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.

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.

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.

The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Overview of Challenges and Opportunities in Revising the Nodal Classification of Lung Cancer.

The status of lymph node involvement is a major component of the TNM staging system. The N categories for lung cancer have remained unchanged since the fourth edition of the TNM staging system, partly because of differences in nodal mapping nomenclature, partly because of insufficient details to verify possible alternative approaches for staging. In preparation for the rigorous analysis of the International Association for the Study of Lung Cancer database necessary for the ninth edition TNM staging system, members of the N-Descriptors Subcommittee of the International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee reviewed the evidence for alternative approaches to categorizing the extent of lymph node involvement with lung cancer, which is currently based solely on the anatomical location of lymph node metastasis.

Professional qualifications of medical affairs pharmaceutical physicians and other internal stakeholders in the pharmaceutical industry.

Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that benefit regulators, payors, prescribers and patients. This study assessed whether MAPPs' specialist training and education in pharmaceutical medicine could account for this level of value by determining whether there was significant variation in education and training between MAPPs and other internal stakeholders of pharmaceutical companies. A systematic search of LinkedIn profiles from the 10 pharmaceutical companies by revenue was conducted between June and October 2021.

Perceived Pain Severity and Disability After the Recurrence of Tennis Elbow Following a Local Corticosteroid Injection.

Background: We hypothesized that there is no difference in the perceived pain and disability when the tennis elbow symptoms recur after a corticosteroid injection (CSI). Consequently, we secondarily aimed to assess the approximate time from CSI until symptom recurrence. Moreover, we aimed to evaluate factors associated with the time to recurrence.

Strengths and weaknesses of alternative noninvasive imaging approaches for microvascular ischemia.

Structural and functional abnormalities of coronary microvasculature are highly prevalent in several clinical settings and often associated with worse clinical outcomes. Therefore, there is a growing interest in the detection and treatment of this, often overlooked, disease. Coronary angiography allows the assessment of the Coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR).

Oral stem cells, decoding and mapping the resident cells populations.

The teeth and their supporting tissues provide an easily accessible source of oral stem cells. These different stem cell populations have been extensively studied for their properties, such as high plasticity and clonogenicity, expressing stem cell markers and potency for multilineage differentiation in vitro. Such cells with stem cell properties have been derived and characterised from the dental pulp tissue, the apical papilla region of roots in development, as well as the supporting tissue of periodontal ligament that anchors the tooth within the alveolar socket and the soft gingival tissue.

Event-related brain dynamics during mind wandering in attention-deficit/hyperactivity disorder: An experience-sampling approach.

Adults with attention-deficit/hyperactivity disorder (ADHD) report increased spontaneous mind wandering (MW) compared to control adults. Since MW is associated with ADHD severity and functional impairment, elucidating the brain mechanisms underlying MW may inform new interventions targeting MW and point to neural markers to monitor their efficacy. Population-based electroencephalographic (EEG) studies suggest that weaker event-related decreases in occipital alpha power characterise periods of MW, but no study has examined event-related brain oscillations during MW in individuals with ADHD.