The principle of benefit from drug development for patients in clinical research

From an ethical perspective, clinical research involving humans is only acceptable if it involves the potential for benefit. Various characteristics can be applied to differentiate research benefit. Often benefit is categorized in direct or indirect benefit, whereby indirect benefit might be further differentiated in collective or benefit for the society, excluding or including the trial patient in the long term. Ethical guidelines, such as the Declaration of Helsinki in its latest version, do not precisely favor a particular type of benefit.

Benefit News: Employee Benefit News, Department of Administrative Services, October 2016

Benefit News, brought to you by the DAS Benefits Team, providing you with the most up-to-date information about the state of Iowa’s employee benefits.

Giving the benefit of the doubt: the role of vulnerability in the perception of Dark Triad behaviours.

The 'Dark Triad' of socially aversive personality traits (Machiavellianism, Narcissism, and Psychopathy) is typically associated with grandiosity, callousness, and exploitation. Despite this, people with such traits can be very successful in life, especially in the occupational context. This study investigated the characteristics of individuals who enable and abet people high on Dark Triad traits (e.g. through tolerating unpleasant behaviours, not challenging unethical conduct, etc.). High Dark Triad individuals may be able to identify individuals who are susceptible to social manipulation and who are therefore less likely to challenge their behaviours. This study used a 20-item Vulnerability Scale to capture the characteristics of individuals who fall victim to people high on the Dark Triad traits. Cronbach's alpha for the Vulnerability Scale was .80. Pearson's correlation between total vulnerability scores and each of the Big Five personality traits revealed that predictors of vulnerability to social manipulation include low extraversion, low conscientiousness, high neuroticism, and high agreeableness. The vignette method was used to elicit perceptions of Dark Triad behaviours from those who are found to demonstrate signs of social vulnerability. Differences in response styles on Likert-type statements and open-ended questions were found between the high and low vulnerability groups.

A cost-efficiency and health benefit approach to improve urban air quality

When ambient air quality standards established in the EU Directive 2008/50/EC are exceeded, Member States are obliged to develop and implement Air Quality Plans (AQP) to improve air quality and health. Notwithstanding the achievements in emission reductions and air quality improvement, additional efforts need to be undertaken to improve air quality in a sustainable way - i.e. through a cost-efficiency approach. This work was developed in the scope of the recently concluded MAPLIA project "Moving from Air Pollution to Local Integrated Assessment", and focuses on the definition and assessment of emission abatement measures and their associated costs, air quality and health impacts and benefits by means of air quality modelling tools, health impact functions and cost-efficiency analysis. The MAPLIA system was applied to the Grande Porto urban area (Portugal), addressing PM10 and NOx as the most important pollutants in the region. Four different measures to reduce PM10 and NOx emissions were defined and characterized in terms of emissions and implementation costs, and combined into 15 emission scenarios, simulated by the TAPM air quality modelling tool. Air pollutant concentration fields were then used to estimate health benefits in terms of avoided costs (external costs), using dose-response health impact functions. Results revealed that, among the 15 scenarios analysed, the scenario including all 4 measures lead to a total net benefit of 0.3M€·y(-1). The largest net benefit is obtained for the scenario considering the conversion of 50% of open fire places into heat recovery wood stoves. Although the implementation costs of this measure are high, the benefits outweigh the costs. Research outcomes confirm that the MAPLIA system is useful for policy decision support on air quality improvement strategies, and could be applied to other urban areas where AQP need to be implemented and monitored.

The Spanish online program "Educar en Positivo" ("The Positive Parent"): whom does it benefit the most?

This study evaluated the Spanish online program 'Educar en Positivo' ("The Positive Parent") (http://educarenpositivo.es). Eighty-five users were surveyed to examine changes in views of online parenting support and satisfaction with the module completed, as a function of their sociodemographic profile, their level of experience with the Internet, and their general and educational use of Internet resources. Results showed that parents changed their views of online support, the benefits thereof, and their parenting skills. Participants reported high satisfaction with the program's usability, the module content, and their perception of parental self-efficacy. These findings are moderated by level of Internet experience and educational use of web-based resources, suggesting that improving parents' digital literacy and promoting Internet use may be an effective avenue for improving access to prevention resources. In sum, this program offers a space for Spanish-speaking parents to learn and exchange experiences, thereby filling a gap in ensuring the promotion of positive parenting in this large community of potential users.

