Tag: pubmed

Biom J. 2025 Oct;67(5):e70072. doi: 10.1002/bimj.70072.

ABSTRACT

Phase I dose escalation trials in oncology generally aim to find the maximum tolerated dose. However, with the advent of molecular-targeted therapies and antibody drug conjugates, dose-limiting toxicities are less frequently observed, giving rise to the concept of optimal biological dose (OBD), which considers both efficacy and toxicity. The estimand framework presented in the addendum of the ICH E9(R1) guidelines strengthens the dialogue between different stakeholders by bringing in greater clarity in the clinical trial objectives and by providing alignment between the targeted estimand under consideration and the statistical analysis methods. However, there is a lack of clarity in implementing this framework in early-phase dose optimization studies. This paper aims to discuss the estimand framework for dose optimization trials in oncology, considering efficacy and toxicity through utility functions. Such trials should include pharmacokinetics data, toxicity data, and efficacy data. Based on these data, the analysis methods used to identify the optimized dose/s are also described. Focusing on optimizing the utility function to estimate the OBD, the population-level summary measure should reflect only the properties used for estimating this utility function. A detailed strategy recommendation for intercurrent events has been provided using a real-life oncology case study. Key recommendations regarding the estimand attributes include that in a seamless phase I/II dose optimization trial, the treatment attribute should start when the subject receives the first dose. We argue that such a framework brings in additional clarity to dose optimization trial objectives and strengthens the understanding of the drug under consideration, which would enable the correct dose to move to phase II of clinical development.

PMID:40931383 | DOI:10.1002/bimj.70072

Wounds. 2025 Aug;37(8):283-291.

ABSTRACT

BACKGROUND: To estimate the prevalence of biofilms in chronic wounds.

METHODS: The authors performed a systematic review of prevalence studies and meta-analysis, structured according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Articles were searched in Scopus (Elsevier), Web of Science (Clarivate), MEDLINE/PubMed (National Institutes of Health), and Embase (Elsevier) databases. Data collected included the author and year of publication, total number of lesions evaluated, number of lesions with biofilm, detected bacteria, biofilm levels, country where the research was conducted, and the methodological quality of the studies. The meta-analysis was performed using a random effects model in R software (The R Foundation for Statistical Computing).

RESULTS: A total of 281 articles were retrieved; after applying the reading and exclusion criteria, 24 studies were included. The meta-analysis incorporated 24 studies from 12 countries, evaluating 2666 lesions with a biofilm prevalence of 68% (95% CI, 58%-79%; I² = 92%). A high prevalence was observed in Asian publications (73%; 95% CI, 62%-84%; I² = 98%), with of Staphylococcus aureus (71%; 95% CI, 51%-90%; I² = 98%) and Pseudomonas aeruginosa (65%; 95% CI, 47%-82%; I² = 98%) being the most common found in all publications.

CONCLUSIONS: Despite the methodological heterogeneity of the studies included in this review, the findings indicate a high prevalence of biofilms in chronic wounds presented in the studies that made up the sample.

PMID:40931368

BMC Emerg Med. 2025 Sep 10;25(1):180. doi: 10.1186/s12873-025-01344-3.

ABSTRACT

BACKGROUND: Identifying suspected anterior circulation large-vessel occlusion (aLVO) strokes during emergency calls could enhance dispatch efficiency, particularly in rural areas. However, data on emergency medical dispatchers’ (EMDs) ability to recognize aLVO symptoms remain limited. This simulation study aimed to evaluate the feasibility of identifying side-specific arm paresis, side-specific conjugate eye deviation (CED), and aphasia during emergency calls by instructing layperson callers to perform brief, standardized examination steps. Two communication methods were compared: (1) telephone calls and (2) video calls.

METHODS: Forty-eight laypersons interacted with simulated patients presenting various stroke syndromes. Simulated EMDs conducted standardized assessments during simulated emergency calls, guiding laypersons through patient examinations.

