Retinal Dystrophies Associated With Peripherin-2: Genetic Spectrum and Novel Clinical Observations in 241 Patients.

Purpose: To describe the clinical, electrophysiological and genetic spectrum of inherited retinal diseases associated with variants in the PRPH2 gene. Methods: A total of 241 patients from 168 families across 15 sites in 9 countries with pathogenic or likely pathogenic variants in PRPH2 were included. Records were reviewed for age at symptom onset, visual acuity, full-field ERG, fundus colour photography, fundus autofluorescence (FAF), and SD-OCT. Images were graded into six phenotypes. Statistical analyses were performed to determine genotype-phenotype correlations. Results: The median age at symptom onset was 40 years (range, 4-78 years). FAF phenotypes included normal (5%), butterfly pattern dystrophy, or vitelliform macular dystrophy (11%), central areolar choroidal dystrophy (28%), pseudo-Stargardt pattern dystrophy (41%), and retinitis pigmentosa (25%). Symptom onset was earlier in retinitis pigmentosa as compared with pseudo-Stargardt pattern dystrophy (34 vs 44 years; P = 0.004). The median visual acuity was 0.18 logMAR (interquartile range, 0-0.54 logMAR) and 0.18 logMAR (interquartile range 0-0.42 logMAR) in the right and left eyes, respectively. ERG showed a significantly reduced amplitude across all components (P < 0.001) and a peak time delay in the light-adapted 30-Hz flicker and single-flash b-wave (P < 0.001). Twenty-two variants were novel. The central areolar choroidal dystrophy phenotype was associated with 13 missense variants. The remaining variants showed marked phenotypic variability. Conclusions: We described six distinct FAF phenotypes associated with variants in the PRPH2 gene. One FAF phenotype may have multiple ERG phenotypes, demonstrating a discordance between structure and function. Given the vast spectrum of PRPH2 disease our findings are useful for future clinical trials.

Postoperative fluid therapy in enhanced recovery after surgery for pancreaticoduodenectomy.

Backgrounds/Aims: Optimal intravenous fluid management during the perioperative period for patients undergoing pancreaticoduodenectomy (PD) within the framework of enhanced recovery after surgery (ERAS) is unclear. Studies have indicated that excessive total body salt and water can contribute to the development of oedema, leading to increased morbidity and extended hospital stays. This study aimed to assess the effects of an intravenous therapy regimen during postoperative day (POD) 0 to 2 in PD patients within ERAS. Methods: A retrospective interventional cohort study was conducted, and it involved all PD patients before and after implementation of ERAS (2009-2017). In the ERAS group, a targeted maintenance fluid regimen of 20 mL/kg/day with a sodium requirement of 0.5 mmoL/kg/day was administered. Outcome measures included the mmol of sodium and chloride administered, length of stay, and morbidity (postoperative pancreatic fistula, POPF; acute kidney injury, AKI; ileus). Results: The study included 169 patients, with a mean age of 64 ± 11.3 years. Following implementation of the intravenous fluid therapy protocol, there was a significant reduction in chloride and sodium loading. However, in the multivariable analysis, chloride administered (mmoL/kg) did not independently influence the length of stay; or rates of POPF, ileus, or AKI (p > 0.05). Conclusions: The findings suggested that a postoperative intravenous fluid therapy regimen did not significantly impact morbidity. Notably, there was a trend towards reduced length of stay within an increasingly comorbid patient cohort. This targeted fluid regimen appears to be safe for PD patients within the ERAS program. Further prospective research is needed to explore this area.

Analysis of the Outer Retinal Bands in ABCA4 and PRPH2-Associated Retinopathy using OCT.

