Definitions and major prerequisites of direct and indirect approaches for estimating reference limits.

Reference intervals are established either by direct or indirect approaches. Whereas the definition of direct is well established, the definition of indirect is still a matter of debate. In this paper, a general definition that covers all indirect models presently in use is proposed.

Problems with estimating reference change values (critical differences).

The concept of reference change values (RCVs) for diagnosis and monitoring of diseases has become well established. Several models habe been developed, e. g.

The importance of correct stratifications when comparing directly and indirectly estimated reference intervals.

Objectives: There are generally two major reasons for the comparison of reference intervals (RIs): when externally determined RIs (from the literature or provided by a manufacturer) are compared with presently used intra-laboratory RIs and when indirectly estimated RIs are compared with directly established RIs. Discrepancies within these comparisons may occur for two reasons: 1. the pre-analytical and/or analytical conditions do not agree and/or 2.

A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach.

All known direct and indirect approaches for the estimation of reference intervals (RIs) have difficulties in processing very skewed data with a high percentage of values at or below the detection limit. A new model for the indirect estimation of RIs is proposed, which can be applied even to extremely skewed data distributions with a relatively high percentage of data at or below the detection limit. Furthermore, it fits better to some simulated data files than other indirect methods.

Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study.

Purpose: Previous studies suggested that serum levels of microRNA (miR)-371a-3p (so-called M371 test) have a much higher sensitivity and specificity than the classic markers of testicular germ cell tumors (GCTs) and are applicable toward both seminoma and nonseminoma. We sought to confirm the usefulness of this test as a novel biomarker for GCT.

Patients And Methods: In a prospective, multicentric study, serum samples of 616 patients with testicular GCTs and 258 male controls were examined for serum levels of miRNA-371a-3p (miR levels) by quantitative polymerase chain reaction.

Challenges and Perspectives in Bridging In- and Outpatient Sectors: The Implementation of Two Alternative Models of Care and Their Effect on the Average Length of Stay.

New models of care aimed at reinforcing the outpatient sector have been introduced in Germany over the last few years. Initially, a subscription-based model ("integrated care") was introduced in 2012 in the Immanuel Klinik Rüdersdorf, wherein patients had to actively subscribe to the integrated care program. This integrated care model was replaced after 2 years by a subscription-free "model project," in which all patients insured by the contracting insurance company took part in the program.

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.

Critical comments to a recent EFLM recommendation for the review of reference intervals.

In a recent EFLM recommendation on reference intervals by Henny et al., the direct approach for determining reference intervals was proposed as the only presently accepted "gold" standard. Some essential drawbacks of the direct approach were not sufficiently emphasized, such as unacceptably wide confidence limits due to the limited number of observations claimed and the practical usability for only a limited age 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.].

Myocardial scintigraphy - a method for detecting cardiac comorbidity in psoriasis patients?

Background: In recent years, cardiac comorbidities in psoriasis patients have increasingly moved into the focus of clinical research. The objective of the present study was to evaluate myocardial scintigraphy as a screening method in patients with psoriasis.

Patients And Methods: Assessment of various comorbidities in 50 psoriasis patients without clinical symptoms of cardiac disease.

Myokardszintigraphie - eine Methode zur Erfassung der kardialen Komorbidität bei Psoriasis-Patienten?

Hintergrund: Kardiale Komorbiditäten bei Patienten mit Psoriasis stehen seit Jahren im Fokus. Ziel dieser Arbeit war es, im Rahmen einer Pilotstudie die Myokardszintigraphie als mögliche Früherkennungsmethode zu evaluieren.

Patienten Und Methodik: Es wurden bei insgesamt 50 kardial asymptomatischen Patienten mit einer Psoriasis der Haut verschiedene Begleiterkrankungen erfasst.

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 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.

HMGA2 expression distinguishes between different types of postpubertal testicular germ cell tumour.

The group of postpubertal testicular germ cell tumours encompasses lesions with highly diverse differentiation - seminomas, embryonal carcinomas, yolk sac tumours, teratomas and choriocarcinomas. Heterogeneous differentiation is often present within individual tumours and the correct identification of the components is of clinical relevance. HMGA2 re-expression has been reported in many tumours, including testicular germ cell tumours.

Serum Levels of MicroRNA miR-371a-3p: A Sensitive and Specific New Biomarker for Germ Cell Tumours.

Background: Clinical management of germ cell tumours (GCTs) relies on monitoring of serum tumour markers. However, the markers α-fetoprotein (AFP), the β-subunit of human chorionic gonadotropin (bHCG), and lactate dehydrogenase (LDH) are expressed in <60% of GCT cases.

Objective: To test the utility of the microRNAs (miRNAs) miR-371a-3p, miR-372-3p, miR-373-3p, and miR-367-3p as sensitive and specific GCT serum biomarkers.

Resources of dark skies in German climatic health resorts.

Illumination of nocturnal environments is increasing steadily worldwide. While there are some benefits for mankind, light at night affects animals, plants, and human health by blurring the natural distinction between day and night. International regulations exist to protect the environment for the maintenance of human health but nocturnal darkness is not considered.