The need for a marker predicting benefit following cardiovascular disease risk reduction treatment

Developing a robust method to study characteristics of vascular flow using ultrasound may be useful to assess endothelial function and vasodilatation. There are four stages in this proposal. 1.The first stage is to standardise and validate the methodology to enable computational risk flow data and other flow characteristics to be used clinically. (Current Study). Further development of fluid modelling methods will enable particulate haemodynamics to be investigated, and incorporate detailed endothelial structure together with cellular pathways. 2. This should be followed up by studies in different patient groups investigating the association between the derived values and estimated risk (using other methods such as Framingham risk score). 3. Then, associated with underlying cardiovascular risk, prospective studies would be made to establish whether computational flow dynamic data can predict outcome. If successful it could prove to be a very useful marker of benefit following treatment in a clinical setting.

Current Legal Rules Benefit Spray Applicators When It Comes to Pesticide Drift

Homeowners, landowners, pesticide applicators, and farmers are concerned about pesticide drift. It may injure a homeowner’s garden or flowers or ruin a neighboring farmer’s crop. While no Maryland court has considered the issue of liability from pesticide drift, courts in other states have. These decisions provide some guidance on how a Maryland court might handle the issue. Depending on the facts of the drift case, pesticide applicators and farmers could owe damages for nuisance or trespass case, or for uses inconsistent with the pesticide label.

A COST-BENEFIT ANALYSIS OF A 25% RPS IN MICHIGAN

Michigan depends heavily on fossil fuels to generate electricity. Compared with fossil fuels, electricity generation from renewable energy produces less pollutants emissions. A Renewable Portfolio Standard (RPS) is a mandate that requires electric utilities to generate a certain amount of electricity from renewable energy sources. This thesis applies the Cost-Benefits Analysis (CBA) method to investigate the impacts of implementing a 25% in Michigan by 2025. It is found that a 25% RPS will create about $20.12 billion in net benefits to the State. Moreover, if current tax credit policies will not change until 2025, its net present value will increase to about $26.59 billion. Based on the results of this CBA, a 25% RPS should be approved. The result of future studies on the same issue can be improved if more state specific data become available.

WIPO and the Reinforcement of the Nagoya Protocol: Towards Effective Implementation of an Access and Benefit Sharing Regime for the Protection of Traditional Knowledge Associated with Genetic Resources

Traditional knowledge associated with genetic resources (TKaGRs) is acknowledged as a valuable resource. Its value draws from economic, social, cultural, and innovative uses. This value places TK at the heart of competing interests as between indigenous peoples who hold it and depend on it for their survival, and profitable industries which seek to exploit it in the global market space. The latter group seek, inter alia, to advance and maintain their global competitiveness by exploiting TKaGRs leads in their research and development activities connected with modern innovation. Biopiracy remains an issue of central concern to the developing world and has emerged in this context as a label for the inequity arising from the misappropriation of TKaGRs located in the South by commercial interests usually located in the North. Significant attention and resources are being channeled at global efforts to design and implement effective protection mechanisms for TKaGRs against the incidence of biopiracy. The emergence and recent entry into force of the Nagoya Protocol offers the latest example of a concluded multilateral effort in this regard. The Nagoya Protocol, adopted on the platform of the Convention on Biological Diversity (CBD), establishes an open-ended international access and benefit sharing (ABS) regime which is comprised of the Protocol as well as several complementary instruments. By focusing on the trans-regime nature of biopiracy, this thesis argues that the intellectual property (IP) system forms a central part of the problem of biopiracy, and so too to the very efforts to implement solutions, including through the Nagoya Protocol. The ongoing related work within the World Intellectual Property Organization (WIPO), aimed at developing an international instrument (or a series of instruments) to address the effective protection of TK, constitutes an essential complementary process to the Nagoya Protocol, and, as such, forms a fundamental element within the Nagoya Protocol’s evolving ABS regime-complex. By adopting a third world approach to international law, this thesis draws central significance from its reconceptualization of biopiracy as a trans-regime concept. By construing the instrument(s) being negotiated within WIPO as forming a central component part of the Nagoya Protocol, this dissertation’s analysis highlights the importance of third world efforts to secure an IP-based reinforcement to the Protocol for the effective eradication of biopiracy.

