scholarly journals Prompt closure versus gradual weaning of extraventricular drainage for hydrocephalus in adult patients with aneurysmal subarachnoid haemorrhage: a systematic review protocol with meta-analysis and trial sequential analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e029719 ◽  
Author(s):  
Tenna Capion ◽  
Alexander Lilja-Cyron ◽  
Marianne Juhler ◽  
Tiit Illimar Mathiesen ◽  
Jørn Wetterslev
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Subarachnoid Haemorrhage ◽  
Sequential Analysis ◽  
Adult Patients ◽  
Randomised Clinical Trials ◽  
Trial Sequential Analysis ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Increased Risk

IntroductionIn Neuro Intensive Care Units (NICU) and neurosurgical units, patients with an external ventricular drain (EVD) due to hydrocephalus following aneurysmal subarachnoid haemorrhage (SAH) are commonly seen. Cessation of the EVD involves the dilemma of either closing the EVD directly, or gradually weaning it before removal. Development of increased intracranial pressure (ICP) and acute hydrocephalus with subsequent need of a permanent shunt has been associated with prompt closure of theEVD, whereas increased risk of infection with possible spreading to the brain and subsequent patient fatality is suspected in connection to a longer treatment as seen in gradual weaning. Sparse data exist on the recommendation of cessation strategy and patients are currently being treated on the basis of personal experience and expert opinion. The objective of this systematic review is to assess the available evidence from clinical trials on the effects of prompt closure versus gradual weaning of EVD treatment for hydrocephalus in adult patients with SAH.Methods and analysisWe will search for randomised clinical trials in major international databases. Two authors will independently screen and select references for inclusion, extract data and assess the methodological quality of the included randomised clinical trials using the Cochrane risk of bias tool. Any disagreement will be resolved by consensus. We will analyse the extracted data using Review Manager and trial sequential analysis. To assess the quality of the evidence, we will create a ‘Summary of Findings’ table containing our primary and secondary outcomes using the GRADE assessment.Ethics and disseminationResults will be published widely according to the interest of the society. No possible impact, harm or ethical concerns are expected doing this protocol.Trial registration numberPROSPERO CRD42018108801

scholarly journals Effects of adding ivabradine to usual care in patients with angina pectoris: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001288
Author(s):  
Mathias Maagaard ◽  
Emil Eik Nielsen ◽  
Naqash Javaid Sethi ◽  
Liang Ning ◽  
Si-hong Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Angina Pectoris ◽  
Adverse Events ◽  
Sequential Analysis ◽  
Randomised Clinical Trials ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Artery Disease

ObjectiveTo determine the impact of ivabradine on outcomes important to patients with angina pectoris caused by coronary artery disease.MethodsWe conducted a systematic review. We included randomised clinical trials comparing ivabradine versus placebo or no intervention for patients with angina pectoris due to coronary artery disease published prior to June 2020. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane methodology, Trial Sequential Analysis, Grading of Recommendations Assessment, Development, and Evaluation, and our eight-step procedure. Primary outcomes were all-cause mortality, serious adverse events and quality of life.ResultsWe included 47 randomised clinical trials enrolling 35 797 participants. All trials and outcomes were at high risk of bias. Ivabradine compared with control did not have effects when assessing all-cause mortality (risk ratio [RR] 1.04; 95% CI 0.96 to 1.13), quality of life (standardised mean differences −0.05; 95% CI −0.11 to 0.01), cardiovascular mortality (RR 1.07; 95% CI 0.97 to 1.18) and myocardial infarction (RR 1.03; 95% CI 0.91 to 1.16). Ivabradine seemed to increase the risk of serious adverse events after removal of outliers (RR 1.07; 95% CI 1.03 to 1.11) as well as the following adverse events classified as serious: bradycardia, prolonged QT interval, photopsia, atrial fibrillation and hypertension. Ivabradine also increased the risk of non-serious adverse events (RR 1.13; 95% CI 1.11 to 1.16). Ivabradine might have a statistically significant effect when assessing angina frequency (mean difference (MD) 2.06; 95% CI 0.82 to 3.30) and stability (MD 1.48; 95% CI 0.07 to 2.89), but the effect sizes seemed minimal and possibly without any relevance to patients, and we identified several methodological limitations, questioning the validity of these results.ConclusionOur findings do not support that ivabradine offers significant benefits on patient important outcomes, but rather seems to increase the risk of serious adverse events such as atrial fibrillation and non-serious adverse events. Based on current evidence, guidelines need reassessment and the use of ivabradine for angina pectoris should be reconsidered.PROSPERO registration numberCRD42018112082.

scholarly journals Ketamine for critically ill patients with severe acute brain injury: Protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259899
Author(s):  
Frederik Andreas Madsen ◽  
Trine Hjorslev Andreasen ◽  
Jane Lindschou ◽  
Christian Gluud ◽  
Kirsten Møller
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Brain Injury ◽  
Functional Outcome ◽  
Sequential Analysis ◽  
Acute Brain Injury ◽  
Randomised Clinical Trials ◽  
Trial Sequential Analysis ◽  
Secondary Brain Injury ◽  
Serious Adverse Events

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.

scholarly journals Quinolones for sepsis. A protocol for a systematic review of randomised clinical trials with meta‐analysis and trial sequential analysis

2019 ◽  
Vol 63 (8) ◽  
pp. 1113-1123
Author(s):  
Steven Kwasi Korang ◽  
Mathias Maagaard ◽  
Joshua Feinberg ◽  
Anders Perner ◽  
Christian Gluud ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Trial Sequential Analysis
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