"Such an institution represents the circle of life" - bringing an inpatient hospice into an academic setting: a pre-implementation exploratory study.

Background: To combine the benefits of hospice and palliative care, the integration of both seems self-evident. Aim of this study was to explore clinical staff's and volunteers' expectations and concerns of the first university hospice in Germany planning for implementation.

Methods: Staff and volunteers of the Department of Palliative Medicine of the University Hospital in Cologne received questionnaires and were interviewed following three themes of interest: opportunities, challenges, general criteria.

Communication about the desire to die: Development and evaluation of a first needs-oriented training concept - A pilot study.

Objective: Patients' desire to die (DD) is rarely discussed in palliative care (PC) due to health professionals' (HPs) feeling of uncertainty. The aim of the study was to develop and evaluate a training to increase HPs' self-confidence in responding professionally to patient's DD and to assess the feasibility of this approach.

Methods: The training course was developed via focus groups and relevant literature and refined with an advisory board.

Mobile Palliative Care Consultation Service (PCCS): Overview of Hospice and Palliative Care Evaluation (HOPE) Data on In-Patients With End-Stage Cancer, Multiple Sclerosis, and Noncancer, Nonneurological Disease From 4 PCCS Centers in Germany in 2013.

Context: During the last decade, numerous in-patient Palliative Care Consultation Service (PCCS) units were established throughout Germany.

Objective: To provide an epidemiological overview on a whole year cohort of palliative patients in terms of demography, complaints, and therapy on admission to PCCS and the impact of PCCS treatment, and identify differences and similarities in different palliative patient subgroups.

Methods: Chi-square, analysis of variance (ANOVA), Kruskal-Wallis followed by Games-Howell analysis of HOspice and Palliative care Evaluation (HOPE 2013) data on 4 PCCS centers and in total 919 patients, with solid tumors (237), metastatic cancer (397), leukemia and lymphoma (99), neurological (109, mostly multiple sclerosis [MS]), and noncancer, nonneurological disease (NCNND, 77).

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.

Workshop on Animal free Detection of Pertussis Toxin in Vaccines--Alternatives to the Histamine Sensitisation Test.

The Paul-Ehrlich-Institut (PEI), the Nederlands Vaccin Instituut (NVI) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised the international scientific workshop "Animal free Detection of Pertussis Toxin in Vaccines--Alternatives to the Histamine Sensitisation Test" at the PEI in Langen (Germany) on 09-10 June 2011. Twenty-seven experts (regulators, representatives from national control laboratories, vaccine manufacturers and academia) from 7 countries participated in this workshop. The meeting was triggered by the lack of satisfaction with the current safety testing for acellular pertussis vaccines, the "Histamine Sensitisation Test" (HIST) in mice, and the growing attention for the alternatives under development.

Bordetella Pertussis Toxin does not induce the release of pro-inflammatory cytokines in human whole blood.

Pertussis Toxin (PTx) is one of the most important virulence factors of Bordetella pertussis, the cause of whooping cough. Therefore, the inactivated toxin is an obligatory constituent of acellular pertussis vaccines. It is described in the literature that both native PTx and recombinant Pertussis Toxin (PTg) activate human monocytes whereas others report an inhibition of mammalian monocytes during pertussis infection.

Methicillin-resistant Staphylococcus aureus (MRSA) management in palliative care units and hospices in Germany: a nationwide survey on patient isolation policies and quality of life.

Background: For palliative care settings, little is known about the benefits of specific methicillin-resistant Staphylococcus aureus containment regimens and the burdens patient isolation imposes on affected patients, their families, and professional caregivers.

Aim: To explore the current practice of MRSA management and its impact on inpatients' quality of life as perceived by professional caregivers.

Design: Survey of inpatient palliative care institutions using 23-item questionnaires (infrastructural data: six items, management process: 14, clinical significance: three).

Laboratory Evaluation of the Effectiveness of Pathogen Reduction Procedures for Bacteria.

SUMMARY: Bacterial contamination remains a leading factor for transfusion-associated serious morbidity and mortality. Pathogen reduction procedures offer a pro-active approach to prevent bacterial contamination of cellular blood components and especially of platelet concentrates. In the past, the laboratory evaluation of the effectiveness of the pathogen reduction procedures to minimise the bacterial load of blood components has been primarily based on log reduction assays similar to the assessment of antiviral activities.

Monocyte activation test (MAT) reliably detects pyrogens in parenteral formulations of human serum albumin.

Disadvantages of the regulatory pyrogen test to assure safety of the end-product Human Serum Albumin (HSA) for parenteral use call for the implementation of an alternative test. In the current study, 16 HSA batches were assayed for pyrogens in parallel with the Rabbit Pyrogen Test, conventional and endotoxin-specific LAL assay and monocyte activation test (MAT). It was found that all HSA batches were contaminated with (1,3)-beta-glucans, which interfere with the conventional LAL.

Palliative care needs of chronically ill nursing home residents in Germany: focusing on living, not dying.

Objectives: To explore the palliative care needs of nursing home residents in Germany who had not yet entered the dying phase.

Methods: Semi-structured interviews were conducted with a sample of nine residents suffering from chronic disease or frailty. The interviews were audio-recorded, transcribed, and analysed using a grounded theory approach.

Lipopolysaccharide-induced experimental immune activation does not impair memory functions in humans.

Systemic immune activation occurring together with release of peripheral cytokines can affect behavior and the functioning of the central nervous system (CNS). However, it remains unknown whether and to what extent cognitive functions like memory and attention are affected during transient immune activation. We employed a human endotoxemia model and standardized neuropsychological tests to assess the cognitive effects of an experimental inflammation in two groups of 12 healthy young men before and after intravenous injection of lipopolysaccharide (LPS, Escherichia coli, 0.

