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Introduction: Since 2019 people who have insured in the German statutory health insurance are entitled to use certified apps called the Digitale Gesundheitsanwendungen [Digital Health Applications (DiGAs)]. The prerequisite for this is that an app certified as DiGA and suitable for their diagnosis exists. The DiGA can then either be prescribed by a physician or psychotherapist or requested by the patient from the statutory health insurance fund. Given the novelty of this type of healthcare, the implementation of a DiGA should be closely monitored to identify potential weaknesses and achieve quality improvements. To enable an analysis of the supply of DiGAs step-by-step, we aimed to create the DiGA-Care Path. Methods: We conducted three steps to create the DiGA-Care Path. First, a knowledge base was created based on a structured literature research matched with knowledge gathered from the superordinate research project "QuaSiApps" funded by the German Federal Joint Committee. Second, we aimed to create an "ideal-typical" DiGA-Care Path using a flowchart. Third, based on the first path, a final path was developed using the graphical modeling language "Event-Driven Process Chain." Results: The DiGA-Care Path was developed to depict the supply of DiGAs in Germany. The final path is constituted by a "main path" as well as a corresponding "sub-path". While the "main path" focuses more on the supply environment in which a DiGA is used, the "sub-path" depicts the supply delivered by the DiGA itself. Besides the process itself, the paths include relevant actors to indicate responsibilities for individual process steps. Discussion: The DiGA-Care Path helps to analyze the current supply of DiGAs step-by-step. Thereby, each step can be investigated in detail to identify problems and to detect further steps where quality improvements can be enabled. Depending on the perspective, focused either on the supply environment, or the supply delivered by the DiGA itself, the "main path" or the "sub-path" can be used, respectively. Besides the potential of the DiGA-Care Path to improve the current supply of DiGAs, it can help as an orientation for international policymakers or further stakeholders either to develop their own integration of apps into healthcare systems or for international manufacturers to consider entering the German market. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are complex diseases that affect 28% (about 17.8 million people) of the adult population in Germany annually. Since 2020, certain mobile health (mHealth) apps, so-called digital health applications (DiGA), are reimbursable in the German statutory health insurance system. A total of 27 of the 56 currently available DiGA are approved for the treatment of mental and behavioral diseases. An indicator of existing problems hindering the use of DiGA is the rather hesitant prescribing behavior., Objective: This project aims to develop health policy recommendations for the optimal integration of DiGA into outpatient psychotherapeutic care. The project is funded by the Innovation Fund of the Joint Federal Committee (grant 01VSF22029). The current status quo of the use of DiGA will be analyzed. Furthermore, concepts for the integration of mHealth apps, as well as their transfer into the care process will be investigated. In addition, barriers will be identified, and existing expectations of different perspectives captured., Methods: The project will be based on a mixed methods approach. A scoping review and a qualitative analysis of focus groups and expert interviews will be carried out. Additionally, an analysis of claims data of the statutory health insurance will be conducted. This will be followed by a written survey of insured persons and health care providers. Finally, health policy recommendations will be derived in cooperation with stakeholders., Results: The scoping reviews and qualitative analyses have been completed, and the quantitative surveys are currently being carried out. The target number of responses in the survey of insured persons has already been achieved. Furthermore, the analysis claims data of the statutory health insurance is currently being conducted., Conclusions: There is a need for research on how DiGA can be optimally integrated into the care process of patients with mental disorders as evidence regarding the topic is limited and prescribing behavior low. Although the potential of DiGA in mental health care has not yet fully unfolded, Germany serves as a model for other countries regarding reimbursable mHealth apps. This project aims to explore the potentials of DiGA and to describe the organizational, institutional, and procedural steps necessary for them to best support mental health care., International Registered Report Identifier (irrid): DERR1-10.2196/56205., (©Klemens Höfer, Felix Plescher, Sarah Schlierenkamp, Stefanie Solar, Silke Neusser, Udo Schneider, Dieter Best, Jürgen Wasem, Carina Abels, Anna Bußmann. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.12.2024.)

Background: High-dose long-term opioid therapy (LTOT) has been associated with increased mortality and hospitalizations. Therefore, the evidence-based German guideline on LTOT for chronic non-cancer pain (CNCP) recommends to only exceed the maximum daily dose (MDD) of opioids in exceptional cases. This study aimed to determine the portion of LTOT patients who exceeded the guideline-recommended MDD and identify predictors of exceeding in administrative claims data., Methods: The retrospective observational analysis of opioid prescriptions in patients receiving LTOT for CNCP was based on administrative claims by a large German statutory health insurance company. Patients with at least two quarters of opioid prescriptions between January 2018 and June 2019 were included and followed up for two years. Predictors were identified by logistic regression. In addition, the number of patients still in opioid therapy and the extent of exceeded MDDs were analyzed over time., Results: The sample consisted of 113,475 patients. Overall, 10.5% of the patients exceeded the guideline-recommended MDD averaged over the observation period. Strong predictors for exceeding the MDD were receiving opioid prescriptions from > 7 physicians (OR = 7.66, p < .001), receiving predominantly strong opioids (OR = 6.79, p < .001) and receiving opioids for at least one year prior to inclusion (OR = 5.35, p < .001). Within the non-exceeding group, 28.1% discontinued opioid therapy. In contrast, 9.9% of patients in the exceeding group discontinued opioid therapy, whereas the vast majority remained on treatment until the end of the observation period. Furthermore, a slight increase in prescribed doses was observed over time., Conclusions: The results indicate that a moderate proportion of patients exceeded the guideline-recommended MDD. However, certain patient groups were more likely to receive high doses. This applied in particular to those who were already on treatment at the time of inclusion and continued to receive opioids until the end of the observation period. Further research should examine whether the continuous opioid therapy among the patients with exceeding the guideline-recommended MDD might be related to specific indications, a lack of therapeutic options or avoidance of withdrawal., Trial Registration: German Clinical Trials Register (drks.de/search/en). Identifier: DRKS00024854. Registered 28 April 2021., (© 2024. The Author(s).)

