Incidence trend of type 2 diabetes from 2012 to 2021 in Germany: an analysis of health claims data of 11 million statutorily insured people.

AIMS/HYPOTHESIS: The aim of the study is to describe the time trend of type 2 diabetes incidence in the largest state of Germany, Bavaria, from 2012 to 2021, and to compare the incidence rates during the pandemic period (2020-2021) to the pre-pandemic period (2012-2019). METHODS: This secondary data analysis uses health claims data provided by the Bavarian Association of Statutory Health Insurance Physicians (KVB), covering approximately 11 million insurees, accounting for 85% of the total population of Bavaria, Germany. Newly diagnosed type 2 diabetes cases in adults (≥20 years) coded as E11 (Diabetes mellitus, Type 2) or E14 (Unspecified diabetes mellitus) under ICD-10, German modification (ICD-10-GM) for the study period 2012 to 2021 were included. Annual and quarterly age-standardised incidence rates (ASIR) stratified by sex, age and region were calculated using the European standard population. Sex-specific crude incidence rates (CIR) were calculated using 10-year age groups. Regression analyses adjusted for time trends, seasonal effects, and pandemic effects were used to analyse the incidence trend and to assess the effect of the pandemic. RESULTS: Overall, 745,861 new cases of type 2 diabetes were diagnosed between 2012 and 2021: 50.4% (376,193 cases) in women. The male/female ratio remained stable over the observation period, while the median age at diagnosis decreased from 61 to 58 years in men and from 66 years to 61 years in women. ASIR were consistently higher for men compared with women, with the yearly difference remaining stable over time (2012: 18%; 2021: 20%). An overall decreasing trend in ASIR was observed during the study period, with a strong decrease from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021 for both sexes. For men, ASIR decreased from 1514 per 100,000 person-years in 2012 to 995 per 100,000 person-years in 2021 (4.6% average annual reduction), and for women from 1238 per 100,000 person-years in 2012 to 796 per 100,000 person-years in 2021 (4.8% average annual reduction). This downward trend was also observed for age groups above 50 years. Regression analyses showed no significant change in incidence rates during the pandemic period (2020 and 2021) compared with the pre-pandemic period. CONCLUSIONS/INTERPRETATION: For the first time, a 10-year incidence trend of type 2 diabetes is reported for Germany, showing a strong decline from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021. The incidence trend of type 2 diabetes appears not to have been affected by the first 2 years of the COVID-19 pandemic. Despite an overall increasing prevalence, the incidence is decreasing, potentially resulting from robust screening by family physicians, reducing the median age at diagnosis by 3 to 5 years. However, further investigation is needed to fully identify the reasons for the declining incidence trend. Continued incidence monitoring is necessary to identify the long-term trend and the potential effect of the pandemic on diagnoses of type 2 diabetes.

The role of mesolevel characteristics of the health care system and socioeconomic factors on health care use - results of a scoping review.

BACKGROUND: Besides macrolevel characteristics of a health care system, mesolevel access characteristics can exert influence on socioeconomic inequalities in healthcare use. These reflect access to healthcare, which is shaped on a smaller scale than the national level, by the institutions and establishments of a health system that individuals interact with on a regular basis. This scoping review maps the existing evidence about the influence of mesolevel access characteristics and socioeconomic position on healthcare use. Furthermore, it summarizes the evidence on the interaction between mesolevel access characteristics and socioeconomic inequalities in healthcare use. METHODS: We used the databases MEDLINE (PubMed), Web of Science, Scopus, and PsycINFO and followed the 'Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols extension for scoping reviews (PRISMA-ScR)' recommendations. The included quantitative studies used a measure of socioeconomic position, a mesolevel access characteristic, and a measure of individual healthcare utilisation. Studies published between 2000 and 2020 in high income countries were considered. RESULTS: Of the 9501 potentially eligible manuscripts, 158 studies were included after a two-stage screening process. The included studies contained a wide spectrum of outcomes and were thus summarised to the overarching categories: use of preventive services, use of curative services, and potentially avoidable service use. Exemplary outcomes were screening uptake, physician visits and avoidable hospitalisations. Access variables included healthcare system characteristics such as physician density or distance to physician. The effects of socioeconomic position on healthcare use as well as of mesolevel access characteristics were investigated by most studies. The results show that socioeconomic and access factors play a crucial role in healthcare use. However, the interaction between socioeconomic position and mesolevel access characteristics is addressed in only few studies. CONCLUSIONS: Socioeconomic position and mesolevel access characteristics are important when examining variation in healthcare use. Additionally, studies provide initial evidence that moderation effects exist between the two factors, although research on this topic is sparse. Further research is needed to investigate whether adapting access characteristics at the mesolevel can reduce socioeconomic inequity in health care use.

