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Successful participation in Proficiency Testing/Interlaboratory Comparison (PT/ILC) schemes is a method to ensure validity of results for any laboratory. It is also a component of a complex of means for demonstrating technical competence of a laboratory as an organization. The new accreditation standard ISO 17043 for PT providers together with the newly updated ILAC Policy of PT participation introduce a different perspective on the activity of PT provider in regard to quality assurance. Technical and management requirements from the ISO 17043:2023 that are essential for a competent activity of PT/provider are identified with a rationale for their increased importance. This importance is related both to the practical impact on the PT/ILC providers’ customers (laboratories) activity and laboratory benefits of participation in PT/ILS schemes besides the traditional qualitative and quantitative interpretation of their participation. Identified requirements are accompanied by a practical and explained potential implementation strategy which is aligned with the ILAC Policy on PT/ILC participation. Successful implementation of the essential requirements of the ISO 17043:2023 is a necessary step for any PT/ILC provider that seeks credibility on the proficiency testing market. Such implementation may also be an important step towards full implementation of the ISO 17043:2023 and achieving accreditation thus benefiting from full confidence in the activities of the provider.

ABSTRACT IN GERMAN: Gesundheitsdienstleister sind zunehmend gefordert, neben qualitätsorientierten Zielen insbesondere ökonomische Ziele umzusetzen. Vor diesem Hintergrund ist der Bedarf nach betriebswirtschaftlichen Instrumenten zur Unterstützung dieser Ziele entsprechend hoch. Behandlungspfade bilden eine geeignete Bezugsgröße, die eine Dokumentation und Bewertung relevanter Prozesse und Leistungen ermöglichen. Um dies zu gewährleisten, ist eine verursachungsgerechte Kostenbestimmung und -verrechnung notwendig. Der Beitrag skizziert ein Pfadkostenmodell, welches Kosten und Leistungen von Behandlungspfaden auf verschiedenen Aggregationsstufen für das Controlling von Gesundheitseinrichtungen zur Verfügung stellt. // ABSTRACT IN ENGLISH: Health Care Institutions are increasingly challenged to fulfill economical aims besides quality-orientated aims. For this reason there is a need for economical instruments which are able to support those aims. Clinical Pathways seem to be a good concept to document, analyse and compare relevant processes and activities in the health care sector. For this reason it is necessary to define and allocate the costs fairly. This paper demonstrates an activity-based costing model for clinical pathways, which is able to provide the costs and the activities of clinical pathways on several aggregation levels. Therefore it can be of high use for the controlling of health care institutions. Reprinted by permission of Nomos Verlagsgesellschaft

Gesundheitsdienstleister sind zunehmend gefordert, neben qualitätsorientierten Zielen insbesondere ökonomische Ziele umzusetzen. Vor diesem Hintergrund ist der Bedarf nach betriebswirtschaftlichen Instrumenten zur Unterstützung dieser Ziele entsprechend hoch. Behandlungspfade bilden eine geeignete Bezugsgröβe, die eine Dokumentation und Bewertung relevanter Prozesse und Leistungen ermöglichen. Um dies zu gewährleisten, ist eine verursachungsgerechte Kostenbestimmung und - Verrechnung notwendig. Der Beitrag skizziert ein Pfadkostenmodell, welches Kosten und Leistungen von Behandlungspfaden auf verschiedenen Aggregationsstufen fur das Controlling von Gesundheitseinrichtungen zur Verfügung stellt. Health Care Institutions are increasingly challenged to fulfill economical aims besides qualityorientated aims. For this reason there is a need for economical instruments which are able to support those aims. Clinical Pathways seem to be a good concept to document, analyse and compare relevant processes and activities in the health care sector. For this reason it is necessary to define and allocate the costs fairly. This paper demonstrates an activity-based costing model for clinical pathways, which is able to provide the costs and the activities of clinical pathways on several aggregation levels. Therefore it can be of high use for the controlling of health care institutions.

The majority of patients with epithelial ovarian cancer (EOC) continue to be diagnosed at an advanced stage despite great advances in this disease treatment. To impact overall survival, we need better methods of EOC early diagnosis. We performed a case control study to predict high-grade serous cancer (HGSC) using artificial intelligence methodology and methylated DNA from surgical specimens. Initial prediction models with MethylNet were accurate but complex (AUC = 100%). We optimized these models by selecting the most informative probes with univariate ANOVA analyses first, and then multivariate lasso regression modelling. This step-wise approach resulted in 9 methylated probes predicting HGSC with an AUC of 100%. These models were validated with different analytics and with an independent DNA-methylation experiment with excellent performances.

