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  • Book Review
    Digit Biomark. Pub Date : 2020-07-02
    Ritu Kapur

    Digit Biomark 2020;4:60–61

    更新日期:2020-07-02
  • Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials
    Digit Biomark. Pub Date : 2020-06-30
    Frank Kramer; Javed Butler; Sanjiv J. Shah; Christian Jung; Savina Nodari; Stephan Rosenkranz; Michele Senni; Luke Bamber; Stephan Cichos; Chrysanthi Dori; Toeresin Karakoyun; Gabriele Jenny Köhler; Kinjal Patel; Paolo Piraino; Thomas Viethen; Praneeth Chennuru; Ayse Paydar; Jason Sims; Richard Clark; Rob van Lummel; Alexandra Müller; Chad Gwaltney; Salko Smajlovic; Hans-Dirk Düngen; Wilfried Dinh

    Aims: Heart failure (HF) affects approximately 26 million people worldwide. With an aging global population, innovative approaches to HF evaluation and management are needed to cope with the worsening HF epidemic. The aim of the Real-Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF) study (NCT03507439) is to evaluate a composite instrument comprising remote, real-time, activity-monitoring

    更新日期:2020-06-30
  • Developing Smartphone-Based Objective Assessments of Physical Function in Rheumatoid Arthritis Patients: The PARADE Study.
    Digit Biomark. Pub Date : 2020-04-30
    Valentin Hamy,Luis Garcia-Gancedo,Andrew Pollard,Anniek Myatt,Jingshu Liu,Andrew Howland,Philip Beineke,Emilia Quattrocchi,Rachel Williams,Michelle Crouthamel

    Background: Digital biomarkers that measure physical activity and mobility are of great interest in the assessment of chronic diseases such as rheumatoid arthritis, as it provides insights on patients’ quality of life that can be reliably compared across a whole population. Objective: To investigate the feasibility of analyzing iPhone sensor data collected remotely by means of a mobile software application

    更新日期:2020-04-30
  • The Need for Artificial Intelligence in Digital Therapeutics.
    Digit Biomark. Pub Date : 2020-04-08
    Adam Palanica,Michael J Docktor,Michael Lieberman,Yan Fossat

    Digital therapeutics is a newly described concept in healthcare which is proposed to change patient behavior and treat medical conditions using a variety of digital technologies. However, the term is rarely defined with criteria that make it distinct from simply digitizedversions of traditional therapeutics. Our objective is to describe a more valuable characteristic of digital therapeutics, which

    更新日期:2020-04-08
  • Continuous Digital Assessment for Weight Loss Surgery Patients.
    Digit Biomark. Pub Date : 2020-03-26
    Ernesto Ramirez,Nikki Marinsek,Benjamin Bradshaw,Robert Kanard,Luca Foschini

    We conducted a survey about recent surgical procedures on a large connected population and requested each individual’s permission to access data from commercial wearable devices they may have been wearing around the time of the procedure. For subcohorts of 66–118 patients who reported having a weight loss procedure and who had dense Fitbit data around their procedure date, we examined several daily

    更新日期:2020-03-26
  • Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.
    Digit Biomark. Pub Date : 2020-02-07
    Joan E Adamo,Robert V Bienvenu Ii,Felipe Dolz,Michael Liebman,Wendy Nilsen,Scott J Steele

    The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific

    更新日期:2020-02-07
  • Usability of a Wrist-Worn Smartwatch in a Direct-to-Participant Randomized Pragmatic Clinical Trial.
    Digit Biomark. Pub Date : 2019-12-20
    Michael Galarnyk,Giorgio Quer,Kathryn McLaughlin,Lauren Ariniello,Steven R Steinhubl

    Background: The availability of a wide range of innovative wearable sensor technologies today allows for the ability to capture and collect potentially important health-related data in ways not previously possible. These sensors can be adopted in digitalized clinical trials, i.e., clinical trials conducted outside the clinic to capture data about study participants in their day-to-day life. However

    更新日期:2019-12-20
  • Continuous Sound Collection Using Smartphones and Machine Learning to Measure Cough.
    Digit Biomark. Pub Date : 2019-12-10
    Lucia Kvapilova,Vladimir Boza,Peter Dubec,Martin Majernik,Jan Bogar,Jamileh Jamison,Jennifer C Goldsack,Duncan J Kimmel,Daniel R Karlin

    Background: Despite the efforts of research groups to develop and implement at least partial automation, cough counting remains impractical. Analysis of 24-h cough frequency is an established regulatory endpoint which, if addressed in an automated manner, has the potential to ease cough symptom evaluation over multiple 24-h periods in a patient-centric way, supporting the development of novel treatments

    更新日期:2019-12-10
  • Sweat as a Source of Next-Generation Digital Biomarkers.
    Digit Biomark. Pub Date : 2019-12-05
    Noé Brasier,Jens Eckstein

    Sweat has been associated with health and disease ever since it was linked to high body temperature and exercise. It contains a broad range of electrolytes, proteins, and lipids, and therefore hosts a broad panel of potential noninvasive biomarkers. The development of novel smartphone-based biosensors will enable a more sophisticated, patient-driven sweat analysis. This will provide a broad range of

