East Metropolitan Health Service

Introduction The burden of chronic kidney disease (CKD) is growing rapidly around the world. However, there is limited information on the overall regional prevalence of CKD, as well as the variations in national prevalence within Asia. We aimed to consolidate available data and quantify estimates of the CKD burden in this region. Methods We systematically searched MEDLINE, Embase and Google Scholar for observational studies and contacted national experts to estimate CKD prevalence in countries of Asia (Eastern, Southern and South Eastern Asia). CKD was defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m 2 or the presence of proteinuria. For countries without reported data, we estimated CKD prevalence using agglomerative average-linkage hierarchical clustering, based on country-level risk factors and random effects meta-analysis within clusters. Published CKD prevalence data were obtained for 16 countries (of the 26 countries in the region) and estimates were made for 10 countries. Results There was substantial variation in overall and advanced (eGFR <30 mL/min/1.73 m 2 ) CKD prevalence (range: 7.0%–34.3% and 0.1%–17.0%, respectively). Up to an estimated 434.3 million (95% CI 350.2 to 519.7) adults have CKD in Asia, including up to 65.6 million (95% CI 42.2 to 94.9) who have advanced CKD. The greatest number of adults living with CKD were in China (up to 159.8 million, 95% CI 146.6 to 174.1) and India (up to 140.2 million, 95% CI 110.7 to 169.7), collectively having 69.1% of the total number of adults with CKD in the region. Conclusion The large number of people with CKD, and the substantial number with advanced CKD, show the need for urgent collaborative action in Asia to prevent and manage CKD and its complications.

OBJECTIVES: To determine whether a multidisciplinary, multimodal Patient Blood Management (PBM) program for patients undergoing surgery is effective in reducing perioperative complication rate, and thereby is effective in improving clinical outcome. BACKGROUND: PBM is a medical concept with the focus on a comprehensive anemia management, to minimize iatrogenic (unnecessary) blood loss, and to harness and optimize patient-specific physiological tolerance of anemia. METHODS: A systematic review and meta-analysis was performed. Eligible studies had to address each of the 3 PBM pillars with at least 1 measure per pillar, for example, preoperative anemia management plus cell salvage plus rational transfusion strategy. The study protocol has been registered with PROSPERO (CRD42017079217). RESULTS: Seventeen studies comprising 235,779 surgical patients were included in this meta-analysis (100,886 pre-PBM group and 134,893 PBM group). Implementation of PBM significantly reduced transfusion rates by 39% [risk ratio (RR) 0.61, 95% confidence interval (CI) 0.55-0.68, P < 0.00001], 0.43 red blood cell units per patient (mean difference -0.43, 95% CI -0.54 to -0.31, P < 0.00001), hospital length of stay (mean difference -0.45, 95% CI -0.65 to -0.25, P < 0,00001), total number of complications (RR 0.80, 95% CI 0.74-0.88, P <0.00001), and mortality rate (RR 0.89, 95% CI 0.80-0.98, P = 0.02). CONCLUSIONS: Overall, a comprehensive PBM program addressing all 3 PBM pillars is associated with reduced transfusion need of red blood cell units, lower complication and mortality rate, and thereby improving clinical outcome. Thus, this first meta-analysis investigating a multimodal approach should motivate all executives and health care providers to support further PBM activities.

The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19), the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a pandemic. Global health care now faces unprecedented challenges with widespread and rapid human-to-human transmission of SARS-CoV-2 and high morbidity and mortality with COVID-19 worldwide. Across the world, medical care is hampered by a critical shortage of not only hand sanitizers, personal protective equipment, ventilators, and hospital beds, but also impediments to the blood supply. Blood donation centers in many areas around the globe have mostly closed. Donors, practicing social distancing, some either with illness or undergoing self-quarantine, are quickly diminishing. Drastic public health initiatives have focused on containment and "flattening the curve" while invaluable resources are being depleted. In some countries, the point has been reached at which the demand for such resources, including donor blood, outstrips the supply. Questions as to the safety of blood persist. Although it does not appear very likely that the virus can be transmitted through allogeneic blood transfusion, this still remains to be fully determined. As options dwindle, we must enact regional and national shortage plans worldwide and more vitally disseminate the knowledge of and immediately implement patient blood management (PBM). PBM is an evidence-based bundle of care to optimize medical and surgical patient outcomes by clinically managing and preserving a patient's own blood. This multinational and diverse group of authors issue this "Call to Action" underscoring "The Essential Role of Patient Blood Management in the Management of Pandemics" and urging all stakeholders and providers to implement the practical and commonsense principles of PBM and its multiprofessional and multimodality approaches.

