Extradigital Symplastic Glomus Tumor and Review of the Literature.

Symplastic glomus tumors are a rare subtype of glomus tumor defined by nuclear atypia without additional markers of malignancy such as large size, deep location, or atypical/prevalent mitotic figures. Glomus tumors, including the symplastic subtype, most commonly present in the subungual area with rarer extradigital presentation. To our knowledge, there have been less than 25 cases of symplastic glomus tumors described in the literature.

Longitudinal White and Gray Matter Response to Precision Medicine-Guided Intervention for Alzheimer's Disease.

Background: Alzheimer's disease (AD) is a debilitating condition that is widely known to adversely affect gray matter (GM) and white matter (WM) tracts within the brain. Recently, precision medicine has shown promise in alleviating the clinical and gross morphological trajectories of patients with AD. However, regional morphological changes have not yet been adequately characterized.

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial.

Background: Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.

Methods: An ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions.

Precision Medicine Approach to Alzheimer's Disease: Rationale and Implications.

The neurodegenerative disease field has enjoyed extremely limited success in the development of effective therapeutics. One potential reason is the lack of disease models that yield accurate predictions and optimal therapeutic targets. Standard clinical trials have pre-determined a single treatment modality, which may be unrelated to the primary drivers of neurodegeneration.

Perceived Stress, Grit, and Self-Care Behaviors in First-Year Medical Students.

Medical students experience more stress than the general population, which over time can cause mental and physical disease, including burnout. Identifying factors impacting stress during early medical training could inform strategies to minimize its impacts throughout training and in clinical practice. This study surveyed 238 first-year osteopathic medical students to assess stress (Perceived Stress Scale; PSS), grit, sleep quality (Pittsburgh Sleep Quality Index; PSQI), physical activity (Godin-Shephard Leisure-Time Physical Activity Score; LTPA), and nutrition habits (Rapid Eating Assessment for Participants; REAP) within the first 2 weeks of starting medical school and again 10 weeks later.

Precision Medicine Approach to Alzheimer's Disease: Successful Pilot Project.

Background: Effective therapeutics for Alzheimer's disease are needed. However, previous clinical trials have pre-determined a single treatment modality, such as a drug candidate or therapeutic procedure, which may be unrelated to the primary drivers of the neurodegenerative process. Therefore, increasing data set size to include the potential contributors to cognitive decline for each patient, and addressing the identified potential contributors, may represent a more effective strategy.

Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non-muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial.

A recent phase 3 trial of intravesical nadofaragene firadenovec reported a promising complete response rate for patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. This study examined the ability of antiadenovirus antibody levels to predict the durability of therapeutic response to nadofaragene firadenovec. A standardized and validated quantitative assay was used to prospectively assess baseline and post-treatment serum antibody levels among 91 patients from the phase 3 trial, of whom 47 (52%) were high-grade recurrence free at 12 mo (responders).

Case Report: Infantile Urticaria as a Herald of Neonatal Onset Multisystem Inflammatory Disease With a Novel Mutation in NLRP3.

Neonatal multisystem onset inflammatory disorder (NOMID) is a severe autoinflammatory syndrome that can have an initial presentation as infantile urticaria. Thus, an immediate recognition of the clinical symptoms is essential for obtaining a genetic diagnosis and initiation of early therapies to prevent morbidity and mortality. Herein, we describe a neonate presenting with urticaria and systemic inflammation within hours after birth who developed arthropathy and neurologic findings.

Clinical and Histopathologic Characteristics of Metastatic and Locally Advanced Cutaneous Basal Cell Carcinomas.

Locally advanced or metastatic basal cell carcinomas (laBCCs or mBCCs) are rare, with few case series providing information on their epidemiology. We aimed to describe the clinical and histologic features of locally advanced and metastatic basal cell carcinomas. Forty cases of laBCC or mBCC were identified by searching Vanderbilt's database from 1984 to January 2019.

Vinpocetine, cognition, and epilepsy.

Objective: Vinpocetine has been shown to enhance memory in animal models, with possible cognitive benefit in humans. The present study sought to demonstrate if vinpocetine can enhance cognition in healthy volunteers or patients with epilepsy. In addition, we compare blood levels of vinpocetine and its active metabolite (apovincaminic acid; AVA) in humans and animals to further characterize factors related to possible therapeutic benefit.

