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1.
Int J Stroke ; 14(7): 678-685, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-30961463

RESUMO

BACKGROUND: Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. METHODS: Comparisons were made of baseline and outcome data between patients with acute ischemic stroke (AIS) recruited into the alteplase-dose arm of the international, multi-center, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) in the United Kingdom (UK), and alteplase-treated AIS patients registered in the UK Sentinel Stroke National Audit Programme (SSNAP) registry, over the study period June 2012 to October 2015. RESULTS: There were 770 AIS patients (41.2% female; mean age 72 years) included in ENCHANTED at sites in England and Wales, which was 19.5% of alteplase-treated AIS patients registered in the SSNAP registry. Trial participants were significantly older, had lower baseline neurological severity, less likely Asian, and had more premorbid symptoms, hypertension and atrial fibrillation. Although ENCHANTED participants had higher rates of symptomatic intracerebral hemorrhage than those in SSNAP, there were no differences in onset-to-treatment time, levels of disability (assessed by the modified Rankin scale) at hospital discharge, and mortality over 90 days between groups. CONCLUSIONS: Despite the high level of participation, equipoise over the dose of alteplase among UK clinician investigators favored the inclusion of older, frailer, milder AIS patients in the ENCHANTED trial. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616.

2.
J Hum Hypertens ; 33(5): 411-418, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30894658

RESUMO

The Head Positioning in Acute Stroke Trial (HeadPoST) is a pragmatic, international, cluster crossover randomized trial of 11,093 patients with acute stroke assigned to a lying-flat (0°) or sitting-up (head elevated ≥30°) position. This post hoc analysis aimed to determine the association between blood pressure variability (BPV) and outcomes for patients from a wide range of international clinical settings and how the association was modified by randomized head position. BPV was defined according to the standard criteria, with the key parameter considered the coefficient of variation (CV) of systolic BP (SBP) over 24 h. Outcome was ordinal 90-day Modified Rankin Scale (mRS) score. The association was analyzed by ordinal, logistic regression, hierarchical, mixed models with fixed intervention (lying flat vs. sitting up), and fixed period, random cluster, and random cluster-period, effects. Nine thousand one hundred and fifty six (8324 acute ischemic stroke and 817 intracerebral hemorrhage; mean age 68.1 years; 39.2% women) were included in the analysis. CV of SBP had a significant linear association with unfavorable shift of mRS at 90 days (adjusted odds ratio 1.06, 95% confidence interval 1.02-1.11; P = 0.01). There was no heterogeneity of the association by randomized head positioning. In addition, CV of diastolic BP (DBP) (1.08, 1.03-1.12; P = 0.001) over 24 h post stroke was significantly associated with 3-month poor outcome. The association was more apparent in sitting-up position (1.12, 1.06-1.19) compared with lying-flat position (1.03, 0.98-1.09) (P interaction = 0.005). BPV was associated with adverse stroke outcome, and the magnitude of the association was greater with sitting-up head positioning in terms of DBP variability.

