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Comparability of external and internal control patients for the prospective randomized HOVON-103 trial in older AML patients
No full textReal-world data (RWD) previously contributed to post-marketing regulatory decision-making, but are currently also considered as external controls to single-arm trials. The use of RWD control data may be compromised by methodological issues, urging validation of RWD control cohorts. Two external control cohorts of newly diagnosed acute myeloid leukaemia patients, one registered by the HARMONY Alliance (HA) and one by the Netherlands Cancer Registry (NCR), were compared to the control arm of the randomized HOVON-103 trial (H103 controls). All patients, aged >65 years with a WHO performance score of 0–2 (or missing), received standard induction chemotherapy. 1:1 propensity score calliper matching (PSM) was applied to improve comparability, and overall (OS) and relapse-free survival (RFS) were assessed. Fewer data elements were available in external cohorts compared to H103 controls, specifically in the NCR cohort. Baseline characteristics of the external cohorts differed from H103 controls; missing data were also more frequent and predominantly concerned WHO performance score. After PSM, HA patients demonstrated non-significantly different OS and RFS to H103 controls at 2 years (26 ± 4% vs. 31 ± 5%, p = 0.59; 24 ± 5% vs. 30 ± 6%, p = 0.52), while NCR patients had 12% lower OS (28 ± 4% vs. 40 ± 4%, p = 0.21). Validation of external control cohorts is needed before incorporating RWD control data into comparative analyses, as missing data, specifically comorbidities, and residual confounding may limit comparability.</p
Artificial intelligence for source code understanding tasks:A systematic mapping study
No full textContext: Artificial intelligence (AI) techniques, particularly natural language processing (NLP) and machine learning (ML), are increasingly used to support source code understanding, an essential activity in software engineering. Objective: This systematic mapping study investigates how these techniques are applied, guided by four Research Questions (RQs) focusing on the types of tasks, embedding methods & preprocessing techniques used, machine learning models employed, and existing research gaps. Methods: A review of 227 peer-reviewed studies identifies trends and provides a structured mapping addressing each RQ. Results: The findings reveal a dominant shift toward deep learning, especially transformer-based and graph-based models, highlighting underexplored areas such as explainability. Conclusion: This study provides a task-based classification and offers insights and directions for future research in AI-enabled source code understanding, supporting both researchers and practitioners.</p
No Association Between Vocal Emotion Recognition and Subjective Parental Reporting of Alexithymia in School-Age Children With Hearing Aids
No full textObjectives: Alexithymia is characterized by difficulties in identifying and describing one's own emotions. Alexithymia has previously been associated with deficits in the processing of emotional information at both behavioral and neurobiological levels, and some studies have shown elevated levels of alexithymic traits in adults with hearing loss. This explorative study investigated alexithymia in young and adolescent school-age children with hearing aids in relation to (1) a sample of age-matched children with normal hearing, (2) age, (3) hearing thresholds, and (4) vocal emotion recognition.Design: A translated-to-Turkish version of the Children's Alexithymia Measure (CAM), where higher scores indicate higher levels of alexithymic traits, was filled in by the parents of 37 children (5.5 to 17.8 yr) with bilateral hearing aids and 37 children (5.1 to 18.3 yr) with normal hearing, all native speakers of Turkish. Vocal emotion recognition scores, assessed using the psychophysical vocal emotion recognition test for hearing-impaired populations (EmoHI), were available from a previous study for the group with hearing aids. This test uses non-language-specific pseudospeech sentence recordings expressing three basic emotions: angry, happy, and sad.Results: Parent-reported CAM scores of children with normal hearing (mean = 7.19 ± 6.61) and children with hearing aids (mean = 8.59 ± 4.38) were within the range previously reported for neurotypical children. Group-level comparison showed no statistically significant difference in CAM scores. However, when considering age, CAM scores of children with normal hearing increased as a function of age, while CAM scores of children with hearing aids were not affected by age. Furthermore, for the youngest children up to 8.8 yr, children with hearing aids had significantly higher CAM scores than children with normal hearing. In children with hearing aids, neither unaided nor aided pure-tone audiometric thresholds were significant predictors for CAM scores. Furthermore, the CAM scores and EmoHI scores were not significantly correlated.Conclusions: Although the developmental patterns of parent-reported alexithymia scores as a function of age differed between the sample of children with hearing aids and the sample of children with normal hearing, the group difference was observed only for the youngest participants (<8.8 yr). When collapsed across the full age range, there was no group effect, and for both groups, the parent-reported alexithymia scores were within the ranges previously reported in neurotypical children. For the children with hearing aids, unaided and aided hearing thresholds did not have a predictive value for parent-reported alexithymia scores and there was no significant correlation between the CAM and EmoHI scores. These findings together indicate no elevated levels of alexithymic traits in children with hearing aids, at least for 8.8 yr and older. This is not consistent with previous research with adults with hearing loss, assessed with adult-directed questionnaires via self-report. The difference between our findings with children and earlier results from studies with adults with hearing loss may be due to differing methodologies. Alternatively, alexithymia patterns may be different between children and adults with hearing loss. The lack of alexithymia indications implies that the difficulties in vocal emotion recognition for children with hearing aids may be specific to the perception of auditory information and not related to challenges in the general processing of emotional information.</p
