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.

A Best-Worst Scaling Study of the General Population's Preferences for Activities in Living Arrangements for Persons With Dementia.

BACKGROUND: Activity involvement is a central element of dementia care. However, few studies have examined preferences for types of activities for persons who may be in need of care in the future. In this study, a best-worst scaling (BWS) was conducted to gather insights on preferred activities in small-scale living arrangements for dementia in the general population aged 50-65 years from rural and urban regions. METHODS: BWS tasks were developed based on literature searches and focus groups. The final BWS contains ten activities, namely 'interaction with animals', 'gardening', 'painting, handicrafts, manual activities', 'household activities (e.g., folding laundry, cooking)', 'watching television', 'practicing religion', 'listening to music and singing familiar songs', 'conversations about the past', 'walks and excursions', 'sport activities (e.g., gymnastics)'. Each participant had to fill out subsets of four objects each and identify them as best and worst. A postal survey was sent to a total of 4390 persons from rural and urban regions aged between 50 and 65 years. Results were analyzed by count analysis and logit models. It was examined if preferences differ with respect to gender, religiousness, and informal caregiving experience. RESULTS: A total of 840 questionnaires were returned, and 627 surveys were included in the analysis. In the rural sample, the highest relative importance (RI) was assigned to 'walks and excursions' (RI: 100%), 'sport activities (e.g., gymnastics)' (RI: 56%), 'gardening' (RI: 28%), and 'interaction with animals' (26%). In the urban sample, 'walks and excursions' (RI: 100%), 'sport activities (e.g., gymnastics)' (RI: 37%), 'interaction with animals' (25%) and 'gardening' (RI: 22%) were perceived as most important. In both groups, household activities and practicing religion were of lowest importance. Importance ranks differed between subgroups. Results of the logit models with random effects showed the same order as results from the count analyses. DISCUSSION: Our findings show that respondents generally favored activities with an outdoor component, while the household activities that are part of many concepts were of low importance to respondents. Thus, our study can inform the design of a preference-based specific range of activities in small-scale living arrangements for dementia.

Preferences for Living Arrangements in Dementia: A Discrete Choice Experiment.

BACKGROUND: Dementia affects about 55 million people worldwide. Demographic change and shifting lifestyles challenge the organization of dementia care. A discrete choice experiment (DCE) was conducted to elicit preferences for living arrangements in dementia in urban and rural regions of Germany. METHODS: Preliminary work included review of previous literature and focus groups. The DCE consists of seven attributes (group size, staff qualifications, organization of care, activities offered, support of religious practice, access to garden, consideration of food preferences) with three levels each. Individuals from the general population between the ages of 50 and 65 years were identified through population registration offices in three rural municipalities and one urban area, and 4390 individuals were approached via postal survey. A hierarchical Bayesian mixed logit model was estimated and interactions with sociodemographic characteristics were investigated. RESULTS: A total of 428 and 412 questionnaires were returned by rural and urban respondents, respectively. Access to a garden was perceived as the most important attribute (average importance 36.0% in the rural sample and 33.4% in the urban sample), followed by consideration of food preferences (15.8%, 17.8%), staff qualification (14.6%, 15.3%), care organization (11.4%, 12.3%), group size (12.2%, 11.1%), and range of activities (8.0%, 10.1%). The attribute relating to religious practice was given the least importance (2.1%, 0%). Preferences vary according to gender, age, religious beliefs, experience as an informal caregiver, and migrant background. CONCLUSION: Heterogeneous preferences for living arrangements for people with dementia were identified. The expansion of concepts with access to natural environments for persons with dementia might be a viable option for the formal care market in Germany. Further research is needed to meet the challenges of setting up and designing innovative living arrangements for people with dementia. Preferences vary by gender, age, religious beliefs, experience as an informal caregiver, and migrant background.

Vaccinating the German Population Aged 60 Years and Over with a Quadrivalent High-Dose Inactivated Influenza Vaccine Compared to Standard-Dose Vaccines: A Transmission and Budget Impact Model.

