Abstract

The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.

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Acknowledgements

The study is funded by the Icahn School of Medicine at Mount Sinai, UL1TR001433-01, and with technology support from LifeMap Solutions.

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Affiliations

  1. Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Yu-Feng Yvonne Chan
    • , Pei Wang
    • , Nicole Tignor
    • , Micol Zweig
    • , Nicholas Genes
    • , Erick R Scott
    • , Marcus Badgeley
    • , Samantha Violante
    • , Joel T Dudley
    •  & Eric E Schadt
  2. Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Yu-Feng Yvonne Chan
    •  & Nicholas Genes
  3. Department of Medicine, Pulmonary, Critical Care and Sleep Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Linda Rogers
    • , Rosalind Wright
    •  & Charles A Powell
  4. LifeMap Solutions, Inc., New York, New York, USA.

    • Steven G Hershman
    • , Eric Krock
    •  & Ron Edgar
  5. Department of Pediatrics, Pulmonary and Critical Care, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Rosalind Wright
  6. Department of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Rosalind Wright
  7. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

    • Joel T Dudley

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Contributions

Y.-F.Y.C. developed the initial study design/protocol, including electronic informed consent and the statistical plan, IRB submission and approval, app design and implementation, and budget management, ensured proper study execution, provided clinical support, refined surveys, and assisted in data interpretation, manuscript writing and revision and preparation for submission. P.W. contributed to study design and survey refinement, led statistical support and provided oversight for all data analysis and interpretation, generated figures and tables, and was a major contributor to manuscript writing and revision. L.R. assisted in the initial study design/protocol and IRB preparation and submission, led in the design of surveys, provided clinical support, participated in manuscript writing, and served as NJH liaison. N.T. provided statistical support, including data analysis and interpretation, generated figures and tables, participated in study design and survey refinement, provided major contributions to manuscript writing and revision, and served as a graphic artist liaison. M.Z. assisted in electronic informed consent design, led subsequent IRB submission and provided support, refined surveys, and was a major contributor to manuscript writing and preparation for submission. S.G.H. served as LifeMap Solutions scientific lead and provided support for AHA design, implementation, and functionality, served as a liaison to other technology partners, refined surveys, and assisted in data interpretation and manuscript writing. N.G. led the latter part of the study execution, provided subsequent IRB support, provided clinical support, refined surveys, and assisted in data interpretation and manuscript writing. E.R.S. provided statistical support and data analysis and interpretation, assisted in generating figures and tables, provided subsequent IRB support, and participated in manuscript writing. S.V. was involved in study execution and manuscript writing. M.B. assisted in data analysis and interpretation, and generated figures and tables. E.K. contributed to app design and implementation, as well as initial IRB document preparation. R.E. was the LifeMap Solutions technical lead, participated in app design and implementation, and helped ensure data integrity. R.W. assisted in study design and data interpretation. C.A.P. contributed to study design and data interpretation. J.T.D. contributed to study design input and manuscript revision. E.E.S. participated in study design, oversaw study execution, interpreted data, and participated in manuscript writing and revision.

Competing interests

E.E.S. (a co-investigator in this study, Chair of the Department of Genetics and Genomics Sciences, and Director of the Icahn Institute for Genomics and Multiscale Biology) and J.T.D. (a co-Investigator in this study and the Director of Biomedical Informatics at the Icahn School of Medicine at Mount Sinai (ISMMS) both hold equity in the form of stock options in LifeMap Solutions, a privately held company. In addition E.E.S. serves as an uncompensated advisory board member and is administratively responsible for the medical school's collaboration with LifeMap Solutions.

Corresponding authors

Correspondence to Yu-Feng Yvonne Chan or Eric E Schadt.

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DOI

https://doi.org/10.1038/nbt.3826

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