The role of sociodemographic, psychosocial, and behavioral factors in the use of preventive healthcare services in children and adolescents: results of the KiGGS Wave 2 study.

BACKGROUND: In Germany, various preventive services are offered to children and adolescents. These include regular standardized examinations (so called U/J examinations) and several vaccinations. Although strongly recommended, most of them are not mandatory. Our aim is to identify factors associated with the use of U/J examinations and vaccination against diphtheria, hepatitis B, Hib, pertussis, polio, and tetanus. While previous research has focused on sociodemographic factors, we also include socioeconomic, behavioral, and psychosocial factors. METHODS: We analyzed cross-sectional data from 15,023 participants (aged 0-17 years) of the nationwide representative KiGGS Wave 2 Survey. Participation in U/J examinations was assessed using a questionnaire, filled out by participants and/or their parents. Information on vaccination status was drawn from the participants' vaccination booklets. To identify relevant determinants for the use of preventive examinations and vaccinations, unadjusted and adjusted logistic regression models were employed with up to 16 different independent variables. RESULTS: Various independent variables showed an association with the use of preventive services. Higher socioeconomic status, absence of migration background, and lower household size were associated with significantly higher utilization of U examinations. Parents' marital status, area of residence, behavioral and psychosocial factors yielded insignificant results for most U/J examinations. Higher vaccination rates were found for children with no migration background, with residence in eastern Germany, lower household size, and with married parents. CONCLUSION: This study attempted to depict the influence of sociodemographic, psychosocial, and behavioral factors on the use of several preventive services. Our results indicate that predominantly sociodemographic variables influence the use of preventive services. Further efforts should be made to investigate the interplay of different determinants of healthcare use in children and adolescents.

Analytical methods for identifying sequences of utilization in health data: a scoping review.

BACKGROUND: Healthcare, as with other sectors, has undergone progressive digitalization, generating an ever-increasing wealth of data that enables research and the analysis of patient movement. This can help to evaluate treatment processes and outcomes, and in turn improve the quality of care. This scoping review provides an overview of the algorithms and methods that have been used to identify care pathways from healthcare utilization data. METHOD: This review was conducted according to the methodology of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews (PRISMA-ScR) Checklist. The PubMed, Web of Science, Scopus, and EconLit databases were searched and studies published in English between 2000 and 2021 considered. The search strategy used keywords divided into three categories: the method of data analysis, the requirement profile for the data, and the intended presentation of results. Criteria for inclusion were that health data were analyzed, the methodology used was described and that the chronology of care events was considered. In a two-stage review process, records were reviewed by two researchers independently for inclusion. Results were synthesized narratively. RESULTS: The literature search yielded 2,865 entries; 51 studies met the inclusion criteria. Health data from different countries ([Formula: see text]) and of different types of disease ([Formula: see text]) were analyzed with respect to different care events. Applied methods can be divided into those identifying subsequences of care and those describing full care trajectories. Variants of pattern mining or Markov models were mostly used to extract subsequences, with clustering often applied to find care trajectories. Statistical algorithms such as rule mining, probability-based machine learning algorithms or a combination of methods were also applied. Clustering methods were sometimes used for data preparation or result compression. Further characteristics of the included studies are presented. CONCLUSION: Various data mining methods are already being applied to gain insight from health data. The great heterogeneity of the methods used shows the need for a scoping review. We performed a narrative review and found that clustering methods currently dominate the literature for identifying complete care trajectories, while variants of pattern mining dominate for identifying subsequences of limited length.

Diffusion of a new drug among ambulatory physicians-The impact of patient pathways.

