TY - JOUR
T1 - A roadmap for implementation of patient-centered digital outcome measures in Parkinson's disease obtained using mobile health technologies
AU - Espay, Alberto J.
AU - Hausdorff, Jeffrey M.
AU - Sánchez-Ferro, Álvaro
AU - Klucken, Jochen
AU - Merola, Aristide
AU - Bonato, Paolo
AU - Paul, Serene S.
AU - Horak, Fay B.
AU - Vizcarra, Joaquin A.
AU - Mestre, Tiago A.
AU - Reilmann, Ralf
AU - Nieuwboer, Alice
AU - Dorsey, E. Ray
AU - Rochester, Lynn
AU - Bloem, Bastiaan R.
AU - Maetzler, Walter
AU - on behalf of the Movement Disorder Society Task Force on Technology
N1 - Funding Information:
Dr. Espay has received grant support from the National Institutes of Health (NIH), Great Lakes Neurotechnologies and the Michael J Fox Foundation; personal compensation as a consultant/scientific advisory board member for Abbvie, Adamas, Acadia, Acorda, Neuroderm, Impax, Sunovion, Lundbeck, Osmotica Pharmaceutical, and USWorldMeds; publishing royalties from Lippincott Williams & Wilkins, Cambridge University Press, and Springer; and honoraria from USWorldMeds, Lundbeck, Acadia, Sunovion, the American Academy of Neurology, and the Movement Disorders Society. He serves as chair of the MDS Task Force on Technology. Dr. Hausdorff has received grant support from the NIH, the Michael J Fox Foundation for Parkinson's Research, the European Union (EU) (H2020), the United States-Israel Binational Science Foundation (BSF), the Israeli Science Foundation and the National Multiple Sclerosis Society. He has or currently serves on the Movement Disorders Society Technology Task Force and on Michael J Fox Foundation task force on gait, on the board of the International Society for the Measurement of Physical Behavior, and on advisory boards for Sanofi and Biogen. He has submitted a patent application on the use of body-fixed sensors for assessing PD symptoms, the intellectual property rights for which are held by the Tel Aviv Medical Center. Dr. Sanchez-Ferro research is sponsored by the ?Consejer?a de Educaci?n, Juventud y Deporte of Comunidad de Madrid? and the People Programme (Marie Curie Actions) of the European Union's Seventh Framework Programme (FP7/2007-2013) under REA agreement no. 291820. He holds a patent on a Method and Apparatus for Motor Function Characterization and has received spaker honoraria from Teva, Zambon, Abbvie, Alter and Novartis pharmaceutica. Dr. S?nchez-Ferro is the current chair of the Rating Scales Electronic Development Ad Hoc Committee. Dr. Klucken has received institutional research grants from Bavarian Research Foundation; Emerging Field Initiative, Friedrich-Alexander-Universit?t Erlangen-N?rnberg (FAU); European Institute for Innovation & Technology (EIT)-Health; EIT-Digital; EU (H2020), German Research Foundation (DFG); Bundesministerium f?r Bildung und Forschung (BMBF).
Publisher Copyright:
© 2019 International Parkinson and Movement Disorder Society
PY - 2019/5
Y1 - 2019/5
N2 - Obtaining reliable longitudinal information about everyday functioning from individuals with Parkinson's disease (PD) in natural environments is critical for clinical care and research. Despite advances in mobile health technologies, the implementation of digital outcome measures is hindered by a lack of consensus on the type and scope of measures, the most appropriate approach for data capture (eg, in clinic or at home), and the extraction of timely information that meets the needs of patients, clinicians, caregivers, and health care regulators. The Movement Disorder Society Task Force on Technology proposes the following objectives to facilitate the adoption of mobile health technologies: (1) identification of patient-centered and clinically relevant digital outcomes; (2) selection criteria for device combinations that offer an acceptable benefit-to-burden ratio to patients and that deliver reliable, clinically relevant insights; (3) development of an accessible, scalable, and secure platform for data integration and data analytics; and (4) agreement on a pathway for approval by regulators, adoption into e-health systems and implementation by health care organizations. We have developed a tentative roadmap that addresses these needs by providing the following deliverables: (1) results and interpretation of an online survey to define patient-relevant endpoints, (2) agreement on the selection criteria for use of device combinations, (3) an example of an open-source platform for integrating mobile health technology output, and (4) recommendations for assessing readiness for deployment of promising devices and algorithms suitable for regulatory approval. This concrete implementation guidance, harmonizing the collaborative endeavor among stakeholders, can improve assessments of individuals with PD, tailor symptomatic therapy, and enhance health care outcomes.
AB - Obtaining reliable longitudinal information about everyday functioning from individuals with Parkinson's disease (PD) in natural environments is critical for clinical care and research. Despite advances in mobile health technologies, the implementation of digital outcome measures is hindered by a lack of consensus on the type and scope of measures, the most appropriate approach for data capture (eg, in clinic or at home), and the extraction of timely information that meets the needs of patients, clinicians, caregivers, and health care regulators. The Movement Disorder Society Task Force on Technology proposes the following objectives to facilitate the adoption of mobile health technologies: (1) identification of patient-centered and clinically relevant digital outcomes; (2) selection criteria for device combinations that offer an acceptable benefit-to-burden ratio to patients and that deliver reliable, clinically relevant insights; (3) development of an accessible, scalable, and secure platform for data integration and data analytics; and (4) agreement on a pathway for approval by regulators, adoption into e-health systems and implementation by health care organizations. We have developed a tentative roadmap that addresses these needs by providing the following deliverables: (1) results and interpretation of an online survey to define patient-relevant endpoints, (2) agreement on the selection criteria for use of device combinations, (3) an example of an open-source platform for integrating mobile health technology output, and (4) recommendations for assessing readiness for deployment of promising devices and algorithms suitable for regulatory approval. This concrete implementation guidance, harmonizing the collaborative endeavor among stakeholders, can improve assessments of individuals with PD, tailor symptomatic therapy, and enhance health care outcomes.
KW - Parkinson's disease
KW - mobile health technologies
KW - remote monitoring
KW - wearable technology
UR - http://www.scopus.com/inward/record.url?scp=85063317882&partnerID=8YFLogxK
U2 - 10.1002/mds.27671
DO - 10.1002/mds.27671
M3 - Review article
C2 - 30901495
AN - SCOPUS:85063317882
SN - 0885-3185
VL - 34
SP - 657
EP - 663
JO - Movement Disorders
JF - Movement Disorders
IS - 5
ER -