Informed consent is an essential component of surgical care; however, patients often struggle to fully understand procedures, associated risks and available alternatives. Factors such as preoperative anxiety, limited health literacy and the complexity of consent documents can further impair comprehension and information retention. The active informed consent (CIA) pathway, based on a Patient Educational Program that combines multimedia resources with a comprehension test, aims to enhance patient understanding, improve satisfaction and reduce medicolegal issues.

The study will be conducted as a multicentre, non-pharmacological, randomised controlled trial in three hospitals in the Emilia-Romagna region (Italy). A total of 300 patients undergoing elective complex spinal surgery or robotic radical prostatectomy will be enrolled and randomised (1:1) to the experimental arm or to the standard informed consent arm, using block randomisation stratified by centre. Outcomes will include patient satisfaction (Client Satisfaction Questionnaire), comprehension, psychological distress (Depression Anxiety Stress Scales), pain (Numeric Rating Scale), functional recovery (Oswestry Disability Index/International Prostate Symptom Score/International Consultation on Incontinence Questionnaire Short Form/International Index of Erectile Function) and medicolegal complaints. Assessments will be performed at baseline (T0), discharge (T1), 2 months (T2) and 6 months (T3), with extended monitoring of medicolegal outcomes for up to 5 years.

The study has been approved by the Regional Ethics Committee of Emilia-Romagna (protocol CIA21, V.1.3 dated 14 December 2022). Participation is voluntary and does not affect standard care. Results will be disseminated through peer-reviewed journals, conference presentations and communication with health authorities. If effective, the intervention may be implemented as a scalable model to improve patient empowerment and transparency in surgical consent.

NCT06059599.

To explore physical and mental health professionals' hopes and concerns around integrating their services in a colocated children’s hospital.

One-off semi-structured interviews were conducted with 31 participants (16 mental health and 15 physical health professionals). Participants were purposively sampled to ensure representation across each trust and professional background. Participants included allied health professionals, nurses, team managers, paediatricians, psychiatrists and psychologists.

Staff described integration as both promising and ambiguous. While many welcomed the potential for improved collaboration and holistic care, others expressed uncertainty about what integration would entail. Six key themes were identified: (a) siloed and patchy beginnings, (b) one whole child, (c) day-to-day of colocation, (d) the integrated worker, (e) patients not in the same boat and (f) extending integration.

This novel analysis offers insights around the practical and emotional processes involved in integrating care systems. Staff valued the potential for holistic, child-centred care, improved collaboration and shared learning but expressed concerns around ambiguity, shifting professional identities and the practicalities of colocating services. These tensions underscore the need for clearer communication, relationship-building and support structures during service redesign. Our findings also support integrating wider community and social care systems and call for future research involving young people’s perspectives to ensure meaningful, inclusive integration.

Globally, up to 15% of children and adolescents experience a mental health (MH) condition. In the UK, an increasing number of children and young people (CYP) are presenting to acute paediatric settings (paediatric emergency departments and paediatric medical wards) with MH issues. However, the literature suggests that the MH support available in acute paediatric settings is insufficient and unsafe in England. A key principle in NHS England’s plan for joint working to support CYP with MH needs in acute paediatric settings is for care to be personalised to the needs of CYP. However, there is a paucity of research that explores the needs of ethnic minority CYP with MH issues in acute paediatric settings, and recent research has highlighted racial disparities in the accessibility and outcomes of MH services for CYP. This is significant as MH issues in childhood are associated with lifelong inequalities in health, employment, education and mortality outcomes in later life. We aim to explore how, why and under what circumstances acute paediatric settings support (or do not support) ethnic minority CYP to access appropriate MH support, and to develop a refined programme theory for the important contextual factors and mechanisms that can influence whether acute paediatric settings support ethnic minority CYP in accessing appropriate MH support.

