860,296 research outputs found

    RESTART trial main results dataset

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    Analysis dataset used for the RESTART main results and imaging sub-study results papers in 2019Protocol, SAP, data dictionary, sharing dataset, annotated CRF

    Exploration of the outcomes and experiences of people living with cognitive impairment and intracerebral haemorrhage: a mixed methods approach

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    Introduction Stroke due to intracerebral haemorrhage (ICH) is the most devastating and least treatable type of stroke, where onset is sudden, often leaving the individual and family ill-prepared to deal with the long-term consequences. Associations between cognitive impairment and ischaemic stroke have been well described in the literature however fewer data are available for ICH and cognitive impairment. Although some studies have investigated the prevalence and risk factors of cognitive decline before and after ICH, very little is known about the influence of cognitive decline on functional outcome after ICH. Furthermore, there have been no qualitative studies designed specifically to examine the experiences of people living with cognitive impairment after intracerebral haemorrhage. Aims To explore the outcomes and experiences of people living with cognitive impairment and intracerebral haemorrhage: (a) To study the prevalence of pre-existing dementia and cognitive impairment in patients with ICH, and to quantify their incidence at specific time points thereafter, (b) To investigate the demographic, clinical, radiographic and functional outcomes associated with the occurrence of cognitive impairment following an ICH, and (c) Evaluate the experience of life after ICH with cognitive impairment. Methods (a) A retrospective analysis of all patients diagnosed with ICH in one region of Scotland between June 2010 and May 2013, who had available CT data from the time of the index ICH (n=404), was conducted. Data were taken from the Lothian Audit of the Treatment of Cerebral Haemorrhage, including people aged ≥ 16 years at the time of diagnosis. Data on demographics, medical history, and medication was drawn on. In addition to determining the prevalence and risk factors of pre-existing cognitive decline, survival analysis was used to determine cumulative rates of patients remaining free of cognitive decline up to 5 years after their ICH (LATCH COG). (b) A prospective observational cohort sub-study (LINCHPIN COG) of adults with ICH (n=45) was conducted using a detailed assessment of cognition and functional outcomes at 6 and 12-24 months after ICH. Pre-existing cognitive decline was measured using the IQCODE informant questionnaire, whilst also collecting basic demographic data, data on vascular risk factors, stroke severity, level of dependency, and neuroimaging features on computed tomography and magnetic resonance imaging. The primary outcome was new-onset cognitive impairment (defined as MoCA score <26) at 6 months, when functional outcomes (depression, fatigue, health-related quality of life) were also measured. (c) In an embedded qualitative study, six ICH survivors and four family members participated in semi-structured interviews and gave details about their experiences of life after ICH. The data collected was analysed using a thematic analysis approach. Results (a) Using data from LATCH COG, I found that roughly 1 in 4 (23%) patients had cognitive decline prior to their ICH. Forty-one patients (10%) had cognitive impairment with no dementia. Fifty-two patients met the criteria for pre-existing dementia (13%). In univariate analysis of LATCH COG, CT neuroimaging markers of cerebral amyloid angiopathy and small vessel disease were associated with pre-existing cognitive decline. In logistic regression analysis, patients who had a lobar ICH were twice as likely to exhibit preexisting cognitive decline and 3 times more likely to exhibit pre-existing dementia than those who had a non-lobar ICH. Patients with central (deep) atrophy were over 4 times more likely to exhibit cognitive decline and 8 times more likely to exhibit dementia before their stroke than those without. In line with this, severity of white matter changes was associated with pre-existing cognitive decline, suggesting a neurodegenerative process. Increasing age and larger haemorrhage volume were also associated with an increased likelihood of patients having cognitive decline prior to their stroke. During the first 5 years of follow-up of LATCH COG, of the 168 patients who survived longer than 30-days after their ICH, 47 patients developed new-onset cognitive decline (cognitive impairment and dementia). Cumulative survival rates for patients remaining free of cognitive decline were 82% in the first year and 65% at 5 years. In univariate analysis of LATCH COG, presence of posterior white matter lucencies was associated with new-onset dementia, indicating an association with markers of small vessel disease. In Cox regression analysis, patients who had a lobar ICH were twice as likely to exhibit new-onset cognitive decline than those who had a non-lobar ICH. In those who survived past 30 days, the incidence of new-onset cognitive decline was 37% in patients with lobar ICH and 20% in patients with non-lobar ICH. (b) Cognitive impairment is frequent after ICH with 43% of participants from LINCHPIN COG scoring <26 on the MOCA at 6 months. In univariate analysis of LINCHPIN COG, new-onset cognitive impairment at 6 months was associated with pre-ICH history of hypertension. I could not detect statistically significant associations between new-onset cognitive impairment and functional outcomes at 6 months. The small sample size may have been a significant contributory factor, making it difficult to identify any statistically significant differences between those with and without cognitive impairment (c) Thematic analysis of the qualitative interviews identified four overarching themes relating to how survivor’s and their family members experienced life after stroke: ‘the effects of stroke on sense of self and identity’, ‘adaptions and adjustment’, ‘uncertainty’, and ‘impact on family members’. These findings were interpreted in relation to theories of biographical disruption and suggest the necessity for individualised assessment of needs and the planning of services to best assist stroke survivors in coming to terms with their illness and its longterm consequences. Conclusion Pre-existing cognitive decline affects more than one-fifth of patients with ICH. For survivors of ICH without pre-existing cognitive decline, over two-fifths develop new-onset cognitive impairment by 6 months after ICH. Neuroimaging markers of cerebral amyloid angiopathy and small vessel disease were associated with pre-existing and new-onset cognitive decline. New-onset cognitive impairment at 6 months was associated with pre-ICH history of hypertension. This implies an important role of vascular processes on the pathophysiology of post-ICH cognitive decline. The qualitative accounts in this study indicate the devastating effect that a stroke due to haemorrhage can have on the lives of survivors and their families, with participants often indicating that they could no longer be the person that they were before the stroke. These data may help inform patients, their family and caregivers about the risk of cognitive impairment after ICH and its resultant impact on the lives of survivors

