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Phosphorus recycling from sewage sludge will be obligatory in Germany from 2029. Phosphorus content determination in sewage sludge is crucial to assess the prescribed recycling rates. Currently, German law regards sample preparation using aqua regia digestion in a microwave or under reflux conditions as well as instrumental phosphorus determination by ICP-OES, ICP-MS, or photometric determination with ammonium molybdate as equivalent. However, it is questionable whether these methods are indeed equivalent regarding phosphorus quantification in sludges near the limit of 20 g/kg for mandatory recycling. To answer this question, 15 sewage sludges of 11 different wastewater treatment plants were investigated with all permitted method (digestion and measurement) combinations. Moreover, one sewage sludge was also examined in an interlaboratory comparison (ILC) with 28 participants. This study shows that the above-mentioned methods differ in some cases significantly but across all method combinations and sludges, phosphorus recovery was between 80 and 121% after normalization to the grand mean (average of 15 sludges between 85 and 111%). The ILC and the examination of 15 sludges produced largely similar results. There is a tendency to higher phosphorus recovery after microwave digestion compared to reflux digestion and ICP-OES measurements determine higher phosphorus contents than ICP-MS and photometric phosphorus determination. As a result, the authors recommend ICP-OES determination of phosphorus in sewage sludge after microwave digestion. [ABSTRACT FROM AUTHOR]

Longitudinal studies regarding the reproducibility of Interferon-gamma release assay (IGRA) T-SPOT.TB for the diagnosis of Mycobacterium tuberculosis (M. tb) infection in serial testing are limited. We retrospectively analysed results of serially tested subjects in a medical laboratory in Germany over a time period of 14 years. From October 2004 to December 2018, a total of 5440 subjects were identified with a second T-SPOT.TB test after a median time interval of 258 days (interquartile range [IQR] 62–665). Consistently negative (n = 4520) or positive results (n = 682) were observed in 5202 (95.6%) subjects, indicating a high degree of concordance in serial testing (κ = 0.83). Test conversions occurred in 101 of 4621 (2.2%) subjects with initially negative tests. Of 819 subjects with initially positive test results, 137 (16.7%) had a test reversion which was associated with low spot numbers of the first test. Of 529 subjects retested within 1 year, only 60 (11.3%) displayed a test reversion. In subjects retested after more than 1 year, 77 of 290 (26.6%) tests reverted. This significantly higher rate of test reversions after more than 1 year was age-dependent and only observed in subjects above the age of 40 years. In the medical laboratory, the T-SPOT.TB test demonstrates a high reproducibility in serial testing. [ABSTRACT FROM AUTHOR]

Purpose: One of the most frequently cited radiomics investigations showed that features automatically extracted from routine clinical images could be used in prognostic modeling. These images have been made publicly accessible via The Cancer Imaging Archive (TCIA). There have been numerous requests for additional explanatory metadata on the following datasets — RIDER, Interobserver, Lung1, and Head–Neck1. To support repeatability, reproducibility, generalizability, and transparency in radiomics research, we publish the subjects' clinical data, extracted radiomics features, and digital imaging and communications in medicine (DICOM) headers of these four datasets with descriptive metadata, in order to be more compliant with findable, accessible, interoperable, and reusable (FAIR) data management principles. Acquisition and validation methods: Overall survival time intervals were updated using a national citizens registry after internal ethics board approval. Spatial offsets of the primary gross tumor volume (GTV) regions of interest (ROIs) associated with the Lung1 CT series were improved on the TCIA. GTV radiomics features were extracted using the open‐source Ontology‐Guided Radiomics Analysis Workflow (O‐RAW). We reshaped the output of O‐RAW to map features and extraction settings to the latest version of Radiomics Ontology, so as to be consistent with the Image Biomarker Standardization Initiative (IBSI). Digital imaging and communications in medicine metadata was extracted using a research version of Semantic DICOM (SOHARD, GmbH, Fuerth; Germany). Subjects' clinical data were described with metadata using the Radiation Oncology Ontology. All of the above were published in Resource Descriptor Format (RDF), that is, triples. Example SPARQL queries are shared with the reader to use on the online triples archive, which are intended to illustrate how to exploit this data submission. Data format: The accumulated RDF data are publicly accessible through a SPARQL endpoint where the triples are archived. The endpoint is remotely queried through a graph database web application at http://sparql.cancerdata.org. SPARQL queries are intrinsically federated, such that we can efficiently cross‐reference clinical, DICOM, and radiomics data within a single query, while being agnostic to the original data format and coding system. The federated queries work in the same way even if the RDF data were partitioned across multiple servers and dispersed physical locations. Potential applications: The public availability of these data resources is intended to support radiomics features replication, repeatability, and reproducibility studies by the academic community. The example SPARQL queries may be freely used and modified by readers depending on their research question. Data interoperability and reusability are supported by referencing existing public ontologies. The RDF data are readily findable and accessible through the aforementioned link. Scripts used to create the RDF are made available at a code repository linked to this submission: https://gitlab.com/UM‐CDS/FAIR‐compliant_clinical_radiomics_and_DICOM_metadata. [ABSTRACT FROM AUTHOR]