3.
Lancet ; 393(10174): 877-888, 2019 03 02.
Artigo em Inglês | MEDLINE | ID: mdl-30739745

RESUMO

BACKGROUND: Systolic blood pressure of more than 185 mm Hg is a contraindication to thrombolytic treatment with intravenous alteplase in patients with acute ischaemic stroke, but the target systolic blood pressure for optimal outcome is uncertain. We assessed intensive blood pressure lowering compared with guideline-recommended blood pressure lowering in patients treated with alteplase for acute ischaemic stroke. METHODS: We did an international, partial-factorial, open-label, blinded-endpoint trial of thrombolysis-eligible patients (age ≥18 years) with acute ischaemic stroke and systolic blood pressure 150 mm Hg or more, who were screened at 110 sites in 15 countries. Eligible patients were randomly assigned (1:1, by means of a central, web-based program) within 6 h of stroke onset to receive intensive (target systolic blood pressure 130-140 mm Hg within 1 h) or guideline (target systolic blood pressure <180 mm Hg) blood pressure lowering treatment over 72 h. The primary outcome was functional status at 90 days measured by shift in modified Rankin scale scores, analysed with unadjusted ordinal logistic regression. The key safety outcome was any intracranial haemorrhage. Primary and safety outcome assessments were done in a blinded manner. Analyses were done on intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01422616. FINDINGS: Between March 3, 2012, and April 30, 2018, 2227 patients were randomly allocated to treatment groups. After exclusion of 31 patients because of missing consent or mistaken or duplicate randomisation, 2196 alteplase-eligible patients with acute ischaemic stroke were included: 1081 in the intensive group and 1115 in the guideline group, with 1466 (67·4%) administered a standard dose among the 2175 actually given intravenous alteplase. Median time from stroke onset to randomisation was 3·3 h (IQR 2·6-4·1). Mean systolic blood pressure over 24 h was 144·3 mm Hg (SD 10·2) in the intensive group and 149·8 mm Hg (12·0) in the guideline group (p<0·0001). Primary outcome data were available for 1072 patients in the intensive group and 1108 in the guideline group. Functional status (mRS score distribution) at 90 days did not differ between groups (unadjusted odds ratio [OR] 1·01, 95% CI 0·87-1·17, p=0·8702). Fewer patients in the intensive group (160 [14·8%] of 1081) than in the guideline group (209 [18·7%] of 1115) had any intracranial haemorrhage (OR 0·75, 0·60-0·94, p=0·0137). The number of patients with any serious adverse event did not differ significantly between the intensive group (210 [19·4%] of 1081) and the guideline group (245 [22·0%] of 1115; OR 0·86, 0·70-1·05, p=0·1412). There was no evidence of an interaction of intensive blood pressure lowering with dose (low vs standard) of alteplase with regard to the primary outcome. INTERPRETATION: Although intensive blood pressure lowering is safe, the observed reduction in intracranial haemorrhage did not lead to improved clinical outcome compared with guideline treatment. These results might not support a major shift towards this treatment being applied in those receiving alteplase for mild-to-moderate acute ischaemic stroke. Further research is required to define the underlying mechanisms of benefit and harm resulting from early intensive blood pressure lowering in this patient group. FUNDING: National Health and Medical Research Council of Australia; UK Stroke Association; Ministry of Health and the National Council for Scientific and Technological Development of Brazil; Ministry for Health, Welfare, and Family Affairs of South Korea; Takeda.


Assuntos
Pressão Sanguínea/efeitos dos fármacos , Isquemia Encefálica/tratamento farmacológico , Fibrinolíticos/administração & dosagem , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/administração & dosagem , Administração Intravenosa , Idoso , Austrália/epidemiologia , Pressão Sanguínea/fisiologia , Isquemia Encefálica/patologia , Brasil/epidemiologia , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Hemorragias Intracranianas/epidemiologia , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , República da Coreia/epidemiologia , Ativador de Plasminogênio Tecidual/uso terapêutico , Resultado do Tratamento
4.
Lancet ; 392(10154): 1269-1278, 2018 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-30319114

RESUMO

Along with the rising global burden of disability attributed to stroke, costs of stroke care are rising, providing the impetus to direct our research focus towards effective measures of stroke prevention. In this Series paper, we discuss strategies for reducing the risk of the emergence of disease (primordial prevention), preventing the onset of disease (primary prevention), and preventing the recurrence of disease (secondary prevention). Our focus includes global strategies and campaigns, and measurements of the effectiveness of worldwide preventive interventions, with an emphasis on low-income and middle-income countries. Our findings reveal that effective tobacco control, adequate nutrition, and development of healthy cities are important strategies for primordial prevention, whereas polypill strategies, use of mobile technology (mHealth), along with salt reduction and other dietary interventions, are effective in the primary prevention of stroke. An effective collaboration between various health-care sectors, government policies, and campaigns can successfully implement secondary prevention strategies, through surveillance and registries, such as the WHO's non-communicable diseases programmes, across high-income and low-income countries.


Assuntos
Carga Global da Doença , Acidente Vascular Cerebral/prevenção & controle , Países em Desenvolvimento , Promoção da Saúde , Humanos , Prevenção Primária , Medição de Risco , Fatores de Risco , Prevenção Secundária , Acidente Vascular Cerebral/epidemiologia , Organização Mundial da Saúde
5.
Int J Stroke ; : 1747493018790076, 2018 Jul 25.
Artigo em Inglês | MEDLINE | ID: mdl-30044209

RESUMO

Background Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. Aims This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients', carers', and providers' perspectives. Methods Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. Results Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients' motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. Conclusion Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development.

