Category: Nevin Manimala

Med J Aust. 2024 Nov 18;221(10):546-553. doi: 10.5694/mja2.52511.

ABSTRACT

OBJECTIVE: To evaluate the management in Victorian general practice of people who have been hospitalised with stroke or transient ischaemic attacks (TIA).

STUDY DESIGN: Retrospective observational study; analysis of linked Australian Stroke Clinical Registry (AuSCR) and general practice data.

SETTING: 383 general practices in the Eastern Melbourne, South Eastern Melbourne, and Gippsland primary health networks (Victoria), 1 January 2014 – 31 December 2018.

PARTICIPANTS: Adults who had been hospitalised with acute stroke or TIA and had at least two encounters with the same general practice during the observation period (7-18 months after the acute event).

MAIN OUTCOME MEASURES: Assessment of cardiometabolic risk factors (blood pressure, serum lipids, blood glucose, urinary protein); prescribing of guideline-recommended prevention medications (blood pressure-, lipid-, or glucose-lowering, antithrombotic agents); attainment of guideline targets for cardiometabolic risk factors at final assessment during observation period.

RESULTS: During 2014-2018, 3376 eligible AuSCR registrants (1465 women, 43.4%) had at least two encounters with one of the 383 general practices during the observation period; median age at stroke onset was 73.9 (interquartile range, 64.4-81.9) years, 737 events were TIAs (21.8%). Blood pressure was assessed in 2718 patients (80.5%), serum lipids in 1830 (54.2%), blood glucose in 1708 (50.6%). Prevention medications were prescribed for 2949 patients (87.4%), including lipid-lowering (2427, 71.9%) and blood pressure-lowering agents (2363, 70.0%). Blood glucose targets had been achieved by 1346 of 1708 patients assessed for this risk factor (78.8%), blood pressure targets by 1935 of 2717 (71.2%), and serum lipid targets by 765 of 1830 (41.8%). The incidence of having risk factors assessed was lower among patients aged 60 years or younger (incidence rate ratio [IRR], 0.97; 95% confidence interval [CI], 0.92-1.03) and those over 80 years of age (IRR, 0.92; 95% CI 0.88-0.97) than for those aged 61-80 years, and for women (IRR, 0.91; 95% CI, 0.87-0.95) and people with dementia (IRR, 0.89; 95% CI, 0.81-0.98). The likelihood of having classes of prevention medication prescribed was lower for patients aged 60 years or younger (IRR, 0.92; 95% CI, 0.88-0.97) and those over 80 years of age (IRR, 0.96; 95% CI, 0.92-0.997) than for patients aged 61-80 years, and for women (IRR, 0.95; 95% CI, 0.91-0.98) and people with dementia (IRR, 0.88; 95% CI, 0.78-0.98).

CONCLUSIONS: The general practice management of people who have been hospitalised with stroke or TIA could be improved. Effective monitoring of cardiometabolic risk factors will enable general practitioners to optimise care for people who need careful attention to prevent adverse secondary events.

PMID:39550757 | DOI:10.5694/mja2.52511

Lifetime Data Anal. 2024 Nov 17. doi: 10.1007/s10985-024-09641-y. Online ahead of print.

ABSTRACT

Interval sampling is widely used for collection of disease registry data, which typically report incident cases during a certain time period. Such sampling scheme induces doubly truncated data if the failure time can be observed exactly and doubly truncated and interval censored (DTIC) data if the failure time is known only to lie within an interval. In this article, we consider nonparametric estimation of the cumulative incidence functions (CIF) using doubly-truncated and interval-censored competing risks (DTIC-C) data obtained from interval sampling scheme. Using the approach of Shen (Stat Methods Med Res 31:1157-1170, 2022b), we first obtain the nonparametric maximum likelihood estimator (NPMLE) of the distribution function of failure time ignoring failure types. Using the NPMLE, we proposed nonparametric estimators of the CIF with DTIC-C data and establish consistency of the proposed estimators. Simulation studies show that the proposed estimator performs well for finite sample size.

PMID:39550754 | DOI:10.1007/s10985-024-09641-y

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

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

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

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

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

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

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

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