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Abstract Background Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. Methods/design Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. Conclusions This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. Trial registration ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil

Objective: We developed and evaluated a training program for Accredited Social Health Activists (ASHAs), female community health workers (CHWs) in India, on non-communicable diseases (NCDs). Methods: A 5-day training program, developed using government-approved manuals, was tested in a randomised controlled trial in the Tehri-Garhwal district. Quantitative comparisons were undertaken using Student's t-test and two-way ANOVA. ASHAs in the intervention group were asked questions about new skills learnt. Results: Thirty-six ASHAs (20 intervention, 16 controls) participated (response rate 75.0%). Mean pre-test knowledge score was 43.3/100 points (95% CI 36.7–49.9) for the intervention group and 44.4 (38.9–49.9) for controls. The mean post-test knowledge score increased more in the intervention group (48.5-point increase; P

Objectives The identification of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia (VITT) followed the recognition of a hitherto uncommon clinical syndrome frequently associated with cerebral venous sinus thrombosis (CVST), termed ‘thrombosis with thrombocytopenia’ syndrome (TTS). While anecdotally recognised as rare, the background incidence of TTS is unknown. We therefore aimed to investigate the background incidence of CVST with TTS in a large, well-defined population-based CVST cohort.Methods We performed an analysis of our previously obtained retrospective population-based cohort of patients with CVST from Adelaide, Australia (2005–2011, comprising an adult population of 953 390) to identify the background incidence of CVST associated with TTS.Results Among 105 people with CVST, the background population-based incidence of TTS-associated CVST was 1.2 per million per year (95% CI 0.5 to 2.4). A single case of a severe CVST VITT-like syndrome with multiorgan thrombosis was identified, occurring 3 weeks postrotavirus infection.Conclusions In our population-based study, the background incidence of CVST with associated TTS was very low, and the sole clinically severe case with multiorgan thrombosis occurred following a rotaviral precipitant. Our study establishes a benchmark against which to measure future potential ‘TTS’ clusters and suggests that viruses other than adenovirus may trigger this syndrome.

Abstract Background Socioeconomic status (SES) is associated with stroke occurrence and survival following stroke but its association with health-related quality of life (HRQoL) following stroke remains uncertain. We performed a systematic review and meta-analysis to examine the association between SES and HRQoL after stroke. Methods PubMed, SCOPUS, EMBASE, and Web of Science were searched to identify relevant cohort and case–control studies between January 2000 and May 2022. Two authors screened titles, abstracts and full text articles. One author extracted data from all included studies. Meta-analyses were performed for studies with comparable measurements of SES and HRQoL. Random effects models were used to estimate pooled summary standardised mean differences in HRQoL by SES. Results Out of 1,876 citations, 39 studies incorporated measurement of overall HRQoL following stroke and were included in the systematic review, with 17 studies included in the meta-analyses. Overall, reports including education, income, occupation and work status effects on HRQoL after stroke were inconsistent among all included 39 studies. In the global meta-analysis of 17 studies, HRQoL among survivors of stroke was lower in the low SES group than in the high SES group (standardised mean difference (SMD) -0.36, 95% CI -0.52, -0.20, p

Declining worldwide or national stroke incidence rates are not always mirrored in disadvantaged, minority populations. Logistical barriers exist for effective measurement of incidence in minority populations; such data are required to identify targets for culturally appropriate interventions. In this comparative review, we aimed to examine whether “gold-standard” methodologies of stroke incidence studies are most effective for minority populations. We compared three studies of stroke incidence in Aboriginal Australians, each using different methodologies of case ascertainment. In Study 1, “gold-standard” population-based methods were used, while in Study 2, a retrospective hospital-based cohort design was utilized, and in Study 3, whole-of-population linked hospital and mortality data was employed. Study 1 captured both in-hospital and out-of-hospital stroke events but had a small sample size for Aboriginal patients. Study 2 provided a larger sample size while still allowing for clinical and radiological subtyping of stroke but was subject to selection bias and was limited to hospitalized cases. Study 3 had a large sample size and allowed for subgroup analysis, though lacked clinical adjudication and had large proportions of ‘undetermined stroke'. Despite diagnostic imprecision, we recommend a paradigm shift in measuring stroke incidence in Indigenous, minority populations, favoring the use of whole-of-population data linkage including non-hospitalized stroke deaths, over resource-intensive prospective methods, where more suitable for the target population.

