Retaliatory Termination of Physician Employment by Hospitals: The Case of Zelman versus Cape Cod Hospital.

A disturbing problem in the United States is that of illegal termination by hospitals of professional employees. Nurses, for example, have consistently decried poor staffing levels and, more recently in times of COVID-19, inadequate Personal Protective Equipment (PPE) that places both nurse and patient at high risk. For the most part, hospitals do little to correct these issues.

Abbreviated lipid guidelines for clinical practice : Based on ESC lipid guidelines 2019 and ESC cardiovascular disease prevention in clinical practice guidelines 2021.

Background: Lipid disorders are now considered causal for atherosclerotic cardiovascular disease (ASCVD) which remains one of the most important contributors to morbidity and mortality in the developed world. Identification and early treatment of lipid disarrays remains the cornerstone of good clinical practice to prevent, halt and even reverse ASCVD. Guidelines for lipid management are imperative to help promote good clinical practice.

Criminal Liability for Nursing and Medical Harm.

There is a ubiquitous problem with medical errors and the concomitant costs it brings in terms of human suffering and financial loss for patients, families, and caregivers. Professional caregivers, including physicians, nurses, and others who have made clinical errors normally will fall under the risk management and quality improvement policies of the organization at which they are employed and subsequent investigation and response occurs internally. Sometimes further consequences can entail the caregiver being named as a defendant or codefendant in a civil lawsuit, and sometimes the caregiver can have professional licensure restricted or even revoked.

The DA VINCI study: is Ireland achieving ESC/EAS guideline-directed LDL-C goals?

Background: The EU-wide, cross-sectional observational study of lipid-lowering therapy (LLT) use in secondary and primary care (DA VINCI) assessed the proportion of patients achieving low-density lipoprotein cholesterol (LDL-C) goals recommended by the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines and provided an insight into regional use of LLT in Europe, including Ireland.

Aims: This analysis focuses on data from patients in Ireland who participated in the DA VINCI study.

Methods: The DA VINCI study enrolled patients receiving LLT at primary and secondary care sites across 18 European countries between June 2017 and November 2018.

Opportunities for Education in Heart Failure Pharmacotherapy Demonstrated by a Survey of Clinicians.

Aim We conducted a survey of practitioners' knowledge of the clinical application of the major drug classes in HF, with reference to the European Society of Cardiology guidelines. The aim was to identify areas for practice development through education, which may improve HF morbidity and mortality. Methods We distributed a 14 item questionnaire assessing doctors knowledge of indications and contraindications for the major HF drug classes.

Implications of ACC/AHA Versus ESC/EAS LDL-C Recommendations for Residual Risk Reduction in ASCVD: A Simulation Study From DA VINCI.

Purpose: Low-density lipoprotein cholesterol (LDL-C) recommendations differ between the 2018 American College of Cardiology/American Heart Association (ACC/AHA) and 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for patients with atherosclerotic cardiovascular disease (ASCVD) (< 70 vs. < 55 mg/dl, respectively). In the DA VINCI study, residual cardiovascular risk was predicted in ASCVD patients.

Persisting Symptomatic Severe Secondary Mitral Regurgitation in Heart Failure Patients.

Aims We aimed to assess the rate of persisting severe symptomatic secondary mitral regurgitation (MR) in a newly diagnosed heart failure (HF) population following optimisation of guideline directed medical therapy (GDMT), cardiac resynchronisation therapy (CRT) and revascularisation. Methods We assessed all new patients referred to our hospital group’s HF clinics. We retrospectively reviewed these patients at HF clinic enrolment, HF programme completion, as well as most recent follow up.

When Surgeons Are "Too Old" to Practice Surgery: Recommendations to Balance the Imperatives of Public Safety and Practical Necessity.

Few countries have legally set a maximum age for practicing surgery. This is difficult to sustain as surgeon shortages in many localities require hospitals to grant surgical privileges based on internal peer review systems. This approach is not without problems.

The impact of a virtual cardiology outpatient clinic in the COVID-19 era.

Background: Restrictions as a result of the COVID-19 pandemic have demanded an innovative approach to provide appropriate patient review. We have been running virtual cardiology clinics as per Health Service Executive guidance.

Aims: Our study aims to determine how virtual clinics change practice vs traditional clinics.

EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study.

Aims: To provide contemporary data on the implementation of European guideline recommendations for lipid-lowering therapies (LLTs) across different settings and populations and how this impacts low-density lipoprotein cholesterol (LDL-C) goal achievement.

Methods And Results: An 18 country, cross-sectional, observational study of patients prescribed LLT for primary or secondary prevention in primary or secondary care across Europe. Between June 2017 and November 2018, data were collected at a single visit, including LLT in the preceding 12 months and most recent LDL-C.

Presentation of Severe Rheumatic Mitral Stenosis at the Peak of the COVID-19 Pandemic and the Presumptive Treatment as Severe Coronavirus Illness.

Unlabelled: This case report describes a young female Caucasian patient with newly presenting severe mitral stenosis at the peak of the coronavirus pandemic in the Republic of Ireland. The initial presumptive diagnosis was of severe coronavirus illness. This case report highlights the importance of keeping an open mind to alternative diagnoses and examines some of the challenges in the diagnosis and management of a rare condition in the pandemic environment.

Evaluation of lipid services in the Republic of Ireland.

Background: Abnormal cholesterol profiles are a major risk factor for cardiovascular disease and severe triglyceride disorders cause life threatening pancreatitis. Identification and treatment of these disorders are essential.

Aim: We evaluated the services available in Ireland to manage these problems.

Low Dose Resistance Exercise: A Pilot Study Examining Effects on Blood Pressure and Augmentation Index Between Intensities.

Introduction: The effects of resistance exercise on vascular function are unclear.

