Risultati per: Standard di qualità sulla Fibrillazione Atriale

Per oncologi Usa e Ue è tra parametri valutazione valore farmaci

Infliximab is typically given over a standard infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. Several retrospective and prospective studies have assessed the safety of accelerated infliximab infusions, but not in a randomized controlled setting. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared to the standard 2 hour infusion.

Procedura indolore dura 10 minuti, test positivo su 2 pazienti

This Medical News feature examines the possible health consequences of making daylight saving time permanent.

Introduction
Sleep and epilepsy have an established bidirectional relationship yet only one randomised controlled clinical trial has assessed the effectiveness of behavioural sleep interventions for children with epilepsy. The intervention was successful, but was delivered via face-to-face educational sessions with parents, which are costly and non-scalable to population level. The Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E trial addresses this problem by comparing clinical and cost-effectiveness in children with Rolandic epilepsy between standard care (SC) and SC augmented with a novel, tailored parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components.

Methods and analyses
CASTLE Sleep-E is a UK-based, multicentre, open-label, active concurrent control, randomised, parallel-group, pragmatic superiority trial. A total of 110 children with Rolandic epilepsy will be recruited in outpatient clinics and allocated 1:1 to SC or SC augmented with COSI (SC+COSI). Primary clinical outcome is parent-reported sleep problem score (Children’s Sleep Habits Questionnaire). Primary health economic outcome is the incremental cost-effectiveness ratio (National Health Service and Personal Social Services perspective, Child Health Utility 9D Instrument). Parents and children (≥7 years) can opt into qualitative interviews and activities to share their experiences and perceptions of trial participation and managing sleep with Rolandic epilepsy.

Ethics and dissemination
The CASTLE Sleep-E protocol was approved by the Health Research Authority East Midlands (HRA)–Nottingham 1 Research Ethics Committee (reference: 21/EM/0205). Trial results will be disseminated to scientific audiences, families, professional groups, managers, commissioners and policymakers. Pseudo-anonymised individual patient data will be made available after dissemination on reasonable request.

Trial registration number
ISRCTN13202325.

Ricerca Centro medicina sonno Molinette di Torino e Università

Introduction
Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders.

Methods
This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of –0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled).

Results
100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions.

Conclusion
The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding.

Trial registration number
NCT03160911.

Annals of Internal Medicine, Ahead of Print.

Objective
Most health literacy measures rely on subjective self-assessment. The Critical Thinking about Health Test is an objective measure that includes two multiple-choice questions (MCQs) for each of the nine Informed Health Choices Key Concepts included in the educational resources for secondary schools. The objective of this study was to determine cut-off scores for passing (the border between having and not having a basic understanding and the ability to apply the nine concepts) and mastery (the border between having mastered and not having mastered them).

Design
Using a combination of two widely used methods: Angoff’s and Nedelsky’s, a panel judged the likelihood that an individual on the border of passing and another on the border of having mastered the concepts would answer each MCQ correctly. The cut-off scores were determined by summing up the probability of answering each MCQ correctly. Their independent assessments were summarised and discussed. A nominal group technique was used to reach a consensus.

Setting
The study was conducted in secondary schools in East Africa.

Participants
The panel included eight individuals with 5 or more years’ experience in the following areas: evaluation of critical thinking interventions, curriculum development, teaching of lower secondary school and evidence-informed decision-making.

Results
The panel agreed that for a passing score, students had to answer 9 of the 18 questions and for a mastery score, 14 out of 18 questions correctly.

Conclusion
There was wide variation in the judgements made by individual panel members for many of the questions, but they quickly reached a consensus on the cut-off scores after discussions.

Introduction
Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.

Methods and analyses
This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.

Ethics and dissemination
Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.

Trial registration number
ISRCTN 10278811.

Esperto a Trieste al workshop sui cibi sostenibili del futuro

Introduction
Therapeutic education for patients with asthma has been shown to reduce asthma morbidity. The high availability of smart phones provides the opportunity to furnish patient training via specifically designed chatbot applications. The goal of this protocol is to perform a first pilot comparison of traditional face to face versus chatbot-guided patient therapeutic education programmes for patients with asthma.

Methods and analysis
Eighty adult patients with a physician-confirmed diagnosis of asthma will be enrolled in a two-parallel-arm, randomised (1:1) controlled pilot trial. A single-Zelen consent procedure is deployed to first enrol all participants in the comparator arm, that is, the standard patient therapeutic education programme at the University Hospitals of Montpellier, France. This means of patient therapeutic education is based on reoccurring interviews and discussion with qualified nursing staff as per usual care. Following baseline data acquisition, randomisation will be performed. Those patients randomised to the comparator arm will not be informed of the second arm. Those patients randomised to the experimental arm will be proposed access to a specifically designed chatbot (Vik-Asthme) as the second tested means of patient training (refusals continue with standard training, though analysed as intention to treat). The primary outcome is change in the total Asthma Quality of Life Questionnaire score at the end of follow-up (6 months). Secondary outcomes cover asthma control, spirometry, general health status, programme adherence and burden for medical staff, exacerbations and medical resource use (medications, consults, emergency visits, hospitalisation and intensive care).

Ethics and dissemination
This study (‘AsthmaTrain’ protocol version 4–20220330) has been approved by the Committee for the Protection of Persons Ile-de-France VII on 28 March 2022 (reference number 21.03617.000059). Enrolment began on 24 May 2022. Results will be published in international peer-reviewed journals.

Trial registration number
NCT05248126.

Presso Iccs Milano usato catetere ad alta potenza e breve durata

Rapporto Cergas Bocconi-Essity, troppa eterogeneità tra Regioni

New England Journal of Medicine, Ahead of Print.

We read with interest the randomised controlled trial (RCT) addressing over-the-scope clips (OTSC) as a primary method of haemostasis in patients at high risk with non-variceal upper gastrointestinal bleeding (UGI).1 We commend the authors for having completed a well-conducted, difficult study. This study and some of its methodological aspects deserve examination in light of society guidelines suggesting OTSC should be reserved for patients who have failed initial traditional endoscopic therapy.2 One hundred patients with a complete Rockall score ≥7 were randomised to OTSC or standard treatment (through-the-scope clips (TTSC) and epinephrine injection in 98%). The primary endpoint of haemostasis without recurrent bleeding for 7 days was achieved in 91.7% with OTSC versus 73.1% with TTSC (p=0.019). Two previous fully published randomised trials assessing OTSC in non-variceal UGI bleeding have suggested its superiority to standard approaches in managing recurrent bleeding,3 or as primary therapy.