Methodological challenges using routine clinical care data for real-world evidence: a rapid review utilizing a systematic literature search and focus group discussion.

Background: The integration of real-world evidence (RWE) from real-world data (RWD) in clinical research is crucial for bridging the gap between clinical trial results and real-world outcomes. Analyzing routinely collected data to generate clinical evidence faces methodological concerns like confounding and bias, similar to prospectively documented observational studies. This study focuses on additional limitations frequently reported in the literature, providing an overview of the challenges and biases inherent to analyzing routine clinical care data, including health claims data (hereafter: routine data).

Early life factors and later metabolic syndrome in European children and adolescents.

Background And Aims: Early life factors have been suggested to be associated with later cardiometabolic risk in children, adolescents and adults. Our study aimed to investigate the associations between early life factors and metabolic syndrome (MetS) in children and adolescents.

Methods And Results: Our analysis sample comprised of 8852 children aged 2-9 years at baseline that participated in up to three examination waves of the pan-European IDEFICS/I.

Low income, being without employment, and living alone: how they are associated with cognitive functioning-Results from the German national cohort (NAKO).

Aim was to investigate to what extent cognitive functioning differs by three socioeconomic conditions: low income, being without employment, and living alone. A total of N = 158,144 participants of the population-based German National Cohort (NAKO) provided data on socioeconomic conditions and completed cognitive tests. Multivariable confounder-adjusted regression analyses indicated that cognitive functioning was lower in those with low income (b = -0.

Protocol for lipid mediator profiling and phenotyping of human M1- and M2-monocyte-derived macrophages during host-pathogen interactions.

Here, we present a protocol for primary, human immune cell isolation and stimulation for lipid mediator profiling. We describe steps for the isolation of monocytes from human leukocyte concentrates via density centrifugation and differentiation/polarization toward M1- or M2-monocyte-derived macrophages (MDMs). We detail stimulation approaches of MDMs with live bacteria or influenza A virus for lipid mediator profiling and sample preparation for subsequent analysis, such as enzyme expression, mRNA analysis, or surface marker determination.

Aspergillus fumigatus-derived gliotoxin impacts innate immune cell activation through modulating lipid mediator production in macrophages.

Gliotoxin (GT), a secondary metabolite and virulence factor of the fungal pathogen Aspergillus fumigatus, suppresses innate immunity and supports the suppression of host immune responses. Recently, we revealed that GT blocks the formation of the chemotactic lipid mediator leukotriene (LT)B in activated human neutrophils and monocytes, and in rodents in vivo, by directly inhibiting LTA hydrolase. Here, we elucidated the impact of GT on LTB biosynthesis and the entire lipid mediator networks in human M1- and M2-like monocyte-derived macrophages (MDMs) and in human tissue-resident alveolar macrophages.

Individual differences in developmental trajectories of affective attention and relations with competence and social reticence with peers.

This study examined individual differences in affective attention trajectories in infancy and relations with competence and social reticence at 24 months. Data collection spanned 2017 to 2021. Infants ( = 297, 53% White, 49% reported as assigned male at birth) recruited in South Central and Central Pennsylvania and Northern New Jersey provided eye-tracking data at five assessments.

Medical management of endometriosis.

Purpose Of Review: While laparoscopic surgery plays a key role in the management of endometriosis, symptoms commonly recur, and repeat surgery comes with increased risk. Medical management, including hormonal and nonhormonal treatment, is vital in managing painful symptoms. This review summarizes recent evidence regarding various medical management options available to treat pelvic pain associated with endometriosis.

Implementing mobile eye tracking in psychological research: A practical guide.

Eye tracking provides direct, temporally and spatially sensitive measures of eye gaze. It can capture visual attention patterns from infancy through adulthood. However, commonly used screen-based eye tracking (SET) paradigms are limited in their depiction of how individuals process information as they interact with the environment in "real life".

Evaluation of a Digital Decision Aid for Knee Replacement Surgery.

Background: We studied whether an individualized digital decision aid can improve decision-making quality for or against knee arthroplasty.

Methods: An app-based decision aid (EKIT tool) was developed and studied in a stepped-wedge, cluster-randomized trial. Consecutive patients with knee osteoarthritis who were candidates for knee replacement were included in 10 centers in Germany.

Best timing of bilateral total hip arthroplasty - an analysis of revision and mortality rates from the German Arthroplasty Registry (EPRD).

Background: The burden of osteoarthritis (OA) in multiple joints is high and for patients with bilateral OA of the hip there is no clear recommendation about the indication for simultaneous (one-stage) bilateral total hip arthroplasty (THA) versus two-staged procedures. The purpose of this study was therefore to compare revision and mortality rates after different strategies of surgical timing in bilateral hip OA from the German Arthroplasty Registry (EPRD).