6.
Clin Rehabil ; 32(8): 1086-1097, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29843517

RESUMO

OBJECTIVE: To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. DESIGN: Non-funded, pilot randomized controlled trial of intervention versus usual care. SETTING: International, multicentre, community-based. PARTICIPANTS: Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. INTERVENTIONS: Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. MAIN MEASURES: Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. RESULTS: In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). CONCLUSION: Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

7.
Cerebrovasc Dis ; 45(5-6): 213-220, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29705803

RESUMO

BACKGROUND: Debate exists as to whether statin pretreatment confers an increased risk of 90-day mortality and symptomatic intracranial haemorrhage (sICH) in acute ischaemic stroke (AIS) patients treated with intravenous thrombolysis. We assessed the effects of undifferentiated lipid-lowering pretreatment on outcomes and interaction with low-dose versus standard-dose alteplase in a post hoc subgroup -analysis of the Enhanced Control of Hypertension and Thrombolysis Stroke Study. METHODS: In all, 3,284 thrombolysis-eligible AIS patients (mean age 66.6 years; 38% women), with information on lipid-lowering pretreatment, were randomly assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) intravenous alteplase within 4.5 h of symptom onset. Of the total number of patients, 615 (19%) received statin or other lipid-lowering pretreatment. The primary clinical outcome was combined endpoint of death or disability (modified Rankin Scale scores 2-6) at 90 days. RESULTS: Compared with patients with no lipid-lowering pretreatment, those with lipid-lowering pretreatment were significantly older, more likely to be non-Asian and more likely to have a medical history including vascular co-morbidity. After propensity analysis assessment and adjustment for important baseline variables at the time of randomisation, as well as imbalances in management during the first 7 days of hospital admission, there were no significant differences in mortality (OR 0.85; 95% CI 0.58-1.25, p = 0.42), or in overall -90-day death and disability (OR 0.85, 95% CI 0.67-1.09, p = 0.19), despite a significant decrease in sICH among those with -lipid-lowering pretreatment according to the European Co-operative Acute Stroke Study 2 definition (OR 0.49, 95% CI 0.28-0.83, p = 0.009). No differences in key efficacy or safety outcomes were seen in patients with and without lipid-lowering pretreatment between low- and standard-dose alteplase arms. CONCLUSIONS: Lipid-lowering pretreatment is not associated with adverse outcome in AIS patients treated with intravenous alteplase, whether assessed by 90-day death and disability or death alone.

8.
Int J Stroke ; 13(2): 129-137, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29148963

RESUMO

Background Most stroke research is conducted in high income countries, yet most stroke occurs in low- and middle-income countries. There is an urgent need to build stroke research capacity in low- and middle-income countries. Aims To review the global health literature on how to improve research capacity in low- and middle-income countries, provide additional data from the recently completed ATTEND Trial and provide examples from our own experience. Summary of review The main themes from our literature review were: manpower and workload, research training, research question and methodology and research funding. The literature and our own experience emphasized the importance of local stakeholders to ensure that the research was appropriate, that there were robust local ethics and regulatory processes, and research was conducted by trained personnel. Research training opportunities can be developed locally, or internationally, with many international schemes available to help support new researchers from low- and middle-income country settings. International collaboration can successfully leverage funding from high income countries that not only generate data for the local country, but also provide new data appropriate to high income countries. Conclusions Building stroke research capacity in low- and middle-income countries will be vital in improving global health given the huge burden of stroke in these countries.

