TY - JOUR
T1 - Common data elements for epilepsy mobile health systems
AU - Goldenholz, Daniel M.
AU - Moss, Robert
AU - Jost, David A.
AU - Crone, Nathan E.
AU - Krauss, Gregory
AU - Picard, Rosalind
AU - Caborni, Chiara
AU - Cavazos, Jose E.
AU - Hixson, John
AU - Loddenkemper, Tobias
AU - Salazar, Tracy Dixon
AU - Lubbers, Laura
AU - Harte-Hargrove, Lauren C.
AU - Whittemore, Vicky
AU - Duun-Henriksen, Jonas
AU - Dolan, Eric
AU - Kasturia, Nitish
AU - Oberemk, Mark
AU - Cook, Mark J.
AU - Lehmkuhle, Mark
AU - Sperling, Michael R.
AU - Shafer, Patricia O.
N1 - Funding Information:
This project was made possible in part by the International Seizure Diary Consortium (https://sites.google.com/site/isdc home/). We would also like to acknowledge the efforts and suggestions of our colleagues Dr. William Theodore at National Institutes of Health, Dr. Sheryl Haut at Montefiore Medical Center, Dr. Robert Fisher at Stanford, Nick Hasu-lak and Dr. Martha Morrell from Neuropace, Matteo Lai and Daniel Bender from Empatica, Anoo Nathan from Smart Monitor, Mike Girouard from Brain Sentinel, and Dr. Brandy Fureman from the Epilepsy Foundation.
Funding Information:
R.M. is the owner of SeizureTracker. R.P. is a cofounder, stockholder, chief scientist, and chairman of the board of Empatica. She is also a cofounder and stockholder of Affectiva. The companies from whom she has recently received consulting payments, travel reimbursements, or directed research funding are Takeda, Medimmune, Suno-vion, NEC, Intel, Deloitte, Millipore, Apple, and Empatica. C.C. is an employee of Empatica. D.A.J. is Senior Director of Digital Strategies, Epilepsy Foundation. J.E.C. is a cofounder, stockholder, and consultant for Brain Sentinel. J.D.-H. is employed by UNEEG Medical, which makes devices for ultra–long-term electroencephalographic measurements. E.D. is cofounder and CEO of Neutun Labs. N.K. is an employee of Neutun Labs. M.O. is an employee of Neutun Labs. P.O.S. is employed by the Epilepsy Foundation, owner of My Seizure Diary. M.L. is employed by and a shareholder of Epitel. T.L. serves on the Laboratory Accreditation Board for Long Term (Epilepsy and Intensive Care Unit) Monitoring, on the Council (and as Vice President and President Elect) of the American Clinical Neurophysiology Society, on the American Board of Clinical Neurophysiology, as founder and consortium principal investigator of the pediatric status epilepticus research group, as an Associate Editor for Seizure, on the Editorial Board of Epilepsia, and as an Associate Editor for Wyllie’s Treatment of Epilepsy 6th and 7th editions. He is part of pending patent applications to detect and predict seizures and to diagnose epilepsy. He receives research support from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Epilepsy Research Fund, American Epilepsy Society, Epilepsy Foundation of America, Epilepsy Therapy Project, Pediatric Epilepsy Research Foundation, Citizens United for Research in Epilepsy, and HHV-6 Foundation, and has received research grants from Lundbeck, Eisai, Upsher-Smith Laboratories, Mallinckrodt, Acorda, Sage, and Pfizer. He serves as a consultant for Zogenix, Engage, Amzell, Upsher-Smith Laboratories, Eisai, Sunovion, and Lundbeck. He performs video-electroencephalographic long-term and intensive care unit monitoring, electroencephalograms, and other electrophysiological studies at Boston Children’s Hospital and affiliated hospitals and bills for these procedures, and he evaluates pediatric neurology patients and bills for clinical care. He has received speaker honorariums from national societies including the American Academy of Neurology, American Epilepsy Society, and American Clinical Neurophysiology Society, and for grand rounds at various academic centers. His wife, Dr. Karen Stannard, is a pediatric neurologist; she performs video-electroencephalographic long-term and intensive care unit monitoring, electroencephalograms, and other electrophysiological studies and bills for these procedures, and she evaluates pediatric neurology patients and bills for clinical care. M.R.S. receives research funding from the National Institutes of Health, Defense Advanced Research Projects Agency, UCB Pharma, Eisai, SK Life Science, Pfizer, Brain Sentinel, Medtronic, Neurelis, Upsher-Smith Laboratories, and Sunovion; he also consults for Medtronic and Medscape. None of the other authors has any conflict of interest to disclose. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
PY - 2018/5
Y1 - 2018/5
N2 - Objective: Common data elements (CDEs) are currently unavailable for mobile health (mHealth) in epilepsy devices and related applications. As a result, despite expansive growth of new digital services for people with epilepsy, information collected is often not interoperable or directly comparable. We aim to correct this problem through development of industry-wide standards for mHealth epilepsy data. Methods: Using a group of stakeholders from industry, academia, and patient advocacy organizations, we offer a consensus statement for the elements that may facilitate communication among different systems. Results: A consensus statement is presented for epilepsy mHealth CDEs. Significance: Although it is not exclusive, we believe that the use of a minimal common information denominator, specifically these CDEs, will promote innovation, accelerate scientific discovery, and enhance clinical usage across applications and devices in the epilepsy mHealth space. As a consequence, people with epilepsy will have greater flexibility and ultimately more powerful tools to improve their lives.
AB - Objective: Common data elements (CDEs) are currently unavailable for mobile health (mHealth) in epilepsy devices and related applications. As a result, despite expansive growth of new digital services for people with epilepsy, information collected is often not interoperable or directly comparable. We aim to correct this problem through development of industry-wide standards for mHealth epilepsy data. Methods: Using a group of stakeholders from industry, academia, and patient advocacy organizations, we offer a consensus statement for the elements that may facilitate communication among different systems. Results: A consensus statement is presented for epilepsy mHealth CDEs. Significance: Although it is not exclusive, we believe that the use of a minimal common information denominator, specifically these CDEs, will promote innovation, accelerate scientific discovery, and enhance clinical usage across applications and devices in the epilepsy mHealth space. As a consequence, people with epilepsy will have greater flexibility and ultimately more powerful tools to improve their lives.
KW - common data elements
KW - devices
KW - epilepsy
KW - mHealth
KW - seizure diary
KW - standards
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U2 - 10.1111/epi.14066
DO - 10.1111/epi.14066
M3 - Article
C2 - 29604050
AN - SCOPUS:85044636685
VL - 59
SP - 1020
EP - 1026
JO - Epilepsia
JF - Epilepsia
SN - 0013-9580
IS - 5
ER -