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Nevin Manimala Statistics

Concordance of patient- and clinician-reported outcomes of acute radiation dermatitis in breast cancer

Support Care Cancer. 2024 Nov 4;32(11):767. doi: 10.1007/s00520-024-08966-6.

ABSTRACT

BACKGROUND AND PURPOSE: The study evaluated the concordance between patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) of acute radiation dermatitis (RD) symptoms following adjuvant radiotherapy for early-stage and locally advanced breast cancer.

MATERIAL AND METHODS: This is a secondary analysis of a multi-center randomized phase 3 trial (376 patients). Ordinal logistic regression analysis was used to compare the Skin Symptom Assessment (SSA) independently reported by both patients and clinicians. Concordance between patient- and clinician-reported SSAs for RD symptoms was measured by percent concordance, concordance index (C-statistic), and Cohen’s Kappa. Analyses were performed across all patients in the original modified intention-to-treat analysis and those with only grade 2-3 (CTCAE) RD.

RESULTS: PROs were significantly more severe than CROs across all RD symptoms (Odds Ratio [OR] > 1; p < 0.0001). Pigmentation (OR 5.4), blistering/peeling (OR 4.0), and pain/soreness (OR 3.9) were the most differentially reported symptoms. Poor-to-low concordance was noted between patient- and clinician-reported SSAs for all RD symptoms for the entire cohort (percent concordance < 50%, C-statistic 0.52-0.63, Cohen’s Kappa 13.9-23.4%) and those with grade 2-3 RD (percent concordance < 50%, C-statistic 0.56-0.66, Cohen’s Kappa 2.0-24.5%). Similarly, poor-to-low concordance was noted in both Mepitel film and standard-of-care arms.

CONCLUSION: PROs and CROs have poor concordance in breast RD, and patients report worse outcomes than clinicians, regardless of RD severity or prophylaxis. PROs must be further integrated into routine clinical practice and clinical trial design to reduce the risk of underreporting symptoms.

PMID:39495339 | DOI:10.1007/s00520-024-08966-6

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The role of autologous bone in cranioplasty. A systematic review of complications and risk factors by using stored bone

Acta Neurochir (Wien). 2024 Nov 4;166(1):438. doi: 10.1007/s00701-024-06312-7.

ABSTRACT

BACKGROUND: Autologous bone cranioplasty is associated with a high complication rate, particularly infections and bone resorption. Although there are studies on the incidence and risk factors for complications following autologous bone cranioplasty, the study design is typically limited to retrospective analysis with multiple statistical explorations in small cohorts from single centers. Thus, there is a need for systematic analysis of aggregated data to determine the rate and risk factors for cranioplasty complications.

OBJECTIVE: To determine the incidence and risk factors for complications after autologous bone cranioplasty.

METHODS: In this systemic review, we conducted a Medline, Embase, Cochrane, and Web of Science search: 11,172 papers were identified. Duplicates were removed and only articles on complications following autologous bone cranioplasty between the years 2000 and 2022 were included. After title, abstract, and article screening, 132 papers were included for further analysis.

RESULTS: In total, the 132 studies are based on 13,592 patients (14960 implants). One third of the studies include patients with less than 3 months of postoperative follow-up. Complication management (flap removal, revision without flap removal, and conservative treatment) of infection, bone resorption, and hematoma/seromas are not reported in 19-30% of the studies. In the studies with defined complications management, the overall complication rate is 7.6% (95% Confidence Interval (CI) [7.1-8.2]) for infection, 14.4% (95% CI [13.7-15.2]) for bone resorption with indication for reconstruction, and 5.8%, (95% CI 5.2-6.5) for hematoma/seromas. Factors such as younger age, an extended interval between craniectomy and cranioplasty, the use of a fragmented bone implant, a larger implant size, and shunt treatment are linked to an increased risk of postoperative bone resorption.

CONCLUSION: The lack of consistent definitions of complications, variations in follow-up time, and small study cohorts limit the external validity of many studies. Overall, the rate of bone flap resorption that required reoperation is high, while the rate of infectious complications is comparable to synthetic implants. Thus, autologous bone should preferably be used in cases without strong risk factors for bone necrosis.

PMID:39495337 | DOI:10.1007/s00701-024-06312-7

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Spatial and seasonal association study between P M 2.5 and related contributing factors in India

Environ Monit Assess. 2024 Nov 4;196(12):1153. doi: 10.1007/s10661-024-13333-3.

