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1.
  • Vahlberg, Birgit, 1964-, et al. (författare)
  • Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study) : a randomized controlled trial
  • 2021
  • Ingår i: Clinical Rehabilitation. - : Sage Publications. - 0269-2155 .- 1477-0873. ; 35:2, s. 276-287
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To evaluate whetherdaily mobile-phone delivered messages with training instructions during three months increase physical activity and overall mobility in patients soon after stroke or transient ischemic attack.DESIGN: Randomised controlled trial with intention-to-treat analyses.SETTING: University hospital. Data collection from November 2016 until December2018.SUBJECTS: Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women) were allocated to either intervention (n = 40) or control group (n = 39). Participants had to be independent (modified Ranking Scale ⩽2) and able to perform the six-minute walking test at discharge from the hospital.INTERVENTIONS: The intervention group received standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care; that is, primary care follow-up.MAIN MEASURES: Walking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery (0-12 points) and 10-metres walk test (m/s) were assessed at baseline and after three months.RESULTS: The estimated median difference in the six-minute walking test was in favour of the intervention group by 30 metres (95% CI, 55 to 1; effect size 0.64; P = 0.037) and in the chair-stand test by 0.88 seconds (95% CI, 0.02 to 1.72; effect size 0.64; P = 0.034). There were no differences between groups on the short physical performance battery or in 10-metres walking time.CONCLUSIONS: Three months of daily mobile phone text messages with guided training instructions improved composite mobility measures; that is, walking performanceand lower body strength.CLINICAL TRIAL REGISTRY: The study is registered with ClinicalTrials.gov, number NCT02902367.
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2.
  • Vahlberg, Birgit, 1964-, et al. (författare)
  • Factors associated with changes in walking performance in individuals 3 months after stroke or TIA : secondary analyses from a randomised controlled trial of SMS-delivered training instructions in Sweden
  • 2024
  • Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 14:3
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA.Design: Cross-sectional study with post hoc analysis of a randomised controlled study.Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test.Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test.Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test.Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.
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3.
  • Vahlberg, Birgit, 1964-, et al. (författare)
  • Potential effects on cardiometabolic risk factors and body composition by short message service (SMS)-guided training after recent minor stroke or transient ischaemic attack : Post hoc analyses of the STROKEWALK randomised controlled trial
  • 2021
  • Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:10
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke.Design: Randomised controlled intervention study with per-protocol analyses.Setting: University Hospital in Sweden.Participants: Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) ≥18 years with good motor function (modified Rankin Scale ≤2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: Subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations.Interventions: The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care.Main outcome measures: Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months.Results: Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI-2.45 to-0.14; p=0.029, ES=0.41 vs-0.76 kg, 95% CI-1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol-0.65 mmol/L, 95% CI-1.10 to-0.2; p=0.06, ES: 0.5 vs-1.1 mmol/L, 95% CI-1.47 to-0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups.Conclusions: No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived health. Further research is needed to evaluate secondary prevention efforts in larger populations after recent stroke.Trial registration number: NCT02902367.
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4.
  • Abzhandadze, Tamar, 1980, et al. (författare)
  • Development of a short-form Swedish version of the Montreal Cognitive Assessment (s-MoCA-SWE): protocol for a cross-sectional study
  • 2021
  • Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 11:5
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction Short forms of the Montreal Cognitive Assessment (MoCA) have allowed quick cognitive screening. However, none of the available short forms has been created or validated in a Swedish sample of patients with stroke. The aim is to develop a short-form Swedish version of the MoCA (s-MoCA-SWE) in a sample of patients with acute and subacute stroke. The specific objectives are: (1) to identify a subgroup of MoCA items that have the potential to form the s-MoCA-SWE; (2) to determine the optimal cut-off value of s-MoCA-SWE for predicting cognitive impairment and (3) and to compare the psychometric properties of s-MoCA-SWE with those of previously developed MoCA short forms. Methods and analysis This is a statistical analysis protocol for a cross-sectional study. The study sample will comprise patients from Vaststroke, a local stroke registry from Gothenburg, Sweden and Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke (EFFECTS), a randomised controlled trial in Sweden. The s-MoCA-SWE will be developed by using exploratory factor analysis and the boosted regression tree algorithm. The cut-off value of s-MoCA-SWE for impaired cognition will be determined based on binary logistic regression analysis. The psychometric properties of s-MoCA-SWE will be compared with those of other MoCA short forms by using cross-tabulation and area under the receiving operating characteristic curve analyses. Ethics and dissemination The Vaststroke study has received ethical approval from the Regional Ethical Review Board in Gothenburg (346-16) and the Swedish Ethical Review Authority (amendment 2019-04299). The handling of data generated within the framework of quality registers does not require written informed consent from patients. The EFFECTS study has received ethical approval from the Stockholm Ethics Committee (2013/1265-31/2 on 30 September 2013). All participants provided written consent. Results will be published in an international, peer-reviewed journal, presented at conferences and communicated to clinical practitioners in local meetings and seminars.
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5.
  • Abzhandadze, Tamar, 1980, et al. (författare)
  • DEVELOPMENT OF A SWEDISH SHORT VERSION OF THE MONTREAL COGNITIVE ASSESSMENT FOR COGNITIVE SCREENING IN PATIENTS WITH STROKE
  • 2023
  • Ingår i: Journal of Rehabilitation Medicine. - : Medical Journals Sweden. - 1650-1977 .- 1651-2081. ; 55
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: The primary objective was to develop a Swedish short version of the Montreal Cognitive Assessment (s-MoCA-SWE) for use with patients with stroke. Secondary objectives were to iden-tify an optimal cut-off value for the s-MoCA-SWE to screen for cognitive impairment and to compare its sensitivity with that of previously developed short forms of the Montreal Cognitive Assessment. Design: Cross-sectional study.Subjects/patients: Patients admitted to stroke and rehabilitation units in hospitals across Sweden. Methods: Cognition was screened using the Mont-real Cognitive Assessment. Working versions of the s-MoCA-SWE were developed using supervised and unsupervised algorithms.Results: Data from 3,276 patients were analysed (40% female, mean age 71.5 years, 56% minor stroke at admission). The suggested s-MoCA-SWE compri-sed delayed recall, visuospatial/executive function, serial 7, fluency, and abstraction. The aggregated scores ranged from 0 to 16. A threshold for impai-red cognition & LE; 12 had a sensitivity of 97.41 (95% confidence interval, 96.64-98.03) and positive pre-dictive value of 90.30 (95% confidence interval 89.23-91.27). The s-MoCA-SWE had a higher abso-lute sensitivity than that of other short forms.Conclusion: The s-MoCA-SWE (threshold & LE; 12) can detect post-stroke cognitive issues. The high sensitivity makes it a potentially useful "rule-out" tool that may eliminate severe cognitive impair-ment in people with stoke.
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6.
  • Ahmed, Niaz, et al. (författare)
  • Consensus statements and recommendations from the ESO-Karolinska Stroke Update Conference, Stockholm 11-13 November 2018.
  • 2019
  • Ingår i: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 4:4, s. 307-317
  • Tidskriftsartikel (refereegranskat)abstract
    • The purpose of the European Stroke Organisation-Karolinska Stroke Update Conference is to provide updates on recent stroke therapy research and to give an opportunity for the participants to discuss how these results may be implemented into clinical routine. The meeting started 22 years ago as Karolinska Stroke Update, but since 2014 it is a joint conference with European Stroke Organisation. Importantly, it provides a platform for discussion on the European Stroke Organisation guidelines process and on recommendations to the European Stroke Organisation guidelines committee on specific topics. By this, it adds a direct influence from stroke professionals otherwise not involved in committees and work groups on the guideline procedure. The discussions at the conference may also inspire new guidelines when motivated. The topics raised at the meeting are selected by the scientific programme committee mainly based on recent important scientific publications. This year's European Stroke Organisation-Karolinska Stroke Update Meeting was held in Stockholm on 11-13 November 2018. There were 11 scientific sessions discussed in the meeting including two short sessions. Each session except the short sessions produced a consensus statement (Full version with background, issues, conclusions and references are published as web-material and at www.eso-karolinska.org and http://eso-stroke.org) and recommendations which were prepared by a writing committee consisting of session chair(s), scientific secretary and speakers. These statements were presented to the 250 participants of the meeting. In the open meeting, general participants commented on the consensus statement and recommendations and the final document were adjusted based on the discussion from the general participants Recommendations (grade of evidence) were graded according to the 1998 Karolinska Stroke Update meeting with regard to the strength of evidence. Grade A Evidence: Strong support from randomised controlled trials and statistical reviews (at least one randomised controlled trial plus one statistical review). Grade B Evidence: Support from randomised controlled trials and statistical reviews (one randomised controlled trial or one statistical review). Grade C Evidence: No reasonable support from randomised controlled trials, recommendations based on small randomised and/or non-randomised controlled trials evidence.
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7.
  • Ahmed, Niaz, et al. (författare)
  • Recommendations from the ESO-Karolinska Stroke Update Conference, Stockholm 13–15 November 2016
  • 2017
  • Ingår i: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 2:2, s. 95-102
  • Tidskriftsartikel (refereegranskat)abstract
    • About the meeting: The purpose of the European Stroke Organisation (ESO)-Karolinska Stroke Update Conference is to provide updates on recent stroke therapy research and to give an opportunity for the participants to discuss how these results may be implemented into clinical routine. Several scientific sessions discussed in the meeting and each session produced consensus statements. The meeting started 20 years ago as Karolinska Stroke Update, but since 2014, it is a joint conference with ESO. Importantly, it provides a platform for discussion on the ESO guidelines process and on recommendations to the ESO guidelines committee on specific topics. By this, it adds a direct influence from stroke professionals otherwise not involved in committees and work groups on the guidelines procedure. The discussions at the conference may also inspire new guidelines when motivated. The topics raised at the meeting are selected by the scientific programme committee mainly based on recent important scientific publications. The ESO-Karolinska Stroke Update consensus statement and recommendations will be published every 2 years and it will work as implementation of ESO-guidelinesBackground: This year’s ESO-Karolinska Stroke Update Meeting was held in Stockholm on 13–15 November 2016. There were 10 scientific sessions discussed in the meeting and each session produced a consensus statement (Full version with background, issues, conclusions and references are published as web-material and at http://www.eso-karolinska.org/2016 and http://eso-stroke.org) and recommendations which were prepared by a writing committee consisting of session chair(s), secretary and speakers and presented to the 312 participants of the meeting. In the open meeting, general participants commented on the consensus statement and recommendations and the final document were adjusted based on the discussion from the general participants.Recommendations (grade of evidence) were graded according to the 1998 Karolinska Stroke Update meeting with regard to the strength of evidence. Grade A Evidence: Strong support from randomised controlled trials and statistical reviews (at least one randomised controlled trial plus one statistical review). Grade B Evidence: Support from randomised controlled trials and statistical reviews (one randomised controlled trial or one statistical review). Grade C Evidence: No reasonable support from randomised controlled trials, recommendations based on small randomised and/or non-randomised controlled trials evidence.
