Risultati per: Standard di cura nel diabete 2024

Tra Aoui Verona, Irccs Negrar, Iov Padova e ‘Angelo’ Mestre

Introduction
Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive–compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3–4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established.

Methods and analysis
This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events.

Ethics and dissemination
This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome.

Trial registration number
NCT05608278.

New England Journal of Medicine, Volume 389, Issue 24, Page 2245-2255, December 2023.

Objective
We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response.

Design
A total of 120 cirrhotic patients (72.5% decompensated) were randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL.

Results
Efficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); OR 2.63, p=0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR 4.72; p=0.007), from 24.4% to 50% (OR 3.09; p=0.012) and from 24.4% to 53.8% (OR 3.62; p=0.007), in Child A, Model for End-Stage Liver Disease (MELD)

Le Quattro stagioni di Vivaldi, con Orchestra Santa Cecilia

Audizione Siv in Consiglio comunale

Introduction
Intravenous fluid therapy is the most common intervention in critically ill children. There is an increasing body of evidence questioning the safety of high-volume intravenous fluid administration in these patients. To date, the optimal fluid management strategy remains unclear. We aimed to test the feasibility of a pragmatic randomised controlled trial comparing a restrictive with a standard (liberal) fluid management strategy in critically ill children.

Methods and analysis
Multicentre, binational pilot, randomised, controlled, open-label, pragmatic trial. Patients

Due giorni di workshop nella sede dell’Ince con l’Oms

Introduction
Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.

Methods and analysis
The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.

Ethics and dissemination
This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.

PROSPERO registration number
CRD42022341607.

L’80% ha attivato un percorso dedicato. Su X l’appello a usare il 1522

Objective
Symptoms in gastroparesis (Gp) and functional dyspepsia (FD) overlap; using egg protein substitute to measure gastric emptying of solids (GES), ~40% of patients are reclassified from Gp to FD, and vice versa. Our aim was to assess inter-individual and intra-individual coefficients of variation (COV) in GES in symptomatic patients with Gp or FD with documented slow or normal GES, respectively.

Design
Scintigraphic GES (T1/2 and GE% at 2 and 4 hours) using a 320 kcal real egg meal (30% fat) was tested in the following: single measurements in 20 patients with diabetes mellitus (10 each type 1 and type 2); repeat GES to estimate COVintra measured: 3 days apart in 9 Gp, 4 weeks apart in 21 Gp and 18 with FD with normal GE assigned to placebo and in 70 patients at 94.3 weeks (median) apart.

Results
COVinter for GE% at 4 hours and GE T1/2 were respectively 14.2% and 23.5% in FD and 27.5% and 33% in Gp; COVintra for GE% at 4 hours and GE T1/2 up to 4 weeks apart were 23.4% and 37.9% in FD and 20.1% and 33% in Gp. GE% at 2 hours showed less consistent results. However, >85% retained original diagnosis as normal or delayed. From clinical GES to baseline research for Gp group, repeat GES (after treatment) showed the COVintra for GE% at 4 hours was 37.3% at median 94.3 weeks, with 26/70 changed diagnoses.

Conclusion
The 320 kcal (30% fat) GES scintigraphic test provides consistent diagnosis in >85% and should be the standard test for suspected gastric emptying disorders.

Introduction
Osteoarthritis (OA) is one of the main causes of mobility impairment in the elderly worldwide. Therefore, total knee arthroplasty (TKA) is often performed and is one of the most successful surgery and has resulted in substantial quality-of-life gains for people with end-stage arthritis. There is still room for improvement in the standard treatment process in the preoperative, intraoperative and postoperative period of TKA. Telerehabilitation has the potential to become a positive alternative to face-to-face rehabilitation nowadays. But it remains unclear how well telemedicine interventions cover the entire surgical pathway (preoperation, intraoperation, postoperation). This study aims to explore the effectiveness of Joint Cloud (JC, an online management platform) compared with existing standard process in regulating functional recovery, pain management, muscle strength changes and other health-related outcomes in patients undergoing total knee arthroplasty preoperation, intraoperation and postoperation.

Methods and analysis
A randomised controlled trial was designed to compare the online management platform (JC) with standard process (SP) in patients undergoing TKA. A total of 186 TKA patients will be randomly assigned to the intervention (n=93) or control (n=93) group. Patients in the intervention group will receive access to the ‘JC’ mini-program. This mini-program provides popular science information (eg, information about OA and TKA), functional exercise information and communication channels. Patients evaluate their condition and functional level through standardised digital questionnaires. The control group of patients will not accept any functions of this mini-program. The primary outcome is knee functional recovery, and the secondary outcomes are pain management, isometric knee extensor muscle strength, patient satisfaction and cost-benefit analysis. Assessments will be performed 1 month and 3 days before surgery (T0) and 1 month and 3 months after surgery. Data analysis will be performed according to the intent-to-treat (ITT) principle. Repeated measures of linear mixed models and parametric and non-parametric testing will be used for statistical analysis.

Ethics and dissemination
The study was reviewed and approved by the Tianjin Hospital Medical Ethics Review Committee on 10 February 2023 (2022YLS155). Test data are considered highly sensitive but are available upon request. The findings will be disseminated in peer-reviewed publications.

Trial registration number
ChiCTR2300068486.

Introduction
Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis
AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination
Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number
NCT05134454.

Utilizzata dalla Neurochirurgia di Sassari per la prima volta

I dati dello studio Prevasc: “evitabili 150 mila decessi l’anno”