Population-Based Clinical Cancer Registration in Germany.

INTRODUCTION: In 2013, a new federal law obligated all German federal states to collect additional clinical data in population-based cancer registries as an active tool for monitoring and improving the quality of cancer care, increasing transparency and promoting health research. Now, 10 years later, the current status of the expanded cancer registration is presented, including current figures on cancer in Germany. METHODS: Reporting of cancer is mandatory for physicians, and about 5 to 10 reports from different healthcare providers are expected for each case. A uniform national dataset of about 130 items is used, and reports are usually sent electronically to the registry. We used the most recent data available from cancer registries up to the year of diagnosis in 2019. We calculated incidence rates and 5-year relative survival (5YRS) for common cancers. Data on clinical outcomes and benchmarking based on quality indicators (QIs) from guidelines were provided by the Cancer Registry Schleswig-Holstein (CR SH). RESULTS: All federal state cancer registries met most of the previously defined national eligibility criteria. Approximately 505,000 cancer cases were registered in 2019, with breast, prostate, colorectal and lung cancer being the most common cancers. The age-standardised cancer incidence has slightly decreased during the last decade. and spatial heterogeneity can be observed within Germany. 5YRS for all cancers was 67% and 63% for women and men, respectively. Therapy data for rectal cancer in 2019-2021 from the CR SH are shown as an example: 69% of the registered patients underwent surgery, mostly with curative intent (84%) and tumour-free resection (91%). Radiotherapy was given to 33% of the patients, and chemotherapy was given to 40%. Three selected QIs showed differences between involved healthcare providers. DISCUSSION: The implementation of population-based clinical cancer registration can be considered a success. Comprehensive recording of diagnosis, treatment and disease progression and the use of registry data for quality assurance, benchmarking and feedback have been implemented.

Reasons for Non-Attendance in the German National Mammography Screening Program: Which Barriers Can Be Overcome Using Telephone Counseling?-A Randomized Controlled Trial.

INTRODUCTION: Germany has established a national mammography screening program (MSP). Despite extensive awareness campaigns, the participation rate is only 54%, which is considerably below the European guidelines' recommendation of at least 70%. Several reasons why women do not participate are already known. Telephone consultations along with invitation letters have improved the participation rate. Here, we analyzed the reasons for non-participation and offered barrier-specific counseling to examine which impediments can be overcome to improve participation. STUDY DESIGN: In a randomized controlled trial, women who had not attended their proposed screening appointment in the MSP after a written invitation were contacted by telephone and asked why they did not attend. Barrier-specific counseling via telephone was then offered. Participation in the MSP was rechecked 3 months after counseling. SETTING: 1772 women, aged 50-69 years, who had not scheduled a mammography screening after a written invitation were contacted by telephone and asked for their reasons for non-participation. INTERVENTION: The reasons were recorded by the calling consultant and categorized either during the call or later based on their recorded statements. Afterward, the women received counseling specific to their statements and were given general information about the MSP. MAIN OUTCOME MEASURES: We categorized the reasons given, calculated their frequency, and analyzed the probabilities to which they could be successfully addressed in individual counseling. Participation rates were determined post-consultation according to the reason(s) indicated. RESULTS: The data were analyzed in 2022. After exclusions, 1494 records were analyzed. Allowing for multiple reasons to be stated by every individual 3280 reasons for not attending were abstracted. The most frequent reason was participation in "gray screening" (51.5%), which included various breast cancer prevention measures outside the national MSP. Time problems (26.6%) and health reasons (17.3%) were also important. Counseling was most effective when women had not participated for scheduling reasons. CONCLUSION: Several reasons prevented women from participating in the MSP. Some reasons, such as time-related issues, could be overcome by telephone counseling, but others, like barriers resulting from fear of the examination procedure or its result, could not.

Population-Based Analysis of the Impact of Demographics on the Current and Future Blood Supply in the Saarland.

