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Ocular Adverse Effects of Over-the-Counter Cosmetics and Personal Care Products Reported to the Food and Drug Administration

Ophthalmic Plast Reconstr Surg. 2024 Aug 13. doi: 10.1097/IOP.0000000000002718. Online ahead of print.

ABSTRACT

PURPOSE: Personal care and cosmetic products can cause periocular and ocular adverse effects (AEs), for example, ocular surface disease, trauma, and hypersensitivity. The publicly available Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database includes AE reports by consumers, healthcare practitioners, and manufacturers. The purpose of this study was to characterize ophthalmic AE associated with cosmetics and personal care products reported by the FDA CAERS database.

METHODS: AE related to the eye or ocular adnexa from cosmetics submitted by consumers, healthcare practitioners, and manufacturers from January 2004 to June 2022 were identified after filtering using the Medical Dictionary for Regulatory Activities coding system. Demographic information, case outcome, and categories of product and AE were included. Chi-square analysis, with statistical significance at a = 0.05, was performed to ascertain variation in ocular, periocular, and general outcomes by product category.

RESULTS: Reports of ophthalmic AEs related to cosmetics per year increased from 2006 to 2018, reaching a maximum of 161 reports in 2018, then decreased from 2018 to 2021. In total, 959 and 1382 unique periocular and ocular AEs were reported. There were 1711 total incidences of reported periocular AEs and 2485 ocular AEs. The most reported periocular AEs were inflammation (770/1711) and hypersensitivity (331/1711). The most reported ocular effects were discomfort (946/2485) and inflammation (709/2485). Ocular, periocular, and general outcomes significantly varied by product category.

CONCLUSIONS: Consumers, healthcare practitioners, and manufacturers should be made aware of potential ophthalmic AE and outcomes associated with cosmetics and personal care products.

PMID:39136955 | DOI:10.1097/IOP.0000000000002718

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Use of Generative AI to Identify Helmet Status Among Patients With Micromobility-Related Injuries From Unstructured Clinical Notes

JAMA Netw Open. 2024 Aug 1;7(8):e2425981. doi: 10.1001/jamanetworkopen.2024.25981.

ABSTRACT

IMPORTANCE: Large language models (LLMs) have potential to increase the efficiency of information extraction from unstructured clinical notes in electronic medical records.

OBJECTIVE: To assess the utility and reliability of an LLM, ChatGPT-4 (OpenAI), to analyze clinical narratives and identify helmet use status of patients injured in micromobility-related accidents.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used publicly available, deidentified 2019 to 2022 data from the US Consumer Product Safety Commission’s National Electronic Injury Surveillance System, a nationally representative stratified probability sample of 96 hospitals in the US. Unweighted estimates of e-bike, bicycle, hoverboard, and powered scooter-related injuries that resulted in an emergency department visit were used. Statistical analysis was performed from November 2023 to April 2024.

MAIN OUTCOMES AND MEASURES: Patient helmet status (wearing vs not wearing vs unknown) was extracted from clinical narratives using (1) a text string search using researcher-generated text strings and (2) the LLM by prompting the system with low-, intermediate-, and high-detail prompts. The level of agreement between the 2 approaches across all 3 prompts was analyzed using Cohen κ test statistics. Fleiss κ was calculated to measure the test-retest reliability of the high-detail prompt across 5 new chat sessions and days. Performance statistics were calculated by comparing results from the high-detail prompt to classifications of helmet status generated by researchers reading the clinical notes (ie, a criterion standard review).

RESULTS: Among 54 569 clinical notes, moderate (Cohen κ = 0.74 [95% CI, 0.73-0.75) and weak (Cohen κ = 0.53 [95% CI, 0.52-0.54]) agreement were found between the text string-search approach and the LLM for the low- and intermediate-detail prompts, respectively. The high-detail prompt had almost perfect agreement (κ = 1.00 [95% CI, 1.00-1.00]) but required the greatest amount of time to complete. The LLM did not perfectly replicate its analyses across new sessions and days (Fleiss κ = 0.91 across 5 trials; P < .001). The LLM often hallucinated and was consistent in replicating its hallucinations. It also showed high validity compared with the criterion standard (n = 400; κ = 0.98 [95% CI, 0.96-1.00]).

