Medicine (Austin & Northern Health) - Research Publications

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    A systematic review: Cost-effectiveness of continuous glucose monitoring compared to self-monitoring of blood glucose in type 1 diabetes.
    Jiao, Y ; Lin, R ; Hua, X ; Churilov, L ; Gaca, MJ ; James, S ; Clarke, PM ; O'Neal, D ; Ekinci, EI (Wiley, 2022-11)
    Continuous glucose monitoring (CGM) is rapidly becoming a vital tool in the management of type 1 diabetes. Its use has been shown to improve glycaemic management and reduce the risk of hypoglycaemic events. The cost of CGM remains a barrier to its widespread application. We aimed to identify and synthesize evidence about the cost-effectiveness of utilizing CGM in patients with type 1 diabetes. Studies were identified from MEDLINE, Embase and Cochrane Library from January 2010 to February 2022. Those that assessed the cost-effectiveness of CGM compared to self-monitored blood glucose (SMBG) in patients with type 1 diabetes and reported lifetime incremental cost-effectiveness ratio (ICER) were included. Studies on critically ill or pregnant patients were excluded. Nineteen studies were identified. Most studies compared continuous subcutaneous insulin infusion and SMBG to a sensor-augmented pump (SAP). The estimated ICER range was [$18,734-$99,941] and the quality-adjusted life year (QALY) gain range was [0.76-2.99]. Use in patients with suboptimal management or greater hypoglycaemic risk revealed more homogenous results and lower ICERs. Limited studies assessed CGM in the context of multiple daily injections (MDI) (n = 4), MDI and SMBG versus SAP (n = 2) and three studies included hybrid closed-loop systems. Most studies (n = 17) concluded that CGM is a cost-effective tool. This systematic review suggests that CGM appears to be a cost-effective tool for individuals with type 1 diabetes. Cost-effectiveness is driven by reducing short- and long-term complications. Use in patients with suboptimal management or at risk of severe hypoglycaemia is most cost-effective.
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    Healthy Life-Year Costs of Treatment Speed From Arrival to Endovascular Thrombectomy in Patients With Ischemic Stroke A Meta-analysis of Individual Patient Data From 7 Randomized Clinical Trials
    Almekhlafi, MA ; Goyal, M ; Dippel, DWJ ; Majoie, CBLM ; Campbell, BCV ; Muir, KW ; Demchuk, AM ; Bracard, S ; Guillemin, F ; Jovin, TG ; Mitchell, P ; White, P ; Hill, MD ; Brown, S ; Saver, JL (AMER MEDICAL ASSOC, 2021-05-03)
    Importance: The benefits of endovascular thrombectomy (EVT) are time dependent. Prior studies may have underestimated the time-benefit association because time of onset is imprecisely known. Objective: To assess the lifetime outcomes associated with speed of endovascular thrombectomy in patients with acute ischemic stroke due to large-vessel occlusion (LVO). Data Sources: PubMed was searched for randomized clinical trials of stent retriever thrombectomy devices vs medical therapy in patients with anterior circulation LVO within 12 hours of last known well time, and for which a peer-reviewed, complete primary results article was published by August 1, 2020. Study Selection: All randomized clinical trials of stent retriever thrombectomy devices vs medical therapy in patients with anterior circulation LVO within 12 hours of last known well time were included. Data Extraction/Synthesis: Patient-level data regarding presenting clinical and imaging features and functional outcomes were pooled from the 7 retrieved randomized clinical trials of stent retriever thrombectomy devices (entirely or predominantly) vs medical therapy. All 7 identified trials published in a peer-reviewed journal (by August 1, 2020) contributed data. Detailed time metrics were collected including last known well-to-door (LKWTD) time; last known well/onset-to-puncture (LKWTP) time; last known well-to-reperfusion (LKWR) time; door-to-puncture (DTP) time; and door-to-reperfusion (DTR) time. Main Outcomes and Measures: Change in healthy life-years measured as disability-adjusted life-years (DALYs). DALYs were calculated as the sum of years of life lost (YLL) owing to premature mortality and years of healthy life lost because of disability (YLD). Disability weights were assigned using the utility-weighted modified Rankin Scale. Age-specific life expectancies without stroke were calculated from 2017 US National Vital Statistics. Results: Among the 781 EVT-treated patients, 406 (52.0%) were early-treated (LKWTP ≤4 hours) and 375 (48.0%) were late-treated (LKWTP >4-12 hours). In early-treated patients, LKWTD was 188 minutes (interquartile range, 151.3-214.8 minutes) and DTP 105 minutes (interquartile range, 76-135 minutes). Among the 298 of 380 (78.4%) patients with substantial reperfusion, median DTR time was 145.0 minutes (interquartile range, 111.5-185.5 minutes). Care process delays were associated with worse clinical outcomes in LKW-to-intervention intervals in early-treated patients and in door-to-intervention intervals in early-treated and late-treated patients, and not associated with LKWTD intervals, eg, in early-treated patients, for each 10-minute delay, healthy life-years lost were DTP 1.8 months vs LKWTD 0.0 months; P < .001. Considering granular time increments, the amount of healthy life-time lost associated with each 1 second of delay was DTP 2.2 hours and DTR 2.4 hours. Conclusions and Relevance: In this study, care delays were associated with loss of healthy life-years in patients with acute ischemic stroke treated with EVT, particularly in the postarrival time period. The finding that every 1 second of delay was associated with loss of 2.2 hours of healthy life may encourage continuous quality improvement in door-to-treatment times.
