Quality assessment of mHealth apps: a scoping review.

Introduction: The number of mHealth apps has increased rapidly during recent years. Literature suggests a number of problems and barriers to the adoption of mHealth apps, including issues such as validity, usability, as well as data privacy and security. Continuous quality assessment and assurance systems might help to overcome these barriers. Aim of this scoping review was to collate literature on quality assessment tools and quality assurance systems for mHealth apps, compile the components of the tools, and derive overarching quality dimensions, which are potentially relevant for the continuous quality assessment of mHealth apps. Methods: Literature searches were performed in Medline, EMBASE and PsycInfo. Articles in English or German language were included if they contained information on development, application, or validation of generic concepts of quality assessment or quality assurance of mHealth apps. Screening and extraction were carried out by two researchers independently. Identified quality criteria and aspects were extracted and clustered into quality dimensions. Results: A total of 70 publications met inclusion criteria. Included publications contain information on five quality assurance systems and further 24 quality assessment tools for mHealth apps. Of these 29 systems/tools, 8 were developed for the assessment of mHealth apps for specific diseases, 16 for assessing mHealth apps for all fields of health and another five are not restricted to health apps. Identified quality criteria and aspects were extracted and grouped into a total of 14 quality dimensions, namely "information and transparency", "validity and (added) value", "(medical) safety", "interoperability and compatibility", "actuality", "engagement", "data privacy and data security", "usability and design", "technology", "organizational aspects", "social aspects", "legal aspects", "equity and equality", and "cost(-effectiveness)". Discussion: This scoping review provides a broad overview of existing quality assessment and assurance systems. Many of the tools included cover only a few dimensions and aspects and therefore do not allow for a comprehensive quality assessment or quality assurance. Our findings can contribute to the development of continuous quality assessment and assurance systems for mHealth apps. Systematic Review Registration: https://www.researchprotocols.org/2022/7/e36974/, International Registered Report Identifier, IRRID (DERR1-10.2196/36974).

Problems and Barriers Related to the Use of mHealth Apps From the Perspective of Patients: Focus Group and Interview Study.

BACKGROUND: Since fall 2020, mobile health (mHealth) apps have become an integral part of the German health care system. The belief that mHealth apps have the potential to make the health care system more efficient, close gaps in care, and improve the economic outcomes related to health is unwavering and already partially confirmed. Nevertheless, problems and barriers in the context of mHealth apps usually remain unconsidered. OBJECTIVE: The focus groups and interviews conducted in this study aim to shed light on problems and barriers in the context of mHealth apps from the perspective of patients. METHODS: Guided focus groups and individual interviews were conducted with patients with a disease for which an approved mHealth app was available at the time of the interviews. Participants were recruited via self-help groups. The interviews were recorded, transcribed, and subjected to a qualitative content analysis. The content analysis was based on 10 problem categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs") identified in a previously conducted scoping review. Participants were asked to fill out an additional questionnaire about their sociodemographic data and about their use of technology. RESULTS: A total of 38 patients were interviewed in 5 focus groups (3 onsite and 2 web-based) and 5 individual web-based interviews. The additional questionnaire was completed by 32 of the participants. Patients presented with a variety of different diseases, such as arthrosis, tinnitus, depression, or lung cancer. Overall, 16% (5/32) of the participants had already been prescribed an app. During the interviews, all 10 problem categories were discussed and considered important by patients. A myriad of problem manifestations could be identified for each category. This study shows that there are relevant problems and barriers in the context of mHealth apps from the perspective of patients, which warrant further attention. CONCLUSIONS: There are essentially 3 different areas of problems in the context of mHealth apps that could be addressed to improve care: quality of the respective mHealth app, its integration into health care, and the expandable digital literacy of patients.

Prescription of Opioid Analgesics for Chronic Non-Cancer Pain in Germany despite Contraindications: Administrative Claims Data Analysis.

In Germany, long-term opioid treatment (L-TOT) for chronic non-tumor pain (CNTP) is discussed as not being performed according to the German guideline on L-TOT for CNTP. In the present analysis, the occurrence and predictors of inappropriate care/overuse in a cohort of German insureds with L-TOT for CNTP by the presence of a contraindication with concurrent opioid analgesic (OA) therapy were investigated. We also analyzed whether prescribing physicians themselves diagnosed a contraindication. The retrospective cohort study was based on administrative claims data from a German statutory health insurance. Eight contraindication groups were defined based on the German guideline. Logistic regressions were performed in order to identify predictors for OA prescriptions despite contraindications. The possible knowledge of the prescribing physician about the contraindication was approximated by analyzing concordant unique physician identification numbers of OA prescriptions and contraindication diagnoses. A total of 113,476 individuals (75% female) with a mean age of 72 years were included. The most common documented contraindications were primary headaches (8.7%), severe mood disorders (7.7%) and pain in somatoform disorders (4.5%). The logistic regressions identified a younger age, longer history of OA therapy, opioid related psychological problems, and outpatient psychosomatic primary care as positive predictors for all contraindication groups.

Problems and Barriers Related to the Use of Digital Health Applications: Scoping Review.

BACKGROUND: The digitization of health care led to a steady increase in the adoption and use of mobile health (mHealth) apps. Germany is the first country in the world to cover the costs of mHealth apps through statutory health insurance. Although the benefits of mHealth apps are discussed in detail, aspects of problems and barriers are rarely studied. OBJECTIVE: This scoping review aimed to map and categorize the evidence on problems and barriers related to the use of mHealth apps. METHODS: Systematic searches were conducted in the MEDLINE, Embase, and PsycINFO databases. Additional searches were conducted on JMIR Publications and on websites of relevant international organizations. The inclusion criteria were publications dealing with apps similar to those approved in the German health care system, publications addressing problems and barriers related to the use of mHealth apps, and articles published between January 1, 2015, and June 8, 2021. Study selection was performed by 2 reviewers. The manuscript was drafted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included publications and categorization of problems and hurdles were performed using MAXQDA (VERBI Software GmbH). RESULTS: The database search identified 1479 publications. Of the 1479 publications, 21 (1.42%) met the inclusion criteria. A further 8 publications were included from citation searching and searching in JMIR Publications. The identified publications were analyzed for problems and barriers. Problems and barriers were classified into 10 categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs"). The most frequently mentioned categories were use and adherence (eg, incorporating the app into daily life or dropouts from use; n=22) and usability (eg, ease of use and design; n=19). CONCLUSIONS: The search identified various problems and barriers in the context of mHealth apps. Although problems at the app level (such as usability) are studied frequently, problems at the system level are addressed rather vaguely. To ensure optimal use of and care with mHealth apps, it is essential to consider all types of problems and barriers. Therefore, researchers and policy makers should have a special focus on this issue to identify the needs for quality assurance. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32702.

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

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.

Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review.

BACKGROUND: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention. OBJECTIVE: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA. METHODS: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA. RESULTS: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022. CONCLUSIONS: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32702.