Ethical decision-making (EDM) descriptive theoretical models often conflict with each other and typically lack comprehensiveness. To address this deficiency, a revised EDM model is proposed that ...consolidates and attempts to bridge together the varying and sometimes directly conflicting propositions and perspectives that have been advanced. To do so, the paper is organized as follows. First, a review of the various theoretical models of EDM is provided. These models can generally be divided into (a) rationalist-based (i.e., reason); and (b) non-rationalistbased (i.e., intuition and emotion). Second, the proposed model, called 'Integrated Ethical Decision Making,' is introduced in order to fill the gaps and bridge the current divide in EDM theory. The individual and situational factors as well as the process of the proposed model are then described. Third, the academic and managerial implications of the proposed model are discussed. Finally, the limitations of the proposed model are presented.
Physiological properties of tumors can be measured both in vivo and noninvasively by diffusion‐weighted imaging and dynamic contrast‐enhanced magnetic resonance imaging. Although these techniques ...have been used for more than two decades to study tumor diffusion, perfusion, and/or permeability, the methods and studies on how to reduce measurement error and bias in the derived imaging metrics is still lacking in the literature. This is of paramount importance because the objective is to translate these quantitative imaging biomarkers (QIBs) into clinical trials, and ultimately in clinical practice. Standardization of the image acquisition using appropriate phantoms is the first step from a technical performance standpoint. The next step is to assess whether the imaging metrics have clinical value and meet the requirements for being a QIB as defined by the Radiological Society of North America's Quantitative Imaging Biomarkers Alliance (QIBA). The goal and mission of QIBA and the National Cancer Institute Quantitative Imaging Network (QIN) initiatives are to provide technical performance standards (QIBA profiles) and QIN tools for producing reliable QIBs for use in the clinical imaging community. Some of QIBA's development of quantitative diffusion‐weighted imaging and dynamic contrast‐enhanced QIB profiles has been hampered by the lack of literature for repeatability and reproducibility of the derived QIBs. The available research on this topic is scant and is not in sync with improvements or upgrades in MRI technology over the years. This review focuses on the need for QIBs in oncology applications and emphasizes the importance of the assessment of their reproducibility and repeatability.
Level of Evidence: 5
Technical Efficacy Stage: 1
J. Magn. Reson. Imaging 2019;49:e101–e121.
Business codes are a widely used management instrument. Research into the effectiveness of business codes has, however, produced conflicting results. The main reasons for the divergent findings are: ...varying definitions of key terms; deficiencies in the empirical data and methodologies used; and a lack of theory. In this paper, we propose an integrated research model and suggest directions for future research.
Abstract
Many previously unexplained life-threatening ventricular arrhythmias and sudden cardiac deaths (SCDs) in young individuals are now recognized to be genetic in nature and are ascribed to a ...growing number of distinct inherited arrhythmogenic diseases. These include hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia (VT), and short QT syndrome. Because of their lower frequency compared to coronary disease, risk factors for SCD are not very precise in patients with inherited arrhythmogenic diseases. As randomized studies are generally non-feasible and may even be ethically unjustifiable, especially in the presence of effective therapies, the risk assessment of malignant arrhythmic events such as SCD, cardiac arrest due to ventricular fibrillation (VF), appropriate implantable cardioverter defibrillator (ICD) interventions, or ICD therapy on fast VT/VF to guide ICD implantation is based on observational data and expert consensus. In this document, we review risk factors for SCD and indications for ICD implantation and additional therapies. What emerges is that, allowing for some important differences between cardiomyopathies and channelopathies, there is a growing and disquieting trend to create, and then use, semi-automated systems (risk scores, risk calculators, and, to some extent, even guidelines) which then dictate therapeutic choices. Their common denominator is a tendency to favour ICD implantation, sometime with reason, sometime without it. This contrasts with the time-honoured approach of selecting, among the available therapies, the best option (ICDs included) based on the clinical judgement for the specific patient and after having assessed the protection provided by optimal medical treatment.
To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma.
A total of 24 patients were enrolled in an ...institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy.
With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated.
This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.
Porter and Kramer's “creating shared value” (CSV) proposal has achieved significant penetration into both the academic and corporate communities. Building on other critiques of CSV, this paper ...assesses whether the CSV framework, notwithstanding its popularity, currently possesses an appropriate and adequate theoretical foundation to represent an overarching normative framework for the entire business and society field. The analysis does so by comparing CSV with a series of other dominant business and society approaches including corporate social responsibility, business ethics, stakeholder management, sustainability, and corporate citizenship. The analysis finds that while CSV does address the fundamental business and society normative requirement that business activities should contribute to sustainable net societal value, it currently fails to adequately incorporate the equally important notions of (i) appropriately balancing stakeholder interests with those of the corporation's shareholders, as well as (ii) demonstrating sufficient accountability (i.e., taking responsibility) by properly reporting on and addressing any negative impacts resulting from the firm's activities. The paper concludes with a revised and expanded restatement of the CSV concept, which attempts to take into account and address its current theoretical limitations in order to enhance its appeal as an overarching business and society normative paradigm.