BACKGROUND: Coronary heart disease is rapidly increasing in developing countries, but access to cardiac rehabilitation and secondary prevention remains low. In this study, we aimed to assess the effectiveness of a smartphone-based cardiac rehabilitation and secondary prevention programme delivered via the social media platform WeChat (SMART-CR/SP). METHODS: In this parallel-group, single-blind, randomised controlled trial, we recruited patients aged 18 years or older with coronary heart disease who had received percutaneous coronary interventions from a large tertiary hospital in Shanghai, China. Participants were randomly assigned (1:1) by block randomisation to either a 2-month intensive programme followed by a 4-month step-down phase of SMART-CR/SP or to usual care. In the SMART-CR/SP group, participants received comprehensive cardiac rehabilitation and secondary prevention via WeChat. The usual care group received standard outpatient cardiology follow-up but without formal cardiac rehabilitation and secondary prevention. Assessments were done at baseline, 2 months, 6 months, and 12 months. The primary outcome was change in functional capacity from baseline, measured by 6-min walk distance, at 2 months and 6 months. Analysis was by intention to treat. Research personnel involved in assessments were blinded to group allocation. Adverse-event analysis was based on percentage of patients who discontinued the study owing to adverse events. SMART-CR/SP programme-related safety issues were also recorded. This study was registered with the Chinese Clinical Trial Registry, number ChiCTR-INR-16009598. FINDINGS: Between Nov 17, 2016, and March 18, 2017, 312 patients (mean age 60·5 years [SD 9·2]), of whom 58 (19%) were female and 254 (81%) were male, were recruited and subsequently randomly assigned to SMART-CR/SP (n=156) or usual care (n=156). The improvement in 6-min walk distance at 2 months was significantly greater in the SMART-CR/SP group (from 489·2 m [99·4] at baseline to 539·1 m [68·0]) than in the control group (from 485·0 m [93·5] at baseline to 517·8 m [74.6]), with an adjusted mean difference of 20·64 m (95% CI 7·50-33·77; p=0·034). This improvement was maintained at 6 months (mean 6-min walk distance 543·4 m [67·5] in the SMART-CR/SP group vs 523·5 m [60·2] in the control group), with a mean between-group difference of 22·29 m (8·19-36·38; p=0·027). No adverse events or SMART-CR/SP programme-related safety issues were reported by participants during the study. INTERPRETATION: SMART-CR/SP was found to be a cardiac rehabilitation and secondary prevention service model with high efficacy and accessibility and to be easy to use. These results justify the implementation of similar models of care on a broader scale. FUNDING: Curtin University.

BACKGROUND: Supermarkets have unprecedented political and economic power in the food system and an inherent responsibility to demonstrate good corporate citizenship via corporate social responsibility (CSR). The aim of this study was to investigate the world's largest and most powerful supermarkets' publically available CSR commitments to determine their potential impact on public health. METHODS: The world's largest 100 retailers were identified using the Global Powers of Retailing report. Thirty-one supermarkets that published corporate reports referring to CSR or sustainability, in English, between 2013 and 2018, were included and thematically analysed. RESULTS: Although a large number of themes were identified (n = 79), and there were differences between each business, supermarket CSR commitments focused on five priorities: donating surplus food to charities for redistribution to feed the hungry; reducing and recovering food waste; sustainably sourcing specific ingredients including seafood, palm oil, soy and cocoa; governance of food safety; and growing the number of own brand foods available, that are made by suppliers to meet supermarkets' requirements. CONCLUSIONS: CSR commitments made by 31 of the world's largest supermarkets showed they appeared willing to take steps to improve sustainable sourcing of specific ingredients, but there was little action being taken to support health and nutrition. Although some supermarket CSR initiatives showed promise, the world's largest supermarkets could do more to use their power to support public health. It is recommended they should: (1) transparently report food waste encompassing the whole of the food system in their waste reduction efforts; (2) support healthful and sustainable diets by reducing production and consumption of discretionary foods, meat, and other ingredients with high social and environmental impacts; (3) remove unhealthful confectionery, snacks, and sweetened beverages from prominent in-store locations; (4) ensure a variety of minimally processed nutritious foods are widely available; and (5) introduce initiatives to make healthful foods more affordable, support consumers to select healthful and sustainable foods, and report healthful food sales as a proportion of total food sales, using transparent criteria for key terms.

Several lines of study suggest that peripheral metabolism of amyloid beta (Aß) is associated with risk for Alzheimer disease (AD). In blood, greater than 90% of Aß is complexed as an apolipoprotein, raising the possibility of a lipoprotein-mediated axis for AD risk. In this study, we report that genetic modification of C57BL/6J mice engineered to synthesise human Aß only in liver (hepatocyte-specific human amyloid (HSHA) strain) has marked neurodegeneration concomitant with capillary dysfunction, parenchymal extravasation of lipoprotein-Aß, and neurovascular inflammation. Moreover, the HSHA mice showed impaired performance in the passive avoidance test, suggesting impairment in hippocampal-dependent learning. Transmission electron microscopy shows marked neurovascular disruption in HSHA mice. This study provides causal evidence of a lipoprotein-Aß /capillary axis for onset and progression of a neurodegenerative process.

