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Background. International associations admit that specialized palliative care (SPC) is an obvious component of excellent cancer care. Nevertheless, gaps in integration at the international level have been identified. Recommendations for integrating SPC in clinical care, research, and education are needed, which are subject of the present study. Materials and Methods. A Delphi study, with three written Delphi rounds, including a face-to-face-meeting with a multi-professional expert panel (n = 52) working in SPC in 15 German Comprehensive Cancer Centers (CCCs) funded by the German Cancer Aid was initiated. Initial recommendations are built on evidence-based literature. Consensus was defined in advance with ≥80% agreement based on the question of whether each recommendation was unambiguously formulated, relevant, and realizable for a CCC. Results. A total of 38 experts (73.1%) from 15 CCCs performed all three Delphi rounds. Consensus was achieved for 29 of 30 recommendations. High agreement related to having an organizationally and spatially independent palliative care unit (≥6 beds), a mobile multiprofessional SPC team, and cooperation with community-based SPC. Until round 3, an ongoing discussion was registered on hospice volunteers, a chair of palliative care, education in SPC among staff in emergency departments, and integration of SPC in decision-making processes such as tumor boards or consultation hours. Integration of SPC in decision-making processes was not consented by a low-rated feasibility (76.3%) due to staff shortage. Conclusion. Recommendations should be considered when developing standards for cancer center of excellence in Germany. Definition and implementation of indicators of integration of SPC in CCCs and evaluation of its effectiveness are current and future challenges. [ABSTRACT FROM AUTHOR]

Background: Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. Methods/design: The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Discussion: Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. [ABSTRACT FROM AUTHOR]

Background: Obesity is increasing worldwide and weight-control strategies, including the consumption of plant food supplements (PFS), are proliferating. This article identifies the herbal ingredients in PFS consumed for weight control and by overweight/obese dieters in six European countries, and explores the relationship between their consumption and their self-reported BMI. Methods: Data used were a subset from the PlantLIBRA PFS Consumer Survey 2011-2012, a retrospective survey of 2359 PFS consumers. The survey used a bespoke frequency-of-PFS-usage questionnaire. Analyses were performed in two consumer subsamples of 1) respondents taking the products for "body weight reasons", and 2) "dieters for overweight/obesity", to identify the herbal ingredients consumed for these reasons. The relationship between the 5 most consumed herbal ingredients and self-reported BMI in groups 1 and 2 is explored by comparing BMI proportions of consumers vs. non-consumers (using Chi-squared test). Results: 252 PFS (8.8 %) were consumed for "body weight reasons" (by 240 PFS consumers); 112 PFS consumers (4.8 %) were "dieting for overweight/obesity". Spain is the country where consuming herbal ingredients for body weight control and dieting were most popular. Artichoke was the most consumed herbal ingredient. Considering only the 5 top products consumed by those who responded "body weight", when using the total survey sample, a greater proportion of BMI ≥ 25 was observed among consumers of PFS containing artichoke and green tea as compared to non-consumers (58.4 % vs. 49.1 % and 63.2 % vs. 49.7 % respectively). Considering only the 5 top products consumed by "dieters" and using only the "dieters" sample, a lower proportion of BMI ≥ 25 was observed among pineapple-containing PFS consumers (38.5 % vs. 81.5 %); however, when using the entire survey sample, a greater proportion of BMI ≥ 25 was observed among artichoke-containing PFS consumers (58.4 % vs. 49.1 %). Conclusions: A comparison of results among the scarce publications evaluating the use of weight-loss supplements at the population level is limited. Nevertheless every hint is important in finding out which are the self-treatment strategies used by overweight/obese individuals in European countries. Although limited by a small sample size, our study represents a first attempt at analysing such data in six EU countries. Our findings should encourage the conduction of further studies on this topic, long-term and large sample-sized studies, ideally conducted in the general population. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the tolerability, effectiveness and utilization of tocilizumab for the treatment of RA in a usual care setting. Methods. ROUTINE was a prospective, non-interventional, observational 52-week study performed at 174 sites throughout Germany. RA patients were selected and treated according to label. Study objectives included the targeted documentation of infections, other adverse events, and various effectiveness out-comes (e.g. DAS28, clinical disease activity). Statistical analyses were performed primarily based on the data as observed. Results. A total of 850 patients (75% women, mean age: 56 ±13 years, mean RA duration: 10.3 ±8.6 years) were enrolled. Most patients (79%) were pretreated with TNF-inhibitors, whereas 21% were pre-treated with conventional DMARDs only. Most common DMARD pretreatments were MTX (79%), LEF (68%), adalimumab (53%) and etanercept (50%). At baseline, 60.5% of patients received tocilizumab in combination with any other RA drugs, while 39.5% were treated in monotherapy. Mean baseline DAS28 was 5.5 ±1.3, and this decreased to 2.6 ±1.6 at week 52. At week 52, good EULAR response was achieved in 62.3%, low disease activity state in 66.4%, and DAS28 remission in 55.1 % of patients (ad-justed relative frequencies). 35.3% of patients discontinued the study prematurely; common reasons were lack of effectiveness (10.5%) and intolerability (7.3%). Any infections and severe infections occurred in 37.6% and 7.2% of patients, respectively (N = 836); serious infections were seen in 5.3% (N = 850). Event rates of any, severe and serious infections were 70.3, 9.8 and 4.4 events/100 patient-years, respectively. Conclusion. Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies. [ABSTRACT FROM AUTHOR]

