Analysing the impact of a case management model on the specialised palliative care multi-professional team.

PURPOSE: Palliative care (PC) involves many health care providers leading to a high complexity of structures that requires efficient coordination as provided by case management (CM). Our study aimed to evaluate the effects of CM newly implemented in a specialised palliative care unit by evaluating team members' tasks and time resources before (T0) and after implementation (T1). It was hypothesised that team members would be able to spend less time on organisational and administrative tasks and more time on patient care. METHODS: A prospective pre-post study design was used. Time distribution of different tasks at T0 and T1 was compared between three different professional groups: physicians, nursing staff and social work. To document their tasks and time required, a documentation form with several items for each profession was developed. Data was analysed using t tests for independent samples. RESULTS: After Bonferroni correction, a significant pre-post difference was found for the time spent on "discharge interview and discharge" as rated by the physicians (p < .001) with less time spent on this activity after CM implementation. The nursing staff had significantly more time for "conversations with patients" (p < .001) after CM implementation. Moreover, they spent significantly less time on "patient-related requests/advice by telephone" (p < .001) and "discussions with relatives/participation in family discussions" at post-assessment (p < .001). The social worker had significantly more time for "patient advice and support services" (p = .013) after CM implementation. CONCLUSIONS: Integrating CM can be time efficient and ensures team members to spend more time on their core tasks in patient care.

Reply to the EFSA (2016) on the relevance of recent publications (Hofmann et al. 2014, 2016) on environmental risk assessment and management of Bt-maize events (MON810, Bt11 and 1507).

In this commentary, we respond to a report of the EFSA GMO Panel (EFSA EFSA Supp Publ, 1) that criticises the outcomes of two studies published in this journal (Hofmann et al. Environ Sci Eur 26: 24, 2; Environ Sci Eur 28: 14, 3). Both publications relate to the environmental risk assessment and management of Bt-maize, including maize events MON810, Bt11 and maize 1507. The results of Hofmann et al. (Environ Sci Eur 26: 24, 2), using standardised pollen mass filter deposition measurements, indicated that the EFSA Panel model had underestimated pollen deposition and, hence, exposure of non-target organisms to Bt-maize pollen. The results implied a need for safety buffer distances in the kilometre range for protected nature reserve areas instead of the 20-30 m range recommended by the EFSA Panel. As a result, the EFSA Panel revised their model (EFSA EFSA J 13: 4127, 4), adopting the slope of the empirical data from Hofmann et al. The intercept, however, was substantially reduced to less than 1% at one point by introducing further assumptions based on the estimates of mainly panel members, citing possible 'uncertainty'. Hofmann et al. (Environ Sci Eur 28: 14, 3) published extensive empirical data regarding pollen deposition on leaves. These results were part of a larger 3-year study involving detailed measurements of pollen release, dispersal and deposition over the maize flowering period. The data collected in situ confirmed the previous predictions of Hofmann et al. (Environ Sci Eur 26: 24, 2). Mean levels and observed variability of pollen deposition on maize and four lepidopteran host plants exceeded the assumptions and disagreed with the conclusions of the EFSA Panel. The EFSA Panel reacted in a report (EFSA EFSA Supp Publ, 1) criticising the methods and outcomes of the two published studies of Hofmann et al. while reaffirming their original recommendations. We respond here point-by-point, showing that the critique is not justified. Based on our results on Urtica leaf pollen density, we confirm the need for specific environmental impact assessments for Bt-maize cultivation with respect to protected habitats within isolation buffer distances in the kilometre range.

Erratum to: Reply to the EFSA (2016) on the relevance of recent publications (Hofmann et al. 2014, 2016) on environmental risk assessment and management of Bt-maize events (MON810, Bt11 and 1507).

[This corrects the article DOI: 10.1186/s12302-017-0106-0.].

Accumulation and variability of maize pollen deposition on leaves of European Lepidoptera host plants and relation to release rates and deposition determined by standardised technical sampling.