BACKGROUND: Older people are at high risk of falls after hospital discharge. The study aimed to evaluate the effect of providing individualized falls prevention education in addition to usual care on falls rates in older people after hospital discharge compared to providing a social intervention in addition to usual care. METHODS: A randomized clinical trial at three hospitals in Western Australia: participants followed for 6 months after discharge. Baseline and outcomes measured by assessors masked to group allocation. Participants: aged 60 years and over, admitted for rehabilitation. Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10). Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist. Main outcomes: falls in the 6 months after discharge; proportion of participants sustaining one or more falls. RESULTS: There were 382 (194 intervention; 188 control) participants (mean age 77.7 [SD 8.7] years). There were 378 falls (fall rate per 1,000 patient-days, 5.9 intervention; 5.9 control) reported by 164 (42.9%) participants in the 6 months following hospital discharge; 188 (49.7%) of these falls were injurious. There were no significant differences in falls rates between intervention and control groups: (adjusted IRR, 1.09; 95% CI [0.78 to 1.52]) or the proportion of participants who fell once or more (adjusted OR, 1.37; 95% CI [0.90 to 2.07]). CONCLUSIONS: Providing individualized falls prevention education prior to discharge did not reduce falls at home after discharge. Further research is warranted to investigate how to reduce falls during this high-risk transition period.

CONTEXT: Community and consumer involvement in health professions education (HPE) is of growing interest among researchers and educators, particularly in preparing health care graduates to effectively learn from, and collaborate with, people with lived experience of health issues. However, to date there has been limited direction on methodological approaches to engage health care consumers in the research and co-design of HPE. APPROACH: In this paper, we describe the background to our work with health care consumers including the five core principles for successful co-design (inclusive; respectful; participative; iterative; outcomes focused) and how they can be applied as a research approach in HPE. We introduce the use of arts and humanities-based teaching methodologies including engagement, meaning-making and translational education strategies to illustrate how this research approach has been applied to reframe mental health education and practice in Australia. Furthermore, we share some reflective insights on the opportunities and challenges inherent in using a co-design research approach in HPE. CONCLUSIONS: For the consumer voice to be embedded across HPE, there needs to be a collective commitment to curriculum redesign. This paper advances our understandings of the educational research potential of working with health care consumers to co-design rich and authentic learning experiences in HPE. Co-design research approaches that partner with and legitimise health care consumers as experts by experience may better align education and health professional practice with consumers' actual needs, an important first step in transforming hierarchical health care relationships towards more humanistic models of care.

Abstract Background The ability to predict transfusions arising during hospital admission might enable economized blood supply management and might furthermore increase patient safety by ensuring a sufficient stock of red blood cells (RBCs) for a specific patient. We therefore investigated the precision of four different machine learning–based prediction algorithms to predict transfusion, massive transfusion, and the number of transfusions in patients admitted to a hospital. Study Design and Methods This was a retrospective, observational study in three adult tertiary care hospitals in Western Australia between January 2008 and June 2017. Primary outcome measures for the classification tasks were the area under the curve for the receiver operating characteristics curve, the F 1 score, and the average precision of the four machine learning algorithms used: neural networks (NNs), logistic regression (LR), random forests (RFs), and gradient boosting (GB) trees. Results Using our four predictive models, transfusion of at least 1 unit of RBCs could be predicted rather accurately (sensitivity for NN, LR, RF, and GB: 0.898, 0.894, 0.584, and 0.872, respectively; specificity: 0.958, 0.966, 0.964, 0.965). Using the four methods for prediction of massive transfusion was less successful (sensitivity for NN, LR, RF, and GB: 0.780, 0.721, 0.002, and 0.797, respectively; specificity: 0.994, 0.995, 0.993, 0.995). As a consequence, prediction of the total number of packed RBCs transfused was also rather inaccurate. Conclusion This study demonstrates that the necessity for intrahospital transfusion can be forecasted reliably, however the amount of RBC units transfused during a hospital stay is more difficult to predict.

OBJECTIVE: The unprecedented rise in synthetic drugs, many containing unknown toxic agents, has made timely analytical diagnosis more difficult, and has reduced the confidence of clinicians providing ED management to this population of patients. This has also impacted the quality of evidence informing harm reduction responses. The Emerging Drugs Network of Australia (EDNA) brings together emergency physicians, toxicologists and forensic laboratories to establish a standardised ED toxicosurveillance system in Australia. METHODS: Blood analysis of intoxicated patients will be conducted by forensic laboratories to enable precise identification of the substances causing acute toxicity. This will be linked with clinical data collected at the time of ED presentation to enable analysis of the clinical effects and outcomes associated with different illicit and emerging drugs. Toxicological and clinical data collected across sentinel sites will align with a nationally endorsed minimum dataset. RESULTS: EDNA's collaborative network will establish a national system of surveillance and reporting of illicit and emerging drugs causing acute toxicity. Standardisation of data collection recorded in a national clinical registry will provide more robust data on epidemiology and associated harms. This will facilitate the translation of clinical and toxicological evidence into timely, appropriate harm reduction and policy. CONCLUSION: Our work represents a collaborative response to calls for more sophisticated data on emerging drug trends in Australia. EDNA will improve coordination between clinicians and analytical services by way of its standardised approach to surveillance and reporting.

