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Patricia Commiskey, Email: patricia.commiskey@vumc.org

PC and EAK led the development, compiled sections, and refined and edited the manuscript. All authors participated in the development of the concept, contributed content, and reviewed the final manuscript.

ERD has received honoraria for speaking at American Academy of Neurology courses, American Neurological Association, MCM Education, Physician’s Education Resource, LLC, Stanford University, University of California Irvine, and University of Michigan. ERD also received compensation for consulting services from 23andMe, Abbott, Abbvie, Acadia, Acorda, Biogen, BrainNeuroBio, Clintrex, Curasen Therapeutics, DeciBio, Denali Therapeutics, Eli Lilly, Grand Rounds, Karger, MC10, Medopad, Michael J. Fox Foundation, Olson Research Group, Origent Data Sciences, Inc, Otsuka, Pear Therapeutics, Praxis, Roche, Sanofi, Spark, Sunovion Pharma, Theravance, and Voyager Therapeutics. In addition, ERD received research support from Abbvie, Biogen, Biosensics, Burroughs Wellcome Fund, Food and Drug Administration, Greater Rochester Health Foundation, Huntington Study Group, Massachusetts Institute of Technology, Michael J Fox Foundation, National Institutes of Health and National Institute of Neurological Disorders and Stroke and National Center for Advancing Translational Sciences, PICORI, Pfizer, Photopharmics, Roche, and Safra Foundation; editorial services for Karger Publications; and ownership interests with Grand Rounds (second opinion service).

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Research Funding:

The research reported in this publication was partially funded by the PCORI Awards (HIS-071502-IC, IH-12-11-4168-IC, AD-12-11-4701, PCS-2017C3-9081, HSRP-2018-1686, PCS-2018C1-10621, HIS-2017C3-8930). The views, statements, and opinions in this publication are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or Methodology Committee.

PC is supported by a grant from PCORI (grant PCS-2017C3-9081) and partially supported by a grant from the United States Department of Agriculture Distance Learning and Telemedicine program (grant TN 754-A17). AWA is supported by a grant from PCORI (grant IHS-071502-IC). TRC is supported by a grant from PCORI (grant IH-12-11-4168-IC). ERD is supported by a grant from PCORI (grant AD-12-11-4701). JF was supported by a grant from the PCORI (grant PCS-1406-19295) and by a Research Career Scientist award from the Department of Veterans Affairs.

KJG is supported by a grant from PCORI (grant PCS-2017C3-9081). BG is supported by a grant from PCORI (grant IHS-071502-IC). HQN is supported by a grant from PCORI (grant PLC-1609-36108). DRS is supported by a grant from PCORI (grant PCS-2018C1-10621) and by an Academic Scholars Award from the Department of Psychiatry at the University of Toronto. ES is supported by a grant from PCORI (grant IHS-2017C3-8930).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Health Care Sciences & Services
  • Medical Informatics
  • telemedicine trials
  • randomized trials
  • challenges
  • multisite
  • mobile phone
  • HEALTH-CARE
  • TELEHEALTH
  • ACCESS
  • CHALLENGES
  • PROTOCOL
  • IMPACT

A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine

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Journal Title:

JOURNAL OF MEDICAL INTERNET RESEARCH

Volume:

Volume 23, Number 9

Publisher:

, Pages e29511-e29511

Type of Work:

Article | Final Publisher PDF

Abstract:

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

Copyright information:

©Patricia Commiskey, April W Armstrong, Tumaini R Coker, Earl Ray Dorsey, John C Fortney, Kenneth J Gaines, Brittany M Gibbons, Huong Q Nguyen, Daisy R Singla, Eva Szigethy, Elizabeth A Krupinski. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.09.2021.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/rdf).
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