Medicine (Austin & Northern Health) - Research Publications
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ItemEffectiveness of a shared team approach between nurses and doctors for improved risk factor management in survivors of stroke: a cluster randomized controlled trial(WILEY, 2017-07)BACKGROUND AND PURPOSE: Limited evidence exists on the benefits of organized care for improving risk factor control in patients with stroke or transient ischaemic attack. The effectiveness of an individualized management programme in reducing absolute cardiovascular disease risk in this high-risk population was determined. METHODS: This was a prospective, multicentre, cluster-randomized controlled trial with blinded assessment of outcomes and intention-to-treat analysis. Patients hospitalized for stroke/transient ischaemic attack and aged ≥18 years were recruited from four hospitals. General practices treating recruited patients were randomized to provide either usual care or an individualized management programme comprising nurse-led education and review of care plans by stroke specialists in addition to usual care. The primary outcome was a change in cardiovascular Framingham Risk Score between baseline and 12 months. RESULTS: From January 2010 to November 2013, 156 general practices (280 patients) were randomly assigned to usual care (control) and 159 (283 patients) to the intervention. The median age was 70.1 years; 65% were male. Overall, >80% of participants were prescribed recommended secondary prevention therapies at baseline. The primary efficacy analysis comprised 533 participants, with 30 either dying or lost to follow-up. In adjusted analyses, no significant between-group difference was found in the cardiovascular risk score at 12 months (0.04, 95% confidence interval -1.7, 1.8). CONCLUSIONS: The effectiveness of an organized secondary prevention programme for stroke may be limited in patients from high-performing hospitals with regular post-discharge follow-up and communication with general practices.
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ItemChanges in Activity Levels in the First Month after Stroke(SOC PHYSICAL THERAPY SCIENCE, 2013-05)[Purpose] To quantify the activity levels of individuals in an acute stroke ward, and to determine if their activity levels change within the first month after stroke. [Methods] In this pilot study, participant activity was monitored prospectively over a single day from 8 a.m. to 5 p.m. on two separate occasions. Individuals with confirmed stroke > 18 years of age and less than 15 days post-stroke at the time of recruitment were eligible for inclusion in this study. Activity was recorded using an electronic device. The first day was scheduled within 15 days and the second at four weeks post-stroke. We looked at the following activity categories: number of transitions, and the times spent lying, sitting and in dynamic activity. [Results] Sixteen individuals were included in this study with a median age of 79.5 years (interquartile range 62.5 to 85). Fifty-six % of the participants had mild, 31% had moderate and 13% had severe stroke, according to the NIHSS score. There were no significant changes in number of transitions, or times spent in dynamic activity and lying and sitting. [Conclusion] Activity levels were low at an acute stroke ward and did not significantly change within the first month.
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ItemUpright activity and higher motor function may preserve bone mineral density within 6 months of stroke: a longitudinal study(SPRINGER LONDON LTD, 2018-01-08)PURPOSE: Bone fragility contributes to increased fracture risk, but little is known about the emergence of post-stroke bone loss. We investigated skeletal changes and relationships with physical activity, stroke severity, motor control and lean mass within 6 months of stroke. METHODS: This is a prospective observational study. Participants were non-diabetic but unable to walk within 2 weeks of first stroke. Distal tibial volumetric bone mineral density (vBMD, primary outcome), bone geometry and microstructure (high-resolution peripheral quantitative computed tomography) were assessed at baseline and 6 months, as were secondary outcomes total body bone mineral content and lean mass (dual energy X-ray absorptiometry), bone metabolism (serum osteocalcin, N-terminal propeptide of type 1 procollagen (P1NP), C-terminal telopeptide of type 1 collagen (CTX)), physical activity (PAL2 accelerometer) and motor control (Chedoke McMaster) which were also measured at 1 and 3 months. RESULTS: Thirty-seven participants (69.7 years (SD 11.6), 37.8% females, NIHSS 12.6 (SD 4.7)) were included. The magnitude of difference in vBMD between paretic and non-paretic legs increased within 6 months, with a greater reduction observed in paretic legs (mean difference = 1.5% (95% CI 0.5, 2.6), p = 0.007). At 6 months, better motor control was associated with less bone loss since stroke (r = 0.46, p = 0.02). A trend towards less bone loss was observed in people who regained independent walking compared to those who did not (p = 0.053). Higher baseline daily count of standing up was associated with less change in bone turnover over 6 months: osteocalcin (r = -0.51, p = 0.01), P1NP (r = -0.47, p = 0.01), CTX (r = -0.53, p = 0.01). CONCLUSION: Better motor control and walking recovery were associated with reduced bone loss. Interventions targeting these impairments from early post-stroke are warranted. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au . Unique identifier: ACTRN12612000123842.
