Co-design and mixed methods evaluation of an interdisciplinary digital resource for undergraduate health profession students to improve the prevention, recognition, and management of delirium in Ireland: a study protocol.

BACKGROUND: Delirium is a common symptom of acute illness which is potentially avoidable with early recognition and intervention. Despite being a growing concern globally, delirium remains underdiagnosed and poorly reported, with limited understanding of effective delirium education for undergraduate health profession students. Digital resources could be an effective approach to improving professional knowledge of delirium, but studies utilising these with more than one profession are limited, and no evidence-based, interdisciplinary, digital delirium education resources are reported. This study aims to co-design and evaluate a digital resource for undergraduate health profession students across the island of Ireland to improve their ability to prevent, recognise, and manage delirium alongside interdisciplinary colleagues. METHODS: Utilising a logic model, three workstreams have been identified. Workstream 1 will comprise three phases: (1) a systematic review identifying the format, methods, and content of existing digital delirium education interventions for health profession students, and their effect on knowledge, self-efficacy, and behavioural change; (2) focus groups with health profession students to determine awareness and experiences of delirium care; and (3) a Delphi survey informed by findings from the systematic review, focus groups, and input from the research team and expert reference group to identify resource priorities. Workstream 2 will involve the co-design of the digital resource through workshops (n = 4) with key stakeholders, including health profession students, professionals, and individuals with lived experience of delirium. Lastly, Workstream 3 will involve a mixed methods evaluation of the digital resource. Outcomes include changes to delirium knowledge and self-efficacy towards delirium care, and health profession students experience of using the resource. DISCUSSION: Given the dearth of interdisciplinary educational resources on delirium for health profession students, a co-designed, interprofessional, digital education resource will be well-positioned to shape undergraduate delirium education. This research may enhance delirium education and the self-efficacy of future health professionals in providing delirium care, thereby improving practice and patients' experiences and outcomes. TRIAL REGISTRATION: Not applicable.

Malnutrition defined by GLIM criteria identifies a higher incidence of malnutrition and is associated with pulmonary complications after oesophagogastric cancer surgery, compared to ICD-10-defined malnutrition.

BACKGROUND & OBJECTIVES: Low muscle mass, measured using computed tomography (CT), is associated with poor surgical outcomes. We aimed to include CT-muscle mass in malnutrition diagnosis using the Global Leadership Initiative on Malnutrition (GLIM) criteria, compare it to the International Classification of Diseases 10th Revision (ICD-10) criteria, and assess the impact on postoperative outcomes after oesophagogastric (OG) cancer surgery. METHODS: One hundred and eight patients who underwent radical OG cancer surgery and had preoperative abdominal CT imaging were included. GLIM and ICD-10 malnutrition data were assessed against complication and survival outcomes. Low CT-muscle mass was determined using predefined cut-points. RESULTS: GLIM-defined malnutrition prevalence was significantly higher than ICD-10-malnutrition (72.2% vs. 40.7%, p < 0.001). Of the 78 patients with GLIM-defined malnutrition, low muscle mass (84.6%) was the predominant phenotypic criterion. GLIM-defined malnutrition was associated with pneumonia (26.9% vs. 6.7%, p = 0.010) and pleural effusions (12.8% vs. 0%, p = 0.029). Postoperative complications did not correlate with ICD-10 malnutrition. Severe GLIM (HR: 2.51, p = 0.014) and ICD-10 (HR: 2.15, p = 0.039) malnutrition were independently associated with poorer 5-year survival. CONCLUSIONS: GLIM criteria appear to identify more malnourished patients and more closely relate to surgical risk than ICD-10 malnutrition, likely due to incorporating objective muscle mass assessment.

Multidisciplinary inpatient rehabilitation for older adults with COVID-19: a systematic review and meta-analysis of clinical and process outcomes.