When drugs enter the market, physicians' prescribing behavior plays a crucial role in the diffusion process. Although regulations to foster economically efficient prescribing exist, physicians have some degree of freedom in choosing medication and are subject to various influencing factors. The aim of the present analysis is to investigate how interaction among patients and physicians affects the diffusion. We look at two different ways that patient pathways might influence physicians and examine these effects for Sacubitril/Valsartan (S/V), a new drug for patients with heart failure. Using administrative data from Germany, we identify physicians who prescribed S/V in the first 2 years of its availability. We apply survival models to estimate the impact of the patient-physician interaction on the physicians' adoption time. To this end, we determine whether individual physicians treated patients that had been prescribed S/V, and how many other physicians already prescribing S/V were connected in patient-sharing networks. Our main findings are that patients with a previous prescription seem to induce adoption by demanding repeat prescriptions. Moreover, patients establish connections between physicians that may lead to prescriptions for new patients. Our results therefore suggest that patient pathways play a significant role in the diffusion of a new drug.

Do physician networks with standardized audit and feedback deliver better quality care for older patients compared to regular care?: a quasi-experimental study using claims data from Bavaria, Germany.

BACKGROUND: Physician networks (PNs) are a recent development in Germany, designed to improve the coordination and quality of healthcare. We compared the performance of PNs that use a standardized system of audit and feedback to that of regular care. METHODS: We analysed a large sample of claims data from Bavaria, Germany, using nearest-neighbour propensity score matching. Patients who had ambulatory care-sensitive conditions (ACSCs) and were enrolled in PNs were matched with control patients receiving regular care. We examined potentially avoidable hospitalizations related to the 13 most common ACSCs (primary endpoints), as well as processes-of-care indicators for disease prevention, pharmacotherapy and coordination of care. RESULTS: There were no significant differences in rates of potentially avoidable hospitalizations between the two groups. However, the networks showed higher vaccination rates, increased participation in disease management programmes, and more frequent use of referrals when consulting specialist physicians. On average, network patients visited a greater number of specialists and had lower continuity of care compared to patients receiving regular care. Polypharmacy and PRISCUS-list prescriptions were more prevalent in the networks. CONCLUSIONS: PNs using audit and feedback do not appear to perform better than regular care in preventing hospitalizations due to ACSCs. However, they do perform better in disease prevention measures while showing inconclusive results for care coordination and pharmacotherapy. Further research is needed to understand effective collaboration among providers and its impact on the quality of care within PNs.

Regional variations in multimorbidity burden among office-based physicians in Germany.

BACKGROUND: Multimorbidity is associated with higher utilization of healthcare services. However, many countries do not consider multimorbidity when estimating physician supply. The main aim of this study was to assess how regional multimorbidity levels can be integrated when estimating the need for office-based physician supply. METHODS: Claims data were used to measure and compare the proportions of multimorbid patients of GPs, ophthalmologists, orthopaedic specialists and neurologists, and examine spatial variations through Bernoulli cluster analysis of regional multimorbidity levels. To explore the interrelationship between current capacities and spatial occurrence of high-rate clusters, clusters were compared with the current supply of physicians. RESULTS: About 17 239 488 individuals out of approximately 67 million records were classified as multimorbid. Multimorbidity levels varied greatly between physician disciplines (31.5-60.1%). Bernoulli cluster analysis demonstrated that many high-rate areas were found for all specialized physicians, but clusters varied partially by size and location. The comparison with current physician supply at cluster level showed that more than a third of clusters with a significantly higher share of morbid patients seeing a GP are met, on an average, by GP supply below targeted values. In turn, clusters with significantly higher multimorbidity levels of specialized physicians were met, on an average, by supply that exceeded targeted values. CONCLUSION: Our study offers an approach to how to include discipline-specific multimorbidity at area level when estimating physician supply and discusses its relevance. The outcomes of our article can be used by policymakers to advance current planning strategies and to improve the quality of office-based care.

Assessing needs-based supply of physicians: a criteria-led methodological review of international studies in high-resource settings.