Abstract Background Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. Methods We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0–4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7–14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. Results Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. Conclusion The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-7237

Abstract Introduction Despite digital health tools being popular for supporting self‐management of chronic diseases, little research has been undertaken on stroke. We developed and pilot tested, using a randomized controlled design, a multicomponent digital health programme, known as Inspiring Virtual Enabled Resources following Vascular Events (iVERVE), to improve self‐management after stroke. The 4‐week trial incorporated facilitated person‐centred goal setting, with those in the intervention group receiving electronic messages aligned to their goals, versus limited administrative messages for the control group. In this paper, we describe the participant experience of the various components involved with the iVERVE trial. Methods Mixed method design: satisfaction surveys (control and intervention) and a focus group interview (purposively selected intervention participants). Experiences relating to goal setting and overall trial satisfaction were obtained from intervention and control participants, with feedback on the electronic message component from intervention participants. Inductive thematic analysis was used for interview data and open‐text responses, and closed questions were summarized descriptively. Triangulation of data allowed participants' perceptions to be explored in depth. Results Overall, 27/54 trial participants completed the survey (13 intervention: 52%; 14 control: 48%); and 5/8 invited participants in the intervention group attended the focus group. Goal setting: The approach was considered comprehensive, with the involvement of health professionals in the process helpful in developing realistic, meaningful and person‐centred goals. Electronic messages (intervention): Messages were perceived as easy to understand (92%), and the frequency of receipt was considered appropriate (11/13 survey; 4/5 focus group). The content of messages was considered motivational (62%) and assisted participants to achieve their goals (77%). Some participants described the benefits of receiving messages as a ‘reminder’ to act. Overall trial satisfaction: Messages were acceptable for educating about stroke (77%). Having options for short message services or email to receive messages was considered important. Feedback on the length of the intervention related to specific goals, and benefits of receiving the programme earlier after stroke was expressed. Conclusion The participant experience has indicated acceptance and utility of iVERVE. Feedback from this evaluation is invaluable to inform refinements to future Phase II and III trials, and wider research in the field. Patient or Public Contribution Two consumer representatives sourced from the Stroke Foundation (Australia) actively contributed to the design of the iVERVE programme. In this study, participant experiences directly contributed to the further development of the iVERVE intervention and future trial design.

BackgroundPost-stroke pneumonia is a frequent complication of stroke and is associated with high mortality. Investigators have described its associations with beta-blocker. However, there has been no evaluation of the role of recombinant tissue plasminogen activator (RTPA). We postulate that RTPA may modify the effect of stroke on pneumonia by reducing stroke disability. We explore this using data from neuroprotection trials in Virtual International Stroke Trials Archive (VISTA)-Acute.MethodWe evaluated the impact of RTPA and other medications in random forest model. Random forest is a type of supervised ensemble tree-based machine learning method. We used the standard approach for performing random forest and partitioned the data into training (70%) and validation (30%) sets. This action enabled to the model developed on training data to be evaluated in the validation data. We borrowed idea from Coalition Game Theory on fair distribution of marginal profit (Shapley value) to determine proportional contribution of a covariate to the model. Consistent with other analysis using the VISTA-Acute data, the diagnosis of post-stroke pneumonia was based on reports of serious adverse events.ResultsThe overall frequency of pneumonia was 10.9% (614/5652). It was present in 11.5% of the RTPA (270/2358) and 10.4% (344/3295) of the no RTPA groups. There was significant (pConclusionIn this cohort pneumonia was strongly associated with stroke severity and age whereas RTPA had a much lower effect. An intriguing finding is a possible association between benzodiazepine and pneumonia but this requires further evaluation.

Background: Hypertension is the largest contributor to the global burden of disease. Emerging risk factors for cardiovascular disease include blood pressure variability (BPV), but evidence on BPV is lacking among older Nigerians. We reported BPV in a cohort of older persons at the University College Hospital (UCH), Ibadan. Methods: We conducted a retrospective cohort study of respondents aged >50 years within the Ibadan Ambulatory Blood Pressure Registry at the UCH, Ibadan, Nigeria. Socio-demographic characteristics, lifestyle habits and anthropometric measurements were obtained. Results: Among 639 respondents, 332 (52.0%) were female. The blood pressure (BP) variables were strongly associated with age. Compared with younger age groups, mean diastolic BP (DBP) was less at an older age, whereas mean pulse pressure was greater. During the wake-up and sleep periods, mean DBP and mean arterial BP were less with each increasing age category, whereas mean pulse pressure was larger with each increasing age category. BP dipping, systolic, diastolic and mean arterial BP decreased with age. Overall, timed BPV increased significantly with increasing age. The prevalence of white-coat hypertension was greater among older participants than younger participants. Most respondents in the 50–59 years' age group were non-dippers (55.8%), whereas 33.7% of older respondents were reverse-dippers. Conclusion: Older persons experienced a greater abnormal circadian blood variation and greater BPV than younger people. In Nigeria, follow-up data are needed to determine the prognostic significance of these data in this population.

Movement-based mindfulness interventions (MBI) are complex, multi-component interventions for which the design process is rarely reported. For people with stroke, emerging evidence suggests benefits, but mainstream programs are generally unsuitable. We aimed to describe the processes involved and to conduct a formative evaluation of the development of a novel yoga-based MBI designed for survivors of stroke. We used the Medical Research Council complex interventions framework and principles of co-design. We purposefully approached health professionals and consumers to establish an advisory committee for developing the intervention. Members collaborated and iteratively reviewed the design and content of the program, formatted into a training manual. Four external yoga teachers independently reviewed the program. Formative evaluation included review of multiple data sources and documentation (e.g., formal meeting minutes, focus group discussions, researcher observations). The data were synthesized using inductive thematic analysis. Three broad themes emerged: (a) MBI content and terminology; (b) manual design and readability; and (c) barriers and enablers to deliver the intervention. Various perspectives and feedback on essential components guided finalizing the program. The design phase of a novel yoga-based MBI was strengthened by interdisciplinary, consumer contributions and peer review. The 12-week intervention is ready for testing among survivors of stroke.