Objectives This study sought to evaluate the association of air pollution with the onset of atrial fibrillation (AF). Background Air pollution in general and more specifically particulate matter has ...been associated with cardiovascular events. Although ventricular arrhythmias are traditionally thought to convey the increased cardiovascular risk, AF may also contribute. Methods Patients with dual chamber implantable cardioverter-defibrillators (ICDs) were enrolled and followed prospectively. The association of AF onset with air quality including ambient particulate matter <2.5 μm aerodynamic diameter (PM2.5 ), black carbon, sulfate, particle number, NO2 , SO2 , and O3 in the 24 h prior to the arrhythmia was examined utilizing a case-crossover analysis. In sensitivity analyses, associations with air pollution between 2 and 48 h prior to the AF were examined. Results Of 176 patients followed for an average of 1.9 years, 49 patients had 328 episodes of AF lasting ≥30 s. Positive but nonsignificant associations were found for PM2.5 in the prior 24 h, but stronger associations were found with shorter exposure windows. The odds of AF increased by 26% (95% confidence interval: 8% to 47%) for each 6.0 μg/m3 increase in PM2.5 in the 2 h prior to the event (p = 0.004). The odds of AF were highest at the upper quartile of mean PM2.5. Conclusions PM was associated with increased odds of AF onset within hours following exposure in patients with known cardiac disease. Air pollution is an acute trigger of AF, likely contributing to the pollution-associated adverse cardiac outcomes observed in epidemiological studies.
This article is a tribute to the late Dr. W. Michael Hoffman's life and professional career (1943–2018), including his important contribution to the business ethics academic community, as well as to ...the practical world of business. Following a brief summary of Dr. Hoffman's professional achievements, several tributes are provided including from Professor Richard De George, columnist Gael O'Brien, and Professor Patricia Werhane. The tributes are followed by synopses of a small sample of Dr. Hoffman's many journal articles published in several different business ethics journals spanning 35 years (1982–2017). The tribute concludes with a personal note of gratitude by the author to Dr. Hoffman.
In this study, once-daily treatment with oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients with genotype 1, 2, or 3 HCV infection, ...including those in whom previous therapy with telaprevir or boceprevir had failed.
Chronic infection with hepatitis C virus (HCV) affects approximately 170 million people worldwide and is a major cause of cirrhosis and hepatocellular carcinoma.
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HCV-related morbidity and mortality are increasing; since 2007, HCV-related deaths in the United States have exceeded those from human immunodeficiency virus (HIV) infection.
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HCV is classified into six major genotypes.
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Genotypes 1, 2, and 3 are found worldwide, with subtype 1a predominating in the United States and subtype 1b predominating in Europe, Japan, and China.
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Peginterferon alfa–ribavirin treatment for chronic HCV infection is associated with a sustained virologic response (undetectable HCV RNA . . .
Summary Background Neovascular, or wet, age-related macular degeneration causes central vision loss and represents a major health problem in elderly people, and is currently treated with frequent ...intraocular injections of anti-VEGF protein. Gene therapy might enable long-term anti-VEGF therapy from a single treatment. We tested the safety of rAAV.sFLT-1 in treatment of wet age-related macular degeneration with a single subretinal injection. Methods In this single-centre, phase 1, randomised controlled trial, we enrolled patients with wet age-related macular degeneration at the Lions Eye Institute and the Sir Charles Gairdner Hospital (Nedlands, WA, Australia). Eligible patients had to be aged 65 years or older, have age-related macular degeneration secondary to active subfoveal choroidal neovascularisation, with best corrected visual acuity (BCVA) of 3/60–6/24 and 6/60 or better in the other eye. Patients were randomly assigned (3:1) to receive either 1 × 1010 vector genomes (vg; low-dose rAAV.sFLT-1 group) or 1 × 1011 vg (high-dose rAAV.sFLT-1 group), or no gene-therapy treatment (control group). Randomisation was done by sequential group assignment. All patients and investigators were unmasked. Staff doing the assessments were masked to the study group at study visits. All patients received ranibizumab at baseline and week 4, and rescue treatment during follow-up based on prespecified criteria including BCVA measured on the Early Treatment Diabetic Retinopathy Study (EDTRS) scale, optical coherence tomography, and fluorescein angiography. The primary endpoint was ocular and systemic safety. This trial is registered with ClinicalTrials.gov , number NCT01494805. Findings From Dec 16, 2011, to April 5, 2012, we enrolled nine patients of whom eight were randomly assigned to receive either intervention (three patients in the low-dose rAAV.sFLT-1 group and three patients in the high-dose rAAV.sFLT-1 group) or no treatment (two patients in the control group). Subretinal injection of rAAV.sFLT-1 was highly reproducible. No drug-related adverse events were noted; procedure-related adverse events (subconjunctival or subretinal haemorrhage and mild cell debris in the anterior vitreous) were generally mild and self-resolving. There was no evidence of chorioretinal atrophy. Clinical laboratory assessments generally remained unchanged from baseline. Four (67%) of six patients in the treatment group required zero rescue injections, and the other two (33%) required only one rescue injection each. Interpretation rAAV.sFLT-1 was safe and well tolerated. These results support ocular gene therapy as a potential long-term treatment option for wet age-related macular degeneration. Funding National Health and Medical Research Council of Australia, Richard Pearce Bequest, Lions Save Sight Foundation, Brian King Fellowship, and Avalanche Biotechnologies, Inc.
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