CONCLUSIONS AND RELEVANCE: This study’s findings suggest that although there are efficiency gains for using the LLM to extract information from clinical notes, the inadequate reliability compared with a text string-search approach, hallucinations, and inconsistent performance significantly hinder the potential of the currently available LLM.

PMID:39136946 | DOI:10.1001/jamanetworkopen.2024.25981

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Incidence of Cancer and Cardiovascular Disease After Bariatric Surgery in Older Patients

JAMA Netw Open. 2024 Aug 1;7(8):e2427457. doi: 10.1001/jamanetworkopen.2024.27457.

ABSTRACT

IMPORTANCE: Bariatric surgery is associated with decreased risk of obesity-related cancer and cardiovascular disease but is typically reserved for patients younger than 60 years. Whether these associations hold for patients who undergo surgery at older ages is uncertain.

OBJECTIVE: To determine whether bariatric surgery is associated with a decreased risk of obesity-related cancer and cardiovascular disease in patients who underwent surgery at age 60 years or older.

DESIGN, SETTING, AND PARTICIPANTS: Population-based cohort study of patients from Denmark, Finland, and Sweden who underwent bariatric surgery at age 60 years or older without previous malignant neoplasm or cardiovascular disease between 1989 and 2019. Each patient who underwent surgery was exactly matched to 5 patients with nonoperative treatment for obesity of the same country, sex, and age at the date of surgery. Data were analyzed in December 2023.

EXPOSURE: Receiving treatment for obesity, including bariatric surgery and nonoperative treatments.

MAIN OUTCOMES AND MEASURES: The main outcome was obesity-related cancer, defined as a composite outcome of breast, endometrial, esophageal, colorectal, and kidney cancer, identified from the national cancer registries. The secondary outcome was cardiovascular disease, defined as a composite outcome of myocardial infarction, ischemic stroke, and cerebral hemorrhage, identified from the patient registries. Multivariable Cox regression provided hazard ratios (HR) with 95% CIs adjusted for diabetes, hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, kidney disease, and frailty.

RESULTS: In total, 15 300 patients (median [IQR] age, 63 [61-65] years; 10 152 female patients [66.4%]) were included, of which 2550 (16.7%) had bariatric surgery at age 60 or older and 12 750 (83.3%) had nonoperative treatment. During a median (IQR) of 5.8 (2.8-8.5) person-years of follow-up, 658 (4.3%) developed obesity-related cancer and 1436 (9.4%) developed cardiovascular disease. The risk of obesity-related cancer (HR, 0.81; 95% CI, 0.64-1.03) and cardiovascular disease (HR, 0.86; 95% CI, 0.74-1.01) were similar among who underwent surgery and those who did not. Gastric bypass (1930 patients) was associated with a decreased risk of obesity-related cancer (71 patients [3.7%]; HR, 0.74; 95% CI, 0.56-0.97) and cardiovascular disease (159 patients [8.2%]; HR, 0.82; 95% CI, 0.69-0.99) compared with matched controls (9650 patients; obesity-related cancer: 442 patients [4.6%]; cardiovascular disease: 859 patients [8.9%]).

CONCLUSIONS AND RELEVANCE: This cohort study found that bariatric surgery in older patients is not associated with lower rates of obesity-related cancer and cardiovascular events, but there was evidence that gastric bypass may be associated with lower risk of both outcomes.

PMID:39136945 | DOI:10.1001/jamanetworkopen.2024.27457

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The effect of economic growth, investment, and unemployment on renewable energy transition: evidence from OECD countries

Environ Sci Pollut Res Int. 2024 Aug 13. doi: 10.1007/s11356-024-34143-7. Online ahead of print.

