Robot-assisted surgery has been widely adopted in urology, particularly as the mainstream approach for radical prostatectomy. Despite the advantages of robotic systems in surgical precision and complication control, postoperative sexual dysfunction-mainly erectile dysfunction-remains a core issue affecting patients' quality of life. Currently, a systematic visualization analysis of research trends and the intellectual structure of this topic is lacking. Therefore, this study uses bibliometric methods based on the Web of Science Core Collection to delineate the global research landscape, evolving hotspots, and emerging frontiers in the association between robot-assisted radical prostatectomy and sexual function outcomes, aiming to provide references for clinical practice and future research. We retrieved literature from the Web of Science Core Collection on the association between robot-assisted radical prostatectomy and postoperative sexual function outcomes, covering the period from 2007 to 2025. Subsequently, a series of bibliometric and visualization analyses were performed using CiteSpace (version 6.4.R1), VOSviewer (version 1.6.20), and the Bibliometrix R package (version 5.0). CiteSpace was primarily employed for country collaboration network analysis; VOSviewer was mainly used to construct keyword co-occurrence networks and journal co-citation networks; and the Bibliometrix R package was applied to generate global country collaboration world maps and to conduct annual publication output analyses. A total of 218 eligible publications were included in this bibliometric analysis, involving 1,320 authors, 414 institutions, and 39 countries, published across 73 journals and citing 3,941 references. Annual publication output fluctuated over the study period (2007-2025) but displayed a consistent upward trajectory, peaking in 2024. The United States led all countries in both publication volume (77 papers) and total citations (3,399), followed by Italy, Japan, and South Korea, while Australia achieved the highest average citations per paper. The United States also served as the central hub in the international collaboration network, with Europe and North America remaining the core research regions and Asian countries showing steadily growing contributions. Regarding institutional contributions, the most productive institutions were primarily concentrated in the United States, followed by Europe and Asia. European Urology emerged as the most influential journal in terms of total citations and average citations per article, and occupied a central position within the co-citation network. Menon, Mani, and Montorsi, Francesco were the most prolific authors, while Honda, Masashi achieved the highest average citations per article. Keyword co-occurrence analysis revealed three major research clusters: foundational surgical techniques, postoperative urinary and sexual function outcomes with comparative studies, and nerve-sparing techniques with quality of life assessments. Erectile dysfunction and urinary incontinence emerged as the most prominent outcome-specific terms, confirming their dominant positions as the primary functional outcomes of concern, while penile rehabilitation and urinary continence also appeared with lower frequencies. Co-citation analysis identified the systematic reviews by Ficarra V et al. (2012) as the most highly cited references, and the co-citation network was categorized into three major research lineages: oncologic outcomes, functional health-related quality of life, and surgical safety with comprehensive outcome assessment. This study presents the first bibliometric and visualization analysis of the literature on sexual function outcomes after robot-assisted radical prostatectomy (RARP) using the Web of Science Core Collection (2007-2025). The findings reveal a steady increase in annual publication output, with a peak observed in 2024, indicating growing global research attention to this topic. The United States emerged as the dominant contributor in terms of both publication volume and citation impact, followed by Italy and other European and Asian countries. European Urology was identified as the most influential journal, while the systematic reviews by Ficarra V et al. (2012) constituted the intellectual cornerstone of the co-citation network. Keyword analysis demonstrated that research hotspots have progressively shifted from early descriptions of surgical complications toward robotic technique optimization, nerve-sparing, functional recovery, and quality of life assessment. Notably, erectile dysfunction and urinary incontinence were the most prominent outcome-specific terms, reflecting their clinical significance as primary concerns after RARP. Despite the leadership of a small group of high-impact authors and institutions, international collaborative research remains insufficient, particularly across regions.Key limitations include database and language restrictions, citation and synonym biases, author/institution disambiguation challenges, and the inherent inability of bibliometric methods to assess clinical evidence quality. Future research should prioritize multicenter prospective studies, standardized patient-reported outcome measures, and strengthened cross-regional and interdisciplinary collaboration to advance individualized functional preservation strategies.
