scholarly journals Fever control interventions versus placebo, sham or no intervention in adults: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032389 ◽  
Author(s):  
Naqash Sethi ◽  
Arushma Imran Naqash ◽  
Niklas Nielsen ◽  
Janus Christian Jakobsen
Keyword(s):  
Systematic Review ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Physiological Role ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Control Intervention ◽  
Registration Number ◽  
Meta Analyses

IntroductionFever is an integral part of the inflammatory response and has therefore likely a physiological role in fighting infections. Nevertheless, whether fever in itself is beneficial or harmful in adults is unknown. This protocol for a systematic review aims at identifying the beneficial and harmful effects of fever control interventions in adults.Methods and analysisThis protocol for a systematic review was conducted following the recommendations of Cochrane, GRADE and the eight-step assessment suggested by Jakobsen and colleagues for better validation of meta-analytical results in systematic reviews. We plan to include all relevant randomised clinical trials comparing any fever control intervention with placebo, sham or no intervention in adults. We plan to search CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, CINAHL, Scopus and Web of Science Core Collection to identify relevant trials. Any eligible trial will be assessed and classified as either at high risk of bias or low risk of bias, and our primary conclusions will be based on trials at low risk of bias. We will perform our meta-analyses of the extracted data using Review Manager 5.3 and Trial Sequential Analysis. For all our outcomes, we will create a ‘Summary of Findings’ table based on GRADE assessments of the certainty of the evidence.Ethics and disseminationNo formal approval or review of ethics is required for this systematic review as individual patient data will not be included. This systematic review has the potential to highlight (1) whether one should believe fever to be beneficial, harmful or neither in adults; (2) the existing knowledge gaps on this topic; and (3) whether the recommendations from guidelines and daily clinical practice are correct. These results will be disseminated through publication in a leading peer-reviewed journal.PROSPERO registration numberCRD42019134006

scholarly journals Eversion technique versus conventional endarterectomy with patch angioplasty in carotid surgery: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e030503 ◽  
Author(s):  
Martijn S. Marsman ◽  
Jorn Wetterslev ◽  
Patrick W.H.E. Vriens ◽  
Ronald L.A.W. Bleys ◽  
Abdelkarime Kh. Jahrome ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sequential Analysis ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Symptomatic Carotid ◽  
Patch Angioplasty ◽  
Symptomatic Carotid Stenosis ◽  
Meta Analyses

IntroductionTraditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis.Methods and outcomesThe review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences.PROSPERO registration numberCRD42019119361.

scholarly journals Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026419 ◽  
Author(s):  
Martijn S Marsman ◽  
Jørn Wetterslev ◽  
Abdelkarime Khodadade Jahrome ◽  
Christian Gluud ◽  
Frans L Moll ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Closure ◽  
Sequential Analysis ◽  
Risk Of Bias ◽  
Low Risk ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Point Estimates ◽  
Patch Angioplasty ◽  
Meta Analyses

IntroductionUse of patch angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with patch angioplasty in patients with a symptomatic and significant carotid stenosis.Methods and analysisThe review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with patch angioplasty (regardless of used patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.PROSPERO registration numberCRD42014013416.

scholarly journals Mindfulness-based cognitive therapy for preventing recurrence of depression: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Yuxi Li ◽  
Juan Li ◽  
Dongling Zhong ◽  
Lihong Shi ◽  
Yijie Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Depressive Disorder ◽  
Sample Size ◽  
Relapse Rate ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Trial Sequential Analysis ◽  
Significant Difference ◽  
Pooled Sample

