[The MDK Reform Act and its effect on outpatient potential : Risk or opportunity for urology?] / Das MDK-Reformgesetz und seine Auswirkungen auf das ambulante Potenzial : Risiko oder Chance für die Urologie?

BACKGROUND: With the introduction of the MDK (Medizinischer Dienst der Krankenversicherung) Reform Act, there have been multiple new regulations for hospitals, some of which are confusing and interact with one another. A major focus of the legal changes is directly or indirectly on expanding the provision of outpatient services. OBJECTIVES: It can be assumed that-as a result of the new version of the framework conditions and the AOP catalog-the relevant OPS list will be expanded in the future. With the revision of the AOP catalog and the effects of the MDK Reform Act, the number of cases with outpatient potential will increase. Can the effects and challenges for hospitals and especially urology be identified? METHODS: Evaluation of official statistics of inpatient and outpatient treatments. Focusing on the problem based on a fictitious practical example from urology. RESULTS: A strategy is developed for dealing with cases with outpatient potential and identification of different solutions to compensate for this shift in services and enabling an increase in performance or a deliberate reduction in the provision of services. CONCLUSIONS: The choice of the type of service provision is increasingly no longer an issue, and the short-term inpatient treatment of many urological cases is coming under considerable pressure due to political measures such as the MDK Reform Act and the demands of health insurance companies. The reduction of different parts of the inpatient reimbursement for special patient groups must be anticipated. Individual strategies will range from simply not providing outpatient services to complex models of cooperation. This change also means opportunities for hospitals!

Effect of everolimus on skin lesions in patients treated for subependymal giant cell astrocytoma and renal angiomyolipoma: final 4-year results from the randomized EXIST-1 and EXIST-2 studies.

BACKGROUND: Tuberous sclerosis complex (TSC) is a genetic disorder associated with tumour growth in various organs, including the brain, kidneys, heart and skin. Cutaneous lesions are prevalent manifestations of TSC, occurring in up to 90% of patients. Oral mammalian target of rapamycin inhibitors, such as everolimus, is believed to be effective for treatment of TSC-associated lesions because they act on the underlying disease pathophysiology. OBJECTIVE: We evaluated the long-term effect of oral everolimus on TSC-associated skin lesions as a secondary objective in the phase III studies EXIST-1 (NCT00789828) and EXIST-2 (NCT00790400) after approximately 4 years of treatment. MATERIALS AND METHODS: Everolimus was dosed 4.5 mg/m2 /day (titrated to trough 5-15 ng/mL) in patients with TSC-associated subependymal giant cell astrocytoma in EXIST-1, and 10 mg/day initially in adult patients with TSC- or sporadic lymphangioleiomyomatosis-associated renal angiomyolipoma in EXIST-2. Following positive results from the core phase, remaining patients were offered open-label everolimus in an extension. Skin lesion response rate was the proportion of patients achieving complete or partial clinical response. RESULTS: A total of 105 patients in EXIST-1 and 107 in EXIST-2 received everolimus and had ≥1 skin lesion at baseline. Skin lesion response rate (95% confidence interval) was 58.1% (48.1-67.7%) in EXIST-1 and 68.2% (58.5-76.9%) in EXIST-2; most were partial responses. At week 192 (EXIST-1: n = 55; EXIST-2: n = 56), 69% and 66% had a response. Most common drug-related adverse event was stomatitis (41-45%). CONCLUSION: Oral everolimus improved TSC-related skin lesions, with responses sustained over 4 years of treatment in EXIST-1 and EXIST-2.

[The cost estimator in the TraumaRegister DGU]. / Der Kostenschätzer im TraumaRegister DGU®.

