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1.
Trials ; 21(1): 388, 2020 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-32381037

RESUMO

Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.

2.
Trials ; 21(1): 233, 2020 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-32111264

RESUMO

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. TRIAL REGISTRATION: 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.

3.
Cochrane Database Syst Rev ; 2019(11)2019 11 26.
Artigo em Inglês | MEDLINE | ID: mdl-31769878

RESUMO

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.

4.
Trials ; 20(1): 618, 2019 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-31666093

RESUMO

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. TRIAL REGISTRATION: The protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID 64 ). The EFFECTS study has EudraCT number 2011-006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number NCT02683213 .

5.
Intern Med J ; 2019 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-31707750

RESUMO

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. This article is protected by copyright. All rights reserved.

6.
Scand J Pain ; 20(1): 125-138, 2019 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-31584875

RESUMO

It has been suggested that alterations in inflammation molecules maintain chronic pain although little is known about how these factors influence homeostatic and inflammatory events in common chronic pain conditions. Nonpharmacological interventions might be associated with alterations in inflammation markers in blood. This study of patients with chronic pain investigates whether an interdisciplinary multimodal rehabilitation program (IMMRP) was associated with significant alterations in the plasma pattern of 68 cytokines/chemokines 1 year after rehabilitation and whether such changes were associated with clinical changes. Blood samples and self-reports of pain, psychological distress, and physical activity of 25 complex chronic pain patients were collected pre-IMMRP and at 12-month follow-up. Analyses of inflammatory proteins (cytokines/chemokines/growth factors) were performed directly in plasma using the multiplex immunoassay technology Meso Scale Discovery. This explorative pilot study found that 12 substances, mainly pro-inflammatory, decreased after IMMRP. In two other relatively small IMMRP studies, four of these proinflammatory markers were also associated with decreases. The pattern of cytokines/chemokines pre-IMMRP was associated with changes in psychological distress but not with pain or physical activity. The present study cannot impute cause and effect. These results together with the results of the two previous IMMRP studies suggest that there is a need for larger and more strictly controlled studies of IMMRP with respect to inflammatory markers in blood. Such studies need to consider responders/non-responders, additional therapies, involved pain mechanisms and diagnoses. This and the two other studies open up for developing biologically measurable outcomes from plasma. Such biomarkers will be an important tool for further development of IMMRP and possibly other treatments for patients w ith chronic pain.

7.
Int J Stroke ; : 1747493019879655, 2019 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-31619137

RESUMO

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.

8.
Stroke ; 50(11): 3280-3282, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31426731

RESUMO

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.

9.
BMJ Open ; 8(4): e019749, 2018 04 19.
Artigo em Inglês | MEDLINE | ID: mdl-29674367

RESUMO

OBJECTIVES: We examined trends of diagnosis-specific work disability before and after ischaemic heart disease (IHD). DESIGN: Participants were followed 4 years before and 4 years after an IHD event for diagnosis-specific work disability (sickness absence and disability pension). SETTING AND PARTICIPANTS: A Swedish population-based cohort study using register data on all individuals aged 25-60 years, living in Sweden, and who suffered their first IHD event in 2006-2008 (n=23 971) was conducted. RESULTS: Before the event, the most common diagnoses of work disability were musculoskeletal disorders (21 annual days for men and 44 for women) and mental disorders (19 men and 31 for women). After multivariable adjustments, we observed a fivefold increase (from 12 to 60 days) in work disability due to diseases of the circulatory system in the first postevent year compared with the last pre-event year among men. Among women, the corresponding increase was fourfold (from 14 to 62 days). By the second postevent year, the number of work disability days decreased significantly compared with the first postevent year among both sexes (to 19 days among men and 23 days among women). Among women, mean days of work disability due to diseases of the circulatory system remained at a higher level than among men during the postevent years. Work disability risk after versus before an IHD event was slightly higher among men (rate ratio (RR) 2.49; 95% CI 2.36 to 2.62) than among women (RR 2.29, 95% CI 2.12 to 2.49). When pre-event long-term work disability was excluded, diseases of the circulatory system were the most prevalent diagnosis for work disability after an IHD event among both men and women. CONCLUSIONS: An IHD event was strongly associated with an increase in work disability due to diseases of the circulatory system, especially among men and particularly in the first postevent year.


Assuntos
Pessoas com Deficiência , Transtornos Mentais , Doenças Musculoesqueléticas , Isquemia Miocárdica , Licença Médica , Adulto , Estudos de Coortes , Feminino , Humanos , Masculino , Transtornos Mentais/epidemiologia , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/epidemiologia , Isquemia Miocárdica/complicações , Isquemia Miocárdica/fisiopatologia , Pensões , Fatores de Risco , Licença Médica/estatística & dados numéricos , Suécia/epidemiologia
10.
Trials ; 19(1): 14, 2018 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-29310679

RESUMO

BACKGROUND: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. METHODS: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. DISCUSSION: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke. TRIAL REGISTRATIONS: The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.


