Efficacy and safety of levetiracetam in children with epilepsy: protocol for an umbrella review of systematic reviews and meta-analyses of randomised controlled trials

IntroductionEpilepsy causes serious suffering in children and is associated with high morbidity and increased mortality. It impairs children’s quality of life and places a heavy burden on healthcare resources. Levetiracetam has been used to prevent and treat paediatric epilepsy for years. To date, a number of systematic reviews have been performed to assess the efficacy and safety of levetiracetam in a variety of clinical settings. Conflicting outcomes have been reported for the same clinical issues. Our objective is to provide a comprehensive overview of the literature for clinicians and policymakers via an umbrella review that assesses the efficacy and safety of levetiracetam in children with epilepsy.Methods and analysisWe will follow the Joanna Briggs Institute’s guidelines for umbrella reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The following seven databases will be searched from 1990 to February 2019: PubMed, Embase, Cochrane Database of Systematic Reviews, JBISRIR, EPPI, Epistemonikos and PROSPERO. We will provide evidence from existing systematic reviews and meta-analyses of randomised controlled trials regarding the use of levetiracetam in children with epilepsy. The intervention of interest is levetiracetam monotherapy and add-on therapies for prevention or treatment purposes. Studies will be individually selected and assessed by two reviewers. The primary outcomes of interest are epilepsy control, the efficacy of prophylaxis for provoked seizures and the mortality rate of children with epilepsy who received levetiracetam treatment. The secondary outcomes are adverse events and withdrawal rates due to adverse effects. The methodological quality of all reviews will be individually assessed by two reviewers using the ‘A Measurement Tool to Assess Systematic Reviews’ instrument. The Grading of Recommendations Assessment, Development and Evaluation assessment will be applied to evaluate the quality of evidence for each outcome of interest. A narrative description of an analysis of the systematic reviews will be tabulated to address objective and specific questions. Information from each review will be detailed in a table including the population, number of studies, total number of participants, year range of the trials, study designs of the primary trials, countries and settings of the trials, heterogeneity of results and assessment tools. Recommendations regarding each outcome of levetiracetam will be categorised based on a protocol.Ethics and disseminationThis umbrella review will inform clinical and policy decisions regarding the efficacy and safety of levetiracetam for preventing and treating paediatric epilepsy. The results will be disseminated through a peer-reviewed publication and conference presentations. Ethical approval is not required for this study.

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Systematic reviews and meta-analyses comparing mortality in restrictive and liberal haemoglobin thresholds for red cell transfusion: protocol for an overview of systematic reviews

BMJ Open ◽

10.1136/bmjopen-2019-029828 ◽

2019 ◽

Vol 9 (8) ◽

pp. e029828 ◽

Cited By ~ 1

Author(s):

Kevin M Trentino ◽

Shannon L Farmer ◽

Frank M Sanfilippo ◽

Michael F Leahy ◽

James Isbister ◽

...

Keyword(s):

Blood Cell ◽

Systematic Reviews ◽

Red Blood Cell ◽

Randomised Controlled Trials ◽

Red Blood Cell Transfusion ◽

Controlled Trials ◽

Overview Of Systematic Reviews ◽

Randomised Controlled ◽

Meta Analyses

IntroductionThere has been a significant increase in the number of systematic reviews and meta-analyses of randomised controlled trials investigating thresholds for red blood cell transfusion. To systematically collate, appraise and synthesise the results of these systematic reviews and meta-analyses, we will conduct an overview of systematic reviews.Methods and analysisThis is a protocol for an overview of systematic reviews. We will search five databases: MEDLINE, Embase, Web of Science Core Collection, PubMed (for prepublication, in process and non-Medline records) and Google Scholar. We will consider systematic reviews and meta-analyses of randomised controlled trials evaluating the effect of haemoglobin thresholds for red blood cell transfusion on mortality. Two authors will independently screen titles and abstracts retrieved in the literature search and select studies meeting the eligibility criteria for full-text review. We will extract data onto a predefined form designed to summarise the key characteristics of each review. We will assess the methodological quality of included reviews and the quality of evidence in included reviews.Ethics and disseminationFormal ethics approval is not required for this overview as we will only analyse published literature. The findings of this study will be presented at relevant conferences and submitted for peer-review publication. The results are likely to be used by clinicians, policy makers and developers of clinical guidelines and will inform suggestions for future systematic reviews and randomised controlled trials.PROSPERO registration numberCRD42019120503.

