Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized controlled trial.

Introduction: This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.

Research Design And Methods: In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 670G) or standard therapy (insulin pump or multiple daily injections without real-time continuous glucose monitoring). Psychological outcomes (awareness and fear of hypoglycemia; and diabetes-specific positive well-being, diabetes distress, diabetes treatment satisfaction, and diabetes-specific quality of life (QoL)) were measured at enrollment, mid-trial and end-trial.

Therapeutic Potential of Ketogenic Interventions for Autosomal-Dominant Polycystic Kidney Disease: A Systematic Review.

Background: Recent findings have highlighted that abnormal energy metabolism is a key feature of autosomal-dominant polycystic kidney disease (ADPKD). Emerging evidence suggests that nutritional ketosis could offer therapeutic benefits, including potentially slowing or even reversing disease progression. This systematic review aims to synthesise the literature on ketogenic interventions to evaluate the impact in ADPKD.

Balancing precision and affordability in assessing infant development in large-scale mortality trials: secondary analysis of a randomised controlled trial.

Objective: Large-scale mortality trials require reliable secondary assessments of impairment. We compared the Ages and Stages Questionnaire (ASQ-3), a screening tool self-administered by parents, in classifying impairment using the 'gold standard' Bayley Scales of Infant Development (Bayley-III), a diagnostic tool administered by trained assessors.

Design: Analysis of 405 children around 2 years corrected age from the Australian Placental Transfusion Study, a trial conducted over 8 years.

Cardiovascular, kidney and safety outcomes with canagliflozin in older adults: A combined analysis from the CANVAS Program and CREDENCE trial.

Aim: SGLT2 inhibitors may be underused in older adults with type 2 diabetes due to concerns about safety and tolerability. This pooled analysis of the CANVAS Program and CREDENCE trial examined the efficacy and safety of canagliflozin according to age.

Methods: Pooled individual participant data from the CANVAS Program (n = 10 142) and CREDENCE trial (n = 4401) were analysed by baseline age (<65 years, 65 to <75 years, and ≥75 years).

AGITG MONARCC: A Randomized Phase 2 Study of Panitumumab Monotherapy and Panitumumab Plus 5-Fluorouracil as First-Line Therapy for Older Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer. A Study by the Australasian Gastro-Intestinal Trials Group (AGITG).

Background: Panitumumab (pan) plus chemotherapy is a preferred first-line therapy for unresectable RAS and BRAF wild type metastatic colorectal cancer (mCRC). Older patients may not be suitable for combination regimens. We investigated 2 lower intensity pan-containing regimens.

A phase II trial of larotrectinib in tumors with NTRK fusions or extremes of NTRK mRNA overexpression identified by comprehensive genomic profiling.

Background: TRK-inhibitors have demonstrated efficacy across several cancers with NTRK fusions. Their activity in cancers with NTRK overexpression remains unclear.

Methods: This trial enrolled patients with advanced cancers harboring NTRK fusions or extreme mRNA overexpression, defined as NTRK1/2/3 expression by RNA profiling >5 SDs for a given cancer type.

Predicting type 2 diabetes and testosterone effects in high-risk Australian men: development and external validation of a 2-year risk model.

Objective: We have shown that men aged 50 years+ at high risk of type 2 diabetes treated with testosterone together with a lifestyle program reduced the risk of type 2 diabetes at 2 years by 40% compared to a lifestyle program alone. To develop a personalized approach to treatment, we aimed to explore a prognostic model for incident type 2 diabetes at 2 years and investigate biomarkers predictive of the testosterone effect.

Design: Model development in 783 men with impaired glucose tolerance but not type 2 diabetes from Testosterone for Prevention of Type 2 Diabetes; a multicenter, 2-year trial of Testosterone vs placebo.

Identifying and counteracting fraudulent responses in online recruitment for health research: a scoping review.

Objectives: This study aimed to describe how health researchers identify and counteract fraudulent responses when recruiting participants online.

Design: Scoping review.

Eligibility Criteria: Peer-reviewed studies published in English; studies that report on the online recruitment of participants for health research; and studies that specifically describe methodologies or strategies to detect and address fraudulent responses during the online recruitment of research participants.

Conceptualising, operationalising and utilising equity, diversity and inclusion in clinical trials: a scoping review.

Introduction: Equity, diversity and inclusion (EDI) are social constructs which when used in clinical trials help generate the highest quality evidence for interventions in the populations most likely to benefit. However, the incorporation of these constructs in clinical trials is unclear and inconsistent. This scoping review sought to understand how EDI is applied in clinical trials.

Patient and Staff Experiences of Embedding Electronic Patient Reported Outcome Measures for Distress Screening and Quality of Life Assessment, Into Routine Melanoma Care: A Mixed-Methods Study.

