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Regret in Clinical Trial Participation Among Cancer Patients

J Palliat Med. 2024 Nov 28. doi: 10.1089/jpm.2024.0147. Online ahead of print.

ABSTRACT

Background: This analysis examined regret from participation in cancer clinical trials (CCT) and explored associations between regret and symptom burden, symptom bother, therapeutic optimism, and the importance of spiritual beliefs. Methods: This is a secondary analysis of cross-sectional data from a study of American CCT patient-participants conducted from 2015 to 2019. Descriptive statistics, bivariate associations, and logistic regression were used to evaluate regret in this sample (n = 325). Results: About 10% of the sample reported regret. Younger age, increased symptom burden, increased symptom bother, increased severe symptoms, and a lower level of therapeutic optimism were significantly associated with regret (p < 0.05) compared to those who did not experience regret. The final regression model identified that younger age, symptom burden, and therapeutic optimism significantly predicted regret (p < 0.05). Conclusions: Understanding regret among research participants may improve CCT retention and ensure ethical research practices. Symptom experiences may play a key role in experiences of regret in CCT participation.

PMID:39607718 | DOI:10.1089/jpm.2024.0147

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Occlusal outcome of orthodontic treatment: a systematic review with meta-analyses of randomized trials

Eur J Orthod. 2024 Dec 1;46(6):cjae060. doi: 10.1093/ejo/cjae060.

ABSTRACT

BACKGROUND: Several appliances or treatment protocols are marketed to either patients or orthodontists as being associated with improved orthodontic outcomes. However, clinical decision-making should be based on robust scientific evidence and not marketing claims or anecdotal evidence.

OBJECTIVE: To identify appliances/protocols being associated with improved outcomes of fixed appliance treatment.

SEARCH METHODS: Unrestricted literature searches in seven databases/registers for human studies until March 2024.

SELECTION CRITERIA: Randomized or quasi-randomized clinical trials on human patients of any age, sex, or ethnicity receiving comprehensive orthodontic treatment with fixed appliances and assessing occlusal outcome with either the Peer Assessment Rating (PAR) or the American Board of Orthodontics-Objective Grading System (ABO-OGS) index.

DATA COLLECTION AND ANALYSIS: Duplicate/independent study selection, data extraction, and risk of bias assessment with the Cochrane RoB 2 tool. Random-effects meta-analyses of averages or mean differences with their 95% Confidence Intervals (CI), followed by meta-regression/subgroup/sensitivity analyses and assessment of the quality of clinical recommendations with the Grades of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

RESULTS: Data from 20 small- to moderately-sized trials covering 1470 patients indicated that orthodontic treatment with fixed appliances is effective and results on average in a final PAR score of 6.0 points (95% CI 3.9-8.2 points), an absolute PAR reduction of 23.0 points (95% CI 15.6-30.4 points), a % PAR reduction of 82.6% (95% CI 70.8%-94.4%), and an absolute ABO-OGS score of 18.9 points (95% CI 11.7-26.2 points). However, very high between-study heterogeneity (I2 > 75%) was seen for both PAR and ABO-OGS. Extraction treatment was associated with significantly better occlusal outcome than non-extraction treatment with ABO-OGS (12.9 versus 16.6 points; P = .02). There was no statistically significant difference in occlusal outcome with (i) 0.018″-slot or 0.022″-slot brackets; (ii) customized or prefabricated brackets; (iii) anchorage reinforcement with temporary anchorage devices; (iv) use of vibrational adjuncts; and (v) aligners or fixed appliances (P > .05 in all instances), while small benefits were seen with indirectly bonded brackets.

CONCLUSIONS: Considerable between-study heterogeneity exists in the reported occlusal outcome of fixed appliance treatment, and different appliances or adjuncts have little effect on this. Standardization and/or automatization of the scoring procedures for PAR and ABO-OGS might help to improve consistency and reliability of outcome measurement in orthodontic trials.

REGISTRATION: PROSPERO (CRD42024525088).

PMID:39607678 | DOI:10.1093/ejo/cjae060

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Impact of antibiotic treatment duration for preoperative asymptomatic bacteriuria, during urological surgery, on postoperative infectious complications: results from the multicentric TOCUS cohort

Minerva Urol Nephrol. 2024 Nov 28. doi: 10.23736/S2724-6051.24.05725-2. Online ahead of print.

ABSTRACT

BACKGROUND: According to the European guidelines, any urological surgery breaching the mucosa requires preoperative screening and antibiotic treatment of any asymptomatic bacteriuria (ABU).

