Tag: nevin manimala

JAMA Netw Open. 2023 Sep 5;6(9):e2333618. doi: 10.1001/jamanetworkopen.2023.33618.

ABSTRACT

IMPORTANCE: Breast cancer mortality is complex and traditional approaches that seek to identify determinants of mortality assume that their effects on mortality are stationary across geographic space and scales.

OBJECTIVE: To identify geographic variation in the associations of population demographics, environmental, lifestyle, and health care access with breast cancer mortality at the US county-level.

DESIGN, SETTING, AND PARTICIPANTS: This geospatial cross-sectional study used data from the Surveillance, Epidemiology, and End Results (SEER) database on adult female patients with breast cancer. Statistical and spatial analysis was completed using adjusted mortality rates from 2015 to 2019 for 2176 counties in the US. Data were analyzed July 2022.

EXPOSURES: County-level population demographics, environmental, lifestyle, and health care access variables were obtained from open data sources.

MAIN OUTCOMES AND MEASURES: Model coefficients describing the association between 18 variables and age-adjusted breast cancer mortality rate. Compared with a multivariable linear regression (OLS), multiscale geographically weighted regression (MGWR) relaxed the assumption of spatial stationarity and allowed for the magnitude, direction, and significance of coefficients to change across geographic space.

RESULTS: Both OLS and MGWR models agreed that county-level age-adjusted breast cancer mortality rates were significantly positively associated with obesity (OLS: β, 1.21; 95% CI, 0.88 to 1.54; mean [SD] MGWR: β, 0.72 [0.02]) and negatively associated with proportion of adults screened via mammograms (OLS: β, -1.27; 95% CI, -1.70 to -0.84; mean [SD] MGWR: β, -1.07 [0.16]). Furthermore, the MGWR model revealed that these 2 determinants were associated with a stationary effect on mortality across the US. However, the MGWR model provided important insights on other county-level factors differentially associated with breast cancer mortality across the US. Both models agreed that smoking (OLS: β, -0.65; 95% CI, -0.98 to -0.32; mean [SD] MGWR: β, -0.75 [0.92]), food environment index (OLS: β, -1.35; 95% CI, -1.72 to -0.98; mean [SD] MGWR: β, -1.69 [0.70]), exercise opportunities (OLS: β, -0.56; 95% CI, -0.91 to -0.21; mean [SD] MGWR: β, -0.59 [0.81]), racial segregation (OLS: β, -0.60; 95% CI, -0.89 to -0.31; mean [SD] MGWR: β, -0.47 [0.41]), mental health care physician ratio (OLS: β, -0.93; 95% CI, -1.44 to -0.42; mean [SD] MGWR: β, -0.48 [0.92]), and primary care physician ratio (OLS: β, -1.46; 95% CI, -2.13 to -0.79; mean [SD] MGWR: β, -1.06 [0.57]) were negatively associated with breast cancer mortality, and that light pollution was positively associated (OLS: β, 0.48; 95% CI, 0.24 to 0.72; mean [SD] MGWR: β, 0.27 [0.04]). But in the MGWR model, the magnitude of effect sizes and significance varied across geographical regions. Inversely, the OLS model found that disability was not a significant variable for breast cancer mortality, yet the MGWR model found that it was significantly positively associated in some geographical locations.

CONCLUSIONS AND RELEVANCE: This cross-sectional study found that not all social determinants associated with breast cancer mortality are spatially stationary and provides spatially explicit insights for public health practitioners to guide geographically targeted interventions.

PMID:37707814 | DOI:10.1001/jamanetworkopen.2023.33618

JAMA Netw Open. 2023 Sep 5;6(9):e2333786. doi: 10.1001/jamanetworkopen.2023.33786.

ABSTRACT

IMPORTANCE: The Clinical Dementia Rating (CDR) is a well-validated instrument widely used to detect and stage dementia due to Alzheimer disease. The digital Electronic Clinical Dementia Rating (eCDR) can be remotely self-administered and automatically scored, with potential to facilitate efficient dementia screening and staging.

OBJECTIVE: To evaluate the association of the eCDR with the CDR and other in-clinic assessments for screening older adults for cognitive impairment.

