The critical importance of using mobile technology is obvious to anyone in the health professions, particularly those who treat people with central nervous system disorders, said Steven Hyman, director of the Stanley Center for Psychiatric Research at the Broad Institute of Harvard and the Massachusetts Institute of Technology. Whether those conditions are psychiatric or neurologic, he said, “We know remarkably little about the patients we’re treating.” Even if those patients are enrolled in a clinical trial where they are assessed every three or four weeks, important clinical and regulatory decisions are made on what he called “intermittent, brief, and superficial cross-sectional examinations.”
“Digital phenotyping” is one approach to addressing these measurement gaps and methodological problems. Jukka-Pekka (“JP”) Onnela, associate professor of biostatistics at the Harvard T.H. Chan School of Public Health, defined digital phenotyping as the moment-by-moment quantification of social, behavioral, and cognitive markers in situ using data from personal digital devices (Onnela and Rauch, 2016). Hyman contrasted these digital tools to the types of periodic assessments typically done in clinical trials, which he said provide shallow rather than deep phenotyping of participants. In addition, he said, retrospective bias—the tendency for false reporting if a person has had a particularly good or bad day—may color an individual’s responses to even well-administered rating scales.
1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They should not be construed as reflecting any group consensus.
Patient-reported outcomes (PROs) may also be misleading if patients consciously or subconsciously want to demonstrate to their physician either how bad or how well they are doing, said Hyman. Digital technologies offer the potential to do better, he said, if they can be implemented in ways that are meaningful, sensible, and cost effective.
Husseini Manji, global therapeutic head for neuroscience at Janssen Research & Development, LLC, agreed. The twin revolutions in neurobiology and mobile computing have the potential to offer important benefits for people with neurological disorders, he said. There are reasons to think these technologies could be transformational, yet he cautioned against overhyping what they can do. “Let’s be thoughtful and systematic about it, so we can really make a difference for some of these complex neuropsychiatric, neurodevelopmental, and neurodegenerative conditions,” he said.
To explore current developments and opportunities for using mobile technology to advance research and treatment of central nervous system (CNS) disorders, the National Academies’ Forum on Neuroscience and Nervous System Disorders hosted a workshop on June 5–6, 2018. This publication summarizes the presentations and discussions at that workshop.
The workshop brought together a diverse group from federal research and regulatory agencies, academia, industry, and foundations, along with advocates presenting the patient point of view to discuss how to ensure that technological advances are translated into something meaningful for individuals and society as a whole. The workshop also addressed key concerns that society will have to grapple with regarding digital technologies, including privacy and data ownership, said Manji (see Box 1-1 for the workshop Statement of Task).
Chapter 2 summarizes opportunities and challenges associated with digital technologies, including their potential to elucidate understanding of health and disease, increase the efficiency and productivity of clinical trials, and improve patient care, as well as the challenges associated with gathering and interpreting digital data. Chapter 3 provides a deeper dive into the challenges associated with data collection, validation, standardization, and analysis. Regulatory considerations and steps being undertaken to address regulatory concerns are discussed in Chapter 4. Chapter 5 delves into the promise and challenges associated with incorporating mobile technologies into clinical practice. The importance of addressing consumer attitudes and preferences when developing mobile technologies is addressed in Chapter 6. The potential to move these technologies forward by building research partnerships is addressed in Chapter 7.
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