BACKGROUND: The federal state of Saarland (SL) is experiencing the fastest demographic change in the western part of Germany. In this study, we analyzed retrospective data on the current and future supply of red blood cell concentrates (RBC) in this region and compared it to the current and future RBC demand in SL hospitals. METHODS: The projection of the SL blood supply in 2030 was modeled based on SL demographics for age distribution and donation frequency of donors, and the RBC transfusion data for in-house patients. These results were compared to published data on the transfusion demand from the state of Mecklenburg-Western Pomerania (MV). RESULTS: For the period January 1 to December 31, 2017, a total of 43,205 whole blood donations were collected. The donation frequency in SL never exceeded 80 per 1,000 inhabitants and was well below the numbers in MV. Thirty-one percent of the donors were responsible for 53.5% of the donations, and donors older than 45 years of age contributed highly to the total blood supply. In addition, 40,614 RBC transfusions at 10 SL hospitals were analyzed representing nearly all RBC transfusions for in-house patients in this region. RBC transfusions per 1,000 inhabitants increased with age from 24 (50-54) to 140 (80-84) years. Facing an already existing structural deficit of nearly 8,200 RBC in 2017, the projection predicts a dramatic increase in the regional deficit to >18,300 RBC in 2030. CONCLUSION: Our results on RBC demand in SL are comparable but not identical to those projected for the region of MV in eastern Germany. Due to the ongoing demographic changes in Germany as a whole, regular regional monitoring of RBC demand and the age structure of blood recipients and donors should be implemented to allow for better strategic planning in blood transfusion services and hospitals.

Tables for effective dose assessment from diagnostic radiology (period 1946-1995) in epidemiologic studies.

Diagnostic radiology is a leading cause of man-made radiation exposure to the population. It is an important factor in many epidemiological studies as variable of interest or as potential confounder. The effective dose as a risk related quantity is the most often stated patient dose. Nevertheless, there exists no comprehensive quantification model for retrospective analysis for this quantity. This paper gives a catalog of effective dose values for common and rare examinations and demonstrates how to modify the dose values to adapt them to different calendar years using a quantification concept already used for retrospective analysis of the red bone marrow dose. It covers the time period of 1946 to 1995 and allows considering technical development and different practical standards over time. For an individual dose assessment, if the dose area product is known, factors are given for most examinations to convert the dose area product into the effective dose. Additionally factors are stated for converting the effective dose into the red bone marrow dose or vice versa.

Analysis of DCM associated protein alterations of human right and left ventricles.

Dilated cardiomyopathy (DCM) is characterized by ventricular chamber enlargement and impaired myocardial function. Endomyocardial biopsies (EMB) enable immunohistochemical and molecular characterization of this disease. However, knowledge about specific molecular patterns and their relation to cardiac function in both ventricles is rare. Therefore, we performed a mass spectrometric analysis of 28 paired EMBs of left (LV) and right ventricles (RV) of patients with DCM or suspected myocarditis allowing quantitative profiling of 743 proteins. We analysed associations between protein abundance of LV and RV as well as the echocardiographic parameters LVEF, TAPSE, LVEDDI, and RVEDDI by linear regression models. Overall, more LV than RV proteins were associated with LV parameters or with RVEDDI. Most LV and RV proteins increasing in level with impairing of LVEF were annotated to structural components of cardiac tissue. Additionally, a high proportion of LV proteins with metabolic functions decreased in level with decreasing LVEF. Results were validated with LV heart sections of a genetic murine heart failure model. The study shows, that remodelling and systolic dysfunction in DCM is mirrored by distinct alterations in protein composition of both ventricles. Loss of LV systolic function is reflected predominantly by alterations in proteins assigned to metabolic functions in the LV whereas structural remodelling was more obvious in the RV. Alterations related to intermediate filaments were seen in both ventricles and highlight such proteins as early indicators of LV loss of function. SIGNIFICANCE: The present study report protein sets in the RV and the LV being associated with ventricular function and remodelling in DCM. Protein abundances in the LV and the RV emphasize and expand current knowledge on pathophysiological changes in heart failure and DCM. While RV and LV EMBs do not differ concerning diagnostic assessment of inflammatory status and virus persistence, additional information reflecting disease severity associated protein alterations can be gained by EMB protein profiling. RV and LV protein data provided complementary information. The protein pattern of the LV reflects metabolic changes and an impaired energy production, which is associated with the degree of LV systolic dysfunction and remodelling and may yield important information about the disease status in DCM. On the other hand, at this disease stage of DCM with still preserved RV function, RV alterations in structural proteins may reflect myocardial compensatory protective mechanisms for maintenance of structure and cellular function. The study highlight particular proteins being of interest as heart failure biomarkers in both ventricles which seem to reflect the severity of the disease. Further comparative studies between different HF aetiologies have to evaluate those proteins as markers specific for DCM.

