Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke.

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.).

Implementation of low-intensity thrombolysis monitoring care in routine practice: process evaluation of the Optimal Post rtPA-IV Monitoring in Acute Ischemic Stroke (OPTIMISTmain) study in the United States.

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.

The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): protocol for a pragmatic, stepped wedge, cluster randomized controlled trial.

Introduction Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low-risk of symptomatic intracerebral hemorrhage (sICH) and other complications. \ Methods OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically-stable adult patients with mild AIS (defined by a NIHSS <10) who do not require intensive care within 2 hours post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, US and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 minutes for 2 hours, 2 hourly (versus every 30 minutes) for 8 hours, and 4 hourly (versus every 1 hour) until 24 hours, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH and serious adverse events. Conclusion OPTIMISTmain will provide Level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS.

Early and intensive motor training to enhance neurological recovery in people with spinal cord injury: trial protocol.

STUDY DESIGN: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). OBJECTIVES: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). SETTING: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. METHODS: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants' perceptions about ability to perform self-selected goals, length of hospital stay and participants' impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. CONCLUSIONS: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. TRIAL REGISTRATION: ACTRN12621000091808 (1.2.2021).

Do Australian policies enable a primary health care system to identify family adversity and subsequently support these families-A scoping study.

ISSUE ADDRESSED: To determine if Australian policies support a primary health care system to identify family adversity and subsequently support these families. METHODS: Two methodological approaches were used: (i) a scoping review of Australian federal and two states (Victoria and New South Wales) policies related to family adversity (e.g., childhood maltreatment or household dysfunction, such as parental mental illness); (ii) thirteen semi-structured interviews with Victorian Community Health Service (CHS) staff and government policy makers, recruited via snowball sampling to understand the context of policy making and service implementation. Data collected were subsequently discussed in relation to the Stages Model of policy analysis. RESULTS: One hundred and eighty-eight policies referenced family adversity. Of these, 37 policies met all eligibility criteria including a focus on early intervention within primary care and were included in the review. Most policies were developed within health departments (78%) and included a wide range of adversities, with the majority based within maternal and child health and CHS platforms. Most policy development included consultation with stakeholders. Although most policies received some level of funding, few included funding details and only a third included evaluation. CONCLUSIONS: There are many policies related to family adversity in Australia, with most focused within existing primary care platforms. Given these policies, Australia should be well positioned to identify and respond to family adversity. SO WHAT: More work needs to be done to ensure policies are adequately implemented, evaluated and transparently and appropriately funded. The co-occurrence of adversity should focus policy action; and potentially lead to more effective and efficient outcomes.

Implementing a Goal-Directed Care Bundle after Acute Intracerebral Haemorrhage: Process Evaluation for the Third INTEnsive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial Study in China.

BACKGROUND: The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Haemorrhage Trial is an ongoing international, multicentre, stepped wedge, cluster-randomized trial to determine the effectiveness of a goal-directed care bundle (early intensive blood pressure [BP] lowering, glycaemic control, treatment of pyrexia, and reversal of anticoagulation), as compared to standard of care, on patient-centred outcomes after acute intracerebral haemorrhage (ICH). An embedded process evaluation aims to identify factors related to the uptake and implementation of the intervention. Herein, we present the process evaluation results for hospital sites in China. METHODS/DESIGN: A mixed methods approach, including surveys, focused group discussions and interviews with clinicians, routine monitoring, and recruitment logs were used to collect data across purposively sampled hospitals. Medical Research Council guidance and normalization process theory were used as theoretical frameworks for design, data analysis, and synthesis. RESULTS: Twenty quantitative surveys were completed with clinicians, and 26 interviews and 2 focus group discussions were conducted during 2019-2020. The care bundle was generally delivered as planned and acceptable by doctors and nurses, but difficulties were reported in achieving the protocol-defined target levels of BP and glycaemic control. Resistance to implementing the care bundle occurred for patients perceived to be at high risk of adverse effects. Common organizational contextual factors that impeded implementation included delayed processes and limited medication supply, while established background care procedures, expertise, and capacity influenced its integration into routine practice. Areas to facilitate implementation included optimizing workflow within available resources, having a dedicated team, and recognizing the potential benefits of the intervention. CONCLUSIONS: Varied established care protocols across sites, different levels of background expertise, and lack of staff capacity impeded the integration of goal-directed care bundle into routine practice for ICH patients in China. Ready identification, and efforts to address, these barriers could facilitate uptake of future guideline-recommended interventions for the management of patients with ICH.

