doing"). In this evaluation of those best practices, they conclude that "since in this case sensor technologies respect privacy and do not add any additional burden, there are scarcely any downsides, as would occur with adding additional wearables or tasks requiring interaction."
Agnostic
DHTs
AI/ML/algorithms
An evaluation of biometric monitoring technologies for vital signs in the era of COVID‐19
https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12874
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The authors, which provide an overview of BioMeTs available for collecting vital signs, discuss the variability around protocol for the verification, analytical validation, and clinical validation of BioMeTs and cite V3 as a means to identify high-quality BioMeTs. They also outline what it means to be "fit for purpose" per DiMe publication 'Modernizing and designing evaluation frameworks...'. Excerpt from the text: "The term “validation” or “validity” means that a BioMeT was tested according to a defined protocol to determine if its performance characteristics meet predefined criteria. A closely related term is “fit for purpose,” which means that a data collection method is adequate for its purpose and confirmed experimentally. The term “fit for purpose” is broader and may include validation parameters along with many other useful BioMeT characteristics, such as utility and usability, security risks, data protections, and economic feasibility that are beyond the scope of this paper and can be found elsewhere. It is also important to distinguish between “validation” and “evaluation” studies commonly found in the literature. Validation studies are conducted prior to product release to the market or use in a specific study; the validation testing is done according to predefined methods and parameters. In contrast, evaluation studies can be conducted any time, the evaluation criteria may not be defined before the experiment and may include any evaluation parameters of interest, such as accuracy or usability."
Cardiovascular Diseases
Agnostic
BioMeTs
An IoT framework for screening of COVID-19 using real-time data from wearable sensors
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8070194/
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors use DiMe's publication to discuss existing proposed methods for screening COVID-19. They build on DiMe's publication, in addition to others, to propose new ways of screening.
COVID
Wearables
An objective methodology for the selection of a device for continuous mobility assessment
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696193/
Digital measures that matter to patients
In the discussion around the limitations of this work, authors share that "Users (i.e., wearer, either patients or participants), which are the real stakeholders who will directly use this technology, did not participate in this questionnaire, which certainly represents the main limitation of this study." They referenced DiMe's Measures that Matter work, noting that " both patients and care partners should be engaged in the selection and development of digital mobility outcome solutions for identifying a solution that is effective, helpful, and improves both quality and efficiency in clinical research and care."
Agnostic
DHTs
Assessment of neonatal respiratory rate variability
https://link.springer.com/article/10.1007/s10877-022-00840-2
V3
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
The author's research is a result of data analyzed during systematic verification conducted within a device comparison study. As such, the authors note that if further research leverage the V3 framework, there may be future cross-comparable research on neonatal respiratory rate variability.
Neonatal Respiratory Rate
DHTs
Association Between In-Person vs Telehealth Follow-up and Rates of Repeated Hospital Visits Among Patients Seen in the Emergency Department
https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2797629
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort
Authors compare the results of DiMe's publication to that of another study, in addition to their own investigation. Excerpt from text: "More recent work has shifted to examining telehealth use in the acute care setting, which differs from chronic disease management in that clinicians are tasked to caring for discrete chief concerns rather than preventative measures around known chronic conditions. These studies have found different findings: a study by Li et al5 found that primary care clinics with higher percentage of telehealth usage were associated with increased rates of acute care visits, and a study by Hatef et al25 found that primary care telehealth visits for acute and chronic conditions were associated with increased ED encounters overall. Our study builds on this work by looking at post–ED discharge telehealth follow-up across conditions, controlling for patient characteristics as well as secular changes and COVID-19 surges. Unlike the aforementioned studies, in our primary model, we found an increased association between telehealth visits and subsequent hospitalizations, suggesting that the patients with telehealth follow-up who return to the ED might have greater illness severity when they arrive or possibly other medical or social circumstances that prevent ED physicians from being able to discharge them home."
Emergency Care
Telehealth
Automated semantic relevance as an indicator of cognitive decline: Out‐of‐sample validation on a large‐scale longitudinal dataset
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/dad2.12294
V3
Researchers followed the rigorous analytical and clinical validation best practices for “fit for purpose” algorithm development, as put forth by in V3, to evaluate a machine learning (ML) algorithm.
ADRD
AI/ML/algorithms
B cell receptor repertoire analysis in clinical context: new approaches for clonal grouping, intra-clonal diversity studies, and repertoire visualization
https://tel.archives-ouvertes.fr/tel-03482030/document
V3
Authors use DiMe's V3 framework to develop a "linear model of interdisciplinary communication to carry out the BCR repertoire analysis," including Verification, Analytical Validation, and Clinical Validation as steps in the model. Excerpt from the authors: "To adapt the V3 model to our context, we added two extra steps to cover the whole process of developing Rep-Seq tools from the initial idea to clinical validation, see dotted lines in Figure 6. The communication model proposed in Figure 6 is appealing to all experts involved in this process: mathematical or computational scientists and medical or biological specialists. The nature of Rep-Seq data can be intrinsically interesting to mathematical or computational scientists due to the complexity of the immune system’s behaviour and the modelisation complexities. It can also be engaging for medical and biological experts to respond to their research or clinical questions."
Agnostic
AI/ML/algorithms
Beyond the Therapist's office: Merging measurement-based care and digital medicine in the real world
https://www.karger.com/Article/FullText/517748
Digital measures that matter to patients
In the discussion around implementing digital tools in therapy, authors leverage concepts from DiMe's Measures that Matter work, noting that the "expansion of real-world measurements should be patient-focused, otherwise there is a risk of simply applying burdensome and ineffective traditional measurements in a digital format. Applying digital measures that matter to patients can help them define symptoms that affect activities, make sense of these symptoms in personal contexts, and gauge the degree of change that they need to make to experience meaningful change in their lives... The key in assuring clinical assessment value for patients (and clinicians) may be in the selection and relevance of real-world outcome metrics."
Mental Disorder
DHTs
BioMeT and algorithm challenges: a proposed digital standardized evaluation framework
https://ieeexplore.ieee.org/abstract/document/9103089
V3
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors included concept's from DiMe's V3 framework throughout the article, including: (1) the use of terminology standardized by V3 (2) the idea that there is a need to support knowledge exchange across a range of expertise and practical tools to help guide clinical staff to make well-informed decisions (3) the conclusion that structured evaluation frameworks are essential to ensure that 'going digital' is a trustworthy process. As a whole, the framework ultimately proposed aligned with V3, partly by involving authors of V3 in developing this new framework. Additionally, the authors reference DiMe work 'A systematic review of feasibilities studies' and listed several resources within the publication in the manuscript. In the evaluation of the resources gathered in DiMe's publication, the authors conclude that "future work must link engineering and computer science-based studies and developments with clinical trials that adopt the same technology as well as provide information regarding the successful use of BioMeTs in drug approval and/or use in clinical practice."
Agnostic
BioMeTs
Blockchain enabled tracking of physician burnout and stressors during the covid-19 pandemic
https://www.frontiersin.org/articles/10.3389/fbloc.2020.586742/full
Digital measures that matter to patients
In the authors discussion around ethical frameworks for data collection and study design of physician burnout, they reference DiMe's Playbook and Measures that Matter work, noting the four-step framework that should be used to think about physician burnout: "Meaningful aspect of health: The first step is identification of a disease process (physiological or psychological) that is negatively impacting the quality of life for a patient Concept of interest: Once a disease process is identified, the second step is to synthesize measurable element(s) or variable(s) from that meaningful aspect of health Outcome to be measured: The third step is to describe how to measure the variables and track them over time as active interventions are being applied. Endpoints: Th final step is capturing how the variables that we track respond to interventions that we introduced"
Mental Disorder
DHTs
Body-worn sensors for remote monitoring of parkinson's disease motor symptoms: vision, state of the art, and challenges ahead
https://pubmed.ncbi.nlm.nih.gov/33523020/
Digital measures that matter to patients
Authors use DiMe's Measures that Matter in the creation of a table outlining recent (2017-2020) work on remote monitoring of PD motor symptoms using body worn sensors: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385520/table/jpd-11-jpd202471-t001/
Parkinson's Disease
Neurological Disorders
Wearables
Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?
https://pubmed.ncbi.nlm.nih.gov/35034352/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9305159/
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Authors used content from DiMe's publication to offer examples of precompetitve collaborations.
Neurological Disorders
DHTs
Can Real-World Evidence Help Restore Decades of Health Inequalities by Informing Health Care Decision-Making? Certainly, and Here is How
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9241066/
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors used DiMe's publication to highlight how the new era of digital health have changed the type of evidence generated, and the subsequent changes in interaction with healthcare policy makers.
Agnostic
DHTs
Challenges and best practices for digital unstructured data enrichment in health research: a systematic narrative review
https://www.medrxiv.org/content/10.1101/2022.07.28.22278137v1
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Authors leverage DiMe's work in their systematic review of unstructured data enrichment in digital health research to highlight the current barriers to be addressed, specifically as it relates to including the patient perspective in research. They also spotlight DiMe's publication's case study on engaging regulatory agencies, noting that "the importance of engagement with regulatory agencies in early stages of research was emphasized to ensure alignment of unstructured data processing with best practices."
Agnostic
DHTs
Challenges and opportunities for advancing patient-centered clinical decision support: findings from a horizon scan
https://pubmed.ncbi.nlm.nih.gov/35534996/
mHealth and patient generated health data
In the authors' discussion about their results, they cite DiMe's work, which highlights some of the barriers to leveraging patient-generated health data (PGHD). Excerpt from the text: "The diversity of data types and devices used to collect PGHD presents a challenge when managing data across platforms. Standardized data elements are lacking for PGHD, hindering the seamless incorporation of PGHD into care, the pooling of data from multiple participants and data sets, and the consistent analysis and interpretation of PGHD."
Agnostic
DHTs
PGHD
Challenges of Incorporating Digital Health Technology Outcomes in a Clinical Trial: Experiences from PD STAT
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9398088/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors cite the recommendation from DiMe's work that "when selecting DHTs for use in trials, it is important to ensure the DHT is valid for assessment of the outcome of interest and can be feasibly deployed in the intended trial environment, including any costs for technology support or further development." Leveraging this recommendation in their protocol design, they note that "given the successful prior largescale use of BTT, we did not anticipate the problems we encountered with organisational firewalls and connectivity in study centres (which were mostly in NHS hospitals)—issues that were not found to be relevant to use of the measure in the home. Had we undertaken feasibility assessments across a few pilot sites, we may have identified these issues and built mitigation into the protocol. Implementing the PD Monitor within a study protocol that had already started meant that opportunities for robust feasibility testing were limited and some of the risk mitigation strategies (such as incorporating DHT reminders in the data-capture documentation) were not in place."
Parkinson's Disease
Neurological Disorders
DHTs
Change management and digital innovations in hospitals of five European countries
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8625074/
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
The authors leverage the DiMe publication to outline the opportunities and threats for digital innovations, specifically in the context of telemedicine and wearables. See the full table of opportunities and threats here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8625074/table/healthcare-09-01508-t008/?report=objectonly
Agnostic
DHTs
Clinical validation of a liquid chromatography-tandem mass spectrometry method for the quantification of calcineurin and mTOR inhibitors in dried matrix on …
https://www.sciencedirect.com/science/article/pii/S2667145X22000177
V3
Authors leverage concepts from the V3 Framework in designing the study's methodology. Excerpt from the text: "Clinical validation is concerned with patients receiving the right medical treatment based on laboratory test results. This procedure is intended to take a method that has undergone the bioanalytical validation step and evaluate whether it can be used for a specific clinical purpose before its implementation in the laboratory routine. For this reason, the equivalence between DMPD-based results and those obtained in WB should be demonstrated by a method comparison procedure. In this work, we assessed the feasibility of DMPD for therapeutic monitoring of four immunosuppressive drugs."
Agnostic
DHTs
Clinical validation of digital biomarkers and machine learning models for remote measurement of psoriasis and psoriatic arthritis
https://www.medrxiv.org/content/10.1101/2022.04.13.22273676v1
V3
The author's objective of this work was to "develop and clinically validate a suite of novel, smartphone sensor-based assessments that can be self-administered to measure cutaneous and musculoskeletal signs and symptoms of psoriatic disease," a using a component of the V3 framework.
Autoimmune Disorder
DHTs
Clinical Validation of the Medical Devices: A General Prospective
https://link.springer.com/chapter/10.1007/978-981-16-2782-8_11
V3
Authors reference several concepts from V3, including the definition of clinical evaluation and other terminology established by the framework. They tie in the V3 framework with other bodies of work focused on clinical validation to summarize current standards, opportunities, and challenges. Excerpt from text: "The goal of clinical validation is to demonstrate the device acceptably identifies, measures, or predicts the clinical, biological, physical, functional state, or experience in the defined context of use. In simple terms, the entire procedure provides a legal defense against the malpractices on the medical devices."
Agnostic
DHTs
Clinicians and Older Adults' Perceptions of the Utility of Patient-Generated Health Data in Caring for Older Adults: Exploratory Mixed Methods Study
https://pubmed.ncbi.nlm.nih.gov/34738913/
mHealth and patient generated health data
The authors, who are exploring the patient perception of PGHD, address DiMe's publication to showcase work contrary to their findings:"Patients display a natural tendency to please the doctor, and the older adults expressed fear and anxiety about the capacity of PGHD to highlight noncompliance with the care plan. As a result, it was perceived to have a negative impact on the patient-provider relationship. This finding expanded a recent interview study that called for the exploration of the unintended consequences of PGHD, which might include a feeling of failure or inadequacy on the part of healthcare consumers. However, our findings directly contradicted those of previous studies" Authors explore why their study may have had opposite results to DiMe's, and determine that the difference may be due to differences in the study population.
Agnostic
DHTs
PGHD
Clinicians' Perspectives in Using Patient-Generated Health Data to Improve Ischemic Heart Disease Management
https://pubmed.ncbi.nlm.nih.gov/35854732/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9285148/
mHealth and patient generated health data
Authors leverage DiMe's work to showcase the benefits of using PGHD in the context of Ischemic Heart Disease (IHD): "PGHD is a valuable source of information for IHD and can help in improving patient-provider communication, patient engagement, and support care decisions." The authors leverage takeaways from DiMe's publication throughout the study to apply learnings from that study to theirs.
Cardiovascular Diseases
PGHD
DHTs
Computerized migraine diagnostic tools: a systematic review
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8793115/
Digital Medicine: A Primer on Measurement
The authors use DiMe's Digital Medicine Primer in their conclusion to highlight the advantages of using digital medicine and opportunities specifically within the context of headache care. For example, "headache care providers can obtain a comprehensive, objective overview of the patient including real-time monitoring via sensors and diary recording."
Neurological Disorders
AI/ML/algorithms
Telehealth
Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures
https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/article/conducting-a-pediatric-randomized-clinical-trial-during-a-pandemic-a-shift-to-virtual-procedures/7C7A3696BA3461405ECA23C472AE952E
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID, noting, "Other sources present a theoretical basis of how digital clinical trials or telehealth-based research may be accomplished based on current clinical uses of digital technology [referencing DiMe's work in addition to other publications]. Here we describe procedural changes with regard to recruitment, screening, data collection, and regulatory study activities in a multicenter clinical trial focused on pediatric rural populations during the COVID-19 global pandemic."
Agnostic
Telehealth
DHTs
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
https://www.karger.com/Article/Abstract/525897
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Sensor Data Integration: A New Cross-Industry Collaboration
Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
The authors of this publication cite several DiMe resources, including V3, Digital Measures that Matter to Patients, The Playbook, and more, to (1) leverage a common language and (2) unite the resources together to build a scientific framework for demonstrating the clinical validity of novel digital measures and highlights key considerations for using some statistical methods. Given the challenges associated with using BioMeTs in clinical trials, the authors conclude that for- and nonprofit stakeholders would benefit from pre-competitive collaborations, and cites DiMe's Nocturnal Scratch project as an example of a partnership that is accelerating the adoption of novel BioMeTs in clinical trials.
Agnostic
BioMeTs
Considerations for Conducting Bring Your Own “Device”(BYOD) Clinical Studies
https://www.proquest.com/openview/636bbdc5c2970e253f771ae271c15605/1?pq-origsite=gscholar&cbl=2047985
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital measures that matter to patients
Advancing the Use of Mobile Technologies in Clinical Trials
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
DiMe Research Committee working group explores the potential, risks, and key considerations for organizations to consider when using a “BYOD” approach in clinical research. Authors leverage DiMe resources to apply industry standards to BYOD trials, showing how these trials require similar requirements to be successful. Check out DiMe's Resources in Action Hub to learn more about how the authors leverage DiMe resources.
DiMe Case Study: https://www.dimesociety.org/wp-content/uploads/BYOD-Research-Committee-DiMe-Case-Study-1.pdf DiMe journal club recording: https://www.youtube.com/watch?v=ZZveS2rxC8M
Agnostic
BYOD Tools
Considerations to address missing data when deriving clinical trial endpoints from digital health technologies
https://www.sciencedirect.com/science/article/pii/S1551714421003979
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
The authors acknowledge the previous work done to (1) derive clinical endpoints that are robust and reliable to enable regulatory decision-making ("Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials"), (2) validate those new digital endpoints (V3), and (3) support device selection and reliability of measures (The Playbook) to contextualize the need for how to deal with missing data.
Agnostic
DHTs
Constraints in clinical cardiology and personalized medicine: Interrelated concepts in clinical cardiology
https://www.mdpi.com/2035-8148/11/2/7/pdf
Digital Medicine: A Primer on Measurement
Authors highlight the benefits of using digital, as discussed in DiMe's Digital Medicine Primer, noting that for some, "digital health applications can offer new diagnoses and chances for novel treatment, but worldwide use of new digital health devices will need clinical trials to prove their usefulness."
Cardiovascular Diseases
DHTs
Deep phenotyping of Parkinson's disease
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202006
V3
Digital Medicine: A Primer on Measurement
In the author's discussion of the limitations associated with leveraging deep clinical phenotyping of PH, they note the additional work required to ensure validity. They cite DiMe's Digital Medicine Primer's definition of validation, which is the “process of ensuring that the digital measurement tool is meeting its intended use by generating objective data that accurately represents the concept of interest... that it purports to be measuring.” The authors continue the discussion, leveraging concepts from V3, to discuss the need for larger-scale studies and rigorous validation of novel digital measures is needed for PD. Further, they note that "the field should recognize that comparison against traditional measures may not be the best approach for such validation, particularly because many of the digital measures can be more accurate and sensitive than traditional “gold” standards."
Parkinson's Disease
DHTs
Designing a Social Marketing-Based Intervention to Promote Sun-protective Behaviors among Urban Adolescent Boys: A Study Protocol
https://ijcbnm.sums.ac.ir/article_48601.html
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors note that "after the development of the intervention package, the research team will seek to investigate the possibility of its implementation, including the "acceptance, demand, implementation, and practicality of the intervention package components will be evaluated," as recommended in DiMe's work.
Prevention
DHTs
Digital Health Applications
Detection and Monitoring of Viral Infections via Wearable Devices and Biometric Data
https://www.annualreviews.org/doi/abs/10.1146/annurev-bioeng-103020-040136
V3
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
Authors leverage DiMe's definition of digital medicine and use V3's definition of BioMeTs and highlight the framework as a best practice to ensure BioMeT accuracy. Leveraging concepts from other cited DiMe work, authors note that "it is also essential to determine whether a BioMeT is fit for purpose, in other words, that its data collection and processing methods are adequate for the BioMeT's intended purpose and that these functions have been confirmed experimentally. This determination may include assessing other useful BioMeT characteristics such as economic feasibility, security risks, data protections, utility, and usability, all of which are currently understudied areas."
Viral Infections
Agnostic
BioMeTs
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations
https://www.karger.com/Article/FullText/518024
V3
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
DiMe Library of Digital Endpoints
The authors propose measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and describe the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation, incorporating recommendations from the V3 framework in the proposal. Authors also recommend that future work leverages 'Considerations for development of an evidence dossier...' when providing evidence to "support the use of mobile sensor technology for COAs in clinical trials." Excerpt from the text: "According to the V3 framework, besides the technical verification, the sleep sensor should be analytically validated against a PSG reference and its accuracy and reliability determined to measure sleep in this RA population. Suppose the sensor is only validated in the healthy population. In that case, additional analytical validation will need to be conducted to demonstrate the sensitivity and specificity of the measurements in the population of interest."
Autoimmune Disorder
DHTs
Development of novel, value-based, digital endpoints for clinical trials: a structured approach toward fit-for-purpose validation
https://pharmrev.aspetjournals.org/content/72/4/899
Advancing the Use of Mobile Technologies in Clinical Trials
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The authors leverage several DiMe publications to showcase the value of precompetitive collaboration. They also reference DiMe's systematic review of feasibility studies, organizing the publication results in a table that outlines devices and candidate digital endpoints for use in clinical trials outside of clinical units. Referencing DiMe's work on validating endpoints, the authors note the need to technically and analytically validate novel value-based endpoints before they can be accepted by clinicians or regulators, and that digital endpoints may require a more focused and pragmatic approach.
Agnostic
DHTs
Digital Biomarker
Development of Smart Healthcare Web System using PWA with AI: A Review of Related Literature
https://www.researchgate.net/publication/360042756_Development_of_Smart_Healthcare_Web_System_using_PWA_with_AI_A_Review_of_Related_Literature
mHealth and patient generated health data
Authors included DiMe's publication in their literature review on a smart healthcare web system using emerging technologies, Progressive Web Applications, and Artificial Intelligence. DiMe's publication was relevant in addressing "accuracy" and "security and privacy" concerns when implementing AI and PWA in healthcare.
