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.
Risultati per: Linea guida sullo standard di assistenza medica nel diabete
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Effects of a multicomponent physical activity programme, Mobility-Fit, compared with a standard care lower limb strengthening programme, to promote safe mobility among older adults in care facilities: protocol for a cluster randomised controlled trial
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.
Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness–a protocol for a randomised controlled trial (ASTUTE trial)
Introduction
Adalimumab is an effective treatment for autoimmune non-infectious uveitis (ANIU), but it is currently only funded for a minority of patients with ANIU in the UK as it is restricted by the National Institute for Health and Care Excellence guidance. Ophthalmologists believe that adalimumab may be effective in a wider range of patients. The Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness (ASTUTE) trial will recruit patients with ANIU who do and do not meet funding criteria and will evaluate the effectiveness and cost-effectiveness of adalimumab versus placebo as an add-on therapy to standard care.
Methods and analysis
The ASTUTE trial is a multicentre, parallel-group, placebo-controlled, pragmatic randomised controlled trial with a 16-week treatment run-in (TRI). At the end of the TRI, only responders will be randomised (1:1) to 40 mg adalimumab or placebo (both are the study investigational medicinal product) self-administered fortnightly by subcutaneous injection. The target sample size is 174 randomised participants. The primary outcome is time to treatment failure (TF), a composite of signs indicative of active ANIU. Secondary outcomes include individual TF components, retinal morphology, adverse events, health-related quality of life, patient-reported side effects and visual function, best-corrected visual acuity, employment status and resource use. In the event of TF, open-label drug treatment will be restarted as per TRI for 16 weeks, and if a participant responds again, allocation will be switched without unmasking and treatment with investigational medicinal product restarted.
Ethics and dissemination
The trial received Research Ethics Committee (REC) approval from South Central – Oxford B REC in June 2020. The findings will be presented at international meetings, by peer-reviewed publications and through patient organisations and newsletters to patients, where available.
Trial registration
ISRCTN31474800. Registered 14 April 2020.
Italiani sempre più celiaci, ecco le linee guida per terapia
Sono 224mila i casi diagnosticati, ma si stimano circa 600mila
Italiani sempre più celiaci, ecco le linee guida per terapia
Sono 224mila i casi diagnosticati, ma si stimano circa 600mila
Previsione precoce semplice e affidabile del diabete
Il diabete spesso rimane inosservato finché non ha già danneggiato […]
Linee guida sul trattamento sistemico del cancro al seno metastatico
Revisione sull’uso degli anticoagulanti diretti come trattamento standard
Società Italiana d’Igiene: “guida alle buone pratiche vaccinali”
Colpa medica, Fnomceo chiede di “estendere lo scudo penale Covid”
300mila cause aperte, il 97% finisce in un nulla di fatto
Linee guida sulla diagnosi e la gestione del cancro al seno precoce e localmente avanzato
Influenza, in Ue numero forme gravi in linea con gli altri anni
In calo Covid, responsabile solo del 13% delle infezioni serie
Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >= 65 years: CONSIDERING-AF study design
Introduction
Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.
Methods and analysis
CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.
Ethics and dissemination
This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.
Trial registration number
NCT05838781.
Diabete, al via in Uk il programma per adottare il «pancreas artificiale»
Un comitato indipendente del Nice (National Institute for Health and Care Excellence) ha raccomandato l’uso di questo dispositivo che consente a una persona con diabete di tipo 1 di svolgere la propria vita quotidiana senza dover monitorare se i livelli di glucosio nel sangue sono troppo alti o troppo bassi
Con il pancreas artificiale nuova era per il diabete
Il dispositivo eroga autonomamente l’insulina necessaria
Covid: calano incidenza, Rt e ricoveri in area medica
Monitoraggio Iss-ministero, terapie intensive stabili, Jn1 resta la variante dominante