METHODS: The aim of this study was to determine whether the preoperative antibiotic treatment duration of ABU in urological surgery impact postoperative infectious complications. National multicenter, retrospective study including all consecutive patients screened for ABU before urologic surgery in 10 centers from 1st April 2019 to April 2023. The primary endpoint was all postoperative infectious complications occurring within 30 days after surgery. Short antibiotic treatment (SAT) of ABU was defined by 5- day regimen or less. Long antibiotic treatment (LAT) was defined by duration longer than 5 days.

RESULTS: Among the 2389 patients included, 839 (35.1%) patients had positive urine culture (UC), of whom 546 (65%) had positive mono or bimicrobial UC and 292 (34.8%) polymicrobial UC. There were 106 (4.4%) postoperative infectious complications occurring within 30 days including 62 (58.5%) in the positive UC group. In the positive UC group, 336 (40%) had received SAT, 261 (31.1%) LAT and 231 (27.5%) had not received any treatment. The 30-day surgery-related infection rates were 8.3%, 6.1% and 7.36% respectively. There was no statistical difference between SAT versus LAT in the univariate analysis (P=0.6) or in the multivariate analysis OR 1.97 [0.37, 1.86] (P=0.06).

CONCLUSIONS: Our results found no association between antibiotic treatment duration and urinary infectious complication among patients with preoperative ABU who undergo urological surgery. These results need a RCT to be confirmed.

PMID:39607671 | DOI:10.23736/S2724-6051.24.05725-2

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Inhibition of CHI3L1 decreases N-cadherin and VCAM-1 levels in glioblastoma

Pharmacol Rep. 2024 Nov 14. doi: 10.1007/s43440-024-00677-3. Online ahead of print.

ABSTRACT

The protein CHI3L1 contributes to cancer development by several mechanisms, including stimulation of angiogenesis and invasion as well as immunomodulatory effects. These properties make it a potential target for the development of targeted therapies in precision medicine. In this context, the particular potential of CHI3L1 inhibition could be considered in glioblastoma multiforme (GBM), whose tumors exhibit high levels of angiogenesis and increased CHI3L1 expression. This study aims to investigate whether inhibition of CHI3L1 in spheroids used as a GBM model affects the mechanisms of invasiveness; METHODS: We analyzed the interactions between CHI3L1 and the inhibitor G721-0282 in molecular docking and molecular dynamics (in silico) and infrared spectroscopy. Uptake of G721-0282 in GBM spheroids was measured using a label-free physical cytometer. Changes in E-, N- and VE-cadherins, VCAM-1, and EGFR were analyzed by immunohistochemical reactions, Western blot, and ddPCR methods in U-87 MG cells and GBM spheroids consisting of U-87 MG glioblastoma cells, HMEC-1 endothelial cells and macrophages; RESULTS: A direct interaction between CHI3L1 and G721-0282 was confirmed. G721-0282 decreased N-cadherins and VCAM-1 in GBM spheroids, but the changes in the 2D model of U-87 MG glioblastoma cells were different; CONCLUSION: Inhibition of CHI3L1 has the potential to reduce the invasiveness of GBM tumors. The 3D model of GBM spheroids is of great significance for investigating changes in membrane proteins and the tumor microenvironment.

PMID:39607670 | DOI:10.1007/s43440-024-00677-3

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AARC score and urine NGAL predict terlipressin non-response and mortality in patients with acute-on-chronic liver failure

Hepatol Int. 2024 Nov 28. doi: 10.1007/s12072-024-10749-4. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Acute-on-chronic liver failure (ACLF) patients with hepatorenal syndrome (HRS-AKI) have limited response to vasoconstrictors and worse outcomes, requiring biomarkers for early detection.

METHODS: In a prospective cohort of ACLF patients (n = 240), urine NGAL was performed in patients with the clinical diagnosis of HRS-AKI, while in a subset of patients (n = 30), a complete panel of 17 urinary biomarkers was assessed for identifying terlipressin non-response (T-NR).