Background: Previous studies have reported MRI abnormalities of the corpus callosum (CC) in patients with bipolar disorder (BD), although only a few studies have directly compared callosal areas in psychotic versus nonpsychotic patients with this disorder. We sought to compare regional callosal areas in a large international multicentre sample of patients with BD and healthy controls. Methods: We analyzed anatomic T1 MRI data of patients with BD-I and healthy controls recruited from 4 sites (France, Germany, Ireland and the United States). We obtained the mid-sagittal areas of 7 CC subregions using an automatic CC delineation. Differences in regional callosal areas between patients and controls were compared using linear mixed models (adjusting for age, sex, handedness, brain volume, history of alcohol abuse/dependence, lithium or antipsychotic medication status, symptomatic status and site) and multiple comparisons correction. We also compared regional areas of the CC between patients with BD with and without a history of psychotic features. Results: We included 172 patients and 146 controls in our study. Patients with BD had smaller adjusted mid-sagittal CC areas than controls along the posterior body, the isthmus and the splenium of the CC. Patients with a positive history of psychotic features had greater adjusted area of the rostral CC region than those without a history of psychotic features. Limitations: We found small to medium effect sizes, and there was no calibration technique among the sites. Conclusion: Our results suggest that BD with psychosis is associated with a different pattern of interhemispheric connectivity than BD without psychosis and could be considered a relevant neuroimaging subtype of BD. [ABSTRACT FROM AUTHOR]

Background: To investigate the periodontal disease status in a multi-center cross-sectional study in Germany. Associations of dental, socio-economic, blood and biomedical variables with periodontal outcome parameters were evaluated. Methods: From 4 different centers N = 311 persons were included, drawn randomly from the registration offices. Maximal pocket depth (PD) was used as primary indicator for periodontitis. It was classified as: no/mild ≤3 mm, moderate 4-5 mm, severe ≥6 mm. Associations between socioeconomic (household income, education), lifestyle, and biomedical factors and PD or bleeding on probing (BOP) per site (“Yes”/”No”) was analyzed with logistic regression analysis. Results: Mean age of subjects was 46.4 (range 20-77) years. A significantly higher risk of deeper pockets for smokers (OR = 2.4, current vs. never smoker) or persons with higher BMI (OR = 1.6, BMI increase by 5) was found. Severity of periodontitis was significantly associated with caries lesions (p = 0.01), bridges (p < .0001), crowns (p < .0001), leukocytes (p = 0.04), HbA1c (p < .0001) and MCV (p = 0.04). PD was positively correlated with BOP. No significant associations with BOP were found in regression analysis. Conclusions: Earlier findings for BMI and smoking with severity of PD were confirmed. Dental variables might be influenced by potential confounding factors e.g. dental hygiene. For blood parameters interactions with unknown systemic diseases may exist. [ABSTRACT FROM AUTHOR]