Abstract Objective: We aim to report the accuracy of linking data from a non‐government‐held clinical quality registry to national claims data and identify associated sources of systematic bias. Methods: Patients with stroke or transient ischaemic attack admitted to hospitals participating in the Australian Stroke Clinical Registry (AuSCR) were linked with Medicare and medication dispensings through the Australian Medicare enrolment file (MEF). The proportion of registrants in the datasets was calculated and factors associated with a non‐merge assessed using multivariable analyses. Results: A total of 17,980 AuSCR registrants (January 2010 – July 2014) were submitted for linkage (median age 76 years; 46% female; 67% ischaemic stroke); the proportion merged was 97% MEF, 93% Medicare and 95% medication dispensings. Data from registrants born in Asia were less likely to link with the MEF (adjusted Odds Ratio [aOR]: 0.20; 95%Confidence Interval [CI]: 0.15, 0.27). Data for those aged 85‐plus compared to those under 65 years were less likely to merge with Medicare (aOR 0.25; 95%CI:0.21, 0.30) but more likely to merge with dispensing claims data (aOR: 2.15 (95%CI:1.71, 2.69). Implications for public health: Linkage between the AuSCR, a national clinical quality registry and Commonwealth datasets was achieved and potential sources of bias were identified.

Abstract Background Electronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke. Methods A phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1–2 years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2–3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability. Results Of 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16 months after stroke): 25 to intervention (median age 69 years; 40% female) and 29 to control (median age 68 years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ≥ 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: β coefficient 0.34; 95% CI − 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group. Conclusion These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke. Trial registration ANZCTR, ACTRN12618001519246 . Registered on 11 September 2018—retrospectively registered.

BackgroundSmall unruptured intracranial aneurysms (UIAs) are considered to have low risk of rupture. The proportion of UIAs measuring 10 mm or less in size that rupture when selected for conservative management without repair is not well known. The aim of this study is to determine the proportion of UIAs that rupture by size threshold from ≤10 to ≤3 mm when selected for management without repair and to determine the level of precision and sources of heterogeneity in the rupture risk estimate.MethodsThis study was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42019121522). The Ovid MEDLINE, EMBASE, Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials were searched (inception to August 2020). Studies with longitudinal follow-up of patients with UIAs ( ≤10 mm to ≤3 mm) without endovascular or neurosurgical repair were eligible. We included studies, which provided details of aneurysm size and in which UIA rupture was reported as an outcome. The primary outcome of the pooled proportion of UIA rupture during follow-up was synthesized with random-effects meta-analysis; heterogeneity was explored using meta-regression.ResultsA total of 31 studies that included 13,800 UIAs ≤10 mm in size were eligible for data synthesis. The pooled proportion of ≤10 mm UIAs that ruptured when managed without repair was 1.1% (95% CI 0.8–1.5; I2 = 52.9%) over 3.7 years. Findings were consistent in sensitivity analyses at all the size stratified thresholds including ≤5 and ≤3 mm; rupture occurred in 1.0% (95% CI 0.8–1.3; I2 = 0%) of 7,280 ≤5 mm UIAs and 0.8% (95% CI 0.4–1.5; I2 = 0%) of 1,228 ≤3 mm UIAs managed without repair. In higher quality studies with lower risk of bias, rupture occurred in 1.8% (95% CI 1.5–2.0; I2 = 0%) over 3.9 years. In meta-regression, aneurysm size, shape, anatomical location, and exposure to prior subarachnoid hemorrhage were not identified as sources of heterogeneity.ConclusionFor every 1,000 UIAs that are 10 mm or less in size and selected for conservative management without repair, between 8 and 15 UIAs are estimated to rupture over 3.7 years. When stratified by size, these pooled rupture risk estimates are consistent and clinically applicable for ≤5 mm UIAs selected for management without repair.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier: CRD42019121522.