Incidence, severity and time course of pressure injuries over the first two years following discharge from hospital in people with spinal cord injuries in Bangladesh.

DESIGN: Cohort study embedded in a clinical trial. SETTING: Community, Bangladesh. OBJECTIVES: To determine the incidence, severity and time course of pressure injuries over the first two years following discharge from hospital in people with spinal cord injuries (SCI) in Bangladesh. METHODS: Participants (n = 186) were contacted by telephone 39 times and assessed face-to-face 4 to 6 times over the two years following discharge. At each point of contact the presence and severity of pressure injuries were determined using the Pressure Ulcer Scale for Healing (PUSH). Survival analyses were conducted to determine the time course of development of pressure injuries and recovery from pressure injuries. Lasso regression was used to construct multivariable prediction models. RESULTS: Seventy-seven participants (41%; 95% CI 34% to 49%) developed at least one pressure injury in the first two years after discharge (incidence rate 0.27 per person-year, 95% CI 0.22 to 0.34). Most pressure injuries were on the sacrum (23%). Pressure injuries took a median (IQR) of 40 (29 to 57) days to heal. The median (IQR) peak PUSH score was 11.0/17 (8.0 to 13.5). The multivariable prediction models had poor predictive properties (maximum c-statistic 0.75). CONCLUSION: Pressure injuries impose a large health burden on people with SCI in Bangladesh. However, they are difficult to predict, treat and prevent. Further research is needed to identify who is at most risk and to find solutions for the treatment and prevention of pressure injuries in Bangladesh and other low-middle income countries.

The value of process evaluation for public health interventions: field-case studies for non-communicable disease prevention and management in five countries.

Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ-ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven-tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

Stroke care and collaborative academic research in Latin America.

OBJECTIVE: A narrative overview of regional academic research collaborations to address the increasing burden and gaps in care for patients at risk of, and who suffer from, stroke in Latin America (LA). MATERIALS AND METHODS: A summary of experiences and knowledge of the local situation is presented. No systematic literature review was performed. RESULTS: The rapidly increasing burden of stroke poses immense challenges in LA, where prevention and manage-ment strategies are highly uneven and inadequate. Clinical research is increasing through various academic consortia and networks formed to overcome structural, funding and skill barriers. However, strengthening the ability to generate, analyze and interpret randomized evidence is central to further develop effective therapies and healthcare systems in LA. CONCLUSIONS: Regional networks foster the conduct of multicenter studies -particularly randomized controlled trials-, even in resource-poor regions. They also contribute to the external validity of international studies and strengthen systems of care, clinical skills, critical thinking, and international knowledge exchange.

A realist evaluation of the implementation of a large-scale school eye health programme in India: a qualitative study.

