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Nevin Manimala Statistics

Active surveillance follow-up for prostate cancer: from guidelines to real-world clinical practice

World J Urol. 2024 Nov 26;42(1):646. doi: 10.1007/s00345-024-05373-8.

ABSTRACT

PURPOSE: To assess active surveillance (AS) adherence for prostate cancer (PCa) in a “real-world” clinical practice.

MATERIALS AND METHODS: We utilized our institutional database which was built by interrogating electronic medical records for all men who got diagnosed with PCa from 1995 to 2022. Our cohort included all patients aged < 76 years, with PCa Gleason Grade (GG) 1 or 2, ≤ cT2c, PSA ≤ 20 ng/ml at diagnosis, enrolled on AS, and with at least one biopsy after diagnosis. Patients were separated into two groups based on the monitoring intensity. Patients with at least 1 PSA/year and at least 1 biopsy every 4 years were categorized as adherent to guidelines. Univariable and Multivariable logistic regression analyses were used to examine the impact of covariates on non-adherence to guidelines. Competing risks cumulative incidence was used to depict prostate cancer-specific mortality (PCSM).

RESULTS: A total of 546 men met the inclusion criteria. Overall, 63 (11%) patients were adherent to guidelines (Group 1), while 483 (89%) were not (Group 2). Median PSAs/year and median biopsies/year were 2.3 (2.0-2.7) and 0.4 (0.3-0.6) for Group 1, and 1.2 (0.7-1.8) and 0.2 (0.1-0.2) for Group 2, respectively (both p < 0.0001). At multivariable analysis, Black men had a 2.20-fold higher risk of being in Group 2 than White men (p < 0.05). Patients with cT2 (OR:0.24, CI:0.11-0.52) and those with CCI ≥2 (OR:0.40, CCI:0.19-0.82) were less likely to be in Group 2, when compared to cT1 stage and CCI = 0, respectively (both p < 0.05). At 10 years, the cumulative incidence estimate of PCSM for the entire cohort was 2.1%.

CONCLUSION: We found substantial deviations from AS monitoring guidelines, particularly in biopsy frequency, which did not seem to compromise PCSM in patients with stable PSA. Notably, our findings suggest that strict adherence to guidelines, especially in patients with cT2 at diagnosis, remains crucial.

PMID:39589591 | DOI:10.1007/s00345-024-05373-8

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A newly developed method for assessing co-exposure to free dose combinations: a proof-of-concept study using antihypertensive medications in Danish registers

Aging Clin Exp Res. 2024 Nov 26;36(1):226. doi: 10.1007/s40520-024-02879-4.

ABSTRACT

BACKGROUND: Elevated blood pressure is a major risk factor for severe medical conditions. Adherence to antihypertensive medication, especially in free-dose combinations, poses a significant challenge. This study aims to develop a novel method for assessing co-exposure to free-dose antihypertensive medications using secondary data sources.

METHODS: A register-based cohort study was conducted on individuals aged 65 years or older in Denmark who initiated antihypertensive therapy from 1996 to 2016 and followed for 730 days from the index date. A new method was developed to assess co-exposure to antihypertensive medications through redeemed prescriptions, treatment episodes, and overlapping medication events. The method’s accuracy was evaluated using a random sample of 400 individuals.

RESULTS: A total of 1,021,819 individuals were included in the study, with a mean age of 68.8 years, and 53.7% were women. The method achieved 100% accuracy in identifying co-exposure periods. During the early stage of the follow-up (0-180 days), 54.1% of individuals were co-exposed to at least two antihypertensive medications, while 37.5% were co-exposed during the late stage of the follow-up period (181-730 days). The most frequent antihypertensive combinations included bendroflumethiazide and potassium with either amlodipine or enalapril in the early (13.2% and 12.5% of patients, respectively) and late stages (16.9% and 15.0% of patients, respectively).

CONCLUSIONS: The newly developed method effectively assesses co-exposure to antihypertensive medications, overcoming previous limitations. The findings reveal common co-exposure combinations and evolving trends in antihypertensive medication use among older individuals, reflecting changes in clinical practice and guidelines over two decades.

PMID:39589584 | DOI:10.1007/s40520-024-02879-4

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The impact of positive resection margin in perihilar cholangiocarcinoma, ductal margin vs radial margin

Langenbecks Arch Surg. 2024 Nov 26;409(1):359. doi: 10.1007/s00423-024-03547-x.

ABSTRACT

INTRODUCTION: Resection margin status is the important prognostic factor in resected perihilar cholangiocarcinoma (pCCA). Although the impact of ductal margin (DM) was reported in many studies, the influence of radial margin (RM) is unclear. This study aims to investigate the effect of positive RM on survival.