BackgroundInformation and communication technology (ICT) offers considerable potential for supporting older adults in managing their health, including chronic diseases. However, there are mixed opinions about the benefits and effectiveness of ICT interventions for older adults with chronic diseases. ObjectiveWe aim to map the use of ICT interventions in health care and identified barriers to and enablers of its use among older adults with chronic disease. MethodsA scoping review was conducted using 5 databases (Ovid MEDLINE, Embase, Scopus, PsycINFO, and ProQuest) to identify eligible articles from January 2000 to July 2020. Publications incorporating the use of ICT interventions, otherwise known as eHealth, such as mobile health, telehealth and telemedicine, decision support systems, electronic health records, and remote monitoring in people aged ≥55 years with chronic diseases were included. We conducted a strengths, weaknesses, opportunities, and threats framework analysis to explore the implied enablers of and barriers to the use of ICT interventions. ResultsOf the 1149 identified articles, 31 (2.7%; n=4185 participants) met the inclusion criteria. Of the 31 articles, 5 (16%) mentioned the use of various eHealth interventions. A range of technologies was reported, including mobile health (8/31, 26%), telehealth (7/31, 23%), electronic health record (2/31, 6%), and mixed ICT interventions (14/31, 45%). Various chronic diseases affecting older adults were identified, including congestive heart failure (9/31, 29%), diabetes (7/31, 23%), chronic respiratory disease (6/31, 19%), and mental health disorders (8/31, 26%). ICT interventions were all designed to help people self-manage chronic diseases and demonstrated positive effects. However, patient-related and health care provider–related challenges, in integrating ICT interventions in routine practice, were identified. Barriers to using ICT interventions in older adults included knowledge gaps, a lack of willingness to adopt new skills, and reluctance to use technologies. Implementation challenges related to ICT interventions such as slow internet connectivity and lack of an appropriate reimbursement policy were reported. Advantages of using ICT interventions include their nonpharmacological nature, provision of health education, encouragement for continued physical activity, and maintenance of a healthy diet. Participants reported that the use of ICT was a fun and effective way of increasing their motivation and supporting self-management tasks. It gave them reassurance and peace of mind by promoting a sense of security and reducing anxiety. ConclusionsICT interventions have the potential to support the care of older adults with chronic diseases. However, they have not been effectively integrated with routine health care. There is a need to improve awareness and education about ICT interventions among those who could benefit from them, including older adults, caregivers, and health care providers. More sustainable funding is required to promote the adoption of ICT interventions. We recommend involving clinicians and caregivers at the time of designing ICT interventions.

Objectives: To examine sex differences in disease profiles, management, and survival at 1 and 5 years after ischemic stroke (IS) among people with atrial fibrillation (AF). Methods: We performed a systematic literature search of reports of AF at IS onset according to sex. We undertook an individual participant data meta-analysis (IPDMA) of nine population-based stroke incidence studies conducted in Australasia, Europe, and South America (1993?2014). Poisson regression was used to estimate women:men mortality rate ratios (MRRs). Study-specific MRRs were combined using random effects meta-analysis. Results: In our meta-analysis based on aggregated data from 101 studies, the pooled AF prevalence was 23% (95% confidence interval [CI]: 22%?25%) in women and 17% (15%?18%) in men. Our IPDMA is of 1,862 IS-AF cases, with women (79.2???9.1, years) being older than men (76.5???9.5, years). Crude pooled mortality rate was greater for women than for men (1-year MRR 1.24; 1.01?1.51; 5-year 1.12; 1.03?1.22). However, the sex difference was greatly attenuated after accounting for age, prestroke function, and stroke severity (1-year 1.09; 0.97?1.22; 5-year 0.98; 0.84?1.16). Women were less likely to have anticoagulant prescription at discharge (odds ratio [OR] 0.94; 95% CI: 0.89?0.98) than men when pooling IPDMA and aggregated data. Conclusions: AF was more prevalent after IS among women than among men. Among IS-AF cases, women were less likely to receive anticoagulant agents at discharge; however, greater mortality rate in women was mostly attributable to prestroke factors. Further information needs to be collected in population-based studies to understand the reasons for lower treatment of AF in women.

Background: To improve the control of hypertension in low- and middle-income countries, we trialed a community-based group program co-designed with local policy makers to fit within the framework of India's health system. Trained accredited social health activists (ASHAs), delivered the program, in three economically and developmentally diverse settings in rural India. We evaluated the program's implementation and scalability.Methods: Our mixed methods process evaluation was guided by the United Kingdom Medical Research Council guidelines for complex interventions. Meeting attendance reports, as well as blood pressure and weight measures of attendees and adherence to meeting content and use of meeting tools were used to evaluate the implementation process. Thematic analysis of separate focus group discussions with participants and ASHAs as well as meeting reports and participant evaluation were used to investigate the mechanisms of impact.Results: Fifteen ASHAs led 32 community-based groups in three rural settings in the states of Kerala and Andhra Pradesh, Southern India. Overall, the fidelity of intervention delivery was high. Six meetings were delivered over a 3-month period to each of the intervention groups. The mean number of meetings attended by participants at each site varied significantly, with participants in Rishi Valley attending fewer meetings [mean (SD) = 2.83 (1.68)] than participants in West Godavari (Tukeys test, p = 0.009) and Trivandrum (Tukeys test, p < 0.001) and participants in West Godavari [mean (SD) = 3.48 (1.72)] attending significantly fewer meetings than participants in Trivandrum [mean (SD) = 4.29 (1.76), Tukeys test, p < 0.001]. Culturally appropriate intervention resources and the training of ASHAs, and supportive supervision of them during the program were critical enablers to program implementation. Although highly motivated during the implementation of the program ASHA reported historical issues with timely remuneration and lack of supportive supervision.Conclusions: Culturally appropriate community-based group programs run by trained and supported ASHAs are a successful and potentially scalable model for improving the control of hypertension in rural India. However, consideration of issues related to unreliable/insufficient remuneration for ASHAs, supportive supervision and their formal role in the wider health workforce in India will be important to address in future program scale up.Trial Registration: Clinical Trial Registry of India [CTRI/2016/02/006678, Registered prospectively].

