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.

Preference-Based Implementation of Video Consultations in Urban and Rural Regions in Outpatient Care in Germany: Protocol for a Mixed Methods Study.

BACKGROUND: Particularly in rural regions, factors such as lower physician density and long travel distances complicate adequate outpatient care. However, urban regions can also be affected by deficits in care, for example, long waiting times. One model of care intending to improve the situation is the implementation of video consultations. The study protocol presents the methodology of the research project titled "Preference-based implementation of the video consultation in urban and rural regions" funded by the German Federal Joint Committee (funding number 01VSF20011). OBJECTIVE: This study aims to identify existing barriers to the use of video consultation and the preferences of insured individuals and physicians as well as psychotherapists in order to optimize its design and thus increase acceptance and use of video consultations in urban and rural regions. METHODS: Built on a mixed methods approach, this study first assesses the status quo of video consultation use through claims data analysis and carries out a systematic literature review on barriers and promoting factors for the use of video consultations. Based on this preliminary work, focus groups are conducted in order to prepare surveys with insureds as well as physicians and psychotherapists in the second study phase. The central element of the survey is the implementation of discrete choice experiments to elicit relevant preferences of (potential) user groups and service providers. The summarized findings are discussed in a stakeholder workshop and translated into health policy recommendations. RESULTS: The methodological approach used in this study is the focus of this paper. The study is still ongoing and will continue until March 2024. The first study phase has already been completed, in which preliminary work has been done on potential applications and hurdles for the use of video consultations. Currently, the survey is being conducted and analyses are being prepared. CONCLUSIONS: This study is intended to develop a targeted strategy for health policy makers based on actual preferences and perceived obstacles to the use of video consultations. The results of this study will contribute to further user-oriented development of the implementation of video consultations in German statutory health insurance. Furthermore, the iterative and mixed methods approach used in this study protocol is also suitable for a variety of other research projects. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50932.

Epidemiology of Diagnosed Age-related Macular Degeneration in Germany: An Evaluation of the Prevalence Using AOK PLUS Claims Data.

INTRODUCTION: Epidemiologic data on age-related macular degeneration (AMD) are mainly based on cohort studies, including both diagnosed and undiagnosed cases. Using health claims data allows estimating epidemiological data of diagnosed subjects with AMD within the health care system using diagnosis codes from a regional claims database (AOK PLUS) to estimate the prevalence and incidence of non-exudative and exudative AMD in Germany. METHODS: Patients with AMD were identified among AOK PLUS insured patients based on at least two outpatient, ophthalmologic or one inpatient H35.3 diagnoses for the years 2012 to 2021. Patients without continuous observation in a calendar year were excluded. Prevalence was assessed, and 1-year cumulative incidence was determined by the number of newly diagnosed patients divided by the number of individuals at risk. For 2020 and 2021, the AMD stage was assessed by diagnostic subcodes for non-exudative and exudative AMD, respectively. For 2012 to 2019, patient numbers were estimated based on the average proportions of non-exudative AMD and exudative AMD, respectively, in 2020 and 2021. Incidence and prevalence numbers were then extrapolated to Germany. RESULTS: Between 2012 to 2021, the prevalence of diagnosed AMD cases remained relatively stable among approximately 3.27 million AOK PLUS insured persons, ranging from 0.96% (minimum in 2021) to 1.31% (maximum in 2014) for non-exudative AMD, about twice as high as for exudative AMD (min-max: 0.53-0.72%). The age- and sex-adjusted projections amounted to 644,153 diagnosed non-exudative and 367,086 diagnosed German patients with exudative AMDs in 2021. The 1-year cumulative incidence for non-exudative and exudative AMD, respectively, ranged from 122,427-142,932 to 46,092-86,785 newly diagnosed cases. CONCLUSION: The number of diagnosed cases with AMD in Germany has increased slightly over the past decade. For the first time, patient counts with non-exudative and exudative AMD were approximated for Germany based on a representative, large-scale database study.

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.

Health Economic Evaluation of an Online-Based Motivational Program to Reduce Problematic Media Use and Promote Treatment Motivation for Internet Use Disorder-Results of the OMPRIS Study.