Agnostic
AI/ML/algorithms
PGHD
DHTs
Diagnostic Features and Potential Applications of PPG Signal in Healthcare: A Systematic Review
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8950880/
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's work to showcase different PPG waveforms and their applications based on the health domain: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8950880/table/healthcare-10-00547-t003/?report=objectonly And when showcasing specific applications of PPG signal in healthcare in each domain: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8950880/table/healthcare-10-00547-t004/?report=objectonly
Agnostic
DHTs
Digital approaches to enhancing community engagement in clinical trials
https://www.nature.com/articles/s41746-022-00581-1
Digital measures that matter to patients
Authors referenced DiMe's Measures that Matter work to highlight the benefits of engaging patients in the clinical trial development process: "Community engagement processes have contributed to the successful implementation of trials by helping to identify digital health measures that are relevant to patients and communities, and address barriers to recruitment and implementation of trial components"
Agnostic
DHTs
Digital Biomarkers in Psychiatric Research: Data Protection Qualifications in a Complex Ecosystem
https://www.frontiersin.org/articles/10.3389/fpsyt.2022.873392/full
Digital Medicine: A Primer on Measurement
Advancing the Use of Mobile Technologies in Clinical Trials
Remote Digital Monitoring for Medical Product Development
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors leveraged the terminology and conclusions made from several DiMe resources to effectively discuss "the GDPR legal qualifications of controller, processor, and joint controllers in the complex ecosystem unfolded by the integration of digital biomarkers in psychiatric research, considering their implications and proposing some general practical recommendations." They also thread DiMe's publications throughout the text to confirm their claims (e.g., the potential of biomarkers, the need for rigorous validation for regulatory approval, etc.)
Pyschiatry
Digital Biomarker
Digital endpoints: Definition, benefits, and current barriers in accelerating development and adoption
https://www.karger.com/Article/FullText/517885
Digital Medicine: A Primer on Measurement
DiMe Library of Digital Endpoints
The authors, who seek to unify the field on definitions, considerations, challenges, and opportunities surrounding endpoints, use DiMe's Library of Endpoints to contextualize the increased use of digital endpoints. Authors access the library and selected examples to demonstrate the "broad set if contexts in which digital endpoints are employed and for their relatively recent initiation dates." The authors also leverage DiMe's Digital Medicine Primer to provide examples of how digital endpoints can be leveraged.
Agnostic
DHTs
Digital Health Technologies for Medical Devices–Real World Evidence Collection–Challenges and Solutions Towards Clinical Evidence
https://ijdigitalhealth.com/articles/10.29337/ijdh.49/
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors leverage DiMe's systematic review to showcase the potential benefits of DHTs, and outline the need for "feasibility/pilot studies before starting a clinical trial, with the overall goal of reducing risk by assessing sensor accuracy, developing and/or validating algorithms and optimizing data quality." They also leverage learnings from DiMe's publication on advancing digital health applications through Germany's Fast-Track pathway. They highlight an example from Pear Therapeutics, as outlined in DiMe's work.
Agnostic
RWD
DHTs
Digital health technology for non-motor symptoms in people with Parkinson's disease: Futile or future?
https://www.sciencedirect.com/science/article/abs/pii/S1353802021002819
V3
Authors leverage the V3 framework in their discussion of digital monitoring of non-motor symptoms (NMS) in Parkinson's Disease (PD). They note that a "consensus to evaluate the quality and usefulness of digital devices, including but not limited to clinical utility, user experience, and governance for collection" is required. They continue on to cite DiM'es a three-step approach (e.g., verification, analytical validation, and clinical validation), incorporating the framework in their review of digital health technology for NMS. Authors ultimately determined that the identified studies align to the clinical validation step. They note that "some evidence presented here is based on indirect markers for specific NMS based on motor outcomes. Nonetheless, such markers (mostly bradykinesia and dopaminergic by default) of NMS based on wearable and objective motor measures, might be a good starting point to improve at least some NMS in PD."
Neurological Disorders
Parkinson's Disease
DHTs
Digital health technology to measure drug efficacy in clinical trials for Parkinson's disease: a regulatory perspective
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202416
V3
Authors from FDA's Office of Medical Policy's Center for Drug Evaluation and Research cite V3 when discussing the decisions to choose the most useful combinations of measurements, sensors, tests and algorithms, given the number of available options. They begin by noting that the "first goal is to obtain measurements that have been demonstrated to be accurate and reliable over time and across patients... For the approval of drugs, the Food, Drug and Cosmetic Act requires that substantial evidence of effectiveness be provided. They affirm that, to satisfy this need for evidence, DHTs need well-defined assessment of a patient’s response to treatment. The authors note the importance of verification and validation, citing V3 when stating that "analytical validation and clinical validation ensure the reliability of algorithms that translate accelerometry or other sensor readings into clinical observations (e.g., tremor, falls, steps)." The citation of V3 suggests that the effective use of this framework should result in the evidence required for using DHTs for PD.
Neurological Disorders
Parkinson's Disease
DHTs
Digital health; what do we mean by clinical validation?
https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2012447
V3
The authors of this publication apply the V3 framework in the context of digital health solutions, suggesting that the framework should be used to understand the safety, effectiveness, and efficacy of digital health solutions to ensure that technologies reflect the patient and healthcare provider’s needs, safely.
Agnostic
DHTs
Digital phenotyping adherence, feasibility, and tolerability in outpatients with schizophrenia
https://www.sciencedirect.com/science/article/abs/pii/S0022395621002491
V3
Authors of this study note the "critical methodological factors that must be addressed before digital phenotyping can be used for [symptom assessment in clinical trials for schizophrenia]." The study evaluated adherence, feasibility, and tolerability for active and passive digital phenotyping methods recorded from smartphone and smartband devices. Given the study's limitations, the authors conclude with a set of recommendations for the design and implementation of digital phenotyping in schizophrenia, including the examination of passive data streams using the V3 Framework.
Mental Disorder
DHTs
Wearables
Digital progression biomarkers as novel endpoints in clinical trials: A multistakeholder perspective
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202428
V3
Digital measures that matter to patients
Remote Digital Monitoring for Medical Product Development
The authors, aim to which identify opportunities to advance this field forward in accelerated ways through the publication, note the advanced analytics and rigor required when monitoring patients outside the lab, and the significant value in clinical decision-making and clinical trials such data can provide. They cite the critical need for analytical and clinical validation of digital biomarkers (e.g., the V3 framework) as necessary to ensure that clinical and healthcare decisions are not at scrutiny if machine learning algorithms fail to work as intended. They also note that it is pivotal to develop DHTs with patient-centricity at the core and reference DiMe's measures that matter work as a framework - and imperative - to guide future researchers.
Parkinson's Disease
DHTs
Digital Biomarker
Digital resilience biomarkers for personalized health maintenance and disease prevention
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8521930/
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Authors use DiMe's Digital Medicine Primer's definitions. They also use DiMe's Measure that Matter work to discuss meaningful measures in the context of personalized health maintenance and disease prevention. Authors determine that it is "relevant to be able to measure an intervention effect, for example, dietary change, exercise, stress coaching, or nutritional supplementation. While for some of these types of interventions, there may be clear effects on specific variables (e.g., bodyweight reduction with a weight loss program), the effects of most interventions are subtle and focused on the long term (e.g., increasing vegetable intake to improve immune health)." The authors then evaluate biomarkers that measure what matters to patients, citing DiMe's publication on this topic.
Prevention
Digital Biomarker
Digitalisation in Clinical Trials: trends in connected sensor technology use
https://studenttheses.uu.nl/handle/20.500.12932/587
Digital measures that matter to patients
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
DiMe Library of Digital Endpoints
The author used DiMe's Library of Digital Endpoints and PubMed to identify studies on connected sensor technologies in which the product type was "drug" and "biologic," and compare data from those studies in aggregate and over time. The author uses this data throughout the paper, discussing how DiMe work can be applied to various endpoints.
Agnostic
DHTs
Digitally enabled, patient‐centric clinical trials: shifting the drug development paradigm
https://pubmed.ncbi.nlm.nih.gov/33048475/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993267/
Digital Medicine: A Primer on Measurement
In a discussion around the benefits of digital biomarkers, authors reference DiMe's Digital Medicine Primer to note that digital biomarkers, including novel endpoints, "are amenable to at‐home measurement and can be measured on a near‐continuous basis, enabling the potential for more frequent, objective, and sensitive measures of disease progression and of the ability of INDs to treat or modify the course of the disease."
Agnostic
Digital Biomarker
Discovering Digital Biomarkers of Glycemic Health from Wearable Sensors
https://www.proquest.com/openview/eb4bdaeffa29f503cd272ad851b1df67/1?pq-origsite=gscholar&cbl=18750&diss=y
V3
Authors use the V3 framework to investigate sources of inaccuracy in wearable optical heart rate sensors.
Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9157265/
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
The authors leverage the results from the IMPACT-AFib trial to outline the effect of mailing education materials to patients with Atrial Fibrillation.
Cardiovascular Diseases
DHTs
Electronic health record implementation and healthcare workers' work characteristics and autonomous motivation—a before-and-after study
https://pubmed.ncbi.nlm.nih.gov/35505319/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9063104/
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
The authors of this publication aim to go beyond the "existing work on technology implementation, which tends to focus on specific groups of workers," as is the topic of DiMe's publication. They build on concepts from DiMe's publication to inform their study's methodology, and leverage the work in the discussion of their findings.
Agnostic
EHR
Emerging Role of Translational Digital Biomarkers Within Home Cage Monitoring Technologies in Preclinical Drug Discovery and Development
https://www.frontiersin.org/articles/10.3389/fnbeh.2021.758274/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Behavioral_Neuroscience&id=758274
V3
In the discussion around the emerging role of translational digital biomarkers within home cage monitoring technologies in preclinical drug discovery and development, authors leverage definitions from V3 in the introduction to first align readers on the important terminology related to digital biomarkers. Next, authors discuss the importance of V3 in the "Limitations and Barriers to Implementation" section of the text, noting that the "early and careful consideration of [Technology Verification and Validation] will help ensure successful implementation of DB technologies." The authors outline the importance of technical verification and clinical/ analytical validation, recommending a robust assessment of reliability, reproducibility, and usability.
Agnostic
Digital Biomarker
Enabling technologies daily nursing work and its practical implications
http://www.ijmp.jor.br/index.php/ijmp/article/view/1525
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
In this literature review of the main technologies used by nursing professionals and their impacts on work, the authors review DiMe's publication, using the main takeaways in concert with the other reviewed literature to come to their conclusion on the topic.
Agnostic
DHTs
Engineering digital biomarkers of interstitial glucose from noninvasive smartwatches
https://www.nature.com/articles/s41746-021-00465-w
V3
The authors, who demonstrated the feasibility of using noninvasive DHTs to detect glucose deviations and predict interstitial glucose value in real time, discussed the V3 Framework in the context of future work needed to successfully leverage DHTs in this context. The authors "recommend the evaluation of this technology following the V3 (verification, analytical validation, and clinical validation) framework," noting that through this study, they focused solely on feasibility, but that "follow up studies are needed to clinically evaluate this technology."
Diabetes
DHTs
Wearables
Estimating sleep stages using cardiorespiratory signals: validation of a novel algorithm across a wide range of sleep-disordered breathing severity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314617/
V3
The authors performed an analytical validation study, one phase of V3, and noted the necessity of completing another validation study should CReSS be deployed in another context. Excerpt from the text where authors cite V3: "The flexibility of CReSS to be deployed across a range of devices and minimally invasive signal types may be advantageous as a means to enhance the efficiency of clinical trials requiring sleep staging as a screening tool, covariate, or endpoint, which would require additional validation data in the intended research population(s)."
Sleep
Evaluating evaluation frameworks: a scoping review of frameworks for assessing health apps
https://www.semanticscholar.org/paper/Evaluating-evaluation-frameworks%3A-a-scoping-review-Lagan-Sandler/3580f944f6135c0676137c70928b54b2834b6441
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors review DiMe's work, among other frameworks, to understand what aspects are considered in existing evaluation frameworks to create a new framework endorsed by the American Psychiatric Association (APA).
Agnostic
Pyschiatry
Digital Health Applications
Evaluation frameworks for digital nursing technologies: analysis, assessment, and guidance. An overview of the literature
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369663/
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors use DiMe's work in an evaluation of digital technologies related to nursing. By evaluating frameworks, the authors aim to showcase "comprehensive evaluation frameworks that can be applied to the field of DNT." Results of evaluation: "Eighteen relevant comprehensive evaluation frameworks for DNT were identified. Nine overarching evaluation areas, seven categories of purposes, five evaluation perspectives and three categories of success definitions could be identified. Eleven quality criteria for the strengths and weaknesses of DNT-related evaluation frameworks were developed and the included frameworks were assessed against them."
Agnostic
DHTs
Evaluation of speech-based digital biomarkers for Alzheimer's disease
https://winterlightlabs.com/assets/publications/CTAD_2020_AD_evaluation.pdf
V3
Based on this V3 framework, authors summarize the components of evaluation of speech-based biomarkers in the subcategories: verification, analytical validation, and clinical validation. For each, authors briefly define the evaluation step, discuss how it could be applied in the context of speech-based biomarkers, and review applicable examples. See a visual summary of the paper here: https://winterlightlabs.com/assets/publications/CTAD_2020_AD_evaluation.pdf
ADRD
Digital Biomarker
Evaluation of speech-based digital biomarkers: review and recommendations
https://www.karger.com/Article/Abstract/510820
V3
Digital Medicine: A Primer on Measurement
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
This paper outlines and provides examples from the literature of evaluation steps for speech-based digital biomarkers based on the V3 framework. "In recent papers, members of the Digital Medicine (DiMe) society have proposed a framework and common vocabulary for the evaluation of digital biomarkers. This rigorous framework provides an excellent resource for researchers developing digital health tools, and adherence to a common vocabulary will allow for more consistency across evaluation studies. Based on this V3 framework [9], we summarize the components of evaluation of speech-based biomarkers in the subcategories: verification, analytical validation, and clinical validation. For each, we briefly define the evaluation step, discuss how it could be applied in the context of speech-based biomarkers, and review applicable examples"
Agnostic
Digital Biomarker
Evaluation, acceptance, and qualification of digital measures: from proof of concept to endpoint
https://www.karger.com/Article/Abstract/514730
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Remote digital monitoring in clinical trials in the time of COVID-19
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Remote Digital Monitoring for Medical Product Development
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
The authors build on the work done in V3, 'Modernizing and designing evaluation frameworks for connected sensor technologies in medicine,' and other frameworks by providing examples of digital health measurement tools, and the key decisions, challenges, and considerations at different stages of implementing these tools. Given the lack of a common, broadly accepted lexicon describing digital medicine, authors use and promote the language and concepts codified in 'Digital Measurement Primer on Measurement' and 'Digital Measures That Matter to Patients' to decrease the confusion associated with developing digital measures of health. In all, this article uses several DiMe resources as the foundation to provide strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.
Agnostic
EVIDENCE publication checklist for studies evaluating connected sensor technologies: explanation and elaboration
https://www.karger.com/Article/Abstract/515835
V3
Digital Medicine: A Primer on Measurement
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital measures that matter to patients
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
The EVIDENCE checklist was developed by a group of multidisciplinary experts convened by the Digital Medicine Society to equip those preparing, reading, or reviewing studies evaluating digital measurement products to better distinguish necessary reporting requirements to drive high-quality research. In developing the EVIDENCE Checklist, the authors outline 5 types of evaluations to which EVIDENCE can be applied: (1) proof of concept; the V3 framework consisting of (2) verification, (3) analytical validation, and (4) clinical validation; and (5) utility and usability assessments. The authors heavily use concepts from V3 throughout the article and build on V3's reporting requirements. Further, the use of DiMe's V3 framework in this publication allows the authors to provide concrete examples of when the checklist can be used. Other DiMe publications, such as the Primer on Measurement, are used as foundational bodies of work upon which the EVIDENCE Checklist is built on.
Agnostic
BioMeTs
Exploring clinical applications for a novel multi-task functional assessment: matching appropriate technology to clinical need
https://orca.cardiff.ac.uk/id/eprint/150165
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
The authors provide details on DiMe's feasibility study, which they say highlights "the increasing importance of such systems and the need for clinicians, engineers, and other study stakeholders to work together to provide adequate solutions and so continue to drive forward research."
Agnostic
DHTs
Exploring inertial-based wearable technologies for objective monitoring in sports-related concussion: a single-participant report
https://academic.oup.com/ptj/article/102/5/pzac016/6534728
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
The author explores the challenges and opportunities associated with wearable technology related to sports-related concussion assessments. Authors note one advantage of remote evaluations, including the opportunity for habitual monitoring of a variety of individualized digital (bio)makers, such as gait and sleep, as referenced in V3. Further, the author notes the specialized training and prior experience required to process data, and the need for "no-code" software that clinicians or non-technically skilled researchers can easily use, as outlined in "Fit-for-Purpose Biometric Monitoring Technologies: leveraging the laboratory biomarker experience" and "BioMeT and algorithm challenges: a proposed digital standardized evaluation framework."
Sport-related concussions
Wearables
Exploring the safety, effectiveness, and cost-effectiveness of a Chinese patent medicine (Fufang E'jiao syrup) for alleviating cancer-related fatigue: a protocol for a …
https://pubmed.ncbi.nlm.nih.gov/33834863/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
In this study, the authors referenced the "Remote monitoring in clinical trials during the COVID-19 pandemic" paper, noting they "managed to put up more recruitment advertising and increase screening work to accelerate patients’ enrollment and utilized online remote techniques to communicate with patients and express delivered their research materials to reduce the risk of lost follow-up."
Oncology
AI/ML/algorithms
Final version on guidance tools on data/sample sharing and use
https://www.imi-neuronet.org/wp-content/uploads/2022/03/NEURONET_D3.7_v1.0-Final-Version.pdf
Digital measures that matter to patients
The authors outline the necessary considerations when working with neurodegenerative disorders real-world data (ND-RWD), noting that understanding the patients' motivations are a critical step in the research process, a concept from DiMe's Measures that Matter work. They also note the components of effective patient engagement, also a concept from DiMe's work.
Neurological Disorders
RWD
Fit‐for‐purpose biometric monitoring technologies: leveraging the laboratory biomarker experience
https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1111/cts.12865
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
The authors of this publication summarized and leveraged historical perspectives, and lessons learned from laboratory biomarkers as they apply to BioMeTs with the goal of developing a common framework, appropriate vocabulary, and standardized approaches to evaluate digitally measured biomarkers. The V3 framework was leveraged to compare digital and laboratory biomarkers in an adapted figure that highlights the common features of both. This figure is used to frame the conversation around how digitally measured and conventional laboratory biomarkers share a common foundation.
Agnostic
BioMeTs
Five-Step Action Plan to Implement Your PGHD Strategy
https://evidation.com/resources/five-step-action-plan-to-implement-your-pghd-strategy-leveraging-person-generated-health-data-pghd-to-deliver-actionable-insights
Digital measures that matter to patients
In Evidation's article on "Five Actionable Insights to Aid in Collection and Use of PGHD," they cite DiMe's Measures that Matter work in the 'Evidence-Based Study Design to Ensure Collection of High Quality Data' section, noting that "Selecting objectives and asking questions that are important to patients."
Agnostic
DHTs
Gait analysis in neurological populations: Progression in the use of wearables
https://www.sciencedirect.com/science/article/abs/pii/S1350453320301697
V3
In a narrative review about the current technology for gait assessment, authors describe the evolution of the field and provide limitations and future recommendations for gait assessment. Authors note that "validity (and reliability) of wearables for robust gait analysis of neurological conditions is crucial for clinic and free-living assessment and of great importance as the field matures," and subsequently explain the appropriateness of the V3 framework in the context of gait analysis. They go on to conclude that "wearable validation studies should adopt the V3 approach of clearly presenting verification (bench testing), analytical validation (efficiency and accuracy of sample-level sensor measurements into physiological metrics) and clinical validation (acceptably identifying or measuring clinically meaningful outcomes in a stated context of use with a predefined disease/condition) approaches within standalone or within a series of research output/papers." They determine that processes such as V3 "will aid the next wave of targeted gait assessment in the home and community where so many environmental unknowns will complicate interpretation of gait outcomes from high resolution, multi-model sensing."
Neonatal Respiratory Rate
Wearables
Gender blindness: On health and welfare technology, AI and gender equality in community care
https://www.researchgate.net/publication/351536208_Gender_blindness_On_health_and_welfare_technology_AI_and_gender_equality_in_community_care
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors leverage DiMe's work to highlight the unintended consequences of new digital solutions. Excerpt from the text: "[managers] often fail to procure new digital solutions that are compatible with legacy systems and technological solutions that are already embedded. This, in turn, results in that care workers frequently need to resort to workarounds, “invisible work,” which is largely performed by women."
Agnostic
DHTs
Identifying and characterising sources of variability in digital outcome measures in Parkinson's disease
https://www.nature.com/articles/s41746-022-00643-4
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
The authors cite the DiMe publication when using a three-part measurement process for both active and passive approaches. Detailed descriptions of each factor included in the three distinct phases, namely data acquisition, management, and analysis, are included in the following table: https://www.nature.com/articles/s41746-022-00643-4/tables/2
Parkinson's Disease
Neurological Disorders
DHTs
Implementation of wearable sensing technology for movement: Pushing forward into the routine physical rehabilitation care field
https://www.mdpi.com/1424-8220/20/20/5744
V3
Authors leverage V3 to contextualize the current situation with wearable device systems. They say, "Using terminology set out in the V3 framework, the problem is not in the verification of the sensor itself, but rather lies in the analytic and clinical validation of the algorithm. People seeking rehabilitation services often do not move normally, such that the algorithms programmed into consumer-grade devices are inaccurate in identifying or quantifying their movement." They also leverage V3 when discussing the lack of standardization of output variables to date, noting, "Beyond the verification of sensor signals, variables must first demonstrate reliability, or consistency of results obtained, indicating that one can trust that the obtained value is stable. Validity is the second hurdle, with multiple layers of validity."
