Standardized monitoring of cytomegalovirus-specific immunity can improve risk stratification of recurrent cytomegalovirus reactivation after hematopoietic stem cell transplantation.

Recurrence of cytomegalovirus reactivation remains a major cause of morbidity and mortality following allogeneic hematopoietic stem cell transplantation. Monitoring cytomegalovirus-specific cellular immunity using a standardized assay might improve the risk stratification of patients. A prospective multicenter study was conducted in 175 intermediate- and high-risk allogeneic hematopoietic stem cell transplant recipients under preemptive antiviral therapy. Cytomegalovirus-specific cellular immunity was measured using a standardized IFN-γ ELISpot assay (T-Track® CMV). Primary aim was to evaluate the suitability of measuring cytomegalovirus-specific immunity after end of treatment for a first cytomegalovirus reactivation to predict recurrent reactivation. 40/101 (39.6%) patients with a first cytomegalovirus reactivation experienced recurrent reactivations, mainly in the high-risk group (cytomegalovirus-seronegative donor/cytomegalovirus-seropositive recipient). The positive predictive value of T-Track® CMV (patients with a negative test after the first reactivation experienced at least one recurrent reactivation) was 84.2% in high-risk patients. Kaplan-Meier analysis revealed a higher probability of recurrent cytomegalovirus reactivation in high-risk patients with a negative test after the first reactivation (hazard ratio 2.73; p=0.007). Interestingly, a post-hoc analysis considering T-Track® CMV measurements at day 100 post-transplantation, a time point highly relevant for outpatient care, showed a positive predictive value of 90.0% in high-risk patients. Our results indicate that standardized cytomegalovirus-specific cellular immunity monitoring may allow improved risk stratification and management of recurrent cytomegalovirus reactivation after hematopoietic stem cell transplantation. This study was registered at www.clinicaltrials.gov as #NCT02156479.

Social and legal frame conditions for 3D (and) bioprinting in medicine.

The beginnings of three-dimensional (3D) printing and bioprinting can be traced to as early as 1984. From printing inorganic models for the generation of biologic scaffolds, additive manufacturing (AM) developed to the direct printing of organic materials, including specialized tissues, proteins, and cells. In recent years, these technologies have gained significantly in relevance, and there have been several innovations, especially in the field of regenerative medicine. It is becoming increasingly important to consider the economic and social aspects of AM, particularly in education and information of medical human resources, society, and politics, as well as for the establishment of homogenous, globally adapted legal regulations.

Ethical Orientation and Research Misconduct Among Business Researchers Under the Condition of Autonomy and Competition.

The topics of ethical conduct and governance in academic research in the business field have attracted scientific and public attention. The concern is that research misconduct in organizations such as business schools and universities might result in practitioners, policymakers, and researchers grounding their decisions on biased research results. This study addresses ethical research misconduct by investigating whether the ethical orientation of business researchers is related to the likelihood of research misconduct, such as selective reporting of research findings. We distinguish between deontological and consequentialist ethical orientations and the competition between researchers and investigate the moderating role of their perceived autonomy. Based on global data collected from 1031 business scholars, we find that researchers with a strong deontological ethical orientation are less prone to misconduct. This effect is robust against different levels of perceived autonomy and competition. In contrast, researchers having a consequentialist ethical orientation is positively associated with misconduct in business research. High levels of competition in the research environment reinforce this effect. Our results reveal a potentially toxic combination comprising researchers with a strong consequentialist orientation who are embedded in highly competitive research environments. Our research calls for the development of ethical orientations grounded on maxims rather than anticipated consequences among researchers. We conclude that measures for ethical governance in business schools should consider the ethical orientation that underlies researchers' decision-making and the organizational and institutional environment in which business researchers are embedded.

Comparison of Cytomegalovirus-Specific Immune Cell Response to Proteins versus Peptides Using an IFN-γ ELISpot Assay after Hematopoietic Stem Cell Transplantation.