BACKGROUND AND OBJECTIVES: Estimated treatment costs of severely injured patients were often added to registry-based analyses. In the past, the TraumaRegister DGU® used a modular cost estimator for this purpose. A recent research project initiated by the German Trauma Society (DGU) evaluated the reimbursement of severely injured patients in the German DRG system. This project also allowed the generation of an improved update of the registry's cost estimator. METHODS: Detailed cost data for the acute therapy of severely injured patients were available from 10 hospitals that also participate in the TraumaRegister DGU®. Cost and registry data were matched using hospital code, date of admission, age, sex, and length of stay. A multivariate regression analysis with hospital costs as dependent variable included patients with an injury severity score (ISS) ≥ 9 points who stayed in hospital at least three days. All injuries were coded using the abbreviated injury scale (AIS). A total of 1002 patients treated in 2007 and 2008 were successfully matched. Cost data was collected for each case according to the method of calculation provided by the German DRG Institute (InEK). RESULTS: The mean age was 44 years and 73 % were males; the mean ISS was 27 points. The following aspects were significantly associated with the overall hospital costs: length of stay on the intensive care unit (ICU) (1152 € per day); length on intubation/ventilation (568 € per day); length of stay on normal ward (531 € per day); number of blood products (packed red blood cells; fresh frozen plasma) transfused until ICU admission (258 € per unit); a serious abdominal injury (AIS ≥3; 2849 €); an instable pelvic fracture with relevant blood loss (AIS 5; 7505 €); and a serious injury of the extremities (AIS 3-4; 2418 €). The estimated overall treatment costs calculated by the above mentioned formula averaged 22,138 € per case. The deviation from the measured real costs (21,546 € per case) was less than 3 %. CONCLUSION: Using only key data available for all patients in the registry, a valid cost estimator for acute care costs is now available in the TraumaRegister DGU®.

Meta-analysis of stomatitis in clinical studies of everolimus: incidence and relationship with efficacy.

BACKGROUND: Everolimus, an oral mammalian target of rapamycin (mTOR) inhibitor, is used to treat solid tumors and tuberous sclerosis complex (TSC). Stomatitis, an inflammation of the mucous membranes of the mouth, is a common adverse event associated with mTOR inhibitors, including everolimus. We conducted a meta-analysis of data from seven randomized, double-blind phase 3 clinical trials of everolimus to determine the clinical impact of stomatitis on efficacy and safety. PATIENTS AND METHODS: Data were pooled from the safety sets of solid tumor [breast cancer (BOLERO-2 and BOLERO-3), renal cell carcinoma (RECORD-1), carcinoid tumors (RADIANT-2), and pancreatic neuroendocrine tumors (RADIANT-3)] and TSC studies (EXIST-1 and EXIST-2). Data from solid tumor trials and TSC trials were analyzed separately. RESULTS: The rate of stomatitis was 67% in the solid tumor trials (973/1455 patients) and 70% in the TSC trials (110/157 patients). Most stomatitis events were grade 1/2, with grade 3/4 events reported in only 9% (solid tumor trials) and 8% (TSC trials) of patients. Low TSC patient numbers prevented an in-depth evaluation of stomatitis and response. In the solid tumor trials, most first stomatitis episodes (89%; n = 870) were observed within 8 weeks of starting everolimus. Patients with stomatitis occurring within 8 weeks of everolimus initiation had longer progression-free survival (PFS) than everolimus-treated patients without stomatitis in BOLERO-2 {8.5 versus 6.9 months, respectively; hazard ratio (HR), 0.78 [95% confidence interval (CI), 0.62-1.00]} and RADIANT-3 [13.9 versus 8.3 months, respectively; HR, 0.70 (95% CI, 0.48-1.04)]. A similar trend was observed in RECORD-1 [HR, 0.90 (95% CI, 0.66-1.22)] and RADIANT-2 [HR, 0.87 (95% CI, 0.61-1.22)] but not in BOLERO-3 [HR, 1.01 (95% CI, 0.75-1.36)]. CONCLUSIONS: Stomatitis did not adversely affect PFS, supporting the administration of everolimus in accordance with standard management guidelines.

[Quality of case allocation of orthopedics and trauma surgery in the 2004 and 2014 versions of the German DRG system. An interim assessment of the development process]. / Abbildung orthopädisch-unfallchirurgischer Leistungen in den G-DRG-Systemversionen 2004 und 2014. Eine Zwischenbilanz des Weiterentwicklungsprozesses.