Internet Use Disorders (IUD) have a relevant effect on national economies. In the randomized, controlled, multicenter, prospective, and single-blinded OMPRIS study (pre-registration number DRKS00019925; Innovation Fund of the Joint Federal Committee of Germany, grant number 01VSF18043), a four-week online program to reduce media addiction symptoms, was evaluated for cost-effectiveness. The intervention group (IG) was compared to a waiting control group (WCG) from German statutory health insurance (SHI) and a societal perspective. Resource use, namely indirect and direct (non) medical costs, was assessed by a standardized questionnaire at baseline and after the intervention. Additionally, intervention costs were calculated. Determining the Reliable Change Index (RCI) based on the primary outcome, assessed by the "Scale for the Assessment of Internet and Computer Game Addiction" (AICA-S), individuals with and without reliable change (RC) were distinguished. The incremental cost-effectiveness ratio was calculated using the difference-in-difference approach. There were 169 (IG n = 81, WCG n = 88) persons included in the analysis. The mean age was 31.9 (SD 12.1) years. A total of 75.1% were male, and 1.8% diverse. A total of 65% (IG) and 27% (WCG) had an RC. The cost per person with RC was about EUR 860 (SHI) and EUR 1110 (society). The intervention leads to an improvement of media addiction symptoms at moderate additional costs.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.

Ten years of German benefit assessment: price analysis for drugs with unproven additional benefit.

INTRODUCTION: Since 2011, the prices for all new drugs in Germany are negotiated based on a benefit assessment. The purpose of this study was to analyze the price regulation of drugs with unproven additional benefit. METHODS: Benefit assessment procedures from 2011 to 2020 were reviewed and selected through AMNOG Monitor and Lauer Taxe. Negotiated annual therapy costs, the annual costs of the most cost-efficient appropriate comparative therapy (ACT) and the potential budget impact for 33 included procedures were calculated. RESULTS: 55% of the included drugs achieved a negotiated price higher than the most cost-efficient ACT, 3% were identified as equal and 42% showed lower negotiated prices. The potential savings exceeded expenditures by around EUR 523.5 m. After price flexibility was adopted by the legislator in 2017, the overall potential savings still outweighed the expenditures by around EUR 62 m. CONCLUSIONS: Our analysis shows that making price negotiations more flexible by law does not undermine the fundamental aim of the AMNOG, which is to avoid additional expenditure without increased patient benefit. The regulation can thus fulfill the objective provided by the legislature of keeping drugs without proven additional benefits in the German healthcare system.

The socioeconomic impact of disability progression in multiple sclerosis: A retrospective cohort study of the German NeuroTransData (NTD) registry.

Background: Multiple sclerosis (MS) is a progressively debilitating neurologic disease that poses significant costs to the healthcare system and workforce. Objective: To evaluate the impact of MS disease progression on societal costs and quality of life (QoL) using data from the German NeuroTransData (NTD) MS registry. Methods: Cross-sectional cohort study. The cost cohort included patients with MS disability assessed using Expanded Disability Status Scale (EDSS) in 2019 while the QoL cohort included patients assessed using EDSS and EuroQol-5 Dimension 5-Levels between 2009 and 2019. Direct and indirect medical, and non-medical resource use was quantified and costs derived from public sources. Results: Within the QoL cohort (n = 9821), QoL worsened with increasing EDSS. Within the cost cohort (n = 7286), increasing resource use with increasing EDSS was observed. Societal costs per patient, excluding or including disease-modifying therapies, increased from €5694 or €19,315 at EDSS 0 to 3.5 to €25,419 or €36,499 at EDSS 4 to 6.5, and €52,883 or €58,576 at EDSS 7 to 9.5. In multivariate modeling, each 0.5-step increase in EDSS was significantly associated with increasing costs, and worsening QoL. Conclusion: This study confirms the major socioeconomic burden associated with MS disability progression. From a socioeconomic perspective, delaying disability progression may benefit patients and society.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study.

BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective. METHODS:  The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs. RESULTS:  The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of €3072 (SD: 3485), of which €699 (SD: 743) could be assigned to allergic respiratory diseases. CONCLUSIONS:  Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low.

