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Background: 15-20% of all patients initially diagnosed with colorectal cancer develop metastatic disease and surgical resection remains the only potentially curative treatment available. Current 5-year survival following R0-resection of liver metastases is 28-39%, but recurrence eventually occurs in up to 70%. To date, adjuvant chemotherapy has not improved clinical outcomes significantly. The primary objective of the ongoing LICC trial (L-BLP25 In Colorectal Cancer) is to determine whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer patients following R0/R1 resection of hepatic metastases. L-BLP25 targets MUC1 glycoprotein, which is highly expressed in hepatic metastases from colorectal cancer. In a phase IIB trial, L-BLP25 has shown acceptable tolerability and a trend towards longer survival in patients with stage IIIB locoregional NSCLC.
Methods: This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 patients from 20 centers in 3 countries. Patients with stage IV colorectal adenocarcinoma limited to liver metastases are included. Following curative-intent complete resection of the primary tumor and of all synchronous/metachronous metastases, eligible patients are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with s.c. L-BLP25 930 mug once weekly for 8 weeks, followed by s.c. L-BLP25 930 mug maintenance doses at 6-week (years 1&2) and 12-week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint is the comparison of recurrence-free survival (RFS) time between groups. Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. The primary endpoint will be assessed in Q3 2016. Follow-up will end Q3 2017. Interim analyses are not planned.
Discussion: The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrence-free and overall survival rates of groups in an unbiased fashion. Trial Registration EudraCT Number 2011-000218-20
Background: It is not well established how psychosocial factors like social support and depression affect health-related quality of life in multimorbid and elderly patients. We investigated whether depressive mood mediates the influence of social support on health-related quality of life.
Methods: Cross-sectional data of 3,189 multimorbid patients from the baseline assessment of the German MultiCare cohort study were used. Mediation was tested using the approach described by Baron and Kenny based on multiple linear regression, and controlling for socioeconomic variables and burden of multimorbidity.
Results: Mediation analyses confirmed that depressive mood mediates the influence of social support on health-related quality of life (Sobel's p < 0.001). Multiple linear regression showed that the influence of depressive mood (beta = -0.341, p < 0.01) on health-related quality of life is greater than the influence of multimorbidity (beta = -0.234, p < 0.01).
Conclusion: Social support influences health-related quality of life, but this association is strongly mediated by depressive mood. Depression should be taken into consideration in research on multimorbidity, and clinicians should be aware of its importance when caring for multimorbid patients.
Obesity and associated lifestyle in a large sample of multi-morbid German primary care attendees
(2014)
Background: Obesity and the accompanying increased morbidity and mortality risk is highly prevalent among older adults. As obese elderly might benefit from intentional weight reduction, it is necessary to determine associated and potentially modifiable factors on senior obesity. This cross-sectional study focuses on multi-morbid patients which make up the majority in primary care. It reports on the prevalence of senior obesity and its associations with lifestyle behaviors.
Methods: A total of 3,189 non-demented, multi-morbid participants aged 65–85 years were recruited in primary care within the German MultiCare-study. Physical activity, smoking, alcohol consumption and quantity and quality of nutritional intake were classified as relevant lifestyle factors. Body Mass Index (BMI, general obesity) and waist circumference (WC, abdominal obesity) were used as outcome measures and regression analyses were conducted.
Results: About one third of all patients were classified as obese according to BMI. The prevalence of abdominal obesity was 73.5%. Adjusted for socio-demographic variables and objective and subjective disease burden, participants with low physical activity had a 1.6 kg/m2 higher BMI as well as a higher WC (4.9 cm, p<0.001). Current smoking and high alcohol consumption were associated with a lower BMI and WC. In multivariate logistic regression, using elevated WC and BMI as categorical outcomes, the same pattern in lifestyle factors was observed. Only for WC, not current but former smoking was associated with a higher probability for elevated WC. Dietary intake in quantity and quality was not associated with BMI or WC in either model.
Conclusions: Further research is needed to clarify if the huge prevalence discrepancy between BMI and WC also reflects a difference in obesity-related morbidity and mortality. Yet, age-specific thresholds for the BMI are needed likewise. Encouraging and promoting physical activity in older adults might a starting point for weight reduction efforts.