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ItemEconomic evaluation of a phase III international randomised controlled trial of very early mobilisation after stroke (AVERT)(BMJ PUBLISHING GROUP, 2019-05)OBJECTIVES: While very early mobilisation (VEM) intervention for stroke patients was shown not to be effective at 3 months, 12 month clinical and economical outcomes remain unknown. The aim was to assess cost-effectiveness of a VEM intervention within a phase III randomised controlled trial (RCT). DESIGN: An economic evaluation alongside a RCT, and detailed resource use and cost analysis over 12 months post-acute stroke. SETTING: Multi-country RCT involved 58 stroke centres. PARTICIPANTS: 2104 patients with acute stroke who were admitted to a stroke unit. INTERVENTION: A very early rehabilitation intervention within 24 hours of stroke onset METHODS: Cost-utility analyses were undertaken according to pre-specified protocol measuring VEM against usual care (UC) based on 12 month outcomes. The analysis was conducted using both health sector and societal perspectives. Unit costs were sourced from participating countries. Details on resource use (both health and non-health) were sourced from cost case report form. Dichotomised modified Rankin Scale (mRS) scores (0 to 2 vs 3 to 6) and quality adjusted-life years (QALYs) were used to compare the treatment effect of VEM and UC. The base case analysis was performed on an intention-to-treat basis and 95% CI for cost and QALYs were estimated by bootstrapping. Sensitivity analysis were conducted to examine the robustness of base case results. RESULTS: VEM and UC groups were comparable in the quantity of resource use and cost of each component. There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost). Sensitivity analysis achieved results with mostly overlapped CIs. CONCLUSIONS: VEM and UC were associated with comparable costs, mRS outcome and QALY gains at 12 months. Compared with to UC, VEM is unlikely to be cost-effective. The long-term data collection during the trial also informed resource use and cost of care post-acute stroke across five participating countries. TRIAL REGISTRATION NUMBER: ACTRN12606000185561; Results.
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ItemA systematic review protocol of timing, efficacy and cost effectiveness of upper limb therapy for motor recovery post-stroke(BMC, 2019-07-25)BACKGROUND: Improving upper limb (UL) motor recovery after stroke represents a major clinical and scientific goal. We aim to complete three systematic reviews to estimate the (1) association between time to start of UL therapy and motor recovery, (2) relative efficacy of different UL therapy approaches post-stroke and (3) cost-effectiveness of UL therapy interventions. METHODS: We have designed a systematic review protocol to address three systematic review questions that were each registered with PROSPERO. The search will be conducted in MEDLINE, EMBASE, and Cochrane Controlled Register of Trials. We will include randomised controlled trials, non-randomised clinical trials, before-after studies and observational studies of adult stroke survivors with an average stroke onset < 6 months, undergoing hospital-based therapy to improve UL function. Eligible interventions will aim to promote UL functional recovery. Two reviewers will independently screen, select and extract data. Study risk of bias will be appraised using appropriate tools. Clinical measures of motor recovery will be investigated (primary measure Fugl Meyer UL assessment), as well as measures of health-related quality of life (primary measure EQ-5D) and all cost-effectiveness analyses completed. Secondary outcomes include therapy dose (minutes, weeks, repetitions as available) and safety (i.e. adverse events, serious adverse events). A narrative synthesis will describe quality and content of the evidence. If feasible, we will conduct random effects meta-analyses where appropriate. DISCUSSION: We anticipate the findings of this review will increase our understanding of UL therapy and inform the generation of novel, data-driven hypotheses for future UL therapy research post-stroke. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018019367, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111629, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111628.