Background: Discharge planning is recommended to optimise the transition from acute care to home for patients admitted with stroke. Despite this guideline recommendation, many patients do not receive a discharge care plan. Also, there is limited evidence on factors influencing the provision of discharge care plan post-stroke. We evaluated patient, clinical and system factors associated with receiving a care plan on discharge from hospital back to the community after stroke. Methods: This was an observational cohort study of patients with acute stroke who were discharged to the community between 2009–2013, using data from the Australian Stroke Clinical Registry linked to hospital administrative data. For this analysis, we used merged dataset containing information on patient demographics, clinical characteristics, and receipt of acute care processes. Multivariable logistic regression models were used to determine factors associated with receiving a discharge care plan. Results: Among 7812 eligible patients (39 hospitals, median age 73 years, 44.7% female, 56.9% ischaemic stroke), 47% received a care plan at discharge. The odds of receiving a discharge care plan increased over time (odds ratio [OR] 1.39 per year, 95% CI 1.37–1.48), and varied between hospitals. Factors associated with receiving a discharge care plan included greater socioeconomic position (OR 1.18, 95% CI 1.02–1.38), diagnosis of ischaemic stroke (OR 1.18, 95% CI 1.05–1.33), greater stroke severity (OR 1.15, 95% CI 1.01–1.31), or being discharged on antihypertensive medication (OR 3.07, 95% CI 2.69–3.50). In contrast, factors associated with a reduced odds of receiving a discharge care plan included being aged 85+ years (vs300 beds; OR 0.30, 95% CI 0.10–0.92). Conclusions: Implementing practices to target people who are older, discharged to residential aged care, or discharged on a weekend may improve discharge planning and post-discharge care after stroke.

Background: Australian Primary Care Practitioners are incentivised through Medicare funded policies to provide chronic disease management and facilitate multidisciplinary care. Little is known about how these policies are claimed in the long-term management of stroke. The objective of this study was to describe the use of funded primary care policies for people with stroke by impairment status. Methods: Linked Australian Stroke Clinical Registry (2010–2014) and Medicare data from adults with 90–180 days post-stroke EQ-5D health status survey data and admitted to one of 26 participating Australian hospitals were analysed. Medicare item claims for Primary Care Practitioner led chronic disease management and multidisciplinary care coordination policies, during the 18 months following stroke are described. Registrants were classified into impairment groups using their EQ-5D dimension responses through Latent Class Analysis. Associations between impairment and use of relevant primary care policies were explored using multivariable regression. Results: 5432 registrants were included (median age 74 years, 44% female, 86% ischaemic), 39% had a chronic disease management claim and 39% a multidisciplinary care coordination claim. Three latent classes emerged representing minimal, moderate and severe impairment. Compared to minimal, those with severe impairment were least likely to receive chronic disease management (adjusted Odds Ratio (aOR): 0.61, 95% Confidence Interval (CI): 0.49, 0.75) but were most likely to receive multidisciplinary care coordination. Podiatry was the commonest allied health service prescribed, regardless of impairment. Conclusions: Less than half of people living with stroke had a claim for primary care initiated chronic disease management, with mixed access for those with severe impairments.

Background and Aims: Despite known Indigenous health and socioeconomic disadvantage in countries with a Very High Human Development Index, data on the incidence of stroke in these populations are sparse. With oversight from an Indigenous Advisory Board, we will undertake a systematic review of the incidence of stroke in Indigenous populations of developed countries or regions, with comparisons between Indigenous and non-Indigenous populations of the same region, though not between different Indigenous populations.Methods: Using PubMed, OVID-EMBASE, and Global Health databases, we will examine population-based incidence studies of stroke in Indigenous adult populations of developed countries published 1990-current, without language restriction. Non-peer-reviewed sources, studies including

Abstract Background Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). Methods Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. Results The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. Conclusion This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts.

