Articles: adult.
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Acta Anaesthesiol Scand · Jul 2023
Randomized Controlled TrialComparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial - Statistical Analysis Plan.
The international advanced trauma life support guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for 8 h. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). This manuscript presents the statistical analysis plan for TRAUMOX2. ⋯ This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients.
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Randomized Controlled Trial
Treatment of adult spasticity with Botox (onabotulinumtoxinA): Development, insights, and impact.
Upper and lower limb spasticity (ULS, LLS) often occur following a stroke or in patients with other neurological disorders, leading to difficulties in mobility and daily living and decreased quality of life. Prior to the use of onabotulinumtoxinA, antispastic medications had limited efficacy and often caused sedation. Phenol injections were difficult for physicians to perform, painful, and led to tissue destruction. ⋯ Lessons learned from the successful ULS trials were applied to design an LLS trial that led to approval for the latter indication. Additional observational trials mimicking real-world treatment have shown continued effectiveness and patient satisfaction. The use of onabotulinumtoxinA for spasticity has ushered in a more patient-centered treatment approach that has vastly improved patients' quality of life.
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Randomized Controlled Trial
Does use of continuous or flash glucose monitors decrease hypoglycemia episodes in T2D?
NO. In adults with insulin-treated type 2 diabetes (T2D), continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) do not decrease symptomatic hypoglycemia episodes (strength of recommendation [SOR], B) but do lower time in hypoglycemia (SOR, C; disease-oriented evidence). ⋯ FGM, in which glucose levels are sent on demand to a device, did not significantly reduce hypoglycemic episodes (SOR, B; 1 small RCT and 1 prospective study). Hypoglycemia duration was reduced significantly with FGM in a 6-month RCT (SOR, B) but not in a 1-year prospective study (SOR, B).
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Randomized Controlled Trial Multicenter Study
Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial.
Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. ⋯ National Institute for Health Research.
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Randomized Controlled Trial Multicenter Study Comparative Study
Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial.
In patients with cancer who have venous thromboembolism (VTE) events, long-term anticoagulation with low-molecular-weight heparin (LMWH) is recommended to prevent recurrent VTE. The effectiveness of a direct oral anticoagulant (DOAC) compared with LMWH for preventing recurrent VTE in patients with cancer is uncertain. ⋯ Among adults with cancer and VTE, DOACs were noninferior to LMWH for preventing recurrent VTE over 6-month follow-up. These findings support use of a DOAC to prevent recurrent VTE in patients with cancer.