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Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

BMJ Paediatrics Open ◽

10.1136/bmjpo-2021-001129 ◽

2021 ◽

Vol 5 (1) ◽

pp. e001129

Author(s):

Bill Stevenson ◽

Wubshet Tesfaye ◽

Julia Christenson ◽

Cynthia Mathew ◽

Solomon Abrha ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Grey Literature ◽

Risk Of Bias ◽

Controlled Trials ◽

Head Lice ◽

Efficacy And Safety ◽

Randomised Controlled ◽

Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

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Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement

Oncology Research and Treatment ◽

10.1159/000055014 ◽

2000 ◽

Vol 23 (6) ◽

pp. 597-602 ◽

Cited By ~ 61

Author(s):

D. Moher ◽

D.J. Cook ◽

S. Eastwood ◽

I. Olkin ◽

D. Rennie ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Controlled Trials ◽

Quality Of Reports ◽

Randomised Controlled ◽

Meta Analyses

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Evaluation of Quality Assessment Tools for Non-Randomised Controlled Trials Assessing Surgical Interventions: A Systematic Review of Systematic Reviews

Value in Health ◽

10.1016/j.jval.2015.09.2740 ◽

2015 ◽

Vol 18 (7) ◽

pp. A722

Author(s):

UB Nurmatov ◽

T Xiong ◽

MA Kroes

Keyword(s):

Systematic Review ◽

Quality Assessment ◽

Systematic Reviews ◽

Randomised Controlled Trials ◽

Assessment Tools ◽

Controlled Trials ◽

Surgical Interventions ◽

Randomised Controlled

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Electroconvulsive therapy (ECT) versus sham ECT for depression: do study limitations invalidate the evidence (and mean we should stop using ECT)?

BJPsych Advances ◽

10.1192/bja.2021.23 ◽

2021 ◽

Vol 27 (5) ◽

pp. 285-291

Author(s):

Ian M. Anderson

Keyword(s):

Electroconvulsive Therapy ◽

Randomised Controlled Trials ◽

Memory Loss ◽

Placebo Treatment ◽

Controlled Trials ◽

Therapeutic Benefits ◽

Permanent Memory ◽

Randomised Controlled ◽

Meta Analyses

SUMMARYElectroconvulsive therapy (ECT) for depression is a controversial treatment with highly polarised views about the balance between therapeutic benefits and adverse effects. Studies investigating whether ECT is more effective than a placebo treatment started in the 1950s, with the most important randomised controlled trials carried out about four decades ago in which ECT was compared with sham ECT (SECT) involving anaesthesia but no electrically induced seizure. Subsequently the data have been pooled in a number of meta-analyses which have found that ECT is an effective treatment. However, a recent review of the quality of the SECT-controlled studies, and the meta-analyses based on them, concludes that their quality is too poor to allow assessment of the efficacy of ECT and that, given its risks (permanent memory loss and death), the use of ECT should be suspended. This commentary critically discusses the methodology of this review and its conclusions.

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A survey of instructions to authors in surgical journals on reporting by CONSORT and PRISMA

Annals of The Royal College of Surgeons of England ◽

10.1308/003588412x13373405386619 ◽

2012 ◽

Vol 94 (7) ◽

pp. 468-471 ◽

Cited By ~ 5

Author(s):

S Shantikumar ◽

J Wigley ◽

W Hameed ◽

A Handa

Keyword(s):