BACKGROUND: Older adults are at increased risk for disease severity and poorer prognosis following COVID-19 infection. The aim of this systematic review and meta-analysis is to explore the impact of multidisciplinary rehabilitation in the acute or post-acute hospital setting for older adults with COVID-19. METHODS: The Cochrane library, EMBASE, Cinahl and Medline (via EBSCO), PubMed, and Web of Science were systematically searched in June 2022 and a repeat search was completed in March 2023. Screening, data extraction and quality appraisal were conducted independently by two reviewers. Studies reporting outcomes for older adults following multidisciplinary rehabilitation (provided by two or more Health and Social Care Professionals) were included. Both observational and experimental study designs were included. The primary outcome was functional ability. Secondary outcomes included discharge disposition, acute hospital and rehabilitation unit length of stay, mortality, primary and secondary healthcare utilisation, and long-term effects of COVID-19. RESULTS: Twelve studies met the inclusion criteria, comprising a total of 570 older adults. Where reported, older adults stayed in the acute hospital for a mean of 18 days (95%CI, 13.35- 23.13 days) and in rehabilitation units for 19 days (95%CI, 15.88-21.79 days). There was a significant improvement in functional ability among older adults with COVID-19 who received multidisciplinary rehabilitation (REM, SMD = 1.46, 95% CI 0.94 to 1.98). The proportion of older adults who were discharged directly home following rehabilitation ranged from 62 to 97%. Two studies reported a 2% inpatient mortality rate of older persons during rehabilitative care. No study followed up patients after the point of discharge and no study reported on long term effects of COVID-19. CONCLUSIONS: Multidisciplinary rehabilitation may result in improved functional outcomes on discharge from rehabilitation units/centres for older adults with COVID-19. Findings also highlight the need for further research into the long-term effect of rehabilitation for older adults following COVID-19. Future research should comprehensively describe multidisciplinary rehabilitation in terms of disciplines involved and the intervention provided.

Experience and perceptions among rheumatoid arthritis patients following a telehealth-delivered dietary intervention: a qualitative study.

The effects of dietary modifications have been assessed in people living with rheumatoid arthritis (RA) with consistent benefits reported from clinical trials. However, the lived experience of making and sustaining positive dietary changes for people with RA remains unknown. The aim of this qualitative study was to explore the experiences of adults with RA and their perceptions of a 12-week telehealth-delivered dietary intervention and to assess the acceptability of the programme. Qualitative data was collected via four online focus groups with participants who had just completed a 12-week dietary intervention programme delivered through telehealth methods. Thematic analysis was used to code and summarize the identified key themes. Twenty-one adults with RA (47.5 ± 12.3 years, 90.5% females) were included in this qualitative study. Overarching themes included: (a) motivation to join the programme, (b) benefits of the programme, (c) factors influencing adherence to dietary prescription, and (d) advantages and disadvantages of telehealth. The study demonstrated that a dietary intervention delivered through telehealth methods by a Registered Dietitian (RD) appears to be well-accepted and may be used to complement face-to-face care for people with RA. The identified factors influencing the adoption of a healthier eating pattern will aid in the development of future dietary interventions for a RA population.

A Mediterranean and low-fat dietary intervention in non-alcoholic fatty liver disease patients: Exploring participant experience and perceptions about dietary change.

BACKGROUND: A Mediterranean diet (MD) appears to be beneficial in non-alcoholic fatty liver disease (NAFLD) patients in Mediterranean countries; however, the acceptability of a MD in non-Mediterranean populations has not been thoroughly explored. The present study aimed to explore the acceptability through understanding the barriers and enablers of the MD and low-fat diet (LFD) interventions as perceived by participating Australian adults from multicultural backgrounds with NAFLD. METHODS: Semi-structured telephone interviews were performed with 23 NAFLD trial participants at the end of a 12-week dietary intervention in a multicentre, parallel, randomised clinical trial. Data were analysed using thematic analysis. RESULTS: Participants reported that they enjoyed taking part in the MD and LFD interventions and perceived that they had positive health benefits from their participation. Compared with the LFD, the MD group placed greater emphasis on enjoyment and intention to maintain dietary changes. Novelty, convenience and the ability to swap food/meals were key enablers for the successful implementation for both of the dietary interventions. Flavour and enjoyment of food, expressed more prominently by MD intervention participants, were fundamental components of the diets with regard to reported adherence and intention to maintain dietary change. CONCLUSIONS: Participants randomised to the MD reported greater acceptability of the diet than those randomised to the LFD, predominantly related to perceived novelty and palatability of the diet.

'Good, honest food': older adults' and healthcare professionals' perspectives of dietary influences and food preferences in older age in Ireland.

