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Accessible and easy-to-use standardized bioinformatics workflows are necessary to advance microbiome research from observational studies to large-scale, data-driven approaches. Standardized multi-omics data enables comparative studies, data reuse, and applications of machine learning to model biological processes. To advance broad accessibility of standardized multi-omics bioinformatics workflows, the National Microbiome Data Collaborative (NMDC) has developed the Empowering the Development of Genomics Expertise (NMDC EDGE) resource, a user-friendly, open-source web application (https://nmdc-edge.org). Here, we describe the design and main functionality of the NMDC EDGE resource for processing metagenome, metatranscriptome, natural organic matter, and metaproteome data. The architecture relies on three main layers (web application, orchestration, and execution) to ensure flexibility and expansion to future workflows. The orchestration and execution layers leverage best practices in software containers and accommodate high-performance computing and cloud computing services. Further, we have adopted a robust user research process to collect feedback for continuous improvement of the resource. NMDC EDGE provides an accessible interface for researchers to process multi-omics microbiome data using production-quality workflows to facilitate improved data standardization and interoperability.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.

Marketing products/services internationally entails a bold decision that has high-cost implications and significant performance consequences: Should the firm standardize or adapt its marketing strategy across borders? The dilemma is a seminal issue, and perhaps the most enduring in international marketing scholarship. However, despite the voluminous work on the topic, an ontological assumption induces inconclusive conceptualizations and impedes theoretical advancement. The author contends that a self-contained, atomistic representation of the standardization/adaptation decision is such an impediment. This work problematizes a portrayal of the decision as if it is taken following a detached, own judgment of broad environmental contingencies. In turn, the study builds on fit literature and promotes an alternative perspective that acknowledges relational imperatives for requisite theorizing. Hence, standardization/adaptation is framed as a coconstituted process toward relational fit, with international marketing strategies being contingent on the role of significant "others." [ABSTRACT FROM AUTHOR]

IntroductionTau-positron emission tomography (PET) outcome data of patients with Alzheimer's disease (AD) cannot currently be meaningfully compared or combined when different tracers are used due to differences in tracer properties, instrumentation, and methods of analysis.MethodsUsing head-to-head data from five cohorts with tau PET radiotracers designed to target tau deposition in AD, we tested a joint propagation model (JPM) to harmonize quantification (units termed "CenTauR" [CTR]). JPM is a statistical model that simultaneously models the relationships between head-to-head and anchor point data. JPM was compared to a linear regression approach analogous to the one used in the amyloid PET Centiloid scale.ResultsA strong linear relationship was observed between CTR values across brain regions. Using the JPM approach, CTR estimates were similar to, but more accurate than, those derived using the linear regression approach.DiscussionPreliminary findings using the JPM support the development and adoption of a universal scale for tau-PET quantification.HighlightsTested a novel joint propagation model (JPM) to harmonize quantification of tau PET. Units of common scale are termed "CenTauRs". Tested a Centiloid-like linear regression approach. Using five cohorts with head-to-head tau PET, JPM outperformed linearregressionbased approach. Strong linear relationship was observed between CenTauRs values across brain regions.

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To accelerate and facilitate clinical trials, the Ataxia Global Initiative (AGI) was established as a worldwide research platform for trial readiness in ataxias. One of AGIs major goals is the harmonization and standardization of outcome assessments. Clinical outcome assessments (COAs) that describe or reflect how a patient feels or functions are indispensable for clinical trials, but similarly important for observational studies and in routine patient care. The AGI working group on COAs has defined a set of data including a graded catalog of COAs that are recommended as a standard for future assessment and sharing of clinical data and joint clinical studies. Two datasets were defined: a mandatory dataset (minimal dataset) that can ideally be obtained during a routine clinical consultation and a more demanding extended dataset that is useful for research purposes. In the future, the currently most widely used clinician-reported outcome measure (ClinRO) in ataxia, the scale for the assessment and rating of ataxia (SARA), should be developed into a generally accepted instrument that can be used in upcoming clinical trials. Furthermore, there is an urgent need (i) to obtain more data on ataxia-specific, patient-reported outcome measures (PROs), (ii) to demonstrate and optimize sensitivity to change of many COAs, and (iii) to establish methods and evidence of anchoring change in COAs in patient meaningfulness, e.g., by determining patient-derived minimally meaningful thresholds of change.

The documentation, preservation and rescue of biological diversity increasingly uses living biological samples. Persistent associations between species, biosamples, such as tissues and cell lines, and the accompanying data are indispensable for using, exchanging and benefiting from these valuable materials. Explicit authentication of such biosamples by assigning unique and robust identifiers is therefore required to allow for unambiguous referencing, avoid identification conflicts and maintain reproducibility in research. A predefined nomenclature based on uniform rules would facilitate this process. However, such a nomenclature is currently lacking for animal biological material. We here present a first, standardized, human-readable nomenclature design, which is sufficient to generate unique and stable identifying names for animal cellular material with a focus on wildlife species. A species-specific human- and machine-readable syntax is included in the proposed standard naming scheme, allowing for the traceability of donated material and cultured cells, as well as data FAIRification. Only when it is consistently applied in the public domain, as publications and inter-institutional samples and data are exchanged, distributed and stored centrally, can the risks of misidentification and loss of traceability be mitigated. This innovative globally applicable identification system provides a standard for a sustainable structure for the long-term storage of animal bio-samples in cryobanks and hence facilitates current as well as future species conservation and biomedical research.

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are 300 mg/dL (16.7 mmol/L), respectively, and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels are suggested that enable the collection of comparator data with these characteristics. This work is an important step toward establishing a future standard for the performance evaluation of CGM systems.