ABSTRACT

In today’s world, where the dramatic effects of climate change continue to increase, it is critical to turn from fossil fuels to renewable energy sources to achieve the CO2 emission reduction targets that countries have committed at the Paris Climate Agreement and COP 27 conference. This study analyzes the effects of macroeconomic factors, including economic growth, investments, and unemployment, on the transition to renewable energy in OECD countries. From 1996 to 2020, long-run relationships between variables were examined using advanced econometric methodologies for empirical analysis. For this purpose, panel data analysis, second-generation panel unit root tests, cross-sectional dependence tests, and panel cointegration tests were applied. Economically, in the long run, according to panel CCEMG and AMG estimator, while economic growth enhances the renewable energy transitions, investment does not statistically promote an impact on the renewable energy transitions. Renewable energy transition increases with unemployment. Moreover, the role of the considered variables in the renewable energy transition varies among country-specific. Within the framework of the results obtained, it has been proven that before determining policies for renewable energy transformation, it is necessary to do the necessary groundwork in the economy to increase economic growth and investments and reduce unemployment.

PMID:39136924 | DOI:10.1007/s11356-024-34143-7

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Alterations in neurotransmitters, steroid hormones, vitellogenin, and antioxidant system induced by di-n-butyl phthalate and di-isopentyl phthalate on catfish Rhamdia quelen

Environ Sci Pollut Res Int. 2024 Aug 13. doi: 10.1007/s11356-024-34392-6. Online ahead of print.

ABSTRACT

Phthalates, such as di-n-butyl phthalate (DBP) and di-isopentyl phthalate (DiPeP), are pollutants with a high potential for endocrine disruption. This study aimed to evaluate parameters of endocrine disruption in specimens of the Neotropical fish Rhamdia quelen exposed to DBP and DiPeP through their food. After 30 days of exposure, the fish were anesthetized and then euthanized, and blood, hypothalamus, liver, and gonads were collected. DBP caused statistically significant alterations in the serotoninergic system of males (5 and 25 ng/g) and females (5 ng/g) of R. quelen and it increased testosterone levels in females (25 ng/g). DiPeP significantly altered the dopaminergic system in females, reduced plasma estradiol levels (125 ng/g) and hepatic vitellogenin expression (25 ng/g), and changed the antioxidant system in gonads (125 ng/g). The results suggest that DBP and DiPeP may have different response patterns in females, with the former being androgenic and the latter being anti-estrogenic. These findings provide additional evidence regarding the molecular events involving DBP and DiPeP in the endocrine disruption potential in juvenile specimens of Rhamdia quelen.

PMID:39136918 | DOI:10.1007/s11356-024-34392-6

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Genetic Diagnostic Yield in Autism Spectrum Disorder (ASD) and Epilepsy Phenotypes in Children with Genetically Defined ASD

J Autism Dev Disord. 2024 Aug 13. doi: 10.1007/s10803-024-06512-1. Online ahead of print.

ABSTRACT

We compared the epilepsy phenotypes in children with genetically defined versus undefined autism spectrum disorder (ASD). A single-center retrospective study was conducted to investigate diagnostic yields of different genetic testing for children with ASD. Patients with at least one testing modality were included and classified as having genetically defined ASD or not based on updated genotype-phenotype correlation. Of the 523 patients included, 79 (15.1%) had results explaining their ASD diagnosis. WES (whole exome sequencing) outperformed CMA (chromosomal microarray) on diagnostic yield (23.0% versus 8.3%). Compared to those with non-diagnostic test(s), children with genetically defined ASD were associated with higher rates for microcephaly, hypotonia, dysmorphic features, and developmental delay/regression. The prevalence of epilepsy was significantly higher in children with genetically defined ASD than those without a genetic diagnosis (35.4% versus 16.4%, p < 0.001, power = 0.97). Furthermore, children with genetically defined ASD had a younger age of epilepsy onset (median 2.2 versus 5.0 years, p = 0.002, power = 0.90) and a higher rate of drug-resistant epilepsy although not reaching statistical significance (35.7% versus 21.9%, p = 0.20). Our study has provided further evidence to support WES as first-tier test for children with ASD and that an early genetic diagnosis has the potential to inform further surveillance and management for ASD comorbid conditions including epilepsy.

