Methodological frameworks and dimensions to be taken into consideration in digital health technology assessment: Protocol for a scoping review (Preprint)

BACKGROUND Health technology assessment (HTA) is one of the main tools that health systems have to generate evidence and determine the value of a given health technology. Although the existing HTA frameworks are useful tools for the evaluation of a wide range of health technologies, more and more experts, organizations across the world, and HTA agencies are highlighting the need to update or develop specific methodological frameworks for the evaluation of digital health technologies in order to take into account additional domains to cover their intrinsic characteristics. OBJECTIVE The purpose of this scoping review is to identify the methodological frameworks used worldwide for the assessment of digital health technologies, determine what dimensions and aspects are being considered, and generate, through a thematic analysis, a proposal of a methodological framework based on the most frequently described dimensions found in the literature. METHODS The scoping review will be performed in accordance with guidelines established in the updated statement of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR). Peer-reviewed and grey literature published between 2011 and the date of the search execution will be searched for. The retrieved references will be reviewed in a single-blind manner by two independent authors, and their quality will be assessed using the Critical Appraisal Skills Program (CASP) tool. The ATLAS.ti software will be used for data extraction and to perform the thematic analysis. RESULTS The scoping review is currently (May 2022) in progress. It is expected to be completed in October 2022 and the final results of the research will be presented and published by November 2022. CONCLUSIONS This scoping review aims to identify the existing methodological frameworks for digital HTA, determine what dimensions should be evaluated for correct decision-making, and become the basis for a methodological reference framework to be used by healthcare systems to carry out this kind of assessments. To our knowledge, no equivalent study has been published so far.