Impact of digital health interventions for adolescents with type 1 diabetes mellitus on health literacy: a systematic review.

BACKGROUND: Evidence shows that living with diabetes mellitus type 1 (T1DM) in adolescent age is particularly challenging and difficult to manage. A high level of health literacy is important to prevent and avoid debilitating complications. Despite the increasing prevalence and incidence of T1DM by adolescent and the large use of digital health interventions, little is known about the association between this use and health literacy. This systematic review provides an overview on the impact of digital health interventions for adolescents with type 1 diabetes on health literacy and derive recommendations for further research. METHODS: Electronic searches were performed in five databases in Medline (Medline, PubMed + via PubMed), The Cochrane Library, EMBASE (via Ovid), Web of Science and PsycINFO from 2011 to 2021. In addition, grey literature searches were conducted in Google Scholar, OAlster and Trip. Relevant studies that have been missed by electronic and hand-searching strategies were searched in the reference lists of all included studies. The review followed PRISMA guidelines. Two researchers independently screened abstracts for initial eligibility and applied the inclusion and exclusion criteria to the relevant full-text articles. Quality was assessed using the tools RoB2 Cochrane, ROBINS I, NOS (Newcastle-Ottawa Scale), CASP (Critical Appraisal Skills Programme) for primary studies and Amstar-2 for secondary studies. RESULTS: Out of 981 studies, 22 were included in the final review. Most primary studies included in this review were judged as moderate overall risk of bias or with some concerns and most of the secondary studies as critically low quality reviews. Our findings suggest that the interplay of health care providers (HCP) and patients through social media helps the management of the disease. This corroborates Bröder et al.' (2017) dimension of 'communication and interactions' in their concept of health literacy. CONCLUSIONS: For adolescents with T1DM, social media may be a specific and beneficial intervention for an improved communication and interaction with their HCP. Further research should investigate what specific form of social media suits best for which adolescents. TRIAL REGISTRATION: The study protocol was registered on the 15th of November 2021 on Prospero (reg. NR: CRD42021282199).

Why should stakeholders consider the effect of tensions in collaborative innovation in healthcare-lessons learned from surveying integrated care projects in Germany.

INTRODUCTION: The German Innovation Fund supports projects that aim to improve healthcare through integration and intersectoral collaboration. As is typical for collaborative innovation projects, partners often pursue different objectives, which can create tensions and affect outcomes. The study aims to explore the causes and effects of tensions in integrated care projects and how frameworks, processes, and management should be designed to deal with tensions and achieve their productive effects. METHODS: In an online survey we asked participants about the causes, effects, and management of tensions and their implications for integrated care projects (n = 58 completed questionnaires). We applied bivariate descriptive statistics to analyse the quantitative data. RESULTS: Tensions between stakeholders, caused by deep-seated differences and the design of the project frameworks, often affect the course and outcome of innovative integrated care projects. However, through appropriate conflict management and negotiation processes such tensions can be managed constructively and lead to better outcomes. DISCUSSION: Tension is usually seen as something unpleasant to be avoided and/or overcome. In fact, tensions can have positive effects, the importance of which remains little understood. Developing appropriate frameworks for managing and integrating different perspectives are key factors in unlocking the positive potential of tensions in integrated care projects.

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A systematic review with meta-analysis.

