Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment: Comparative Effectiveness Update

Objectives: To update the 2006 systematic review of the comparative benefits and harms of erythropoiesis-stimulating agent (ESA) strategies and non-ESA strategies to manage anemia in patients undergoing chemotherapy and/or radiation for malignancy (excluding myelodysplastic syndrome and acute leukemia), including the impact of alternative thresholds for initiating treatment and optimal duration of therapy. Data sources: Literature searches were updated in electronic databases (n=3), conference proceedings (n=3), and Food and Drug Administration transcripts. Multiple sources (n=13) were searched for potential gray literature. A primary source for current survival evidence was a recently published individual patient data meta-analysis. In that meta-analysis, patient data were obtained from investigators for studies enrolling more than 50 patients per arm. Because those data constitute the most currently available data for this update, as well as the source for on-study (active treatment) mortality data, we limited inclusion in the current report to studies enrolling more than 50 patients per arm to avoid potential differential endpoint ascertainment in smaller studies. Review methods: Title and abstract screening was performed by one or two (to resolve uncertainty) reviewers; potentially included publications were reviewed in full text. Two or three (to resolve disagreements) reviewers assessed trial quality. Results were independently verified and pooled for outcomes of interest. The balance of benefits and harms was examined in a decision model. Results: We evaluated evidence from 5 trials directly comparing darbepoetin with epoetin, 41 trials comparing epoetin with control, and 8 trials comparing darbepoetin with control; 5 trials evaluated early versus late (delay until Hb ≤9 to 11 g/dL) treatment. Trials varied according to duration, tumor types, cancer therapy, trial quality, iron supplementation, baseline hemoglobin, ESA dosing frequency (and therefore amount per dose), and dose escalation. ESAs decreased the risk of transfusion (pooled relative risk [RR], 0.58; 95% confidence interval [CI], 0.53 to 0.64; I2 = 51%; 38 trials) without evidence of meaningful difference between epoetin and darbepoetin. Thromboembolic event rates were higher in ESA-treated patients (pooled RR, 1.51; 95% CI, 1.30 to 1.74; I2 = 0%; 37 trials) without difference between epoetin and darbepoetin. In 14 trials reporting the Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale, the most common patient-reported outcome, scores decreased by −0.6 in control arms (95% CI, −6.4 to 5.2; I2 = 0%) and increased by 2.1 in ESA arms (95% CI, −3.9 to 8.1; I2 = 0%). There were fewer thromboembolic and on-study mortality adverse events when ESA treatment was delayed until baseline Hb was less than 10 g/dL, in keeping with current treatment practice, but the difference in effect from early treatment was not significant, and the evidence was limited and insufficient for conclusions. No evidence informed optimal duration of therapy. Mortality was increased during the on-study period (pooled hazard ratio [HR], 1.17; 95% CI, 1.04 to 1.31; I2 = 0%; 37 trials). There was one additional death for every 59 treated patients when the control arm on-study mortality was 10 percent and one additional death for every 588 treated patients when the control-arm on-study mortality was 1 percent. A cohort decision model yielded a consistent result—greater loss of life-years when control arm on-study mortality was higher. There was no discernible increase in mortality with ESA use over the longest available followup (pooled HR, 1.04; 95% CI, 0.99 to 1.10; I2 = 38%; 44 trials), but many trials did not include an overall survival endpoint and potential time-dependent confounding was not considered. Conclusions: Results of this update were consistent with the 2006 review. ESAs reduced the need for transfusions and increased the risk of thromboembolism. FACT-Fatigue scores were better with ESA use but the magnitude was less than the minimal clinically important difference. An increase in mortality accompanied the use of ESAs. An important unanswered question is whether dosing practices and overall ESA exposure might influence harms.

One size fits all? Managing trust and privacy on social networking sites in Russia and Germany

When it comes to platform sustainability, mitigating user privacy concerns and enhancing trust represent two major tasks providers of Social Networking Sites (SNSs) are facing today. State-of-the-art research advocates reliance on the justice-based measures as possible means to address these challenges. However, as providers are increasingly expanding into foreign markets, the effectiveness of these measures in a cross-cultural setting is questioned. In an attempt to address this set of issues, in this study we build on the existing model to examine the impact of culture on the robustness of four justice-based means in mitigating privacy concerns and ensuring trust. Survey responses from German and Russian SNS members are used to evaluate the two structural equation models, which are then compared. We find that perceptions regarding Procedural and Informational Justice are universally important and hence should be addressed as part of the basic strategy by the SNS provider. When expanding to collectivistic countries like Russia, measures enhancing perceptions of Distributive and Interpersonal Justice can be additionally applied. Beyond practical implications, our study makes a significant contribution to the theoretical discourse on the role of culture in determining individual perceptions and behavior.