Aim: To investigate the acute haemodynamic (blood pressure and augmentation index) and rate of perceived exertion (RPE) response to two types of resistance exercises of equal workload-a set of unilateral 35% of one repetition maximum (1RM) quadriceps extension and a set of unilateral 70% 1RM quadriceps extension.

Methods: Twenty two young healthy males completed both exercises on separate days.

ADAPT identifies an ESCRT complex composition that discriminates VCaP from LNCaP prostate cancer cell exosomes.

Libraries of single-stranded oligodeoxynucleotides (ssODNs) can be enriched for sequences that specifically bind molecules on naïve complex biological samples like cells or tissues. Depending on the enrichment strategy, the ssODNs can identify molecules specifically associated with a defined biological condition, for example a pathological phenotype, and thus are potentially useful for biomarker discovery. We performed ADAPT, a variant of SELEX, on exosomes secreted by VCaP prostate cancer cells.

Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer.

Purpose: To harmonize the eligibility criteria and radiologic disease assessment definitions in clinical trials of adjuvant therapy for renal cell carcinoma (RCC).

Method: On November 28, 2017, US-based experts in RCC clinical trials, including medical oncologists, urologic oncologists, regulators, biostatisticians, radiologists, and patient advocates, convened at a public workshop to discuss eligibility for trial entry and radiologic criteria for assessing disease recurrence in adjuvant trials in RCC. Multiple virtual meetings were conducted to address the issues identified at the workshop.

An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.

A systematic analysis of new commercial investigational new drug applications (IND) submitted to the FDA's Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research was conducted to quantify the most common reasons INDs for oncology indications go on clinical hold. In OHOP, less than 10% of INDs went on hold or were withdrawn within the 30-day safety review period. Of INDs that were placed on hold, deficiencies were mainly clinical, followed by concerns related to pharmaceutical quality and nonclinical development.

Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.

Objective: To harmonize eligibility criteria and radiographic disease assessments in clinical trials of adjuvant therapy for muscle-invasive bladder cancer (MIBC).

Methods: National experts in bladder cancer clinical trial research, including medical and urologic oncologists, radiologists, biostatisticians, and patient advocates, convened at a public workshop on November 28, 2017, to discuss eligibility, radiographic entry criteria, and assessment of disease recurrence in adjuvant clinical trials in patients with MIBC.

Results: The key workshop conclusions for adjuvant MIBC clinical trials included the following points: (1) patients with urothelial carcinoma with divergent histologic differentiation should be allowed to enroll; (2) neoadjuvant chemotherapy is defined as at least 3 cycles of neoadjuvant cisplatin-based combination chemotherapy; (3) patients with muscle-invasive, upper-tract urothelial carcinoma should be included in adjuvant trials of MIBC; (4) patients with severe renal insufficiency can enroll into trials using agents that are not renally excreted; (5) patients with microscopic surgical margins can be included; (6) patients should undergo a standard bilateral lymph node dissection prior to enrollment; (7) computed tomographic (CT) imaging should be performed within 4 weeks prior to enrollment.

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.

Purpose: To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated with anti-programmed death protein 1 or ligand 1 (anti-PD-1/L1) antibodies.

Patients And Methods: We examined seven trials in 1,747 patients with metastatic or locally advanced urothelial cancer that led to approval of an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy, and two enrolled patients who were cisplatin ineligible.

Latest Updates on Lipid Management.

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death worldwide. Despite the clinical long-term and near-term benefits of lowering cholesterol in, respectively, primary and secondary prevention of ASCVD, cholesterol levels remain under-treated, with many patients not achieving their recommended targets. The present article will review the latest updates on lipid management with emphases on the different classes of cholesterol-lowering agents and their clinical uses.

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.

The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Overview of the current status of familial hypercholesterolaemia care in over 60 countries - The EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC).

Background And Aims: Management of familial hypercholesterolaemia (FH) may vary across different settings due to factors related to population characteristics, practice, resources and/or policies. We conducted a survey among the worldwide network of EAS FHSC Lead Investigators to provide an overview of FH status in different countries.

Methods: Lead Investigators from countries formally involved in the EAS FHSC by mid-May 2018 were invited to provide a brief report on FH status in their countries, including available information, programmes, initiatives, and management.

Evolving use of natriuretic peptide receptor type-C as part of strategies for the treatment of pulmonary hypertension due to left ventricle heart failure.

Pulmonary hypertension (PH) due to left ventricular heart failure (LV-HF) is a disabling and life-threatening disease for which there is currently no single marketed pharmacological agent approved. Despite recent advances in the pathophysiological understanding, there is as yet no prospect of cure, and the majority of patients continue to progress to right ventricular failure and die. There is, therefore an urgent unmet need to identify novel pharmacological agents that will prevent or reverse the increase in pulmonary artery pressures while enhancing cardiac performance in PH due to LV-HF.

A snapshot of lipid levels in the Republic of Ireland in 2017.

Background: Abnormalities in blood lipid levels are causally linked with cardiovascular disease and pancreatitis. Data is limited regarding lipid abnormalities in Ireland.

Aims: As part of a cholesterol awareness campaign, we performed a pilot study of current lipid levels to preliminarily assess the extent and pattern of lipid abnormalities in Ireland.

Erratum: New insights and new hope for pulmonary arterial hypertension: natriuretic peptides clearance receptor as a novel therapeutic target for a complex disease.

[This corrects the article on p. 112 in vol. 9, PMID: 28951773.

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.

Within one year, five immunotherapies have been approved for the treatment of patients with locally advanced or metastatic urothelial cancer. The availability of these immunotherapies brings challenges to all stakeholders in the field. Additional research is needed to identify biomarkers that are predictive of individual patient response to different immunotherapies.