BACKGROUND: Risk assessment for GMOs such as Bt maize requires detailed data concerning pollen deposition onto non-target host-plant leaves. A field study of pollen on lepidopteran host-plant leaves was therefore undertaken in 2009-2012 in Germany. During the maize flowering period, we used in situ microscopy at a spatial resolution adequate to monitor the feeding behaviour of butterfly larvae. The plant-specific pollen deposition data were supplemented with standardised measurements of pollen release rates and deposition obtained by volumetric pollen monitors and passive samplers. RESULTS: In 2010, we made 5377 measurements of maize pollen deposited onto leaves of maize, nettle, goosefoot, sorrel and blackberry. Overall mean leaf deposition during the flowering period ranged from 54 to 478 n/cm2 (grains/cm2) depending on plant species and site, while daily mean leaf deposition values were as high as 2710 n/cm2. Maximum single leaf-deposition values reached up to 103,000 n/cm2, with a 95 % confidence-limit upper boundary of 11,716 n/cm2. CONCLUSIONS: Daily means and variation of single values uncovered by our detailed measurements are considerably higher than previously assumed. The recorded levels are more than a single degree of magnitude larger than actual EU expert risk assessment assumptions. Because variation and total aggregation of deposited pollen on leaves have been previously underestimated, lepidopteran larvae have actually been subjected to higher and more variable exposure. Higher risks to these organisms must consequently be assumed. Our results imply that risk assessments related to the effects of Bt maize exposure under both realistic cultivation conditions and worst-case scenarios must be revised. Under common cultivation conditions, isolation buffer distances in the kilometre range are recommended rather than the 20-30 m distance defined by the EFSA.

Prioritizing stream types according to their potential risk to receive crop plant material--A GIS-based procedure to assist in the risk assessment of genetically modified crops and systemic insecticide residues.

Crop plant residues may enter aquatic ecosystems via wind deposition or surface runoff. In the case of genetically modified crops or crops treated with systemic pesticides, these materials may contain insecticidal Bt toxins or pesticides that potentially affect aquatic life. However, the particular exposure pattern of aquatic ecosystems (i.e., via plant material) is not properly reflected in current risk assessment schemes, which primarily focus on waterborne toxicity and not on plant material as the route of uptake. To assist in risk assessment, the present study proposes a prioritization procedure of stream types based on the freshwater network and crop-specific cultivation data using maize in Germany as a model system. To identify stream types with a high probability of receiving crop materials, we developed a formalized, criteria-based and thus transparent procedure that considers the exposure-related parameters, ecological status--an estimate of the diversity and potential vulnerability of local communities towards anthropogenic stress--and availability of uncontaminated reference sections. By applying the procedure to maize, ten stream types out of 38 are expected to be the most relevant if the ecological effects from plant-incorporated pesticides need to be evaluated. This information is an important first step to identifying habitats within these stream types with a high probability of receiving crop plant material at a more local scale, including accumulation areas. Moreover, the prioritization procedure developed in the present study may support the selection of aquatic species for ecotoxicological testing based on their probability of occurrence in stream types having a higher chance of exposure. Finally, this procedure can be adapted to any geographical region or crop of interest and is, therefore, a valuable tool for a site-specific risk assessment of crop plants carrying systemic pesticides or novel proteins, such as insecticidal Bt toxins, expressed in genetically modified crops.

Identifying patients suitable for palliative care--a descriptive analysis of enquiries using a Case Management Process Model approach.

BACKGROUND: In Germany, case management in a palliative care unit was first implemented in 2005 at the Department of Palliative Medicine at the University Hospital Cologne. One of the purposes of this case management is to deal with enquiries from patients and their relatives as well as medical professionals. Using the Case Management Process Model of the Case Management Society of America as a reference, this study analysed (a) how this case management was used by different enquiring groups and (b) how patients were identified for case management and for palliative care services. The first thousand enquiries were analysed considering patient variables, properties of the enquiring persons and the content of the consultations. RESULTS: Most enquiries to the case management were made by telephone. The majority of requests regarded patients with oncological disease (84.3 %). The largest enquiring group was composed of patients and relatives (40.8 %), followed by internal professionals of the hospital (36.1 %). Most of the enquiring persons asked for a patient's admission to the palliative care ward (46.4 %). The second most frequent request was for consultation and advice (30.9 %), followed by requests for the palliative home care service (13.3 %). Frequent reasons for actual admissions were the need for the treatment of pain, the presence of symptoms and the need for nursing care. More than half of the enquiries concerning admission to the palliative care ward were followed by an admission. CONCLUSIONS: Case management has been made public among the relevant target groups. Case management as described by the Case Management Process Model helps to identify patients likely to benefit from case management and palliative care services. In addition, with the help of case management palliative patients may be allocated to particular health care services.

Estimated personal soot exposure is associated with acute myocardial infarction onset in a case-crossover study.