Software-based and AI-enabled medical devices are increasingly networked and updatable, expanding the attack surface and making cybersecurity governance intersect with quality management and postmarket oversight. Regulated device risk management nevertheless remains primarily oriented toward patient-safety harms under ISO 14971 frameworks, which may not fully capture cybersecurity risks affecting data integrity, system resilience, or service continuity. This study aimed to compare how Korea's Ministry of Food and Drug Safety (MFDS), the US Food and Drug Administration (FDA), and the European Union/Medical Device Coordination Group (EU/MDCG) define and operationalize cybersecurity for medical device software across premarket review and postmarket surveillance, and to identify informatics-relevant gaps between safety vigilance and vulnerability-focused cybersecurity practice. We conducted a qualitative comparative document analysis of 10 jurisdiction-specific regulatory and guidance documents (MFDS: n=2, FDA: n=4, and EU/MDCG: n=4), supplemented by cross-sectoral instruments and peer-reviewed literature. Using a common analytic framework informed by functional comparative legal analysis, we mapped (1) conceptual scope (definitions and life cycle boundaries), (2) premarket operationalization (required artifacts and evidence such as threat modeling, software bills of materials, and vulnerability management plans), and (3) postmarket operationalization (monitoring, reporting, and update governance). Of the 10 documents analyzed (MFDS: n=2, FDA: n=4, and EU/MDCG: n=4), all 3 jurisdictions converged on protecting confidentiality, integrity, and availability of data and device functions but embedded these expectations in different regulatory architectures. MFDS emphasized documentation completeness aligned with ISO 14971 risk management; the FDA framed cybersecurity as quality-system and design-control activities spanning the total product life cycle, including statutory requirements for "cyber devices" under Federal Food, Drug, and Cosmetic Act section 524B; and the European Union treated cybersecurity as an extension of safety under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), interpreted through MDCG guidance, with additional cross-sector obligations from the Network and Information Security 2 (NIS2) Directive and the General Data Protection Regulation (GDPR). A common limitation was that vigilance pathways were largely triggered by patient-harm thresholds, whereas vulnerabilities and near-miss security events were often managed through parallel information-security processes. Mapping to ISO 13485 Clauses 7.3 and 8 indicated that integration of cybersecurity controls into existing quality management system (QMS) processes is feasible but not consistently mandated. Across the 3 jurisdictions examined in this study, regulatory approaches to medical device cybersecurity show definitional alignment but operational fragmentation at the interface between patient-safety vigilance and vulnerability-centric cybersecurity practice. Within the limits of this document-based analysis, the findings suggest that integrating cybersecurity as an interoperable process within the QMS-linking vulnerability monitoring, incident response, and software update controls to corrective and preventive action (CAPA) and change control-and expanding postmarket surveillance to incorporate vulnerability and performance signals could support more trustworthy deployment of regulated AI-enabled medical software.
Lung cancer is typically a cancer of the elderly, with a median age at diagnosis of 71, and more than one third of the people diagnosed with lung cancer are over 75 years old. Immune checkpoint inhibitors (ICIs) have revolutionised the treatment of cancers, including lung cancer. ICIs targeting the programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) axis, administered in the neoadjuvant setting, the adjuvant setting, or both, are currently the standard of care for resectable non-small-cell lung cancer (NSCLC) worldwide. These ICIs are commonly used in combination with platinum-based chemotherapy and have shown superior efficacy in patients eligible for curative surgery. The concept of immunosenescence, which refers to age-related changes in the immune system - particularly a decline in the efficiency of T-cell mediated responses - raises concerns about the benefits of ICIs in the elderly population. To assess the benefits and harms of ICI with or without chemotherapy compared to no treatment or placebo with or without chemotherapy given before surgery, after, or both in older adults diagnosed with NSCLC at the early resectable stage. We searched for all eligible randomised controlled trials (RCTs) in electronic databases (CENTRAL, MEDLINE, and Embase), trial registries (clinicaltrials.gov and the World Health Organization ICTRP), references of eligible studies, meeting abstracts of the main world conferences, and the Food and Drug Administration (FDA) and European Medicines Agency (EMA) websites. The search was up to 3 July 2025. We included parallel designed RCTs comparing ICI with or without chemotherapy versus no treatment or placebo with or without chemotherapy administered before surgery, after, or both for early-stage resectable NSCLC. We excluded studies comparing differential sequencing of ICIs or combinations of ICIs with alternate interventions (e.g. radiotherapy). Our critical outcomes were overall survival and grade ≥ 3 treatment-related adverse events. Our important outcomes were disease-free survival, event-free survival, pathological complete response rate, major pathological response rate, and health-related quality of life. Two review authors independently used version 2 of the Cochrane risk of bias tool for randomised trials (RoB 2) to assess bias in the included studies. We synthesised results for each outcome and pooled data where possible (using a random-effects model with DerSimonian and Laird methods for all outcomes; and the Mantel-Haenszel method for dichotomous outcomes). Where this was not possible due to the nature or the amount of data, we narratively summarised the results. Three authors independently assessed the certainty of the evidence, using the five GRADE considerations for each outcome. We included a total of 11 studies with 6788 participants, of whom 3152 were ≥ 65 years old (46.4% of all participants). We were also interested in those aged ≥ 75 years old but could not obtain the exact number of such participants in nine studies. The inclusion criteria were similar across studies: adults presenting with a resectable NSCLC (stages II to IIIB according to the eighth edition of the Tumor, Node, Metastasis (TNM) classification), with an Eastern Cooperative Oncology Group performance status score of 0 or 1. One study excluded