PMID:39136901 | DOI:10.1007/s10803-024-06512-1

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Percutaneous Metallic Stents in Malignant Biliary Obstruction: Comparison of Nitinol and Wall Stents

J Gastrointest Cancer. 2024 Aug 13. doi: 10.1007/s12029-024-01101-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Palliation of malign biliary obstruction is important which is commonly carried out by percutaneous biliary stenting. Our primary aim with this study was assessment of performance of wall stents, and nitinol stents for the palliation of malign biliary obstruction.

METHODS: The medical records of 157 patients who underwent biliary stenting in our department between January 1, 1995, and December 31, 2005, were retrospectively analyzed. Technical success, treatment success, mortality in the first 30 days, minor, and major complications were evaluated and compared among the wall stent, and the nitinol stent groups in all patients which constituted the primary study endpoints. Additionally, stent patency, and mean patient survival times after stent implantation were evaluated in patients for whom follow-up information could be obtained.

RESULTS: A total of 213 metallic stents were placed in 157 patients. Wall stent was placed in 83 of the patients with mean age, and SD of 60.4 and 13.5. Nitinol stent was placed in 74 of the patients with mean age of 57.8, and SD of 15.5. Gender ratio was equal in both groups. Biliary stent dysfunction was observed in 13 patients in each of nitinol, and wall stent groups throughout the study period. There was no statistical difference among re-occlusion rates (p = 0.91). For the nitinol stent group median primary patency time was 119 days (90-185 days CI 95%), and for the wall stent group median primary patency time was 81 days (60-150 days CI 95%).

CONCLUSION: Nitinol stents, and wall stents are safe options that can be safely used in the percutaneous treatment of malignant biliary obstruction with similar treatment and therapeutic success, low complication rates, and patency times that can extend beyond expected survival times.

PMID:39136894 | DOI:10.1007/s12029-024-01101-y

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Immediate and Transient Perturbances in EEG Within Seconds Following Controlled Soccer Head Impact

Ann Biomed Eng. 2024 Aug 13. doi: 10.1007/s10439-024-03602-0. Online ahead of print.

ABSTRACT

Athletes in contact and collision sports can sustain frequent subconcussive head impacts. Although most impacts exhibit low kinematics around or below 10 g of head linear acceleration, there is growing concern regarding the cumulative effects of repetitive sports head impacts. Even mild impacts can lead to brain deformations as shown through neuroimaging and finite element modeling, and thus may result in mild and transient effects on the brain, prompting further investigations of the biomechanical dose-brain response relationship. Here we report findings from a novel laboratory study with continuous monitoring of brain activity through electroencephalography (EEG) during controlled soccer head impacts. Eight healthy participants performed simulated soccer headers at 2 mild levels (6 g, 4 rad/s and 10 g, 8 rad/s) and three directions (frontal, oblique left, oblique right). Participants were instrumented with an inertial measurement unit (IMU) bite bar and EEG electrodes for synchronized head kinematics and brain activity measurements throughout the experiment. After an impact, EEG exhibited statistically significant elevation of relative and absolute delta power that recovered within two seconds from the impact moment. These changes were statistically significantly higher for 10 g impacts compared with 6 g impacts in some topographical regions, and oblique impacts resulted in contralateral delta power increases. Post-session resting state measurements did not indicate any cumulative effects. Our findings suggest that even mild soccer head impacts could lead to immediate, transient neurophysiological changes. This study paves the way for further dose-response studies to investigate the cumulative effects of mild sports head impacts, with implications for long-term athlete brain health.