Numerous studies have focused on digital twins (DTs) and their applications. However, a common method for evaluating the performance of DTs is lacking. Digital twins performance assessment mechanism is crucial when improving or monitoring any process or system in a business, such a strategy could serve as a guide to help researchers and practitioners create more effective digital twins. Guided by these challenges, we propose a structured method for measuring the performance and flexibility of digital twins, and our study provides a procedure for quantitative calculation of the performance of DTs based on four key performance indicators (KPIs). Moreover, we propose a new KPI, DTflex, for determining the flexibility of digital twins. We evaluated the performance of DTflex as a KPI to demonstrate its use as a simple tool for designers and practitioners to quickly compare different DT methodologies, which might provide valuable input for the iterative improvement of DTs to increase their efficiency in future applications. The knowledge provided along with the method proposed in this paper is expected to help researchers and practitioners working in different fields to compare DT methodologies and DT performance which will lead to higher efficiency DT solutions and increased re-usage of existing DTs. [ABSTRACT FROM AUTHOR]

Digoxin, a cardiac glycoside, is widely used in the treatment of cardiovascular diseases. Due to its narrow therapeutic range, precise monitoring of its blood concentration is essential. A reference measurement procedure (RMP) is pivotal for ensuring result accuracy and comparability. The RMP for serum digoxin by ID-LC-MS/MS was optimized with sample pre-treatment and detection processes, and the bracketing calibration method was used, which facilitates more accurate measurement, especially for extreme concentrations. The performance of this optimized RMP was thoroughly evaluated. The limit of detection (LoD) was 0.05 ng/mL (0.06 nmol/L) and the lowest limit of quantification (LLoQ) was 0.10 ng/mL (0.13 nmol/L). The intra- and inter-assay imprecisions were 2.24%, 2.51%, 1.40% and 1.72%, 1.65%, 0.97% at 0.5, 2.0, 5.0 ng/mL, respectively. Recoveries were 99.63 to 101.42% and the linear response ranged from 0.1 to 10.0 ng/mL. The relative bias was 0.41% and 2.00% of our results compared with the median of all participating reference laboratories for IFCC-RELA (External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine) 2023A and 2023B. The uncertainty, calibration and measurement capability (CMC) of this method were also evaluated. The optimized RMP was applied in the Trueness Verification Plan of Southern China, which indicates significant differences among clinical systems, highlighting the need for standardization efforts. In addition, two commonly used clinical systems which employed immunoassay methods were compared with this optimized RMP, and 26 individual serum samples were analyzed. The good correlations indicate the feasibility of standardization for serum digoxin. The optimized RMP serves as an accurate reference baseline for routine methods, aiming to enhance the accuracy and precision of measurements in clinical laboratories. [ABSTRACT FROM AUTHOR]

Standardization and harmonization are widely studied by scholars of Science and Technology Studies (STS) to understand how knowledge and things circulate across geographies, yet it often remains unclear what these terms exactly refer to. In dictionaries, they are generally defined as actions or processes aimed at achieving uniformity, similarity, or alignment. In STS literature, it is often assumed that when a practice is (un)successfully standardized or harmonized, the circulation of knowledge and things across distance and difference is made (im)possible. However, it is questionable whether the geographical circulation of things and knowledge is necessarily enabled by the uniformity of practices. When analyzing the global exchange of financial intelligence, a different picture emerges, whereby the coordination of security operations and the exchange of financial intelligence are actually enabled by disparate quantification practices. Financial Intelligence Units (FIUs) – governmental organizations that globally exchange financial intelligence for combatting money laundering and terrorist financing – are geographically scattered and very different in nature, each constructing security threats such as terrorism or terrorist financing uniquely. Yet through their complex quantification practices, they make coordination possible while persisting in maintaining differences, without relying on an increasingly uniform and universal sameness of practices. For FIUs, quantification practices, even though differently practiced, generate a shared domain with its own transnational, depoliticized, and highly technical proxy grammar that makes it possible to work beyond and background otherwise incommensurable issues. [ABSTRACT FROM AUTHOR]

Testing practices and the construct of English both serve separately and interactionally to promote activities of modernity and coloniality. Tests categorize and rank learning and knowledge in discrete, static ways. The construct of the English language through standardization and other processes upholds linguistic purism ideologies. Such concerns in both areas lead to the guiding question: What and whose purposes are being served with testing in English? In engaging with this question, the author posits that decolonizing approaches to testing and the construct of English are needed. In this article, she presents assessment practices developed within Indigenous learning contexts that can inform general approaches to assessment and language with implications for English language testing. In doing so, the article offers actions toward imaginative and creative reconfigurations of English testing according to epistemologies of communities that have confronted colonialist activities. [ABSTRACT FROM AUTHOR]

The article deals with the use of the 5S methodology in an organization. It focuses on the implementation of 5S in an organization involved in the production and processing of metal components for the automotive industry. 5S is a Japanese methodology that was first applied in the automotive industry to improve productivity. The article is dedicated to the basic principles of lean manufacturing.The practical part analyses the state of the workplaces before the introduction of 5S and the actual implementation of this methodology. The implementation of 5S brings a number of benefits to the organization, including: - reducing time wasted searching for tools, - improving safety, - boosting employee morale, - building the culture of the organization. Keeping the workspace organized with visual aids helps to increase productivity and reduce waste. The ultimate goal of 5S is continuous improvement in the workplace. The final section evaluates the benefits to the organization after the implementation of 5S. By implementing this strategy, the workplace becomes clean and standardized, allowing employees to work as efficiently as possible. The 5S method creates a more efficient work environment by improving the organization and optimizing the system of operation. [ABSTRACT FROM AUTHOR]

