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Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants
BackgroundExtremely preterm infants have a high mortality and morbidity. Here, we present a statistical analysis plan for secondary Bayesian analyses...
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Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs)
BackgroundPeople need high-quality information to make decisions about research participation. Providing information in written format alone is...
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Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
BackgroundThe primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the...
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Extracorporeal cardiopulmonary resuscitation versus conventional CPR in cardiac arrest: an updated meta-analysis and trial sequential analysis
BackgroundExtracorporeal cardiopulmonary resuscitation (ECPR) may reduce mortality and improve neurological outcomes in patients with cardiac arrest....
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Connecting a disconnected trial network with a new trial: optimizing the estimation of a comparative effect in a network meta-analysis
BackgroundIn network meta-analysis, estimation of a comparative effect can be performed for treatments that are connected either directly or...
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B vitamins and bone health: a meta-analysis with trial sequential analysis of randomized controlled trials
SummaryOur study showed that B vitamins did not have significant effect on fracture incidence, bone mineral density, and bone turnover markers....
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Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial
BackgroundPhysical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients’ compliance is...
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Prospective benchmarking of an observational analysis in the SWEDEHEART registry against the REDUCE-AMI randomized trial
Prospective benchmarking of an observational analysis against a randomized trial increases confidence in the benchmarking process as it relies...
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Remote ischemic conditioning may improve graft function following kidney transplantation: a systematic review and meta-analysis with trial sequential analysis
BackgroundRemote ischemic conditioning (RIC) has the potential to benefit graft function following kidney transplantation by reducing...
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Physiological-based cord clam** in very preterm infants: the Aeration, Breathing, Clam** 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial
BackgroundMortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor...
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Optimal trial design selection: a comparative analysis between two-arm and three-arm trials incorporating network meta-analysis for evaluating a new treatment
BackgroundPlanning the design of a new trial comparing two treatments already in a network of trials with an a-priori plan to estimate the effect...
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Indirect laryngoscopy is more effective than direct laryngoscopy when tracheal intubation is performed by novice operators: a systematic review, meta-analysis, and trial sequential analysis
PurposeWe sought to perform a systematic review and meta-analysis to determine whether indirect laryngoscopy has an advantage over direct...
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Complications of preventive loop ileostomy versus colostomy: a meta-analysis, trial sequential analysis, and systematic review
BackgroundPreventive colostomy is required for colorectal surgery, and the incidence of complications associated with ileostomy and colostomy remains...
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The ACCELERATE Plus (assessment and communication excellence for safe patient outcomes) Trial Protocol: a stepped-wedge cluster randomised trial, cost-benefit analysis, and process evaluation
BackgroundNurses play an essential role in patient safety. Inadequate nursing physical assessment and communication in handover practices are...
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Racial/ethnic and socioeconomic disparities in achievement of treatment goals within a clinical trial: a secondary analysis of the ACCORD trial
Aims/hypothesisClinical trial participation should theoretically reduce barriers to care by ensuring medication and healthcare access. We aimed to...
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The Fontan Udenafil Exercise Longitudinal Trial: Subgroup Analysis
The Pediatric Heart Network’s Fontan Udenafil Exercise Longitudinal (FUEL) Trial (Mezzion Pharma Co. Ltd., NCT 02741115) demonstrated improvements in...
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Patient-Centered Clinical Trial Design for Heart Failure Devices via Bayesian Decision Analysis
BackgroundThe statistical significance of clinical trial outcomes is generally interpreted quantitatively according to the same threshold of 2.5% (in...
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Hybrid ablation for persistent/long-standing persistent atrial fibrillation: a meta-analysis and trial sequential analysis of randomized controlled trials
The efficacy and safety of hybrid ablation (HA) for patients with non-paroxysmal atrial fibrillation (AF) remain unclear. PubMed, Embase, Cochrane,...
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Prophylactic tranexamic acid in Cesarean delivery: an updated meta-analysis with a trial sequential analysis
PurposePostpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide. Although several studies on the prophylactic use of tranexamic...
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Haloperidol for the treatment of delirium in critically ill patients: an updated systematic review with meta-analysis and trial sequential analysis
BackgroundHaloperidol is frequently used in critically ill patients with delirium, but evidence for its effects has been sparse and inconclusive. By...