people ≥ 70 years old. Six studies excluded NSCLC with known alterations in epidermal growth factor receptor and anaplastic lymphoma kinase genes. The following results relate to people ≥ 65 years old only. The term perioperative is used to label studies evaluating the administration of treatment before (neoadjuvant) and after (adjuvant) surgery. Overall survival at any time point (in all studies) Aggregated data from three studies (590 participants) showed that perioperative ICI probably results in little to no difference in overall survival compared to placebo or no treatment, with a hazard ratio (HR) of 0.88 (95% confidence interval (CI) 0.61 to 1.26) and moderate-certainty evidence (downgraded for risk of bias). Treatment-related adverse events ≥ grade 3 at any time point One study (39 participants) provided data indicating that perioperative ICI combined with neoadjuvant chemotherapy may result in little to no difference in treatment-related adverse events ≥ grade 3 compared to neoadjuvant chemotherapy alone, with a risk ratio (RR) of 2.75 (95% CI 0.38 to 19.83) and low-certainty evidence (downgraded for indirectness and imprecision). Disease-free survival at any time point Aggregated data from three studies (1403 participants) showed that adjuvant ICI probably slightly increases disease-free survival compared to placebo or no treatment (HR 0.85, 95% CI 0.73 to 0.99) with moderate-certainty evidence (downgraded for risk of bias). Event-free survival at any time point Aggregated data from seven studies (1531 participants) showed that neoadjuvant or perioperative ICI likely increases event-free survival compared to placebo or no treatment (HR 0.61, 95% CI 0.52 to 0.71) with moderate-certainty evidence (downgraded for risk of bias). Pathological complete response Aggregated data from six studies (1068 participants) showed that neoadjuvant or perioperative ICI may result in a large increase in pathological complete response rates compared to placebo or no treatment (RR 5.07, 95% CI 3.40 to 7.54) with low-certainty evidence (downgraded for risk of bias and imprecision). Major pathological response Aggregated data from six studies (1068 participants) showed that neoadjuvant or perioperative ICI probably results in a large increase in major pathological response rates compared to placebo or no treatment (RR 2.94, 95% CI 2.32 to 3.72) with moderate-certainty evidence (downgraded for risk of bias). In people aged ≥ 65 years old, the addition of ICIs probably results in little to no improvement in overall survival. Based on one study, treatment-related adverse events showed a similar profile, with low-certainty evidence. However, ICIs probably increase disease-free survival, event-free survival, and major pathological response rates by a clinically meaningful margin. ICI may also increase complete pathological response rates. No study reported health-related quality of life assessments in older adults. Data were also insufficient to evaluate outcomes precisely in participants aged 65 to 75 years, those ≥ 75 years, or in PD-L1 stratified subgroups. We classified 12 studies as ongoing, as no results are yet available for elderly participants. This Cochrane review had no dedicated funding. Protocol available via DOI: 10.1002/14651858.CD014907.
The SUPREMO trial reported adjuvant chest wall radiotherapy had no effect on 10-year overall survival (primary endpoint) in patients with intermediate-risk breast cancer after mastectomy. The quality of life (QOL) substudy of SUPREMO (UK patients only) examines the effects of chest wall radiotherapy in patients with intermediate-risk breast cancer 1 year, 2 years, 5 years, and 10 years after treatment. Here, we report 5-year QOL results (a secondary endpoint), including prespecified subgroup analyses. SUPREMO is an international, parallel-group, randomised, controlled, phase 3 trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1 or pT3N0 or pT2N0 with histological grade 3, or lymphovascular invasion, or both) who had undergone mastectomy (and axillary surgery) were randomly assigned (1:1) to receive chest wall radiotherapy (40-50 Gy in 15-25 fractions) or no radiotherapy. Randomisation was in permuted blocks with varying block length, stratified by centre, without masking of patients or investigators. All UK patients were invited to the QOL substudy. Consenting patients completed validated questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Core 30-item questionnaire; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module, 23 items; Body Image Scale; and Hospital Anxiety and Depression Scale) before randomisation and at 1 year, 2 years, 5 years, and 10 years. Here, we report the prespecified primary QOL outcomes of global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, anxiety, and depression in the intention to treat population, using repeated measures mixed-effects models. This trial is registered with the ISRCTN registry, ISRCTN61145589 and is now completed. Between Aug 4, 2006, and April 29, 2013, SUPREMO recruited 1691 patients internationally, of whom 1679 were randomly assigned to receive chest wall radiotherapy (n=845) or not (n=834). Of 1233 patients from UK centres (619 in the chest wall radiotherapy group and 614 in the no chest wall radiotherapy group), 989 (80%) consented to the QOL substudy: 947 (96%) of 989 returned baseline questionnaires and 620 (75%) of 832 patients returned the expected year-5 questionnaires. Chest wall symptoms were worse with chest wall radiotherapy (effect estimate 1·99 [95% CI 0·36-3·62]; p=0·017) with an improvement between years 1, 2, and 5. Chemotherapy was associated with less improvement over time (effect estimate 2·97 [95% CI 0·24-5·71]; p=0·033) but without interaction with chest wall radiotherapy. No statistically significant differences were observed in other QOL domains (arm symptoms, body image, fatigue, pain, overall QOL, physical functioning, or anxiety and depression). In the subgroup analyses, patients who had a sentinel lymph node biopsy followed up by an axillary lymph node clearance with chest wall radiotherapy had worse chest wall symptoms than those having a single axillary operation (difference chest wall radiotherapy vs no chest wall radiotherapy -5·29 [95%CI -8·53 to -2·05]; p=0·0015). The 5-year QOL findings showed worse chest wall toxicity and no effect on other QOL domains. The subgroup analyses suggested a potential negative effect of chemotherapy and axillary clearance after sentinel node biopsy. UK Medical Research Council, National Institute for Health and Care Research, European Organisation for Research and Treatment of Cancer, Edinburgh Trustees of Breast Cancer Institute in Edinburgh and the Edinburgh Cancer Centre NHS Endowment funds, The Dutch Cancer Society, Trustees of the Hong Kong and Shanghai Banking Corporation.
