Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials

2017 ◽  
Vol 4 (11) ◽  
pp. e524-e533 ◽  
Author(s):  
Nicole U Stoffel ◽  
Colin I Cercamondi ◽  
Gary Brittenham ◽  
Christophe Zeder ◽  
Anneke J Geurts-Moespot ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Iron Absorption ◽  
Oral Iron ◽  
Controlled Trials ◽  
Open Label ◽  
Iron Supplements ◽  
Split Dosing ◽  
Randomised Controlled

scholarly journals Definitions of blinding in randomised controlled trials of interventions published in high-impact anaesthesiology journals: a methodological study and survey of authors

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035168 ◽  
Author(s):  
Antonija Penić ◽  
Dinka Begić ◽  
Karolina Balajić ◽  
Martin Kowalski ◽  
Ana Marušić ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Methodological Study ◽  
Cross Sectional Survey ◽  
Open Label ◽  
Double Blind ◽  
Cross Sectional ◽  
The Status ◽  
Peer Reviewers ◽  
Randomised Controlled

ObjectivesTo analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors’ interpretation of blinding terminology related to RCTs.MethodsThis was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors’ interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications.ResultsOut of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials.ConclusionsReporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term ‘double-blind’ for different blinding practices.

Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials

The Lancet ◽  
2009 ◽  
Vol 374 (9698) ◽  
pp. 1339-1350 ◽  
Author(s):  
Roman Prymula ◽  
Claire-Anne Siegrist ◽  
Roman Chlibek ◽  
Helena Zemlickova ◽  
Marie Vackova ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Antibody Responses ◽  
Controlled Trials ◽  
Open Label ◽  
Randomised Controlled

scholarly journals Analysis of revascularisation in ischaemic stroke with EmboTrap (ARISE I study) and meta-analysis of thrombectomy

2018 ◽  
Vol 25 (3) ◽  
pp. 261-270 ◽  
Author(s):  
Heinrich P Mattle ◽  
Carl Scarrott ◽  
Mairsil Claffey ◽  
John Thornton ◽  
Juan Macho ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Large Vessel ◽  
Controlled Trials ◽  
Open Label ◽  
Vessel Occlusion ◽  
Randomised Controlled ◽  
Multicentre Prospective Study

Background and purpose The goal of the analysis of revascularisation in ischaemic stroke with EmboTrap study (ARISE I) was to demonstrate the effectiveness of EmboTrap. Methods ARISE I was an open label, single arm, multicentre, prospective study for the treatment of acute stroke due to large vessel occlusion. The primary outcome was revascularisation of the target vessel as measured by the modified thrombolysis in cerebrovascular infarction (mTICI) score of at least 2b following thrombectomy with EmboTrap. For comparison of the ARISE I results a meta-analysis of eight randomised controlled trials was performed. Results ARISE I enrolled 40 patients. Their baseline characteristics that are predictors of stroke outcome and procedure timings in ARISE I were similar to those reported in recent randomised controlled trials. The primary outcome, good revascularisation rates (mTICI 2b/3 scores) after three or fewer passes with EmboTrap were 75% (95% confidence interval (CI) 62–88%), which is the same as 74% found in randomised controlled trials (difference of 0.8%, P = 0.95). After additional EmboTrap passes or the use of another device mTICI 2b/3 scores rose to 85% (95% CI 74–96%), which was also similar to the randomised controlled trials (difference 11%, P = 0.38). The high revascularisation rates in ARISE I converted into 64% good clinical outcomes (modified Rankin scale ≤2) compared to 50% in randomised controlled trials (difference 14%; 95% CI –13.7–41.7%; P = 0.32). Conclusions ARISE I demonstrates that thrombectomy using the EmboTrap stent retriever yields similar results to devices that were used in recent randomised controlled trials for the treatment of stroke due to large vessel occlusions. ClinicalTrials.gov identifier NCT02190552

NOACs for treatment of venous thromboembolism in clinical practice

2017 ◽  
Vol 117 (07) ◽  
pp. 1317-1325 ◽  
Author(s):  
Sam Schulman ◽  
Daniel Singer ◽  
Walter Ageno ◽  
Ivan B. Casella ◽  
Marc Desch ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Observational Studies ◽  
Randomised Controlled Trials ◽  
Oral Anticoagulants ◽  
Drug Regimen ◽  
Controlled Trials ◽  
Open Label ◽  
Randomised Controlled

SummaryRandomised controlled trials have provided important information on the efficacy and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) for treatment of venous thromboembolism (VTE), leading to registration and increasing use in clinical practice. Many questions remain to be answered, and observational studies are often more suitable for answering “real-world” questions than randomised controlled trials. Patient satisfaction, quality of life, and adherence and persistence in clinical practice with the drug regimen can only be assessed with an open-label design. Evaluation of risk for long-term sequelae of the disease requires much longer follow-up than is possible in registration trials. Treatment patterns and utilisation of health care resources can be assessed from observations in the clinical practice setting. We will review published as well as currently active observational studies with NOACs in VTE, with or without a comparator anticoagulant. These studies are based on cohorts of different sizes, registries, or administrative health care databases. We will also discuss some limitations in analysis and interpretation of observational studies.

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