Standards allow companies to improve their competitiveness and achieve their strategic goals. Encouraging a strong willingness among firms to develop and implement standards is a complex task; consequently, the linkages between internal and external factors influencing this willingness require further exploration. This study considers interorganizational learning as an intermediate mechanism for empirical research and investigates the relationship between external motivation for collective action and a firm's willingness to participate in standards development. To verify the proposed theoretical model, this study used a questionnaire to collect 205 responses from companies belonging to the Zhejiang Brand Building Association. Structural equation modeling was conducted to verify the research framework. The results of this study reveal that an association's organizational capability has a direct positive effect on its willingness to develop and implement standards; however, government support and industrial scale have no significant positive direct effects on collective action willingness. Moreover, knowledge acquisition and knowledge application have mediating effects on the relationship between external motivation for collective action and willingness for collective action. This study analyzes the factors influencing a firm's participation in standardization activities on the basis of a collective action perspective and the mediating role of interorganizational learning. This study contributes to the literature by developing collective action and interorganizational learning theories. [ABSTRACT FROM AUTHOR]

When patients lack information about their medications, they are more likely to experience adverse events that may have costly health outcomes. One possible approach for improving the information that patients receive about their medications is to standardize the written information that pharmacies provide so that it is uniform and easier to read. While patients have expressed a preference for this standardization, no previous study has provided nationally representative estimates of its monetary benefits. In this paper, we estimate willingness to pay (WTP) to measure the potential benefits of standardizing the medication information leaflets that pharmacies provide to patients. We use data collected from an online, nationally representative, stated preference survey administered to non-institutionalized adults age 18 and over in the United States. Survey respondents were randomized to receive either open-ended valuation questions or referendum-style valuation questions. Responses from the open-ended questions suggest a mean WTP between approximately $3 and $13 per year depending on the treatment of outliers. Regression results suggest that those who received the referendum-style questions would be willing to pay, on average, just under $7 per year for the standardization. [ABSTRACT FROM AUTHOR]

The presented guidelines are an update of the position paper, endorsed by the International Osteoporosis Foundation (IOF), on nomenclature of bone markers published over 2 decades ago. Novel insight into bone biology and pathophysiology of bone disorders has highlighted the increasing relevance of new and known mediators implicated in various aspects of bone metabolism. This updated guideline proposes the nomenclature Bone Status Indices (BSI) as the comprehensive classification rather than bone turnover markers, bone markers, metabolic markers of bone turnover or metabolic markers of bone turnover, that are currently in use for the implicated molecules. On behalf of the IFCC Committee on Bone Metabolism and the Joint IOF Working Group and IFCC Committee on Bone Metabolism, the authors propose standardized nomenclature, abbreviations and measurement units for the bone status indices. [ABSTRACT FROM AUTHOR]

Background: Total hip and knee arthroplasties are among the most effective and widely performed procedures in modern medicine, providing substantial benefits to patients with end-stage osteoarthritis. These surgeries have transformed the treatment of degenerative joint disease, significantly enhancing functionality and quality of life for patients. Despite considerable advancements in surgical techniques and postoperative care, managing postoperative pain remains a major challenge, impacting both clinical recovery and patient satisfaction. The persistence of postoperative pain as a barrier to recovery underscores the need for improved pain management strategies. Methods: A comprehensive narrative review of the literature was conducted, focusing on the physiological mechanisms underlying surgical pain, the role of anesthesia techniques, and the development of multimodal pain management approaches used in total joint arthroplasty. This review emphasizes the components of modern multimodal strategies, which combine multiple pharmacologic and non-pharmacologic methods to address the various mechanisms of postoperative pain. Results: Current pain management strategies employ a dynamic, multimodal approach that covers the perioperative period. These strategies aim to optimize pain control while minimizing side effects. They incorporate a range of methods, including nerve blocks, non-opioid analgesics, opioids, and non-pharmacologic techniques such as physical therapy. However, evidence regarding the efficacy and optimal combinations of these interventions varies widely across studies. Conclusions: This variation has led to inconsistent pain management practices across institutions. To standardize and improve care, this paper presents the authors' institutional pain management model, offering a potential framework for broader application and adaptation in the field of joint arthroplasty. [ABSTRACT FROM AUTHOR]

As a critical metabolite, the standardization of lactate quantification is increasingly crucial. Therefore, we developed LaconicSF, a lactate-responsive biosensor exhibiting exceptional specificity in lactate detection. LaconicSF enables efficient lactate quantification in CHO cell culture medium and holds potential as a user-friendly detection tool for lactate quantification in vitro. [ABSTRACT FROM AUTHOR]

Antimicrobial resistance (AMR) poses an increasing threat to global health. To deliberate the distribution and transmission of environmental resistance in a wide geographic and longitudinal scope, standardization of the analytical methods is desperately required for the extensive implementation of large-scale environmental antibiotic resistance gene (ARGs) surveillance. In this review, a standardized surveillance method using metagenomic analysis, coupled with proper quantification tools and environmental reference materials as technical benchmarks, was established to facilitate the generation of comparable and informative resistome datasets. As global and long-term ARGs surveillance has recently been performed in various environmental compartments, increasing efforts are also needed for assessing the health risks of ARGs. The development of risk assessment schemes that incorporate factors including transfer potential, host species, viability, and absolute quantification is essential to the regulatory guidelines for high-risk priority ARGs. This review provides guidance to ARGs surveillance regarding the level and the risk of ARG exposure, especially to identify and address critical hotspots. [ABSTRACT FROM AUTHOR]

This study developed an Occupational Personality Inventory (OPI). Specifically, it answered and accomplished the following objectives: (1) To construct items of the proposed Occupational Personality Inventory based on literature and studies. (2) To establish the validity of the proposed Occupational Personality Inventory by: (1.1) Face Validity and (2.2) Content Analysis. (3) To establish the reliability of the proposed Occupational Personality Inventory by Test Re-Test Design. (4) To establish a standardization process of the proposed Occupational Personality Inventory. Research and Development (R&D) was the research method used in the study. Most of the items were found valid after it underwent experts' face validation and Lawshe's content validity method. The items garnered an excellent reliability using test re-test method. A manual was made for the uniformity of administration of the test and consistent scoring of the inventory to guarantee the standardization process. The study's findings led to the conclusions that the items of the created Occupational Personality Inventory evaluated and represented various occupational personalities of the employees; employees were discriminated against based on their occupational personalities according to the items in the scale; every item in the inventory met statistical validity requirements; and the reliability index of the OPI is excellent. [ABSTRACT FROM AUTHOR]