Assuntos
Contratos , Fluoxetina/administração & dosagem , Seleção de Pacientes , Pesquisadores/psicologia , Inibidores de Captação de Serotonina/administração & dosagem , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/terapia , Telecomunicações , Fluoxetina/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Recuperação de Função Fisiológica , Tamanho da Amostra , Inibidores de Captação de Serotonina/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Reabilitação do Acidente Vascular Cerebral/efeitos adversos , Suécia , Fatores de Tempo , Resultado do Tratamento
11.
J Am Heart Assoc ; 7(1)2018 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-29301760

RESUMO

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.


Assuntos
Absenteísmo , Saúde do Trabalhador/tendências , Licença Médica/tendências , Acidente Vascular Cerebral/diagnóstico , Sobreviventes , Avaliação da Capacidade de Trabalho , Adulto , Feminino , Nível de Saúde , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/fisiopatologia , Acidente Vascular Cerebral/psicologia , Sobreviventes/psicologia , Suécia/epidemiologia , Fatores de Tempo
12.
Eur Stroke J ; 3(2): 157-164, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31008347

RESUMO

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.

13.
Trials ; 18(1): 627, 2017 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-29282099

RESUMO

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. TRIAL REGISTRATION: FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011. EFFECTS: ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.


Assuntos
Fluoxetina/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Interpretação Estatística de Dados , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
BMJ Open ; 7(9): e017910, 2017 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-28965101

RESUMO

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.


Assuntos
Avaliação da Deficiência , Pessoas com Deficiência/estatística & dados numéricos , Isquemia Miocárdica/fisiopatologia , Acidente Vascular Cerebral/fisiopatologia , Adulto , Comorbidade , Emprego/estatística & dados numéricos , Feminino , Humanos , Modelos Lineares , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Pensões/estatística & dados numéricos , Sistema de Registros , Fatores Sexuais , Suécia/epidemiologia
15.
J Stroke Cerebrovasc Dis ; 26(10): 2264-2271, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28601259

RESUMO

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.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/tratamento farmacológico , Terapia Trombolítica , Tomografia Computadorizada por Raios X , Idoso , Alberta , Isquemia Encefálica/mortalidade , Hemorragia Cerebral/diagnóstico por imagem , Hemorragia Cerebral/etiologia , Hemorragia Cerebral/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Sistema de Registros , Índice de Gravidade de Doença , Acidente Vascular Cerebral/mortalidade , Centros de Atenção Terciária , Fatores de Tempo , Tomografia Computadorizada por Raios X/métodos , Resultado do Tratamento
16.
Stroke ; 48(5): 1256-1261, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28386043

RESUMO

BACKGROUND AND PURPOSE: We assessed the feasibility of obtaining diagnostic quality images of the heart and thoracic aorta by extending the z axis coverage of a non-ECG-gated computed tomographic angiogram performed in the primary evaluation of acute stroke without increasing the contrast dose. METHODS: Twenty consecutive patients with acute ischemic stroke within the 4.5 hours of symptom onset were prospectively recruited. We increased the longitudinal coverage to the domes of the diaphragm to include the heart. Contrast administration (Omnipaque 350) remained unchanged (injected at 3-4 mL/s; total 60-80 mL, triggered by bolus tracking). Images of the heart and aorta, reconstructed at 5 mm slice thickness in 3 orthogonal planes, were read by a radiologist and cardiologist, findings conveyed to the treating neurologist, and correlated with the transthoracic or transesophageal echocardiogram performed within the next 24 hours. RESULTS: Of 20 patients studied, 3 (15%) had abnormal findings: a left ventricular thrombus, a Stanford type A aortic dissection, and a thrombus of the left atrial appendage. Both thrombi were confirmed by transesophageal echocardiography, and anticoagulation was started urgently the following day. None of the patients developed contrast-induced nephropathy on follow-up. The radiation dose was slightly increased from a mean of 4.26 mSV (range, 3.88-4.70 mSV) to 5.17 (range, 3.95 to 6.25 mSV). CONCLUSIONS: Including the heart and ascending aorta in a routine non-ECG-gated computed tomographic angiogram enhances an existing imaging modality, with no increased incidence of contrast-induced nephropathy and minimal increase in radiation dose. This may help in the detection of high-risk cardiac and aortic sources of embolism in acute stroke patients.


Assuntos
Aneurisma Dissecante/diagnóstico por imagem , Aneurisma Aórtico/diagnóstico por imagem , Isquemia Encefálica/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Cardiopatias/diagnóstico por imagem , Acidente Vascular Cerebral/diagnóstico por imagem , Trombose/diagnóstico por imagem , Idoso , Aorta Torácica/diagnóstico por imagem , Apêndice Atrial/diagnóstico por imagem , Isquemia Encefálica/etiologia , Meios de Contraste , Ecocardiografia Transesofagiana , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Iohexol , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Acidente Vascular Cerebral/etiologia , Trombose/complicações
17.
Sci Rep ; 7(1): 1142, 2017 04 25.
Artigo em Inglês | MEDLINE | ID: mdl-28442715