RESULTS: In 96 telephone-assisted and 95 video-assisted calls, EMDs identified aLVO stroke symptoms with high accuracy. In telephone calls, accuracy was 0.92 for side-specific arm paresis, 0.98 for side-specific CED, and 0.88-0.99 for aphasia. In video calls, accuracy was 0.97 for side-specific arm paresis, 0.97 for side-specific CED, and 0.94-1.00 for aphasia.

CONCLUSIONS: These findings suggest that EMDs can identify stroke symptoms indicative for aLVO via both telephone and video calls using a standardized dispatch protocol to guide lay bystanders. This study provides a foundation for future real-world research on implementing aLVO detection protocols in emergency dispatch.

PMID:40931358 | DOI:10.1186/s12873-025-01344-3

Parasit Vectors. 2025 Sep 10;18(1):369. doi: 10.1186/s13071-025-07023-3.

NO ABSTRACT

PMID:40931344 | DOI:10.1186/s13071-025-07023-3

BMC Nurs. 2025 Sep 10;24(1):1167. doi: 10.1186/s12912-025-03835-x.

ABSTRACT

BACKGROUND: Organizational virtuousness and just culture, which both foster justice, honesty, and trust, have a major impact on positive work environments in the healthcare industry. Strengthening nurses’ emotional engagement and vocational commitment requires these components. With an emphasis on the mediating function of just culture, this study attempts to investigate the relationship between organizational virtuousness and nurses’ vocational commitment.

METHODS: This study used a descriptive correlational design that was informed by the STROBE checklist. A non-probability convenience sample from Alexandria Main University Hospital was chosen following accepted structural equation modeling (SEM) principles to guarantee sufficient statistical power and trustworthy parameter estimation. A sample of 400 nurses was considered adequate due to the model’s moderate complexity, the use of 61-item measurement methods, and the inclusion of several latent variables. Three validated tools-the Just Culture Survey, the Occupational Commitment Survey, and the Organizational Virtuousness Scale-were used to gather data.

RESULTS: According to linear regression analysis, nurses’ occupational commitment was significantly predicted by both organizational virtuousness and just culture, which together accounted for 15.5% of the variation. Organizational virtuousness was a significant positive predictor (B = 0.220), meaning that occupational commitment rose by 0.220 units for every unit rise in perceived virtuousness. The greatest predictor was only culture (B = 0.352, β = 0.342, t = 7.207, p < 0.001, 95% CI [0.256, 0.448]), underscoring its crucial influence on commitment. These results highlight the value of open, equitable workplace cultures and moral organizational climates in raising nurses’ levels of professional engagement. These correlations were further validated by the structural equation model, which showed good model fit (GFI = 0.961, AGFI = 0.941, RMSEA = 0.069).

CONCLUSIONS: Nurses’ commitment to their work is strengthened by an organization’s moral character and fair culture. These elements improve trust, engagement, and emotional involvement by creating a courteous, moral, and encouraging work atmosphere. In healthcare contexts, fostering such cultural values improves employee retention, productivity, and overall organizational resilience.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:40931338 | DOI:10.1186/s12912-025-03835-x

Exp Appl Acarol. 2025 Sep 10;95(3):37. doi: 10.1007/s10493-025-01059-x.

ABSTRACT

The phytoseiid mite, Neoseiulus longispinosus (Evans) is considered as one of the effective biological control agents against the tetranychid mites in the Indian subcontinent. This predator can be effectively utilized to manage the two-spotted spider mite, Tetranychus urticae Koch under protected conditions. Carnation holds a significantly important position as cut flower crop in India as well as throughout the world. In this study, the biology and population growth parameters of predatory mite were studied against three different stages of T. urticae on three different cultivars of carnation viz., Kleos, Bizet and Baltico. The predator was able to complete its life cycle on all the offered stages of the prey and on all the three cultivars. The results indicated that the biology was not much affected by the different cultivars. However, the cultivar Bizet was found to be slightly better for the development of the predatory mite as the maximum fecundity (62.26 eggs/female) was recorded on this cultivar. Although numerically higher fecundity was observed on Bizet, no statistically significant superiority was found. Among the different stages of prey fed to the predator i.e., egg, protonymph and deutonymph, the predator showed better biology and population growth parameters on egg stage compared to both protonymphal and deutonymphal stages of T. urticae.