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8.
  • Ball, Emily L., et al. (författare)
  • Predicting post-stroke cognitive impairment using acute CT neuroimaging : A systematic review and meta-analysis
  • 2022
  • Ingår i: International Journal of Stroke. - : Sage Publications. - 1747-4930 .- 1747-4949. ; 17:6, s. 618-627
  • Forskningsöversikt (refereegranskat)abstract
    • Background Identifying whether acute stroke patients are at risk of cognitive decline could improve prognostic discussions and management. Structural computed tomography neuroimaging is routine in acute stroke, and may identify those at risk of post-stroke dementia or post-stroke cognitive impairment (PSCI).Aim To systematically review the literature to identify which stroke or pre-stroke features on brain computed tomography scans, performed at the time of stroke, are associated with post-stroke dementia or PSCI.Summary of review We searched electronic databases to December 2020. We included studies reporting acute stroke brain computed tomography, and later diagnosis of a cognitive syndrome. We created summary estimates of size of unadjusted association between computed tomography features and cognition. Of 9536 citations, 28 studies (41 papers) were eligible (N = 7078, mean age 59.8-78.6 years). Cognitive outcomes were post-stroke dementia (10 studies), PSCI (17 studies), and one study analyzed both. Fifteen studies (N = 2952) reported data suitable for meta-analyses. White matter lesions (WML) (six studies, N = 1054, OR = 2.46, 95% CI = 1.25-4.84), cerebral atrophy (four studies, N = 558, OR = 2.80, 95% CI = 1.21-6.51), and pre-existing stroke lesions (three studies, N = 352, OR = 2.38, 95% CI = 1.06-5.32) were associated with post-stroke dementia. WML (four studies, N = 473, OR = 3.46, 95% CI = 2.17-5.52) were associated with PSCI. Other computed tomography features were either not associated with cognitive outcome, or there were insufficient data.Conclusions Cognitive impairment following stroke is of great concern to patients and carers. Features seen on visual assessment of acute stroke computed tomography brain scans are strongly associated with cognitive outcomes. Clinicians should consider when and how this information should be discussed with stroke survivors.
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9.
  • Ball, Emily Louise, et al. (författare)
  • Predictors of post-stroke cognitive impairment using acute structural MRI neuroimaging : A systematic review and meta-analysis
  • 2023
  • Ingår i: International Journal of Stroke. - : Sage Publications. - 1747-4930 .- 1747-4949. ; 18:5, s. 543-554
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Stroke survivors are at an increased risk of developing post-stroke cognitive impairment and post-stroke dementia; those at risk could be identified by brain imaging routinely performed at stroke onset.AIM: This systematic review aimed to identify features which are associated with post-stroke cognitive impairment (including dementia), on magnetic resonance imaging (MRI) performed at stroke diagnosis.SUMMARY OF REVIEW: We searched the literature from inception to January 2022 and identified 10,284 records. We included studies that performed MRI at the time of stroke (0-30 days after a stroke) and assessed cognitive outcome at least three months after stroke. We synthesised findings from 26 papers, comprising 27 stroke-populations (N=13,114, average age range=40-80 years, 19-62% female). When data were available, we pooled unadjusted (ORu) and adjusted (ORa) odds ratios.We found associations between cognitive outcomes and presence of cerebral atrophy (3 studies, N=453, ORu=2.48, 95%CI=1.15-4.62), presence of microbleeds (2 studies, N=9151, ORa=1.36, 95%CI=1.08-1.70), and increasing severity of white matter hyperintensities (3 studies, N=704, ORa=1.26, 95%CI=1.06-1.49). Increasing cerebral small vessel disease score was associated with cognitive outcome following unadjusted analysis only (2 studies, N=499, ORu=1.34, 95%CI=1.12-1.61; 3 studies, N=950, ORa=1.23, 95%CI=0.96-1.57). Associations remained after controlling for pre-stroke cognitive impairment. We did not find associations between other stroke features and cognitive outcome, or there were insufficient data.CONCLUSIONS: Acute stroke MRI features may enable healthcare professionals to identify patients at risk of post-stroke cognitive problems. However, there is still substantial uncertainty about the prognostic utility of acute MRI for this.
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10.
  • Berge, Eivind, et al. (författare)
  • Effects of alteplase on survival after ischaemic stroke (IST-3) : 3 year follow-up of a randomised, controlled, open-label trial
  • 2016
  • Ingår i: Lancet Neurology. - 1474-4422 .- 1474-4465. ; 15:10, s. 1028-34
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The effect of alteplase on patient survival after ischaemic stroke is the subject of debate. We report the effect of intravenous alteplase on long-term survival after ischaemic stroke of participants in the Third International Stroke Trial (IST-3).METHODS: In IST-3, done at 156 hospitals in 12 countries (Australia, Europe, and the UK), participants (aged >18 years) were randomly assigned with a telephone voice-activated or web-based system in a 1:1 ratio to treatment with intravenous 0·9 mg/kg alteplase plus standard care or standard care alone within 6 h of ischaemic stroke. We followed up participants in the UK and Scandinavia (Sweden and Norway) for survival up to 3 years after randomisation using data from national registries and compared survival in the two groups with proportional hazards survival analysis, adjusting for key prognostic variables. IST-3 is registered with the ISRCTN registry, number ISRCTN25765518.FINDINGS: Between May 5, 2000, and July 27, 2011, 3035 participants were enrolled in IST-3. Of these, 1948 (64%) of 3035 participants were scheduled for analysis of 3 year survival, and 1946 (>99%) of these were included in the analysis (967 [50%] in the alteplase plus standard care group and 979 [50%] in the standard care alone group). By 3 years after randomisation, 453 (47%) of 967 participants in the alteplase plus standard care group and 494 (50%) of 979 in the standard care alone group had died (risk difference 3·6% [95% CI -0·8 to 8·1]). Participants allocated to alteplase had a significantly higher hazard of death during the first 7 days (99 [10%] of 967 died in the alteplase plus standard care group vs 65 [7%] of 979 in the standard care alone group; hazard ratio 1·52 [95% CI 1·11-2·08]; p=0·004) and a significantly lower hazard of death between 8 days and 3 years (354 [41%] of 868 vs 429 [47%] of 914; 0·78 [0·68-0·90]; p=0·007).INTERPRETATION: Alteplase treatment within 6 h after ischaemic stroke was associated with a small, non-significant reduction in risk of death at 3 years, but among individuals who survived the acute phase, treatment was associated with a significant increase in long-term survival. These results are reassuring for clinicians who have expressed concerns about the effect of alteplase on survival.FUNDING: Heart and Stroke Scotland, UK Medical Research Council, Health Foundation UK, Stroke Association UK, Research Council of Norway, AFA Insurance, Swedish Heart Lung Fund, Foundation of Marianne and Marcus Wallenberg, Polish Ministry of Science and Education, Australian Heart Foundation, Australian National Health and Medical Research Council, Swiss National Research Foundation, Swiss Heart Foundation, Assessorato alla Sanita (Regione dell'Umbria), and Danube University.
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11.
  • Borota, Ljubisa, et al. (författare)
  • Complete functional recovery in a child after endovascular treatment of basilar artery occlusion caused by spontaneous dissection : a case report
  • 2022
  • Ingår i: Child's Nervous System. - : Springer Nature. - 0256-7040 .- 1433-0350. ; 38:8, s. 1605-1612
  • Tidskriftsartikel (refereegranskat)abstract
    • Stroke caused by dissection of arteries of the vertebrobasilar system in children is still poorly investigated in terms of etiology, means of treatment, course of disease, and prognosis. The aim of this report was to describe the unusual course of a spontaneous dissection of the basilar artery (BA) in a child treated with endovascular techniques and to point out that the plasticity of the brain stem can fully compensate for structural damage caused by stroke. We report the case of a 15-year-old boy who suffered a wake-up stroke with BA occlusion caused by spontaneous dissection. A blood clot was aspirated from the false lumen and the true lumen re-opened, but the patient deteriorated a few hours later, and repeated angiography revealed that the intimal flap was detached, occluding the BA again. The lumen of BA was then reconstructed by a stent. Despite a large pons infarction, the patient was completely recovered 11 months after the onset. The case was analyzed with angiograms and magnetic resonance imaging, macroscopic and microscopic pathological analysis, computed tomographic angiography, magnetic resonance-based angiography, and diffusion tensor imaging. This case illustrates that applied endovascular techniques and intensive care measures can alter the course of potentially fatal brain stem infarction. Our multimodal analysis gives new insight into the anatomical basis for the plasticity mechanism of the brain stem.
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12.
  • Chye, Alexander, et al. (författare)
  • Repeated Measures of Modified Rankin Scale Scores to Assess Functional Recovery From Stroke : AFFINITY Study Findings
  • 2022
  • Ingår i: Journal of the American Heart Association. - : Ovid Technologies (Wolters Kluwer Health). - 2047-9980. ; 11:16
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Function after acute stroke using the modified Rankin Scale (mRS) is usually assessed at a point in time. The analytical implications of serial mRS measurements to evaluate functional recovery over time is not completely understood. We compare repeated-measures and single-measure analyses of the mRS from a randomized clinical trialMethods and Results: Serial mRS data from AFFINITY (Assessment of Fluoxetine in Stroke Recovery), a double-blind placebo randomized clinical trial of fluoxetine following stroke (n=1280) were analyzed to identify demographic and clinical associations with functional recovery (reduction in mRS) over 12 months. Associations were identified using single-measure (day 365) and repeated-measures (days 28, 90, 180, and 365) partial proportional odds logistic regression. Ninety-five percent of participants experienced a reduction in mRS after 12 months. Functional recovery was associated with age at stroke <70 years; no prestroke history of diabetes, coronary heart disease, or ischemic stroke; prestroke history of depression, a relationship partner, living with others, independence, or paid employment; no fluoxetine intervention; ischemic stroke (compared with hemorrhagic); stroke treatment in Vietnam (compared with Australia or New Zealand); longer time since current stroke; and lower baseline National Institutes of Health Stroke Scale & Patient Health Questionnaire-9 scores. Direction of associations was largely concordant between single-measure and repeated-measures models. Association strength and variance was generally smaller in the repeated-measures model compared with the single-measure model.Conclusions: Repeated-measures may improve trial precision in identifying trial associations and effects. Further repeated-measures stroke analyses are required to prove methodological value. Registration URL: http://www.anzctr.org.au; Unique identifier: ACTRN12611000774921.