BACKGROUND: This study aimed to explore older adults' and healthcare professionals' (HCPs) perceptions of dietary influences and food preferences in older age. METHODS: The research design was phenomenological qualitative description. Semistructured one-to-one interviews and focus groups were held separately with community-dwelling older adults and HCPs involved in care of the older person in Ireland. Data were analysed using inductive thematic analysis. RESULTS: A total of 47 adults aged 55+ years were recruited (50% male; 49% aged 60-69 years; 28% aged above 70 years), and 26 HCPs were involved, comprising dietitians (n = 8); geriatricians (n = 6); clinical therapists (n = 4); and nurses, pharmacists, catering managers and meal delivery service coordinators (n = 2 each). There are strong desires for 'good, honest food' within the diet for an older person; however, gaps in current nutrition priorities, dietary guidance and health promotion were perceived. There were differences in the perspectives held by HCPs and adults aged 55+ years, as some HCPs centred their discussion around nutrition for preventing sarcopenia, frailty or cognitive decline, whereas many adults aged 55+ years desired foods which promote cardiometabolic health and reflect wider personal health and environmental values. Other themes included the impact of health and lifestyle changes accompanying ageing on dietary priorities, the importance of personal and psychosocial values in determining food choice and the impact of the external food environment on accessibility and shopping experiences. CONCLUSIONS: Influences on dietary choice for the older person are multifactorial, driven by a range of health, psychological, sociocultural and environmental perspectives. Future nutrition priorities for older adults should encourage health-promoting approaches and not just disease-mitigating efforts.

Impact of a Mediterranean diet on hepatic and metabolic outcomes in non-alcoholic fatty liver disease: The MEDINA randomised controlled trial.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is predominantly managed by lifestyle intervention, in the absence of effective pharmacotherapies. Mediterranean diet (MedDiet) is the recommended diet, albeit with limited evidence. AIMS: To compare an ad libitum MedDiet to low-fat diet (LFD) in patients with NAFLD for reducing intrahepatic lipids (IHL) by proton magnetic resonance spectroscopy (1 H-MRS). Secondary outcomes include insulin resistance by homeostatic model of assessment (HOMA-IR), visceral fat by bioelectrical impedance analysis (BIA), liver stiffness measurement (LSM) and other metabolic outcomes. METHODS: In this parallel multicentre RCT, subjects were randomised (1:1) to MedDiet or LFD for 12 weeks. RESULTS: Forty-two participants (25 females [60%], mean age 52.3 ± 12.6 years) were included, 23 randomised to LFD and 19 to MedDiet.; 39 completed the study. Following 12 weeks, there were no between-group differences. IHL improved significantly within the LFD group (-17% [log scale]; p = .02) but not within the MedDiet group (-8%, p = .069). HOMA-IR reduced in the LFD group (6.5 ± 5.6 to 5.5 ± 5.5, p < .01) but not in the MedDiet group (4.4 ± 3.2 to 3.9 ± 2.3, p = .07). No differences were found for LSM (MedDiet 7.8 ± 4.0 to 7.6 ± 5.2, p = .429; LFD 11.8 ± 14.3 to 10.8 ± 10.2 p = .99). Visceral fat reduced significantly in both groups; LFD (-76% [log scale], p = <.0005), MedDiet (-61%, p = <.0005). CONCLUSIONS: There were no between-group differences for hepatic and metabolic outcomes when comparing MedDiet to LFD. LFD improved IHL and insulin resistance. Significant improvements in visceral fat were seen within both groups. This study highlights provision of dietary interventions in free-living adults with NAFLD is challenging.

Probiotic use in adults with cystic fibrosis is common and influenced by gastrointestinal health needs: A cross-sectional survey study.