OBJECTIVE: To evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus active physical interventions on pain intensity and disability in adults with nonspecific chronic low back pain. INTRODUCTION: Research has shown that primary care biopsychosocial interventions (PCBI) can reduce pain intensity and disability. While scattered studies support low-dosed (≤ 15 treatment hours) PCBI, no systematic review exists comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomized controlled trials that evaluate low-dosed PCBI compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older), who suffer from CLBP were included. Not recommended interventions that feature only passive therapies, spinal surgery or pharmacological treatment, and studies with inpatient multidisciplinary-based rehabilitation (MBR) were excluded. METHODS: Databases were searched from inception to December 31, 2021. Language was restricted to English or German. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" were used. Sources were CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. Search was finished on March 08, 2022. Data appraisal, extraction and synthesis followed JBI guidance for systematic reviews of effectiveness. Risk of Bias was assessed using JBI 13-item checklist for randomized controlled trials. The GRADE approach for grading the certainty of evidence was followed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2022 CRD42022302771. RESULTS: Eighteen RCTs were found eligible and 15 trials comprising a total of 1531 participants suffering from CLBP were entered in the meta-analyses. Risk of Bias was low. Overall evidence was moderate. Significant effects in favor of PCBI were found for pain intensity post-treatment (standardized mean difference (SMD) = -1.09, 95% confidence interval (CI) = -1.84 to -0.34, I2  = 97%, p = 0.004) as well as at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004), long term (SMD = -0.79, 95% CI = -1.42 to -0.17, I2  = 96%, p = 0.01) and very long-term (SMD = -1.13, 95% CI = -1.93 to -0.33, I2  = 94%, p = 0.005) follow-up. Significant effects in favor of PCBI for physical function were found post-treatment (SMD = -1.33, 95% CI = -2.17 to -0.49, I2  = 97%, p = 0.002) at short-term (SMD = -0.20, 95% CI = -0.36 to -0.04, I2  = 0%, p = 0.01) and at long-term follow-up (SMD = -1.17, 95% CI = -2.06 to -0.28, I2  = 98%, p = 0.01). The results were characterized by high heterogeneity due to different types (cognitive behavioral therapy, pain-neuroscience education, mindfulness, and motivation), delivery modes (individual and/or group), durations (3-12 weeks) and contact times (2-15 h) of PCBI. In sensitivity analysis outliers were removed to reduce heterogeneity. The results remained significant for pain intensity at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004) and long-term follow-up (SMD = -0.22, 95% CI = -0.41 to -0.03, I2  = 39%, p = 0.02). CONCLUSIONS: This meta-analysis suggests that low-dosed PCBI has favorable effects in terms of disability and pain intensity compared to active physical treatments alone. All conducted meta-analyses indicate that biopsychosocial interventions produce better outcomes than active physical treatment alone. Therefore, we strongly recommend decision makers and clinical practitioners to analyze how psychosocial elements can be introduced into outpatient (low-dosed) CLBP interventions.

What can healthcare systems learn from looking at tensions in innovation processes? A systematic literature review.

BACKGROUND: Until now, scholarship on innovation processes in healthcare systems lack an in-depth appreciation of tensions. Tensions often revolve around barriers and result from individual assessments and prioritizations that guide actions to eventually overcome these barriers. In order to develop a more differentiated understanding of tensions' role in healthcare innovation processes, this paper aims to shed light on the multifaceted ways in which tensions emerge, are being dealt with, and how they hinder or, at times, facilitate innovation processes. METHODS: A systematic review of published and grey literature was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline. The review involved searching three databases for original research articles and manually searching citations. Twenty-nine original full texts were identified, evaluated, and coded. These include papers on innovation in healthcare systems that investigated innovation-related organizational tensions. The findings were synthesized into different types of tensions in healthcare system innovation and the descriptions of the conflicting elements. We also analyzed the investigated innovations by type, process stages, and across different countries and healthcare systems. RESULTS: A total of forty-two tensions were identified and grouped into nine categories. Organizing tensions were predominant, followed by learning/belonging, performing, and performing/organizing tensions. Tensions most frequently occurred in the implementation phase and in the form of a dilemma. Included studies were conducted mainly in government-funded healthcare systems. CONCLUSION: Our data suggest that innovation processes in healthcare systems are impaired by conflicts between contradictory elements, working cultures, and convictions and the organizational and regulatory context. Since the majority of the tensions we collected in our study can be addressed, future policy-making and research should take advantage of this fact and develop strategies that significantly influence the successful management of tensions and thus improve the implementation of innovations.

[10 Years Accountable Care Organizations in the USA: Impulses for Health Care Reform in Germany?] / 10 Jahre Accounable Care Organizations in den USA: Impulse für Reformen in Deutschland?