Climate Change Adaptation Case Study: Benefit-Cost Analysis of Coastal Flooding Hazard Mitigation

The damage Hurricane Sandy caused had far-reaching repercussions up and down the East Coast of the United States. Vast coastal flooding accompanied the storm, inundating homes, businesses, and utility and emergency facilities. Since the storm, projects to mitigate similar future floods have been scrutinized. Such projects not only need to keep out floodwaters but also be designed to withstand the effect that climate change might have on rising sea levels and increased flood risk. In this study, we develop an economic model to assess the costs and benefits of a berm (sea wall) to mitigate the effects of flooding from a large storm. We account for the lifecycle costs of the project, which include those for the upfront construction of the berm, ongoing maintenance, land acquisition, and wetland and recreation zone construction. Benefits of the project include avoided fatalities, avoided residential and commercial damages, avoided utility and municipal damages, recreational and health benefits, avoided debris removal expenses, and avoided loss of function of key transportation and commercial infrastructure located in the area. Our estimate of the beneficial effects of the berm includes ecosystem services from wetlands and health benefits to the surrounding community from a park and nature system constructed along the berm. To account for the effects of climate change and verify that the project will maintain its effectiveness over the long term, we allow the risk of flooding to increase over time. Over our 50-year time horizon, we double the risk of 100- and 500-year flood events to account for the effects of sea level rise on coastal flooding. Based on the economic analysis, the project is highly cost beneficial over its 50-year timeframe. This analysis demonstrates that climate change adaptation investments can be cost beneficial even though they mitigate the impacts of low-probability, high-consequence events.

Long-term benefit of early pre-reperfusion metoprolol administration in patients with acute myocardial infarction: Results from the Metocard-CNIC trial (Effect of Metoprolol in Cardioprotection during an Acute Myocardial Infarction)

The goal of this trial was to study the long-term effects of intravenous (IV) metoprolol administration before reperfusion on left ventricular (LV) function and clinical events. Early IV metoprolol during ST-segment elevation myocardial infarction (STEMI) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention (pPCI). The METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) trial recruited 270 patients with Killip class ≤II anterior STEMI presenting early after symptom onset (<6 h) and randomized them to pre-reperfusion IV metoprolol or control group. Long-term magnetic resonance imaging (MRI) was performed on 202 patients (101 per group) 6 months after STEMI. Patients had a minimal 12-month clinical follow-up. Left ventricular ejection fraction (LVEF) at the 6 months MRI was higher after IV metoprolol (48.7 ± 9.9% vs. 45.0 ± 11.7% in control subjects; adjusted treatment effect 3.49%; 95% confidence interval [CI]: 0.44% to 6.55%; p = 0.025). The occurrence of severely depressed LVEF (≤35%) at 6 months was significantly lower in patients treated with IV metoprolol (11% vs. 27%, p = 0.006). The proportion of patients fulfilling Class I indications for an implantable cardioverter-defibrillator (ICD) was significantly lower in the IV metoprolol group (7% vs. 20%, p = 0.012). At a median follow-up of 2 years, occurrence of the pre-specified composite of death, heart failure admission, reinfarction, and malignant arrhythmias was 10.8% in the IV metoprolol group versus 18.3% in the control group, adjusted hazard ratio (HR): 0.55; 95% CI: 0.26 to 1.04; p = 0.065. Heart failure admission was significantly lower in the IV metoprolol group (HR: 0.32; 95% CI: 0.015 to 0.95; p = 0.046). In patients with anterior Killip class ≤II STEMI undergoing pPCI, early IV metoprolol before reperfusion resulted in higher long-term LVEF, reduced incidence of severe LV systolic dysfunction and ICD indications, and fewer heart failure admissions.

Applied genomics to monitor the genetic diversity and integrity of honey bee (Apis mellifera) populations and define sustainable strategies to benefit the beekeeping sector

Honey bees are considered keystone species in ecosystem, the effect of harmful pesticides for the honey bees, the action of extreme climatic waves and their consequence on honey bees health can cause the loss of many colonies which could contribute to the reduction of the effective population size and incentive the use of non-autochthonous queens to replace dead colonies. Over the last decades, the use of non-ligustica bee subspecies in Italy has increased and together with the mentioned phenomena exposed native honey bees to hybridization, laeding to a dramatic loss of genetic erosion and admixture. Healthy genetic diversity within honey bee populations is critical to provide tolerance and resistance to current and future threatening. Nowadays it is urgent to design strategies for the conservation of local subspecies and their valorisation on a productive scale. In this Thesis we applied genomics tool for the analysis of the genetic diversity and the genomic integrity of honey bee populations in Italy are described. In this work mtDNA based methods are presented using honey bee DNA or honey eDNA as source of information of the genetic diversity of A. mellifera at different level. Taken together, the results derived from these studies should enlarge the knowledge of the genetic diversity and integrity of the honey bee populations in Italy, filling the gap of information necessary to design efficient conservation programmes. Furthermore, the methods presented in these works will provide a tool for the honey authentication to sustain and valorise beekeeping products and sector against frauds.

