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数字疗法(DTx)作为医生治疗手段中的新工具:支持其有效且合理开发与使用的关键观察结果

Digital Therapies (DTx) as New Tools within Physicians' Therapeutic Arsenal: Key Observations to Support their Effective and Responsible Development and Use.

作者信息

Bélisle-Pipon Jean-Christophe, David Pierre-Marie

机构信息

Faculty of Health Sciences, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia, V5A 1S6, Canada.

Faculty of Pharmacy, Université de Montréal, 2900 Blvd Edouard Montpetit, Montréal, Québec, H3T 1J4, Canada.

出版信息

Pharmaceut Med. 2023 Mar;37(2):121-127. doi: 10.1007/s40290-022-00459-3. Epub 2023 Jan 18.

Abstract

In recent years, there has been a swift rise in the development of digital therapies (DTx). As a result of various technological advances and accessibility to patients, it is now possible to develop and offer therapeutic interventions in a digital manner. These take the form of an evidence-based intervention that is administered in digital form to prevent, manage, or treat a medical condition. What makes DTx significantly different from other types of digital applications or services (e.g., wellness applications) is that they are interventions authorised by regulatory agencies for the treatment, like a drug, of a health condition. Yielding actual therapeutic benefits and being at the crossroads of health and digital means that DTx are subject to both the upsides and downsides of both sectors. Thus, it is of particular interest to look at the facilitators and barriers to be foreseen in the development, assessment, and implementation of DTx. In this article, we will present key observations and outline the main challenges that may be faced in the development and integration of DTx into practice. It is certain that DTx can represent an interesting avenue for physicians to bring their prescribing role into the 21st century. We conclude with broad lessons that the emerging field of DTx can learn from decades of drug industry practice to avoid history repeating itself and to fast-track the development and ethical and optimal use of DTx.

摘要

近年来,数字疗法(DTx)的发展迅速崛起。由于各种技术进步以及患者可及性的提高,现在能够以数字方式开发并提供治疗干预措施。这些干预措施采取基于证据的干预形式,以数字形式实施,用于预防、管理或治疗医疗状况。DTx与其他类型的数字应用或服务(如健康应用)的显著不同之处在于,它们是经监管机构授权用于治疗健康状况的干预措施,类似于药物。产生实际治疗效益且处于健康与数字的交叉点意味着DTx既面临两个领域的优势,也面临劣势。因此,特别值得关注在DTx的开发、评估和实施中可预见的促进因素和障碍。在本文中,我们将呈现关键观察结果,并概述在将DTx开发并整合到实践中可能面临的主要挑战。可以肯定的是,DTx对于医生将其处方角色带入21世纪而言,可能是一条有趣的途径。我们最后总结了DTx这个新兴领域可以从制药行业数十年的实践中学到的广泛经验教训,以避免历史重演,并加快DTx的开发以及道德和最佳使用。

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