GOAL OF THE STUDY: An intent of the Patient Protection and Affordable Care Acts (ACA), also know as Obama Care, was to slow the expenditure growth in the public Medicare-System by shifting the accountability for health care outcomes and costs to the provider. For this purpose, provider were allowed to form networks, which would then take accountability for a defined population - Accountable Care Organizations (ACOs). Ten years after the introduction of ACOs, this paper looks at the impact of ACOs both on quality of care and costs of care to assess if ACOs can be a model of care delivery for Germany. METHODS: In a mixed-method approach, a rapid review was conducted in Health System Evidence and PubMed. This was supported with further papers identified using the snowballing-technique. After screening the abstracts, we included articles containing information on cost- and/or quality impact of US-Medicare-ACOs. The findings of the rapid review were challenged with 16 ACO-experts and stakeholder in the USA. RESULTS: In total, we included 60 publications which incorporated 6 reports that were either conducted directly by governmental institutions or ordered by them, along with 3 previous reviews. Among these, 31 contained information on costs of care, 18 contained information on quality of care and 11 had information on both aspects. The publications show that ACOs reduced costs of of care. Cost reductions were achieved compared to historic costs, to populations not cared for in ACOs, and counterfactuals. Quality of care stayed the same or improved. CONCLUSION: ACOs contributed to slowing the cost growth in US Medicare without compromising quality of care. Thus, a transferal of this model of care to Germany should be considered. However, various policies have led to ACOs failing to unleash their full potential. Against this background, and against the background of stark differences between US Medicare and the German health care system, a critical reflection of the necessary policies underlying ACOs-like structures in Germany, needs to be undertaken.

RubiN - continuous care in regional networks: a study protocol for a prospective controlled trial.

BACKGROUND: The health care situation of geriatric patients is often multifaceted, complex and often overlaps with social living conditions. Due to the lack of cross-sectoral and interprofessional health care geriatric patients often, receive insufficient care. Only a holistic view enables a comprehensive evaluation of the complex health risks, but also the potential to preserve the health of geriatric patients. The implementation of cross-sectoral, multi-professional case management could reduce the gaps in care, improve the autonomy of the geriatric patients in their own homes, and allow them to retain it as long as possible. The "RubiN" project examines the effects of multi-professional, cross-sectoral and assessment-based case management on the quality of the care of geriatric patients. The results of the study aim to show whether geriatric patients receive better care using case management than patients who receive standard health care. In addition, data on the effects of case management on practices of general practitioners (GP), the satisfaction with the care concept amongst the case managers, patients and relatives will be collected. Furthermore, a health economic analysis will be carried out. METHODS: The project is designed as a prospective controlled study and compares geriatric patients from practice networks in different regions in Germany. Inclusion criteria are: Age ≥ 70 years and care requirements from two different care complexes (identified with the screening instrument 'Angelina'-questionnaire). The intervention is the use of a geriatric case management, where health care is organised based on patient-specific care requirements. Five practice networks of physicians will implement the intervention (n = 3200 patients) and three practice networks will serve as the control group (n = 1200 patients). The primary endpoint is the ability to manage activities of daily living, measured using the Barthel Index. The patients in the intervention group receive geriatric case management and the patients in the control networks receive standard care ("care as usual"). The analysis of the primary data, which is pseudonymised, occurs according to the intention-to-treat principle. For this purpose, the endpoints will be analysed using a group comparison after 12 months. For the health economic analysis, secondary data from the statutory health insurance providers will be included in the analysis, in addition to the primary data. Data for the analysis of the effects the concept has on the GP practices as well as on the satisfaction of the project participants will be collected with questionnaires and interviews with experts. DISCUSSION: The implementation of cross-sectoral and interdisciplinary geriatric case management has been a topic of discussion for years, whereby positive effects have already been-shown. This planned study will be the first evaluation of the effect of case management for geriatric patients with a very large sample. In addition, the effects of case management on the GP practices and also on the relatives of the geriatric patients will be shown. It is intended that the study results pave the way for a widespread implementation of this concept. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00016642 . Registered on 29 October 2019 - Retrospectively registered.

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF.

BACKGROUND: The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies. METHODS: This is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms. DISCUSSION: This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF. TRIAL REGISTRATION: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642 ).

Public preferences for primary care provision in Germany - a discrete choice experiment.

BACKGROUND: Primary care is a central element of healthcare and addresses the main health problems of the population. While primary care gains in importance due to an aging population, there is an ongoing debate on physician shortages in German rural regions. The study aims on analyzing the population's preferences on primary healthcare and, therefore, on helping policy makers to make care delivery more responsive to patients' needs when planning political reforms of primary care. METHODS: A paper-based discrete choice experiment (DCE) was used to assess preferences of the population of eight rural regions in Germany. Based on literature search and qualitative research, six attributes were selected and included in the choice experiment. The survey presented participants with eight choice sets in which they had to choose between two possible scenarios of care. A conditional logistic regression as well as a latent class model (LCM) were used to analyze preferences for primary healthcare. RESULTS: Nine hundred four participants completed the survey (response rate 46.1%). The conditional logistic regression showed significant impact of the attributes "home visits", "distance to practice", "number of healthcare providers", "opening hours of the practice", and "diagnostic facilities" on the respondents' choices of primary healthcare alternatives. Moreover, the LCM identified four classes that can be characterized by preference homogeneity within and heterogeneity between the classes. CONCLUSION: Although the study revealed heterogeneous preferences among the latent classes, several similarities in preferences for primary care could be detected. The knowledge on these public preferences may help policy makers when implementing new models of primary care and, thus, raise the populations' acceptance of future primary care provision and innovative care models.