Musculoskeletal Disorders
Wearables
Implementing Digital Technologies in Clinical Trials: Lessons Learned
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9341314/
DiMe Library of Digital Endpoints
Authors use DiMe's Library of Endpoints to contextualize the use of digital endpoints in clinical trials at present.
Agnostic
DHTs
Insights into the Use of Digital Tools for People with Mental Health Disorders
https://pubmed.ncbi.nlm.nih.gov/34382865/
Digital Medicine: A Primer on Measurement
The author uses DiMe's Digital Medicine Primer's definition of digital medicine to outline the potential it has to transform the delivery of clinical practice. The author leverages concepts from the Primer, noting that digital medicine provides "objective, data-driven insights into patient behaviors... [and] empowers patients and health care providers with intelligent and accessible tools to address a wide range of conditions through high-quality technology, effective measurements, and data-driven interventions." The author continues on to outline existing work and the promise of using digital medicine to manage mental illness.
Mental Disorder
DHTs
Integrating Patient-Generated Digital Health Data into Electronic Health Records in Ambulatory Care Settings: An Environmental Scan
https://www.researchgate.net/profile/Gloria-Porter/publication/356105655_Environmental_Scan_Report_Integrating_Patient-Generated_Digital_Health_Data_into_Electronic_Health_Records_in_Ambulatory_Care_Settings_An_Environmental_Scan/links/618be95961f09877207a85e7/Environmental-Scan-Report-Integrating-Patient-Generated-Digital-Health-Data-into-Electronic-Health-Records-in-Ambulatory-Care-Settings-An-Environmental-Scan.pdf
mHealth and patient generated health data
The authors identified resources from the literature that may serve as exemplars in integrating PGHD into ambulatory care settings. Leveraging DiMe's work, they present stakeholders' perspectives on a broad range of PGHD types (including biometric and PRO data) and describe the six themes and a number of values and barriers outlined in DiMe's publication. They also use DiMe's work to showcase the opportunities and barriers to adopting PGHD and apply it to the context of ambulatory care settings.
Emergency Care
EHR
PGHD
It takes a village: development of digital measures for computer scientists
https://dl.acm.org/doi/10.1145/3469266.3470465
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors leveraged DiMe resources, including 'Digital Medicine: A Primer on Measurement,' to present critical terms related to digital measures in a unified lexicon to aid people from data-orientated backgrounds apply their skills in a clinical setting. Additionally, 'Digital Measure that Matter to Patients' was leveraged to draw a connection between non-healthcare product development and healthcare product development for computer scientists.
Agnostic
DHTs
Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative
https://pubmed.ncbi.nlm.nih.gov/32913915/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473867/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors reference DiMe's work in their discussion around the meaningfulness of measurements to patients, noting these measurements "should be identified before deciding which (and whether) digital health technology should be used. If the use of digital health technology is determined to be appropriate for a trial, technology selection should be based on the requirements of the study and the needs of the intended user population." Additionally, the authors leverage DiMe's publication when discussing protocol: "When developing the protocol, it is also critical to consider the unique concerns pertaining to the use of digital health technologies from the perspectives of a variety of stakeholders, including regulators, site staff, investigators, and participants. The protocol should address safety signals not previously observed using traditional protocol design and monitoring, as well as data collected and observed by the study participant in the absence of context provided by clinicians"
Agnostic
PGHD
DHTs
Leveraging digital medicine to support providers and their patients in managing serious mental illness
https://pubmed.ncbi.nlm.nih.gov/34382864/
Digital Medicine: A Primer on Measurement
The author uses DiMe's Digital Medicine Primer's definition of digital medicine and provide examples of tools that qualify as digital medicine. They use this definition to discuss the existing use of digital medicine in mental healthcare and opportunities to leverage it further.
Mental Disorder
DHTs
Measuring Health-Related Quality of Life With Multimodal Data
https://www.jmir.org/2022/5/e35951/
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Sensor Data Integration: A New Cross-Industry Collaboration
Multimodal biometric monitoring technologies drive the development of clinical assessments in the home environment
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Experts from the field of digital health were convened as part of a multi-stakeholder workshop to examine the progress of multimodal digital measures in two key areas: detection of disease and the measurement of meaningful aspects of health relevant to the quality of life. The article outlines the workshop, highlighting several DiMe publications. For example, panelists use definitions from 'Digital Medicine: A Primer on Measurement' to align readers on key terms. Additionally, the framework to evaluate the meaningfulness of digital measures in 'Digital measures that matter to patients' is discussed to focus efforts around the most meaningful and valuable candidate measures. DiMe's cross-industry collaboration, namely the Sensor Data Integrations project, is cited as a critical component to scale and efficiently evaluate innovations.
Agnostic
DHTs
Mechanobiology of the female reproductive system
https://onlinelibrary.wiley.com/doi/full/10.1002/rmb2.12404
V3
Authors discuss the V3 framework in the context of future work needed. They note that to generalize the findings to the clinic, V3 process is essential. Authors discuss the challenges associated with completing the V3 in the study of the human female reproductive system due to a lack of high-quality multiscale experimental data.
Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson's Disease
https://pubmed.ncbi.nlm.nih.gov/35336307/
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
A companion paper to 'Identifying and characterising sources of variability in digital outcome measures in Parkinson's disease,' this perspectives paper "proposes a metadata framework that divides the DHT metadata into metadata that is independent of the therapeutic area or clinical trial design (concept of interest and context of use), and metadata that is dependent on these factors." Again, the authors leverage the three-part measurement process, also used in the companion paper, to propose their metadata framework.
Parkinson's Disease
Neurological Disorders
DHTs
Mobile Health: making the leap to research and clinics
https://www.nature.com/articles/s41746-021-00454-z
DiMe Library of Digital Endpoints
The authors use DiMe's Library of Endpoints to provide an example of data sharing in healthcare to support their proposed resource sharing to accelerate mHealth adoption.
Agnostic
Digital Health Applications
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
https://www.nature.com/articles/s41746-020-0237-3
V3
The authors outline emerging to evaluate digital health, highlighting their strengths and shortcomings with reference to the connected sensor technologies industry, and, building on these frameworks as a guide, they outline a practical guide for evaluating fit-for-purpose connected products across biomedical research and clinical care. The authors offer five dimensions that carry risks posed by connected sensor technologies: (1) validation, (2) security practices, (3) data rights and governance, (4) utility and usability; and (5) economic feasibility. The first dimension, validation, is based on DiMe's V3 Framework, which is outlined in the author's manuscript.
Agnostic
BioMeTs
Moving forward from the COVID-19 pandemic: needed changes in movement disorders care and research
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8809223/
Remote digital monitoring in clinical trials in the time of COVID-19
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
In the authors' discussion around future work that needs to be done, they cite DiMe's work on precompetitive collaborations, noting that "among others, the barriers include the complexity and shear amount of raw data, challenges in validation, concerns regarding adherence, acceptability to regulatory agencies, constantly changing technology, and challenges integrating data. Pre-competitive collaborations, such as those led by the Digital Medicine Society and Critical Path for Parkinson’s, may help to streamline and efficiently advance the development of new digital tools and endpoints." Authors also cite DiMe's work on remote digital monitoring, noting that few clinical trials actually use digital endpoints.
Agnostic
DHTs
Oral anticoagulant underutilization among elderly patients with atrial fibrillation: insights from the United States Medicare database
https://pubmed.ncbi.nlm.nih.gov/35804258/
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
In the authors' discussion of their results, they outline the results of relevant publications, including DiMe's work, to compare and contrast their findings.
Cardiovascular Diseases
DHTs
EHR
Personalized therapies in the Future of Health
https://www2.deloitte.com/us/en/insights/industry/life-sciences/importance-of-personalized-therapies.html
DiMe Library of Digital Endpoints
In the authors discussion around the product development life cycle in drug development, they note that "clinical development and digital teams should have access to internal and external libraries of validated electronic clinical outcomes assessments (eCOAs)," such as DiMe's Library of Digital Endpoints. They say that "access to such libraries could be an important starting point for developing digital therapeutics, as the efficacy of a digital therapeutic could be measured by the same or similar endpoints."
Agnostic
DHTs
Piloting the clinical value of wearable cardiorespiratory monitoring for people with cystic fibrosis
https://www.medrxiv.org/content/10.1101/2020.07.27.20151589v1.full-text
V3
The authors of this publication performed a feasibility study to evaluate the use of a cardiorespiratory monitoring wearable, which has a modular design to enable iterative optimization. They leverage V3, noting that "this is important to ensure it can become fit-for-purpose, while still adhering to verification, analytical and clinical validation (V3) requirements as a clinical care and drug development tool." Thus, the authors "collected data were examined a posteriori for patterns that might be interesting digital biomarker candidates."
Cardiovascular Diseases
Wearables
Precompetitive consensus building to facilitate the use of digital health technologies to support parkinson disease drug development through regulatory science
https://www.karger.com/Article/Abstract/512500
V3
Digital measures that matter to patients
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
DiMe Library of Digital Endpoints
Authors of this article review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies, such as DiMe. The authors use DiMe as a case example illustrating how pre-competitive collaborative activities are being employed efficiently to address challenges in the field. The authors explore the benefit of DiMe's pre-competitive nature and highlight impactful work, such as V3.
Parkinson's Disease
Agnostic
DHTs
Predicting Changes in Depression Severity Using the PSYCHE-D (Prediction of Severity Change-Depression) Model Involving Person-Generated Health …
https://mhealth.jmir.org/2022/3/e34148/
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
In the authors' discussion around the limitations of their work, they note that the performance of their algorithm was below expectations. As such, they plan to perform further validation with independently generated data (as recommended in DiMe's work), building off their existing work to improve performance.
Pyschiatry
AI/ML/algorithms
Quantifying the Benefits of Digital Biomarkers and Technology-Based Study Endpoints in Clinical Trials: Project Moneyball
https://www.karger.com/Article/Abstract/525255
V3
Digital measures that matter to patients
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
DiMe Library of Digital Endpoints
The authors of this publication identified "five gaps for pharmaceutical sponsors and technology providers to address in the ecosystem of digital biomarkers." The first, which focused on gaps in evidence requirements, is based on DiMe's V3 framework. "Digital biomarker development follows the V3 (verification, analytical validation, and then clinical validation) process. Clinical validation is often the most resource-consuming step and needs drug development sponsor engagement. The third gap focuses on the shortage of technical expertise and/or mistakes made to assume that fast technology development cycles in the consumer IT world translate to regulated health devices, which draws from a DiMe research committee paper "Defining and Developing the Workforce Needed for Success in the Digital Era." These DiMe resources are leveraged to allow authors to isolate the issues they want to talk about more specifically - namely, uncertainties in clinical study impact and the lack of a common value framework in multiparty technology collaborations.
DiMe journal club recording: https://www.youtube.com/watch?v=oo_pXXxw9R8&feature=youtu.be
Parkinson's Disease
Digital Biomarker
Racial discrepancies in oximetry: where do we stand?
https://www.researchgate.net/profile/Matthew-Knight-11/publication/356620177_Racial_discrepancies_in_oximetry_where_do_we_stand/links/61adea6150e22929cd4eb8ed/Racial-discrepancies-in-oximetry-where-do-we-stand.pdf
V3
The authors, who discuss racial discrepancies in oximetry, leverage V3 in the discussion around regulations. They note that, "Patients, consumers and clinicians alike should be able to see how medical devices are validated to verify that sensors work, algorithms are validated against a defined standard and devices are clinically validated in defined populations, and these data should be presented in an easily understood manner to enhance patient safety." They use this concept from DiMe's V3 work to discuss future action that should be taken.
Agnostic
DHTs
Real-world monitoring of PD with wearables
https://eprints.ncl.ac.uk/file_store/production/272463/2AB07552-879A-49B1-BD99-A7EADE8460A2.pdf
Digital measures that matter to patients
Authors leveraged the framework from DiMe's Measures that Matter work to create a table that outlines: (a) the clinical concept of interest; (b) quantified digital outcomes; (c) validity: i. criterion validity: digital outcome validated against a reference system, ii. construct validity: digital outcome validated against clinical scales (convergent validity) and/or showed known groups differences (discriminant validity) (d) digital outcome regulatory/ qualification status assessed by regulatory bodies (e.g., EMA, FDA)
CREATE?
Parkinson's Disease
Wearables
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
https://www.jmir.org/2021/9/e29875/
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital measures that matter to patients
DiMe Library of Digital Endpoints
The authors found that Verification, analytical validation, and clinical validation studies (e.g., V3) are this review's most frequently published study types. They note that given this analysis is "foundational to establishing whether a digital clinical measure is fit-for-purpose, these findings indicate that academic research supporting the development and evaluation of digital clinical measures is appropriate for a nascent field." They compared the number of Verification, analytical validation, and clinical validation studies with the number of published studies examining the security, data rights, and governance, ethics, standards, and economic feasibility of digital sensing products and noted that paucity is "alarming given the rapid growth and adoption of digital clinical measures" - using DiMe's endpoints library to contextualize the increase. The authors also found that "the number of publications reporting measure identification is relatively low compared to research into the development and deployment of these same measures. This may be cause for concern if we cannot be certain that digital clinical measures being developed have already been determined to be clinically relevant and grounded in aspects of health that patients and clinicians care most about" - leveraging DiMe's digital measures that matter to patients as the basis for this claim.
Agnostic
DHTs
Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review
https://www.jmir.org/2022/4/e33537/
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Advancing the Use of Mobile Technologies in Clinical Trials
Remote digital monitoring in clinical trials in the time of COVID-19
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
The authors, convened through a DiMe research committee working group, conducted a systematic literature review of published studies reporting adherence captured by BioMeTs. The authors leveraged V3's definition of and supporting information about BioMeTs to inform their methodology, namely, which literature to include in their systematic review. With the literature identified, the authors used 'A systematic review of feasibility studies promoting the use of mobile technologies in clinical research' to guide the information related to the BioMeTs to be included in their data extraction. Ultimately, the authors' recommendations build on the minimum requirements recommended in the several DiMe resources referenced.
Agnostic
BioMeTs
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims
https://link.springer.com/article/10.1007/s43441-022-00412-1
DiMe Library of Digital Endpoints
The authors discuss the absence of a central resource where the use of BYOD in clinical trials is systematically documented and offer DiMe's crowdsourced library of digital endpoints as a solution.
Agnostic
BYOD Tools
Regulatory considerations to keep pace with innovation in digital health products
https://www.nature.com/articles/s41746-022-00668-9
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors leverage DiMe's publication to highlight the potential of harnessing real-world evidence to assess the effectiveness of digital products while balancing this promise with the notion that there are numerous challenges to consider, including missing data and the validity of digital endpoints. Further, they speak to the need to align on a common vocabulary and framework, such as the types of additional privacy and security requirements that have been put in place for Germany's regulated digital health apps may be appropriate for the kinds of SaMD tools that collect and store sensitive health data, as outlined in DiMe's publication.
Agnostic
DHTs
Reliability of Automatic Computer Vision-Based Assessment of Orofacial Kinematics for Telehealth Applications
https://www.karger.com/Article/FullText/525698
V3
The authors describe the importance of the V3 Framework, and note that "previous studies included an analytical validation of 3D cameras in comparison to relevant ground truths, and early clinical validation of 3D cameras has been performed in the context of detecting neurological impairments." This study focused on the final piece of the V3 framework: analytical validation. The authors outline the analytical validation "of a 2D camera as an essential step in its eventual clinical adaptation. For home-based recording technologies, the process of analytical validation includes comparing their psychometric properties to those of a lab-based 3D-capable camera."
Neurological Disorders
2D mobile cameras
AI/ML/algorithms
Remote digital monitoring for medical product development
https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12851
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors note that "the performance characteristics of technology should fit its purpose and intended use," as outlined in V3, and conclude that "established performance characteristics do not necessarily translate to readiness for use in clinical trials or patient care; the security, data rights/governance, utility/usability, and economic feasibility also need to be evaluated," a concept from DiMe's 'Modernizing and designing evaluation frameworks for connected sensor technologies in medicine.'
Agnostic
DHTs
Remote digital monitoring in clinical trials in the time of COVID-19
https://www.nature.com/articles/d41573-020-00094-0
V3
DiMe Library of Digital Endpoints
The authors, who report on a February 2020 workshop on remote digital monitoring convened by the Foundation for the National Institutes of Health Biomarkers Consortium, outline V3 and how it unites the different disciplines that should participate in the development and evaluation of sensor technologies. Authors also leverage DiMe's endpoints library to note that despite the potential benefits of integrating digital in clinical trials, "only 55 digital efficacy end points are currently being used in industry-sponsored trials of new medical products." Excerpt from the text: "In conclusion, the frameworks are in place to guide developers of medical products and digital measurement tools during the COVID-19 pandemic and beyond."
Agnostic
DHTs
Research data management challenges in citizen science projects and recommendations
https://orbit.dtu.dk/files/253861709/RDM_challenges_in_CS.pdf
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
The authors of this study aimed to identify research data management (RDM) challenges for citizen science (CS) projects and discuss how university libraries may support any such challenges. They leverage and provide an overview of DiMe's work in their "Ethical and legal challenges" table (2) to provide an overview of challenges to leveraging patients in CS research. Based on the authors' work reviewing the literature to identify challenges, they provide recommendations for university libraries to focus their efforts to secure contextualization and data quality.
Agnostic
DHTs
RESPONSE OF THE PHARMACEUTICAL INDUSTRY TO COVID-19
Bavaskar, Ravindra, Mahak Khurana, and Himmat Dhodi. "RESPONSE OF THE PHARMACEUTICAL INDUSTRY TO COVID-19." DR. DY PATIL B-SCHOOL, PUNE, INDIA: 1018.
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
The authors reference the DiMe publication to contextualize the readiness of pharmaceutical companies to integrate remote monitoring capabilities at the onset of the COVID-19 pandemic.
COVID
DHTs
Rise of digital medicine and the use of digital biomarkers: Piloting computational methods for discovering and characterizing digital medicine trials
Pfizer case; link coming
DiMe Library of Digital Endpoints
The authors derived study sets from ClinicalTrials.gov and DiMe's endpoints library study sets to characterize temporal trends in the use of wearable sensors and found that there was variability in how studies reported the use of digital technologies.
DiMe Case Study: https://www.dimesociety.org/wp-content/uploads/Pfizer_Endpoints-Library-Case-Study_FINAL.pdf
Agnostic
DHTs
Role reconfiguration: what ethnographic studies tell us about the implications of technological change for work and collaboration in healthcare
https://hal.archives-ouvertes.fr/hal-03229513/
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors included DiMe's work in their review of changes for work and collaboration in healthcare, extracting what they perceived as the key findings from the work: "The implementation of health information technology generated significant reconfigurations of work practices at the expense of nurse–patient interaction. Following such changes, nursing leadership described a realignment in staffing in order to have more versatile staff and task delegation of largely invisible work to unit clerks." They embed other points from DiMe's work throughout the review to propose 4 types of role reconfigurations in this new era of technology.
Agnostic
DHTs
Sensor data integration: a new cross-industry collaboration to articulate value, define needs, and advance a framework for best practices
https://www.jmir.org/2021/11/e34493/
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
DiMe convened a group of multistakeholder experts (e.g., AWS, FDA, CHDR, and more) to work on the Sensor Data Integrations Tour of Duty, including this publication. This article describes the current state of sensor data integration in health care, examines the importance of sensor data integration in achieving the promise of digital health to improve clinical research and patient care at scale, and offers a vision of what overcoming these challenges and continuing progress will enable. The work builds off DiMe initiatives, such as The Playbook, in advancing the adoption and utility of digital medicine tools. It also uses resources, such as V3, to outline the importance and key problems for sensor data integrations.
SDI project resources: https://www.dimesociety.org/tours-of-duty/sensor-data-integrations/
Agnostic
DHTs
Sensor Verification and Analytical Validation of Algorithms to Measure Gait and Balance and Pronation/Supination in Healthy Volunteers
https://www.mdpi.com/1424-8220/22/16/6275/htm
V3
Authors leveraged the V3 Framework, exemplifying a systematic, stepwise evaluation of body-worn sensors with data processing algorithms prior to testing in patients.
DiMe Case Study: https://www.dimesociety.org/wp-content/uploads/Koneksa_V3_PD.pdf
Parkinson's Disease
Neurological Disorders
Agnostic
DHTs
Wearables
Smart wearable devices in cardiovascular care: where we are and how to move forward
https://www.nature.com/articles/s41569-021-00522-7
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe's work to highlight the importance (and timely nature) of DiMe's framework, particularly how it adds data security/privacy, data rights/governance, utility/usability, and economic feasibility to the widely adopted V3 framework.
Cardiovascular Diseases
Wearables
Stakeholder perspectives on barriers and facilitators for the adoption of virtual clinical trials: Qualitative study
https://www.jmir.org/2021/7/e26813/
V3
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
The authors state the need to validate wearables through V3 before they can be used in a virtual clinical trial. They note that "it should become clear, within a very short time frame, if the technology is suitable to accurately measure clinically meaningful endpoints" and that "the evaluation of a wearable device, or a biometric monitoring device, should consist of a three-component framework, consisting of verification, analytical validation, and clinical validation," which is DiMe's V3 framework.
Agnostic
Wearables
Streamlining Adoption of Digital Technology in Clinical Trials Through Use of Open-Source Algorithms
https://static1.squarespace.com/static/5e25d2f01a1efa04733519ef/t/614b2a10dc7ad111c972ba49/1632315920722/Streamlining+Adoption+of+Digital_Clinical+Researcher.pdf
V3
The author, who advocates for the mainstream use of open-source algorithms to streamline use of DHTs in clinical trails, uses the V3 framework to argue his point. He walks through each step of V3, noting how it applies to open-source algorithms: "The first step, verification, depends only on the sensor. It should be performed by the manufacturer and should only need to be done once. Assuming verified data, both analytical and clinical validation depend on the algorithm. By using open-source algorithms, researchers can effectively share algorithm validation—no matter what sensor was used to generate the data—if the sensor went through the verification step" They author also demonstrates the V3 approach using Atopic Dermatitis as an example.
