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Article
Open AccessSeizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT))
Paediatric convulsive status epilepticus is the most common neurological emergency presenting to emergency departments. Risks of resultant neurological morbidity and mortality increase with seizure duration. I...
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Article
Open AccessGood Statistical Practice—development of tailored Good Clinical Practice training for statisticians
Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international...
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Article
Open AccessUsing healthcare systems data for outcomes in clinical trials: issues to consider at the design stage
Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, iss...
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Article
Open AccessCorrection: Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing
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Article
Open AccessMedicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing
In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and dev...
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Article
Open AccessProviding multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs
Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information shee...
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Article
Open AccessDevelo** guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study
Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the ...
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Article
Open AccessManaging clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance
The complexities associated with delivering randomised surgical trials, such as clustering effects, by centre or surgeon, and surgical learning, are well known. Despite this, approaches used to manage these co...
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Article
Open AccessBlinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units
Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the p...
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Article
Open AccessA randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan
Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over rec...
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Chapter and Conference Paper
Document Ranking for Curated Document Databases Using BERT and Knowledge Graph Embeddings: Introducing GRAB-Rank
Curated Document Databases (CDD) play an important role in hel** researchers find relevant articles in scientific literature. Considerable recent attention has been given to the use of various document ranki...
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Article
Open AccessProspective reporting of statistical analysis plans for randomised controlled trials
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Article
Open AccessManaging clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. A health professional’s skill in delivery improves with experience, meaning that outcomes may be associa...
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Chapter and Conference Paper
Open Information Extraction for Knowledge Graph Construction
An open information extraction approach for knowledge graph construction is presented. The motivation for the work is that large quantities of scholarly documents are available within many domains of discourse...
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Article
Open AccessWhat are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is l...
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Article
Open AccessA review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known abo...
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Article
Open AccessDIABRISK-SL trial: further consideration of age and impact of imputations
Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality worldwide. Early interventions may help to delay or prevent onset of cardiometabolic endpoints of clinical importance to T2DM patients.
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Article
Open AccessEnhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study
EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediate...
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Article
Open AccessIdentifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study
Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy st...
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Article
Open Access‘Recruitment, recruitment, recruitment’ – the need for more focus on retention: a qualitative study of five trials
Loss to follow-up (attrition) is a frequent problem in clinical trials and can introduce bias or reduce power. So, understanding retention issues and strategies to address these are important. As part of a mul...