Background: Multimorbidity is a common phenomenon in primary care. Until now, no clinical guidelines for multimorbidity exist. For the development of these guidelines, it is necessary to know whether or not patients are aware of their diseases and to what extent they agree with their doctor. The objectives of this paper are to analyze the agreement of self-reported and general practitioner-reported chronic conditions among multimorbid patients in primary care, and to discover which patient characteristics are associated with positive agreement.
Methods: The MultiCare Cohort Study is a multicenter, prospective, observational cohort study of 3,189 multimorbid patients, ages 65 to 85. Data was collected in personal interviews with patients and GPs. The prevalence proportions for 32 diagnosis groups, kappa coefficients and proportions of specific agreement were calculated in order to examine the agreement of patient self-reported and general practitioner-reported chronic conditions. Logistic regression models were calculated to analyze which patient characteristics can be associated with positive agreement.
Results: We identified four chronic conditions with good agreement (e.g. diabetes mellitus κ = 0.80;PA = 0,87), seven with moderate agreement (e.g. cerebral ischemia/chronic stroke κ = 0.55;PA = 0.60), seventeen with fair agreement (e.g. cardiac insufficiency κ = 0.24;PA = 0.36) and four with poor agreement (e.g. gynecological problems κ = 0.05;PA = 0.10).Factors associated with positive agreement concerning different chronic diseases were sex, age, education, income, disease count, depression, EQ VAS score and nursing care dependency. For example: Women had higher odds ratios for positive agreement with their GP regarding osteoporosis (OR = 7.16). The odds ratios for positive agreement increase with increasing multimorbidity in almost all of the observed chronic conditions (OR = 1.22-2.41).
Conclusions: For multimorbidity research, the knowledge of diseases with high disagreement levels between the patients' perceived illnesses and their physicians' reports is important. The analysis shows that different patient characteristics have an impact on the agreement. Findings from this study should be included in the development of clinical guidelines for multimorbidity aiming to optimize health care. Further research is needed to identify more reasons for disagreement and their consequences in health care.
Background: Multimorbidity is a phenomenon with high burden and high prevalence in the elderly. Our previous research has shown that multimorbidity can be divided into the multimorbidity patterns of 1) anxiety, depression, somatoform disorders (ADS) and pain, and 2) cardiovascular and metabolic disorders. However, it is not yet known, how these patterns are influenced by patient characteristics. The objective of this paper is to analyze the association of socio-demographic variables, and especially socio-economic status with multimorbidity in general and with each multimorbidity pattern.
Methods: The MultiCare Cohort Study is a multicentre, prospective, observational cohort study of 3.189 multimorbid patients aged 65+ randomly selected from 158 GP practices. Data were collected in GP interviews and comprehensive patient interviews. Missing values have been imputed by hot deck imputation based on Gower distance in morbidity and other variables. The association of patient characteristics with the number of chronic conditions is analysed by multilevel mixed-effects linear regression analyses.
Results: Multimorbidity in general is associated with age (+0.07 chronic conditions per year), gender (-0.27 conditions for female), education (-0.26 conditions for medium and -0.29 conditions for high level vs. low level) and income (-0.27 conditions per logarithmic unit). The pattern of cardiovascular and metabolic disorders shows comparable associations with a higher coefficient for gender (-1.29 conditions for female), while multimorbidity within the pattern of ADS and pain correlates with gender (+0.79 conditions for female), but not with age or socioeconomic status.
Conclusions: Our study confirms that the morbidity load of multimorbid patients is associated with age, gender and the socioeconomic status of the patients, but there were no effects of living arrangements and marital status. We could also show that the influence of patient characteristics is dependent on the multimorbidity pattern concerned, i.e. there seem to be at least two types of elderly multimorbid patients. First, there are patients with mainly cardiovascular and metabolic disorders, who are more often male, have an older age and a lower socio-economic status. Second, there are patients mainly with ADS and pain-related morbidity, who are more often female and equally distributed across age and socio-economic groups.
Background Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. Methods The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. Discussion The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns) with a comparable impact (e.g. on quality of life and/or functional status) will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an instrument for prediction of the deterioration of the illness process and point at possibilities of prevention. The practical consequences of the study results for primary care will be analysed in expert focus groups in order to develop strategies for the inclusion of the aspects of multimorbidity in primary care guidelines.