to describe the garbage codes (GCs) identified in the Global Burden of Disease Study (GBD) 2023 and their redistribution to underlying causes of death in Italy in 2021. Specifically, the study aims to: 1. compare temporal trends in the proportion of GCs in Italy with those of other Western European countries with similar population sizes; 2. identify the most frequent GC packages, analyze their geographic distribution, and determine the causes to which they are reassigned; 3. examine the relationship between the proportion of GCs and contextual factors related to death certification, including the type of certifier, place of death, and requests for autopsy. descriptive epidemiological study based on GBD 2023 estimates. the analysis focuses on the Italian population in 2021, stratified by 21 subnational units, including 19 regions and 2 autonomous provinces. total number of deaths; number of GCs, defined as deaths attributed to causes that do not represent underlying causes of death; percentage of GCs, calculated as the number of GCs divided by total deaths and multiplied by 100. the proportion of GCs in Italy gradually decreased over time, from 34.6% in 1990 to 28.8% in 2021. In 2021, the three most frequent GC packages at the national level were 'unspecified type of stroke' (4.28% of total deaths), 'unspecified type of diabetes' (2.44%), and 'heart failure, right or left' (2.38%). In the same year, the proportion of GCs was positively correlated with the share of deaths occurring at home (r 0.71; p <0.001), with missing data on the type of certifying physician (r 0.54, p=0.020), on place of death (r 0.77, p <0.001), and on autopsy requests (r 0.76, p <0.001). misreporting of causes of death arises from multiple mechanisms, reflecting errors of different nature and severity, with important implications for public health policies and health information systems. While redistribution methods are essential to produce comparable and policy-relevant estimates, improving data quality at the source remains a critical priority.
Chemotherapy-induced alopecia is among the most psychologically distressing adverse effects of systemic cancer therapy. Although scalp cooling is increasingly used to mitigate hair loss, it is still largely perceived as a cosmetic intervention. Its broader psychological relevance and the biological basis of treatment success, particularly the preservation of follicular integrity under ongoing cytotoxic exposure, remain insufficiently explored. This study aimed to reconceptualize scalp cooling beyond visible hair preservation by examining its psychological impact on patients receiving highly alopecia-inducing chemotherapy, while integrating quantitative objective hair preservation metrics with structural and ultrastructural analyses of hair follicle damage to identify avenues for improving follicular integrity and scalp-cooling efficiency. A total of 82 patients undergoing highly alopecia-inducing chemotherapy consisting of a sequential anthracycline-taxane regimen (4 cycles of epirubicin and cyclophosphamide followed by 12 weekly paclitaxel applications) received standardized scalp cooling. Objective hair preservation was quantified using the hair mass index (HMI) as a standardized and reproducible measure of hair retention. Structural and ultrastructural follicular integrity was assessed using light microscopy as well as scanning and transmission electron microscopy. Objective hair preservation metrics were analyzed in relation to patient-reported quality-of-life outcomes (EORTC [European Organisation for Research and Treatment of Cancer]-based measures), subjective treatment burden, and cognitive appraisal of the scalp-cooling experience. Multivariable regression models were applied to identify determinants of posttherapeutic quality of life. Visible chemotherapy-induced alopecia was successfully prevented in more than half of the treated patients. Scalp cooling resulted in substantial objective hair preservation as quantified by the HMI. However, HMI values showed only a limited association with posttherapeutic quality-of-life outcomes. In contrast, the cognitive appraisal of scalp cooling emerged as a central determinant of posttherapeutic quality of life, independent of the degree of objective hair retention. Structural and ultrastructural analyses demonstrated that the preservation of follicular integrity was closely associated with successful macroscopic hair retention under ongoing cytotoxic exposure, supporting a biological basis for the clinical effectiveness of scalp cooling. The clinical relevance of scalp cooling extends beyond objective and visible hair preservation and appears to reside predominantly in its psychological impact on patients undergoing highly alopecia-inducing chemotherapy. Importantly, the identification of structural and ultrastructural markers of follicular vulnerability provides a mechanistic foundation for the future optimization of scalp-cooling approaches and for the development of adjunct follicle-directed protective strategies to enhance follicular integrity and support patient well-being during cytotoxic therapy.
The rapid emergence of artificial intelligence (AI) has outpaced its formal adoption in health care organizations, contributing to the emergence of Shadow AI, defined here as the use of unauthorized AI tools by medical professionals. Under the European Union Medical Device Regulation, AI tools used for clinical purposes must undergo conformity assessment before use; general-purpose tools such as ChatGPT have not done so, rendering their clinical application unauthorized at the regulatory level. While Shadow AI offers potential efficiency gains and higher performance, it poses significant risks to data privacy, clinical safety, and regulatory compliance. Despite its growing prevalence, empirical research on the purposes for which physicians use Shadow AI remains scarce. This study explores the purposes for which physicians describe using Shadow AI in their work. We conducted a cross-sectional survey of physicians employed in Swedish health care organizations (N=357; response rate~64%). Data were collected between December 2023 and January 2024 via a verified online panel. We conducted a qualitative content analysis of free-text responses on the use of unauthorized AI tools. We applied theoretical lenses from the sociology of professions and paradox theory to interpret the empirical findings. Physicians use Shadow AI for several purposes, which we grouped into 4 categories: clinical work and decision-making, administrative work, research and professional development, and technological interest and curiosity. More specifically, Shadow AI is used as a colleague and second opinion for clinical decision support (eg, differential diagnoses and rare cases), administrative tasks such as patient communication and documentation, and research aimed at staying up to date and exploring developments in generative AI. Physicians described using these tools compensated for perceived gaps in institutional systems, reducing workload, and accessing knowledge considered difficult to obtain through conventional channels. The findings reveal a tension between physicians' drive to improve their practice and the regulatory and organizational constraints that render such use unauthorized. Shadow AI used by physicians presents both opportunities and risks for health care professionals and organizations. Shadow AI indicates gaps where formal hospital systems may fail to meet health care professionals' needs and signals a way for physicians to strengthen their experience-based knowledge. It represents a renegotiation of professional boundaries, as physicians bypass institutional constraints to maintain professional efficacy. The findings highlight a paradox in which the same tools that pose regulatory and safety risks also address real gaps in clinical and administrative support, suggesting that governance approaches must account for this tension rather than relying on prohibition alone.
