The Role of Digital Health Technologies in Drug Development Proceedings of a Workshop (2020) / Chapter Skim
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3 Digital Health Technologies for Characterizing Disease
3 Digital Health Technologies for Characterizing Disease
Pages 21-40
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From page 21... ...
(Omberg) • Making digital health data widely available to a broad range of stakeholders, with frameworks and initiatives in place, could encourage researchers to collaborate and compare find ings using impartial benchmarks.
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(Staley) • Leveraging consumer behaviors that are driving the adop tion of commercial mobile health technologies could increase the uptake of these technologies in clinical care and research while also bridging the digital divide.
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The session was moderated by Effy Vayena, director of the Health Ethics and Policy Lab at ETH Zurich. CHALLENGES IN DERIVING HEALTH INSIGHTS FROM REAL-WORLD SENSOR DATA Larsson Omberg, Vice President of Systems Biology, Sage Bionetworks To explore the challenges and opportunities associated with the use of real-world sensor data to derive health insights, Omberg drew on experiences and lessons learned from conducting research using data collected from mobile phones and wearable devices.
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From page 24... ...
Compared to well-controlled clinical trials, large-scale observational studies with open recruitment tend to be more vulnerable to selection bias. For instance, an observational study using real-life data from a PD mobile health study, mPower, was intended to build a classifier of PD status, but most of the volunteer participants were young and healthy (Neto et al., 2019)
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From page 25... ...
Omberg explained that in protocols that use digital health, much larger volumes of data are collected from single individuals than in other types of protocols that collect measurements more infrequently. Therefore, the possibility of autocorrelation must be considered in DHT datasets that involve repeated measurements from a single individual.
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From page 26... ...
Synapse also houses analytical tools for processing and analyzing DHT data and other mobile health resources. The mPower researcher community has benefited from this type of ethical data sharing.
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DIGITAL DATA COLLECTION BY THE ALL OF US RESEARCH PROGRAM Chris Lunt, Chief Technology Officer, All of Us Research Program All of Us is an innovative research effort, launched by NIH in 2015 with the aim of collecting data from at least 1 million people in the United States. All of Us additionally strives to include participants from races or ethnicities that have been historically underrepresented by medical research.
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There is a strong focus on returning value to the participants in the program, and the project is built to be a longitudinal study that enables participants to be re-contacted over time. Multiple data types are being collected, including electronic health records (EHRs)
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For example, participants who wish to share their Fitbit data with All of Us are directed through a process of granting consent for data sharing over which Fitbit maintains strict control and is not modifiable in any way by All of Us. Similarly, participants can modify the types of data that can be read by program researchers simply by changing the settings within the Apple Health/HealthKit smartphone app.
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Value of the Bring-Your-Own-Device Strategy Lunt described some of the advantages and drawbacks of the initial BYOD strategy adopted by All of Us. Around 77 percent of people already have smartphones and about 12 percent of people -- and up to 30 percent in some segments -- already have their own wearable devices, he said.
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ADOPTION OF DIGITAL HEALTH TECHNOLOGIES Alicia Staley, Senior Director of Patient Engagement, Medidata Solutions Staley's remarks were framed by her perspective as a three-time cancer survivor with more than 30 years of survivorship. Three decades of paperbased and DHT data have been collected from her across different health systems in multiple states, she said, but there is not yet a single, comprehensive way for her to look at her medical record in its entirety.
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Barriers to Patient Use of Digital Health Technologies To increase the uptake of DHTs in clinical care and research and increase the volume of data collected, Staley suggested finding ways to take advantage of the consumer behaviors driving the adoption of commercial mobile health technologies that are already pervasive. For instance, she said an estimated 120 million Apple Watches10 have been used at some point in the previous 1.5 years.
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From page 33... ...
In addition to the lack of full-scale adoption in clinical research, Staley said that another current barrier is the lack of data sharing from consumer mobile health technologies to health care providers. For instance, she cannot easily and directly share critical information from her Oura Ring about her respiration with her primary care physician or oncologist.
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From page 34... ...
Leveraging Person-Generated Health Data to Inform Public Health Interventions PGHD makes it possible to carry out universal research on how individuals feel, function, and survive, Foschini said, because the data can be collected remotely and on a large scale. He suggested that collecting PGHD should be the first step in building health interventions -- from the development of drugs and devices to public health policies -- and in understanding how those developments affect the people they are ultimately intended to serve.
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SOURCES: As presented by Luca Foschini, March 24, 2020. Originally from Gambhir et al., 2018.
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Around 40 percent reported increased anxiety over the previous week. Financial anxiety is generally mediated by social determinants of health, Foschini said, and in the United States, people without health insurance tend to have much greater levels of anxiety.
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However, the patient may care more about outcomes such as sleeping better, walking more, or better fitness conditioning that can be captured using real-world PGHD. Ways Forward for Person-Generated Health Data Foschini outlined opportunities to expand the use of PGHD to inform participatory discovery and rapid development of interventions that have the individual at the center, ranging from public health policies to drugs, devices, and digital therapeutics.
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All stakeholders -- including individuals, providers, and regulators -- should have a common data format for storing and transmitting PGHD in order to share data collected using DHTs (e.g., sharing Oura Ring data with a provider)
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Currently, different platforms for data collection (e.g., Apple HealthKit, Fast Healthcare Interoperability Resources within EHR systems, or Clinical Data Interchange Standards Consortium/Clinical Data Acquisition Standards Harmonization) do not have a common way to represent data collected in a multivariable timeseries format.
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40 THE ROLE OF DIGITAL HEALTH TECHNOLOGIES IN DRUG DEVELOPMENT gold standard. For instance, the UK Biobank ran a study for 10 years before granting any access to its data, at which point the cardiology community suggested that a more appropriate measure should have been used for some of the data.
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