BACKGROUND: Many health systems embrace the normative principle that the supply of health services ought to be based on the need for healthcare. However, a theoretically grounded framework to operationalize needs-based supply of healthcare remains elusive. The aim of this paper is to critically assess current methodologies that quantify needs-based supply of physicians and identify potential gaps in approaches for physician planning. To this end, we propose a set of criteria for consideration when estimating needs-based supply. METHODS: We conducted searches in three electronic bibliographic databases until March 2020 supplemented by targeted manual searches on national and international websites to identify studies in high-resource settings that quantify needs-based supply of physicians. Studies that exclusively focused on forecasting methods of physician supply, on inpatient care or on healthcare professionals other than physicians were excluded. Additionally, records that were not available in English or German were excluded to avoid translation errors. The results were synthesized using a framework of study characteristics in addition to the proposed criteria for estimating needs-based physician supply. RESULTS: 18 quantitative studies estimating population need for physicians were assessed against our criteria. No study met all criteria. Only six studies sought to examine the conceptual dependency between need, utilization and supply. Apart from extrapolations, simulation models were applied most frequently to estimate needs-based supply. 12 studies referred to the translation of need for services with respect to a physician's productivity, while the rest adapted existing population-provider-ratios. Prospective models for estimating future care needs were largely based on demographic predictions rather than estimated trends in morbidity and new forms of care delivery. CONCLUSIONS: The methodological review shows distinct heterogeneity in the conceptual frameworks, validity of data basis and modeling approaches of current studies in high-resource settings on needs-based supply of physicians. To support future estimates of needs-based supply, this review provides a workable framework for policymakers in charge of health workforce capacity planning.

Identifying and Investigating Ambulatory Care Sequences Before Invasive Coronary Angiography.

BACKGROUND: The concept of care pathways is widely used to provide efficient, timely, and evidence-based medical care. Recently, the investigation of actual empirical patient pathways has gained attention. We demonstrate the usability of State Sequence Analysis (SSA), a data mining approach based on sequence clustering techniques, on comprehensive insurance claims data from Germany to identify empirical ambulatory care sequences. We investigate patients with coronary artery disease before invasive coronary angiography (CA) and compare identified patterns with guideline recommendations. This patient group is of particular interest due to high and regionally varying CA rates. METHODS: Events relevant for the care of coronary artery disease patients, namely physician consultations and medication prescriptions, are identified based on medical guidelines and combined to define states. State sequences are determined for 1.5 years before CA. Sequence similarity is defined for clustering, using optimal matching with theory-informed substitution costs. We visualize clusters, present descriptive statistics, and apply logistic regression to investigate the association of cluster membership with subsequent undesired care events. RESULTS: Five clusters are identified, the included patients differing with respect to morbidity, urbanity of residential area, and health care utilization. Clusters exhibit significant differences in the timing, structure, and extent of care before CA. When compared with guideline recommendations, 3 clusters show signs of care deficits. CONCLUSIONS: Our analyses demonstrate the potential of SSA for exploratory health care research. We show how SSA can be used on insurance claims data to identify, visualize, and investigate care patterns and their deviations from guideline recommendations.

Regional variation in coronary angiography rates: the association with supply factors and the role of indication: a spatial analysis.

BACKGROUND: Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA. METHODS: We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level. RESULTS: Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI. CONCLUSIONS: The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.

Using social network analysis methods to identify networks of physicians responsible for the care of specific patient populations.

BACKGROUND: Coordinating health care within and among sectors is crucial to improving quality of care and avoiding undesirable negative health outcomes, such as avoidable hospitalizations. Quality circles are one approach to strengthening collaboration among health care providers and improving the continuity of care. However, identifying and including the right health professionals in such meetings is challenging, especially in settings with no predefined patient pathways. Based on the Accountable Care in Germany (ACD) project, our study presents a framework for and investigates the feasibility of applying social network analysis (SNA) to routine data in order to identify networks of ambulatory physicians who can be considered responsible for the care of specific patients. METHODS: The ACD study objectives predefined the characteristics of the networks. SNA provides a methodology to identify physicians who have patients in common and ensure that they are involved in health care provision. An expert panel consisting of physicians, health services researchers, and data specialists examined the concept of network construction through informed decisions. The procedure was structured by five steps and was applied to routine data from three German states. RESULTS: In total, 510 networks of ambulatory physicians met our predefined inclusion criteria. The networks had between 20 and 120 physicians, and 72% included at least ten different medical specialties. Overall, general practitioners accounted for the largest proportion of physicians in the networks (45%), followed by gynecologists (10%), orthopedists, and ophthalmologists (5%). The specialties were distributed similarly across the majority of networks. The number of patients this study allocated to the networks varied between 95 and 45,268 depending on the number and specialization of physicians per network. CONCLUSIONS: The networks were constructed according to the predefined characteristics following the ACD study objectives, e.g., size of and specialization composition in the networks. This study shows that it is feasible to apply SNA to routine data in order to identify groups of ambulatory physicians who are involved in the treatment of a specific patient population. Whether these doctors are also mainly responsible for care and if their active collaboration can improve the quality of care still needs to be examined.

