Search Results for: Report aggiornato sulla qualità dell’aria in Europa (2015)

The Brief Report titled “Genetic Ancestry–Based Differences in Biomarker-Based Eligibility for Precision Oncology Therapies,” published online on January 9, 2025, was corrected to clarify language and fix errors in the Methods, Results, and Discussion sections. Specifically, the statement “Herein, patients of European ancestry excluding those of Ashkenazi Jewish ancestry will be referred to as being of European ancestry” was included in the Methods section. In addition, there were 7 instances of “non–Ashkenazi Jewish European” that were correctly changed to state “European.” Six instances of “in the (African/East Asian/South Asian/non–Ashkenazi Jewish European) groups” were changed to “of (African/East Asian/South Asian/European) ancestry.” The word “descent” in the Discussion was changed to “ancestry.” This article was corrected online.

This case report describes a woman in her late 60s with progressive enlarged painful groin masses spreading from the labia to the perianal area, bleeding, and weight loss.

This case report describes a patient in her 50s with prurigo nodularis and itch at the elbows, which spread to all extremities, the trunk, and genital area.

A study that was included in “Effect of Vitamin D Supplementation on Blood Pressure: A Systematic Review and Meta-analysis Incorporating Individual Patient Data,” published in JAMA Internal Medicine online on March 16, 2015, and in the May 2015 issue, was retracted after the meta-analysis was conducted and published. The following notice has been added to the article: “Correction: This meta-analysis was published before 1 of the included studies was retracted. A reanalysis without that study does not affect the reported results.” This article was corrected online.

This case report describes a young, elementary school–aged boy with nevus anemicus.

This case report describes a man in his 30s presenting with foul-smelling verrucous plaques and whitish papules with central black dots observed on the feet, legs, knees, buttocks, elbows, and hands, with nail dystrophy.

In Europa copertura all’11%, somministrati 15 milioni di vaccini

Circulation, Ahead of Print. Aim:The “2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes” incorporates new evidence since the “2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction” and the corresponding “2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes” and the “2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction.” The “2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes” and the “2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization” retire and replace, respectively, the “2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease.”Methods:A comprehensive literature search was conducted from July 2023 to April 2024. Clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants were identified that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline.Structure:Many recommendations from previously published guidelines have been updated with new evidence, and new recommendations have been created when supported by published data.

Introduction
For adolescents with brain injury, challenges with social function often persist into adulthood, impacting social participation and quality of life. The Programme for the Education and Enrichment of Relational Skills (PEERS) is a manualised group-based intervention with preliminary evidence demonstrating improved social knowledge and participation for adolescents with acquired brain injury or cerebral palsy when delivered face to face. The recent COVID-19 pandemic and challenges for families living outside metropolitan centres to access the programme suggest a telehealth delivered PEERS should be explored. This study aims to compare telehealth PEERS to usual care in a mixed-methods randomised waitlist-controlled trial to determine preliminary efficacy to improve social functioning and secondarily to determine acceptability, feasibility, cost and contextual factors impacting the implementation.

Methods and analysis
In this single-centre mixed-methods randomised waitlist-controlled trial, 32 adolescents with brain injury, aged 11–17 years attending mainstream high school and their caregivers will be randomised to receive either (a) telehealth PEERS once/week for 1.5 hours for 14 weeks or (b) usual care (UC). UC is highly variable in Australia but often comprises fortnightly occupational therapy, physiotherapy or speech therapy. The waitlist group will then receive PEERS following the 26-week retention time point. Measures will be administered at baseline, 14 weeks (immediately post) and then 26 and 52 weeks post baseline. The primary outcome is self-reported performance and satisfaction with social goals on the Canadian Occupational Performance Measure at 14 weeks. Secondary outcomes include self and parent-reported social competence, frequency of get-togethers with peers, self-report knowledge of social skills, frequency of peer victimisation and quality of life. An implementation evaluation will be done to determine acceptability, feasibility, cost and identify barriers and facilitators in the implementation of the intervention and map these against the Consolidated Framework for Implementation Research. This study will assess the unit costs of implementing the PEERS from an Australian health system perspective.

Ethics and dissemination
The Children’s Health Queensland Hospital and Health Service and The University of Queensland Human Research Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number
ACTRN1263000082606.