RESUMO

We examined the trajectories of work disability before and after IHD and stroke events. New IHD (n = 13521) and stroke (n = 7162) cases in 2006-2008 were retrieved from nationwide Swedish hospital records and their annual work disability days five years before and after the date of diagnosis were retrieved from a nationwide disability register. There was no pre-event differences in disability days between the IHD and stroke cases and five years prior to the event, they were close to those observed in the general population. In the first post-event year, the adjusted mean days increased to 83.9 (95% CI 80.6-86.5) in IHD; to 179.5 (95% CI 172.4-186.8) in stroke, a six-fold increase in IHD and 14-fold in stroke. Work disability leveled off among the IHD cases but not among those who had stroke. The highest disability levels for the fifth post-event year after a stroke event was associated with pre-existing diabetes (146.9), mental disorder (141.2), non-employment (137.0), and immigrant status (117.9). In a working-age population, the increase in work disability after a cardiovascular event decreases close to the pre-event level in IHD but remains particularly high after stroke; among patients with comorbid depression or diabetes, immigrants, and those not in employment.


Assuntos
Pessoas com Deficiência , Emprego , Isquemia Miocárdica/complicações , Isquemia Miocárdica/epidemiologia , Humanos , Seguro , Sistema de Registros , Suécia/epidemiologia
18.
J Thromb Thrombolysis ; 44(1): 104-111, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28220330

RESUMO

A cardiocerebral ischemic attack (CCI) or a concurrent acute ischemic stroke (AIS) and myocardial infarction (AMI) is a severe event with no clear recommendations for ideal management because of the rarity of the scenario. The narrow time window for treatment and complexity of the treatment decision puts immense pressure on the treating physician. We evaluated this challenging situation at our tertiary center. Using our prospective stroke database out of a total of 555 patients with acute ischemic stroke between 2009 and 2014, we identified five consecutive cases with CCI (incidence 0.009%). Demography, risk factor characteristics, vascular occlusions and treatment approach were recorded. Good functional outcome was defined by the modified Rankin scale (mRS) score of 0-2 points. Out of five patients, AIS was treated with endovascular treatment in three cases, while two were treated with intravenous thrombolysis only. One out of three patients had embolectomy of the brain performed prior to the coronary intervention, while the other two patients underwent coronary intervention first. One patient developed sudden cardiac arrest on day-2 and passed away. CCI is an uncommon and devastating clinical scenario, further research is needed for the ideal management strategy that provides the best outcomes. However, the rarity of the disease does not lend itself to the conduct of a trial easily. We have proposed a considered treatment algorithm based on the current literature and our experience.


Assuntos
Algoritmos , Infarto Cerebral , Infarto do Miocárdio , Intervenção Coronária Percutânea , Fatores Etários , Infarto Cerebral/complicações , Infarto Cerebral/diagnóstico , Infarto Cerebral/epidemiologia , Infarto Cerebral/cirurgia , Feminino , Humanos , Masculino , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/cirurgia , Fatores de Risco
19.
Lancet Neurol ; 15(10): 1028-34, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27450474

RESUMO

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.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/mortalidade , Fibrinolíticos/farmacologia , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/mortalidade , Ativador de Plasminogênio Tecidual/farmacologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Fibrinolíticos/efeitos adversos , Seguimentos , Humanos , Masculino , Análise de Sobrevida , Ativador de Plasminogênio Tecidual/efeitos adversos
20.
Acta Neurochir (Wien) ; 158(2): 233-9, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26676517

RESUMO

BACKGROUND: Returning to work is a major issue for patients having had an aneurysmal subarachnoid hemorrhage (SAH). It is important, at an early stage, to identify the patients that are unlikely to return to work. The objective of this study was to assess the predictive value of the Montreal Cognitive Assessment (MoCA) at 6 months after ictus on return to work at 12 months. METHODS: In this prospective study were 96 patients with SAH included in the acute phase. Cognitive functions were assessed at 6 months using the MoCA and return to work at 12 months. The predictive value of MoCA on return to work was analyzed using the area under the receiver operating characteristic curve as well as logistic regression. RESULTS: Of those that had work before the SAH, 52 % were working at 12 months after the ictus. These patients had scored significantly better on MoCA at 6 months (p = 0.01). The area under the receiver operating characteristic curve was 0.75. By using a cut-off on MoCA of <27, 68 % of the patients could be correctly classified as returned/not returned to work. Adding data from the acute phase to the MoCA in a logistic regression model increased the percentage of patients correctly classified as returned/not returned to work by 2 %. CONCLUSIONS: Returning to work is a major issue for SAH patients. It is important to identify factors that may interfere with a patient's ability to return to work, and address these issues appropriately. In our study, estimating cognitive functions at 6 months after SAH using the MoCA alone allowed us to predict return to work correctly in 68 % of the cases. We feel that this provides useful information in planning rehabilitation, but that other post-SAH symptoms have to be considered as well.


Assuntos
Transtornos Cognitivos/psicologia , Testes Neuropsicológicos , Retorno ao Trabalho/psicologia , Retorno ao Trabalho/estatística & dados numéricos , Hemorragia Subaracnóidea/psicologia , Idoso , Cognição , Transtornos Cognitivos/etiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Curva ROC , Hemorragia Subaracnóidea/complicações , Hemorragia Subaracnóidea/cirurgia , Resultado do Tratamento
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