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Protocol for a non-randomised stepped-wedge pilot trial for 'Nra:gi Ya:yun' (very good foods): a co-designed type 2 diabetes and metabolic syndrome initiative with Aboriginal people living on Ngarrindjeri Ruwe.2 days agoType 2 diabetes mellitus (T2D) and metabolic syndrome (MetS) have reached epidemic proportions for Indigenous populations globally. In Australia, disproportionate rates of T2D and MetS are inextricably tied to the experience of colonisation. As part of a growing shift towards strengths-based, Aboriginal-led initiatives, this project sought to co-design and assess the feasibility of a metabolic remission initiative, whereby Aboriginal people living on Ngarrindjeri Ruwe (Country) are supported to adopt a low-carbohydrate diet.
This 28-week pilot takes the form of a non-randomised stepped-wedge design. Aboriginal adults (≥18 years) living on Ngarrindjeri Ruwe with T2D or MetS will be recruited to two sites in rural South Australia. Participants will transition through three phases (control phase, remission phase and maintenance phase) with repeated measures taken across five key time points (T1-T5). While centring on the adoption of a low-carbohydrate diet, participants will be equipped with continuous glucose and ketone monitors and meal boxes and offered ongoing support through weekly to fortnightly check-ins. The primary outcome is to assess the feasibility of Nra:gi Ya:yun in preparation for a large-scale clinical trial of similar design. Feasibility will be assessed through recruitment, retention and adherence rates. Self-reported dietary recall, out-of-pocket food costs and national pharmaceutical and medical benefits scheme data will also be examined. Qualitative data obtained using the Aboriginal research method of yarning will aid analysis and interpretation of results. Clinical measures (such as blood pressure, weight, waist circumference, capillary ketones and capillary glucose) and venous blood draws will assist in the evaluation of our secondary outcome, namely the initiatives' preliminary effect on participant metabolic health.
Findings will be disseminated to Community, participants and policymakers in the form of digital posters, manuals, infographics and peer-reviewed publications. Lessons from this study have the potential to provide insights and benefits to Australian public health policy and research, as well as Indigenous populations globally who face similar metabolic challenges. Findings will be used to advise on an implementation strategy for a large-scale clinical trial. Pilot trial approved by the Aboriginal Health Research Ethics Committee (HREC), Flinders University HREC and Southern Adelaide Local Health Network HREC.
Pilot prospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12624001019594.DiabetesDiabetes type 2AccessCare/ManagementAdvocacy -
Palliative care experience among primary caregivers of children with cancer in low and lower-middle-income countries: a qualitative systematic review protocol.2 days agoPaediatric palliative care (PPC) improves the quality of life of children with life-limiting and life-threatening conditions, with caregivers playing an important role. Providing PPC in low-income and lower-middle-income countries (LMICs) is challenging due to limited resources, inadequate access to specialised care, financial constraints, and cultural or religious beliefs. This study aims to synthesise qualitative research on the experiences of primary care givers caring for children with cancer receiving palliative care in LMICs.
A systematic search will be conducted using electronic databases: MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase, CINAHL (Cumulative Index to Nursing and Health Literature), Web of Science, and PsycINFO. Additional articles will be searched in the reference list of the selected articles. Review questions will be framed into different components according to the Population, phenomena of Interest, Context, and Outcome (PICO) framework. Primary caregivers of children with cancer will be the population of interest. Both title and abstract screening and full-text screening will be done by two independent reviewers. The quality of included studies will be assessed using the Joanna Briggs Institute critical appraisal checklist for qualitative research. The thematic synthesis approach will be followed as it will allow a transparent summarising of the qualitative data.
This study is not subject to ethics approval, as the work is carried out on published documents. The findings of this review will be disseminated among a broader audience through scientific channels, including publication in open-access journals and presentations at both national and international forums.