BACKGROUND: Cystic fibrosis (CF) primarily affects the lung, however, gastrointestinal disorders and symptoms, including dysbiosis, also impact on morbidity and quality of life. There is interest in strategies to modulate the gastrointestinal microbiota, including probiotics, although the evidence remains inadequate to guide practice, and information on use is limited. The present study aimed to characterise probiotic use, beliefs and experiences of adults with CF. METHODS: A cross-sectional questionnaire study was conducted in adults with CF (n = 205) and a general population Control group (n = 158), recruited from Victoria, Australia. Participants were classified as probiotic 'Ever Users' or 'Never Users'. Outcomes included self-reported probiotic use and factors associated with probiotic use, which were analysed using logistic regression analysis. Open-ended questionnaire responses were thematically analysed. RESULTS: In total, 70% of adults with CF had ever used probiotics (supplements and/or foods), comparable to Controls (80%) (p = 0.03). Key reasons for CF probiotic use were gastrointestinal- and antibiotic-related (75%). Most CF Ever Users (73%) did not discuss probiotic use with CF clinicians and 33% were uncertain if probiotics had been helpful. Female gender (odds ratio [OR] = 2.82; 95% confidence interval [CI] = 1.36-5.87; p = 0.005), university-level education (OR = 2.73; 95% CI = 1.24-6.01; p = 0.01) and bloating on antibiotics (OR = 2.14; 95% CI = 1.04-4.40; p = 0.04) were independently associated with probiotic use in CF; as was female gender in Controls (OR = 2.84; 95% CI = 1.20-6.71; p = 0.02). CONCLUSIONS: Probiotics were used by adults with CF for gastrointestinal- and antibiotic-related reasons often without informing clinicians and despite uncertainty about perceived helpfulness. Further research investigating gastrointestinal outcomes of probiotics will inform practice recommendations guiding their use in CF and other chronic diseases.

Probiotic knowledge of adults with cystic fibrosis is limited but is associated with probiotic use: A cross-sectional survey study.

Background: Probiotics are used by people with cystic fibrosis (CF) and other chronic diseases to manage gastrointestinal symptoms. Aim: To describe probiotic knowledge; its relationship with probiotic use, probiotic information sources and factors influencing choice in adults with CF and a general population control group. Methods: A cross-sectional questionnaire study was conducted in adults with CF (n = 205) and Controls (n = 158). Probiotic knowledge was compared between CF and Controls using a knowledge score (maximum 5) based on predefined criteria: (1a) bacteria/microorganism; (1b) live; (2a) administered; (2b) adequate dose and (3) health benefit, using independent samples t-test. Two-way analysis of variance explored knowledge scores between CF and Control and between Ever User and Never User groups. Chi-square and Fisher's exact tests compared knowledge criterion, probiotic sources and influences on probiotic choice between groups. Thematic analysis of open-text responses explored probiotic-related knowledge and influences on probiotic decision making. Results: Knowledge scores (mean ± SD) did not differ between CF (1.70 ± 1.12) and Controls (1.89 ± 0.99), p = 0.13. Probiotic use was associated with knowledge score (p < 0.001). More CF Ever Users than Never Users correctly identified criteria 1a (65% vs. 38%), 1b (16% vs. 0%), 2a (45% vs. 22%) and 3 (73% vs. 42%) (all p < 0.005). CF participants considered 'dairy yoghurt' (69%), 'live cultures' (64%) and 'fermented foods' (37%) as 'all/mostly' probiotic sources. The internet was the commonest source of probiotic-related information. Conclusion: Probiotic knowledge and use were associated in adults with CF. Understanding of probiotic characteristics and sources were limited. Education is needed to help guide patient probiotic decision making.

The Cardio-Med survey tool: development and pilot validation of a FFQ in a multicultural cardiology cohort.

OBJECTIVE: (i) Describe the development of a multipurpose Cardio-Med survey tool (CMST) comprising a semi-quantitative FFQ designed to measure dietary intake in multicultural patients with or at high risk of CVD and (ii) report pilot evaluation of test-retest reliability and validity of the FFQ in measuring energy and nutrient intakes. DESIGN: The CMST was developed to identify CVD risk factors and assess diet quality over 1 year using an FFQ. Design of the ninety-three-item FFQ involved developing food portion photographs, and a list of foods appropriate for the Australian multicultural population allowing the capture of adherence to a Mediterranean diet pattern. The FFQ was administered twice, 2 weeks apart to assess test-retest reliability, whilst validity was assessed by comparison of the FFQ with a 3-d food record (3DFR). SETTING: The Northern Hospital and St Vincent's Hospital, Melbourne, Australia. PARTICIPANTS: Thirty-eight participants aged 34-81 years with CVD or at high risk. RESULTS: Test-retest reliability of the FFQ was good: intraclass correlation coefficient (ICC) ranged from 0·52 (Na) to 0·88 (alcohol) (mean 0·79), with energy and 70 % of measured nutrients being above 0·75. Validity was moderate: ICC ranged from 0·08 (Na) to 0·94 (alcohol) (mean 0·59), with energy and 85 % of measured nutrients being above 0·5. Bland-Altman plots demonstrated good levels of agreement between the FFQ and 3DFR for carbohydrates, protein, alcohol, vitamin D and Na. CONCLUSIONS: The CMST FFQ demonstrated good test-retest reliability and moderate validity for measuring dietary energy and nutrients in a multicultural Australian cardiology population.

