Primary progressive aphasia (PPA) is a neurodegenerative syndrome associated with Alzheimer’s disease and frontotemporal degeneration. Non-invasive brain stimulation (NIBS) is a promising treatment, especially associated with language therapy, but comparative efficacy and long-term effects between the different techniques (transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)) remain unknown. The present study aims to investigate the effects of non-invasive brain stimulation, alone or associated (tDCS/TMS/tDCS plus TMS) combined with language therapy delivered during a period of 6 months, in the progression of language impairment in PPA, compared with sham stimulation combined with language therapy.

The study is a randomised, double-blinded, parallel, sham-controlled clinical trial. Patients with PPA in early stages (global Clinical Dementia Rating equal to or less than 1) are eligible. They are to be randomised to one of the four treatment arms of the study (active tDCS-active TMS, active tDCS-sham TMS, sham tDCS-active TMS, sham tDCS-sham TMS). All patients will receive language therapy immediately after each session of NIBS, for 6 months. The primary outcome is the Mini-Linguistic State Examination. The secondary outcomes are naming of trained items, Addenbrooke’s Cognitive Examination, Interview for Deterioration in Daily Living Activities, Clinical Dementia Rating including behaviour and language domains, Neuropsychiatric Inventory and regional brain metabolism. Exploratory substudies will be conducted including blood biomarkers, quantitative electroencephalography and spontaneous speech assessment.

The study is registered (ClinicalTrials.gov: NCT07158216) and approved by the Ethics Committee of the Hospital Clinico San Carlos (code 25/309-IC_P_CE). Patients will be enrolled after signing an informed consent form. Study outcomes will be disseminated through presentations at scientific conferences, publications in peer-reviewed journals and other academic forums.

NCT07158216.

Population ageing and the rise in chronic diseases are driving a shift from residential models to home care where family carers play a key role. Although education programmes have shown benefits, limited attention has been paid to how family caregivers can be effectively trained to prevent unintentional mistakes in home care and to how they should be prepared to respond to them related to the care they provide.

This scoping review aims to examine education programmes that enhance family caregivers’ knowledge and skills to promote safe home care, prevent unintentional mistakes and mitigate their impact on both care recipients and family caregivers.

This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) methodology for scoping reviews.

Comprehensive searches were conducted in PubMed, Scopus and Embase in April 2024.

The review included studies on family caregivers in home-based care, focusing on education programmes promoting safe practices; quantitative, qualitative and mixed-methods designs were eligible while studies on professional care or unrelated to home safety were excluded.

Extracted data included study characteristics, education type, target population and safety-related outcomes, which were summarised descriptively to map the available evidence.

31 studies on home safety education programmes for family caregivers across oncological, neurological, chronic and paediatric conditions were identified, mostly from the USA and conducted in hospital, home and other health and care facilities. Randomised controlled trials predominated and were generally high quality. Education programmes targeting technical, daily living and self-care skills improved caregiver burden, knowledge, preparedness and quality of life although physical health outcomes showed limited change.

Evidence indicates that structured education programmes enhance family caregivers’ knowledge, preparedness, competence and psychological well-being, supporting safer home care. While current education programmes are mostly short-term and caregiver-centred, this review identifies core technical, daily life and self-care competencies to guide future education programmes, highlighting the need for co-designed, rigorously evaluated education programmes that include patient safety outcomes and caregiver emotional support.

Lung cancer (LC) is the leading cause of cancer-related mortality worldwide, primarily due to diagnosis at advanced stages. Although low-dose computed tomography (LDCT) screening reduces lung cancer mortality in high-risk populations, current screening programmes are largely restricted to individuals defined by age and smoking history. This approach excludes never-smokers and individuals with non-smoking-related risk factors, limiting the equity, efficiency and scalability of lung cancer screening. The LUng Cancer risk factors and their Impact Assessment (LUCIA) project aims to overcome these limitations by developing personalised lung cancer risk prediction models and evaluating novel non-invasive technologies for early detection within a risk-adapted screening strategy.

LUCIA is a multicentre, observational, longitudinal cohort study that will recruit approximately 4000 participants across four European regions: Andalusia and the Basque Country (Spain), Liège (Belgium) and Riga (Latvia). The study population includes smokers, never-smokers and reduced smokers with low-to-moderate lung cancer risk. All participants will initially enter phase 1 (wide population screening) and may transition to phase 2 (precision screening) or phase 3 (diagnosis) based on LDCT findings, results from non-invasive screening devices and artificial intelligence-based risk prediction models. Participants will be followed up for 24 months, with assessments at baseline and at 6, 12 and 24 months. Data collection includes sociodemographic characteristics, medical history, environmental and occupational exposures, lifestyle factors, spirometry, multi-omics profiles and outputs from novel non-invasive devices, including a breath analyser, spectrometry-on-card and a skin-applied volatile organic compound sensing patch. The study will develop and validate integrated lung cancer risk prediction models and evaluate the diagnostic performance of these technologies to support population stratification and personalised screening.

The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable national and European regulations. Ethical approval has been obtained from the relevant ethics committees in all participating countries. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed open-access publications, scientific conferences and communication with public health stakeholders.

ClinicalTrials.gov, NCT06473870.

Depressive symptoms are common in the growing geriatric surgical population and are associated with important patient-centred surgical outcomes, including postoperative delirium, discharge to postacute care facility and decline in functional status. Few interventions have been developed to address depressive symptoms in the perioperative setting.

We designed a feasibility and acceptability study of a nine-session problem-solving therapy (PST) telehealth perioperative intervention aimed at reducing postoperative functional decline and depressive symptoms among at-risk older adults undergoing major surgical procedures. Acceptability will be evaluated using a patient-centred five-question survey, assessing participant satisfaction and perceived usefulness of the perioperative intervention. A feasibility assessment will rely on objective measures including ease of participant recruitment, frequency and timing of delivery of intervention sessions and retention of participants throughout the duration of the intervention. With respect to the efficacy of the proposed PST intervention, the primary outcome of interest is postoperative functional status, as measured by the WHO Disability Assessment Schedule 2.0 at the 6-month postoperative time point. The secondary outcome of interest is the degree of depressive symptoms as assessed by the Patient Health Questionnaire-9 at both 3 months and 6 months postoperatively. The broader goals of this study include: (1) assessing the feasibility of implementing a PST perioperative intervention for older surgical patients at risk of postoperative functional decline, (2) demonstrating the acceptability of the PST intervention and (3) assessing the preliminary impact of the PST intervention on postoperative functional status and depressive symptoms.

The study received ethical approval from the University of California San Francisco Institutional Review Board. Results of this study will be published in peer-reviewed scientific journals with further dissemination at local institutional meetings and professional conferences.

NCT06174701.

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

NCT06835517.

Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.

A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.

Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.

EudraCT 2022-003589-19.