2,258 research outputs found

    Update on the Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II):Statistical analysis plan

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    <p>Abstract</p> <p>Background</p> <p>Previous studies had suggested that the outcome for patients with spontaneous lobar intracerebral haemorrhage (ICH) and no intraventricular haemorrhage (IVH) might be improved with early evacuation of the haematoma. The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) set out to establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH would improve outcome compared to a policy of initial conservative treatment. It is an international, multi-centre, prospective randomised parallel group trial of early surgery in patients with spontaneous lobar ICH. Outcome is measured at six months via a postal questionnaire.</p> <p>Results</p> <p>Recruitment to the study began on 27 November 2006 and closed on 15 August 2012 by which time 601 patients had been recruited. The protocol was published in <it>Trials</it> (<url>http://www.trialsjournal.com/content/12/1/124/</url>). This update presents the analysis plan for the study without reference to the unblinded data. The trial data will not be unblinded until after follow-up is completed in early 2013. The main trial results will be presented in spring 2013 with the aim to publish in a peer-reviewed journal at the same time.</p> <p>Conclusion</p> <p>The data from the trial will provide evidence on the benefits and risks of early surgery in patients with lobar ICH.</p> <p>Trial registration</p> <p>ISRCTN: ISRCTN22153967</p

    Early surgery versus initial conservative treatment in patients with traumatic intracerebral haemorrhage [STITCH(Trauma)] : the first randomized trial

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    Acknowledgements This project was funded by the NIHR Health Technology Assessment programme (project number 07/37/16). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.Peer reviewedPublisher PD

    The Virtual International Stroke Trials Archive

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    BACKGROUND AND PURPOSE: Stroke has global importance and it causes an increasing amount of human suffering and economic burden, but its management is far from optimal. The unsuccessful outcome of several research programs highlights the need for reliable data on which to plan future clinical trials. The Virtual International Stroke Trials Archive aims to aid the planning of clinical trials by collating and providing access to a rich resource of patient data to perform exploratory analyses. METHODS: Data were contributed by the principal investigators of numerous trials from the past 16 years. These data have been centrally collated and are available for anonymized analysis and hypothesis testing. RESULTS: Currently, the Virtual International Stroke Trials Archive contains 21 trials. There are data on \u3e15,000 patients with both ischemic and hemorrhagic stroke. Ages range between 18 and 103 years, with a mean age of 69+/-12 years. Outcome measures include the Barthel Index, Scandinavian Stroke Scale, National Institutes of Health Stroke Scale, Orgogozo Scale, and modified Rankin Scale. Medical history and onset-to-treatment time are readily available, and computed tomography lesion data are available for selected trials. CONCLUSIONS: This resource has the potential to influence clinical trial design and implementation through data analyses that inform planning

    Association Between Clinical Pathways Leading to Medical Management and Prognosis in Patients With NSTEACS.

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    : A large proportion of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) are initially selected for medical management (MM) and do not undergo coronary revascularization during or immediately after the index event. The aim of this study was to explore the clinical pathways leading to MM in NSTEACS patients and their influence on prognosis. : Patient characteristics, pathways leading to MM, and 2-year outcomes were recorded in a prospective cohort of 5591 NSTEACS patients enrolled in 555 hospitals in 20 countries across Europe and Latin America. Cox models were used to assess the impact of hospital management on postdischarge mortality. : Medical management was the selected strategy in 2306 (41.2%) patients, of whom 669 (29%) had significant coronary artery disease (CAD), 451 (19.6%) had nonsignificant disease, and 1186 (51.4%) did not undergo coronary angiography. Medically managed patients were older and had higher risk features than revascularized patients. Two-year mortality was higher in medically managed patients than in revascularized patients (11.0% vs 4.4%; P &lt; .001), with higher mortality rates in patients who did not undergo angiography (14.6%) and in those with significant CAD (9.3%). Risk-adjusted mortality was highest for patients who did not undergo angiography (HR = 1.81; 95%CI, 1.23-2.65), or were not revascularized in the presence of significant CAD (HR = 1.90; 95%CI, 1.23-2.95) compared with revascularized patients. : Medically managed NSTEACS patients represent a heterogeneous population with distinct risk profiles and outcomes. These differences should be considered when designing future studies in this population.<br/

    Memory, space and time: Researching children's lives

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    This article discusses the research approach in 'Pathways through Childhood', a small qualitative study drawing on memories of childhood. The research explores how wider social arrangements and social change influence children's everyday lives.The article discusses the way that the concepts of social memory, space and time have been drawn on to access and analyse children's experiences, arguing that attention to the temporal and spatial complexity of childhood reveals less visible yet formative influences and connections. Children's everyday engagements involve connections between past and present time, between children, families, communities and nations, and between different places. Children carve out space and time for themselves from these complex relations. © The Author(s) 2010

    Cupid at the Ivory Gates: Ausonius as a Reader of Vergil\u27s Aeneid

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    Building model trains and planes : an autoethnographic investigation of a human occupation.

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    This research paper utilises an autoethnographic method, termed collective autobiography, to explore the nature and meaning of the amateur hobby of building models from childhood to adulthood. Hobbies and leisure activities are areas of human occupation of increasing interest to a variety of disciplines e.g. healthcare. Although model making may concern the miniature representation of any subject, this paper focuses on the construction of model aircraft kits, trains and their layouts. As a complex specific human occupation modelling is revealed as significant to personal wellbeing, and while the activity may start in childhood its associated motivations and required skills develop over a life time. The findings reveal aspects of the nature of the relationship between the modeller, the process of modelling and the final product. In addition they also reveal some elements of the gendered nature of modelling, its role within father-son relationships, and the accommodation of modelling activities within shared domestic spaces. The specific modelling activities described are recognised as having their origins within the culture of post-war baby boomer Britain, and the socioeconomic and technological environment of that period. This recognition necessitates discussion of the modeller as a skilled consumer as well as a creative individual
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