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13.
  • Dennis, Martin, et al. (författare)
  • Effects of fluoxetine on functional outcomes after acute stroke (FOCUS) : a pragmatic, double-blind, randomised, controlled trial
  • 2019
  • Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 393:10168, s. 265-274
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.Methods FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.Findings Between Sept 10,2012, and March 31,2017,3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99.3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0.951 [95% CI 0.839-1.079]; p=0.439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13.43%] patients vs 269 [17.21%]; difference 3.78% [95% CI 1.26-6.30]; p=0.0033), but they had more bone fractures (45 [2.88%] vs 23 [1.47%]; difference 1.41% [95% CI 0.38-2.43]; p=0.0070). There were no significant differences in any other event at 6 or 12 months.Interpretation Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.
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14.
  • Dennis, Martin, et al. (författare)
  • Fluoxetine and Fractures After Stroke : Exploratory Analyses From the FOCUS Trial
  • 2019
  • Ingår i: Stroke. - : Lippincott Williams & Wilkins. - 0039-2499 .- 1524-4628. ; 50:11, s. 3280-3282
  • Tidskriftsartikel (refereegranskat)abstract
    • Background and Purpose- 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.
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15.
  • Dennis, Martin, et al. (författare)
  • Fluoxetine to improve functional outcomes in patients after acute stroke : the FOCUS RCT
  • 2020
  • Ingår i: Health technology assessment (Winchester, England). - : National Institute for Health Research. - 2046-4924 .- 1366-5278. ; 24:22, s. 1-
  • Rapport (refereegranskat)abstract
    • BackgroundOur Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias.ObjectivesThe Fluoxetine Or Control Under Supervision (FOCUS) trial tested the hypothesis that fluoxetine improves recovery after stroke.DesignThe FOCUS trial was a pragmatic, multicentre, parallel-group, individually randomised, placebo-controlled trial.SettingThis trial took place in 103 UK hospitals.ParticipantsPatients were eligible if they were aged ≥ 18 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset.InterventionsPatients were randomly allocated 20 mg of fluoxetine once per day or the matching placebo for 6 months via a web-based system using a minimisation algorithm.Main outcome measuresThe primary outcome was the modified Rankin Scale at 6 months. Patients, carers, health-care staff and the trial team were masked to treatment allocation. Outcome was assessed at 6 and 12 months after randomisation. Patients were analysed by their treatment allocation as specified in a published statistical analysis plan.ResultsBetween 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated fluoxetine and 1563 of whom were allocated placebo. The modified Rankin Scale score at 6 months was available for 1553 out of 1564 (99.3%) of those allocated fluoxetine and 1553 out of 1563 (99.4%) of those allocated placebo. The distribution across modified Rankin Scale categories at 6 months was similar in the two groups (common odds ratio adjusted for minimisation variables 0.951, 95% confidence interval 0.839 to 1.079; p = 0.439). Compared with placebo, patients who were allocated fluoxetine were less likely to develop a new episode of depression by 6 months [210 (13.0%) vs. 269 (16.9%), difference –3.78%, 95% confidence interval –1.26% to –6.30%; p = 0.003], but had more bone fractures [45 (2.9%) vs. 23 (1.5%), difference 1.41%, 95% confidence interval 0.38% to 2.43%; p = 0.007]. There were no statistically significant differences in any other recorded events at 6 or 12 months. Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs.LimitationsSome non-adherence to trial medication, lack of face-to-face assessment of neurological status at follow-up and lack of formal psychiatric diagnosis during follow-up.Conclusions20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients’ functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients’ characteristics and health-care setting.
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16.
  • Eltoft, Agnethe, et al. (författare)
  • Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
  • 2022
  • Ingår i: Trials. - : Springer Nature. - 1745-6215. ; 23:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Patients with wake-up ischemic stroke are frequently excluded from thrombolytic treatment due to unknown symptom onset time and limited availability of advanced imaging modalities. The Tenecteplase in Wake-up lschaemic Stroke Trial (TWIST) is a randomized controlled trial of intravenous tenecteplase 0.25 mg/kg and standard care versus standard care alone (no thrombolysis) in patients who wake up with acute ischemic stroke and can be treated within 4.5 h of wakening based on non-contrast CT findings. Objective: To publish the detailed statistical analysis plan for TWIST prior to unblinding. Methods: The TWIST statistical analysis plan is consistent with the Consolidating Standard of Reporting Trials (CON-SORT) statement and provides clear and open reporting. Discussion: Publication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly outlines the pre-specified analyses.
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17.
  • Ervasti, Jenni, et al. (författare)
  • Permanent work disability before and after ischaemic heart disease or stroke event : a nationwide population-based cohort study in Sweden.
  • 2017
  • Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 7:9
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: We examined the risk of disability pension before and after ischaemic heart disease (IHD) or stroke event, the burden of stroke compared with IHD and which factors predicted disability pension after either event.DESIGN: A population-based cohort study with follow-up 5 years before and after the event. Register data were analysed with general linear modelling with binary and Poisson distributions including interaction tests for event type (IHD/stroke).SETTING AND PARTICIPANTS: All people living in Sweden, aged 25‒60 years at the first event year, who had been living in Sweden for 5 years before the event and had no indication of IHD or stroke prior to the index event in 2006‒2008 were included, except for cases in which death occurred within 30 days of the event. People with both IHD and stroke were excluded, resulting in 18 480 cases of IHD (65%) and 9750 stroke cases (35%).PRIMARY OUTCOME MEASURES: Disability pension.RESULTS: Of those going to suffer IHD or stroke event, 25% were already on disability pension a year before the event. The adjusted OR for disability pension at first postevent year was 2.64-fold (95% CI 2.25 to 3.11) for people with stroke compared with IHD. Economic inactivity predicted disability pension regardless of event type (OR=3.40; 95% CI 2.85 to 4.04). Comorbid mental disorder was associated with the greatest risk (OR=3.60; 95% CI 2.69 to 4.83) after an IHD event. Regarding stroke, medical procedure, a proxy for event severity, was the largest contributor (OR=2.27, 95% CI 1.43 to 3.60).CONCLUSIONS: While IHD event was more common, stroke involved more permanent work disability. Demographic, socioeconomic and comorbidity-related factors were associated with disability pension both before and after the event. The results help occupational and other healthcare professionals to identify vulnerable groups at risk for permanent labour market exclusion after such an event.
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18.
  • Graham, C., et al. (författare)
  • 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
  • 2017
  • Ingår i: Trials. - : BioMed Central Ltd.. - 1745-6215. ; 18:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: 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.
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19.
  • Gustavsson, Leif, 1954-, et al. (författare)
  • Climate change effects of forestry and substitution of carbon-intensive materials and fossil fuels
  • 2017
  • Ingår i: Renewable & sustainable energy reviews. - : Elsevier. - 1364-0321 .- 1879-0690. ; 67:January, s. 612-624
  • Tidskriftsartikel (refereegranskat)abstract
    • We estimate the climate effects of directing forest management in Sweden towards increased carbon storage in forests with more land set-aside for protection, or towards increased forest production for the substitution of carbon-intensive materials and fossil fuels, relative to a reference case of current forest management. We develop various scenarios of forest management and biomass use to estimate the carbon balances of the forest systems, including ecological and technological components, and their impacts on the climate in terms of radiative forcing. The scenario with increased set-aside area and the current level of forest residue harvest resulted in lower cumulative carbon emissions compared to the reference case for the first 90 years, but then showed higher emissions as reduced forest harvest led to higher carbon emissions from energy and material systems. For the reference case of current forest management, increased harvest of forest residues gave increased climate benefits. The most climatically beneficial alternative, expressed as reduced cumulative radiative forcing, in both the short and long terms is a strategy aimed at high forest production, high residue recovery rate, and high efficiency utilization of harvested biomass. Active forest management with high harvest levels and efficient forest product utilization will provide more climate benefit, compared to reducing harvest and storing more carbon in the forest.
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20.
  • Hankey, Graeme J., et al. (författare)
  • Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration
  • 2021
  • Ingår i: Stroke. - : Lippincott Williams & Wilkins. - 0039-2499 .- 1524-4628. ; 52:8, s. 2502-2509
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND AND PURPOSE: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. METHODS: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. RESULTS: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76-1.14]; P=0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%]; P=0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%]; P=0.08), bone fractures (23 [3.58%] versus 11 [1.72%]; P=0.05), or seizures (11 [1.71%] versus 8 [1.25%]; P=0.64) at 12 months. CONCLUSIONS: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding.
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21.
  • Hedlund, Fredrik, et al. (författare)
  • Trends in stroke reperfusion treatment and outcomes in New Zealand
  • 2020
  • Ingår i: Internal medicine journal (Print). - : Wiley. - 1444-0903 .- 1445-5994. ; 50:11, s. 1367-1372
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT) can help reverse stroke symptoms in selected patients but are both time sensitive interventions.AIMS: To report current stroke reperfusion rates and quality measures as well as trends over time in New Zealand.METHOD: Since 2015 New Zealand treatment centers have been mandated to prospectively enter all IVT and EVT patients into a low cost National Stroke Register. Data was cleaned and missing data added where possible through contact with individual hospitals. Main outcomes include treatment delays, vital status at day seven and complications.RESULTS: In 2018, there were 719 of 7173 (10.0%) patients with ischemic stroke or stroke unspecified treated with intravenous IVT, up from 389 of 5963 (6.5%) patients in 2015 (p < 0.001), with no change in day seven mortality (p = 0.63) or sICH rate (p = 0.22). Median (interquartile range (IQR)) door-to-needle times decreased from 65 (47-89) minutes in 2017 to 59 (40-84) minutes in 2018 (p = 0.022), and patients treated within 60 min increased from 40% to 51% (p < 0.001). In 2018, there were 243 (3.4%) patients treated with EVT up from 134/6859 (1.9%) in 2017 (p < 0.0001), with no change in seven mortality (p = 0.39) or sICH (p = 0.78). There was no significant change in onset-to-needle (p = 0.21), arrival-to-groin (p = 0.28) or onset-to-reperfusion time (p = 0.32).CONCLUSION: Stroke reperfusion rates in New Zealand are continuously rising with no associated increase in complications. More patients are being treated faster upon hospital arrival but there remains room for further improvement in reducing onset to treatment delays.
