BMJ open
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Observational Study
Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry.
To evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients. ⋯ Individualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.
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Randomized Controlled Trial
Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial.
Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial. ⋯ The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media.
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Recent publications have called for substantial improvements in the design, conduct, analysis and reporting of prediction models. Publication of study protocols, with prespecification of key aspects of the analysis plan, can help to improve transparency, increase quality and protect against increased type I error. Valid population-based risk algorithms are essential for population health planning and policy decision-making. The purpose of this study is to develop, evaluate and apply cardiovascular disease (CVD) risk algorithms for the population setting. ⋯ This study has been approved by the Ottawa Health Science Network Research Ethics Board. The findings will be disseminated through professional and scientific conferences, and in peer-reviewed journals. The algorithm will be accessible electronically for population and individual uses.
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Randomized Controlled Trial Multicenter Study
Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial.
Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. ⋯ All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement.
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Current techniques for monitoring patients for apnoea suffer from significant limitations. These include insufficient availability to meet diagnostic needs, cost, accuracy of results in the presence of artefacts and difficulty of use in unsupervised conditions. ⋯ The performance of the novel device compares very well to the scoring by an experienced clinician even in the presence of breathing artefacts, in this small pilot study. This can potentially make it a real solution for apnoea home monitoring.