Assessing switchability for biosimilar products: modelling approaches applied to children's growth

The present paper describes two statistical modelling approaches that have been developed to demonstrate switchability from the original recombinant human growth hormone (rhGH) formulation (Genotropin^®) to a biosimilar product (Omnitrope^®) in children suffering from growth hormone deficiency. Demonstrating switchability between rhGH products is challenging because the process of growth varies with the age of the child and across children. The first modelling approach aims at predicting individual height measured at several time‐points after switching to the biosimilar. The second modelling approach provides an estimate of the deviation from the overall growth rate after switching to the biosimilar, which can be regarded as an estimate of switchability. The results after applying these approaches to data from a randomized clinical trial are presented. The accuracy and precision of the predictions made using the first approach and the small deviation from switchability estimated with the second approach provide sufficient evidence to conclude that switching from Genotropin^® to Omnitrope^® has a very small effect on growth, which is neither statistically significant nor clinically relevant. Copyright © 2015 John Wiley & Sons, Ltd.     

Measuring societal effects of transdisciplinary research projects: design and application of an evaluation method

Most Transdisciplinary Research (TdR) projects combine scientific research with the building of decision making capacity for the involved stakeholders. These projects usually deal with complex, societally relevant, real-world problems. This paper focuses on TdR projects, which integrate the knowledge of researchers and stakeholders in a collaborative transdisciplinary process through structured methods of mutual learning. Previous research on the evaluation of TdR has insufficiently explored the intended effects of transdisciplinary processes on the real world (societal effects). We developed an evaluation framework for assessing the societal effects of transdisciplinary processes. Outputs (measured as procedural and product-related involvement of the stakeholders), impacts (intermediate effects connecting outputs and outcomes) and outcomes (enhanced decision making capacity) are distinguished as three types of societal effects. Our model links outputs and outcomes of transdisciplinary processes via the impacts using a mediating variables approach. We applied this model in an ex post evaluation of a transdisciplinary process. 84 out of 188 agents participated in a survey. The results show significant mediation effects of the two impacts "network building" and "transformation knowledge". These results indicate an influence of a transdisciplinary process on the decision making capacity of stakeholders, especially through social network building and the generation of knowledge relevant for action.     

Expert Review on Poliovirus Immunity and Transmission

Successfully managing risks to achieve wild polioviruses (WPVs) eradication and address the complexities of oral poliovirus vaccine (OPV) cessation to stop all cases of paralytic poliomyelitis depends strongly on our collective understanding of poliovirus immunity and transmission. With increased shifting from OPV to inactivated poliovirus vaccine (IPV), numerous risk management choices motivate the need to understand the tradeoffs and uncertainties and to develop models to help inform decisions. The U.S. Centers for Disease Control and Prevention hosted a meeting of international experts in April 2010 to review the available literature relevant to poliovirus immunity and transmission. This expert review evaluates 66 OPV challenge studies and other evidence to support the development of quantitative models of poliovirus transmission and potential outbreaks. This review focuses on characterization of immunity as a function of exposure history in terms of susceptibility to excretion, duration of excretion, and concentration of excreted virus. We also discuss the evidence of waning of host immunity to poliovirus transmission, the relationship between the concentration of poliovirus excreted and infectiousness, the importance of different transmission routes, and the differences in transmissibility between OPV and WPV. We discuss the limitations of the available evidence for use in polio risk models, and conclude that despite the relatively large number of studies on immunity, very limited data exist to directly support quantification of model inputs related to transmission. Given the limitations in the evidence, we identify the need for expert input to derive quantitative model inputs from the existing data.     

Integration between flow scheduling and personnel allocation in a parallel line system in automotive industry

A state-of-the-art review over fifty years of flow shop scheduling research, written by Gupta and Stafford (2006), comes to the conclusion that the mathematical theory of flow shop scheduling “suffers from too much abstraction and too little application”. In this paper we will develop an extended mathematical model for flow shop scheduling with parallel lines and simultaneously a worker assignment to machines as well as a solution concept for practical use. Such production systems are realized by applying the BTO-(Build to order) concept, as can be found in the automotive or computer industry, which allows customers to make any changes to their vehicles or hardware configuration within a few days before final assembly. In these cases late configuration is an important task for the producer and a complex scheduling problem arises in this context.     

How are employees of the nonprofit sector motivated? A research need

This article reviews research on motivation of employees in the nonprofit sector, with a major emphasis on the motivation of teachers and hospital nursing staff. Although both areas are widely researched in the nonprofit sector, empirical motivation research conducted in schools and hospitals is certainly not extensive. Nevertheless, based on these limited research findings, we derive potential hypotheses for future research in schools and hospitals.     

Agency conflicts between board and manager

Detecting agency problems is an important task when assessing the effectiveness of a nonprofit organization's governance. A first step is to examine the objectives of principals and agents and determine whether there is a systematic difference between them. Using a discrete choice experiment, we identify the objectives of board chairpersons (principals) and headmasters (agents) of Flemish nonprofit schools. We find systematic differences between the two groups. Of the seven possible objectives set out in the experiment, six are relevant for both headmasters and board chairpersons. For four of these, the preferences of both groups differ significantly. Whereas ideological values play an important role for both the board and the headmaster, they are significantly more important for the board. Both parties dislike having a large number of pupils, and the disutility is larger for the board. With respect to job satisfaction and pupil satisfaction, we find the opposite: while the board is prepared to give up pupil and job satisfaction in favor of the other objectives, these two objectives score very high on the priority list of the headmasters.     

Philanthropic racism in Britain: The Liverpool university settlement,the anti‐slavery society and the issue of ‘half‐caste’ children, 1919–51

The history of racial ideology in Britain has focused mainly on extreme groups of the political right. Less attention has been paid to more ‘respectable’ forms of racism. This paper attempts to redress the balance. It concentrates upon two groups, the Anti‐Salvery Society and the Settlement Movement and, with particular reference to Liverpool and Cardiff between 1919 and 1951, examines their attitudes towards Britain's ‘half‐caste’ population.     

Expertise-based lobbying and accounting regulation

It has long been recognised that accounting regulation is not a mere technical exercise but one that takes place in a political context and lobbying has been examined in numerous empirical studies. Most of these studies address lobbying of the accounting standard setter. However, standard setting is embedded in a political and institutional context. In their decision-making, these institutions depend on the expertise of potentially self-interested lobbyists. This expertise-provision element tends to be ignored in most lobbying studies. The present paper proposes an analytical model of lobbying of an accounting regulator that explicitly focuses on the provision of relevant information by lobbyists. It suggests that lobbying will generally be non-controversial, i.e. either those opposed to a standard will lobby or those favouring it, but not both. Analysis of the model furthermore implies an important role for the regulator’s ex ante leanings, both perceived and real, even when the regulator treats all information received impartially. This implies an important role for the institutional context of accounting regulation.     

Social Network Methodology in the Study of Disasters: Issues and Insights Prompted by Post-Katrina Research

Dynamic social networks, a key concept in modern social science research, are beginning to play a major role in understanding the ways in which individuals and communities respond to disasters. The authors of this paper review the relevant theory and research regarding how crises cause change in social networks, and how those changes may or may not facilitate recovery, as a function of the kinds of changes that occur. It applies the In/Out/Seeker/Provider (IOSP) framework to identify categories in which we might study disasters and the impact both on the networks and the impacts to the networks. This paper details options for applying social network analysis to research of both pre- and post-disaster settings and concludes by framing a research agenda for the future study of the dynamics of network change following a disaster.