Characteristics of Recipients of Red Blood Cell Concentrates in a German Federal State.

BACKGROUND: Annual transfusion rates in many European countries range between 25 and 35 red blood cell concentrates (RBCs)/1,000 population. It is unclear why transfusion rates in Germany are considerably higher (approx. 50-55 RBCs/1,000 population). METHODS: We assessed the characteristics of transfusion recipients at all hospitals of the German federal state Mecklenburg-Western Pomerania during a 10-year longitudinal study. RESULTS: Although 75% of patients received ≤4 RBCs/patient in 2015 (1 RBC: 11.3%; 2 RBCs: 42.6%; 3 RBCs: 6.3%; 4 RBCs: 15.0%), the mean transfusion index was 4.6 RBCs due to a minority of patients with a high transfusion demand. Two thirds of all RBCs were transfused to only 25% of RBC recipients. Consistently, male patients received a higher number of RBCs (2005: 54.2%; 2015: 56.8%) and had a higher mean transfusion index than female patients (mean 5.1 ± 7.2; median 2; inter-quartile range [IQR] 2-4 vs. mean 4.0 ± 5.8; median 2; IQR 2-4). The absolute transfusion demand decreased between 2005 and 2015 by 13.5% due to a composite of active reduction (clinical practice change) and population decline in the 65- to 75-year age group (lower birth rate cohort 1940-1950); however, with major differences between hospitals (range from -61.0 to +41.4%). CONCLUSION: Transfusion demand in a population could largely be driven by patients with high transfusion demand. Different treatment practices in this group of patients probably add to the major differences in transfusion demand per 1,000 individuals between countries. The available data cannot prove this hypothesis. Implementation of a diagnosis-related group-based monitoring system is urgently needed to allow informative monitoring on the population level and meaningful comparisons between transfusion practices.

[Evaluation of Quality Indicators of Evidence-Based Guidelines Using ADT/GEKID Base Dataset and its Organ-Specific Modules]. / Berechenbarkeit der Qualitätsindikatoren der onkologischen S3-Leitlinien mit dem ADT-/GEKID-Basisdatensatz und seiner Zusatzmodule.

AIM: According to the Cancer Screening and Registers Act (KFRG, §65c SGB V), clinical cancer registration in Germany has to be based on the consistent set of variables developed by the "Association of German Tumor Centers" (ADT) and "Association of Population-based Cancer Registries in Germany" (GEKID) to improve oncological care. Quality indicators in evidence-based guidelines are measures to assess the quality of treatment and outcome in clinical care. The aim of this study was to find out the extent to which it is possible to determine these quality indicators using the ADT/GEKID's set of variables and the organ-specific modules. METHODS: After screening all available evidence-based guidelines for inclusion and exclusion criteria to calculate quality indicators, we evaluated for each indicator whether it can be computed using a single variable or a combination of variables of the ADT/GEKID's base variables set and the organ-specific modules. RESULTS: A total of 151 quality indicators were defined in 17 available evidence-based guidelines. Of these, 82 (54%) quality indicators could be determined with the variables of the base dataset. The highest proportion of calculable quality indicators was 100% for pancreatic cancer, which, however, was the only entity where all indicators were calculable. The least proportion of quality indicators was calculable for cancer of the oral cavity (10%). CONCLUSIONS: This analysis shows considerable differences in the possibility to evaluate the quality indicators defined in S3-guidelines for different tumor entities based on the variables documented in the clinical cancer registries throughout Germany. The ADT/GEKID core variables set should be extended with additional modules, for instance, for colorectal cancer, to allow a complete documentation of all criteria needed for the determination of clinical quality indicators as suggested in the pertinent evidence-based guidelines.

Global plasma protein profiling reveals DCM characteristic protein signatures.