ABSTRACT

Global environmental pollution and rapid climate change have become a serious matter of concern. Remarkable spatial and seasonal variations have been observed due to rapid industrialization, urbanization, different festive occasions, etc. Among all the existing pollutants, the fine airborne particles PM 2.5 (with aerodynamic equivalent diameter 2.5 μ m ) and PM 10 (with aerodynamic equivalent diameter 10 μ m ) are associated with chronic diseases. This leads to carry out the study regarding the varying relationship between PM 2.5 and other associated factors so that its concentration level might be under control. Existing literature has explored the geographical association between the pollutants and a few other important factors. To address this problem, the present study aims to explore the wide spatio-temporal relationships between the particulate matter ( PM 2.5 ) with the other associated factors (e.g., socio-demographic, meteorological factors, and air pollutants). For this analysis, the geographically weighted regression (GWR) model with different kernels (viz. Gaussian and Bisquare kernels) and the ordinary least squares (OLS) model have been carried out to analyze the same from the perspective of the four major seasons (i.e., autumn, winter, summer, and monsoon) in different districts of India. It may be inferred from the results that the local model (i.e., GWR model with Bisquare kernel) captures the spatial heterogeneity in a better way and their performances have been compared in terms of R 2 values ( > 0.99 in all cases) and corrected Akaike information criterion ( AIC c ) (maximum value 618.69 and minimum value 896.88 ). It has been revealed that there is a strong negative impact between forest coverage and PM pollution in northern India during the major seasons. The same has been found in Delhi, Haryana, and a few districts of Rajasthan during the 1-year cycle (October 2022-September 2023). It has also been found that PM concentration levels become high over the specified period with the temperature drop in Delhi, Uttar Pradesh, etc. Moreover, a strong positive association is visible in PM pollution level with the total population.

PMID:39495335 | DOI:10.1007/s10661-024-13333-3

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Nevin Manimala Statistics

Bleeding Associated With Antiarrhythmic Drugs in Patients With Atrial Fibrillation Using Direct Oral Anticoagulants: A Nationwide Population Cohort Study

J Am Heart Assoc. 2024 Nov 4:e033513. doi: 10.1161/JAHA.123.033513. Online ahead of print.

ABSTRACT

BACKGROUND: This study investigated drug-drug interactions in patients with atrial fibrillation taking both a direct oral anticoagulant (DOAC) and an antiarrhythmic drug.

METHODS AND RESULTS: Using data from the National Health Insurance database (2012-2018), we identified 78 805 patients with atrial fibrillation on DOACs, with 24 142 taking amiodarone, 8631 taking propafenone, 2784 taking dronedarone, 297 taking flecainide, 177 taking sotalol, and 42 772 on DOACs alone. Patients with bradycardia, heart block, heart failure, mitral stenosis, prosthetic valves, or incomplete data were excluded. Propensity score matching compared those taking both DOACs and antiarrhythmic drugs with those on DOACs alone. There was an increased risk of major bleeding in patients concomitantly taking DOACs with amiodarone when compared with matched patients taking DOACs alone (hazard ratio [HR],1.13 [95% CI, 1.04-1.23]; P=0.0044), particularly in patients taking dabigatran (HR, 1.19 [95% CI, 1.03-1.38]; P=0.0175). No significant difference in bleeding risk was found for propafenone, dronedarone, flecainide, or sotalol. The small sample sizes in the flecainide and sotalol groups limit interpretation. Notably, intracranial bleeding risk was higher in patients on DOACs and amiodarone, regardless of age. Additionally, patients <80 years old taking dabigatran with amiodarone or propafenone had a higher risk of gastrointestinal bleeding.

CONCLUSIONS: Concomitant use of DOACs with amiodarone, but not dronedarone or propafenone, increases the risk of major bleeding, particularly intracranial bleeding. This study provides new evidence to guide clinicians to tailor concomitant anticoagulation and antiarrhythmic therapy for patients with atrial fibrillation.

PMID:39494558 | DOI:10.1161/JAHA.123.033513

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A predictive model based on serum bicarbonate for cardiovascular events after initiation of peritoneal dialysis

Ren Fail. 2024 Dec;46(2):2422428. doi: 10.1080/0886022X.2024.2422428. Epub 2024 Nov 4.

ABSTRACT

BACKGROUND: The risk of cardiovascular events (CVEs) in peritoneal dialysis (PD) patients is high, but varies widely among individuals. Metabolic acidosis is prevalent in PD patients and may be involved in the development of CVEs. The aim of the study was to evaluate serum bicarbonate as a risk factor and derive a model of new CVE.

METHODS: A predictive model was established by performing an observational study in 187 PD patients obtained from the First Affiliated Hospital of Anhui Medical University. The variables were extracted using least absolute shrinkage and selection operator (LASSO) regression, and the modeling was developed using multivariable Cox regression.