PURPOSE: To evaluate the outer retinal bands using OCT in ABCA4- and PRPH2-associated retinopathy and develop a novel imaging biomarker to differentiate between these 2 genotypes. DESIGN: Multicenter case-control study. PARTICIPANTS: Patients with a clinical and genetic diagnosis of ABCA4- or PRPH2-associated retinopathy and an age-matched control group. METHODS: Macular OCT was used to measure the thickness of the outer retinal bands 2 and 4 by 2 independent examiners at 4 retinal loci. MAIN OUTCOME MEASURES: Outcome measures included the thicknesses of band 2, band 4, and the band 2/band 4 ratio. Linear mixed modeling was used to make comparisons across the 3 groups. Receiver operating characteristic (ROC) analysis determined the optimal cutoff for the band 2/band 4 ratio to distinguish PRPH2- from ABCA4-associated retinopathy. RESULTS: We included 45 patients with ABCA4 variants, 45 patients with PRPH2 variants, and 45 healthy controls. Band 2 was significantly thicker in patients with PRPH2 compared with ABCA4 (21.4 vs. 15.9 µm, P < 0.001) variants, whereas band 4 was thicker in patients with ABCA4 variants than those with PRPH2 variants (27.5 vs. 21.7 µm, P < 0.001). Similarly, the band 2/band 4 ratio was significantly different (1.0 vs. 0.6 for PRPH2 vs. ABCA4, P < 0.001). The area under the ROC curve was 0.87 for either band 2 (> 18.58 µm) or band 4 (< 26.17 µm) alone and 0.99 (95% confidence interval: 0.97-0.99) for the band 2/band 4 ratio with a cutoff threshold of 0.79, providing 100% specificity. CONCLUSIONS: We report an altered outer retinal band profile whereby the band 2/band 4 ratio was able to discriminate between PRPH2- and ABCA4-associated retinopathy. This may have future clinic utility in predicting the genotype and provide further insight into the anatomic correlate of band 2. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Higher Overall Intakes Are the Defining Feature of Dietary Intakes in NAFLD and Compared to the General Population.

We aimed to compare the dietary intakes of Australian patients with non-alcoholic fatty liver disease (NAFLD) to general Australian population intake data and determine whether the intake of any nutrient or food group was able to predict the degree of steatosis. Dietary data from fifty adult patients with NAFLD were compared to intake data from the Australian Health Survey for energy, macronutrients, fat sub-types, alcohol, iron, folate, sugar, fibre, sodium and caffeine. Linear regression models adjusting for potential confounders (age, sex, physical activity and body mass index) were used to examine predictive relationships between hepatic steatosis (quantified via magnetic resonance spectroscopy) and dietary components. The mean percentage differences between NAFLD and Australian usual intakes were significant for energy, protein, total fat, saturated fat, monounsaturated and polyunsaturated fats (all p < 0.001). The contribution of fat and protein to total energy intake was significantly higher in the NAFLD cohort (p < 0.05). No individual nutrients or food groups were strongly related to hepatic fat in the adjusted models. Higher overall consumption appears to be a major feature of dietary intake in NAFLD when compared to the general population. A whole-diet approach to NAFLD treatment and prevention is likely to be more effective than focusing on single food components.

Driving with retinitis pigmentosa.

BACKGROUND: To establish the proportion of patients with retinitis pigmentosa (RP) meeting the Australian fitness to drive (FTD) visual standards. METHODOLOGY: A prospective consecutive case series of patients with a clinical or genetic diagnosis of RP. Data on age at symptom onset, current driving status, inheritance pattern, better eye visual acuity (BEVA), binocular Esterman visual field (BEVF) parameters, genotype and ability to meet the driving standards based on BEVA and BEVF were collected. Outcome measures included the proportion of RP patients overall meeting the standards and clinical predictors for passing. A sub-analysis was performed on those RP patients who reported to drive. Change in BEVA and BEVF parameters across age in specific genotype groups was assessed. RESULTS: Overall, 228 patients with RP had a BEVF assessment. Only 39% (89/228) met the driving standards. Younger age at the time of testing was the only significant predictor (p < 0.01) for passing. Of the 55% of RP patients who reported to drive, 52% (65/125) met the standards, decreasing to 14% in the 56- to 65-year-old age group. RP patients harbouring mutations in HK1 or RHO genes may have slower rates of decline in their VF parameters. CONCLUSION: Nearly 40% of RP patients met the driving standards. However, almost 50% of RP drivers were unaware of their failure to meet the current standards. BEVF testing is essential in the assessment of RP patients who are still driving. Phenotype and genotype predictors for passing the standards warrant further investigation.Abbreviation: FTD, fitness to drive; IRD, inherited retinal disease; RP, retinitis pigmentosa; RHO, rhodopsin; HK1, hexokinase 1; PRPF31 pre-mRNA processing factor 31; RPGR, retinitis pigmentosa GTPase regulator; VF, visual field; BEVA, better eye visual acuity; BEVF, binocular Esterman visual field.