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    Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit-TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit
    Bivard, A ; Zhao, H ; Coote, S ; Campbell, B ; Churilov, L ; Yassi, N ; Yan, B ; Valente, M ; Sharobeam, A ; Balabanski, A ; Dos Santos, A ; Ng, F ; Langenberg, F ; Stephenson, M ; Smith, K ; Bernard, S ; Thijs, V ; Cloud, G ; Choi, P ; Ma, H ; Wijeratne, T ; Chen, C ; Olenko, L ; Davis, SM ; Donnan, GA ; Parsons, M (BMJ PUBLISHING GROUP, 2022-04-01)
    INTRODUCTION: Mobile stroke units (MSUs) equipped with a CT scanner are increasingly being used to assess and treat stroke patients' prehospital with thrombolysis and transfer them to the most appropriate hospital for ongoing stroke care and thrombectomy when indicated. The effect of MSUs in both reducing the time to reperfusion treatment and improving patient outcomes is now established. There is now an opportunity to improve the efficacy of treatment provided by the MSU. Tenecteplase is a potent plasminogen activator, which may have benefits over the standard of care stroke lytic alteplase. Specifically, in the MSU environment tenecteplase presents practical benefits since it is given as a single bolus and does not require an infusion over an hour like alteplase. OBJECTIVE: In this trial, we seek to investigate if tenecteplase, given to patients with acute ischaemic stroke as diagnosed on the MSU, improves the rate of early reperfusion. METHODS AND ANALYSIS: TASTE-A is a prospective, randomised, open-label, blinded endpoint (PROBE) phase II trial of patients who had an ischaemic stroke assessed in an MSU within 4.5 hours of symptom onset. The primary endpoint is early reperfusion measured by the post-lysis volume of the CT perfusion lesion performed immediately after hospital arrival. ETHICS AND DISSEMINATION: The study was approved by the Royal Melbourne Hospital Human Ethics committee. The findings will be published in peer-reviewed journals, presented at academic conferences and disseminated among consumer and healthcare professional audiences. TRIAL REGISTRATION NUMBER: NCT04071613.
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    The Association Between Sarcopenia and Functional Improvement in Older and Younger Patients Who Completed Inpatient Rehabilitation: A Prospective Cohort Study.
    Churilov, I ; Churilov, L ; Brock, K ; Murphy, D ; MacIsaac, RJ ; Ekinci, EI (Frontiers Media SA, 2021)
    Objective: To investigate the association between sarcopenia and functional improvement in patients older and younger than 65 years upon completion of an inpatient rehabilitation program. Design: Prospective cohort study. Participants: Adult consecutive patients who completed the inpatient rehabilitation program at a metropolitan tertiary referral hospital general inpatient rehabilitation unit. Methods: Sarcopenia status was determined using the European Working Group on Sarcopenia in Older People 2 algorithm, using muscle mass measured by BioImpedance Analysis and grip strength. Progress in rehabilitation was measured using change in the Functional Independence Measure and Goal Attainment Scaling score. To investigate the age group by sarcopenia status interaction we used quantile regression models with bootstrapped standard error estimation for functional improvement and linear regression model with robust standard error estimation for GAS score. Results: 257 participants [128 (50%) male, median age 63 years (IQR: 52-72)], 33(13%) with sarcopenia, completed inpatient rehabilitation [median length of stay 16 days (IQR: 11-27.5)]. Participants' median Functional Independence Measure change was 24 (IQR 15-33.5) and mean total Goal Attainment Scaling score was 57.6 (SD 10.2). Adjusting for admission Functional Independence Measure score, the median difference in Functional Independence Measure change between participants with and without sarcopenia was: -4.3 (95% CI: -10.6, 1.9); p = 0.17 in participants 65 years and younger, and 4.6 (95% CI: 1.0, 8.2); p = 0.01 in participants older than 65; age-by-sarcopenia interaction p = 0.02. Conclusions: Unlike younger people, older people with sarcopenia have greater functional improvement in inpatient rehabilitation than those without sarcopenia.