To identify potential biomarkers supporting better phenotyping and to improve understanding of the pathophysiology of dilated cardiomyopathy (DCM), this study comparatively analyzed plasma protein profiles of DCM patients and individuals with low normal and normal left ventricular ejection fraction (LVEF) by mass spectrometry. After plasma depletion using a MARS Hu-6 column, global proteome profiling was performed using a LTQ-Orbitrap Velos mass spectrometer. To compare and confirm results, two different discovery sets of samples were investigated. Differentially abundant proteins are involved in lipid metabolism, coagulation, and acute phase response. Serum paraoxonase 1 (PON1), cystatin C, lysozyme C, apolipoprotein A-II, and apolipoprotein M were validated by targeted protein analysis in a third independent patient cohort. Additionally, PON1 levels were also determined by an ELISA. These data highlight PON1 as a potential marker for differentiating DCM patients not only from patients with normal LVEF, but also from heart failure patients with preserved ejection fraction. The results highlight lipid metabolism and inflammation as the major pathways being altered in DCM patients in comparison to patients presenting with suspicious myocarditis to the hospital. SIGNIFICANCE: Several studies focused on the identification of heart failure (HF) associated protein signatures in blood plasma, but only few that are largely based on only small sample series considered specific HF pathologies. Therefore, we performed a comparative global blood plasma protein profiling of a larger sample of individuals with reduced left ventricular ejection fraction (LVEF) classified as dilated cardiomyopathy patients and individuals with normal LVEF but presenting with suspicious myocarditis. DCM patients displayed altered levels of proteins involved in lipid metabolism, coagulation, and acute phase response. The most reliable candidates, such as serum paraoxonase 1 (PON1), cystatin C, lysozyme C, apolipoprotein A-II, and apolipoprotein M were validated by targeted protein analysis in an independent patient cohort. PON1 levels were also determined by an ELISA. These data highlight PON1 as a potential marker for differentiating DCM patients not only from patients with normal LVEF, but also from heart failure patients with preserved ejection fraction.

Correlation of gene expression and clinical parameters identifies a set of genes reflecting LV systolic dysfunction and morphological alterations.

To gain new insights into the complex pathophysiology of dilated cardiomyopathy (DCM) we performed a quantitative approach to identify genes with expression patterns that linearly correlate with parameters of cardiac morphology (left ventricular end-diastolic diameter indexed by body surface are (LVEDDI), systolic function [LV ejection fraction (LVEF)], and serum levels of cardiac peptide hormone NH2-terminal probrain natriuretic peptide (NT-proBNP) in human endomyocardial biopsies of 47 DCM patients and eight individuals with normal LVEF. A set of genes was identified as common heart failure markers characterized by correlation of their expression with cardiac morphology, systolic function, and NT-proBNP. Among them are already known genes encoding e.g., the natriuretic peptide hormones NPPA and NPPB and its converting enzyme corin, but also potential new heart failure markers like EP300 antisense RNA1 and dimethylarginine dimethylaminohydrolase 1 (DDAH1) along with other genes with so far unknown relation to heart function. In contrast, the expression of other genes including the Ca2+ flux regulating genes phospholamban (PLN), sarcoplasmic/endoplasmic reticulum calcium ATPase 2 (SERCA), and extracellular matrix proteins showed significant correlation with LVEF and LVEDDI only. Those genes seem to reflect more specifically pathological alterations of systolic function and morphology in DCM hearts.

Sugars make the difference - Glycosylation of cardiodepressant antibodies regulates their activity in dilated cardiomyopathy.

BACKGROUND: Cardiodepressant antibodies contribute to cardiac dysfunction in dilated cardiomyopathy (DCM). Changes in immunoglobulin G (IgG) glycosylation modulate the activity of various autoimmune diseases and influence disease activity as well as severity of various autoimmune diseases. We hypothesized that alterations in IgG glycosylation are involved in the disease course of DCM. METHODS AND RESULTS: IgG glycosylation was analyzed in plasma samples of 50 DCM patients using a lectin-based ELISA. Negative inotropic (cardiodepressant) activity (NIA) of antibodies was assessed by measuring the effect of purified DCM-IgG on the shortening of isolated rat cardiomyocytes by means of a video-edge detection system. IgG obtained from plasma of healthy blood donors served as control. DCM-IgG contained significantly less sialic acid (-25%) and galactose (-16%; both P < 0.001), but showed no significant differences in core-fucosylation compared to controls. Interestingly, IgG with NIA displayed a lower percentage of sialylation (-16%, P < 0.001) core-fucosylation (-15%, P = 0.015) and galactosylation (-10%, P = 0.129) than IgG without NIA. The extent of NIA was directly associated with IgG sialylation (r = 0.68; P < 0.001) and galactosylation (r = 0.37; P = 0.001). CONCLUSION: Reduced sialylation and galactosylation of IgGs enhances their cardiodepressant activity in DCM indicating that changes in IgG glycosylation may be involved in the pathogenesis of DCM.

