quality by design

Recurrent ventricular tachycardia (VT) in patients with prior myocardial infarction is associated with adverse quality of life and clinical outcomes, despite the presence of implanted defibrillators (ICDs). Suppression of recurrent VT can be accomplished with antiarrhythmic drug therapy or catheter ablation. The Ventricular Tachycardia Antiarrhythmics or Ablation In Structural Heart Disease 2 (VANISH2) trial is designed to determine whether ablation is superior to antiarrhythmic drug therapy as first line therapy for patients with ischemic cardiomyopathy and VT...

Patient reported outcomes (PROs) are measures of patients' health that are conveyed directly by individual patients. These measures serve as instruments to evaluate the impact of interventions on any aspect of patients' health, from specific symptoms to broader quality-of-life indicators. However, their effectiveness relies on capturing relevant factors accurately. While commonly utilized in clinical trials, PROs extend their influence across healthcare settings, informing clinicians, healthcare payers, regulators, and administrators to guide quality improvement and reimbursement decisions...

BACKGROUND: Estimation of the drug and development of the method is a critical aspect of formulation development and a critical factor for analytical scientists. Gefitinib is a poorly soluble anticancer drug. OBJECTIVE: The present research enlightens the topic of the development of innovative quality by design methods for the estimation of Gefitinib (GF) from bulk, pharmaceutical tablet formulation and complex nanoformulations. METHODS: To simplify the estimation of poorly soluble drugs like GF, Response Surface Methodology (RSM) was adopted with effective leverages to obtain precise computation design space using the Box-Behnken Design (BBD) model...

A recent article in Perspectives on Psychological Science (Webb & Tangney, 2022) reported a study in which just 2.6% of participants recruited on Amazon's Mechanical Turk (MTurk) were deemed "valid." The authors highlighted some well-established limitations of MTurk, but their central claims-that MTurk is "too good to be true" and that it captured "only 14 human beings . . . [out of] N = 529"-are radically misleading, yet have been repeated widely. This commentary aims to (a) correct the record (i.e., by showing that Webb and Tangney's approach to data collection led to unusually low data quality) and (b) offer a shift in perspective for running high-quality studies online...

Purpose: Research and lived experience demonstrate that sexual orientation and gender identity (SOGI) can change over the life course; however, little empirical work exists to understand the prevalence of such changes. To address this gap, we used data from a large nationally representative panel of adults and adolescents to assess changes in self-reported SOGI over time and identify trends by sex assigned at birth, age, race and ethnicity, and survey mode. Methods: We reviewed SOGI data collected between 2014 and 2022 for a sample of 19,469 adults and 970 adolescents...

Supporting ageing in place, quality of life, and activity engagement are public health priorities for people with dementia. The importance of maintaining opportunities for meaningful activities has been widely acknowledged for those with dementia in long-term care, but little is known about what makes activities meaningful for, and how they are experienced by, people with different types of dementia in their own homes. This study used focussed ethnographic methods to explore the motivations and meanings of everyday activity engagement within the homes of 10 people with memory-led Alzheimer's disease and 10 people with posterior cortical atrophy...

BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking...

During the ex vivo expansion of umbilical cord-derived mesenchymal stem cells (hUCMSCs) in a stirred tank bioreactor, the formation of cell-microcarrier aggregates significantly affects cell proliferation and physiological activity, making it difficult to meet the quantity and quality requirements for in vitro research and clinical applications. In this study, computational fluid dynamic (CFD) simulations were used to investigate the effect of an impeller structure in a commercial spinner flask on flow field structure, aggregate formation, and cellular physiological activity...

In recent years, generative machine learning algorithms have been successful in designing innovative drug-like molecules. SMILES is a sequence-like language used in most effective drug design models. Due to data's sequential structure, models such as recurrent neural networks and transformers can design pharmacological compounds with optimized efficacy. Large language models have advanced recently, but their implications on drug design have not yet been explored. Although one study successfully pre-trained a large chemistry model (LCM), its application to specific tasks in drug discovery is unknown...

A gate stack that facilitates a high-quality interface and tight electrostatic control is crucial for realizing high-performance and low-power field-effect transistors (FETs). However, when constructing conventional metal-oxide-semiconductor structures with two-dimensional (2D) transition metal dichalcogenide channels, achieving these requirements becomes challenging due to inherent difficulties in obtaining high-quality gate dielectrics through native oxidation or film deposition. Here, we report a gate-dielectric-less device architecture of van der Waals Schottky gated metal-semiconductor FETs (vdW-SG MESFETs) using a molybdenum disulfide (MoS2 ) channel and surface-oxidized metal gates such as nickel and copper...