BACKGROUND: Since 2004 the German diagnosis-related groups (DRG) system has been applied nationwide in all German somatic hospitals. The G-DRG system is updated annually in order to increase the quality of case allocation. What developments have occurred since 2004 from the perspective of orthopedics and trauma surgery? This article takes stock of the developments between 2004 and 2014. METHODS: Analysis of relevant diagnoses, medical procedures and G-DRGs in the versions 2004 and 2014 based on the publications of the German DRG Institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI). RESULTS: The number of G-DRGs in the whole system increased by 45.1 % between 2004 and 2014. The number of G-DRGs in the major diagnostic category (MDC) 08 that contains the majority of orthopedic and trauma surgery categories increased in the same period by 61.6 %. The reduction of variance of inlier costs in the MDC 08 category, a statistical measure of the performance of the G-DRG system, was below the corresponding value of the total system in 2004 as well in 2014. However, the reduction of variance of inlier costs in MDC 08 (+ 30.0 %) rose more from 2004 to 2014 than the corresponding value of the overall system (+ 21.5 %). CONCLUSION: Many modifications of the classification systems of diagnoses (ICD-10-GM) and medical procedures (OPS) and the structures of the G-DRG system could significantly improve the quality of case allocation from the perspective of orthopedics and trauma surgery between 2004 and 2014. Th assignment of cases could be differentiated so that complex cases with more utilization of resources were allocated to higher rated G-DRGs and vice versa. However, further improvements of the G-DRG system are necessary. Only correct and complete documentation and coding can provide a high quality of calculation of costs as a basis for a correct case allocation in future G-DRG systems.

[Bone substitutes - basic principles and clinical applications]. / Knochenersatzmaterialien - Grundlagen und klinischer Nutzen.

Treatment of bone defects and non-unions frequently requires the transplantation of autologous bone. As an alternative, different kinds of bone substitutes have been used more often during the past years. These bone substitutes include synthetic materials, just as well as processed materials from human donors (allogen) or animals (xenogen). The relatively low hurdles in the approval process, compared to pharmaceutical drugs, have led to an almost unmanageable amount of different kinds of bone substitutes. Due to sparse clinical studies, evidence-based decisions for a specific product or a specific indication are hardly possible. Therefore, a deeper knowledge about basic properties of different bone substitutes is needed for a rational clinical decision. The present review aims to clarify the sometimes confusing nomenclature of bone substitutes and discuss their different biological properties. Generally, bone substitutes can be discriminated in osteogenic, osteoinductive and osteoconductive materials. The great majority of bone substitutes and especially synthetic materials serve as a matrix for bone growth and therefore possess mainly osteoconductive properties. The combination of these osteoconductive materials with osteogenic cells or osteoinductive growth factors, leads to composite materials with higher bone forming potential. Clinically, the quality and vitality of the recipient bone defect is of great importance. As a prerequisite for successful transplantation of bone substitutes or autologous bone, the recipient bone defect should be mechanically stable, free of infection with vital bone ends and intact soft tissue coverage. Bone defects in the spine, methaphyseal defects after trauma/tumour and diaphyseal segmental defects are typical indications for the application of bone substitutes. Unfortunately, the current literature does not allow concrete recommendations for specific bone substitutes or specific clinical indications. However, this review aims to discuss clinical benefits and limitations of bone substitutes for frequent indications to help clinicians in their decision making process.

Magnetic resonance imaging of less common pancreatic malignancies and pancreatic tumors with malignant potential.

Pancreatic tumors are an increasingly common finding in abdominal imaging. Various kinds of pathologies of the pancreas are well known, but it often remains difficult to classify the lesions radiologically in respect of type and grade of malignancy. Magnetic resonance imaging (MRI) is the method of choice for the evaluation of pancreatic pathologies due to its superior soft tissue contrast. In this article we present a selection of less common malignant and potentially malignant pancreatic neoplasms with their characteristic appearance on established MRI sequences with and without contrast enhancement.

[Description of the severely injured in the DRG system: is treatment of the severely injured still affordable?]. / Abbildung von Schwerverletzten im DRG-System : Wird die Schwerverletztenversorgung doch bezahlbar?