BACKGROUND AND OBJECTIVE: In Germany, influenza vaccination is mainly advised for persons aged 60 years and over and individuals with health risks. Since 2021, an inactivated, quadrivalent high-dose influenza vaccine (IIV4-HD) has been recommended for persons aged 60 years and over. The aim of this study was to calculate the impact of vaccinating the German population aged 60 years and over with IIV4-HD compared to standard-dose influenza vaccines (IIV4-SD) with regard to health outcomes and costs. METHODS: An age-stratified deterministic compartment model was built to simulate the course of influenza infection for the German population in the season 2019/20. Probabilities for health outcomes and cost data were searched from the literature and were used to compare the influenza-related health and economic effects for different scenarios. Perspectives were those of the statutory health insurance and the society. Deterministic sensitivity analyses were conducted. RESULTS: From the statutory health insurance perspective, vaccinating the German population aged 60 years and over with IIV4-HD would have prevented 277,026 infections (- 1.1%) with an increase of overall direct costs of €224 million (+ 40.1%) compared with IIV4-SD. A separate analysis showed that increased vaccination of 75% (World Health Organization recommendation for older age groups) in persons aged 60 years and over using IIV4-SD only would prevent 1,289,648 infections (- 5.1%) and would save costs from a statutory health insurance perspective of €103 million (- 13.2%) compared with IIV4-HD at actual vaccination rates. CONCLUSIONS: The modeling approach offers important insights into the epidemiological and budgetary impact of different vaccination scenarios. Achieving a higher vaccination coverage with IIV4-SD in persons aged 60 years and over would result in lower costs and fewer influenza infections compared with the scenario with IIV4-HD and actual vaccination rates.

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.

Facilitators and barriers of vaccine uptake in patients with autoimune inflammatory rheumatic disease: a scoping review.

OBJECTIVES: Patients with autoimmune inflammatory rheumatic diseases (AIRD) often have lower vaccination coverage rates compared with the general population, despite being disproportionately affected by infectious complications. We aim to systematically review the literature regarding vaccination willingness and hesitancy in AIRD. METHODS: A scoping review was conducted in PubMed, EMBASE and the Cochrane Library in June 2021. Study selection was performed by two independent reviewers and data were extracted using a standardised form. Risk of bias was assessed using instruments from McMaster University. Identified barriers were categorised into the WHO's measuring behavioural and social drivers (BeSD) of vaccination conceptual model. RESULTS: The search yielded 1644 hits of which 30 publications were included (cross-sectional studies based on interviews (n=27) and intervention studies (n=3)). The majority of studies reported barriers to influenza and pneumococcal vaccination only (n=9) or in combination with another vaccination (n=8) from the patients' perspective. Only one study assessed the view of rheumatologists. Coverage of domains matched to the BeSD model suggests a lack of awareness of infection risk by both patients and physicians. Patients mainly mentioned behavioural and social factors that negatively influenced their willingness to be vaccinated while physicians mentioned organisational deficits as major barriers. CONCLUSIONS: The view on vaccination in patients with AIRD diverges between patients and rheumatologists. Our results show that in-depth counselling on vaccines is important for patients, whereas physicians need support in implementing specific immunisation recommendations. The themes identified provide a starting point for future interventions to improve vaccine rates in patients with AIRD.

The impossibility of mortality evaluation of skin cancer screening in Germany based on health insurance data: a case-control study.

BACKGROUND: The aim of this paper was to perform a mortality evaluation of skin cancer screening (SCS) in Germany using General Local Health Insurance Fund (AOK) data. METHODS: AOK-insured men and women aged 35-99 years who died of cutaneous malignant melanoma in 2015-2016 were identified. Controls were AOK-insured people who survived to the end of each case's year of death. For each case, 10 controls were matched. The SCS history of each individual was reconstructed using the billing codes 01745 and 01746. RESULTS: In total, 1037 melanoma deaths and 10,370 controls were included. Cumulative SCS prevalence increased among controls over calendar years, as expected (males and females, 2009: 13.5% and 12.5%; 2015: 52.1% and 55.1%). In contrast, among cases, cumulative SCS prevalence was already high in 2009 and did not show a monotonic increase over the years of diagnosis. Of the 1037 melanoma deaths, 224 (21.6%) had at least one SCS settled in the 12 months after diagnosis. DISCUSSION: A mortality evaluation with health insurance data alone is not possible because SCS billing codes are not only used for real SCS but also for occasion-related diagnostic work-up of abnormal skin findings. A mortality evaluation with health insurance data requires an individual linking with data of the screening physician and the cancer registries.

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.

One-year follow-up healthcare costs of patients diagnosed with skin cancer in Germany: a claims data analysis.

