Search Results for: Standard Italiani per la cura del diabete mellito

Objectives
The double blind, multicentre, randomised, placebo-controlled GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/Interstitial cystitis (GETSBI) study aims to evaluate the efficacy of intravesical glycosaminoglycans therapy with hyaluronic acid and chondroitin sulfate in symptomatic bladder pain syndrome/interstitial cystitis (BPS/IC) patients with Hunner lesions. This trial encompasses multiple methodologies, including a standard randomised controlled trial (RCT), a cross-over trial and an N-of-1 trial. An N-of-1 trial is a multiple crossover trial, usually randomised and often blinded, conducted in a single patient (1). The N-of-1 methodology is, however, only valid under the condition that there is no carry-over effect, meaning a carry-over of effect from an a-priori intervention period into the placebo period. Therefore, it is important to examine any potential carry-over effects to determine the validity of the study protocol concerning the N-of-1 trial part and thereby justifying recruitment.

Design
Interim analysis for potential carry-over effects.

Setting
Secondary care, 21 participants.

Participants
21 participants, participants concluded part one from the GETSBI study at time of this analysis (October 2023).

Outcome measure
The primary outcome of the study is the change from baseline in pain intensity, measured by visual analogue scale (VAS) pain. To assess for carry-over effects, the placebo responses on VAS pain were compared between groups with (n=10) and without (n=11) potential carry-over effects. The threshold for a clinically relevant carry-over effect was set at a difference on VAS pain >0.50 points. Data were analysed using descriptive statistics, T-tests, effect sizes and 95% CI. Statistical significance was set at α=0.05.

Results
The mean baseline VAS pain did not differ (p=0.12) between group A (n=10, VAS 7.52, SD=0.52) and group B (n=11, VAS 6.02, SD=2.47). The mean placebo responses on VAS pain for groups A and B were 0.97 (SD=1.85) and 1.47 (SD=1.81), respectively. The mean carry-over effect was 0.50 (SD=1.83), which was not statistically significant with a 95% CI of –1.17 to 2.17 and p=0.5369.

Conclusions
This interim analysis shows that an N-of-1 trial probably will be feasible for evaluating non-curative treatment efficacy in chronic disease using only half the patients as are required for a classic RCT. Future analysis will provide a direct comparison of outcomes between the RCT, crossover and the N-of-1 part for a complete evaluation.

Trial registration number
ClinicalTrials.gov, NCT05518864 (GETSBI study).

Introduction
Oesophageal squamous cell carcinoma (ESCC) is a globally challenging digestive tract malignancy with poor prognosis and limited treatment options. Early-stage ESCC is often asymptomatic, leading to a late-stage diagnosis in many cases. Neoadjuvant therapy combined with surgery is the standard treatment approach for locally advanced ESCC. In recent years, immunotherapy has shown significant efficacy in ESCC. However, various neoadjuvant treatment regimens, including chemotherapy, radiotherapy and immunotherapy, have produced inconsistent outcomes. This study aims to evaluate the efficacy and safety of neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiotherapy (nCRT) combined with immunotherapy compared with nCRT alone.

Methods and analysis
This is a prospective, multicentre, randomised, controlled phase III trial enrolling 420 patients with locally advanced thoracic ESCC. Patients will be randomly assigned (1:1:1) into three groups: (A) nCT plus sintilimab, (B) nCRT plus sintilimab or (C) nCRT alone. The primary endpoints are pathological complete response and event-free survival. Secondary endpoints include the objective remission rate, disease control rate, R0 resection rate, major pathological remission rate, disease-free survival, overall survival, patient quality of life and patient-reported outcomes. Data will be analysed using both the intention-to-treat and per-protocol approaches, with multiple imputation methods for handling missing data.

Ethics and dissemination
The study has been approved by the Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital (approval number: SCCHEC-02-2022-108). Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number
NCT05244798

Introduction
Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT.

Methods and analysis
KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT.

Ethics and dissemination
This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal.

Trial registration number
NCT06263283.

Objectives
To compile and compare the Comprehensive Geriatric Assessment (CGA) models that exist worldwide and their applicability in primary healthcare (PHC).

Introduction
The world’s population is ageing rapidly, but health systems are slow to keep up with this trend, making it difficult to provide care for older adults. The broad concept of frailty has prompted a comprehensive and holistic approach to patients, where the assessment is related not only to functional, physical and cognitive abilities of the older adults, but also their social, environmental and economic context. In recent decades, the approach to frailty has taken the CGA as the gold standard. With this project, we intend to carry out a scoping review to identify and describe tools to help standardise and generalise CGA in PHC.

Inclusion criteria
Individuals aged 65 years or over; CGA in a PHC setting; the CGA methods reported must include at least three domains: physical, cognitive and social; Articles without language restrictions; Articles published in the last 30 years.

Methods
All studies that refer to CGA models and fulfil the inclusion criteria will be selected. A bibliographic search of articles will be carried out using the following electronic scientific publication databases: MEDLINE-PubMed, Embase, Cochrane Library and Web of Science. We will search for grey literature on sites such as ‘OpenGrey’ and thesis repositories such as RCAAP, EBSCO and EThOS, as well as on the WHO pages. The articles will be independently selected by two reviewers, and the data will be presented in narrative format, structured according to the objective, focus and question of the review.

