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      Methodological Frameworks and Dimensions to Be Taken Into Consideration in Digital Health Technology Assessment: Protocol for a Scoping Review

      research-article
      , BSS, MSc, PT 1 , , , BScPharm, PhD 1 , , BA, MA, MsC 1 , , MPH, MD, PhD 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      digital health, eHealth, mobile health, artificial intelligence, framework, health technology assessment

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          Abstract

          Background

          Health technology assessment (HTA) is one of the main tools that health systems have to appraise 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 that cover these technologies’ intrinsic characteristics.

          Objective

          The purpose of our scoping review is to identify the methodological frameworks that are 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 for a methodological framework that is based on the most frequently described dimensions in the literature.

          Methods

          The scoping review will be performed in accordance with the guidelines established in the updated statement of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). We will search for peer-reviewed and grey literature published between 2011 and the date of the search execution. The retrieved references will be reviewed in a single-blind manner by 2 independent authors, and their quality will be assessed by using the Critical Appraisal Skills Program tool. The ATLAS.ti software (Scientific Software Development GmbH) 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

          To our knowledge, no studies have been published to date that identify the existing methodological frameworks for digital HTA, determine which dimensions must be evaluated for correct decision-making, and serve as a basis for the development of a methodological framework of reference that health care systems can use to carry out this kind of assessment. This work is intended to address this knowledge gap of key relevance for the field of HTA.

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/39905

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          Most cited references30

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          PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation

          Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist and explanation. The checklist was developed by a 24-member expert panel and 2 research leads following published guidance from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The final checklist contains 20 essential reporting items and 2 optional items. The authors provide a rationale and an example of good reporting for each item. The intent of the PRISMA-ScR is to help readers (including researchers, publishers, commissioners, policymakers, health care providers, guideline developers, and patients or consumers) develop a greater understanding of relevant terminology, core concepts, and key items to report for scoping reviews.
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            Methods for the thematic synthesis of qualitative research in systematic reviews

            Background There is a growing recognition of the value of synthesising qualitative research in the evidence base in order to facilitate effective and appropriate health care. In response to this, methods for undertaking these syntheses are currently being developed. Thematic analysis is a method that is often used to analyse data in primary qualitative research. This paper reports on the use of this type of analysis in systematic reviews to bring together and integrate the findings of multiple qualitative studies. Methods We describe thematic synthesis, outline several steps for its conduct and illustrate the process and outcome of this approach using a completed review of health promotion research. Thematic synthesis has three stages: the coding of text 'line-by-line'; the development of 'descriptive themes'; and the generation of 'analytical themes'. While the development of descriptive themes remains 'close' to the primary studies, the analytical themes represent a stage of interpretation whereby the reviewers 'go beyond' the primary studies and generate new interpretive constructs, explanations or hypotheses. The use of computer software can facilitate this method of synthesis; detailed guidance is given on how this can be achieved. Results We used thematic synthesis to combine the studies of children's views and identified key themes to explore in the intervention studies. Most interventions were based in school and often combined learning about health benefits with 'hands-on' experience. The studies of children's views suggested that fruit and vegetables should be treated in different ways, and that messages should not focus on health warnings. Interventions that were in line with these suggestions tended to be more effective. Thematic synthesis enabled us to stay 'close' to the results of the primary studies, synthesising them in a transparent way, and facilitating the explicit production of new concepts and hypotheses. Conclusion We compare thematic synthesis to other methods for the synthesis of qualitative research, discussing issues of context and rigour. Thematic synthesis is presented as a tried and tested method that preserves an explicit and transparent link between conclusions and the text of primary studies; as such it preserves principles that have traditionally been important to systematic reviewing.
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              De-duplication of database search results for systematic reviews in EndNote.

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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                October 2022
                11 October 2022
                : 11
                : 10
                : e39905
                Affiliations
                [1 ] Health Technology Assessment and Quality of Care Area Agency for Health Quality and Assessment of Catalonia Barcelona Spain
                Author notes
                Corresponding Author: Joan Segur-Ferrer joan.segur@ 123456gencat.cat
                Author information
                https://orcid.org/0000-0001-8305-5127
                https://orcid.org/0000-0001-6831-6210
                https://orcid.org/0000-0002-9561-9038
                https://orcid.org/0000-0001-7547-0291
                Article
                v11i10e39905
                10.2196/39905
                9597420
                36222788
                f065f833-506e-492c-86de-6ec046814834
                ©Joan Segur-Ferrer, Carolina Moltó-Puigmartí, Roland Pastells-Peiró, Rosa Maria Vivanco-Hidalgo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.10.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 27 May 2022
                : 10 July 2022
                : 15 July 2022
                : 31 July 2022
                Categories
                Protocol
                Protocol

                digital health,ehealth,mobile health,artificial intelligence,framework,health technology assessment

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