Effects of Tai Chi on the quality of life, mental wellbeing, and physical function of adults with chronic diseases: Protocol for a single-blind, two-armed, randomised controlled trial.

INTRODUCTION: Quality of life (QoL), mental wellbeing, and physical function are often diminished among people with chronic disease. Tai Chi is a moderate form of exercise that may be effective in improving chronic disease management. This protocol paper outlines a trial to determine the therapeutic effects of a Tai Chi program on chronic disease management. METHODS AND ANALYSIS: This study will be a pilot, interventional, single-blind, two-armed, randomised, parallel, and controlled trial involving a 12-week Tai Chi program for Australian adults. Forty people aged 18 years and older, diagnosed with one or more chronic disease from general community will be recruited. All participants will be randomised to either a 12-week Tai Chi program or a waiting list control group. The Tai Chi program will involve 12 weeks of group Tai Chi sessions, with 45 minutes per session, twice a week. The primary outcome will be QoL as measured by mean scores on the 12-item Short Form Health Survey (SF-12v2) and the EuroQoL (EQ-5D). The secondary outcomes will include anxiety as measured by mean score on the generalised anxiety disorder 7 (GAD-7) survey; depression as measured by mean score on the patient health questionnaire (PHQ-9); work productivity and activity assessment (WPAI:SHP); pain (if any) as measured by mean scores on the visual analogue scale (VAS) and the McGill pain questionnaire (MPQ). These primary and secondary outcomes will be self-administered via two online assessments prior to (T0) and post-intervention (T1). Objective measures as additional secondary outcomes, will also be carried out by the research team including flexibility as measured by the finger to floor distance (FFD); obesity as measured by mean scores on body mass index (BMI); vital signs (blood pressure, heart rate, respiratory rate, temperate, and oxygen saturation) as measured by a blood pressure monitor, tympanic, and pulse oximetry device, and these outcomes will be measured at T0 and T1 in the ECU Holistic Health Research Clinic. People diagnosed with pre-diabetes or diabetes, their glycosylated haemoglobin (HbA1C) and fasting (before breakfast) blood glucose level (BGL) will also be measured via test kits at T0 and T1 in the clinic. Linear mixed modelling will be conducted to assess changes in outcomes. Statistical significance will be set at an alpha level of 0.05 with a medium effect size. All analyses will be conducted using R version 4.1. Qualitative data will be analysed using template thematic analysis. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Edith Cowan University (ECU) Human Research Ethics Committee (2021-03042-WANG). Research findings will be disseminated to the public, health professionals, researchers, and healthcare providers through conference presentations, lay summaries, and peer-reviewed publications. This study will provide an updated evidence on a safe, sustainable, and inexpensive non-pharmacological approach in the management of chronic disease, the number one burden of disease in Australia. TRIAL REGISTRATION: Trial registration number: ACTRN12622000042741p.

Should Acupuncture-Related Therapies be Considered in Prediabetes Control? Results From a Systematic Review and Meta-analysis of Randomized Controlled Trials.