Methods: Since 2012 22,500 patients with bilateral THA (including 767 patients with one-staged bilateral surgery and 11,796 patients with another separate procedures within one year after first THA) are documented in the registry.

Serum heat shock protein concentrations are not associated with amyotrophic lateral sclerosis risk or survival in three European populations.

: Serum heat shock protein (HSP) concentrations have been reported as potential biomarkers for amyotrophic lateral sclerosis (ALS). Here, we investigate the role of serum HSP70, HSP90, and DNAJC7 as biomarkers for ALS. : Serum samples were collected from ALS patients and volunteer controls from three different clinical cohorts (in Germany, Ireland, and Italy).

Evidence-based and Patient-centered Indication for Knee Arthroplasty - Update of the Guideline.

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel.

Characterization of clinical serum cardiac biomarker levels in individuals with Friedreich ataxia.

Friedreich ataxia is a progressive autosomal recessive neurodegenerative disorder characterized by ataxia, dyscoordination, and cardiomyopathy. A subset of patients with Friedreich ataxia have elevated levels of serum cardiac troponin I, but associations with disease outcomes and features of cardiomyopathy remain unclear. In this study, we characterized clinically obtained serum cardiac biomarker levels including troponin I, troponin T, and B-type natriuretic peptide in subjects with Friedreich ataxia and evaluated their association with markers of disease.

Integrative metabolomics-genomics analysis identifies key networks in a stem cell-based model of schizophrenia.

Schizophrenia (SCZ) is a neuropsychiatric disorder, caused by a combination of genetic and environmental factors. The etiology behind the disorder remains elusive although it is hypothesized to be associated with the aberrant response to neurotransmitters, such as dopamine and glutamate. Therefore, investigating the link between dysregulated metabolites and distorted neurodevelopment holds promise to offer valuable insights into the underlying mechanism of this complex disorder.

Small fibre neuropathy in Fabry disease: a human-derived neuronal disease model and pilot data.

Acral burning pain triggered by fever, thermal hyposensitivity and skin denervation are hallmarks of small fibre neuropathy in Fabry disease, a life-threatening X-linked lysosomal storage disorder. Variants in the gene encoding alpha-galactosidase A may lead to impaired enzyme activity with cellular accumulation of globotriaosylceramide. To study the underlying pathomechanism of Fabry-associated small fibre neuropathy, we generated a neuronal disease model using patient-derived induced pluripotent stem cells from three Fabry patients and one healthy control.

Single-cell Profiling of Reprogrammed Human Neural Stem Cells Unveils High Similarity to Neural Progenitors in the Developing Central Nervous System.

Background: Similar to induced pluripotent cells (iPSCs), induced neural stem cells (iNSCs) can be directly converted from human somatic cells such as dermal fibroblasts and peripheral blood monocytes. While previous studies have demonstrated the resemblance of iNSCs to neural stem cells derived from primary sources and embryonic stem cells, respectively, a comprehensive analysis of the correlation between iNSCs and their physiological counterparts remained to be investigated.

Methods: Nowadays, single-cell sequencing technologies provide unique opportunities for in-depth cellular benchmarking of complex cell populations.

Now it's your turn!: Eye blink rate in a Jenga task modulated by interaction of task wait times, effortful control, and internalizing behaviors.

Dopamine is a versatile neurotransmitter with implications in many domains, including anxiety and effortful control. Where high levels of effortful control are often regarded as adaptive, other work suggests that high levels of effortful control may be a risk factor for anxiety. Dopamine signaling may be key in understanding these relations.

Differences in Anthropometric Measures Based on Sex, Age, and Health Status: Findings From the German National Cohort (NAKO).

Background: Obesity is a worldwide health problem. We conducted detailed analyses of anthropometric measures in a comprehensive, population-based, current cohort in Germany.

Methods: In the German National Cohort (NAKO), we analyzed cross-sectional data on body mass index (BMI), waist and hip circumference, subcutaneous (SAT) and visceral adipose tissue (VAT) as measured by ultrasound, and body fat percentage.

Alternative translation contributes to the generation of a cytoplasmic subpopulation of the Junín virus nucleoprotein that inhibits caspase activation and innate immunity.

The highly pathogenic arenavirus, Junín virus (JUNV), expresses three truncated alternative isoforms of its nucleoprotein (NP), i.e., NP, NP, and NP.

Girdlestone resection arthroplasty for femoral neck fractures has poorer outcomes than hemiarthroplasty in frail patients with increased risk for arthroplasty-related complications: a retrospective case study of 21 patients.

Background And Purpose: Hemiarthroplasty (HA) is the usual treatment for displaced femoral neck fractures (FNF) in elderly patients. Patients may be unsuitable for HA due to secondary conditions such as systemic infections or severe neurological conditions, which is why Girdlestone resection arthroplasty (GRA) may be an option. We aimed to determine (1) patient survival in matched patient groups treated with either GRA or HA and (2) functional outcomes.