Gabapentinoids are increasingly being prescribed in older adults (aged 60 years or older), but concerns have been raised that their adverse effects on the CNS can increase the risk of fractures. Previous studies have reported associations between gabapentinoid use and fracture, but many have not adequately addressed confounding by indication or examined risk across the treatment journey. Therefore, we aimed to investigate the temporal association between gabapentinoid treatment and fracture in older adults, and to assess whether concomitant opioid or benzodiazepine use further modifies this risk. In this retrospective multinational population-based study, we used data from the UK Clinical Practice Research Datalink (CPRD) Aurum database and the South Korea National Health Insurance Service-National Health Screening Cohort (NHIS-HEALS). The analysis included individuals aged 60 years or older prescribed a gabapentinoid and who had a hospitalised fracture between Jan 1, 2010, and Dec 31, 2020, in the UK and between Jan 1, 2003, and Dec 31, 2019, in South Korea. The observation period for each included individual was divided into four mutually exclusive windows: 90 days before gabapentinoid treatment (pre-exposure window), first 60 days of treatment period (focal window 1), remaining time of the treatment period (focal window 2), and all other non-treatment periods (referent window), to capture how risk varied across the treatment course. Adjusted incidence rate ratios (aIRRs) with 95% CI of fracture during different risk windows were estimated using conditional Poisson models within each country, and the country-specific aIRRs for the same risk window were then pooled using a random-effects model. We included 20 030 participants in CPRD and 2935 in NHIS-HEALS in the analysis. In the CPRD cohort, 15 366 (76·7%) were women and the mean age at event was 77·85 years. In the NHIS-HEALS cohort, 2007 (68·4%) were women and the mean age at event was 69·24 years. The pooled results showed an increased risk of fracture during the pre-exposure window (aIRR 2·92, 95% CI 1·61-5·28, p=0·0004). The aIRR was 1·31 (95% CI 1·00-1·71, p=0·051) in the first 60 days of the treatment period and did not increase for the remainder of the treatment period (0·84, 0·54-1·32, p=0·45). Concurrent prescription of opioids or benzodiazepines elevated the risk of fracture, with an aIRR of 3·15 (95% CI 2·85-3·48, p<0·0001) for opioids and 1·91 (1·50-2·44, p<0·0001) for benzodiazepines during the first 60 days of gabapentinoid treatment period. The risk of fracture was the highest in the period before the commencement of gabapentinoid treatment and declined after initiation of treatment. The results do not support a sustained causal relationship between gabapentinoid use and risk of fracture in older adults but warrant fall and fracture-prevention measures around gabapentinoid initiation. The elevated fracture risk observed with concomitant opioid or benzodiazepine use highlights the need for careful review of concurrent sedating medicines when initiating gabapentinoids. UK National Institute for Health and Care Research; Hong Kong Innovation and Technology Commission; Ministry of Food and Drug Safety, South Korea.
The European Organisation for Research and Treatment of Cancer (EORTC) questionnaires are some of the most widely used patient-reported outcome measures (PROMs) for health-related quality of life assessment in oncology. The EORTC Item Library is an online platform comprising all EORTC PROMs that enables the creation of customised questionnaires (item lists). To characterise and better understand the breadth of functioning, disability and health coverage within the EORTC Item Library, this study aimed to link and analyse its content using the International Classification of Functioning, Disability and Health (ICF). A team of reviewers applied the most recent ICF linking rules to map the items currently included in the EORTC Item Library. Descriptive analysis was used to summarise the content covered in ICF categories and concepts coded as not covered or not definable. The 1076 EORTC items covered 1860 concepts overall, with most (n = 1641, 88.2%) linked to the ICF. Concepts were linked to the majority of ICF chapters (n = 28/30, 93.3%), covering 60.9% (168/276) of all second-level ICF categories. The components of 'b-Body functions' and 'd-Activities and participation' had the highest coverage, with concepts linked to 80.0% (64/80) and 68.5% (63/92) of all second-level categories respectively. The EORTC Item Library provides broad coverage of functioning, disability and health within the ICF. Using the ICF to describe its content can inform the selection of EORTC items and PROMs and facilitate standardised comparison across measures and contexts, supporting the use and interpretation of EORTC measures in research and clinical practice.
