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Nevin Manimala Statistics

Social norms in Korsakoff’s syndrome and alcohol-related dementia

J Clin Exp Neuropsychol. 2024 Nov 17:1-10. doi: 10.1080/13803395.2024.2426826. Online ahead of print.

ABSTRACT

OBJECTIVE: Social cognition is essential for individuals to perceive, process, and interpret social information that enables them to function effectively in society. Korsakoff’s syndrome (KS) and alcohol-related dementia (ARD) are alcohol-related cognitive disorders that are likely to impair social cognition. This study aimed to investigate the ability to judge social norms in KS and ARD in comparison to healthy subjects.

METHOD: The study included 30 patients with KS, 10 patients with ARD, and 74 age-, sex-, and education-matched control participants. The Social Norms Questionnaire – Dutch version (SNQ-NL) was used to measure social cognition, and standardized tests were used to examine the association between social cognition and executive functioning.

RESULTS: Both KS and ARD patients performed worse in judging social norms when compared to healthy controls, but there was no significant difference between KS and ARD. Both KS and ARD patients performed worse on the SNQ-NL, judging appropriate behavior as inappropriate (Overadhere errors), than controls. When compared to control participants, patients with KS demonstrated significantly more Break Errors, while the differences between the ARD group and the control group did not reach statistical significance. There were no significant correlations between the SNQ-NL variables and performances on standardized tests for executive functioning in both the KS and control group.

CONCLUSIONS: This study aimed to investigate the ability to judge social norms in KS and ARD in comparison to healthy subjects. The results show that compared to a control group, both KS and ARD patients performed worse in judging social norms. KS and ARD patients scored equally low on social norms identification. Overall, these findings can further help us understand the difficulties in social behavior as experienced by patients and care staff, since problems in accurately judging social norms could possibly contribute to the severe behavioral issues as observed in alcohol-related disorders.

PMID:39550715 | DOI:10.1080/13803395.2024.2426826

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Sicurezza degli integratori alimentari: dagli influencer alle segnalazioni del sistema italiano di fitosorveglianza

Recenti Prog Med. 2024 Nov;115(11):566-567. doi: 10.1701/4365.43605.

ABSTRACT

OBJECTIVES: To assess the safety profile of dietary supplements with a focus on those purchased online or reported via the internet.

RESULTS: Among the 2,367 reports of Adverse Reactions (ARs) to dietary supplements collected within the Italian Phitovigilance System, 49.4% were from citizens and 33.7% from companies. From these we selected 129 reports (6%) in which an online purchase or an adverse reaction retrieved from the web was indicated (e.g. Amazon®). The most frequent ARs referred to the gastrointestinal tract (31.4%) and the central nervous system (17.6%). Nineteen percent were used for sleep disorders and 14% for disturbances of the prostate.

CONCLUSIONS: The Italian Phytovigilance System is the only tool that provides information on the possible risks associated with the use of food supplements purchased online but the quality of the information collected needs to be improved.

PMID:39550666 | DOI:10.1701/4365.43605

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Nevin Manimala Statistics

ChatGPT: una risorsa formativa per gli studenti di medicina italiani?

Recenti Prog Med. 2024 Nov;115(11):556-557. doi: 10.1701/4365.43600.

ABSTRACT

This study evaluated the use of ChatGPT among current and former medical students enrolled at Italian universities. The primary goal was to assess its usage and applications in education. Secondary objectives included gathering opinions and satisfaction levels with ChatGPT for educational purposes. The survey included 208 participants, mainly Italian (95%) and aged 18-23 (76%). Most students were from public universities (62%). Nearly all respondents (99%) knew ChatGPT, and 79% used it for study support. Additionally, 81% consider AI suitable for educational purposes, and 39% positively changed their opinion after using it. While 78% found ChatGPT helpful, limitations like confusion (25%) and accuracy concerns (18%) were noted. Still, 85% found responses accurate, and 89% planned to keep using it, with 81% recommending it to peers. Our findings show ChatGPT is widely used by Italian medical students, despite concerns about accuracy and over-reliance. As we witness the rapid advent and evolution of these tools, it is crucial to consider their attentive and deliberate integration into various aspects of our lives.

PMID:39550661 | DOI:10.1701/4365.43600

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Nevin Manimala Statistics

Il percorso di cura nel fine vita dei pazienti con tumore del sistema nervoso centrale nella Regione Lazio: analisi preliminari

Recenti Prog Med. 2024 Nov;115(11):550-551. doi: 10.1701/4365.43597.

ABSTRACT

This analysis aims to describe the care pathways of patients with central nervous system (Cns) tumors during the last 30 days of life, using relevant indicators retrieved from regional healthcare information system data, compare these indicators with those of patients who died from other solid tumors, and assess the role of socioeconomic position (Sep) in accessing end-of-life care among Cns patients. The study included 2,795 patients who died from Cns tumors between 2015 and 2019. In the last 30 days of life, compared to the solid tumor cohort, Cns patients had less access to emergency services and hospitalizations. Regarding treatments, the percentage of opioid users was significantly lower than that of solid tumor patients. Concerning the role of Sep, Cns patients with a higher Sep were less likely to access the Emergency Room and more likely to receive antitumor. In conclusion, the analysis of administrative databases in epidemiology is essential in order to monitor care pathways targeted at highly vulnerable populations.

