Quality assurance and improvement in oncology using guideline-derived quality indicators - results of gynaecological cancer centres certified by the German cancer society (DKG).

PURPOSE: Based on the example of Gynaecological Cancer Centres (GCCs) certified by the German Cancer Society, this study evaluates the results of medical-guideline-derived quality indicators (QIs) for cervical cancer (CC) and ovarian cancer (OC), examines the development of indicator implementation over time as well as the status of guideline-compliant care and identifies improvement measures. METHODS: QI results for patients with CC and OC treated in GCCs between 2015 and 2019 are analysed. The median, overall proportion and standard deviation of each QI were calculated. Two-sided Cochran-Armitage tests were applied. RESULTS: QIs are divided into two categories: process-organization (PO-QIs) and treatment-procedures (TP-QIs), to allow a differentiated analysis for identifying improvement measures. PO-QIs that reflect the implementation of processes and structures show a high degree of application. PO-QIs have a tremendous influence on the quality of care and are easy to implement through SOPs. TP-QIs report on treatments that are performed in the GCC. TP-QIs that report on systemic therapies reach a plateau where the guideline is known, but patient-related-factors meaningfully prevent further increase. TP-QIs that report on surgical interventions fluctuate. The most relevant factors are practitioners' personal skills. Besides the discussion of results amongst peers during the audit, improvement measures could include surgical courses or coaching. CONCLUSION: The analysis shows that a combination of different measures is necessary to anchor quality sustainably in health care and thus improve it.

The role of follicular anti-Mullerian hormone in women undergoing IVF/ICSI with regard to size, oocyte presence, sociodemographic parameters, treatment variables, and other hormones and vitamins.

AIMS: The aim of this study was to evaluate the relationship between follicular anti-Mullerian hormone (fAMH) regarding follicle size, the presence of an oocyte, sociodemographic parameters, and other hormones and vitamins in follicular fluid. MATERIALS AND METHODS: This prospective exploratory cohort study included 376 follicles from 61 women undergoing IVF/ICSI cycles. The size of each follicle was measured individually, and they were divided into a large and a small group according to their size. The presence of oocytes was detected on the day of oocyte retrieval. Sociodemographic factors were documented during the course of preliminary testing. Then, other parameters of patients' serum and follicular fluid were measured. RESULTS: Small follicles contained a significantly higher concentration of fAMH than large ones did. We showed that the presence of an oocyte in a follicle is associated with a significantly higher fAMH level than in those without one (p < .001). There exists a significant but weak correlation between fAMH and the sociodemographic parameter of patients' age (r = -0.11, p < .001). We did not find a correlation with the patients' BMI (r = 0.03, p < .006). We also investigated the connections between fAMH and other parameters, such as vitamin D (r = -0.13, p < .001), LH (r = 0.35, p < .001)), and progesterone (r = -0.21, p < .001) in follicular fluid. CONCLUSIONS: This knowledge can be useful for the future development of reproductive medicine. Our results can provide an important building block for this matter.

Pelvic exenteration for recurrent or advanced gynecologic malignancies - Analysis of outcome and complications.

Pelvic exenterations are known to be a last resort therapeutic option for advanced or recurrent gynecologic malignancies, which are known to have poor prognosis. All women treated with anterior (APE) or total (TPE) pelvic exenteration at our University hospital within a five-year period were identified and their data retrospectively analysed. Parameters such as demographic information, tumor type and stage, previous therapy as well as complication rate and overall survival were evaluated. 47 women were enrolled in this study. Most common indication for PE was cervical cancer (51.1%) followed by carcinoma of the vagina (17%), vulva (10.6%), endometrium (8.5%), ovaries (4.3%) and uterus (2.1%). Patients had received 1, 2 or 3 treatment modalities prior in 12.8%, 38.8% and 21.2% respectively. Predominant urinary diversion was ileum conduit (75.5%). Major complications (Clavien Dindo ≥ III) were observed in 40.4%, none in 19.2%. Early mortality was 4.3%. Median Overall Survival (mOS) was 14 months with 2- and 3-year survival rates of 38.8% and 21.2% respectively. After a median follow up of 47 months, 25.5% were still alive. Excluding patients with metastatic disease (n = 10), mOS was 20.6 months with 2- and 3-year survival rates of 46% and 35.2%. OS was significantly worse for patients with positive margins (p = 0.003). Receiving neoadjuvant treatment (25.5%) correlated with negative margins (p = 0.013) but not with overall survival. PE is feasible with acceptable complication and mortality rates. The long-time benefit is notable bearing in mind the extensive nature of the malignancies and the procedure undertaken.