To assess the effects and safety of acupuncture-related therapy (AT) interventions on glycemic control for prediabetes, we systematically searched 14 databases and 5 clinical registry platforms from inception to December 2020. Randomized controlled trials involving AT interventions for managing prediabetes were included (PROSPERO registration no. CRD42020209809). Of the 855 identified trials, 34 articles were included for qualitative synthesis, 31 of which were included in the final meta-analysis. Compared with usual care, sham intervention, or conventional medicine, AT treatments yielded greater reductions in the primary outcomes, including fasting plasma glucose (FPG) (standard mean difference [SMD] = -0.83; 95% confidence interval [CI], -1.06, -0.61; P < .00001), 2-hour plasma glucose (2hPG) (SMD = -0.88; 95% CI, -1.20, -0.57; P < .00001), and glycated hemoglobin (HbA1c) levels (SMD = -0.91; 95% CI, -1.31, -0.51; P < .00001), as well as a greater decline in the secondary outcome, which is the incidence of prediabetes (RR = 1.43; 95% CI, 1.26, 1.63; P < .00001). AT is thus a potential strategy that can contribute to better glycemic control in the management of prediabetes. Because of the substantial clinical heterogeneity, the effect estimates should be interpreted with caution. More research is required for different ethnic groups and long-term effectiveness.

Human leucocyte antigen genotype association with the development of immune-related adverse events in patients with non-small cell lung cancer treated with single agent immunotherapy.

INTRODUCTION: Biomarkers that predict the risk of immune-mediated adverse events (irAEs) among patients with non-small cell lung cancer (NSCLC) may reduce morbidity and mortality associated with these treatments. METHODS: We carried out high resolution human leucocyte antigen (HLA)-I typing on 179 patients with NSCLC treated with anti-program death (PD)-1/program death ligand (PDL)-1. Toxicity data were collected and graded as per common terminology criteria for adverse event (CTCAE) v5.0. We used 14.8-week for landmark analysis to address lead-time bias to investigate the correlation between HLA-I/II zygosity, supertypes and alleles with irAE. Furthermore, we assessed the association for irAE with clinical benefit rate (CBR), progression-free survival (PFS) and overall survival (OS). RESULTS: Homozygosity at one or more HLA-I loci, but not HLA-II, was associated with a reduced risk of irAE (relative risk (RR) = 0.61, 95% CI 0.33-0.95, P = 0.035) especially pneumonitis or any grade 3 toxicity. Patients with HLA-A03 supertype had a higher risk of developing irAE (RR = 1.42, 95% CI 1.02-2.01, P = 0.039). The occurrence of any irAE was significantly associated with improved CBR (RR = 1.48, P < 0.0001), PFS (HR = 0.45, P = 0.0003) and OS (HR = 0.34, P < 0.0001). CONCLUSIONS: Homozygosity at one or more HLA-I loci may serve as biomarker to predict patients who are unlikely to experience severe irAEs among patients with NSCLC and treated with anti-PD1/PDL1, but less likely to derive clinical benefit. Patients with HLA-I homozygous might benefit from additional therapy.

Food Supply Impacts and Solutions Associated with the COVID-19 Pandemic: A Regional Australian Case Study.

This study aimed to explore how food supply chains were impacted by COVID-19 and identify how the region could be better prepared for future crises. An online survey was completed by 107 consumers. In-depth interviews were conducted with 27 food supply stakeholders working in food production, distribution, retail, hospitality, institutions (i.e., childcare), logistics/freight and local government. Pre-COVID-19, farmer-direct distribution options and hospitality businesses comprised a substantial proportion of local food producer businesses. During the COVID-19 pandemic, consumers favoured local food supply options, farmers collaborated, and produce usually destined for export was redirected into local markets. Critical food supply actions included keeping borders open to food freight, enhancing social capital through real-time business communication, and business flexibility. Solutions included business adaptation, for example, farmers selling produce boxes and hospitality businesses selling excess stock, COVID-safe delivery, and collaboration through digital networks. To better prepare the region for future crises, actions to support communities could include a community approach to agriculture, increasing food supply diversity, facilitating transport to aid food distribution and purchasing, and more effective messaging to discourage panic buying. Actions to support retailers could include increasing access to wholesalers through online platforms. Actions to support producers could include improving infrastructure, such as more regional distribution facilities.