[Aspects of outpatient palliative care and assessment of the nursing workload. Survey among care givers in Germany].

Introduction: The aim of this study is to explore aspects of the health care situation of outpatient palliative patients in Germany as well as effort and workload of care from the viewpoint of involved care givers. Additionally the future development with regard to the cooperation with other health care providers is assessed.

Methods: A detailed questionnaire was developed and sent to 188 outpatient care givers, all members of the German Association for Palliative Medicine, in January 2009.

Microbial safety of cell based medicinal products--what can we learn from cellular blood components?

Today, sterility of established parenteral drugs including biologicals, such as plasma derived products, is practically guaranteed. Bacterially contaminated products are extremely rare exceptions owing to the efficiency of the manufacturing processes in the pharmaceutical industry. In contrast, the manufacturing processes of cell based medicinal products or tissue preparations show much less defined conditions.

Bacteria detection by flow cytometry.

Since bacterial infection of the recipient has become the most frequent infection risk in transfusion medicine, suitable methods for bacteria detection in blood components are of great interest. Platelet concentrates are currently the focus of attention, as they are stored under temperature conditions, which enable the multiplication of most bacteria species contaminating blood donations. Rapid methods for bacteria detection allow testing immediately before transfusion in a bed-side like manner.

Methods for the detection of bacterial contamination in blood products.

Culture-based and molecular assays have been developed for the screening of platelet concentrates and other blood components for bacterial contaminations. In this review, the principles of the assays are outlined. The focus of this review is the assessment of the analytical qualities of the methods.

Strategies of bacteria screening in cellular blood components.

Since the impressive reduction of transfusion-transmitted virus infections, bacterial infections by blood transfusion represent the most important infection risk. Platelet concentrates are the current focus of attention, as they are stored under temperature conditions which allow growth of contaminating bacteria up to 10(10) and more microbes per platelet bag. This paper does not consider the pathogen reduction methods but will assess suitable screening methods.

Safety testing of cell-based medicinal products: opportunities for the monocyte activation test for pyrogens.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) pointed out the need to involve authorities throughout the process of validation and legal acceptance of alternatives to animal experiments. The Paul-Ehrlich-Institute (PEI), Federal Agency for Sera and Vaccines, is the national competent authority in Germany which is responsible for the quality and safety of biologicals including blood and cell-based products. This paper is intended to contribute to the discussion concerning the use of alternative methods in safety testing of medicinal products and considers the scientific work of the PEI in this field.

Fever in the test tube--towards a human(e) pyrogen test.

The human whole blood IL-1 test exploits the reaction of monocytes/macrophages for the detection of pyrogens: human whole blood taken from healthy volunteers is incubated in the presence of the test sample in any form, be it a solution, a powder or even solid material. Pyrogenic contaminations initiate the release of the "endogenous pyrogen" Interleukin-1beta determined by ELISA after incubation. In order to understand any differences between the pyrogenic activity in this test and the existing live rabbit test (species differences versus aberrant response of the particular blood sample), the rabbit whole blood test was developed.

International validation of pyrogen tests based on cryopreserved human primary blood cells.

Pyrogens as fever-inducing agents can be a major health hazard in parenterally applied drugs. For the control of these contaminants, pyrogen testing for batch release is required by pharmacopoeias. This has been done either by the in vivo rabbit pyrogen test (since 1942) or the limulus amoebocyte lysate test (LAL), since 1976.

A comparison of three rapid bacterial detection methods under simulated real-life conditions.

Background: Bacterial screening of all produced platelet concentrates (PCs) is implemented in many countries to reduce the risk of transfusion-transmitted sepsis. This study compares three rapid bacterial detection methods by imitating real-life conditions.

Study Design And Methods: The sensitivity of a solid-phase scanning cytometer (optimized Scansystem, Hemosystem), fluorescence-activated cell sorting (FACS) analysis, and 16S RNA in-house nucleic acid testing (NAT) was evaluated by spiking PCs with four transfusion relevant bacteria (Staphylococcus aureus, Bacillus cereus, Klebsiella pneumoniae, and Escherichia coli ).

Sterility testing of platelet concentrates prepared from deliberately infected blood donations.

Background: In general the bacterial count in freshly donated blood is low and even lower in the corresponding platelet concentrates (PCs). By use of flow cytometry (FACS) for sterility testing, the reliability of early versus later sampling times was evaluated.

Study Design And Methods: Blood donations were spiked with various numbers of Staphylococcus epidermidis, Staphylococcus aureus, Bacillus cereus, and Klebsiella pneumoniae.

Basics of flow cytometry-based sterility testing of platelet concentrates.

Background: Flow cytometry (FACS) is a common technique in blood banking. It is used, for example, for the enumeration of residual white blood cells in plasma and in cellular blood products. It was investigated whether it can also be applied for sterility testing of buffy coat-derived platelet concentrates (PCs).

Optimized Scansystem platelet kit for bacterial detection with enhanced sensitivity: detection within 24 h after spiking.

Background And Objectives: The prevention and detection of bacterial contamination of platelet concentrates remains a major challenge for transfusion medicine. To be suitable for blood-transfusion services, the contamination detection method must be highly sensitive, easy to perform and preferably of low cost. In this spiking study, we evaluated the new optimized Scansystem Platelet Kit detection method for use on apheresis platelets.

Optimisation of pyrogen testing in parenterals according to different pharmacopoeias by probabilistic modelling.

The rabbit test to detect pyrogenic contamination in parenterals is crucial to ensure patient safety. The pharmacopoeial tests in Europe, the US and Japan are based on the fever reaction of rabbits, but differ in their experimental design and in their algorithms to assess contamination. Employing an international reference endotoxin, fever can be induced in rabbits.