The use of x‐ray fluorescence (XRF) instruments for metallome analysis of herbarium specimens to discover hyperaccumulator plant species has gained popularity, but a growing concern arises about intercomparability from the use of different instrument makes and models. Therefore, this study aimed to assess the performance and comparability of the results generated by three different XRF instruments and three different quantification methods (empirical calibration based on XRF versus inductively coupled plasma atomic emission spectroscopy [ICP‐AES] regression, in‐built manufacturer algorithms, and an independent GeoPIXE software pipeline based on Fundamental Parameters). Three instruments with distinct specifications were chosen to improve the generalizability of the results, ensuring relevance to a wide range of instruments that may be used in the future for metallome analysis of herbarium specimens. Each instrument was used to scan a representative set of dried hyperaccumulator plant leaf samples, and their accuracy in quantifying elemental concentrations was then compared. The manufacturer algorithms overestimate the elemental concentrations and have the highest errors. The empirical calibrations have the closest mean concentration to the mean concentrations reported by ICP‐AES, but can produce negative values. The independent pipeline performance is marginally better than the empirical calibration, but it takes substantially more time and effort to setup the Fundamental Parameters through reverse engineering the instrument hardware parameters. Using the GeoPIXE independent pipeline to extract the XRF peak intensity to use in the empirical calibration performs better than manufacturer algorithms, while avoiding the complicated setup requirements, and this should be considered for further development. [ABSTRACT FROM AUTHOR]

With the rapid development of quantum computing technology, existing public key cryptographic systems face severe challenges. This article first discusses the basic principles and applications of public key cryptography, explaining the important role of these systems in modern information security. It then analyzes the threat of quantum computers, particularly the powerful potential of future quantum computing in solving specific complex mathematical problems, which may render widely used public key cryptographic systems such as Rivest-Shamir-Adleman (RSA) and Elliptic Curve Cryptography (ECC) vulnerable. Against this backdrop, the article introduces the development of post-quantum cryptography, explaining the process of the US government promoting the standardization of post-quantum cryptographic algorithms and the mathematical tools used by these post-quantum cryptographic systems to effectively defend against quantum computer attacks. Finally, it explores the current status and challenges of post-quantum cryptography migration and its applications, emphasizing the need for collaboration among government, businesses, and academia to develop transition plans and strategies to ensure effective information security protection before the quantum computing threat truly manifests. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to assess the short‐term outcomes of robotic colorectal surgery implemented through a structured, standardized training pathway in five colorectal centres in the United Kingdom. Method: A multicentre retrospective observational study was conducted, involving 523 consecutive patients who underwent robotic colorectal resection between 2015 and 2019. All participating centres followed the European Academy of Robotic Colorectal Surgery training pathway. Patient data, including demographics, operative details, postoperative outcomes and pathology results, were collected and analysed. Results: The study included 447 rectal resections and 76 colonic operations. The median age of the patients was 64.7 years, with the majority of patients (70%) being men. The mean body mass index was 27.4 kg/m2, and 89.7% of the patients underwent surgery for malignancy. The overall conversion rate to open surgery was 4.2%. The median length of stay was 6 days and there was no 30‐day mortality. The readmission and reoperation rates were 8.8% and 7.3%, respectively. The anastomotic leak rate was 4.1% for rectal resections and 3.9% for colonic resections. Pathological examination showed a positive circumferential resection margin rate of 2.6%. Conclusion: Through the implementation of a structured, standardized training pathway, the participating colorectal centres in the UK achieved safe and effective robotic colorectal surgery pathways with favourable short‐term oncological and clinical outcomes. Further studies examining long‐term and functional outcomes are needed to assess the broader impact of robotic surgery in colorectal procedures. [ABSTRACT FROM AUTHOR]

In quantitative ankle stress sonography, different examiners use different techniques, which may cause measurement variability. This study aimed to clarify whether standardizing stress sonography techniques reduces variability in the quantitative measurement of anterior talofibular ligament length change. Fourteen examiners with a mean ultrasound experience of 8.7 years participated in this study. Each examiner performed stress ultrasonography of the ankle using their preferred method on one patient with an intact anterior talofibular ligament (Patient 1) and on two patients with chronic ankle instability (Patient 2 and 3). Changes in the ligament length between the resting and stressed positions were determined. A consensus meeting was then conducted to standardize the sonographic technique, which was used by the examiners during a repeat stress sonography on the same patients. The variance and measured values were compared between the preferred and standardized techniques using F-tests and paired t-tests, respectively. At a consensus meeting, a sonographic technique in which the examiner pushed the lower leg posteriorly against the fixed foot was adopted as the standardized technique. In Patient 1, the change in the anterior talofibular ligament length was 0.4 (range, −2.3–1.3) mm and 0.6 (−0.6–1.7) mm using the preferred and standardized techniques, respectively, with no significant difference in the variance (P = 0.51) or the measured value (P = 0.52). The length changes in Patient 2 were 2.0 (0.3–4.4) mm and 1.7 (−0.9–3.8) mm using the preferred and standardized techniques, respectively. In Patient 3, the length changes were 1.4 (−2.7–7.1) mm and 0.7 (−2.0–2.3) mm. There were no significant differences between the techniques in either patient group. Variability in the quantitative measurement of ankle stress sonography was not reduced despite the standardization of the technique among examiners. Hence, comparing the measured values between different examiners should be avoided. [ABSTRACT FROM AUTHOR]