Mission statement from rheumatologists in the German Society of Rheumatology (DGRh e. V.) : We live rheumatology.

Systemic disease demands systemic thinkers. In this mission statement we define rheumatology, describe the role of the German Society of Rheumatology and the rheumatologist's spirit to their discipline. Rheumatologists are dedicated to improving the quality of life of their acute, chronic, and rehabilitative patients on the basis of up to date evidence and strong physician-patient relations. We think, act and interact systemically, scientifically, consistently, transparently, reliably, inclusively, innovatively and enthusiastically.

[Mission statement from rheumatologists in the German Society of Rheumatology (DGRh e. V.) : We live rheumatology. German version]. / Leitbild der Rheumatologinnen und Rheumatologen in der Deutschen Gesellschaft für Rheumatologie e. V. (DGRh e. V.) : Wir sind die Rheumatologie.

Systemic disease demands systemic thinkers. In this mission statement we define rheumatology, describe the role of the German Society of Rheumatology and the rheumatologist's spirit to their discipline. Rheumatologists are dedicated to improving the quality of life of their acute, chronic, and rehabilitative patients on the basis of up to date evidence and strong physician-patient relations. We think, act and interact systemically, scientifically, consistently, transparently, reliably, inclusively, innovatively and enthusiastically.

Cost-effectiveness of social oocyte freezing in Germany: estimates based on a Markov model.

PURPOSE: Is oocyte freezing for non-medical reasons-the so-called "social freezing" (SF)-cost-effective compared to standard in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) in Germany today? METHODS: We developed a model based on three strategies for women planning to postpone pregnancy. In each strategy, women actively practiced contraception until 40 then tried to conceive naturally for 1 year. If unsuccessful, women using strategy I (oocyte cryopreservation) attempted ICSI with frozen oocytes in the 2nd year, while women using strategy II (no action) further attempted natural conception. In strategy III (IVF/ICSI), women underwent 1 year of IVF/ICSI. If still unsuccessful, each strategy was followed by attempting natural conception again until 45. We used an adaptive Markov model to estimate and compare live birth rates and cost-effectiveness measures. RESULTS: For strategy I, cumulative live birth rates at age 45 generally declined with the woman's age at freezing and were between 71.4% (25 years) and 67.6% (38 years), while the cumulative success rate was 51.5% for strategy II and 60.8% for strategy III. The costs per live birth of egg freezing were age-dependent ranging between 22,418 € (30 years) and 25,590 € (38 years). The costs for strategy III were lower at 20,293 € per live birth. CONCLUSION: Based on our results, social freezing in Germany may lead to additional pregnancies among women over 40 but also to significantly higher costs, since given the current live birth success rates and pricing, social freezing does not appear to be cost-effective.

The effects of thin film homogeneity on the performance of ferroelectric tunnel junctions.

The compelling physical properties of the recently discovered ferroelectric phase in thin film Hf x Zr1-x O2 have opened a window for applications such as non-volatile resistive switching memory devices with high retention known as ferroelectric tunnel junctions. In this article, we investigate the stability of these two-terminal, polarization induced resistance-switching devices with respect to the statistical reproducibility of constitutive electrical parameters based on surface thickness inhomogeneities. We provide a straightforward, quantitative model to estimate tunneling currents dependent on thickness variations, and the resulting tunneling electroresistance (TER) ratios and breakdown probability. An analytical expression for the probability distribution of tunneling currents for normally distributed thicknesses is given. Using material parameters of a TiN/HZO/Pt heterostructure, practical design requirements are deduced and an estimation with respect to the surface roughness is given for practical ferroelectric layer thicknesses and voltages below 4 nm and 1 V, respectively. In this regime, the simple model of a ballistic, direct tunneling mechanism can be used to adequately model the thickness and voltage dependence of the resistivity.

[Biologics in rheumatology]. / Biologika in der Rheumatologie.