L-Carnitine-Mediated Tumor Cell Protection and Poor Patient Survival Associated with OCTN2 Overexpression in Glioblastoma Multiforme.

PURPOSE: Apoptotic dysregulation, redox adaptive mechanisms, and resilience to hypoxia are major causes of glioblastoma (GBM) resistance to therapy. Commonly known as crucial factors in energy metabolism, OCTN2 (SLC22A5) and its substrate L-carnitine (LC) are increasingly recognized as actors in cytoprotection. This study provides a comprehensive expression and survival analysis of the OCTN2/LC system in GBM and clarifies the system's impact on GBM progression. EXPERIMENTAL DESIGN: OCTN2 expression and LC content were measured in 121 resected human GBM specimens and 10 healthy brain samples and analyzed for prognostic significance. Depending on LC administration, the effects of hypoxic, metabolic, and cytotoxic stress on survival and migration of LN18 GBM cells were further studied in vitro. Finally, an orthotopic mouse model was employed to investigate inhibition of the OCTN2/LC system on in vivo GBM growth. RESULTS: Compared with healthy brain, OCTN2 expression was increased in primary and even more so in recurrent GBM on mRNA and protein level. High OCTN2 expression was associated with a poor overall patient survival; the unadjusted HR for death was 2.7 (95% CI, 1.47-4.91; P < 0.001). LC administration to GBM cells increased their tolerance toward cytotoxicity, whereas siRNA-mediated OCTN2 silencing led to a loss of tumor cell viability. In line herewith, OCTN2/LC inhibition by meldonium resulted in reduced tumor growth in an orthotopic GBM mouse model. CONCLUSIONS: Our data indicate a potential role of the OCTN2/LC system in GBM progression and resistance to therapy, and suggests OCTN2 as a prognostic marker in patients with primary GBM.

MD-2 is a new predictive biomarker in dilated cardiomyopathy and exerts direct effects in isolated cardiomyocytes.

BACKGROUND: Myeloid differentiation factor-2 (MD-2) has been shown to be an important modulator of the innate immune system, but its role in cardiac diseases is unknown. We investigated whether MD-2 plays a role as risk predictor and contributor in dilated cardiomyopathy (DCM). METHODS AND RESULTS: We included 174 patients with reduced left ventricular (LV) ejection fraction (LVEF <45%) due to DCM. Coronary artery disease and severe valvular diseases were excluded in all patients by angiography or echocardiography. Cardiac inflammation, viral infection and MD-2 expression were analyzed from right ventricular endomyocardial biopsies. MD-2 was quantified by ELISA in serum upon first hospital admission. Myocyte contractility and inflammatory response after stimulation with recombinant MD-2 protein were analyzed in isolated rat cardiomyocytes. Median follow-up of the patients was 3.51 years (2.73; 4.48) with 34 deaths. Absolute mortality risk increases in patients displaying a MD-2 serum concentration greater than the median (302 ng/ml) was 23% (P < 0.0001). Age- and sex-adjusted Cox regression analyses demonstrated that mortality risk was highly related to MD-2 concentrations (P < 0.001), but not to age or sex. An increase of 100 ng/ml in the MD-2 level was associated with an absolute mortality risk increase of 50.4%. Receiver operating characteristic (ROC) analyses showed no difference between MD-2 and nterminal-pro brain natriuretic peptide (NT-pro-BNP), while the combination of both MD-2 and NT-pro-BNP resulted in a significantly increased capability of risk prediction when compared to NT-pro-BNP alone (P = 0.014). In-vitro, recombinant MD-2 decreases cell shortening and modulates cytokine activation in isolated cardiomyocytes. CONCLUSION: MD-2 predicts long-term outcome in DCM patients and improves mortality risk prediction capability compared to NT-pro-BNP alone. In addition, MD-2 exerts direct negative inotropic effects on isolated cardiomyocytes in-vitro. Further randomized trials should confirm MD-2 as a diagnostic and therapeutic target.

