BACKGROUND Non-inferiority and equivalence trials require tailored methodology and therefore adequate conduct and reporting is an ambitious task. The aim of our review was to assess whether the criteria recommended by the CONSORT extension were followed. METHODS We searched the Medline database and the Cochrane Central Register for reports of randomised non-inferiority and equivalence trials ...

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...

Background: Thalassemia is an inherited disorder of hemoglobin (Hb) synthesis. Treatment thalassemia has not yet reached the level cure. Globally, management symptomatic in form lifelong blood transfusions. Data on children with major Indonesia been widely published. However, various studies clearly showed growth and development disorders behavior that greatly affected quality life thalassemia....

The objective of the research was to evaluate in university students from Hidalgo, México, psychological impact during distance education, confinement pandemic by SARS-CoV-2 virus. design non-experimental cross-sectional; Through a non-probabilistic demonstration for convenience, 101 people, 66 women and 35 men participated, with an age range 17 34 years (SD=2.49) (M=21.47), survey information ...

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...