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BACKGROUND: Treatment of acute stroke, before a distinction can be made between ischemic and hemorrhagic types, is challenging. Whether very early blood-pressure control in the ambulance improves outcomes among patients with undifferentiated acute stroke is uncertain. METHODS: We randomly assigned patients with suspected acute stroke that caused a motor deficit and with elevated systolic blood pressure (≥150 mm Hg), who were assessed in the ambulance within 2 hours after the onset of symptoms, to receive immediate treatment to lower the systolic blood pressure (target range, 130 to 140 mm Hg) (intervention group) or usual blood-pressure management (usual-care group). The primary efficacy outcome was functional status as assessed by the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days after randomization. The primary safety outcome was any serious adverse event. RESULTS: A total of 2404 patients (mean age, 70 years) in China underwent randomization and provided consent for the trial: 1205 in the intervention group and 1199 in the usual-care group. The median time between symptom onset and randomization was 61 minutes (interquartile range, 41 to 93), and the mean blood pressure at randomization was 178/98 mm Hg. Stroke was subsequently confirmed by imaging in 2240 patients, of whom 1041 (46.5%) had a hemorrhagic stroke. At the time of patients' arrival at the hospital, the mean systolic blood pressure in the intervention group was 159 mm Hg, as compared with 170 mm Hg in the usual-care group. Overall, there was no difference in functional outcome between the two groups (common odds ratio, 1.00; 95% confidence interval [CI], 0.87 to 1.15), and the incidence of serious adverse events was similar in the two groups. Prehospital reduction of blood pressure was associated with a decrease in the odds of a poor functional outcome among patients with hemorrhagic stroke (common odds ratio, 0.75; 95% CI, 0.60 to 0.92) but an increase among patients with cerebral ischemia (common odds ratio, 1.30; 95% CI, 1.06 to 1.60). CONCLUSIONS: In this trial, prehospital blood-pressure reduction did not improve functional outcomes in a cohort of patients with undifferentiated acute stroke, of whom 46.5% subsequently received a diagnosis of hemorrhagic stroke. (Funded by the National Health and Medical Research Council of Australia and others; INTERACT4 ClinicalTrials.gov number, NCT03790800; Chinese Trial Registry number, ChiCTR1900020534.).
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Anti-Hipertensivos , Pressão Sanguínea , Serviços Médicos de Emergência , Hipertensão , Acidente Vascular Cerebral , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ambulâncias , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , AVC Isquêmico/terapia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Tempo para o Tratamento , Doença Aguda , Estado Funcional , ChinaRESUMO
INTRODUCTION: The ongoing OPTIMISTmain study, an international, multicenter, stepped-wedge cluster randomized trial, aims to determine effectiveness and safety of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate acute ischemic stroke (AIS). An embedded process evaluation explored integration and impact of the intervention on care processes at participating US sites. METHODS: A mixed-methods approach with quantitative and qualitative data were collected between September 2021 and November 2022. Implementer surveys were undertaken at pre- and post-intervention phases to understand the perceptions of low-intensity monitoring strategy. A sample of stroke care nurses were invited to participate in semi-structured interviews at an early stage of post-intervention. Qualitative data were analyzed deductively using the normalization process theory; quantitative data were tabulated. RESULTS: Interviews with 21 nurses at 8 hospitals have shown low-intensity monitoring was well accepted, as there were less time constraints and reduced workload for each patient. There were initial safety concerns over missing deteriorating patients and difficulties in changing established routines. Proper training, education, and communication, and changing the habits and culture of care, were key elements to successfully adopting the new monitoring care into routine practice. Similar results were found in the post-intervention survey (42 nurses from 13 hospitals). Nurses reported time being freed up to provide patient education (56%), daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (i.e. communication, family support). CONCLUSIONS: Low-intensity monitoring for patients with mild-to-moderate acute ischemic stroke, facilitated by appropriate education and organizational support, appears feasible and acceptable at US hospitals.
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Introduction: The World Health Organisation (WHO) accepted the Integrated People-centred Health Services (IPCHS) framework in 2016 as an essential component for achieving universal health coverage in fragmented health systems. We aimed to examine the empirical applications of the WHO IPCHS framework to guide its use in strengthening health-service research. Methods: Academic databases and the IPCHS website were searched for relevant articles published between 2016 and July 2023. Two reviewers independently screened and extracted data on the study design, setting, IPCHS framework components, and facilitators and barriers to implementing the IPCHS strategies. Descriptive and content analyses were conducted. Results: Six studies were identified using the IPCHS framework. Studies have examined a combination of the five IPCHS strategies. All studies reported building strong primary care-based systems and coordinating care for individuals. Continued relationships and trust, co-production of health programmes, diversity of health care team, and technology were major facilitators, while low health literacy, lack of primary setting capacity and healthcare workforce were principal barriers to IPCHS implementation. Conclusion: This scoping review offers an overview of IPCHS strategies employed in healthcare research. Generally, the IPCHS framework remains underutilised in primary research. These results offer guidance for future research to support effective healthcare delivery.