RESULTS: ACLF patients with HRS-AKI, aged 45.84 ± 10.6 years, 91.2% males, 74.2% with alcohol etiology, mean urine NGAL of 1541.66 ± 1684.69 ng/ml, AARC score 10.19 ± 1.86, 155 (64.5%) had T-NR at day 4. T-NR was maximal for AARC grade 3 and was associated with a higher need of dialysis (50.3% vs 5.9%; OR 16.21, 6.23-42.19) and 28-day mortality (49.0% vs. 17.9%; HR 3.42, 1.96-5.95). AARC grade 3 (OR 38.21, 2.93-497.74), (HR 5.10, 1.19-21.84) and urine NGAL (OR 11.53, 5.66-23.49; AUROC 0.97, NGAL > 900 ng/ml) (HR 1.23, 1.02-1.49) were independent predictors of T-NR and 28-day mortality, respectively. It was interesting to observe a significant elevation in renal injury and a decrease in the repair markers in T-NR (p < 0.05).

CONCLUSION: Almost 60% of patients with ACLF and HRS-AKI experience non-response to terlipressin which predicts higher mortality and need for dialysis. High NGAL above 900 ng/ml predicts T-NR with 100% specificity for T-NR. ACLF patients with HRS, with AARC grade 3 and high NGAL have a high likelihood of T-NR and should be considered for alternative therapeutic modalities.

PMID:39607651 | DOI:10.1007/s12072-024-10749-4

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Prediction of cerebral infarction after bypass surgery in adult moyamoya disease: combing parameters on 4D perfusion CT with clinical related factors

Acta Neurochir (Wien). 2024 Nov 28;166(1):484. doi: 10.1007/s00701-024-06373-8.

ABSTRACT

OBJECTIVE: This study aimed to identify predictive factors for cerebral infarction after bypass surgery in adult patients with moyamoya disease (MMD) using quantitative parameters in 4D-CT perfusion software.

METHODS: A total of 108 patients who underwent combined revascularization, including superficial temporal artery-middle cerebral artery (STA-MCA) anastomosis and encephalo-duro-myo-synangiosis (EDMS), in our hospital between September 2019 and August 2023 were analyzed retrospectively. Preoperative relative cerebral blood flow (rCBF), relative cerebral blood volume (rCBV), relative mean transit time (rMTT), and relative time to maximum residual function (rTmax) perfusion parameters were obtained using 4D-CT perfusion software. These quantitative parameters, combined with related clinical and angiographic factors, were statistically analyzed using univariate and multivariate regression analyses to determine the significant predictors of cerebral infarction after bypass surgery.

RESULTS: Acute cerebral infarction occurred in 12 patients postoperatively. Univariate analysis showed that a history of previous ischemic events (P = 0.024), higher Suzuki stage (P = 0.006), higher modified Rankin score (mRS) (P = 0.013), rCBV (P = 0.026), rMTT (P = 0.001), and rTmax (P < 0.001) were associated with postoperative cerebral infarction. Further multivariate regression analysis showed that a history of previous ischemic events (OR = 12.830, 95%CI = 1.854-875.672, P = 0.031) and higher rTmax (OR = 16.968, 95%CI = 2.035-141.451, P = 0.009) were independently associated with new postoperative cerebral infarction. The cutoff value for rTmax was 2.025 (AUC = 0.935).

CONCLUSIONS: Previous ischemic event history and rTmax greater than 2.025 are independent risk factors for predicting cerebral infarction after combined revascularization with high sensitivity in adult patients with MMD. These patients should be more cautious when deciding on combined revascularization.

PMID:39607649 | DOI:10.1007/s00701-024-06373-8

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Beyond Borders, Beyond Bias: Unveiling Medical Xenophobia Among Resident Physicians in Türkiye

J Immigr Minor Health. 2024 Nov 28. doi: 10.1007/s10903-024-01658-7. Online ahead of print.

ABSTRACT

Xenophobia among healthcare professionals can significantly impact the quality of care provided to immigrant and refugee populations, particularly in countries with high influxes such as Türkiye. This study evaluated xenophobia among resident physicians at Pamukkale University Hospital and identified factors influencing these attitudes. This cross-sectional study involving 271 resident physicians at Pamukkale University Hospital was conducted between August 1 and August 20, 2022. The participants were randomly selected and stratified by department. Data were collected via a 38-item questionnaire, including the 11-item Xenophobia Scale. Descriptive statistics, the Mann‒Whitney U test, the Kruskal‒Wallis test, and multiple linear regression analysis were used for data analysis. The mean xenophobia scale score among participants was 57.53 (SD = 7.82), indicating high levels of xenophobic attitudes. The significant factors associated with higher xenophobia scores included being from a surgical department (B = 0.571, p < 0.001) and lacking foreign nationals in their close environment (B = 0.724, p < 0.001). Additionally, 58.7% of the resident physicians opposed providing free healthcare services to refugees, and 10.0% indicated that they might delay providing health services to these patients because of their status. Additionally, 7.7% of the resident physicians admitted to discriminating against migrant/refugee patients. The study reveals pervasive xenophobic attitudes among resident physicians in Türkiye, which are influenced by departmental affiliation and the social environment. These findings underscore the need for targeted interventions to address xenophobia in healthcare settings, including cultural competence training and policy changes, to ensure equitable healthcare access for all patients.