CRD420251065491.CancerAccessCare/ManagementAdvocacy -
Genetic engineering and allogeneic optimization of Vδ1 γδ CAR-T cells (ADI-270) for cancer immunotherapy.2 days agoGenetic engineering has fundamentally transformed T cell-based therapies by enabling tumor targeting capability, improving their functionality, and facilitating allogeneic use. These strategies-originally developed in αβ chimeric antigen receptor (CAR)-T cells-have become increasingly established as blueprints for enhancing the function of other immune effector cells, including gamma delta (γδ) T cells. A recent study by Nishimoto et al showcased the adaptation of these engineering approaches to Vδ1 γδ T cells (ADI-270) by coexpressing a CD70-targeted CAR and a dominant-negative TGFβRII receptor (dnTGFβRII) to target CD70+ malignancies, addressing immunosuppression and host-versus-graft rejection. This commentary explores αβ T cell-derived engineering strategies applicable to γδ T cells, while also highlighting genome-editing innovations poised to advance next-generation γδ CAR-T development.CancerCare/Management
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Ethics and dilemmas regarding acceptance of COVID-19 vaccine among people living in an Indian metropolitan city during the pandemic: a qualitative study.2 days agoTo explore public perceptions of COVID-19 vaccine acceptance and hesitancy in India, and to identify underlying factors influencing attitudes toward vaccination during the second wave of the pandemic.
A cross-sectional qualitative study based on a grounded theory approach.
Community-based interviews conducted in Mumbai, a densely populated metropolitan city in India, during the second COVID-19 wave (April-June 2021).
Twenty purposively selected adults (men and women aged 22-87 years) from varied educational and occupational backgrounds. Inclusion criteria were willingness to participate and the ability to provide informed consent; individuals directly involved in COVID-19 vaccine policy or administration were excluded.
In-depth semi-structured interviews were conducted using an interview guide exploring perceptions of COVID-19 vaccination. Interviews were audio-recorded, transcribed verbatim and analysed inductively following grounded theory principles. Reflexivity was maintained throughout data collection and analysis.
Key emergent themes relating to vaccine acceptance, hesitancy and influencing factors such as safety concerns, efficacy perceptions, media influence and social determinants of vaccine choice.
Attitudes toward vaccination ranged from strong acceptance to hesitancy driven by concerns about safety, side effects and the speed of vaccine development. Media coverage, peer and healthcare professional opinions, and personal experiences shaped the decision of the participants. Cost considerations and lack of vaccine choice influenced uptake. Many participants favoured vaccination being voluntary rather than mandatory for the general population.
Trust in authorities, transparent risk communication and culturally sensitive engagement are critical to improving vaccine confidence. Public health strategies should address safety concerns, ensure equitable access and promote consistent messaging to enhance vaccine acceptance in current and future pandemic contexts.Chronic respiratory diseaseAccessCare/ManagementAdvocacy -
Physician beliefs regarding venous thromboembolism prophylaxis at a large multihospital US healthcare system: a cross-sectional survey study.2 days agoVenous thromboembolism (VTE) contributes to hospitalisation-associated morbidity. Although guidelines recommend limiting VTE prophylaxis to high-risk patients, some physicians prescribe it broadly. We compared beliefs of low and high prescribing physicians.
We surveyed hospitalists and medical residents who had the opportunity to prescribe prophylaxis ≥50 times. Best-worst scaling was used to assess their beliefs. Using a balanced incomplete block design, we created seven choice tasks with seven statements regarding prophylaxis beliefs each presented four times. For each task, physicians selected the statement that most and least reflected their beliefs. We used a count method to calculate best-worst scores and a conditional logistic regression choice model to compare low and high prescribers.
Of 434 invitees, 172 (40%) completed all survey questions between June and November 2023. Low (n=86, ≤62.5% prescribing rate) and high (n=86, >62.5 prescribing rate) prescribers endorsed similar beliefs with differing levels of agreement. All felt confident to prescribe prophylaxis appropriately (low: +1.13, high: +1.10, p=0.81). High prescribers expressed more concern about VTE without prophylaxis (+1.02 vs +0.65, p=0.002). Low prescribers disagreed more that prophylaxis had no downside (-1.03 vs -0.73, p=0.01). High prescribers worried less about prophylaxis risks (-0.49 vs -0.22, p=0.01), and overuse (-0.61 vs -0.34, p=0.02).