BACKGROUND: Monoclonal antibodies and fusion proteins were introduced into clinical rheumatology 20 years ago. Nowadays they are an established component of modern internal medical practice. OBJECTIVE: This article gives an overview of the breadth of biologics currently in clinical use. MATERIAL AND METHODS: Evaluation of published approval studies and guideline recommendations, discussion of the immunological principles and targets in the treatment with biologics. RESULTS: Monoclonal antibodies and fusion proteins for influencing cytokine signals, T­cell costimulation and B­cell function are the most important innovations in the treatment of rheumatological diseases. Nowadays they are indispensible for the treatment of moderate and severe disease courses of rheumatoid arthritis, spondylarthropathies and vasculitides. CONCLUSION: Although a cure or permanent freedom from symptoms in rheumatological autoimmune diseases is still not possible, much more favorable disease courses with less long-term limitations can be achieved by the early administration of biologics.

Towards X-ray transient grating spectroscopy.

The extension of transient grating spectroscopy to the x-ray regime will create numerous opportunities, ranging from the study of thermal transport in the ballistic regime to charge, spin, and energy transfer processes with atomic spatial and femtosecond temporal resolution. Studies involving complicated split-and-delay lines have not yet been successful in achieving this goal. Here we propose a novel, simple method based on the Talbot effect for converging beams, which can easily be implemented at current x-ray free electron lasers. We validate our proposal by analyzing printed interference patterns on polymethyl methacrylate and gold samples using ∼3 keV X-ray pulses.

[Revised version of the statement by the DGRh on biosimilars-update 2017]. / Neufassung der Stellungnahme der DGRh zu Biosimilars ­ Update 2017.

The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product. Since 2015, biosimilars of inifliximab, adalimumab, etanercept and rituximab have been granted approval in the European Union, the USA, Japan and in other countries. Further biosimilar products for these reference products are in development for treatment in rheumatology. From a societal and medical point of view, this opens up the possibility to increase the availability of biopharmaceutical products for patients through lower prices. In Germany, this possibility has already occurred-statutory health insurance physicians have introduced quotas for biosimilars, which will ultimately decrease spending and healthcare costs. This can lead to price reductions of the original products, which has already happened in Germany. Biosimilars can be prescribed for new patients or as a change from the original to the generic drug. When switching, a distinction is made between individual switching (interchangeability), which is made in individual consultation between the physician and the patient, and nonmedical switching (substitution) made at the societal or governmental level, which is made in the context of health care cost containment, and then, for example, implemented at the pharmacy level. Preliminary data from Norway and Denmark are available for substitution on the basis of results from large studies or registries in which systematic changes were made. The previous conclusion was that this does not lead to new problems for the patients. The German Society for Rheumatology recognizes the advantages of introducing biosimilars in Germany, but recommends that their use be based primarily on a joint decision by the treating physician and patient.

[Differential diagnostic spectrum of psoriasis vs. psoriatic arthritis in skin and joints]. / Differenzialdiagnostisches Spektrum der Psoriasis versus Psoriasisarthritis an Haut und Gelenken.

Psoriasis and psoriatic arthritis are common disease entities in the daily routine of dermatologists and rheumatologists. The clinical management of the diseases profits tremendously from interdisciplinary contacts and shared decision-making processes. For dermatologists, recognition of early clinical symptoms of inflammatory arthropathies is pivotal. Rheumatologists, on the other hand, are required to make an early assessment of skin and nail changes in patients, since they are important parameters in the clinical classification of inflammatory joint diseases, in particular for the diagnosis of psoriatic arthritis. In patients with psoriasis, lesions on the scalp, in the anal cleft, and nail changes as well as severe generalized skin disease are all regarded as risk factors for psoriatic arthritis. The symptoms of the associated joint and spinal afflictions can vary considerably and confirmation of the diagnosis, in particular in early stages of the disease often represents a considerable challenge. The most common clinical manifestations of psoriasis and psoriatic arthritis and their differential diagnostics are discussed.

Procedures for cryogenic X-ray ptychographic imaging of biological samples.

Biological sample-preparation procedures have been developed for imaging human chromosomes under cryogenic conditions. A new experimental setup, developed for imaging frozen samples using beamline I13 at Diamond Light Source, is described. This manuscript describes the equipment and experimental procedures as well as the authors' first ptychographic reconstructions using X-rays.

Patient preferences for palliative treatment of locally advanced or metastatic gastric cancer and adenocarcinoma of the gastroesophageal junction: a choice-based conjoint analysis study from Germany.

