Estimands in hematologic oncology trials

The estimand framework included in the addendum to the ICH E9 guideline facilitates discussions to ensure alignment between the key question of interest, the analysis, and interpretation. Therapeutic knowledge and drug mechanism play a crucial role in determining the strategy and defining the estimand for clinical trial designs. Clinical trials in patients with hematological malignancies often present unique challenges for trial design due to complexity of treatment options and existence of potential curative but highly risky procedures, for example, stem cell transplant or treatment sequence across different phases (induction, consolidation, maintenance). Here, we illustrate how to apply the estimand framework in hematological clinical trials and how the estimand framework can address potential difficulties in trial result interpretation. This paper is a result of a cross-industry collaboration to connect the International Conference on Harmonisation (ICH) E9 addendum concepts to applications. Three randomized phase 3 trials will be used to consider common challenges including intercurrent events in hematologic oncology trials to illustrate different scientific questions and the consequences of the estimand choice for trial design, data collection, analysis, and interpretation. Template language for describing estimand in both study protocols and statistical analysis plans is suggested for statisticians' reference.     

Kübra Gümüşay,Muslim digital feminism and the politics of visuality in Germany

abstract

Muslim women’s digital activism exists in complexly racialized visual contexts. This is exemplified in the journalism and activism of Kübra Gümü?ay, who first gained public attention as the purportedly first “hijabi columnist” in Germany. This essay draws on her series “50 Thoughts” as an entry point into her digital activism. I suggest that Gümü?ay uses this series to reveal the larger visual dilemmas with which she engages. Her digital activism functions by taking the risk to both expose and reconfigure the very conditions under which she is visible and comprehensible to her publics. In particular, I consider her activism as using digital spaces for self-poiesis (an imaginative remaking of self) as well as teleopoiesis (an imaginative reaching out to the other). This latter move functions both to gesture to an anti-racist community as well as to alliances among multiple feminisms.     

Ich fühle was ich will!

The theoretical part of this article gives an insight into the big field of emotions. In addition, the two-process theories answer the questions of where feelings come from and what feelings are. For some people, the perception of and the handling of emotions is easy, others find it difficult. In the latter case, it may be that a feeling blindness, the so-called alexithymia, is present. This well-studied personality trait is described and a practical tool from the Zurich Resource Model is presented, which offers people the opportunity to organize and translate their feelings in order to use them for personal self-management.     

Long-Run Identification in a Fractionally Integrated System

We propose an extension of structural fractionally integrated vector autoregressive models that avoids certain undesirable effects on the impulse responses that occur if long-run identification restrictions are imposed. We derive the model’s Granger representation and investigate the effects of long-run restrictions. Simulations illustrate that enforcing integer integration orders can have severe consequences for impulse responses. In a system of U.S. real output and aggregate prices, the effects of structural shocks strongly depend on the specification of the integration orders. In the statistically preferred fractional model, shocks that are typically interpreted as demand disturbances have a very brief influence on GDP. Supplementary materials for this article are available online.     

Bonding to Youth Clubs and Delinquency

Youth clubs and their relationship to delinquency has received surprisingly little attention in the literature. The applicability of social bonding theory, a prominent sociological theory of delinquency, to the experiences of youth in their clubs is the primary focus of this research. The reliability and validity analysis of indices specifically created to assess club bonding suggest the legitimacy of this approach. Belief in the rules and the regulations of the club is found to be negatively correlated with delinquency. Surprisingly, weekly involvement in the club is found to be positively associated with delinquency. Implications for practice and/or intervention are discussed.