The proliferation marker Ki67 has prognostic and predictive values in breast cancer, and the cutoff of the Ki67 label index (LI) is a key index for chemotherapy. However, poor interobserver consistency in Ki67 assessment has limited the clinical use of Ki67, especially in luminal cancers. Here, we reported a modified Ki67 assessment method, size-set semiautomatic counting (SSSAC) and investigated its interobserver reproducibility. One hundred invasive breast cancer tissues were set immunostained for Ki67 in one laboratory, scanned as digital slides, and sent to 41 pathologists at the laboratories of 16 hospitals for Ki67 LI assessment using size-set semiautomatic counting (SSSAC), size-set visual assessment (SSVA) and size-set digital image analysis (SSDIA) with a specific image viewing software (Aperio Image Scope, Leica, Germany). The intraclass correlation coefficient (ICC) and Bland-Altman plot were used to evaluate interobserver reproducibility. The Wilcoxon signed-rank test was used to analyze the difference in the Ki67 values assessed by SSSAC and SSDIA. SSSAC demonstrated better interobserver reproducibility (ICC = 0.942) than SSVA (ICC = 0.802). The interobserver reproducibility was better in Ki67 homogeneously stained slides and centralized hot-spot slides than in scattered hot-spot slides. The Ki67 value assessed with SSSAC was obviously higher than that assessed with SSDIA (negative ranks (SSDIA < SSSAC): N = 80, sum of ranks = 4274.50; positive ranks (SSDIA > SSSAC): N = 17, sum of ranks = 478.50; Z = −6.837; P < 0.001). SSSAC shows satisfactory interobserver reproducibility in the Ki67 assessment of breast cancer and may be a candidate standard method for Ki67 LI assessment in breast cancer and other malignancies. • A modified method for Ki67 LI assessment based on digital image, size-set semiautomatic counting (SSSAC). • Investigated the interobserver reproducibility of SSSAC for Ki67 LI assessment of 100 cases in 41 pathologists of 16 hospitals. • SSSAC has better interobserver reproducibility than current visual assessment and was more accurate than DIA in Ki67 assessment. • SSSAC is a better choice for Ki67 LI assessment. [ABSTRACT FROM AUTHOR]

Aims and objectives To determine (1) What is the degree of interrater agreement and reliability of Glamorgan scale item and sum scores? and (2) Are Glamorgan scale sum scores valid? Background Pressure ulcer risk assessment scales are recommended for use in clinical practice. For paediatric patients, 12 instruments are currently described. Empirical evidence about the performance of Glamorgan scale scores in clinical practice is limited. Design An observational validation study was conducted on a paediatric cardiac unit of a large university hospital in Germany in April and May 2010. Methods Children were assessed simultaneously and independently by varying convenience samples of three nurses per assessment situation. Pressure ulcer risk was measured by the Glamorgan scale and a 100 mm Visual Analogue Scale (VAS). Proportions of agreement ( p o), multirater kappa and intraclass correlation coefficients were calculated. Results Thirty children were rated by 27 nurses. Median children's age was 5·5 years. Agreement among item scores was high, whereas reliability coefficients of item scores were low. Interrater reliability for the Glamorgan scale sum scores was higher than for VAS scores. Correlation between both scales was moderate. Conclusions High agreement among item scores indicates that nurses are able to make precise judgements. The low interrater reliability of item and sum scores indicates that nurses were unable to differentiate the rated children based on their item and sum scores, thus providing little additional clinical relevant information about pressure ulcer risk in this setting. Relevance to clinical practice The Glamorgan scale and the VAS are unable to make clear distinctions in a low-risk setting. Therefore, it is unlikely that the tools in this setting provide additional information for clinical decision making. Both tools are not recommended for daily use. [ABSTRACT FROM AUTHOR]

Use of a digital preparation assistant system may improve considerably the quality of preclinical dental education, provided the system works reliably. Thus, the purpose of this pilot study was to quantitatively assess the reliability of a new preclinical digital preparation assistant system (PREPassist, KaVo, Germany). The system was used to repeatedly scan four different unprepared and four different prepared teeth both with and without repositioning. Corresponding measurements were made to quantify accuracy, repeatability, and reproducibility. This was done by estimating the measurement error. Based on this estimation, respective limits of agreement were calculated. We used these ranges, along with assessments of the measurement's accuracy, to judge whether the results satisfy our expectations for clinically acceptable measurements. For preclinical laboratory instruction, the results indicate an acceptable accuracy (mean accuracy of 89 μm) of the measurements. This assessment applies as well to repeatability, given by the range of the respective limits of agreement (range <200 μm). However, in the case of reproducibility, the limits revealed discrepancies of practical importance (range >200 μm). Reproducibility of tooth repositioning in the available mounting device is unacceptable for preclinical laboratory instruction because of the observed range >200 μm. Thus, there is a need for the manufacture of new and more reliable mounting devices because reproducibility procedures are mostly encountered in preclinical instruction in restorative techniques. In contrast to reproducibility, accuracy and repeatability are acceptable for practical purposes. Balancing advantages and disadvantages, we conclude that, in general, the PREPassist system delivers reliable results. [ABSTRACT FROM AUTHOR]

Purpose: Assessment of the blood-brain barrier (BBB) permeability without the need for contrast agent is desirable, and the ability to measure the permeability to small molecules such as water may further increase the sensitivity in detecting diseases. This study proposed a time-efficient, noncontrast method to measure BBB permeability to water, evaluated its test-retest reproducibility, and compared it with a contrast agent-based method., Methods: A single-delay water extraction with phase-contrast arterial spin tagging (WEPCAST) method was devised in which spatial profile of the signal along the superior sagittal sinus was used to estimate bolus arrival time, and the WEPCAST signal at the corresponding location was used to compute water extraction fraction, which was combined with global cerebral blood flow to estimate BBB permeability surface area product to water. The reliability of WEPCAST sequence was examined in terms of intrasession, intersession, and inter-vendor (Philips [Ingenia, Best, the Netherlands] and Siemens [Prisma, Erlangen, Germany]) reproducibility. Finally, we compared this new technique to a contrast agent-based method., Results: Single-delay WEPCAST reduced the scan duration from approximately 20 min to 5 min. Extract fraction values estimated from single-delay WEPCAST showed good consistency with the multi-delay method (R = 0.82, P = .004). Group-averaged permeability surface area product values were found to be 137.5 ± 9.3 mL/100 g/min. Intrasession, intersession, and inter-vendor coefficient of variation of the permeability surface area product values were 6.6 ± 4.5%, 6.9 ± 3.7%, and 8.9 ± 3.0%, respectively. Finally, permeability surface area product obtained from WEPCAST MRI showed a significant correlation with that from the contrast-based method (R = .73, P = .02)., Conclusion: Single-delay WEPCAST MRI can measure BBB permeability to water within 5 min with an intrasession, intersession, and inter-vendor test-retest reproducibility of 6% to 9%. This method may provide a useful marker of BBB breakdown in clinical studies., (© 2021 International Society for Magnetic Resonance in Medicine.)

There is still some doubt about the reproducibility of patch tests. A sound assessment needs optimized and unbiased studies. This study analysed the results of a double-blind multicentre study with nickel sulfate and potassium dichromate patch tests attached synchronously to both sides of the back of patients with a history of nickel allergy, conducted with a highly standardized randomized test system (TRUE-test ®). Out of 589 patients tested, a total of 388 had responded with allergic reactions to nickel sulfate and 130 to potassium dichromate. The reproducibility of positive nickel (dichromate) patch tests was 99.2 % (90.8 % ). The reaction index was also calculated, which relates the number of allergic reactions obtained with a test preparation to the number of questionable and irritant reactions; the reaction index can range from -1 (questionable and irritant reactions only occur) to 1 (allergic reactions only occur). For nickel sulfate the reaction index was 0.91, but it was only 0.23 for potassium dichromate, as a result of considerably more questionable reactions. In conclusion, a highly synchronous reproducibility of results can be achieved by using a well-standardized patch-test system, especially withnickel sulfate. However,distinct allergens and test systems need to be evaluated separately. [ABSTRACT FROM AUTHOR]