BACKGROUND: Routine skin cancer screening (SCS) is covered by the German statutory health insurance (SHI) since 2008. The objective of this study was to compare direct healthcare costs between patients in whom skin cancer was detected by routine SCS and patients in whom skin cancer was not detected by routine SCS. METHODS: A retrospective observational study of administrative claims data from a large German SHI was performed. Patients with a diagnosis of malignant melanoma (MM) or non-melanoma skin cancer (NMSC) diagnosed in 2014 or 2015 were included. Costs were obtained for one year before and one year after diagnosis and analyzed in a difference-in-differences approach using regression models. Frequency matching was applied and risk adjustment was performed. Additional analyses were conducted, separately for specific age groups, excluding persons who died during the observation period and without taking costs for screening into consideration. RESULTS: A total of 131,801 patients were included, of whom 13,633 (10.3%) had a diagnosis of MM and 118,168 (89.7%) had a diagnosis of NMSC. The description of total costs (without risk adjustment) shows lower mean total costs among patients whose skin cancer was detected via routine SCS compared to patients in whom skin cancer was not detected by routine SCS (MM: €5,326 (95% confidence interval (CI) €5,073; €5,579) vs. €9,038 (95% CI €8,629; €9,448); NMSC: €4,660 (95% CI €4,573; €4,745) vs. €5,890 (95% CI €5,813; €5,967)). Results of the regression analysis show cost savings of 18.8% (95% CI -23.1; -8.4) through routine SCS for patients with a diagnosis of MM. These cost savings in MM patients were more pronounced in patients younger than 65 years of age. For patients with a diagnosis of NMSC, the analysis yields a non-substantial increase in costs (2.5% (95% CI -0.1; 5.2)). CONCLUSION: Cost savings were detected for persons with an MM diagnosed by routine SCS. However, the study could not detect lower costs due to routine SCS in the large fraction of persons with a diagnosis of NMSC. These results offer important insights into the cost structure of the routine SCS and provide opportunities for refinements.

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.

Methodological guidance for rapid reviews in healthcare: A scoping review.

The aim of the present work was to identify published methodological guidance for rapid reviews (RRs) and to analyze the recommendations with regard to time-saving measures. A literature search was performed in PubMed and EMBASE in November 2020. In addition, a search based on Google Scholar and websites of governmental and non-governmental organizations was conducted. Literature screening was carried out by two researchers independently. A total of 34 publications were included. These describe 38 distinct RR types. The timeframe to complete the identified RR types ranges from 24 h to 6 months (mean time 2.2 months). For most RR types a specific research question (n = 21) and a prioritizing search (n = 25; preference for e.g., systematic reviews and meta-analyses) is employed. Different approaches such as reduced personnel in literature screening (n = 21) and data extraction (n = 21) are recommended. The majority of RR types include a bias assessment (n = 28) and suggest a narrative report focusing on safety and efficacy. The included RR types are heterogeneous in terms of completion time, considered domains and strategies to alter the standard systematic review methods. A rationale for the recommended shortcuts is rarely presented.

Discrete choice experiment to determine preferences of decision-makers in healthcare for different formats of rapid reviews.

BACKGROUND: Time-saving formats of evidence syntheses have been developed to fulfill healthcare policymakers' demands for timely evidence-based information. A discrete choice experiment (DCE) with decision-makers and people involved in the preparation of evidence syntheses was undertaken to elicit preferences for methodological shortcuts in the conduct of abbreviated reviews. METHODS: D-efficient scenarios, each containing 14 pairwise comparisons, were designed for the DCE: the development of an evidence synthesis in 20 working days (scenario 1) and 12 months (scenario 2), respectively. Six attributes (number of databases, number of reviewers during screening, publication period, number of reviewers during data extraction, full-text analysis, types of HTA domains) with 2 to 3 levels each were defined. These were presented to the target population in an online survey. The relative importance of the individual attributes was determined using logistic regression models. RESULTS: Scenario 1 was completed by 36 participants and scenario 2 by 26 participants. The linearity assumption was confirmed by the full model. In both scenarios, the linear difference model showed a preference for higher levels for "number of reviewers during data extraction", followed by "number of reviewers during screening" and "full-text analysis". Subgroup analyses showed that preferences were influenced by participation in the preparation of evidence syntheses. CONCLUSION: The surveyed persons expressed preferences for quality standards in the process of literature screening and data extraction.