METHODS: Patients with pCCA underwent curative resection between 2013 and 2018 were retrospectively reviewed. Resection margin status was divided into negative resection margin (R0) and positive resection margin (R1); positive RM alone (RM+) and positive DM with or without positive RM (DM+).

RESULTS: Of the 167 pCCA patients, 62 (37.1%) had R1 margin. Among 62 R1 patients; 17 (27.4%) had positive DM alone, 20 (32.3%) had positive RM alone and 25 (40.3%) had both positive DM and RM. The R1 patients had a significantly greater number of lymph node metastasis (LNM) and advanced tumor staging than R0 patients, however there was no difference between the RM + and DM + patients. The median survival time of patients with RM + was significantly poorer than R0 patients (13.8 vs. 24.5 months; p < 0.001, respectively) and similar to the DM + patients (9.1 months, p = 0.556). However, in patients with LNM, those who underwent R0 resection had no statistically significant difference in survival outcomes compared to those with R1 resection.

CONCLUSION: Positive resection margin remains the important prognostic factor, and positive RM is common in these patients. Positive RM also had a comparable effect on survival as positive DM. As a result, in pCCA, surgical resection should target both RM and DM.

PMID:39589565 | DOI:10.1007/s00423-024-03547-x

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Prevalence of serum vitamin D and B12, Ca, P, Mg levels and rheumatoid factor status in the patients with bilateral TMJ-OA and their correlations with clinical and radiological findings

Cranio. 2024 Nov 26:1-12. doi: 10.1080/08869634.2024.2431347. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the prevalence of serum vitamin D and B12, calcium, phosphorus, magnesium levels, and rheumatoid factor (RF) status in patients with bilateral temporomandibular joint osteoarthritis (TMJ-OA) and their correlations with clinical and radiological findings.

METHODS: The clinical and radiologic findings and serum vitamin and mineral levels of 90 patients diagnosed with bilateral TMJ-OA were recorded. Descriptive statistics and the Spearman’s Rho correlation test were performed.

RESULTS: Low serum vitamin D and B12 levels were detected in 82 (91.1%) and 74 (82.2%) patients. Calcium and phosphorus levels were seen at low rates. RF status was recorded as unfavorable in all patients. Correlations were found between age and the serum vitamin and mineral levels, except phosphorus. Low serum vitamin D levels correlated with pain complaints at rest and painless MIO. Serum B12 levels correlated with condylar erosion. Serum magnesium levels correlated with painful MIO and condylar osteophyte.

CONCLUSION: Patients with bilateral TMJ-OA showed a high prevalence of low serum vitamin D and B12 levels.

PMID:39588727 | DOI:10.1080/08869634.2024.2431347

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Nurse-Led Mobile Phone Intervention to Promote Self-Management in Type 2 Diabetes in Ghana: A Randomized Controlled Trial

Sci Diabetes Self Manag Care. 2024 Nov 26:26350106241293113. doi: 10.1177/26350106241293113. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of the study was to test the effectiveness of a nurse-led mobile phone intervention (NMPI) on glycemic variability and self-management among people living with type 2 diabetes (T2DM) in Ghana.

METHODS: In this randomized controlled trial, the intervention group received a 3-month NMPI program plus standard care, and the control group received standard care alone in a tertiary health care setting. Ninety-eight participants (baseline A1C > 7%) were randomized 1:1 to either NMPI or standard care group. The primary study outcomes were changes in A1C testing and self-management assessed using the Summary of Diabetes Self-Care Activities tool at baseline and end of the study.

RESULTS: The intervention group had statistically significant improvement in their mean A1C level from baseline to the end of the study. In comparison, the control group also had improvement in their mean A1C level but was not statistically significant. Consistently, the intervention participants had better statistically significant improvements in self-management behaviors than the control group. There was a medium, negative correlation between A1C changes and overall self-care changes for the intervention group, whereas that of the control group was smaller.

CONCLUSIONS: Study findings have shown that a tailored NMPI program in addition to standard care could improve glycemic variability and self-management among people living with poorly managed T2DM in Ghana better than standard care alone.

PMID:39588726 | DOI:10.1177/26350106241293113

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Impact of Specimen Extraction Site and Gallstone Size on Early Postoperative Pain Following Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study

Surg Laparosc Endosc Percutan Tech. 2024 Nov 25. doi: 10.1097/SLE.0000000000001343. Online ahead of print.

ABSTRACT

BACKGROUND: Laparoscopic cholecystectomy (LC) is widely performed with generally favorable outcomes, but postoperative pain remains a significant issue, influenced by various factors including the specimen extraction site and gallstone size.

METHODS: A prospective randomized controlled study was conducted on 100 patients undergoing LC. Participants were randomized to have the specimen removed through either the epigastric or umbilical trocar. Postoperative pain was assessed using the visual analog scale (VAS) on postoperative days 1, 3, and 7. Statistical analyses were performed to evaluate the impact of trocar site and gallstone size on pain levels.

RESULTS: Patients whose specimens were extracted through the umbilical trocar experienced significantly less pain on postoperative days 1 and 3 (P=0.006 and 0.014, respectively) than those with epigastric trocar extraction. In addition, patients with gallstones larger than 10 mm reported higher pain levels on day 3 (P=0.001) irrespective of the extraction site.

CONCLUSIONS: The umbilical trocar site for specimen extraction and smaller gallstone size is associated with reduced early postoperative pain following LC. These findings suggest the importance of considering extraction site and gallstone size in managing postoperative pain in LC patients.

PMID:39588713 | DOI:10.1097/SLE.0000000000001343

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Cognitive Mechanisms Between Psychosocial Resources and the Behavioral Intention of Professional Help-Seeking for Internet Gaming Disorder Among Chinese Adolescent Gamers: Cross-Sectional Mediation Study

JMIR Public Health Surveill. 2024 Nov 14;10:e52478. doi: 10.2196/52478.

ABSTRACT

BACKGROUND: Internet gaming disorder (IGD) is a global public health concern for adolescents due to its potential severe negative consequences. Professional help-seeking is important for early screening, diagnosis, and treatment of IGD. However, research on the factors associated with professional help-seeking for IGD as well as relevant mediation mechanisms among adolescents is limited.

OBJECTIVE: Based on the stress coping theory, the conservation of resource theory, and behavioral change theories, this study investigated the prevalence and factors influencing the behavioral intention of professional help-seeking for internet gaming disorder (BI-PHSIGD). The research also explored the underlying mechanisms, including psychosocial resources like resilience and social support, perceived resource loss due to reduced gaming time, and self-efficacy, in professional help-seeking among adolescent internet gamers.

METHODS: A cross-sectional survey was conducted among secondary school students who were internet gamers in 2 Chinese cities from October 2019 to January 2020. Data from the full sample (N=1526) and a subsample of 256 IGD cases (according to the 9-item DSM-5 [Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition] IGD Checklist) were analyzed. Multivariate logistic regression analysis was conducted to examine the factors of BI-PHSIGD, while structural equation modeling was performed to test the proposed mediation mechanisms.

RESULTS: The prevalence of BI-PHSIGD was 54.3% (829/1526) in the full sample and 40.6% (104/256) in the IGD subsample (vs 708/1239, 57.1% among non-IGD cases). In the full sample, psychosocial resources of resilience (adjusted odds ratio [aOR] 1.03, 95% CI 1.02-1.05) and social support (aOR 1.03, 95% CI 1.02-1.04) as well as self-efficacy in professional help-seeking (aOR 1.64, 95% CI 1.49-1.81) were positively associated with BI-PHSIGD, while perceived resource loss due to reduced gaming time was negatively associated with BI-PHSIGD (aOR 0.97, 95% CI 0.96-0.98); the positive association between psychosocial resources and BI-PHSIGD was fully mediated via 2 single-mediator indirect paths (via self-efficacy in professional help-seeking alone: effect size=53.4%; indirect effect/total effect=0.10/0.19 and via perceived resource loss due to reduced gaming time alone: effect size=17.8%; indirect effect/total effect=0.03/0.19) and one 2-mediator serial indirect path (first via perceived resource loss due to reduced gaming time then via self-efficacy in professional help-seeking: effect size=4.7%; indirect effect/total effect=0.009/0.19). In the IGD subgroup, a full mediation via self-efficacy in professional help-seeking alone but not the other 2 indirect paths was statistically significant.

CONCLUSIONS: Many adolescent internet gamers, especially those with IGD, were unwilling to seek professional help; as a result, early treatment is often difficult to achieve. To increase BI-PHSIGD, enhancing psychosocial resources such as resilience and social support, perceived resource loss due to reduced gaming time, and self-efficacy in professional help-seeking may be effective. Future longitudinal and intervention studies are needed to confirm and extend the findings.

PMID:39588703 | DOI:10.2196/52478

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Effect of Social Isolation Due to the COVID-19 Pandemic on Cognitive Dysfunction of Patients With Alzheimer Disease: Subanalysis of Double-blinded Noninferiority Study of Donepezil Patches and Donepezil Tablets

Alzheimer Dis Assoc Disord. 2024 Oct-Dec 01;38(4):351-357. doi: 10.1097/WAD.0000000000000648. Epub 2024 Nov 13.

ABSTRACT

BACKGROUND: Previous studies were examined effects of social restriction by COVID-19 pandemic on elderly peoples or compared difference of before/after restrictions on patients with Alzheimer disease-related dementia (ADRD). Here, we assessed the effects of restrictions on the cognitive function of the patients by comparing control group.