Data in social and behavioral sciences typically contain measurement errors and do not have predefined metrics. Structural equation modeling (SEM) is widely used for the analysis of such data, where the scales of the manifest and latent variables are often subjective. This article studies how the model, parameter estimates, their standard errors (SEs), and the corresponding z-statistics are affected by the scales of the manifest and latent variables. Analytical and empirical results show that (1) the normal-distribution-based likelihood ratio statistic is scale-invariant with respect to scale changes of manifest and latent variables as well as to anchor change of latent variables; (2) the normal-distribution-based maximum likelihood (NML) parameter estimates are scale-equivariant with respect to scale-change of manifest and latent variables as well as to anchor change of latent variables; (3) standard errors (SEs) following the NML method are parallel-scale-equivariant with respect to scale changes of the manifest and latent variables; and (4) the z-statistics are scale-invariant with respect to scale changes of the manifest and latent variables. However, only (1) and (2) hold if latent variables are rescaled by changing anchors. Nevertheless, parameters that are not directly related to latent variables with changing anchors are still scale-equivariant and their z-statistics are still scale-invariant. The results are expected to advance understanding of SEM analysis, and also facilitate result interpretation and comparison across studies as in meta analysis. [ABSTRACT FROM AUTHOR]

Background: Comparing outcomes across different health measurement tools is essential where various patient-reported outcome measures (PROMs) are used. In spinal surgery, where recent studies show that over 30 different PROMs are applied, this need becomes even more pressing. Although several statistical transformations between the Oswestry Disability Index (ODI) and the PROMIS Profile 29 have been proposed, validation studies on conversion equations and cross-walk tables remain limited. In this study, we examined the agreement between observed ODI scores and those predicted from the PROMIS Profile 29 in a large sample of patients with low back pain, collected from routine clinical care. Methods: We compared the performance of regression and linking models at both the individual and group levels. Using Bland–Altman plots, we assessed the mean difference, 95% limits of agreement, root mean squared error (RMSE), and standardized mean differences (Cohen's d) between predicted and observed ODI scores. Results: While group-level agreement was satisfactory, with negligible effect sizes, individual prediction accuracy was relatively poor. Additionally, regression models showed inconsistent performance across the ODI score range, though incorporating more domains marginally improved predictions. Conclusions: The equipercentile linking approach demonstrated stable agreement across all ODI scores, making it the preferred method. Future regression models should account for nonlinear relationships between PROMs to enhance prediction accuracy. [ABSTRACT FROM AUTHOR]

The widespread use of milk mid-infrared (MIR) spectroscopy for phenotype prediction has urged the application of prediction models across regions and countries. Spectra standardization is the most effective way to reduce the variability in the spectral signal provided by different instruments and labs. This study aimed to develop different standardization models for MIR spectra collected by multiple instruments, across 2 provinces of China, and investigate whether the standardization method (piecewise direct standardization, PDS, and direct standardization, DS), testing scenario (standardization of spectra collected on the same day or after 7 mo), infrared prediction model accuracy (high or low), and instrument (6 instruments from 2 brands) affect the performance of the standardization model. The results showed that the determination coefficient (R2) between absorbance values at each wavenumber provided by the primary and the secondary instruments increased from less than 0.90 to nearly 1.00 after standardization. Both PDS and DS successfully reduced spectra variation among instruments, and performed significantly better than nonstandardization. However, DS was more prone to overfitting than PDS. Standardization accuracy was higher when tested using spectra collected on the same day compared with those collected 7 mo after, but great improvement in model transferability was obtained for both scenarios compared with the nonstandardized spectra. The less accurate infrared prediction model (for C8:0 and C10:0 content) benefited the most from spectra standardization compared with the more accurate model (for total fat and protein content). For spectra collected 7 mo after standardization, after PDS the root mean square error between predictions obtained by different machines decreased on average by 86% and 94% compared with the values before standardization for C8:0 and C10:0, respectively. The secondary instrument had no significant effect on the R2 between predictions. The variation in the spectral signal provided by different instruments was successfully reduced by standardization across 2 provinces in China. This study lays the foundations for developing a national MIR spectra database to provide consistent predictions across provinces to be used in dairy farm management and breeding programs in China. Additionally, this provides opportunities for data exchange and cooperation at international levels. The list of standard abbreviations for JDS is available at adsa.org/jds-abbreviations-24. Nonstandard abbreviations are available in the Notes. [ABSTRACT FROM AUTHOR]

Quantitative evidence synthesis methods aim to combine data from multiple medical trials to infer relative effects of different interventions. A challenge arises when trials report continuous outcomes on different measurement scales. To include all evidence in one coherent analysis, we require methods to "map" the outcomes onto a single scale. This is particularly challenging when trials report aggregate rather than individual data. We are motivated by a meta‐analysis of interventions to prevent obesity in children. Trials report aggregate measurements of body mass index (BMI) either expressed as raw values or standardized for age and sex. We develop three methods for mapping between aggregate BMI data using known or estimated relationships between measurements on different scales at the individual level. The first is an analytical method based on the mathematical definitions of z‐scores and percentiles. The other two approaches involve sampling individual participant data on which to perform the conversions. One method is a straightforward sampling routine, while the other involves optimization with respect to the reported outcomes. In contrast to the analytical approach, these methods also have wider applicability for mapping between any pair of measurement scales with known or estimable individual‐level relationships. We verify and contrast our methods using simulation studies and trials from our data set which report outcomes on multiple scales. We find that all methods recreate mean values with reasonable accuracy, but for standard deviations, optimization outperforms the other methods. However, the optimization method is more likely to underestimate standard deviations and is vulnerable to non‐convergence. [ABSTRACT FROM AUTHOR]