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22.
  • Hu, Xiao-Lei, et al. (författare)
  • Digital Graphic Follow-up Tool (Rehabkompassen) for Identifying Rehabilitation Needs among People after Stroke : Randomized Clinical Feasibility Study
  • 2022
  • Ingår i: JMIR Human Factors. - : JMIR Publications. - 2292-9495. ; 9:3
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Stroke is a leading cause of disability among adults, with heavy social and economic burden worldwide. A cost-effective solution is urgently needed to facilitate the identification of individual rehabilitation needs and thereby provide tailored rehabilitations to reduce disability among people who have had a stroke. A novel digital graphic follow-up tool Rehabkompassen has recently been developed to facilitate capturing the multidimensional rehabilitation needs of people who have had a stroke.Objective: The aim of this study was to evaluate the feasibility and acceptability of conducting a definitive trial to evaluate Rehabkompassen as a digital follow-up tool among people who have had a stroke in outpatient clinical settings.Methods: This pilot study of Rehabkompassen was a parallel, open-label, 2-arm prospective, proof-of-concept randomized controlled trial (RCT) with an allocation ratio of 1:1 in a single outpatient clinic. Patients who have had a stroke within the 3 previous months, aged ≥18 years, and living in the community were included. The trial compared usual outpatient visits with Rehabkompassen (intervention group) and without Rehabkompassen (control group) at the 3-month follow-up as well as usual outpatient visit with Rehabkompassen at the 12-month follow-up. Information on the recruitment rate, delivery, and uptake of Rehabkompassen; assessment and outcome measures completion rates; the frequency of withdrawals; the loss of follow-up; and satisfaction scores were obtained. The key outcomes were evaluated in both groups.Results: In total, 28 patients (14 control, 14 Rehabkompassen) participated in this study, with 100 patients screened. The overall recruitment rate was 28% (28/100). Retention in the trial was 86% (24/28) at the 12-month follow-up. All participants used the tool as planned during their follow-ups, which provided a 100% (24/24) task completion rate of using Rehabkompassen and suggested excellent feasibility. Both patient- and physician-participants reported satisfaction with the instrument (19/24, 79% and 2/2, 100%, respectively). In all, 2 (N=2, 100%) physicians and 18 (N=24, 75%) patients were willing to use the tool in the future. Furthermore, modified Rankin Scale as the primary outcome and various stroke impacts as secondary outcomes were both successfully collected and compared in this study.Conclusions: This study demonstrated the high feasibility and adherence of the study protocol as well as the high acceptability of Rehabkompassen among patients who have had a stroke and physicians in an outpatient setting in comparison to the predefined criterion. The information collected in this feasibility study combined with the amendments of the study protocol may improve the future definitive RCT. The results of this trial support the feasibility and acceptability of conducting a large definitive RCT.
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23.
  • Hu, Xiao-Lei, et al. (författare)
  • Study protocol for a randomized, controlled, multicentre, pragmatic trial with Rehabkompassen®-a digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke
  • 2023
  • Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 24:1
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundStroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients' rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease disability is largely lacking in current stroke care. The overall purpose of this study is to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen (R), among persons discharged from acute care settings after a stroke.MethodsThis multicentre, parallel, open-label, two-arm pragmatic randomized controlled trial with an allocation ratio of 1:1 will be conducted in Sweden. A total of 1106 adult stroke patients will have follow-up visits in usual care settings at 3 and 12 months after stroke onset. At the 3-month follow-up, participants will have a usual outpatient visit without (control group, n = 553) or with (intervention group, n = 553) the Rehabkompassen (R) tool. All participants will receive the intervention at the 12-month follow-up visit. Feedback from the end-users (patient and health care practitioners) will be collected after the visits. The primary outcomes will be the patients' independence and social participation at the 12-month visits. Secondary outcomes will include end-users' satisfaction, barriers and facilitators for adopting the instrument, other stroke impacts, health-related quality of life and the cost-effectiveness of the instrument, calculated by incremental cost per quality-adjusted life year (QALY).DiscussionThe outcomes of this trial will inform clinical practice and health care policy on the role of the Rehabkompassen (R) digital follow-up tool in the post-acute continuum of care after stroke.Trial registrationClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023.
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24.
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25.
  • Isaksson, Eva, et al. (författare)
  • Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel
  • 2019
  • Ingår i: Trials. - : BMC. - 1745-6215. ; 20:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively. Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%). Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.
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26.
  • Isaksson, Eva, et al. (författare)
  • Validation of the Simplified Modified Rankin Scale Questionnaire
  • 2020
  • Ingår i: European Neurology. - : S. Karger. - 0014-3022 .- 1421-9913. ; 83:5, s. 493-499
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: The modified Rankin scale (mRS) is the most common assessment tool for measuring overall functional outcome in stroke studies. The traditional way of using mRS face-to-face is time- and cost-consuming. The aim of this study was to test the validity of the Swedish translation of the simplified modified Rankin scale questionnaire (smRSq) as compared with the mRS assessed face-to-face 6 months after a stroke.Methods: Within the ongoing EFFECTS trial, smRSq was sent out to 108 consecutive stroke patients 6 months after a stroke. The majority, 90% (97/108), of the patients answered the questionnaire; for the remaining 10%, it was answered by the next of kin. The patients were assessed by face-to-face mRS by 7 certified healthcare professionals at 4 Swedish stroke centres. The primary outcome was assessed by Cohen's kappa and weighted kappa.Results: There was good agreement between postal smRSq, answered by the patients, and the mRS face-to-face; Cohen's kappa was 0.43 (CI 95% 0.31-0.55), weighted kappa was 0.64 (CI 95% 0.55-0.73), and Spearman rank correlation was 0.82 (p < 0.0001). In 55% (59/108), there was full agreement, and of the 49 patients not showing exact agreement, 44 patients differed by 1 grade and 5 patients had a difference of 2 grades.Discussion/Conclusion: Our results show good validity of the postal smRSq, answered by the patients, compared with the mRS carried out face-to-face at 6 months after a stroke. This result could help trialists in the future simplify study design and make multicentre trials and quality registers with a large number of patients more feasible and time-saving.
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27.
  • Johansson Buvarp, Dongni, et al. (författare)
  • Physical Activity Trajectories and Functional Recovery After Acute Stroke Among Adults in Sweden.
  • 2023
  • Ingår i: JAMA network open. - : American Medical Association (AMA). - 2574-3805. ; 6:5
  • Tidskriftsartikel (refereegranskat)abstract
    • The optimum level and timing of poststroke physical activity interventions to enhance functional recovery remain unclear.To assess the level of physical activity in the first 6 months after stroke among individuals with similar physical activity patterns over time and to investigate the association between physical activity trajectories and functional recovery at 6 months after stroke.This cohort study obtained data from the Efficacy of Fluoxetine-a Randomized Controlled Trial in Stroke, which was conducted in 35 stroke and rehabilitation centers across Sweden from October 2014 to June 2019. Adult participants (aged >18 years) were recruited between 2 and 15 days after stroke onset and followed up for 6 months. Participants who withdrew or were lost to follow-up were excluded from the longitudinal analysis. Data analyses were performed between August 15 and October 28, 2022.Physical activity was assessed at 1 week, 1 month, 3 months, and 6 months. Multiple factors associated with physical activity trajectories were investigated. Association of the distinct trajectories with functional recovery was assessed in multivariable logistic regression.The primary outcomes were the distinct physical activity trajectories over time, which were identified using group-based trajectory modeling. The secondary outcome was the functional recovery at 6 months after stroke, which was assessed using the modified Rankin Scale.Of the 1367 included participants (median [IQR] age, 72 years [65-79] years; 844 males [62%]), 2 distinct trajectory groups were identified: increaser (n=720 [53%]) and decreaser (647 [47%]). The increaser group demonstrated a significant increase in physical activity level (mean difference, 0.27; linear slope β1=0.46; P<.001) and sustained it at light intensity from 1 week to 6 months, whereas the decreaser group showed a decline in physical activity and eventually became inactive (mean difference, -0.26; linear slope β1=1.81; P<.001). Male participants and those with normal cognition had higher odds of being in the increaser group, regardless of stroke severity. Increasing physical activity and sustaining it at light intensity were associated with a good functional outcome at 6 months (adjusted odds ratio, 2.54; 99% CI, 1.72-3.75; P<.001).Results of this study suggest that increased physical activity was associated with functional recovery 6 months after stroke. Interventions targeting individuals with decreasing physical activity in the subacute phase of stroke may play a role in improved functional outcomes.
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28.
  • Kong, Wan-Yee, et al. (författare)
  • Validation of Serial Alberta Stroke Program Early CT Score as an Outcome Predictor in Thrombolyzed Stroke Patients.