9.
JAMA Neurol ; 74(11): 1328-1335, 2017 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28973174

RESUMO

Importance: A lower dose of intravenous alteplase appears to be a safer treatment option than the standard dose, reducing the risk of symptomatic intracerebral hemorrhage. There is uncertainty, however, over how this effect translates into an overall clinical benefit for patients with acute ischemic stroke (AIS). Objective: To assess whether older, Asian, or severely affected patients with AIS who are considered at high risk of thrombolysis may benefit more from low-dose rather than standard-dose alteplase treatment. Design, Setting, and Participants: This study is a prespecified secondary analysis of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED), an international, randomized, open-label, blinded, end-point clinical trial of low-dose vs standard-dose intravenous alteplase for patients with AIS. From March 1, 2012, to August 31, 2015, a total of 3310 patients who had a clinical diagnosis of AIS as confirmed by brain imaging and who fulfilled the local criteria for thrombolysis treatment were included in the alteplase-dose arms. Patients were randomly assigned to receive low-dose (0.6 mg/kg; 15% as bolus and 85% as infusion over 1 hour) or standard-dose (0.9 mg/kg; 10% as bolus and 90% as infusion over 1 hour) alteplase. Of the 3310 randomized patients, 13 patients were excluded for missing consent, mistaken randomization, and duplicate randomization numbers. This secondary analysis was conducted between May 1, 2016, and April 28, 2017. Main Outcomes and Measures: The primary end point was a poor outcome defined by the combination of death and any disability as scored by the modified Rankin Scale (scores range from 2 to 6, with the highest score indicating death) at 90 days. Results: Of the 3297 patients included in the analysis, 1248 (37.9%) were women, and the mean (SD) age was 67 (13) years. No significant differences in the treatment effects were observed between low- and standard-dose alteplase for poor outcomes (death or disability) by age, ethnicity, or severity (all P > .37 for interaction). Similarly, the treatment effects of low- vs standard-dose alteplase on function outcome (ordinal shift of the modified Rankin Scale) in Asians (odds ratio, 1.05; 95% CI, 0.90-1.22) was consistent with non-Asians (odds ratio, 0.93; 95% CI, 0.76-1.14) (P = .32 for interaction). There were generally consistent reductions in rates of symptomatic intracerebral hemorrhage with low-dose alteplase, although this reduction was not statistically significant by age, ethnicity, or severity. Conclusions and Relevance: This analysis found that the effects of low-dose alteplase were not clearly superior to the effects of standard-dose alteplase on death or disability in key demographic subgroups of patients with AIS. Further investigation is required to identify patients with AIS who may benefit from low-dose alteplase. Trial Registration: clinicaltrials.gov Identifier: NCT01422616.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Fibrinolíticos/farmacologia , Avaliação de Resultados (Cuidados de Saúde) , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/farmacologia , Administração Intravenosa , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Grupo com Ancestrais do Continente Asiático/etnologia , Isquemia Encefálica/etnologia , Feminino , Fibrinolíticos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etnologia , Ativador de Plasminogênio Tecidual/administração & dosagem
10.
N Engl J Med ; 376(25): 2437-2447, 2017 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-28636854

RESUMO

BACKGROUND: The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. METHODS: In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). RESULTS: The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were no significant between-group differences in the rates of serious adverse events, including pneumonia. CONCLUSIONS: Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying-flat position for 24 hours and patients assigned to a sitting-up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017 .).


Assuntos
Posicionamento do Paciente , Postura , Acidente Vascular Cerebral/terapia , Idoso , Estudos Cross-Over , Avaliação da Deficiência , Feminino , Cabeça , Humanos , Masculino , Pessoa de Meia-Idade , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/mortalidade
11.
Stroke ; 48(7): 1877-1883, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28619989

RESUMO

BACKGROUND AND PURPOSE: Many patients receiving thrombolysis for acute ischemic stroke are on prior antiplatelet therapy (APT), which may increase symptomatic intracerebral hemorrhage risk. In a prespecified subgroup analysis, we report comparative effects of different doses of intravenous alteplase according to prior APT use among participants of the international multicenter ENCHANTED study (Enhanced Control of Hypertension and Thrombolysis Stroke Study). METHODS: Among 3285 alteplase-treated patients (mean age, 66.6 years; 38% women) randomly assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) intravenous alteplase within 4.5 hours of symptom onset, 752 (22.9%) reported prior APT use. Primary outcome at 90 days was the combined end point of death or disability (modified Rankin Scale [mRS] scores, 2-6). Other outcomes included mRS scores 3 to 6, ordinal mRS shift, and symptomatic intracerebral hemorrhage by various standard criteria. RESULTS: There were no significant differences in outcome between patients with and without prior APT after adjustment for baseline characteristics and management factors during the first week; defined by mRS scores 2 to 6 (adjusted odds ratio [OR], 1.01; 95% confidence interval [CI], 0.81-1.26; P=0.953), 3 to 6 (OR, 0.95; 95% CI, 0.75-1.20; P=0.662), or ordinal mRS shift (OR, 1.03; 95% CI, 0.87-1.21; P=0.770). Alteplase-treated patients on prior APT had higher symptomatic intracerebral hemorrhage (OR, 1.82; 95% CI, 1.00-3.30; P=0.051) according to the safe implementation of thrombolysis in stroke-monitoring study definition. Although not significant (P-trend, 0.053), low-dose alteplase tended to have better outcomes than standard-dose alteplase in those on prior APT compared with those not using APT (mRS scores of 2-6; OR, 0.84; 95% CI, 0.62-1.12 versus OR, 1.16; 95% CI, 0.99-1.36). CONCLUSIONS: Low-dose alteplase may improve outcomes in thrombolysis-treated acute ischemic stroke patients on prior APT, but this requires further evaluation in a randomized controlled trial. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Hemorragia Cerebral/induzido quimicamente , Fibrinolíticos , Avaliação de Resultados (Cuidados de Saúde) , Inibidores da Agregação de Plaquetas/uso terapêutico , Índice de Gravidade de Doença , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual , Idoso , Idoso de 80 Anos ou mais , Feminino , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , Fibrinolíticos/farmacologia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Método Simples-Cego , Ativador de Plasminogênio Tecidual/administração & dosagem , Ativador de Plasminogênio Tecidual/efeitos adversos , Ativador de Plasminogênio Tecidual/farmacologia
13.
BMJ Open ; 6(9): e012027, 2016 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-27633636