DESIGN, SETTING, AND PARTICIPANTS: This multisite, cross-sectional study used baseline data from a longitudinal, observational study from 2020 to 2023, including up to 3 years of follow-up. Participants were enrolled from 3 Alzheimer Disease Research Centers and the Brain Health Registry. Participants (aged ≥55 years, with a study partner, and no acute or unstable major medical conditions) were recruited during in-clinic visits or by automated emails.

EXPOSURES: Participants completed the Uniform Data Set Version 3 (UDS; including the CDR) in supervised clinical research settings, and then completed the eCDR remotely, online and unsupervised, using their own device.

MAIN OUTCOMES AND MEASURES: The primary outcomes were eCDR scores (item; categorical box and global; continuous box and global), CDR scores (item; categorical box and global), and UDS assessment scores. Associations were evaluated using linear and logistic regressions.

RESULTS: A total of 3565 participants were contacted, and 288 were enrolled. Among 173 participants with item-level data (mean [SD] age, 70.84 [7.65] years; 76 women [43.9%]), eCDR to CDR concordance was 90% or higher for 33 items (63%) and 70% to 89% for 13 items (25%). Box (domain) level concordance ranged from 80% (memory) to 99% (personal care). The global score concordance rate was 81%. κ statistics were fair to moderate. Among 206 participants with box and global scores (mean [SD] age, 71.34 [7.68] years; 95 women [46.1%]), eCDR continuous global score was associated with CDR global (categorical) score with an area under the receiver operating characteristic curve of 0.79 (95% CI, 0.70-0.87). Correlations between eCDR and in-clinic UDS assessments were similar to those between CDR sum of box scores and the same in-clinic assessments.

CONCLUSIONS AND RELEVANCE: These findings suggest that the eCDR is valid and has potential use for screening and assessment of older adults for cognitive and functional decline related to Alzheimer disease. Instrument optimization and validation in diverse cohorts in remote settings are crucial for evaluating scalability and eCDR utility in clinical research, trials, and health care settings.

PMID:37707812 | DOI:10.1001/jamanetworkopen.2023.33786

Drug Saf. 2023 Sep 14. doi: 10.1007/s40264-023-01346-9. Online ahead of print.

ABSTRACT

INTRODUCTION: During the signal detection process, statistical methods are used to identify drug-event combinations (DECs) which are disproportionately reported when compared with other drugs and events in the entire database. We hypothesise that the high volume of COVID-19 vaccine adverse drug reaction (ADR) reports transmitted to EudraVigilance may have affected the performance of disproportionality statistics used in routine signal detection, potentially resulting in signals either being masked, or false associations being flagged as potential signals.

OBJECTIVE: Our aim was to study the impact of COVID-19 vaccine spontaneous reporting on statistical signal detection in EudraVigilance.

METHODS: We recalculated the reporting odds ratio (ROR) for signals that were previously discussed at the level of the Pharmacovigilance Risk Assessment Committee, or signals that were retrieved from EudraVigilance, by omitting COVID-19 vaccine reports from the standard ROR calculation and then comparing the lower confidence interval (LCI) of the recalculated ROR to the LCI of the actual ROR in EudraVigilance.

RESULTS: In total, 52 signals for 38 active substances were reviewed. For 35 signals, the LCI of the recalculated ROR value was lower than the LCI of the actual ROR (suggesting that COVID-19 vaccine ADR reporting had a positive effect on the strength of the signal) while for 15 signals the LCI of the recalculated ROR value was higher than the LCI of the actual ROR (suggesting that COVID-19 vaccine ADR reporting had an attenuating effect on the strength of the signal). For two signals, no change in the ROR was observed. In our analysis, six significant results were found. Five DECs were found to be masked: bleomycin and immune thrombocytopenia (actual ROR LCI = 0.94, recalculated ROR LCI = 1.02), vortioxetine and heavy menstrual bleeding (actual ROR LCI = 0.3, recalculated ROR LCI = 1.06), caplacizumab and heavy menstrual bleeding (actual ROR LCI = 0.98, recalculated ROR LCI = 3.47), ziprasidone and amenorrhoea (actual ROR LCI = 0.84, recalculated ROR LCI = 1.67), and azacitidine and pericarditis (actual ROR LCI = 0.81, recalculated ROR LCI = 2.01). For the DEC of adalimumab and immune reconstitution inflammatory syndrome, the LCI of the actual ROR value was 1.14 and removing COVID-19 vaccine reporting resulted in an LCI of the recalculated ROR value of 0.94 (below threshold).

