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Study Protocol for a Stepped-Wedge Cluster (Nested) Randomized Controlled Trial of Antenatal Colostrum Expression (ACE) Instruction in First-Time Mothers: The ACE Study.
Cuffe, C, Giglia, R, Cooper, MN, Hill, J, Silva, D, Moorhead, AM, Verhasselt, V, Lewis, JR, Ireson, D, Demirci, JR, et al
Journal of human lactation : official journal of International Lactation Consultant Association. 2024;(1):80-95
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Abstract
BACKGROUND Although many mothers initiate breastfeeding, supplementation with human-milk substitutes (formula) during the birth hospitalization is common and has been associated with early breastfeeding cessation. Colostrum hand expressed in the last few weeks before birth, known as antenatal colostrum expression (ACE), can be used instead of human-milk substitutes. However, evidence is lacking on the efficacy of ACE on breastfeeding outcomes and in non-diabetic mothers. METHODS AND PLANNED ANALYSIS This multicenter stepped-wedge cluster (nested) randomized controlled trial aims to recruit 945 nulliparous pregnant individuals. The trial is conducted in two phases. During Phase 1, control group participants are under standard care. During Phase 2, participants are randomized to ACE instruction via a pre-recorded online video or a one-on-one session with a midwife. Adjusted logistic regression analysis will be used to examine the relationship between ACE instruction and breastfeeding outcomes. RESEARCH AIMS AND QUESTIONS Primary aim: (1) Does advising pregnant individuals to practice ACE and providing instruction improve exclusive breastfeeding rates at 4 months postpartum? Secondary research questions: (2) Do individuals who practice ACE have higher rates of exclusive breastfeeding during the initial hospital stay after birth? (3) Is teaching ACE via an online video non-inferior to one-on-one instruction from a midwife? (4) Does expressing colostrum in pregnancy influence time to secretory activation, or (5) result in any differences in the composition of postnatal colostrum? DISCUSSION Trial findings have important implications for maternity practice, with the online video providing an easily accessible opportunity for ACE education as part of standard antenatal care.
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Protocol: Can coronary artery calcium score identified on thoracic planning CT scans be used and actioned to identify cancer survivors at high risk of cardiac events: A feasibility study in cancer survivors undergoing radiotherapy in Australia.
Dalla Via, J, Stewart, N, Kennedy, MA, Cehic, DA, Purnell, P, Toohey, J, Morton, J, Ramchand, SK, Lewis, JR, Zissiadis, Y
BMJ open. 2023;(7):e072376
Abstract
INTRODUCTION A coronary artery calcium (CAC) CT scan can identify calcified plaque and predict risk of future cardiac events. Cancer survivors undergoing thoracic radiotherapy routinely undergo a planning CT scan, which presents a unique opportunity to use already obtained medical imaging to identify those at the highest risk of cardiac events. While radiation therapy is an important modality for many cancer treatments, radiation dose to the heart in thoracic radiotherapy leads to cardiotoxicity and may accelerate pre-existing atherosclerosis. The primary aims of this study are to investigate the feasibility of using CAC scores calculated on thoracic radiotherapy planning CT scans to identify a subset of cancer survivors at an increased risk of future cardiac events, and to establish and evaluate a referral pathway for assessment and management in a cardio-oncology clinic. An optional substudy aims to investigate using abdominal aortic calcification (AAC) as a practical, low-radiation alternative to CAC to evaluate and monitor vascular health. METHODS AND ANALYSIS This is an observational, prospective study in a minimum of 100 cancer survivors commencing radiotherapy. Participants will have CAC scored from thoracic radiotherapy planning CT scans. Those identified as high risk (CAC score>0) will be referred to a cardio-oncology clinic. Feasibility, determined by adherence to the recommended pathway, and impact on quality of life and anxiety measured via questionnaire, will be assessed. Participants in Western Australia will be invited to participate in a 12-month observational pilot substudy, investigating lifestyle behaviours and the use of a dual-energy X-ray absorptiometry machine to measure musculoskeletal health and AAC. ETHICS AND DISSEMINATION Ethics approval has been obtained from St Vincent's Hospital, Sydney (Project number 2021/ETH11847), GenesisCare and Edith Cowan University (2022-03326-DALLAVIA). Study results will be reported in peer-reviewed academic journals, at scientific conferences, and at clinical forums, irrespective of the results observed. TRIAL REGISTRATION NUMBER ACTRN12621001343897.