Agnostic
AI/ML/algorithms
Survey on Acceptance of Passive Technology Monitoring for Early Detection of Cognitive Impairment
https://www.karger.com/Article/Abstract/512207
Digital Medicine: A Primer on Measurement
The authors, who sought to evaluate public opinion on the use of passive technology for monitoring cognition, referenced DiMe's Digital Medicine Primer in their discussion around the ethicals of digital biomarkers development. The authors drew parallels between the Primer's stated requirement to "obtain informed consent that ensures that participants understand the technology and its implications" and their study's methodology. Notably, in their study, "health-care professionals were significantly less likely to agree to monitoring... [and] participants with greater experience with technology were more amenable to monitoring," concluding that, as noted in the Primer, that "informed consent needs to be tailored to the technological literacy of a participant."
Cognitive Impairment
Agnostic
DHTs
Telemedicine in Intensive Care Units: Scoping Review
https://www.jmir.org/2021/11/e32264/
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors reference DiMe's work to showcase how roles are evolving within healthcare, noting, "Implementation of health technology can lead to changes in work practice inside the care team, in particular for nursing and support staff. Clear definition of the roles, responsibility, and composition of the team should therefore be addressed early on during the planning of the intervention."
Intensive Care
Telehealth
The digital biomarker discovery pipeline: An open-source software platform for the development of digital biomarkers using mHealth and wearables data
https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/article/digital-biomarker-discovery-pipeline-an-opensource-software-platform-for-the-development-of-digital-biomarkers-using-mhealth-and-wearables-data/A6696CEF138247077B470F4800090E63
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The authors weave concepts from V3 and 'Modernizing and designing evaluation frameworks for connected sensor technologies in medicine' throughout their discussion to substantiate the importance of verification and validation.
Agnostic
Digital Biomarker
The Emerging Role of Digital Therapeutics in Medical, Surgical and Radiation Oncology
https://appliedradiationoncology.com/articles/the-emerging-role-of-digital-therapeutics-in-medical-surgical-and-radiation-oncology
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
DiMe Library of Digital Endpoints
The authors reference DiMe's work to point to the work that has been done to date.
Oncology
DHTs
Digital Therapeutics
The Future of Digital Health: Meeting Report
https://www.karger.com/Article/FullText/515355
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Remote Digital Monitoring for Medical Product Development
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
This meeting report, which provides an overview of the expert panel and workshop held in early 2021, references several DiMe publications to highlight the state of digital medicine and what is required in terms of a workforce, collaborative efforts, and technology to drive the field forward.
Agnostic
DHTs
The future of oncology care requires integration of patient engagement and equity into practice
https://www.futuremedicine.com/doi/full/10.2217/fon-2021-0912
The role of digital clinical measures in improving cancer care and research.
While describing the landscape of digital measures, authors leverage DiMe's work to note that "there are no digital measures or endpoints being used in industry-sponsored clinical trials for oncology medical products among the 166 unique digital endpoints contained in its library, or among the seven under evaluation by the FDA." Further, they leverage the work to highlight the importance of collaborative efforts to successfully deploy digital endpoints, noting, "Consensus-defined best practices in clinical care, technology development and operations exist to support the development of digital endpoints to enable safe and equitable delivery of quality oncology care outside of the clinic or investigator site."
Oncology
DHTs
The Health and Productivity Effects of Remote Work on Clinical Research Associates
https://www.acrpnet.org/wp-content/uploads/dlm_uploads/2021/09/September-2021-ACRP-Clinical-Researcher.pdf#page=6
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
"To maintain oversight for studies, clinical research sponsors decided to push for remote source document verification methods to be implemented where possible."
COVID
DHTs
The impact of COVID-19 on otolaryngology research: a cross-sectional analysis of discontinued trials
https://www.degruyter.com/document/doi/10.1515/jom-2021-0278/html
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
"However, the integration of telemedicine poses its challenges; trial developers must consider the additional costs of technology, and they have to establish amendments protecting patient rights and procedure operations"
otolaryngology
COVID
Telehealth
The impact of the COVID-19 pandemic on Oncology Care and Clinical Trials
https://www.mdpi.com/2072-6694/13/23/5924/htm
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
"Remote monitoring systems were also implemented, allowing patients to be followed-up from their homes. For example, the use of wearable devices that provide a stream of real time data (e.g., blood pressure/heart rate monitors) was also expanded. This is a welcome innovation, as these approaches have the advantage that the data can be collected over extended periods of time and in a more natural and relaxed environment, mitigating issues such as “whitecoat hypertension”
Oncology
COVID
DHTs
The path forward for digital measures: suppressing the desire to compare apples and pineapples
https://www.karger.com/Article/FullText/511586
V3
Digital Medicine: A Primer on Measurement
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital measures that matter to patients
Remote digital monitoring in clinical trials in the time of COVID-19
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Remote Digital Monitoring for Medical Product Development
DiMe Library of Digital Endpoints
The authors use DiMe resources, including the Library of Digital Endpoints, to contextualize the growing interest in the use of digital clinical measures, and the current efforts being made to develop an industry consensus around terms and best practices.
Agnostic
DHTs
The Patient Matters in the End (point)
https://link.springer.com/article/10.1007/s12325-022-02271-6
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
DiMe Library of Digital Endpoints
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Griffiths, et al. leveraged several DiMe resources, including the Crowdsourced Library of Digital Endpoints, which they used to contextualize the increased interest in using digital endpoints, and Measures that Matter to Patients, which they used to underscore the importance of beginning research with an understanding of what's important to patients. The authors also acknowledged the importance of pre-competitive collaborations to encourage the adoption of digital standards to help compare results across clinical trials. Learn more about the authors' use of DiMe resources on our Resources in Action Hub.
Case 1 on DiMe's endpoints library: https://www.dimesociety.org/wp-content/uploads/Endpoints-Library_Research_The-Patient-Matters-in-the-Endpoint.pdf Case 2 on measures that matter: https://www.dimesociety.org/wp-content/uploads/MTM-Research_The-Patient-Matters-in-the-Endpoint.pdf Case 3 on Pre-competitive collaborations: https://www.dimesociety.org/wp-content/uploads/Pre-Collab_NS_The-Patient-Matters-in-the-Endpoint.pdf
Agnostic
DHTs
The Role of Digital Health Technologies in Drug Development: Proceedings of a Workshop
https://books.google.com/books?hl=en&lr=&id=xEgHEAAAQBAJ&oi=fnd&pg=PR1&dq=The+Role+of+Digital+Health+Technologies+in+Drug+Development:+Proceedings+of+a+Workshop&ots=TRSBxz0-8t&sig=pHB4TFZlD7_-lUZhj6qDK9ezuEA
Digital Medicine: A Primer on Measurement
V3
This work, which outlines proceedings from a workshop on DHTs in drug development, introduces the workshop by grounding readers in current limitations associated with using DHTs in research. DiMe's V3 framework and Primer on Digital Medicine are referenced to highlight the work that has been done thus far, and outline the need for future standardization. Themes from these two bodies of work are discussed in the workshop.
Agnostic
DHTs
The role of digital navigators in promoting clinical care and technology integration into practice
https://www.karger.com/Article/Abstract/510144
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The authors leverage DiMe's three core responsibilities of a digital navigator, which include (1) selecting apps, (2) troubleshooting technology, and (3) reviewing and quality checking digital data to facilitate care. The authors develop training for digital navigators, complete with 5 distinct modules, that builds on the competencies outlined in DiMe's work.
Agnostic
DHTs
The Strategies for Quantitative and Qualitative Remote Data Collection: Lessons From the COVID-19 Pandemic
https://formative.jmir.org/2022/4/e30055
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
In adapting measures for remote delivery, it is essential to examine previous literature to assess the availability of remote alternatives and evidence to support the validity of remote alternatives or adaptations [10]. Study teams’ attention to usability and patient burden is essential [10]. It may also be important to account for the modality of data collection during data analysis (eg, evaluating whether the mode of data collection is a confounder in multimodal studies).
COVID
DHTs
The use of Real‐World Data to assess the impact of safety‐related regulatory interventions
https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.2464
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
Authors leverage DiMe's work to compare against another similar study. They highlight the challenges associated with both DiMe's study and the comparing study.
Agnostic
RWD
Total Knee Arthroplasty and Intra-Articular Pressure Sensors: Can They Assist Surgeons with Intra-Operative Decisions?
https://link.springer.com/article/10.1007/s12178-021-09724-5
V3
In the authors evaluation of intra-operative sensors used to balance total knee arthroplasty (TKA), the authors affirm that "all diagnostic tests, including BioMeTs, should be systematically evaluated to verify and validate their findings" The go on to outline each step of V3 as it relates to TKA in the following table: https://link.springer.com/article/10.1007/s12178-021-09724-5/tables/1 The authors also noted that V3 was one of the publications that was "of particular interest and importance," highlighting the significant influence V3 had on this work.
Musculoskeletal Disorders
Toward modernization of geriatric oncology by digital health technologies
https://ascopubs.org/doi/full/10.1200/EDBK_279505
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
In the article, authors provide guidelines for proper selection, implementation, and testing of digital health solutions in the context of geriatric oncology. The authors highlight the framework described in 'Modernizing and designing evaluation frameworks for connected sensor technologies in medicine' to evaluate whether a device is fit for purpose. They discuss the five key dimensions for evaluation (validation, security practices, data rights and governance, utility and usability, and economic feasibility), which builds on concepts from V3, specifically in the context of geriatric oncology.
Oncology
DHTs
Traditional and digital biomarkers: two worlds apart?
https://www.karger.com/Article/Abstract/502000
Digital Medicine: A Primer on Measurement
Authors use DiMe's Primer on Digital Medicine to cite the definition for software as a medical device (SaMD) as "software that performs a medical function without being part of the hardware (e.g., machine learning tools in mobile apps)" in their discussion around how standardizing novel semantics is challenging.
Agnostic
Digital Biomarker
Use of digital health applications for the detection of atrial fibrillation
https://link.springer.com/article/10.1007/s00399-022-00888-2
V3
The authors note that to evaluate whether such digital health application for the detection of AFib fulfil their purpose, one must answer three questions related to V3: "1. Is the sensor precise and consistent (verification)? 2. Are the measurements and the processing algorithms comparable to high-quality reference systems (analytical validation) 3. Does the application improve medical outcomes or confer positive effects on clinical care (clinical validation)?" They found substantial evidence with regard to verification and analytical validation, but a lack of with regard to clinical validation. They propose that "Two main clinical settings seem appropriate for the use of DiHA in the setting of AFib: 1. Screening (e.g. in asymptomatic patients at high risk for AFib or in patients with palpitations); 2. Monitoring of patients with known AFib after interventions to restore sinus rhythm (e.g. cardioversion, catheter ablation)" Authors then draw on external literature to discuss clinical validation, but conclude that "evidence regarding hard clinical endpoints and positive care effects (clinical validation) still requires improvement."
Cardiovascular Diseases
Digital Health Applications
Ushering in safe, effective, secure, and ethical medicine in the digital era
https://www.nature.com/articles/s41746-021-00424-5
V3
Digital Medicine: A Primer on Measurement
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
This article is the result of a symposium hosted by Harvard Business School and the Harvard MIT Center for Regulatory Science. The consortia discuss the role of industry, government, and academics in the future of digitally empowered health care. To frame the scope of the discussion, the article draws on DiMe's Digital Medicine Primer: "Digital medicine products are driven by high-quality hardware and software products that support health research and the practice of medicine broadly, including treatment, recovery, disease prevention, and health promotion for individuals and across populations" Additionally, the first important topic of the symposium was understanding the evaluation of digital medicine tools. The authors first reference 'Modernizing and designing evaluation frameworks for connected sensor technologies in medicine' to discuss the "five dimensions of connected sensors' benefit-risk—(1) validation, (2) security practices, (3) data rights and governance, (4) utility and usability, and (5) economic feasibility." The authors then highlight DiMe's V3 Framework, noting the importance of the framework for evaluating BioMeTs. The authors conclude the "Evaluating Digital Medicine" section by saying "understanding the dimensions of benefit–risk, practical challenges, terminology, and frameworks outlined in these articles will only continue to grow in importance as connected sensors are expected to play a growing role in both health care delivery and clinical research."
Agnostic
DHTs
Utilizing DHTs for Clinical Trial Endpoints
https://www.appliedclinicaltrialsonline.com/view/utilizing-dhts-for-clinical-trial-endpoints
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors leverage the framework proposed by the author's of DiMe's publication, including the framework, noting that, "by understanding these valued aspects, pertinent endpoints can be defined, and an appropriate measurement approach can be identified–which may include a DHT."
Agnostic
DHTs
Validation of accelerometry as a digital phenotyping measure of negative symptoms in schizophrenia
https://www.nature.com/articles/s41537-022-00241-z
V3
The authors' findings determine the "proof-of-concept that ACL is feasible for use as an objective measure of negative symptoms in research studies." Based on the scope of their work, they propose incorporating additional evaluation frameworks into future studies, including the V3 Framework. Authors note that V3 should be used to evaluate Devices used to collect ACL, apps, and metrics before being implemented in future clinical trials as outcome measures.
Mental Disorder
DHTs
Virtual Exam for Parkinson's Disease Enables Frequent and Reliable Measurements of Motor Function
https://www.medrxiv.org/content/10.1101/2021.12.22.21268260v1
V3
Digital measures that matter to patients
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors of this research, who developed a smartwatch-based active assessment that enables unsupervised measurement of motor signs of PD, draw on DiMe's measures that matter work to note that "before such measurements can be used as endpoints in clinical trials to quantify disease progression, a careful evaluation of the clinical validity, reliability, and sensitivity to change is required." They also include details on the clinical validation step of V3 (excerpt from the publication below). Excerpt from the text: In people with PD, dopaminergic medication can considerably improve severity of motor signs over short time frames. This “on-off” difference is well-accepted as a clinically meaningful change, and when coupled with wearable sensors and patient-reported tagging of daily medication regimen, creates multiple “natural experiments” in the course of patients’ daily lives. These allow us to test the clinical validity of the PD-VME measures as pharmacodynamic/response biomarkers for people with PD in the remote setting. Indeed, we demonstrate that digital measures for tremor, upper-extremity bradykinesia and gait are able to detect significant change in patients’ motor signs before and after medication intake.
Parkinson's Disease
Neurological Disorders
Wearables
Vital Signs and Sensors for Post-Exertional Malaise Prevention
https://www.degruyter.com/document/doi/10.1515/cdbme-2021-2094/html
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors reference DiMe's work to note that other publications have targeted monitoring of Covid-19 symptoms. They aim to study Post-exertional malaise (PEM), a core symptom that provides a drastic loss of quality of life in COVID, and discuss appropriate vital signs and sensors for Post-exertional malaise monitoring.
Prevention
DHTs
Watching Parkinson’s disease with wrist-based sensors
https://www.nature.com/articles/s41746-022-00619-4
DiMe Library of Digital Endpoints
The authors reference both DiMe's 3Ps of Digital Endpoint Value and the Endpoints Library when discussing the continued challenges (e.g., "pharma, payers, and other industry stakeholders continue to seek consensus on best practices") and growth (e.g., the increased proliferation of digital endpoints).
Parkinson's Disease
Neurological Disorders
DHTs
Wearables
Wearables beyond borders: A case study of barriers to gait assessment in low-resource settings
https://www.sciencedirect.com/science/article/abs/pii/S0378512220302437#preview-section-references
V3
The authors note that, while wearables are emerging as useful screening/diagnostic tools in pathology, "no standard methodologies exist to guide validation/verification processes which has implications for deployment, raising questions about devices being fit-for-purpose," stifling the use of wearables on a global scale as lack of progression in wealthier nations has downstream impacts for a low-resource nations where there is critical need for such technology. The authors cite V3, referencing the need for "more stringent efforts to guide validation and verification processes with wearables," which will invoke trust and facilitate use of wearables in all regions.
Agnostic
Wearables
DHTs
Wearables in the SARS-CoV-2 pandemic: What are they good for?
https://mhealth.jmir.org/2020/12/e25137
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
Authors leverage concepts from V3 and other DiMe work on digital clinical measures to discuss the need for better information exchange and explore scenarios to "support and incentivize the open evaluation and reporting of consumer-targeted BioMeT performance." Excerpt from the text: "BioMeT users should understand the product’s intended purpose, know about the product’s limitations, and adhere to the instructions for wear to ensure that measurements are interpreted correctly, while also minding the effects of noise, errors, and biological variability on measurements. To support this, information should be provided in an easy-to-find and easy-to-digest format. Recently, researchers at Elektra Labs and the Digital Medicine Society have proposed the use of a “connected sensor label” (ie, similar to a nutrition facts label) to report on the objective measures of a BioMeT’s validation, usability, utility, security, and data governance components. To support transparent validation, [DiMe] also developed the V3 Framework, which is a systematic assessment tool for BioMeT performance... Perhaps the most integral component of the V3 framework is reporting results in a standardized and transparent manner. These protocols and findings are “key tools for documenting scientific evidence needed to draw inferences on whether a technology is fit-for-purpose for the intended use and context of use”.
Agnostic
Wearables
BioMeTs
A Brief Overview of Enabling Technologies for Digital Medicine and Smart Healthcare
https://ieeexplore.ieee.org/document/9460172/
Digital Medicine: A Primer on Measurement
Author's use definitions and terms from DiMe's Digital Medicine Primer.
Agnostic
DHTs
A data-driven performance dashboard for surgical dissection
https://www.nature.com/articles/s41598-021-94487-9
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors use DiMe's resource, among others, to confirm the notion that "for performance assessments and patient monitoring in the operating room (OR), however, the AI-oriented and data-driven technologies are lagging behind their counterparts in other healthcare sector."
Agnostic
Surgery
AI/ML/algorithms
A Hybrid Operating Room in the Making-Coordinating the lntroduction and Use of New Technology
https://gupea.ub.gu.se/handle/2077/64108
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
The author uses the DiMe publication to contextualize the strain of new health technologies on existing workflows. They leverage concepts from the publication, noting that, "the introduction of new health information technologies often both requires and mediates multidisciplinary relationships among professionals who usually work in isolation."
Surgery
Agnostic
DHTs
A Remote Digital Monitoring Platform to Assess Cognitive and Motor Symptoms in Huntington Disease: Cross-sectional Validation Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9277525/
Digital measures that matter to patients
Following recommendations from DiMe's Measures that Matter work, the authors noted the initiation of a "qualitative research study to investigate what matters most for patients in their daily life in relation to the HD Digital Monitoring Platform," which builds off the work outlined in the author's work.
Neurological Disorders
DHTs
A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05880-8
V3
The authors mention the V3 framework for Biometric Monitoring Technologies as one standard used by the field.
Agnostic
DHTs
A roadmap to inform development, validation and approval of digital mobility outcomes: the Mobilise-D approach
https://www.karger.com/Article/Abstract/512513
V3
Digital Medicine: A Primer on Measurement
Advancing the Use of Mobile Technologies in Clinical Trials
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
The authors note the important contributions that have been made to bring stakeholders onto the same page about the adoption of digital health technology development, validation, and approval, including the frameworks for validation (e.g., V3) and primers (e.g., Digital Medicine: Primer on Measurement). They work to bring these bodies of work together in one roadmap in the context of Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease, proximal femoral fracture, and congestive heart failure.
Parkinson's Disease
Cardiovascular Diseases
Musculoskeletal Disorders
Neurological Disorders
Multiple Sclerosis
DHTs
A Sensor-Driven Visit Detection System in Older Adults' Homes: Towards Digital Late-Life Depression Marker Extraction
https://pubmed.ncbi.nlm.nih.gov/34550895/
Digital Medicine: A Primer on Measurement
Author's use definitions and terms from DiMe's Digital Medicine Primer.
A systematic review of methods used to conduct decentralised clinical trials
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9306873/
Advancing the Use of Mobile Technologies in Clinical Trials
The authors reference the DiMe publication to highlight the benefits of leveraging digital tools in decentralized clinical trials.
Agnostic
DHTs
A systems approach towards remote health-monitoring in older adults: Introducing a zero-interaction digital exhaust
https://www.nature.com/articles/s41746-022-00657-y
V3
Digital Medicine: A Primer on Measurement
It takes a village: development of digital measures for computer scientists
Authors note that future research that leverages remote monitoring should "emphasize further analytical and prospective, clinical validation of the included digital measures," citing the V3 framework. They also nod to concepts and terminology used in other foundational DiMe publications.
Agnostic
DHTs
Accuracy of guided biopsy of the jawbone in a clinical setting: A retrospective analysis
https://www.sciencedirect.com/science/article/pii/S1010518221000822
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer to introduce the opportunities of digitization, including the higher degree of safety and predictability that comes with it.
Dentistry
DHTs
AI/ML/algorithms
Adapting to a Pandemic—Conducting Oncology Trials during the SARS-CoV-2 PandemicOncology Trials during the SARS-CoV-2 Pandemic
https://pubmed.ncbi.nlm.nih.gov/32312892/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7357670/
Digital Medicine: A Primer on Measurement
Authors used DiMe's Digital Medicine Primer to outline what is involved with decentralized clinical trials.
Oncology
DHTs
Advances in nucleic acid architectures for electrochemical sensing
https://www.sciencedirect.com/science/article/pii/S2451910321000090
V3
The authors reference V3, noting that "analytical and clinical validations are critical to determining whether biosensing technologies are fit for purpose... [but] the few platforms that have been validated using real specimens often lack proper cost analyses and/or meaningful demonstrations of portability and ease of use in clinical settings...Thus, the field critically needs a push toward statistically sound, adequate and sustained validation of biosensing platforms under real-world conditions."
Agnostic
DHTs
Aligning mission to digital health strategy in academic medical centers
https://www.nature.com/articles/s41746-022-00608-7
V3
Authors note that potential technology solutions used in academic medical centers to transform patient care and engagement must meet key tenants of adoption, e.g., V3.
