Risultati per: Linea guida sullo standard di assistenza medica nel diabete

Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We aimed to investigate the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting.

Introduction
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries in sports, and the gold standard for treating ACL rupture is tendon graft reconstruction. Internal brace technology is being used nowadays for ligament repair; however, more relevant in vivo clinical evidence is required for using internal brace technology in ACL reconstruction (ACLR). We conducted a randomised controlled trial to investigate the clinical efficacy of internal brace technology in ACLR.

Methods and analysis
This randomised, parallel-controlled trial included patients with ACL rupture who underwent inpatient surgery at the Department of Orthopaedics, Xiangya Hospital, Central South University. Random number table method was used to assign the participants to either the test or the control group. The test group underwent ACLR using the internal brace technique, whereas the control group underwent standard ACLR. Uniform postoperative rehabilitation protocol was used for both the groups. Patient-reported outcomes included preoperative baseline and postoperative recovery at 1, 3, 6, 12 and 24 months. The primary outcome was International Knee Documentation Committee function from baseline (ACL rupture) to 6 months postoperatively. Secondary outcomes included (1) other patient outcome reporting metrics, Lysholm knee score, Knee Injury and Osteoarthritis Outcome Score and Visual Analog Scale; (2) the use of Kneelax3 knee stabiliser to assess knee stability; (3) occurrence of adverse events, such as graft refraction or symptomatic instability, postoperative infection and contralateral injury and (4) magnetic resonance images at 12 and 24 months after ACLR.

Ethics and dissemination
This trial was approved by the Medical Ethics Committee of the Xiangya Hospital of Central South University on 26 October 2021. Data will be published in peer-reviewed journals and presented at national and international conferences.

Trial registration number
ChiCTR2200057526.

Rapporto Cittadinanzattiva, disegnare sanità vicina alle persone

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)