Risultati per: Standard Italiani per la cura del diabete mellito

Introduction
Children having surgery, and their parents, commonly have anxiety in the preoperative period, and this may impact longer-term health and quality of life. Psychological preparation can be expensive and time-consuming, and the type and effectiveness of preparatory interventions are variable. The aim of this randomised controlled trial (RCT) is to evaluate the clinical effectiveness of a preoperative smartphone psychological preparation application with virtual reality (VR) capability (the ‘Little Journey app’ (LJ)), at reducing anxiety and its sequelae in children and their carers.

Methods and analysis
Multicentre, assessor-blinded, two-armed, parallel group, RCT in children aged between 3 and 12 years, undergoing ambulatory surgery and receiving their first general anaesthetic. Randomisation is one-to-one between an intervention and a control arm. Participants in the intervention arm are provided with access to the LJ app and a low-cost cardboard VR headset (to be used with a smartphone) to use in the weeks leading up to their operation. Children in the control arm receive the same VR headset and suggestions of unrelated VR games to play, but no access to the LJ app. To improve accessibility, smart devices are provided to children whose families do not have a smart phone, and the app content has been translated from English into multiple languages. Both groups receive standard perioperative care at the hospital where they are having treatment. The primary outcome measure is the modified Yale Preoperative Anxiety Scale-Short Form applied by independent blinded observers, immediately before induction of general anaesthesia. Secondary outcomes include process measures, psychological and socioeconomic outcomes for both children and parents/carers. The planned sample size was 304 participants, including an anticipated 15% attrition rate. An interim analysis was conducted when the trial was temporarily paused because of the COVID-19 pandemic, at which point 119 participants had been recruited. The trial steering committee and data monitoring committee recommended continuation of the trial, but the sample size was increased to 596 to account for differences between the previously anticipated and actual outcomes of recruited participants.

Ethics and dissemination
The study was approved by Surrey Borders—Research Ethics Committee 251219, and all participating sites were in England. Results will be presented in academic manuscripts and presentations and summarised for diverse audiences (including clinicians and patients/public) in podcasts, infographics and other multimedia formats.

Trial registration number
NCT03797716.

Barbara, ‘stress e alimentazione influenzano suo benessere’

This study compares knowledge of diagnosis and worry among adults presented with prostate biopsy reports in a patient-centered format, which presents important clinical data in plain language, vs standard report format.

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Introduction
Gestational diabetes mellitus (GDM) poses health risks due to hyperglycaemia, which can lead to clinical complications for mother and child. While dietary therapy serves as first-line treatment, approximately one-third of women with GDM require insulin to obtain glycaemic control. However, insulin therapy amplifies hospital care expenses and personal burdens. Intensive nutrition education, training and support may improve dietary intake leading to glycaemic control and reducing the need for insulin therapy. This study investigates the effectiveness of intensified dietary therapy versus standard dietary therapy in reducing the need for insulin and consequently lowering hospital care costs among women with GDM at high risk of requiring insulin therapy. Responses to the dietary interventions will also be examined within ethnic subgroups.

Methods and analysis
This study is a randomised controlled parallel-group trial involving women with GDM randomised in a 1:1 ratio to receive either intensive dietary therapy (intensive group) or standard dietary therapy with only one educational consultation (control group). The educational content of the first consultation is according to routine care and similar in both groups. The intensive group receives two additional dietitian consultations and two additional consultations on request to facilitate training and support in addition to education. Assessments are conducted at baseline and 2–3 weeks before planned delivery, with additional data gathered from medical records. The primary outcome is the difference in the proportion of women requiring insulin therapy. Maternal outcomes, neonatal outcomes, patient-reported outcomes, health behaviour and cost-saving aspects of hospital care will also be assessed. Recruitment began in January 2024 and ends in December 2025, with a target enrolment of 214 women.

Ethics and dissemination
The study received approval from the Ethics Committee of the Capital Region of Denmark (H-23055674). Results will be disseminated through peer-reviewed journals, and detailed presentations to key stakeholders.