RESULTS: Left ventricular hypertrophy (HR = 1.965, 95%CI 1.086-3.557) and history of CVEs (HR = 2.435, 95%CI 1.342-4.49) were risk parameters for a new CVE. Serum albumin (HR = 0.924, 95%CI 0.864-0.989) and bicarbonate levels (HR = 0.817, 95%CI 0.689-0.969) were protective parameters, in which the risk of CVEs was reduced by 7.6% and 18.3% for each 1-unit increase in serum albumin (g/L) and bicarbonate (mmol/L) levels, respectively. A nomogram based on the above predictive indicators was proposed with a C-statistic of 0.806, indicating good discrimination. Moreover, it successfully stratified patients into low-, intermediate-, and high-risk groups.

CONCLUSIONS: We performed a risk prediction model for the development of CVEs in patients with PD, which may help physicians to evaluate the risk of new CVEs and provide a scientific basis for further interventions. Further studies are needed to externally validate current risk models before clinical application.

PMID:39494539 | DOI:10.1080/0886022X.2024.2422428

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Nevin Manimala Statistics

DNAproDB: an updated database for the automated and interactive analysis of protein-DNA complexes

Nucleic Acids Res. 2024 Nov 4:gkae970. doi: 10.1093/nar/gkae970. Online ahead of print.

ABSTRACT

DNAproDB (https://dnaprodb.usc.edu/) is a database, visualization tool, and processing pipeline for analyzing structural features of protein-DNA interactions. Here, we present a substantially updated version of the database through additional structural annotations, search, and user interface functionalities. The update expands the number of pre-analyzed protein-DNA structures, which are automatically updated weekly. The analysis pipeline identifies water-mediated hydrogen bonds that are incorporated into the visualizations of protein-DNA complexes. Tertiary structure-aware nucleotide layouts are now available. New file formats and external database annotations are supported. The website has been redesigned, and interacting with graphs and data is more intuitive. We also present a statistical analysis on the updated collection of structures revealing salient patterns in protein-DNA interactions.

PMID:39494533 | DOI:10.1093/nar/gkae970

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Nevin Manimala Statistics

Investigating heterogeneity in IRTree models for multiple response processes with score-based partitioning

Br J Math Stat Psychol. 2024 Nov 4. doi: 10.1111/bmsp.12367. Online ahead of print.

ABSTRACT

Item response tree (IRTree) models form a family of psychometric models that allow researchers to control for multiple response processes, such as different sorts of response styles, in the measurement of latent traits. While IRTree models can capture quantitative individual differences in both the latent traits of interest and the use of response categories, they maintain the basic assumption that the nature and weighting of latent response processes are homogeneous across the entire population of respondents. In the present research, we therefore propose a novel approach for detecting heterogeneity in the parameters of IRTree models across subgroups that engage in different response behavior. The approach uses score-based tests to reveal violations of parameter heterogeneity along extraneous person covariates, and it can be employed as a model-based partitioning algorithm to identify sources of differences in the strength of trait-based responding or other response processes. Simulation studies demonstrate generally accurate Type I error rates and sufficient power for metric, ordinal, and categorical person covariates and for different types of test statistics, with the potential to differentiate between different types of parameter heterogeneity. An empirical application illustrates the use of score-based partitioning in the analysis of latent response processes with real data.

PMID:39494491 | DOI:10.1111/bmsp.12367

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High-frequency whole blood donation and its impact on mortality: Evidence from a data linkage study in Australia

Transfusion. 2024 Nov 4. doi: 10.1111/trf.18049. Online ahead of print.

ABSTRACT

BACKGROUND: Previous reports suggest that blood donors have a lower mortality risk, which may partially reflect the “healthy donor effect” (HDE). HDE arises in donors due to selection bias and confounding if not appropriately addressed.

STUDY DESIGN AND METHODS: Using the Sax Institute’s 45 and Up Study data linked with blood donation history, we used a “5-year exposure window” method to select donors into regular high-frequency whole blood (WB)donors (at least two donations per exposure year) and low-frequency donors (remaining donors) with an active donation career of 5 years. To further reduce the confounding, we used statistical approaches like the inverse probability weighted (IPW) marginal structural model and the doubly robust targeted minimum loss-based estimator (TMLE), which incorporated machine learning algorithms and time-varying analyses.