PMID:40931302 | DOI:10.1007/s10493-025-01059-x

Clin Rheumatol. 2025 Sep 10. doi: 10.1007/s10067-025-07679-3. Online ahead of print.

ABSTRACT

OBJECTIVE: Systemic sclerosis (SSc) is a complex autoimmune connective tissue disease. Genetic factors may play a pivotal role in determining susceptibility to these disorders. HLA associations with SSc, especially HLA class II, were investigated in different populations but not in Tunisia. Our aim was to study HLA profile in South Tunisian patients with SSc.

METHODS: We conducted a case-control study on 19 SSc patients and 123 healthy controls. HLA class I (HLA-A and -B) typing was performed using a microlymphocytotoxicity complement-dependent technique followed by polymerase chain reaction sequence specific primer (PCR-SSP). HLA class II DRB1/DQB1 of all patients and controls was genotyped using the PCR-SSP technique. Statistical analysis was performed using SPSS software and R language.

RESULTS: Nineteen SSc patients and 123 healthy controls were included. The HLA-DRB1*11 was associated with the genetic susceptibility to SSc (corrected p-value (pc) = 0.005; OR = 5.56; 95% CI = [2-15.4]). The HLA-DQB1*03:01 had also increased the risk of SSc in our study (pc = 0.002; OR = 5.9; 95% CI = [2-16.8]). Concerning HLA class I typing, we found a significant association between HLA-B53 and SSc (pc = 0.01; OR = 9; 95% CI = [2.53-31.99]). The association of HLA-B53 was independent of HLA-DRB1*11 in binary logistic regression test (HLA-B53: p = 0.01; HLA-DRB1*11: p = 0.008). Concerning the haplotype study, a significant difference in the distribution of the haplotype B53-DRB1*11 was found between patients and controls (13.15% in SSc patients vs. 0.8% in controls; p = 1.33 10^-5; HaploScore = 4.35).

CONCLUSION: Our results showed that in South Tunisia SSc is associated with HLA-DRB1*11 and DQB1*03:01 alleles. A susceptibility to SSc was found in positive HLA-B53 patients. This association of HLA alleles with SSc needs further study. Key Points •HLA-DR and DQ alleles represent the most common associations reported in Systemic Sclerosis (SSc). •In this study, in addition to the known association with HLA-DRB1*11, we identified an association with HLA-B53 in a cohort of 19 South Tunisian patients.

PMID:40931287 | DOI:10.1007/s10067-025-07679-3

Obes Surg. 2025 Sep 10. doi: 10.1007/s11695-025-08244-2. Online ahead of print.

ABSTRACT

BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are common bariatric procedures that lead to substantial and sustained weight loss. Although both procedures induce hormonal and physiological effects, RYGB includes both a restrictive and malabsorptive component due to anatomical rerouting, whereas SG is considered primarily restrictive. This study aimed to quantify differences in energy and fat absorption between both procedures using near-infrared spectroscopy (NIRS).

METHODS: Female patients, 12-24 months post-RYGB or SG, followed a strictly controlled, tailor-made diet for 6 days. Faecal samples collected over the final 3 days were analysed using NIRS to assess energy and fat malabsorption. Physical activity and stool consistency were also evaluated.

RESULTS: Twenty-nine patients were initially included; one RYGB patient was excluded due to implausibly high reported energy intake leaving 14 RYGB and 14 SG patients. We found higher (p = 0.03) malabsorption in patients after RYGB (194.8 malabsorbed kcal, 13.2%) as compared to patients after SG (111.7 malabsorbed kcal, 7.6%). Furthermore, in the RYGB group, malabsorbed fat was higher (p = 0.01) with 9.7 g (15.4%) malabsorbed as compared to 3.9 g (6.1%) malabsorbed in SG. Even when adjusting for percentage weight loss, both differences remained statistically significant.

