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Patients discharged from an intensive care unit (ICU) are frequently malnourished and experience ongoing inadequate nutrition intake because of a variety of barriers, which may lead to further declines in nutrition status. The coronavirus disease 2019 (COVID‐19) pandemic has drawn increased awareness to this vulnerable patient population and the importance of nutrition rehabilitation to promote optimal recovery from acute illness. Despite this, there are no formal guidelines addressing medical nutrition therapy during the post‐ICU recovery phase. This review provides an overview of the nutrition management of patients during the post‐ICU recovery phase with a specific focus on COVID‐19. A case study will demonstrate how medical nutrition therapy improved the nutrition status and quality of life for a patient who became severely malnourished after a prolonged hospitalization for COVID‐19.

Medical stabilization, nutrition rehabilitation, and weight restoration, while minimizing risk for the potentially fatal complication of refeeding syndrome, are the primary goals for the treatment of hospitalized individuals with anorexia nervosa and other restrictive-type eating disorders. The purpose of this review was to examine the literature exploring the prophylactic supplementation of phosphate, magnesium, and potassium, in addition to routine thiamin and multivitamin supplementation, for the prevention of refeeding syndrome in adolescents and adults with anorexia nervosa. Through evaluation of outcomes (including serum electrolyte levels and clinical signs and symptoms such as respiratory failure, cardiac failure, peripheral edema, rhabdomyolysis, and encephalopathy), three studies found that prophylactic supplementation of potassium, magnesium, and/or phosphate were effective in preventing refeeding syndrome or refeeding hypophosphatemia (a characteristic of refeeding syndrome). Although all studies found that prophylactic supplementation was effective in preventing refeeding syndrome, refeeding approaches (including the method, amount, and duration of nutrient delivery) as well as the populations studied varied considerably, making it difficult to arrive at specific recommendations for practice. Randomized controlled trials are needed to further examine the safety and effectiveness of prophylactic supplementation of phosphate, magnesium, and potassium on the prevention of refeeding syndrome, utilizing similar feeding and supplementation protocols.

Despite recent reviews of best practice for the treatment of Australian venomous bites and stings, there is controversy about some aspects of care, particularly the use of antivenom. Our aim was to understand current attitudes and practice in the management of suspected snake envenoming. A single-stage, cross-sectional survey of Australian emergency care physicians who had treated snake envenomation in the previous 36 months was conducted. Hospital pharmacists were also invited to complete a survey about antivenom availability, usage, and wastage in Australian hospitals. The survey was available between 5 March and 16 June 2019. A total of 121 snake envenoming cases were reported, and more than a third (44.6%) of patients were not treated with antivenom. For those treated with antivenom (n = 67), 29 patients (43%) received more than one ampoule. Nearly a quarter of respondents (21%) identified that antivenom availability was, or could be, a barrier to manage snake envenoming, while cost was identified as the least important factor. Adverse reactions following antivenom use were described in 11.9% of cases (n = 8). The majority of patients with suspected envenoming did not receive antivenom. We noted variation in dosage, sources of information, beliefs, and approaches to the care of the envenomed patient.

Community harm associated with prescription opioids is causing global concern, and post-hospital discharge prescribing is contributing to the problem. We surveyed anaesthetists in Australia and New Zealand to determine which opioid stewardship measures are currently in place, and to gauge interest in participating in future health services research on introducing an opioid stewardship bundle of care. A total of 87 anaesthetists from 87 hospitals were invited to participate, and 45 (52%) responded. The extent of nine current opioid stewardship measures reported was highly variable. One respondent (2%) reported no measures introduced at their hospital; 12 (27%) one to two measures; 16 (36%) three or four measures; 13 (29%) five to seven measures; and 3 (7%), all nine measures were in place. Respondents were often interested in being contacted about future trial participation ( n = 33, 73%); however, concerns regarding feasibility of introducing an opioid stewardship bundle of care were widespread ( n = 22, 49%). It is possible that the variability in Australian and New Zealand opioid stewardship practice is due, in part, to the current limited evidence base for the individual measures, in addition to challenges in research translation. We have found that interest in further research on opioid stewardship is high. Comprehensive, locally adapted, evidence-based opioid stewardship measures may increase the safety of patients and the community following opioid therapy.