BACKGROUND: Due to the heterogeneity of severely injured patients (multiple trauma) it is difficult to assign them to homogeneic diagnosis-related groups (DRG). In recent years this has led to a systematic underfunding in the German reimbursement system (G-DRG) for cases of multiply injured patients. This project aimed to improve the reimbursement by modifying the case allocation algorithms of multiply injured patients within the G-DRG system. METHODS: A retrospective analysis of standardized G-DRG data according to §21 of the Hospital Reimbursement Act (§ 21 KHEntgG) including case-related cost data from 3,362 critically injured patients from 2007 and 2008 from 10 university hospitals and 7 large municipal hospitals was carried out. For 1,241 cases complementary detailed information was available from the trauma registry of the German Trauma Society to monitor the case allocation of multiply injured patients within the G-DRG system. Analysis of coding and grouping, performance of case allocation and the homogeneity of costs in the G-DRG versions 2008-2012 was carried out. RESULTS: The results showed systematic underfunding of trauma patients in the G-DRG version 2008 but adequate cost covering in the majority of cases with the G-DRG versions 2011 and 2012. Cost coverage was foundfor multiply injured patients from the clinical viewpoint who were identified as multiple trauma by the G-DRG system. Some of the overfunded trauma patients had high intensive care costs. Also there was underfunding for multiple injured patients not identified as such in the G-DRG system. CONCLUSIONS: Specific modifications of the G-DRG allocation structures could increase the appropriateness of reimbursement of multiply injured patients. Data-based analysis is an essential prerequisite for a constructive development of the G-DRG system and a necessary tool for the active participation of medical specialist societies.

[Orthopedic and trauma surgery in the German DRG system. Recent developments]. / Orthopädie und Unfallchirurgie im deutschen DRG-System. Aktuelle Entwicklungen.

BACKGROUND: Orthopedics and trauma surgery are subject to continuous medical advancement. The correct and performance-based case allocation by German diagnosis-related groups (G-DRG) is a major challenge. This article analyzes and assesses current developments in orthopedics and trauma surgery in the areas of coding of diagnoses and medical procedures and the development of the 2012 G-DRG system. METHODS: The relevant diagnoses, medical procedures and G-DRGs in the versions 2011 and 2012 were analyzed based on the publications of the German DRG Institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI). RESULTS: Changes were made for the International Classification of Diseases (ICD) coding of complex cases with medical complications, the procedure coding for spinal surgery and for hand and foot surgery. The G-DRG structures were modified for endoprosthetic surgery on ankle, shoulder and elbow joints. The definition of modular structured endoprostheses was clarified. CONCLUSION: The G-DRG system for orthopedic and trauma surgery appears to be largely consolidated. The current phase of the evolution of the G-DRG system is primarily aimed at developing most exact descriptions and definitions of the content and mutual delimitation of operation and procedures coding (OPS). This is an essential prerequisite for a correct and performance-based case allocation in the G-DRG system.

Gestational immune activation and Tsc2 haploinsufficiency cooperate to disrupt fetal survival and may perturb social behavior in adult mice.

Approximately 40-50% of individuals affected by tuberous sclerosis (TSC) develop autism spectrum disorders (ASDs). One possible explanation for this partial penetrance is an interaction between TSC gene mutations and other risk factors such as gestational immune activation. In this study, we report the interactive effects of these two ASD risk factors in a mouse model of TSC. Combined, but not single, exposure had adverse effects on intrauterine survival. Additionally, provisional results suggest that these factors synergize to disrupt social approach behavior in adult mice. Moreover, studies in human populations are consistent with an interaction between high seasonal flu activity in late gestation and TSC mutations in ASD. Taken together, our studies raise the possibility of a gene × environment interaction between heterozygous TSC gene mutations and gestational immune activation in the pathogenesis of TSC-related ASD.

[Heterogeneity of costs and performance for penetrating eye injuries and suturing amniotic membranes under DRG conditions : Analysis of case constellations of the G-DRG C01B of the Regensburg University eye clinic]. / Kosten- und Leistungsheterogenität bei penetrierenden Augenverletzungen und Amnionmembranaufnähungen unter DRG-Bedingungen : Analyse von Fallkonstellationen der G-DRG C01B der Universitätsaugenklinik Regensburg.

