Human-Centered Design Strategies for Device Selection in mHealth Programs: Development of a Novel Framework and Case Study

Background Despite the increasing use of remote measurement technologies (RMT) such as wearables or biosensors in health care programs, challenges associated with selecting and implementing these technologies persist. Many health care programs that use RMT rely on commercially available, “off-the-shelf” devices to collect patient data. However, validation of these devices is sparse, the technology landscape is constantly changing, relative benefits between device options are often unclear, and research on patient and health care provider preferences is often lacking. Objective To address these common challenges, we propose a novel device selection framework extrapolated from human-centered design principles, which are commonly used in de novo digital health product design. We then present a case study in which we used the framework to identify, test, select, and implement off-the-shelf devices for the Remote Assessment of Disease and Relapse-Central Nervous System (RADAR-CNS) consortium, a research program using RMT to study central nervous system disease progression. Methods The RADAR-CNS device selection framework describes a human-centered approach to device selection for mobile health programs. The framework guides study designers through stakeholder engagement, technology landscaping, rapid proof of concept testing, and creative problem solving to develop device selection criteria and a robust implementation strategy. It also describes a method for considering compromises when tensions between stakeholder needs occur. Results The framework successfully guided device selection for the RADAR-CNS study on relapse in multiple sclerosis. In the initial stage, we engaged a multidisciplinary team of patients, health care professionals, researchers, and technologists to identify our primary device-related goals. We desired regular home-based measurements of gait, balance, fatigue, heart rate, and sleep over the course of the study. However, devices and measurement methods had to be user friendly, secure, and able to produce high quality data. In the second stage, we iteratively refined our strategy and selected devices based on technological and regulatory constraints, user feedback, and research goals. At several points, we used this method to devise compromises that addressed conflicting stakeholder needs. We then implemented a feedback mechanism into the study to gather lessons about devices to improve future versions of the RADAR-CNS program. Conclusions The RADAR device selection framework provides a structured yet flexible approach to device selection for health care programs and can be used to systematically approach complex decisions that require teams to consider patient experiences alongside scientific priorities and logistical, technical, or regulatory constraints.

[1]  Hyun-Sung An,et al.  Concurrent Validity of Wearable Activity Trackers Under Free-Living Conditions , 2017, Journal of strength and conditioning research.

[2]  Robert W Motl,et al.  Motion sensors in multiple sclerosis: Narrative review and update of applications , 2017, Expert review of medical devices.

[3]  An Ihi Resource A Framework for Selecting Digital Health Technology , 2014 .

[4]  S. Masand,et al.  Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges , 2019, Therapeutic innovation & regulatory science.

[5]  D. Berwick About the Institute for Healthcare Improvement , 1993 .

[6]  Wynne W. Chin,et al.  A Fast Form Approach to Measuring Technology Acceptance and Other Constructs , 2008, MIS Q..

[7]  A. Schulze-Bonhage,et al.  Wearable technology in epilepsy: The views of patients, caregivers, and healthcare professionals , 2018, Epilepsy & Behavior.

[8]  E. Dooley,et al.  Estimating Accuracy at Exercise Intensities: A Comparative Study of Self-Monitoring Heart Rate and Physical Activity Wearable Devices , 2017, JMIR mHealth and uHealth.

[9]  Yoshio Nakata,et al.  Accuracy of Wearable Devices for Estimating Total Energy Expenditure: Comparison With Metabolic Chamber and Doubly Labeled Water Method. , 2016, JAMA internal medicine.

[10]  J. A. Oliveira,et al.  The Impact of mHealth Interventions: Systematic Review of Systematic Reviews , 2018, JMIR mHealth and uHealth.

[11]  Marie-Pierre Gagnon,et al.  m-Health adoption by healthcare professionals: a systematic review , 2016, J. Am. Medical Informatics Assoc..

[12]  Jobke Wentzel,et al.  Designing eHealth that Matters via a Multidisciplinary Requirements Development Approach , 2013, JMIR research protocols.

[13]  T. Wykes,et al.  Barriers to and Facilitators of Engagement With Remote Measurement Technology for Managing Health: Systematic Review and Content Analysis of Findings , 2018, Journal of medical Internet research.

[14]  Eric J Topol,et al.  State of Telehealth. , 2016, The New England journal of medicine.

[15]  Elizabeth Cummings,et al.  Design Thinking for mHealth Application Co-Design to Support Heart Failure Self-Management , 2017, CSHI.

[16]  Michele Angelaccio,et al.  Remote Patient Monitoring via Non-Invasive Digital Technologies: A Systematic Review , 2017, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[17]  Cindy Howry,et al.  Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. , 2017, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[18]  M. Peeples,et al.  Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework , 2016, JMIR research protocols.

[19]  Brijesh Singh,et al.  The Lean Startup:How Today's Entrepreneurs Use Continuous Innovation to Create Radically Successful Businesses , 2016 .