Agnostic
DHTs
An Overview of Technology Availability to Support Remote Decentralized Clinical Trials
https://publications.waset.org/10012285/an-overview-of-technology-availability-to-support-remote-decentralized-clinical-trials
Advancing the Use of Mobile Technologies in Clinical Trials
Authors cite DiMe's publication to show how mobile technologies are advancing and applied in healthcare.
Agnostic
DHTs
Analysis of the regulatory, legal, and medical conditions for the prescription of mobile health applications in the United States, the European Union, and …
https://pubmed.ncbi.nlm.nih.gov/34853541/v
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors cite DiMe's publication to note the existing work that has been done in the field.
Agnostic
DHTs
Analytical and clinical validation of an RNA sequencing-based assay for quantitative, accurate evaluation of a molecular signature response classifier in rheumatoid …
https://www.tandfonline.com/doi/full/10.1080/14737159.2021.2000394
V3
Authors found that their results were "consistent with other studies that necessitated the integration of elements of analytical and clinical validation to appropriately assess assay validation," e.g., V3.
Autoimmune Disorder
DHTs
Assessing pain research: a narrative review of emerging pain methods, their technosocial implications, and opportunities for multidisciplinary approaches
https://www.frontiersin.org/articles/10.3389/fpain.2022.896276/pdf
V3
Authors cite limitation referenced in V3 framwork. Excerpt from text: "Moreover, many direct-to-consumer devices claim to accomplish similar things or perform similarly to SOTA devices without openly shared data or validation studies"
Chronic Pain
DHTs
Assessment of the feasibility of using noninvasive wearable biometric monitoring sensors to detect influenza and the common cold before symptom onset
https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2784555
V3
Authors cite V3 noting that their "model could be extensible to commercial wearables, which are used by 21% of US adults, for population-level detection of respiratory viral infections."
Wearables
Attitudes and Expectations of Clinical Research Participants Toward Digital Health and Mobile Dietary Assessment Tools: Cross-Sectional Survey Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8959345/
Digital Medicine: A Primer on Measurement
Authors reference DiMe's Digital Medicine Primer to highlight the opportunities associated with using digital.
Nutrition
DHTs
Digital Health Applications
Beyond wellness monitoring: continuous multiparameter remote automated monitoring of patients
https://www.onlinecjc.ca/article/S0828-282X(21)00812-6/fulltext
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors use DiMe resource to outline how body temperature is measured using wearables.
Agnostic
DHTs
Biometric monitoring technologies in cancer: The past, present, and future
https://ascopubs.org/doi/full/10.1200/CCI.21.00019
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Authors note that lessons learned from other types of biomarkers can provide useful insights for BioMeT adoption, such as V3. The authors note that V3 needs to be adapted and tested within the oncology setting.
Oncology
BioMeTs
Brain health INnovation Diplomacy: a model binding diverse disciplines to manage the promise and perils of technological innovation
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423685/
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer's definitions of key terms and concepts.
Agnostic
DHTs
Building the case for actionable ethics in digital health research supported by artificial intelligence
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1377-7
Digital Medicine: A Primer on Measurement
Authors use conclusions from the Primer about the need to demonstrate value before using technologies. They cite the Primer specifically noting that "value is based on the product being valid and reliable, which means that scientific research is needed before a product is deployed within the health sector."
Agnostic
AI/ML/algorithms
Can the COVID-19 pandemic disrupt the current drug development practices?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196831/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors use terms defined in DiMe's publication to set the foundation for their article.
COVID
Agnostic
DHTs
Can vital signs recorded in patients' homes aid decision making in emergency care? A Scoping Review
https://findresearcher.sdu.dk/ws/portalfiles/portal/184287404/1_s2.0_S2666520421000412_main.pdf
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors reference DiMe's publications to show the increased use of remote patient monitoring during the COVID-19 pandemic.
Agnostic
Emergency Care
DHTs
Wearables
Cardiovascular disease screening in women: leveraging artificial intelligence and digital tools
https://www.ahajournals.org/doi/full/10.1161/CIRCRESAHA.121.319876
V3
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
The authors use the terminology outlined in DiMe publications to standardize their work among the other bodies of work that have also adopted this language.
Cardiovascular Diseases
AI/ML/algorithms
DHTs
Cgmquantify: Python and R Software Packages for Comprehensive Analysis of Interstitial Glucose and Glycemic Variability from Continuous Glucose Monitor Data
https://ieeexplore.ieee.org/abstract/document/9517001
V3
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors leverage concepts from V3, such as the fact that proprietary algorithms cannot be externally validated by clinical researchers, to factor into their research methodology.
Diabetes
DHTs
Characteristics and challenges of the clinical pipeline of digital therapeutics
https://www.nature.com/articles/s41746-020-00370-8
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe's work to compare the risks of unauthorized access and manipulation of connected sensors in medicine with DTx, noting how bad actors "could compromise both trust in the product and patient care."
Agnostic
Digital Therapeutics
Characterizing COVID-19 and influenza illnesses in the real world via person-generated health data
https://www.sciencedirect.com/science/article/pii/S2666389920302580
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
COVID
RWD
Clinical trial enrollment at a rural satellite hospital during COVID-19 pandemic
https://pubmed.ncbi.nlm.nih.gov/34367680/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
The COVID-19 pandemic called attention to the need for clinical outcome assessments that can be administered remotely
COVID
Respiratory
DHTs
EHR
Closer to the Patient Means Better Decisions: Wearable Remote Monitoring of Patients with COVID-19
https://www.scienceopen.com/document_file/097e42e0-6d11-4088-869a-2be6af15d1c9/PubMedCentral/097e42e0-6d11-4088-869a-2be6af15d1c9.pdf
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
The COVID-19 pandemic called attention to the need for clinical outcome assessments that can be administered remotely
COVID
Respiratory
Wearables
Cognitive Digital Biomarkers from Automated Transcription of Spoken Language
https://link.springer.com/article/10.14283/jpad.2022.66
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer's definitions.
Agnostic
Neurological Disorders
Digital Biomarker
Collecting and sharing self-generated health and lifestyle data: Understanding barriers for people living with long-term health conditions–a survey study
https://journals.sagepub.com/doi/full/10.1177/20552076221084458
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight potential concerns about using PGHD.
Agnostic
PGHD
DHTs
Communication Breakdowns between nurses and it department: why hospitals fail at improving the usability of health information technology
https://open.lnu.se/index.php/ishimr/article/download/2516/2713/9632
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors leverage the DiMe publication to note that nurses' are heavily involved with health information technology (HIT), given the need to 'track, organize, and update patient information' daily.
Agnostic
DHTs
Computerization and digital workflow in medicine: Focus on digital dentistry
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254335/
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer's definitions.
Dentistry
AI/ML/algorithms
Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic
https://www.sciencedirect.com/science/article/pii/S1551714421001439
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
The COVID-19 pandemic called attention to the need for clinical outcome assessments that can be administered remotely
Vital Signs
Wearables
Contactless sleep monitoring for early detection of health deteriorations in community-dwelling older adults: Exploratory study
https://pubmed.ncbi.nlm.nih.gov/34114966/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235297/
Digital Medicine: A Primer on Measurement
The authors use DiMe's Digital Medicine Primer to lay the foundation for existing work in digital medicine.
Agnostic
DHTs
Contemporary clinical and economic outcomes among oral anticoagulant treated and untreated elderly patients with atrial fibrillation: Insights from the United …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8853505/
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
Authors leverage the DiMe publication to highlight previous work done on the research subject.
Cardiovascular Diseases
DHTs
Content analysis and review of mobile health applications on COVID-19
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505686/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
DHTs
Coupled Multiphysics Modelling of Sensors for Chemical, Biomedical, and Environmental Applications with Focus on Smart Materials and Low-Dimensional …
https://pubmed.ncbi.nlm.nih.gov/35909810/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9171916/
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors leverage DiMe's work to highlight how biosensors will continue to transform clinical trials.
Agnostic
AI/ML/algorithms
Data management in diabetes clinical trials: a qualitative study
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06110-5
Advancing the Use of Mobile Technologies in Clinical Trials
Authors leverage DiMe's work to contextualize the importance of information and communication technologies (ICT)in clinical trials.
Diabetes
DHTs
EHR
Deep Canonical Correlation Alignment for Sensor Signals
https://arxiv.org/abs/2106.03637
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe work to showcase how the field is using connected sensors in healthcare.
Agnostic
AI/ML/algorithms
Deep learning methods for remote heart rate measurement: a review and future research agenda
https://www.mdpi.com/1424-8220/21/18/6296
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage the DiMe publication to show how connected sensors can measure vital signs that are indicators of different diseases.
Cardiovascular Diseases
DHTs
Demographic Imbalances Resulting From the Bring-Your-Own-Device Study Design
https://mhealth.jmir.org/2022/4/e29510/
V3
Authors, who evaluated the demographic imbalances in BYOD studies, cite V3, noting that "because the performance of technology across demographic characteristics is not systematically evaluated and published for most commercial wearable devices, the technology and models derived from them may fail to generalize across demographic characteristics."
Agnostic
BYOD Tools
Developing a digital solution for remote assessment in multiple sclerosis: from concept to software as a medical device
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8471038/
Remote Digital Monitoring for Medical Product Development
The authors leverage DiMe's work to acknowledge the speed at which technology is advancing and the subsequent need for a rigorous process to evaluate and implement technology.
Multiple Sclerosis
Neurological Disorders
DHTs
Development of a mobile app for ecological momentary assessment of circadian data: Design considerations and usability testing
https://pubmed.ncbi.nlm.nih.gov/34296999/
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors studied DiMe's work to ensure their own work was not duplicating existing efforts.
Sleep
DHTs
Digital Health Applications
Development of Duchenne Video Assessment scorecards to evaluate ease of movement among those with Duchenne muscular dystrophy
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0266845
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Remote digital monitoring in clinical trials in the time of COVID-19
The COVID-19 pandemic called attention to the need for clinical outcome assessments that can be administered remotely
Neurological Disorders
Musculoskeletal Disorders
Digital Health Applications
Development of novel, value-based, digital endpoints for clinical trials: a structured approach toward fit-for-purpose validation
https://pharmrev.aspetjournals.org/content/72/4/899
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors leverage DiMe's publications to showcase the existing work done to standardize the field.
Agnostic
Digital Biomarker
Development of Optical Devices for Digital Medicine
https://scholarworks.unist.ac.kr/handle/201301/31729
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer's definitions.
Agnostic
DHTs
AI/ML/algorithms
Digital endpoints for self‐administered home‐based functional assessment in pediatric Friedreich's ataxia
https://onlinelibrary.wiley.com/doi/full/10.1002/acn3.51438
V3
Authors leverage concepts from V3 in their introduction to the use of of home-based, self-administered digital endpoints in children with Friedreich’s ataxia.
Neurological Disorders
DHTs
Digital Gait Biomarkers Allow to Capture 1‐Year Longitudinal Change in Spinocerebellar Ataxia Type 3
https://movementdisorders.onlinelibrary.wiley.com/doi/full/10.1002/mds.29206
Digital measures that matter to patients
In the discussion around the limitations of the study, the authors note that "larger future studies are needed, including a higher number of preataxic subjects, to further validate the promises of gait measures and relate longitudinal gait changes to patient-centered outcomes and patient-meaningful aspects of health," referencing DiMe's Measures that Matter work.
Musculoskeletal Disorders
DHTs
Digital Biomarker
Digital health applications and the fast-track pathway to public health coverage in Germany: Challenges and opportunities based on first results
https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08500-6
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors leverage DiMe resources when evaluating strategies to bring DHTs to market.
Agnostic
DHTs
Digital Health Applications
Digital health applications for pharmacogenetic clinical trials
https://pubmed.ncbi.nlm.nih.gov/33114567/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692850/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors cite DiMe's publication to show how mobile technologies are advancing and applied in healthcare: "DH is increasingly being used in clinical trials, with specific recommendations for its use being made by clinical trial networks for mobile data collection and management, protocol design, and other applications."
Agnostic
DHTs
Digital health for patients with multiple myeloma: An unmet need
https://ascopubs.org/doi/10.1200/CCI.20.00145
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Although PROs by their very nature are suitable to be monitored by a lay person, physiologic health presents feasibility issues that must be addressed before digital data can be collected reliably.
Oncology
DHTs
Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective
https://www.nature.com/articles/d41573-020-00168-z
V3
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Mantua et al. specify that “DHT development comprises at least three phases: verification, analytical validation, and clinical validation,” as outlined in DiMe’s V3 Framework, and use the resource as the blueprint to discuss the principles and challenges for DHT development as it relates to the EU regulatory environment. Learn more about the authors' use of DiMe resources on our Resources in Action Hub.
DiMe Case Study: https://www.dimesociety.org/wp-content/uploads/EU_V3-Case-Study-1.pdf
Neurological Disorders
Agnostic
DHTs
Digital health—the need to assess benefits, risks, and value
https://jamanetwork.com/journals/jama/fullarticle/2774657
Digital Medicine: A Primer on Measurement
Authors used DiMe's Digital Medicine Primer to highlight the opportunities associated with digital health.
Agnostic
DHTs
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
https://www.karger.com/Article/Abstract/509725
V3
Digital Medicine: A Primer on Measurement
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
The authors leverage the definitions and concepts outlined in DiMe publications. They also point DiMe publications, such as V3, to offer readers additional information on more technical considerations.
Agnostic
DHTs
Digital medicine community perspectives and challenges: survey study
https://mhealth.jmir.org/2021/2/e24570/
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital Medicine: A Primer on Measurement
The authors provided information about what is working in digital medicine to establish frameworks and best practices for interoperability. They leveraged foundational DiMe resources, including V3 and The Digital Medicine Primer, highlighting the resources' common use in digital medicine research.
Agnostic
DHTs
Digital therapeutics in Parkinson's disease: practical applications and future potential
https://pubmed.ncbi.nlm.nih.gov/33646177/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8292155/
Digital Medicine: A Primer on Measurement
Authors use definitions DiMe's Digital Medicine Primer to describe the difference between digital health, digital medicine, and digital therapeutics.
Parkinson's Disease
Neurological Disorders
Digital Therapeutics
Digitalization, Participation and Interaction: Towards More Inclusive Tools in Urban Design—A Literature Review
https://www.mdpi.com/2071-1050/14/8/4514
Remote Digital Monitoring for Medical Product Development
The authors cite DiMe's resource to showcase the advantages of leveraging DHTs.
Agnostic
DHTs
Diurnal emotions, valence and the coronavirus lockdown analysis in public spaces
https://www.sciencedirect.com/science/article/pii/S0952197620303596
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage the DiMe resource to showcase what appropriate use of a wearable is, and to highlight the barriers to wearable adoption and adherence.
Agnostic
DHTs
Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial
https://pubmed.ncbi.nlm.nih.gov/34529944/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Effectiveness of MHealth Apps and Their Prescribability in General Practice
https://research.bond.edu.au/en/studentTheses/effectiveness-of-mhealth-apps-and-their-prescribability-in-genera
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors leverage DiMe's resources to show the advantages of collaborative work.
Agnostic
Digital Health Applications
Effects of lean interventions supported by digital technologies on healthcare services: a systematic review
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9330917/
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors cite DiMe's work, noting "[lean healthcare] and [digital technologies] as a dual intervention entail significant technical and organizational challenges, including the reallocation of labor and equipment resources. Such reorganization is needed to adapt the technology to social needs, including the beliefs and barriers of patients and caretakers."
Agnostic
DHTs
eHealth-mind the gap
https://www.tandfonline.com/doi/pdf/10.1080/0284186X.2020.1794037
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage concepts from DiMe resources to build their thesis. Excerpt from the text: "However, there seems to be a lack of uniformity, definitions and frameworks within the work with new technologies in healthcare. A pragmatic guide based on knowledge from drug and nutrition labels for how to put an evaluation framework into practice as suggested by ['Modernizing and designing evaluation frameworks for connected sensor technologies in medicine'] might be crucial, crafting a connected sensor technology label"
Agnostic
Oncology
DHTs
Electrical Tomography Reconstruction Using Reconfigurable Waveforms in a FPGA
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8125997/
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors cite DiMe's publication to note that it is "necessary to monitor important vital signs of the patients continuously during extended periods of time that can range up to several days."
Agnostic
DHTs
Electronic Patient-Generated Health Data for Healthcare
https://www.ncbi.nlm.nih.gov/books/n/cod9780645332018/Ch1/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
Estimating sleep stages using cardiorespiratory signals: validation of a novel algorithm across a wide range of sleep-disordered breathing severity
https://jcsm.aasm.org/doi/full/10.5664/jcsm.9192
V3
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use DiMe resources to describe future work that needs to be done to do additional validation. Excerpt from the text referencing the V3 framework: "The flexibility of CReSS to be deployed across a range of devices and minimally invasive signal types may be advantageous as a means to enhance the efficiency of clinical trials requiring sleep staging as a screening tool, covariate, or endpoint, which would require additional validation data in the intended research population(s)"
Cardiovascular Diseases
AI/ML/algorithms
Evaluating the Use of Digital Biomarkers to Test Treatment Effects on Cognition and Movement in Patients with Lewy Body Dementia
https://pubmed.ncbi.nlm.nih.gov/35694933/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535589/
Advancing the Use of Mobile Technologies in Clinical Trials
The authors leverage the DiMe publications to showcase the value of precompetitive collaboration.
Neurological Disorders
Digital Biomarker
Evaluation of a blockchain‐based dynamic consent platform (METORY) in a decentralized and multicenter clinical trial using virtual drugs
https://pubmed.ncbi.nlm.nih.gov/35157788/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors cite "Remote monitoring in clinical trials during the COVID-19 pandemic" paper as validation that "most decentralized clinical trials involve home-based drug administration and remote monitoring"
COVID
Blockchain
DHTs
Examination of distributed learning on recent and remote memory using in-person and online experimental paradigms
https://psyarxiv.com/xk9rw/
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Agnostic
DHTs
Examining the cultural impacts of an emergency department move using ethnography
https://pubmed.ncbi.nlm.nih.gov/34763250/
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors leverage DiMe's publication to highlight the topic of change management in the emergency department "given that patient care delivery processes are highly dependent on clinician ability to adapt to change on a moment-to-moment basis."
Emergency Care
DHTs
Exercise and Rehabilitation of Chronically Ill Patients Assisted by Small Digital Bio-Pulse Sensors
https://www.researchgate.net/publication/359998562_Exercise_and_Rehabilitation_of_Chronically_Ill_Patients_Assisted_by_Small_Digital_Bio-Pulse_Sensors
Multimodal biometric monitoring technologies drive the development of clinical assessments in the home environment
Authors leverage DiMe's publication to note the importance "for economic and social stability and harmonious development to seek effective measures to curb the high incidence of noncommunicable diseases, improve the health of the public, and control the rapidly increasing social medical costs and economic burden."
Musculoskeletal Disorders
Wearables
Digital Biomarker
BioMeTs
Experiences of Norwegian child and school health nurses with the “Starting Right™” child health assessment innovation: a qualitative interview study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9157476/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight potential concerns about using PGHD.
Pediatrics
Prevention
PGHD
Exploring healthcare professionals' perceptions of artificial intelligence: Validating a questionnaire using the e-Delphi method
https://journals.sagepub.com/doi/abs/10.1177/20552076211003433
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Authors reference DiMe's work to highlight the uncertainty around workforce preparedness in adopting technology in healthcare.
Agnostic
AI/ML/algorithms
Exploring the feasibility and acceptability of a sleep wearable headband among a community sample of chronic pain individuals: An at-home observational study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102155/
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Authors reference DiMe's work to point to the importance of training: "validating the headband data, funding for devices, and training development for researchers and clinicians are equally important in facilitating the uptake of these devices."
Sleep
Wearables
Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
https://pubmed.ncbi.nlm.nih.gov/35657813/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Feasibility of Wearable-Based Remote Monitoring in Patients During Intensive Treatment for Aggressive Hematologic Malignancies
https://pubmed.ncbi.nlm.nih.gov/35025669/
The role of digital clinical measures in improving cancer care and research.
Authors leverage DiMe's work to contextualize the current state of digital measures development for this population.
Hematology
Wearables
First Regulatory Qualification of a Novel Digital Endpoint in Duchenne Muscular Dystrophy: A Multi-Stakeholder Perspective on the Impact for Patients and for Drug …
https://www.karger.com/Article/FullText/517411
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors leverage DiMe resources to showcase the opportunities associated with continuous monitor in a real-world setting and note that principles of Good Clinical Practice, data privacy, and protection should be respected when applying novel digital endpoints.
Neurological Disorders
Musculoskeletal Disorders
BioMeTs
Digital Biomarker
Fostering the use of Learning Health Systems through a fellowship program for interprofessional clinicians
https://onlinelibrary.wiley.com/doi/abs/10.1002/lrh2.10340
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Authors reference DiMe's work to point to the importance of training when adopting new technologies, especially in healthcare.
Agnostic
DHTs
Free-living gait does not differentiate chronic mTBI patients compared to healthy controls
https://link.springer.com/article/10.1186/s12984-022-01030-6
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
The authors use DiMe resources to address the evidence base required for (V3) and the limitations of using DHTs, as outlined in "Fit-for-Purpose Biometric Monitoring Technologies: leveraging the laboratory biomarker experience" and "BioMeT and algorithm challenges: a proposed digital standardized evaluation framework."
mild traumatic brain injury
DHTs
Free-living Turning Rather Than Gait Differentiates People with Chronic Mild Traumatic Brain Injury from Controls
https://assets.researchsquare.com/files/rs-270331/v1/a5949fd5-cdc1-4269-a0bc-e7cfcdbb7f91.pdf?c=1631878088
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
The authors use DiMe resources to address the evidence base required for (V3) and the limitations of using DHTs, as outlined in "Fit-for-Purpose Biometric Monitoring Technologies: leveraging the laboratory biomarker experience" and "BioMeT and algorithm challenges: a proposed digital standardized evaluation framework."
mild traumatic brain injury
DHTs
Generalized workflow with uncertainty quantification for detecting abnormalities in lung sounds
https://ntnuopen.ntnu.no/ntnu-xmlui/bitstream/handle/11250/2781081/no.ntnu%3Ainspera%3A76427839%3A45154694.pdf?sequence=1
Digital Medicine: A Primer on Measurement
Authors cite DiMe's primer to validate the claim that, despite technology's revolutionary developments, the healthcare sector lags in putting tools to use.