How a 7-Week Food Literacy Cooking Program Affects Cooking Confidence and Mental Health: Findings of a Quasi-Experimental Controlled Intervention Trial.

Obesity and mental health disorders are rising simultaneously with shifting dietary behavior away from home cooking, toward typically nutrition-poor and energy-dense convenience meals. Food literacy strongly influences nutrition choices. Community-based cooking interventions target barriers to healthy eating and facilitate development of food literacy skills, thereby potentially increasing preparation of home-cooked meals and positively influencing health. This study of 657 healthy Australian adults explored the efficacy of a 7-week cooking program in improving cooking confidence, whether this transferred to behavior surrounding food, and/or affected mental health. Significant post-program improvements in cooking confidence and satisfaction (all p < 0.001, η p 2 1.12 large), ability to change eating habits (p < 0.001) and overcome lifestyle barriers (p = 0.005) were observed for the intervention group but not control. Participation also improved mental and general health (all p < 0.05, η p 2 0.02 small). No changes were observed for acquisition and consumption of food, or nutrition knowledge in either group. This 7-week cooking program built cooking confidence and improved general and mental health but did not change dietary behavior. To further improve nutrition related behaviors associated with better mental health, more effort is needed to recruit those with below-average nutrition knowledge and interest in cooking.

Light acupuncture and five-element music therapy for nurses' mental health and well-being during and post-COVID-19: protocol for a randomised cross-over feasibility study.

INTRODUCTION: Australian nurses have experienced higher levels of anxiety during the COVID-19 pandemic compared with the prepandemic. This may have affected their long-term mental health and intention to stay in the profession resulting in a workforce shortage, which further impacts the health of the public. Management is urgently required to improve nurses' well-being. However, there is limited evidence available. The proposed clinical trial aims to evaluate the feasibility and therapeutic effects of using a combination of light acupuncture and five-element music therapy to improve nurses' mental health and well-being during and post-COVID-19. METHODS AND ANALYSIS: This randomised, single blinding, two-arm cross-over feasibility study involves a 1-week run-in period, 2-week intervention and 1-week run-in period in between interventions. Thirty-six eligible nurses will be recruited from the community and randomised into either a combination of light acupuncture treatment and five-element music therapy group or no treatment group for 2 weeks. After a 1-week run in period, they will be swapped to the different group. The primary outcome of this study is to evaluate the feasibility of a combination of light acupuncture treatment and five-element music therapy to improve nurses' mental health and well-being. The secondary outcomes will include anxiety and depression, work productivity and activity, and quality of life assessments. Participants will be asked to complete a set of online questionnaires throughout the trial period. All analyses will be performed in R Studio V.1.1.463. ETHICS AND DISSEMINATION: Ethical approval was attained from Edith Cowan University's Human Research Ethics Committee (No. 2021-02728-WANG). Research findings will be shared with hospitals and in various forms to engage broader audiences, including national and international conferences, presentations, open-access peer-reviewed journal publications, and local community workshop dissemination with healthcare professionals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: ACTRN12621000957897p https://www.anzctr.org.au/ACTRN12621000957897p.aspx.

SIBLING CONCORDANCE IN SYMPTOM ONSET AND ATROPHY GROWTH RATES IN STARGARDT DISEASE USING ULTRA-WIDEFIELD FUNDUS AUTOFLUORESCENCE.