Hyperglycemia is associated with increased morbidity and mortality. Low-carbohydrate, high-fat (LCHF) enteral formulas are marketed to improve glycemic control; however, given the multifactorial mechanisms contributing to hyperglycemia in patients who are critically ill, the effect that LCHF formulas may have on improving glycemic control in this patient population is unclear. Current guidelines for the use of LCHF formulas among patients who are critically ill are limited by a lack of evidence. This review explores recent research published in the past 7 years to determine whether LCHF enteral formulas improve glycemic control compared with standard enteral formulas in patients who are critically ill. Four randomized controlled trials met the inclusion criteria for this review. Their results suggest that LCHF formulas may improve glycemic control in patients who are critically ill with diabetes mellitus and/or who are hyperglycemic. Further large-scale randomized controlled trials are warranted to validate these findings among different subgroups of patients with critical illness. The potential benefits of LCHF formulas need to be weighed against specific limitations, including that LCHF formulas typically do not contain sufficient protein to meet the recommended needs of patients who are critically ill.

Despite the tremendous interest in cryptocurrencies like Bitcoin and Ethereum today, many aspects of the underlying consensus protocols are poorly understood. Therefore, the search for protocols that improve either throughput or security (or both) continues. Bitcoin always selects the longest chain (i.e., the one with most work). Forks may occur when two miners extend the same block simultaneously, and the frequency of forks depends on how fast blocks are propagated in the network. In the GHOST protocol, used by Ethereum, all blocks involved in the fork contribute to the security. However, the greedy chain selection rule of GHOST does not consider the full information available in the block tree, which has led to some concerns about its security. This paper introduces a new family of protocols, called Medium, which takes the structure of the whole block tree into account, by weighting blocks differently according to their depths. Bitcoin and GHOST result as special cases. This protocol leads to new insights about the security of Bitcoin and GHOST and paves the way for developing network- and application-specific protocols, in which the influence of forks on the chain-selection process can be controlled. It is shown that almost all protocols in this family achieve strictly greater throughput than Bitcoin (at the same security level) and resist attacks that can be mounted against GHOST.

ObjectivesTo investigate associations between maternal body mass index (BMI) at delivery (using pregnancy-specific BMI cut-off values 5 kg/m2higher in each of the WHO groups) and clinical, theatre utilisation and health economic outcomes for women undergoing caesarean section (CS). DesignA prospective multicentre observational study. SettingSeven secondary or tertiary referral obstetric hospitals. ParticipantsOne thousand and four hundred and fifty-seven women undergoing all categories of CS. Data collectionHeight and weight were recorded at the initial antenatal visit and at delivery. We analysed the associations between delivery BMI (continuous and pregnancy-specific cut-off values) and total theatre time, surgical time, anaesthesia time, maternal and neonatal adverse outcomes, total hospital admission and theatre costs. ResultsMean participant characteristics were: age 32 years, gestation at delivery 38.4 weeks and delivery BMI 32.2 kg/m2. Fifty-five per cent of participants were overweight, obese or super-obese using delivery pregnancy-specific BMI cut-off values. As BMI increased, total theatre time, surgical time and anaesthesia time increased. Super-obese participants had approximately 27% (17 min, p ConclusionsIncreased maternal BMI was associated with increased total theatre time, surgical and anaesthesia time, increased total hospital admission costs and theatre costs. Clinicians and health administrators should consider these clinical risks, time implications and financial costs when managing pregnant women.

