Reaction-time task reliability is more accurately computed with permutation-based split-half correlations than with Cronbach's alpha.

While it has become standard practice to report the reliability of self-report scales, it remains uncommon to do the same for experimental paradigms. To facilitate this practice, we review old and new ways to compute reliability in reaction-time tasks, and we compare their accuracy using a simulation study. Highly inaccurate and negatively biased reliability estimates are obtained through the common practice of averaging sets of trials and submitting them to Cronbach's alpha.

FAMS-A Targeted Fatty Acid Mass Spectrometry Method for Monitoring Free Fatty Acids from Polysorbate Hydrolysis.

Polysorbates are the predominant surfactants used to stabilize protein formulations. Unfortunately, polysorbates can undergo hydrolytic degradation, which releases fatty acids that can accumulate to form visible particles. The detection and quantitation of these fatty acid degradation products are critical for assessing the extent of polysorbate degradation and the associated risks of particle formation.

Applying Exercise Capacity and Physical Activity as Single vs Composite Endpoints for Trials of Cardiac Rehabilitation Interventions: Rationale, Use-case, and a Blueprint Method for Sample Size Calculation.

Objective: To conceptualize a composite primary endpoint for parallel-group RCTs of exercise-based cardiac rehabilitation (CR) interventions and to explore its application and statistical efficiency.

Design: We conducted a statistical exploration of sample size requirements. We combined exercise capacity and physical activity for the composite endpoint (CE), both being directly related to reduced premature mortality in patients with cardiac diseases.

MR Lymphangiography in Lymphatic Disorders: Clinical Applications, Institutional Experience, and Practice Development.

Lymphatic flow and anatomy can be challenging to study, owing to variable lymphatic anatomy in patients with diverse primary or secondary lymphatic pathologic conditions and the fact that lymphatic imaging is rarely performed in healthy individuals. The primary components of the lymphatic system outside the head and neck are the peripheral, retroperitoneal, mesenteric, hepatic, and pulmonary lymphatic systems and the thoracic duct. Multiple techniques have been developed for imaging components of the lymphatic system over the past century, with trade-offs in spatial, temporal, and contrast resolution; invasiveness; exposure to ionizing radiation; and the ability to obtain information on dynamic lymphatic flow.

The need for robust critique of arts and health research: the treatment of the Gene Cohen et al. (2006) paper on singing, wellbeing and health in subsequent evidence reviews.

Background: This paper considers weaknesses in a study by Cohen et al. (2006) on the impacts of community singing on health. These include high demand characteristics, lack of attention to attrition, flawed statistical analysis, and measurement.

Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials.

Background: Recommendations for statistical methods in rare disease trials are scarce, especially for cross-over designs. As a result various state-of-the-art methodologies were compared as neutrally as possible using an illustrative data set from epidermolysis bullosa research to build recommendations for count, binary, and ordinal outcome variables. For this purpose, parametric (model averaging), semiparametric (generalized estimating equations type [GEE-like]) and nonparametric (generalized pairwise comparisons [GPC] and a marginal model implemented in the R package nparLD) methods were chosen by an international consortium of statisticians.

How to analyze continuous and discrete repeated measures in small-sample cross-over trials?

To optimize the use of data from a small number of subjects in rare disease trials, an at first sight advantageous design is the repeated measures cross-over design. However, it is unclear how these within-treatment period and within-subject clustered data are best analyzed in small-sample trials. In a real-data simulation study based upon a recent epidermolysis bullosa simplex trial using this design, we compare non-parametric marginal models, generalized pairwise comparison models, GEE-type models and parametric model averaging for both repeated binary and count data.

Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control.

The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins.

High throughput FAMS - A fatty acid mass spectrometry method for monitoring polysorbate hydrolysis in QC.

Surfactant degradation in biopharmaceuticals has recently gained significant attention in the pharmaceutical industry. Specifically, hydrolytic degradation of polysorbates, leading to the release of free fatty acids potentially forming visible particles, is a key theme in technical development. To address this emerging topic, we present the development of a fully automated liquid-chromatography single quad mass detector method for the quantification of free fatty acids in biopharmaceuticals.

A neutral comparison of statistical methods for analyzing longitudinally measured ordinal outcomes in rare diseases.

Ordinal data in a repeated measures design of a crossover study for rare diseases usually do not allow for the use of standard parametric methods, and hence, nonparametric methods should be considered instead. However, only limited simulation studies in settings with small sample sizes exist. Therefore, starting from an Epidermolysis Bullosa simplex trial with the above-mentioned design, a rank-based approach using the R package nparLD and different generalized pairwise comparisons (GPC) methods were compared impartially in a simulation study.

mD-UPLC-MS/MS: Next Generation of mAb Characterization by Multidimensional Ultraperformance Liquid Chromatography-Mass Spectrometry and Parallel On-Column LysC and Trypsin Digestion.

For the past few years, multidimensional liquid chromatography-mass spectrometry (LC-MS) systems have been commonly used to characterize post-translational modifications (PTMs) of therapeutic antibodies (mAbs). In most cases, this is performed by fractionation of charge variants by ion-exchange chromatography and subsequent online LC-MS peptide mapping analysis. In this study, we developed a multidimensional ultra-performance-liquid-chromatography-mass spectrometry system (mD-UPLC-MS/MS) for PTM characterization and quantification, allowing both rapid analysis and decreased risk of artificial modifications during sample preparation.