PMID:39550658 | DOI:10.1701/4365.43597

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Nevin Manimala Statistics

Aderenza e persistenza come indicatori di esito in tempo reale dei trattamenti farmacologici oncoematologici e il caso degli anti-EGFR in prima linea nello NSCLC

Recenti Prog Med. 2024 Nov;115(11):547-549. doi: 10.1701/4365.43596.

ABSTRACT

For many new oncological drugs, including target therapy and immunotherapy, the treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Drug survival or Time to treatment discontinuation (Ttd) or persistence have become important intermediate efficacy endpoints, especially in real-world settings due to their strong correlation with endpoints such as Time to treatment failure (Ttf) and Progression free survival (Pfs). Our methodology is based on validated indicators and information technology tools, to develop continuous and updated oncology drug utilization reports in hospital setting which include data about enrolment curves, Ttd, adherence, dose intensity, dose changes and budget impact. We present, as real-world example, the case of anti-EGFR in first line NSCLC. We analysed data of first and second generation drugs (afatinib, gefitinib, erlotinib) and the new third generation drug (osimertinib). Median Ttd and adherence as Proportion of days covered (Pdc) were respectively 11.6 versus 23.4 months and 0.92 versus 0.95.

PMID:39550657 | DOI:10.1701/4365.43596

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Transportability of model-based estimands in evidence synthesis

Stat Med. 2024 Sep 30;43(22):4217-4249. doi: 10.1002/sim.10111.

ABSTRACT

In evidence synthesis, effect modifiers are typically described as variables that induce treatment effect heterogeneity at the individual level, through treatment-covariate interactions in an outcome model parametrized at such level. As such, effect modification is defined with respect to a conditional measure, but marginal effect estimates are required for population-level decisions in health technology assessment. For noncollapsible measures, purely prognostic variables that are not determinants of treatment response at the individual level may modify marginal effects, even where there is individual-level treatment effect homogeneity. With heterogeneity, marginal effects for measures that are not directly collapsible cannot be expressed in terms of marginal covariate moments, and generally depend on the joint distribution of conditional effect measure modifiers and purely prognostic variables. There are implications for recommended practices in evidence synthesis. Unadjusted anchored indirect comparisons can be biased in the absence of individual-level treatment effect heterogeneity, or when marginal covariate moments are balanced across studies. Covariate adjustment may be necessary to account for cross-study imbalances in joint covariate distributions involving purely prognostic variables. In the absence of individual patient data for the target, covariate adjustment approaches are inherently limited in their ability to remove bias for measures that are not directly collapsible. Directly collapsible measures would facilitate the transportability of marginal effects between studies by: (1) reducing dependence on model-based covariate adjustment where there is individual-level treatment effect homogeneity or marginal covariate moments are balanced; and (2) facilitating the selection of baseline covariates for adjustment where there is individual-level treatment effect heterogeneity.

PMID:39550630 | DOI:10.1002/sim.10111

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Frequency and clinical associations of common mental disorders in adults with high-grade glioma-A multicenter study

Cancer. 2024 Nov 17. doi: 10.1002/cncr.35653. Online ahead of print.

ABSTRACT

BACKGROUND: One third of adults with cancer suffer from common mental disorders in addition to their malignant disease. However, it is unknown whether this proportion is the same in patients who have brain tumors and which factors modulate the risk for psychiatric comorbidity.

METHODS: In a multicenter study, patients with high-grade glioma at 13 neurooncology clinics were enrolled consecutively and interviewed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) to diagnose common mental disorders. Predictors of psychiatric comorbidity were investigated using binary logistic regression.

RESULTS: Six hundred ninety-one patients were interviewed. The proportion of patients who had mental disorders was 31% (95% confidence interval [CI], 28%-35%). There was evidence for an association of psychiatric comorbidity with the following factors: younger age (odds ratio [OR], 1.9; 95% CI, 1.1-3.4; p = .04), stable disease versus complete remission (OR, 1.7; 95% CI, 1.1-2.8; p = .04), lower income (OR, 1.7; 95% CI, 1.0-2.8; p = .04), living alone (OR, 1.6; 95% CI, 1.0-2.6; p = .05), fatigue (OR, 1.6; 95% CI, 1.1-2.4; p = .03), and impaired cognitive functioning (OR, 2.3; 95% CI, 1.5-3.6; p < .01). There was no evidence for independent effects of gender, histology, affected lobe, time since diagnosis, or employment status.

CONCLUSIONS: Approximately one third of adult patients with high-grade glioma may suffer from a clinically relevant common mental disorder, without notable disparity between the genders. In particular, clinicians should pay attention to possible comorbidities for cases in which patients exhibit compromised subjective cognitive function, are younger than 50 years, maintain a state of stable disease, or live alone.