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BACKGROUND: The effects of seasonal influenza vaccination on cardiovascular disease (CVD) outcomes, including among individuals with established CVD, are uncertain. METHODS: To evaluate the efficacy and safety of influenza vaccines compared to no vaccines or placebo for preventing all-cause/CVD mortality or all-cause/CVD hospitalization in the general population and in populations with pre-existing CVD, we conducted a living systematic review (LSR) and prospective meta-analysis (PMA). Published randomized controlled trials (RCT) and observational studies between 1994 and 2023 were searched. PRISMA guidelines were followed in the extraction of study details, and risk of bias was assessed using the Cochrane tools. Analyses were stratified by study design and CVD history. Study quality was evaluated using GRADE system. Meta analyses based on random-effects models were performed between July and October 2022. Pooled risk ratios (RRs) for all-cause/CVD mortality and all-cause/CVD hospitalization were main outcomes. RESULTS: Six published RCTs comprising 12,662 participants (mean age, 62 years; 45 % women; 8,797 with pre-existing CVD) and 37 observational studies comprising 6,311,703 participants (mean age, 49 years; 50 % women; 1,189,955 with pre-existing CVD) were included. Only those RCTs judged to be low risk were included in the analyses, and observational studies at anything greater than moderate risk of bias were excluded. In RCTs, influenza vaccine was not significantly associated with lower all-cause mortality (RR, 0.85; 95 %CI, 0.61-1.17), cardiovascular death (RR, 0.80; 95 %CI, 0.60-1.07), or CVD hospitalization (RR, 0.69; 95 %CI, 0.47-1.02). A statistically significant reduction in all-cause hospitalization (RR, 0.86; 95 %CI, 0.76-0.97) was observed. The evidence level was assessed as moderate for all-cause hospitalization, and low for other outcomes. Overall, observational studies suggested a stronger protective association between influenza vaccination and outcomes, except for CVD hospitalization. Based on RCTs, there was no difference in the effects of influenza vaccination on all-cause mortality among the general population compared to those with pre-existing CVD, although the summary point estimate favored benefits only in those with pre-existing CVD. CONCLUSIONS: While observational studies suggest that influenza vaccination may be associated with lower all-cause and CVD mortality and all-cause hospitalization, RCTs reported to date suggest a reduction in the risk of all-cause hospitalization but do not provide clear evidence to support preventive effects on mortality (all-cause or CVD) or CVD hospitalization.
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Doenças Cardiovasculares , Hospitalização , Vacinas contra Influenza , Influenza Humana , Vacinação , Humanos , Vacinas contra Influenza/administração & dosagem , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Hospitalização/estatística & dados numéricos , Influenza Humana/prevenção & controle , Influenza Humana/mortalidade , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Pessoa de Meia-Idade , Feminino , MasculinoRESUMO
OBJECTIVE: To describe clinical characteristics and longitudinal patterns of representation in a cohort of patients who frequently present to EDs for care. METHODS: A retrospective data analysis linking routinely collected ED data across three hospitals. The study population consisted of patients who presented to any ED on 10 or more occasions in any continuous 365-day period from 1 July 2015 to 30 June 2021. Presenting complaints were divided into those with any mental health, drug and alcohol, or social presentations (MHDAS group) and those without (non-MHDAS group). Outcomes of interest were number of presentations as well as temporal and facility clustering of presentations. A per patient regression analysis was performed to identify independent risk factors for increased presentations. RESULTS: Presentations by 1640 frequent ED presenters in the study constituted 4.6% of total ED presentations. MHDAS study group were younger, predominantly English speaking, twice as likely to be married, had lower hospital admission rates and almost three times as many of them did not wait for treatment. Statistically significant differences were also found between these groups regarding presentation clustering, facility entropy, each of the four categories of the number of ED presentations, and Index of Relative Socio-Economic Advantage and Disadvantage. CONCLUSION: Representations associated with MHDAS have a different trajectory of representation episodes compared to non-MHDAS group. Escalating number of presentations and clustering are important predictors of future representation numbers. Those 'did not waits' who appear to be representing would be the highest risk of ongoing and persistent representations in the future and should be the target of early interventions to ensure they are accessing appropriate care before this happens.