PURPOSE: To investigate concordance in symptom onset, area of dark autofluorescence (DAF), and growth rate (GR) between Stargardt disease siblings at an age-matched time point. METHODS: In this retrospective longitudinal study of sibling pairs with identical biallelic ABCA4 variants, age at symptom onset, best-corrected visual acuity, atrophy area, and effective radius of DAF on ultra-widefield fundus autofluorescence were recorded. Absolute intersibling differences for both eyes were compared with absolute interocular differences using the Mann-Whitney test. RESULTS: Overall 39 patients from 19 families were recruited. In 16 families, age-matched best-corrected visual acuity and DAF were compared between siblings. In 8 families, DAF GR was compared. The median (range) absolute difference in age at symptom onset between siblings was 3 (0-35) years. Absolute intersibling differences in age-matched best-corrected visual acuity were greater than interocular differences ( P = 0.01). Similarly, absolute intersibling differences in DAF area and radius were greater than interocular differences ( P = 0.04 for area and P = 0.001 for radius). Differences between absolute interocular and intersibling GR were not statistically significant ( P = 0.44 for area GR and P = 0.61 for radius GR). CONCLUSION: There was significant discordance in age-matched best-corrected visual acuity and DAF beyond the expected limits of interocular asymmetry. Lack of significant intersibling differences in GR warrants further investigation.

A mixed-methods study to determine the impact of COVID-19 on food security, food access and supply in regional Australia for consumers and food supply stakeholders.

BACKGROUND: The COVID-19 pandemic has impacted the Australian food supply through changed consumer purchasing patterns, and potentially, household food security. The aim of this study was to determine the impact of COVID-19 on the prevalence of food insecurity and food supply issues, and perspectives of food supply stakeholders in regional Australia. METHODS: A mixed-methods consumer survey and in-depth interviews with food supply stakeholders were conducted in regional Australia, more specifically South West Western Australia between May and July 2020, immediately after the 1st wave of the pandemic. RESULTS: The prevalence of food insecurity was 21% among consumers, and significantly more prevalent for those aged less than 30 years and living with a disability. Most consumers (73%) agreed that the COVID-19 pandemic had impacted the food supply. Food insecure respondents were more likely to report that food was more expensive, resulting in changes to the types and quantities of food bought. Food supply stakeholders perceived that consumers increased their intention to buy locally grown produce. Panic buying temporarily reduced the availability of food for both food suppliers and consumers, regardless of their food security status. CONCLUSIONS: This study provided novel insights from South West Australian consumer and food supply stakeholder perceptions. Food insecure consumers provided insights about the high cost of food and the subsequent adaptation of their shopping habits, namely type and amount of food purchased. Stakeholder perceptions largely focused on supply chain issues and corroborated consumer reports.

Anti-retinal IgG antibodies in patients with early and advanced type 2 macular telangiectasia.

Type 2 idiopathic macular telangiectasia (MacTel-2) is a progressive adult-onset macular disease associated with bilateral perifoveal vascular changes, Muller cell degeneration and increased blood-retinal barrier permeability. The pathophysiological mechanisms of MacTel-2 remain unclear, however it was previously reported that anti-retinal antibodies in MacTel-2 patients are a significant feature of the disease. In this study, we aimed to compare the prevalence of anti-retinal antibodies in patients MacTel-2, healthy controls and patients with other retinal diseases. MacTel-2 patients diagnosed with multimodal imaging were enrolled and their disease severities were graded using spectral-domain optical coherence tomography. For comparison, patients with age-related macular degeneration (AMD), inherited retinal diseases (IRDs) or no retinal disease (healthy controls) were recruited as controls. Blood serum samples were screened for immunoglobulin G anti-retinal antibodies by western blotting, followed by densitometry analysis. Odds ratios (OR) with 95% confidence intervals (CI) were calculated and p < 0.05 considered statistically significant. Overall, anti-retinal antibody-positive cases were older (64 ± 15 vs 53 ± 17 years, p < 0.001) and females were more likely to develop anti-retinal antibodies (OR: 2.41, CI: 1.12-5.18). The frequency of anti-retinal antibody detection in MacTel-2 patients (n = 42, 36%) was not significantly different from healthy controls (n = 52, 25%) or IRD patients (n = 18, 25%) and the majority of MacTel-2 patients had no anti-retinal antibodies. In contrast, the frequency of anti-retinal antibody detection was significantly higher in patients with AMD (n = 15, 73%, p < 0.001). The lack of a greater anti-retinal antibody frequency or specificity in the MacTel-2 cohort suggests that antibody mediated immunological mechanisms may play a less significant role in MacTel-2 disease pathogenesis.