Myocardial strain is a convenient parameter to quantify left ventricular (LV) function. Fast strain-encoding (fSENC) enables the acquisition of cardiovascular magnetic resonance images for strain-measurement within a few heartbeats during free-breathing. It is necessary to analyze inter-vendor agreement of techniques to determine strain, such as fSENC, in order to compare existing studies and plan multi-center studies. Therefore, the aim of this study was to investigate inter-vendor agreement and test-retest reproducibility of fSENC for three major MRI-vendors. fSENC-images were acquired three times in the same group of 15 healthy volunteers using 3 Tesla scanners from three different vendors: at the German Heart Institute Berlin, the Charité University Medicine Berlin-Campus Buch and the Theresien-Hospital Mannheim. Volunteers were scanned using the same imaging protocol composed of two fSENC-acquisitions, a 15-min break and another two fSENC-acquisitions. LV global longitudinal and circumferential strain (GLS, GCS) were analyzed by a trained observer (Myostrain 5.0, Myocardial Solutions) and for nine volunteers repeatedly by another observer. Inter-vendor agreement was determined using Bland-Altman analysis. Test-retest reproducibility and intra- and inter-observer reproducibility were analyzed using intraclass correlation coefficient (ICC) and coefficients of variation (CoV). Inter-vendor agreement between all three sites was good for GLS and GCS, with biases of 0.01-1.88%. Test-retest reproducibility of scans before and after the break was high, shown by ICC- and CoV values of 0.63-0.97 and 3-9% for GLS and 0.69-0.82 and 4-7% for GCS, respectively. Intra- and inter-observer reproducibility were excellent for both parameters (ICC of 0.77-0.99, CoV of 2-5%). This trial demonstrates good inter-vendor agreement and test-retest reproducibility of GLS and GCS measurements, acquired at three different scanners from three different vendors using fSENC. The results indicate that it is necessary to account for a possible bias (< 2%) when comparing strain measurements of different scanners. Technical differences between scanners, which impact inter-vendor agreement, should be further analyzed and minimized.DRKS Registration Number: 00013253.Universal Trial Number (UTN): U1111-1207-5874.

Studies of how the microbiome varies among individuals, populations, and abiotic conditions are critical for understanding this key component of an organism's biology and ecology. In the case of Daphnia, aquatic microcrustaceans widely used in population/community ecology and environmental science studies, understanding factors that influence microbiome shifts among individuals is useful for both basic and applied research contexts. In this study, we assess differences in the microbiome among genotypes of D. magna collected from three regions along a large latitudinal gradient (Finland, Germany, and Israel). After being reared in the lab for many years, we sought to characterize any differences in genotype- or population-specific microbial communities, and to assess whether the microbiota varied among temperatures. Our study is similar to a recent comparison of the microbial communities among D. magna genotypes raised in different temperatures published by Sullam et al. (Microb Ecol 76(2):506-517, 2017), and as such represents one of the first examples of a reproducible result in microbiome research. Like the previous study, we find evidence for a strong effect of temperature on the microbiome of D. magna, although across a much smaller temperature range representing potential near-future climates. In addition, we find evidence that the microbiomes of D. magna genotypes from different regions are distinct, even years after being brought into the laboratory. Finally, our results highlight a potentially common finding in the expanding area of microbiome research-differences among treatments are not necessarily observed in the most abundant taxonomic groups. This highlights the importance of considering sampling scheme and depth of coverage when characterizing the microbiome, as different experimental designs can significantly impact taxon-specific results, even when large-scale effects are reproduced.

Objectives: Androstenedione is an androgen produced as an intermediate product of the biosynthesis of testosterone and estradiol in testicles, ovaries and also in the adrenal cortex. Measurement is used for diagnosing and differentiating hirsutism and virilisation, enzyme deficiencies of the steroid hormone biosynthesis, and in suspicion of androgen-producing tumors., Methods: Specimens included de-identified residual serum specimens submitted for routine testing and banked adult and pediatric sera. Samples were measured with tandem mass spectrometry, two automated immunoassays, the newly developed DiaSorin LIAISON androstenedione assay, the Immulite assay, and a radioimmunoassay (Beckman Coulter) according to manufacturer's protocols. All methods were correlated, and the analytical sensitivity, linearity and imprecision of each assay determined. Diagnostic accuracy with respect to detection of PCOS in women was evaluated by verifying the respective reference ranges of the different assays and receiver operating characteristic (ROC) curve analysis., Results: Due to the methodology, LC-MS/MS demonstrated the highest analytical specificity, good performance and excellent diagnostic accuracy. The best agreement was found with the LIAISON chemiluminescent immunoassay method. Due to its lower analytical sensitivity, the measured values in children were often outside the measuring range. Although, the coefficient of correlation between LC-MS/MS and the Beckman Coulter radioimmunoassay was lower, the assay demonstrated the best analytical sensitivity and a similar diagnostic accuracy in adults. The Immulite androstenedione chemiluminescent immunoassay showed the poorest performance and was not interchangeable with the other assays., Conclusions: These data suggest the LIAISON androstenedione assay may be a suitable alternative for the measurement of androstenedione in serum of adult patients with all advantages of a fully automated assay., (Copyright © 2018. Published by Elsevier Inc.)

