Nutrition delivery across hospitalisation in critically ill patients with COVID-19: An observational study of the Australian experience.

BACKGROUND: Data on nutrition delivery over the whole hospital admission in critically ill patients with COVID-19 are scarce, particularly in the Australian setting. OBJECTIVES: The objective of this study was to describe nutrition delivery in critically ill patients admitted to Australian intensive care units (ICUs) with coronavirus disease 2019 (COVID-19), with a focus on post-ICU nutrition practices. METHODS: A multicentre observational study conducted at nine sites included adult patients with a positive COVID-19 diagnosis admitted to the ICU for >24 h and discharged to an acute ward over a 12-month recruitment period from 1 March 2020. Data were extracted on baseline characteristics and clinical outcomes. Nutrition practice data from the ICU and weekly in the post-ICU ward (up to week four) included route of feeding, presence of nutrition-impacting symptoms, and nutrition support received. RESULTS: A total of 103 patients were included (71% male, age: 58 ± 14 years, body mass index: 30±7 kg/m2), of whom 41.7% (n = 43) received mechanical ventilation within 14 days of ICU admission. While oral nutrition was received by more patients at any time point in the ICU (n = 93, 91.2% of patients) than enteral nutrition (EN) (n = 43, 42.2%) or parenteral nutrition (PN) (n = 2, 2.0%), EN was delivered for a greater duration of time (69.6% feeding days) than oral and PN (29.7% and 0.7%, respectively). More patients received oral intake than the other modes in the post-ICU ward (n = 95, 95.0%), and 40.0% (n = 38/95) of patients were receiving oral nutrition supplements. In the week after ICU discharge, 51.0% of patients (n = 51) had at least one nutrition-impacting symptom, most commonly a reduced appetite (n = 25; 24.5%) or dysphagia (n = 16; 15.7%). CONCLUSION: Critically ill patients during the COVID-19 pandemic in Australia were more likely to receive oral nutrition than artificial nutrition support at any time point both in the ICU and in the post-ICU ward, whereas EN was provided for a greater duration when it was prescribed. Nutrition-impacting symptoms were common.

Nutrition care processes across hospitalisation in critically ill patients with COVID-19 in Australia: A multicentre prospective observational study.

BACKGROUND: The COVID-19 pandemic highlighted major challenges with usual nutrition care processes, leading to reports of malnutrition and nutrition-related issues in these patients. OBJECTIVE: The objective of this study was to describe nutrition-related service delivery practices across hospitalisation in critically ill patients with COVID-19 admitted to Australian intensive care units (ICUs) in the initial pandemic phase. METHODS: This was a multicentre (nine site) observational study in Australia, linked with a national registry of critically ill patients with COVID-19. Adult patients with COVID-19 who were discharged to an acute ward following ICU admission were included over a 12-month period. Data are presented as n (%), median (interquartile range [IQR]), and odds ratio (OR [95% confidence interval {CI}]). RESULTS: A total of 103 patients were included. Oral nutrition was the most common mode of nutrition (93 [93%]). In the ICU, there were 53 (52%) patients seen by a dietitian (median 4 [2-8] occasions) and malnutrition screening occurred in 51 (50%) patients most commonly with the malnutrition screening tool (50 [98%]). The odds of receiving a higher malnutrition screening tool score increased by 36% for every screening in the ICU (1st to 4th, OR: 1.39 [95% CI: 1.05-1.77] p = 0.018) (indicating increasing risk of malnutrition). On the ward, 51 (50.5%) patients were seen by a dietitian (median time to consult: 44 [22.5-75] hours post ICU discharge). The odds of dietetic consult increased by 39% every week while on the ward (OR: 1.39 [1.03-1.89], p = 0.034). Patients who received mechanical ventilation (MV) were more likely to receive dietetic input than those who never received MV. CONCLUSIONS: During the initial phases of the COVID-19 pandemic in Australia, approximately half of the patients included were seen by a dietitian. An increased number of malnutrition screens were associated with a higher risk score in the ICU and likelihood of dietetic consult increased if patients received MV and as length of ward stay increased.

Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has exposed the disproportionate effects of pandemics on frontline workers and the ethical imperative to provide effective prophylaxis. We present a model for a pragmatic randomised controlled trial (RCT) that utilises Bayesian methods to rapidly determine the efficacy or futility of a prophylactic agent. METHODS: We initially planned to undertake a multicentre, phase III, parallel-group, open-label RCT, to determine if hydroxychloroquine (HCQ) taken once a week was effective in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in healthcare workers (HCW) aged ≥ 18 years in New Zealand (NZ) and Ireland. Participants were to be randomised 2:1 to either HCQ (800 mg stat then 400 mg weekly) or no prophylaxis. The primary endpoint was time to Nucleic Acid Amplification Test-proven SARS-CoV-2 infection. Secondary outcome variables included mortality, hospitalisation, intensive care unit admissions and length of mechanical ventilation. The trial had no fixed sample size or duration of intervention. Bayesian adaptive analyses were planned to occur fortnightly, commencing with a weakly informative prior for the no prophylaxis group hazard rate and a moderately informative prior on the intervention log hazard ratio centred on 'no effect'. Stopping for expected success would be executed if the intervention had a greater than 0.975 posterior probability of reducing the risk of SARS-CoV-2 infection by more than 10%. Final success would be declared if, after completion of 8 weeks of follow-up (reflecting the long half-life of HCQ), the prophylaxis had at least a 0.95 posterior probability of reducing the risk of SARS-CoV-2 infection by more than 10%. Futility would be declared if HCQ was shown to have less than a 0.10 posterior probability of reducing acquisition of SARS-CoV-2 infection by more than 20%. DISCUSSION: This study did not begin recruitment due to the marked reduction in COVID-19 cases in NZ and concerns regarding the efficacy and risks of HCQ treatment in COVID-19. Nonetheless, the model presented can be easily adapted for other potential prophylactic agents and pathogens, and pre-established collaborative models like this should be shared and incorporated into future pandemic preparedness planning. TRIAL REGISTRATION: The decision not to proceed with the study was made before trial registration occurred.

Protocol summary and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial.

Background: Targeted therapeutic mild hypercapnia may attenuate brain injury in comatose adults resuscitated from out-of-hospital cardiac arrest. Objective: To describe the study protocol and statistical analysis plan for the Targeted Therapeutic Mild Hypercapnia after Resuscitated Cardiac Arrest (TAME) trial. Design, setting, participants and interventions: TAME is a phase 3, multicentre, parallel-group, participant- and outcome assessor-blinded randomised controlled trial that will be conducted in intensive care units in Australia, Canada, Ireland, Saudi Arabia, New Zealand, Scandinavia, Singapore, Central and Western Europe, and the United Kingdom. A total of 1700 comatose adults resuscitated from out-of-hospital cardiac arrest will be randomly assigned to 24 hours of targeted therapeutic mild hypercapnia (arterial carbon dioxide tension 50-55 mmHg) or targeted normocapnia (arterial carbon dioxide tension 35-45 mmHg) in a 1:1 ratio. TAME recruitment began in March 2018 and is expected to be complete in September 2021. Main outcome measures: The primary outcome measure is the proportion of participants with a favourable functional outcome at 6 months. Functional outcomes will be assessed using the Glasgow Outcome Scale-Extended (GOSE); this scale ranges from 1 to 8, with a higher value indicating a better outcome. We will define participants with a GOSE of 5 to 8 as having a favourable functional outcome. Secondary outcomes include 6-month mortality, cognitive function and quality of life. All analyses will be conducted on an intention-to-treat basis. Results and conclusions: TAME will compare the effect of targeted therapeutic mild hypercapnia versus targeted normocapnia on functional outcomes in adults resuscitated from out-of-hospital cardiac arrest who are admitted to an intensive care unit. Trial registration: Australian and New Zealand Clinical Trials Registry (ACTRN12617000036314p) and ClinicalTrials.gov (NCT03114033).