Ileocolic anastomosis after right hemicolectomy: stapled end-to-side, stapled side-to-side, or handsewn?

PURPOSE: Anastomotic leak (AL) following ileocolic anastomosis is a cause of significant morbidity and mortality. Stapled end-to-side (ESA), stapled side-to-side (SSA), and handsewn anastomoses (HSA) are commonly performed techniques. There is however conflicting data on the superiority of one technique over the other. The aim of this study was to compare the outcomes of ESA against SSA and HSA. METHODS: This retrospective cohort study was conducted at a tertiary colorectal unit. All patients who underwent an ileocolic anastomosis from October 2008 to May 2020 were included. Exclusion criteria were missing data on anastomotic technique or clinicopathological variables. Primary outcomes were AL and anastomotic bleeding (AB). Secondary outcomes were length of stay (LoS) and return of gut function. RESULTS: A total of 1390 patients met the inclusion criteria. A total of 976 (70%) ESA, 308 (22%) SSA, and 108 (8%) HSA were performed. AL occurred in 17/1390 (1.2%) patients, and 54/1390 (3.9%) had AB. On adjusted analysis, ESA experienced a lower AL when compared with SSA (OR 4.93, p = 0.005), with a trend towards a lower AL when compared to HSA (OR 2.6, p = 0.27). There was no difference in AB between all techniques: ESA vs. SSA (OR 1.07 p = 0.84), and ESA vs. HSA (OR 0.24 p = 0.76). Both stapled techniques were associated with a shorter return to gut function compared to HSA; 3.3 vs. 4.2 days (p < 0.001). There was no difference in LoS. CONCLUSION: ESA has the lowest leak rate when compared to other anastomotic techniques without any increased risk of anastomotic bleeding.

Feasibility and therapeutic efficacy of a two-week low-level laser acupuncture therapy for shoulder and neck pain in office workers: Protocol for a pilot, single-blind, double-armed, randomised controlled trial.

BACKGROUND: Shoulder and neck pain (SNP) is common in office workers and represents a serious public health problem given its detrimental impact on quality of life, physical functioning, personal finances, employers, and the health care system. Management with painkillers has adverse implications such as tolerance, addiction, and opioid abuse. Safe, sustainable, cost-effective, and evidence-based solutions are urgently needed. The non-invasive, painless, non-infectious, and safe modality of low-level laser acupuncture (LLLA) has shown promise for SNP management. OBJECTIVE: The overarching aim of this study is to provide evidence of the feasibility and therapeutic efficacy of LLLA for office workers with SNP. METHODS: This is a pilot, single-blind, double-armed, randomised controlled trial on the feasibility and therapeutic efficacy of a two-week LLLA therapy for office workers with SNP, aged 18 to 65 years. Each of the two study groups will contain 35 participants: the intervention group will receive LLLA from a licensed acupuncturist at the researchers' university clinic (10-20 min/session, 3 sessions/week) for two weeks; the control group will receive usual care without painkillers. Outcomes will be measured at baseline, throughout the two-week intervention, and at trial end. Surveys including open-ended questions will be completed. The primary outcome of this study is to evaluate the feasibility of a two-week LLLA therapy for office workers with SNP, as measured by recruitment and completion rates, patient safety, and treatment adherence and compliance. Participants' attitudes, motivation, and challenges to participation, intervention non-compliance, and experience of participating in the trial will be investigated via qualitative data. The secondary outcome is to evaluate the therapeutic efficacy of LLLA on SNP using the visual analogue scale (VAS) and the Short-Form McGill Pain Questionnaire (SF-MPQ); the work productivity and activity assessment (WPAI:SHP); 12-Item Short Form Survey (SF-12) for quality of life assessment; and the past 3-month out-of-pocket (OOP) cost for prescription and non-prescription SNP therapy, which is an indicative of the economic burden of SNP on patients and health care systems. This study was approved by Edith Cowan University's Human Research Ethics Committee (No. 2021-02225-WANG). RESULTS: Data collection will commence in December 2021 with anticipated completion by December 2022. CONCLUSIONS: Safe, sustainable, cost-effective, evidence-based interventions are needed to minimise the negative implications of SNP in office workers. LLLA is a promising modality in managing SNP. However, more consolidated evidence is required to provide insight regarding the effectiveness of LLLA. This study is expected to contribute to the challenging work of reducing the burden of SNP in office workers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000426886p; https://www.anzctr.org.au/ACTRN12621000426886p.aspx.

