Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

ACTRN12618000932268.

Funnel plots are used to identify intensive care units (ICUs) with a higher than expected risk-adjusted mortality. ICUs with a standardised mortality ratio (SMR) within pre-defined control limits (often the 99.8% CL) are regarded as ‘in control’ and not labelled as a potential outlier for a particular calendar year. However, increased mortality rates not due to random fluctuations within and across the calendar years may be overlooked. We examined whether statistically significant and relevant differences in mortality over time between ICUs regarded as ‘in control’ are present.

A longitudinal register-based study.

88 ICUs in the Netherlands registering the admissions of all critically ill patients in the National Intensive Care Evaluation registry in the Netherlands from 2013 to 2023.

Hospital death analysed in a multivariable logistic regression analysis with a random intercept for ICU. The random intercept variance was translated to the median OR (MOR).

877 ICU-calendar year combinations were included, covering 759 498 unique admissions. The MOR increased from 1.12 (95% CI 1.10 to 1.15) for ICU-calendar year combinations with an SMR within the narrowest 95% CL (N=677) to 1.20 (1.17 to 1.24) for combinations with an SMR within the expanded 99.8% CL (including adjustment for overdispersion) (N=194) and to 1.21 (1.17 to 1.25) when including all ICU-calendar year combinations. Similar results were found for separate calendar years and separate diagnostic groups.

These results show differences in mortality between ICUs that were not labelled as outliers. Assessment of mortality performance should integrate cross-sectional funnel plots, the MOR and longitudinal trends in the SMR to better capture persistent patterns of excess risk.

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Multicentre observational cohort study.

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

NCT04749212

Intensive care units (ICUs) can be a particularly challenging environment for patients who are mentally vulnerable. In addition to the physical stress associated with critical illness and its management, there are physiological and psychosocial factors that can negatively impact a patient’s mental health. Approximately half of ICU survivors will experience post-intensive care syndrome, a set of emotional, neuropsychological and physical sequelae that can significantly affect patients’ functionality and quality of life, both in the short and long term. The main objective of this study is to investigate whether the ICU Recovery Answers (ICURA) digital follow-up platform can effectively detect emotional and cognitive problems in critically ill patients and its impact on functionality and health-related quality of life during the first year after ICU discharge.

Multicentre longitudinal prospective study involving ICU adult patients, with randomised follow-up comparing a telemedicine monitoring programme versus usual medical care during 1 year after discharge. A total of 360 participants will be recruited during their ICU admission in two hospitals in Spain. Efficacy outcomes will focus on participants’ level of functioning, assessed with the WHO Short Disability Assessment Schedule, and quality of life, measured with the 12-Item Short Form Survey at 1, 6 and 12 months after ICU discharge. Emotional state and cognitive impairment will be evaluated using the Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 and Treatment-Outcome Post-Traumatic Stress Disorder Scale and the Montreal Cognitive Assessment by telephone at 1, 3, 6, 9 and 12 months after ICU discharge.

The implementation of this project is expected to have a direct impact on the satisfaction of ICU survivors, improving their well-being, personalised follow-up and quality of life. Results from this study will be disseminated at various scientific conferences, national and international meetings, and will be shared with the general public and other relevant parties. The dissemination of these results will occur through scientific publications, allowing the medical and scientific community to benefit from the study’s findings. Ethics approval from the Ethics Board of Parc Taulí Foundation and Balearic Islands with reference numbers 2022/3031 and IB 5072/22 PI: Protocol version 1 of 18 November 2022.

NCT06504979.

Co-design of the PREDICT-Kidney online tool by patients, members of the public and healthcare professionals (HCPs), to support the communication of the risk of recurrence following surgical treatment for kidney cancer.

Qualitative co-design study. Using an iterative process, feedback was collected (via workshops), prioritised and implemented.

Online workshops with participants from across the UK were conducted between December 2023 and November 2024.

18 adult participants, including patients surgically treated for kidney cancer, members of the public without a history of kidney cancer and HCPs involved in kidney cancer care.

To produce an online tool to support the communication of risk of kidney cancer recurrence that is easy to use, easy to understand and acceptable to stakeholders. Secondary outcomes are the properties of the feedback collected, including volume and type.