Background: Fecal Microbiota Transplant (FMT) is an effective treatment for recurring Clostridioides Difficile Infections (rCDI). FMT administered via oral capsules (caFMT) offers several practical advantages to conventional liquid FMT. We began using caFMT in 2021 imported from an external institution. Based on similar production methods, we began our own caFMT production in 2022. We aimed to evaluate the quality of our caFMT. Study Design and Methods: We created a database of all FMT treatments (n = 180) provided by our institution. Quality of all FMT was evaluated by treatment success rates. We compared our caFMT to the imported caFMT. Results: Our caFMT yielded similar success rates compared to that of the imported caFMT, 65% (CI 95% 58–72%) and 72% (CI 95% 66–79%) respectively. FMT administered via colonoscopy had a significantly higher success rate, 79% (CI 95% 73–85%) than own our caFMT and other routes of administration. The combined success rate of treatments increased notably for all routes of administration when repeating FMT after prior failure. Discussion: The fact that our caFMT compared similarly to the imported caFMT was viewed as a success in terms of quality assurance. Our caFMT had a slightly lower success rates compared to data from other studies, but could be affected by several other factors than our FMT-production methods. A lower success rate of caFMT compared to FMT via colonoscopy is acceptable due to the practical advantages offed by caFMT. Our study serves as a practical example, proving that of the standardization of caFMT production is indeed viable. [ABSTRACT FROM AUTHOR]

MRI has gained prominence in the diagnostic workup of prostate cancer (PCa) patients, with the Prostate Imaging Reporting and Data System (PI-RADS) being widely used for cancer detection. Beyond PI-RADS, other MRI-based scoring tools have emerged to address broader aspects within the PCa domain. However, the multitude of available MRI-based grading systems has led to inconsistencies in their application within clinical workflows. The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) assesses the likelihood of clinically significant radiological changes of PCa during active surveillance, and the Prostate Imaging for Local Recurrence Reporting (PI-RR) scoring system evaluates the risk of local recurrence after whole-gland therapies with curative intent. Underlying any system is the requirement to assess image quality using the Prostate Imaging Quality Scoring System (PI-QUAL). This article offers practicing radiologists a comprehensive overview of currently available scoring systems with clinical evidence supporting their use for managing PCa patients to enhance consistency in interpretation and facilitate effective communication with referring clinicians. Key Points: Assessing image quality is essential for all prostate MRI interpretations and the PI-QUAL score represents the standardized tool for this purpose. Current urological clinical guidelines for prostate cancer diagnosis and localization recommend adhering to the PI-RADS recommendations. The PRECISE and PI-RR scoring systems can be used for assessing radiological changes of prostate cancer during active surveillance and the likelihood of local recurrence after radical treatments respectively. [ABSTRACT FROM AUTHOR]

As both the European Union (EU) and the United States (US) construct their approaches to governing the digital economy in a global context, the role and influence of international organisations are being questioned. Specifically, the EU, traditionally a champion of multilateral regimes, has embarked on a strategy that tends toward a 'digital sovereignty' approach. However, the EU's sovereigntist approach relies upon the power of multilateral regimes to ensure 'managed interdependence'. This article focuses on the differences between the EU and the US regarding global standardisation processes and bodies. It argues that across the Atlantic, there is political agreement on how to manage standards development, but that policies to achieve this often diverge. This article focuses on some of the efforts of the EU-US Trade and Technology Council working group on standardization to show how this agreement on politics, but not policies, has emerged. [ABSTRACT FROM AUTHOR]

Glycated albumin (GA) has potential value in the management of people with diabetes; however, to draw meaningful conclusions between clinical studies it is important that the GA values are comparable. This study investigates the standardization of the Norudia Glycated Albumin and Lucica Glycated Albumin-L methods. The manufacturer reported imprecision was verified by performing CLSI-EP15-A3 protocol using manufacturer produced controls. The Japanese Clinical Chemistry Reference Material (JCCRM)611-1 was measured 20 times to evaluate the accuracy of both methods. GA was also measured in 1,167 patient samples and results were compared between the methods in mmol/mol and %. Maximum CV for Lucica was ≤0.6 % and for Norudia ≤1.8 % for control material. Results in mmol/mol and % of the JCCRM611-1 were within the uncertainty of the assigned values for both methods. In patient samples the relative difference in mmol/mol between the two methods ranged from −10.4 % at a GA value of 183 mmol/mol to +8.7 % at a GA value of 538 mmol/mol. However, the relative difference expressed in percentage units ranged from of 0 % at a GA value of 9.9 % to +1.7 % at a GA value of 30 %. The results in mmol/mol between the two methods for the patient samples were significantly different compared to the results in %. It is not clear why patient samples behave differently compared to JCCRM611-1 material. Valuable lessons can be learnt from comparing the standardization process of GA with that of HbA1c. [ABSTRACT FROM AUTHOR]

Even in the current era of hematology analyzer automation and peripheral equipment, quality control sample measurement remains a manual task, leading to variability in quality control data and increased workload. In this study, we evaluated the performance of quality control measurement using the BT-50 Transportation Unit (BT-50, Sysmex, Kobe, Japan), equipped with a scheduled automatic quality control function, to ensure measurement accuracy and streamline the workflow of hematology testing. We evaluated the automatic measurement performance of quality control samples using the BT-50 for six representative blood test parameters: WBC (white blood cell), RBC (red blood cell), HGB (hemoglobin), HCT (hematocrit), PLT (platelet), and RET% (reticulocyte percent). We evaluated the equivalence and compared measurement accuracy between the BT-50 and the manual method. We then compared the variability to other laboratories and confirmed the stability of quality control samples. We also evaluated changes in workflow and staff resources before and after the introduction of the BT-50. The quality control measurement results for the BT-50 and the manual method were found to be equivalent for all six parameters. The variability measured by the BT-50 was lower for some parameters compared to the manual method. Furthermore, the workflow was streamlined by reducing manual processes, resulting in increased efficiency. We confirmed the performance of quality control measurements using the schedule function of the BT-50. Introducing the BT-50 reduced the operator's workload, improved operational efficiency, and promoted the standardization of quality control measurements. [ABSTRACT FROM AUTHOR]