Managing Things and Services with Semantics: A Survey

This paper presents a survey on the usage, opportunities and pitfalls of semantic technologies in the Internet of Things. The survey was conducted in the context of a semantic enterprise integration platform. In total we surveyed sixty-one individuals from industry and academia on their views and current usage of IoT technologies in general, and semantic technologies in particular. Our semantic enterprise integration platform aims for interoperability at a service level, as well as at a protocol level. Therefore, also questions regarding the use of application layer protocols, network layer protocols and management protocols were integrated into the survey. The survey suggests that there is still a lot of heterogeneity in IoT technologies, but first indications of the use of standardized protocols exist. Semantic technologies are being recognized as of potential use, mainly in the management of things and services. Nonetheless, the participants still see many obstacles which hinder the widespread use of semantic technologies: Firstly, a lack of training as traditional embedded programmers are not well aware of semantic technologies. Secondly, a lack of standardization in ontologies, which would enable interoperability and thirdly, a lack of good tooling support.

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Troublesome Issues: Current Debates on Tensions between Gender Equality and Cultural Diversity in Austria

This paper will first deal with the legal and social situation of Islam and Muslims in Austria and then turn to particular “troublesome issues” at the intersection of gender equality and ethnic/religious diversity. The public debate on Muslims particularly focuses on the notion “not willing to integrate” and in the assumption of “parallel societies”. Hierarchical gender relations and “harmful traditions” such as veiling, female genital cutting, forced marriage and honour based violence recently became the centre of attention. We will show that the Austrian debate on these issues is shaped by the idea of “dangerous cultural difference” as something coming from outside and being concentrated in segregated Muslim enclaves. Despite the public authorities’ rejection of the idea that Islam was responsible for “harmful traditions”, legal as well as political measures in Austria not only combat violence against women but also fuel “cultural anxieties” between different ethnic and religious groups.

Managing Knowledge Transfer in Software-Maintenance Outsourcing Transitions: A System-Dynamics Perspective

The existing literature suggests that transitions in software-maintenance offshore outsourcing projects are prone to knowledge transfer blockades, i.e. situations in which the activities that would yield effective knowledge transfer do not occur, and that client management involvement is central to overcome them. However, the theoretical understanding of the knowledge transfer blockade is limited, and the reactive management behavior reported in case studies suggests that practitioners may frequently be astonished by the dynamics that may give rise to the blockade. Drawing on recent research from offshore sourcing and reference theories, this study proposes a system dynamics framework that may explain why knowledge transfer blockades emerge and how and why client management can overcome the blockade. The results suggest that blockades may emerge from a vicious circle of weak learning due to cognitive overload of vendor staff and resulting negative ability attributions that result in reduced helping behavior and thus aggravate cognitive load. Client management may avoid these vicious circles by selecting vendor staff with strong prior related experience. Longer phases of coexistence of vendor staff and subject matter experts and high formal and clan controls may also mitigate vicious circles.

Gender-fair language use in online job advertisements - relations to job status and gender equality

Purpose Gender fair language use in job advertisements has been shown to impact the outcome of personnel selections. It is thus important to assess, to what extent gender fair language is used in job advertisements and with which factors it is associated, e.g., language, culture, status, and gender typicality of profession. Design/Methodology In the present research we investigated gender fair language use in job advertisements published online in four European countries with different socio-economic rankings of gender equality (World Economic Forum, 2011), namely Austria (rank 34), Czech Republic (75), Poland (42), and Switzerland (10). From four lines of business with different percentages of female employees – steels/metals, science, restaurants/food services, and health care –we randomly selected 100 job advertisements, summing up to 1600 job advertisements in total. Results A first analysis of the Swiss data indicates that the phrasing of job advertisements is closely related to a profession’s gender typicality (e.g., merely masculine forms are used in steels and metals, gender-fair forms in healthcare). Feminine forms however are almost never used. Cross-cultural comparisons will be presented. Limitations We analyzed job advertisements of four specific lines of business in four European countries. To what extend results can be generalized remains an open question. Research/Practical Implications The present data provide a sound basis for future studies on gender fair language use in job advertisements. Furthermore it sheds a light on how companies comply with national guidelines of gender equality. Originality/Value This is the first time that gender fair language use in job advertisements is investigated (a) across different countries and languages and (b) considering status and gender typicality of professions.

Gender references in job advertisements – relations to job status and gender equality

Research has shown that gender references in job advertisements play an important role for gender (in)equality in personnel selection. The use of pair forms (masculine and feminine form) in German-language job advertisements, for example, was found to reduce the lack of fit between women and leadership roles (Horvath & Sczesny, 2013). Therefore the present study addresses the question which forms of gender reference are used in job advertisements, how these forms are distributed in different countries and how language use is related to gender typicality and status of the job. We collected job advertisements published online in four countries with different rankings of gender equality (i.e., Switzerland, Austria, Poland, and Czech Republic; World Economic Forum, 2011). We randomly selected 100 advertisements per country from four branches that are characterized by different proportions of female and male employees: steels/metals, science, restaurants/food services, and health care. The advertisements were analyzed with regard to gender references as well as different indicators of job status. The results show that, in general, men and women are addressed more equally in Swiss and Austrian job advertisements compared to Polish and Czech job advertisements. The results also show that women and men are addressed more equally in branches where the proportion of women is high than where the proportion of women is low. We thus can conclude that the use of gender references is associated with the degree of gender equality achieved in a country and with the gender typicality of a profession.