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.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

[Evaluating the reform of the psychotherapy guideline using a mixed-methods approach: a study protocol]. / Mixed-Methods-Ansatz zur Evaluation der Reform der Psychotherapie-Richtlinie: ein Studienprotokoll.

INTRODUCTION: In Germany, psychotherapy in outpatient statutory health care is regulated by the Psychotherapy Guideline (PT-GL). A discussion on waiting times and inadequate care for patients resulted in a structural reform of the PT-GL in 2017. The reform aims to improve access to psychotherapy and the entire course of care and treatment. The purpose of the present study was the evaluation of the new elements and identification of obstacles and barriers in their implementation. METHODS: Quantitative and qualitative methods were used to evaluate the reform of the PT-GL. In a retrospective cohort-based analysis of anonymized administrative claim data from the statutory health insurances BARMER and AOK, the health care situation before and after the reform were compared. In addition, a cross-sectional questionnaire survey evaluated the implementation of the new care elements from the perspective of psychotherapists, general practitioners and patients. The questionnaires were developed based on focus groups with stakeholders and a literature search. The survey results provided the data basis for the cross-sectional analysis together with the routine data on the care situation after the reform of the PT-GL as well as aggregated, anonymized data from the National Association of Statutory Health Insurance Physicians on statutory health insurance care and on the use of the appointment service centers. CONCLUSION: By combining quantitative and qualitative data, the effects of the structural reform of the PT-GL of 2016 can be analyzed at the individual and structural level as well as in relation to the entire care and treatment process. Based on this, proposals for a needs-oriented further development of the PT-GL will be prepared, considering the perspectives of various interest groups.

Evaluation criteria for health apps supporting medication adherence in early-stage technology development - a scoping review.

Introduction: Health apps offer an approach to improve the patients' management of their medication. Although the Digital Healthcare Act (DVG) has created a claim in the statutory health insurance (SHI), the large number of health apps available and their varying quality make it difficult for service providers and especially for medical laypersons to select an adequate high-quality medication app. Manufacturers need guidance for the development of high-quality apps right from the start. Various general evaluation concepts for health apps have been available to date. However, the requirements that should be met by healthcare depend largely on the field of application and the type of apps. This article aims to provide an overview of the international evidence on specific criteria for the evaluation of medication apps. Methods: Within the framework of a scoping review, a systematic search was conducted in PubMed and EMBASE on January 29, 2020. The search was limited to publications from 2007 onwards as well as to English and German articles. Additionally, a semi-systematic research of reference lists of the previously included articles as well as a structured search of websites of relevant stakeholders were conducted. Inclusion criteria were the following: the publication deals with health apps that can be used on smartphones and focus on supporting medication intake; the publication does not refer to evaluation criteria for a single app exclusively. The included publications were examined in a qualitative content analysis searching for evaluation criteria and categorizing them according to the framework criteria of the DVG and the Digital Health Applications Ordinance (DiGAV). Results: 2,542 articles were identified in the systematic search (999 in PubMed, 1,543 in EMBASE, 560 duplicates). A total of 16 studies met the inclusion criteria. The semi-systematic research and the structured search identified one further study. A catalog of criteria was developed based on the included 17 studies. This catalog covers the general topics "patient orientation" (data protection and security, consumer protection, user friendliness) and "quality/core functions of medication apps" (reminder, self-monitoring, (drug) information, motivation to change behavior, drug/patient safety, robustness) as well as "interoperability/cooperation". Due to its specific importance for medication apps, the subcategory "motivation for behavioral change" stands out beneath the general topic "quality/core functions of medication apps". This category aims to evaluate the design of individual functions with regard to their potential to actually change the behavior of app users. Discussion: The criteria for the evaluation of health apps mentioned in the DiGAV intersected with the criteria identified in the literature research. However, the area of positive health care effects was hardly covered by the included studies. In the development of the criteria catalog, it was not possible to weight the identified criteria. Therefore, the catalog should be understood as a supporting checklist for service providers, manufacturers, and/or users. Conclusions: A large variety of possible evaluation criteria for medication apps could be shown. Future research should focus on the possibilities of weighting these diverse evaluation criteria, using not only clinical studies but also methods to identify preferences.

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.