Abstract Background There are few available data regarding the prevalence of diabetes in the sub-Himalayan region of India. The aim of this study was to determine the prevalence of pre-diabetes and diabetes in rural Garhwal based on glycosylated hemoglobin. Methods In a cross-sectional survey of 500 adults from five randomly selected villages in Chamba, a mountainous Tehri Garhwal district in Uttarakhand in north-west India, we determined the prevalence of diabetes (hemoglobin (Hb) A1c ≥ 6.5%) and pre-diabetes (5.7% ≤ HbA1c ≤ 6.4%). In a sub-sample of those diagnosed with diabetes or pre-diabetes (n = 140), fasting blood glucose (FBG, n = 117) or postprandial blood glucose (PBG, n = 23), and blood hemoglobin concentration, was measured at follow-up. Results Based on HbA1c, 10.0% had diabetes and 56.4% pre-diabetes. Of those diagnosed as diabetic by HbA1c, 10 of 16 (62.5%) were diagnosed as diabetic by FBG (> 125 mg/dL) or PBG (≥200 mg/dL). In those diagnosed as pre-diabetic by HbA1c, only 55 of 124 (44.4%) were diagnosed as pre-diabetic by FBG (100–125 mg/dL) or PBG (140–199 mg/dL). A large proportion of these 140 individuals (67.1%) were moderately to severely anemic (Hb

Introduction Recent advances in Australia mean that it is possible to link national clinical registries with government held administrative datasets. However, formal evaluations of such activities and the potential impact for research are lacking. Objectives and Approach We aimed to assess the feasibility and accuracy of linking registrants from the Australian Stroke Clinical Registry (AuSCR) with the Medicare enrolment file. Following data custodian and ethics approvals, personal linkage identifiers were submitted to the Australian Institute of Health and Welfare (AIHW). De-identified data from AuSCR and the AIHW were submitted into the Secure Unified Research Environment and merged using project specific person-based IDs. We calculated the proportion of patients linked with the Medicare enrolment file that were present in the associated Medicare and medication dispensing datasets and the proportion with claims after their date of death. Logistic regression was used to identify factors associated with a non-merged patient. Results 17,980 AuSCR registrants (January 2010-July 2014) were submitted for linkage (median age 76 years; 46% female; 67% ischaemic stroke; 16% TIA). Of these, 93% were merged with Medicare (N=16,648) and 95% with subsidised medication dispensing claims data (N=17,079). In those who died, 127 (0.8%) had one or more Medicare claim and 411 (2.4%) had one or more medications dispensed after their death date. Asian born registrants were less likely to be merged with Medicare (adjusted Odds Ratio [aOR]: 0.54; 95% Confidence Interval [CI]: 0.40, 0.72) than Australian born registrants. Those aged ≥85 years were less likely to be merged with Medicare data than those aged

Introduction Despite being recommended in clinical guidelines for secondary prevention of stroke, there are limited real-world data on outcomes associated with use of statins post-stroke. Objectives and Approach We aimed to investigate the association between statin use and cardiovascular mortality post-stroke. We conducted a retrospective cohort study using prospectively collected data from the Australian Stroke Clinical Registry (2010-2014), linked with national medication dispensing and mortality data. We observed adult patients with first-ever ischaemic stroke or transient ischaemic attack (TIA) for 1-year following hospital discharge, or until their date of death, whichever occurred first. Statin use, defined as having an available statin dispensing, was assessed daily and treated as a time-varying exposure to account for patients who discontinued or reinitiated statins during follow-up. Multivariable, competing-risks regression, with non-cardiovascular death as the competing risk, was used to investigate the association between statin use and 1-year cardiovascular mortality. Results Among 8363 patients discharged following first-ever ischaemic stroke or TIA (48% aged ≥75 years, 45% female, 20% TIA, median length-of-stay 5 days), 945 died within 1 year, with 763 deaths being cardiovascular-related. The proportion of statin users was 65% at 90 days, 64% at 180 days, and 62% at 1 year. Groups least likely to be statin users at 1-year were women (odds ratio [OR]: 0.75; 95% CI: 0.67-0.85), patients aged

Introduction and Purpose Chronic Disease Management (CDM) plans are used by general practitioners to manage chronic diseases such as stroke. However, there is limited evidence that being on these plans improve adherence to secondary prevention medications after stroke. We aimed to assess the association of the duration on a CDM plan in improving adherence to secondary prevention medications following stroke. Methods Australian survivors of stroke or transient ischaemic attack were participants from the STAND FIRM trial. Patients were individually linked with claims for CDM plans from Medicare and dispensings of secondary prevention medications from the Pharmaceutical Benefits Scheme. We estimated (1) duration on a CDM plan based on the timing and Medicare items claimed and (2) the proportion of days that patients would have been covered by these medications (PDC), while accounting for deaths and instances of over-supply. Dosage for each quantity of medication was determined by the regularity in which patients returned for a refill. Logistic regression was used to evaluate factors associated with ≥80% adherence, up to 3 years after stroke, for each of antihypertensive, antithrombotic and lipid-modifying drugs. Results The median PDC for 563 patients (median age 70yrs; 36% female) ranged from 92% to 95% among the three classes of medications. Approximately 27% did not take up a CDM plan, 33% were on plans for