Background: Substance Use Disorder (SUD) is frequently associated with psychiatric comorbidity, including psychotic symptoms, impulsivity and neurodevelopmental traits. The influence of age and duration of substance use on these clinical characteristics and on treatment retention remains insufficiently understood. Objectives: To examine the influence between age, duration of substance use, clinical presentation, patterns of violence, and treatment retention in individuals with SUD. Methods: A prospective 6-month cohort study was conducted at the Alcoholism Treatment Unit of the CAUSA Hospital Complex in Salamanca, Spain. A total of 264 patients with SUD were classified into two groups: prolonged substance use (≥55 years of age or ≥25 years of substance use; n = 127) and shorter substance use trajectories (<55 years and <25 years of substance use; n = 137). Participants completed structured clinical interviews and validated measures of quality of life, impulsivity, autistic traits, addiction severity, psychotic symptoms and violence. Non-parametric analyses were applied (α = 0.05; 95% CI). Results: Younger participants showed a significantly higher prevalence of auditory and visual hallucinations and persecutory delusions at baseline. During follow-up, both groups exhibited a reduction in physical aggression while driving and an increase in insults and verbal threats. No significant differences were observed in recent uncontrolled violence. Positive screening results for ADHD, autistic traits and impulsivity were not associated with treatment retention. Lower baseline physical functioning was associated with reduced completion of the 6-month follow-up assessment. Conclusions: Age and duration of substance use were associated with differences in the clinical presentation of SUD. Younger individuals exhibited a greater burden of psychotic symptoms and violence-related behaviours, whereas poorer physical functioning was associated with lower follow-up retention among individuals with prolonged substance use histories. These findings support the importance of age-sensitive assessment and management strategies in patients with SUD.
Informal caregivers (ICs) of people living with dementia (PwD) are often referred to as invisible second patients, as they frequently experience chronic stress and related health issues. Identifying factors that contribute to or buffer caregiver stress is therefore of critical importance. This study aimed to explore how caregiver burden and resilience jointly are associated with stress among ICs of PwD - a rarely adopted approach. The sample consists of n = 172 ICs. To examine the associations between our dependent variable, stress (PSS), and caregiver burden (BIZA-D-PV), caregiver resilience (BRS), the quality of life of the PwD (QoL-AD), as well as the IC's sociodemographic characteristics, we conducted a hierarchical multivariate regression analysis. Resilience was included as a second block to assess changes in model fit and variable effects. Furthermore, an interaction model was calculated to investigate potential moderating effect of resilience. In Block 1, without considering resilience, personal constraints of the IC (p < 0.001), the QoL of the PwD (p < 0.001), and cohabitation of the IC and PwD (p = 0.006) were significantly associated with stress. In Block 2, only personal constraints (p < 0.001) and the QoL of the PwD (p = 0.001) remained significant, and, additionally, the explained variance (R²) increased significantly (p < 0.001). In the interaction model, only the main effects of resilience (p = 0.004), personal constraints (p = 0.002), and QoL of the PwD (p = 0.002) were significant. These findings might highlight important considerations for future interventions aimed at supporting ICs and PwD. Special attention could be given to cohabiting IC-PwD dyads, as these relationships often involve unique challenges and stressors that could be mitigated through tailored support strategies. German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 Retrospectively registered, https//www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00023560.
A work-related death from sudden causes among physicians is not a new problem although still not enough explored in the scientific literature. Estimating the scale of the phenomenon is important from a social and public health point of view. Thus, the aim of this paper is to gather the current state of knowledge on the frequency and the main causes of unexpected sudden causes of death within physicians' community. The authors of the article reviewed medical databases on publications in English concerning the topic released in this century. The cases of sudden death, work-overload death including those resulting from suicide and incidences of direct violence from other individuals while performing professional duties were analyzed. It turns out that the problem appears regardless of the region of the world and has been increasing in frequency in recent times. Some medical specialties, i.e., surgery, psychiatry, anesthesiology, intensive care and emergency medicine, seem to carry significantly higher risk than others. In addition to the conclusions from literature review, also letters to the editors and mass-media reports from different parts of the world indicate that the problem is alarming and requires more specific research and urgent solutions. Int J Occup Med Environ Health. 2026;39(3):223-35.
RSV infections in children affect the entire family. Nevertheless, evidence on the overall impact is scarce. This multi-country observational study aims to investigate the association between disease severity and health-related quality of life (HRQoL) in affected families and to explore the role of factors related to mental well-being. Data were collected during the 2022-2023 RSV season in Germany, France, Italy and Sweden via an online questionnaire from parents of children (24 months) hospitalised for RSV. Parental HRQoL was assessed using the validated caregiver-reported PedsQL Family Impact Module. Exploratory analyses and multivariate linear regression models were performed focusing on potential key determinants. A total set of 138 participants was assembled. Parents of children with a severe RSV infection had on average - 12.1 [95% CI: -21.2 to - 3.03; P = 0.010] lower HRQoL Summary Score than parents of children with low severity index scores. Subsequent stratified analyses revealed a stronger association among parents who had not been offered (adequate) mental health support. Higher RSV disease severity was associated with lower parental HRQoL. These findings highlight the importance of preventing severe RSV infection and the need for further research to identify and evaluate appropriate (psychosocial) support for affected families. ClinicalTrials.gov, identifier, NCT05550545. Registered 12 September 2022.