CONCLUSION: Fat and energy malabsorption are significantly higher following RYGB compared to SG, and NIRS proves to be a feasible method for assessing these differences. However, the differences are relatively modest and do not appear to be directly proportional to the reduction in functional intestinal length exposed to nutrients.

PMID:40931276 | DOI:10.1007/s11695-025-08244-2

J Cancer Res Clin Oncol. 2025 Sep 10;151(9):253. doi: 10.1007/s00432-025-06295-7.

ABSTRACT

PURPOSE: Next-generation sequencing (NGS) has revolutionized cancer treatment by enabling comprehensive cancer genomic profiling (CGP) to guide genotype-directed therapies. While several prospective trials have demonstrated varying outcomes with CGP in patients with advanced solid tumors, its clinical utility in colorectal cancer (CRC) remains to be evaluated.

METHODS: We conducted a prospective observational study of CGP in our hospital between September 2019 and March 2024. Overall survival (OS) of the patients who received CGP-based therapy and those did not was compared, and genomic variables associated with OS were evaluated.

RESULTS: A total of 100 patients with CRC underwent CGP using four platforms. The median patient age was 67 years, and most had a good performance status. The most frequent genomic alterations were TP53 (82%), APC (82%), and KRAS (55%). Actionable mutations such as ERBB2 amplification and BRAF V600E were identified in some patients, and 9% received CGP-based therapy, including immune checkpoint inhibitors for tumor mutational burden-high or microsatellite instability-high tumors. Patients receiving CGP-based therapy had longer OS from expert panel discussion (16.0 vs. 10.8 months) compared to those who did not. Alterations in TP53, SMAD4, and NF1 were associated with worse OS. Interestingly, PTEN mutations were linked to improved survival. TP53 alterations were more common in left-sided CRC.

CONCLUSION: Although some patients with CRC received CGP-guided therapy, a statistically significant survival benefit was not observed. However, TP53 and SMAD4 mutations were identified as negative prognostic markers, indicating their potential as targets for future drug development.

PMID:40931253 | DOI:10.1007/s00432-025-06295-7

J Relig Health. 2025 Sep 10. doi: 10.1007/s10943-025-02445-w. Online ahead of print.

ABSTRACT

The study was conducted to investigate the religious coping and psychological resilience levels of women survivors of the earthquake living in temporary shelters after the devastating earthquakes that struck southern and eastern Turkey in 2023. In this cross-sectional study conducted between July 24, 2024, and September 24, 2024, 386 women living in a temporary shelter in a province in the eastern part of Turkey were included. Data were collected using the Personal Information Form, Religious Coping Scale, and Brief Resilience Scale. In the analysis of the data, descriptive statistics, independent samples t test, Mann-Whitney U test, ANOVA test, Kruskal-Wallis test, and Pearson correlation test were used. The findings indicated that statistically significant differences were determined between the scores the participating women obtained from the overall Positive Religious Coping Subscale of the Religious Coping Scale in terms of the variables such as age, education level, marital status, perceived income level, having living children, presence of a chronic disease, their views on the disaster they were struck by, and their perspectives on the future after the earthquake (p < .05). Statistically significant differences were determined between the scores the participating women obtained from the overall Brief Resilience Scale in terms of the variables such as post-earthquake changes in their sleep pattern and future perspectives (p < .05). There was a statistically significant weak negative relationship between the mean scores the participating women obtained from the Negative Religious Coping subscale of the Religious Coping Scale and the mean scores they obtained from the Brief Resilience Scale (p < .05). The participating women’s psychological resilience levels decreased as their negative religious coping levels increased.

PMID:40931237 | DOI:10.1007/s10943-025-02445-w