Introduction To prevent further vascular events, prescribing of multiple classes of medications (antihypertensive, antithrombotic and lipid-lowering) is recommended in national clinical guidelines following ischaemic stroke. Objectives and Approach Using real-world data, we determined the association between optimal combination pharmacotherapy (supply of all three classes, “optimal pharmacotherapy”) and survival after stroke. We linked a cohort of patients with first-ever ischaemic stroke from the Australian Stroke Clinical Registry (2010-2014) with national pharmaceutical dispensing and national mortality data. Cox regression was used to determine associations between pharmacotherapy in the first 30 days of stroke with 1-year (from day 31 to 395) all-cause mortality. All analyses were adjusted for socio-demographic (age, sex) and clinical characteristics (stroke severity, discharge destination). Results Among 6684 patients discharged following first-ever ischaemic stroke (median length-of-stay 5 days), 6466 patients who survived to 30 days were included (44% female, median age 74 years). During the first 30 days from discharge, 71.4% received ≥1 medication class, and 32.9% (n=2125) received optimal pharmacotherapy. Patients with optimal pharmacotherapy were older (≥75 years 50.3% vs

Objective: We aimed to utilize the data on lifetime risk of stroke, from Global Burden of Disease (GBD) 2016, in combination with open data platforms to create an interactive map for use by clinicians and members of the public. Further, we explore the relationship between life expectancy and lifetime risk of stroke.Design: Enhancing visual display of large volume of data.Setting: Worldwide estimates of the lifetime risk of stroke obtained from the GBD 2016.Participants: None.Intervention: None.Methods: Data were extracted from a portable document format (pdf) copy of the GBD article on the lifetime risk of stroke and exported into the R programming environment (version 3.4.4). These data were merged with (i) the world map boundary, (ii) open data platforms from the World Bank (life expectancy and income), and (ii) open data from the United Nation Population Prospects 2017. Further we plotted the relationship between the adjusted lifetime risk of stroke and life expectancy.Outcomes: The map of the global burden of stroke shows a higher lifetime risk of stroke among high-income countries than in low-income countries (https://gntem3.shinyapps.io/strokeglobal/). The greatest risk was among upper-middle-income countries such as China and Eastern and Central European countries such as Latvia and Romania. The lifetime risk of stroke increased in countries with higher life expectancy (β = 0.48 ± 0.047, 95% confidence interval = 0.390–0.574, R2 = 0.38, p < 0.01).Conclusion: Overall life expectancy is a major driver of the lifetime risk of stroke. The interactive map enables clinicians to search information about the lifetime risk of stroke interactively and navigate by zooming in and out, while still retaining high resolution.

Background Various indicators of socioeconomic position (SEP) may have opposing effects on the risk of hypertension in disadvantaged settings. For example, high income may reflect sedentary employment, whereas greater education may promote healthy lifestyle choices. We assessed whether education modifies the association between income and hypertension in 3 regions of South India at different stages of epidemiological transition. Methods and Results Using a cross‐sectional design, we randomly selected villages within each of rural Trivandrum, West Godavari, and Rishi Valley. Sampling was stratified by age group and sex. We measured blood pressure and anthropometry and administered a questionnaire to identify lifestyle factors and SEP, including education, literacy, and income. Logistic regression was used to assess associations between various components of SEP and hypertension, and interaction analyses were used to determine whether educational attainment modified the association between income and hypertension. Trivandrum, the region of highest SEP, had the greatest prevalence of hypertension, whereas Rishi Valley, the lowest SEP region, had the least. Overall, greater income was associated with greater risk of hypertension. In interaction analyses, there was no evidence that educational attainment modified the association between income and hypertension. Conclusions Education is widely considered to ameliorate the risk of hypertension in high‐income countries. Why this effect is absent in rural India merits investigation.

BACKGROUND:New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS:We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS:While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION:The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Abstract Objective: To describe the challenges of obtaining state and nationally held data for linkage to a non‐government national clinical registry. Methods: We reviewed processes negotiated to achieve linkage between the Australian Stroke Clinical Registry (AuSCR), the National Death Index, and state held hospital data. Minutes from working group meetings, national workshop meetings, and documented communications with health department staff were reviewed and summarised. Results: Time from first application to receipt of data was more than two years for most state data‐sets. Several challenges were unique to linkages involving identifiable data from a non‐government clinical registry. Concerns about consent, the re‐identification of data, duality of data custodian roles and data ownership were raised. Requirements involved the development of data flow methods, separating roles and multiple governance and ethics approvals. Approval to link death data presented the fewest barriers. Conclusion: To our knowledge, this is the first time in Australia that person‐level data from a clinical quality registry has been linked to hospital and mortality data across multiple Australian jurisdictions. Implications for Public Health: The administrative load of obtaining linked data makes projects such as this burdensome but not impossible. An improved national centralised strategy for data linkage in Australia is urgently needed.