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ItemNo Preview AvailableA stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery and Rehabilitation Roundtable(SAGE PUBLICATIONS LTD, 2019-10)A major goal of the Stroke Recovery and Rehabilitation Roundtable (SRRR) is to accelerate development of effective treatments to enhance stroke recovery beyond that expected to occur spontaneously or with current approaches. In this paper, we describe key issues for the next generation of stroke recovery treatment trials and present the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF). An exemplar (an upper limb recovery trial) is presented to demonstrate the utility of this framework to guide the GO, NO-GO decision-making process in trial development.
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ItemRationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review(HINDAWI LTD, 2018)BACKGROUND: The ineffectiveness of most complex stroke recovery trials may be explained by inadequate intervention design. The primary aim of this review was to explore the rationales given for interventions and dose in stroke rehabilitation randomised controlled trials (RCTs). METHODS: We searched the Cochrane Stroke Group library for RCTs that met the following criteria: (1) training based intervention; (2) >50% participants who were stroke survivors; (3) full peer-reviewed text; (4) English language. We extracted data on 16 quality items covering intervention dose (n= 3), trial design (n= 10), and risk of bias (n= 3) and 18 items related to trial method. Logistic regression analyses were performed to determine whether (1) reporting of trial quality items changed over time; (2) reporting of quality items was associated with the likelihood of a positive trial, adjusted for sample size and number of outcomes. RESULTS: 27 Cochrane reviews were included, containing 9,044 participants from 194 trials. Publication dates were 1979 to 2013, sample size was median 32 (IQR 20,58), and primary outcome was reported in 49 trials (25%). The median total quality score was 4 (IQR 3,6) and improved significantly each year (OR 1.12, 95% CI 1.07, 1.16, p<0.001). Total quality score was not associated with likelihood of a positive trial, but trials containing a biological rationale for the intervention were more likely to find a difference in patient outcome (OR 2.18, 95% CI 1.14, 4.19, p=0.02). CONCLUSION: To develop breakthrough treatments we need to build the rationale for research interventions and testing of intervention dosage. This will be achieved through a collective research agenda to understand the mechanistic principles that drive recovery and identification of clearer targets for clinical trials.
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ItemA Framework for Designing Inpatient Stroke Rehabilitation Facilities: A New Approach Using Interdisciplinary Value-Focused Thinking(SAGE PUBLICATIONS INC, 2019-10)AIM: To use Value-Focused Thinking to investigate what is important in the design of inpatient stroke rehabilitation facility buildings. BACKGROUND: Many stroke patients require inpatient rehabilitation in a dedicated facility. Rehabilitation facilities are healthcare spaces, but they are also learning spaces where patients practice targeted tasks to acquire new skills and to reacquire skills and abilities that were compromised as a result of their stroke. There is currently no consensus regarding how the design of inpatient rehabilitation facilities could be optimized for patients' learning. METHOD: We used Value-Focused Thinking to develop a framework of what interdisciplinary experts consider important for inpatient stroke rehabilitation facility design. Two workshops were conducted. The following experts were invited to participate: past patients with experience of stroke rehabilitation; stroke rehabilitation clinicians; stroke rehabilitation academics; healthcare environments academics; learning environments academics; architects, designers, and wayfinders with experience designing healthcare or learning environments; and healthcare design policy makers. RESULTS: Thirty experts participated. The experts' final framework included 16 criteria that were considered fundamentally important for inpatient stroke rehabilitation facility design, and 14 criteria that were considered instrumentally important. Inpatient stroke rehabilitation facility design should maximize efficiency, maximize effectiveness (i.e., patients' clinical and functional outcomes), foster emotional well-being, and maximize safety. Opportunities to practice physical, cognitive, and social activity were considered important for patients' outcomes. CONCLUSIONS: Value-Focused Thinking was an effective and equitable means of engaging experts from multiple disciplines. Designers, planners, and developers of inpatient stroke rehabilitation facilities should consider the rehabilitation-specific framework developed in this study alongside evidence from other healthcare settings.