    sj-pdf-2-eso-10.1177_23969873231194811 – Supplemental material for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review

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    Supplemental material, sj-pdf-2-eso-10.1177_23969873231194811 for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review by Mohshin Syed, Helena Martin, Emily S Sena, Paula R Williamson and Rustam Al-Shahi Salman in European Stroke Journal</p

    The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial.

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    BackgroundFor adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs.Methods/designThe REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study).DiscussionFinal results of RESTART will be analysed and disseminated in 2019.Trial registrationISRCTN71907627 ( www.isrctn.com/ISRCTN71907627 ). Prospectively registered on 25 April 2013

    sj-pdf-5-eso-10.1177_23969873231194811 – Supplemental material for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review

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    Supplemental material, sj-pdf-5-eso-10.1177_23969873231194811 for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review by Mohshin Syed, Helena Martin, Emily S Sena, Paula R Williamson and Rustam Al-Shahi Salman in European Stroke Journal</p

    sj-pdf-4-eso-10.1177_23969873231194811 – Supplemental material for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review

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    Supplemental material, sj-pdf-4-eso-10.1177_23969873231194811 for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review by Mohshin Syed, Helena Martin, Emily S Sena, Paula R Williamson and Rustam Al-Shahi Salman in European Stroke Journal</p

    Sharjah, U.A.E.: the urban conservative dilemma

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    This thesis has two broad aims, to outline and analyse the urban development of the city of Sharjah, United Arab Emirates, illuminating significant events leading to the establishment and subsequent spatial expansion of the settlement. This analysis provides the basis from which the second part of the thesis is derived, thus fulfilling the second aim; to create a series of conservation zones in the city based upon the historical, architectural and cultural significance of groups of buildings, plus their feasibility for preservation according to their physical condition. It is to attempt to redress the balance of the wholesale demolition of historic areas of Middle-Eastern cities that this thesis is offered, in the hope that the suggestions contained within may provide, at the very least, a stimulus or springboard that could result in the extension and application of ideas to other Gulf cities, so resulting in the regional development of conservation zones. Chapters 1.1, 1.2 and 2 trace the establishment and development of the settlement called Sharjah, outlining significant historic events and their geographical impact upon the town, including the Master Plan of 1959.Chapter 3 widens the approach, comparing the town to others in the Middle East with respect to components considered to be essential elements of urban cores ('medinas').Chapters 4, 5 and 6 analyse these individual components; religious institutional buildings, suqs and residential structures, collating evidence to create proposed conservation zones based on both broad-based patterns and individual case studies to exemplify such findings in detail. Chapter 7 outlines potential problems of large-scale conservation schemes, offering some possible solutions but significantly, presenting the dilemma common to many such cities: the conflict of land use at the heart of the city: its historic urban core. Chapter 8 concludes the thesis by summarizing all previous evidence and submitting up-to-date findings from a field visit in 1991, thus illustrating any significant developments with respect to conservation in the city

    sj-pdf-3-eso-10.1177_23969873231194811 – Supplemental material for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review

    No full text
    Supplemental material, sj-pdf-3-eso-10.1177_23969873231194811 for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review by Mohshin Syed, Helena Martin, Emily S Sena, Paula R Williamson and Rustam Al-Shahi Salman in European Stroke Journal</p

    sj-xlsx-1-eso-10.1177_23969873231194811 – Supplemental material for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review

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    Supplemental material, sj-xlsx-1-eso-10.1177_23969873231194811 for Selective outcome reporting in randomised controlled trials including participants with stroke or transient ischaemic attack: A systematic review by Mohshin Syed, Helena Martin, Emily S Sena, Paula R Williamson and Rustam Al-Shahi Salman in European Stroke Journal</p
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