Risultati per: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

New England Journal of Medicine, Volume 387, Issue 22, Page 2056-2066, December 2022.

New England Journal of Medicine, Ahead of Print.

Ritorno sintomi per 45% persone depresse in passato 

Al centro potenziamento capacità anti-cancro cellule dendritiche

Colonoscopy screening reduced the risk of colorectal cancer by 18% in a trial but did not significantly reduce cancer-related deaths during 10 years of follow-up. The results, published in the New England Journal of Medicine, were “both surprising and disappointing” and similar to reductions in colorectal cancer and deaths found in previous randomized trials of sigmoidoscopy, which is considered to be a less effective screening tool than colonoscopy, according to an accompanying editorial.

In aree chiave legate a funzioni cognitive,attenzione,linguaggio

Introduction
Increasing evidence suggests that the BCG vaccine has non-specific effects, altering the susceptibility to non-tuberculous infections. Thus, early BCG vaccination may reduce mortality. BCG is recommended at birth but is often delayed. Vaccination opportunities are missed due to multidose vials not being opened for a few children. We will assess the effect of making BCG available at the first health-facility contact on early infant mortality and morbidity in a rural setting in Guinea-Bissau.

Methods and analysis
In a cluster-randomised crossover trial, we randomise 23 health centres to two different treatment groups. In half of the health centres, BCG is provided as per current practice; in the remaining health centres, we make BCG available everyday to allow opening a vial of BCG if there is just one eligible child present. The randomisation of centres will be crossed over after 12 months and enrolment will continue for another 12 months.
We will use logistic regression models with adjustment for village to assess the effect of making BCG available at the first health-facility contact. The main outcome is non-accidental mortality between day 1 and day 42 after birth. We will adjust for sex, health centre, period (before/after crossover) and level of surveillance (level 1 or level 2). Further analyses include assessment of the effect on hospital admission and a cost-effectiveness evaluation.

Ethics and dissemination
If BCG vaccination reduces early infant mortality, missed opportunities and delays of vaccinations expose infants in several low-income countries to unnecessary excess mortality risk. The present trial will provide information on the effect of implementing a feasible intervention, where all children receive BCG at their first health-facility contact. Consent is obtained from all pregnant women registered as part of the trial. The results of the study will be published and communicated to the National Institute of Public Health in Guinea-Bissau.

Trial registration number
NCT04658680; Clinicaltrials.gov.

Background
Children with acute respiratory tract infections (ARTIs) receive 11.4 million unnecessary antibiotic prescriptions annually. A noted contributor is inadequate parent–clinician communication, however, efforts to reduce overprescribing have only indirectly targeted communication or been impractical.

Objectives
Compare two feasible (higher vs lower intensity) interventions for enhancing parent–clinician communication on the rate of inappropriate antibiotic prescribing.

Design
Multisite, parallel group, cluster randomised comparative effectiveness trial. Data collected between March 2017 and March 2019.

Setting
Academic and private practice outpatient clinics.

Participants
Clinicians (n=41, 85% of eligible approached) and 1599 parent–child dyads (ages 1–5 years with ARTI symptoms, 71% of eligible approached).

Interventions
All clinicians received 20 min ARTI diagnosis and treatment education. Higher intensity clinicians received an additional 50 min communication skills training. All parents viewed a 90 second antibiotic education video.

Main outcome(s) and measure(s)
Inappropriate antibiotic treatment was assessed via blinded medical record review by study clinicians and a priori defined as prescriptions for the wrong diagnosis or use of the wrong agent. Secondary outcomes were revisits, adverse drug reactions (both assessed 2 weeks after the visit) and parent ratings of provider communication, shared decision-making and visit satisfaction (assessed at end of the visit on Likert-type scales).

Results
Most clinicians completed the study (n=38, 93%), were doctors (n=25, 66%), female (n=30, 78%) and averaged 8 years in practice. All parent–child dyad provided data for the main outcome (n=855 (54%) male, n=1043 (53%)

Appello Oxfam-Emergency, nazioni ricche fanno incetta Paxlovid

Introduction
Perceived social isolation and loneliness are understudied in individuals with spinal cord injuries and disorders (SCI/D). The few existing studies reported that they are common, yet poorly treated, in persons with SCI/D. We developed an intervention called Caring Connections (CC) aimed at reducing loneliness and perceived social isolation in persons with SCI/D. CC is a peer-based, recurrent letter writing programme designed to provide moments of positivity. We will conduct and evaluate a randomised controlled trial (RCT) to assess changes in loneliness and social isolation outcomes between the CC intervention and control conditions in community-dwelling individuals with SCI/D.

