Quality Assessment of Digital Health Applications: Protocol for a Scoping Review

Abstract

Background All over the world, development and usage of mobile health (mHealth) apps is increasing. While apps offer numerous opportunities to improve health care, there are associated problems that differ significantly from those of traditional health care services. Further investigations on the quality of mHealth apps are needed to address these problems. Objective This study aims to identify and map research on quality assessment and quality assurance of mHealth apps and their transferability to continuous quality assurance of mHealth apps. Methods The scoping review will follow published methodological frameworks for scoping studies as well as Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews criteria. Electronic databases (Medline, EMBASE, and PsycINFO), reference lists of relevant articles, and websites of relevant institutions will be searched. Two reviewers will independently assess eligibility of articles. Therefore, a 2-stage (title and abstract, followed by full text) screening process was conducted. Quality management systems and quality assessment tools will be analyzed and included in our review. Particular focus is placed on quality dimensions. Results This scoping review provides an overview of the available evidence and identifies research gaps regarding continuous quality assessment of mHealth apps. Thereby, relevant quality dimensions and criteria can be identified and their eligibility and relevance for the development of a continuous quality assurance system of mHealth apps can be determined. Our results are planned to be submitted to an indexed, peer-reviewed journal in the second half of 2022. Conclusions This is the first review in the context of continuous quality assurance of mHealth apps. Our results will be used within the research “Continuous quality assurance of Digital Health Applications” (“QuaSiApps”) project funded by the German Federal Joint Committee. International Registered Report Identifier (IRRID) DERR1-10.2196/36974

Quality assessment of mHealth apps: a scoping review

“…In addition, the exclusive use of bibliometric databases and the omission of secondary literature are limitations in this context. With regard to the search strategy, there is currently disagreement on terminology ( 27 ). Therefore, different strategies were tested beforehand and the results were compared to ensure an optimal search strategy.…”

“…While this definition identifies the fundamentals of usability and makes clear that effectiveness, efficiency and satisfaction are key criteria ( 101 ), ISO 9241-11:2018 is not intended to describe usability evaluation methods ( 100 ). Finally, the study protocol ( 27 ) announced the assessment of the suitability of the criteria and derived dimensions for the continuous quality assurance of mHealth apps in Germany as part of this review. In the light of our results, this seems unattainable without taking further steps (e.g., focus groups with patients).…”

“…Reporting followed the PRISMA extension for scoping reviews ( 26 ). A review protocol was written and published prior to screening ( 27 ). The protocol contains detailed information on the databases searched, the search terms used, and the inclusion and exclusion criteria applied during the screening process.…”

“…Reference lists of included articles were screened for further eligible literature. Further information such as the search string can be found in the corresponding research protocol ( 27 ).…”

“…Apart from the publication date, the inclusion and exclusion criteria were all set manually and not using the filter function of the databases. Further information on the inclusion and exclusion criteria, including the search timeframe, can be found in the review protocol ( 27 ).…”