Abstract Background: Mindfulness-based cognitive therapy (MBCT) has been increasingly applied to clinical management of relapse of depression. However, the uncertainties of MBCT versus active-control conditions (ACCs) in reducing relapse rate in subjects with recurrent depression exist. This systematic review and meta-analysis intend to compare the effects of MBCT versus ACCs in reducing relapse of depressive disorder. Methods: Electronic search of relevant literatures was performed on major medical databases. Randomized controlled trials evaluating MBCT versus ACCs for recurrent depressive disorder among adults were included. Risk of bias evaluation, meta-analysis, trial sequential analysis and evidence rating of all extracted information were conducted by two independent reviewers. Results: Six trials with 1061 participants were deemed eligible for meta-analysis. Low risk of bias was found across the 6 studies and no heterogeneity was found among them. There was no significant difference between MBCT and ACCs in reducing relapse rate in patients with recurrent depressive disorder. The pooled sample size did not meet the inquired information size of trial sequential analysis which indicated that the result may be false negative. A total of 25 adverse events were formally recorded, but none were attributed to intervention. The quality of evidence was moderate due to the inadequate pooled sample size. Conclusions: There was no significant difference between MBCT and ACCs in reducing relapse rate in patients with recurrent depressive disorder based on the available evidence. Future research will be needed to obtain a more explicit conclusion.

scholarly journals Clinical Effects of Mercury in Conservative Dentistry: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Romeo Patini ◽  
Gianrico Spagnuolo ◽  
Federica Guglielmi ◽  
Edoardo Staderini ◽  
Michele Simeone ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sequential Analysis ◽  
Biological Fluids ◽  
Meta Analysis ◽  
Dental Amalgam ◽  
Risk Of Bias ◽  
Composite Resins ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Clinical Effects

Background and Purpose. Following the new directives of the European Union, which foresee the amalgam ban, the debate on its hypothetical toxicity has started again. So, the aim of this systematic review is to definitively evaluate the eventual effects of the exposure to Hg in adults and children with and without dental amalgam fillings measuring the Hg concentration in various biological fluids. Methods. A systematic literature search was conducted in four electronic databases (Ovid via PubMed, Web of Science, Scopus, and CENTRAL) including all available randomised controlled trials published in the last 15 years comparing the use of dental amalgam with composite resins in humans with a follow-up period of at least one year. The primary outcome was the Hg concentration in biological fluids (urine, hair, blood, and saliva) with the aim of assessing their reliability as biomarkers of Hg exposure. The risk of bias was assessed through the Cochrane Collaboration tool and the overall quality of evidence through the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. The results of the meta-analysis were expressed using a random-effects model, and their power was assessed through the trial sequential analysis (TSA). Results. From the initial 2555 results, only 6 publications were included in the review: five were considered as having high risk of bias, whereas one as having moderate risk. Only two articles were eligible for quantitative analysis. The meta-analysis gathered data from 859 patients but was nevertheless not significant (p = 0.12). The TSA confirmed this evidence revealing that it was due to a lack of statistical power since the required information size (RIS) threshold is not reached. Conclusions. The existing evidence revealed that there are not enough data to support the hypothesis that restorations with dental amalgam can cause nephrotoxicity when compared with composite resins restorations.

scholarly journals The effects of adding glucocorticosteroids to standard care for children with sepsis. A systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis

2021 ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sanam Safi ◽  
Christian Gluud ◽  
Janus C Jakobsen
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Standard Care ◽  
Sequential Analysis ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
Meta Analyses

Abstract Background: Glucocorticosteroids are widely used to treat severe sepsis in pediatric intensive care units. However, the evidence on the clinical effects is unclear.Objective: To assess the benefits and harms of glucocorticosteroids for children with sepsis. Data Sources: We conducted a systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis (TSA) (PROSPERO CRD42017054341). We searched CENTRAL, MEDLINE, Embase, LILACS, SCI-Expanded, and more. Study Selection: Randomized clinical trials assessing the effects of adding glucocorticosteroids to standard care for children with sepsis. Data Extraction: Two independent reviewers screened studies and extracted data. Evidence was assessed by GRADE according to our published protocol.Data Synthesis: We included 24 trials randomizing 3073 participants. Meta-analyses showed no evidence of an effect of adding glucocorticosteroids for children with sepsis with a mixed focus for any of our outcomes. Meta-analyses suggested evidence of a beneficial effect of dexamethasone for children with meningitis when assessing serious adverse events (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.53 to 0.86; P = 0.001, very low certainty of evidence) and ototoxicity (RR 0.63, 95% CI 0.45 to 0.88; P = 0.007, low certainty of evidence). TSAs showed that we did not have sufficient data to confirm or reject these results. We found insufficient evidence to confirm or reject an effect on mortality or our other outcomes. No trials reported quality of life or organ failure. Most trials were at high risks of bias. We found high clinical heterogeneity between participants. None of our TSAs showed benefits, harms or futility. Conclusions: Generally, we found no evidence of an effect of glucocorticosteroids for children with sepsis without meningitis. Dexamethasone for sepsis in children due to meningitis may decrease serious adverse events and ototoxicity.