PURPOSE: This study investigates how and in what circumstances a school-based eye health programme, the Refractive Errors Among CHildren (REACH) programme, achieved its desired outcomes: accessibility, standards of refractive care, fidelity and availability of comprehensive services, for over 2 million school children in six districts across India. METHODS: We conducted a realist evaluation to identify programme aspects and their causal relationships with outcomes. Deductive and inductive thematic analysis of qualitative data included three phases: 1. theory gleaning, 2. eliciting programme theory, 3. revisiting programme theory. The Initial Programme Theories (IPTs) were developed and revised through review of the literature, programme documents and field notes. We reviewed informal and formal discussions from the participatory advisory workshops and conducted semi-structured interviews with key stakeholders for the development and refinement of the IPTs. We based our analysis on the programme designers' perspective; used contexts, mechanisms and outcomes configuration for the analysis and presentation of the findings and reported the revised IPTs for the REACH programme. RESULTS: We identified four major programme aspects of the REACH programme for evaluation: programme governing unit, human resource, innovation and technology and funding. Based on the intended outcomes of the programme, themes and contexts were sorted and IPTs were defined. We revised the IPTs based on the analysis of the interviews (n = 19). The contexts and mechanisms that were reported to have potential influence on the attainment of favourable programme outcomes were identified. The revisions to the IPTs included: co-designing a collaborative model and involving local government officials to reinforce trust, community partnerships; local well-trained staff to encourage participation; use of the web-based data capturing system with built-in quality control measures and continued technical support; pre-determined costs and targets for the outputs promoted transparency and adherence with costs. CONCLUSION: This process provided a comprehensive understanding of the opportunities and possibilities for a large-scale school eye health programme in diverse local contexts in India. This illustrated the importance of embracing principles of system thinking and considering contextual factors for School Eye Health programmes in low and middle-income countries.

The cost of providing a community-based model of care to people with spinal cord injury, and the healthcare costs and economic burden to households of spinal cord injury in Bangladesh.

DESIGN: Descriptive. SETTING: Community, Bangladesh. OBJECTIVES: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households. METHODS: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty. RESULTS: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452-1129) and US$464 (US$214-799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury. CONCLUSION: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty.

A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial.

STUDY DESIGN: Randomised controlled trial. OBJECTIVES: To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. SETTING: Bangladesh. METHODS: A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. RESULTS: Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. CONCLUSION: A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

Loss of work-related income impoverishes people with SCI and their families in Bangladesh.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To determine the degree of impoverishment of people with spinal cord injury (SCI) and their families in Bangladesh caused by loss of work-related income following injury. SETTING: Spinal cord injury centre, Bangladesh. METHODS: A total of 410 wheelchair-dependent people with recent SCI about to be discharged from a hospital in Bangladesh were interviewed to determine the size of their families, their incomes from paid work prior to injury and the incomes of their family members. These data were used to calculate income per family unit and per family member prior to and immediately after injury. RESULTS: Ninety percent of the participants were men, 98% were from rural areas of Bangladesh and 58% were manual labours prior to injury. Median (interquartile range, IQR) family size was 5 (4-6) people. Prior to injury, 74% of participants were the main income earners for their families and 50% provided the only source of income for their families. Participants' median (IQR) monthly income prior to injury was US$106 (US$60-US$180) per person and family members' income was US$30 (US$19-US$48) per person. After injury, the median income (IQR) of each family member dropped to US$0 (US$0-US$18) placing 91% of families below the extreme poverty line of US$37.50 per person per month (equivalent to US$1.25 per day). CONCLUSION: In Bangladesh, SCI have profound financial implications for individuals and their families and causes extreme poverty. This is because those most often injured are young and the main income earners for their families.

Understanding how a community-based intervention for people with spinal cord injury in Bangladesh was delivered as part of a randomised controlled trial: a process evaluation.

DESIGN: Mixed methods study SETTING: Community, Bangladesh OBJECTIVES: To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention. METHODS: A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers. RESULTS: Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments. CONCLUSION: A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.

The role of contextualisation in enhancing non-communicable disease programmes and policy implementation to achieve health for all.

The September 2019 United Nations' High-Level Meeting renewed political commitments to invest in universal health coverage by strengthening health systems, programmes and policies to achieve 'health for all'. This Political Declaration is relevant to addressing the increasing global burden of non-communicable diseases, but how can evidence-based programmes and policies be meaningfully implemented and integrated into local contexts? In this Commentary, we describe how the process of contextualisation and associated tools, such as ecological frameworks, implementation research frameworks, health system indicators, effective system strengthening strategies and evidence mapping databases with priority-setting, can enhance the implementation and integration of non-communicable disease prevention and control policies and programmes. Examples across health platforms include (1) population approaches to reducing excess sodium intake, (2) fixed-dose combination therapy for cardiovascular disease prevention and control, and (3) health systems strengthening for improving the quality and safety of cardiovascular care. Contextualisation is needed to transfer evidence into locally relevant and impactful policies and programmes. The systematic and comprehensive use of contextualisation tools leverages key implementation research principles to achieve 'health for all'.