The current study investigates the association of estimated personal exposure to traffic-related air pollution and acute myocardial infarction (AMI). Cases of AMI were interviewed in the Augsburg KORA Myocardial Infarction Registry from February 1999 through December 2003, and 960 AMI survivors were included in the analyses. The time-varying component of daily personal soot exposure (the temporally variable contribution due to the daily area level of exposure and daily personal activities) was estimated using a linear combination of estimated mean ambient soot concentration, time spent outdoors, and time spent in traffic. The association of soot exposure with AMI onset was estimated in a case-crossover analysis controlling for temperature and day of the week using conditional logistic regression analyses. Estimated personal soot exposure was associated with AMI (relative risk, 1.30 per 1.1 m(-1) × 10(-5) [95% confidence interval, 1.09-1.55]). Estimated ambient soot and measured ambient PM(2.5) particulate matter 2.5 µm and smaller in aerodynamic diameter were not significantly associated with AMI onset. Our results suggest that an increase in risk of AMI in association with personal soot exposure may be in great part due to the contribution of personal soot from individual times spent in traffic and individual times spent outdoors. As a consequence, estimates calculated based on measurements at urban background stations may be underestimations. Health effects of traffic-related air pollution may need to be updated, taking into account individual time spent in traffic and outdoors, to adequately protect the public.

A New Method for in Situ Measurement of Bt-Maize Pollen Deposition on Host-Plant Leaves.

Maize is wind pollinated and produces huge amounts of pollen. In consequence, the Cry toxins expressed in the pollen of Bt maize will be dispersed by wind in the surrounding vegetation leading to exposure of non-target organisms (NTO). NTO like lepidopteran larvae may be affected by the uptake of Bt-pollen deposited on their host plants. Although some information is available to estimate pollen deposition on host plants, recorded data are based on indirect measurements such as shaking or washing off pollen, or removing pollen with adhesive tapes. These methods often lack precision and they do not include the necessary information such as the spatial and temporal variation of pollen deposition on the leaves. Here, we present a new method for recording in situ the amount and the distribution of Bt-maize pollen deposited on host plant leaves. The method is based on the use of a mobile digital microscope (Dino-Lite Pro, including DinoCapture software), which can be used in combination with a notebook in the field. The method was evaluated during experiments in 2008 to 2010. Maize pollen could be correctly identified and pollen deposition as well as the spatial heterogeneity of maize pollen deposition was recorded on maize and different lepidopteran host plants (Centaurea scabiosa, Chenopodium album, Rumex spp., Succina pratensis and Urtica dioica) growing adjacent to maize fields.

St. John's wort extract LI160 for the treatment of depression with atypical features - a double-blind, randomized, and placebo-controlled trial.

Preliminary data suggest that hypericum extract LI160 is effective in atypical depression. Reported is the outcome of an 8-week double-blind, placebo-controlled, randomized trial of 600 mg LI160 vs. placebo in patients with vegetative features of atypical depression, i.e. hyperphagia or hypersomnia. One-hundred (100) patients with mild and 100 patients with moderate severity of a major depression according to ICD-10 were randomized. Patients needed to meet a score of 2 in at least one of the items 22-26 of the Hamilton-Depression-Rating-Scale (HAM-D) 28-item version and episode duration of at least 3 months. The primary outcome variable was the relative change of the HAM-D(17) from Baseline. Secondary outcome variables were the depression sub-score of the Patient Health Questionnaire (PHQ-9), the Clinical Global Impression (CGI), a patient's satisfaction scale, the Hamilton-Anxiety-Scale (HAM-A) and the sum score of atypical vegetative symptoms of the HAM-D(28). The percentage reduction of the HAM-D(17) for LI160 compared to placebo approached statistical significance (p=0.051) in the Full Analysis Set (FAS)-population. Using the conventional criterion of the absolute reduction of the HAM-D(17) significance was achieved (p<0.05). No significant benefit could be observed for the sum score of the atypical vegetative items of the HAM-D(28;) however, the sum score of the hypersomnia items (items 22-24) showed a significant superiority for LI160. The HAM-A, PHQ-9, and CGI-I scales demonstrated superiority of LI160 (p<0.01). Confining the analysis to moderately depressed patients, a highly significant benefit for the primary outcome variable was revealed. The study supports the beneficial effect of LI160 in depression with atypical features and the validity of the definition of atypical depression on the basis of reversed vegetative signs. Further, it identifies the PHQ-9 as a useful outcome variable in this population.

Secretory cargo composition affects polarized secretion in MDCK epithelial cells.