Respiratory
AI/ML/algorithms
Going remote: Implementing digital research methods at an academic medical center during COVID-19
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8593367/
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Agnostic
DHTs
Health app policy: international comparison of nine countries' approaches
https://www.nature.com/articles/s41746-022-00573-1
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe work to showcase how the field is using connected sensors in healthcare.
Agnostic
Digital Health Applications
Health Workforce Learning in Response to Artificial Intelligence
https://link.springer.com/chapter/10.1007/978-3-030-81850-0_8
Digital Medicine: A Primer on Measurement
Authors leverage DiMe's Digital Medicine Primer to outline the scope of digital health technologies.
Agnostic
AI/ML/algorithms
How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?
https://pubmed.ncbi.nlm.nih.gov/34405554/
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
mHealth and patient generated health data
Authors leverage DiMe resources to contextualize the current state of use of real-world data in health care, and what needs to be done to facilitate stronger use.
Wellness
RWD
HRS white paper on clinical utilization of digital health technology
https://www.sciencedirect.com/science/article/pii/S2666693621000621
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe work to showcase how the field is using connected sensors in healthcare.
Agnostic
DHTs
Identification of thresholds for accuracy comparisons of heart rate and respiratory rate in neonates
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8630397/
V3
As noted by the authors, "the Evaluation of Technologies for Neonates in Africa (ETNA) platform aims to independently establish the accuracy and feasibility of novel continuous monitors suitable for use in neonates in resource-constrained settings." They cited V3 noting that, "to determine the accuracy and agreement, new technologies should be compared against existing reference methods or technologies." However, "before the comparison process can proceed, a clinical reference verification step is necessary to determine appropriate accuracy thresholds," which is the focus of this study.
Agnostic
DHTs
Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials
https://mansapublishers.com/IJCH/article/view/2933
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Impact of the coronavirus (COVID-19) pandemic on scientific research and implications for clinical academic training–a review
https://pubmed.ncbi.nlm.nih.gov/33444873/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833269/
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Agnostic
DHTs
Impact of the COVID-19 pandemic on the conduct of clinical trials: a quantitative analysis
https://pubmed.ncbi.nlm.nih.gov/35968522/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9367669/
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Agnostic
DHTs
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9128333/
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors leverage DiMe's work, citing, "Technological advances including the wide use of mobile devices and increasing popularity in the adoption of wearable devices also facilitate DCTs."
Agnostic
DHTs
Implementation of mobile health technologies in clinical trials of movement disorders: underutilized potential
https://pubmed.ncbi.nlm.nih.gov/32734442/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors leverage DiMe's work to highlight the important need for evidence of clinical meaningfulness of digital measures for regulatory decisions, noting that "this is a pivotal step for FDA and EMA registrations and acceptance of new digital measures in clinical trials."
Musculoskeletal Disorders
DHTs
Implementing health apps for digital public health–an implementation science approach adopting the consolidated framework for implementation research
https://www.frontiersin.org/articles/10.3389/fpubh.2021.610237/full
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
In the discussion of the text, the authors note that "technical aspects for clinical validation should be considered" in future work, and note that the V3 framework for biometric monitoring technologies, "which highlight[s] the need for appropriate vocabulary and standardized approaches to evaluate digitally measured biomarkers, including defining performance characteristics and acceptance criteria" could be used for such clinical validation.
Agnostic
DHTs
Implications of consumerism in health care
https://www.cghjournal.org/article/S1542-3565(20)30280-9/fulltext
Digital Medicine: A Primer on Measurement
The author offers an example of an "idealized scenario in which digital technologies improve the traditional care delivery model by providing the physician relevant data through collection, tracking, and analysis of patient health information from settings that previously were unavailable or unreliable," basing the example off of concepts from DiMe's Digital Medicine Primer.
Agnostic
DHTs
Information system support for medical secretaries' work in patient administration tasks in different phases of the care process
https://erepo.uef.fi/bitstream/handle/123456789/26372/1635767950883304500.pdf?sequence=2&isAllowed=y
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors reference DiMe's work to showcase how roles are evolving within healthcare.
Agnostic
EHR
Innovation in precision cardio-oncology during the coronavirus pandemic and into a post-pandemic world
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456950/
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Oncology
DHTs
Integrating real-world evidence in the regulatory decision-making process: a systematic analysis of experiences in the US, EU, and China using a logic model
https://pubmed.ncbi.nlm.nih.gov/34136505/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200400/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors leverage DiMe's work to showcase existing efforts to work with regulatory agencies.
Agnostic
RWD
Intelligent Pervasive Monitoring Solution of COVID-19 Patients
https://pubmed.ncbi.nlm.nih.gov/35773938/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Intelligent physiological signal infosecurity: Case study in photoplethysmography (PPG) signal
https://ietresearch.onlinelibrary.wiley.com/doi/full/10.1049/sil2.12089
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's resource to confirm that a "PPG sensor can be embedded into a watch or a wristband with a mobile phone display to measure and transmit symptom signals via a communication network."
Agnostic
Wearables
DHTs
BioMeTs
Internet of things issues related to psychiatry
https://journalbipolardisorders.springeropen.com/articles/10.1186/s40345-020-00216-y
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors acknowledge DiMe's work in their discussion around the limitations of their publication, noting validation and efficacy testing were omitted from their scope.
Pyschiatry
DHTs
Investigating sources of inaccuracy in wearable optical heart rate sensors
https://www.nature.com/articles/s41746-020-0226-6?ref=hackernoon.com
V3
Given the increased use of wearable technologies in clinical research and healthcare, authors outline the criticality of understanding wearables' "accuracy and determine how measurement errors may affect research conclusions and impact healthcare decision-making." They use V3 to further cement that the "lack of clarity around the verification and validation procedures and the unknown reliability of the data generated by these wearable technologies poses significant challenges for their adoption in research and healthcare applications."
DiMe journal club recording: https://youtu.be/RQOJOemF1vc
Agnostic
Wearables
Investigating the AX6 inertial-based wearable for instrumented physical capability assessment of young adults in a low-resource setting
https://www.sciencedirect.com/science/article/abs/pii/S2352648321000428
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
Authors note that "the AX3 has been of particular interest for use in healthcare as it is developed under Open Movement (OM1), which is of growing interest as clarification and transparency on how wearables are created for generating digital biomarkers is of increased importance" - referencing DiMe resources as evidence of such interest.
Agnostic
Wearables
Investigating the process of ethical approval in citizen science research: the case of public health
https://jcom.sissa.it/archive/20/06/JCOM_2006_2021_A04
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
Authors leverage DiMe's resource to note that ethical issues concerning participatory citizen science studies have received attention only recently.
Agnostic
DHTs
Is this an epic innovation? Electronic health record implementation and healthcare workers' work characteristics and autonomous motivation–a before-and-after …
https://assets.researchsquare.com/files/rs-563136/v1/efc81efd-1f20-423b-8951-0ef10caaf7cb.pdf?c=1631883726
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors reference DiMe's work to showcase how roles are evolving within healthcare, and the associated challenges with these changes.
Agnostic
EHR
Lack of Acceptance of Digital Healthcare in the Medical Market: Addressing Old Problems Raised by Various Clinical Professionals and Developing Possible …
https://pubmed.ncbi.nlm.nih.gov/34581521/
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
Authors leverage DiMe's work to note that "various issues in digital healthcare devices have been noted, such as lack of improvements in regulations of digital healthcare, lack of data standardization, privacy, and legal liability issues."
Agnostic
DHTs
Left atrial appendage occlusion should be offered only to select atrial fibrillation patients
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9463703/
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
Authors use DiMe's publication when noting that nearly half of eligible atrial fibrillation patients do not receive Oral anticoagulants (OACs), owing to a multitude of factors.
Cardiovascular Diseases
DHTs
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials
https://www.tandfonline.com/doi/full/10.1080/10543406.2022.2080698
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use DiMe's work to highlight the challenges associated with using mobile technologies in clinical trials.
Agnostic
DHTs
EHR
Lost in translation-Silent reporting and electronic patient records in nursing handovers: An ethnographic study
https://www.sciencedirect.com/science/article/pii/S0020748920301206
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors use DiMe's work to showcase how other work aligns with their findings, noting, "This article supports assertions in the literature that when new technologies are implemented, this may be particularly problematic for already marginalized and invisible practices such as those of nurses."
Agnostic
DHTs
Maintaining momentum in infant mental health research during COVID-19: Adapting observational assessments
https://academic.oup.com/jpepsy/article/46/3/254/6178643
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Measuring COVID-19 and influenza in the real world via person-generated health data
https://www.medrxiv.org/content/10.1101/2020.05.28.20115964v1
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
COVID
RWD
Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7974765/
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use DiMe's publication to highlight the advantages of using mobile technologies in clinical trials: "The growing use of mobile technologies, wearable biosensors, and telemedicine in RCTs allows for closer patient monitoring and increased engagement while limiting overhead."
Diabetes
DHTs
Digital Health Applications
mHealth for pediatric chronic pain: state of the art and future directions
https://pubmed.ncbi.nlm.nih.gov/32881587/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657989/
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer to conclude that "at present, objective assessment and patient-reported measures have the stronger evidence-base and continue to be the gold standard for use in healthcare"
Chronic Pain
Telehealth
More than a biomarker: could language be a biosocial marker of psychosis?
https://www.nature.com/articles/s41537-021-00172-1
V3
The authors discuss the need for analytical and clinical validations, in addition to other evaluations, including that of the social determinants of linguistic aberrations highlighted here.
Multimodal biometric monitoring technologies drive the development of clinical assessments in the home environment
https://www.sciencedirect.com/science/article/pii/S0378512221001109
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Digital measures that matter to patients
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Remote Digital Monitoring for Medical Product Development
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
The authors acknowledges the importance of several DiMe resources as foundational bodies of work and builds on them to provide recommendations to advance the use of multimodal BioMeTs in clinical care.
Agnostic
BioMeTs
Narrative review of citizen science in environmental epidemiology: Setting the stage for co-created research projects in environmental epidemiology
https://pubmed.ncbi.nlm.nih.gov/33677244/https://www.sciencedirect.com/science/article/pii/S0160412021000957?via%3Dihub
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
Authors leverage DiMe's work to note that "only recently have the ethical issues concerning [citizen science] (CS) received any attention. Nevertheless, a number of ethical challenges relevant to CS in environmental epidemiology have already been discussed in the context of health and biomedical research."
Epidemiology
Agnostic
Neuromechanical biomarkers for robotic neurorehabilitation
https://www.frontiersin.org/articles/10.3389/fnbot.2021.742163/full
Digital measures that matter to patients
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors use DiMe resources to highlight the challenges associated with using biomarkers in research, including the "requirement of the high-quality engagement of the patient necessary to obtain and deploy biomarkers."
Neurological Disorders
Digital Biomarker
Neuropsychological test validation of speech markers of cognitive impairment in the Framingham Cognitive Aging Cohort
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570561/
Digital Medicine: A Primer on Measurement
Authors reference DiMe's Digital Medicine Primer to offer an additional reason record and digitize cognitive examination speech data, nothing that this form of speech data collection is "cost-effective and accessible and incurs a minimal clinical burden on clinicians and patients."
Neurological Disorders
Mental Disorder
AI/ML/algorithms
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective
https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.2628
V3
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The authors note the "challenges associated with the validation of digital technologies have been said to impede their uptake... [and that' a discussion of the requirements for the qualification of digital technology is beyond the scope of this paper, but these have been previously described," and refer to DiMe's V3.
Agnostic
DHTs
Opportunity for efficiency in clinical development: An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the …
https://www.sciencedirect.com/science/article/pii/S1551714421001336?via%3Dihub
Digital Medicine: A Primer on Measurement
Authors discuss the use of AI/ML "can help meet the growing complexities of clinical research and adaptive designs." They stipulate that the effective use of such technologies requires "carefully defined and properly validated digital endpoints [to] improve assessment of the outcomes and increase power and efficiency of clinical [and] be useful in adaptive design applications."
Agnostic
AI/ML/algorithms
Optimization of IoT-based artificial intelligence assisted telemedicine health analysis system
https://ieeexplore.ieee.org/abstract/document/9450819/references#references
V3
Authors reference the V3 publication, noting that in "health sensing devices, the physiological indicators that can be detected include blood oxygen, pulse rate, blood pressure, blood sugar, bone density, Electrocardiograph (ECG), body temperature, respiration, etc."
Agnostic
AI/ML/algorithms
Telehealth
Outcome measures based on digital health technology sensor data: data-and patient-centric approaches
https://www.nature.com/articles/s41746-020-0305-8
Advancing the Use of Mobile Technologies in Clinical Trials
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors use DiMe's work to highlight the challenges associated with using mobile technologies in clinical trials.
Agnostic
DHTs
Overcoming Pilotitis in Digital Medicine at the Intersection of Data, Clinical Evidence, and Adoption
https://onlinelibrary.wiley.com/doi/full/10.1002/aisy.202200056
V3
Digital Medicine: A Primer on Measurement
Digital measures that matter to patients
Advancing the Use of Mobile Technologies in Clinical Trials
Advancing digital health applications: priorities for innovation in real-world evidence generation
Sensor Data Integration: A New Cross-Industry Collaboration
Authors reference DiMe's definition of digital medicine, as well as other DiMe publications, to underscore the diligence needed to effectively leverage digital medicine and avoid pilotitis: "Although seemingly straightforward in theory, designing clinical study programs with biomarkers as a core element of efficacy and safety outcomes will require that developers of digital medicine build up extensive knowledge in the fields of diagnostics expertise, e.g., IVD, electrophysiology, and radiology, consequently take on the roles and responsibilities of medical technology manufacturers, and use established validation frameworks to ensure quality and reliability of products."
Agnostic
DHTs
Participatory approaches to delivering clinical sexually transmitted infections services: a narrative review
https://pubmed.ncbi.nlm.nih.gov/35942569/
Digital measures that matter to patients
Authors leverage concepts from DiMe's Measures that Matter work to highlight the importance of integrating patients' perspectives.
Sexually Transmitted Infections
DHTs
Passive monitoring of physiological data and self-reported symptoms to detect clusters of people with COVID-19
https://www.medrxiv.org/content/10.1101/2020.07.06.20141333v1
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors reference DiMe's work to note that digital trials such as the one the authors studied "come with unique challenges to assure privacy and security, which can only be dealt with by effectively informing participants before consent, storing the data with the needed level of security and providing access to the data only for research purposes."
COVID
PGHD
DHTs
Patent landscape of automated systems for personalized health management (ASHM): features, shortcomings, and implications for developing an optimal …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522012/
Digital Medicine: A Primer on Measurement
Authors leverage DiMe's definition of Digital Medicine to align readers on the scope of the field.
Agnostic
health management system
Patient barriers to participation in breast cancer clinical trials
https://www.futuremedicine.com/doi/10.2217/bmt-2020-0004
Digital Medicine: A Primer on Measurement
Authors leverage DiMe's Digital Medicine Primer to introduce the idea that decentralize clinical trials can improve access to clinical trials by changing where and how the data are collected.
Oncology
DHTs
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications
https://link.springer.com/article/10.1007/s43441-021-00306-8
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Patient-Generated Health Photos and Videos Across Health and Well-being Contexts: Scoping Review
https://www.jmir.org/2022/4/e28867/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
Patient-powered research networks of the autoimmune research collaborative: rationale, capacity, and future directions
https://link.springer.com/article/10.1007/s40271-021-00515-1
Digital measures that matter to patients
Authors leverage concepts from DiMe's Measures that Matter work to highlight the importance of integrating patients' perspectives.
Patient–Physician Relationship in Telemedicine
https://link.springer.com/chapter/10.1007/978-3-030-99457-0_4
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's work to note that "remote biometric monitoring of multiple essential parameters, particularly widespread during a pandemic, to prevent the progression of the disease towards disability or premature death, has shown all its effectiveness in tertiary prevention."
Agnostic
Telehealth
Patients' Perspectives on Transforming Clinical Trial Participation: Large Online Vignette-based Survey
https://www.jmir.org/2022/2/e29691/
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to introduce the topic of their paper
COVID
DHTs
Paving the Way for Electronic Patient-Centered Measurement in Team-Based Primary Care: Integrated Knowledge Translation Approach
https://formative.jmir.org/2022/3/e33584/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight barriers to using PGHD.
Agnostic
PGHD
Pervasive lying posture tracking
https://www.mdpi.com/864754
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors leverage DiMe work to showcase how the field is using connected sensors in healthcare.
Agnostic
DHTs
Piecing Together the Puzzle of Adherence in Sleep Medicine
https://pubmed.ncbi.nlm.nih.gov/33485535/
Digital measures that matter to patients
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
The Authors leverage DiMe work to contextualize the changing landscape of biometric monitoring technology as of the time of publication.
Sleep
DHTs
Postdischarge recovery after acute pediatric lung disease can be quantified with digital biomarkers
https://www.karger.com/Article/Abstract/516328
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use DiMe's publication to highlight the advantages of using mobile technologies in clinical trials.
Respiratory
Digital Biomarker
Practice co-evolution: Collaboratively embedding artificial intelligence in retail practices
https://link.springer.com/article/10.1007/s11747-022-00896-1
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Authors reference DiMe's work to showcase how roles are evolving within healthcare.
Agnostic
DHTs
Practicing with uncertainty: kidney transplantation during the COVID-19 pandemic
https://www.sciencedirect.com/science/article/pii/S0272638620311914
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's publication to showcase the advantages of remote technologies, including the fact that "home blood-pressure monitoring and other remote monitoring tools may increase options for adjunctive testing and monitoring outside of the clinic setting."
Nephrology
DHTs
Predicting Parkinson's Disease and Its Pathology via Simple Clinical Variables
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd212876
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Authors leverage DiMe's publication to highlight the future work that needs to be done in PD.
Parkinson's Disease
Neurological Disorders
DHTs
AI/ML/algorithms
Predicting subjective recovery from lower limb surgery using consumer wearables
https://www.karger.com/Article/Abstract/511531
V3
Digital Medicine: A Primer on Measurement
Remote Digital Monitoring for Medical Product Development
Authors note that digital measures are becoming increasingly sophisticated in terms of their development for clinical usage (citing V3) and that we are seeing the first accepted and qualified examples already emerging (citing Remote digital monitoring for medical product development) as the "preamble" to their work assessing recovery from a range of lower limb surgeries relative to a personal baseline derived from long-term passive monitoring with consumer wearables.
Musculoskeletal Disorders
Wearables
Prediction of VO2max From Submaximal Exercise Using the Smartphone Application Myworkout GO: Validation Study of a Digital Health Method
https://cardio.jmir.org/2022/2/e38570/
V3
Authors who sought to determine the accuracy of using a smartphone and the application Myworkout GO for submaximal prediction of VO2max reference a finding from DiMe's V3 work in the introduction to their work. They note that "since wearable technology companies are solely responsible for reporting the accuracy of their products, little information about the evaluation method is made publicly available."
Cardiovascular Diseases
Agnostic
DHTs
Quantifying Participant Burden In Clinical Trials: Data From Prostate Cancer Rcts
https://www.researchsquare.com/article/rs-1339592/latest.pdf
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Oncology
RWD
Quantifying the use of connected digital products in clinical research
https://www.nature.com/articles/s41746-020-0259-x
Digital Medicine: A Primer on Measurement
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors, who found a 34% CAGR in use of connected sensors, cite DiMe work saying that that "verification and validation of digital products through clinical studies is a necessary first step to stimulate broader adoption in the clinical research and care settings." They also use DiMe's systematic review of feasibility studies to show the increased use of mobile and remote monitoring technologies in clinical studies.
Agnostic
DHTs
Regulatory agilities in the time of covid-19: overview, trends, and opportunities
https://www.sciencedirect.com/science/article/pii/S0149291820305257
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to validate the need for more international cooperation around clinical trials
COVID
DHTs
Regulatory, legal, and market aspects of smart wearables for cardiac monitoring
https://www.mdpi.com/1424-8220/21/14/4937/htm
V3
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
The authors use the terminology outlined in DiMe publications to standardize their work among the other bodies of work that have also adopted this language.
Cardiovascular Diseases
Agnostic
Wearables
Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study
https://link.springer.com/article/10.1007/s00415-022-11306-5
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Authors note DiMe's work when discussing the need for future work. Excerpt from the text below: "Overall, the observed reliability and high grade of perceived meaningfulness of the tests included in dreaMS encourage further development of this software application as an important future monitoring tool for PwMS. As with other proposed applications for monitoring MS, longer-term studies, for example in well-documented large cohorts of PwMS, must follow to support sensitivity to change and concurrent as well as content validity as digital biomarkers"
Multiple Sclerosis
Neurological Disorders
Digital Health Applications
Remote administration of BICAMS measures and the Trail-Making Test to assess cognitive impairment in multiple sclerosis
https://www.tandfonline.com/doi/abs/10.1080/09602011.2022.2052324
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Multiple Sclerosis
Neurological Disorders
DHTs
Digital Biomarker
Remote cardiac safety monitoring through the lens of the FDA biomarker qualification evidentiary criteria framework: a case study analysis
https://pubmed.ncbi.nlm.nih.gov/34056520/
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Remote digital monitoring in clinical trials in the time of COVID-19
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to illustrate the benefits of remote monitoring
Cardiovascular Diseases
Digital Biomarker
Remote monitoring in clinical trials during the covid‐19 pandemic
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors of this publication leverage DiMe's systematic review to note that while clinical trials may take longer to adjust to the pandemic conditions, they are likely to adapt in a similar way to telehealth and that there are "safety and efficacy clinical measurements can be performed remotely as attested by several feasibility studies."