Cost-effectiveness of a mobile health-supported lifestyle intervention for pregnant women with an elevated body mass index.

OBJECTIVE: To assess the cost-effectiveness of a mobile health-supported lifestyle intervention compared with usual care. METHODS: We conducted a cost-effectiveness analysis from the perspective of the publicly-funded health care system. We estimated costs associated with the intervention and health care utilisation from first antenatal care appointment through delivery. We used bootstrap methods to quantify the uncertainty around cost-effectiveness estimates. Health outcomes assessed in this analysis were gestational weight gain (GWG; kg), incidence of excessive GWG, quality-adjusted life years (QALYs), and incidence of large-for-gestational-age (LGA). Incremental cost-effectiveness ratios (ICERs) were calculated as cost per QALY gained, cost per kg of GWG avoided, cost per case of excessive GWG averted, and cost per case of LGA averted. RESULTS: Total mean cost including intervention and health care utilisation was €3745 in the intervention group and €3471 in the control group (mean difference €274, P = 0.08). The ICER was €2914 per QALY gained. Assuming a ceiling ratio of €45,000, the probability that the intervention was cost-effective based on QALYs was 79%. Cost per kg of GWG avoided was €209. The cost-effectiveness acceptability curve (CEAC) for kg of GWG avoided reached a confidence level of 95% at €905, indicating that if one is willing to pay a maximum of an additional €905 per kg of GWG avoided, there is a 95% probability that the intervention is cost-effective. Costs per case of excessive GWG averted and case of LGA averted were €2117 and €5911, respectively. The CEAC for case of excessive GWG averted and for case of LGA averted reached a confidence level of 95% at €7090 and €25,737, respectively. CONCLUSIONS: Results suggest that a mobile-health lifestyle intervention could be cost-effective; however, a better understanding of the short- and long-term costs of LGA and excessive GWG is necessary to confirm the results.

An observational analysis of meal patterns in overweight and obese pregnancy: exploring meal pattern behaviours and the association with maternal and fetal health measures.

BACKGROUND: Nutrient intakes are known to be poorer among pregnant women with raised body mass index (BMI) than those with a healthy BMI. While meal patterns have the potential to influence obstetric, metabolic and anthropometric measures for mother and infant, limited data exists regarding meal patterns among pregnant women with raised BMI. AIM: To identify categories of meal patterns among pregnant women with overweight and obesity and determine whether patterns change with advancing gestation. To determine if maternal meal patterns are associated with dietary intakes and pregnancy outcomes. METHODS: Prospective, observational analysis of pregnant women (n = 143) (BMI 25-39.9 kg/m2). Meal pattern data were analysed from 3-day food diaries at 16 and 28 weeks' gestation. Outcomes include maternal blood glucose, insulin resistance, gestational diabetes, gestational weight gain and infant anthropometry. RESULTS: Three meal pattern categories were identified: 'main meal dominant' (3 main eating occasions + 0-3 snacks), 'large meal dominant' (≤ 2 main eating occasions + < 2 snacks), and 'snack dominant' (3 main eating occasions + > 3 snacks and ≤ 2 main + ≥ 2 snacks). A main meal-dominant pattern prevailed at 16 weeks' (85.3%) and a snack-dominant pattern at 28 weeks' (68.5%). Dietary glycaemic index was lower among the main meal versus large meal-dominant pattern at 28 weeks (P = 0.018). Infant birth weight (kg) and macrosomia were highest among participants with a large meal-dominant pattern at 28 weeks (P = 0.030 and P = 0.008, respectively). CONCLUSION: Women with raised BMI changed eating patterns as pregnancy progressed, moving from main meal-dominant to snack-dominant patterns. Large meal-dominant meal patterns in later pregnancy were associated with higher glycaemic index and greater prevalence of macrosomia.

Nutrition, Behavior Change and Physical Activity Outcomes From the PEARS RCT-An mHealth-Supported, Lifestyle Intervention Among Pregnant Women With Overweight and Obesity.