Substantial inter-individual variations in insulin secretion and sensitivity across the glucometabolic spectrum.

Impaired insulin secretion and action are important for development of type 2 diabetes (T2D) and metabolic syndrome (MetS). Despite recognized heterogeneity of these glucometabolic disorders, few data are available of biological variation in insulin secretion and action among individuals with T2D and MetS. The aim of this study was to explore the inter-individual variations using gold standard methods in a cross-sectional study of two independent cohorts of phenotypically well-characterized subjects. Cohort I included 486 subjects with MetS, and cohort II 62 subjects with established T2D. First phase insulin secretion was defined as the incremental area under the curve 0-8 min (iAUC0-8 min) during an intravenous glucose tolerance test (IVGTT). Insulin sensitivity was measured as the insulin sensitivity index (SI) modelled from IVGTT in cohort I, and in II as total glucose disposal (TGD) estimated from a euglycaemic-hyperinsulinaemic clamp. Variation is given as total range and, fold-variation between 5%- and 95%-percentile. The iAUC0-8 min ranged from -60 to 3397 mUL-1min-1 among subjects with MetS and from -263 to 1194 mUL-1min-1 in subjects with T2D, representing a more than 10-fold variation. Insulin sensitivity ranged from SI 0.19 to 15.29 (mU/L)-1min-1 among subjects with MetS and TGD 12.9-101.6 µmolkgFFM-1min-1 in subjects with T2D, representing a 6.8 and 5.5-fold variation, respectively. The other components of MetS; BMI, waist-hip ratio, HDL-cholesterol, triglycerides and blood pressure (BP), showed a 1.4-4.7-fold variation. In conclusion, our data demonstrated extensive inter-individual variations in insulin secretion and sensitivity. These variations may be essential to take into account when planning clinical research and treatment in subjects with T2D and MetS.

The prevalence of malnutrition and impact on patient outcomes among older adults presenting at an Irish emergency department: a secondary analysis of the OPTI-MEND trial.

BACKGROUND: Malnutrition is common among older adults and is associated with adverse outcomes but remains undiagnosed on healthcare admissions. Older adults use emergency departments (EDs) more than any other age group. This study aimed to determine the prevalence and factors associated with malnutrition on admission and with adverse outcomes post-admission among older adults attending an Irish ED. METHODS: Secondary analysis of data collected from a randomised controlled trial exploring the impact of a dedicated team of health and social care professionals on the care of older adults in the ED. Nutritional status was determined using the Mini Nutritional Assessment- short form. Patient parameters and outcomes included health related quality of life, functional ability, risk of adverse health outcomes, frailty, hospital admissions, falls history and clinical outcomes at index visit, 30-day and 6-month follow up. Aggregate anonymised participant data linked from index visit to 30-days and 6-month follow-up were used for statistical analysis. RESULTS: Among 353 older adults (mean age 79.6 years (SD = 7.0); 59.2% (n = 209) female) the prevalence of malnutrition was 7.6% (n = 27) and 'risk of malnutrition' was 28% (n = 99). At baseline, those who were malnourished had poorer quality of life scores, functional ability, were more frail, more likely to have been hospitalised or had a fall recently, had longer waiting times and were more likely to be discharged home from the ED than those who had normal nutrition status. At 30-days, those who were malnourished were more likely to have reported another hospital admission, a nursing home admission, reduced quality of life and functional decline than older adults who had normal nutrition status at the baseline ED visit. Differences between the MNA SF and 6-month outcomes were similar but not statistically significant. CONCLUSION: Over one-third of older adults admitted to an Irish ED are either malnourished or at risk of malnourishment. Malnutrition was associated with a longer stay in the ED, functional decline, poorer quality of life, increased risk of hospital admissions and a greater likelihood of admission to a nursing home at 30 days. TRIAL REGISTRATION: Protocol registered in ClinicalTrials.gov, ID: NCT03739515 , first posted November 13, 2018.

Validity of multi-frequency bioelectric impedance methods to measure body composition in obese patients: a systematic review.

