How to avoid concerns with the interpretation of two primary endpoints if significant superiority in one is sufficient for formal proof of efficacy

Formal proof of efficacy of a drug requires that in a prospective experiment, superiority over placebo, or either superiority or at least non-inferiority to an established standard, is demonstrated. Traditionally one primary endpoint is specified, but various diseases exist where treatment success needs to be based on the assessment of two primary endpoints. With co-primary endpoints, both need to be “significant” as a prerequisite to claim study success. Here, no adjustment of the study-wise type-1-error is needed, but sample size is often increased to maintain the pre-defined power. Studies that use an at-least-one concept have been proposed where study success is claimed if superiority for at least one of the endpoints is demonstrated. This is sometimes also called the dual primary endpoint concept, and an appropriate adjustment of the study-wise type-1-error is required. This concept is not covered in the European Guideline on multiplicity because study success can be claimed if one endpoint shows significant superiority, despite a possible deterioration in the other. In line with Röhmel's strategy, we discuss an alternative approach including non-inferiority hypotheses testing that avoids obvious contradictions to proper decision-making. This approach leads back to the co-primary endpoint assessment, and has the advantage that minimum requirements for endpoints can be modeled flexibly for several practical needs. Our simulations show that, if planning assumptions are correct, the proposed additional requirements improve interpretation with only a limited impact on power, that is, on sample size.     

You can go your own way! The long‐term effectiveness of a self‐employment programme for welfare recipients in Germany

In this study, we examined the long‐term effects of supporting welfare recipients by means of a subsidy to start their own business. We used administrative data and propensity score matching to estimate the impact of the subsidy on the probability of receiving welfare benefits and on unemployment status up to 72 months after programme start. We supplemented our estimation results with the results of a qualitative survey which provided insights into the diversity of entrepreneurial activities and the recipients' motivation for starting a business. Our results are encouraging. We found a stable positive effect on the outcomes of interest. We further found that foreign nationals and the long‐term unemployed benefit the most. We conclude that the subsidy allows some people to successfully start a business who would not have otherwise done so and who would have been less successful by choosing the alternative of continued job search.     

‘Scarred’ young entrepreneurs. Exploring young adults’ transition from former unemployment to self-employment

The recent increase in youth unemployment has major implications for the current and future development of European labour markets. Previous studies reveal the long lasting ‘scarring effects’ of early unemployment experience on later career prospects, including a higher probability of future unemployment or social exclusion. Self-employment is often advocated as a potential remedy for unemployment in general and youth unemployment in particular. In this study, we investigate the individual-level factors that lead young people with the ‘scar’ of previous unemployment to engage in self-employment. Based on a recent survey among young adults in eleven European countries, we show that previous unemployment has a significant moderating effect on other individual-level characteristics usually associated with a higher likelihood of being self-employed. While the overall propensity of self-employment is not affected by unemployment experience, the reasons for becoming one’s own boss differ considerably between those young adults who have and those who have not experienced unemployment in the past.     

The power of “mapping the territory”. Why economists should become more aware of the performativity of their models

Economics is not simply about representing reality; it is also about shaping it, an approach encapsulated in Donald MacKenzie’s aphorism that economics is best conceived as an “engine, not as a camera” (MacKenzie and Millo (Am J Sociol 109(1):107–145, 2003). The making and application of economic theories and models contribute actively and intentionally towards the making of our social world, by encouraging, guiding and legitimizing actions and decisions, or discouraging others, and by steering them in certain directions. It follows that economists do not simply draw maps of the economic territory within their compass: they are not straightforwardly the cartographers of the economy, and cannot be seen as the disinterested observers that they commonly represent themselves to be, and indeed are often thought of as. Their theoretical work has or aims at practical consequences for the economy, and indeed for society at large, and their interests and influence are thus by no means confined to academia alone. This article calls for a discussion of the ethical responsibilities of economists, and of economics, and challenges the discipline properly to assume those responsibilities; and it concludes by considering the key questions—what makes a ‘good’ economic model; and what criteria should be used to distinguish the good models, and the ‘good ways’ of handling models and their results, from the bad ones. As far as epistemology, the methodology of research programmes and the relation of theory and (social) practice are concerned, the insights of mainly von Hayek (Br J Philos Sci 6(23):209–225, 1955, The pretence of knowledge. Lecture to the memory of Alfred Nobel, 1974; Individualism and economic order, University of Chicago Press, Chicago, pp 33–56, 1980a; Individualism and economic order, University of Chicago Press, Chicago, pp 57–76, 1980b; The theory of complex phenomena. Readings in the philosophy of social science, MIT Press, Cambridge, 1994) and Popper (e.g. The myth of the framework: in defence of science and rationality, Routledge, New York 1994a; Models, instruments, and truth. The status of the rationality principle in the social sciences, pp 154–184, 1994b) provide the background of my discussion of the mentioned issues.     

The Effects of Unemployment on Non-monetary Job Quality in Europe: The Moderating Role of Economic Situation and Labor Market Policies

Social Indicators Research - Previous research has illustrated that unemployment not only has short-term, but also medium-term negative effects on workers’ careers. While most studies have...     

Left-censored dementia incidences in estimating cohort effects

Lifetime Data Analysis - We estimate the dementia incidence hazard in Germany for the birth cohorts 1900 until 1954 from a simple sample of Germany’s largest health insurance company....     

From Dependent to Independent Variable: A Critical Assessment of Operationalisations of ‘Welfare Stateness’ as Macro-Level Indicators in Multilevel Analyses

Social Indicators Research - This paper explores different ways to operationalise properties of the welfare state as explanatory variable in multilevel frameworks. Based on the observation that...     

Feuerwehr und Supervision

Supervision in the fire services is not too common. This article will first describe the multifunctional field of work of the emergency services as well as their job requirements. Then the article will show possible starting points for supervision, and the difficulties in its acquisition and execution. Concludingly there will be a special example of supervision with psychotraumatherapeutic approaches.     

The making of ‘the elderly’: Constructing the subject of care

The provision and arrangement of care for elderly people is one of the main challenges for the future of European welfare states. In both political and public discourses elderly people feature as the subjects who are associated with particular needs, wishes and desires and for whom care needs to be guaranteed and organised. Underlying the cultural construction of the care regime and culture is an ideal type model of the elderly person. This paper analyses the discursive construction of elderly people in the discourses on care in Austria. An understanding of how elderly people as subjects, their wishes and needs and their position within society are constructed enables us to analyse, question and challenge the current dominant care arrangements and its cultural embeddings. The paper demonstrates the processes of silencing, categorisation and passivation of elderly people and it is argued that the socio-discursive processes lead to a particular image of the elderly person which consequently serves as the basis on which the care regime is built.