This review will use the realist approach developed by Pawson and Tilly which involves six steps: (1) Clarifying the scope of the review, (2) Searching for evidence, (3) Selecting and appraising the primary studies, (4) Extracting and organising the data, (5) Analysing and synthesising the findings and (6) Disseminating the findings. We will search OVID Medline, PsycINFO, CINAHL and SCOPUS. Relevant data will also be sought through snowballing and backward citation searching on included studies, seeking document recommendations from relevant professionals, and grey literature searches on Grey Matters, Health Management Information Centre and Google Scholar. The search will cover documents published from database inception. Documents featuring Black and/or Mixed-Black CYP with MH issues in acute paediatric settings will be included. Documents that do not separately report the results of CYP (

This realist review will only involve secondary data, so ethical approval will not be required. The developed programme theory will be disseminated through the advisory group, peer-reviewed publications, discussions with relevant stakeholders and presentations at relevant research conferences and community events. Additionally, the theory will inform a primary realist evaluation study where the theory will be tested and refined further.

PROSPERO, CRD420251009912.

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.

A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.

16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.

Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.

Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.

A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.

It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).

Values and preferences are key determinants of optimal care, and variability in patient values and preferences often dictates differences in patient management. Clinicians’ views of patients’ values and preferences may differ across cultural aspects and stage of training, but the extent to which this is the case remains uncertain. One key value and preference issue is the trade-off between quantity and quality of life, and this issue is particularly prominent among patients with dementia. We therefore propose to investigate the extent to which physicians’ perceptions of optimal management for patients living with advanced dementia may differ due to cross-cultural factors and stage of medical training.

We will conduct a sequential explanatory mixed-methods study (QUAN -> qual). First, we will administer paper-based or electronic surveys during educational sessions, conferences and rounds to medical students, residents and physicians in ten countries, either in person or online. Following that, a qualitative inquiry, guided by the findings of the quantitative study and the principles of the interpretive description design, will inform an in-depth exploration of the predictive factors identified in the quantitative data analysis.

The Hamilton Integrated Research Ethics Board at McMaster University has approved this study (approval number 2024-17651). We will disseminate our findings in peer-reviewed publications and present results at conferences as oral and poster presentations.

The analgesic and antipyretic paracetamol (acetaminophen) is generally considered safe in therapeutic doses. The most important toxic effect is hepatotoxicity after supratherapeutic doses or in the presence of risk factors (eg, malnutrition, alcoholism). According to the WHO analgesic ladder, a combination of a non-opioid analgesic such as paracetamol with a strong opioid is recommended as step III treatment of patients with chronic pain, despite limited evidence for this approach. The main aim of this study is to test the hypothesis that paracetamol does not provide clinically relevant benefits when added to strong opioids in patients with chronic pain.

Investigator-initiated, randomised, double-blind, placebo-controlled, non-inferiority trial at two Swiss hospitals. A total of 140 patients with chronic pain requiring strong opioids and paracetamol ≥1.5 g/day for at least 7 days will be enrolled and randomised to either continued combination treatment or strong opioid plus placebo. In the first study phase (days 1–7), patients receive identically looking capsules containing either paracetamol at the exact dose previously used or a placebo. During a second study phase (days 7–14), all patients stop the blinded study medication (paracetamol and placebo) with follow-up to day 14. Adherence will be assessed by pill count and measurement of paracetamol and opioid serum concentrations. Patients are instructed to use a pain diary daily during the whole study. The primary outcome is the average pain score on day 7 using a 10 cm visual analogue scale (VAS). A difference between groups of ≤8 mm will be considered clinically irrelevant. Secondary outcomes will include VAS pain score on day 14, number of opioid rescue doses used, subjective ratings of overall feeling of well-being, quality of life, nausea/vomiting, drowsiness and constipation, and other adverse events, and potential effects of study drug concentrations and opioid receptor and cytochrome P450 (CYP) genotypes on the observed differences.

The study was approved by the Ethics Committee (Ethikkommission Bern, reference number 2021-01518) and the Swiss Agency for Therapeutic Products (Swissmedic, reference number 701286). Results will be published in open-access policy peer-reviewed journals. The study is funded by the Swiss National Science Foundation (grant number 32 003B_201072).

NCT05088876.

This study aimed to describe the epidemiology, outcomes and costs of four immune-mediated inflammatory rheumatic diseases (IMIRDs)—systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)—in Brazil’s public and private healthcare systems from 2018 to 2022.

Retrospective observational study.

The study was conducted across hospital and outpatient levels of care in Brazil, based on nationwide data representing the public (Department of Informatics of the Unified Health System—DATASUS) and private (National Supplementary Health Agency—ANS) healthcare sectors.

