Methodological Frameworks and Dimensions to Be Considered in Digital Health Technology Assessment: Scoping Review and Thematic Analysis

Abstract

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.

We acknowledge Benigno Rosón Calvo (Servicio Gallego de Salud [SERGAS]), Carme Carrion (Universitat Oberta de Catalunya [UOC]), Carlos A Molina Carrón (Dirección General de Salud Digital y Sistemas de Información para el SNS. Ministerio de Sanidad, Gobierno de España), Carme Pratdepadua (Fundació Tic Salut i Social [FTSS]), Celia Muñoz (Instituto Aragonés de Ciencias de la Salud [IACS]), David Pijoan (Biocat, BioRegió de Catalunya), Felip Miralles (Eurecat – Centre Tecnològic de Catalunya), Iñaki Guiterrez Ibarluzea (Osasun Teknologien Ebaluazioko Zerbitzua [Osteba]), Janet Puñal Riobóo (Unidad de Asesoramiento Científico-técnico [avalia-t], Agencia Gallega para la Gestión del Conocimiento en Salud [ACIS]), Jordi Piera-Jiménez (Àrea de Sistemes d’Informació del Servei Català de la Salut [CatSalut]), Juan Antonio Blasco (Evaluación de Tecnologías Sanitarias de Andalucía [AETSA]), Liliana Arroyo Moliner (Direcció General de Societat Digital, Departament d’Empresa i Treball de la Generalitat de Catalunya), Lilisbeth Perestelo-Perez (Servicio de Evaluación del Servicio Canario de la Salud [SESCS]), Lucía Prieto Remón (IACS), Marifé Lapeña (Dirección General de Salud Digital y Sistemas de Información para el SNS. Ministerio de Sanidad, Gobierno de España), Mario Cárdaba (Insituto de Salud Carlos III [ISCIII]), Montserrat Daban (Biocat, BioRegió de Catalunya), Montserrat Moharra Frances (Agència de Qualitat i Avaluació Sanitàries de Catalunya), and Oscar Solans (CatSalut) for reviewing the protocol of this scoping review (ScR) and the ScR. This research was framed within the budget of the work plan of the Spanish Network of Health Technology Assessment Agencies, commissioned by the General Directorate of Common Portfolio of Services of the National Health System and Pharmacy