  • 2017
  • Ingår i: Journal of Stroke & Cerebrovascular Diseases. - : Elsevier BV. - 1052-3057 .- 1532-8511. ; 26:10, s. 2264-2271
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The Alberta Stroke Program Early CT Score (ASPECTS) on baseline imaging is an established predictor of functional outcome in anterior circulation acute ischemic stroke (AIS). We studied ASPECTS before intravenous thrombolysis (IVT) and at 24 hours to assess its prognostic value.METHODS: Data for consecutive anterior circulation AIS patients treated with IVT from 2006 to 2013 were extracted from a prospectively managed registry at our tertiary center. Pre-thrombolysis and 24-hour ASPECTS were evaluated by 2 independent neuroradiologists. Outcome measures included symptomatic intracranial hemorrhage (SICH), modified Rankin Scale (mRS) at 90 days, and mortality. Unfavorable functional outcome was defined by mRS >1. Dramatic ASPECTS progression (DAP) was defined as deterioration in ASPECTS by 6 points or more.RESULTS: Of 554 AIS patients thrombolyzed during the study period, 400 suffered from anterior circulation infarction. The median age was 65 years (interquartile range (IQR): 59-70) and the median National Institutes of Health Stroke Scale score was 18 points (IQR: 12-22). Compared with the pre-IVT ASPECTS (area under the curve [AUC] = .64, 95% confidence interval [CI]: .54-.65, P = .001), ASPECTS on the 24-hour CT scan (AUC = .78, 95% CI: .73-.82, P < .001), and change in ASPECTS (AUC = .69, 95% CI: .64-.74, P < .001) were better predictors of unfavorable functional outcome at 3 months. DAP, noted in 34 (14.4%) patients with good baseline ASPECTS (8-10 points), was significantly associated with unfavorable functional outcome (odds ratio [OR]: 9.91, 95% CI: 3.37-29.19, P ≤ .001), mortality (OR: 21.99, 95% CI: 7.98-60.58, P < .001), and SICH (OR: 8.57, 95% CI: 2.87-25.59, P < .001).CONCLUSION: Compared with the pre-thrombolysis score, ASPECTS measured at 24 hours as well as serial change in ASPECTS is a better predictor of 3-month functional outcome.
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29.
  • Lallukka, Tea, et al. (författare)
  • Trends in Diagnosis-Specific Work Disability Before and After Stroke : A Longitudinal Population-Based Study in Sweden.
  • 2018
  • Ingår i: Journal of the American Heart Association. - 2047-9980. ; 7:1
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Although a stroke event often leads to work disability, diagnoses behind work disability before and after stroke are largely unknown. We examined the pre-event and postevent trends in diagnosis-specific work disability among patients of working age.METHODS AND RESULTS: We included all new nonfatal stroke events in 2006-2008 from population-based hospital registers in Sweden among women and men aged 25 to 60 years (n=12 972). Annual days of diagnosis-specific work disability were followed for 4 years before and after stroke. Repeated measures negative binomial regression models using the generalized estimating equations method were fitted to examine trends in diagnosis-specific work disability before and after the event. Already during the 4 pre-event years, work disability attributed to circulatory diseases increased among women (rate ratio, 1.99; 95% confidence interval, 1.68-2.36) and men (rate ratio, 2.20; 95% confidence interval, 1.88-2.57). Increasing trends before stroke were also found for work disability attributed to mental disorders, musculoskeletal diseases, neoplasms, diseases of the nervous, respiratory, and digestive systems, injuries, and diabetes mellitus. As expected, a sharp increase in work disability days attributed to circulatory diseases was found during the first year after the event among both sexes. Overall, during 4 years after the stroke, there was a decreasing trend for circulatory diseases and injuries, whereas the trend was increasing for nervous diseases and diabetes mellitus.CONCLUSIONS: Work disability attributed to several mental and somatic diagnoses is higher already before a stroke event.
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30.
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31.
  • Legg, Lynn A, et al. (författare)
  • Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery
  • 2019
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; 2019:11
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Stroke is a major cause of adult disability. Selective serotonin reuptake inhibitors (SSRIs) have been used for many years to manage depression and other mood disorders after stroke. The 2012 Cochrane Review of SSRIs for stroke recovery demonstrated positive effects on recovery, even in people who were not depressed at randomisation. A large trial of fluoxetine for stroke recovery (fluoxetine versus placebo under supervision) has recently been published, and it is now appropriate to update the evidence.OBJECTIVES: To determine if SSRIs are more effective than placebo or usual care at improving outcomes in people less than 12 months post-stroke, and to determine whether treatment with SSRIs is associated with adverse effects.SEARCH METHODS: For this update, we searched the Cochrane Stroke Group Trials Register (last searched 16 July 2018), the Cochrane Controlled Trials Register (CENTRAL, Issue 7 of 12, July 2018), MEDLINE (1946 to July 2018), Embase (1974 to July 2018), CINAHL (1982 July 2018), PsycINFO (1985 to July 2018), AMED (1985 to July 2018), and PsycBITE March 2012 to July 2018). We also searched grey literature and clinical trials registers.SELECTION CRITERIA: We included randomised controlled trials (RCTs) that recruited ischaemic or haemorrhagic stroke survivors at any time within the first year. The intervention was any SSRI, given at any dose, for any period, and for any indication. We excluded drugs with mixed pharmacological effects. The comparator was usual care or placebo. To be included, trials had to collect data on at least one of our primary (disability score or independence) or secondary outcomes (impairments, depression, anxiety, quality of life, fatigue, healthcare cost, death, adverse events and leaving the trial early).DATA COLLECTION AND ANALYSIS: We extracted data on demographics, type of stroke, time since stroke, our primary and secondary outcomes, and sources of bias. Two review authors independently extracted data from each trial. We used standardised mean differences (SMDs) to estimate treatment effects for continuous variables, and risk ratios (RRs) for dichotomous effects, with their 95% confidence intervals (CIs). We assessed risks of bias and applied GRADE criteria.MAIN RESULTS: We identified a total of 63 eligible trials recruiting 9168 participants, most of which provided data only at end of treatment and not at follow-up. There was a wide age range. About half the trials required participants to have depression to enter the trial. The duration, drug, and dose varied between trials. Only three of the included trials were at low risk of bias across the key 'Risk of bias' domains. A meta-analysis of these three trials found little or no effect of SSRI on either disability score: SMD -0.01 (95% CI -0.09 to 0.06; P = 0.75; 2 studies, 2829 participants; moderate-quality evidence) or independence: RR 1.00 (95% CI 0.91 to 1.09; P = 0.99; 3 studies, 3249 participants; moderate-quality evidence). We downgraded both these outcomes for imprecision. SSRIs reduced the average depression score (SMD 0.11 lower, 0.19 lower to 0.04 lower; 2 trials, 2861 participants; moderate-quality evidence), but there was a higher observed number of gastrointestinal side effects among participants treated with SSRIs compared to placebo (RR 2.19, 95% CI 1.00 to 4.76; P = 0.05; 2 studies, 148 participants; moderate-quality evidence), with no evidence of heterogeneity (I2 = 0%). For seizures there was no evidence of a substantial difference. When we included all trials in a sensitivity analysis, irrespective of risk of bias, SSRIs appeared to reduce disability scores but not dependence. One large trial (FOCUS) dominated the results. We identified several ongoing trials, including two large trials that together will recruit more than 3000 participants.AUTHORS' CONCLUSIONS: We found no reliable evidence that SSRIs should be used routinely to promote recovery after stroke. Meta-analysis of the trials at low risk of bias indicate that SSRIs do not improve recovery from stroke. We identified potential improvements in disability only in the analyses which included trials at high risk of bias. A further meta-analysis of large ongoing trials will be required to determine the generalisability of these findings.
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32.
  • Legg, Lynn A., et al. (författare)
  • Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery
  • 2021
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :11
  • Forskningsöversikt (refereegranskat)abstract
    • BackgroundSelective serotonin reuptake inhibitors (SSR1s)might theoretically reduce post-stroke disability by direct effects on the brain. This Cochrane Review was first published in 2012 and last updated in 2019.ObjectivesTo determine if SSRIs are more effective than placebo or usual care at improving outcomes in people less than 12 months post-stroke, and to determine whether treatment with SSRIs is associated with adverse effects.Search methodsWe searched the Cochrane Stroke Group Trials Register (last searched 7 January 2021), Cochrane Controlled Trials Register (CENTRAL, Issue 7 of 12, 7 January 2021), MEDLINE (1946 to 7 January 2021), Embase (1974 to 7 January 2021), CINAHL (1982 to 7 January 2021), PsycINFO (1985 to 7 January 2021), and AMED (1985 to 7 January 2021). PsycBITE had previously been searched (16 July 2018). We searched clinical trials registers.Selection criteriaWe included randomised controlled trials (RCTs) recruiting stroke survivors vvithin the firstyear. The intervention was any SSRI, at any dose, for any period, and for any indication. The comparator was usual care or placebo. Studies reporting at least one of our primary (disability score or independence) or secondary outcomes (impairments, depression, anxiety, quality of life, fatigue, cognition, healthcare cost, death, adverse events and leaving the study early) were included in the meta-analysis. The primary analysis included studies at low risk of bias.Data collection and analysisWe extracted data on demographics, stroke type and, our pre-specified outcomes, and bias sources. Two review authors independently extracted data. We used mean difference (MD) or standardised mean differences (SMDs) for continuous variables, and risk ratios (RRs) for dichotomous variables, with 95% confidence intervals (as). We assessed bias risks and applied GRADE criteria.Main resultsWe identified 76 eligible studies (13,029 participants); 75 provided data at end of treatment, and of these two provided data at follow-up. Thirty-eight required participants to have depression to enter. The duration, drug, and dose varied. Six studies were at low risk of bias across all domains; all six studies did not need participants to have depression to enter, and all used fluoxetine. Of these six studies, there was little to no difference in disability between groups SMD-0.0; 95 % CI -0.05 to 0.05; 5 studies, 5436 participants, high-quality evidence) or in independence (RR 0.98; 95% CI 0.93 to 1.03; 5 studies, 5926 participants; high-quality evidence) at the end of treatment. In the studies at low risk of bias across all domains, SSRIs slightly reduced the average depression score (SMD 0.14 lower, 9.50/0 CI 0.19 lower to 0.08 lower; 4 studies; 5356 participants, high-quality evidence) and there was a slight reduction in the proportion with depression (RR 0.75, 95% CI 0.65 to 0.86; 3 studies, 5907 participants, high-quality evidence). Cognition was slightly better in the control group (MD -1.22, 95% CI -2.37 to -0.07; 4 studies, 5373 participants, moderate-quality evidence). Only one study (n = 30) reported neurological deficit score (SMD -0.39, 95% CI -1.12 to 0.33; low-quality evidence). SSRIs resulted in little to no difference in motor deficit (SMD 0.03, -0.02 to 0.08; 6 studies, 5518 participants, moderate-quality evidence). SSRIs slightly increased the proportion leaving the study early (RR 1.57, 95% C I 1.03 to 2.40; 6 studies, 6090 participants, high-quality evidence). SSRIs slightly increased the outcome of a seizure (RR 1.40, 95% CI 1.00 to 1.98; 6 studies, 6080 participants, moderate-quality evidence and a bone fracture (RR 2.35, 95% CI 1.62 to 3.41; 6 studies, 6080 participants, high-quality evidence). One study at low risk of bias across all domains reported gastrointestinal side effects (RR 1.71, 95% CI 0.33, to 8.83; 1 study, 30 participants). There was no difference in the total number of deaths between SSRI and placebo (RR 1.01, 95% CI 0.82 to 1.24; 6 studies, 6090 participants, moderate quality evidence). SSRIs probably result in little to no difference in fatigue (MD -0.06; 95% CI -1.24 to 1.11; 4 studies, 5524 participants, moderate-quality of evidence), nor in quality of life (MD 0.00; 95% CI -0.02 to 0.02, 3 studies, 5482 participants, high-quality evidence). When all studies, irrespective of risk of bias, were included, SSRIs reduced disability scores but not the proportion independent. There was insufficient data to perform a meta-analysis of outcomes at end of follow-up. Several small ongoing studies are unlikely to alter conclusions.Authors' conclusionsThere is high-quality evidence that SSRIs do not make a difference to disability or independence after stroke compared to placebo or usual care, reduced the risk of future depression, increased bone fractures and probably increased seizure risk.