Effectiveness of chronic care models: opportunities for improving healthcare practice and health outcomes: a systematic review.

BACKGROUND: The increasing prevalence of chronic disease and even multiple chronic diseases faced by both developed and developing countries is of considerable concern. Many of the interventions to address this within primary healthcare settings are based on a chronic care model first developed by MacColl Institute for Healthcare Innovation at Group Health Cooperative. METHODS: This systematic literature review aimed to identify and synthesise international evidence on the effectiveness of elements that have been included in a chronic care model for improving healthcare practices and health outcomes within primary healthcare settings. The review broadens the work of other similar reviews by focusing on effectiveness of healthcare practice as well as health outcomes associated with implementing a chronic care model. In addition, relevant case series and case studies were also included. RESULTS: Of the 77 papers which met the inclusion criteria, all but two reported improvements to healthcare practice or health outcomes for people living with chronic disease. While the most commonly used elements of a chronic care model were self-management support and delivery system design, there were considerable variations between studies regarding what combination of elements were included as well as the way in which chronic care model elements were implemented. This meant that it was impossible to clearly identify any optimal combination of chronic care model elements that led to the reported improvements. CONCLUSIONS: While the main argument for excluding papers reporting case studies and case series in systematic literature reviews is that they are not of sufficient quality or generalizability, we found that they provided a more detailed account of how various chronic care models were developed and implemented. In particular, these papers suggested that several factors including supporting reflective healthcare practice, sending clear messages about the importance of chronic disease care and ensuring that leaders support the implementation and sustainability of interventions may have been just as important as a chronic care model's elements in contributing to the improvements in healthcare practice or health outcomes for people living with chronic disease.

Factors influencing the implementation of chronic care models: A systematic literature review.

BACKGROUND: The increasing prevalence of chronic disease faced by both developed and developing countries is of considerable concern to a number of international organisations. Many of the interventions to address this concern within primary healthcare settings are based on the chronic care model (CCM). The implementation of complex interventions such as CCMs requires careful consideration and planning. Success depends on a number of factors at the healthcare provider, team, organisation and system levels. METHODS: The aim of this systematic review was to systematically examine the scientific literature in order to understand the facilitators and barriers to implementing CCMs within a primary healthcare setting. This review focused on both quantitative and qualitative studies which included patients with chronic disease (cardiovascular disease, chronic kidney disease, chronic respiratory disease, type 2 diabetes mellitus, depression and HIV/AIDS) receiving care in primary healthcare settings, as well as primary healthcare providers such as doctors, nurses and administrators. Papers were limited to those published in English between 1998 and 2013. RESULTS: The search returned 3492 articles. The majority of these studies were subsequently excluded based on their title or abstract because they clearly did not meet the inclusion criteria for this review. A total of 226 full text articles were obtained and a further 188 were excluded as they did not meet the criteria. Thirty eight published peer-reviewed articles were ultimately included in this review. Five primary themes emerged. In addition to ensuring appropriate resources to support implementation and sustainability, the acceptability of the intervention for both patients and healthcare providers contributed to the success of the intervention. There was also a need to prepare healthcare providers for the implementation of a CCM, and to support patients as the way in which they receive care changes. CONCLUSION: This systematic review demonstrated the importance of considering human factors including the influence that different stakeholders have on the success or otherwise of the implementing a CCM.

Examining the Use and Application of the WHO Integrated People-Centred Health Services Framework in Research Globally - a Systematic Scoping Review.

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.

The association between influenza vaccination, cardiovascular mortality and hospitalization: A living systematic review and prospective meta-analysis.

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.

Clinical and longitudinal patterns of frequent presenters to emergency departments: A multi-centre data linkage analysis.

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.