PMID:39607644 | DOI:10.1007/s10903-024-01658-7

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Immunotherapy Following Anaplastic Lymphoma Kinase Inhibitor Therapy for Patients with Anaplastic Lymphoma Kinase‑Positive Non‑small Cell Lung Cancer in Japan

Target Oncol. 2024 Nov 28. doi: 10.1007/s11523-024-01116-2. Online ahead of print.

ABSTRACT

BACKGROUND: Although anaplastic lymphoma kinase inhibitors (ALKis) are the effective initial treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), most patients experience resistance to ALKis, leading to the need for alternative therapies. Immune checkpoint inhibitors (ICIs) are a standard NSCLC treatment. On the other hand, their efficacy remains unclear for ALK-positive NSCLC.

OBJECTIVE: We aim to describe the treatment patterns and treatment outcomes for patients with ALK-positive NSCLC receiving later-line ICI treatment.

METHODS: This retrospective cohort study used claims data from Japanese acute care hospitals and included patients with lung cancer (International Classification of Diseases, 10th version (ICD-10), code: C34) diagnosed between 1 December 2015 and 31 January 2023. We extracted patients who received ALKis as first-line therapy and subsequent lines of treatment. Patient characteristics and treatment patterns and durations were descriptively summarized. Time to treatment discontinuation (TTD) for ICIs was examined using Kaplan-Meier estimates.

RESULTS: Of 478 patients who received ALKi as first-line treatment, 30 received ICIs, 249 ALKis, and 154 non-ICI/ALKi therapy as second-line treatment. Most patient characteristics showed no differences among the groups. ICIs were more likely to be administered to patients who underwent shorter durations of ALKi treatment. The median TTD for ICIs was 66 days, with a 1 year TTD rate of 13%.

CONCLUSIONS: Given the rarity of ALK-positive NSCLC, this study contributes to add evidence through an expanded database and increased sample size, supporting previous suggestions that ICIs have limited effectiveness in patients positive for ALK.

PMID:39607635 | DOI:10.1007/s11523-024-01116-2

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Correction: Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study)

Gastric Cancer. 2024 Nov 28. doi: 10.1007/s10120-024-01570-x. Online ahead of print.

NO ABSTRACT

PMID:39607631 | DOI:10.1007/s10120-024-01570-x

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Normative values of the brief international cognitive assessment for multiple sclerosis (BICAMS) in an Italian young adolescent population: the influence of age, sex, and education

Neurol Sci. 2024 Nov 28. doi: 10.1007/s10072-024-07900-2. Online ahead of print.

ABSTRACT

BACKGROUND: The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is the most widely used in clinical practice and the least time-consuming battery to estimate cognitive function in adults with Multiple Sclerosis (MS), while it has been included in few studies on young MS, also because of the absence of normative values.

OBJECTIVE: The aim of this study is to evaluate the impact of age, sex and education on BICAMS scores in a young adolescent population.

METHODS: We administered the BICAMS to 169, 11-to-18-year-old, healthy subjects. Linear regression models were used to assess the impact of age, sex, and education on sub-test scores. When statistically significant (p < 0.05), we used the regression coefficient to correct the raw scores.

RESULTS: younger age was associated with worse performance on SDMT (β = 1.76; p < 0.05), CVLT-II (β = 3.33; p < 0.05) and BVMT-R (β = 0.62; p < 0.05). Female sex was associated SDMT (β = 2.75 (p < 0.05) and CVLT-II (β = 2.51 (p < 0.05). Educational attainment was associated with better performance on SDMT (β = 1.79 (p = < 0.05) and BVMT-R (β = 0.61; p < 0.05). Cut-off points were suggested at the 5th lowest percentile.

CONCLUSION: Age, sex, and education must be accounted for when applying the BICAMS to young population. Its use in everyday assessment of patients with Pediatric Onset Multiple Sclerosis (POMS) could help to compare and combine data across centers, identifying patients requiring a comprehensive evaluation and ad hoc cognitive stimulation programs.

PMID:39607616 | DOI:10.1007/s10072-024-07900-2