Valid Interpretation Research Articles

The Hunt Lab Guide to De Novo Peptide Sequence Analysis by Tandem Mass Spectrometry

Donald Hunt has made seminal contributions to the fields of proteomics, immunology, epigenetics, and glycobiology. The foundation of every important work to come out of the Hunt Laboratory is de novo peptide sequencing. For decades, he taught hundreds of students, postdocs, engineers, and scientists to directly interpret mass spectral data. To honor his legacy and ensure that the art of de novo sequencing is not lost, we have adapted his teaching materials into “The Hunt Lab Guide to De Novo Peptide Sequence Analysis by Tandem Mass Spectrometry”. In addition to the de novo sequencing tutorials, we present two freely available software tools that facilitate manual interpretation of mass spectra and validation of search results. The first, “Hunt Lab Peptide Fragment Calculator”, calculates precursor and fragment mass-to-charge ratios for any peptide. The second program, “Predator Protein Fragment Calculator”, was inspired in part by the fragment calculator developed in the Hunt Lab. Its capabilities are enhanced to facilitate interpretation of mass spectral data derived from intact proteins. We hope that the combination of these educational tools will continue to benefit students and researchers by empowering them to interpret data on their own.

Latent structure and measurement invariance of the Depression Self-Rating Scale for Children across sex and age.

Measurement tools from which valid interpretations can be made are critical for assessing early emerging depressive symptoms, as depressive symptoms in childhood are associated with increased risk for early-onset depressive disorder, recurrence, suicidality, and other psychopathology. The Depression Self-Rating Scale for Children (DSRS) is a widely used self-report scale assessing youth depressive symptoms. The relatively few studies investigating the DSRS' latent structure have yielded mixed results, and measurement invariance (MI) based on sex and age has not been examined. We examined the factor structure and MI of the DSRS across sex and age in a community sample of 6-9-year-olds (N = 352; Mage = 7.57 years, SD = .70). Consistent with the largest prior structural study of the DSRS, a two-factor structure, with factors reflecting elevated negative affect (NA) and low positive affect (PA), showed strong model fit. Although this structure was consistent across sex and age (i.e., configural invariance), loadings of DSRS items varied across sex and age (i.e., metric noninvariance). Allowing the loadings of items contributing to noninvariance to vary across groups improved model fit. Implications for the clinical and research utility of the DSRS and suggestions for future research are discussed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A critical review of the use of R2 in risk equalization research.

Nearly all empirical studies that estimate the coefficients of a risk equalization formula present the value of the statistical measure R2. The R2-value is often (implicitly) interpreted as a measure of the extent to which the risk equalization payments remove the regulation-induced predictable profits and losses on the insured, with a higher R2-value indicating a better performance. In many cases, however, we do not know whether a model with R2 = 0.30 reduces the predictable profits and losses more than a model with R2 = 0.20. In this paper we argue that in the context of risk equalization R2 is hard to interpret as a measure of selection incentives, can lead to wrong and misleading conclusions when used as a measure of selection incentives, and is therefore not useful for measuring selection incentives. The same is true for related statistical measures such as the Mean Absolute Prediction Error (MAPE), Cumming's Prediction Measure (CPM) and the Payment System Fit (PSF). There are some exceptions where the R2 can be useful. Our recommendation is to either present the R2 with a clear, valid, and relevant interpretation or not to present the R2. The same holds for the related statistical measures MAPE, CPM and PSF.

Application of Machine Learning in Nanotoxicology: A Critical Review and Perspective.

The massive production and application of nanomaterials (NMs) have raised concerns about the potential adverse effects of NMs on human health and the environment. Evaluating the adverse effects of NMs by laboratory methods is expensive, time-consuming, and often fails to keep pace with the invention of new materials. Therefore, in silico methods that utilize machine learning techniques to predict the toxicity potentials of NMs are a promising alternative approach if regulatory confidence in them can be enhanced. Previous reviews and regulatory OECD guidance documents have discussed in detail how to build an in silico predictive model for NMs. Nevertheless, there is still room for improvement in addressing the ways to enhance the model representativeness and performance from different angles, such as data set curation, descriptor selection, task type (classification/regression), algorithm choice, and model evaluation (internal and external validation, applicability domain, and mechanistic interpretation, which is key to ensuring stakeholder confidence). This review explores how to build better predictive models; the current state of the art is analyzed via a statistical evaluation of literature, while the challenges faced and future perspectives are summarized. Moreover, a recommended workflow and best practices are provided to help in developing more predictive, reliable, and interpretable models that can assist risk assessment as well as safe-by-design development of NMs.