[Primary Healthcare Provision and Introduction of New Models of Care in Hard to Serve Regions: A Population Survey]. / Hausärztliche Versorgungssituation und Einführung neuer Versorgungsformen in schwer zu versorgenden Regionen: Eine Befragung der Bevölkerung.

OBJECTIVE OF THE STUDY: One of the central challenges in health policy is to ensure nationwide provision of primary healthcare services. However, it is not clear how the general public rates the current primary healthcare provision in their region. Furthermore, there is very little information on whether people are willing to make use of new models of care that could contribute to ensuring a nationwide provision of healthcare services. Thus, the objective of this study was to analyse the general public's ratings of the local primary healthcare provision as well as their acceptance of selected new models of care. Furthermore, potential differences in the ratings of the population between hard to serve regions and normal regions will be analysed. METHODOLOGY: Focus group discussions and a literature review were conducted in order to develop a questionnaire to elicit the expectations of the population concerning the local provision of primary healthcare as well as their acceptance of new models of care. A postal questionnaire was sent to a random sample of 2,000 persons in 8 regions in Lower Saxony. RESULTS: The adjusted response rate of the postal survey was 51% (n=996). 97% of respondents saw a general practitioner regularly, with 5.4 visits per year on average. Patients could reach the practice in 13 min on average. Respondents predominantly rated the current healthcare provision as being good. However, the majority of respondents expected the local primary healthcare provision to deteriorate in the future. New models of care most preferred by the respondents were the delegation of medical tasks to non-medical professionals and mobility-oriented models. On the other hand, the provision of healthcare via telemedicine was rejected. DISCUSSION: According to the results of this study, respondents believe that new models of care can play an important role in ensuring the nationwide provision of healthcare services. Introducing, at an early stage, those new models of care that people accept could contribute to ensuring a sustainable provision of primary healthcare services. Furthermore, the introduction of these new models of care could reduce the public's concerns regarding a worsening provision of primary healthcare services in their regions. Additionally, pilot projects with those new models of care that are rather rejected might increase acceptance with these models of care if they prove to be successful.

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

BACKGROUND: In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects. OBJECTIVE: To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA). METHODS: For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications. RESULTS: Eleven of 21 benefit assessments included crossover trials. Significant intergroup differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without crossover. For 6 of 11 medicines with crossover, these were demonstrated before crossover. Treatment effects generally worsened with increasing proportions of crossover. The EMA requested additional data more frequently if crossover was performed, particularly if no OS data were available before crossover. The G-BA granted a considerable benefit to 73% of medicines with crossover and 40% of those without. Evidence levels were intermediate for 50% and 75%, respectively. None of the medicines received the highest evidence level. CONCLUSIONS: In G-BA appraisals, oncology medicines with crossover received better additional benefit ratings, but were assigned lower evidence levels, than those without. The five medicines with crossover after progression were assigned lower evidence levels than the six medicines with crossover after demonstration of superior OS, indicating that the way in which crossover is implemented may be one factor influencing the assignment of evidence levels by the G-BA.

[The Role of Municipalities in Lower Saxony for Future Physician's Care - A Survey of Mayors and District Administrators]. / Die Rolle von niedersächsischen Kommunen für die zukünftige ärztliche Versorgung ­ Eine Befragung der Bürgermeister und Landräte.