[20]  Alvaro Gauterin,et al.  Comparison of wrist-worn Fitbit Flex and waist-worn ActiGraph for measuring steps in free-living adults , 2017, PloS one.

[21]  Nicol Nijland,et al.  A Holistic Framework to Improve the Uptake and Impact of eHealth Technologies , 2011, Journal of medical Internet research.

[22]  Paul Bate,et al.  Experience-based design: from redesigning the system around the patient to co-designing services with the patient , 2006, Quality and Safety in Health Care.

[23]  Brennan M. R. Spiegel,et al.  Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials , 2018, npj Digital Medicine.

[24]  E. Chiauzzi,et al.  Free-Living Physical Activity Monitoring in Adult US Patients with Multiple Sclerosis Using a Consumer Wearable Device , 2018, Digital Biomarkers.

[25]  Peter Feys,et al.  The Use of Digital and Remote Communication Technologies as a Tool for Multiple Sclerosis Management: Narrative Review , 2018, JMIR rehabilitation and assistive technologies.

[26]  Jessica Y. Breland,et al.  Design Thinking in Health Care , 2018, Preventing chronic disease.

[27]  M. J. Pletcher,et al.  Continuous daily assessment of multiple sclerosis disability using remote step count monitoring , 2017, Journal of Neurology.

[28]  Colin Potts,et al.  Design of Everyday Things , 1988 .

[29]  Tim Olds,et al.  The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study , 2015, International Journal of Behavioral Nutrition and Physical Activity.

[30]  Alan R. Hevner,et al.  The Three Cycle View of Design Science , 2007, Scand. J. Inf. Syst..

[31]  N. V. Manyakov,et al.  Remote assessment of disease and relapse in major depressive disorder (RADAR-MDD): a multi-centre prospective cohort study protocol , 2019, BMC Psychiatry.

[32]  Matthew P Buman,et al.  Twenty-four Hours of Sleep, Sedentary Behavior, and Physical Activity with Nine Wearable Devices. , 2016, Medicine and science in sports and exercise.

[33]  Hoda Javadikasgari,et al.  Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise , 2017, Medicine and science in sports and exercise.

[34]  Peter Hanlon,et al.  Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies , 2016, BMC Medical Informatics and Decision Making.

[35]  Helana Scheepers,et al.  Health information systems evaluation frameworks: A systematic review , 2017, Int. J. Medical Informatics.

[36]  Mohammad Mehdi Sepehri,et al.  A framework for m-health service development and success evaluation , 2018, Int. J. Medical Informatics.

[37]  J. Kientz,et al.  Consumer Sleep Technologies: A Review of the Landscape. , 2015, Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine.

[38]  Gregory J Welk,et al.  The Wild Wild West: A Framework to Integrate mHealth Software Applications and Wearables to Support Physical Activity Assessment, Counseling and Interventions for Cardiovascular Disease Risk Reduction. , 2016, Progress in cardiovascular diseases.

[39]  Jennifer C. Goldsack,et al.  Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010–2016: A Systematic Literature Review , 2018, Digital Biomarkers.

[40]  R. Lau,et al.  Factors that influence the implementation of e-health: a systematic review of systematic reviews (an update) , 2016, Implementation Science.

[41]  James R. Lewis,et al.  Psychometric Evaluation of the PSSUQ Using Data from Five Years of Usability Studies , 2002, Int. J. Hum. Comput. Interact..

[42]  M. Hotopf,et al.  Barriers to and Facilitators of Engagement With mHealth Technology for Remote Measurement and Management of Depression: Qualitative Analysis , 2019, JMIR mHealth and uHealth.

[43]  B. Caulfield,et al.  The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study , 2018, Journal of medical Internet research.

[44]  Jasmine Travers,et al.  A user-centered model for designing consumer mobile health (mHealth) applications (apps) , 2016, J. Biomed. Informatics.

[45]  M. C. Reid,et al.  Older adults are mobile too!Identifying the barriers and facilitators to older adults’ use of mHealth for pain management , 2013, BMC Geriatrics.

[46]  T. Wykes,et al.  Engaging across dimensions of diversity: A cross-national perspective on mHealth tools for managing relapsing remitting and progressive multiple sclerosis. , 2019, Multiple sclerosis and related disorders.

[47]  E. Cummings,et al.  Partnering in Digital Health Design: Engaging the Multidisciplinary Team in a Needs Analysis. , 2018, Studies in health technology and informatics.

[48]  Stephen Sutton,et al.  IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior , 2016, Journal of medical Internet research.

[49]  Dermot Phelan,et al.  Accuracy of Wrist-Worn Heart Rate Monitors , 2017, JAMA cardiology.

[50]  Kumanan Wilson,et al.  Agile research to complement agile development: a proposal for an mHealth research lifecycle , 2018, npj Digital Medicine.

[51]  M. Freeman,et al.  A systematic review of clinician and staff views on the acceptability of incorporating remote monitoring technology into primary care. , 2014, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.