Agnostic
DHTs
Research is in the air in Valle del Serchio
https://www.sciencedirect.com/science/article/pii/S0016328722000064
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
Authors leverage DiMe's work to note that "ethical issues concerning participatory [citizen science] studies have only recently become the subject of attention."
Agnostic
DHTs
Review of Remote Usability Methods for Aging in Place Technologies
https://link.springer.com/chapter/10.1007/978-3-030-78108-8_3
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's work to note the evaluation methods used by medical technology designers during the COVID-19 pandemic.
Agnostic
DHTs
Review on emerging Internet of Things technologies to fight the COVID-19
https://ieeexplore.ieee.org/abstract/document/9296161/
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's work to note the capabilities of Smart Thermometers
COVID
DHTs
Six digital health technologies that will transform diabetes
https://journals.sagepub.com/doi/abs/10.1177/19322968211043498
Digital Medicine: A Primer on Measurement
Authors use DiMe's Digital Medicine Primer to validate the notion that "the adoption of digital technologies in healthcare compared to other industries has been challenging, given the need for coordination between many stakeholders including patients, clinicians, engineers, ethicists, payers, and regulatory agencies"
Diabetes
DHTs
AI/ML/algorithms
Telehealth
Smoking and Caffeine Consumption during Pregnancy and Offspring Mental Health: Disentangling Causal from Confounded Associations using Genetic and …
https://research-information.bris.ac.uk/ws/portalfiles/portal/306780892/Final_Copy_2021_12_30_Schellhas_L_PhD.pdf
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's work to contextualize the growth of remote monitoring during COVID.
Womens Health
Mental Disorder
AI/ML/algorithms
Sports related concussion: an emerging era in digital sports technology
https://www.nature.com/articles/s41746-021-00538-w
V3
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Authors discuss the need for more routine "validation, standardization in testing paradigms, and transparency on their use, including algorithms and data analysis methods," citing V3 as a framework to establish such standardization.
Standardized Integration of Person-Generated Data Into Routine Clinical Care
https://mhealth.jmir.org/2022/2/e31048/
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors leverage DiMe's work to note that "person-generated data (PGD) are a valuable source of information on a person’s health state in daily life and in between clinic visits."
Prevention
Agnostic
DHTs
Strengthening the Impact of Digital Cognitive Behavioral Interventions Through a Dual Intervention: Proficient Motivational Interviewing–Based Health …
https://formative.jmir.org/2022/5/e34552/
Digital Medicine: A Primer on Measurement
The authors use DiMe's Digital Medicine Primer to introduce the current use and potential of digital health tools.
Mental Disorder
Agnostic
DHTs
Stride Velocity 95th Centile: Insights into Gaining Regulatory Qualification of the First Wearable-Derived Digital Endpoint for use in Duchenne Muscular …
https://content.iospress.com/articles/journal-of-neuromuscular-diseases/jnd210743
Remote Digital Monitoring for Medical Product Development
Authors leverage DiMe's research to show that, while promising, "concerns regarding the accuracy and the lack of regulatory support have limited the incorporation of wearables into clinical trials."
Neurological Disorders
Musculoskeletal Disorders
Wearables
Strong Men, Strong Communities: Revision of a Diabetes Prevention Intervention for American Indian and Alaska Native Men During the COVID-19 Pandemic
https://coloradosph.cuanschutz.edu/docs/librariesprovider205/journal_files/vol29/29_2_2022_85_sinclair.pdf
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Authors leverage high-level concepts from 'Remote Monitoring in Clinical Trials During the COVID-19 Pandemic' to illustrate the benefits of remote monitoring
Diabetes
COVID
DHTs
The AI-Powered Digital Health Sector: Ethical and Regulatory Considerations When Developing Digital Mental Health Tools for the Older Adult Demographic
https://link.springer.com/chapter/10.1007/978-3-030-74188-4_11
Digital Medicine: A Primer on Measurement
In the discussion around the regulatory environment surrounding AI-powered tools, authors cite DiMe's Primer on Digital Medicine to confirm the FDA's definition of a medical device - that is "when the intended use refers to a specific disease or condition."
Mental Disorder
Agnostic
AI/ML/algorithms
The collaborative aging research using technology initiative: An open, sharable, technology-agnostic platform for the research community
https://www.karger.com/Article/Abstract/512208
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors leverage DiMe's work to note that while remote monitoring tools have been developed to advance aging research, "the broader gerontological research communities have not seen more widespread uptake of these methods, despite the demonstrated feasibility and potential of smart home and pervasive computing platforms to uniquely inform aging research and healthcare of older adults."
Agnostic
DHTs
The evolving direct and indirect platforms for the detection of SARS-CoV-2
https://www.sciencedirect.com/science/article/pii/S0166093421003207
V3
Authors use concepts from V3 to note the challenges surrounding the need for "trained personnel and expensive laboratory instruments."
COVID
DHTs
The Future of Design for Health and Wellbeing
https://link.springer.com/chapter/10.1007/978-3-030-86596-2_15
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
The German Fast Track Toward Reimbursement of Digital Health Applications (DiGA): Opportunities and Challenges for Manufacturers, Healthcare Providers, and …
https://journals.sagepub.com/doi/abs/10.1177/19322968221121660
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors leverage DiMe's work to note the challenges with performing randomized controlled clinical trials (RCT).
Agnostic
DHTs
The hopes and hazards of using personal health technologies in the diagnosis and prognosis of infections
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(21)00064-9/fulltext
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Authors leverage DiMe's work to note that it is "important to recognise that the accuracy of the information provided is variable and should not be considered clinically dependable unless appropriate validation evidence exists, and ideally regulatory agency approval."
Viral Infections
DHTs
The impact of digital therapeutics on current health technology assessment frameworks
https://www.frontiersin.org/articles/10.3389/fdgth.2021.667016/full
Digital Medicine: A Primer on Measurement
Authors cite DiMe's primer to validate the claim that "healthcare lags behind other industries (e.g., financial, transportation) which have already incorporated digital technologies in their workflow."
Agnostic
Digital Therapeutics
The impact of expanded telehealth availability on primary care utilization
https://www.nature.com/articles/s41746-022-00685-8
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort
Authors leverage DiMe's work to confirm their observation that "telehealth was mostly utilized for patients whose medical needs required multiple primary care visits during each year, suggesting that these telehealth encounters enabled follow-up for patients with chronic illness."
Agnostic
Telehealth
The National Institute of Neurological Disorders and Stroke (NINDS)'sBest Practices for Digital Health Outcomes
https://www.commondataelements.ninds.nih.gov/sites/nindscde/files/Doc/PD/F3012_Best_Practices_for_Digital_Health_Outcomes.pdf
V3
Digital measures that matter to patients
EVIDENCE Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
The working group, which released Best Practices for Digital Health Outcomes in 2022, extensively leveraged several DiMe resources, namely Digital Measures that Matter to Patients, V3, EVIDENCE Checklist, and The Playbook: Digital Clinical Measures. Specifically, authors use the DiMe resources to develop new, standardized best practices for improved digital measurement in PD research. Check out DiMe's Resources in Action Hub to learn more about how the working group is driving PD research forward using DiMe resources.
DiMe Case Studies: 1. EVIDENCE CHecklist: https://www.dimesociety.org/wp-content/uploads/NIH-working-group-uses-EVIDENCE.pdf 2. V3: https://www.dimesociety.org/wp-content/uploads/NIH-working-group-uses-V3-1.pdf 3. Other DiMe resources:https://www.dimesociety.org/wp-content/uploads/NIH-working-group-uses-DiMe-resources.pdf
Parkinson's Disease
DHTs
The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?
https://journals.sagepub.com/doi/abs/10.1177/1073110520917031
Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research
Authors state "Patrick-Lake and Goldsack more recently noted an alarming ethics gap for citizen science and called for tailored efforts to address the special ethical challenges it presents" to contextualize the citizen science current state.
Agnostic
DHTs
The pursuit of health equity in digital transformation, health informatics, and the cardiovascular learning healthcare system
https://www.sciencedirect.com/science/article/pii/S2666602222000775
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
The role of digital medicine in autism spectrum disorder
https://www.sciencedirect.com/science/article/pii/S0924977X21001528
Digital Medicine: A Primer on Measurement
Authors leverage DiMe's definition of Digital Medicine to align readers on the scope of the field.
The Role of Machine Learning and Artificial Intelligence in Clinical Decisions and the Herbal Formulations Against COVID-19
https://www.igi-global.com/article/the-role-of-machine-learning-and-artificial-intelligence-in-clinical-decisions-and-the-herbal-formulations-against-covid-19/298635
Digital Medicine: A Primer on Measurement
Authors leverage DiMe's definition of Digital Medicine to align readers on the scope of the field.
The state of telemedicine for persons with Parkinson's disease
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8279892/
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Authors leverage DiMe's publication to highlight the future work that needs to be done in PD.
Parkinson's Disease
Neurological Disorders
Telehealth
The technical landscape for patient-centered CDS: progress, gaps, and challenges
https://academic.oup.com/jamia/article-abstract/29/6/1101/6545920
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Agnostic
PGHD
The UpSMART Accelerator: driving digital innovation to change the conduct of early phase cancer medicine trials
https://www.digitmedicine.com/article.asp?issn=2542-629X;year=2022;volume=8;issue=1;spage=1;epage=1;aulast=Fouziah
Digital Medicine: A Primer on Measurement
Remote digital monitoring in clinical trials in the time of COVID-19
Authors leverage DiMe's definition of Digital Medicine to align readers on the scope of the field.
The use of wearables in clinical trials during cancer treatment: Systematic review
https://mhealth.jmir.org/2020/11/e22006/
V3
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
The authors performed a systematic review on the use of wearables in clinical trials during cancer treatment. They ultimately suggest that "future research include measurements of relevant, well-defined outcomes and be based on guidelines within the field," leveraging concepts foundational to the V3 framework.
Oncology
Wearables
Towards a Digital Sleep Diary Standard
https://aisel.aisnet.org/amcis2022/sig_health/sig_health/10/
mHealth and patient generated health data
Authors leverage DiMe's publication to highlight opportunities to use PGHD.
Sleep
PGHD
Towards remote healthcare monitoring using accessible IoT technology: state-of-the-art, insights and experimental design
https://biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-020-00825-9
V3
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
Authors discussed the importance of establishing that a device is fit-for-purpose in their methodology, leveraging DiMe resources (such as V3). Excerpt from text: "Sensor use within healthcare research is becoming more prevalent, but it has often been reactive rather than proactive as innovation in this field can be quite fractious. With continued uptake of emergent technologies, biomedical engineers must perform robust and vigorous bench testing to ensure new sensor-based technologies are valid and fit-for-purpose. There is no absolute standard regarding sensor selection, as choosing an appropriate sensor will depend on what the researcher needs to measure and the subsequent digital endpoint(s) that is/are sensitive to the pathology in question. Once fit-for-purpose sensors have been selected, appropriate and equally fit-for-purpose processing units (i.e. what the sensors are integrated into) must also be selected, to send control signals to the sensors as well as read and process sensor data."
Agnostic
DHTs
Translation of digital health technologies to advance precision medicine: informing regulatory science
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204775/
Digital Medicine: A Primer on Measurement
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors use DiMe's Digital Medicine Primer to introduce the subject of digital technologies.
Agnostic
DHTs
Digital Biomarker
Translational precision medicine: an industry perspective
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-02910-6
V3
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Authors note that it is "vital to thoroughly verify technology and analytical solutions and clinically validate digital biomarkers in the desired cohorts and context of use, prior to their adoption as clinical endpoints," yet, very limited solutions are undergoing clinical validation. The spotlight several efforts, including DiMe, that are "shaping and accelerating the development of validated digital biomarkers."
Agnostic
DHTs
Usability of a wrist-worn smartwatch in a direct-to-participant randomized pragmatic clinical trial
https://www.karger.com/Article/Abstract/504838
Digital Medicine: A Primer on Measurement
Authors used DiMe's Primer on Digital Medicine Measurement to describe how trials "may be conducted outside the clinic to capture data about study participants in their day-to-day life."
Agnostic
Wearables
Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study
https://www.researchprotocols.org/2021/5/e26096/
V3
Authors leverage V3, among other literature, to put forth one definition of "wearable."
Oncology
BioMeTs
Utilizing graph machine learning within drug discovery and development
https://academic.oup.com/bib/article-abstract/22/6/bbab159/6278145
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use DiMe's publication to highlight the advantages of using mobile technologies in clinical trials.
Agnostic
AI/ML/algorithms
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
https://www.nature.com/articles/s41746-020-0260-4
Digital Medicine: A Primer on Measurement
The authors of the V3 Framework leverage the Digital Medicine Primer when discussing pathways for regulatory oversight of the validation process.
V3 project website: https://www.dimesociety.org/access-resources/v3/ V3 Resource in Action Stories: https://www.dimesociety.org/resources-in-action/#V3
Agnostic
BioMeTs
Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes
https://www.nature.com/articles/s41746-021-00513-5
V3
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Remote Digital Monitoring for Medical Product Development
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Authors note that "The regulatory pathway for validating and qualifying DMOs—and digital outcomes in general—is taking shape due to the collaborative efforts of regulators, industry, academics, and pre-competitive consortia" - citing DiMe research as an example of this collaboration. The authors continue: "The time is right for collaborative development of terminology, algorithms, methods, and evaluation frameworks for mutually interesting DMOs, which may streamline the validation of DMOs in PD, MS, COPD, PFF, and other medical conditions."
Parkinson's Disease
Neurological Disorders
Cardiovascular Diseases
Musculoskeletal Disorders
DHTs
Wearable Accelerometers in Cancer Patients
https://link.springer.com/chapter/10.1007/978-3-030-83620-7_5
V3
Authors note the need for well-defined outcomes, using available guidance within the field, such as V3, amid the growing use of wearable accelerometers in cancer research.
Oncology
Wearables
Wearable Based Calibration of Contactless In-home Motion Sensors for Physical Activity Monitoring in Community-Dwelling Older Adults
https://www.frontiersin.org/articles/10.3389/fdgth.2020.566595/full
Digital Medicine: A Primer on Measurement
Authors use language from DiMe's Primer on Digital Medicine Measurement to establish the definition of digital biomarker.
Agnostic
Wearables
Wearable devices: current status and opportunities in pain assessment and management
https://www.karger.com/Article/Abstract/515576
Advancing the Use of Mobile Technologies in Clinical Trials
Authors use the DiMe publication to highlight the importance of standardization in the use of wearables.
Chronic Pain
Wearables
Wearable sensor data and self-reported symptoms for COVID-19 detection
https://www.nature.com/articles/s41591-020-1123-x?mc_cid=b6080dc7a6&mc_eid=7babf33fda
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Authors reference the DiMe publication when noting privacy and security challenges associated with the use of digital in clinical trials. Excerpt from text: "Digital trials such as DETECT also do come with unique challenges to assure privacy and security, which can only be dealt with by effectively informing participants before consent, storing the data with the appropriate level of security and providing access to the data only for research purposes."
COVID
Wearables
Web-Based Patient Self-Reported Outcome After Radiotherapy in Adolescents and Young Adults With Cancer: Survey on Acceptance of Digital Tools
https://mhealth.jmir.org/2021/1/e19727/
mHealth and patient generated health data
Authors reference the DiMe publication, noting that "significant obstacles are the lack of technical standards and often difficulties integrating a system that needs external access to the clinic network."
Oncology
DHTs
What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients
https://www.mdpi.com/2072-6643/14/14/2999
Advancing digital health applications: priorities for innovation in real-world evidence generation
Authors reference the DiMe publication to highlight the future work to be done to advance the adoption of digital health applications. Excerpt from the text: "In general, large-scale analyses of real-world data sets that capitalize on the richness of digital devices as data sources will likely aid the understanding of the uptake, adherence, patient-friendliness, and clinical outcomes of BBCI"
Agnostic
DHTs
Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019–2020? A cross-sectional study in ClinicalTrials. gov
https://bmjopen.bmj.com/content/12/8/e063236.abstract
Digital Medicine: A Primer on Measurement
The authors reference DiMe's Primer on Digital Medicine while advocating for decentralized digital trials, using the primer when noting that "data generated through wearables is less influenced by recall and observer bias and could lead to more continuous data collection, which may reduce trial timelines and improve safety monitoring."
Agnostic
Wearables
DHTs
Patient Acceptance of Self-Monitoring on Smartwatch in a Routine Digital Therapy: a Mixed-Methods Study
https://doi.org/10.1145/3617361
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research
Two years of approved digital health applications in Germany – Perspectives and experiences of general practitioners with an affinity for their use
https://doi.org/10.1080/13814788.2023.2186396
Advancing digital health applications: priorities for innovation in real-world evidence generation
Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis
https://doi.org/10.1186/s12913-023-09287-w
Advancing digital health applications: priorities for innovation in real-world evidence generation
Methods for Navigating the Mobile Mental Health App Landscape for Clinical Use
https://doi.org/10.1007/s40501-023-00288-4
Advancing digital health applications: priorities for innovation in real-world evidence generation
Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review
https://doi.org/10.2196/48000
Advancing digital health applications: priorities for innovation in real-world evidence generation
Digital Health Applications: Toward a Lifecycle and Pay-for-Performance Approach
https://doi.org/10.1016/j.mcpdig.2023.07.001
Advancing digital health applications: priorities for innovation in real-world evidence generation
Non-pharmaceutical interventions to optimize cancer immunotherapy
https://doi.org/10.1080/2162402X.2023.2255459
Advancing digital health applications: priorities for innovation in real-world evidence generation
Non-pharmaceutical interventions to optimize cancer immunotherapy
https://doi.org/10.1080/2162402X.2023.2255459
Advancing digital health applications: priorities for innovation in real-world evidence generation
Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping
https://doi.org/10.2196/49003
Advancing digital health applications: priorities for innovation in real-world evidence generation
The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study
https://doi.org/10.1080/17434440.2023.2291454
Advancing digital health applications: priorities for innovation in real-world evidence generation
Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review
https://doi.org/10.2196/48000
Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care
Mobile Apps and Quality of Life in Patients With Breast Cancer and Survivors: Systematic Literature Review
https://doi.org/10.2196/42852
Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care
Data-Driven Personalized Care in Lung Cancer: Scoping Review and Clinical Recommendations on Performance Status and Activity Level of Patients With Lung Cancer Using Wearable Devices
https://ascopubs.org/doi/full/10.1200/CCI.23.00016
Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care
Understanding Medical 4.0 implementation through enablers: An integrated multi-criteria decision-making approach
https://www.sciencedirect.com/science/article/pii/S294995342300005X
Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care
Mobility recorded by wearable devices and gold standards: the Mobilise-D procedure for data standardization
https://doi.org/10.1038/s41597-023-01930-9
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Technologies in Mobility Disorders
https://doi.org/10.1007/978-3-031-32246-4_6
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST
https://doi.org/10.1159/000533189
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Review of strategies to investigate low sample return rates in remote tobacco trials: A call to action for more user-centered design research
https://doi.org/10.1016/j.addicn.2023.100090
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
A Systematic Review on ICT-based Remote and Automatic COVID-19 Patient Monitoring and Care
https://doi.org/10.21203/rs.3.rs-2627405/v1
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
Clinical Validation of Novel Digital Measures: Statistical Methods for Reliability Evaluation
https://doi.org/10.1159/000531054
Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials
Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective
https://doi.org/10.1186/s13023-023-02693-7
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
The Importance of Data Quality Control in Using Fitbit Device Data From the All of Us Research Program
https://doi.org/10.2196/45103
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Digging Deep into Digital Biomarkers: Empowering Clinical Trials
https://phuse.s3.eu-central-1.amazonaws.com/Archive/2023/Connect/US/Florida/PAP_ST10.pdf
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
https://doi.org/10.1007/s12311-023-01625-2
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Exploring how health professionals equip themselves to successfully adapt to digital technologies – by examining the generational differences
https://www.healthinformaticscertification.com/exploring-how-health-professionals-equip-themselves-to-successfully-adapt-to-digital-technologies-by-examining-the-generational-differences/?utm_source=rss&utm_medium=rss&utm_campaign=exploring-how-health-professionals-equip-themselves-to-successfully-adapt-to-digital-technologies-by-examining-the-generational-differences
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
Commentary: Patient Perspectives on Artificial Intelligence; What have We Learned and How Should We Move Forward?