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Evidence for the cardiovascular effects of osteoporosis treatments in randomized trials of post-menopausal women: A systematic review and Bayesian network meta-analysis.
Seeto, AH, Tadrous, M, Gebre, AK, Lewis, JR, Fink, HA, Ebeling, PR, Rodríguez, AJ
Bone. 2023;:116610
Abstract
Osteoporosis medications have been reported to have beneficial and harmful cardiovascular effects. Much of this evidence stems from single reports and as such, a comprehensive examination of the evidence is needed. We conducted a network meta-analysis (NMA) of cardiovascular adverse event (CAE) data from randomized trials of osteoporosis medications in postmenopausal women. Trials were identified from recent NMAs of osteoporosis treatment for fracture reduction with an updated literature search (December 2020). Included studies were randomized, included over 100 participants, and reported skeletal primary outcomes. We investigated three-point major adverse cardiovascular events (MACE3), four- (MACE4) and five-point MACE (MACE5), as well as myocardial infarction (MI) and stroke. Data were synthesized in a random-effects network meta-analysis using Bayesian modelling. Probabilistic ranking of treatment safety was performed. Relative to placebo, point estimates for the odds ratios (OR) with 95 % credible intervals (CrI) were also generated. We identified 75 trials (n = 136,940 women), of which 27 (68,699 women, nine arms) reported CAEs. In women randomized to placebo, the overall event rate for the MACE3 outcome was 2.58 % compared with 1.99 % in those randomized to all other active comparators. Probabilistic ranking found abaloparatide, oral bisphosphonates, teriparatide, and menopausal hormone therapy were less likely to have increased risk of CAEs than placebo, while romosozumab ranked more likely to have increased risk of CAEs than placebo for all outcomes. Compared with placebo, abaloparatide (one trial, n = 1642) was associated with a reduced odds for MACE3 (OR = 0·31; 95%CrI: 0·06 to 0·99), MACE4 (0·28; 0·06 to 0·88) and MACE5 (0·25; 0·06 to 0·79). When all PTH analogues were grouped together, magnitude and direction of effects were consistent but no longer statistically significant. We did not find pooled direct and indirect evidence that osteoporosis treatments significantly increased the risk of adverse cardiovascular events relative to placebo. (PROSPERO CRD42020178702).
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Measures of carotid atherosclerosis and fall-related hospitalization risk: The Perth Longitudinal Study of Ageing Women.
Gebre, AK, Sim, M, Via, JD, Rodríguez, AJ, Hodgson, JM, Bondonno, CP, Thompson, PL, Prince, RL, Lewis, JR
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2023;(1):95-104
Abstract
BACKGROUND AND AIMS We and others have identified links between cardiovascular conditions and poor musculoskeletal health. However, the relationship between measures of carotid atherosclerosis such as focal carotid plaque and common carotid intima media thickness (CCA-IMT) and falls remains understudied. This study examined the association between measures of carotid atherosclerosis and fall-related hospitalization over 11.5 years in community dwelling older women. METHODS AND RESULTS 1116 older women recruited in 1998 to a five-year randomized controlled trial to examine the effect of calcium supplementation in preventing fracture and who had undertaken B-mode ultrasound in 2001 (three years after the baseline clinical visit) were included in this study. The participants were followed for over 11.5 years as Perth Longitudinal Study of Ageing Women (PLSAW). Over the follow up period, 428 (38.4%) women experienced a fall-related hospitalization. Older women with carotid plaque had 44% a higher relative hazard for fall-related hospitalization (HR 1.44; 95%CI, 1.18 to 1.76) compared to those without carotid plaque. The association persisted after adjustment for established falls risk factors such as measures of muscle strength and physical function.Each SD increase in the mean and maximum CCA-IMT was also associated with a higher risk of fall-related hospitalizations (HR 1.10; 95%CI, 1.00 to 1.21 and HR 1.11; 95%CI, 1.01 to 1.22, respectively). CONCLUSIONS Measures of carotid atherosclerosis are associated with a higher risk of fall-related hospitalization independent of established falls risk factors. These findings suggest the importance of vascular health when considering falls risk.
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Psychological distress and quality of life in asymptomatic adults following provision of imaging results for prevention of cardiovascular disease events: a scoping review.
Anokye, R, Jackson, B, Dimmock, J, Dickson, JM, Blekkenhorst, LC, Hodgson, JM, Lewis, JR, Stanley, M
European journal of cardiovascular nursing. 2023;(1):13-22
Abstract
AIMS: Psychological distress and changes in health-related quality of life (HRQoL) may occur after screening for disease. Reporting outcomes related to potential benefits and harms of screening is a key recommendation in the guidelines for reporting high-quality trials or interventions. However, no reviews have directly investigated outcomes related to psychological distress and/or changes in HRQoL following imaging assessment of cardiovascular risk and communication of cardiovascular findings to asymptomatic adults. A scoping review was conducted to map research on psychological distress and/or HRQoL following screening. METHODS AND RESULTS Six electronic databases (MEDLINE, PsychINFO, Social Work Abstracts, Psychology and Behavioural Sciences Collection, CINAHL, and EMBASE) were searched for articles that assessed psychological distress and/or HRQoL following screening. Two investigators independently screened titles and abstracts for all records retrieved using predefined criteria. Studies were conducted among active smokers, military personnel, athletes, post-menopausal women, and high-risk individuals. Seven constructs related to psychological distress and HRQoL appeared across 11 articles (randomized controlled trials, n = 4 and non-randomized studies, n = 7). Worry, depression, perceived stress, anxiety, and quality of life were most prominent. Multiple-item measures of psychological distress (e.g. Taylor Anxiety Score and Beck Depression Inventory) were used in 5/9 (56%) studies. Key findings on psychological distress and/or changes in HRQoL following screening were mixed. CONCLUSIONS Findings support the need for multiple-item measures with better psychometric properties to examine the psychological responses to screening results in future studies. Strategies to support individuals during and following vascular screening to maximise potential benefits of screening and minimize harms are discussed.
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Three-dimensional food printing: its readiness for a food and nutrition insecure world.
Zhong, L, Lewis, JR, Sim, M, Bondonno, CP, Wahlqvist, ML, Mugera, A, Purchase, S, Siddique, KHM, Considine, MJ, Johnson, SK, et al
The Proceedings of the Nutrition Society. 2023;(4):468-477
Abstract
Three-dimensional (3D) food printing is a rapidly emerging technology offering unprecedented potential for customised food design and personalised nutrition. Here, we evaluate the technological advances in extrusion-based 3D food printing and its possibilities to promote healthy and sustainable eating. We consider the challenges in implementing the technology in real-world applications. We propose viable applications for 3D food printing in health care, health promotion and food waste upcycling. Finally, we outline future work on 3D food printing in food safety, acceptability and economics, ethics and regulations.
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Abdominal Aortic Calcification, Bone Mineral Density, and Fractures: A Systematic Review and Meta-analysis of Observational Studies.
Gebre, AK, Lewis, JR, Leow, K, Szulc, P, Scott, D, Ebeling, PR, Sim, M, Wong, G, Lim, WH, Schousboe, JT, et al
The journals of gerontology. Series A, Biological sciences and medical sciences. 2023;(7):1147-1154
Abstract
BACKGROUND Abdominal aortic calcification (AAC) has been inconsistently associated with skeletal health. We aimed to investigate the association of AAC with bone mineral density (BMD) and fracture risk by pooling the findings of observational studies. METHODS MEDLINE, EMBASE, Web of Science, and Google Scholar were searched (August 2021). All clinical studies that assessed the association between AAC and BMD or fracture were included. AAC was categorized into any/advanced (all higher reported groups) versus no/less advanced (lowest reported group). Pooled standardized mean differences (SMDs) and risk ratios (RRs) with 95% confidence intervals (CI) were determined for BMD and fracture, respectively, using random-effects models. RESULTS Of 2 192 articles screened, 86 (61 553 participants) were included in the review, while 42 provided data for meta-analysis. AAC was associated with lower BMD at the total hip (SMD = -1.05 [95%CI: -1.47 to -0.63]; 16 studies), femoral neck (-0.25 [-0.46 to-0.04]; 10), and lumbar spine (-0.67 [-1.21 to -0.12]; 20). AAC was associated with a greater risk of any fracture (RR = 1.73 [95%CI: 1.48-2.02]; 27). AAC was also associated with vertebral, non-vertebral, and hip fractures. In dose-response analysis, the highest AAC group had greater risks of any, vertebral and non-vertebral fractures. CONCLUSIONS AAC is associated with lower BMD and increased fracture risk at multiple sites, underscoring the potential importance of vascular disease on skeletal health. Detection of AAC at the time of BMD testing may provide clinicians with prognostic information about bone health to enhance osteoporosis screening programs and fracture risk prediction.
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Consensus guidelines for sarcopenia prevention, diagnosis and management in Australia and New Zealand.
Zanker, J, Sim, M, Anderson, K, Balogun, S, Brennan-Olsen, SL, Dent, E, Duque, G, Girgis, CM, Grossmann, M, Hayes, A, et al
Journal of cachexia, sarcopenia and muscle. 2023;(1):142-156
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Abstract
BACKGROUND Sarcopenia is an age-associated skeletal muscle condition characterized by low muscle mass, strength, and physical performance. There is no international consensus on a sarcopenia definition and no contemporaneous clinical and research guidelines specific to Australia and New Zealand. The Australian and New Zealand Society for Sarcopenia and Frailty Research (ANZSSFR) Sarcopenia Diagnosis and Management Task Force aimed to develop consensus guidelines for sarcopenia prevention, assessment, management and research, informed by evidence, consumer opinion, and expert consensus, for use by health professionals and researchers in Australia and New Zealand. METHODS A four-phase modified Delphi process involving topic experts and informed by consumers, was undertaken between July 2020 and August 2021. Phase 1 involved a structured meeting of 29 Task Force members and a systematic literature search from which the Phase 2 online survey was developed (Qualtrics). Topic experts responded to 18 statements, using 11-point Likert scales with agreement threshold set a priori at >80%, and five multiple-choice questions. Statements with moderate agreement (70%-80%) were revised and re-introduced in Phase 3, and statements with low agreement (<70%) were rejected. In Phase 3, topic experts responded to six revised statements and three additional questions, incorporating results from a parallel Consumer Expert Delphi study. Phase 4 involved finalization of consensus statements. RESULTS Topic experts from Australia (n = 62, 92.5%) and New Zealand (n = 5, 7.5%) with a mean ± SD age of 45.7 ± 11.8 years participated in Phase 2; 38 (56.7%) were women, 38 (56.7%) were health professionals and 27 (40.3%) were researchers/academics. In Phase 2, 15 of 18 (83.3%) statements on sarcopenia prevention, screening, assessment, management and future research were accepted with strong agreement. The strongest agreement related to encouraging a healthy lifestyle (100%) and offering tailored resistance training to people with sarcopenia (92.5%). Forty-seven experts participated in Phase 3; 5/6 (83.3%) revised statements on prevention, assessment and management were accepted with strong agreement. A majority of experts (87.9%) preferred the revised European Working Group for Sarcopenia in Older Persons (EWGSOP2) definition. Seventeen statements with strong agreement (>80%) were confirmed by the Task Force in Phase 4. CONCLUSIONS The ANZSSFR Task Force present 17 sarcopenia management and research recommendations for use by health professionals and researchers which includes the recommendation to adopt the EWGSOP2 sarcopenia definition in Australia and New Zealand. This rigorous Delphi process that combined evidence, consumer expert opinion and topic expert consensus can inform similar initiatives in countries/regions lacking consensus on sarcopenia.
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Impact of vascular screening interventions on perceived threat, efficacy beliefs and behavioural intentions: a systematic narrative review.
Anokye, R, Jackson, B, Dimmock, J, Dickson, JM, Kennedy, MA, Schultz, CJ, Blekkenhorst, LC, Hodgson, JM, Stanley, M, Lewis, JR
Health promotion international. 2023;(3)
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Health-related behaviours contribute to the global burden of cardiovascular disease (CVD). Cardiovascular imaging can be used to screen asymptomatic individuals for increased risk of CVD to enable earlier interventions to promote health-related behaviours to prevent or reduce CVD risk. Some theories of behaviour and behaviour change assume that engagement in a given behaviour is a function of individual threat appraisals, beliefs regarding the performance of behaviour, self-efficacy for performing the desired behaviour and/or dispositions to act (e.g. behavioural intentions). To date, little is known about the impact of cardiovascular imaging interventions on these constructs. This article summarises evidence related to perceived threat, efficacy beliefs, and behavioural intentions after CVD screening. We identified 10 studies (2 RCTs and 8 non-randomised studies, n = 2498) through a combination of screening citations from published systematic reviews and meta-analyses and searching electronic databases. Of these, 7 measured behavioural intentions and perceived susceptibility and 3 measured efficacy beliefs. Findings showed largely encouraging effects of screening interventions on bolstering self-efficacy beliefs and strengthening behavioural intentions. Imaging results that suggest the presence of coronary or carotid artery disease also increased perceived susceptibility to CVD. However, the review also identified some gaps in the literature, such as a lack of guiding theoretical frameworks and assessments of critical determinants of health-related behaviours. By carefully considering the key issues highlighted in this review, we can make significant strides towards reducing CVD risks and improving population health.
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The effect of vitamin K1 on arterial calcification activity in subjects with diabetes mellitus: a post hoc analysis of a double-blind, randomized, placebo-controlled trial.
Bellinge, JW, Francis, RJ, Lee, SC, Bondonno, NP, Sim, M, Lewis, JR, Watts, GF, Schultz, CJ
The American journal of clinical nutrition. 2022;(1):45-52
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BACKGROUND Coronary and aortic artery calcifications are generally slow to develop, and their burden predicts cardiovascular disease events. In patients with diabetes mellitus, arterial calcification is accelerated and calcification activity can be detected using 18F-sodium fluoride positron emission tomography (18F-NaF PET). OBJECTIVES We aimed to determine whether vitamin K1 supplementation inhibits arterial calcification activity in individuals with diabetes mellitus. METHODS This was a post hoc analysis of the ViKCoVaC (effect of Vitamin-K1 and Colchicine on Vascular Calcification activity in subjects with Diabetes Mellitus) double-blind randomized controlled trial conducted in Perth, Western Australia. Individuals with diabetes mellitus and established coronary calcification (coronary calcium score > 10), but without clinical coronary artery disease, underwent baseline 18F-NaF PET imaging, followed by oral vitamin K1 supplementation (10 mg/d) or placebo for 3 mo, after which 18F-NaF PET imaging was repeated. We tested whether individuals randomly assigned to vitamin K1 supplementation had reduced development of new 18F-NaF PET positive lesions within the coronary arteries and aorta. RESULTS In total, 149 individuals completed baseline and follow-up imaging studies. Vitamin K1 supplementation independently decreased the odds of developing new 18F-NaF PET positive lesions in the coronary arteries (OR: 0.35; 95% CI: 0.16, 0.78; P = 0.010), aorta (OR: 0.27; 95% CI: 0.08, 0.94; P = 0.040), and in both aortic and coronary arteries (OR: 0.28; 95% CI: 0.13, 0.63; P = 0.002). CONCLUSIONS In individuals with diabetes mellitus, supplementation with 10 mg vitamin K1/d may prevent the development of newly calcifying lesions within the aorta and the coronary arteries as detected using 18F-NaF PET. Further long-term studies are needed to test this hypothesis.This trial was registered at anzctr.org.au as ACTRN12616000024448.