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DiMe Virtual Journal Club

To participate in this discussion live, you must be a member of DiMe.

Each month we will select a manuscript tackling an important topic in digital medicine and DiMe members can register to participate in an intimate discussion with the manuscript author(s).

Sessions will take an AMA (“ask me anything”) approach

Immediately after the session, the recording will be posted to a new Slack channel in DiMe’s Workspace. For the next week, we will moderate a discussion in Slack between all of DiMe’s members and the author(s).

To participate in this discussion live, you must be a member of DiMe. 

Upcoming Discussion


Date/Time

October 13, 2021 @ 11:00 am ET

Discussants

mobashir shandhi

Postdoctoral Researcher at Duke University, Big Ideas Lab

Jessilyn Dunn

Assistant Professor at Duke University, Big Ideas Lab

John Pateña

Program Director at Brown Lifespan Center for Digital Health

Simona Carini

Analyst at Open mHealth

Tina Hurst

Scientific Officer at ActiveInsight

A Systematic Review of Recent Academic Research on Clinically-Relevant Digital Measures

The collaborators on The Playbook have published findings of a systematic review that identifies the need for more research funding related to digital clinical measures.

Among all its findings, one that stands out is that in the last two years, out of 295 research studies published on digital clinical measures, there was only one academic publication reporting cybersecurity research, one study examining data rights and governance, and zero publications reporting research into the ethical implications of remote patient monitoring tools.

Join the co-authors of this manuscript in a discussion about the current state of funding for academic research and help shape an integrated and coordinated effort across academia, academic partners, and academic funders to establish the field of digital clinical measures as an evidence-based field worthy of our trust.

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Listen to Previous Journal Club Discussions


“It takes a village: development of digital measures for computer scientists”

As digital measures become more complex, in terms of 1) the technologies, methods and data used to derive them, and 2) in terms of the aspects of health that they address, computer scientists, electrical engineers and other people coming from a data or computing background are increasingly important members of this village.

What can we do to bridge the gap from data-orientated background to clinical application of their skills? Can a unified lexicon aid communication throughout this process?

Ieuan Clay and Jen Goldsack presented their publication, “It takes a village: development of digital measures for computer scientists” and opened up a discussion on the range of challenges and considerations where computer scientists can have a particular impact on the development of a new digital measure.

>>Watch the recording

>> View the presentation slides

 

 

Statistical considerations for successful digital health innovation

Why should you report your modeling plan or statistical analysis plan before seeing any data? Why should we all ditch the term ‘statistical significance’ but keep statistical evidence? And how? A fantastic discussion with Eric Daza, Lead Statistician for Digital Health Outcomes at Evidation Health, as he dives into key themes from his recent pieces: Artifice or intelligence? and Ditch ‘statistical significance’.

Our conversation explored two proposed research changes for our field: 1) Splitting all gathered data into a small number of random subsamples to test reproducibility/replicability of results; 2) For exploratory analyses, continue to report CI’s and p-values—but explicitly state as possible uncertainty to expect using new data.

>>Listen to the recording

>>View the presentation slides

Age and environment-related differences in gait in healthy adults using wearables


Do we fully understand the sensitivity of gait speed as a potential endpoint for clinical trials studies? Matthew D. Czech, Isik Karahanoglu, Xuemei Cai, Charmaine Demanuele, and their colleagues aimed to find out through their recent study, “Age and environment-related differences in gait in healthy adults using wearables” in NPJ. Their work shows that a single lumbar-worn sensor can be used for monitoring gait under free-living conditions and capture meaningful information about real-world functions that might not be possible in controlled settings. Their work also shows that despite higher variability, at-home gait speed was able to capture age-related group differences in healthy volunteers, which were not observed during in-lab gait assessments. Furthermore, they present the statistical methodology for deriving the number of monitoring days required to reliably estimate at-home gait speed that can be used to optimize clinical study design.

>> Click here to read the article

>> Click here to listen to the discussion

>> Click here to view the presentation slides

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Contextualizing Progress In The AI Revolution

Science is catalyzed by new technology, but the process of technology adoption and implementation typically requires more time and ingenuity than often appreciated. Join us for DiMe’s #AskMeAnything Journal Club with Dr. David Shaywitz as he reviews the life cycle of technology innovations (Perez model), and then introduces five new books he recently reviewed in the Wall Street Journal that attempt to contextualize where we are in the artificial intelligence (AI) journey.

A physician-scientist by training, Dr. Shaywitz has focused his career on biomedical innovation as an operator and investor. In January 2020, he founded Astounding HealthTech, advising senior executives on digital health and connected fitness. He is a lecturer in the Department of Biomedical Informatics at Harvard Medical School, and an adjunct scholar at the American Enterprise Institute in Washington, D.C. He lives in the Boston Area with his wife, three daughters, and a clumber spaniel named Roscoe.

Listen in to this #AskMeAnything Journal event and join the conversation with Dr. Shaywitz and your fellow DiMe colleagues. You can check out his review of several AI books here!

>> Click here to read the article

>> Click here to listen to the discussion

>> Click here to view the presentation slides

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Did you miss the launch event featuring creators and authors of the EVIDENCE Checklist as well as journal editors and FDA colleagues? Watch it now!

Launch of EVIDENCE Check List

The EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist promotes high-quality reporting in studies where the primary objective is an evaluation of a digital measurement product or its constituent parts. The checklist is a product of DiMe’s most recent Tour of Duty and will be published on May 18.

The EVIDENCE checklist is applicable to five types of evaluations: (1) proof of concept; (2) verification, (3) analytical validation, and (4) clinical validation as defined by the V3 framework; and (5) utility and usability assessments.  Using EVIDENCE, those preparing, reading, or reviewing studies evaluating digital measurement products will be better equipped to distinguish necessary reporting requirements to drive high-quality research. With broad adoption, the EVIDENCE checklist will serve as a much-needed guide to raise the bar for quality reporting in published literature evaluating digital measurement products.

Did you miss it? You can still check out the following:

>> Click here to read the article

>> Click here to listen to the discussion

>> Click here to view the presentation slides

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Digital Measurement of Mental Health: Challenges, Promises, and Future Directions

With the adoption of digital phenotyping in clinical research and patient care, a common vision for the future of these technologies remains unclear. Listen in to this Journal Club recording with author Anzar Abbas, PhD who opened up a discussion on his work, “Digital Measurement of Mental Health: Challenges, Promises, and Future Directions.” The discussion explored how to classify emerging tools for digital measurement of mental health and discuss the promises and challenges they face.

Anzar Abbas is a neuroscientist focused on developing technology to improve the measurement of health, increase access to care, and inform clinical decision-making using data-driven insights. He is one of the co-creators of OpenDBM, an open-source library of methods in digital phenotyping.

>> Click here to read the article

>> Click here to listen to the discussion

>> Click here to view the presentation slides

>> Share this Journal Club

Digital inclusion as a social determinant of health

Digital inclusion as a social determinant of health
Cynthia J. Sieck, et al. npj Digital Medicine volume 4, Article number: 52 (2021)

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Biopharma and Digital Health: Winning with digital medicine products

“Personalized therapies in the Future of Health: Winning with digital medicine products.” Deloitte Insights. Davis B., Ahmed A., Elsner N., Miranda W. March 2021.

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Digital Health – The Need to Assess Benefits, Risks, and Value.

Perakslis E, Ginsburg GS. Digital Health—The Need to Assess Benefits, Risks, and Value. JAMA. 2021;325(2):127–128

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Telehealth Impact: Physician Survey Analysis

Rethinking CMS Coverage and Reimbursement for the Fourth Industrial (AKA Digital) Revolution

“Rethinking CMS Coverage And Reimbursement For The Fourth Industrial (AKA Digital) Revolution, ” Health Affairs Blog, October 23, 2020.

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Using Smartphones and Wearable Devices to Monitor Behavioral Changes During COVID-19.

Narayan VA,et al RADAR-CNS Consortium. “Using Smartphones and Wearable Devices to Monitor Behavioral Changes During COVID-19.” J Med Internet Res 2020;22

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Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health.

Manta, Christine, Bray Patrick-Lake, and Jennifer C. Goldsack. “Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health.” Digital Biomarkers 4.3 (2020).

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Fit‐for‐Purpose Biometric Monitoring Technologies (BioMeT): Leveraging the Laboratory Biomarker Experience.

Izmailova, E., Godfrey, A. A., Vandendriessche, B., Bakker, J. P., Fitzer‐Attas, C., Gujar, N., Hobbs, M., … & Zipunnikov, V. Clinical and Translational Science. (2020).

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Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries

Gerke, S., Stern, A.D. & Minssen, T. “Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries.” npj Digit. Med. 3, 94 (2020).

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Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Rothstein, Mark A., et al. The Journal of Law, Medicine & Ethics 48.1_suppl (2020): 196-226.

 

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Precision Health: The Role of the Social and Behavioral Sciences in Advancing the Vision

Indicators of retention in remote digital health studies: a cross-study evaluation of 100,000 participants

Indicators of retention in remote digital health studies: a cross-study evaluation of 100,000 participants

Pratap, Abhishek, et al. NPJ digital medicine 3.1 (2020): 1-10.

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Investigating Sources of Inaccuracy in Wearable Optical Heart Rate Sensors

Bent, B., Goldstein, B.A., Kibbe, W.A. et al. Investigating sources of inaccuracy in wearable optical heart rate sensors. npj Digit. Med. 3, 18 (2020).

 

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Development of digital biomarkers for resting tremor and bradykinesia using a wrist-worn device

Mahadevan, N., Patel, S. et al. Development of digital biomarkers for resting tremor and bradykinesia using a wrist-worn wearable device. npj Digit. Med. 3, 5 (2020).

 

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Continuous digital monitoring of walking speed in frail elderly patients: non interventional validation study and longitudinal clinical trial.

Mueller, Arne, et al. “Continuous digital monitoring of walking speed in frail elderly patients: noninterventional validation study and longitudinal clinical trial.” JMIR mHealth and uHealth 7.11 (2019): e15191.

 

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How Artificial Intelligence is Changing Health Care Delivery

Sanders, Samantha F., et al. “How Artificial Intelligence Is Changing Health Care Delivery.” NEJM Catalyst 5.5 (2019).

 

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The Case for a Hippocratic Oath for Connected Medical Devices

A Systematic Review of Feasibility Studies: Promoting the Use of Mobile Technologies in Clinical Research

Bakker, J. P., Goldsack, J. C., Clarke, M., Coravos, A., Geoghegan, C., Godfrey, A., … & Ramirez, E. (2019).

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research. npj Digital Medicine, 2(1), 47.

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>> Click here to access CTTI Feasibility Studies Database

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Teleneurology and Mobile Technologies: The Future of Neurological Care

Dorsey, E. R., Glidden, A. M., Holloway, M. R.,

Birbeck, G. L., & Schwamm, L. H. (2018).

Teleneurology and mobile technologies: the future of neurological care. Nature Reviews Neurology, 14(5), 285.

 

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Digital Medicine: A Primer on Measurement

Coravos, A., Goldsack, J. C., Karlin, D. R.,

Nebeker, C., Perakslis, E., Zimmerman, N., & Erb,

M. K. (2019). Digital Medicine: A Primer on Measurement. Digital Biomarkers, 3(2), 31-71

 

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