BACKGROUND Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M. MAIN TEXT Non-inferiority trials allow for the conclusion of: (a) non-inferiority of Test to Con...

BACKGROUND Non-inferiority clinical trials (NIFCTs) aim to demonstrate that the experimental therapy has advantages over the standard of care, with acceptable loss of efficacy. We evaluated the purposes underlying the selection of a non-inferiority design in oncology and the size of their non-inferiority margins (NIFm's). PATIENTS AND METHODS All NIFCTs of cancer-directed therapies and suppor...

Educational personnel are seen as agents of change toward inclusive schools. This research aims to examine the daily-based interactions through which inclusion is experienced by support teachers and how their social identity constructed within a secondary school in northern Italy province. The theoretical basis this formed conceptual contributions approach symbolic interactionism understand sel...

Social anxiety is marked by viewing social interactions as competitive, hypervigilance to signs of social threat, and avoidance of interactions that may result in social rejection. Therefore, social anxiety should relate to: (1) greater hostile feelings toward others, (2) heightened perceptions of hostility in others, and (3) relatively low levels of violence and aggression. To date, however, l...

The contribution of the feelings-as-information hypothesis to our understanding of the role of affect in judgment and decision making is discussed. Basic principles and regularities in how affective feelings guide judgments and decisions are then identified. Based on these principles and regularities, it is argued that the role of feelings in judgment and decision making may be more adaptive th...

BACKGROUND When comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP) on a visual analog scale (VAS). However, t...