Minimal Detectable Change of Cough and Lingual Strength Outcomes in Neurodegenerative Disease.

Minimal detectable change (MDC) represents the smallest amount of change required for an outcome to be considered real and not merely due to measurement error or task variability. This study aimed to examine MDC for cough and lingual strength outcomes among individuals with neurodegenerative disease. In a single session, individuals diagnosed with Parkinson's disease (PD), progressive supranuclear palsy (PSP), and cerebellar ataxia completed repeated measurements of voluntary sequential cough via spirometry (n = 143) and lingual isometric and swallowing pressure with the Iowa Oral Performance Instrument (n = 231). The MDC at the 95% confidence level was calculated with the following formula: MDC = 1.96 × √2 × SEM. MDC for cough strength was 0.52 L/s (PD), 0.57 L/s (PSP), and 0.20 L/s (ataxia). On trials with the same number of coughs, MDC for cough strength was 0.18 L/s in PD and 0.24 L/s in ataxia. MDC for lingual isometric pressure was 5.44 kPa (PD), 2.35 kPa (PSP), and 3.41 kPa (ataxia), whereas swallowing pressure was 5.60 kPa (PD), 2.97 kPa (PSP), and 7.34 kPa (ataxia). These findings elucidate MDC for cough and lingual strength outcomes and expand our understanding of change that can be considered "real" and not merely due to task variability. MDC facilitates valid interpretations of changes following treatment, as well as power analyses to determine the smallest effect size of interest before data collection. To illustrate the application of MDC, we situate these findings in the context of hypothetical case studies and research studies. 3 Laryngoscope, 2024.

Correlation between serum uric acid level and atrial fibrillation in patients with hyperthyroidism on medical data analysis context of IoT.

Dysfunctions in metabolism and endocrine systems are outcomes of disruptions in human physiological processes, often leading to disease onset. External factors can hinder the human body's innate capacity for self-regulation and healing, particularly when immune responses are compromised, allowing these factors to interfere with normal bodily functions directly. To explore the effect of uric acid expression water in blood on the occurrence of atrial fibrillation in patients with hyperthyroidism, the expression level of uric acid in the blood and other physiological indexes were compared between patients with no symptoms of atrial fibrillation and patients with hyperthyroidism with symptoms of atrial fibrillation, to find the correlation between them. A group of 112 hyperthyroidism patients who were admitted to our hospital from September 2019 to March 2020 were chosen and split into two groups. The control group consisted of 56 individuals (21 men and 35 women) aged between 16 and 86 years old, with an average age of 46.23 years (± 7.63). The observation group consisted of 56 individuals (24 males and 32 females) between 15 and 79 years, with an average age of 53.44 years (± 8.91). In the patients who were not treated with drugs before hospitalization the disease course and symptoms varied. The patients' clinical medical and demographic data were recorded and the patients' physiological indexes were obtained through blood tests and analysis. The differences between the two groups were analyzed by renal function, blood lipid index, thyroid function, and cardiac ultrasound, and these influencing factors were analyzed by regression analysis. The research adhered to ethical norms and ensured clear data presentation by using a rigorous technique to compare uric acid levels and physiological indicators among various patient groups. The study concentrated on the validation, repeatability, and contextual interpretation of data to provide a robust and rigorously scientific comparison. The most common is the increase of uric acid in the blood, which can induce other diseases, and atrial fibrillation is one of the most common diseases of cardiovascular diseases.

Identification and validation of microbial biomarkers from cross-cohort datasets using xMarkerFinder.