Summary Background Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV. Methods We did pharmacokinetic and safety substudies within the open-label, multicentre, randomised ODYSSEY trial (NCT02259127) of children with HIV starting treatment in four research centres in Uganda and Zimbabwe. Eligible children were randomised to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg. In children weighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which were approved by the SRAs for the children's weight band; then switched to 50 mg film-coated tablets once daily. Steady-state 24 h dolutegravir plasma concentration-time pharmacokinetic profiling was done in all enrolled children at baseline and 1, 2, 3, 4, 6, and 24 h after observed dolutegravir intake. Target dolutegravir trough concentrations (Ctrough) were based on reference adult pharmacokinetic data and safety was evaluated in all children in the corresponding weight bands who consented to pharmacokinetic studies and received the studied doses. Findings Between Sept 22, 2016, and May 31, 2018, we enrolled 62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles). In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) Ctrough (coefficient of variation) was 0·32 mg/L (94%), which was 61% lower than the GM Ctrough of 0·83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 kg to less than 30 kg taking 25 mg film-coated tablets, the GM Ctrough was 0·39 mg/L (48%), which was 54% lower than the GM Ctrough in fasted adults; and in those 30 kg to less than 40 kg taking 35 mg film-coated tablets the GM Ctrough was 0·46 mg/L (63%), which was 45% lower than the GM Ctrough in fasted adults. On 50 mg film-coated tablets or 30 mg dispersible tablets, Ctrough was close to the adult reference (with similar estimates on the two formulations in children in the 20 to

The Australian and New Zealand College of Anaesthetists (ANZCA) has more than 200 accredited training sites in Australia, New Zealand, Hong Kong, Malaysia and Singapore, many of which participate in ANZCA Clinical Trials Network (CTN)–endorsed clinical trials. We undertook a survey of accredited sites to determine research capability, activity and potential. With ethics committee approval an electronic survey was distributed to accredited sites in July 2015. Of 207 accredited sites, 167 were sent the questionnaire (after eliminating ineligible sites) and 128 responded. Response rates for Australia, New Zealand, Hong Kong, Malaysia and Singapore were 100%, 100%, 35%, 25% and 75% respectively. Forty-four (34%) of 128 responding sites had a head of research; 101 (80%) of 126 responding sites were active in research; 42 (33%) of 126 responding sites had no publications since January 2011 and 15 (12%) had >50 publications; 95 (76%) of 125 responding sites had at least one specialist anaesthetist engaged in research (median = 4 [range 1–25]); and 45 (36%) of 125 responding sites had at least one research coordinator (median = 2 [range 1–15]). Fifty-eight (28%) of the 207 accredited sites were identified as participating in recent ANZCA CTN–endorsed clinical trials. Research capability and activity were higher in these sites. This survey has identified a strong base upon which to expand clinical trial activity, and regions, sectors, investigators and research coordinators who may benefit from additional support.

Background Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to both mother and child. A major contributor to both prepregnancy obesity and excessive GWG is physical inactivity; however, past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution for increasing activity levels in this population. Objective This initial feasibility randomized controlled trial aimed to test a pedometer-based intervention to increase activity and reduce excessive GWG in pregnant women. Methods We supplied 30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups: control (pedometer only), app (pedometer synced to patients’ personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach–delivered behavioral change program). Feasibility outcomes included participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity. Activity outcomes (step counts and active minutes) were analyzed using linear mixed models and generalized estimating equations. Results A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30; 2 withdrawals and 1 stillbirth); 27 participants thus completed the study. Mean BMI in all groups was ≥35 kg/m2. Mean (SD) percentage of missing data days were 23.4% (20.6%), 39.5% (32.4%), and 21.1% (16.0%) in control, app group, and app-coach group patients, respectively. Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration. There was a mean decrease of 7.8 steps/day for each increase in gestation day over the study period (95% CI 2.91 to 12.69, P=.002). Conclusions Activity data syncing with a personal smartphone is feasible in a cohort of pregnant women with obesity. However, our results do not support a future definitive study in its present form. Recruitment and retention rates were adequate, as was activity data syncing to participants’ smartphones. A follow-up interventional trial seeking to reduce GWG and improve activity in this population must focus on improving compliance with activity data recording and behavioral interventions delivered. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884