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    Early Brain Volume Changes After Stroke: Subgroup Analysis From the AXIS-2 Trial
    Bu, N ; Churilov, L ; Khlif, MS ; Lemmens, R ; Wouters, A ; Fiebach, JB ; Chamorro, A ; Ringelstein, EB ; Norrving, B ; Laage, R ; Grond, M ; Wilms, G ; Brodtmann, A ; Thijs, V (FRONTIERS MEDIA SA, 2022-01-28)
    BACKGROUND AND PURPOSE: The evolution of total brain volume early after stroke is not well understood. We investigated the associations between age and imaging features and brain volume change in the first month after stroke. METHODS: We retrospectively studied patients with acute ischemic stroke enrolled in the AXIS-2 trial. Total brain volume change from hyperacute MRI data to the first month after stroke was assessed using unified segmentation in SPM12. We hypothesized that age, ischemic brain lesion size, and white matter (WM) changes were associated with larger brain volume change. Enlarged perivascular spaces (EPVSs) and white matter hyperintensities (WMHs) were rated visually and the presence of lacunes was assessed. RESULTS: We enrolled 173 patients with a mean age of 67 ± 11 years, 44% were women. There was a median 6 ml decrease in volume (25th percentile -1 ml to 75th percentile 21 ml) over time, equivalent to a median 0.5% (interquartile range [IQR], -0.07%-1.4%), decrease in brain volume. Age was associated with larger brain volume loss (per 10 years of age, 5 ml 95% CI 2-8 ml). Baseline diffusion weighted imaging (DWI) lesion volume was not associated with greater volume loss per 10 ml of lesion volume, change by 0 ml (95% CI -0.1 to 0.1 ml). Increasing Fazekas scores of deep WMH were associated with greater tissue loss (5 ml, 95% CI 1-10 ml). CONCLUSIONS: Total brain volume changes in a heterogenous fashion after stroke. Volume loss occurs over 1 month after stroke and is associated with age and deep WM disease. We did not find evidence that more severe strokes lead to increased early tissue loss.
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    Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)
    Cadilhac, DA ; Cameron, J ; Kilkenny, MF ; Andrew, NE ; Harris, D ; Ellery, F ; Thrift, AG ; Purvis, T ; Kneebone, I ; Dewey, H ; Drummond, A ; Hackett, M ; Grimley, R ; Middleton, S ; Thijs, V ; Cloud, G ; Carey, M ; Butler, E ; Ma, H ; Churilov, L ; Hankey, GJ ; English, C ; Lannin, NA (SAGE PUBLICATIONS LTD, 2021-06-14)
    RATIONALE: To address unmet needs, electronic messages to support person-centered goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomization. METHODS AND DESIGN: Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive administrative messages. The trial includes a process evaluation, assessment of treatment fidelity, and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization. OUTCOMES: Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α = 0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n = 668 are obtained, with maximum sample capped at 1100. DISCUSSION: We will provide new evidence on the potential effectiveness, implementation, and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.
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    Aeromedical retrieval diagnostic trends during a period of Coronavirus 2019 lockdown
    Gardiner, FW ; Gillam, M ; Churilov, L ; Sharma, P ; Steere, M ; Hanna, M ; Hooper, A ; Quinlan, F (Cold Spring Harbor Laboratory, 2020-08-19)
    Abstract Background We aimed to compare the pre, lockdown, and post-lockdown aeromedical retrieval (AR) diagnostic reasons and patient demographics during a period of Coronavirus 2019 (COVID-19) social isolation. Methods An observational study with retrospective data collection, consisting of Australians who received an AR between the 26 January to the 23 June 2020. The main outcome measures were patient diagnostic category proportions and trends prior (28 January to 15 March), during (16 March to 4 May), and following (5 May to 23 June 2020) social isolation restrictions. Results There were 16981 ARs consisting of 1959 (11.5) primary evacuations (PE) and 12724 (88.5) inter-hospital transfer (IHT), with a population median age of 52 years old (interquartile range [IQR] 29.0–69.0), with 49.0% (n = 8283) of the cohort being male and 38.0% (n = 6399) being female. There were a total of 6 confirmed and 209 suspected cases of COVID-19, with the majority of cases (n = 114; 53.0%) in the social isolation period. As compared to pre-restriction, the odds of retrieval for the restriction and post-restriction period differed across time between the major diagnostic groups. This included, an increase in cardiovascular retrieval for both restriction and post-restriction periods (OR 1.12 95% CI 1.02-1.24 and OR 1.18 95% CI 1.08-1.30 respectively), increases in neoplasm in the post restriction period (OR 1.31 95% CI 1.04-1.64), and increases for congenital conditions in the restriction period (OR 2.56 95% CI 1.39-4.71). Cardiovascular and congenital conditions had increased rates of priority 1 patients in the restriction and post restriction periods. There was a decrease in endocrine and metabolic disease retrievals in the restriction period (OR 0.72 95% CI 0.53-0.98). There were lower odds during the post-restriction period for a retrievals of the respiratory system (OR 0.78 95% CI 0.67-0.93), and disease of the skin (OR 0.78 95% CI 0.6-1.0). Distribution between the 2019 and 2020 time periods differed (p< 0.05), with the lockdown period resulting in a significant reduction in activity. Conclusion The lockdown period resulted in increased AR rates of circulatory and congenital conditions. However, this period also resulted in a reduction of overall activity, possibly due to a reduction in other infectious disease rates, such as influenza, due to social distancing.