Ethics and dissemination
Approved by the ethics committee of the regional health administration of the centre, registered as Project 11/2024 and approved on 8 May 2024. The findings of this study will be disseminated through peer-reviewed publications and national or international conference presentations. Updates of the review will be conducted, as necessary.

Trial registration number
Open Science (DOI 10.17605/OSF.IO/REH43).

Objectives
The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design
Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting
Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants
People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

‘Non ci siano ospedali di serie A e B’

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Mixed urinary incontinence presents a clinical conundrum. Patients with mixed urinary incontinence report symptoms of both stress incontinence (loss of urine with exertion) and urge incontinence (loss of urine with urgency). Mixed urinary incontinence is a combination of the two that affects 37% of women older than age 65 years. The personal and societal costs of incontinence are significant. In women with symptoms of severe urinary incontinence, the cost of supplies, laundry, and dry cleaning range from $900 to $4000 annually. By 80 years of age, 20% of women will undergo surgery for stress or mixed urinary incontinence. Physical and behavioral therapy improves both incontinence types, and medications are standard treatment for urgency urinary incontinence. When conservative therapies fail, conventional guidance has been to treat the urgency prior to the stress component of mixed incontinence, because anti-incontinence surgical procedures can worsen urgency incontinence, and many urgency treatments are medical rather than surgical. Another strategy has been to treat whichever symptom is dominant.

This cohort study examines the imaging quality and time efficiency of a novel autonomous total body photographic and dermoscopic device compared with traditional manual digital dermoscopic imaging.

Internists are experts in treating the adverse effects of alcohol, yet rarely initiate treatment for the underlying diagnosis of alcohol use disorder (AUD). The clinical trial by Magane et al in JAMA Internal Medicine provides evidence for a new paradigm, hospital-initiated treatment with naltrexone, that should prompt hospital-based clinicians to adopt this practice. The initiation and use of medications to treat opioid use disorder has become standard practice in primary care and is growing in emergency departments and hospitals. The current study provides a roadmap for similar practice change using naltrexone for AUD in hospitals.

Il 2 giugno giornata mondiale, oltre mezzo milione con anoressia

Objective
To assess the appropriateness, acceptability and feasibility of implementing the Test-it PrCr Urinalysis Dipstick Test (LifeAssay Diagnostics, South Africa) in referral hospitals in Ghana.

Participants
96 healthcare professionals were trained on the protein-to-creatinine (PrCr) test, which was integrated into protocols alongside standard-of-care tests between November 2021 and April 2022. Test users completed questionnaires post training. Three focus group discussions (FGDs) and seven key informant interviews were conducted to evaluate test procedure comprehension, insights into training effectiveness, usability/user confidence, perceptions, attitudes towards the test and barriers and facilitators of use.

Results
High product usability, user confidence and satisfaction were reported. Staff perceived the test as easy to use and similar to current products. Misinterpretations of test results were less likely for strong results. Facilitators of use included effective trainings, sensitisation of the product and key stakeholder endorsement. Challenges impacting implementation feasibility included the short shelf life of test strips (3 months) after opening cannisters, the added complexity of the ratiometric result interpretation and the test’s lack of other parameters that are included in current products (eg, glucose, nitrate), limiting its broader clinical utility for antenatal care screening. All FGD participants agreed that the use of the PrCr test would not change current practices/protocols for dipstick use.

Conclusion
Although the Test-It PrCr test is easy to use and well accepted, key product attributes limit its implementation feasibility in this setting. It may be more appropriate for monitoring high-risk women in this context.

Introduction
Intensive care unit-acquired weakness (ICUAW) is a common and severe complication in critically ill patients, associated with high morbidity and poor prognosis. Despite increasing focus on ICUAW, definitive diagnostic and therapeutic strategies remain absent. Early mobilisation has been demonstrated as an effective intervention for preventing and alleviating ICUAW. This study aims to evaluate the early-stage efficacy of suspended lower-limb rehabilitation robot-assisted therapy in patients with ICUAW.

Methods and analysis
This study is a self-controlled randomised trial aiming to include 60 patients with ICUAW. Each patient’s lower limbs will be randomly assigned to either the experimental group or the control group. The control group will receive standard rehabilitation therapy, while the experimental group will receive additional suspended lower-limb rehabilitation robot-assisted therapy alongside standard care. The intervention will be delivered for 40 min daily, 5 days per week, over a 2-week period. The primary outcome measure is the thickness of key lower-limb muscles assessed via musculoskeletal ultrasound. Secondary outcome measures include the Medical Research Council score, range of motion of the lower-limb joints, and limb circumference. Data will be collected at baseline, after 1 week of intervention and at the 2-week endpoint.

Ethics and dissemination
This study has received ethical approval from the Research Ethics Committee of Changhai Hospital, affiliated with the Naval Medical University (approval reference: CHEC2023-055). Written informed consent will be obtained from all participants prior to their inclusion in the study. The findings, including both positive and negative outcomes, will be disseminated through publication in international peer-reviewed journals and presentation at relevant academic conferences.

Trial registration number
ChiCTR2300070118.