Microbial signatures have emerged as promising biomarkers for disease diagnostics and prognostics, yet their variability across different studies calls for a standardized approach to biomarker research. Therefore, we introduce xMarkerFinder, a four-stage computational framework for microbial biomarker identification with comprehensive validations from cross-cohort datasets, including differential signature identification, model construction, model validation and biomarker interpretation. xMarkerFinder enables the identification and validation of reproducible biomarkers for cross-cohort studies, along with the establishment of classification models and potential microbiome-induced mechanisms. Originally developed for gut microbiome research, xMarkerFinder's adaptable design makes it applicable to various microbial habitats and data types. Distinct from existing biomarker research tools that typically concentrate on a singular aspect, xMarkerFinder uniquely incorporates a sophisticated feature selection process, specifically designed to address the heterogeneity between different cohorts, extensive internal and external validations, and detailed specificity assessments. Execution time varies depending on the sample size, selected algorithm and computational resource. Accessible via GitHub ( https://github.com/tjcadd2020/xMarkerFinder ), xMarkerFinder supports users with diverse expertise levels through different execution options, including step-to-step scripts with detailed tutorials and frequently asked questions, a single-command execution script, a ready-to-use Docker image and a user-friendly web server ( https://www.biosino.org/xmarkerfinder ).

Validation of Single-Nucleotide Mosaic Variants Through Droplet Digital PCR.

The detection, validation, and subsequent interpretation of potentially mosaic single-nucleotide variants (SNV) within next-generation sequencing data remains a challenge in both research and clinical laboratory settings. The ability to identify mosaic variants in high genome coverage sequencing data at levels of ≤1% underscores the necessity for developing guidelines and best practices to verify these variants orthogonally. Droplet digital PCR (ddPCR) has proven to be a powerful and precise method that allows for the determination of low-level variant fractions within a given sample. Herein we describe two precise ddPCR methods using either a fluorescent TaqMan hydrolysis probe approach or an EvaGreen fluorescent dye protocol. The TaqMan approach relies on two different fluorescent probes (FAM and HEX/VIC), each designed to amplify selectively only in the presence of a single nucleotide change denoting the variant or reference position. The fractional abundance is then calculated to determine the relative quantities of both alleles in the final sample. The EvaGreen protocol relies on two independent reactions with oligonucleotide primers designed with the single nucleotide change denoting the variant at the penultimate position of the primer. The relative amplification efficiency of both primer sets (reference and variant) can be compared to determine the mosaic level of a given variant. As the cost of high-coverage sequencing continues to decrease, the identification of potentially mosaic variants will also increase. The approaches outlined will allow clinicians and researchers a more precise determination of the true mosaic level of a given variant allowing them to better assess not only its potential pathogenicity but also its possible recurrence risk when offering genetic counseling to families. © 2024 Wiley Periodicals LLC. Basic Protocol: Droplet digital PCR (ddPCR) with TaqMan hydrolysis probes Alternate Protocol: EvaGreen oligonucleotide-specific ddPCR.

Causal interpretation of the hazard ratio in randomized clinical trials.

Although the hazard ratio has no straightforward causal interpretation, clinical trialists commonly use it as a measure of treatment effect. We review the definition and examples of causal estimands. We discuss the causal interpretation of the hazard ratio from a two-arm randomized clinical trial, and the implications of proportional hazards assumptions in the context of potential outcomes. We illustrate the application of these concepts in a synthetic model and in a model of the time-varying effects of COVID-19 vaccination. We define causal estimands as having either an individual-level or population-level interpretation. Difference-in-expectation estimands are both individual-level and population-level estimands, whereas without strong untestable assumptions the causal rate ratio and hazard ratio have only population-level interpretations. We caution users against making an incorrect individual-level interpretation, emphasizing that in general a hazard ratio does not on average change each individual's hazard by a factor. We discuss a potentially valid interpretation of the constant hazard ratio as a population-level causal effect under the proportional hazards assumption. We conclude that the population-level hazard ratio remains a useful estimand, but one must interpret it with appropriate attention to the underlying causal model. This is especially important for interpreting hazard ratios over time.

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items.