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33.
  • Lindvall, Elias, et al. (författare)
  • The impact of stroke on the ability to live an independent life at old age : a community-based cohort study of Swedish men
  • 2023
  • Ingår i: BMC Geriatrics. - : BioMed Central (BMC). - 1471-2318. ; 23:1
  • Tidskriftsartikel (refereegranskat)abstract
    • INTRODUCTION: Few studies with controls from the same cohort have investigated the impact of stroke on the ability to live an independent life at old age. We aimed to analyze how great an impact being a stroke survivor would have on cognition and disability. We also analyzed the predictive value of baseline cardiovascular risk factors.METHODS: We included 1147 men, free from stroke, dementia, and disability, from the Uppsala Longitudinal Study of Adult Men, between 69-74 years of age. Follow-up data were collected between the ages of 85-89 years and were available for 481 of all 509 survivors. Data on stroke diagnosis were obtained through national registries. Dementia was diagnosed through a systematic review of medical charts and in accordance with the current diagnostic criteria. The primary outcome, preserved functions, was a composite outcome comprising four criteria: no dementia, independent in personal activities of daily living, ability to walk outside unassisted, and not living in an institution.RESULTS: Among 481 survivors with outcome data, 64 (13%) suffered a stroke during the follow-up. Only 31% of stroke cases, compared to 72% of non-stroke cases (adjusted OR 0.20 [95% CI 0.11-0.37]), had preserved functions. The chance of being free of dementia was 60% lower in the stroke group, OR 0.40 [95% CI 0.22-0.72]. No cardiovascular risk factors were independently able to predict preserved functions among stroke cases.CONCLUSION: Stroke has long lasting consequences for many aspects of disability at very high age.
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34.
  • Lundström, Erik, 1964-, et al. (författare)
  • Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke Results From EFFECTS, a Randomized Controlled Trial
  • 2021
  • Ingår i: Stroke. - : Ovid Technologies (Wolters Kluwer Health). - 0039-2499 .- 1524-4628. ; 52:10, s. 3082-3087
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND AND PURPOSE: The EFFECTS (Efficacy of Fluoxetine-a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. METHODS: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. RESULTS: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76-1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75-100) versus 93 (interquartile range, 82-100); P=0.0021 and communication 93 (interquartile range, 82-100) versus 96 (interquartile range, 86-100); P=0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. CONCLUSIONS: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance.
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35.
  • Lundström, Erik, 1964-, et al. (författare)
  • Four-fold increase in direct costs of stroke-survivors with spas-ticity compared to stroke-survivors without spasticity : the first year after the event
  • 2010
  • Ingår i: Stroke. - 0039-2499 .- 1524-4628. ; 41:2, s. 319-324
  • Tidskriftsartikel (refereegranskat)abstract
    • Background and Purpose:The prevalence of spasticity after first-ever stroke is approximately 20%, but there are no health economic studies on costs associated with spasticity after stroke. The objective of our study was to estimate direct costs of stroke with spasticity for patients surviving up to one year after the stroke event in comparison to costs of stroke without spastic-ity.Methods:A representative sample of first-ever stroke patients hospitalized at Uppsala University Hospital was eligible for our cross-sectional survey. All direct costs during one year were identified for each patient, includ-ing costs for hospitalization (acute and rehabilitation), primary health care, medication, and costs for municipality services. The Swedish currency (SEK) was converted into Purchasing Power Parities US dollar (PPP$).Results:Median age (inter-quartile range) was 73 years (18), and the proportion of women was 48%. The majority of the direct costs (78%) were associated with hospitalization, whereas 20% was associated with municipality services during one year after first-ever stroke. Only 1% of all direct costs were related to primary health care and 1% to medication. The level of costs for stroke patients was correlated with the presence of spasticity, as measured with modified Ashworth Scale (rs = 0.524), and with the degree of disability, as measured with modified Rankin Scale (rs = 0.624). The mean (median, inter-quartile range) direct cost for stroke patients with spasticity was PPP$ 84 195 (72 116, 53 707) compared to PPP$ 21 842 (12 385, 17 484) for stroke patients without spasticity (P < 0.001).Conclusions:Direct costs for stroke patients with spasticity are four times higher than direct costs for non-spasticity stroke patients during the first year after the event.
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36.
  • Lundström, Erik, 1964-, et al. (författare)
  • How common is isolated dysphasia among patients with stroke treated with intravenous thrombolysis, and what is their outcome? Results from the SITS-ISTR.
  • 2015
  • Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 5:11
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: To describe the frequency and outcome of isolated dysphasia among patients treated with intravenous thrombolysis (IVT).DESIGN: Patients registered in the SITS International Stroke Thrombolysis Register (SITS-ISTR).PARTICIPANTS: Patients with stroke (N=58,293) treated with IVT between December 2002 and December 2012.SETTING: A multinational, prospective, observational monitoring register.MAIN OUTCOME MEASURES: Isolated dysphasia and modified Rankin Scale (mRS).METHODS: We identified patients presenting with isolated dysphasia by reviewing items within the baseline National Institutes of Health Stroke Scale (NIHSS). We performed descriptive statistics for baseline and demographic data, and reported patients' characteristics, radiological data and changes in their NIHSS score within 7 days and mRS score at 3 months. We also reported corresponding data from the general SITS-ISTR cohort.RESULTS: We found isolated dysphasia at baseline in 1.14% (663/58,293) of all patients treated with IVT patients. Patients with isolated dysphasia had a longer onset to treatment time, lower proportion of visible infarctions on admission imaging scan and atrial fibrillation, and were less often classified as having large vessels causing strokes, in comparison with the rest of the SITS-ISTR. Symptomatic intracerebral haemorrhage occurred in 2.3% of patients per SITS-MOST definition and fatal outcome in 5.5%. At 7 days, 50% of patients with isolated dysphasia recovered completely and at 3 months, 86.3% patients were functionally independent (mRS score 0-2), 71.7% had an excellent outcome (mRS score 0-1) and 45.5% had an mRS score of 0.CONCLUSIONS: A low proportion of patients with isolated dysphasia are treated with IVT. Half of these patients were fully recovered at 7 days.
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37.
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38.
  • Lundström, Erik, 1964-, et al. (författare)
  • Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.
  • 2020
  • Ingår i: The Lancet. Neurology. - 1474-4465 .- 1474-4422. ; 19:8, s. 661-669
  • Tidskriftsartikel (refereegranskat)abstract
    • Studies have suggested that fluoxetine could improve neurological recovery after stroke. The Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke (EFFECTS) trial aimed to assess whether administration of oral fluoxetine for 6 months after acute stroke improves functional outcome.EFFECTS was an investigator-led, multicentre, randomised, placebo-controlled, double-blind, parallel group trial that enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden. Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit. A web-based randomisation system that incorporated a minimisation algorithm was used to randomly assign (1:1) participants to receive oral fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months, analysed in all patients with available mRS data at the 6-month follow-up; we did an ordinal analysis adjusted for the minimisation variables used in the randomisation. This trial is registered with EudraCT, 2011-006130-16; ISRCTN, 13020412; and ClinicalTrials.gov, NCT02683213.Between Oct 20, 2014, and June 28, 2019, 1500 patients were enrolled, of whom 750 were randomly assigned to fluoxetine and 750 were randomly assigned to placebo. At 6 months, mRS data were available for 737 (98%) patients in the fluoxetine group and 742 (99%) patients in the placebo group. There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42). The proportion of patients with a new diagnosis of depression was lower with fluoxetine than with placebo (54 [7%] patients vs 81 [11%] patients; difference -3·60% [-6·49 to -0·71]; p=0·015), but fluoxetine was associated with more bone fractures (28 [4%] vs 11 [2%]; difference 2·27% [0·66 to 3·87]; p=0·0058) and hyponatraemia (11 [1%] vs one [<1%]; difference 1·33% [0·43 to 2·23]; p=0·0038) at 6 months.Functional outcome after acute stroke did not improve with oral fluoxetine 20 mg once daily for 6 months. Fluoxetine reduced the occurrence of depression but increased the risk of bone fractures and hyponatraemia. Our results do not support the use of fluoxetine after acute stroke.The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Brain Foundation, the Swedish Society of Medicine, King Gustav V and Queen Victoria's Foundation of Freemasons, and the Swedish Stroke Association (STROKE-Riksförbundet).
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39.