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality following hematopoietic stem cell transplantation (HSCT). Measuring CMV-specific cellular immunity may improve the risk stratification and management of patients. IFN-γ ELISpot assays, based on the stimulation of peripheral blood mononuclear cells with CMV pp65 and IE-1 proteins or peptides, have been validated in clinical settings. However, it remains unclear to which extend the T-cell response to synthetic peptides reflect that mediated by full-length proteins processed by antigen-presenting cells. We compared the stimulating ability of pp65 and IE-1 proteins and corresponding overlapping peptides in 16 HSCT recipients using a standardized IFN-γ ELISpot assay. Paired qualitative test results showed an overall 74.4% concordance. Discordant results were mainly due to low-response tests, with one exception. One patient with early CMV reactivation and graft-versus-host disease, sustained CMV DNAemia and high CD8+ counts showed successive negative protein-based ELISpot results but a high and sustained response to IE-1 peptides. Our results suggest that the response to exogenous proteins, which involves their uptake and processing by antigen-presenting cells, more closely reflects the physiological response to CMV infection, while the response to exogenous peptides may lead to artificial in vitro T-cell responses, especially in strongly immunosuppressed patients.

Working Time Society consensus statements: Regulatory approaches to reduce risks associated with shift work-a global comparison.

A large number of workers worldwide engage in shift work that can have significant influences upon the quality of working life. For most jurisdictions, setting and enforcing appropriate policies, regulations, and rules around shift work is considered essential to (a) prevent potentially negative consequences of shift work and (b) to improve worker health and well-being. However, the best ways to do this are often highly contested theoretical spaces and often culturally and historically bound. In this paper, we examine the regulatory approaches to regulating shift work in four different regions: Europe, North America, Australasia, and East Asia (Japan, China, and Korea). Despite the fact that social and cultural factors vary considerably across the regions, comparing regulatory frameworks and initiatives in one region can be instructive. Different approaches can minimally provide a contrast to stimulate discussion about custom and practice and, potentially, help us to develop new and innovative models to improve worker well-being and organizational productivity simultaneously. In this paper, our goal is not to develop or even advocate a "perfect" sets of regulations. Rather, it is to compare and contrast the diversity and changing landscape of current regulatory practices and to help organizations and regulators understand the costs and benefits of different approaches. For example, in recent years, many western countries have seen a shift away from prescriptive regulation toward more risk-based approaches. Advocates and critics vary considerably in what drove these changes and the benefit-cost analyses associated with their introduction. By understanding the different ways in which shift work can be regulated, it may be possible to learn from others and to better promote healthier and safer environments for shift-working individuals and workplaces.

Analyzing irregular working hours: lessons learned in the development of RAS 1.0--The Representation and Analysis Software.

Actual working hours of employees vary widely, especially in the transportation industry. We developed a tool, the RAS (Representation and Analysis Software), to ease the assessment of such irregular hours and the transfer of existing knowledge of proper schedule design to the problem of irregular hours. This article discusses several critical design questions that were addressed during software development in order for it to assess irregular work patterns, including the (1) importance, in spite of a lack of established definitions, of basic concepts like, e.g., night shift, (2) difficulty of modeling and adapting existing knowledge on proper design, and (3) large number of analytical methods and additional data beyond company schedule that are necessary to meet the needs of various research groups. This article describes how the RAS addresses these three issues by illustrating its application to the work schedule of a train driver involved in the Hinton train disaster.

Flexible working hours, health, and well-being in Europe: some considerations from a SALTSA project.

The project brought together researchers from 9 EU-Countries and resulted in a number of actions, in particular the following: (a) There is an urgent need of defining the concept of flexible working hours, since it has been used in many different and even counterintuitive ways; the most obvious distinction is where the influence over the working hours lies, that is between the "company-based flexibility" and the "individual-oriented flexibility"; (b) The review of the Legislation in force in the 15 European countries shows that the regulation of working times is quite extensive and covers (Council Directive 93/104/EC) almost all the various arrangements of working hours (i.e., part-time, overtime, shift, and night work), but fails to provide for flexibility; (c) According to the data of the Third EU Survey on Working Conditions, longer and "irregular" working hours are in general linked to lower levels of health and well-being; moreover, low (individual) flexibility and high variability of working hours (i.e., company-based flexibility) were consistently associated with poor health and well-being, while low variability combined with high autonomy showed positive effects; (d) Six substudies from different countries demonstrated that flexible working hours vary according to country, economic sector, social status, and gender; overtime is the most frequent form of company-based flexibility but has negative effects on stress, sleep, and social and mental health; individual flexibility alleviates the negative effects of the company-based flexibility on subjective health, safety, and social well-being; (e) The literature review was able to list more than 1,000 references, but it was striking that most of these documents were mainly argumentative with very little empirical data. Thus, one may conclude that there is a large-scale intervention ongoing in our society with almost completely unknown and uncontrolled effects. Consequently, there is a strong need for systematic research and well-controlled actions in order to examine in detail what flexible working hours are considered, what and where are their positive effects, in particular, as concerns autonomy, and what regulation seem most reasonable.