Standardized, trauma-informed pre-certification trainings for resource parents may influence placement stability and outcomes for children in foster care. Eight focus groups were conducted to elicit feedback from resource parents and child welfare trainers on their experiences with pre-certification trainings and an urban child welfare system. Using directed content analysis, four major categorical themes emerged: relationships and supports, knowledge and understanding, motivations and expectations, and attitudes and perspectives. These findings provide insight into factors that both promote successful caregiving and offer considerations for training curricula content for foster care organizations. [ABSTRACT FROM AUTHOR]

Objective: Immunocytochemistry (ICC) is essential for enhancing diagnostic accuracy and identifying markers for diagnosis, prognosis and targeted therapies. While cell blocks (CBs) are preferred for standardization and optimized staining, cytological smears are an alternative when CBs are unavailable. However, the literature on ICC protocols for smears is sparse. This review addresses preparation, fixation and protocols for nuclear and cytoplasmic antibodies on smears, drawing from our laboratory's experience. Methods: We reviewed procedures for ICC on cytological smears using existing literature and practical insights from our laboratory. Results: Commercially available antibodies were found to be reliable for ICC on smears if specimens are properly prepared and fixed. Protocols developed in our laboratory maintained antigenicity and provided clear staining results. Conclusions: Although ICC on CBs is the gold standard for standardization, cytological smears are a viable alternative when CBs are unavailable. Success in ICC on smears depends on proper preparation and fixation. This review offers practical protocols and insights to help laboratories optimize ICC on cytological smears. Further research and standardization are necessary to enhance reproducibility and reliability of ICC on smears. The practical information provided is based on personal experience in our laboratory. [ABSTRACT FROM AUTHOR]

The ex vivo human placenta perfusion model has proven to be clinically relevant to study transfer- and fetal exposure of various drugs. Although the method has existed for a long period, the setup of the perfusion model has not been generalized yet. This review aims to summarize the setups of ex vivo placental perfusion models used to examine drug transfer across the placenta to identify generalized properties and differences across setups. A literature search was carried out in PubMed September 26, 2022. Studies were labeled as relevant when information was reported, between 2000 and 2022, on the setups of ex vivo placental perfusion models used to study drug transfer across the placenta. The placenta perfusion process, and the data extraction, was divided into phases of preparation, control, drug, and experimental reflecting the chronological timeline of the different phases during the entire placental perfusion process. 135 studies describing an ex vivo human placental perfusion experiment were included. Among included studies, the majority (78.5%) analyzed drug perfusion in maternal to fetal direction, 18% evaluated bi-directional drug perfusion, 3% under equilibrium conditions, and one study investigated drug perfusion in fetal to maternal direction. This literature review facilitates the comparison of studies that employ similar placenta perfusion protocols for drug transfer studies and reveals significant disparities in the setup of these ex vivo placental perfusion models. Due to interlaboratory variability, perfusion studies are not readily comparable or interchangeable. Therefore, a stepwise protocol with multiple checkpoints for validating placental perfusion is needed. • Ex vivo human placenta perfusion model is relevant to study transfer- and fetal drug exposure. • No generalization has been conducted on the setup of the perfusion model. • Due to interlaboratory variability, perfusion studies are not readily comparable or interchangeable. • A stepwise protocol with multiple checkpoints for validating placental perfusion is needed. [ABSTRACT FROM AUTHOR]

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Clinical biomarker strategies increasingly integrate translational research to gain new insights into disease mechanisms or to define better biomarkers in clinical trials. High‐dimensional flow cytometry (HDFCM) holds the promise to enhance the exploratory potential beyond traditional, targeted biomarker strategies. However, the increased complexity of HDFCM poses several challenges, which need to be addressed in order to fully leverage its potential and to align with current regulatory requirements in clinical flow cytometry. These challenges include among others extended timelines for assay development and validation, the necessity for extensive knowledge in HDFCM, and sophisticated data analysis strategies. However, no guidelines exist on how to manage such challenges in adopting clinical HDFCM. Our CYTO 2024 workshop "Potential and challenges of clinical high‐dimensional flow cytometry" aimed to find consensus across the pharmaceutical industry and broader scientific community on the overall benefits and most urgent challenges of HDFCM in clinical trials. Here, we summarize the insights we gained from our workshop. While this report does not provide a blueprint, it is a first step in defining and summarizing the most pressing challenges in implementing HDFCM in clinical trials. Furthermore, we compile current efforts with the goal to overcome some of these challenges. As such we bring the scientific community and health authorities together to build solutions, which will accelerate and simplify the full adoption of HDFCM in clinical trials. [ABSTRACT FROM AUTHOR]

Despite advancements in precision medicine, many cancer patients globally, particularly those in resource-constrained environments, face significant challenges in accessing high-quality molecular testing and targeted therapies. The considerable heterogeneity in molecular testing highlights the urgent need to harmonize practices across Europe and beyond, establishing a more standardized and consistent approach in MP laboratories. Professionals, especially molecular pathologists, must move beyond traditional education to cope with this heterogeneity. This perspective addresses critical issues in molecular pathology (MP), such as limited access to high-quality molecular testing, leading to disparities in cancer treatment, and the consequences of inconsistent practices. Recognizing the necessity for a standardized framework for education to address these issues, educational programs play a pivotal role in updating professionals' skills to achieve standardization in MP. European experts from the Steering Committee, the Pathology Section of the European Union of Medical Specialists, and the European Society of Pathology have proposed creating a comprehensive Master's degree program called the "European Masters in Molecular Pathology" (EMMP). This program emerges as a strategic response to the demand for a specialized and standardized framework for education in MP, catering to professionals who concurrently work and study. The program's design aligns with evidence-based education methods, ensuring effective learning and engagement while integrating computational pathology to analyze complex molecular data, enhance diagnostic accuracy, and improve treatment outcomes. EMMP's structured curriculum, strategic partnerships, and regular updates underscore its significance in standardizing MP practices. Exploring future developments, this perspective delves into technology integration and interdisciplinary collaboration, anticipating ongoing advances and harmonization. Challenges and future directions in MP education are discussed, emphasizing the necessity for dynamic curriculum updates, seamless technology integration, and interdisciplinary cooperation. This perspective underscores EMMP's pivotal role in preparing pathologists for this dynamic field, advocating continuous advancements in education and training to uphold excellence in MP practices and maintain the highest patient care standards. [ABSTRACT FROM AUTHOR]