HADES : ein Dielektronenspekrometer hoher Akzeptanz für relativistische Schwerionenkollisionen
(1995)
Das Dielektronenspektrometer HADES (High Acceptance Dielectron Spectrometer) wird gegenwärtig am Schwerionensynchrotron der Gesellschaft für Schwerionenforschung (Darmstadt) aufgebaut. Die Spektroskopie von Elektron-Positron-Paaren (Dielektronen) aus Kern-Kern-Kollisonen mit Projektilenergien von 1 bis 2 GeV/Nukleon verspricht einen Einblick in die Eigenschaften von Hadronen bei Dichten, die das Dreifache von normaler Kerndichte erreichen. Es wird erwartet, daß sich die Massenverteilung der unterhalb der Schwelle erzeugten leichten Vektormesonen rho. omega und phi anhand ihres Zerfalls in Dielektronen experimentell untersuchen läßt. Die Beobachtung von Massenänderungen kann Hinweise auf die Restauration der im Vakuum gebrochenen chiralen Symmetrie geben. Die Eigenschaften des Spektrometers wurden in der vorliegenden Arbeit mit Simulationsrechnungen (GEANT) untersucht und optimiert. Zur Leptonenidentifizierung dient ein ortsempfindlicher Cerenkov-Zähler (RICH1) mit Gasradiator, azimutal symmetrischem Spiegel und V-Photonendetektor. Durch die geometrische Anordnung des RICH und mit sechs supraleitenden Spulen in toroidaler Anordung erreicht HADES eine Polarwinkelakzeptanz von 18 bis 85 Grad. Die Feldverteilung ist der kinematischen Impulsverteilung angepaßt und garantiert Feldfreiheit im RICH. Je ein Paar Minidriftkammern vor und hinter dem Magnetfeldbereich messen die Trajektorie zur anschließenden Rekonstruktion von Impuls, Winkel und Vertex. Zuletzt passieren die Teilchen META, eine Detektorkombination von Szintillatoren und Schauerdetektor. Aus der Multiplizität geladener Teilchen in den Szintillatoren werden zentrale Kollisionen für den Trigger der ersten Stufe selektiert. Den Trigger der zweiten Stufe definieren zwei erkannte Ringe im RICH, die jeweils einem Elektronensignal in META zuzuordnen sind. HADES ist ein Experiment der zweiten Generation. Die Messungen mit dem Dileptonenspektrometer DLS am BEVALAC (Berkeley, USA) ergaben nur für leichte Stoßsysteme e+e- -Spektren guter Statistik. HADES besitzt mit 35% die hundertfache geometrische e+e- - Akzeptanz des DLS. Darüber hinaus können mit einer Massenauflösung von weniger als 1% (DLS 12%) die e+e- -Beiträge von omega- und rho-Meson getrennt werden. Es ist für die Anforderungen von Au+Au-Kollisionen bei hohen Kollisionsraten von 106 pro Sekunde konzipiert. Bei einer Anzahl von bis zu 170 Protonen und 20 geladenen Pionen sowie mehr als 0.1 e+e- -Paaren durch den pi 0-Zerfall werden pro zentralerKollision etwa 10 exp 6 Dielektronen aus dem rho- oder omega-Zerfall erwartet. Leptonen, die aus dem Zerfall verschiedener pi 0-Mesonen stammen, bilden kombinatorische e+e- -Paare, die auch im e+e- -Massenbereich der Vektormesonen beitragen können. Durch Rekonstruktion und durch Methoden der Untergrunderkennung wird der e+e- -Untergrund um nahezu zwei Größenordnungen unterdrückt, während die Effizienz für echte Dielektronen etwa 55% beträgt. Die Leptonen des verbleibenden Untergrunds stammen zu mehr als 50% aus dem pi-0-Dalitz-Zerfall und zu etwa 40% aus externer Paarkonversion von ..-Quanten des Zerfalls pi 0.. , wobei Konversionsprozesse im Radiatorgas und im Target zu gleichen Teilen beitragen. pi 0-Dalitz-Zerfall überwiegt im kombinatorischen Massenspektrum bis 500 MeV/c2 ; oberhalb von 500 MeV/c2 dominiert externe Paarkonversion.