Polarized epithelial cells secrete proteins at either the apical or basolateral cell surface. A number of non-epithelial secretory proteins also exhibit polarized secretion when they are expressed in polarized epithelial cells but it is difficult to predict where foreign proteins will be secreted in epithelial cells. The question is of interest since secretory epithelia are considered as target tissues for gene therapy protocols that aim to express therapeutic secretory proteins. In the parathyroid gland, parathyroid hormone is processed by furin and co-stored with chromogranin A in secretory granules. To test the secretion of these proteins in epithelial cells, they were expressed in MDCK cells. Chromogranin A and a secreted form of furin were secreted apically while parathyroid hormone was secreted 60% basolaterally. However, in the presence of chromogranin A, the secretion of parathyroid hormone was 65% apical, suggesting that chromogranin can act as a "sorting escort" (sorting chaperone) for parathyroid hormone. Conversely, apically secreted furin did not affect the sorting of parathyroid hormone. The apical secretion of chromogranin A was dependent on cholesterol, suggesting that this protein uses an established cellular sorting mechanism for apical secretion. However, this sorting does not involve the N-terminal membrane-binding domain of chromogranin A. These results suggest that foreign secretory proteins can be used as "sorting escorts" to direct secretory proteins to the apical secretory pathway without altering the primary structure of the secreted protein. Such a system may be of use in the targeted expression of secretory proteins from epithelial cells.

Double-blind, randomized evaluation of clinical efficacy and tolerability of an apple pectin-chamomile extract in children with unspecific diarrhea.

BACKGROUND: Acute diarrhea is one of the most common childhood diseases. The main aim of therapy is oral rehydration, mostly using a glucose-electrolyte solution. Results from a previous study (DIALOG I) investigating adjuvant treatment with a medicinal preparation containing an apple pectin-chamomile extract (Diarrhoesan) indicated a significantly reduced duration of diarrhea in children. OBJECTIVES: The objective of the present clinical placebo-controlled, double-blind study (DIALOG II) was to assess the clinical efficacy and tolerability of the apple pectin-chamomile extract on a larger number of patients. METHODS: The investigation was designed as a multicenter, randomized, double-blind, placebo-controlled parallel study enrolling 255 patients presenting with acute diarrhea. Patients were aged between 6 months and 6 years and treated on an outpatient basis with either an apple pectin-chamomile preparation or placebo. As a basic medication, each child received a glucose-electrolyte solution on the first day of treatment. RESULTS: The primary outcome (primary efficacy parameter) included a combined analysis of stool frequency, stool The statistical analysis revealed a superior efficacy of the tested preparation over placebo with a significantly reduced stool frequency in the treatment group compared to the control group. The results were corroborated by efficacy assessment performed by investigators and patients. Treatment was well tolerated, with an incidence of adverse effects similar to placebo. CONCLUSION: These findings support the concept of a beneficial influence of the investigated vegetable extract in shortening the course of the disease and relieving associated symptoms.

Topical treatment of chronic low back pain with a capsicum plaster.

The efficacy and tolerance of a capsicum plaster in non-specific low back pain was investigated in a double-blind, randomised, placebo-controlled multicentre parallel group study. A total of 320 patients were randomly assigned to two groups of n=160 subjects treated by the active or the placebo plaster. The main outcome measures used were a compound pain subscore of the Arhus low back rating scale (continuous variable), and a response criterion of a reduction in pain subscore=30% from baseline to final assessment (secondary, non-continuous variable). In addition, the partial pain scores, disability and mobility restriction subscores, the total score of the Arhus low back rating scale, the global evaluation of efficacy by investigator and patient, adverse events, a patient questionnaire on use of the plaster, and an evaluation of tolerance by investigator and patient were obtained. After 3 weeks treatment with capsicum and placebo plaster respectively, the compound pain subscore was reduced by 42% (capsicum) and 31% (placebo) from values on entry. Responder rate was 67% versus 49% (p=0.002). The investigators rated efficacy as "excellent" or "good" by 74% and 36%; the patient's efficacy rating "symptomfree" or "improved" reached 82% and 50%. Adverse local drug reactions were found in 12 patients (7.5%) on capsicum and 5 (3.1%) on placebo. No systemic side-effects were observed. The superiority of the treatment of chronic non-specific low back pain with capsicum plaster compared to placebo was clinically relevant and highly statistically significant. The capsicum plaster offers a genuine alternative in the treatment of non-specific low back pain.