Third dose of SARS-CoV-2 vaccination in hemato-oncological patients and health care workers: immune responses and adverse events - a retrospective cohort study.

Background: Due to potentially immune-escaping virus variants and waning immunity, a third SARS-CoV-2 vaccination dose is increasingly recommended. However, data in patients with cancer are limited.

Patients And Methods: We measured anti-SARS-CoV-2 spike protein antibody levels after the third vaccination dose in 439 patients with cancer and 41 health care workers (HCW) at an academic centre in Austria and a rural community hospital in Italy.

The Need for Robust Critique of Arts and Health Research: Young People, Art Therapy and Mental Health.

We describe work in progress to conduct a systematic review of research on effects of arts-based programs for mental health in young people. We are at the stage of searching for relevant studies through major databases and screening extant systematic reviews for additional research which meet our inclusion criteria. At this stage, however, concerns have arisen regarding both the quality of existing primary studies and of recently published systematic reviews in this area of arts and health.

Are High Frequency Oscillations in Scalp EEG Related to Age?

Background: High-frequency oscillations (HFOs) have received much attention in recent years, particularly in the clinical context. In addition to their application as a marker for pathological changes in patients with epilepsy, HFOs have also been brought into context with several physiological mechanisms. Furthermore, recent studies reported a relation between an increase of HFO rate and age in invasive EEG recordings.

Testing for equality of distributions using the concept of (niche) overlap.

Unlabelled: In this paper, we propose a new non-parametric test for equality of distributions. The test is based on the recently introduced measure of (niche) overlap and its rank-based estimator. As the estimator makes only one basic assumption on the underlying distribution, namely continuity, the test is universal applicable in contrast to many tests that are restricted to only specific scenarios.

Macroclimatic conditions as main drivers for symbiotic association patterns in lecideoid lichens along the Transantarctic Mountains, Ross Sea region, Antarctica.

Lecideoid lichens as dominant vegetation-forming organisms in the climatically harsh areas of the southern part of continental Antarctica show clear preferences in relation to environmental conditions (i.e. macroclimate).

Fast analysis of antibody-derived therapeutics by automated multidimensional liquid chromatography - Mass spectrometry.

Characterization of post-translational modifications (PTMs) of therapeutic antibodies is commonly performed by bottom-up approaches, involving sample preparation and peptide analysis by liquid chromatography-mass spectrometry (LC-MS). Conventional sample preparation requires extensive hands-on time and can increase the risk of inducing artificial modifications as many off-line steps - denaturation, disulfide-reduction, alkylation and tryptic digestion - are performed. In this study, we developed an on-line multidimensional (mD)-LC-MS bottom-up approach for fast sample preparation and analysis of (formulated) monoclonal antibodies and antibody-derived therapeutics.

SARS-CoV-2 screening in cancer outpatients during the second wave of the COVID-19 pandemic : Conclusions for crisis response at a high-volume oncology center.

Background: During the second wave of the coronavirus disease 2019 (COVID-19) pandemic Austria suffered one of the highest severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rates worldwide. We report performance parameters of a SARS-CoV‑2 screening program established for cancer outpatients at our center.

Methods: Institutional policy recommended routine biweekly SARS-CoV‑2 testing.

Inter-laboratory study to evaluate the performance of automated online characterization of antibody charge variants by multi-dimensional LC-MS/MS.

An international study was conducted to evaluate the performance and reliability of an online multi-dimensional (mD)-LC-MS/MS approach for the characterization of antibody charge variants. The characterization of antibody charge variants is traditionally performed by time-consuming, offline isolation of charge variant fractions by ion exchange chromatography (IEC) that are subsequently subjected individually to LC-MS/MS peptide mapping. This newly developed mD-LC-MS/MS approach enables automated and rapid characterization of charge variants using much lower sample requirements.

Automatic vs. Manual Detection of High Frequency Oscillations in Intracranial Recordings From the Human Temporal Lobe.

High frequency oscillations (HFOs) have attracted great interest among neuroscientists and epileptologists in recent years. Not only has their occurrence been linked to epileptogenesis, but also to physiologic processes, such as memory consolidation. There are at least two big challenges for HFO research.

SARS-CoV-2 Testing in Patients With Cancer Treated at a Tertiary Care Hospital During the COVID-19 Pandemic.

Purpose: To analyze the prevalence of SARS-CoV-2 infection in patients with cancer in hospital care after implementation of institutional and governmental safety measurements.

Methods: Patients with cancer routinely tested for SARS-CoV-2 RNA by nasal swab and real-time polymerase chain reaction between March 21 and May 4, 2020, were included. The results of this cancer cohort were statistically compared with the SARS-CoV-2 prevalence in the Austrian population as determined by a representative nationwide random sample study (control cohort 1) and a cohort of patients without cancer presenting to our hospital (control cohort 2).

Prediction of Cognitive Decline in Temporal Lobe Epilepsy and Mild Cognitive Impairment by EEG, MRI, and Neuropsychology.

Cognitive decline is a severe concern of patients with mild cognitive impairment. Also, in patients with temporal lobe epilepsy, memory problems are a frequently encountered problem with potential progression. On the background of a unifying hypothesis for cognitive decline, we merged knowledge from dementia and epilepsy research in order to identify biomarkers with a high predictive value for cognitive decline across and beyond these groups that can be fed into intelligent systems.