Background: Diet quality and physical activity positively impact pregnancy outcomes among women with obesity, but successful lifestyle interventions require intense clinician time. We aimed to investigate the impact of a behavioral-lifestyle intervention (PEARS) supported by a smartphone app among pregnant women with overweight and obesity, on nutrient intake, behavioral stage-of-change and physical activity. Methods: Pregnant women (BMI 25-39.9 kg/m2, measured, n = 565) were randomized at 15.6 weeks' gestation to the intervention (n = 278), or a control group (n = 287) (ISRCTN29316280). The intervention was grounded in behavior-change theory. Participants received nutrition (low glycaemic index and healthy eating) and exercise advice, a smartphone app and fortnightly emails. The control group received usual care which does not include dietary advice. At baseline and 28 weeks' gestation, dietary data were obtained through 3-day food diaries (n = 290 matched), and stage-of-change and physical activity data were self-reported. App usage data were collected. Results: There were no differences between the groups at baseline. Compared with the control group, the intervention group had improved dietary intakes post-intervention with; lower glycaemic index (MD -1.75); free sugars (%TE) (MD -0.98); fat (%TE) (MD -1.80); and sodium (mg) (MD -183.49). Physical activity (MET-minutes/week) was higher in the intervention group post-intervention (MD 141.4; 95% CI 62.9, 219.9). The proportion of participants at "maintenance" stage-of-change for physical activity was higher in the intervention group (56.3 vs. 31.2%). App use was associated with lower glycaemic index and less energy from free sugars, but not with physical activity. Conclusion: A behavioral-lifestyle intervention in pregnancy supported by a smartphone app improved dietary intakes, physical activity, and motivation to engage in exercise.

Pregnancy Exercise and Nutrition With Smartphone Application Support: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of a healthy lifestyle package (an antenatal behavior change intervention supported by smartphone application technology) on the incidence of gestational diabetes mellitus (GDM) in overweight and obese women. METHODS: Women with body mass indexes (BMIs) 25-39.9 were enrolled into this randomized controlled trial. The intervention consisted of specific dietary and exercise advice that addressed behavior change supported by a tailor-designed smartphone application. Women in the control group received usual care. The primary outcome was the incidence of GDM at 28-30 weeks of gestation. To reduce GDM from 15% to 7.2%, we estimated that 506 women would be required to have 80% power to detect this effect size at a significance of .05, that is, 253 in each group. RESULTS: Between March 2013 and February 2016, 565 women were recruited with a mean BMI of 29.3 and mean gestational age of 15.5 weeks. The incidence of GDM did not differ between the two groups, 37 of 241 (15.4%) in the intervention group compared with 36 of 257 (14.1%) in the control group (relative risk 1.1, 95% CI 0.71-1.66, P=.71). CONCLUSIONS: A mobile health-supported behavioral intervention did not decrease the incidence of GDM. CLINICAL TRIAL REGISTRATION: ISRCTN registry, https://www.isrctn.com/, ISRCTN29316280.

Behaviour change in overweight and obese pregnancy: a decision tree to support the development of antenatal lifestyle interventions.

OBJECTIVE: Antenatal healthy lifestyle interventions are frequently implemented in overweight and obese pregnancy, yet there is inconsistent reporting of the behaviour-change methods and behavioural outcomes. This limits our understanding of how and why such interventions were successful or not. DESIGN: The current paper discusses the application of behaviour-change theories and techniques within complex lifestyle interventions in overweight and obese pregnancy. The authors propose a decision tree to help guide researchers through intervention design, implementation and evaluation. The implications for adopting behaviour-change theories and techniques, and using appropriate guidance when constructing and evaluating interventions in research and clinical practice are also discussed. CONCLUSIONS: To enhance the evidence base for successful behaviour-change interventions during pregnancy, adoption of behaviour-change theories and techniques, and use of published guidelines when designing lifestyle interventions are necessary. The proposed decision tree may be a useful guide for researchers working to develop effective behaviour-change interventions in clinical settings. This guide directs researchers towards key literature sources that will be important in each stage of study development.

Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

OBJECTIVE: Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population. METHODS: We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference. CONCLUSION: This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM.