Risultati per: Standard di qualità sulla Fibrillazione Atriale

New England Journal of Medicine, Ahead of Print.

Introduction
Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

Methods and analysis
The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

Trial registration number
ISRCTN11499185.

Comunicato del 22/03/2024 n°17

L’80% delle pazienti seguite da Breast Unit

In a unique review, experts discuss conditions for which warfarin or antiplatelet drugs are preferable to DOACs and conditions for which DOAC safety and efficacy is uncertain.

Objective
To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it.

Design
Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales.

Data sources
Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022.

Eligibility criteria
Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022.

Data extraction and synthesis
Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines.

Results
Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended.

Conclusion
The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.

We appreciate the considerations of Hsu et al about the recommendation of empiric first-line therapies in our Maastricht VI/Florence consensus report for the management of Helicobacter pylori.1 2 We fully agree that H. pylori eradication therapy should aim at a cure rate of ≥90%. This also meets the expectation of patients as referred by the authors from a real-world expectation survey of the Asia-Pacific region.3 However, we disagree that the cut-off for clarithromycin resistance, at least for now, is too high at 15% for triple therapy consisting of proton pump inhibitor (PPI), amoxicillin and clarithromycin used as empirical first-line option.2 Hsu et al suggest a cutoff for clarithromycin resistance at or below 5 % for the empirical use of PPI-amoxicillin-clarithromycin and base their claim on a recent systematic review.4 However, this review has several relevant limitations: First, the…

Introduction
Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits.

Methods
This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%.

Ethics and dissemination
This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals.

Trial registration number
ANZCTR12622001527752

We read with high interest the randomised controlled trial (RCT) of Chan et al investigating over-the-scope clips (OTSC) versus standard therapy for the prevention of rebleeding in large (≥1.5 cm) peptic ulcers.1 However, this study and some aspects of study design deserve further critical evaluation and interpretation. One hundred patients with peptic ulcer bleeding and lesion size ≥1.5 cm were randomised to OTSC or standard treatment. In the intention-to-treat analysis, the primary endpoint of clinical rebleeding within 30 days was achieved in 10% with OTSC vs 18% with standard therapy. The difference was statistically not significant. Two previously published RCTs assessing OTSC first-line therapy in non-variceal upper gastrointestinal (GI) bleeding have shown superiority to standard treatment.2 3 In both trials, only high-risk patients were included (eg, patients with haemodynamic instability or Rockall Score ≥7). The only selection criterium in the study of Chan et al…

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Stroke, Ahead of Print. BACKGROUND:Timely intravenous thrombolysis and endovascular thrombectomy are the standard reperfusion treatments for large vessel occlusion stroke. Currently, it is unknown whether a low-dose thrombolytic agent (0.6 mg/kg alteplase) can offer similar efficacy to the standard dose (0.9 mg/kg alteplase).METHODS:We enrolled consecutive patients in the multicenter Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke who had received combined thrombolysis (within 4.5 hours of onset) and thrombectomy treatment from January 2019 to April 2023. The choice of low- or standard-dose alteplase was based on the physician’s discretion. The outcomes included successful reperfusion (modified Thrombolysis in Cerebral Infarction score, 2b–3), symptomatic intracerebral hemorrhage, 90-day modified Rankin Scale score, and 90-day mortality. The outcomes between the 2 groups were compared using multivariable logistic regression and inverse probability of treatment weighting-adjusted analysis.RESULTS:Among the 2242 patients in the Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke, 734 (33%) received intravenous alteplase. Patients in the low-dose group (n=360) were older, had more women, more atrial fibrillation, and longer onset-to-needle time compared with the standard-dose group (n=374). In comparison to low-dose alteplase, standard-dose alteplase was associated with a lower rate of successful reperfusion (81% versus 87%; adjusted odds ratio, 0.63 [95% CI, 0.40–0.98]), a numerically higher incidence of symptomatic intracerebral hemorrhage (6.7% versus 3.9%; adjusted odds ratio, 1.81 [95% CI, 0.88–3.69]), but better 90-day modified Rankin Scale score (functional independence [modified Rankin Scale score, 0–2], 47% versus 31%; adjusted odds ratio, 1.91 [95% CI, 1.28–2.86]), and a numerically lower mortality rate (9% versus 15%; adjusted odds ratio, 0.73 [95% CI, 0.43–1.25]) after adjusting for covariates. Similar results were observed in the inverse probability of treatment weighting-adjusted models. The results were consistent across predefined subgroups and age strata.CONCLUSIONS:Despite the lower rate of successful reperfusion and higher risk of symptomatic intracerebral hemorrhage with standard-dose alteplase, standard-dose alteplase was associated with a better functional outcome in patients receiving combined thrombolysis and thrombectomy.