BACKGROUND: Patients with penetrating eye injuries are a very heterogeneous group both medically and economically. Since 2009, treatment involving sutures for open eye injuries and cases requiring amniotic membrane transplantation (AMT) were allocated to DRG C01B of the German diagnosis-related group system. However, given the significant clinical differences between these treatments, an inhomogeneity of costs to performance is postulated. This analysis describes case allocation problems within the G-DRG C01B category and presents solutions. METHODS: A retrospective analysis was conducted from the standardized G-DRG data of 277 patients with open eye injuries and AMT between 2007 and 2008, grouped under the 2008 G-DRG system version to the G-DRG C01Z category. This data was provided by the Department of Ophthalmology at the University Hospital Regensburg. Additionally case-based data of the following were supplemented: length of surgery, time of anesthesia and intensity of patient care. Fixed and variable costs were determined for surgery and other inpatient treatment. Finally, an analysis of the heterogeneity of costs within the G-DRG C01B of the G-DRG system 2009 was implemented. RESULTS: Inhomogeneity was evident within the G-DRG C01B of the G-DRG system 2009 for the two groups suture of open eye injuries and AMT concerning the parameters length of stay, proportion of high outliers and cost per case. Multiple surgeries during an inpatient stay lead to an extended length of stay and increasing costs, especially within the AMT group. Intensity of patient care and the consideration of patient comorbidity did not yield relevant differences. CONCLUSION: The quality of the G-DRG system is measured by its ability to obtain adequate funding for highly complex and heterogeneous cases. Specific modifications of the G-DRG structures could increase the appropriateness of case allocation for patients with open eye injuries within the G-DRG C01B of the German DRG system 2009. As a result of the present study, cases with amniotic membrane transplantation should not be allocated to the G-DRG C01B. A petition has been presented by the German Association of Ophthalmology (DOG) to the German DRG Institute to restructure the G-DRG C01B. Data-based analysis is an essential prerequisite for a constructive development of the G-DRG system and a necessary tool for the active participation of medical societies in this process.

[Financing of inpatient orthopaedics and trauma surgery in the 2011 G-DRG System]. / Finanzierung der stationären Orthopädie und Unfallchirurgie im G-DRG-System 2011.

BACKGROUND: The German DRG system forms the basis for billing inpatient hospital services. It includes not only the case groups (G-DRGs), but also copayments. This paper analyses and evaluates the relevant developments of the 2011 G-DRG system for orthopaedics and traumatology from the medical and classificatory perspective. METHODS: An analysis was performed of relevant diagnoses, medical procedures and G-DRGs in the 2010 and 2011 versions based on the publications of the German DRG Institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI). RESULTS: A number of codes for surgical measures have been newly established or modified - above all in foot surgery, arthroscopic surgery and wound surgery. Here, the identification and the correct and performance-based mapping of complex and elaborate scenarios was again the focus of the restructuring of the G-DRG system. The G-DRG structure in orthopaedics and traumatology is changed, especially for polytraumata. CONCLUSION: The allocation of common cases with a standardized treatment pattern appears to be appropriate and the reimbursement adequate. For the less common and more complex cases the 2011 G-DRG system still shows need for further modification (e.g. polytraumata, joint replacement, spine surgery). The proper integration of the modified OPS classification for foot surgery to the appropriate G-DRGs will be essential to maintain the high quality of the reimbursement structure for the future.

[Financing of inpatient orthopedics and trauma surgery in the G-DRG system 2010]. / Finanzierung der stationären Orthopädie und Unfallchirurgie im G-DRG-System 2010.

BACKGROUND: The German DRG (diagnosis-related groups) system forms the basis for billing inpatient hospital services. It includes not only the case groups (G-DRGs), but also additional and innovation payments. This paper analyzes and evaluates the relevant developments of the G-DRG System 2010 for orthopedics and traumatology from the medical and classification perspectives. METHODS: Analyses of relevant diagnoses, medical procedures and G-DRGs in the versions 2009 and 2010 based on the publications of the German DRG institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI) were carried out. RESULTS: The DRG catalog is has grown from 8 to 1,200 G-DRGs. A number of codes for surgical measures have been newly established or modified. Here, the identification and the correct and performance-based mapping of complex and elaborate scenarios was again the focus of the restructuring of the G-DRG system. The G-DRG structure in orthopedics and traumatology has been changed, especially in the areas of spinal surgery and surgery of the upper and lower extremities. The actual impact of the changes may vary depending on the individual hospital services. CONCLUSION: For the first time since the introduction of the G-DRG system, the pure numerical changes at the level of DRGs themselves are so marginal that only part of the DRG users in the hospitals will register them. The changes implemented not only a high selectivity between complex and less complex scenarios, but partly also unintended and unjustified revaluation of less complex measures. The G-DRG system has gained complexity again. Especially the G-DRG allocation of spinal surgery and multiple surgical interventions of the upper and/or lower extremities have reached such a complexity that only a few DRG users can follow them.

