Literature DB >> 32095767

Digital Medicine: A Primer on Measurement.

Andrea Coravos1,2,3, Jennifer C Goldsack3,4, Daniel R Karlin3,5,6, Camille Nebeker7,8, Eric Perakslis9,10, Noah Zimmerman11,12, M Kelley Erb13.   

Abstract

Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, requiring knowledge from many people across many fields. We aim to drive the field forward by unpacking that barrier, providing a brief introduction to core concepts and terms that define digital medicine. Specifically, we contrast "clinical research" versus routine "clinical care," outlining the security, ethical, regulatory, and legal issues developers must consider as digital medicine products go to market. We classify types of digital measurements and how to use and validate these measures in different settings. To make this resource engaging and accessible, we have included illustrations and figures throughout that we hope readers will borrow from liberally. This primer is the first in a series that will accelerate the safe and effective advancement of the field of digital medicine.
Copyright © 2019 by S. Karger AG, Basel.

Entities:  

Keywords:  Clinical care; Clinical research; Cybersecurity; Data governance; Data rights; Decentralized clinical trials; Digital biomarkers; Digital health; Digital medicine; Digital technology tools; Ethics; FDA; Mobile technology; Privacy; Regulatory science; Research ethics; Sensors

Year:  2019        PMID: 32095767      PMCID: PMC7015383          DOI: 10.1159/000500413

Source DB:  PubMed          Journal:  Digit Biomark        ISSN: 2504-110X


  27 in total

Review 1.  A cybersecurity primer for translational research.

Authors:  Eric D Perakslis; Martin Stanley
Journal:  Sci Transl Med       Date:  2016-01-20       Impact factor: 17.956

2.  Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations.

Authors:  Sean Khozin; Andrea Coravos
Journal:  Clin Pharmacol Ther       Date:  2019-04-23       Impact factor: 6.875

Review 3.  Wearables and the medical revolution.

Authors:  Jessilyn Dunn; Ryan Runge; Michael Snyder
Journal:  Per Med       Date:  2018-09-27       Impact factor: 2.512

Review 4.  Molecular and Digital Biomarker Supported Decision Making in Clinical Studies in Cardiovascular Indications.

Authors:  Frank Kramer; Wilfried Dinh
Journal:  Arch Pharm (Weinheim)       Date:  2016-04-23       Impact factor: 3.751

5.  Communicating information to patients: the use of cartoon illustrations to improve comprehension of instructions.

Authors:  C Delp; J Jones
Journal:  Acad Emerg Med       Date:  1996-03       Impact factor: 3.451

6.  Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial.

Authors:  A C King; W L Haskell; C B Taylor; H C Kraemer; R F DeBusk
Journal:  JAMA       Date:  1991-09-18       Impact factor: 56.272

7.  Reimagining Human Research Protections for 21st Century Science.

Authors:  Cinnamon Bloss; Camille Nebeker; Matthew Bietz; Deborah Bae; Barbara Bigby; Mary Devereaux; James Fowler; Ann Waldo; Nadir Weibel; Kevin Patrick; Scott Klemmer; Lori Melichar
Journal:  J Med Internet Res       Date:  2016-12-22       Impact factor: 5.428

8.  Acceptance of Mobile Health in Communities Underrepresented in Biomedical Research: Barriers and Ethical Considerations for Scientists.

Authors:  Camille Nebeker; Kate Murray; Christina Holub; Jessica Haughton; Elva M Arredondo
Journal:  JMIR Mhealth Uhealth       Date:  2017-06-28       Impact factor: 4.773

9.  The Case for a Hippocratic Oath for Connected Medical Devices: Viewpoint.

Authors:  Beau Woods; Andrea Coravos; Joshua David Corman
Journal:  J Med Internet Res       Date:  2019-03-19       Impact factor: 5.428

10.  Drugs and Devices: Comparison of European and U.S. Approval Processes.

Authors:  Gail A Van Norman
Journal:  JACC Basic Transl Sci       Date:  2016-08-29
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  31 in total

Review 1.  A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach.

Authors:  Lynn Rochester; Claudia Mazzà; Arne Mueller; Brian Caulfield; Marie McCarthy; Clemens Becker; Ram Miller; Paolo Piraino; Marco Viceconti; Wilhelmus P Dartee; Judith Garcia-Aymerich; Aida A Aydemir; Beatrix Vereijken; Valdo Arnera; Nadir Ammour; Michael Jackson; Tilo Hache; Ronenn Roubenoff
Journal:  Digit Biomark       Date:  2020-11-26

2.  The Path Forward for Digital Measures: Suppressing the Desire to Compare Apples and Pineapples.

Authors:  Carrie R Houts; Bray Patrick-Lake; Ieuan Clay; R J Wirth
Journal:  Digit Biomark       Date:  2020-11-26

3.  Brain health INnovation Diplomacy: a model binding diverse disciplines to manage the promise and perils of technological innovation.

Authors:  Kylie Ternes; Vijeth Iyengar; Helen Lavretsky; Walter D Dawson; Laura Booi; Agustin Ibanez; Ipsit Vahia; Charles Reynolds; Steven DeKosky; Jeffrey Cummings; Bruce Miller; Carla Perissinotto; Jeffrey Kaye; Harris A Eyre
Journal:  Int Psychogeriatr       Date:  2020-02-13       Impact factor: 3.878

Review 4.  mHealth for pediatric chronic pain: state of the art and future directions.

Authors:  Patricia A Richardson; Lauren E Harrison; Lauren C Heathcote; Gillian Rush; Deborah Shear; Chitra Lalloo; Korey Hood; Rikard K Wicksell; Jennifer Stinson; Laura E Simons
Journal:  Expert Rev Neurother       Date:  2020-09-23       Impact factor: 4.618

5.  Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.

Authors:  Joan E Adamo; Robert V Bienvenu Ii; Felipe Dolz; Michael Liebman; Wendy Nilsen; Scott J Steele
Journal:  Digit Biomark       Date:  2020-02-07

Review 6.  Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health.

Authors:  Christine Manta; Bray Patrick-Lake; Jennifer C Goldsack
Journal:  Digit Biomark       Date:  2020-09-15

Review 7.  Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint.

Authors:  Jennifer C Goldsack; Ariel V Dowling; David Samuelson; Bray Patrick-Lake; Ieuan Clay
Journal:  Digit Biomark       Date:  2021-03-23

8.  Predicting Subjective Recovery from Lower Limb Surgery Using Consumer Wearables.

Authors:  Marta Karas; Nikki Marinsek; Jörg Goldhahn; Luca Foschini; Ernesto Ramirez; Ieuan Clay
Journal:  Digit Biomark       Date:  2020-11-26

Review 9.  EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration.

Authors:  Christine Manta; Nikhil Mahadevan; Jessie Bakker; Simal Ozen Irmak; Elena Izmailova; Siyeon Park; Jiat-Ling Poon; Santosh Shevade; Sarah Valentine; Benjamin Vandendriessche; Courtney Webster; Jennifer C Goldsack
Journal:  Digit Biomark       Date:  2021-05-18

10.  Contactless Sleep Monitoring for Early Detection of Health Deteriorations in Community-Dwelling Older Adults: Exploratory Study.

Authors:  Narayan Schütz; Hugo Saner; Angela Botros; Bruno Pais; Valérie Santschi; Philipp Buluschek; Daniel Gatica-Perez; Prabitha Urwyler; René M Müri; Tobias Nef
Journal:  JMIR Mhealth Uhealth       Date:  2021-06-11       Impact factor: 4.773

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