The epigenome offers an additional facet of cancer that can help categorize patients into those at risk of disease, recurrence, or treatment failure. We conducted a retrospective, nested, case-control study of advanced and recurrent high-grade serous ovarian cancer (HGSOC) patients in which we assessed epigenome-wide association using Illumina methylationEPIC arrays to characterize DNA methylation status and RNAseq to evaluate gene expression. Comparing HGSOC tumors with normal fallopian tube tissues we observe global hypomethylation but with skewing towards hypermethylation when interrogating gene promoters. In total, 5,852 gene interrogating probes revealed significantly different methylation. Within HGSOC, 57 probes highlighting 17 genes displayed significant differential DNA methylation between primary and recurrent disease. Between optimal vs suboptimal surgical outcomes 99 probes displayed significantly different methylation but only 29 genes showed an inverse correlation between methylation status and gene expression. Overall, differentially methylated genes point to several pathways including RAS as well as hippo signaling in normal vs primary HGSOC; valine, leucine, and isoleucine degradation and endocytosis in primary vs recurrent HGSOC; and pathways containing immune driver genes in optimal vs suboptimal surgical outcomes. Thus, differential DNA methylation identified numerous genes that could serve as potential biomarkers and/or therapeutic targets in HGSOC.

The aim of article was to assess the risk for random errors in outcomes graded as high certainty of evidence (CoE). We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using Grading of Recommendations Assessment, Development, and Evaluation. To detect increased risks for random errors, two investigators independently conducted trial sequential analysis using conventional thresholds for type I (α = 0.05) and type II (β = 0.10) errors. We dually regraded all outcomes with increased risks for random errors and conducted multivariate logistic regression analyses to determine predictors of increased risks for random errors. Overall, 38% (95% confidence interval: 28–47%) of high CoE outcomes had increased risks for random errors. Outcomes assessing harms were more frequently affected than outcomes assessing benefits (47% vs. 12%). Regrading of outcomes with increased random errors showed that 74% should have been downgraded based on current guidance. Regression analyses rendered small absolute risk differences (P = 0.009) and low number of events (P = 0.001) as significant predictors of increased risks for random errors. Decisionmakers need to be aware that outcomes rated as high CoE often have increased risks for false-positive or false-negative findings.

To assess the effects of abbreviated literature searches on evidence syntheses conclusions. We randomly selected 60 Cochrane reviews of clinical interventions and repeated literature searches using 14 abbreviated approaches (combinations of MEDLINE, Embase, CENTRAL with and without searches of reference lists). If abbreviated searches missed included studies, we recalculated meta-analyses. Cochrane authors determined whether the new evidence base would change conclusions. We assessed the noninferiority of abbreviated searches allowing for a maximum of 10% changed conclusions. We conducted 840 abbreviated literature searches. Noninferiority varied based on the definition of “changed conclusion”. When the reduction of the certainty of a conclusion was of concern, all abbreviated searches were inferior. Searching Embase only rendered the greatest proportion of changed conclusions (27%, 95% confidence interval [CI]: 16%–40%); combining MEDLINE, Embase, CENTRAL with searches of references lists the lowest (8%, 95% CI 3%–18%). When falsely reaching an opposite conclusion was of concern, combining one database with another or with searches of reference lists was noninferior to comprehensive searches (2%, 95% CI: 0%–9%). If decision-makers are willing to accept less certainty and a small risk for opposite conclusions, some abbreviated searches are viable options for rapid evidence syntheses. Decisions demanding high certainty require comprehensive searches.

