Non-inferiority trials, a distinct category within randomized controlled trials, are garnering increased attention in medical research. Their unique and evolving role comes to the forefront in scenarios where new treatments, despite not surpassing the efficacy of an existing standard, bring additional benefits like reduced side effects, enhanced compliance, or cost savings. As the field of surgery witnesses a growing number of published non-inferiority trials, it becomes imperative for surgeons to grasp the intricacies of this trial type to accurately decipher and interpret their outcomes.
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http://dx.doi.org/10.1097/PRS.0000000000011633 | DOI Listing |
JMIR Ment Health
January 2025
School of Applied Psychology & Centre for Mental Health, Griffith University, Mt Gravatt, Australia.
Background: Self-guided internet-delivered cognitive behavioral therapy (ICBT) achieves greater reach than ICBT delivered with therapist guidance, but demonstrates poorer engagement and fewer clinical benefits. Alternative models of care are required that promote engagement and are effective, accessible, and scalable.
Objective: This randomized trial evaluated whether a stepped care approach to ICBT using therapist guidance via videoconferencing for the step-up component (ICBT-SC[VC]) is noninferior to ICBT with full therapist delivery by videoconferencing (ICBT-TG[VC]) for child and adolescent anxiety.
Lancet
January 2025
Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, ON, Canada.
Background: Support for the treatment of uncomplicated appendicitis with non-operative management rather than surgery has been increasing in the literature. We aimed to investigate whether treatment of uncomplicated appendicitis with antibiotics in children is inferior to appendicectomy by comparing failure rates for the two treatments.
Methods: In this pragmatic, multicentre, parallel-group, unmasked, randomised, non-inferiority trial, children aged 5-16 years with suspected non-perforated appendicitis (based on clinical diagnosis with or without radiological diagnosis) were recruited from 11 children's hospitals in Canada, the USA, Finland, Sweden, and Singapore.
Trials
January 2025
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Background: Surgical intervention is critical in the treatment of hip developmental dysplasia in children. Perioperative analgesia, usually based on high opioid dosages, is frequently used in these patients. In some circumstances, regional anesthetic procedures such as caudal block and lumbar plexus block have also been used.
View Article and Find Full Text PDFJACC Cardiovasc Interv
January 2025
Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China. Electronic address:
Background: First-generation bioresorbable scaffolds (BRS) increased risks of stent thrombosis and adverse events. The Bioheart scaffold is a new poly-L-lactic acid-based BRS.
Objectives: This study sought to evaluate the efficacy and safety of the BRS in patients with coronary artery disease.
Anesth Analg
February 2025
From the Department of Surgical Specialties and Anesthesiology of São Paulo State University (UNESP), Medical School, Botucatu, Brazil.
Background: Proficiency in endotracheal intubation (ETI) is essential for medical professionals and its training should start at medical schools; however, large caseload may be required before achieving an acceptable success rate with direct laryngoscopy. Video laryngoscopy has proven to be an easier alternative for intubation with a faster learning curve, but its availability in medical training may be an issue due to its high market prices. We devised a low-cost 3-dimensionally printed video laryngoscope (3DVL) and performed a randomized trial to evaluate if the intubation success rate on the first attempt with this device is noninferior to a standard commercially available video laryngoscope (STVL).
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