BACKGROUND: This study investigated the association between nadir anemia and mortality and length of stay (LOS) in a general population of hospitalized patients. STUDY DESIGN AND METHODS: A retrospective cohort study of tertiary hospital admissions in Western Australia between July 2010 and June 2015. Outcome measures were in-hospital mortality and LOS. RESULTS: Of 80,765 inpatients, 45,675 (56.55%) had anemia during admission. Mild and moderate/severe anemia were independently associated with increased in-hospital mortality (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.36-1.86, p = 0.001; OR 2.77, 95% CI 2.32-3.30, p < 0.001, respectively). Anemia was also associated with increased LOS, demonstrating a larger effect in emergency (mild anemia-incident rate ratio [IRR] 1.52, 95% CI 1.48-1.56, p < 0.001; moderate/severe anemia-IRR 2.18, 95% CI 2.11-2.26, p < 0.001) compared to elective admissions (mild anemia-IRR 1.30, 95% CI 1.21-1.41, p < 0.001; moderate/severe anemia-IRR 1.69, 95% CI 1.55-1.83, p < 0.001). LOS was longer in patients who developed anemia during admission compared to those who had anemia on admission (IRR 1.13, 95% CI 1.10-1.17, p < 0.001). Red cell transfusion was independently associated with 2.23 times higher odds of in-hospital mortality (95% CI 1.89-2.64, p < 0.001) and 1.31 times longer LOS (95% CI 1.25-1.37, p < 0.001). CONCLUSION: More than one-third of patients not anemic on admission developed anemia during admission. Even mild anemia is independently associated with increased mortality and LOS; however, transfusion to treat anemia is an independent and additive risk factor.

BACKGROUND: In 2016, a preoperative clinic was implemented to screen, evaluate, and manage anemia and suboptimal iron stores at a major tertiary care medical center in Western Australia. Few studies compare the costs and reimbursements associated with preoperative anemia and suboptimal iron stores management. The objective of our study was to conduct a net cost analysis associated with the implementation of this clinic. METHODS: We designed a retrospective cohort study involving elective colorectal surgical admissions over a 3-year period. The baseline year selected was the 2015-2016 financial year, with outcomes in the 2016-2017 and 2017-2018 year compared to baseline. The study perspective was the Western Australian Health System. Hospital costs were extracted from the health service clinical costing system, which captures costs at the admission level. The primary outcome was net cost, defined as gross cost minus reimbursement (or funding) received. RESULTS: Our 3-year study included 544 admissions for elective colorectal surgery. After the implementation of the preoperative clinic, 73.4% (n = 257) of admissions were screened for anemia and suboptimal iron stores, and 31.4% (n = 110) received intravenous iron. In our adjusted analysis, when comparing the final year (2017-2018) with baseline (2015-2016), the units of red blood cells transfused per admission decreased 53% (142 vs 303 units per 1000 discharges; P = .006), and mean hospital length of stay decreased 15% (7.7 vs 9.1 days; P = .008). When comparing the final year with baseline, rectal resection admissions were associated with a mean decrease in the net cost of Australian dollar (A$) 7619 (95% confidence interval, 4230-11,008; P < .001) between 2015-2016 and 2017-2018. For small and large bowel procedures, there was a mean decrease of A$6744 (95% confidence interval, 2430-11,057; P = .002). CONCLUSIONS: The implementation of a preoperative anemia and suboptimal iron stores screening and management clinic in elective colorectal surgery was associated with reductions in red cell transfusions, length of stay, and net costs.

OBJECTIVE: To summarise and synthesise the qualitative literature relating to constraint-induced movement therapy (CIMT) among stroke survivors, carers, therapists and rehabilitation service managers. DESIGN: Systematic review of qualitative studies. Quantitative studies using survey data were also included if they investigated perceptions and/or experiences related to CIMT. DATA SOURCES: Cochrane Library, Medline, JBI, Emcare, Embase, PsycInfo, CINAHL, PEDro, OT Seeker and NICE from inception to January 2022. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data from the included studies and assessed comprehensiveness of reporting using established tools. Thematic synthesis was undertaken to synthesise findings for studies using focus groups and interviews. A summary of themes from quantitative studies using survey data was compiled to complement the qualitative synthesis. RESULTS: Searches yielded 1,450 titles after removal of duplicates; 60 full-text articles were assessed for eligibility and 14 studies were included (1,570 total participants). Thematic synthesis identified nine descriptive themes from which four analytical themes were developed: CIMT is challenging but support at all levels helps; therapists need the know-how, resources and staffing; CIMT is different to other interventions, and there are positives and negatives to this; and functional outcomes do not always meet high expectations. Quantitative survey themes included: knowledge, skills and confidence in delivering CIMT programs; patient factors; and institutional factors. CONCLUSIONS: This review identified several determinants of implementation related to CIMT. Rehabilitation therapists need to develop their knowledge and skills to deliver CIMT, engage with organisational leaders, and develop CIMT protocols to fit the local clinical context in order to sustainably deliver CIMT in stroke rehabilitation services. Stroke survivors and carers require improved education to increase their engagement and participation. After addressing these determinants, future research should evaluate population-level outcomes and policy-level implementation in establishing CIMT as global standard rehabilitation practice. REGISTRATION: CRD42021237757.