Excipients are ubiquitous in pharmaceutical products, and often, they can also play a critical role in maintaining product quality. For a product containing a moisture-sensitive drug, moisture can be deleterious to the product stability during storage. Therefore, using excipients that interact with moisture in situ can potentially alleviate product stability issues. In this study, the interactive behavior of starch with moisture was augmented by coprocessing maize starch with sodium chloride (NaCl) or magnesium nitrate hexahydrate [Mg(NO3 )2 ·6H2 O] at different concentrations (5 and 10%, w/w)...

PURPOSE: To investigate whether parallel imaging-imposed geometric coil constraints can be relaxed when using a deep learning (DL)-based image reconstruction method as opposed to a traditional non-DL method. THEORY AND METHODS: Traditional and DL-based MR image reconstruction approaches operate in fundamentally different ways: Traditional methods solve a system of equations derived from the image data whereas DL methods use data/target pairs to learn a generalizable reconstruction model...

BACKGROUND: Health-related quality-of-life (HRQoL) assessment tools are becoming increasingly important for the assessment of diseases in veterinary medicine. OBJECTIVES: To develop a tool to assess the HRQoL of hyperthyroid cats and their owners. ANIMALS: Cats with hyperthyroidism (n = 229) and without hyperthyroidism (n = 322). METHODS: Cross-sectional study design. A preliminary list of 28 questions relating to the HRQoL of hyperthyroid cats and the influence their cat's disease might have on owners was created...

OBJECTIVE: To assess the differences in scar outcomes between modified rotation-advancement techniques proposed by Drs. Mohler and Noordhoff, designed to address issues such as inadequate vertical lip length and scarring on the upper third of the lip in the original rotation-advancement technique. DESIGN: Retrospective single-surgeon (RD) study. PATIENTS: Consecutive non-syndromic children ( n  = 68) with unilateral complete cleft lip and palate...

Central nervous system disorders are prevalent, profoundly debilitating, and poorly managed. Developing innovative treatments for these conditions, including Alzheimer's disease, could significantly improve patients' quality of life and reduce the future economic burden on healthcare systems. However, groundbreaking drugs for central nervous system disorders have been scarce in recent years, highlighting the pressing need for advancements in this field. One significant challenge in the realm of nanotherapeutics is ensuring the precise delivery of drugs to their intended targets due to the complex nature of Alzheimer's disease...

Asparagopsis taxiformis (Asparagopsis) has been shown to be highly efficacious at inhibiting the production of methane (CH4) in ruminants. To date, Asparagopsis has been primarily produced as a dietary supplement by freeze-drying to retain the volatile bioactive compound bromoform (CHBr3) in the product. Steeping of Asparagopsis bioactive compounds into a vegetable oil carrier (Asp-Oil) is an alternative method of stabilizing Asparagopsis as a ruminant feed additive. A dose-response experimental design used 3 Asp-Oil-canola oil blends, Low, Medium and High Asp-Oil which provided 17, 34 and 51 mg Asparagopsis derived CHBr3/kg DMI, respectively (in addition to a zero CHBr3 canola oil control), in a tempered-barley based feedlot finisher diet, fed for 59 days to 20 Angus heifers (5 replicates per treatment)...

Traditional pharmaceutical manufacturing processes for solid oral dosage forms can be inefficient and have been known to produce a large amount of undesired product. With the progressing trend of achieving carbon neutrality, there is an impetus to increase the energy efficiency of these manufacturing processes while maintaining the critical quality attributes of the product. One of the important steps in downstream pharmaceutical manufacturing is wet granulation, and within that, twin screw granulation (TSG) is a popular continuous manufacturing technique...

BACKGROUND: Patient education plays a critical role in healthcare, influencing outcomes and resource utilization. However, effectively integrating patient education into clinical practice remains challenging due to time constraints and inconsistencies in information delivery. Enhancements in Electronic Health Records (EHR) offer potential solutions by facilitating customized, quality education delivery. This study investigates the impact of an EHR-enhanced patient education intervention on short-term revisit rates to healthcare facilities...

Bad design in safety-critical environments like healthcare can lead to users being frustrated, excluded or injured. In contrast, good design can make it easier to use a service correctly, with impacts on both the safety and efficiency of healthcare delivery, as well as the experience of patients and staff. The participative dimension of design as an improvement strategy has recently gained traction in the healthcare quality improvement literature. However, the role of design expertise and professional design has been much less explored...

Thalassemia is a chronic disease caused by impaired globin chain synthesis, leading to ineffective erythropoiesis, hemolysis, and chronic anemia. The treatment of patients with thalassemia, including blood transfusion combined with chelation therapy has progressed and improved their survival and prognosis. However, thalassemia-related psychological problems and impaired health-related quality of life (QoL) challenges still exist. Gender is one of the factors that has been suggested, to contribute to the disparities in psychological outcomes...