  • Lundström, Erik, 1964- (författare)
  • Spasticity after first-ever stroke
  • 2009
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • The prevalence of spasticity after first-ever stroke is approximately 20%, but there are no data on the prevalence of disabling spasticity.The reported prevalence of pain after stroke varies between 19% and 74%, whether pain is associated with spasticity is not known. Until now, there is no health economic analysis of patients with spasticity after stroke. Methods: Two groups of patients were studied. Cohort I was a cross-sectional survey. A representative sample of 140 patients was investigated 1 year after their first-ever stroke. Spasticity was defined as ≥ 1 score on the modified Ashworth scale, disabling spasticity was defined as spasticity having such an impact that intervention, e.g. intensive physiotherapy, orthoses or pharmacological treatment, should be offered. Pain was assesed with the Visual Analogue Scale. All direct costs during one year were identified and converted into Purchasing Power Parities US dollar (PPP$). Cohort II was a prospective cohort study. Forty-nine patients were examined at day 2–10, at one month, and at six months after their first-ever stroke. Assessment and definitions were similar as for cohort I. Results: Spasticity occurs within 1 month and disabling spasticity occur within 6 months. After one year, the prevalence of spasticity was 17% and that of  disabling spasticity 4%. Disabling spasticity was more frequent in the upper extremity. There was an independent effect of severe upper extremity paresis (OR 22, CI 3.9–125) and age below 65 years (OR 9.5, CI 1.5–60). The prevalence of stroke-related pain was 21% after one year. Stroke-related pain was associated with paresis (OR 3.1, 95% CI 1.2–7.7), sensory disturbance (OR 3.1, 95% CI 1.1–8.9) and depression (OR 4.1, 95% CI 1.4–13), but not with spasticity as an independent variable. The majority of the direct costs for one year (78%) were associated with hospitalization, whereas 20% was associated with municipality services. Only 1% of all direct costs were related to primary health care and 1% to medication. The mean (median, inter-quartile range) direct cost for stroke patients with spasticity was PPP$ 84 195 (72 116, 53 707) compared to PPP$ 21 842 (12 385, 17 484) for stroke patients without spasticity (P < 0.001).
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40.
  • Lundström, Erik, Docent, 1964-, et al. (författare)
  • The Effects Of Fluoxetine On Fracture Risk After Stroke : Further Analyses From The Focus Trial
  • 2019
  • Ingår i: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881.
  • Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
    • Background and Aims: The FOCUS trial showed that 20mg of fluoxetine daily, for six months, started 2–15 days post stroke had no effect on the modified Rankin scale (mRS), reduced the risk of new depression (Risk difference 3.8%) but increased the risk of bone fractures (Risk difference 1.4%). Further analyses aimed to explore the factors associated with bone fractures.Methods: Sixty five of the 3127 (2.1%) patients enrolled had a fracture within six months of randomisation. Of these 59 (90.8%) resulted from a fall and 26 (40%) affected the neck of femur. Cox proportional hazards modelling of the risk of fracture showed that only age ≤70yr (Hazard Ratio = 0.51 (95%CI 0.29-0.89; p = 0.017), female sex (HR = 2.13 (1.29-3.51; p = 0.003) and fluoxetine treatment (HR = 2.00 (1.20-3.34; p = 0.008) were independent predictors. Stroke pathology, severity, type of deficit, prior fractures, other medication affecting blood pressure, bone density and balance had no significant effect. Furthermore, removing patients with a fracture from the primary analysis did not significantly alter the effect on mRS (Common odds ratio 0.951 with fractures, 0.961 without).Results: Only increasing age, female sex and fluoxetine were independent predictors of fracture risk. Most fractures resulted from falls. Although many of the fractures were serious, and are likely to have impaired patients’ function, the increased fracture risk did not explain the lack of observed effect of fluoxetine on mRS.Conclusions: A future individual patient data meta-analysis including the patients from the ongoing AFFINITY and EFFECTS trials may clarify the mechanism of fractures due to fluoxetine.Trial registration number: ISRCTN registry, number ISRCTN83290762.
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41.
  • Lundström, Erik, 1964-, et al. (författare)
  • Time-course and determinants of spasticity during the first six months following first-ever stroke
  • 2010
  • Ingår i: Journal of Rehabilitation Medicine. - : Medical Journals Sweden AB. - 1650-1977 .- 1651-2081. ; 42:4, s. 296-301
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose:To explore the occurrence of and risk factors for spasticity until six months after first-ever stroke.Methods:Forty-nine patients were examined at day 2-10, at one month, and at six months. The Modified Ashworth Scale (MAS) was used to assess resistance to passive movements. A comprehensive clinical examination was performed to identify other positive signs of the upper motor neuron syndrome, in accordance with a broader definition of spasticity, and to evaluate if spasticity was disabling. Neurological impairments were determined by use of the National Institutes of Health Stroke Scale and global disability by use of the modified Rankin Scale.Results:Spasticity was present in two patients (4%) at day 2-10, in 13 patients (27%) at one month, and in 11 patients (23%) at six months. Severe paresis at day 2-10 was associated with a 10-fold higher risk for spasticity at one month (OR=10, 95% CI 2-48). Disabling spasticity was present  in one patient at one month and in 6 patients (13%) at six months.Conclusions:Spasticity according to MAS usually occurs within one month and disabling spasticity later in a subgroup. Severe paresis of the arm is a risk factor for spasticity.
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42.
  • Lundström, Erik, Docent, 1964-, et al. (författare)
  • Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden
  • 2020
  • Ingår i: Trials. - Uppsala : Springer Science and Business Media LLC. - 1745-6215. ; 21:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological deficits. Patients were randomised to fluoxetine 20 mg or matching placebo capsules once daily for 6 months. Results Seven amendments were made and included clarification of drug interaction between fluoxetine and metoprolol and the use of metoprolol for severe heart failure as an exclusion criterion, inclusion of data from central Swedish registries and the Swedish Stroke Register, changes in informed consent from patients, and clarification of design of some sub-studies. EFFECTS recruited 1500 patients at 35 centres in Sweden between 20 October 2014 and 28 June 2019. We plan to unblind the data in January 2020 and report the primary outcome in May 2020. Conclusion EFFECTS will provide data on the safety and efficacy of 6 months of treatment with fluoxetine after stroke in a Swedish health system setting. The data from EFFECTS will also contribute to an individual patient data meta-analysis.
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43.
  • Lundström, Erik, Docent, 1964- (författare)
  • Update On The Effects Trial Of Fluoxetine For Stroke Recovery : An Investigator-Led Randomised Controlled Study In Sweden
  • 2019
  • Ingår i: European Stroke Journal. - : SAGE Publications. - 2396-9873 .- 2396-9881. ; 4:1 suppl.
  • Tidskriftsartikel (refereegranskat)abstract
    • Background and Aims: Animal studies and several small human studies suggest that fluoxetine improves neurological recovery after stroke. In contrast, the most recent and largest fluoxetine study for stroke recovery (FOCUS trial, N = 3,127) was neutral. This abstract presents un update on EFFECTS, a trial of fluoxetine for stroke recovery.Methods: In this investigator-led, multicentre, parallel group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2-5 days after stroke. Inclusion required a clinical diagnosis of stroke (ischaemic or intracere- bral haemorrhage) with persisting focal neurological deficits. Patients were randomly assigned to fluoxetine 20 mg once daily or placebo cap- sules for 6 months.The primary outcome is functional status, measured with the modified Rankin scale at the 6-month follow-up, using ordinal logistic regression. Results: Recruitment began on 20 October 2014. Half of the 1,500 patients were recruited from 20% of the centres. The results will be available within one year.Conclusions: The data from the trial will improve the external validity and precision of the estimates of the efficacy and safety of fluoxetine in ischaemic and haemorrhagic stroke. Trial registration number: EudraCT 2011-006130-16. Registered on 8 August 2014.ISRCTN, ISRCTN13020412. Registered on 19 December 2014. ClinicalTrials.gov: NCT02683213, retrospectively registered on 2 February 2016
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44.
  • Lundström, Erik, Docent, 1964- (författare)
  • Återinsättning av trombocythämmare RESTART ger oss (nästan) hela svaret
  • 2019
  • Ingår i: Neurologi i sverige.
  • Tidskriftsartikel (populärvet., debatt m.m.)abstract
    • Återinsättning av trombocythämmare efter en spontan intrakraniell blödning ökar inte risken för en ny blödning jämfört med att avstå. Tvärtom. Återinsättning verkar till och med minska risken för framtida blödningar. Det är det oväntade resultatet av RESTART-studien som pre-senterades på den europeiska strokekongressen ESOC i Milano, maj 2019. I denna artikel sammanfattas RESTART av Erik Lundström, överläkare vid Akademiska sjukhuset. Pågåen-de studier (RESTART-Fr och STATICH) kommer sannolikt att kunna ge oss ett definitivt svar på denna viktiga kliniska fråga.
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45.
  • Mair, Grant, et al. (författare)
  • Arterial Obstruction on Computed Tomographic or Magnetic Resonance Angiography and Response to Intravenous Thrombolytics in Ischemic Stroke
  • 2017
  • Ingår i: Stroke. - 0039-2499 .- 1524-4628. ; 48:2, s. 353-360
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND AND PURPOSE: Computed tomographic angiography and magnetic resonance angiography are used increasingly to assess arterial patency in patients with ischemic stroke. We determined which baseline angiography features predict response to intravenous thrombolytics in ischemic stroke using randomized controlled trial data.METHODS: We analyzed angiograms from the IST-3 (Third International Stroke Trial), an international, multicenter, prospective, randomized controlled trial of intravenous alteplase. Readers, masked to clinical, treatment, and outcome data, assessed prerandomization computed tomographic angiography and magnetic resonance angiography for presence, extent, location, and completeness of obstruction and collaterals. We compared angiography findings to 6-month functional outcome (Oxford Handicap Scale) and tested for interactions with alteplase, using ordinal regression in adjusted analyses. We also meta-analyzed all available angiography data from other randomized controlled trials of intravenous thrombolytics.RESULTS: In IST-3, 300 patients had prerandomization angiography (computed tomographic angiography=271 and magnetic resonance angiography=29). On multivariable analysis, more extensive angiographic obstruction and poor collaterals independently predicted poor outcome (P<0.01). We identified no significant interaction between angiography findings and alteplase effect on Oxford Handicap Scale (P≥0.075) in IST-3. In meta-analysis (5 trials of alteplase or desmoteplase, including IST-3, n=591), there was a significantly increased benefit of thrombolytics on outcome (odds ratio>1 indicates benefit) in patients with (odds ratio, 2.07; 95% confidence interval, 1.18-3.64; P=0.011) versus without (odds ratio, 0.88; 95% confidence interval, 0.58-1.35; P=0.566) arterial obstruction (P for interaction 0.017).CONCLUSIONS: Intravenous thrombolytics provide benefit to stroke patients with computed tomographic angiography or magnetic resonance angiography evidence of arterial obstruction, but the sample was underpowered to demonstrate significant treatment benefit or harm among patients with apparently patent arteries.CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518.
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46.
  • Mair, Grant, et al. (författare)
  • Effect of alteplase on the CT hyperdense artery sign and outcome after ischemic stroke.
