The Causes, Security Issues, and Preventive Actions Associated with Data Integrity

Data integrity is a major issue in today’s world. Many organizations have faltered due to the nature of the date contained within their databases. Some organizations are failing as a result of inaccurate, modified, or incorrect data that is contained with organizational records. Still others are losing customers and clients, and yet others are the subject of malicious lawsuits based upon inaccurate decisions and subsequent actions derived from inaccurate, modified, or missing data. This article explores many of the sources of and issues relating to the entry, storage, and retrieval of data from databases. The article also examines several avenues for reducing data integrity problems, including the adequate training of users, who too often tend to be the inadvertent source of errors. The article was written to highlight several potential sources of errors, because data integrity is so critical for every organization

Cyclone Shaheen: the exceptional tropical cyclone of October 2021 in the Gulf of Oman

Early October 2021 saw Cyclone Shaheen track westward across the far northern Arabian Sea, penetrate the Gulf of Oman and strike the northeast Oman coastline – the first storm to make such a unique landfall in more than 130 years. This paper describes how the unusual cyclogenesis location, favourable initial trajectory and steering, conducive environmental conditions and anomalously warm sea‐surface temperatures were the main influences responsible for Shaheen\u27s extraordinary genesis, intensification and remarkable geographical landfall

Influence of Taxanes on Treatment Sequence in Gastric Cancer

Background: Adenocarcinoma of the stomach and esophagogastric junction (EGJ) remains a tumor entity with a poor prognosis. While meaningful advances have been made in the treatment of other solid tumors in the past years, numerous phase III studies in gastric cancer have had negative outcomes. Successes of targeted therapies so far include the introduction of trastuzumab in the first-line treatment of HER2-positive gastric cancer, and second-line anti-angiogenic treatment with the anti-VEGF-2 receptor antibody ramucirumab. Taxanes have become established in the perioperative setting and in second-line treatment and have set new standards. However, evidence for improved overall survival in the first-line treatment of advanced gastric cancer with taxanes is not convincing. Methodology: Expert consensus discussion on the scientific and clinical evidence for sequential systemic treatment for advanced gastric and EGJ cancer, taking into account data clinical outcomes from randomized controlled phase II and phase III trials. Summary: In first-line treatment of advanced gastric cancer, taxanes in combination with a platinum- and 5-fluorouracil-based regimen are generally not recommended because they lack a survival benefit and confer high toxicity. However, taxanes in first-line can be a treatment option for patients presenting with high tumor burden and strong pressure to achieve remission. Since the publication of several positive studies in second- and third-line therapy, sequential therapy is playing an increasingly important role in metastatic gastric and EGJ cancer. Key Message: Standard of care for the first-line treatment of gastric cancer is a platinum-fluoropyrimidine chemotherapy doublet combination. The standard of care after failure of platinum-based first-line therapy is ramucirumab in combination with paclitaxel. Data supporting this combination after previous taxane therapy are not yet available

Comparison of the King’s and MiToS staging systems for ALS

Objective: To investigate and compare two ALS staging systems, King’s clinical staging and Milano-Torino (MiToS) functional staging, using data from the LiCALS phase III clinical trial (EudraCT 2008-006891-31). Methods: Disease stage was derived retrospectively for each system from the ALS Functional Rating Scale-Revised subscores using standard methods. The two staging methods were then compared for timing of stages using box plots, correspondence using chi-square tests, agreement using a linearly weighted kappa coefficient and concordance using Spearman’s rank correlation. Results: For both systems, progressively higher stages occurred at progressively later proportions of the disease course, but the distribution differed between the two methods. King’s stage 3 corresponded to MiToS stage 1 most frequently, with earlier King’s stages 1 and 2 largely corresponding to MiToS stage 0 or 1. The Spearman correlation was 0.54. There was fair agreement between the two systems with kappa coefficient of 0.21. Conclusion: The distribution of timings shows that the two systems are complementary, with King’s staging showing greatest resolution in early to mid-disease corresponding to clinical or disease burden, and MiToS staging having higher resolution for late disease, corresponding to functional involvement. We therefore propose using both staging systems when describing ALS