Association of Glioblastoma Multiforme Stem Cell Characteristics, Differentiation, and Microglia Marker Genes with Patient Survival.

Patients with glioblastoma multiforme (GBM) are at high risk to develop a relapse despite multimodal therapy. Assumedly, glioma stem cells (GSCs) are responsible for treatment resistance of GBM. Identification of specific GSC markers may help to develop targeted therapies. Here, we performed expression analyses of stem cell (ABCG2, CD44, CD95, CD133, ELF4, Nanog, and Nestin) as well as differentiation and microglia markers (GFAP, Iba1, and Sparc) in GBM compared to nonmalignant brain. Furthermore, the role of these proteins for patient survival and their expression in LN18 stem-like neurospheres was analyzed. At mRNA level, ABCG2 and CD95 were reduced, GFAP was unchanged; all other investigated markers were increased in GBM. At protein level, CD44, ELF4, Nanog, Nestin, and Sparc were elevated in GBM, but only CD133 and Nestin were strongly associated with survival time. In addition, ABCG2 and GFAP expression was decreased in LN18 neurospheres whereas CD44, CD95, CD133, ELF4, Nanog, Nestin, and Sparc were upregulated. Altogether only CD133 and Nestin were associated with survival rates. This raises concerns regarding the suitability of the other target structures as prognostic markers, but makes both CD133 and Nestin candidates for GBM therapy. Nevertheless, a search for more specific marker proteins is urgently needed.

Influence of quartz exposure on lung cancer types in cases of lymph node-only silicosis and lung silicosis in German uranium miners.

Inhaled crystalline quartz is a carcinogen. Analyses show differences in the distribution of lung cancer types depending on the status of silicosis. Using 2,524 lung tumor cases from the WISMUT autopsy repository database, silicosis was differentiated into cases without silicosis in lung parenchyma and its lymph nodes, with lymph node-only silicosis, or with lung silicosis including lymph node silicosis. The proportions of adenocarcinoma, squamous cell carcinoma, and small-cell lung carcinoma mortality for increasing quartz exposures were estimated in a multinomial logistic regression model. The relative proportions of the lung cancer subtypes in lymph node-only silicosis were more similar to lung silicosis than without any silicosis. The results support the hypothesis that quartz-related carcinogenesis in case of lymph node-only silicosis is more similar to that in lung silicosis than in without silicosis.

Longitudinal Changes in the Blood Supply and Demand in North-East-Germany 2005-2015.

BACKGROUND: Securing future blood supply is a major issue of transfusion safety. In this prospective 10-year longitudinal study we enrolled all blood donation services and hospitals of the federal state Mecklenburg-Western Pomerania. METHODS AND RESULTS: From 2005 to 2015 (time period with major demographic effects), whole blood donation numbers declined by 18%. In male donors this paralleled the demographic change, while donation rates of females declined 12.4% more than expected from demography. In parallel, red cell transfusion rates/1,000 population decreased from 2005 to 2015 from 56 to 51 (-8.4%), primarily due to less transfusions in patients >60 years. However, the transfusion demand declined much less than blood donation numbers: -13.5% versus -18%, and the population >65 years (highest transfusion demand) will further increase. The key question is whether the decline in transfusion demand observed over the previous years will further continue, hereby compensating for reduced blood donation numbers due to the demographic change. The population structure of Mecklenburg-Western Pomerania reflects all Eastern German federal states, while the Western German federal states will reach similar ratios of age groups 18-64 years / ≥65 years about 10 years later. CONCLUSIONS: Regular monitoring of age- and sex-specific donation and transfusion data is urgently required to allow transfusion services strategic planning for securing future blood supply.

TranslatiOnal Registry for CardiomyopatHies (TORCH) - rationale and first results.