Adequate folate intake during the female reproductive years plays a vital role in fetal neurodevelopment. To address this public health concern, the FDA required enriched cereal grains to be fortified with folic acid. A positive outcome of fortification with folic acid was a reduction in the number of pregnancies affected by neural tube defects (NTDs). However, there are individuals unable to consume these enriched grains, such as those with a gluten allergy or intolerance. The need for folic acid fortification across all grains, those with and without gluten, should be considered in an effort to provide equivalent folic acid to all and further promote public health efforts aimed at decreasing the incidence of NTDs.

We report a study to design and evaluate an app to support pregnancy information provided to women through an Australian health service. As part of a larger project to provide prenatal resources for culturally and linguistically diverse groups, this study focused on the design and reception of an app with the local Vietnamese community and health professionals of a particular hospital. Our study had three stages: an initial design workshop with the hospital; prototype design and development; prototype-based interviews with health professionals and focus groups with Vietnamese women. We explore how an app of this sort must be designed for a range of different use scenarios, considering its use by consumers with a multiplicity of differing viewpoints about its nature and purpose in relation to pregnancy care.

Bronchopulmonary dysplasia (BPD) is a common complication of premature birth and is associated with significant morbidity. Vitamin A supplementation has been suggested as a potential preventative measure against BPD due to its role in lung maturation and because preterm infants are particularly predisposed to vitamin A deficiency. The aim of this review was to determine whether vitamin A supplementation reduces BPD risk among preterm infants. PubMed, CINAHL, and Web of Science databases were searched with the keywords "bronchopulmonary dysplasia," "vitamin A," and "preterm infants" and with the time frame of 2006-2016, and 4 studies were selected for review per the inclusion criteria. Only 1 study found a significant reduction in BPD risk associated with vitamin A supplementation; however, 2 studies indicated a nonsignificant benefit and may have been underpowered to show statistical significance. One study revealed an increased risk of sepsis associated with vitamin A supplementation (for infants weighing >1000 g at birth), but no risk was seen with vitamin A supplementation in the other studies. Because intramuscular vitamin A has shown benefit with minimal risk, continued supplementation for preterm infants is warranted. Future studies aimed at assessing infant groups that are most likely to benefit from supplementation (based on birth weight or other conditions), as well as determining the optimal dosing while minimizing injections, would be beneficial.

Background Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus. The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings. Objective We investigated the effect of medical nutrition therapy (MNT) compared with usual care on fasting plasma glucose values, glycated hemoglobin (HbA1c), serum lipid levels, and Diabetes Risk Score, from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes. Design Prospective, randomized, parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7% to 6.4%, recruited between April 2010 and May 2011 who completed a 12-week intervention period. Main outcome measures The primary outcome measure was fasting plasma glucose. Secondary outcome measures were HbA1c, serum lipid levels, and Diabetes Risk Score. Statistical analyses A factorial repeated measures analysis of variance was used to make comparisons between the two groups (the MNT and usual care groups) and two measures of time (baseline and 12 weeks postintervention). Data analysis was performed using the Statistical Package for the Social Sciences (release 19.0, 2010, SPSS Inc). Results There was a significant interaction for group assignment and HbA1c ( P =0.01), with the MNT group experiencing significantly lower HbA1c levels than the usual care group (5.79% vs 6.01%) after the 12-week intervention. There was a significant interaction for group assignment and Diabetes Risk Score ( P =0.001). Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score, which went from 17.23±4.69 to 16.83±4.73. Regardless of group assignment, both groups experienced a reduction in total cholesterol ( P =0.01) and low-density lipoprotein cholesterol ( P =0.04) level. Conclusions The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes.