Brain simulation as a cloud service: The Virtual Brain on EBRAINS

open access articleThe Virtual Brain (TVB) is now available as open-source services on the cloud research platform EBRAINS (ebrains.eu). It offers software for constructing, simulating and analysing brain network models including the TVB simulator; magnetic resonance imaging (MRI) processing pipelines to extract structural and functional brain networks; combined simulation of large-scale brain networks with small-scale spiking networks; automatic con- version of user-specified model equations into fast simulation code; simulation-ready brain models of patients and healthy volunteers; Bayesian parameter optimization in epilepsy patient models; data and software for mouse brain simulation; and extensive educational material. TVB cloud services facilitate reproducible online collabo- ration and discovery of data assets, models, and software embedded in scalable and secure workflows, a precondition for research on large cohort data sets, better generalizability, and clinical translation

EXCHANGE-2: investigating the efficacy of add-on plasma exchange as an adjunctive strategy against septic shock—a study protocol for a randomized, prospective, multicenter, open-label, controlled, parallel-group trial

Background Sepsis is as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. The mortality of sepsis and particular of septic shock is very high. Treatment mostly focuses on infection control but a specific intervention that targets the underlying pathological host response is lacking to the present time. The investigators hypothesize that early therapeutic plasma exchange (TPE) will dampen the maladaptive host response by removing injurious mediators thereby limiting organ dysfunction and improving survival in patients with septic shock. Although small prospective studies demonstrated rapid hemodynamic stabilization under TPE, no adequately powered randomized clinical trial has investigated hard outcomes. Methods This is a randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of TPE in patients with early septic shock. Patients with a refractory (defined as norepinephrine (NE) ≥ 0.4 μg/kg/min ≥ 30 min OR NE 0.3 μg/kg/min + vasopressin) and early (shock onset < 24 h) septic shock will be included. The intervention is a standard TPE with donor fresh frozen plasma (1.2 × individual plasma volume) performed within 6 h after randomization and will be compared to a standard of care (SOC) control arm. The primary endpoint is 28 days mortality for which the power analysis revealed a group size of 137 / arm (n = 274) to demonstrate a benefit of 15%. The key secondary objective will be to compare the extent of organ failure indicated by mean SOFA over the first 7 days as well as organ support-free days until day 28 following randomization. Besides numerous biological secondary, safety endpoints such as incidence of bleeding, allergic reactions, transfusion associated lung injury, severe thrombocytopenia, and other severe adverse events will be assessed during the first 7 days. For exploratory scientific analyses, biomaterial will be acquired longitudinally and multiple predefined scientific subprojects are planned. This study is an investigator-initiated trial supported by the German Research Foundation (DFG, DA 1209/7–1), in which 26 different centers in Germany, Switzerland, and Austria will participate over a duration of 33 months. Discussion This trial has substantial clinical relevance as it evaluates a promising adjunctive treatment option in refractory septic shock patients suffering from an extraordinary high mortality. A positive trial result could change the current standard of care for this septic subgroup. The results of this study will be disseminated through presentations at international congresses, workshops, and peer-reviewed publications. Trial registration ClinicalTrials.gov NCT05726825, Registered on 14 February 2023

Latent cluster analysis of ALS phenotypes identifies prognostically differing groups

BACKGROUND Amyotrophic lateral sclerosis (ALS) is a degenerative disease predominantly affecting motor neurons and manifesting as several different phenotypes. Whether these phenotypes correspond to different underlying disease processes is unknown. We used latent cluster analysis to identify groupings of clinical variables in an objective and unbiased way to improve phenotyping for clinical and research purposes. METHODS Latent class cluster analysis was applied to a large database consisting of 1467 records of people with ALS, using discrete variables which can be readily determined at the first clinic appointment. The model was tested for clinical relevance by survival analysis of the phenotypic groupings using the Kaplan-Meier method. RESULTS The best model generated five distinct phenotypic classes that strongly predicted survival (p<0.0001). Eight variables were used for the latent class analysis, but a good estimate of the classification could be obtained using just two variables: site of first symptoms (bulbar or limb) and time from symptom onset to diagnosis (p<0.00001). CONCLUSION The five phenotypic classes identified using latent cluster analysis can predict prognosis. They could be used to stratify patients recruited into clinical trials and generating more homogeneous disease groups for genetic, proteomic and risk factor research