AIMS: Non-ischemic cardiomyopathies (CMPs) comprise heart muscle disorders of different causes with high variability in disease phenotypes and clinical progression. The lack of national structures for the efficient recruitment, clinical and molecular classification, and follow-up of patients with non-ischemic CMPs limit the thorough analysis of disease mechanisms and the evaluation of novel diagnostic and therapeutic strategies. This paper describes a national, prospective, multicenter registry for patients with non-ischemic CMPs. The main objective of this registry is to create a central hub for clinical outcome studies, a joint resource for diagnostic and therapeutic trials, a common biomaterial bank, and a resource for detailed molecular analyses utilizing patients' biomaterials. METHODS AND RESULTS: A comprehensive characterization of the register population and patients' subgroups is planned. First analyses will include descriptive methods evaluating the distribution of outcome variables and possible risk factors followed by test statistics in a cross-sectional design. The aim of the current study is to recruit 2300 patients all over Germany. Eligible participants are patients with primary non-ischemic cardiomyopathies, including hereditary and inflammatory dilated CMP (DCM), left-ventricular noncompaction CMP (LVNC), hypertrophic CMP (HCM), arrhythmogenic right-ventricular CMP (ARVC), myocarditis, and amyloidosis. Of already recruited patients 70% are male and 30% female. With 56% of patients included, DCM is most common. CONCLUSION/OUTCOME: The primary outcome is all-cause death. Key secondary endpoints are cardiovascular death, adequate ICD shock, survived sudden cardiac death, syncope, documented potentially life-threatening arrhythmia, cardiac transplantation, hospitalization due to worsening of heart failure (HF), and any non-elective cardiovascular hospitalization.

Data privacy management and data quality monitoring in the German Centre for Cardiovascular Research's multicentre TranslatiOnal Registry for CardiomyopatHies (DZHK-TORCH).

AIMS: The multicentric TranslatiOnal Registry for CardiomyopatHies (TORCH) of the German Centre for Cardiovascular Research aims to recruit 2300 patients with non-ischemic cardiomyopthies. METHODS AND RESULTS: The investigations were performed after standard operating procedures. The data are collected in standardized electronic case report forms provided by the data holding of the central data management of the German Centre for Cardiovascular Research using secuTrial (interActive Systems GmbH, Berlin, Germany). The personal-identifying data and informed consent are collected, stored, and quality-checked by the independent Trusted Third Party in Greifswald. The quality management of the medical data is performed by the data and quality centre Greifswald. In December 2014, the recruitment for TORCH has started. Currently, data and biomaterial from about 1397 patients and more than 74 500 biomaterial aliquots were collected. Regular study centre-specific quality reports address completeness and plausibility of data and provide detailed information about current missing or implausible data entries to improve the data quality by using a query management in addition. CONCLUSIONS: A regular quality control and reporting improve the data quality in TORCH and will support high-quality data analysis and the translation of research results into routine care.

The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial.

BACKGROUND: Physical activity (PA) can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs) on adherence was examined. METHODS: A randomized study with four groups was conducted in the context of a health examination program among participants aged 40-75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance). The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme "day and night" or "day only" and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days). A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. RESULTS: Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males). The mean wearing time was 84.04 hours (SD 20.75). Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005). SPCs had no additional effect on adherence (IRR 0.80; P=0.168). CONCLUSION: To assess PA, the wearing scheme day and night provides the best possible adherence in this group of participants. Further studies are necessary to examine adherence and the effects of additional SPCs in other samples or settings.

A population-based longitudinal study on the implication of demographic changes on blood donation and transfusion demand.

Transfusion safety includes the risk of transmission of pathogens, appropriate transfusion thresholds, and sufficient blood supply. All industrialized countries experience major ongoing demographic changes resulting from low birth rates and aging of the baby boom generation. Little evidence exists about whether future blood supply and demand correlate with these demographic changes. The ≥50% decline in birth rate in the eastern part of Germany after 1990 facilitates systematic study of the effects of pronounced demographic changes on blood donation and demand. In this prospective, 10-year longitudinal study, we enrolled all whole blood donors and all patients receiving red blood cell transfusions in the state of Mecklenburg-West Pomerania. We compared projections made in 2005 based on the projected demographic changes with: (1) number and age distribution of blood donors and transfusion recipients in 2015 and (2) blood demand within specific age and patient groups. Blood donation rates closely followed the demographic changes, showing a decrease of -18% (vs projected -23%). In contrast, 2015 transfusion rates were -21.3% lower than projected. We conclude that although changes in demography are highly predictive for the blood supply, transfusion demand is strongly influenced by changes in medical practice. Given ongoing pronounced demographic change, regular monitoring of the donor/recipient age distributions and associated impact on blood demand/supply relationships is required to allow strategic planning to prevent blood shortages or overproduction.