PMID:39550627 | DOI:10.1002/cncr.35653

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Nevin Manimala Statistics

Statistical operating characteristics of current early phase dose finding designs with toxicity and efficacy in oncology

J Biopharm Stat. 2024 Nov 16:1-21. doi: 10.1080/10543406.2024.2424845. Online ahead of print.

ABSTRACT

Traditional phase I dose finding cancer clinical trial designs aim to determine the maximum tolerated dose (MTD) of the investigational cytotoxic agent based on a single toxicity outcome, assuming a monotone dose-response relationship. However, this assumption might not always hold for newly emerging therapies such as immuno-oncology therapies and molecularly targeted therapies, making conventional dose finding trial designs based on toxicity no longer appropriate. To tackle this issue, numerous early-phase dose finding clinical trial designs have been developed to identify the optimal biological dose (OBD), which takes both toxicity and efficacy outcomes into account. In this article, we review the current model-assisted dose finding designs, BOIN-ET, BOIN12, UBI, TEPI-2, PRINTE, STEIN, and uTPI to identify the OBD and compare their operating characteristics. Extensive simulation studies and a case study using a CAR T-cell therapy phase I trial have been conducted to compare the performance of the aforementioned designs under different possible dose-response relationship scenarios. The simulation results demonstrate that the performance of different designs varies depending on the particular dose-response relationship and the specific metric considered. Based on our simulation results and practical considerations, STEIN, PRINTE, and BOIN12 outperform the other designs from different perspectives.

PMID:39550615 | DOI:10.1080/10543406.2024.2424845

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Nevin Manimala Statistics

Association between varus thrust and foot alignment and flexibility in knee osteoarthritis

Physiother Theory Pract. 2024 Nov 16:1-6. doi: 10.1080/09593985.2024.2428975. Online ahead of print.

ABSTRACT

BACKGROUND: Varus thrust (VT) is a frequently reported abnormal gait pattern in patients with medial knee osteoarthritis (KOA). VT is important to prevent KOA progression. However, there is no consensus on the relationship between VT and foot alignment and flexibility, although it has been reported that patients with KOA have pronated foot.

OBJECTIVE: In this study, we examined the relationship between VT, foot alignment, and flexibility in patients with KOA.

METHODS: Twenty patients with unilateral KOA were included in this study (mean age: 71.5 ± 4.7 years). KOA severity ranged from grade III (8 patients) to grade IV (12 patients) based on the Kellgren-Lawrence classification. Gait analysis using inertial sensors was performed to determine the difference between the VT of KOA side and the contralateral side without symptoms. The correlations between VT, foot alignment, and flexibility were also analyzed.

RESULTS: VT was significantly greater on the side with KOA than on the contralateral side without KOA (d = 1.09, p = .002). VT was not significantly correlated with foot alignment but was significantly correlated with the arch stiffness index, which indicates foot flexibility (r = 0.642, p = .003).

CONCLUSION: This study suggests that foot flexibility may play a more significant role than foot alignment in addressing VT in patients with KOA. When performing physical therapy for VT, evaluating foot flexibility in addition to foot alignment may help reduce this condition. Further studies with larger sample sizes and more detailed statistical analyses are needed to validate these findings.

PMID:39550614 | DOI:10.1080/09593985.2024.2428975

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Latent class analysis of post-acute sequelae of SARS-CoV-2 infection

J Biopharm Stat. 2024 Nov 16:1-16. doi: 10.1080/10543406.2024.2424844. Online ahead of print.

ABSTRACT

Symptoms post-SARS-CoV-2 infection may persist for months and cause significant impairment and impact to quality of life. Acute symptoms of SARS-CoV-2 infection are well studied, yet data on clusters of symptoms over time, or post-acute sequelae of SARS-CoV-2 infection (PASC), are limited. We aim to characterize PASC phenotypes by identifying symptom clusters over a six-month period following infection in individuals vaccinated (boosted and not) and those unvaccinated. Subjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between January and April 2022. Patient-reported outcomes symptoms, health-related quality of life (HRQoL), work productivity and activity impairment (WPAI) were captured at 1 month, 3 months, and 6 months post-acute infection. Phenotypes of PASC were determined based on subject matter knowledge and balanced consideration of statistical criteria (lower AIC, lower BIC, and adequate entropy) and interpretability. Generalized estimation equation approach was used to investigate relationship between QoL, WPAI and number of symptoms and identified phenotypes, and relationship between phenotypes and vaccination status as well. LCA identified three phenotypes that are primarily differentiated by number of symptoms. These three phenotypes remained consistent across time periods. Subjects with more symptoms were associated with lower HRQoL, and worse WPAI scores. Vaccinated individuals were more likely to be in the low symptom burden latent classes at all time points compared to unvaccinated individuals.

PMID:39550613 | DOI:10.1080/10543406.2024.2424844