Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain.
J Med Internet Res. 2024 Apr 10;26:e48694. doi: 10.2196/48694.
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.
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.
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.
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.
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.
数字健康技术（dHTs）为解决全球医疗保健系统面临的一些重大挑战提供了独特的机会。然而，dHTs 的实施引发了一些关注，例如对其对健康系统和人们福祉的实际影响的理解有限，或者对其使用产生的潜在风险。在这种情况下，健康技术评估（HTA）是医疗保健系统可以用来评估证据并确定给定 dHT 价值的主要工具之一。然而，由于 dHTs 的性质，专家强调需要重新考虑传统 HTA 中使用的框架。
本 scoping 综述（ScR）旨在确定全球范围内用于数字健康技术评估（dHTA）的方法学框架；确定正在考虑哪些领域；并通过主题分析生成一个基于文献中描述最多的领域的方法学框架建议。
根据 PRISMA-ScR 指南中规定的指南进行 ScR。我们在 7 个数据库中搜索了 2011 年 1 月至 2021 年 12 月期间发表的同行评审和灰色文献。使用 Rayyan 对 2 名独立作者进行了单盲筛选，使用 ATLAS.ti 软件提取数据。使用相同的软件进行主题分析。
系统检索检索到 3061 项研究（n=2238，73.1%，独特），其中 26 项（0.8%）研究被纳入。从这些研究中，我们确定了 102 个用于 dHTA 的方法学框架。这些框架由于其不同的结构、方法和 dHTA 中要考虑的项目而存在很大的异质性。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。在分析的第一阶段，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，这些主题又在第三阶段分为 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 个域组成，第 2 级由 38 个维度组成，第 3 级由 11 个子维度组成。从这 61 个分析主题中，我们提出了一个用于 dHTA 的方法学框架的建议。
需要调整现有的用于 dHTA 的框架或创建新的框架，以更全面地评估不同类型的 dHT。通过本 ScR，我们确定了 26 项研究，其中包括 102 个用于 dHTA 的方法学框架和工具。对这 26 项研究的主题分析导致定义了 12 个域、38 个维度和 11 个子维度，这些应该在 dHTA 中考虑。