Polycystic ovary syndrome (PCOS) affects ∼1 in 10 women worldwide. Hypomagnesemia may worsen insulin resistance (IR) due to the role magnesium (Mg) plays in glucose metabolism. This review explores the relation between serum Mg and IR among women with PCOS. A review of primary research focusing on both serum Mg and women with PCOS was conducted from 2011 to 2019. Studies reviewed included human subjects, written in the English language, and limited to community-dwelling women aged ≥18 y. A total of 7 articles were reviewed. The findings from 4 epidemiological analytic studies evaluating serum Mg status suggest there may be a relation between serum Mg concentrations and IR among women with PCOS. However, among the 3 experimental trials, Mg supplementation inconsistently impacted IR among women with PCOS. Women with PCOS are more likely to underconsume Mg-rich foods and have a greater likelihood of lower serum Mg concentrations. Although it remains unclear if dietary Mg and/or supplementation should be a nutritional strategy for all women with PCOS, current research indicates an association between adequate Mg status and improved IR. Further research evaluating dietary interventions and supplementation is warranted.

Nearly 70% of the Australian adult population are either sedentary, or have low levels of physical activity. There has been interest in addressing this problem by the ‘mHealth’, or mobile Health, arena, which is concerned with the confluence of mobile technology and health promotion. The newer generation of activity pedometers has the ability to automatically upload information, to enable aggregation and meta-data analysis of individual patient data. We conducted a ten-week pilot trial of the Fitbit Zip® pedometer using a validated tool in ten volunteers, finding it highly acceptable to both participants and investigators. Data synching was ranked as ‘very easy’ or ‘easy’ by all participants, and investigators could successfully monitor activity levels remotely. Median (interquartile range) daily step counts of participants over the ten-week trial ranged from 5471 (4591–7026) to 18779 (15031–21505) steps. Sedentary time over the study period ranged from 1.4% to 33.3% of study days. Percentage of days reaching the target activity level of >10,000 steps/day varied markedly between participants from 4.5% to 95.7%. This study demonstrates the feasibility and acceptability of a remotely monitored pedometer-guided physical activity intervention. This technology may be useful to encourage increased exercise as a form of ‘prehabilitation’ of adequately screened at-risk surgical or obstetric patients.

The under-representation of culturally and linguistically diverse participants in clinical trials is an ongoing concern for medical researchers and the community. The aim of this review is to examine the complex issue of recruiting culturally and linguistically diverse (CALD) older people to medical research and to examine responses to these issues. The review focuses on (1) trends in the existing literature on barriers to and strategies for recruiting CALD and older people to clinical research, (2) issues with informed consent for CALD populations, and (3) the efficacy of innovative approaches, including approaches incorporating multimedia in research and consent processes. The literature indicates that predominant barriers to greater involvement of CALD patients in clinical trials are communication, including literacy and health literacy considerations; English language competence; and cultural factors in the research setting such as mistrust of consent processes, as well as considerable practical and logistical barriers, including mobility considerations. Some evidence exists that incorporating multimedia resources into the informed consent process can improve patient understanding and is preferred by patients, yet these findings are inconclusive. A multi-methodological approach, including the use of culturally and linguistically sensitive multimedia tools, may help address the issue of low inclusion of CALD groups in clinical research. Researcher education needs to be taken into account to address preconceptions about CALD resistance to research participation and to raise awareness of cultural concerns in regard to research participation.