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Serviço Hospitalar de Emergência , Hospitais , Humanos , Estudos Retrospectivos , Fatores de Risco , Saúde MentalRESUMO
QUESTION: Is remotely delivered physiotherapy as good or better than face-to-face physiotherapy for the management of musculoskeletal conditions? DESIGN: Randomised controlled, non-inferiority trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: A total of 210 adult participants with a musculoskeletal condition who presented for outpatient physiotherapy at five public hospitals in Sydney. INTERVENTION: One group received a remotely delivered physiotherapy program for 6 weeks that consisted of one face-to-face physiotherapy session in conjunction with weekly text messages, phone calls at 2 and 4 weeks, and an individualised home exercise program delivered through an app. The other group received usual face-to-face physiotherapy care in an outpatient setting. OUTCOME MEASURES: The primary outcome was the Patient Specific Functional Scale at 6 weeks with a pre-specified non-inferiority margin of -15 out of 100 points. Secondary outcomes included: the Patient Specific Functional Scale at 26 weeks; kinesiophobia, pain, function/disability, global impression of change and quality of life at 6 and 26 weeks; and satisfaction with service delivery at 6 weeks. RESULTS: The mean between-group difference (95% CI) for the Patient Specific Functional Scale at 6 weeks was 2.7 out of 100 points (-3.5 to 8.8), where a positive score favoured remotely delivered physiotherapy. The lower end of the 95% CI was greater than the non-inferiority margin. Whilst non-inferiority margins were not set for the secondary outcomes, the 95% CI of the mean between-group difference ruled out clinically meaningful differences. CONCLUSION: Remotely delivered physiotherapy with support via phone, text and an app is as good as face-to-face physiotherapy for the management of musculoskeletal conditions. TRIAL REGISTRATION: ACTRN12619000065190.
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Doenças Musculoesqueléticas , Qualidade de Vida , Adulto , Humanos , Terapia por Exercício , Doenças Musculoesqueléticas/terapia , Satisfação do Paciente , Modalidades de FisioterapiaRESUMO
OBJECTIVES: Exercise, support and advice are the key treatment strategies of musculoskeletal problems. The aims of this study were to determine patients', physiotherapists', and other stakeholders' perspectives about supported home physiotherapy for the management of musculoskeletal problems and to identify the barriers and facilitators to rolling out this model of physiotherapy service delivery. METHODS: This study was conducted as part of a process evaluation run alongside a large trial designed to determine whether supported home physiotherapy is as good or better than a course of in-person physiotherapy. Forty interviews were conducted with 20 trial participants, 15 physiotherapists, and 5 other stakeholders. The interviews were semi-structured and based on interview guides. Each interview was transcribed and a three-tiered coding tree was developed. RESULTS: Six key themes were identified. Supported home physiotherapy (i) is convenient for some patients, (ii) does not always align with patients' and therapists' expectations about treatment (iii) is suitable for some but not all, (iv) can reduce personal connection and accountability, (v) has implications for physiotherapists' workloads, and (vi) has barriers and facilitators to future implementation. CONCLUSIONS: Findings suggest that patients are far more accepting of supported home physiotherapy than physiotherapists assume. This model of service delivery could be rolled out to improve access to physiotherapy and to provide a convenient and effective way of delivering physiotherapy to some patients with musculoskeletal conditions if our trial results indicate that supported home physiotherapy is as good or better than in-person physiotherapy. CLINICAL TRIAL REGISTRY NUMBER: ACTRN12619000065190 CONTRIBUTIONS OF THIS PAPER.
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Serviços de Assistência Domiciliar , Doenças Musculoesqueléticas , Fisioterapeutas , Modalidades de Fisioterapia , Pesquisa Qualitativa , Humanos , Doenças Musculoesqueléticas/reabilitação , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Atitude do Pessoal de Saúde , Idoso , Entrevistas como AssuntoRESUMO
Introduction: Behavioural and emotional disorders are a significant cause of morbidity for young people aged 10-19 years. School-based health care (SBHC) provides an innovative approach to addressing these issues within Australia. Description: We describe an innovative and integrative SBHC model called Ngaramadhi Space (NS) based at a specialised behavioural school called Yudi Gunyi school (YGS) in metropolitan Sydney, Australia. NS was developed in partnership with the Aboriginal community to provide holistic, integrated, multidisciplinary child and family centred care to students experiencing problematic externalising behaviour. We contextualise the historical factors leading to the development of NS, highlighting the importance of effective partnerships between sectors, and providing the theoretical framework and key components underpinning the model of care. Discussion: In Australia, schools are an under-utilised resource for the delivery of health and support alongside education. Collaboration between sectors can be challenging but allows a more coordinated approach to the management of complex social and health issues. By forming effective partnerships with schools and communities, the health sector has an opportunity to improve access to health and social care in a culturally safe and acceptable way. This is in line with national and international frameworks for improving health service delivery and addressing inequity. Conclusion: The health sector can play a pivotal role in improving the wellbeing of children by forming effective partnerships with schools and communities. The NS model is a practice-based example of this.
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BACKGROUND AND AIMS: Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. METHODS: INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP] <140mmHg within 30 min) or guideline-recommended BP management. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale scores at 90 days. RESULTS: Between March 2020 and April 2023, 2053 patients (mean age 70 years, female 39%) were recruited with a mean BP 178/98 mmHg in whom 45% have a diagnosis of primary intracerebral hemorrhage upon arrival at hospital. At the time of presentation to hospital, the mean SBP was 160 and 170mmHg in the intensive and control groups (Δ10 mmHg), respectively. The independent data and safety monitoring board has not identified any safety concerns and recommended continuation of the trial. The sample size was reduced from 3116 to 2320 after meetings in August 2022 as the stroke mimic rate was persistently lower than initially estimated (6% vs 30%). The study is expected to be completed in late 2023 and the results announced in May 2024. CONCLUSIONS: INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.