Does a high dietary intake of resistant starch affect glycaemic control and alter the gut microbiome in women with gestational diabetes? A randomised control trial protocol.

BACKGROUND: Gestational Diabetes Mellitus (GDM) is prevalent with lasting health implications for the mother and offspring. Medical nutrition therapy is the foundation of GDM management yet achieving optimal glycaemic control often requires treatment with medications, like insulin. New dietary strategies to improve GDM management and outcomes are required. Gut dysbiosis is a feature of GDM pregnancies, therefore, dietary manipulation of the gut microbiota may offer a new avenue for management. Resistant starch is a fermentable dietary fibre known to alter the gut microbiota and enhance production of short-chain fatty acids. Evidence suggests that short-chain fatty acids improve glycaemia via multiple mechanisms, however, this has not been evaluated in GDM. METHODS: An open-label, parallel-group design study will investigate whether a high dietary resistant starch intake or resistant starch supplement improves glycaemic control and changes the gut microbiome compared with standard dietary advice in women with newly diagnosed GDM. Ninety women will be randomised to one of three groups - standard dietary treatment for GDM (Control), a high resistant starch diet or a high resistant starch diet plus a 16 g resistant starch supplement. Measurements taken at Baseline (24 to 30-weeks' gestation), Day 10 and Day 56 (approximately 36 weeks' gestation) will include fasting plasma glucose levels, microbial composition and short-chain fatty acid concentrations in stool, 3-day dietary intake records and bowel symptoms questionnaires. One-week post-natal data collection will include microbial composition and short-chain fatty acid concentrations of maternal and neonatal stools, microbial composition of breastmilk, birthweight, maternal and neonatal outcomes. Mixed model analysis of variance will assess change in glycaemia and permutation-based multivariate analysis of variance will assess changes in microbial composition within and between intervention groups. Distance-based linear modelling will identify correlation between change in stool microbiota, short-chain fatty acids and measures of glycaemia. DISCUSSION: To improve outcomes for GDM dyads, evaluation of a high dietary intake of resistant starch to improve glycaemia through the gut microbiome needs to be established. This will expand the dietary interventions available to manage GDM without medication. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12620000968976p . Registered 28 September 2020.

Digging for data: How sleep is losing out to roster design, sleep disorders, and lifestyle factors.

Shift workers employed at a remote mining operation may experience sleep loss, impaired alertness, and consequently negative health and safety outcomes. This study determined the sleep behaviors and prevalence of risk for sleep disorders among shift workers; and quantified alertness for a roster cycle. Sleep duration was significantly less following; night shift by 77 ± 7 min and day shift by 30 ± 7 min. The wake after sleep onset was less by 23 ± 3 min for night shifts and 22 ± 3 min for day shifts (p < 0.05 for all). The prevalence of risk for sleep apnea was 31%, insomnia was 8%, and shiftwork disorder was 44%. Average alertness for all working hours was 75%. Shiftwork in remote mining operations is a significant factor that leads to sleep loss and reduced alertness, which is exacerbated by the high prevalence of risk for sleep disorders.