BACKGROUND: Excess weight is a major risk factor for chronic diseases. In Australia, over 60% of adults are overweight or obese. The overconsumption of energy-dense nutrient-poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. OBJECTIVE: This 1-year randomized controlled trial (6-month intervention and 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (aged 18-65 years) who are overweight or obese and recruited through a social marketing campaign (LiveLighter). METHODS: All eligible participants will provide data on demographics and lifestyle behaviors online at baseline, 6 months, and 12 months. Using two-stage randomization, participants will be allocated into one of three conditions (n=200 per group): tailored feedback delivered via email at seven time points, informed by objective dietary (mobile food record app) and activity (wearable activity monitor) assessment; active control receiving no tailored feedback, but undergoing the same objective assessments as tailored feedback; and online control receiving no tailored feedback or objective assessments. Primary outcome measures at 6 and 12 months are changes in body mass, EDNP food and beverage consumption, and daily moderate-to-vigorous PA (measured via accelerometry). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors, and cost effectiveness. RESULTS: Enrolment commenced in August 2017. Primary outcomes at 12 months will be available for analysis from September 2019. CONCLUSIONS: Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA. If found to be successful and cost effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000554369; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=371325&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12782.

We recently conducted an Overview of Systematic Reviews and Meta-analyses reporting mortality outcomes from clinical trials comparing red blood cell (RBC) transfusion strategies.1 The overview identified 19 systematic reviews pooling data from 68 unique randomized controlled trials (RCTs). Within these systematic reviews, 33 meta-analyses reported mortality outcomes. Overall, the 68 RCTs pooled were published between 1956 and 2017, with the number of patients randomized ranging from 30 to 5243, and the number of trial sites ranging from 1 to 73. Albeit in different clinical settings, these 68 RCTs are designed to answer the research question: What is the optimal hemoglobin concentration at which to transfuse RBCs? In general, the results from RCTs in most clinical settings point to no difference in mortality between patients assigned to restrictive or liberal transfusion strategies. These results have led some in the medical community to conclude that there is no dose-dependent relationship between RBC transfusion and increased mortality and morbidity,2 and therefore the observational studies finding such an association are a result of confounding. However, this conclusion assumes the RBC transfusion is the intervention of interest in these RCTs. As these studies do not compare RBC transfusion to placebo or another intervention, they are not designed to “specifically test the efficacy of transfusion.”3 In other words, they do not answer the question: What effect does transfusion have on mortality? In addition, our overview uncovered under-recognized issues limiting interpretation from RCTs. Our objective was to draw attention to 4 common and significant issues limiting the conclusions drawn. In doing so, we also challenge the dogma that RCTs, by default, automatically provide the best evidence for patient blood management (PBM). DISCUSSION A recent systematic overview of systematic reviews investigated mortality in patients assigned to restrictive and liberal transfusion strategies.1 This sizeable overview uncovered 4 important and underappreciated issues common to RCTs. These are small differences in units of RBC transfused between restrictive and liberal groups; small actual differences in hemoglobin concentrations between restrictive and liberal groups; RBCs transfused before randomization; variation in posttransfusion hemoglobin targets. Units of Blood Transfused Many RCTs comparing restrictive and liberal transfusion strategies suffer from small differences in the number of units of blood transfused between groups. Of the 68 RCTs included in our overview, 38 (56%) did not report the number of red cells transfused in the restrictive and liberal arms. Figure 1 demonstrates almost half (n = 14) of trials reporting the units transfused had a mean difference of <1 unit transfused per patient.Figure 1.: Mean difference in red cells units transfused between restrictive and liberal strategy groups from 30 trials that reported the number of red cells transfused in each trial arm.Of the trials with a mean difference below 1 unit, half (n = 7) had a mean difference between groups of half a unit of red cells or less. For example, in 1 trial, 109 patients randomized to the restrictive group were transfused a total of 89 red cell units, while 109 patients randomized to the liberal group received a total of 119 units. Therefore, this trial compared outcomes in a group receiving a mean of 0.82 units per patient to a group receiving 1.09 units per patient.4 It is difficult to comprehend how a difference between groups of <0.5 units of red cells would result in any clinically significant differences in patient outcome. The trial with the smallest mean difference in units of red cells transfused between groups was 0.08. In this trial, 299 patients in the restrictive group were transfused a mean of 0.78 units of red cells per patient, compared with 0.86 units in the 304 patients in the standard care group.5 Observational studies consistently demonstrate that adverse outcomes associated with red cell transfusion are dose-dependent. With such small differences in the mean amount of blood