BACKGROUND: Decisions on palliative chemotherapy (CT) for locally advanced or metastatic gastric cancer (mGC) require trade-offs between potential benefits and risks for patients. Healthcare providers and payers agree that patient-preferences should be considered. We conducted a choice-based conjoint (CBC) analysis study in pre-treated patients from Germany with mGC or locally advanced or metastatic adenocarcinoma of the gastroesophageal junction (mGEJ-Ca), to evaluate their preferences when hypothetically selecting a CT regimen. METHODS: German oncologists and gastroenterologists were contacted to identify patients with mGC or mGEJ-Ca who had completed ≥2 cycles of palliative CT in first or later lines of therapy (CT ongoing or complete). The primary objective was to quantify patient preferences for palliative CT by CBC analysis. Six in-depth qualitative interviews identified 3 attributes: treatment tolerability, quality of life in terms of ability of self-care, and additional survival benefit. The CBC matrix was constructed with 4 factor levels per attribute and each participant was presented with 15 different iterations of these levels. A minimum of 50 participants was needed. Consenting patients completed the CBC survey, choosing systematically among profiles. CBC models were estimated by multinomial logistic regression (MLR) and hierarchical Bayesian (HB) analysis. Estimates of importance for each attribute and factor-level were calculated. RESULTS: Fifty-five patients participated in the CBC survey (78.2% male, median age 63 years, 81.8% currently receiving CT). Across this sample, low treatment toxicity was ranked highest (44.6% relative importance, MLR analysis), followed by ability to self-care (32.3%), and an additional survival benefit of up to 3 months (3 months 23.1%, 2 months 18.3%, 1 month 11.2%). The MLR analysis showed high validity (certainty 37.9%, chi square p < 0.01, root-likelihood 0.505). The HB analysis yielded similar results. CONCLUSIONS: Patients' preferences related to a new hypothetical palliative CT of mGC or mGEJ-Ca can be assessed by CBCanalysis. Although in real-life, patients initially need to decide on CT before they have any experience, and patients' varied experiences with CT will have impacted specific responses, low toxicity and self-care ability were considered as most important by this group of patients with mGC or mGEJ-Ca.

Statement of the AGO Kommission Ovar, AGO Study Group, NOGGO, AGO Austria and AGO Switzerland Regarding the Use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer.

The AGO Kommission Ovar already published a statement in 2013, warning about the uncritical use of hyperthermic intraperitoneal chemotherapy (HIPEC) outside controlled studies. This statement has now been updated after the most recent literature was reviewed by AGO Kommission Ovar, the AGO Study Group, NOGGO, AGO Austria and AGO Switzerland. The authors conclude that HIPEC remains experimental. Its use is not recommended and should be rejected outside of prospective controlled trials.

Pushing the limits: an instrument for hard X-ray imaging below 20 nm.

Hard X-ray microscopy is a prominent tool suitable for nanoscale-resolution non-destructive imaging of various materials used in different areas of science and technology. With an ongoing effort to push the 2D/3D imaging resolution down to 10 nm in the hard X-ray regime, both the fabrication of nano-focusing optics and the stability of the microscope using those optics become extremely challenging. In this work a microscopy system designed and constructed to accommodate multilayer Laue lenses as nanofocusing optics is presented. The developed apparatus has been thoroughly characterized in terms of resolution and stability followed by imaging experiments at a synchrotron facility. Drift rates of ∼2 nm h(-1) accompanied by 13 nm × 33 nm imaging resolution at 11.8 keV are reported.

Disease Management Project Breast Cancer in Hesse - 5-Year Survival Data: Successful Model of Intersectoral Communication for Quality Assurance.

Introduction: The Disease Management Project Breast Cancer (DMP Breast Cancer) was first launched in Hesse in 2004. The project is supported by the health insurance companies in Hesse and the Professional Association of Gynaecologists in Hesse. The aim is to offer structured treatment programmes to all women diagnosed with breast cancer in Hesse by creating intersectoral cooperations between coordinating clinics, associated hospitals and gynaecologists in private practice who registered in the DMP programme. Method: Between 1 January 2005 and 30 June 2011, 13 973 women were enrolled in the DMP programme. Results: After data cleansing, survival rates were calculated for a total of 11 214 women. The 5-year overall survival (OS) rate was 86.3 %; survival rates according to tumour stage on presentation were 92.2 % (pT1) and 82.3 % (pT2), respectively. The impact of steroid hormone receptor status on survival (87.8 % for receptor-positive cancers vs. 78.9 % for receptor-negative cancers) and of age at first diagnosis on survival (≤ 35 years = 91 %) were calculated. Conclusion: The project showed that intersectoral cooperation led to significant improvements in the quality of treatment over time, as measured by quality indicators and outcomes after treatment.

