Evaluation of Drug-Polymer and Drug-Drug Interaction in Cellulosic Multi-Drug Delivery Matrices.

Multi-drug delivery systems have gained increasing interest from the pharmaceutical industry. Alongside this is the interest in amorphous solid dispersions as an approach to achieve effective oral delivery of compounds with solubility-limited bioavailability. Despite this, there is limited information regarding predicting the behavior of two or more drugs (in amorphous forms) in a polymeric carrier and whether molecular interactions between the compounds, between each compound, and if the polymer have any effect on the physical properties of the system.

A randomised controlled trial of the effect of intra-articular lidocaine on pain scores in inflammatory arthritis.

Chronic pain in inflammatory arthritis (IA) reflects a complex interplay between active disease in a peripheral joint and central pronociceptive mechanisms. Because intra-articular lidocaine may be used to abolish joint-specific peripheral input to the central nervous system, we aimed to validate its use as a clinical tool to identify those patients with IA whose pain likely incorporates centrally mediated mechanisms. We began by investigating whether there was a placebo response of intra-articular injection in patients with IA 1:1 randomised to receive intra-articular lidocaine or control (0.

Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

Aim: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness.

Design: Parallel two-arm, cluster-level randomized controlled trial.

Methods: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them.

The International Association for the Study of Lung Cancer Staging Project for Lung Cancer: Proposals for the Revision of the N Descriptors in the Forthcoming Ninth Edition of the TNM Classification for Lung Cancer.

Introduction: The accurate assessment of nodal (N) status is crucial to the management and prognostication of nonmetastatic NSCLC. We sought to determine whether the current N descriptors should be maintained or revised for the upcoming ninth edition of the international TNM lung cancer staging system.

Methods: Data were assembled by the International Association for the Study of Lung Cancer on patients with NSCLC, detailing both clinical and pathologic N status, with information about anatomical location and individual station-level identification.

A protocol for an international, multicenter, prospective, non-interventional observational registry for patients with hypertriglyceridemia.

Background: In the study on triglyceride-induced pancreatitis (TG-IAP), a core clinical dataset using the Jandhyala method was developed to collect the minimum amount of information for each patient presenting with TG-IAP globally. This approach offered a unified framework for observing multiple populations of TG-IAP patients using the same set of indicators, resulting in a considerably larger and uniform real-world population. It was understood that when this core dataset is implemented in a patient registry it could address the issue of missing data in observational studies and produce higher-quality research.

"Please keep on beating"-Participation in a Creative Workshop Offers Unexpected Benefits to Women With Takotsubo Cardiomyopathy.

Takotsubo cardiomyopathy (TCM) or "broken heart syndrome" is a rare condition that is more common in women than men, particularly those who are postmenopausal. It mimics a myocardial infarction and psychological factors have been implicated in its etiology as well as being consequences of its presentation. As part of a public engagement project we brought together 8 women (of 12 invited) previously diagnosed with TCM to facilitate a discussion, through participation in a creative workshop-based process, about their illness experience, how they made sense of it, and the meaning it had for them in their lives, and to identify areas of unmet need.

Observed consensus on research priorities for the hypertriglyceridemia patient registry.

Background: Priority setting in health research has been described as essential due to disparities within and between countries and populations. Commercial benefits to the pharmaceutical industry may increase the generation and use of regulatory Real-World Evidence which has recently been reported in the literature. Research must be steered by valuable priorities.

Cardiovascular Magnetic Resonance from Fetal to Adult Life-Indications and Challenges: A State-of-the-Art Review.

Cardiovascular magnetic resonance (CMR) imaging offers a comprehensive, non-invasive, and radiation-free imaging modality, which provides a highly accurate and reproducible assessment of cardiac morphology and functions across a wide spectrum of cardiac conditions spanning from fetal to adult life. It minimises risks to the patient, particularly the risks associated with exposure to ionising radiation and the risk of complications from more invasive haemodynamic assessments. CMR utilises high spatial resolution and provides a detailed assessment of intracardiac and extracardiac anatomy, ventricular and valvular function, and flow haemodynamic and tissue characterisation, which aid in the diagnosis, and, hence, with the management of patients with cardiac disease.

Neutral theory: applicability and neutrality of clinical study endpoints where a disease-specific instrument is available.

Background: There is a pressing need to improve the accuracy of rare disease clinical study endpoints. Neutral theory, first described here, can be used to assess the accuracy of endpoints and improve their selection in rare disease clinical studies, reducing the risk of patient misclassification.

Methods: Neutral theory was used to assess the accuracy of rare disease clinical study endpoints and the resulting probability of false positive and false negative classifications at different disease prevalence rates.

Leg Ulcer Pathway Acceleration (LUPA) study.

Background: Leg ulcers are common, costly, and significantly impair quality of life, but their management is variable and associated with considerable delays in healing. The aim of this study was to design an accelerated leg ulcer care pathway in a community and hospital setting to improve patient outcomes.

Methods: A new referral pathway was developed using a series of healthcare professional and patient interviews, focus groups, and stakeholder workshops.

Myocardial infarction with non-obstructive coronary arteries: Etiology, diagnosis, treatment and prognosis.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) is responsible for 10% of myocardial infarctions. Previously, patients were thought to have good prognosis, but evidence-based management and treatment strategies were scarce. Today, researchers and physicians recognize MINOCA as a condition with non-trivial mortality and morbidity.

The Use of Stress Cardiovascular Imaging in Pediatric Population.

Although not frequent in the pediatric population, ischemia could occur in children due to several congenital and acquired disease. Stress imaging is key for the non-invasive evaluation of myocardial abnormalities and perfusion defect in this clinical setting. Moreover, beyond ischemia assessment, it can provide complementary diagnostic and prognostic information in valvular heart disease and cardiomyopathies.

Neurosurgical Academic Impact Rankings by h5-Index: A Global Perspective.

Objective: Our aim was to assess the 5-year h-index (h5)-index by nation. We aimed to assess the relationship between a nation's h5-index and numbers of neurosurgeons, population, gross domestic product (GDP), and expenditure on both health and research.

Methods: Using Web of Science we collected data on each nation's h5-index and number of publications for the 5-year period 2016 to 2020.

Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument.

Background: Medical affairs pharmaceutical physicians (MAPPs) are at risk for low work-related quality of life (WRQoL). The aim of this study was to develop, validate and implement the first WRQoL instrument for this population.

Methods: A prospective observational cohort clinical study, the Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg), was registered in November 2021 (NCT05123846).

Commercial impact of adding real-world evidence to clinical trials at regulatory approval: a Markovian-like transition model.

Objective: Regulatory use of real-world evidence (RWE) has been recognized as a useful supplement to clinical trial evidence and could benefit patients by reducing time to treatment. However, commercial benefits have not been documented. The aim was to determine commercial impact of regulatory RWE, using ambrisentan as an illustrative example.

Development of a definition for real-world evidence using the Jandhyala method for observing consensus opinion among medical affairs pharmaceutical physicians.

Objective: Low rates of inclusion of real-world evidence (RWE) during regulation may arise from lack of clarity and consensus on its definition. A conceptually mature definition of RWE may have pragmatic utility, increasing its inclusion during regulation. The aim was to develop a definition of RWE to promote inclusion in regulatory submissions and assess its conceptual maturity.