BACKGROUND: Comprehensive outpatient medical care is being increasingly threatened due to the decreasing willingness of physicians to establish their practices in rural areas. Partly, municipalities feel impelled to support doctors setting up their practices with their own resources. The aim of this study was to get the community perspective on the ambulatory care situation and to examine the role and influence of the local authorities. METHODS: The mayors (n=411) and district administrators (n=38) in Lower Saxony received a self-developed written questionnaire in September 2015 (comprehensive survey). RESULTS: The response rate was 72%. Availability of general practitioners was considered as inadequate by 30% of those surveyed and 71% described specialist care as being insufficient. Two-thirds of respondents saw local problems with filling vacant doctors' offices. 42% of mayors and 65% of district administrators said they had already supported outpatient doctors. The most frequent measures carried out so far included financial support, consulting services and the development of cooperation and networks. The majority considered the model of medical care centers being operated under municipal sponsorship to be unsuitable in principle. CONCLUSIONS: Local governments prevalently see problems with filling vacant doctors' offices as well as a need for local support. A significant proportion of municipalities has already implemented various support measures. Community participation in the outpatient care with medical care centers under municipal sponsorship is assessed rather critically.

[Assessing the benefits of digital health solutions in the societal reimbursement context]. / Nutzenbewertung von digitalen Gesundheitsprodukten (Digital Health) im gesellschaftlichen Erstattungskontext.

For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.

High resource utilization in liver transplantation-how strongly differ costs between the care sectors and what are the main cost drivers?: a retrospective study.

To control treatment pathways of transplant patients across healthcare sectors, a profound knowledge of the underlying cost structure is necessary. The aim of this study was to analyze the resource utilization of patients undergoing liver transplantation. Data on resource utilization for 182 liver-transplanted patients was investigated retrospectively. The observational period started with the entry on the waiting list and ended up to 3 years after transplantation. Median treatment cost was 144 424€. During waiting time, median costs amounted to 9466€; 72% of costs were attributed to inpatient care, 3% to outpatient care, and 26% to pharmaceuticals. During the first year after transplantation, median costs of 105 566€ were calculated; 83% were allocated for inpatient and 1% outpatient care, 14% for drugs, and 1% for rehabilitative care. During follow-up after the first year of transplantation, median costs amounted to 20 115€; 75% of these were caused by pharmaceuticals, 21% by inpatient, 4% by outpatient, and <1% by rehabilitative services. Subgroup analyses (e.g., for labMELD scores) were done. Costs incurred by inpatient care and pharmaceuticals are the dominating cost factors. These findings encourage a debate on challenges and improvements for cost-efficient clinical management between different healthcare sectors.

Patients' preferences for primary health care - a systematic literature review of discrete choice experiments.

BACKGROUND: Primary care is a key element of health care systems and addresses the main health problems of the population. Due to the demographic change, primary care even gains in importance. The knowledge of the patients' preferences can help policy makers as well as physicians to set priorities in their effort to make health care delivery more responsive to patients' needs. Our objective was to describe which aspects of primary care were included in preference studies and which of them were the most preferred aspects. METHODS: In order to elicit the preferences for primary care, a systematic literature search was conducted. Two researchers searched three electronic databases (PubMed, Scopus, and PsycINFO) and conducted a narrative synthesis. Inclusion criteria were: focus on primary health care delivery, discrete choice experiment as elicitation method, and studies published between 2006 and 2015 in English language. RESULTS: We identified 18 studies that elicited either the patients' or the population's preferences for primary care based on a discrete choice experiment. Altogether the studies used 16 structure attributes, ten process attributes and four outcome attributes. The most commonly applied structure attribute was "Waiting time till appointment", the most frequently used process attribute was "Shared decision making / professional's attention paid to your views". "Receiving the 'best' treatment" was the most commonly applied outcome attribute. Process attributes were most often the ones of highest importance for patients or the population. The attributes and attribute levels used in the discrete choice experiments were identified by literature research, qualitative research, expert interviews, or the analysis of policy documents. CONCLUSIONS: The results of the DCE studies show different preferences for primary health care. The diversity of the results may have several reasons, such as the method of analysis, the selection procedure of the attributes and their levels or the specific research question of the study. As the results of discrete choice experiments depend on many different factors, it is important for a better comprehensibility of the studies to transparently report the steps undertaken in a study as well as the interim results regarding the identification of attributes and levels.

Which strategies might improve local primary healthcare in Germany? An explorative study from a local government point of view.