Effects of alvocidib and carboplatin on ovarian cancer cells in vitro.

AIM: Failure of platinum chemotherapy is an unresolved issue in ovarian cancer. Targeted therapy has been added to the treatment options in solid cancers. Alvocidib is a cyclin dependent kinase inhibitor. MATERIALS AND METHODS: This study evaluated the effects of alvocidib together with carboplatin on ovarian cancer cells (BG-1 and Skov-3) in vitro applying proliferation assays, cell cycle distribution analyses, apoptosis induction assays, and drug accumulation assay. RESULTS: Proliferation of both cell lines was inhibited by carboplatin and alvocidib. The interaction index revealed drug synergism at distinct drug concentrations. Cell cycle distribution was altered. Alvocidib induced apoptosis in Skov-3 cells, and necrosis in BG-1 cells. Rhodamine accumulation was increased by alvocidib or both compounds together. CONCLUSION: These data provide evidence for antiproliferative effects of alvocidib on human ovarian cancer cells in vitro associated with changes in cell cycle distribution, the induction of apoptosis, and modulation of intracellular drug accumulation. Alvocidib and carboplatin showed some cooperative activity.

Performance and characterization of the prototype nm-scale spatial resolution scanning multilayer Laue lenses microscope.

Synchrotron based x-ray microscopy established itself as a prominent tool for noninvasive investigations in many areas of science and technology. Many facilities around the world routinely achieve sub-micrometer resolution with a few instruments capable of imaging with the spatial resolution better than 100 nm. With an ongoing effort to push the 2D/3D resolution down to 10 nm in the hard x-ray regime both fabrication of the nano-focusing optics and stability of a microscope become extremely challenging. In this work we present our approach to overcome technical challenges on the path towards high spatial resolution hard x-ray microscopy and demonstrate the performance of a scanning fluorescence microscope equipped with the multilayer Laue lenses focusing optics.

[Fatal incidents by crowd crush during mass events. (Un)preventable phenomenon?]. / Tödliche zwischenfälle durch menschengedränge bei grossveranstaltungen. (Un-)vermeidbares phänomen?

BACKGROUND: Crowd crushes with dozens or even hundreds of casualties have occurred several times at the Hajj in Saudi Arabia and also in soccer stadiums in Western Europe. As fatal accidents after human stampedes during mass events occur very rarely and are usually accompanied by many years of criminal court proceedings in order to identify underlying responsible mechanisms and culprits, it is very difficult to draw conclusions and formulate precautions from an emergency medical point of view. METHODS: This study analyzed a fatal crowd crush which occurred on 4 December 1999 following the "Air & Style" snowboard contest with approximately 22,000 people attending in the Bergisel stadium in Innsbruck, Austria. Firstly, focused interviews were conducted with professional rescuers, police and physicians and secondly publicly available court records dealing with this incident in the district court of Innsbruck, Austria were analyzed. RESULTS: During the snowboard contest 87 emergency medical technicians, 6 emergency physicians, 1 leading emergency physician, 21 policemen and 140 security personnel were present. Following the accident additionally some 100 emergency medical technicians, 36 emergency medical service vehicles and 4 physician-staffed emergency medical service vehicles responded to the scene. The deadly crowd crush resulting in 6 fatalities, 4 patients still in a vegetative state and 38 injured, was due to a severe crowd accumulation at one stadium exit, which was not recognized and dispersed in time. Construction of the exit in line with darkness, steep slope and slippery surface contributed adversely to this dangerous situation, although panic did not occur at any time. CONCLUSIONS: Unfortunately, there is no patent remedy to completely prevent fatal accidents by a crowd crush at mass events. If planning is initiated early, sufficient material and personnel reserves are kept in reserve and despite conflicting interests of the organizers, the host community, security, police and emergency medical services, a joint concept is designed and followed, the risk of a severe incident can be kept to a minimum. Each involved party including the spectators have to be aware of their responsibility in order to contribute to the success and safety of the mass event. A comprehensive and critical review of all facts and implementation of conclusions implies a time and financial burden but has a positive impact on the success and safety of mass events.