Harnessing nature's blueprint:Unlocking the potential of subcellular structure membrane-coated nanosystems for precision medicine
No full textIn the intricate tapestry of life, subcellular structures stand out as the fundamental building blocks that orchestrate the complexities of cellular function. Collectively, they govern the course of events at the subcellular level and cooperate to maintain cellular physiological functions and homeostasis and they are present in all eukaryotic cells, from the unicellular organisms to the more complex ones. Herein, we aim to explore the cutting-edge, bioinspired brunch of nanotechnology focused on the fabrication of biomimetic nanoparticles consisting of a synthetic core coated with the natural membranes deriving from membrane-bound subcellular organelles. Beyond the well-grounded biomedical evidence on the use of membranes derived from cells, exosomes and bacteria, recent insights have unlocked the potential of the nanosystems mimicking the subcellular intricacy for subcellular-oriented medicine. Despite the recent promising results, several challenges remain in the translation of this technology to the clinical settings. The current lack of standardization, challenging industrial scale-up, immunological concerns, as well as demanding regulatory considerations still remains aspects to be analyzed and discussed, in order to fill the current gap between the research and the clinical application
Defensive reactions to a meat reduction intervention
No full textShifting from meat-centric to plant-based diets can mitigate climate change, improve public health, and reduce animal suffering, among other socially beneficial outcomes. However, efforts to encourage these changes sometimes provoke defensive reactions, and there is limited experimental evidence on how and why such reactions occur. We tested a brief meat reduction intervention in a preregistered experiment with a demographically representative sample of 1070 UK meat-eaters (2 × 2 between-subjects design). The intervention had two components: a reflection prompt encouraging participants to consider how their meat consumption might conflict with environmental concerns, and an action plan prompt offering practical suggestions for reducing meat consumption. The action plan prompt backfired, decreasing willingness to reduce meat consumption and increasing psychological reactance. The reflection prompt also increased reactance. Additional analyses revealed that antisocial tendencies - traits such as low empathy and a lack of concern for the morality of one's actions - were associated with lower willingness to reduce meat consumption, reduced support for plant-based food policies, and greater reactance. These traits also amplified the backfire effects of the intervention, further decreasing willingness and policy support among participants higher in antisocial tendencies. These findings help to link defensive reactions and dispositional traits as barriers to sustainable food transitions.</p
Helmet use in patients with severe traumatic brain injury:associations with Rotterdam CT score components, skull fractures, and cervical fractures
No full textBACKGROUND: Helmet use is widely accepted to reduce head injury severity by absorbing impact forces, but the specific effect on the presence of radiologically detected intracranial injuries remains unclear.OBJECTIVE: To examine the relationship between helmet use and Rotterdam CT score components, craniocervical fractures, and short-term mortality in cyclists and motorcyclists with severe TBI.METHOD: This is a secondary analysis of data from the BRAIN-PROTECT dataset, a prospective observational study of 2,589 subjects with severe traumatic brain injury in the Netherlands. Logistic regression analysis was used, with helmet use as the independent variable, and Rotterdam score components, craniocervical fractures, and 30-day mortality as outcome measures.RESULTS: Among 499 severe TBI patients analyzed (median age 43 years), helmet use significantly reduced epidural mass (OR 0.25, 95% CI 0.10-0.60, p = 0.008) and skull fractures (OR 0.37, 95% CI 0.25-0.56, p = 0.004). However, helmeted patients had higher odds of cervical fractures (OR 2.94, 95% CI 1.74-4.98, p = 0.004), which persisted after adjusting for age and motor GCS component. CONCLUSION: Among patients with severe TBI, those wearing helmets showed epidural mass lesions and skull fractures less frequently, but more often had cervical fractures than those not wearing helmets.</p
Comparative effectiveness of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists for incident dementia:A retrospective multicohort study
No full textOBJECTIVE: This study provides real-world evidence on the comparative effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) regarding the risk of incident dementia in adults with type 2 diabetes mellitus (T2DM).RESEARCH DESIGN AND METHODS: This cohort study utilised electronic health records from TriNetX (1 April 2013 to 31 December 2019). Adults with T2DM on metformin who initiated GLP-1 RAs or SGLT2i were analysed using Cox proportional hazards models in 1:1 propensity score-matched cohorts. The primary outcome was all-cause dementia; secondary outcomes included vascular and Alzheimer's dementia. Confounding variables were adjusted.RESULTS: Among 16 271 participants using GLP-1 RAs and 16 271 using SGLT2i over a median 6.3-year follow-up, 581 GLP-1 RA users and 572 SGLT2i users developed dementia. No significant differences were observed in all-cause dementia (hazard ratio: 1.01, 95% confidence interval: 0.90-1.13), vascular, or Alzheimer's dementia. Subgroup analyses confirmed these findings.CONCLUSIONS: SGLT2i use was not associated with increased risk of dementia compared with GLP-1RAs in patients with T2DM. Further research is warranted to explore the effects of (newer) incretin-based (co-)agonists on cognitive outcomes.</p