RESULTS: We selected 4750 (64.7%) low-frequency and 2588 (35.3%) high-frequency donors in the analyses. A total of 69 (1.5%) from the low-frequency and 45 (1.7%) donors from the regular high-frequency group died during the 7-year follow-up period. We did not find any statistically significant association between regular high-frequency blood donation and mortality (IPW RR = 0.98 95% CI 0.68, 1.28). TMLE model also showed similar results to IPW (RR = 0.97 95% CI 0.80, 1.16). Time-varying TMLE did not find any significant association between high-frequency donation and all-cause mortality either (RR = 0.98 95% 0.74, 1.29).

CONCLUSIONS: We did not find a significant association between regular high-frequency WB donation and all-cause mortality when appropriate methods were employed to minimize the HDE.

PMID:39494482 | DOI:10.1111/trf.18049

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Telemedicine Use Following Onset of the COVID-19 Pandemic Was Associated With Youth and White Race but Not With Socioeconomic Deprivation: A Retrospective Cohort Study of Orthopedic Patients

HSS J. 2024 Nov;20(4):539-543. doi: 10.1177/15563316231207632. Epub 2023 Oct 28.

ABSTRACT

BACKGROUND: The use of telemedicine increased greatly following the onset of the COVID-19 pandemic. It is unclear whether and how sociodemographic factors have affected orthopedics patients’ use of this technology in the pandemic.

PURPOSE: The aim of this study was to determine how patient demographic variability in telemedicine use is influenced by the Area Deprivation Index (ADI) and distance to clinical site among patients seeking care for hip and knee arthritis from orthopedic surgeons.

METHODS: Demographic data and visit type were collected from the electronic medical record for patients seen in our academic medical center either before or during the COVID-19 pandemic by orthopedic surgeons who specialize in hip and knee arthroplasty. Univariate and multivariate analyses were performed regarding age, race, insurance status, ADI, and distance to a clinical site.

RESULTS: In the COVID era, among 4901 visits with 3124 unique patients, those using telemedicine were younger and more likely to be White compared to those who did not use telemedicine. There was no significant difference in telemedicine use based on ADI, distance to a clinical site, or insurance status.

CONCLUSIONS: This retrospective analysis suggests that orthopedic patients who were White and of younger age were more likely to use telemedicine in the first year of the COVID-19 pandemic. There was no statistically significant relationship between distance from a clinical site or ADI and telemedicine use, suggesting that factors other than these are greater contributors to telemedicine utilization in our cohort. Further information is needed to determine how telemedicine may disproportionately limit access to orthopedic care according to these and other patient factors.

PMID:39494430 | PMC:PMC11528590 | DOI:10.1177/15563316231207632

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Incidence and Etiology of Rare Saphenous Nerve Injury After Knee Surgery with Adductor Canal Block: A Retrospective Observational Study

HSS J. 2024 Nov;20(4):490-497. doi: 10.1177/15563316231194614. Epub 2023 Sep 12.

ABSTRACT

BACKGROUND: Adductor canal block (ACB) is commonly included in multimodal analgesia regimens for knee surgery. Nonetheless, the incidence, etiology, and procedure-specific risk of saphenous nerve injury after knee surgery with ACB have not been established.

PURPOSE: We sought to identify the risk of saphenous nerve injury during knee surgery with ACB.

METHODS: We conducted a retrospective cohort study of patients at a single institution who underwent elective knee surgery with ultrasound-guided ACB between January 1, 2014, and December 31, 2018, and had subsequent saphenous nerve injury. The primary outcome was the incidence of saphenous nerve injury within 3 months of surgery, by surgical type and approach. Secondary outcomes included attribution of the most likely etiology and clinical outcome of the injury.

RESULTS: In 28,196 cases of knee surgery with ACB, we identified 18 cases (0.06%) of saphenous nerve injury. The most common surgery associated with saphenous nerve injury was anterior cruciate ligament (ACL) reconstruction with autograft (8/18 cases); 3 cases of injury were seen after TKA, 2 after medial patellofemoral ligament reconstruction, 2 after arthroscopy/meniscal surgery, and 1 after patellar fixation. The most likely etiology of nerve injury was attributed to ACB in 5 of 18 cases (28%) and to non-ACB cause in 13 of 18 (72%). Prognosis was rated as unknown in 11 of 18, poor in 2 of 18, favorable in 3 of 18, and full recovery in 2 of 18.

CONCLUSIONS: This 5-year retrospective, single-institution cohort study found a low overall incidence of saphenous nerve injury after knee surgery with ACB, but the injury likelihood varied based on surgery and approach. Although not statistically significant, ACL reconstruction with hamstring autograft and ACB performed for postoperative rescue analgesia were most frequently associated with nerve injury.

PMID:39494428 | PMC:PMC11528913 | DOI:10.1177/15563316231194614