Background: Digital health technologies (dHTs) offer a unique opportunity to address some of the major challenges facing health care systems worldwide. However, the implementation of dHTs raises some concerns, such as the limited understanding of their real impact on health systems and people’s well-being or the potential risks derived from their use. In this context, health technology assessment (HTA) is 1 of the main tools that health systems can use to appraise evidence and determine the value of a given dHT. Nevertheless, due to the nature of dHTs, experts highlight the need to reconsider the frameworks used in traditional HTA. Objective: This scoping review (ScR) aimed to identify the methodological frameworks used worldwide for digital health technology assessment (dHTA); determine what domains are being considered; and generate, through a thematic analysis, a proposal for a methodological framework based on the most frequently described domains in the literature. Methods: The ScR was performed in accordance with the guidelines established in the PRISMA-ScR guidelines. We searched 7 databases for peer reviews and gray literature published between January 2011 and December 2021. The retrieved studies were screened using Rayyan in a single-blind manner by 2 independent authors, and data were extracted using ATLAS.ti software. The same software was used for thematic analysis. Results: The systematic search retrieved 3061 studies (n=2238, 73.1%, unique), of which 26 (0.8%) studies were included. From these, we identified 102 methodological frameworks designed for dHTA. These frameworks revealed great heterogeneity between them due to their different structures, approaches, and items to be considered in dHTA. In addition, we identified different wording used to refer to similar concepts. Through thematic analysis, we reduced this heterogeneity. In the first phase of the analysis, 176 provisional codes related to different assessment items emerged. In the second phase, these codes were clustered into 86 descriptive themes, which, in turn, were grouped in the third phase into 61 analytical themes and organized through a vertical hierarchy of 3 levels: level 1 formed by 13 domains, level 2 formed by 38 dimensions, and level 3 formed by 11 subdimensions. From these 61 analytical themes, we developed a proposal for a methodological framework for dHTA. Conclusions: There is a need to adapt the existing frameworks used for dHTA or create new ones to more comprehensively assess different kinds of dHTs. Through this ScR, we identified 26 studies including 102 methodological frameworks and tools for dHTA. The thematic analysis of those 26 studies led to the definition of 12 domains, 38 dimensions, and 11 subdimensions that should be considered in dHTA.

中文翻译：

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数字医疗技术评估中要考虑的方法框架和维度：范围审查和主题分析

背景：数字医疗技术 (dHT) 为解决全球医疗保健系统面临的一些主要挑战提供了独特的机会。然而，dHT 的实施引起了一些担忧，例如对其对卫生系统和人民福祉的真正影响或其使用带来的潜在风险了解有限。在这种情况下，卫生技术评估 (HTA) 是卫生系统可用来评估证据和确定给定 dHT 价值的主要工具之一。然而，由于 dHT 的性质，专家强调有必要重新考虑传统 HTA 中使用的框架。目标：本次范围界定审查（ScR）旨在确定全球范围内用于数字卫生技术评估（dHTA）的方法框架；确定正在考虑哪些领域；并通过主题分析，根据文献中最常描述的领域提出方法框架提案。方法： ScR 是按照 PRISMA-ScR 指南中制定的指南进行的。我们检索了 7 个数据库，查找 2011 年 1 月至 2021 年 12 月期间发表的同行评审和灰色文献。检索到的研究由 2 位独立作者使用 Rayyan 以单盲方式筛选，并使用 ATLAS.ti 软件提取数据。使用相同的软件进行主题分析。结果：系统检索检索到 3061 篇研究（n=2238，73.1%，唯一），其中纳入 26 篇（0.8%）研究。由此，我们确定了 102 个专为 dHTA 设计的方法框架。这些框架由于其不同的结构、方法和 dHTA 中要考虑的项目而显示出它们之间的巨大异质性。此外，我们还确定了用于指代相似概念的不同措辞。通过主题分析，我们减少了这种异质性。在第一阶段的分析中，出现了176个与不同评估项目相关的临时代码。在第二阶段，这些代码被聚类为 86 个描述性主题，而在第三阶段又被分为 61 个分析主题，并通过 3 个级别的垂直层次结构进行组织：第 1 级由 13 个领域组成，第 2 级由 13 个领域组成。 38个维度，第3层由11个子维度组成。根据这 61 个分析主题，我们制定了 dHTA 方法框架提案。结论：需要调整用于 dHTA 的现有框架或创建新的框架，以更全面地评估不同类型的 dHT。通过此 ScR，我们确定了 26 项研究，包括 102 项 dHTA 方法学框架和工具。对这 26 项研究的主题分析确定了 dHTA 中应考虑的 12 个领域、38 个维度和 11 个子维度。