Background Low-participation of culturally and linguistically diverse (CALD) patients in medical research remains a problem in migrant and refugee destination countries such as Australia. The aims of this study were to explore i) CALD persons’ perceptions and experiences of the medical system and medical research, in this case, older Italian Australians; and ii) the views of research professionals on CALD patient participation in medical research. Design and Methods A qualitative study was conducted in Melbourne, Australia, in 2015 utilising in-depth interviews and focus groups with four stakeholder groups: older Italian Australians (n=21); adult children of older Italian Australians (n=10); hospital Human Research Ethics Committee administrators (n=4); and clinical researchers (n=4). The data were analysed for content and thematic analysis. Results Themes for the CALD and family group were getting by in medical interactions; receptivity to medical research: testing the waters; and, receptivity to technology for support: passive versus active. Themes for the researcher and HREC groups about CALD patient participation in research were: exclusion; cultural factors; and e-consent. Conclusions Our findings from four stakeholder perspectives and experiences confirm that there were considerable cultural, linguistic, and resourcing barriers hindering the participation of older Italian-Australians in medical research. Furthermore, our findings showed that in this study setting there were few enabling strategies in place to address these barriers despite the national ethics guidelines for equitable participation in research. The findings informed the creation of a multimedia tool whose purpose is to address and improve representation of CALD groups in clinical research. Significance for public health Many people from culturally and linguistically diverse (CALD) backgrounds remain excluded from medical research such as clinical trials due to a range of language and cultural factors that can be amplified when this population is ageing. This exclusion has implications for the ability of CALD populations to benefit from participating in medical research and for applying research findings to CALD populations. It is essential to develop and implement strategies to include CALD communities in medical research and to uphold the ethical obligation of obtaining informed consent to research. The findings of this study have guided the development of a tablet-based resource which can be used in clinical and community contexts to raise awareness about the purpose of medical research. The resource has been carefully designed to be appropriate for participants' cultural background as well as their preferred language and literacy level. Such a resource has potential to address some of the cultural and linguistic barriers to clinical trial participation of CALD populations.

Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) represent a spectrum of disease with wide-reaching effects. While often thought of as a surgical disease, a number of medical management strategies may be utilized, in some cases obviating the need for surgical intervention. Central to this issue are the interrelated pressures within the abdominal, thoracic, and vascular compartments within the body. Fluid management and the treatment of renal dysfunction in patients at risk for IAH and ACS is a complex problem and one that cannot be easily separated from concurrent multiorgan system effects. We therefore provide a brief overview of the systemic effects that affect many patients developing acute kidney injury in this setting. We will review in more detail the relevant renal pathophysiology as well as the medical and surgical management strategies for treating patients with IAH and ACS.

linical research has been an area of increasing activity for hospitals, universities and research institutions in Australia, rising from 1960 trials in 2000 to 3208 trials in 2009 (Therapeutic Goods Administration, personal communication). To manage the increasing risks for both patients and institutions, strategies to better monitor research governance are now receiving greater attention. The National Health and Medical Research Council (NHMRC) National statement on ethical conduct in human research 1 requires that individual institutions take responsibility for monitoring clinical research conducted at their institutions. One of the most common methods used to monitor research activities is the annual progress report required by human research ethics committees (HRECs). The report includes information about compliance with the approved protocol, as well as maintenance and security of records. Some institutions also undertake random inspections of research sites, data or consent documentation.

Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based DTG dosing and opened recruitment to children Methods ODYSSEY (Once-daily DTG based ART in Young people vS. Standard thErapY) is an open-label, randomised, non-inferiority, basket trial comparing the efficacy and safety of DTG + 2 nucleos(t) ides (NRTIs) versus standard-of-care (SOC) in HIV-infected children Results Between September 2016 and June 2018, 707 children weighing ≥14 kg were enrolled; including 311 ART-naïve children and 396 children starting second-line. 47% of children were enrolled in Uganda, 21% Zimbabwe, 20% South Africa, 9% Thailand, 4% Europe. 362 (51%) participants were male; median age [range] at enrolment was 12.2 years [2.9–18.0]. 82 (12%) children weighed 14 to Conclusions By employing a basket design, to include ART-naïve and -experienced children, and nested PK sub-studies, the ODYSSEY trial efficiently evaluates multiple scientific questions regarding dosing and effectiveness of DTG-based ART in children. Trial registration NCT, NCT02259127, registered 7th October 2014; EUDRACT, 2014–002632-14, registered 18th June 2014 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002632-14/ES); ISRCTN, ISRCTN91737921, registered 4th October 2014.