Spatially valid data of atmospheric deposition of heavy metals and nitrogen derived by moss surveys for pollution risk assessments of ecosystems.

For analysing element input into ecosystems and associated risks due to atmospheric deposition, element concentrations in moss provide complementary and time-integrated data at high spatial resolution every 5 years since 1990. The paper reviews (1) minimum sample sizes needed for reliable, statistical estimation of mean values at four different spatial scales (European and national level as well as landscape-specific level covering Europe and single countries); (2) trends of heavy metal (HM) and nitrogen (N) concentrations in moss in Europe (1990-2010); (3) correlations between concentrations of HM in moss and soil specimens collected across Norway (1990-2010); and (4) canopy drip-induced site-specific variation of N concentration in moss sampled in seven European countries (1990-2013). While the minimum sample sizes on the European and national level were achieved without exception, for some ecological land classes and elements, the coverage with sampling sites should be improved.

Mercury species in dab (Limanda limanda) from the North Sea, Baltic Sea and Icelandic waters in relation to host-specific variables.

In the framework of the ICON project (Integrated Assessment of Contaminant Impacts on the North Sea), muscle tissue from a total of 135 common dab (Limanda limanda) (20-28 cm total length) was collected in seven offshore sampling areas in the North Sea, at Iceland and in the Baltic Sea during Aug/Sept and December 2008 for a chemical mercury speciation analysis by means of gas chromatography and detection by cold vapour atomic fluorescence spectroscopy (GC-CVAFS). There was a highly significant correlation between concentrations of methylmercury (MeHg) and inorganic mercury (Hg) in individual fish, and the mean ratio of MeHg compared to Σ Hg (MeHg + Hg) was 94.0%.

MicroRNA miR-371a-3p - A Novel Serum Biomarker of Testicular Germ Cell Tumors: Evidence for Specificity from Measurements in Testicular Vein Blood and in Neoplastic Hydrocele Fluid.

Background: microRNAs (miRs)-371-3 are suggested to be novel biomarkers of germ cell tumors (GCTs), but their specificity is unresolved. We aimed at clarifying the origin of miR 371a-3p by measuring this miR in peripheral vein blood, and in fluids present in the vicinity of GCTs.

Methods: miR-371a-3p levels were measured by quantitative PCR in 9 tumor surrounding hydroceles and in cubital vein blood (CVB) and testicular vein blood (TVB) of 64 GCT patients, 51 with clinical stage (CS) 1, 13 with CS2-3.

Diseases of dab (Limanda limanda): Analysis and assessment of data on externally visible diseases, macroscopic liver neoplasms and liver histopathology in the North Sea, Baltic Sea and off Iceland.

In the framework of the ICON project (Integrated Assessment of Contaminant Impacts on the North Sea), common dab (Limanda limanda) from seven offshore sampling areas in the North Sea, Icelandic waters and the western Baltic Sea were examined in 2008 for the presence of externally visible diseases and parasites (EVD), macroscopic liver neoplasms (tumours) (MLN) and histopathological liver lesions (LH). Methodologies applied followed standardised ICES and BEQUALM protocols. The EDV results revealed pronounced spatial variation, with dab from the central and northern North Sea sampling areas showing the highest disease prevalence.

Integrated indicator framework and methodology for monitoring and assessment of hazardous substances and their effects in the marine environment.

Many maritime countries in Europe have implemented marine environmental monitoring programmes which include the measurement of chemical contaminants and related biological effects. How best to integrate data obtained in these two types of monitoring into meaningful assessments has been the subject of recent efforts by the International Council for Exploration of the Sea (ICES) Expert Groups. Work within these groups has concentrated on defining a core set of chemical and biological endpoints that can be used across maritime areas, defining confounding factors, supporting parameters and protocols for measurement.

Quantity quotient reporting. Comparison of various models.

Quantity quotient (QQ) reporting has been proposed by several authors to improve or support the present situation of presenting quantitative laboratory results. This proposal is based on a concept (symmetrical model) known from the intelligence quotient, which was developed to make intelligence tests comparable. In laboratory medicine, however, most measurands follow a non-symmetrical (skewed) distribution, leading to a compression of the QQ values at the lower end of the reference interval.

[Subscription Rates of Psychiatric Patients to an Integrated Care Program in the Context of a Psychiatric Model Project].

In the past years different model projects have been developed in Germany to counteract the known deficits of the German psychiatric care system. Among these, an "integrated care" model project has been set up which offers a more flexible way of managing psychiatric care, especially for patients with a severe mental illness. It however implies an active subscription to the program.

Synthesis and mechanical evaluation of Sr-doped calcium-zirconium-silicate (baghdadite) and its impact on osteoblast cell proliferation and ALP activity.

For the first time the successful preparation of Sr doped baghdadite (Ca3-x Sr x ZrSi2O9 x  =  0.1 and 0.75) is shown.