CONCLUSIONS: We demonstrated five cases of masking and one case of false-positive association due to the influence of COVID-19 vaccine spontaneous reporting on the ROR. This suggests that the high number of adverse drug reaction reports for COVID-19 vaccines in EudraVigilance has the potential to affect routine statistical signal detection activities. The impact of COVID-19 vaccine ADR reports on current signal detection practices requires further evaluation and solutions to tackle masking issues in EudraVigilance may need to be developed.

PMID:37707778 | DOI:10.1007/s40264-023-01346-9

Biol Trace Elem Res. 2023 Sep 14. doi: 10.1007/s12011-023-03836-4. Online ahead of print.

ABSTRACT

This study evaluated the effect of selenium nanoparticles on growth performance, survival rate, chemical composition, and bioaccumulation of selenium in the muscle of Nile tilapia (Oreochromis niloticus). Fish with an average weight of 33.1 ± 1.0 g were distributed in 12 fiberglass tanks and fed for 56 days with different levels of selenium nanoparticles, 0, 0.5, 1, and 2 mg/kg of diet, considered as control, T1, T2, and T3, respectively. Body weight increase (BWI), specific growth rate (SGR), and food conversion ratio (FCR) were significantly influenced by 2 mg/kg of selenium nanoparticles compared to the other treatments, in particular control and T1 with 0.5 mg/kg selenium (P < 0.05). The survival rate was also significantly affected in T2, especially compared to the control (P < 0.05). In addition, protein, ash, and moisture percentages of muscle showed statistically different levels in fish fed a diet containing 2 mg/kg of selenium nanoparticles compared to the control treatment (P < 0.05). The results of the selenium bioaccumulation in the muscle of trial diets showed a significant difference in selenium nanoparticle bioaccumulation among treatments, with the highest revealed in the 2 mg/kg nanoparticle group (P < 0.05). Overall, selenium nanoparticles significantly improved the growth performance, survival, and chemical composition (protein in particular) of Nile tilapia, especially in the T2 and T3 treatments.

PMID:37707756 | DOI:10.1007/s12011-023-03836-4

Int Ophthalmol. 2023 Sep 14. doi: 10.1007/s10792-023-02838-4. Online ahead of print.

ABSTRACT

PURPOSE: We aim to contribute to the literature in terms of treatment safety with our real world data by examining the anterior segment complications and follow-up results of patients who underwent dexamethasone implants in our clinic.

METHODS: The records of patients treated with at least one intravitreal dexamethasone implant for various retinal diseases: diabetic macular edema (265 eyes), central retinal vein occlusion (45 eyes), retinal vein branch occlusion (91 eyes), postoperative cystoid macular edema (18 eyes), non-infectious uveitis (37 eyes) and other (14 eyes) between July 2013 and April 2020 were reviewed.

RESULTS: After 925 injections were applied to 470 eyes of a total of 383 patients, the eyes were controlled during a mean follow-up of 24 months. No complications were detected in 328 eyes. Intraocular pressure (IOP) above 25 mmHg was detected in 97 eyes (20.6%) that had no previous history of ocular hypertension. Of these 97 eyes, 71 (73.1%) eyes with increased IOP were treated with topical monotherapy, 26 (26.8%) eyes were treated with topical combined therapy and 1 (1.03%) patient had glaucoma surgery. Cataracts requiring surgical intervention developed in 55 (%21.73) of 253 phakic eyes. Three patients have anterior chamber dislocation of dexamethasone, 1 patient was hospitalized with sterile endophthalmitis on the 7th day after the injection, and pars plana vitrectomy was performed.

CONCLUSION: This study is the first long-term follow-up study in our country evaluating the safety of dexamethasone implant injections in various retinal diseases and presenting the first real world data. Cataract progression and increased IOP were found to be the most common side effects. We observed that the patient’s diagnosis did not cause a statistically significant change in the observation of side effects. As a result of our findings, close follow-up of IOP after the injection of dexamethasone implants would be appropriate.

PMID:37707746 | DOI:10.1007/s10792-023-02838-4

Aging Clin Exp Res. 2023 Sep 14. doi: 10.1007/s40520-023-02529-1. Online ahead of print.