Introduction
Self-stigma occurs when individuals internalise negative stereotypes about their mental health conditions. Self-stigma is common among those with serious mental illnesses, including youth, and is considered a major barrier to recovery through its impact on hope, self-esteem and self-identity. This patient-oriented protocol aims to assess the feasibility of conducting a future full-scale randomised controlled trial (RCT) of a youth-oriented adaptation of narrative enhancement and cognitive therapy for self-stigma among youth (NECT-Y).

Methods and analysis
This is a two-site, two-arm pilot basket RCT with 1:1 randomisation to NECT-Y or treatment as usual (TAU). Participants are youth, ages 16–29 diagnosed with bipolar disorder, any subtype (Basket 1) or with any two or more mental health conditions (Basket 2). After informed consent, we will conduct baseline assessments and randomisation, then either a 14-week NECT-Y group intervention or TAU. Diagnostic interviews will be used to confirm diagnosis at baseline. A range of self-report questionnaires will be administered at baseline, post-treatment and 3 month follow-up. The primary outcome is feasibility as indicated by the achievement of recruitment goals, retention and adherence, intervention fidelity and the absence of serious adverse events. Secondary outcomes include acceptability and the intervention’s impact on self-stigma, wellness, symptomatology, treatment-seeking attitudes and other related constructs. A youth advisory group is informing all stages of the study process.

Ethics and dissemination
The Research Ethics Board for Centre for Addiction and Mental Health (#062/2024) has approved this study protocol. Ethics is also approved at London Health Sciences Centre (Western Health Sciences Research Ethics Board (HSREB) #125812). Results will be published in international peer-reviewed journals and presented at relevant conferences. Summaries will be provided to the funders of the study, as well as to lay audiences, including study participants.

Trial registration number
NCT06672562.

Claessens Z, Fieuws S, Daems J, et al. Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020. BMJ Open 2025;15:e091361. doi:10.1136/bmjopen-2024–0 91 361
This article has been corrected since it was published online. Figure 4 of the paper has been updated from (lacking number of medicines included in conditional marketing authorisation)
to (including the number of medicines with conditional marketing authorisation)

Introduction
Both physical adaptations (e.g., altered neck kinematics and muscle coordination) and psychological features are common in people presenting with neck pain (NP). Additionally, both physical and psychological features may be relevant for the development of persistent or recurrent NP. Although a number of original studies have reported this, currently there is no available systematic review reporting physical and psychological predictors for the recurrence of non-specific NP.

Methods and analysis
The report of this systematic review protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies will be searched from PubMed, MEDLINE, EMBASE, CINAHL Plus, PsycINFO and grey literature. Title, abstract and full-text screening, data extraction and risk of bias assessment will be conducted by two independent reviewers. Studies investigating the prediction of persistent or recurrent NP from physical or psychological predictors will be included. Physical predictors will be commonly reported objective measures including neck kinematics, measures of muscle activity and sensory function. Psychological predictors will include variables such as kinesiophobia, self-efficacy, pain coping strategies and quality of life. The main outcomes of interest are the Neck Disability Index, presence of pain recurrence, as well as pain intensity and frequency during a persistent or recurrent NP episode. Observational cohort studies will be included, and studies on both single-factor and multifactor predictions or associations will be investigated. Risk of bias will be assessed using the Quality in Prognosis Studies (QUIPS) tool. The certainty of evidence will be rated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). A random-effect meta-analysis will be conducted if methodological and clinical homogeneity is deemed satisfactory.

Ethics and dissemination
Ethical approval will not be required for this review as there is no primary data collection involving humans. The findings will be published in peer-reviewed journals.

PROSPERO registration number
CRD42024596844.

Introduction
Empathy is a core component of high-quality care yet is expressed and received in different ways depending on the characteristics (including gender, race, socioeconomic status and disability) of both practitioners and patients. However, the evidence exploring how these characteristics or their overlap (‘intersectionality’) influence empathy has not been synthesised.