transfused between groups in clinical trials, it is unlikely that a dose response would be identified. Therefore, it is likely that smaller than expected differences in units of blood transfused between groups will skew overall patient outcomes toward no significant differences. Hemoglobin Concentration “It seems hardly probable that a hemoglobin difference <1 g/dL (<10 g/L) may influence the clinical outcome.”6 Although this quote from Leal-Noval et al6 refers to the results of 1 clinical trial, their statement draws attention to a wider issue with RCTs comparing transfusion thresholds. This issue is the small actual differences in hemoglobin thresholds between restrictive and liberal groups. Focusing our attention on 2 points can help better understand this issue. First, the difference in hemoglobin thresholds as planned in the study protocol. Second, the actual difference in hemoglobin thresholds between groups. The actual is usually narrower than the planned. Figure 2 presents the planned hemoglobin threshold protocols by RCT. Of the 68 RCTs included in our overview, 17 (25%) did not provide enough information to determine what the pretransfusion hemoglobin threshold protocol was. Of trials reporting hemoglobin thresholds, almost half (n = 24) compared thresholds with a difference of 20 g/L. This was made up of 9 trials comparing a restrictive threshold of 70 g/L with a liberal threshold of 90 g/L, 14 trials comparing 80 g/L with 100 g/L, and 1 trial comparing 100 g/L with 120 g/L.Figure 2.: Planned restrictive and liberal hemoglobin threshold (g/L) protocols by randomized controlled trial. Blue boxes represent the restrictive group, and red boxes refer to the liberal group.While the majority of trials have planned pretransfusion hemoglobin differences of 20 g/L between groups, the resulting actual difference between groups is usually lower. For example, 1 trial comparing thresholds of 70 g/L with 90 g/L reported the actual pretransfusion hemoglobin level was 68 g/L in the restrictive group and 79 g/L in the liberal group.7 This difference of 11 g/L is significantly lower than the planned 20 g/L. Similarly, another trial comparing pretransfusion hemoglobin thresholds of 80–100 g/L reported actual thresholds of 79 and 92 g/L, a difference of 13 g/L.8 We consistently found that trials comparing hemoglobin thresholds before transfusion with a planned difference between groups of 20 g/L had differences closer to 10 g/L. A Cochrane systematic review and meta-analysis reported that, of 16 trials presenting the actual difference in hemoglobin thresholds between groups, 6 (38%) had an average difference of ≤10 g/L.9 It is difficult to imagine that a hemoglobin difference of 10 g/L would result in significant changes in patient outcomes. RBCs Transfused Before Randomization The timing of randomization varied between individual trials. Some trials randomized patients commencing on admission, some intraoperatively, some after surgery, and others during a portion of a patient’s hospital stay. This creates an issue not often discussed, namely, the implications of comparing patient outcomes between transfusion strategies while ignoring the significant amounts of blood transfused before randomization. A recent feasibility trial comparing traumatic brain injury patients admitted to intensive care highlights the serious implications of prerandomization transfusions. In this study, patients assigned to the restrictive arm received more blood than patients assigned to the liberal arm.10 Despite this, the study authors reported, “fewer RBC units were administered in the restrictive than in the liberal group.” The timing of patient randomization in this trial, like many other trials, likely masked this important point. Leal-Noval et al6 drew attention to this overlooked point. They state, “the total number of RBC units transfused over the length of hospital stay (pre- and postrandomization) was finally higher in the restrictive group (164 U; 7.1 U/patient) than that in the liberal group (131 U; 6.2 U/patient).”6 Any clinical trial ignoring the units of blood transfused prerandomization introduces an inaccurate estimate of the transfusion’s effect on outcome. Furthermore, blood transfused prerandomization may result in even smaller differences between groups in terms of blood administered. For example, the difference in the proportion of patients transfused between trial arms was smaller during the patients’ complete admission (pre-and postrandomization) when compared to their postrandomization hospital stay in the Transfusion Indication Threshold Reduction (TITRe2) RCT (Table).11 Table. - Difference in Transfusion Outcomes When Comparing Complete Hospital Admission to Postrandomization Hospital Stay in the TITRe2 Randomized Controlled Trial Restrictive Transfusion Liberal Transfusion Patients transfused red cells Postrandomization 53.4% 92.2% Complete admission 63.7% 94.9% Mean red cell units transfused per participant Postrandomization 1.49 2.49 Complete admissiona 2.08 3.07 Values derived from Murphy et al.11Abbreviation: TITRe2, Transfusion Indication Threshold Reduction.aValues were derived from Stokes et al.12 It is hard to imagine clinical trials in other settings where researchers investigating the impact of a therapy ignore whether and how frequently patients received the therapy before randomization. For example, a trial studying the administration of intravenous iron in the intensive care unit excluded patients from the trial if they received intravenous iron in the 3 months prior.13 Similarly, another trial comparing antibiotic treatment strategies in intensive care excluded patients who had a course of antibiotics within the previous 24 hours.14 Variation in Posttransfusion Hemoglobin Targets Of the 4 issues identified, variation in posttransfusion hemoglobin thresholds was the least likely to be