OBJECTIVE: Excessive lean tissue loss following bariatric surgery may pose serious metabolic consequences. Accurate methods to assess body composition following bariatric surgery are required. This review aimed to investigate if multi-frequency bioelectric impedance (MF-BI) is a valid tool to determine body composition in obese patients. METHODS: MEDLINE, EMBASE, CINAHL and CENTRAL databases were searched until March 2017. Included studies were published in English with obese (body mass index (BMI) ≥ 30 kg/m2) adults measuring body composition with MF-BI methods in comparison with reference methods. Exclusions were pregnancy, animal studies, non-English language studies, single frequency BI. A total of 6395 studies were retrieved. RESULTS: Sixteen studies were eligible for inclusion. Sample sizes ranged from 15 to 157, with BMI 26-48 kg/m2. MF-BI underestimated fat mass (FM) in 11 studies and overestimated fat-free mass (FFM) in nine studies in comparison with reference methods. Correlations of absolute values from MF-BI and reference methods for FM and FFM were high, however, agreement was lower at an individual level. When adjustments for BMI were made to machine algorithms, measurement accuracy improved. Significant heterogeneity was evident among included studies. CONCLUSIONS: This review found that MF-BI is reliable for use at a group level. Obese-specific adjustment of algorithms for MF-BI machines increases the accuracy of absolute measures of body composition in obese individuals, improving their utility in the clinical setting. Multiple variables contributed a lack of consistency among studies included, highlighting the need for more robust studies that control confounding variables to establish clear validity assessment.

The effect of high-polyphenol extra virgin olive oil on cardiovascular risk factors: A systematic review and meta-analysis.

The polyphenol fraction of extra-virgin olive oil may be partly responsible for its cardioprotective effects. The aim of this systematic review and meta-analysis was to evaluate the effect of high versus low polyphenol olive oil on cardiovascular disease (CVD) risk factors in clinical trials. In accordance with PRISMA guidelines, CINAHL, PubMed, Embase and Cochrane databases were systematically searched for relevant studies. Randomized controlled trials that investigated markers of CVD risk (e.g. outcomes related to cholesterol, inflammation, oxidative stress) were included. Risk of bias was assessed using the Jadad scale. A meta-analysis was conducted using clinical trial data with available CVD risk outcomes. Twenty-six studies were included. Compared to low polyphenol olive oil, high polyphenol olive oil significantly improved measures of malondialdehyde (MD: -0.07µmol/L [95%CI: -0.12, -0.02µmol/L]; I2: 88%; p = 0.004), oxidized LDL (SMD: -0.44 [95%CI: -0.78, -0.10µmol/L]; I2: 41%; P = 0.01), total cholesterol (MD 4.5 mg/dL [95%CI: -6.54, -2.39 mg/dL]; p<0.0001) and HDL cholesterol (MD 2.37 mg/dL [95%CI: 0.41, 5.04 mg/dL]; p = 0.02). Subgroup analyses and individual studies reported additional improvements in inflammatory markers and blood pressure. Most studies were rated as having low-to-moderate risk of bias. High polyphenol oils confer some CVD-risk reduction benefits; however, further studies with longer duration and in non-Mediterranean populations are required.

The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial): A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol.

The Mediterranean diet was first characterized as a heart-protective diet in the 1960s. The significant cardioprotective effects of the Mediterranean diet in comparison to the standard-care low-fat diet have been established in the primary prevention of cardiovascular disease (CVD); however, there is insufficient evidence in secondary prevention research to influence the current standard of care. Opportunity exists to assess the Mediterranean diet as a therapeutic target for secondary CVD prevention within Australia's ethnoculturally diverse communities. The AUSMED Heart Trial is a multisite randomized controlled trial that will evaluate the efficacy of the Mediterranean diet for secondary prevention of CVD in the Australian health care setting. This trial aims to evaluate the effect of a 6-month Mediterranean diet intervention (delivered by dietitians) versus a "standard-care" low-fat diet in reducing the composite incidence of cardiovascular events at 12 months and at trial end in participants with documented evidence of a previous acute myocardial infarction at trial entry. The quality of the diet at baseline and follow-up will be assessed using comprehensive dietary questionnaires and diaries as well as relevant dietary biomarkers (such as urinary polyphenols and erythrocyte fatty acids). Cardiovascular risk markers, including novel measures of immune and inflammatory status, endothelial function, vascular compliance, platelet activity, and body composition, will be collected to explore possible mechanisms for treatment effect. Cost-effectiveness will also be estimated to support policy translation. We plan to recruit 1,032 participants (516 per arm) from cardiology clinics in major Australian hospitals in Melbourne, Adelaide, and Brisbane.