The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

Pengembangan LKPD pendidikan agama Islam dan budi pekerti berbasis inkuiri pada kelas VIII SMP Negeri 2 Bekri

Background: Teaching in the 2013 curriculum emphasizes scientific methods, with one model that applies this approach being inquiry. Inquiry is considered a learning strategy that focuses on the role of students, where they are actively involved in a series of learning activities, including searching for information, analyzing and concluding the results of their findings during the learning process. Purpose: The aim of this research is to develop an inquiry-based Student Worksheet (LKPD) regarding belief in the books of Allah and love of the Koran and also determine the feasibility of the inquiry-based LKPD. Method: Employing the Research and Development (Rnd) methodology, the study follows Thiagarajan's 4D model: Define, Design, Develop, and Disseminate. Findings: LKPD is validated by material experts and media experts. Validation is carried out twice by the material validator. The final validation results by material experts reached a percentage of 96% in that "very feasible" category. That final validation interpretation by media experts, which were carried out once, obtained a percentage figure of 94.6% in the "very feasible" category. Testing of teacher responses showed a percentage of 90% with positive responses. Meanwhile, testing the responses of students in small groups showed a percentage of 90.6% with positive responses. Thus, based on the research results, it can be concluded that the development of inquiry-based Islamic Religious Education and Character Worksheets for class VIII SMP Negeri 2 Bekri is suitable for use as a learning medium in the learning process at school.

Interpretasi Validitas dan Reliabilitas Instrumen Kemampuan Berpikir Aljabar

This research aims to interpret the validity and reliability of the items on the algebraic thinking ability instrument which are linked to content, context, question structure and students' cognitive level. The development of the algebraic thinking ability instrument was carried out in four stages by adapting the Plomp development model. The first stage (initial assessment), conducting a theoretical study of algebraic thinking abilities and curriculum analysis. The second stage (design), draft questions by paying attention to the relationship between indicators of algebraic thinking ability and learning objectives. Furthermore, this question design was validated by three experts in the field of mathematics education. The fourth stage (realization/construction) is testing the instrument which includes testing validity, reliability, distinguishability and level of difficulty. Apart from that, in the fourth stage the test results are also interpreted, evaluated and revised. The instrument was tested on 19 class VII students at one of the junior high schools in Bandung City. Interpretations of validity, reliability, distinguishability and level of difficulty are related to content, context, question structure and students' cognitive level. The results of the analysis at this stage are used as a reference for improving the instrument. The instrument produced in this research is a description question consisting of four items that are valid and reliable and can be used to measure algebraic thinking abilities, especially those related to generalization, transformation and metaglobal abilities.

Capturing Exercise Psychological Need Satisfaction Among Older Adults: The BPNES

ABSTRACT Regular exercise participation which is a component of promoting health and healthy aging among older adults necessitates the creation of environments that fulfill participants’ needs for autonomy, competence, and relatedness, thus, providing opportunities to promote authentic interest in the activities and meaningful social engagement. Appropriate tools to capture satisfaction of these needs may prove invaluable to gain an understanding of the effectiveness of exercise programs from participants’ perspective. The aim of the study was to examine psychometric aspects of the Basic Psychological Needs in Exercise Scale (BPNES) scores based on responses of 675 older adult Greek exercise participants, men and women, aged 65 to 80 years, attending indoor group-based exercise programs. The data supported the factorial validity, internal reliability, nomological validity, and equivalent item interpretation of BPNES scores between groups differing in demographic characteristics. Older adults with exercise experience greater than three years reported higher exercise needs satisfaction for all three needs compared to those exercising less than three years. The favorable psychometric characteristics of the BPNES in this population make it a valuable tool for the assessment of the extent to which older adults’ needs for autonomy, competence, and relatedness are fulfilled in group-based exercise settings.

Electrical Resistivity Tomography (ERT) for investigating subsurface structures in the karst area of the Ek Leuntie Cave, Aceh Province