Osteoporotic vertebral fractures (OVFs) significantly impact morbidity, mortality, function and quality of life. Stable fractures with controllable pain can be managed conservatively. Those that remain painful can be treated with minimally invasive measures of vertebral augmentation (VA). In contrast, severe and unstable OVFs risk collapse, progressive kyphosis and neurological damage. Conventional VA is considered insufficient for these unstable fractures, making surgical stabilisation necessary to restore spinal load-bearing capacity, and allow fast and painless mobilisation. However, spinal surgery in elderly osteoporotic patients is challenging due to tissue fragility and common comorbidities. In addition, poor bone quality increases the risk of surgical implant failure, new fractures, complications and re-intervention.This trial aims to assess the non-inferiority of a novel minimally invasive interventional technique, called stent-screw assisted internal fixation (SAIF), compared with multilevel surgical stabilisation in terms of quality of life and radiological outcomes such as vertebral height restoration and kyphotic correction in patients with unstable OVFs. This is a multicentre, parallel-group, randomised controlled non-inferiority trial that will be conducted in four European centres.A total of 140 patients with type Osteoporotic Fracture (OF) 3-5 OVFs (according to the AO Spine-DGOU Osteoporotic Fracture Classification System) will be randomised 1:1 to receive either SAIF intervention or surgical stabilisation.The primary outcome is to determine whether the effect of SAIF intervention is not inferior to surgical stabilisation on pain and quality of life at 1-year follow-up.The principal secondary outcomes are to evaluate whether the effect of the SAIF intervention is not inferior to surgical stabilisation in terms of radiological outcome and cost-effectiveness. Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE 4004). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. NCT07071870.
In this study, we summarize evidence from the European project TRANSCARE to identify key areas for improvement in transgender care and synthesize our experience into a roadmap of knowledge integration into healthcare systems. According to our roadmap, as a public health concern, progress in transgender care requires its integration into health policy, education and training for healthcare professionals, and availability of essential gender-affirming medications and population-specific healthcare services, including both medical and social care. Our roadmap serves as a model for stakeholders to use when determining the elements and steps necessary for transgender care integration and includes the synthesis of multiple actions to address: (1) transgender care inclusion in national health policy, (2) legislation and finance, (3) availability of essential gender-affirming medications, particularly hormone therapy, (4) education and training for health care professionals, (5) implementation of trans-specific care services at primary and secondary care services, (6) implementation of trans-specific services in social care and linkage with medical care. Results and evidence from all project activities are combined to create a pathway with multiple nodes to guide the development of integrated transgender care and to monitor progress. While the study focuses on the health and social context of Greece, our roadmap serve as a model for adaptation in other settings. As with any public health issue, the implementation of the roadmap requires both stakeholder engagement and policy actions to be further piloted, tested, and eventually adopted.
Coagulopathies, infection, and CNS infiltration are common complications during induction therapy of acute myeloid leukemia (AML). Early identification of adverse-risk patients may improve outcomes. This study evaluated the predictive value of coagulation markers, von Willebrand Factor antigen (vWF-ag), von Willebrand Factor-ristocetin cofactor (vWF-RCof), antihemophilic factor (FVIII), and D-dimer on risk stratification, severity and outcomes of AML patients. Fifty AML patients treated at Oncology Center Mansoura University hospital, from February 2023 to February 2024 were recruited and stratified into three risk groups favourable, intermediate, and adverse risk groups respectively according to the 2022 European leukemianet (ELN) risk stratification for AML. vWF-ag, vWF: RCof, FVIII, and D-dimer were measured at diagnosis and at remission. Adverse-risk group had the highest median levels of vWF-ag, vWF-RCof, FVIII and D-dimer at, both diagnosis and remission (p < 0.05). All markers significantly declined after remission (p < 0.05). vWF-ag, vWF-RCof, and D-dimer differed significantly among risk groups at both diagnosis and remission. ROC analysis showed that in the adverse-risk group, D-dimer had an AUC of 0.813 (cutoff > 1.6), vWF: Ag 0.780 (> 295), and vWF: RCo 0.761 (> 223). FVIII showed lower predictive value (AUC 0.625). Infection was the most frequent complication, followed by bleeding and thrombosis. Infection correlated with higher vWF: Ag after remission; thrombosis correlated with elevated vWF: Ag at diagnosis and remission and bleeding with lower vWF-ag. CNS infiltration showed no association. vWF-ag, vWF-RCof, and D-dimers may be associated with risk and complications in AML, but these findings require external validation in larger cohorts.
Lung cancer remains a major contributor to cancer mortality in sub-Saharan Africa (SSA), where late diagnosis, driven by low awareness, sociocultural barriers, and health system constraints, limits effective treatment. Despite the growing burden, evidence on patients' quality of life (QoL) and symptom experience in SSA is limited. This study aimed to describe the common symptoms and QoL of patients with lung cancer treated at 2 hospitals in SSA, and to investigate the association of demographics, clinical characteristics, and symptom burden with QoL. This was a cross-sectional study that consecutively recruited patients with lung cancer from 2 teaching hospitals in SSA: Bugando Medical Centre (BMC) in Tanzania and the University of the Witwatersrand Centre of Respiratory Excellence (WITS-CORE) in South Africa. Data collected included demographics, clinical information, and performance status using the Eastern Cooperative Oncological Group Performance Scale (ECOG-PS). Health-related QoL was assessed using the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The study followed all ethical procedures, and data were analyzed using both descriptive and inferential statistics in Stata 18. A P value of <.05 was considered statistically significant. A total of 174 patients with lung cancer were enrolled across the 2 sites. The score on the EORTC QLQ-C30 global health status/QoL subscale was low, with a median of 41.67 (IQR 33.33-41.67), and it varied by site. Patients from WITS-CORE demonstrated higher social functioning scores, while those from BMC reported greater financial difficulties. A low global health status/QoL score was independently associated with the BMC site (adjusted odds ratio [aOR] 3.5, 95% CI 1.3-9.3) and poor performance status (ECOG-PS 3-4; aOR 3.4, 95% CI 1.2-6.6). Furthermore, symptoms such as nausea and vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial struggles were all associated with a low global health status/QoL score. QoL among patients with lung cancer in SSA is poor. Low QoL is strongly associated with the Multinational Lung Cancer Control Program study site, poor performance status, and a range of symptoms and financial difficulties. Addressing these factors may help to improve patient outcomes and well-being in SSA.