Compared with low prescribers, high prescribers were more concerned about VTE without prophylaxis and less about harms. These differences in beliefs may underlie physician behaviour and could be targets for interventions to reduce inappropriate prophylaxis.Cardiovascular diseasesAccessCare/ManagementAdvocacy -
Prophylaxis for venous thromboembolism in traumatic brain injury: protocol for a randomised controlled trial.2 days agoVenous thromboembolism (VTE) is a common complication of traumatic brain injury (TBI) and is associated with increased morbidity and mortality. Low molecular weight heparin (LMWH) is recommended for prophylaxis against VTE after trauma but may increase the risk of progression of intracranial bleeding. Limited evidence exists to guide clinicians regarding the optimal timing of VTE prophylaxis in patients with acute TBI. This randomised controlled trial (RCT) will directly compare the safety and effectiveness of early versus delayed initiation of LMWH in patients with moderate to severe TBI.
The study design is a Bayesian adaptive RCT comparing early (within three calendar days of injury) versus delayed (after study Day 7) VTE prophylaxis with the LMWH, dalteparin. All patients receive sequential compression devices until study Day 8. The co-primary effectiveness outcome is the development of clinically important VTE at study Day 8. The co-primary safety outcome is the development of clinically important intracranial bleeding at study Day 8. Secondary outcomes are mortality and functional outcomes (Glasgow Outcome Scale Extended and EQ-5D) measured at study Days 30 and 180; clinically diagnosed VTE to Day 30 and progression of intracranial bleeding to Day 8.
This study has been approved through Clinical Trials Ontario's streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre) and all participating centres. It is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and Health Canada regulatory requirements. We anticipate that the trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of critical care, trauma and neurosurgery. The results of this trial will help guide clinicians aiming to balance the risks and benefits of early anticoagulant prophylaxis after TBI and will inform guideline development.
NCT03559114.Cardiovascular diseasesAccessCare/ManagementAdvocacy -
Impact of physical activity on sleep in adults recovering from substance use disorders: a protocol for an N-of-1 observational study.2 days agoSleep impairments are prevalent among individuals recovering from substance use disorders (SUDs) and are associated with poorer treatment outcomes and increased relapse risk. Physical activity (PA) is known to enhance sleep in general populations, but its day-to-day effects on sleep during SUD recovery remain underexplored, especially across different recovery stages.
In this observational n-of-1 study, we aim to examine within-person associations between daily PA and sleep quality in three groups of individuals at varying stages of substance use recovery (early treatment, continuing care and long-term recovery). A substudy will validate the agreement between two wearable sleep-monitoring devices. A total of 90 participants (30 per recovery group) from Western Australia will complete daily ecological momentary assessments and wear the SENS Motion sensor and/or Withings Sleep Analyzer over a 30-day period. Outcomes include device-derived sleep and PA measures, self-reported affect, craving, well-being and recovery outcomes. Multilevel models will explore within-person and between-person associations. This study will generate individualised evidence on associations between PA and sleep to inform tailored SUD care. It will also assess the feasibility of using wearable sleep monitors in real-world SUD recovery settings. Results may support the future development of just-in-time adaptive intervention procedures.
The study was approved by the Human Research Ethics Committee of Curtin University (HRE2025-0379). Findings will be shared through peer-reviewed publications and conference presentations, with lay summaries provided to treatment facilities and interested participants to support translation into community and service settings.
ACTRN12625000835448.Mental HealthAccessCare/ManagementAdvocacy -
Food insecurity and nutritional status of Latin American and African waste pickers: a systematic review and meta-analysis.2 days agoFood insecurity is the violation of this right to regular and permanent access to quality food in sufficient quantity without compromising other essential needs and is associated with an increase in non-communicable chronic diseases (NCDs). Recyclable waste collectors' vulnerable social groups face a high risk of food insecurity due to low income, precarious working conditions, and a lack of public policies targeting them.
This systematic review aimed to investigate the prevalence of food insecurity as well as changes in nutritional status among recyclable waste collectors.
The review followed the Cochrane guidelines and was registered in PROSPERO. Five databases were searched and observational studies (cross-sectional, case--control, and cohort) were included. The primary outcome was the prevalence of food insecurity and secondary outcomes were nutritional status such as underweight, overweight, and obese. Meta-analysis was performed using the pooled crude proportions (PRAW) method and random effects in software R version 4.1.1.
The search identified 10 studies involving 788 waste collectors. The prevalence of food insecurity was high, reaching 71% with Brazil showing the highest prevalence (77%). Overweight affected 47% of participants, with higher rates in Brazil (52%) compared to South Africa (25%). Additionally, 29% of the collectors were obese.
