With the availability of limited resources, innovation for improved statistical method for the design and analysis of randomized controlled trials (RCTs) is of paramount importance for newer and better treatment discovery for any therapeutic area. Although clinical efficacy is almost always the primary evaluating criteria to measure any beneficial effect of a treatment, there are several important other factors (e.g., side effects, cost burden, less debilitating, less intensive, etc.), which can permit some less efficacious treatment options favorable to a subgroup of patients. This leads to non-inferiority (NI) testing. The objective of NI trial is to show that an experimental treatment is not worse than an active reference treatment by more than a pre-specified margin. Traditional NI trials do not include a placebo arm for ethical reason; however, this necessitates stringent and often unverifiable assumptions. On the other hand, three-arm NI trials consisting of placebo, reference, and experimental treatment, can simultaneously test the superiority of the reference over placebo and NI of experimental treatment over the reference. In this article, we proposed both novel Frequentist and Bayesian procedures for testing NI in the three-arm trial with Poisson distributed count outcome. RCTs with count data as the primary outcome are quite common in various disease areas such as lesion count in cancer trials, relapses in multiple sclerosis, dermatology, neurology, cardiovascular research, adverse event count, etc. We first propose an improved Frequentist approach, which is then followed by it's Bayesian version. Bayesian methods have natural advantage in any active-control trials, including NI trial when substantial historical information is available for placebo and established reference treatment. In addition, we discuss sample size calculation and draw an interesting connection between the two paradigms.
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http://dx.doi.org/10.1093/biostatistics/kxaa014 | DOI Listing |
Front Biosci (Landmark Ed)
January 2025
Department of Clinical Medicine and Surgery, University of Naples "Federico II", 80131 Naples, Italy.
Background: Thyroid Hormones (THs) critically impact human cancer. Although endowed with both tumor-promoting and inhibiting effects in different cancer types, excess of THs has been linked to enhanced tumor growth and progression. Breast cancer depends on the interaction between bulk tumor cells and the surrounding microenvironment in which mesenchymal stem cells (MSCs) exert powerful pro-tumorigenic activities.
View Article and Find Full Text PDFFront Biosci (Landmark Ed)
January 2025
Department of Biomedical Sciences, Grand Valley State University, Allendale, MI 49401, USA.
Background: Diabetes mellitus is associated with morphological and functional impairment of the heart primarily due to lipid toxicity caused by increased fatty acid metabolism. Extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) have been implicated in the metabolism of fatty acids in the liver and skeletal muscles. However, their role in the heart in diabetes remains unclear.
View Article and Find Full Text PDFJ Integr Neurosci
January 2025
Laboratory for the Study of Tactile Communication, Pushkin State Russian Language Institute, 117485 Moscow, Russia.
Background: The significance of tactile stimulation in human social development and personal interaction is well documented; however, the underlying cerebral processes remain under-researched. This study employed functional magnetic resonance imaging (fMRI) to investigate the neural correlates of social touch processing, with a particular focus on the functional connectivity associated with the aftereffects of touch.
Methods: A total of 27 experimental subjects were recruited for the study, all of whom underwent a 5-minute calf and foot massage prior to undergoing resting-state fMRI.
J Oral Rehabil
January 2025
Departamento de Odontologia Restauradora, Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brazil.
Background: Previous research has highlighted the multifactorial nature of awake bruxism (AB), including its associations with stress, anxiety and other psychological factors. Dispositional mindfulness, known for its benefits in enhancing emotional regulation and reducing stress, has not yet been thoroughly investigated in association with AB.
Objective: This study aimed to investigate whether levels of dispositional mindfulness predict the efficacy of ecological momentary intervention (EMI) in reducing the frequency of AB behaviours.
J Clin Nurs
January 2025
The Cheryl Spencer Department of Nursing, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.
Background: Patient self-care is established as improving outcomes, yet acute care in hospitals is provided such that patients tend to be passive recipients of care. Little is known about the extent and type of patient participation in treatment care tasks in acute hospital settings.
Aims: To map and synthesise available literature on self-performance of care tasks in acute hospital settings.
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