scholarly journals The clinical effects of cerebral near-infrared spectroscopy monitoring (NIRS) versus no monitoring: a protocol for a systematic review with meta-analysis and trial sequential analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Mathias Lühr Hansen ◽  
Simon Hyttel-Sørensen ◽  
Janus Christian Jakobsen ◽  
Christian Gluud ◽  
Elisabeth M. W. Kooi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sequential Analysis ◽  
Near Infrared ◽  
Meta Analysis ◽  
Clinical Care ◽  
Risk Of Bias ◽  
Trial Sequential Analysis ◽  
Clinical Settings ◽  
Ischaemic Brain

Abstract Background Multiple clinical conditions are associated with cerebral hypoxia/ischaemia and thereby an increased risk of hypoxic-ischaemic brain injury. Cerebral near-infrared spectroscopy monitoring (NIRS) is a tool to monitor brain oxygenation and perfusion, and the clinical uptake of NIRS has expanded over recent years. Specifically, NIRS is used in the neonatal, paediatric, and adult perioperative and intensive care settings. However, the available literature suggests that clinical benefits and harms of cerebral NIRS monitoring are uncertain. As rates of clinically significant hypoxic-ischaemic brain injuries are typically low, it is difficult for randomised clinical trials to capture a sufficiently large number of events to evaluate the clinical effect of cerebral NIRS monitoring, when focusing on specific clinical settings. The aim of this systematic review will be to evaluate the benefits and harms of clinical care with access to cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings. Methods We will conduct a systematic review with meta-analysis and trial sequential analysis. We will only include randomised clinical trials. The primary outcomes are all-cause mortality, moderate or severe persistent cognitive or neurological deficit, and proportion of participants with one or more serious adverse events. We will search CENTRAL, EMBASE, MEDLINE, and the Science Citation Index Expanded from their inception and onwards. Two reviewers will independently screen all citations, full-text articles, and extract data. The risk of bias will be appraised using the Cochrane risk of bias tool version 2.0. If feasible, we will conduct both random-effects meta-analysis and fixed-effect meta-analysis of outcome data. Additional analysis will be conducted to explore the potential sources of heterogeneity (e.g. risk of bias, clinical setting). Discussion As we include trials across multiple clinical settings, there is an increased probability of reaching a sufficient information size. However, heterogeneity between the included trials may impair our ability to interpret results to specific clinical settings. In this situation, we may have to depend on subgroup analyses with inherent increased risks of type I and II errors. Systematic review registration PROSPERO CRD42020202986. This systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) on the 12th of October 2020 and published on the 12th of November 2020 (registration ID CRD42020202986).

scholarly journals Duloxetine versus ‘active’ placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Faiza Siddiqui ◽  
Marija Barbateskovic ◽  
Sophie Juul ◽  
Kiran Kumar Katakam ◽  
Klaus Munkholm ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Sequential Analysis ◽  
Citation Index ◽  
Trial Sequential Analysis ◽  
Random Errors ◽  
Major Depressive ◽  
Serious Adverse Events ◽  
Meta Analyses

Abstract Background Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses. Methods/design A systematic review will be performed including randomised clinical trials comparing duloxetine with ‘active’ placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index—Science and Conference Proceedings Citation Index—Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events. Discussion No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions. Systematic review registration PROSPERO 2016 CRD42016053931

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