Modello neurocomputazionale per lo studio del benefit dell’integrazione multisensoriale nel processo mnemonico-associativo fra nomi propri e volti

Associare nomi propri a volti di persona è un compito importante, fondamentale nella quotidianità di tutti i giorni. Nonostante questa operazione avvenga quasi sempre in maniera automatica, essa coinvolge una rete neurale complessa ed articolata. Diversi studi offrono strategie che possono aiutare in questo compito; in particolare, è stato riportato che rafforzare i nomi con stimoli cross-modali, ossia presentando più input sensoriali esterni contemporaneamente, può costituire un vantaggio per il recupero in memoria dei nomi stessi. Lo scopo di questa tesi è stato quello di svolgere un’analisi di sensibilità tramite un modello neuro-computazionale su MatLab di ispirazione biologica. Nello specifico sono stati considerati due macro-network: uno per i volti, l’altro per i nomi propri; quest’ultimo in particolare a sua volta si compone di tre aree uni-sensoriali, ciascuna delle quali corrisponde ad un modo specifico con cui codificare un nome (traccia audio, lip reading, name tag). Questi network sono stati dunque implementati attraverso una configurazione articolata su due strati: si potrebbe infatti pensare alla fase di addestramento, basata su un algoritmo hebbiano, come un primo layer del processo, seguito così da un secondo layer, dato invece dalla fase di utilizzo. Dalle simulazioni svolte sembra emergere che addestrare in maniera efficiente le connessioni fra le aree uni-sensoriali dei nomi, ricreando così un'integrazione multi-sensoriale, sia un fattore fondamentale per favorire non solo il ricordo di un nome in sé, ma anche processi mnemonici-associativi che coinvolgono anche lo stimolo visivo di un volto. Le evidenze prodotte risultano inoltre qualitativamente coerenti con analoghi esperimenti in vivo.

Egfr Activating Mutations And Their Association With Response To Platinum-doublet Chemotherapy In Brazilian Non-small Cell Lung Cancer Patients.

The aim of the study was to analyze the frequency of epidermal growth factor receptor (EGFR) mutations in Brazilian non-small cell lung cancer patients and to correlate these mutations with response to benefit of platinum-based chemotherapy in non-small cell lung cancer (NSCLC). Our cohort consisted of prospective patients with NSCLCs who received chemotherapy (platinum derivates plus paclitaxel) at the [UNICAMP], Brazil. EGFR exons 18-21 were analyzed in tumor-derived DNA. Fifty patients were included in the study (25 with adenocarcinoma). EGFR mutations were identified in 6/50 (12 %) NSCLCs and in 6/25 (24 %) adenocarcinomas; representing the frequency of EGFR mutations in a mostly self-reported White (82.0 %) southeastern Brazilian population of NSCLCs. Patients with NSCLCs harboring EGFR exon 19 deletions or the exon 21 L858R mutation were found to have a higher chance of response to platinum-paclitaxel (OR 9.67 [95 % CI 1.03-90.41], p = 0.047). We report the frequency of EGFR activating mutations in a typical southeastern Brazilian population with NSCLC, which are similar to that of other countries with Western European ethnicity. EGFR mutations seem to be predictive of a response to platinum-paclitaxel, and additional studies are needed to confirm or refute this relationship.

[insomnia Symptoms, Daytime Naps And Physical Leisure Activities In The Elderly: Fibra Study Campinas].

The practice of physical activities contributes to reducing the risk of chronic diseases and improves sleep patterns in the elderly. This research aimed to investigate the association between insomnia symptoms and daytime nap and the participation in physical leisure activities in elderly community residents. Data from the Studies Network of the Fragility in Brazilian Elderly (Campinas site), were used. Information from 689 elderly was analyzed, regarding sociodemographic characterization, physical leisure activity, occurrence of daytime napping and its duration, symptoms of insomnia and use of sleep medication. A significant association was found between the practice of walking and the daytime nap of short duration. Studies indicate that a short nap can benefit the quality of sleep and health of the elderly. Therefore, promoting the practice of walking can be a nursing intervention that favors the sleep patterns of the elderly.