METHODS: We examined the impact on cognitive function using the Alzheimer Disease Assessment Scale (Japanese version) cognitive subscale (ADAS-JCOG), in patients with mild to moderate ADRD by a post hoc subgroup analysis of double-blinded, noninferiority study of donepezil 27.5 mg patches and donepezil hydrochloride 5 mg tablets (JapicCTI-194582). After demonstrating the noninferiority of both treatments, we used combined data for this analysis.

RESULTS: The analyzed subpopulation of the per-protocol set groups was balanced (n=126 and 135, respectively). Patient demographics were similar between subgroups. The difference of ADAS-JCOG scores [least-squares mean (95%CI)] between the groups was 0.388 (-0.377 to 1.152, not statistically significant).

CONCLUSION: Social isolation affects cognitive function on ADRD and this knowledge should be considered in future.

PMID:39588690 | DOI:10.1097/WAD.0000000000000648

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Relationship Between Alzheimer Disease Imaging Biomarkers and Performance on the NIH Toolbox Cognition Battery in Late-middle Age Hispanics

Alzheimer Dis Assoc Disord. 2024 Oct-Dec 01;38(4):311-318. doi: 10.1097/WAD.0000000000000641. Epub 2024 Nov 26.

ABSTRACT

PURPOSE: The National Institute of Health Toolbox Cognition Battery (NIHTB-CB) is increasingly used in Alzheimer disease (AD) research. We examined the relation of AD biomarkers with performance in the NIHTB-CB in late middle age.

METHODS: This is a cross-sectional analysis of 334 Hispanic participants aged 64.22±3.35 years from a study of AD biomarkers. White matter hyperintensities (WMH), infarcts, and cortical thickness in AD regions (CT) were assessed with 3T magnetic resonance imaging. Amyloid and tau were assessed with 18F-Florbetaben and 18F-MK6240 positron emission tomography, respectively.

RESULTS: Lower CT and infarcts were associated with worse Oral Reading Recognition and Cognition Crystallized Composite scores. Lower CT and higher WMH were associated with worse Pattern Comparison Processing Speed. Amyloid and tau were not associated with any test.

DISCUSSION: Amyloid and tau, the culprits of AD, are not related to the NIHTB-CB in late middle age. Continued follow-up will reveal if AD impacts performance on the NIHTB-CB.

PMID:39588688 | DOI:10.1097/WAD.0000000000000641

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Estimated Brain Age in Healthy Aging and Across Multiple Neurological Disorders

J Magn Reson Imaging. 2024 Nov 26. doi: 10.1002/jmri.29667. Online ahead of print.

ABSTRACT

BACKGROUND: The brain aging in the general population and patients with neurological disorders is not well understood.

PURPOSE: To characterize brain aging in the above conditions and its clinical relevance.

STUDY TYPE: Retrospective.

POPULATION: A total of 2913 healthy controls (HC), with 1395 females; 331 multiple sclerosis (MS); 189 neuromyelitis optica spectrum disorder (NMOSD); 239 Alzheimer’s disease (AD); 244 Parkinson’s disease (PD); and 338 cerebral small vessel disease (cSVD).

FIELD STRENGTH/SEQUENCE: 3.0 T/Three-dimensional (3D) T1-weighted images.

ASSESSMENT: The brain age was estimated by our previously developed model, using a 3D convolutional neural network trained on 9794 3D T1-weighted images of healthy individuals. Brain age gap (BAG), the difference between chronological age and estimated brain age, was calculated to represent accelerated and resilient brain conditions. We compared MRI metrics between individuals with accelerated (BAG ≥ 5 years) and resilient brain age (BAG ≤ -5 years) in HC, and correlated BAG with MRI metrics, and cognitive and physical measures across neurological disorders.

STATISTICAL TESTS: Student’s t test, Wilcoxon test, chi-square test or Fisher’s exact test, and correlation analysis. P < 0.05 was considered statistically significant.

RESULTS: In HC, individuals with accelerated brain age exhibited significantly higher white matter hyperintensity (WMH) and lower regional brain volumes than those with resilient brain age. BAG was significantly higher in MS (10.30 ± 12.6 years), NMOSD (2.96 ± 7.8 years), AD (6.50 ± 6.6 years), PD (4.24 ± 4.8 years), and cSVD (3.24 ± 5.9 years) compared to HC. Increased BAG was significantly associated with regional brain atrophy, WMH burden, and cognitive impairment across neurological disorders. Increased BAG was significantly correlated with physical disability in MS (r = 0.17).

DATA CONCLUSION: Healthy individuals with accelerated brain age show high WMH burden and regional volume reduction. Neurological disorders exhibit distinct accelerated brain aging, correlated with impaired cognitive and physical function.

LEVEL OF EVIDENCE: 4 TECHNICAL EFFICACY: Stage 2.

PMID:39588683 | DOI:10.1002/jmri.29667