Development of indicators to assess quality and patient pathways in interdisciplinary care for patients with 14 ambulatory-care-sensitive conditions in Germany.

BACKGROUND: In settings like the ambulatory care sector in Germany, where data on the outcomes of interdisciplinary health services provided by multiple office-based physicians are not always readily available, our study aims to develop a set of indicators of health care quality and utilization for 14 groups of ambulatory-care-sensitive conditions based on routine data. These may improve the provision of health care by informing discussions in quality circles and other meetings of networks of physicians who share the same patients. METHODS: Our set of indicators was developed as part of the larger Accountable Care in Deutschland (ACD) project using a pragmatic consensus approach. The six stages of the approach drew upon a review of the literature; the expertise of physicians, health services researchers, and representatives of physician associations and statutory health insurers; and the results of a pilot study with six informal network meetings of office-based physicians who share the same patients. RESULTS: The process resulted in a set of 248 general and disease specific indicators for 14 disease groups. The set provides information on the quality of care provided and on patient pathways, covering patient characteristics, physician visits, ambulatory care processes, pharmaceutical prescriptions and outcome indicators. The disease groups with the most indicators were ischemic heart diseases, diabetes and heart failure. CONCLUSION: Our set of indicators provides useful information on patients' health care use, health care processes and health outcomes for 14 commonly treated groups of ambulatory-care-sensitive conditions. This information can inform discussions in interdisciplinary quality circles in the ambulatory sector and foster patient-centered care.

Routine data-based quality indicators for the treatment of gonarthrosis and coxarthrosis patients in the ambulatory care sector - A study protocol for a cluster-randomised pilot trial to evaluate the MobilE-ARTH study.

BACKGROUND: In 2019, Germany had the highest rate of hip replacement surgery and the fourth highest rate of knee replacement surgery among more than 30 OECD countries. The age-standardised rates were estimated at 174 hip joint and 137 knee joint replacements per 100,000 population. Against this background, the contrast between financial incentives for surgery and missing incentives for non-surgical treatment options is repeatedly discussed. Quality indicators (QIs) can serve to measure and transparently present the quality of evidence-based care. Comparing results in the form of audit and feedback has been shown to improve e.g. guideline-compliant ambulatory care. Existing QIs targeting the care of gon- and coxarthrosis mainly focus on discharge management after joint replacement surgery and/or require additional data collection. Therefore, as part of the MobilE-ARTH project, a set of QIs for ambulatory care prior to joint replacement surgery calculable based on routine data is being developed. The present study's aim is to evaluate the impact of this QI set in terms of providing feedback on the quality of care. METHODS: The MobilE-ARTH project comprises (Phase 1) developing a QI set following the RAND/UCLA Appropriateness Method, (Phase 2) implementing the QIs in established physician networks of a German statutory health insurance (SHI) within a prospective, non-blinded, cluster-randomised pilot study, and (Phase 3) evaluating the QI set's effectiveness. The physicians in the intervention networks will (a) receive feedback reports providing information about the routine data-based QIs of their gon- and/or coxarthrosis patients and aggregated results for their network, and (b) be invited to two voluntary, facilitated network meetings. In these network meetings, the physicians can use the information provided on the feedback reports to discuss multiprofessional care pathways for patients with gon- and/or coxarthrosis. Selected indicators of the QI set will serve as primary and secondary outcome measures. Routine data will be analysed within multi-level models using an intention-to-treat approach. DISCUSSION: Feedback reports help maintaining clinical standards and closing the gap between evidence and medical practice, thus enabling an overall improvement in health care. Providing physicians with QI-based information on quality of care promotes identifying strengths and weaknesses in medical treatments. TRIAL REGISTRATION: German Clinical Trials Register, number DRKS00027516 , Registered 25th January 2022 - Prospectively registered.