  • 2016
  • Ingår i: Neurology. - 0028-3878 .- 1526-632X. ; 86:2, s. 118-25
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To investigate whether the location and extent of the CT hyperdense artery sign (HAS) at presentation affects response to IV alteplase in the randomized controlled Third International Stroke Trial (IST-3).METHODS: All prerandomization and follow-up (24-48 hours) CT brain scans in IST-3 were assessed for HAS presence, location, and extent by masked raters. We assessed whether HAS grew, persisted, shrank, or disappeared at follow-up, the association with 6-month functional outcome, and effect of alteplase. IST-3 is registered (ISRCTN25765518).RESULTS: HAS presence (vs absence) independently predicted poor 6-month outcome (increased Oxford Handicap Scale [OHS]) on adjusted ordinal regression analysis (odds ratio [OR] 0.66, p < 0.001). Outcome was worse in patients with more (vs less) extensive HAS (OR 0.61, p = 0.027) but not in proximal (vs distal) HAS (p = 0.420). Increasing age was associated with more HAS growth at follow-up (OR 1.01, p = 0.013). Treatment with alteplase increased HAS shrinkage/disappearance at follow-up (OR 0.77, p = 0.006). There was no significant difference in HAS shrinkage with alteplase in proximal (vs distal) or more (vs less) extensive HAS (p = 0.516 and p = 0.580, respectively). There was no interaction between presence vs absence of HAS and benefit of alteplase on 6-month OHS (p = 0.167).CONCLUSIONS: IV alteplase promotes measurable reduction in HAS regardless of HAS location or extent. Alteplase increased independence at 6 months in patients with and without HAS.CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients within 6 hours of ischemic stroke with a CT hyperdense artery sign, IV alteplase reduced intra-arterial hyperdense thrombus.
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47.
  • Mead, Gillian E., et al. (författare)
  • Fluoxetine for stroke recovery : Meta-analysis of randomized controlled trials
  • 2020
  • Ingår i: International Journal of Stroke. - : SAGE Publications. - 1747-4930 .- 1747-4949. ; 15:4, s. 365-376
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To determine whether fluoxetine, at any dose, given within the first year after stroke to patients who did not have to have mood disorders at randomization reduced disability, dependency, neurological deficits and fatigue; improved motor function, mood, and cognition at the end of treatment and follow-up, with the same number or fewer adverse effects.METHODS: Searches (from 2012) in July 2018 included databases, trials registers, reference lists, and contact with experts. Co-primary outcomes were dependence and disability. Dichotomous data were synthesized using risk ratios (RR) and continuous data using standardized mean differences (SMD). Quality was appraised using Cochrane risk of bias methods. Sensitivity analyses explored influence of study quality.RESULTS: The searches identified 3414 references of which 499 full texts were assessed for eligibility. Six new completed RCTs (n = 3710) were eligible, and were added to the seven trials identified in a 2012 Cochrane review (total: 13 trials, n = 4145). There was no difference in the proportion independent (3 trials, n = 3249, 36.6% fluoxetine vs. 36.7% control; RR 1.00, 95% confidence interval 0.91 to 1.09, p = 0.99, I2 = 78%) nor in disability (7 trials n = 3404, SMD 0.05, -0.02 to 0.12 p = 0.15, I2 = 81%) at end of treatment. Fluoxetine was associated with better neurological scores and less depression. Among the four (n = 3283) high-quality RCTs, the only difference between groups was lower depression scores with fluoxetine.CONCLUSION: This class I evidence demonstrates that fluoxetine does not reduce disability and dependency after stroke but improves depression.
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48.
  • Mead, Gillian Elizabeth, et al. (författare)
  • Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke : statistical analysis plan for the trials and for the individual patient data meta-analysis
  • 2020
  • Ingår i: Trials. - : Springer Nature. - 1745-6215. ; 21:1
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundThree large trials of fluoxetine for stroke recovery (FOCUS (fluoxetine or control under supervision), AFFINITY (the Assessment oF FluoxetINe In sTroke recovery) and EFFECTS (Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke)) have been collaboratively designed with the same basic protocol to facilitate an individual patient data analysis (IPDM). The statistical analysis plan for the three individual trials has already been reported in Trials, including a brief description of the IPDM. In this protocol, we describe in detail how we will perform the IPDM.Methods/designData from EFFECTS and AFFINITY will be transferred securely to the FOCUS statistician, who will perform a one-stage IPDM and a two-stage IPDM. For the one-stage IPDM, data will be combined into a single data set and the same analyses performed as described for the individual trials. For the two-stage IPDM, the results for the three individual trials will be combined using fixed effects meta-analyses.The primary and secondary outcome domains for the IPDM are the same as for individual trials. We will also perform analyses according to several subgroups including country of recruitment, ethnicity and trial. We will also explore the effects of fluoxetine on our primary and secondary outcomes in subgroups defined by combinations of characteristics.We also describe additional research questions that will be addressed using the combined data set, and published subsequently, including predictors of important post-stroke problems such as seizures, low mood and bone fractures.DiscussionAn IPDM of our three large trials of fluoxetine for stroke recovery will allow us to provide the most precise estimates of any risks and benefits of fluoxetine vs placebo, to detect reliably a smaller overall effect size than those detectable by the individual trials, to better determine the effects of fluoxetine vs placebo in subgroups of patients and outcomes and to broaden the generalisability of the results. Also, we may identify differences in treatment effects between studies.Trial registrationFOCUS: 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.
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49.
  • Roaldsen, M.B., et al. (författare)
  • Safety and efficacy of tenecteplase in patients with wake-up stroke assessed by non-contrast CT (TWIST): a multicentre, open-label, randomised controlled trial
  • 2023
  • Ingår i: The Lancet Neurology. - 1474-4422 .- 1474-4465. ; 22:2, s. 117-126
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Current evidence supports the use of intravenous thrombolysis with alteplase in patients with wake-up stroke selected with MRI or perfusion imaging and is recommended in clinical guidelines. However, access to advanced imaging techniques is often scarce. We aimed to determine whether thrombolytic treatment with intravenous tenecteplase given within 4·5 h of awakening improves functional outcome in patients with ischaemic wake-up stroke selected using non-contrast CT. Methods: TWIST was an investigator-initiated, multicentre, open-label, randomised controlled trial with blinded endpoint assessment, conducted at 77 hospitals in ten countries. We included patients aged 18 years or older with acute ischaemic stroke symptoms upon awakening, limb weakness, a National Institutes of Health Stroke Scale (NIHSS) score of 3 or higher or aphasia, a non-contrast CT examination of the head, and the ability to receive tenecteplase within 4·5 h of awakening. Patients were randomly assigned (1:1) to either a single intravenous bolus of tenecteplase 0·25 mg per kg of bodyweight (maximum 25 mg) or control (no thrombolysis) using a central, web-based, computer-generated randomisation schedule. Trained research personnel, who conducted telephone interviews at 90 days (follow-up), were masked to treatment allocation. Clinical assessments were performed on day 1 (at baseline) and day 7 of hospital admission (or at discharge, whichever occurred first). The primary outcome was functional outcome assessed by the modified Rankin Scale (mRS) at 90 days and analysed using ordinal logistic regression in the intention-to-treat population. This trial is registered with EudraCT (2014–000096–80), ClinicalTrials.gov (NCT03181360), and ISRCTN (10601890). Findings: From June 12, 2017, to Sept 30, 2021, 578 of the required 600 patients were enrolled (288 randomly assigned to the tenecteplase group and 290 to the control group [intention-to-treat population]). The median age of participants was 73·7 years (IQR 65·9–81·1). 332 (57%) of 578 participants were male and 246 (43%) were female. Treatment with tenecteplase was not associated with better functional outcome, according to mRS score at 90 days (adjusted OR 1·18, 95% CI 0·88–1·58; p=0·27). Mortality at 90 days did not significantly differ between treatment groups (28 [10%] patients in the tenecteplase group and 23 [8%] in the control group; adjusted HR 1·29, 95% CI 0·74–2·26; p=0·37). Symptomatic intracranial haemorrhage occurred in six (2%) patients in the tenecteplase group versus three (1%) in the control group (adjusted OR 2·17, 95% CI 0·53–8·87; p=0·28), whereas any intracranial haemorrhage occurred in 33 (11%) versus 30 (10%) patients (adjusted OR 1·14, 0·67–1·94; p=0·64). Interpretation: In patients with wake-up stroke selected with non-contrast CT, treatment with tenecteplase was not associated with better functional outcome at 90 days. The number of symptomatic haemorrhages and any intracranial haemorrhages in both treatment groups was similar to findings from previous trials of wake-up stroke patients selected using advanced imaging. Current evidence does not support treatment with tenecteplase in patients selected with non-contrast CT. Funding: Norwegian Clinical Research Therapy in the Specialist Health Services Programme, the Swiss Heart Foundation, the British Heart Foundation, and the Norwegian National Association for Public Health. © 2023 Elsevier Ltd
  •  
50.
  • Rudberg, Ann-Sofie, et al. (författare)
  • Long-term health-related quality of life, survival and costs by different levels of functional outcome six months after stroke
  • 2018
  • Ingår i: European Stroke Journal. - : SAGE PUBLICATIONS LTD. - 2396-9873 .- 2396-9881. ; 3:2, s. 157-164
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Information about the impact of functional outcome after stroke is currently missing on health-related quality of life, survival and costs. This information would be valuable for health economic evaluations and for allocation of resources in stroke health care. Patients and methods: Data on 297 Swedish patients included in the Third International Stroke Trial were analysed including functional outcome at six months (measured by Oxford Handicap Scale), health-related quality of life up to 18 months (EQ-5D-3L) and survival up to 36 months. We used record linkage to collect data on costs up to 36 months, using national patient registers. Results: Patients with a better functional outcome level at six months had a significantly better health-related quality of life at 18 months (p<0.05), better long-term survival (p<0.05) and lower costs (p<0.001), for all time points up to 36 months. The difference in costs was mainly due to differences in days spent in hospital (p<0.005). Discussion: This study showed an association between functional outcome at six months and health-related quality of life up to 18 months, and costs up to 36 months. Conclusion: Functional outcome six months after stroke is an important determinant of health-related quality of life, survival and costs over 36 months. Effective interventions aimed at reducing short-term disability levels are therefore also expected to reduce the overall burden of stroke.
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