Changing the Irish dietary guidelines to incorporate the principles of the Mediterranean diet: proposing the MedÉire diet.

OBJECTIVE: In Ireland, the major causes of death are CVD. The current Irish healthy eating guidelines and food pyramid primarily advocate a low-fat diet. However, there is overwhelming scientific evidence for the benefits of a Mediterranean diet (Med Diet) in the prevention and management of metabolic disease as well as improving overall health and well-being. In the current commentary, the rationale to incorporate the principles of the Med Diet into the Irish dietary guidelines is presented. DESIGN: Perspectives of authors. SETTING: Local and international. SUBJECTS: Populations in Europe, North America and Australia. RESULTS: Adopting components of the Med Diet presents a more evidence-based approach to updating the current Irish dietary guidelines. Experience and lessons from other non-Mediterranean countries show that it could be a feasible and effective solution to improving the dietary habits of the Irish population to prevent and mange chronic diseases. CONCLUSIONS: Policies and programmes to address perceived barriers to the Med Diet's implementation and uptake in non-Mediterranean countries should be promoted.

Non-alcoholic fatty liver disease patients attending two metropolitan hospitals in Melbourne, Australia: high risk status and low prevalence.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease globally, with increased rates in high-risk populations, including type 2 diabetes and obesity. The condition increases the risk of end-stage liver disease, hepatocellular carcinoma and all-cause mortality. NAFLD is asymptomatic and often remains undiagnosed as routine screening in high-risk groups is not practised. AIMS: The aim of this study was to determine the rates and characteristics of NAFLD patients attending liver clinics at two Melbourne metropolitan hospitals. METHODS: Liver clinics were prospectively screened for 10 consecutive months and participants with a diagnosis of NAFLD were further evaluated using pathology and imaging results obtained from medical records. RESULTS: Of the 2050 patients screened, 148 (7%) had NAFLD predominantly diagnosed using ultrasound (81%). NAFLD patients were obese (mean body mass index 30.7 ± 5.9 kg/m2 ), insulin resistant (median HOMA 4.2 (3.2) mmol/L) and had elevated liver enzymes (ALT median, males 47.0 (34.3), females 36.0 (28.0) U/L), and 18% of patients had liver stiffness measuring >12 kPa, suggesting a moderate probability of cirrhosis. Patients with liver stiffness measuring ≥9.6 kPa had significantly higher: glucose (median 5.5 (1.2) vs 6.2 (5.3) mmol/L, P = 0.007), aspartate aminotransferase levels (median 25.5 (26.0) vs 41.0 (62.0) u/L, P = 0.0005) and HOMA (3.1 (3.0) vs 5.4 (5.5) mmol/L, P = 0.040). CONCLUSIONS: NAFLD constituted a minority of liver clinic patients, most of who were obese, insulin resistant and hypertensive, and many had an elevated liver stiffness measurement. NAFLD poses added adverse health outcomes to high-risk patients, and therefore, early detection is warranted.

Improvement in exercise duration, lung function and well-being in G551D-cystic fibrosis patients: a double-blind, placebo-controlled, randomized, cross-over study with ivacaftor treatment.

G551D, a mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, results in impaired chloride channel function in cystic fibrosis (CF) with multiple end-organ manifestations. The effect of ivacaftor, a CFTR-potentiator, on exercise capacity in CF is unknown. Twenty G551D-CF patients were recruited to a single-centre, double-blind, placebo-controlled, 28-day crossover study of ivacaftor. Variables measured included percentage change from baseline (%Δ) of VO2max (maximal oxygen consumption, primary outcome) during cardiopulmonary exercise testing (CPET), relevant other CPET physiological variables, lung function, body mass index (BMI), sweat chloride and disease-specific health related quality of life (QOL) measures (CFQ-R and Alfred Wellness (AWEscore)). %ΔVO2max was unchanged compared with placebo as was %Δminute ventilation. However, %Δexercise time (mean 7.3, CI 0.5-14,1, P=0.0222) significantly increased as did %ΔFEV1 (11.7%, range 5.3-18.1, P<0·005) and %ΔBMI (1.2%, range 0.1-2.3, P=0·0393) whereas sweat chloride decreased (mean -43.4; range -55.5-18.1 mmol·l-1, P<0·005). Total and activity based domains in both CFQ-R and AWEscore also increased. A positive treatment effect on spirometry, BMI (increased), SCT (decreased) and total and activity based CF-specific QOL measures was expected. However, the lack of discernible improvement in VO2max and VE despite other positive changes including spirometric lung function and exercise time with a 28-day ivacaftor intervention suggests that ventilatory parameters are not the sole driver of change in exercise capacity in this study cohort. Investigation over a more prolonged period may delineate the potential interdependencies of the observed discordances over time. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov-NCT01937325.