Introduction
Current guidelines on clinical nutrition of ventilated patients in the intensive care unit (ICU) recommend initiating continuous enteral nutrition within 48 hours of ICU admission when feasible. However, discontinuous feeding regimens, alternating feeding and fasting intervals, may have an impact on clinical and patient centred outcomes. The ongoing “Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients” (DC-SCENIC) trial aims to compare standard continuous enteral feeding with daily cyclic enteral feeding over 10 hours to evaluate if implementing a fasting-mimicking diet can decrease organ failure in ventilated patients during the acute phase of ICU management.

Methods and analysis
DC-SCENIC is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients 18 years of age or older receiving invasive mechanical ventilation and having an indication for enteral nutrition through a gastric tube. Enteral feeding is continuous in the control group and administered over 10 hours daily in the intervention group. Both groups receive isocaloric nutrition with 4 g of protein per 100 mL, and have the same 20 kcal/kg/day caloric target. The primary endpoint is the change in the Sequential Organ Failure Assessment score at 7 days compared with the day of inclusion in the study. Secondary outcomes include daily caloric and protein delivery, digestive, respiratory and metabolic tolerance as well as 28-day mortality, duration of mechanical ventilation and ventilator-free days. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in June 2023 in 3 French ICU’s and a sample size of 318 patients is expected by February 2026.

Ethics and dissemination
This study received approval from the national ethics review board on 8 November 2022 (Comité de Protection des Personnes Sud-Est VI, registration number 2022-A00827-36). Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT05627167.

Accelerated infliximab administration during induction is used extensively in pediatric patients with Crohn’s disease (CD), though the overall effect of this approach on patients’ outcomes in several studies has been questionable. We aimed to assess in a real-life cohort whether accelerated infliximab administration during induction resulted in improved clinical outcomes in pediatric CD.

Introduction
Upper limb and core strength training is essential for older adults to safely perform daily activities. However, existing exercise programmes mainly focus on lower limb strength and are not designed or delivered to suit people with different functional capacities. This study describes the design of a two-arm cluster randomised controlled trial to examine the effects of a multicomponent physical activity (PA) programme, Mobility-Fit, on mobility and frailty in older adults living in care facilities.

Methods and analysis
160 older adults from 20 care facilities in Hong Kong will be recruited and randomised by care facilities (1:1) to an intervention or a control group. Participants in the intervention group will attend the Mobility-Fit programme, led by facility-based instructors, three times per week, 45 min per session, for 12 weeks, while the control group will participate in a standard care lower limb strengthening programme offered by the care facility. Participants will then be followed up for 9 months. Mobility-Fit comprises agility, postural coordination, balance and strength training, with suitable dosage based on participant’s baseline physical and cognitive function. The primary outcomes encompass upper and lower limb strength, trunk stability, reaction time, mobility function and fall efficacy. Secondary outcomes comprise daily PA level and performance, frailty, cognitive function and quality of life. A repeated measures analysis of variance (ANOVA) and generalised estimating equation (GEE) will be used to examine changes in outcomes over time and between groups. Data will be analysed following the intention-to-treat principles. We will also evaluate programme implementation and health economics throughout the follow-up period.

Ethics and dissemination
Ethical approval was acquired in November 2022 from the Joint CUHK-NTEC Clinical Research Ethics Committee in Hong Kong (CREC-2022-459). Informed consent will be obtained from participants. The results of the study will be disseminated through peer-reviewed articles, conference presentations and social media.

Trial registration number
ChiCTR2300072709.