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., (©Godwin Denk Giebel, Carina Abels, Felix Plescher, Christian Speckemeier, Nils Frederik Schrader, Kirstin Börchers, Jürgen Wasem, Silke Neusser, Nikola Blase. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.04.2024.)

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.

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., Competing Interests: Dieter Best: Mitgliedschaft Deutsche Psychotherapeuten Vereinigung (DPtV), Christa Schaff: Mitgliedschaft Berufsverband für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie in Deutschland e. V. (bkjpp); Helene Timmermann: Mitgliedschaft Vereinigung Analytischer Kinder- und Jugendlichen-Psychotherapeuten in Deutschland e.V. (VAKJP), Kathrin Klipker: Bis Ende März 2023 Beschäftigungsverhältnis beim AOK Bundesverband, Ursula Marschall: Beschäftigungsverhältnis bei der Barmer., (Thieme. All rights reserved.)

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., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

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., (©Godwin Denk Giebel, Christian Speckemeier, Carina Abels, Felix Plescher, Kirstin Börchers, Jürgen Wasem, Nikola Blase, Silke Neusser. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 12.05.2023.)

Background: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany., Methods: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed., Results: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population., Conclusions: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits., (© 2022 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.)

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., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

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., (© 2022. The Author(s).)

Objectives: Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany. Methods: A Markov model was developed in the form of a cohort simulation. It analyzes a population of female relatives of hereditary breast cancer patients. Mutation carriers are offered intensified screening, women with a BRCA1 or BRCA2 mutation can decide on prophylactic mastectomy and/or ovarectomy. The model considers the following scenarios: (a) steady demand for predictive genetic testing, and (b) rising demand. Most input parameters are based on data of the German Consortium for Hereditary Breast and Ovarian Cancer. The model contains 49 health states, starts in 2015, and runs for 10 years. Prices were evaluated from the perspective of statutory health insurance. Results: Steady demand leads to an expenditure of €49.8 million during the 10-year period. Rising demands lead to additional expenses of €125.5 million. The model reveals the genetic analysis to be the main cost driver while cost savings in treatment costs of breast and ovarian cancer are indicated. Conclusions: The results contribute to close the knowledge gap concerning the budgetary consequences due to genetic risk classification. A rising demand leads to additional costs especially due to costs for genetic analysis. The model indicates budget shifts with cost savings due to breast and ovarian cancer treatment in the scenario of rising demands.

Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures. When medically effective prophylactic measures are available in certain cancer diseases, such as in hereditary breast cancer, the current practice of deciding in individual cases appears to be insufficient.The fact that persons with a high or very increased risk of breast cancer are precluded from a standard care procedure raises questions concerning ethical justification as well as medical plausibility. Moreover, it is remarkable that the statutory healthcare system treats persons at risk differently. In some cases there is a regulated way of reimbursement for preventive measures for persons at risk (factor V Leiden mutation) and in other cases there are only case-by-case decisions. Finally, in light of social regulations for persons at high and very increased risk this article considers the need of optimization regarding the risk communication in the decision-making process and the crucial question of budgetary impact for the German healthcare system.From a medical, ethical and legal perspective, a social regulation for persons at high and very increased risk of disease is inevitable and the consequences should be discussed in advance.

The aim of the project is a cost analysis of 2 different strategies "train-the-trainer-seminar" (ttt-seminar) and "implementation guideline" (ig) in the implementation of a standardised patient education program in the inpatient rehabilitation of patients with chronic back pain. The implementation strategies were assigned by chance to 10 rehabilitation clinics. Expenditure of time was evaluated by questionnaire. Additionally materials and travel expenses were calculated. The total implementation costs accounted 4 582 € for the ttt-seminar and were about one third (35%) higher than the costs for the ig-strategy. The higher total implementation costs can basically be attributed to higher personnel costs due to the time-consuming seminar. However, in the ig-strategy postprocessing costs were 23.5% higher than in the ttt-strategy., Competing Interests: Interessenkonflikt: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Prostate cancer (PCA) is the most common form of neoplasm in men and various treatment options are available. Knowledge of health-related quality of life (HRQL) can provide information to support informed decision-making. In addition, information on factors influencing HRQL can provide indications for the further development of medical treatment. The aim of the study was to obtain data on HRQL after inpatient treatment of PCA and the identification of determinants of HRQL after PCA in routine healthcare., Materials and Methods: In this study a total of 1165 beneficiaries of a German health insurance with a hospital stay due to prostate cancer (ICD C61) were surveyed on their health-related quality of life using the European Organization for Research and Treatment of Cancer quality of life questionnaire version 3 (EORTC QLQ-C30 V3.0) and disease-specific symptoms using the perceived sensitivity to medicine (PSM) scale 14 months after discharge. Survey data were linked with pseudonymous claims data of the health insurance provider. Determinants of HRQL were examined by logistic regression., Results: Responses from 825 men (mean age 67.6 years and 80% treated with radical prostatectomy) were available for analysis (response 70.8%). Compared to the reference population impairments in HRQL were reported especially in terms of the roles and social functionality. The prostate-specific symptoms varied depending on the treatment strategy. A nerve-sparing surgical technique reduced the likelihood of erectile dysfunction. Other protective factors were no pre-existing comorbidities and younger age., Discussion: The effects of PCA on the HRQOL varied by age, comorbidities and treatment modality which should be considered in healthcare information and counseling of patients.