Understanding how Ukrainian refugee children accessed the health care system after fleeing the war is essential to inform future preparedness and resource allocation in host countries. To use latent class analysis of registry data to identify distinct health care utilization profiles among young Ukrainian refugee children who accessed the health care system in southern Poland in 2022. This registry-based retrospective cohort study used electronic health record data from 2022 and included Ukrainian refugee children, aged 0 to 5 years, who received health care services in facilities in Małopolska Voivodeship, Poland. Participants were followed up from February 24 through December 31, 2022. The data were analyzed from April to October 2025. Healthcare utilization indicators among postwar displaced Ukrainian refugee children used as inputs to the latent profile analysis. Latent profile membership of health care utilization based on health care visit types, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) coded diagnoses, and intensity of health care use, with temporal patterns of system entry and service trajectories examined after profile identification. The analytic sample included 9845 Ukrainian refugee children aged 0 to 5 years (4849 [49.3%] female) who received 35 199 health care services in Małopolska Voivodeship in 2022. Age at first health care contact was evenly distributed across categories (mean [SD] of 2.7 [1.6] years), 3802 children (38.6%) had a single recorded service, 1845 (18.7%) had more than 5 services, and nearly half (4505 [45.8%]) received care in the regional capital (Krakow). Based on latent class analysis, 5 pediatric patient profiles were identified: mostly primary care (5216 [53.0%]), hospitalized with infectious diseases (1539 [15.6%]), highest health care use (1329 [13.5%]), emergency care for injuries (900 [9.1%]), and dental and preventive care (861 [8.7%]), differing in visit type, diagnostic patterns, and health care utilization intensity. Temporal patterns varied across profiles with earlier system entry among children requiring hospitalization for infectious diseases or emergency care for injuries, and later entry among those using primary care or dental and preventive care. In this cohort study of pediatric Ukrainian refugees in southern Poland, distinct health care utilization patterns were observed with early reliance on hospital and emergency care followed by greater use of primary services. These findings underscore the need for refugee-hosting countries to rapidly adapt health care resources, prioritizing inpatient and emergency care in the initial months following a crisis.
The aim of this study was to evaluate the validity and reliability of the Turkish version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-ELD14 in older patients with cancer. One hundred thirteen older patients with cancer were included in the study. The validity and reliability of the EORTC QLQ-ELD14 were evaluated via exploratory and confirmatory factor analyses, correlation analyses with the EORTC QLQ-C30, known-group comparisons, Cronbach's alpha, test-retest and the intraclass correlation coefficient. Known-group comparisons were evaluated in patient groups divided according to cancer stage, Karnofsky performance status and Charlson Comorbidity Index. Factor analysis results demonstrated that the Turkish EORTC QLQ-ELD14, with its seven-factor structure, is a sufficient measurement instrument. Moderate to high correlations were observed between the EORTC QLQ-ELD14 and the QLQ-C30 (r = -0.40 to -0.83; p < 0.05). The clinical validity of the EORTC QLQ-ELD14 has been demonstrated by its ability to discriminate between different clinical profiles. Cronbach's α coefficient was determined to be 0.719. The intraclass correlation coefficients of all subscales were above 0.80. Excellent agreement was observed in test-retest reliability. The Turkish version of EORTC QLQ-ELD14 is valid and reliable and is suitable for use by researchers and clinicians.
Perioperative risk screening seeks to optimize medical decision-making by identifying cardiac risk in patients undergoing noncardiac surgery. The current guidelines of organizations such as the European Society of Cardiology (ESC) and the Brazilian Society of Cardiology (SBC)incorporate assessments of subjective functional capacity, often using the threshold of 4 METs as a marker of low functional capacity. Despite recent updates to these guidelines, the literature remains conflicting, and the predictive power of subjective tools for perioperative outcomes is uncertain. We conducted a systematic review, in accordance with PRISMA guidelines, on the effectiveness of subjective functional capacity assessment tools regarding their predictive power for perioperative cardiac complications, including death. Four databases were searched: PUBMED, SCOPUS, WOS, and Science Direct. The results indicate that the self-reported ability to climb two flights of stairs, although demonstrating associative power, often did not improve the predictive power of risk models. In contrast, more comprehensive assessment tools with continuous data, such as the Duke Activity Status Index (DASI) and weekly levels of physical activity, appear to be more promising. These results suggest that current perioperative risk stratification guidelines need to be critically re-evaluated with regard to the inclusion of subjective functional capacity. It is of paramount importance to effectively distinguish the associative power of the subjective assessment of functional capacity from its predictive power when compared with information already obtained from the patient.