A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Non Alcoholic Fatty Liver Disease (MEDINA): study protocol.

BACKGROUND: Non-alcoholic fatty liver disease, the most prevalent liver disease in developed countries, remains difficult to manage with no proven safe and effective pharmacotherapy available. While weight reduction is the most commonly practiced treatment strategy, this is difficult to both achieve and/or maintain in the majority. Furthermore evidence-based dietary recommendations to guide the nutritional management of these patients are lacking. Using a randomised controlled trial design, this study compares the effectiveness of the Mediterranean diet to a standard low fat diet in terms of differences in insulin sensitivity, hepatic steatosis and metabolic outcomes in participants with non-alcoholic fatty liver disease. METHODS: Ninety four eligible patients who have non-alcoholic fatty liver disease and who are insulin resistant, will be randomised into either a Mediterranean or low fat diet group for a 3 month intervention period. Insulin sensitivity will be measured on peripheral blood using Homeostatic Model Assessment and liver fat content quantified using Magnetic Resonance Spectroscopy. Both arms will consist of three face to face and three telephone call follow up consultations delivered by an Accredited Practicing Dietitian. The intervention arm focuses on recommendations from the traditional Mediterranean diet which have been tailored for use in the Australian population The standard arm uses the Australian Guide to Healthy Eating and the Australian National Heart Foundation dietary guidelines. Study recruitment will take place at four major metropolitan hospitals in Melbourne, Australia. Data collection will occur at all face to face reviews including baseline, 6, and 12 weeks. A follow up assessment to measure sustainability will take place at 6 and 12 months. The primary end point is improved insulin sensitivity scores at the 12 week time point. DISCUSSION: This trial aims to demonstrate in a large cohort of participants with NALFD that a Mediterranean diet independent of weight loss can result in significant benefits in liver fat and insulin sensitivity and that these changes are sustained at 12 months. These metabolic changes would potentially lead to reductions in the risk of chronic liver disease, heart disease, type 2 diabetes and liver cancer. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register ACTRN: ACTRN12615001010583 .

A behavioural nutrition intervention for obese pregnant women: Effects on diet quality, weight gain and the incidence of gestational diabetes.

BACKGROUND: Obese pregnant women have an increased risk of antenatal, intra- and post-partum complications. At present, there is limited evidence to support specific nutritional management of obese women in pregnancy, and guidelines are infrequently translated into practice. AIMS: To implement an individually tailored nutrition program for obese pregnant women to reduce the rates of gestational diabetes mellitus (GDM), improve diet quality, achieve weight gain targets, limit gestational weight gain (GWG) and reduce complications for mother and child. METHODS: A prospective dietary intervention study was conducted at a hospital in Melbourne, Australia, using a parallel control group from the Birthing Outcomes System (BOS) database. Obese pregnant women were included if they were ≤21 weeks gestation and aged ≥18 years. The intervention group received one face-to-face dietitian-delivered consultation, with reviews conducted over the phone. RESULTS: A total of 92 and 125 obese pregnant women were enrolled into the dietary intervention group and BOS control group, respectively. The diet quality of intervention participants improved, without significant differences in GWG across groups. In the control group, 19.3% of women developed GDM, compared to 6.5% in the diet group (P 0.013). However, after adjusting for ethnicity and body mass index, the association between the diet group and GDM incidence was no longer significant. CONCLUSIONS: This study demonstrates that a behavioural nutrition intervention, individually tailored for obese pregnant women can improve diet quality. A larger randomised controlled trial targeted at obese pregnant women, with comparable groups at baseline, is required to observe the effects of dietary improvement on GDM incidence, and other maternal and neonatal outcomes.