Objective: Patient reported outcome measures (PROMs) are commonly collected in melanoma research. However, they are not used to guide immediate clinical care in Australia. This study explored the views and experiences of patients with Stage III melanoma and clinic staff during implementation of an electronic Patient-Reported Outcome Measures in melanoma (ePROMs-MEL) pilot to assess distress and quality of life.

Evolocumab in metastatic castration-resistant prostate cancer: study protocol for a single-arm, phase II trial, and initial experience with use of a validated lipid biomarker to direct therapy.

Background: Despite advances in the treatment of metastatic castration-resistant prostate cancer (mCRPC), primary and secondary resistance to current therapies remains. Elevated circulating sphingolipids are associated with poor outcomes in patients with mCRPC, including therapeutic resistance and shorter overall survival. PCPro is a clinically accessible, regulatory compliant plasma lipid biomarker of poor prognosis in mCRPC, which incorporates prognostic sphingolipids.

Variation in initial biopsy technique for primary melanoma diagnosis: A population-based cohort study in New South Wales, Australia.

Background: Factors associated with nonadherence to guideline-recommended complete excision of suspicious cutaneous lesions are unclear.

Objective: The purpose of this study was to analyze patient, melanoma, and clinician factors associated with initial diagnostic biopsy type and determine whether unwarranted variation from guidelines occurred.

Methods: This population-based, cohort study involved the analysis of data from questionnaires completed by clinicians who managed patients with newly diagnosed, histopathologically confirmed primary invasive cutaneous melanomas reported to the New South Wales Cancer Registry between 2006 and 2007.

Correlation of Functional and Structural Outcomes with Serum Antibody Profiles in Patients with Neovascular Age-Related Macular Degeneration Treated with Ranibizumab and Healthy Subjects: A Prospective, Controlled Monocenter Trial.

Age-related macular degeneration (AMD) is a multifactorial disorder, and there is growing evidence of immunological involvement in its pathogenesis. To address this, we aimed to identify biomarker candidates related to retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects. This study was designed as a prospective, open, parallel-group, interventional, single-center phase IV trial.

Short-Term Effectiveness of a Stepped-Care Model to Address Fear of Cancer Recurrence in Patients With Early-Stage Melanoma.

Objective: To investigate the effectiveness of the Melanoma Care Programme when implemented into routine clinical practice coupled with fear of cancer recurrence (FCR) screening and a stepped-care model of intervention delivery.

Methods: Using a Type-I hybrid effectiveness-implementation design, individuals with stage 0-II melanoma and a Fear of Cancer Recurrence Inventory FCR severity score of ≥ 13 were offered the Melanoma Care Programme. The programme included a psychoeducational booklet and 3 to 5 psychotherapeutic telehealth sessions with a clinical psychologist, timed around routine dermatological appointments.

The relationship of bispectral index values to conscious state: an analysis of two volunteer cohort studies.

Background: The ability of current depth-of-anaesthesia monitors to differentiate subtle changes in the conscious state has not been well characterised. We examine the variability in bispectral index (BIS) scores associated with disconnected conscious and unconscious states as confirmed by a novel serial awakening paradigm.

Methods: Seventy adult participants, given propofol or dexmedetomidine, had a cumulative 1381 electroencephalographic (EEG) recordings across two centres.

Assessing long-term effectiveness and cost-effectiveness of statin therapy in the UK: a modelling study using individual participant data sets.

Background: Cardiovascular disease has declined but remains a major disease burden across developed countries.

Objective: To assess the effectiveness and cost-effectiveness of statin therapy across United Kingdom population categories.

Design: The cardiovascular disease microsimulation model, developed using Cholesterol Treatment Trialists' Collaboration data and the United Kingdom Biobank cohort, projected cardiovascular events, mortality, quality of life and healthcare costs using participant characteristics.

Engaging Australian healthcare consumers to determine priorities and consensus for precision medicine approaches to detect non-communicable disease in early life: a modified Delphi study.

Objectives: Research to develop early screening tools to determine an individual's risk of developing adult-onset disease is a growing field. Expectant parents may find themselves with an option in the future to undergo screening to determine not only genetic abnormalities in their child but also their risk of developing adult-onset non-communicable diseases (NCD) such as hypertension, obesity or hypercholesterolaemia. To ensure acceptability and feasibility of new screening tools researchers must work in partnership with healthcare consumers to discern consumers' current understanding and acceptance of these technologies in research and the potential for clinical applications.

Molecular biomarkers for predicting complete response to preoperative chemoradiation in people with locally advanced rectal cancer.

This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: Primary objectives To identify and estimate the prognostic value of molecular biomarkers as predictors of pathological complete response to neoadjuvant chemoradiotherapy in people with locally advanced rectal cancer. summarises the review question in population, index prognostic factor, comparator prognostic factor(s), outcome, timing, and setting (PICOTS) format.