Special orthopaedic geriatrics (SOG) - a new multiprofessional care model for elderly patients in elective orthopaedic surgery: a study protocol for a prospective randomized controlled trial of a multimodal intervention in frail patients with hip and knee replacement.

BACKGROUND: Due to demographic change, the number of older people in Germany and worldwide will continue to rise in the coming decades. As a result, the number of elderly and frail patients undergoing total hip and knee arthroplasty is projected to increase significantly in the coming years. In order to reduce risk of complications and improve postoperative outcome, it can be beneficial to optimally prepare geriatric patients before orthopaedic surgery and to provide perioperative care by a multiprofessional orthogeriatric team. The aim of this comprehensive interventional study is to assess wether multimorbid patients can benefit from the new care model of special orthopaedic geriatrics (SOG) in elective total hip and knee arthroplasty. METHODS: The SOG study is a registered, monocentric, prospective, randomized controlled trial (RCT) funded by the German Federal Joint Committee (GBA). This parallel group RCT with a total of 310 patients is intended to investigate the specially developed multimodal care model for orthogeriatric patients with total hip and knee arthroplasty (intervention group), which already begins preoperatively, in comparison to the usual orthopaedic care without orthogeriatric co-management (control group). Patients ≥70 years of age with multimorbidity or generally patients ≥80 years of age due to increased vulnerability with indication for elective primary total hip and knee arthroplasty can be included in the study. Exclusion criteria are age < 70 years, previous bony surgery or tumor in the area of the joint to be treated, infection and increased need for care (care level ≥ 4). The primary outcome is mobility measured by the Short Physical Performance Battery (SPPB). Secondary outcomes are morbidity, mortality, postoperative complications, delirium, cognition, mood, frailty, (instrumental) activities of daily living, malnutrition, pain, polypharmacy, and patient reported outcome measures. Tertiary outcomes are length of hospital stay, readmission rate, reoperation rate, transfusion rate, and time to rehabilitation. The study data will be collected preoperative, postoperative day 1 to 7, 4 to 6 weeks and 3 months after surgery. DISCUSSION: Studies have shown that orthogeriatric co-management models in the treatment of hip fractures lead to significantly reduced morbidity and mortality rates. However, there are hardly any data available on the elective orthopaedic care of geriatric patients, especially in total hip and knee arthroplasty. In contrast to the care of trauma patients, optimal preoperative intervention is usually possible. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024102. Registered on 19 January 2021.

Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial.

BACKGROUND: Mental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD). METHODS: This pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention "ImPuls", among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block-randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios. DISCUSSION: Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (ID: DRKS00024152 , 05/02/2021).

Implementation of an integrated care programme to avoid fragility fractures of the hip in older adults in 18 Bavarian hospitals - study protocol for the cluster-randomised controlled fracture liaison service FLS-CARE.

BACKGROUND: The economic and public health burden of fragility fractures of the hip in Germany is high. The likelihood of requiring long-term care and the risk of suffering from a secondary fracture increases substantially after sustaining an initial fracture. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are well-recognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. Therefore, the aim of the study FLS-CARE is to evaluate whether a coordinated care programme can close the prevention gap for patients suffering from a fragility hip fracture through the implementation of systematic diagnostics, a falls prevention programme and guideline-adherent interventions based on the Fracture Liaison Services model. METHODS: The study is set up as a non-blinded, cluster-randomised, controlled trial with unequal cluster sizes. Allocation to intervention group (FLS-CARE) and control group (usual care) follows an allocation ratio of 1:1 using trauma centres as the unit of allocation. Sample size calculations resulted in a total of 1216 patients (608 patients per group distributed over 9 clusters) needed for the analysis. After informed consent, all participants are assessed directly at discharge, after 3 months, 12 months and 24 months. The primary outcome measure of the study is the secondary fracture rate 24 months after initial hip fracture. Secondary outcomes include differences in the number of falls, mortality, quality-adjusted life years, activities of daily living and mobility. DISCUSSION: This study is the first to assess the effectiveness and cost-effectiveness/utility of FLS implementation in Germany. Findings of the process evaluation will also shed light on potential barriers to the implementation of FLS in the context of the German healthcare system. Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention. TRIAL REGISTRATION: German Clinical Trial Register (DRKS) 00022237 , prospectively registered 2020-07-09.