Across nine workshops, 99 discrete feedback items were collected, resulting in 71 actionable changes to the initial prototype tool. Differences in priorities were observed between participant groups, especially around the inclusion of information about competing risks of death. Participants valued the tool for improving consistency of follow-up information, supporting shared decision-making and providing multiple visual formats to communicate risk. Iterative feedback led to refinements in terminology, design, content and delivery, including adjustments to the presentation of recurrence and mortality risk.

A co-design approach was used to improve the PREDICT-Kidney online tool to align with the needs of patients and HCPs. A feasibility study is required to evaluate its use and impact in clinical practice.

Liver tumours are a leading cause of global morbidity and mortality. Current diagnostic tools, including computed tomography (CT), magnetic resonance imaging (MRI) and intraoperative ultrasound (IOUS), have limitations in detecting liver neoplasms. Indocyanine green (ICG) has emerged as a promising tool for improving liver tumour detection. This study aims to assess the impact of preoperative ICG on intraoperative tumour detection in minimally invasive surgery and develop a machine-learning algorithm to enhance tumour detection using ICG fluorescence.

This prospective, multicentre, phase IV clinical trial adheres to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Patients with liver tumours eligible for minimally invasive surgery and a preoperative imaging test will be included. ICG will be administered intravenously 24 hours before surgery. Intraoperative procedures will include IOUS, ICG mapping and photographic documentation. Patients will be followed for 90 days to assess tumour progression, morbidity and mortality. The photographic analysis will enable the development of an artificial intelligence algorithm using machine learning and neural networks to identify lesions based on ICG fluorescence. The estimated sample size is 173 patients and the trial is predicted to accrue in 3 years.

The trial will be conducted in accordance with the Declaration of Helsinki and the Spanish Agency of Medicines and Medical Devices (AEMPS) guidelines. Approved by the local institutional Ethics Committee and the AEMPS, the results will be shared with the scientific community through publications and conferences.

2023–5 08 316-27-00.

NCT06398028.

V.12, 18 March 2025

To evaluate the feasibility and relevance of the LIFE-UP Day audit, a simple, 1-day benchmarking tool based on the multidisciplinary LIFE-UP bundle (Limit sedation, optimise nutritional Intakes, engage Families, promote Exercise and follow-UP the patients after discharge) and assessing the implementation of postintensive care syndrome (PICS) prevention strategies in daily practice.

Exploratory multicentre cross-sectional audit study.

Eight Belgian adult intensive care units (ICUs), between April and July 2024.

All patients present at 08:00 on the audit day and hospitalised for ≥24 hours.

An independent nurse collected data on sedation, analgesia, nutrition, family empowerment, physical exercise and post-ICU follow-up. A multidimensional LIFE-UP composite score (raw 0–10 points), normalised to a 5-point scale, was created to quantify adherence to PICS prevention practices based on current recommendations. Feasibility was evaluated through data accessibility, resource needs, cooperation of ICU teams and the ability to complete the audit within 1 day. Relevance was evaluated through adherence to the bundle, assessed by comparing LIFE-UP scores between ICUs. Quantitative results were expressed as median and IQR.

The audit was tested in 87 patients aged 68 (59–74) years, 9 (5–15.5) days after their admission. The audit was feasible across all ICUs: necessary data were available, resources required were minimal and cooperation was excellent. The LIFE-UP score highlighted significant variability between ICUs (2.5 (1.75–2.75), p

The LIFE-UP Day audit proved feasible and provides a first structured framework for benchmarking. Broader implementation will be essential to validate the LIFE-UP score, refine the model and ultimately determine whether it can translate into improved patient and family outcomes.

Psoriasis is a chronic inflammatory skin disease that significantly impacts patients’ quality of life. Although biological therapies are effective, they are associated with high costs and potential side effects, necessitating strategies for dose reduction. Pharmacological conditioning, using placebo mechanisms through associative learning, presents a promising approach to maintain therapeutic efficacy with lower doses of medication.

The single-centre, randomised controlled trial aims to investigate pharmacological conditioning with secukinumab in patients with moderate-to-severe psoriasis (N=168). Participants will be randomly allocated to a treatment-as-usual group or one of two experimental groups receiving partial or continuous reinforcement schedules with reduced secukinumab doses combined with a distinctive gustatory stimulus. Primary outcomes include changes in itch intensity, skin-related quality of life and objective disease severity. Secondary outcomes encompass psychological variables, side effects and biological markers. Results may contribute to optimised long-term psoriasis management, reducing medication burden while maintaining treatment efficacy.