RESUMO

INTRODUCTION: We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. METHODS AND ANALYSIS: The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. ETHICS AND DISSEMINATION: The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. TRIAL REGISTRATION NUMBER: CTRI/2013/04/003557.


Assuntos
Cuidadores/educação , Países em Desenvolvimento , Estudos de Avaliação como Assunto , Família , Avaliação de Processos (Cuidados de Saúde) , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Atitude do Pessoal de Saúde , Análise Custo-Benefício , Pessoas com Deficiência , Gastos em Saúde , Humanos , Índia , Projetos de Pesquisa , Reabilitação do Acidente Vascular Cerebral/economia
14.
Neurology ; 86(5): 425-33, 2016 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-26740677

RESUMO

OBJECTIVE: To estimate the incidence, short-term outcome, and spatial distribution of stroke patients and to evaluate the completeness of case ascertainment in Ludhiana. METHODS: This population-based prospective cohort study was conducted in Ludhiana, Punjab, Northwest India. All first-ever stroke patients (≥18 years) were included between March 2010 and March 2013 using WHO Stepwise Approach Surveillance methodology from the city. Stroke patient data were obtained from hospitals, scan centers, and general practitioners, and details of deaths from the Municipal Corporation. RESULTS: Out of 7,199 stroke patients recruited, 3,441 were included in final analysis. The mean age was 59 ± 15 years. The annual incidence rate was 140/100,000 (95% confidence interval [CI] 133-147) and age-adjusted incidence rate was 130/100,000 (95% CI 123-137). The annual incidence rate for stroke in the young (18-49 years) was 46/100,000 (95% CI 41-51). The case fatality at 28 days was 22%. Patients above 60 years of age (p = 0.03) and patients who were managed in public hospitals had poor survival (p = 0.01). Hot spots for cumulative incidence were seen in central and southern parts of the city, and hot spots for poor outcome were seen in the outskirts of the city. CONCLUSIONS: The incidence rates are similar to other studies from India. Stroke patient survival is poor in public hospitals. The finding of spatial analysis is of public health significance for stroke prevention and strengthening of stroke services.


Assuntos
Demografia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , População Urbana , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Demografia/tendências , Estudos de Viabilidade , Feminino , Humanos , Incidência , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , População Urbana/tendências , Adulto Jovem
17.
Int J Stroke ; 10(4): 609-14, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25753445

RESUMO

BACKGROUND: The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care. METHODS: A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133. RESULTS: A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study. CONCLUSION: The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.


Assuntos
Família , Autocuidado/métodos , Reabilitação do Acidente Vascular Cerebral , Cuidadores , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Seleção de Pacientes , Projetos Piloto , Estudos Prospectivos , Autocuidado/economia , Índice de Gravidade de Doença , Método Simples-Cego , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/psicologia , Resultado do Tratamento
18.
Neurology ; 83(11): 1012-7, 2014 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-25107877

RESUMO

OBJECTIVE: We explored the effectiveness of mirror therapy (MT) in the treatment of unilateral neglect in stroke patients. METHODS: This is an open, blinded endpoint, randomized controlled trial carried out from January 2011 to August 2013. We included stroke patients with thalamic and parietal lobe lesions with unilateral neglect 48 hours after stroke. Patients were randomized to the MT group or the control group (sham MT), and both the groups received limb activation. Patients received treatment for 1-2 hours a day 5 days a week for 4 weeks. The primary outcome was unilateral neglect assessed by a blinded assessor using the star cancellation test, the line bisection test, and a picture identification task at 1, 3, and 6 months. This study was registered at http://clinicaltrials.gov (NCT 01735877). RESULTS: Forty-eight patients were randomized to MT (n = 27) or the control group (n = 21). Improvement in scores on the star cancellation test over 6 months was greater in the MT group (mean difference 23, 95% confidence interval [CI] 19-28; p < 0.0001). Similarly, improvement in the MT group was observed in the scores on the picture identification task (mean difference 3.2, 95% CI 2.4-4.0; p < 0.0001) and line bisection test (mean difference 8.6, 95% CI 2.7-14.6; p = 0.006). CONCLUSIONS: In patients with stroke, MT is a simple treatment that improves unilateral neglect. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with neglect from thalamic and parietal lobe strokes, MT improves neglect.


