445 research outputs found
RESTART trial main results dataset
No full textAnalysis dataset used for the RESTART main results and imaging sub-study results papers in 2019Protocol, SAP, data dictionary, sharing dataset, annotated CRF
Supplemental materials for a systematic review of stereotactic radiosurgery for cerebral cavernous malformations
No full textSupplementary data in support of manuscript: "Stereotactic radiosurgery for cerebral cavernous malformations: a systematic review"
Unruptured arteriovenous malformations of the brain
Full text linkUnruptured, asymptomatic arteriovenous malformations (AVMs) lurk in the brains of approximately one person in every thousand; their prevalence, based on four studies of magnetic resonance imaging (MRI) of 7,359 people without brain disorders, 1-4 was 0.1 % (95% confidence interval [CI] 0% to
0.2%). Some of these brain AVMs may be discovered if and when they cause intracranial haemorrhage, epileptic seizure(s), headache, or a focal neurological deficit, but many brain AVMs may potentially lie dormant from the cradle to the grave
Edinburgh diagnostic criteria for lobar ICH associated with CAA
No full textSummary of the Edinburgh diagnostic criteria for lobar ICH associated with CAA, illustrative cases, and the diagnostic test accuracy of two cut-pointsPortable Network Graphics, PDF, and PowerPoint image formats for people to use in PowerPoint presentations or manuscripts that describe the Edinburgh diagnostic criteria for lobar intracerebral haemorrhage associated with moderate/severe cerebral amyloid angiopath
RESTART data request form
No full textTo request access to the RESTART dataset, please fill out the data request form. Associated documentation is available in the other datasets belonging to this collection, see https://datashare.is.ed.ac.uk/handle/10283/3265 .
RESTART recruited 537 participants between 22 May 2013 and 31 May 2018. The main results, based on follow-up of these participants until 30 November 2018, are available and were published on 22 May 2019. A plain English summary is available at:www.RESTARTtrial.org.The main results of the trial were published in The Lancet https://doi.org/10.1016/S0140-6736(19)30840-2. The results of the imaging sub-group analyses of the trial were published in The Lancet Neurology https://doi.org/10.1016/S1474-4422(19)30184-X).
Please read this document about planned secondary analyses:
Salman, Rustam Al-Shahi. (2019). RESTART | planned secondary analyses, 2013-2018 [text]. University of Edinburgh. https://doi.org/10.7488/ds/2551
A fully anonymised version of the dataset used for analysis with individual participant data and a data dictionary will be available for other researchers to apply to use 1 year after publication, from 22 May 2020. Written proposals will be assessed by members of the RESTART trial steering committee and a decision made about the appropriateness of the use of data. A data sharing agreement will be put in place before any data are shared. Please read this document about planned data sharing:
Stephen, Jacqueline; Salman, Rustam Al-Shahi. (2020). RESTART Data Sharing, [text]. University of Edinburgh https://doi.org/10.7488/ds/2806
Supplemental material for Radiosurgical, neurosurgical, or no intervention for cerebral cavernous malformations: A decision analysis
No full textSupplemental Material for Radiosurgical, neurosurgical, or no intervention for cerebral cavernous malformations: A decision analysis by Leon A Rinkel, Rustam Al-Shahi Salman, Gabriel JE Rinkel and Jacoba P Greving in International Journal of Stroke</p
Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage in the UK: a randomised, open-label, assessor-masked, pilot-phase, non-inferiority trial
No full textBackground: oral anticoagulation reduces the rate of systemic embolism for patients with atrial fibrillation by two-thirds, but its benefits for patients with previous intracranial haemorrhage are uncertain. In the Start or STop Anticoagulants Randomised Trial (SoSTART), we aimed to establish whether starting is non-inferior to avoiding oral anticoagulation for survivors of intracranial haemorrhage who have atrial fibrillation.Methods: SoSTART was a prospective, randomised, open-label, assessor-masked, parallel-group, pilot phase trial done at 67 hospitals in the UK. We recruited adults (aged ≥18 years) who had survived at least 24 h after symptomatic spontaneous intracranial haemorrhage, had atrial fibrillation, and had a CHA2DS2-VASc score of at least 2. Web-based computerised randomisation incorporating a minimisation algorithm allocated participants (1:1) to start or avoid long-term (≥1 year) full treatment dose open-label oral anticoagulation. The participants assigned to start oral anticoagulation received either a direct oral anticoagulant or vitamin K antagonist, and the group assigned to avoid oral anticoagulation received standard clinical practice (antiplatelet agent or no antithrombotic agent). The primary outcome was recurrent symptomatic spontaneous intracranial haemorrhage, and was adjudicated by an individual masked to treatment allocation. All outcomes were ascertained for at least 1 year after randomisation and assessed in the intention-to-treat population of all randomly assigned participants, using Cox proportional hazards regression adjusted for minimisation covariates. We planned a sample size of 190 participants (one-sided p=0·025, power 90%, allowing for non-adherence) based on a non-inferiority margin of 12% (or adjusted hazard ratio [HR] of 3·2). This trial is registered with ClinicalTrials.gov (NCT03153150) and is complete.Findings: between March 29, 2018, and Feb 27, 2020, consent was obtained at 61 sites for 218 participants, of whom 203 were randomly assigned at a median of 115 days (IQR 49–265) after intracranial haemorrhage onset. 101 were assigned to start and 102 to avoid oral anticoagulation. Participants were followed up for median of 1·2 years (IQR 0·97–1·95; completeness 97·2%). Starting oral anticoagulation was not non-inferior to avoiding oral anticoagulation: eight (8%) of 101 in the start group versus four (4%) of 102 in the avoid group had intracranial haemorrhage recurrences (adjusted HR 2·42 [95% CI 0·72–8·09]; p=0·152). Serious adverse events occurred in 17 (17%) participants in the start group and 15 (15%) in the avoid group. 22 (22%) patients in the start group and 11 (11%) patients in the avoid group died during the study.Interpretation: whether starting oral anticoagulation was non-inferior to avoiding it for people with atrial fibrillation after intracranial haemorrhage was inconclusive, although rates of recurrent intracranial haemorrhage were lower than expected. In view of weak evidence from analyses of three composite secondary outcomes, the possibility that oral anticoagulation might be superior for preventing symptomatic major vascular events should be investigated in adequately powered randomised trials
Exploration of the outcomes and experiences of people living with cognitive impairment and intracerebral haemorrhage: a mixed methods approach
Full text linkIntroduction
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
Supplemental material for Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: A systematic review
No full textSupplemental material for Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: A systematic review by Blair Wilson, Peter Burnett, David Moher, Douglas G Altman and Rustam Al-Shahi Salman in European Stroke Journal</p
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