Methods and analysis
RCT to compare outcomes of community-dwelling individuals with SCI/D undergoing the CC intervention to an attention control group (receiving informational materials on life domains important to a good quality of life). Eligible participants include adults with chronic SCI/D who have been injured for >1 year. The primary outcome is loneliness, measured using the UCLA (University of California, Los Angeles) 3-item Loneliness Scale. Other outcomes include perceived social isolation and social support. A post-trial process evaluation will assess perceived benefits, negative impacts and satisfaction with the intervention, and areas for improvement. We will test the hypotheses of reduced loneliness and perceived social isolation in the CC intervention arm from baseline to 6 months and will also measure the magnitude of effect (difference between CC arm and attention control arm). We will use generalised linear models for repeated measures. We will assume a one-tailed, α=0.05 level of significance for comparisons. Process outcomes will be analysed using mixed methods, including frequencies for the rating items and thematic analysis for open-ended item responses.

Ethics and dissemination
This study has received Hines Veterans Affairs Institutional Review Board approval (#1673654). Findings will be disseminated widely through healthcare organisations, peer-reviewed publications and conferences.

Trial registration number
NCT05295108

Previene la perdita dei neuroni responsabile dei sintomi motori

Objectives
We conducted a scoping review to identify the types, volume and characteristics of available evidence and analyse the gaps in the knowledge base for evaluated interventions to reduce contraception and abortion stigma.

Design
We conducted a search of five electronic databases to identify articles published between January 2000 and January 2022, and explored the websites of relevant organisations and grey literature databases for unpublished and non-commercial reports. Articles were assessed for eligibility, and data were extracted.

Data sources
We searched MEDLINE, PubMed, Embase, Web of Science and PsycINFO.

Eligibility criteria
Articles included were: (1) published between January 2000 and January 2022, (2) written in English, (3) reports of the evaluation of an intervention designed to reduce contraceptive and/or abortion stigma, (4) used any type of study design and (5) conducted in any country context.

Data extraction and synthesis
Included studies were charted according to study location, study aim, study design, type of contraceptive method(s), study population, type of stigma, and intervention approach.

Results
Some 18 articles were included in the final analysis (11 quantitative, 6 qualitative and 1 mixed methods). Fourteen of the studies focused exclusively on abortion stigma, and two studies focused on contraception stigma only; while two studies considered both. A majority of the studies aimed to address intrapersonal stigma. We found no interventions designed to address stigma at the structural level. In terms of intervention approaches, seven were categorised as education/training/skills building, five as counselling/peer support, three as contact and three as media.

Conclusion
There is a dearth of evaluations of interventions to reduce contraception and abortion stigma. Investment in implementation science is necessary to develop the evidence base and inform the development of effective interventions, and use existing stigma scales to evaluate effectiveness. This scoping review can serve as a precursor to systematic reviews assessing the effectiveness of approaches.

Introduction
This study will compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl esters on fasting apolipoprotein B-48 (apoB-48), a surrogate marker reflecting postprandial hypertriglyceridaemia, which is a residual risk for atherosclerotic cardiovascular disease with statin treatment.

Methods and analysis
This is a prospective, multicentre, open-label, randomised, parallel group, comparative trial. Adult Japanese patients with dyslipidaemia receiving statin treatment for more than 4 weeks with a fasting triglyceride level ≥177 mg/dL will be randomly assigned in a 1:1 ratio to receive pemafibrate (0.4 mg orally per day) or omega-3 fatty acid ethyl esters (4 g orally per day) for 16 weeks. The primary endpoint is the percentage change in fasting apoB-48 from baseline to 16 weeks. The key secondary endpoints include the change in fasting apoB-48 from baseline to 16 weeks, the percentage changes in clinical variables from baseline to 16 weeks and the incidence of adverse events. A total sample size of 128 was set by considering the increased drop-out rate due to the COVID-19 pandemic, in addition to estimation based on a two-sided alpha of 0.05 and a power of 0.8 for apoB-48.

Ethics and dissemination
The study protocol has been approved by the Certified Review Board of the University of the Ryukyus for Clinical Research Ethics (No. CRB7200001) and will be performed in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results of the study will be disseminated through publications and conference presentations to participants, healthcare professionals and the public.

Trial registration number
jRCTs071200011.

Circulation, Volume 146, Issue 20, Page e284-e285, November 15, 2022.

Circulation, Volume 146, Issue 20, Page e282-e283, November 15, 2022.