BACKGROUND: Facing rising inequities and poorer accessibility of physicians in rural areas, new healthcare delivery structures are being considered to support local healthcare in German communities. To better understand perspectives on and attitudes towards different supplementary models, we examined attitudes among local politicians in the German federal state of Lower Saxony towards the suitability of supplementary care models. METHODS: As part of a cross-sectional study, we surveyed local politicians in Lower Saxony at the local authority and district levels (n = 449) by mail questionnaire. We asked for an assessment of four potential supplementary healthcare models at the local level: the use of trained medical assistants, patients' buses, mobile physicians' offices, and telemedicine. RESULTS: The response rate was 71.0% for mayors (n = 292) and 81.6% (n = 31) for county administrators. In summary, 72.4% of respondents supported the use of trained medical assistants, 48.9% voted for patients' buses, 22.0% for mobile physicians' offices, and 13.9% for telemedicine. Except for telemedicine, the politicians' approval of the supplementary models in rural areas was higher than in urban areas. The assessment regarding the suitability of each model was not significantly connected with indicators of a positively or negatively assessed local healthcare situation. The analyses showed that the use of trained medical assistants was associated with the positive effects of division of labor and potential to relieve physicians. In contrast, there was skepticism about technical support via telemedicine, mostly due to concerns about its unsuitability for elderly people and the potential lower quality of healthcare delivery. CONCLUSION: Local politicians widely accept the use of trained medical assistants, whereas the applicability of technical solutions such as telemedicine is perceived with skepticism. Therefore, the knowledge gap between evidence for and prejudices against telemedicine needs to be addressed more effectively. Reasons for the assessments of the presented models are more likely traceable to personal views than to assessments of the actual estimated local primary care situation.

Analysing predictors for future high-cost patients using German SHI data to identify starting points for prevention.

BACKGROUND: Demographic change influences not only the terms of health care, but also its financing. Hence, prevention is becoming a more important key to facing upcoming challenges. Aim of this study was to identify predictors for future high-cost patients and derive implications for potential starting points for prevention. METHODS: Claims data from a German statutory health insurance agency were used. High-cost patients were defined as the 10% most expensive persons to insure in 2011. The predictors stemmed from the previous year. Logistic regression with stepwise forward selection for 10 sex- and age-specific subgroups was performed. Model fit was assessed by Nagelkerke's R-squared value. RESULTS: Model fit values indicated well-suited models that yielded better results among younger age-groups. Identified predictors can be summarized as different sets of variables that mostly pertain to diseases. Some are rather broad and include different disorders, like the set of mental/behavioural disorders including depression and schizophrenia; other sets of variables are more homogenous, such as metabolic diseases, with diabetes mellitus (DM) being the dominant member of every subgroup. CONCLUSION: Because diabetes was a significant predictor for future high-cost patients in all analysed subgroups, it should be considered as a potential starting point for prevention. The disease is specific enough to allow for the implementation of effective prevention strategies, and it is possible to intervene, even in patients already affected by DM. Furthermore, the monetary savings potential is probably high because the long-term complications of DM are expensive to treat and affect a large part of the population.

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

BACKGROUND: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. METHODS: Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer's dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. RESULTS: A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. CONCLUSIONS: This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany.

[Declared dead? Recommendations regarding integrated care from the perspective of German statutory health insurance]. / Totgesagte leben länger : Empfehlungen zur Integrierten Versorgung aus Sicht der gesetzlichen Krankenkassen.

The traditional separation of health care into sectors in Germany causes communication problems that hinder continuous, patient-oriented care. This is most evident in the transition from inpatient to outpatient care. That said, there are also breaks in the flow of information, a lack of supply, or even incorrect information flowing within same-sector care. The transition from a division of functions into sectors to a patient-oriented process represents a change in the paradigm of health care that can only be successfully completed with considerable effort. Germany's statutory health insurance (SHI) funds play a key role here, as they are the contracting parties as well as the financiers of integrated care, and are strategically located at the center of the development process.The objective of this article is to explore how Germany's SHI funds view integrated care, what they regard as being the drivers of and barriers to transitioning to such a system, and what recommendations they can provide with regard to the further development of integrated care. For this purpose semi-structured interviews with board members and those responsible for implementing integrated care into the operations of ten SHI funds representing more than half of Germany's SHI-insured population were conducted. According to the interviewees, a better framework for integrated care urgently needs to be developed and rendered more receptive to innovation.Only in this way will the widespread stagnation of the past several years be overcome. The deregulation of § 140a-d SGB V and the establishment of a uniform basis for new forms of care in terms of a new innovation clause are among the central recommendations of this article. The German federal government's innovation fund was met with great hope, but also implied risks. Nonetheless, the new law designed to strengthen health care overall generated high expectations.