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远程医疗大型多中心试验的实施蓝图。

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

机构信息

Division of Stroke, Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, United States.

Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.

出版信息

J Med Internet Res. 2021 Sep 20;23(9):e29511. doi: 10.2196/29511.

DOI:10.2196/29511
PMID:34542417
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8491114/
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.

摘要

最近的文献支持远程医疗在改善各种健康结果方面的功效和效率,尽管结果存在很大差异。需要了解远程医疗试验实施中的特定地点问题,以更广泛地复制和推广结果的普遍性。可以从现有试验中吸取经验教训,蓝图可以指导研究人员更有效地利用远程医疗进行这些具有挑战性的研究。本观点介绍了使用正在进行的和已完成的 7 项由患者为中心的成果研究所资助的大型多中心试验组合中的远程医疗试验进行多中心远程医疗试验的相关挑战和解决方案,以突出实施远程医疗试验的挑战。确定并描述了确保领导力和认同、适当的资金以及多样化和有代表性的试验的关键问题,以及与临床、信息学、监管、法律、质量和计费相关的挑战。从这些研究中吸取的经验教训被用来创建一个多中心远程医疗试验设计和实施的关键方面的蓝图。

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本文引用的文献

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Clinician Perspectives on Implementing Video Visits in Home-Based Palliative Care.临床医生对在家中开展姑息治疗时实施视频问诊的看法。
Palliat Med Rep. 2020 Oct 6;1(1):221-226. doi: 10.1089/pmr.2020.0074. eCollection 2020.
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Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial.通过非专科提供者和远程医疗扩大获得治疗的机会以扩大孕产妇心理健康保健规模(SUMMIT):一项非劣效性随机对照试验的研究方案。
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Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action.全球远程医疗在卫生系统中的实施和整合,以抗击 COVID-19 大流行:行动呼吁。
JMIR Public Health Surveill. 2020 Apr 2;6(2):e18810. doi: 10.2196/18810.
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Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses.梳理远程医疗干预对糖尿病、血脂异常和高血压有效性的证据:系统评价和荟萃分析的伞状综述
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Moving Toward Evidence-Based Policy: The Value of Randomization for Program and Policy Implementation.迈向基于证据的政策:随机化在项目与政策实施中的价值。
JAMA. 2020 Jan 7;323(1):21-22. doi: 10.1001/jama.2019.18061.
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Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.研究促进农村综合远程精神病学创新(SPIRIT):在农村初级保健诊所管理复杂精神疾病的随机对照效果试验的原理和设计。
Contemp Clin Trials. 2020 Mar;90:105873. doi: 10.1016/j.cct.2019.105873. Epub 2019 Oct 31.
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J Palliat Med. 2019 Sep;22(S1):20-33. doi: 10.1089/jpm.2019.0116.
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Telehealth in Home-Based Primary Care: Factors and Challenges Associated With Integration Into Veteran Care.家庭初级保健中的远程医疗:与纳入退伍军人护理相关的因素和挑战。
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