背景:数字健康技术(dHT)提供了一个独特的机会来解决全球医疗保健系统面临的一些主要挑战。然而,dht的实施引起了一些关注,例如对它们对卫生系统和人民福祉的实际影响的了解有限,或者使用它们带来的潜在风险。在这种情况下,卫生技术评估(HTA)是卫生系统可以用来评估证据和确定给定dHT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。
目的:本范围审查(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;确定正在考虑的领域;并生成,通过主题分析,基于文献中最常描述的领域的方法论框架的建议。
方法:根据PRISMA-ScR指南中建立的指南进行ScR。我们检索了7个数据库,收集2011年1月至2021年12月期间发表的同行评议和灰色文献。检索到的研究由两名独立作者以单盲方式使用Rayyan进行筛选,并使用ATLAS提取数据。ti软件。使用相同的软件进行专题分析。
结果:系统检索到3061篇研究(n=2238,73.1%,独特),其中26项(0.8%)研究纳入.从这些,我们确定了102个为dHTA设计的方法框架。这些框架由于其不同的结构而揭示了它们之间的巨大异质性,方法,以及dHTA中要考虑的项目。此外,我们确定了用于指代类似概念的不同措辞。通过专题分析,我们减少了这种异质性。在分析的第一阶段,出现了176个与不同评估项目有关的临时代码。在第二阶段,这些代码被分为86个描述性主题,which,反过来,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:由13个领域组成的1级,由38个维度形成的2级,和由11个子维度组成的3级。从这61个分析主题中,我们提出了一个dHTA方法框架的建议。
结论:需要调整用于dHTA的现有框架或创建新框架以更全面地评估不同类型的dHT。通过这个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项研究的主题分析导致了12个领域的定义,38个维度,以及在dHTA中应考虑的11个子维度。
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.