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ItemImplementing a protocol for a research impact assessment of the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery(BMC, 2018-08-01)BACKGROUND: There is growing recognition that the wider benefits of research (economic, social and health impacts) should be assessed and valued alongside traditional research performance metrics such as peer-reviewed papers. Translation of findings into policy and practice needs to accelerate and pathways to impact need to be better understood. This research protocol outlines a mixed methods study to apply the Framework to Assess the Impact from Translational health research (FAIT) to the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery (CRE-Stroke). FAIT is purpose-designed to encourage research translation and assess research impact but lacks validation. METHODS/DESIGN: Phase 1 involves application of the FAIT-modified programme logic model to each CRE-Stroke research stream including identifying process, output and impact metrics, as well as end users of the research. A scoping review will inform potential impacts anticipated from CRE-Stroke. In Phase 2, audit and feedback on achievements against plans will track and encourage research translation. Logic models will be updated to account for changes in the research pathways over time. In Phase 3, three proven methods for measuring research impact - Payback, economic assessment and narratives - will be applied to each research stream and the data triangulated and reported in Phase 4. The feasibility of applying FAIT will also be assessed as part of Phase 3. DISCUSSION: Use of prospective, comprehensive research impact frameworks for large interdisciplinary programmes of research is rare. FAIT's application to CRE-Stroke will provide opportunity for the impact of CRE-Stroke to be assessed and a range of impacts beyond standard academic achievements to be reliably reported. The feasibility of FAIT's application will also be assessed and, if necessary, refined. The usefulness of FAIT for encouraging research translation will also be described and may prove useful for other programmes looking to implement a research impact framework.
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ItemA mixed-methods study to explore opinions of research translation held by researchers working in a Centre of Research Excellence in Australia(BMJ PUBLISHING GROUP, 2018-09)OBJECTIVE: There is a growing need for researchers to demonstrate impact, which is reliant on successful research translation. The Australian National Health and Medical Research Council funded a Centre of Research Excellence in Stroke Rehabilitation and Brain Recovery (CRE-Stroke) to enhance collaborations between researchers conducting different types of stroke rehabilitation research. The purpose of this study was to explore opinions about research translation held by CRE-Stroke researchers conducting preclinical and clinical research, in terms of scope, importance, responsibility and perceived skills and knowledge. DESIGN: Mixed-methods study, comprising a paper-based survey and semistructured interviews. Interview data were inductively coded and thematically analysed. Survey and interview data were compared and synthesised. PARTICIPANTS: 55 (7 preclinical, 48 clinical) researchers attending a CRE-Stroke research forum completed a paper-based survey. Semistructured interviews with 22 CRE-Stroke (5 preclinical, 17 clinical) researchers were conducted. RESULTS: Research translation was described as translating to other research and translating to clinical practice and policy. Most researchers (n=54, 98%) reported that research translation was important, particularly in terms of generating research impact, but the most common sign of project completion reported by researchers (n=7, 100% preclinical; n=37, 77% clinical) was publication. Most researchers (preclinical n=4, 57%; clinical n=37, 77%) reported having responsibility for translating research, but less than half reported having the necessary skills (n=1, 14% preclinical; n=17, 35% clinical) and knowledge (n=3, 43% preclinical; n=19, 40% clinical). Differing opinions about who should be responsible for translating findings to clinical practice were expressed. CONCLUSIONS: Stroke rehabilitation researchers appear confident to translate their research via the traditional mechanism of publications. To optimise impact, clarity is needed regarding who is best placed to translate research findings to clinical practice and policy. Education and skills development to apply broader translation processes are needed to maximise the use of research at all stages.