Tuberous sclerosis complex: neurological, renal and pulmonary manifestations.

Tuberous sclerosis complex (TSC) is an important cause of epilepsy and autism, as well as renal and pulmonary disease in adults and children. Affected individuals are subject to hamartomas in various organ systems which result from constitutive activation of the protein kinase mTOR (mammalian target of rapamycin). The clinical course, prognosis and appropriate therapy for TSC patients are often different from that for individuals with epilepsy, renal tumors, or interstitial lung disease, from other causes. Additionally, TSC serves as a model for other conditions in which the mTOR pathways are also up-regulated. This article reviews the molecular pathophysiology and management of neurological, renal and pulmonary manifestations of the disorder. The use of mTOR inhibitors such as rapamycin and everolimus is discussed and recent clinical trials of these drugs in TSC are reviewed.

[Classification of severely injured patients in the G-DRG System 2008]. / Abbildung des schwer verletzten Patienten im G-DRG-System 2008.

BACKGROUND: Since the introduction of a per-case reimbursement system in Germany (German Diagnosis-Related Groups, G-DRG), the correct reimbursement for the treatment of severely injured patients has been much debated. While the classification of a patient in a polytrauma DRG follows different rules than the usual clinical definition, leading to a high number of patients not grouped as severely injured by the system, the system was also criticized in 2005 for its shortcomings in financing the treatment of severely injured patients. The development of financial reimbursement will be discussed in this paper. METHOD: 167 patients treated in 2006 and 2007 due to a severe injury at the University-Hospital Münster and grouped into a polytrauma-DRG were included in this study. For each patient, cost-equivalents were estimated. For those patients treated in 2007 (n=110), exact costs were calculated following the InEK cost-calculation method. The reimbursement was calculated using the G-DRG-Systems of 2007, 2008 and 2009. Cost-equivalents/costs and clinical parameters were correlated. RESULTS: A total of 167 patients treated in 2006 and 2007 for a severe injury at the Münster University Hospital and grouped into a polytrauma DRG were included in this study. Cost equivalents were estimated for each patient. For those patients treated in 2007 (n=110), exact costs were calculated following the InEK (Institute for the Hospital Remuneration System) cost calculation method. Reimbursement was calculated using the G-DRG systems of 2007, 2008 and 2009. Cost equivalents/costs and clinical parameters were correlated. DISCUSSION: With the ongoing development of the G-DRG system, reimbursement for the treatment of severely injured patient has improved, but the amount of underfinancing remains substantial. As treatment of severely injured patients must be reimbursed using the G-DRG system, this system must be further adapted to better meet the needs of severely injured patients. Parameters such as total surgery time, injury severity score (ISS) and LOS in ICU could be used for this purpose. In future, data obtained in trauma networks can help optimize reimbursement for the treatment of these patients.

[Orthopedic and trauma surgery in the German-DRG-System 2009]. / Orthopädie und Unfallchirurgie im G-DRG-System 2009.

BACKGROUND: The German DRG-System was advanced into version 2009. For orthopedic and trauma surgery significant changes concerning coding of diagnoses, medical procedures and concerning the DRG-structure were made. METHODS: Analysis of relevant diagnoses, medical procedures and G-DRGs in the versions 2008 and 2009 based on the publications of the German DRG-institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI). RESULTS: Changes for 2009 focussed on the development of DRG-structure, DRG-validation and codes for medical procedures to be used for very complex cases. The outcome of these changes for German hospitals may vary depending in the range of activities. CONCLUSION: G-DRG-System gained complexity again. High demands are made on correct and complete coding of complex orthopedic and trauma surgery cases. Quality of case-allocation within the G-DRG-System was improved. Nevertheless, further adjustments of the G-DRG-System especially for cases with severe injuries are necessary.