discussed. To determine the amount of blood transfused in each trial arm some RCTs applied posttransfusion hemoglobin targets, others indicated the number of units to transfuse, and many did not provide enough information to determine the criteria applied. This variation likely explains why only 3 of 19 systematic reviews discussed posttransfusion hemoglobin targets,1 and why large variation exists in the actual number of units transfused between trials and within trials. CONCLUSIONS Readers of RCTs are encouraged to evaluate the research based on the quality of the study methods. Some issues are common to all RCTs, such as concealed allocation, blinding, and random allocation. In addition to these, we encourage readers of clinical trials comparing transfusion strategies to ask the following questions unique to these trials: What was the actual number of units of blood transfused in both groups? In addition to the planned hemoglobin thresholds for transfusion, what were the actual hemoglobin concentrations in both groups? Were patients excluded if they received transfusions before randomization? What was the planned posttransfusion hemoglobin target? Some of these issues could be addressed by designing trials that achieve greater separation in pretransfusion hemoglobin thresholds and units of blood transfused between groups, and also by excluding patients transfused before randomization. However, important questions would remain unanswered. For example, if the entry criteria for these trials is anemia, why would the cause and underlying condition leading to the anemia not be investigated or addressed?15 In addition, hemoglobin concentration does not always correlate with total red cell mass. Many factors can result in the hemoglobin concentration going up or down without any change in total red cell mass.16 Factors such as acute hypoxia, sudden cessation of tobacco use, vasodilators, intravenous fluids, stressors, disease state, and neuroendocrine responses can result in plasma volume contraction or expansion, with some of these responses potentially being protective. We believe future RCTs in this field would benefit from incorporating pre- and postrandomization assessment and management of anemia and considering iron deficiency.17 This may be accomplished through cluster RCT designs, which are better suited to study multiple interventions and processes in an approach to patient care (eg, patient blood management) as opposed to evaluate a specific intervention (eg, transfusion threshold strategies). Furthermore, it is important to acknowledge that observational studies are particularly valuable when a research question cannot be answered by traditional RCTs. In some clinical settings, conducting an RCT is impossible (smoking versus no smoking), unethical, or too expensive, and therefore evidence investigating the harms of interventions may need to come from large observational data sets. Demonstrating the important role observational studies play, Sir Austin Bradford Hill, the father of the medical RCT, proposed criteria for assessing causation from observational studies.18 Although well-designed cohort studies continue to rank below RCTs in the hierarchy of evidence, they are vital to answer questions like: What effect does transfusion have on outcomes? To date, a number of large prospective observational studies designed to answer this question have been published.19 In addition, data from a number of observational studies have evaluated multimodal PBM programs and provide evidence from real-world settings about the effects of implementing comprehensive bundles of patient-specific interventions.20 DISCLOSURES Name: Kevin M. Trentino, MPH. Contribution: This author designed, developed, and refined the manuscript with contributions from all other authors, and drafted the manuscript. They were involved in critically revising the draft, and approving the final version to be published. Conflicts of Interest: None. Name: Shannon L. Farmer, DHSc. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: S. L. Farmer reports other from National Blood Authority (Australia), personal fees from ETHICON Biosurgery, other from Thieme (Stuttgart), outside the submitted work. Name: James P. Isbister, MB BS. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: J. P. Isbister reports personal fees and nonfinancial support from Vifor Pharma, personal fees and nonfinancial support from National Blood Authority, personal fees and nonfinancial support from CSL Behring, outside the submitted study. Name: Frank M. Sanfilippo, PhD. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: None. Name: Michael F. Leahy, MB ChB. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: M. F. Leahy reports personal fees from Vifor Pharma, personal fees from Pfizer, grants from Amgen, outside the submitted work. Name: Axel Hofmann, Dr rer medic. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: A. Hofmann reports personal fees and nonfinancial support from Celgene, Belgium, personal fees, and nonfinancial support from G1 Therapeutics, nonfinancial support from South African National Blood Service, South Africa, personal fees and nonfinancial support from Takeda, South Africa, personal fees and nonfinancial support from TEM Innovations, Germany, personal fees and nonfinancial support from Vifor Pharma International AG, Switzerland, outside the submitted study. Name: Aryeh Shander, MD. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: None. Name: Kevin Murray, PhD. Contribution: This author contributed to the design and development of the manuscript, provided substantial contributions to the analysis and interpretation of data for the work, was involved in critically revising the draft, and approved the final version to be published. Conflicts of Interest: None. This manuscript was handled by: Susan Goobie, MD, FRCPC.