Methods and analysis
We will systematically review and meta-analyse studies exploring the influence of healthcare practitioners and patient characteristics on empathy in healthcare. MEDLINE, EMBASE (via Scopus), Scopus, PsycINFO, CINAHL, CENTRAL Web of Science, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects will be searched from database inception to present. Reference chasing will be used to identify additional studies. Studies that report empathy levels using either (1) the patient-reported Consultation and Relational Empathy Measure or (2) the practitioner or student-reported Jefferson Scale of Empathy. This will include validated versions or translations of both scales.
Two reviewers will independently screen titles, abstracts, and full texts and extract data using Rayyan. Discrepancies will be resolved in discussion with a third author if necessary. Two independent authors will evaluate the risk of bias using the Joanna Briggs Institute tools.
Continuous data will be analysed based on the mean, SD, sample size and 95% CIs. Sensitivity analyses will be used to explore the potential impact of risk of bias and use of imputed data. We will explore differences between countries, demographic characteristics, disciplines and lengths of time in practice experience, as well as differences over time (comparing more recent with older studies). We will also explore differences between patient-reported and practitioner-reported empathy.
We will report our findings following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and flowchart.

Ethics and dissemination
Ethical approval is not required for this review as primary data will not be collected. The review will be disseminated through peer-reviewed publication and presented at conferences.

PROSPERO registration number
CRD42024604677.

Introduction
Chronic hip prosthetic joint infection (PJI) treatment needs non-conservative surgery. The recommended treatment follows a two-stage protocol. Between the two surgeries, full-weight bearing is prohibited, and joint stiffness and pain are rather usual complications. The single-stage procedure is thought to be less susceptible to late functional complications with a shorter, single hospital stay. However, infection control could be less efficient; the protocol highly relies on antibiotics and has a list of contra-indications. Most of these contra-indications are directly related to the biofilm formation. As no randomised control trial has ever compared single-stage versus two-stage surgery on infection treatment, the level of evidence for recommending one procedure over the other is low. An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating (DAC), Novagenit SRL) has been proven to mechanically prevent biofilm formation while allowing a prolonged intra-articular antibiotic release. The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for PJI. Moreover, using this device to prevent biofilm formation could expand one-stage surgery to patients who are in theory contra-indicated to one-stage surgery.

Methods and analysis
SINBIOSE-H is a Prospective Randomized Open, Blinded End-point clinical trial that will include patients with a chronic hip PJI as defined by the Musculoskeletal Infection Society (MSIS), with at least one theoretical contra-indication for single-stage surgery. Patients needing a cemented implant will not be included. 440 patients will be randomised in two groups: the experimental group is composed of single-stage procedure associated with the use of biofilm inhibitor (DAC) loaded with topical antibiotics, and the control group is composed of two-stage procedure without biofilm inhibitor. The primary objective will be to demonstrate that single-stage surgery with antibiotic-loaded hydrogel-coated implants is non-inferior to two-stage surgery for chronic hip PJI treatment. The secondary objectives will be to demonstrate that single-stage surgery with antibiotic-loaded hydrogel-coated implants is superior to two-stage surgery on the prevention of functional complications, patient satisfaction scores, death rate, postoperative complications or early revision surgery for any cause other than infection. Based on a failure rate of two-stage surgery of 20% and a reduction of the infection rate using the DAC biofilm inhibitor from 3 to 0.7%, with a non-inferiority margin of 1.35 and power set at 90%, we estimated to enrol 420 patients.

Ethics and dissemination
The protocol is in accordance with ethical principles established by the Helsinki World Medical Assembly and its amendments and will be conducted in accordance with the recommendations of International Conference on Harmonisation Good Clinical Practice. A core information and informed consent form will be provided. The written approval of the Ethics Committee (EC)/Institutional Review Board (IRB) together with the approved subject information/informed consent forms must be filed in the study files. Written informed consent must be obtained before any study-specific procedure takes place. The data will be saved on the internal network in a secured directory, dedicated to the study. At the end of the research, all documents (case report files, investigator files, etc) will be archived and stored for 15 years in each centre. Data on SAEs will be included in the study documentation file. All data and documents will be made available if requested by relevant authorities. The EC and IRB were submitted and approved in France (CPP Ile De France X, 93 602 AULNAY-SOUS-BOIS). Ethics approval covers all centres.

Trial registration number
The study is registered on clinicaltrials.org under NCT04251377 (EUDRACT NUMBER, 2019-A01491-56; trial sponsor, St Etienne University Hospital Center; date of the last version, 24 February 2006).