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  • 1
    Online Resource
    Online Resource
    Impact of Evidence‐Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Journal of the American Heart Association Vol. 8, No. 13 ( 2019-07-02)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 8, No. 13 ( 2019-07-02)
    Abstract: The uptake of proven stroke treatments varies widely. We aimed to determine the association of evidence‐based processes of care for acute ischemic stroke ( AIS ) and clinical outcome of patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial), a multicenter cluster crossover trial of lying flat versus sitting up, head positioning in acute stroke. Methods and Results Use of 8 AIS processes of care were considered: reperfusion therapy in eligible patients; acute stroke unit care; antihypertensive, antiplatelet, statin, and anticoagulation for atrial fibrillation; dysphagia assessment; and physiotherapist review. Hierarchical, mixed, logistic regression models were performed to determine associations with good outcome (modified Rankin Scale scores 0–2) at 90 days, adjusted for patient and hospital variables. Among 9485 patients with AIS, implementation of all processes of care in eligible patients, or “defect‐free” care, was associated with improved outcome (odds ratio, 1.40; 95% CI, 1.18–1.65) and better survival (odds ratio, 2.23; 95% CI , 1.62–3.09). Defect‐free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0–1) (odds ratio, 1.22; 95% CI , 1.04–1.43). No hospital characteristic was independently predictive of outcome. Only 1445 (15%) of eligible patients with AIS received all processes of care, with significant regional variations in overall and individual rates. Conclusions Use of evidence‐based care is associated with improved clinical outcome in AIS . Strategies are required to address regional variation in the use of proven AIS treatments. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique Identifier: NCT 02162017.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.119.012640
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2653953-6
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  • 2
    Online Resource
    Online Resource
    Fluoxetine and Fractures After Stroke : Exploratory Analyses From the FOCUS Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. 11 ( 2019-11), p. 3280-3282
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. 11 ( 2019-11), p. 3280-3282
    Abstract: The FOCUS trial (Fluoxetine or Control Under Supervision) showed that fluoxetine did not improve modified Rankin Scale scores (mRS) but increased the risk of fractures. We aimed to describe the fractures, their impact on mRS and factors associated with fracture risk. Methods— A United Kingdom, multicenter, parallel-group, randomized, placebo-controlled trial. Patients ≥18 years with a clinical stroke and persisting deficit assessed 2 to 15 days after onset were eligible. Consenting patients were allocated fluoxetine 20 mg or matching placebo for 6 months. The primary outcome was the mRS at 6 months and secondary outcomes included fractures. Results— Sixty-five of 3127 (2.1%) patients had 67 fractures within 6 months of randomization; 43 assigned fluoxetine and 22 placebo. Fifty-nine (90.8%) had fallen and 26 (40%) had fractured their neck of femur. The effect of fluoxetine on mRS (common odds ratio =0.951) was not significantly altered by excluding fracture patients (common odds ratio =0.961). Cox proportional hazards modeling showed that only age 〉 70 year (hazard ratio =1.97; 95% CI, 1.13–3.45; P =0.017), female sex (hazard ratio =2.13; 95% CI, 1.29–3.51; P =0.003), and fluoxetine (hazard ratio =2.00; 95% CI, 1.20–3.34; P =0.008) were independently associated with fractures. Conclusions— Most fractures resulted from falls. Although many fractures were serious, and likely to impair patients’ function, the increased fracture risk did not explain the lack of observed effect of fluoxetine on mRS. Only increasing age, female sex, and fluoxetine were independent predictors of fractures. Clinical Trial Registration— URL: http://www.controlled-trials.com . Unique identifier: ISRCTN83290762.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.119.026639
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 1467823-8
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  • 3
    Online Resource
    Online Resource
    Fluoxetine for Improving Functional Outcome After Stroke: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
    Elsevier BV ; 2018
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.3264978
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
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  • 4
    Online Resource
    Online Resource
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials
    Springer Science and Business Media LLC ; 2015
    In:  Trials Vol. 16, No. 1 ( 2015-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 16, No. 1 ( 2015-12)
    Abstract: Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients’ functional outcome. Methods/Design The three trial investigator teams have collaboratively developed a core protocol. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients. The trials include patients ≥18 years old with a clinical diagnosis of stroke, persisting focal neurological deficits at randomisation between 2 and 15 days after stroke onset. Patients are randomised centrally via web-based randomisation systems using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Our primary outcome measure is the modified Rankin scale (mRS) at 6 months. Secondary outcomes include the Stroke Impact Scale, EuroQol (EQ5D-5 L), the vitality subscale of the Short-Form 36, diagnosis of depression, adherence to medication, adverse events and resource use. Outcomes are collected at 6 and 12 months. The methods of collecting these data are tailored to the national setting. If FOCUS, AFFINITY and EFFECTS combined enrol 6000 participants as planned, they would have 90 % power (alpha 5 %) to detect a common odds ratio of 1.16, equivalent to a 3.7 % absolute difference in percentage with mRS 0–2 (44.0 % to 47.7 %). This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm. Discussion If fluoxetine is safe and effective in promoting functional recovery, it could be rapidly, widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke. Trial registration FOCUS: ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011). EFFECTS: ISRCTN13020412 (19/12/2014).