Trial registration number
NCT06127823.

AHCL might be cost-saving compared to SoC for pregnant women with T1D. However, more robust data are needed to assess the potential impact of AHCL therapy on pregnancy and long-term health outcomes.

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Objectives
To conduct a cost-utility analysis of an implementation package that has been developed aiming to embed the referral of people with type 2 diabetes mellitus (T2DM) to structured self-management education (SSME) from primary care into routine practice compared with usual care.

Design
Model-based cost-effectiveness analysis using the School for Public Health Research type 2 diabetes treatment model. With costs and effectiveness parameters coming from analyses of data from a cluster randomised control trial.

Setting
English National Health Service.

Participants
People with T2DM from 64 GP practices in England.

Interventions
Embedding SSME implementation package Usual care.

Primary and secondary outcome measures
The primary outcome measure was the incremental cost-effectiveness ratio. Secondary outcome measures included the probability of Embedding implementation package being cost-effective and value of information.

Results
The estimated cost of the intervention was £40 316 across the study sites, which equates to £0.521 per patient across all practices. For the base case, the estimated mean discounted incremental lifetime cost of the intervention per patient is £48.19. This is associated with a mean per patient incremental quality-adjusted life-year (QALY) estimate of 0.006, producing an incremental cost-effectiveness ratio of £8311 per QALY gained. This has a 73.1% probability of the intervention being cost-effective at a funding threshold of £20 000 per QALY gained. Scenario analyses indicate that alternative parameterisations can lead to this finding being overturned.

Conclusions
The effectiveness of the Embedding packages was hampered by the COVID-19 pandemic. However, our base case analysis shows that Embedding could be cost-effective for this patient population, but this was subject to significant structural uncertainty. This suggests that while implementation initiatives can be highly cost-effective in this population, more robust evidence or further incentivisation will be required before widespread adoption can be recommended.

Trial registration number
ISRCTN23474120, registered 05/04/2018.

Introduction
Patellar tendinopathy (PT) rehabilitation programmes frequently incorporate eccentric exercise (EE), where participants have limited control over the range of motion, speed, force production and load. Newly developed training protocols that employ visual feedback with specialised devices offer controlled management of loads, speeds and forces across the full range of motion, potentially providing greater benefits.

Objective
This protocol outlines a randomised controlled trial designed to compare the effects of a visuomotor torque feedback (TF) protocol with a traditional EE protocol on the rehabilitation of PT over a 6-week period. Our primary objective is to evaluate whether the TF protocol reduces pain and disability more effectively than the EE protocol in individuals with PT. Secondary objectives include analysing structural and architectural changes in the patellar tendon and quadriceps femoris muscles, as well as examining motor unit discharge dynamics in response to EE and TF training. Lastly, we aim to compare these dynamics and structural changes between healthy controls and individuals with PT.

Methods
Thirty two individuals with PT and twenty six healthy controls will be recruited. The PT group will be subdivided into an EE group, and a TF group, with both groups undergoing a 6-week training programme. The EE group will perform their exercises two times per day, while the TF group will do so 2–3 times a week. In individuals with PT, the primary outcomes will be the Victorian Institute of Sport-Patella (VISA-P) questionnaire to measure disability/physical function, and pain with a Numerical Rating Scale (NRS). To gain insights on mechanisms of action for potential improvements, motor unit discharge characteristics of the quadriceps femoris muscles will be assessed with high-density surface electromyography. Additionally, we will measure structural/architectural changes to the patellar tendon and quadriceps femoris muscles using B-mode ultrasonography and shear-wave elastography.

Ethics and dissemination
This study was approved by the Science, Technology, Engineering and Mathematics Ethical Review Committee from the University of Birmingham (ERN_2257-Jun2024). The results of this study will be disseminated in peer-reviewed journals and at international conferences.

Trial registration number
ISRCTN15821610.

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This Viewpoint discusses the public health benefits that could be gained if the US Food and Drug Administration (FDA) were to mandate very low-nicotine-content cigarettes (VLNCs).