Two voluntary front-of-pack nutrition labels (FOPNL) are present in Australia: the government-led Health Star Ratings (HSR) and food industry-led Daily Intake Guide (DIG). Australia's two largest supermarkets are key supporters of HSR, pledging uptake on all supermarket own brand foods (SOBF). This study aimed to examine prevalence of FOPNL on SOBF, and alignment with patterns of nutritional quality. Photographic audits of all SOBF present in three large supermarkets were conducted in Perth, Western Australia, in 2017. Foods were classified as nutritious or nutrient-poor based on the Australian Guide to Healthy Eating (AGTHE), NOVA level of food processing, and HSR score. Most (81.5%) SOBF featured FOPNL, with only 55.1% displaying HSR. HSR was present on 69.2% of Coles, 54.0% of Woolworths, and none of IGA SOBF. Half (51.3%) of SOBF were classified as nutritious using the AGTHE, but using NOVA, 56.9% were ultra-processed foods. Nutrient-poor and ultra-processed SOBF were more likely than nutritious foods to include HSR, yet many of these foods achieved HSR scores of 2.5 stars or above, implying they were a healthy choice. Supermarkets have a powerful position in the Australian food system, and they could do more to support healthy food selection through responsible FOPNL.

One of the most debilitating symptoms of advanced Parkinson's disease is drooling. Currently, the main treatment that is offered for drooling is botulinum toxin injections to the saliva glands which have a number of side effects and do not treat the causes of drooling, such as impaired swallowing and lip closure. This study explored the effect of an alternative therapy approach for drooling that aimed at improving the swallow, expiratory muscle strength training (EMST). Sixteen participants received EMST over a 6- to 8-week period. Measurements were taken pre- and post-training for drooling (Sialorrhea Clinical Scale for Parkinson's Disease; SCS-PD), swallowing, lip strength and peak cough flow. Measures of drooling, swallowing and peak cough flow were stable over pre-training assessments and improved following training (p < 0.01). The most conservative estimate of the within-group change for SCS-PD was - 2.50 (95% confidence interval - 3.22 to - 1.22). No adverse effects were reported and participants gave high satisfaction ratings for the training. A programme of EMST offers promise as a therapy to reduce drooling for people with Parkinson's disease. Adequately powered randomised controlled trials of EMST are now needed.

Mandated policies to improve food environments in public settings are an important strategy for governments. Most Australian governments have mandated policies or voluntary standards for healthy food procurement in healthcare facilities, however, implementation and compliance are poor. A better understanding of the support required to successfully implement such policies is needed. This research explored food retailers' experiences in implementing a mandated food and nutrition policy (the Policy) in healthcare settings to identify barriers, enablers, and impacts of compliance. Three 90-min workshops facilitated by two public health practitioners were undertaken with 12 food retailers responsible for operating 44 outlets across four hospitals in Perth, Western Australia. Workshop discussions were transcribed non-verbatim and inductive thematic content was analyzed. Three main themes were identified: (1) food retailers had come to accept their role in implementing the Policy; (2) the Policy made it difficult for food retailers to operate successfully, and; (3) food retailers needed help and support to implement the Policy. Findings indicate the cost of implementation is borne by food retailers. Communications campaigns, centralized databases of classified products, reporting frameworks, recognition of achievements, and dedicated technical expertise would support achieving policy compliance. Feasibility assessments prior to policy implementation are recommended for policy success.

BACKGROUND: Availability and accessibility of nutritious foods can vary according to the food outlets present within a neighbourhood or community. There is increasing evidence that community food environments influence food choice, diet and the risk of diet-related chronic disease, however contemporary community food environments assessments (e.g. unhealthy fast food outlets versus healthy supermarkets or fruit and vegetable shops) may be too simplistic to accurately summarise the complexities of their impacts on food choice. This study protocol describes the development of the Food Outlets Dietary Risk (FODR) assessment tool for use by local government in Perth, Western Australia. METHODS: Similar to food safety risk assessment, the FODR assessment tool rates the potential harmful public health nutrition impact of food outlets by identifying and characterising the issues, and assessing the risk of exposure. Scores are attributed to six public health nutrition attributes: 1) availability of nutrient-poor foods; 2) availability of nutritious foods; 3) acceptability and appeal; 4) accessibility; 5) type of business operation; and 6) complex food outlet considerations. Food retail outlets are then classified as having a low, medium, high or very high dietary risk based on their total score. DISCUSSION: A local government administered tool to rate the public health nutrition risk of food outlets requires data which can be collected during routine assessments or sourced from the internet. The ongoing categorical classification of foods available within food outlets as either unhealthy or nutritious will require nutrition scientists' input. An objective risk assessment of the dietary impact of food retail outlets can guide local government planning, policies and interventions to create supportive community food environments. It is intended that locally relevant data can be sourced throughout Australia and in other countries to apply the local context to the FODR assessment tool. Utility and acceptability of the tool will be tested, and consultation with environmental health officers and public health practitioners will inform future iterations.

Assessing the implementation of nutrition interventions is important to identify characteristics and dietary patterns of individuals who benefit most. The aim was to report on young adults’ experiences of receiving dietary feedback text messaging intervention. Diet was captured using an image-based 4-day mobile food recordTM application (mFRTM) and assessed to formulate two tailored feedback text messages on fruit and vegetables and energy-dense nutrient-poor (EDNP) foods and beverages. At 6-months 143 participants completed a second mFRTM and a questionnaire evaluating the dietary feedback. Participants who agreed the text messages made them think about how much vegetables they ate were more likely to increase their intake by at least half a serve than those who disagreed [odds ratio (OR) = 4.28, 95% Confidence Interval (CI): 1.76 to 10.39]. Those who agreed the text messages made them think about how much EDNP foods they ate, were twice as likely to decrease their intake by over half a serve (OR = 2.39, 95%CI: 1.12 to 5.25) than those who disagreed. Undertaking detailed dietary assessment ensured the tailored feedback was constructive and relevant. Personal contemplation about vegetable and EDNP food intake appears to be a mediator of dietary change in young adults.