Introduction and Objectives: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. Methods: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. Results: The WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment evaluation, and complications. Forty‐two items were evaluated and graded as: STANDARD—must be included; ADDITIONAL—may be included for a specific study and is inclusive of the Standard items; OPTIMAL—may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY—not relevant. Conclusions: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long‐term outcomes for female patients undergoing surgery to correct SUI. [ABSTRACT FROM AUTHOR]

In event-related potential (ERP) analysis, it is commonly assumed that individual trials from a subject share similar properties and originate from comparable neural sources, allowing reliable interpretation of group-averages. Nevertheless, traditional group-level ERP analysis methods, including cluster analysis, often overlook critical information about individual subjects' neural processes due to using fixed measurement intervals derived from averaging. We developed a multi-set consensus clustering pipeline to examine cognitive processes at the individual subject level. Initially, consensus clustering from diverse methods was applied to single-trial EEG epochs of individual subjects. Subsequently, a second level of consensus clustering was performed across the trials of each subject. A newly modified time window determination method was then employed to identify individual subjects' ERP(s) of interest. We validated our method with simulated data for ERP components N2 and P3, and real data from a visual oddball task to confirm the P3 component. Our findings revealed that estimated time windows for individual subjects provide precise ERP identification compared to fixed time windows across all subjects. Additionally, Monte Carlo simulations with synthetic single-trial data demonstrated stable scores for the N2 and P3 components, confirming the reliability of our method. The proposed method enhances the examination of brain-evoked responses at the individual subject level by considering single-trial EEG data, thereby extracting mutual information relevant to the neural process. This approach offers a significant improvement over conventional ERP analysis, which relies on the averaging mechanism and fixed measurement interval. [ABSTRACT FROM AUTHOR]

A computationally tractable method is suggested for solving N-person games in which players’ pure strategies are staircase functions. The solution is meant to be Pareto-efficient. Owing to the payoff subinterval-wise summing, the N-person staircase-function game is considered as a succession of subinterval N-person games in which strategies are constants. In the case of a finite staircase-function game, each constant-strategy game is an N-dimensional-matrix game whose size is relatively far smaller to solve it in a reasonable time. It is proved that any staircase-function game has a single Pareto-efficient situation if every constant-strategy game has a single Pareto-efficient situation, and vice versa. Besides, it is proved that, whichever the staircase-function game continuity is, any Pareto-efficient situation of staircase function-strategies is a stack of successive Pareto-efficient situations in the constant-strategy games. If a staircase-function game has multiple Pareto-efficient situations, the best efficient situation is one which is the farthest from the most unprofitable payoffs. In terms of 0-1-standardization, the best efficient situation is the farthest from the zero payoffs. [ABSTRACT FROM AUTHOR]

Background: In recent decades, the analytical quality of clinical laboratory results has substantially increased because of collaborative efforts. To effectively utilize laboratory results in applications, such as machine learning through big data, understanding the level of harmonization for each test would be beneficial. We aimed to develop a quantitative harmonization index that reflects the harmonization status of real-world laboratory tests. Methods: We collected 2021–2022 external quality assessment (EQA) results for eight tests (HbA1c, creatinine, total cholesterol, HDL-cholesterol, triglyceride, alpha-fetoprotein [AFP], carcinoembryonic antigen [CEA], and prostate-specific antigen [PSA]). This EQA was conducted by the Korean Association of External Quality Assessment Service, using commutable materials. The total analytical error of each test was determined according to the bias% and CV% within peer groups. The values were divided by the total allowable error from biological variation (minimum, desirable, and optimal) to establish a real-world harmonization index (RWHI) at each level (minimum, desirable, and optimal). Good harmonization was arbitrarily defined as an RWHI value ≤1 for the three levels. Results: Total cholesterol, triglyceride, and CEA had an optimal RWHI of ≤1, indicating an optimal harmonization level. Tests with a desirable harmonization level included HDL-cholesterol, AFP, and PSA. Creatinine had a minimum harmonization level, and HbA1c did not reach the minimum harmonization level. Conclusions: We developed a quantitative RWHI using regional EQA data. This index may help reflect the actual harmonization level of laboratory tests in the field. [ABSTRACT FROM AUTHOR]

Reaching communication consistency across online channels like websites and social media is pivotal for international brands (IBs) in their effort to internationalize their recognition. This study investigates whether and how IBs integrate communication across two online channels in different countries in terms of adaptation and standardization approaches. We perform a content analysis of the websites and Instagram pages of 75 IBs to analyze their integrated marketing communication strategies deployed in two markets: Russia and Italy. This study reveals that IBs may adopt one of the four strategies when considering the design and content of the website and social media simultaneously: (1) standardized convergence, (2) adaptive convergence, (3) mixed convergence, and (4) cross-media divergence. Strategies are described across macro elements developed through a novel fine-grained framework. We discuss our results by exemplifying how communication consistency is reached across identified strategies. With this study that simultaneously analyzes the website and social media communication strategies of IBs, we contribute to the marketing communication literature by conceptualizing key global integrated online marketing communication strategies. In closing, we provide several managerial implications and recommendations for further research on this topic. [ABSTRACT FROM AUTHOR]