Background and Objective: The development and evaluation of interventions in long-term care is time-consuming and expensive due to their complexity. To ensure reproducibility and successful implementation, these interventions must be described and published in a comprehensible and qualitative manner. The aim of this study is to analyze intervention studies from the inpatient long-term care setting with regard to their completeness, reporting quality, transparency and thus reproducibility., Method: The completeness and the reporting quality of the interventions described in the publications were examined in the context of a selective literature review by means of intervention studies from the long-term care setting (n=22). To this end, the Template for Intervention Description and Replication (TIDieR) checklist and the Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 (CReDECI2-DE) list were used. Transparency criteria included study registration and access to study protocols., Results: The TIDieR checklist examination revealed that only three studies contained all the information necessary; the CReDECI2 test provided a complete description for only one study. Frequent shortcomings were observed concerning the information on modifications and titrations for the study participants and the location. Protocols were available for eight studies, 14 studies were registered., Conclusions: In terms of science, this means that the reproducibility of scientific findings is limited, which is why they cannot provide secure knowledge. As a result, the practical benefit to be derived from published studies that are accessible to decision-makers is limited as well. As far as publishers are concerned they should pay more attention to the completeness, registration and availability of materials., (Copyright © 2018. Published by Elsevier GmbH.)

Objective: This study evaluated the responses of the retinal and cutaneous microcirculation to acute hyperlipidemia and hyperhomocysteinemia., Methods: Twenty-five clinically healthy men (mean age 24 ± 2 years) were studied four times in a randomized order, with intervals of at least one week between the two dietary interventions always preceded by a day for baseline assessment. The two interventions consisted of either 0.1 g/kg l-methionine to induce hyperhomocysteinemia or of 500 ml whipping cream (30% fat) to induce hyperlipidemia. Microvascular vasodilator responses to flickering-light and to cutaneous acetylcholine iontophoresis were assessed by retinal vessel analysis and laser Doppler flowmetry respectively., Results: The fat load produced significant increases in triglycerides and total cholesterol which was accompanied by a reduction of the retinal arterial flicker response. Methionine administration induced a threefold increase in homocysteine levels and a concomitant decrease in retinal venous flicker response. Acute hyperlipidemia and hyperhomocysteinemia had no effect on cutaneous microvascular vasodilator responses to acetylcholine. The inter- and intra-subject reproducibility was higher for retinal vessel analysis as compared to laser Doppler flowmetry., Conclusion: The retinal microcirculation is more sensitive to metabolic changes than the cutaneous microcirculation and can be reliably assessed by retinal vessel analysis. Reproducibility of retinal vessel analysis may be enhanced by multi-vessel assessment., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Skin cleansers for occupational use are manufactured for different types and degrees of soiling without common, legally binding requirements for product testing. This leads to different, manufacturer-specific test methods and a lack of comparable information on skin cleansing products., Objectives: The aim of this investigation was to validate a newly developed standardized automated cleansing device (ACiD) for in vivo evaluation of industrial skin cleansers., Methods: Two ACiD were tested regarding the intra- and inter-device specific reproducibility of test results., Results: Skin cleansing process carried out by the three independent washing modules which constitute an ACiD-unit and two separate ACiD-units led to highly comparable results. There was no significant difference between the washing modules or between the two separate ACiD-units detected. Only different parameter settings resulted in significantly different detergency., Conclusions: Intra- and inter-device specific test results of an in vivo model of skin cleansing using the automated cleansing device (ACiD) were reproducible. The long-term aim is a standardized classification of occupational skin cleansing products comparing their skin cleansing effectiveness in relation to their skin irritancy. This might then provide the basis for a rational specific product selection by consumers and may be used as a tool for future product development by manufacturers., (© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)