randomised clinical trials
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Author(s):  
Anders Granholm ◽  
Waleed Alhazzani ◽  
Lennie P. G. Derde ◽  
Derek C. Angus ◽  
Fernando G. Zampieri ◽  
...  

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259899
Author(s):  
Frederik Andreas Madsen ◽  
Trine Hjorslev Andreasen ◽  
Jane Lindschou ◽  
Christian Gluud ◽  
Kirsten Møller

Introduction Intensive care for patients with severe acute brain injury aims both to treat the immediate consequences of the injury and to prevent and treat secondary brain injury to ensure a good functional outcome. Sedation may be used to facilitate mechanical ventilation, for treating agitation, and for controlling intracranial pressure. Ketamine is an N-methyl-D-aspartate receptor antagonist with sedative, analgesic, and potentially neuroprotective properties. We describe a protocol for a systematic review of randomised clinical trials assessing the beneficial and harmful effects of ketamine for patients with severe acute brain injury. Methods and analysis We will systematically search international databases for randomised clinical trials, including CENTRAL, MEDLINE, Embase, and trial registries. Two authors will independently review and select trials for inclusion, and extract data. We will compare ketamine by any regimen versus placebo, no intervention, or other sedatives or analgesics for patients with severe acute brain injury. The primary outcomes will be functional outcome at maximal follow up, quality of life, and serious adverse events. We will also assess secondary and exploratory outcomes. The extracted data will be analysed using Review Manager and Trials Sequential Analysis. Evidence certainty will be graded using GRADE. Ethics and dissemination The results of the systematic review will be disseminated through peer-reviewed publication. With the review, we hope to inform future randomised clinical trials and improve clinical practice. PROSPERO no CRD42021210447.


2021 ◽  
Author(s):  
Camilla Hansen Nejstgaard ◽  
Andreas Lundh ◽  
Suhayb Abdi ◽  
Gemma Clayton ◽  
Mustafe Hassan Adan Gelle ◽  
...  

Author(s):  
Luke Farrow ◽  
William T. Gardner ◽  
Andrew D. Ablett ◽  
Vladislav Kutuzov ◽  
Alan Johnstone

Abstract Introduction The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in “the big five” general medical journals. The quality of this research has, however, not yet been established. Methods We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010–April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool. Results A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias. Conclusions These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted. Level of evidence Level 1.


F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 453
Author(s):  
Christopher A Brennan ◽  
Peter Osei-Bonsu ◽  
Rachael Eimear McClenaghan ◽  
Ahmed Nassar ◽  
Patrice Forget ◽  
...  

Background: Acute mesenteric ischaemia (AMI) is a surgical emergency which has an associated high mortality.  The mainstay of active treatment includes early surgical intervention, with resection of non-viable bowel, and revascularisation of the ischaemic bowel where possible. Due to the physiological insult of AMI however, perioperative care often involves critical care and the use of vasoactive agents to optimise end organ perfusion. A number of these vasoactive agents are currently available with varied mechanism of action and effects on splanchnic blood flow. However, specific guidance on which is the optimal vasoactive drug to use in these settings is limited. This systematic review aimed to evaluate the current evidence comparing vasoactive drugs in AMI. Methods: A systematic search of Ovid Medline, Ovid Embase, Cochrane CENTRAL and the Cochrane Database of Systematic Review was performed on the 5th of November 2020 to identify randomised clinical trials comparing different vasoactive agents in AMI on outcomes including mortality. The search was performed through the Royal College of Surgeons of England (RCSEng) search support library. Results were analysed using the Rayyan platform, and independently screened by four investigators. Results: 614 distinct papers were identified. After screening, there were no randomised clinical trials meeting the inclusion criteria. Conclusions: This review identifies a gap in literature, and therefore recommends an investigation into current practice and clinician preference in relation to vasoactive agents in AMI. Multicentre randomised controlled trials comparing these medications on clinical outcomes will therefore be required to address this question.


2021 ◽  
Vol 154 ◽  
pp. 120-127
Author(s):  
Francesco Massari ◽  
Alessandro Rizzo ◽  
Veronica Mollica ◽  
Matteo Rosellini ◽  
Andrea Marchetti ◽  
...  

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