Systematic Reviews ◽

Randomised Controlled Trials ◽

Trial Registration ◽

Controlled Trials ◽

Clinical Trial Registration ◽

Journal Citation Reports ◽

Randomised Controlled ◽

The Uk ◽

Meta Analyses ◽

Surgical Journals

INTRODUCTION Guidance has been published on how best to report randomised controlled trials (Consolidated Standards of Reporting Trials – CONSORT) and systematic reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses – PRISMA). The aim of this study was to establish to what extent surgical journals formally endorse CONSORT and PRISMA in the respective reporting of randomised controlled trials and systematic reviews. METHODS Overall, 136 surgical journals indexed in Journal Citation Reports® were studied. Author guidelines were scrutinised for the following guidance: conflict of interests (COI), the Uniform Requirements for Manuscripts (URM), clinical trial registration, CONSORT and PRISMA. RESULTS The frequency of guidance endorsement was found to be as follows: COI 82%, URM 62%, trial registration 32%, CONSORT 29% and PRISMA 10%. Journals with a higher impact were more likely to adopt trial registration, CONSORT and PRISMA. Journals with editorial offices in the UK were more likely to insist on disclosure of COI and to endorse CONSORT. CONCLUSIONS Guidelines produced to improve publication practice have not been implemented widely by surgical journals. This may contribute to an overall poorer quality of published research. Editors of surgical journals should uniformly endorse reporting guidance and update their instructions to authors to reflect this.

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Evidence based rehabilitation after hip arthroplasty

Hip International ◽

10.1177/1120700020971314 ◽

2020 ◽

Vol 30 (2_suppl) ◽

pp. 20-29

Author(s):

Virginia Colibazzi ◽

Adriano Coladonato ◽

Milco Zanazzo ◽

Emilio Romanini

Keyword(s):

Systematic Reviews ◽

Hip Arthroplasty ◽

Randomised Controlled Trials ◽

Rehabilitation Program ◽

Controlled Trials ◽

Evidence Based ◽

Post Operation ◽

Research Findings ◽

Randomised Controlled

Background: Hip arthroplasty is considered the treatment of choice to improve the quality of life of patients affected by degenerative arthritis. The post-op rehabilitation regimen, however, is still a matter of debate. The goal of this study was to perform a systematic review of the available best evidence to provide recommendations for rehabilitation after hip arthroplasty. Materials and methods: Biomedical databases were accessed to identify guidelines, systematic reviews and randomised controlled trials addressing rehabilitation after hip arthroplasty published between 2004 and 2019. Studies were selected and extracted by two independent evaluators with standardised tools. Results: 1 guideline, 8 systematic reviews and 5 randomised controlled trials were included. All included papers were organised according the available evidence of clinical course chronology both in pre- and post-operation rehabilitation up to 6 weeks and thereafter. Although the value of a rehabilitation program after hip arthroplasty is universally recognised, the exact timing and number of sessions is still unknown. A solid literature review allows us to partially answer to this question. Conclusions: Evidence-based rehabilitation recommendations are proposed according to literature research findings. Clinical practice is still somewhat dependent on dogma and traditions, highlighting the need for additional high-quality clinical studies to address areas of uncertainty.

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Buteyko method for people with asthma: a protocol for a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2021-049213 ◽

2021 ◽

Vol 11 (10) ◽

pp. e049213

Author(s):

Karla Morganna Pereira Pinto de Mendonça ◽

Sean Collins ◽

Tácito ZM Santos ◽

Gabriela Chaves ◽

Sarah Leite ◽

...

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Meta Analysis ◽

Secondary Data ◽

Controlled Trials ◽

Cochrane Central Register ◽

Plain Language ◽

Randomised Controlled ◽

Meta Analyses

IntroductionButeyko method is recommended as a non-pharmacological treatment for people with asthma. Although the worldwide interest in the Buteyko method, there is a paucity of studies gathering evidence to support its use. Therefore, we aim to conduct a systematic review and meta-analysis to assess the effects of the Buteyko method in children and adults with asthma.Methods and analysisWe will search on Cochrane Central Register of Controlled Trials, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and WHO International Clinical Trials Registry Platform for studies focusing on the Buteyko method for children and adults with asthma. The searches will be carried out in September 2021 from database’s inception to the present. We will include randomised controlled trials comparing Buteyko method alone with asthma education or inactive control intervention. There will be no restriction on language. Primary outcomes include quality of life, asthma symptoms and adverse events/side effects. Two review authors will independently screen the studies for inclusion and extract data. We will assess the quality of the included studies using the ‘Risk of Bias’ tool. The certainty of the evidence will be assessed using the GRADE approach. Data synthesis will be conducted using Review Manager software. Reporting of the review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationThis study will assess and provide evidence for the use of the Buteyko method in people with asthma. We will analyse secondary data and this does not require ethics approval. The findings will be published in peer-reviewed journals, at relevant conferences and will be shared in plain language in social media. Moreover, the findings of this review could guide the direction of healthcare practice and research.PROSPERO registration numberCRD42020193132.

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