Conflicts between employee preferences and ergonomic recommendations in shift scheduling: regulation based on consent is not sufficient.

OBJECTIVE: Contribution to the discussion of the role of participation/consent of employees in working hours regulation. METHODS: Exploratory analysis of conflicts between preferences of employees and ergonomic recommendations in shift scheduling by analysing a large number of participative shift scheduling projects. RESULTS: The analysis showed that very often the pursuit of higher income played the major role in the decision making process of employees and employees preferred working hours in conflict with health and safety principles. CONCLUSIONS: First, the consent of employees or the works council alone does not ensure ergonomically sound schedules. Besides consent, risk assessment procedures seem to be a promising but difficult approach. Secondly, more research is necessary to check the applicability of recommendations under various settings, to support the risk assessment processes and to improve regulatory approaches to working hours.

Reducing understaffing and shift work with Temporal Profile Optimization (TPO).

The ergonomic quality of shift schedules can be improved by reducing time periods with understaffing (resulting in work-pressure, poor quality, etc.) and evening, night and/or weekend work. Improving the quality of forecasts regarding future workforce requirements as well as the optimization of work processes by moving as much work as possible to more suitable time zones are two approaches to this. We introduce and propose Temporal Profile Optimization (TPO) as a systematic approach to question the demand as well as its translation to workforce planning. Temporal profiles describe the number of employees needed over time (e.g. for different days of the week, times of day, for different calendar days) as well as the shift-times and staffing levels planned to meet this workforce demand. With Temporal Profile Forecasts we introduce a forecasting method that is based on time-stamped historical data and methodologically supplements traditional time series models like SARIMA in many ways. With Temporal Profile Reengineering we use systematic and often participatory methods from business process reengineering to identify moveable work and streamline the load lines by (re-)distributing movable work such that shifts and schedules are improved. The approach is illustrated along two business cases. Using TP-Forecasts for air traffic controllers increased forecasting accuracy whereby a different shift design was possible resulting in 3-4% less shift work. In a warehouse of an Austrian freight carrier a TP-Forecast together with TP-Reengineering helped to rearrange work processes such that the resulting workforce requirements curve had a more even form. This allowed for shorter shifts than before (thereby decreasing overtime). Experiences made so far stress the potential of Temporal Profile Optimization.

Conflicts between employee preferences and ergonomic recommendations in shift scheduling: regulation based on consent is not sufficient

OBJETIVO: Contribuir para a discussão do papel da participação/consentimento dos empregados na regulamentação das horas de trabalho. MÉTODOS: Realizou-se um estudo exploratório dos conflitos existentes entre as preferências dos empregados e as recomendações ergonômicas no planejamento de esquemas de trabalho em turnos, analisando-se um grande número de projetos participativos de planejamento dos turnos. RESULTADOS: O estudo mostrou que, com freqüência, a busca por um rendimento maior teve um papel importante no processo de tomada de decisão dos empregados, quando estes optaram pelas horas de trabalho em oposição aos princípios de saúde e segurança. CONCLUSÕES: Em primeiro lugar, o consentimento dos empregados ou da comissão de trabalhadores por si só não garante horários salutares do ponto de vista ergonômico. Além do consentimento, processos de avaliação de risco parecem ser uma abordagem promissora embora complicada. Em segundo lugar, fazem-se necessários mais estudos para verificar a aplicabilidade das recomendações em diversas situações, respaldar os processos de avaliação de risco e melhorar as abordagens regulamentares para as horas de trabalho.