Introduction The growing burden of chronic diseases means some governments have been providing financial incentives for multidisciplinary care and self-management support delivered within primary care. Currently, population-based evaluations of the effectiveness of these policies are lacking. Aim To outline the methodological approach for our study that is designed to evaluate the effectiveness (including cost) of primary care policies for chronic diseases in Australia using stroke as a case study. Methods Person-level linkages will be undertaken between registrants from the Australian Stroke Clinical Registry (AuSCR) and (i) Government-held Medicare Australia claims data, to identify receipt or not of chronic disease management and care coordination primary care items; (ii) state government-held hospital data, to define outcomes; and (iii) government-held pharmaceutical and aged care claims data, to define covariates. N=1500 randomly selected AuSCR registrants will be sent surveys to obtain patient experience information. In Australia, unique identifiers are unavailable. Therefore, personal-identifiers will be submitted to government data linkage units. Researchers will merge the de-identified datasets for analysis using a project identifier. An economic evaluation will also be undertaken. Analysis The index event will be the first stroke recorded in the AuSCR. Multivariable competing risks Poisson regression for multiple events, adjusted by a propensity score, will be used to test for differences in the rates of hospital presentations and medication adherence for different care (policy) types. Our estimated sample size of 25,000 patients will provide 80% estimated power (α >0.05) to detect a 6-8% difference in rates. The incremental costs per Quality-adjusted life years gained of community-based care following the acute event will be estimated from a health sector perspective. Conclusion Completion of this study will provide a novel and comprehensive evaluation of the effectiveness and cost-effectiveness of Australian primary care policies. Its success will enable us to highlight the value of data-linkage for this type of research.

Background and Purpose: Post-stroke pneumonia is a feared complication of stroke as it is associated with greater mortality and disability than in those without pneumonia. Patients are often kept “Nil By Mouth” (NBM) after stroke until after receiving a screen for dysphagia and declared safe to resume oral intake. We aimed to assess the proportional contribution of stroke severity and dysphagia screen to pneumonia by borrowing idea from coalition game theory on fair distribution of marginal profit (Shapley value).Method: Retrospective study of admissions to the stroke unit at Monash Medical Center in 2015. Seventy-five percent of data were partitioned into training set and the remainder (25%) into validation set. Variables associated with pneumonia (p < 0.1) were entered into Shapley value regression and conditional decision tree analysis.Results: In 2015, there were 797 admissions and 617 patients with ischemic and hemorrhagic stroke (age 69.9 ± 16.2, male = 55.0%, National Institute of Health Stroke Scale/NIHSS 8.1 ± 7.9). The frequency of pneumonia was 6.6% (41/617). In univariable analyses NIHSS, time to dysphagia screen, Charlson comorbidity index (CCI), and age were significantly associated with pneumonia but not weekend admission. Shapley value regression showed that the largest contributor to the model was stroke severity (72.8%) followed by CCI (16.2%), dysphagia screen (3.8%), and age (7.2%). Decision tree analysis yielded an NIHSS threshold of 14 for classifying people with (27% of 75 patients) and without pneumonia (2.5% of 308 patients). The area under the ROC curve for training data was 0.83 (95% CI 0.75–0.91) with no detectable difference between the training and test data (p = 0.4). Results were similar when dysphagia was exchanged for the variable dysphagia screen.Conclusion: Stroke severity status, and not dysphagia or dysphagia screening contributed to the decision tree model of post stroke pneumonia. We cannot exclude the chance that using dysphagia screen in this cohort had minimized the impact of dysphagia on development of pneumonia.

Background Women have worse outcomes after stroke than men, and this may be partly explained by stroke severity. We examined factors contributing to sex differences in severity of acute stroke assessed by the National Institutes of Health Stroke Scale. Methods and Results We pooled individual participant data with National Institutes of Health Stroke Scale assessment (N=6343) from 8 population‐based stroke incidence studies (1996–2014), forming part of INSTRUCT (International Stroke Outcomes Study). Information on sociodemographics, stroke‐related clinical factors, comorbidities, and pre‐stroke function were obtained. Within each study, relative risk regression using log‐binominal modeling was used to estimate the female:male relative risk (RR) of more severe stroke (National Institutes of Health Stroke Scale>7) stratified by stroke type (ischemic stroke and intracerebral hemorrhage). Study‐specific unadjusted and adjusted RRs, controlling for confounding variables, were pooled using random‐effects meta‐analysis. National Institutes of Health Stroke Scale data were recorded in 5326 (96%) of 5570 cases with ischemic stroke and 773 (90%) of 855 participants with intracerebral hemorrhage. The pooled unadjusted female:male RR for severe ischemic stroke was 1.35 (95% CI 1.24–1.46). The sex difference in severity was attenuated after adjustment for age, pre‐stroke dependency, and atrial fibrillation but remained statistically significant (pooled RRadjusted 1.20, 95% CI 1.10–1.30). There was no sex difference in severity for intracerebral hemorrhage (RRcrude 1.08, 95% CI 0.97–1.21; RRadjusted 1.08, 95% CI 0.96–1.20). Conclusions Although women presented with more severe ischemic stroke than men, much although not all of the difference was explained by pre‐stroke factors. Sex differences could potentially be ameliorated by strategies to improve pre‐stroke health in the elderly, the majority of whom are women. Further research on the potential biological origin of sex differences in stroke severity may also be warranted.