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    Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
    Bernhardt, J ; Borschmann, K ; Collier, JM ; Thrift, AG ; Langhorne, P ; Middleton, S ; Lindley, RI ; Dewey, HM ; Bath, P ; Said, CM ; Churilov, L ; Ellery, F ; Bladin, C ; Reid, CM ; Frayne, JH ; Srikanth, V ; Read, SJ ; Donnan, GA (LIPPINCOTT WILLIAMS & WILKINS, 2021-02-23)
    OBJECTIVE: This tertiary analysis from AVERT examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days. METHOD: AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours post stroke, termed very early mobilization (VEM) to usual care (UC). Primary outcome was assessed at 3 months. Included: Patients with ischaemic and haemorrhagic stroke within 24 hours of onset. Treatment with thrombolytics allowed. Excluded: Patients with severe premorbid disability and/or comorbidities. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were non-fatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIHSS) and age. RESULTS: 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (IQR 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted Odds Ratio of 1.76 (95% CI 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral haemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in non-fatal SAEs found. CONCLUSION: While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care. Stroke progression was more common in VEM. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that very early mobilization increases mortality at 14 days post stroke. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.
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    Prioritizing guideline recommendations for implementation: a systematic, consumer-inclusive process with a case study using the Australian Clinical Guidelines for Stroke Management
    Lynch, EA ; Lassig, C ; Turner, T ; Churilov, L ; Hill, K ; Shrubsole, K (BMC, 2021-05-22)
    BACKGROUND: Implementation of evidence-based care remains a key challenge in clinical practice. Determining "what" to implement can guide implementation efforts. This paper describes a process developed to identify priority recommendations from clinical guidelines for implementation, incorporating the perspectives of both consumers and health professionals. A case study is presented where the process was used to prioritize recommendations for implementation from the Australian Stroke Clinical Guidelines. METHODS: The process was developed by a multidisciplinary group of researchers following consultation with experts in the field of implementation and stroke care in Australia. Use of the process incorporated surveys and facilitated workshops. Survey data were analysed descriptively; responses to ranking exercises were analysed via a graph theory-based voting system. RESULTS: The four-step process to identify high-priority recommendations for implementation comprised the following: (1) identifying key implementation criteria, which included (a) reliability of the evidence underpinning the recommendation, (b) capacity to measure change in practice, (c) a recommendation-practice gap, (d) clinical importance and (e) feasibility of making the recommended changes; (2) shortlisting recommendations; (3) ranking shortlisted recommendations and (4) reaching consensus on top priorities. The process was applied to the Australian Stroke Clinical Guidelines between February 2019 and February 2020. Seventy-five health professionals and 16 consumers participated. Use of the process was feasible. Three recommendations were identified as priorities for implementation from over 400 recommendations. CONCLUSION: It is possible to implement a robust process which involves consumers, clinicians and researchers to systematically prioritize guideline recommendations for implementation. The process is generalizable and could be applied in clinical areas other than stroke and in different geographical regions to identify implementation priorities. The identification of three clear priority recommendations for implementation from the Australian Stroke Clinical Guidelines will directly inform the development and delivery of national implementation strategies.
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    The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial
    Weinberg, L ; Li, MH-G ; Churilov, L ; Macgregor, C ; Garrett, K ; Eyles, J ; Bellomo, R ; Dal Pizzol, F (PUBLIC LIBRARY SCIENCE, 2021-05-19)
    OBJECTIVES: Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery. METHODS: We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria. RESULTS: The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events. CONCLUSIONS: The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery. TRIAL REGISTRATION: Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.