The study analysed data from four distinct systems: 609 427 patients from the public Outpatient Information System (SIA), 32 119 patients from the public Hospital Information System (SIH), 19 083 deaths from the public Mortality Information System (SIM) and 11 846 hospitalisations from the private healthcare system (ANS).

RA had the highest incidence, ranging from 19.9 to 24.9 per 100 000, while SLE remained stable (6.3–6.7 per 100 000). Prevalence increased for all diseases: RA rose from 95.7 to 136.8, SLE from 23.4 to 38.9, AS from 15.0 to 23.6 and PsA from 10.8 to 17.4 per 100 000. SLE had the highest hospitalisation (7.2%) and lethality rates (8.7%), along with the highest average outpatient cost (US$440.9 per patient). In the private system, RA and SLE accounted for the most hospitalisations (36.3% each). SLE had the highest proportion of emergency hospitalisations (70.5%), while PsA had the highest proportion of elective hospitalisations (61.8%).

RA had the highest prevalence and incidence rates among the studied IMIRDs, while SLE was associated with the highest lethality, outpatient costs and emergency hospitalisations. The rising prevalence of these diseases highlights their growing burden on Brazil’s healthcare systems.

NCT06698900.

Understanding contextual drivers of family planning is crucial for designing effective, context-specific policies and programmes. This study aimed to assess (1) the extent to which province-level contextual factors are associated with both coverage and wealth-related inequalities in demand for family planning satisfied by modern methods (mDFPS) across provinces in low- and middle-income countries (LMICs), and (2) whether these factors influence mDFPS at women’s level.

Observational study using multilevel modelling at both ecological and individual levels.

We analysed data from Demographic and Health Surveys between 2011 and 2022 in 46 LMICs.

Ecological analysis included 621 provinces. Individual-level analysis included 302 493 women aged 15–49 years, currently married or in union, and in need of contraception (unweighted).

Demand for family planning satisfied by modern methods (mDFPS) and wealth-related inequalities in mDFPS, assessed using the slope index of inequality (SII) and the concentration index (CIX).

In both income groups, at the province level, higher mean women’s schooling and greater proportion of employed women were positively associated with mDFPS coverage. In contrast, higher male-to-female educational attainment ratios were inversely associated with mDFPS. Provinces with higher means of women’s schooling also showed lower wealth-related inequalities in mDFPS. At the individual level, women residing in provinces with higher male-to-female educational attainment ratios were found to have lower odds of mDFPS, regardless of the income group. Additionally, the factors influencing individual women’s mDFPS varied depending on the income level of the country’s provinces.

Women’s empowerment and gender equality in education at the province level significantly influence family planning outcomes. Targeted interventions that address each region’s specific educational, economic and demographic contexts are crucial for improving coverage and reducing disparities in family planning services.

This study aims to assess the burden and predictors of age-related macular degeneration (AMD) among older age patients with diabetes attending comprehensive specialised hospitals in Northwest Ethiopia.

A multicentre cross-sectional study was conducted among older patients with diabetes using a systematic random sampling technique.

The study was conducted at five comprehensive specialised hospitals in Northwest Ethiopia from 8 May to 8 June 2023.

The study included 832 diabetic individuals aged 40 years and above.

Data were collected using a pretested structured questionnaire and physical examinations.

In this study, a total of 832 participants were involved, with a response rate of 96.85%. The burden of AMD was 15.4% (95% CI 13.0% to 18.0%). Male sex (adjusted OR (AOR) 2.04, 95% CI 1.17 to 3.56), older age (AOR 6.91, 95% CI 3.17 to 15.08), diabetes duration of 10 and more years (AOR 3.00, 95% CI 1.91 to 4.69), higher body mass index (AOR 2.56, 95% CI 1.15 to 5.71), presence of hypertension (AOR 2.45, 95% CI 1.56 to 3.85) and family history of diabetes mellitus (DM) (AOR 2.29, 95% CI 1.40 to 3.76) were positively associated with AMD.

This study found that the prevalence of AMD among patients with diabetes was 15.4%. Older age, male sex, longer DM duration, higher body mass index, presence of hypertension and family history of DM were significantly associated with AMD. Targeted screening of at-risk individuals for AMD, public health awareness campaigns focusing on these factors and further research to understand the burden and underlying mechanisms of these associations with AMD are recommended.