Background Web applications that employ natural language processing technologies to support systematic reviewers during abstract screening have become more common. The goal of our project was to conduct a case study to explore a screening approach that temporarily replaces a human screener with a semi-automated screening tool. Methods We evaluated the accuracy of the approach using DistillerAI as a semi-automated screening tool. A published comparative effectiveness review served as the reference standard. Five teams of professional systematic reviewers screened the same 2472 abstracts in parallel. Each team trained DistillerAI with 300 randomly selected abstracts that the team screened dually. For all remaining abstracts, DistillerAI replaced one human screener and provided predictions about the relevance of records. A single reviewer also screened all remaining abstracts. A second human screener resolved conflicts between the single reviewer and DistillerAI. We compared the decisions of the machine-assisted approach, single-reviewer screening, and screening with DistillerAI alone against the reference standard. Results The combined sensitivity of the machine-assisted screening approach across the five screening teams was 78% (95% confidence interval [CI], 66 to 90%), and the combined specificity was 95% (95% CI, 92 to 97%). By comparison, the sensitivity of single-reviewer screening was similar (78%; 95% CI, 66 to 89%); however, the sensitivity of DistillerAI alone was substantially worse (14%; 95% CI, 0 to 31%) than that of the machine-assisted screening approach. Specificities for single-reviewer screening and DistillerAI were 94% (95% CI, 91 to 97%) and 98% (95% CI, 97 to 100%), respectively. Machine-assisted screening and single-reviewer screening had similar areas under the curve (0.87 and 0.86, respectively); by contrast, the area under the curve for DistillerAI alone was just slightly better than chance (0.56). The interrater agreement between human screeners and DistillerAI with a prevalence-adjusted kappa was 0.85 (95% CI, 0.84 to 0.86%). Conclusions The accuracy of DistillerAI is not yet adequate to replace a human screener temporarily during abstract screening for systematic reviews. Rapid reviews, which do not require detecting the totality of the relevant evidence, may find semi-automation tools to have greater utility than traditional systematic reviews.

The aim of this study was to investigate whether the lack of signal transducer and activator of transcription 5 (STAT5) in mature adipocytes of obese mice ( Stat5 Adipoq mice) improves glucose and lipid metabolism as previously observed in lean mice. Male Stat5 Adipoq mice and their wild type (WT) littermates were fed high-fat diet (HFD). Effects of adipocyte STAT5 deficiency on adiposity as well as on glucose and lipid metabolism were determined under ad libitum feeding and after weight loss induced by calorie restriction. Compared to WT mice, obese Stat5 Adipoq mice showed modestly accelerated weight gain and blunted depletion of fat stores under calorie restriction (reduction in % body fat after 3 weeks: WT, -9.3±1.1, vs Stat5 Adipoq , -5.9±0.8, p = 0.04). No differences were observed between S tat5 Adipoq and WT mice with regard to parameters of glucose and lipid metabolism including basal glycaemia, glucose tolerance, and plasma triglycerides. In conclusion, STAT5 deficiency in the adipocyte of HFD-fed obese mice was associated with increased fat accumulation. In contrast to previous findings in lean mice, however, lipid accumulation was not associated with any improvement in glucose and lipid metabolism. Our results do not support adipocyte STAT5 as a promising target for the treatment of obesity-associated metabolic derangements.

Background Due to the growing need to provide evidence syntheses under time constraints, researchers have begun focusing on the exploration of rapid review methods, which often employ single-reviewer literature screening. However, single-reviewer screening misses, on average, 13% of relevant studies, compared to 3% with dual-reviewer screening. Little guidance exists regarding methods to recover studies falsely excluded during literature screening. Likewise, it is unclear whether specific study characteristics can predict an increased risk of false exclusion. This systematic review aimed to identify supplementary search methods that can be used to recover studies falsely excluded during literature screening. Moreover, it strove to identify study-level predictors that indicate an elevated risk of false exclusions of studies during literature screening. Methods We performed literature searches for eligible studies in MEDLINE, Science Citation Index Expanded, Social Sciences Citation Index, Current Contents Connect, Embase, Epistemonikos.org, and Information Science & Technology Abstracts from 1999 to June 23, 2020. We searched for gray literature, checked reference lists, and conducted hand searches in two relevant journals and similar article searches current to January 28, 2021. Two investigators independently screened the literature; one investigator performed the data extraction, and a second investigator checked for correctness and completeness. Two reviewers assessed the risk of bias of eligible studies. We synthesized the results narratively. Results Three method studies, two with a case-study design and one with a case-series design, met the inclusion criteria. One study reported that all falsely excluded publications (8%) could be recovered through reference list checking compared to other supplementary search methods. No included methods study analyzed the impact of recovered studies on conclusions or meta-analyses. Two studies reported that up to 8% of studies were falsely excluded due to uninformative titles and abstracts, and one study showed that 11% of non-English studies were falsely excluded. Conclusions Due to the limited evidence based on two case studies and one case series, we can draw no firm conclusion about the most reliable and most valid method to recover studies falsely excluded during literature screening or about the characteristics that might predict a higher risk of false exclusion. Systematic review registration https://osf.io/v2pjr/