The high prevalence of food insecurity and overweight among recyclable waste collectors highlights the urgent need for specific public policies for this group.
PROSPERO CRD42025645499.Non-Communicable DiseasesAccess -
[Endovascular treatment of hospital-acquired ischemic stroke].2 days agoTo study clinical outcomes, safety, and technical outcomes of endovascular thromboextraction (EVT) in patients with in-hospital ischemic stroke (IHS).
A comparative retrospective analysis of EVT outcomes was conducted in 3.963 patients (3.651 with community onset stroke and 312 with IHS) with acute proximal arterial occlusion in the carotid and vertebral-basilar systems (VBS) treated at 12 regional vascular centers in St. Petersburg in the period from 01.03.2017 to 01.10.2023. The clinical and instrumental examination of patients included an assessment using the National Institutes of Health Stroke Scale (NIHSS) and a modified Rankin Scale (mRS). The severity of ischemic changes in the brain was assessed using a CT scan, followed by an ASPECTS score assessment. The technical outcomes were assessed using the mTICI score.
Patients with IHS accounted for 7.9% of all patients who underwent EVT. Patients with IHS had greater comorbidity (significantly more common coronary heart disease, type 2 diabetes mellitus, peripheral arterial atherosclerosis, history of stroke of any type, and chronic renal failure) and the extension of stroke in the VBS, better brain CT scores before the EVT (higher ASPECTS score), and more often received antithrombotic therapy (p≥0.05). Patients with IHS had a shorter time from the onset of stroke to artery puncture, a lower proportion of combined (intravenous thrombolytic therapy+EVT) treatment (p≥0.001), and better technical outcomes (mTICI 2b-3) by the end of the intervention (p≥0.05). The change of neurological disorders (NIHSS) and functional outcomes at discharge (mRS) were comparable across both groups. There was a significantly higher incidence of hemorrhagic changes in the group of community onset stroke (p≥0.05); however, the frequency of type 2 parenchymal hematomas and symptomatic hemorrhages was comparable.
EVT in patients with IHS in the carotid system and VBS showed technical and clinical efficacy, safety, and, if indicated, should be used in all patients with IHS in emergency care.DiabetesCardiovascular diseasesDiabetes type 2AccessCare/ManagementAdvocacy -
Insights into necrotising fasciitis: A prospective pilot study in a Tertiary Care Hospital.2 days agoNecrotising fasciitis, commonly referred to as "flesh-eating disease," is a rapidly spreading soft tissue infection characterised by extensive necrosis of the skin, subcutaneous tissue, and fascia while sparing the underlying muscle. Despite its low overall incidence, it is a significant soft tissue infection due to its rapid spread and associated high mortality risk.
This prospective pilot study aims to analyse 25 consecutive cases of necrotising fasciitis to assess various aspects, including age and sex incidence, microbial flora, role of co-morbidities in prognosis, and overall outcome. We conducted a descriptive study involving 25 patients aged 18-84 years diagnosed with necrotising fasciitis over a 6-month period (January 2022 to June 2022) at Saveetha Medical College.
Of the 25 patients treated, 21 (84%) were male and 4 (21%) were female, resulting in a male-to-female ratio of 5.25. The age ranged from 18 to 84 years (Mean age: 50.24 ± Standard deviation, SD=14.175). Trauma was identified as the main precipitating factor in approximately 40% of cases, while Diabetes Mellitus (40%) emerged as the most common co-morbidity. Lower limb involvement was predominant in both male and female patients. The infection was monomicrobial in 32% of cases (Enterococci 16% + Bacteroides 16%) and poly-microbial in 68% with Streptococcus pyogenes + Escherichia coli being the most common organism combination. Wound debridement followed by split skin graft was the most common treatment modality (84%), with the number of debridement sessions varying based on infection severity (corresponding with higher LRINEC scores). Prolonged hospital stay was the most common complication, observed in 52% of cases.
Our analysis revealed that necrotising fasciitis is more prevalent in individuals aged over 50 years with a male predominance. Streptococcus pyogenes with Escherichia coli was the predominant microflora, and Diabetes Mellitus emerged as the most common comorbidity. Early recognition, prompt control of diabetes mellitus, aggressive surgical treatment, and supportive therapy are essential steps in managing necrotising fasciitis.DiabetesAccessAdvocacy