The study protocol was approved by the ethics committee of the University Hospital Essen (19–8636 BO) on 20 November 2023. Written informed consent will be obtained from all participants. Participant confidentiality will be ensured through pseudonymised data handling and secure storage. The results will be disseminated through peer-reviewed publications.

DRKS00034977.

To examine trends and demographic characteristics of syphilis incidence in Japan using a large nationwide claims database with family linkage, with particular focus on differences by sex, age, HIV status and family relationships.

Retrospective cohort study.

JMDC claims database (JMDC Inc, Tokyo, Japan), a nationwide administrative claims database in Japan, using data from 2016 to 2023.

Individuals aged 16–59 years enrolled in the JMDC database, including employees of medium-to-large companies and their dependents (n=12.5 million).

Syphilis cases were defined by International Classification of Diseases, 10th Revision (ICD-10) codes (A50–A53) with concurrent treatment with relevant antibiotics. We determined syphilis incidence rates per 100 000 person-years, stratified by sex, age, HIV status and family relationships. We also investigated within-couple concordance patterns and reinfection rates.

Among 16.4 million individuals, 9357 syphilis infections were identified among 8881 individuals. Incidence increased markedly during the pandemic, reaching 48.2 (men) and 12.9 (women) per 100 000 person-years in 2023. Men showed consistently high incidence in their 20s–50s, whereas female incidence peaked in the 10s–20s. Among 2 294 184 married couples, dependent women (ie, housewives) showed comparably high incidence to age-matched men (10–20 per 100 000 person-years). In 1286 couples with at least one syphilis case, 12.4% of wives in their 20s were also diagnosed, compared with 2%–3% in older groups. In 20s couples, the proportion of syphilis among wives only and husbands only was similar. Subgroup analysis revealed notably high incidence among unmarried female dependent youths (2022: 66.7 per 100 000 person-years). Individuals living with HIV had substantially elevated incidence (3000–15 000 per 100 000 person-years) and reinfection rates.

Using a large claims database with family linkage, we found that while male syphilis incidence remained dominant, high rates were also observed among dependent women and youths. These findings suggest that syphilis risk may extend beyond traditionally recognised high-risk populations and emphasise the need for targeted screening and preventive strategies in broader demographic groups.

Ethnic communities provide an appropriate setting for examining patterns of pregnancy and childbirth. Policy-making aimed at improving maternal health will be rendered ineffective in the absence of knowledge and comprehension of the traditions and beliefs associated with childbirth. The objective of this study was to cross-ethnically compare childbirth experiences.

This research used a cross-sectional methodology and was conducted in 2023. The sampling in the cities of Tabriz (Azeri), Sanandaj (Kurdish), Babol (Mazani), Khorramabad (Lur), Ahvaz (Arab) and Tehran (Fars) was conducted using the cluster random approach. The data collection instruments included questionnaires of sociodemographic and obstetric characteristics and childbirth experience (Childbirth Experience Questionnaire 2.0). In bivariate analysis, a one-way analysis of variance test was employed. In contrast, a general linear model (GLM) was used in multivariate analysis to adjust for the influence of sociodemographic and obstetric characteristics. The data were analysed using SPSS V.24 software. The p value less than 0.05 was considered significant.

Health centres in cities with different ethnic groups all over Iran.

For this purpose, 1331 women from six ethnic groups who were referred to health centres were selected 4 to 6 weeks after giving vaginal birth.

The following are the mean (SD) scores (scoring range: 1–4) for the childbirth experiences of the participating women: Azeri 2.31 (0.32), Kurdish 2.14 (0.31), Fars 2.26 (0.42), Mazani 1.93 (0.38), Lur 2.14 (0.4) and Arab 2.06 (0.18). Results from GLM multivariate analysis showed that while Azeri (B: 0.25; 95% CI 0.16 to 0.35; p

Women of different Iranian ethnicities have varying childbirth experiences. Women of Azeri and Fars ethnic groups report higher satisfaction with childbirth than those of others. Mazeni women had the lowest mean scores for having a positive birth experience. To offer compassionate and effective treatment for their patients, healthcare providers must have a deep understanding of cultural diversity.