Background: One essential element of research is the successful recruitment of participants. However, concerns are obvious regarding the ethical implications of involving terminally ill and even dying patients and their informal caregivers as research participants. This study aims to illustrate central issues encountered when recruiting bereaved informal caregivers for a questionnaire validation study on the quality of dying and death. Methods: Between July 2012 and November 2013, informal caregivers of deceased inpatients who were treated at two palliative care units in Germany were invited to participate in a questionnaire validation study. Informal caregivers were called by a trained researcher at the end of the fourth week after death at the earliest and by the sixteenth week after death at the latest and asked to participate in a face-to-face interview in their private home. Results: The overall participation rate of all eligible informal caregivers was 76.1% (226/297). The mean burden score was 2.5 (NRS from 0 = no burden to 10 = maximum burden; n = 221). Higher burden scores (>4) were associated with emotional and burdensome memories (n = 34) being invoked throughout the interview. Severe or maximum burden scores (>7) were stated by 13.2% of participants. The average time between the associated patient's death and the informal caregiver's interview was 57.3 days (range 26-176 days, median 49.5 days). 5.3% of all 226 interviews were not completed due to different reasons. Participants' comments on the way in which the study was conducted gave insight into their motivation to take part in the study and their evaluation of the interview situation. Conclusions: The recruitment strategy can be recommended to other researchers developing research with bereaved carers. The burden caused by study participation was acceptable to the researchers carrying out this research, although a small group of participants experienced high levels of burden which should be anticipated and appropriate support services offered. Family caregivers are willing to support end-of-life care research, have different motivations for participation and even reported benefits from participation. Nevertheless, study designs have to take into account and ease the potential burden of interviews for caregivers experiencing grief. [ABSTRACT FROM AUTHOR]

Background: To investigate the periodontal disease status in a multi-center cross-sectional study in Germany. Associations of dental, socio-economic, blood and biomedical variables with periodontal outcome parameters were evaluated. Methods: From 4 different centers N = 311 persons were included, drawn randomly from the registration offices. Maximal pocket depth (PD) was used as primary indicator for periodontitis. It was classified as: no/mild ≤3 mm, moderate 4-5 mm, severe ≥6 mm. Associations between socioeconomic (household income, education), lifestyle, and biomedical factors and PD or bleeding on probing (BOP) per site ("Yes"/"No") was analyzed with logistic regression analysis. Results: Mean age of subjects was 46.4 (range 20-77) years. A significantly higher risk of deeper pockets for smokers (OR = 2.4, current vs. never smoker) or persons with higher BMI (OR = 1.6, BMI increase by 5) was found. Severity of periodontitis was significantly associated with caries lesions (p = 0.01), bridges (p < .0001), crowns (p < .0001), leukocytes (p = 0.04), HbA1c (p < .0001) and MCV (p = 0.04). PD was positively correlated with BOP. No significant associations with BOP were found in regression analysis. Conclusions: Earlier findings for BMI and smoking with severity of PD were confirmed. Dental variables might be influenced by potential confounding factors e.g. dental hygiene. For blood parameters interactions with unknown systemic diseases may exist. [ABSTRACT FROM AUTHOR]

Background To investigate the periodontal disease status in a multi-center cross-sectional study in Germany. Associations of dental, socio-economic, blood and biomedical variables with periodontal outcome parameters were evaluated. Methods From 4 different centers N = 311 persons were included, drawn randomly from the registration offices. Maximal pocket depth (PD) was used as primary indicator for periodontitis. It was classified as: no/mild ≤3 mm, moderate 4-5 mm, severe ≥6 mm. Associations between socioeconomic (household income, education), lifestyle, and biomedical factors and PD or bleeding on probing (BOP) per site ("Yes"/"No") was analyzed with logistic regression analysis. Results Mean age of subjects was 46.4 (range 20-77) years. A significantly higher risk of deeper pockets for smokers (OR = 2.4, current vs. never smoker) or persons with higher BMI (OR = 1.6, BMI increase by 5) was found. Severity of periodontitis was significantly associated with caries lesions (p = 0.01), bridges (p < .0001), crowns (p < .0001), leukocytes (p = 0.04), HbA1c (p < .0001) and MCV (p = 0.04). PD was positively correlated with BOP. No significant associations with BOP were found in regression analysis. Conclusions Earlier findings for BMI and smoking with severity of PD were confirmed. Dental variables might be influenced by potential confounding factors e.g. dental hygiene. For blood parameters interactions with unknown systemic diseases may exist. [ABSTRACT FROM AUTHOR]