    更新日期:2019-12-05
  • Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative.
    Digit Biomark. Pub Date : 2019-11-06
    Philip Coran,Jennifer C Goldsack,Cheryl A Grandinetti,Jessie P Bakker,Marisa Bolognese,E Ray Dorsey,Kaveeta Vasisht,Adam Amdur,Christopher Dell,Jonathan Helfgott,Matthew Kirchoff,Christopher J Miller,Ashish Narayan,Dharmesh Patel,Barry Peterson,Ernesto Ramirez,Drew Schiller,Thomas Switzer,Liz Wing,Annemarie Forrest,Aiden Doherty

    Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use of mobile technologies in clinical trials has been impeded by their perceived challenges. To advance solutions to these challenges, the Clinical Trials Transformation

    更新日期:2019-11-06
  • An Algorithm for Digital Medicine Testing: A NODE.Health Perspective Intended to Help Emerging Technology Companies and Healthcare Systems Navigate the Trial and Testing Period prior to Full-Scale Adoption.
    Digit Biomark. Pub Date : 2018-11-27
    Amy R Sheon,Brian Van Winkle,Yauheni Solad,Ashish Atreja

    Over the last several years, there has been rapid growth of digital technologies attempting to transform healthcare. Unique features of digital medicine technology lead to both challenges and opportunities for testing and validation. Yet little guidance exists to help a health system decide whether to undertake a pilot test of new technology, move right to full-scale adoption or start somewhere in

    更新日期:2019-11-01
  • Harnessing the Digital Exhaust: Incorporating wellness into the pharma model.
    Digit Biomark. Pub Date : 2018-10-03
    Justin M Wright,Graham B Jones

    The increasing availability of devices capable of tracking biomarkers presents major opportunities in contemporary healthcare. Herein we advocate a new role for the pharmaceutical industry to capitalize on these opportunities and in doing so incorporate wellness and patient engagement programs into their standard business models. Medical grade decision making using diagnostic, prognostic, and monitoring

    更新日期:2019-11-01
  • Telehealth Management of Parkinson's Disease Using Wearable Sensors: An Exploratory Study.
    Digit Biomark. Pub Date : 2018-05-05
    Dustin A Heldman,Denzil A Harris,Timothy Felong,Kelly L Andrzejewski,E Ray Dorsey,Joseph P Giuffrida,Barry Goldberg,Michelle A Burack

    Background Parkinson's disease (PD) motor symptoms can fluctuate and may not be accurately reflected during a clinical evaluation. In addition, access to movement disorder specialists is limited for many with PD. The objective was to assess the impact of motion sensor-based telehealth diagnostics on PD clinical care and management. Methods Eighteen adults with PD were randomized to control or experimental

    更新日期:2019-11-01
  • Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.
    Digit Biomark. Pub Date : 2018-01-31
    Brian Perry,Will Herrington,Jennifer C Goldsack,Cheryl A Grandinetti,Kaveeta P Vasisht,Martin J Landray,Lauren Bataille,Robert A DiCicco,Corey Bradley,Ashish Narayan,Elektra J Papadopoulos,Nirav Sheth,Ken Skodacek,Komathi Stem,Theresa V Strong,Marc K Walton,Amy Corneli

    Background The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational

    更新日期:2019-11-01
  • The New Digital Divide For Digital BioMarkers.
    Digit Biomark. Pub Date : 2017-11-07
    John Torous,Jorge Rodriguez,Adam Powell

    As smartphone and sensors continue to become more ubiquitous across the world, digital biomarkers have emerged as a scalable and practical tool to explore disease states and advance health. But as the digital divide of access and ownership begins to fade, a new digital divide is emerging. Who are the types of people that own smartphones or smart watches, who are the types of people that download health

    更新日期:2019-11-01
  • Multimodal Wearable Sensors to Measure Gait and Voice.
    Digit Biomark. Pub Date : 2019-10-29
    Dimitrios Psaltos,Kara Chappie,Fikret Isik Karahanoglu,Rachel Chasse,Charmaine Demanuele,Amey Kelekar,Hao Zhang,Vanessa Marquez,Tairmae Kangarloo,Shyamal Patel,Matthew Czech,David Caouette,Xuemei Cai

    Background: Traditional measurement systems utilized in clinical trials are limited because they are episodic and thus cannot capture the day-to-day fluctuations and longitudinal changes that frequently affect patients across different therapeutic areas. Objectives: The aim of this study was to collect and evaluate data from multiple devices, including wearable sensors, and compare them to standard

    更新日期:2019-10-29
  • Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research
    Digit Biomark. Pub Date : 2019-10-07
    Reham Badawy; Farhan Hameed; Lauren Bataille; Max A. Little; Kasper Claes; Suchi Saria; Jesse M. Cedarbaum; Diane Stephenson; Jon Neville; Walter Maetzler; Alberto J. Espay; Bastiaan R. Bloem; Tanya Simuni; Daniel R. Karlin

    Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual’s disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory

    更新日期:2019-10-07
Contents have been reproduced by permission of the publishers.
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