Ek Leuntie Cave, in the southern city of Banda Aceh, Aceh Province, is recognized as an educational media based on geopark sites because it holds a 7400-year paleotsunami track record. As a karst area, Ek Leuntie Cave is vulnerable to the impact of geological disasters such as earthquakes, sinkholes and subsidence. As an effort to reduce the negative impact of geological disasters, geophysical studies have been applied in the Ek Leuntie Cave Karst area. The study aims to identify the subsurface geological structure of the Karst area. The identification was carried out using the Electrical Resistivity Tomography (ERT) method of Wenner-Schlumberger configuration applied to two measurement trajectories that have South-North and West-East directions in front of the Ek Leuntie Cave door. ERT data acquisition results were then modeled in inversion using Res2Dinv software to produce a 2D model of the subsurface geological structure of the Ek Leuntie Cave karst area based on variations in rock resistivity values. Interpretation of subsurface geological structure modeling is validated with shallow drilling data (Hand Auger). The inversion modeling results show that the rock resistivity value in the Ek Leuntie Cave area reaches a depth of 30 m which has a resistivity value of 0 - 1000 Ωm. The results of the interpretation of resistivity values and validation of drill data show that the Ek Leuntie Cave area is covered by a layer of sand with fine to coarse texture and the layer below is a layer of limestone at a depth of ± 0.4 meters with a resistivity value of 50 - 250 Ωm. Limestone generally shows porosity with the possibility of caves or pores in the rock formation at Ek Leuntie Cave, making it vulnerable to damage from earthquakes, landslides, and subsidence. The results of the study are expected to provide updated information in efforts to develop the Ek Leuntie Cave geopark area.

Experiences and Challenges Updating a Living Evidence-Based Review of Randomized Controlled Trials on Mental Health and Behavioral Disorders in Individuals With Moderate to Severe Traumatic Brain Injury.

To describe experiences and challenges when updating a living evidence-based review database of randomized controlled trials (RCTs) on mental health and behavioral disorders in moderate to severe traumatic brain injury (MSTBI). This commentary derives from our experience developing an extensive database of RCTs on MSTBI that has been conceptualized as a living evidence-based review. Our working group focused on mental health and behavior RCTs and reflected upon their experiences and challenges using the living systematic approach. We discuss challenges associated with metrics of study quality, injury etiology and severity, time post-injury, country of origin, and variability in outcome measures. RCTs were conducted almost solely in high income countries, with smaller sample sizes, and most conducted in the chronic phase post-TBI. Issues related to lack of transparency, unclear and incomplete reporting of injury severity, etiology, and time post-injury remain a concern and can lead to challenges associated with interpretation of results, validity, and reliability of the data. There was significant heterogeneity regarding the use of outcome measures and constructs, underscoring the need for standardization. Lack of standardization and incomplete reporting of injury characteristics makes it difficult to compare data between RCTs of MSTBI, perform meta-analyses, and generate evidence-based clinical recommendations.

Quantitative Signal Detection for COVID-19 Medicinal Products Based on Retrospective Analysis of Spontaneous Reports from the Russian Pharmacovigilance Database

SCIENTIFIC RELEVANCE. The pandemic of novel coronavirus infection (COVID-19) led to a drastic increase in the use of medicinal products of various therapeutic groups and increased spontaneous reporting of adverse drug reactions (ADRs). Therefore, it is necessary to analyse the reported information to identify potential safety signals.AIM. This study aimed at systematisation and quantitative analysis of data on the safety of COVID-19 medicinal products from the Russian pharmacovigilance database.MATERIALS AND METHODS. This retrospective analysis included spontaneous ADR reports submitted to the Russian pharmacovigilance database from 1 January 2020 to 31 December 2022. The authors applied disproportionality analysis to generate safety signals.RESULTS. During the stated period, the database website published 873 spontaneous reports on 1,636 ADRs associated with COVID-19 treatment. Most ADRs were associated with favipiravir (493 reports), hydroxychloroquine (87 reports), and olokizumab (85 reports). The most common ADRs included 273 (16.7%) abnormal investigation results, 203 (12.4%) hepatobiliary disorders, and 191 (11.6%) gastrointestinal disorders. The majority of adverse events, 674 (77%) cases, had favourable outcomes. Using frequency-based disproportionality analysis, the authors identified 23 potential safety signals based on disproportionately reported ADRs for azithromycin, dexamethasone, levilimab, lopinavir+ritonavir, molnupiravir, olokizumab, tofacitinib, tocilizumab, umifenovir, and favipiravir.CONCLUSIONS. The new safety signals require additional assessment of ADR reporting forms for causal relationship analysis, validation, prioritisation, and clinical interpretation. The frequency-based method did not identify safety signals for hydroxychloroquine, remdesivir, baricitinib, sarilumab, and anti-COVID-19 human immunoglobulin, but this does not rule out the possibility of detecting new causal relationships.