[New Forms of Cooperation Between The Outpatient and Inpatient Sectors: An Innovative Funding Concept]. / Neue Formen der Zusammenarbeit im ambulanten und stationären Sektor: ein innovatives Förderkonzept.

INTRODUCTION: Continuity in information and care at the interface between inpatient and outpatient sectors is not always guaranteed. The aim of the study was to develop a funding concept to improve transitional situations such as admission and discharge from inpatient care and to meet the coordination needs of patients with complex diseases or multiple risk factors. METHODOLOGY: Conceptual foundations to support cross-sectoral cooperation were developed by the Bavarian State Working Group on Health Services Research (LAGeV). RESULTS: New forms of cooperation in the outpatient and inpatient sectors should promote intersectoral care networks and modules to foster patient-centered communication and coordination of care. This includes setting up case management systems to support coordination at sectoral interfaces. In the present study, the following modules are explained in more detail: integrated care paths, discharge management, inter-sectoral quality circles, structured pharmacotherapy, involvement of the nursing and rehabilitation sector, and health promotion and prevention. Finally, the importance of systematic and comparative evaluation of the intersectoral networks is discussed. CONCLUSION: To provide effective impulses for the improvement of intersectoral cooperation, a funding concept should include targeted modules to improve patient-centered care at the interface between the inpatient and outpatient sectors. Systematic evaluation should be compulsory, using both generic quality indicators and network-specific targets.

[DNVF Memorandum Health Literacy (Part 1) - Background, Relevance, Research Topics and Questions in Health Services Research]. / DNVF Memorandum Gesundheitskompetenz (Teil 1) ­ Hintergrund, Relevanz, Gegenstand und Fragestellungen in der Versorgungsforschung.

More than half of the German population has difficulties in dealing with health information. It is an important task of health services research to examine how healthcare professionals and health care organizations can meet this challenge. The DNVF Memorandum Health Literacy (Part 1) defines the terms of individual and organizational health literacy, presents the national and international state of research and ethical aspects of health literacy research in health care settings. The relevance of health literacy research is worked out in different phases of life, for different target groups and in different healthcare contexts. Central research topics and future research desiderata are derived.

[DNVF Memorandum Health Literacy (Part 1) - Background, Relevance, Research Topics and Questions in Health Services Research: Short Version]. / DNVF Memorandum Gesundheitskompetenz (Teil 1) ­ Hintergrund, Relevanz, Gegenstand und Fragestellungen in der Versorgungsforschung: Kurzfassung.

More than half of the German population has difficulties in dealing with health information. It is an important task of health services research to examine how healthcare professionals and health care organizations can meet this challenge. This short version of the DNVF Memorandum Health Literacy (Part 1) defines the terms of individual and organizational health literacy, presents the national and international state of research and ethical aspects of health literacy research in health care settings. Central research topics and future research desiderata are derived.

Ambulatory care-sensitive emergency department cases: a mixed methods approach to systemize and analyze cases in Germany.

BACKGROUND: Internationally, emergency departments (ED) are treating increasing numbers of patients with conditions that could have been managed appropriately in ambulatory care (AC) settings. The aim of our study was to develop the first consensus-based list of AC-sensitive conditions commonly seen in German EDs and explore predictors of these visits. METHODS: Our study used a Delphi survey of 30 physicians to compile a list of conditions they agreed were amenable to AC treatment. The group identified reasons why patients visit EDs instead of AC. We used the results to inform spatial regression models analysing the association of patient characteristics and attributes of AC with AC-sensitive ED visits based on 2015 district-level data. RESULTS: Our study provides a list of AC-sensitive conditions based on the German ED context. Results suggest that, up to the age of 70 years, the older the patients, the less likely they seek EDs for these conditions. Results of our regression analyses suggest that AC-sensitive ED rates were significantly higher in districts with lower physician density. Patients' urgency perception and preferences were identified as main drivers of AC-sensitive ED visits. CONCLUSION: Future policy measures should aim to help guide patients through the healthcare system so that they receive the best care in place that is most appropriate in terms of quality, safety and continuity of care. A list of AC-sensitive ED conditions can be used as a monitoring instrument and for further analyses of routine data to inform policy makers seeking to improve resource use and allocation.