Placebo-controlled trials are the ideal for evaluating medical treatment efficacy. They allow for control of the placebo effect and are most efficient, requiring the smallest numbers of patients to detect a treatment effect. A placebo control is ethically justified if no standard treatment exists, if the standard treatment has not been proven efficacious, there are no risks associated with dela...

BACKGROUND There is no consensus on the preferred method for defining the non-inferiority margin in non-inferiority trials, and previous studies showed that the rationale for its choice is often not reported. This study investigated how the non-inferiority margin is defined in the published literature, and whether its reporting has changed over time. METHODS A systematic PubMed search was con...

BACKGROUND Direct oral anticoagulants that target a single coagulation factor have been developed as an alternative to standard therapies with heparin and/or vitamin K antagonists. The purpose of this study was to derive non-inferiority margins suitable for randomised clinical studies designed to evaluate these agents for the treatment of venous thromboembolism (VTE). METHODS We performed a s...

Social identity theory typically emphasizes how low status group members resist and challenge imputations of inferiority (Tajfel & Turner, 1979), whereas system justification theory emphasizes the tendency to accept and justify status hierarchies ( Jost & Banaji, 1994). On the theoretical assumption that responses to ingroup inferiority would vary according to individual differences in social d...

OBJECTIVE To assess the non-inferiority of vonoprazan to lansoprazole for secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer (PU) and the safety of vonoprazan during extended use. DESIGN A phase 3, 24-week, multicenter, randomised, double-blind (DB), active-controlled study, followed by a phase 3, ≥28 week, multicenter, single-blind, parallel-group exten...

Previous research has documented that body dissatisfaction is positively related to social anxiety. However, little known about the mediating and moderating mechanisms underlying this relation. Based on person-environment interaction theory, study aimed examine chain mediation effect of feeling inferiority family cohesion in relationship between anxiety among adolescents whether process was mod...

BACKGROUND Despite years of experience with vitamin K antagonist-associated bleeding events, there is still no evidence to help identify the optimal treatment with prothrombin complex concentrates. Variable dosing and fixed dose strategies are being used. In this observational prospective two-cohort study, we aimed to assess the non-inferiority of a low fixed PCC dose (1,040 IU Factor IX) compa...

AIM We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. METHODS In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary...

PURPOSE The aim of this study was to measure the effect of an iPad-based asynchronous curriculum on emergency medicine resident performance on the in-training exam (ITE). We hypothesized that the implementation of an asynchronous curriculum (replacing 1 hour of weekly didactic time) would result in non-inferior ITE scores compared to the historical scores of residents who had participated in th...