[Reform Implementation of the Psychotherapy Guideline 2017: Results from Focus Groups Within the Framework of the Innovation Fund Project EVA PT-RL]. / Umsetzung der Reform der Psychotherapie-Richtlinie 2017: Ergebnisse aus Fokusgruppen im Rahmen des Innovationsfonds-Projekts EVA PT-RL.

BACKGROUND: Mental illnesses cause both individual and social burdens. The main goal of the structural reform of the Psychotherapy Guideline of 2017 was to improve access to psychotherapeutic care. The focus groups, which were conducted as part of the research project "Evaluation of the Psychotherapy Guideline (Eva PT-RL)" funded by the Innovation Fund, address the implementation of the goals of the reform and the individual newly introduced care elements as well as hurdles to implementation from the perspective of service providers, patients and insurers. METHODS: Six focus groups and five individual interviews were conducted with people from the three stakeholder groups mentioned above. The basis was a semistructured interview guide adapted to the respective group of people based on a structured literature research. The interviews were conducted by a team of moderators via video conference, recorded and transcribed. The analysis was carried out via a qualitative content analysis based on Mayring. RESULTS: The initial psychotherapeutic consultation received a generally positive assessment particularly with regard to timely initial access to psychotherapeutic care. At the same time a delayed transition to subsequent guideline psychotherapy due to a lack of capacity was criticized by all participant groups. Beneficial effects of telephone accessibility as well as increased networking of psychotherapeutic care also with other psychosocial services were mentioned. However the implementation of acute treatment and relapse prophylaxis was found to be inadequate. The central finding was that the impulse for a paradigm shift aimed at by the reform was perceived and implemented differently by the psychotherapists - from a focus on individual therapy processes to a public mental health perspective with a commitment to care coordination. CONCLUSION: Some elements of the reform were criticized by stakeholders, the transition from initial appointments to continuous treatment was considered as not timely enough, and the design of other elements (acute treatment and relapse prevention regulations) was assessed as improvable. There is a need for further research. The results of the focus groups serve as a basis for following project steps including a survey of psychotherapists, patients and GPs.

[Reimbursement for New Examination and Treatment Methods of Outpatients: Comparison of Statutory Health and Private Medical Insurance]. / Die Umsetzung neuer Untersuchungs- und Behandlungsmethoden in die vertragsärztliche Kollektivversorgung und in die privatärztliche ambulante Versorgung.

AIM OF THE STUDY: The aim of the study was to compare the timeliness of reimbursement for new examination and treatment methods in outpatient care in the social (SHI) and private insurance system (PHI) in Germany. METHODOLOGY: For the reimbursement in the SHI system, the decisions and further documentation of the Joint Federal Committee and the evaluation committee could be used. For the reimbursement in the PHI system, for example, the resolutions of the Central Consultation Committee for Fee Schedule Questions and those of the Fee Schedule Committee, but also evaluations of the North Rhine Medical Association and a working group of the German Association of PHI were used. Included were medical methods finally assessed for use in outpatient medical care by the Joint Federal Committee between 2010 and 2019. RESULTS: A total of 17 individual resolutions, two series of resolutions consisting of several individual resolutions, and regulations concerning companion diagnostics were included. The time intervals between the start of the procedure and the introduction of the new method into the SHI system varied widely (14 to 216 months). At the same time, the study showed that for the majority of the methods, reimbursement in PHI was possible earlier than in SHI. Furthermore, five methods showed a potential limitation of reimbursement in PHI dependent on individual insurance contracts, but in two cases also reimbursement by PHI for services later assessed as without benefit by SHI. CONCLUSION: Medical procedures based on the included new methods in most cases were reimbursed in the PHI earlier than in the SHI system. However, this also implies a risk of reimbursing services that are subsequently assessed by the Joint Federal Committee as having no medical benefit. If the joint federal committee assessment is used as a benchmark, this could lead to a reduction in the cost-effectiveness of care and, in individual cases, to patient harm due to overuse or misuse of care. Thus, there is a conflict between early access to new examination and treatment methods (especially in the case of very long Joint Federal Committee procedures) and (cost) effectiveness and assurance of the quality of care.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

BACKGROUND: The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. METHODS: Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. RESULTS: There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as "good", while for a PCS score above 40 there is a reverse effect. CONCLUSIONS: The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.