https://doi.org/10.1007/s12325-023-02511-3
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Patient Willingness to Use Digital Health Technologies: A Quantitative and Qualitative Survey in Patients with Cancer Cachexia
https://doi.org/10.2147/PPA.S396347
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Reverse Engineering of Digital Measures: Inviting Patients to the Conversation
https://doi.org/10.1159/000530413
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Co-Design of a Voice-Based Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 (UpcomingVoice Study): Protocol for a Mixed Methods Study
https://doi.org/10.2196/46103
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
A patient-centred conceptual model of nocturnal scratch and its impact in atopic dermatitis: A mixed-methods study supporting the development of novel digital measurements
https://doi.org/10.1002/ski2.262
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Clinical Application of Technology: Why Are they Needed, How to Implement, and What Challenges
https://doi.org/10.1007/978-3-031-32246-4_2
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
The Case for the Patient-Centric Development of Novel Digital Sleep Assessment Tools in Major Depressive Disorder
https://doi.org/10.1159/000533523
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study
http://dx.doi.org/10.1136/bmjopen-2022-068264
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
An Aligned Framework of Actively-collected and Passively-monitored Clinical Outcome Assessments (COAs) for Measure Selection
https://osf.io/preprints/osf/w7ze3
Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health
Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior
https://ascopubs.org/doi/abs/10.1200/CCI.23.00055
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Mobilizing Patient and Public Involvement in the Development of Real-World Digital Technology Solutions: Tutorial
https://doi.org/10.2196/44206
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
https://doi.org/10.1007/s12311-023-01625-2
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Wearable Biosensors in Congenital Heart Disease: Needs to Advance the Field
https://www.jacc.org/doi/full/10.1016/j.jacadv.2023.100267
Digital Medicine: A Primer on Measurement
Definitions of digital biomarkers: a systematic mapping of the biomedical literature
https://doi.org/10.1101/2023.09.01.23294897
Digital Medicine: A Primer on Measurement
Digital Health Technology for Real-World Clinical Outcome Measurement Using Patient-Generated Data: Systematic Scoping Review
https://doi.org/10.2196/46992
Digital Medicine: A Primer on Measurement
Digging Deep into Digital Biomarkers: Empowering Clinical Trials
https://phuse.s3.eu-central-1.amazonaws.com/Archive/2023/Connect/US/Florida/PAP_ST10.pdf
Digital Medicine: A Primer on Measurement
The use of digital outcome measures in clinical trials in rare neurological diseases: a systematic literature review
https://doi.org/10.1186/s13023-023-02813-3
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST
https://doi.org/10.1159/000533189
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior
https://ascopubs.org/doi/abs/10.1200/CCI.23.00055
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
The Veterans ECS21 (Exploring Cannabigerol for Sleep) Study: A protocol for the first randomized clinical trial of Cannabigerol (CBG), a decentralized study designed for U.S. Veterans in California
https://doi.org/10.1101/2023.03.13.23287212
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Feasibility and usability of a digital health technology system to monitor mobility and assess medication adherence in mild-to-moderate Parkinson's disease
https://doi.org/10.3389/fneur.2023.1111260
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
A systematic review assessing the state of analytical validation for connected, mobile, sensor-based digital health technologies
https://doi.org/10.1101/2023.05.22.23290371
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework
https://doi.org/10.1038/s41746-023-00836-5
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
https://doi.org/10.1007/s12311-023-01625-2
EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration
Immunogenomic Biomarkers and Validation in Lynch Syndrome
https://doi.org/10.3390/cells12030491
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Digital Technologies: Innovations that transform the face of drug development
https://doi.org/10.1111/cts.13533
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
Digital health technology derived measures: Biomarkers or clinical outcome assessments?
https://doi.org/10.1111/cts.13529
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19
https://doi.org/10.2196/40622
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
Ground Reaction Forces and Lower Extremity Fracture Rehabilitation
https://www.proquest.com/docview/2878155147?pq-origsite=gscholar&fromopenview=true&sourcetype=Dissertations%20&%20Theses
mHealth and patient generated health data: stakeholder perspectives on opportunities and barriers for transforming healthcare
Wearable Devices in Cardiovascular Medicine
https://doi.org/10.1161/CIRCRESAHA.122.322389
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Artificial intelligence in healthcare: Complementing, not replacing, doctors and healthcare providers
https://doi.org/10.1177/20552076231186520
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
FactSheets for Hardware-Aware AI Models: A Case Study of Analog In Memory Computing AI Models
https://ieeexplore.ieee.org/abstract/document/10234354
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer’s Disease Drug Development
https://doi.org/10.3233/JAD-230152
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
AGA Clinical Practice Update on Telemedicine in Gastroenterology: Commentary
https://doi.org/10.1053/j.gastro.2022.12.043
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort
Use telehealth as needed: telehealth substitutes in-person primary care and associates with the changes in unplanned events and follow-up visits
https://doi.org/10.1186/s12913-023-09445-0
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort
Toward Personalized Medicine Approaches for Parkinson Disease Using Digital Technologies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10568402/
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
https://doi.org/10.1007/s12311-023-01625-2
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract
https://doi.org/10.2196/47119
Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review
A systematic review assessing the state of analytical validation for connected, mobile, sensor-based digital health technologies
https://doi.org/10.1101/2023.05.22.23290371
Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review
Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer’s Disease Drug Development
https://content.iospress.com/articles/journal-of-alzheimers-disease/jad230152
Remote Digital Monitoring for Medical Product Development
Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice
https://doi.org/10.1007%2Fs12325-023-02441-0
Remote digital monitoring in clinical trials in the time of COVID-19
Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice
https://doi.org/10.1007/s12325-023-02441-0
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
A single experience in the conduction of clinical trial during COronaVIrusDisease-2019 pandemic
https://doi.org/10.37349%2Fetat.2023.00168
Remote Monitoring in Clinical Trials During the COVID-19 Pandemic
Mobility recorded by wearable devices and gold standards: the Mobilise-D procedure for data standardization
https://doi.org/10.1038/s41597-023-01930-9
Sensor Data Integration: A New Cross-Industry Collaboration
Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple
https://doi.org/10.1177/17407745231160459
Underuse of oral anticoagulants in privately insured patients with atrial fibrillation
Remote monitoring of cognition in cirrhosis and encephalopathy: future opportunity and challenge
https://doi.org/10.1007/s11011-022-01134-x
V3
A Framework for Analytical Validation of Inertial-Sensor-Based Knee Kinematics Using a Six-Degrees-of-Freedom Joint Simulator
https://doi.org/10.3390/s23010348
V3
Wearable sensor-based performance status assessment in cancer: A pilot multicenter study from the Alliance for Clinical Trials in Oncology (A19_Pilot2)
https://doi.org/10.1371/journal.pdig.0000178
V3
Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population
https://doi.org/10.3390/biomedicines11020493
V3
Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials
https://doi.org/10.1038/s41746-023-00767-1
V3
An Algorithm to Classify Real-World Ambulatory Status From a Wearable Device Using Multimodal and Demographically Diverse Data: Validation Study
https://doi.org/10.2196/43726
V3
The Veterans ECS21 (Exploring Cannabigerol for Sleep) Study: A protocol for the first randomized clinical trial of Cannabigerol (CBG), a decentralized study designed for U.S. Veterans in California
https://www.medrxiv.org/content/10.1101/2023.03.13.23287212v1
V3
A scoping review of portable sensing for out-of-lab anterior cruciate ligament injury prevention and rehabilitation
https://doi.org/10.1038/s41746-023-00782-2
V3
From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital Endpoints
https://doi.org/10.1007/s43441-023-00502-8
V3
Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective
https://doi.org/10.1186/s13023-023-02693-7
V3
Accuracy and Reliability of a Suite of Digital Measures of Walking Generated Using a Wrist-worn Sensor: Performance Characterization Study
https://doi.org/10.1101/2023.04.21.537226
V3
Analytical Validation of a Webcam-Based Assessment of Speech Kinematics: Digital Biomarker Evaluation following the V3 Framework
https://doi.org/10.1159/000529685
V3
Kinematics-Based Recovery Metrics and Inertial Measurement Units to Monitor Recovery Post-Knee Arthroscopic Surgery: A Case Study
https://uwspace.uwaterloo.ca/handle/10012/19025
V3
Quality, Usability, and Effectiveness of mHealth Apps and the Role of Artificial Intelligence: Current Scenario and Challenges
https://doi.org/10.2196/44030
V3
Digital technologies: Innovations that transform the face of drug development
https://doi.org/10.1111/cts.13533
V3
A systematic review assessing the state of analytical validation for connected, mobile, sensor-based digital health technologies
https://doi.org/10.1101/2023.05.22.23290371
V3
The Analytical and Clinical Validity of the pfSTEP Digital Biomarker of the Susceptibility/Risk of Declining Physical Function in Community-Dwelling Older Adults
https://doi.org/10.3390/s23115122
V3
Prospective Validation of Motor-Based Intervention with Automated Mispronunciation Detection of Rhotics in Residual Speech Sound Disorders
https://doi.org/10.48550/arXiv.2305.19090
V3
GUIDANCE TO INDUSTRY: Classification of Digital Health Technologies
https://dtxalliance.org/wp-content/uploads/2023/06/Guidance-to-Industry-Classification-of-Digital-Health-Technologies-2023Jun05.pdf
V3
How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints
https://doi.org/10.1159/000529878
V3
A speech-based prognostic model for dysarthria progression in ALS
https://doi.org/10.1080/21678421.2023.2222144
V3
Investigating the accuracy of blood oxygen saturation measurements in common consumer smartwatches
https://doi.org/10.1371/journal.pdig.0000296
V3
Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer’s Disease Drug Development
https://doi.org/10.3233/jad-230152
V3
Feasibility of wearable devices and machine learning for sleep classification in children with Rett syndrome: A pilot study
https://doi.org/10.1177/20552076231191622
V3
Clinical Validation of Novel Digital Measures: Statistical Methods for Reliability Evaluation
https://doi.org/10.1159/000531054
V3
AI-based skin cancer detection: the balance between access and overutilization
https://doi.org/10.1038/s41746-023-00900-0
V3
3D Video Tracking Technology in the Assessment of Orofacial Impairments in Neurological Disease: Clinical Validation
https://doi.org/10.1044/2023_JSLHR-22-00321
V3
Wav2DDK: Analytical and Clinical Validation of an Automated Diadochokinetic Rate Estimation Algorithm on Remotely Collected Speech
https://doi.org/10.1044/2023_JSLHR-22-00282
V3
Digital measures of respiratory and upper limb function in spinal muscular atrophy: design, feasibility, reliability, and preliminary validity of a smartphone sensor-based assessment suite
https://doi.org/10.1016/j.nmd.2023.07.008
V3
Wearables for running gait analysis: A study protocol
https://doi.org/10.1371/journal.pone.0291289
V3
Going beyond the means: Exploring the role of bias from digital determinants of health in technologies
https://doi.org/10.1371/journal.pdig.0000244
V3
Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior
https://ascopubs.org/doi/abs/10.1200/CCI.23.00055
V3
Methods for the Clinical Validation of Digital Endpoints: Protocol for a Scoping Review Abstract
https://doi.org/10.2196/47119
V3
Validity and reliability of the DANU sports system for walking and running gait assessment
https://iopscience.iop.org/article/10.1088/1361-6579/ad04b4/meta
V3
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
https://doi.org/10.1007/s12311-023-01625-2
V3
SciKit digital health package for accelerometry-measured physical activity: comparisons to existing solutions and investigations of age effects in healthy adults
https://doi.org/10.3389/fdgth.2023.1321086
V3
Remote Assessment for ALS using Multimodal Dialog Agents: Data Quality, Feasibility and Task Compliance
https://www.vikramr.com/pubs/Richter_et_al_Interspeech_2023_Audio_and_Video_quality_ratings.pdf
V3
What’s after COVID-19?: Communication pathways influencing future use of telehealth
https://doi.org/10.1016/j.pec.2023.108025
A COVID-19 Telehealth Impact Study—Exploring One Year of Telehealth Experimentation
The Impact of Telehealth on Hospitalization of Skilled Nursing Facility Patients During the COVID-19 Pandemic
https://telehealthandmedicinetoday.com/index.php/journal/article/view/416/924
A COVID-19 Telehealth Impact Study—Exploring One Year of Telehealth Experimentation
Experiences and Attitudes Regarding the Availability and Usage of Telemedicine Services Among Providers During a Pandemic
https://www.proquest.com/docview/2833803300?pq-origsite=gscholar&fromopenview=true&sourcetype=Dissertations%20&%20Theses
A COVID-19 Telehealth Impact Study—Exploring One Year of Telehealth Experimentation
A sociotechnical framework to assess patient-facing eHealth tools: results of a modified Delphi process
https://www.nature.com/articles/s41746-023-00982-w
Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework
Exploring the Use of a Digital Platform for Cancer Patients to Report Their Demographics, Disease and Therapy Characteristics, Age, and Educational Disparities: An Early-Stage Feasibility Study
https://doi.org/10.3390/curroncol30080551
Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework
The Impact of Skin Pigmentation on Pulse Oximetry SpO2 and Wearable Pulse Rate Accuracy: A Meta-Analysis
https://www.researchsquare.com/article/rs-3882498/v1
V3
Evaluation metric of smile classification by peri-oral tissue segmentation for the automation of digital smile design
https://doi.org/10.1016/j.jdent.2024.104871
V3
Smartphone applications for Movement Disorders: Towards collaboration and re-use
https://doi.org/10.1016/j.parkreldis.2023.105988
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Exploring an E-Health Cloud Computing Adoption in Saudi Arabia: Review Article
https://www.ijisae.org/index.php/IJISAE/article/view/4457
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Understanding Medical 4.0 implementation through enablers: An integrated multi-criteria decision-making approach
https://doi.org/10.1016/j.infoh.2023.11.001
Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care
NiMBaLWear analytics pipeline for wearable sensors: a modular, open-source platform for evaluating multiple domains of health and behaviour
https://link.springer.com/article/10.1186/s44247-024-00062-3
V3
Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division
https://www.degruyter.com/document/doi/10.1515/cclm-2023-1455/html
V3
A systematic scoping review of studies describing human factors, human-centered design, and usability of sensor-based digital health technologies
https://www.medrxiv.org/content/10.1101/2024.02.23.24303220v1
V3
Speech markers to predict and prevent recurrent episodes of psychosis: A narrative overview and emerging opportunities
https://doi.org/10.1016/j.schres.2024.02.036
V3
Breathing dysfunction as a meaningful and measurable aspect of health in Rett Syndrome: A caregivers perspective
https://www.researchsquare.com/article/rs-3995020/v1
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Development of a Living Library of Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort
https://www.medrxiv.org/content/10.1101/2024.03.18.24304471v1
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 2: Implementation Considerations and Harms
https://journals.sagepub.com/doi/full/10.1177/08465371241236377
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Designing a System to Empower Startup Businesses for Evaluating Digital Health Products
http://www.ijmi.ir/index.php/IJMI/article/view/586
Advancing digital health applications: priorities for innovation in real-world evidence generation
Patient-Generated Health Data (PGHD): Understanding, Requirements, Challenges, and Existing Techniques for Data Security and Privacy
https://doi.org/10.3390/jpm14030282
mHealth and patient generated health data: stakeholder perspectives on opportunities and barriers for transforming healthcare
Deep Learning-Based Psoriasis Assessment: Harnessing Clinical Trial Imaging for Accurate Psoriasis Area Severity Index Prediction
https://karger.com/dib/article/8/1/13/896217
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life
https://www.tandfonline.com/doi/full/10.2147/COPD.S445858
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Development of a Living Library of Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort
https://www.medrxiv.org/content/10.1101/2024.03.18.24304471v1
Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review
Protocol for the Development of Automatic Multisensory Systems to Analyze Human Activity for Functional Evaluation: Application to the EYEFUL System
https://www.mdpi.com/2076-3417/14/8/3415
V3
An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection
https://www.nature.com/articles/s41746-024-01068-x
Digital Medicine: A Primer on Measurement
Definitions of digital biomarkers: a systematic mapping of the biomedical literature
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11015196/
Digital Medicine: A Primer on Measurement
Navigating the U.S. regulatory landscape for neurologic digital health technologies
https://www.nature.com/articles/s41746-024-01098-5
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
The Analytical Validity of Stride Detection and Gait Parameters Reconstruction Using the Ankle-Mounted Inertial Measurement Unit Syde®
https://www.mdpi.com/1424-8220/24/8/2413
V3
Operationalizing Clinical Speech Analytics: Moving From Features to Measures for Real-World Clinical Impact
https://doi.org/10.1044/2024_JSLHR-24-00039
V3
Triage Performance Across Large Language Models, ChatGPT, and Untrained Doctors in Emergency Medicine: Comparative Study
https://doi.org/10.2196/53297
V3
Clinical validation of digital assessment tools and machine learning models for remote measurement of psoriasis and psoriatic arthritis: a proof-of-concept study
https://doi.org/10.3899/jrheum.2024-0074
V3
From wearable sensor data to digital biomarker development: ten lessons learned and a framework proposal
https://doi.org/10.1038/s41746-024-01151-3
V3
A practical guide for selecting continuous monitoring wearable devices for community-dwelling adults
https://doi.org/10.1016/j.heliyon.2024.e33488
V3
Automated speech analytics in ALS: higher sensitivity of digital articulatory precision over the ALSFRS-R
https://doi.org/10.1080/21678421.2024.2371986
V3
Engagement of medication users in the development and implementation of digital medication adherence technologies: a multi-stakeholder study
https://doi.org/10.1080/14737167.2024.2373184
V3
Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration
https://doi.org/10.1080/14737167.2024.2334347
V3
Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance
https://doi.org/10.1038/s41746-024-01110-y
V3
Video-based assessments of activities of daily living: generating real-world evidence in pediatric rare diseases
https://doi.org/10.1080/14737167.2024.2360201
V3
A multimodal approach to automated hierarchical assessment of bulbar involvement in amyotrophic lateral sclerosis
https://doi.org/10.3389/fneur.2024.1396002
V3
Chapter 3 - Innovative clinical trial design and operation—Implementing hybrid and fully decentralized clinical trials in a post-COVID world
https://doi.org/10.1016/B978-0-443-13681-8.00005-9
V3
A Study of Pupil Response to Light as a Digital Biomarker of Recent Cannabis Use
https://doi.org/10.1159/000538561
V3
Unleashing the Full Potential of Digital Endpoints: Eight Questions that Need Attention
https://www.researchsquare.com/article/rs-4564257/v1
V3
Mapping the ethical landscape of digital biomarkers: A scoping review
https://doi.org/10.1371/journal.pdig.0000519
Digital Medicine: A Primer on Measurement
Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort
https://doi.org/10.14283/jpad.2024.103
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Video-based assessments of activities of daily living: generating real-world evidence in pediatric rare diseases
https://doi.org/10.1080/14737167.2024.2360201
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration
https://doi.org/10.1080/14737167.2024.2334347
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance
https://doi.org/10.1038/s41746-024-01110-y
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Increasing psychopharmacology clinical trial success rates with digital measures and biomarkers: Future methods
https://doi.org/10.1038/s44277-024-00008-7
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Video-based assessments of activities of daily living: generating real-world evidence in pediatric rare diseases
https://doi.org/10.1080/14737167.2024.2360201
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities
https://doi.org/10.1080/14737167.2024.2362291
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
From wearable sensor data to digital biomarker development: ten lessons learned and a framework proposal
https://doi.org/10.1038/s41746-024-01151-3
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Standing the test of COVID-19: charting the new frontiers of medicine
https://doi.org/10.3389/fsci.2024.1236919
Advancing digital health applications: priorities for innovation in real-world evidence generation
A practical guide for selecting continuous monitoring wearable devices for community-dwelling adults
https://doi.org/10.1016/j.heliyon.2024.e33488
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration
https://doi.org/10.1080/14737167.2024.2334347
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities
https://doi.org/10.1080/14737167.2024.2362291
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
A coating machine for coating filaments with bioactive nanomaterials for extrusion 3D printing
https://doi.org/10.1016/j.heliyon.2024.e33223
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
Effectiveness of telehealth versus in-person care during the COVID-19 pandemic: a systematic review
https://doi.org/10.1038/s41746-024-01152-2
Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort
Overcoming ‘Digital Divides’: Leveraging higher education to develop next generation digital agriculture professionals
https://doi.org/10.1016/j.compag.2024.109181
Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine
How can regulation and reimbursement better accommodate flexible suites of digital health technologies?
https://doi.org/10.1038/s41746-024-01156-y
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Feasibility of Observing Cerebrovascular Disease Phenotypes with Smartphone Monitoring: Study Design Considerations for Real-World Studies
https://doi.org/10.3390/s24113595
Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
ISB recommendations on the definition, estimation, and reporting of joint kinematics in human motion analysis applications using wearable inertial measurement technology
https://doi.org/10.1016/j.jbiomech.2024.112225
V3
Potential of a New, Flexible Electrode sEMG System in Detecting Electromyographic Activation in Low Back Muscles during Clinical Tests: A Pilot Study on Wearables for Pain Management
https://doi.org/10.3390/s24144510
V3
Validation of the Brazilian Version of the Modified Scale for Delineating Advanced Practice Nursing Roles
https://www.scielo.br/j/reben/a/pH3sHZ444MYYMcjNtbFcvnb/?lang=en
V3
Unlocking Tomorrow’s Health Care: Expanding the Clinical Scope of Wearables by Applying Artificial Intelligence
https://doi.org/10.1016/j.cjca.2024.07.009
V3
A clinical-translational review of sleep problems in neurodevelopmental disabilities
https://doi.org/10.1186/s11689-024-09559-4
V3
Digital Measures Development: Lessons Learned from an Expert Workshop Addressing Cross-Therapeutic Area Measures of Sleep
https://doi.org/10.1159/000539253
V3
An Algorithm for Automated Measurement of Kinetic Tremor Magnitude Using Digital Spiral Drawings
https://doi.org/10.1159/000539529
V3
An automatic measure for speech intelligibility in dysarthrias—validation across multiple languages and neurological disorders
https://doi.org/10.3389/fdgth.2024.1440986
V3
Development of a Living Library of Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort
https://web.archive.org/web/20240429210532id_/https://www.medrxiv.org/content/medrxiv/early/2024/03/19/2024.03.18.24304471.full.pdf
Digital measures that matter to patients: a framework to guide the selection and development of digital measures of health
Unlocking Tomorrow’s Health Care: Expanding the Clinical Scope of Wearables by Applying Artificial Intelligence
https://doi.org/10.1016/j.cjca.2024.07.009
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
An automatic measure for speech intelligibility in dysarthrias—validation across multiple languages and neurological disorders
https://doi.org/10.3389/fdgth.2024.1440986
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
The Integration of Information Technology in the Management and Organization of Nursing Care in a Hospital Environment: A Scoping Review
https://www.mdpi.com/1660-4601/21/8/968
Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team
An automatic measure for speech intelligibility in dysarthrias—validation across multiple languages and neurological disorders
https://doi.org/10.3389/fdgth.2024.1440986
Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint
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