Risultati per: Standard di cura nel diabete 2024

This prospective, observational cohort study uses data from the Researching COVID to Enhance Recovery adult cohort to assess post–COVID-19 condition (or long COVID) with additional participant data and an expanded symptom list.

Circulation, Volume 151, Issue 8, Page 518-520, February 25, 2025.

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Comunicato del 19/02/2025 n°6

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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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Background
Traditionally, intramuscular vitamin B12 injections were considered by patients and clinicians the most effective treatment option for B12 deficiency. The improving understanding of the condition paired with the restricted National Health Service (NHS) resources, resulted in a shift from injections towards tablets. The COVID-19 pandemic accelerated this change, while healthcare services were adapted to reduce COVID-19 transmission. This included new guidelines on vitamin B12 prescribing where injections were substituted by tablets.

Objective
We investigated changes between 2015 and 2024 in prescribing B12 injections and tablets including the effect of the COVID-19 pandemic.

Design, population and setting
This was an observational study of general practice in England covering 100% of the population.

Methods
We used prescribing data published by the NHS Business Service Authority. Monthly prescription counts and rates per 100 000 patients were visualised in longitudinal plots from 1 January 2015 to 30 September 2024. We stratified the analysis by regions in England. Changes in yearly counts and rates were summarised using descriptive statistics. Linear regression and data from before the COVID-19 pandemic were used to model trends from 2020 to 2024 as if the pandemic had not occurred. The predicted values and their 95% CI were used to assess the effect of the pandemic.

Results
The number of prescriptions for B12 formulations doubled in the last 10 years from 2.5 million to 5 million per year. The prescriptions for tablets increased from half a million in 2015 to 2 million in 2024. While the prescriptions for injections increased from 2 million to 3 million. In 2020, there was a sharp drop in prescriptions for injections and a simultaneous rapid increase in prescriptions for tablets coinciding with the onset of the pandemic. There were 806 031 (27%) less than expected prescriptions for injections (2 171 924 observed vs 2 977 956 predicted, 95% CI 2 905 348 to 3 050 565) and 299 834 (27%) more prescriptions for tablets (1 415 315 observed vs 1 115 481 predicted, 95% CI 1 094 350 to 1 136 612). After the 2020 drop, by 2024, injections returned to the prepandemic levels of 3 million prescriptions per year and tablets doubled from 1 million in 2019 to 2 million prescriptions in 2024.

Conclusions
In this study, we document important changes to vitamin B12 prescribing in England over the last 10 years. Before the pandemic, injections were the medication of choice for B12 deficiency but there had been an ongoing debate about the benefits and cost of injections over tablets. The pandemic accelerated the switch from injections to tablets. However, these changes in the pandemic were driven by the availability of resources and not necessarily clinical evidence or patient preference. To establish best practices, more evidence is needed comparing the safety and effectiveness of injections and tablets specific to the condition being treated.

New England Journal of Medicine, Volume 392, Issue 7, Page 711-711, February 2025.

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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Annals of Internal Medicine, Ahead of Print.