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-015-0864-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2015
    detail.hit.zdb_id: 2040523-6
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  • 5
    Online Resource
    Online Resource
    Regional variation in acute stroke care organisation
    Elsevier BV ; 2016
    In:  Journal of the Neurological Sciences Vol. 371 ( 2016-12), p. 126-130
    Details
    In: Journal of the Neurological Sciences, Elsevier BV, Vol. 371 ( 2016-12), p. 126-130
    Type of Medium: Online Resource
    ISSN: 0022-510X
    URL: Article
    DOI: 10.1016/j.jns.2016.10.026
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2016
    detail.hit.zdb_id: 1500645-1
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  • 6
    Online Resource
    Online Resource
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis
    Springer Science and Business Media LLC ; 2017
    In:  Trials Vol. 18, No. 1 ( 2017-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 18, No. 1 ( 2017-12)
    Abstract: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients’ functional outcome. Methods/Design The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2–15 days after stroke onset. Patients are randomised centrally via each trials’ web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. Discussion Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020. Trial registration FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011. EFFECTS: ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-017-2385-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2017
    detail.hit.zdb_id: 2040523-6
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  • 7
    Online Resource
    Online Resource
    The Course and Impact of Poststroke Insomnia in Stroke Survivors Aged 18 to 65 Years: Results from the Psychosocial Outcomes In StrokE (POISE) Study
    S. Karger AG ; 2017
    In:  Cerebrovascular Diseases Extra Vol. 7, No. 1 ( 2017-2-3), p. 9-20
    Details
    In: Cerebrovascular Diseases Extra, S. Karger AG, Vol. 7, No. 1 ( 2017-2-3), p. 9-20
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Insomnia symptoms are common in the population and have negative psychosocial and functional sequelae. There are no prospective studies of the course of such symptoms and their impact, if any, in stroke survivors. This prospective cohort study investigated insomnia after stroke in working-age adults and evaluated its impact on psychological and functional outcomes over the subsequent year. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 We prospectively recruited 441 young ( & #x3c;65 years) consecutive stroke survivors from 20 public hospitals in the New South Wales Stroke Service network. Participants were assessed by self-report and interview at 28 days, 6 months, and 12 months after stroke. Insomnia was defined using a common epidemiological measure of sleep disturbance and daytime consequences. Depression, anxiety, disability, and return to work were assessed through standardized measures. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The point prevalence of insomnia at each time point in the year after stroke was stable at 30–37% and more common in females. Fifty-eight (16%) of all participants reported “chronic” insomnia, with symptoms at both baseline and 6 months later. At 12 months, this group was more likely to be depressed (OR 6.75, 95% CI 2.78–16.4), anxious (OR 3.31, 95% CI 1.54–7.09), disabled (OR 3.60, 95% CI 2.07–6.25), and not have returned to work, compared to those without insomnia over the same period. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Chronic insomnia has a negative effect on disability and return to work 1 year after stroke even after adjusting for demographic, psychiatric, and disability factors. Identifying and appropriately targeting insomnia through known effective treatments may improve functional outcomes after stroke.
    Type of Medium: Online Resource
    ISSN: 1664-5456
    URL: Article
    DOI: 10.1159/000455751
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2017
    detail.hit.zdb_id: 2651613-5
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  • 8
    Online Resource
    Online Resource
    Abstract TP371: Monitoring a Large-scale International Cluster Stroke Trial: Lessons From Head Position in Stroke Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Stroke Vol. 48, No. suppl_1 ( 2017-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 48, No. suppl_1 ( 2017-02)
    Abstract: Background and Purpose: There is limited evidence on head positioning in acute ischemic stroke (AIS) or intracerebral hemorrhage (ICH). Potential benefits for lying flat (0°) include improved collateral blood flow in AIS and for head up (30°) reduced cerebral oedema in ICH. The Head Positioning in Stroke Trial (HeadPoST) aims to provide reliable evidence on the optimum head position in acute stroke. Methods: HeadPoST is a prospective, cluster randomised, crossover, blinded outcome assessed, clinical trial with consecutive patient recruitment who were positioned within 24 hours of admission. Hospitals were randomised to service organisation to compare lying flat vs. sitting up (≥30°) head positioning of stroke patients. An innovative centralized remote monitoring system was used to assess data quality across participating countries. Results: Over a 30 month study period, 10,000+ patients were recruited across 114 hospitals in 9 countries. A web-based monitoring system provided alerts for cross-over time points and achievement of cluster balance. Centralised reports included serious adverse events, protocol deviations, forms completion, data queries, entry delays and data validation, which were distributed to regional co-ordinating centres for action. Details of these procedures are outlined. Conclusions: Reliable, complete, and high quality data were required for this pragmatic international nursing care clinical trial, which used a novel cluster cross-over design.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.48.suppl_1.tp371
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 1467823-8
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