ABSTRACT

BACKGROUND: Frailty has been associated with a higher incidence of overall postoperative complications and mortality. However, the influence of frailty on the risk of venous thromboembolism (VTE) in patients with hip fracture following surgery remains unclear. We performed a meta-analysis to systematically evaluate the above association.

METHODS: PubMed, Embase, Cochrane Library, Wanfang and CNKI were searched for relevant observational studies comparing the incidence of postoperative VTE in patients of hip fracture with and without frailty. Data collection, literature searching, and statistical analysis were conducted independently by two authors. Using a heterogeneity-incorporating random-effects model, the results were pooled.

RESULTS: In this meta-analysis, 9509 patients from nine cohort studies were included. Pooled results showed that compared to those without frailty, patients with frailty at admission had a higher incidence of postoperative VTE (odds ratio [OR]: 2.59, 95% confidence interval [CI]: 1.25-5.39, p = 0.01; I² = 66%). Subgroup analysis suggested the association between frailty and postoperative VTE was more remarkable in studies of patients with frailty prevalence < 50% (OR 6.28, 95% CI 3.31-11.90, p < 0.001; I² = 8%) as compared to those ≥ 50% (OR 1.30, 95% CI 0.80-2.11, p = 0.28; I² = 0%; p for subgroup difference < 0.001). Further meta-analyses showed that frailty at baseline was associated with a higher incidence of deep venous thrombosis (OR 3.15, 95% CI 1.33-7.47, p = 0.009; I² = 59%), but not pulmonary embolism (OR 1.13, 95% CI 0.59-2.16, p = 0.72; I² = 0%).

CONCLUSION: Frailty is associated with a higher incidence of postoperative VTE in patients with hip fracture.

PMID:37707745 | DOI:10.1007/s40520-023-02529-1

Infection. 2023 Sep 14. doi: 10.1007/s15010-023-02093-w. Online ahead of print.

ABSTRACT

BACKGROUND: Several studies suggested pancreatic stone protein (PSP) as a promising biomarker to predict mortality among patients with severe infection. The objective of the study was to evaluate the performance of PSP in predicting intensive care unit (ICU) mortality and infection severity among critically ill adults admitted to the hospital for infection.

METHODS: A systematic search across Cochrane Central Register of Controlled Trials and MEDLINE databases (1966 to February 2022) for studies on PSP published in English using ‘pancreatic stone protein’, ‘PSP’, ‘regenerative protein’, ‘lithostatin’ combined with ‘infection’ and ‘sepsis’ found 46 records. The search was restricted to the five trials that measured PSP using the enzyme-linked immunosorbent assay technique (ELISA). We used Bayesian hierarchical regression models for pooled estimates and to predict mortality or disease severity using PSP, C-Reactive Protein (CRP) and procalcitonin (PCT) as main predictor. We used statistical discriminative measures, such as the area under the receiver operating characteristic curve (AUC) and classification plots.

RESULTS: Among the 678 patients included, the pooled ICU mortality was 17.8% (95% prediction interval 4.1% to 54.6%) with a between-study heterogeneity (I-squared 87%). PSP was strongly associated with ICU mortality (OR = 2.7, 95% credible interval (CrI) [1.3-6.0] per one standard deviation increase; age, gender and sepsis severity adjusted OR = 1.5, 95% CrI [0.98-2.8]). The AUC was 0.69 for PSP 95% confidence interval (CI) [0.64-0.74], 0.61 [0.56-0.66] for PCT and 0.52 [0.47-0.57] for CRP. The sensitivity was 0.96, 0.52, 0.30 for risk thresholds 0.1, 0.2 and 0.3; respective false positive rate values were 0.84, 0.25, 0.10.

CONCLUSIONS: We found that PSP showed a very good discriminative ability for both investigated study endpoints ICU mortality and infection severity; better in comparison to CRP, similar to PCT. Combinations of biomarkers did not improve their predictive ability.

PMID:37707744 | DOI:10.1007/s15010-023-02093-w

Environ Sci Pollut Res Int. 2023 Sep 14. doi: 10.1007/s11356-023-29497-3. Online ahead of print.

