, Susan M. Sherman, Julius Sim, Richard Amloˆt, Nick Sevdalis, G. James Rubin. Data curation: Susan M. Sherman. Formal analysis: Louise E. Smith, Julius Sim, Megan Cutts, Hannah Dasch. Funding ... acquisition: Louise E. Smith, Susan M. Sherman, Julius Sim, Richard Amloˆt, Nick Sevdalis, G. James Rubin. Methodology: Louise E. Smith. Writing – original draft: Louise E. Smith. Writing – review & editing
Feasibility studies and external pilot studies are used increasingly to inform planning decisions related to a definitive randomized controlled trial. These studies can provide information on process measures, such as consent rates, treatment fidelity and compliance, and methods of outcome measurement. Additionally, they can provide initial parameter estimates for a sample size...
Outcome-adaptive randomization (OAR) has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial (RCT) using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and...
Focus group methodology generates distinct ethical challenges that do not correspond fully to those raised by one-to-one interviews. This paper explores, in both conceptual and practical terms, three key issues: consent; confidentiality and anonymity; and risk of harm. The principal challenge in obtaining consent lies in giving a clear account of what will take place in the group...
integrity of the work as a whole, and have given final approval for the version to be published. Disclosures. Basem Al-Omari, Julius Sim, Peter Croft, and Martin Frisher have nothing to disclose. Compliance
Hashim3, Albin Augustine4, Julius Sim ORCID: orcid.org/0000-0002-1816-16762 & Christine Roffe ORCID: orcid.org/0000-0002-5259-66491,2 BMC Neurology volume 20, Article number: 326 (2020) Cite this ... School of Medicine, Keele University, Newcastle-under-Lyme, ST5 5BG, UK Stacey Knight, Julius Sim & Christine Roffe Department of Radiology, Royal Stoke University Hospital, Newcastle Road, Stoke-on
, Julius Sim, Reuben Ogollah & Martyn Lewis AuthorsSearch for Royes Joseph in:PubMed • Google Scholar Search for Julius Sim in:PubMed • Google Scholar Search for Reuben Ogollah in:PubMed • Google Scholar
Background Accurate diagnosis of pneumonia complicating severe stroke is challenging due to difficulties in physical examination, altered immune responses and delayed manifestations of radiological changes. The aims of this study were to describe early clinical features and to examine C-reactive protein (CRP) as a diagnostic marker of post-stroke pneumonia. Methods Patients who...
Saturation has attained widespread acceptance as a methodological principle in qualitative research. It is commonly taken to indicate that, on the basis of the data that have been collected or analysed hitherto, further data collection and/or analysis are unnecessary. However, there appears to be uncertainty as to how saturation should be conceptualized, and inconsistencies in...
Team Trial Management Group: Professor Christine Roffe (Chair), Dr Tracy Nevatte, Professor Julius Sim, Professor Richard Gray, Natalie Ives, Dr Jon Bishop, Dr Sarah Pountain, Peter and Linda Handy
Bolaji E Egbewale 0 Martyn Lewis 0 Julius Sim 0 0 Research Institute for Primary Care and Health Sciences, Keele University , ST5 5BG Staffordshire , UK Background: Analysis of variance (ANOVA
Analysis of variance (ANOVA), change-score analysis (CSA) and analysis of covariance (ANCOVA) respond differently to baseline imbalance in randomized controlled trials. However, no empirical studies appear to have quantified the differential bias and precision of estimates derived from these methods of analysis, and their relative statistical power, in relation to combinations of...
of dropout, the pattern of dropout, the analysis used, and the type of missing data mechanism. Author information AffiliationsKeele University, Staffordshire, UKRoyes Joseph, Julius Sim, Reuben ... Ogollah & Martyn Lewis AuthorsSearch for Royes Joseph in:PubMed • Google Scholar Search for Julius Sim in:PubMed • Google Scholar Search for Reuben Ogollah in:PubMed • Google Scholar Search for Martyn
The aim was to assess the feasibility of a single-centre, single-blind, randomized, crossover design to explore the effects of two slow-release dopamine agonists, ropinirole and pramipexole, on cued recall in Parkinson’s disease. As the design required a switch from the prescribed agonist (pramipexole-to-ropinirole, or ropinirole-to-pramipexole), the primary objectives were to (a...
Background The Stroke Oxygen Study (SO2S) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke. The main hypothesis for the trial is that fixed-dose oxygen treatment during the first 3 days after an acute stroke improves outcome. The secondary hypothesis is that restricting oxygen supplementation to night time only is more...
Background The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)–consisting of a GP consultation followed by information and advice on exercises–with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation. Methods...
Background Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke. The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects. It impedes early mobilization, could pose an infection risk, and may encourage the formation of toxic free radicals, leading to further damage...
Preserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. 516 pateints commencing...