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.

Highlights

  • Multisite clinical trials are critical to advance the detection, diagnosis, and treatment of disease and to drive valid and reliable knowledge that can be generalized to broad integrated populations and health care settings

  • Why do we need a blueprint for researchers conducting multisite telemedicine trials? A key reason is that telemedicine trials present new challenges to researchers that are typically not encountered in more traditional clinical trials

  • This study evaluated an innovative CCHb model where patients and primary care providers could access dermatologists on the web directly and asynchronously via a pragmatic RCTc to test whether a CCH model results in equivalent improvements in disease severity, quality of life, and mental health, and whether the model provides better access to specialty care, compared with usual in-person care for psoriasis management

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Summary

Introduction

Multisite clinical trials are critical to advance the detection, diagnosis, and treatment of disease and to drive valid and reliable knowledge that can be generalized to broad integrated populations and health care settings. An extensive body of literature on modern telemedicine already exists, going back well over 25 years, with at least two mainstream peer review telemedicine journals dedicated to presenting research results with an increasing emphasis on outcomes. Systematic literature reviews and meta-analyses are being conducted at accelerating rates, which could not happen reliably if a large enough body of published studies to draw from were not available. This body of literature as a whole includes many mixed, inconclusive, and even contradictory results [2,3,4,5,6]

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