National accreditation programmes for hospitals in the Eastern Mediterranean Region: Case studies from Egypt, Jordan, and Lebanon.

Background: Many countries use external evaluation programmes such as accreditation in order to improve quality and safety in their healthcare settings. Hospital accreditation has developed in many low-and-middle-income countries (LMICs); however, the implementation and sustainability of these programmes vary in each country. This study addresses design and implementation issues of national hospital accreditation programmes.

Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial.

Background: BCG is the most effective therapy for high-risk non-muscle-invasive bladder cancer. Nadofaragene firadenovec (also known as rAd-IFNa/Syn3) is a replication-deficient recombinant adenovirus that delivers human interferon alfa-2b cDNA into the bladder epithelium, and a novel intravesical therapy for BCG-unresponsive non-muscle-invasive bladder cancer. We aimed to evaluate its efficacy in patients with BCG-unresponsive non-muscle-invasive bladder cancer.

'You're just a locum': professional identity and temporary workers in the medical profession.

Internationally, there has been substantial growth in temporary working, including in the medical profession where temporary doctors are known as locums. There is little research into the implications of temporary work in health care. In this paper, we draw upon theories concerning the sociology of the medical profession to examine the implications of locum working for the medical profession, healthcare organisations and patient safety.

Reforming regulatory relationships: The impact of medical revalidation on doctors, employers, and the General Medical Council in the United Kingdom.

In 2012, medical regulation in the United Kingdom was fundamentally changed by the introduction of revalidation - a process by which all licensed doctors are required to regularly demonstrate that they are up to date and fit to practice in their chosen field and are able to provide a good level of care. This paper examines the implications of revalidation on the structure, governance, and performance management of the medical profession, as well as how it has changed the relationships between the regulator, employer organizations, and the profession. We conducted semi-structured interviews with clinical and non-clinical staff from a range of healthcare organizations.

What methods are used to promote patient and family involvement in healthcare regulation? A multiple case study across four countries.

Background: In the regulation of healthcare, the subject of patient and family involvement figures increasingly prominently on the agenda. However, the literature on involving patients and families in regulation is still in its infancy. A systematic analysis of how patient and family involvement in regulation is accomplished across different health systems is lacking.

The development of hospital accreditation in low- and middle-income countries: a literature review.

Hospital accreditation has been transferred from high-income countries (HICs) to many low- and middle-income countries (LMICs), supported by a variety of advocates and donor agencies. This review uses a policy transfer theoretical framework to present a structured analysis of the development of hospital accreditation in LMICs. The framework is used to identify how governments in LMICs adopted accreditation from other settings and what mechanisms facilitated and hindered the transfer of accreditation.

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training.

The evolution of postgraduate vocational education and training in pharmaceutical medicine is described alongside the growth of this scientific-medical discipline and profession for the development of new medicines. Over the past 50 years, whilst the training of competent professionals for their work has been paramount, this has paralleled the need to engage with the rapid and complex changes in R&D technologies, patient and healthcare system needs, and the ethical and regulatory obligations applied to the development of medicines throughout their lifecycle. The move from unstructured training to formal programs with syllabus, curricula and assessments for certification, has been accompanied by educational changes to outcomes-based, learner-centered, competency-based programs.

Reviving clinical governance? A qualitative study of the impact of professional regulatory reform on clinical governance in healthcare organisations in England.

Background: Until recently, processes of professional regulation and organisational clinical governance in the UK have been largely separate. However, the introduction of medical revalidation in 2012 means that all doctors have to demonstrate periodically to the regulator that they are up to date and fit to practise, and as part of this process doctors must engage with clinical governance activities in the organisations in which they work.

Objective: To explore how the recent implementation of medical revalidation has affected the arrangements for clinical governance in healthcare organisations in England.

Evolution of Ethical Principles in the Practice of Pharmaceutical Medicine From a UK Perspective.

Pharmaceutical medicine has evolved to be a distinct medical scientific discipline over time. Pharmaceutical medicine has distinctive features related to complex innovative medicines development activities in an often commercially focused competitive environment. This sometimes uneasy mix of professionalism and commercialisation demands of its medical and scientific researchers alike, a focus on strict adherence to ethical standards, guidelines, practices and behaviors in the interest of delivering new, effective, high-quality lifesaving and life-enhancing medicines quickly and reliably to patients in need.