The International Citicoline Trial in acUte Stroke is a sequential phase III study of the use of the drug citicoline in the treatment of acute ischaemic stroke, which was initiated in 2006 in 56 treatment centres. The primary objective of the trial is to demonstrate improved recovery of patients randomized to citicoline relative to those randomized to placebo after 12 weeks of follow-up. The primary analysis will take the form of a global test combining the dichotomized results of assessments on three well-established scales: the Barthel Index, the modified Rankin scale and the National Institutes of Health Stroke Scale. This approach was previously used in the analysis of the influential National Institute of Neurological Disorders and Stroke trial of recombinant tissue plasminogen activator in stroke.The purpose of this paper is to describe how this trial was designed, and in particular how the simultaneous objectives of taking into account three assessment scales, performing a series of interim analyses and conducting treatment allocation and adjusting the analyses to account for prognostic factors, including more than 50 treatment centres, were addressed.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/pst.344 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Scaling Up Kangaroo Mother Care Through a Facility Delivery Model in Rural Districts of Pakistan: Protocol for a Mixed Methods Study.
JMIR Res Protoc
January 2025
Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.
Background: The neonatal mortality rate in Pakistan is the third highest in Asia, with 8.6 million preterm babies. These newborns require warmth, nutrition, and infection protection, typically provided by incubators.
View Article and Find Full Text PDFHarnessing Human-Centered Design for Evidence-Based Psychosocial Interventions and Implementation Strategies in Community Settings: Protocol for Redesign to Improve Usability, Engagement, and Appropriateness.
JMIR Res Protoc
January 2025
Division of Services and Interventions Research, National Institute of Mental Health, Bethesda, MD, United States.
Background: Although substantial progress has been made in establishing evidence-based psychosocial clinical interventions and implementation strategies for mental health, translating research into practice-particularly in more accessible, community settings-has been slow.
Objective: This protocol outlines the renewal of the National Institute of Mental Health-funded University of Washington Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center, which draws from human-centered design (HCD) and implementation science to improve clinical interventions and implementation strategies. The Center's second round of funding (2023-2028) focuses on using the Discover, Design and Build, and Test (DDBT) framework to address 3 priority clinical intervention and implementation strategy mechanisms (ie, usability, engagement, and appropriateness), which we identified as challenges to implementation and scalability during the first iteration of the center.
C-reactive Protein for TB Triage Testing Is Not the Answer for Some Populations-Did We Ask the Right Question?
Am J Respir Crit Care Med
January 2025
University of Washington, Global Health, Seattle, Washington, United States.
Estimating the economic consequences of leveraging the novel cobas® HIV-1/HIV-2 Qualitative NAT Test in routine HIV testing.
Clin Infect Dis
January 2025
IQVIA Inc., Falls Church, VA.
Article Synopsis
- The study compared the costs of the current CDC 3-step HIV testing algorithm with a new single-test alternative (cobas) for efficiency in diagnosing HIV.
- A decision-tree model estimated costs and testing needs for 1 million people, revealing significant reductions in total tests and retests required when using the alternative method.
- Findings indicate that the new algorithm could simplify HIV testing processes, cut overall testing numbers, and keep healthcare costs stable, thereby improving patient outcomes.
Working Memory Deficits in School-Age Children With Cochlear Implants Are Primarily Explained by Deficits in the Processing of Auditory and Lexical Information.
J Speech Lang Hear Res
January 2025
Aix-Marseille Université, INSERM, INS, Institut de Neurosciences des Systèmes, France.
Purpose: Prelingual deaf children with cochlear implants show lower digit span test scores compared to normal-hearing peers, suggesting a working memory impairment. To pinpoint more precisely the subprocesses responsible for this impairment, we designed a sequence reproduction task with varying length (two to six stimuli), modality (auditory or visual), and compressibility (sequences with more or less regular patterns). Results on 22 school-age children with cochlear implants and 21 normal-hearing children revealed a deficit of children with cochlear implants only in the auditory modality.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!