Complex In Vitro Model Characterization for Context of Use in Toxicologic Pathology: Use Cases by Collaborative Teams of Biologists, Bioengineers, and Pathologists.

Complex in vitro models (CIVMs) offer the potential to increase the clinical relevance of preclinical efficacy and toxicity assessments and reduce the reliance on animals in drug development. The European Society of Toxicologic Pathology (ESTP) and Society for Toxicologic Pathology (STP) are collaborating to highlight the role of pathologists in the development and use of CIVM. Pathologists are trained in comparative animal medicine which enhances their understanding of mechanisms of human and animal diseases, thus allowing them to bridge between animal models and humans. This skill set is important for CIVM development, validation, and data interpretation. Ideally, diverse teams of scientists, including engineers, biologists, pathologists, and others, should collaboratively develop and characterize novel CIVM, and collectively assess their precise use cases (context of use). Implementing a morphological CIVM evaluation should be essential in this process. This requires robust histological technique workflows, image analysis techniques, and needs correlation with translational biomarkers. In this review, we demonstrate how such tissue technologies and analytics support the development and use of CIVM for drug efficacy and safety evaluations. We encourage the scientific community to explore similar options for their projects and to engage with health authorities on the use of CIVM in benefit-risk assessment.

AmbiFC: Fact-Checking Ambiguous Claims with Evidence

Abstract Automated fact-checking systems verify claims against evidence to predict their veracity. In real-world scenarios, the retrieved evidence may not unambiguously support or refute the claim and yield conflicting but valid interpretations. Existing fact-checking datasets assume that the models developed with them predict a single veracity label for each claim, thus discouraging the handling of such ambiguity. To address this issue we present AmbiFC,1 a fact-checking dataset with 10k claims derived from real-world information needs. It contains fine-grained evidence annotations of 50k passages from 5k Wikipedia pages. We analyze the disagreements arising from ambiguity when comparing claims against evidence in AmbiFC, observing a strong correlation of annotator disagreement with linguistic phenomena such as underspecification and probabilistic reasoning. We develop models for predicting veracity handling this ambiguity via soft labels, and find that a pipeline that learns the label distribution for sentence-level evidence selection and veracity prediction yields the best performance. We compare models trained on different subsets of AmbiFC and show that models trained on the ambiguous instances perform better when faced with the identified linguistic phenomena.

A framework for the clinical implementation of optical genome mapping in hematologic malignancies.

Optical Genome Mapping (OGM) is rapidly emerging as an exciting cytogenomic technology both for research and clinical purposes. In the last 2 years alone, multiple studies have demonstrated that OGM not only matches the diagnostic scope of conventional standard of care cytogenomic clinical testing but it also adds significant new information in certain cases. Since OGM consolidates the diagnostic benefits of multiple costly and laborious tests (e.g., karyotyping, fluorescence in situ hybridization, and chromosomal microarrays) in a single cost-effective assay, many clinical laboratories have started to consider utilizing OGM. In 2021, an international working group of early adopters of OGM who are experienced with routine clinical cytogenomic testing in patients with hematological neoplasms formed a consortium (International Consortium for OGM in Hematologic Malignancies, henceforth "the Consortium") to create a consensus framework for implementation of OGM in a clinical setting. The focus of the Consortium is to provide guidance for laboratories implementing OGM in three specific areas: validation, quality control and analysis and interpretation of variants. Since OGM is a complex technology with many variables, we felt that by consolidating our collective experience, we could provide a practical and useful tool for uniform implementation of OGM in hematologic malignancies with the ultimate goal of achieving globally accepted standards.

Validity and score interpretation of the 12-item Psoriatic Arthritis Impact of Disease: an analysis of pooled data from two phase 3 trials of bimekizumab in patients with psoriatic arthritis

ObjectivesTo investigate psychometric performance of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) total and individual item scores in patients with psoriatic arthritis (PsA) and to estimate score change thresholds...