Assuntos
Dispositivos Ópticos , Transtornos da Percepção/etiologia , Transtornos da Percepção/terapia , Acidente Vascular Cerebral/complicações , Feminino , Seguimentos , Mãos , Humanos , Masculino , Metanálise como Assunto , Pessoa de Meia-Idade , Ilusões Ópticas , Lobo Parietal/patologia , Transtornos da Percepção/patologia , Estudos Prospectivos , Desempenho Psicomotor , Índice de Gravidade de Doença , Acidente Vascular Cerebral/patologia , Tálamo/patologia , Resultado do Tratamento
19.
Int J Stroke ; 9(6): 678-82, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25041736

RESUMO

BACKGROUND: There is limited information available from low and middle-income countries regarding the cost of stroke treatment. Hence, we aimed to review the costs of stroke in low and middle-income countries. SUMMARY OF REVIEW: The literature search was done using databases: PubMed/Medline, Ovid, EconLit and Google Scholar from 1966 until January 2014 using key words 'economic impact of stroke', 'cost of illness in low and middle income countries' and 'cost of stroke'. With these key words, 10/184 articles were retained for this review. The cost data were converted to 2013 currency values using a web-based tool (CCEMG-EPPI-centre cost converter). Most of the included studies were conducted in Asia. The design of these studies was retrospective and conducted predominantly in multicenter private hospitals. The highest mean direct medical cost of stroke was US$ 8424 in Nigeria. The lowest mean cost of stroke was in Senegal (US$ 416). The average length of hospital stay was longest (20 days) in China. The main predictors of higher costs appeared to be due to differences in length of stay and stroke severity. CONCLUSION: Costs of stroke are variable because of heterogeneous healthcare systems prevailing in low and middle-income countries. Length of hospital stay and stroke severity appear to be the main predictors of cost. Understanding the costs of stroke in low and middle-income countries is important. However, the evidence remains limited because there is a lack of standardized research. Future research should focus on using a uniform method across low and middle-income countries for estimating the costs of stroke.


Assuntos
Países em Desenvolvimento/economia , Acidente Vascular Cerebral/economia , Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde , Humanos , Tempo de Internação/economia , Índice de Gravidade de Doença
20.
Neurology ; 80(6): 528-32, 2013 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-23345636

RESUMO

OBJECTIVES: We aimed to study the effectiveness of shoulder taping and conventional treatment vs sham taping and conventional treatment in prevention of shoulder injuries in patients with acute stroke. METHODS: This study was a multicenter, interventional, prospective, randomized, outcome-blinded trial (PROBE design). All first-ever stroke patients were included within 48 hours of stroke onset (August 2009-October 2011). The treatment group included shoulder taping and conventional treatment, and the control group received sham taping and conventional treatment. Primary outcomes were changes in visual analog scale (VAS) and shoulder pain and disability index (SPADI), and secondary outcomes were changes in shoulder range of motion (flexion and abduction) at days 14 and 30. Clinical trials registration no. NCT 01062308. RESULTS: There were 80 patients in the treatment arm and 82 in the control arm. There was a better reduction of VAS (on day 14: mean difference 3.7 mm, p = 0.45; on day 30: 11.9 mm, p = 0.03) and SPADI scores (on day 14: mean difference 3.5, p = 0.33; on day 30: 9.3, p = 0.04) in the treatment arm. CONCLUSIONS: Although there was a trend toward pain reduction and functional improvement associated with shoulder taping for 2 weeks after acute stage of stroke, this did not reach statistical significance. The long-term effects of taping need to be studied in large trials. CLASSIFICATION OF EVIDENCE: This study provided Class III evidence that tri-pull shoulder taping was ineffective in significantly reducing shoulder pain in patients with acute stoke.


Assuntos
Fita Atlética , Dor de Ombro/prevenção & controle , Acidente Vascular Cerebral/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Amplitude de Movimento Articular , Dor de Ombro/etiologia , Resultado do Tratamento , Adulto Jovem
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