ABSTRACT

China is the foremost global consumer, producer, and exporter of fresh apples. In 2021, China produced roughly 44 million tons of apples and exported just over 1 million tons, a nearly 2% increase over the previous year. However, the ongoing COVID-19 pandemic has had a detrimental impact on global trade and has led to a decrease in China’s agricultural exports. The present study aims to contribute to the existing body of literature by analyzing plausible macroeconomic determinants that might impact China’s apple exports. We used novel dynamic autoregressive distributed lag (DYARDL) simulations to model causal relationships among fundamental economic parameters. We made use of annual time series data from 1990 to 2020 from the World Bank and China’s national statistical bureau. We found that increases in apple orchard area, apple production, and trade openness had a positive impact on apple exports over both the short and long term. Conversely, decreases in the prices of exported apples, agrochemicals, and carbon emissions in the agricultural sector had a positive impact on the long-term and short-term exportation of apples. Finally, we note that pictographic illustrations from the DYARDL simulations provide corroborative evidence for our findings. Based on the study results, this study proposes that the adoption of technological advancements in apple orchards could potentially enhance apple production while simultaneously upholding environmental sustainability.

PMID:37707739 | DOI:10.1007/s11356-023-29497-3

Environ Sci Pollut Res Int. 2023 Sep 14. doi: 10.1007/s11356-023-29752-7. Online ahead of print.

ABSTRACT

In this study, it was aimed to investigate the effects of melamine exposure since the weaning period on ovarian tissue and ovarian reserve. Melamine is illegally added to milk and formula to provide high false protein positivity. Female rats (the weaning period = 21 days old, n = 18) were divided into 3 groups. 0.1 mL saline was applied to the control group by gavage for 21 days. Fifty mg/kg and seventy-five mg/kg melamine was dissolved in 0.1 mL of saline and applied by gavage for 21 days, respectively. At the end of the experiment, plasma anti-Mullerian hormone (AMH) was measured, follicle count and ovarian diameter measurement were performed in the right ovaries, and flow cytometric analysis for apoptosis was performed in the left ovaries. While a statistically significant decrease was not observed in the number of the follicle and ovarian diameter between the control and melamine-treated groups (p > 0.05), a significant decrease in the corpus luteum and a significant increase in the number of atretic follicles were observed (p < 0.05). Apoptosis (Annexin V) increased in both melamine groups and AMH plasma level decreased significantly in the 75 mg/kg group (p < 0.05). Melamine exposure from the weaning (early postnatal) period may cause a decrease in ovarian reserve in parallel with a dose increase.

PMID:37707728 | DOI:10.1007/s11356-023-29752-7

Pharmacoecon Open. 2023 Sep 14. doi: 10.1007/s41669-023-00436-9. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Risperidone is used in autism spectrum disorder (ASD) to manage aggressive behavior. Budget impact analysis (BIA) assists managers in promoting more sustainable health systems; however, it is unclear whether BIAs underestimate or overestimate the estimates derived from real-world data. This study aimed to compare the estimated BIA values of risperidone use and the monitoring of adverse events in ASD using theoretical and real data.

METHODS: Analyses were conducted based on the clinical protocol and the Brazilian therapeutic guidelines for ASD. The perspective adopted was that of the Unified Health System (SUS), considering a time horizon of 5 years. Three possible scenarios were considered based on the maximum daily dose of risperidone. Expenses related to the acquisition of risperidone and the monitoring of adverse events were taken into account using health databases in Brazil. For the calculation based on theoretical data, the prevalence of ASD was estimated using information from the scientific literature and the Brazilian demographic census. The model calculated from real data was obtained by analyzing the linear trend of the number of users assisted in the SUS from 2017 to 2021.

RESULTS: The population estimated by the theoretical model compared with the model calculated from the real data was higher. Likewise, the 5-year budgetary impact of the theoretical model versus the model calculated from the real data was higher, with statistical significance in all scenarios (p < 0.001). In the real data model, the most economically advantageous scenarios were Scenario 1 for children (International dollars [I$] 7,630,040.73) and Scenario 3 for adults (I$60,329,288.17). Estimated expenditures for monitoring adverse events ranged from 17 to 74% in children and from 50% to 63% in adults.

CONCLUSIONS: The data revealed significant differences in population and cost estimation between theoretical data and real-world data. The expenses associated with monitoring adverse events represented a substantial expenditure estimate for the SUS.

PMID:37707722 | DOI:10.1007/s41669-023-00436-9