PMID:39136891 | DOI:10.1007/s10439-024-03602-0

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Comparison of single-port versus multi-port robotic assisted partial nephrectomy: a systematic review and meta-analysis of perioperative and oncological outcomes

J Robot Surg. 2024 Aug 13;18(1):321. doi: 10.1007/s11701-024-02066-7.

ABSTRACT

The safety and efficacy of single-port and multi-port robot-assisted partial nephrectomy (SP-RAPN and MP-RAPN, respectively) were assessed for treating partial nephrectomy in this study. A systematic review of PubMed, Cochrane Library, and Web of Science databases was conducted up to June 2024 to compare studies on SP-RAPN and MP-RAPN. Primary outcomes included perioperative results, complications, and oncological outcomes. Eight studies involving 1014 patients were analyzed. For binary outcomes, comparisons were performed using odds ratios (OR), and for continuous variables, weighted mean differences (WMD) with 95% confidence intervals (CI). The search failed to discover significant meaningful variations in operating times (p = 0.54), off-clamp procedure (P = 0.36), blood loss (p = 0.31), positive surgical margins (PSMs) (p = 0.78), or major complications (Clavien-Dindo grade ≥ 3) (p = 0.68) between SP-RAPN and MP-RAPN. However, shorter hospital stays (WMD – 0.26 days, 95% CI – 0.36 to – 0.15; p < 0.00001) and longer warm ischemia times (WIT) (WMD 3.13 min, 95% CI 0.81-5.46; p = 0.008) were related to SP-RAPN, and higher transfusion rate (OR 2.99, 95% CI 1.31-6.80; p = 0.009) compared to MP-RAPN. SP-RAPN performed better in terms of hospital stay but had slightly higher rates of transfusion, off-clamp procedures, and warm ischemia time (WIT) compared to MP-RAPN. As an emerging technology, preliminary research suggests that SP-RAPN is a feasible and safe method for carrying out a nephrectomy partial. However, compared to MP-RAPN, it shows inferior outcomes regarding (WIT) and transfusion rates.

PMID:39136882 | DOI:10.1007/s11701-024-02066-7

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The burden of hyperkalaemia on hospital healthcare resources

Clin Exp Med. 2024 Aug 13;24(1):190. doi: 10.1007/s10238-024-01452-7.

ABSTRACT

Hyperkalaemia is associated with prolonged hospital admission and worse mortality. Hyperkalaemia may also necessitate clinical consults, therapies for hyperkalaemia and high-dependency bed utilisation. We evaluated the ‘hidden’ human and organisational resource utilisation for hyperkalaemia in hospitalised patients. This was a single-centre, observational cohort study (Jan 2017-Dec 2020) at a tertiary-care hospital. The CogStack system (data processing and analytics platform) was used to search unstructured and structured data from individual patient records. Association between potassium and death was modelled using cubic spline regression, adjusted for age, sex, and comorbidities. Cox proportional hazards estimated the hazard of death compared with normokalaemia (3.5-5.0 mmol/l). 129,172 patients had potassium measurements in the emergency department. Incidence of hyperkalaemia was 85.7 per 1000. There were 49,011 emergency admissions. Potassium > 6.5 mmol/L had 3.9-fold worse in-hospital mortality than normokalaemia. Chronic kidney disease was present in 21% with potassium 5-5.5 mmol/L and 54% with potassium > 6.5 mmol/L. For diabetes, it was 20% and 32%, respectively. Of those with potassium > 6.5 mmol/L, 29% had nephrology review, and 13% critical care review; in this group 22% transferred to renal wards and 8% to the critical care unit. Dialysis was used in 39% of those with peak potassium > 6.5 mmol/L. Admission hyperkalaemia and hypokalaemia were independently associated with reduced likelihood of hospital discharge. Hyperkalaemia is associated with greater in-hospital mortality and reduced likelihood of hospital discharge. It necessitated significant utilisation of nephrology and critical care consultations and greater likelihood of patient transfer to renal and critical care.

PMID:39136879 | DOI:10.1007/s10238-024-01452-7