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

2012 ◽  
Vol 94 (7) ◽  
pp. 468-471 ◽  
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.

scholarly journals 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 ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029828 ◽  
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.

scholarly journals Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824)

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Sandeep Ankolekar ◽  
Gillian Sare ◽  
Chamila Geeganage ◽  
Michael Fuller ◽  
Lynn Stokes ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Functional Outcomes ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Trial Registration ◽  
Controlled Trials ◽  
Stroke Study ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Uk

Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown.Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5 mg/24 hours) or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included.Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited.Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT number is 2007-004766-40.

scholarly journals The “NICE Guideline” on the treatment of depression

2006 ◽  
Vol 15 (1) ◽  
pp. 11-15 ◽  
Author(s):  
David Goldberg
Keyword(s):  
Randomised Controlled Trials ◽  
Clinical Excellence ◽  
Stepped Care ◽  
Controlled Trials ◽  
Nice Guideline ◽  
Hierarchy Of Evidence ◽  
Treatment Of Depression ◽  
Randomised Controlled ◽  
The Uk ◽  
Meta Analyses

AbstractThe National Institute of Clinical Excellence (NICE) in the UK is responsible for producing evidence based guidelines for the treatment of most common illnesses, both physical and psychological. NICE uses a hierarchy of evidence, ranging from data from meta-analyses of randomised controlled trials (RCT's) at the apex, to the opinions of acknowledged experts at the bottom. The task of preparing guideline for depression involved us in performing clean meta-analyses of around 8,000 published RCTs of the treatment of this disorder. Where drug treatments were concerned we used three indicators of efficacy, as well as considering toxicity, tolerability and cost. We also distinguished between studies carried out in primary care, and studies in patients treated by the mental health services. We found it helpful to arrange our report in terms of a “stepped care” model, addressing the indications for patients being referred on for more specialised, and expensive, treatments. In the full guideline we included our doubts that depression was a homogenous clinical entity, and our awareness of the limitations of relying on randomised controlled trials (RCT's) as the only source of evidence. This Editorial summarises the content of the guideline on the treatment of depression and discusses how it was received and also what it did not say.

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

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029811 ◽  
Author(s):  
Jing Gan ◽  
Dan Ma ◽  
Tao Xiong
Keyword(s):  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Assessment Tools ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Umbrella Review ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Paediatric Epilepsy

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.

scholarly journals The association between registration status and reported outcomes in physiotherapy randomised controlled trials

2020 ◽  
Vol 27 (3) ◽  
pp. 1-15
Author(s):  
Christopher Ellaway-Barnard ◽  
Hannah Killick ◽  
Guy Peryer ◽  
Jane L Cross ◽  
Toby O Smith
Keyword(s):  
Randomised Controlled Trials ◽  
Multivariate Analyses ◽  
Trial Registration ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Included Trial ◽  
Clinical Trial Registration ◽  
Registration Status ◽  
Registration Number ◽  
Randomised Controlled

Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.

scholarly journals Effects of physical exercise during pregnancy on mothers’ and neonates’ health: a protocol for an umbrella review of systematic reviews and meta-analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030162
Author(s):  
Gema Sanabria-Martínez ◽  
Raquel Poyatos-León ◽  
Blanca Notario-Pacheco ◽  
Celia Álvarez-Bueno ◽  
Iván Cavero-Redondo ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Systematic Reviews ◽  
Fixed Effects ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Evaluation Framework ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Meta Analyses

IntroductionA growing interest has emerged on the effects of exercise during gestation. Several systematic reviews and meta-analyses have shown that prenatal exercise could reduce the mothers’ risk for some disorders. Despite this, evidence regarding the risk of caesarean section, birth weight or Apgar score at delivery is still controversial. Furthermore, practitioners are reluctant to recommend exercise to pregnant women suffering from some disorders, such as hypertension, pre-eclampsia or pregnant women with obesity. Moreover, the scarcity of studies addressing the risks and benefits of exercise at higher intensity prevent practitioners from recommending it at higher dosages. Umbrella reviews represent an appropriate design to elucidate the reasons behind the contradictory findings of previous systematic reviews.MethodsThis protocol was developed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the Cochrane Collaboration Handbook. Medline, EMBASE, Web of Science, Cochrane database of systematic reviews, Epistemonikos, Prospero register and SPORTDiscuss databases will be searched to identify systematic reviews, meta-analyses and randomised controlled trials that examine the effect of exercise on pregnancy outcomes from inception to August 2019. Searches will be conducted from September to November 2019.Statistical analysisMethodological quality will be evaluated using the AMSTAR 2 tool. The certainty of evidence and strength of recommendations for meta-analyses will be assessed by the Grading of Recommendations Assessment, Development and Evaluation framework. The summary effect sizes will be calculated through the use of random-effects and fixed-effects models. Heterogeneity among studies will be assessed using the I2statistic, and evidence of excess significance bias and evidence of small study effects will also be evaluated.Ethics and disseminationEthical approval will not be needed for this review protocol. The results will be disseminated to academic audiences by peer-reviewed publications. Furthermore, results will be disseminated to clinical audiences through professionals’ associations and social networks, and may influence guidelines developers in order to improve outcomes in mothers and offspring.PROSPERO registration numberCRD42019123410.

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

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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