Abstract
Remote health assessments that gather real-world data (RWD) outside clinic settings require a clear understanding of appropriate methods for data collection, quality assessment, analysis and interpretation. Here we examine the performance and limitations of smartphones in collecting RWD in the remote mPower observational study of Parkinson’s disease (PD). Within the first 6 months of study commencement, 960 participants had enrolled and performed at least five self-administered active PD symptom assessments (speeded tapping, gait/balance, phonation or memory). Task performance, especially speeded tapping, was predictive of self-reported PD status (area under the receiver operating characteristic curve (AUC) = 0.8) and correlated with in-clinic evaluation of disease severity (r = 0.71; P < 1.8 × 10−6) when compared with motor Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). Although remote assessment requires careful consideration for accurate interpretation of RWD, our results support the use of smartphones and wearables in objective and personalized disease assessments.
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Data availability
The raw data from 67% of participants who have chosen to share their data broadly with all qualified researchers is available at https://doi.org/10.7303/syn4993293. Features, intermediate results and trained models for these participants are also available in Synapse (https://doi.org/10.7303/syn23277418). Access to data requires users to have their Synapse account validated, submit a data use statement and agree to terms of use. To aid in reproducibility and provide all final and intermediate results to the research community, we have redone the analysis presented here using the broadly shared data.
Code availability
The code, a docker container with all installed packages and a snakemake script that reproduces all of the figure and analysis, is available in GitHub: https://github.com/Sage-Bionetworks/mPowerRerun.
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Acknowledgements
This work was funded through a grant from the Robert Wood Johnson Foundation. These data were contributed by users of the Parkinson mPower mobile application as part of the mPower study developed by Sage Bionetworks and described in Synapse (https://doi.org/10.7303/syn4993293).
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L.O., E.C.N. and L.M.M. wrote the paper. L.O. oversaw the analytical and feature extraction activities. L.M.M. was the principal investigator on the study. E.C.N. developed analytical methods. E.C.N. performed the analyses of the mPower data, assisted by T.M.P., A.P. and L.O. A.T. independently reproduced analyses of the mPower data. T.M.P., A.P. and E.C.N. developed features extraction pipelines and figures. B.M.B. curated data and consulted on analyses. A.K. helped design in-app language, look and logic. M.R.K. led the team that designed and implemented the mPower app, and contributed to study design and data capture methodology. E.R.D. designed and oversaw the ObjectivePD validation study with assistance from M.E. and R.S. C.S. and J.W. led the team that designed and implemented the governance for informed consent and data sharing. A.D.T. conceived the study and helped design the app. J.A. performed in-clinic data collection. B.R.B., S.M.G., K.K., M.A.L., C.T. and C.M.T. served as scientific advisors on the study. All authors assisted with revisions of the paper.
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B.R.B. currently serves as Editor-in-Chief for the Journal of Parkinson’s Disease, serves on the editorial boards of Practical Neurology and Digital Biomarkers, has received honoraria from serving on the scientific advisory board for Zambon, Biogen, UCB and Walk with Path, has received fees for speaking at conferences from AbbVie, Zambon, Roche, GE Healthcare and Bial, and has received research support from the Netherlands Organization for Scientific Research, the Michael J. Fox Foundation, UCB, Abbvie, Zambon, the Stichting Parkinson Fonds, the Hersenstichting Nederland, the Parkinson’s Foundation, Verily Life Sciences, Horizon 2020, the Topsector Life Sciences and Health and the Parkinson Vereniging. E.R.D. has received honoraria for speaking at American Academy of Neurology courses, American Neurological Association and University of Michigan; received compensation for consulting services from 23andMe, Abbott, Abbvie, American Well, Biogen, BrainNeuroBio, Clintrex, Curasen Therapeutics, DeciBio, Denali Therapeutics, GlaxoSmithKline, Grand Rounds, Karger, Lundbeck, MC10, MedAvante, Medical-legal services, Mednick Associates, National Institute of Neurological Disorders and Stroke, Olson Research Group, Optio, Origent Data Sciences, Inc., Otsuka, Prilenia, Putnam Associates, Roche, Sanofi, Shire, Spark, Sunovion Pharma, Teva, Theravance, UCB and Voyager Therapeutics; research support from Abbvie, Acadia Pharmaceuticals, AMC Health, Biosensics, Burroughs Wellcome Fund, Davis Phinney Foundation, Duke University, Food and Drug Administration, GlaxoSmithKline, Greater Rochester Health Foundation, Huntington Study Group, Michael J. Fox Foundation, the NIH/NINDS, NSF, Nuredis Pharmaceuticals, Patient-Centered Outcomes Research Institute, Pfizer, Prana Biotechnology, Raptor Pharmaceuticals, Roche, Safra Foundation, Teva Pharmaceuticals and University of California Irvine; editorial services for Karger Publications; and ownership interests with Grand Rounds (second opinion service). C.M.T. reports grants from Sage Biometrics, during the conducting of the study; grants from Parkinson Foundation, grants from Gateway LLC, grants from Roche/Genentech, grants from Parkinson Study Group, personal fees from Biogen Idec, personal fees from Acorda, personal fees from Adamas Therapeutics, personal fees from Amneal, personal fees from CNS Ratings, personal fees from Grey Matter LLC, grants from Michael J. Fox Foundation, grants from NIH/NIA, grants from NIH/NINDS, grants from VA Merit, grants from Department of Defense, personal fees from Northwestern University, personal fees from Partners, Harvard University, nonfinancial support from Medtronic, Inc., nonfinancial support from Acadia, nonfinancial support from Boston Scientific, nonfinancial support from Neurocrine, nonfinancial support from Acadia, grants from Biogen Idec research support, nonfinancial support from Biogen Idec, personal fees from Guidemark Health, personal fees from Acadia, personal fees from Neurocrine, personal fees from Lundbeck, personal fees from Cadent, nonfinancial support from Neurocrine and grants from Roche Genentech, outside the submitted work.
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Omberg, L., Chaibub Neto, E., Perumal, T.M. et al. Remote smartphone monitoring of Parkinson’s disease and individual response to therapy. Nat Biotechnol 40, 480–487 (2022). https://doi.org/10.1038/s41587-021-00974-9
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DOI: https://doi.org/10.1038/s41587-021-00974-9
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