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Nevin Manimala Statistics

Tropical Data: Approach and Methodology as Applied to Trachoma Prevalence Surveys

Ophthalmic Epidemiol. 2023 Dec;30(6):544-560. doi: 10.1080/09286586.2023.2249546. Epub 2023 Dec 12.

ABSTRACT

PURPOSE: Population-based prevalence surveys are essential for decision-making on interventions to achieve trachoma elimination as a public health problem. This paper outlines the methodologies of Tropical Data, which supports work to undertake those surveys.

METHODS: Tropical Data is a consortium of partners that supports health ministries worldwide to conduct globally standardised prevalence surveys that conform to World Health Organization recommendations. Founding principles are health ministry ownership, partnership and collaboration, and quality assurance and quality control at every step of the survey process. Support covers survey planning, survey design, training, electronic data collection and fieldwork, and data management, analysis and dissemination. Methods are adapted to meet local context and needs. Customisations, operational research and integration of other diseases into routine trachoma surveys have also been supported.

RESULTS: Between 29th February 2016 and 24th April 2023, 3373 trachoma surveys across 50 countries have been supported, resulting in 10,818,502 people being examined for trachoma.

CONCLUSION: This health ministry-led, standardised approach, with support from the start to the end of the survey process, has helped all trachoma elimination stakeholders to know where interventions are needed, where interventions can be stopped, and when elimination as a public health problem has been achieved. Flexibility to meet specific country contexts, adaptation to changes in global guidance and adjustments in response to user feedback have facilitated innovation in evidence-based methodologies, and supported health ministries to strive for global disease control targets.

PMID:38085791 | DOI:10.1080/09286586.2023.2249546

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Cochlear Implant Outcomes: Quality of Life in Prelingually Deafened, Late-Implanted Patients

Otol Neurotol. 2024 Jan 1;45(1):e24-e27. doi: 10.1097/MAO.0000000000004052. Epub 2023 Nov 26.

ABSTRACT

AIMS: Reevaluating and expanding cochlear implantation’s (CI) indication while measuring the quality of life (QoL) outcomes regarding the parent’s point of view of prelingually deafened, late-implanted patients, which are widely known to showcases a limited improvement in speech recognition.

MATERIALS AND METHODS: A retrospective descriptive and analytic study to assess QoL outcomes from CI in 64 early deafened, late-implanted patients, according to their parent’s perspective, between January 2009 and December 2019, using the Nottingham Pediatric Cochlear Implant Program (Nottingham University Hospital, Nottingham, United Kingdom) “Children with cochlear implantation: parents perspective.”

RESULTS: The most represented age interval is the 5 and 7 interval and the mean age is 10.09 years. There was no sex predominance, with rural origin and high school academicals level preponderance. Fourteen children had experienced neonatal icterus, eight had meningitis, and seven were the result of related marriage. The age of the first consultation was typically over 2 years old, with only 45 schooled children. Age had a significantly statistic correlation between Self-reliance and Well-being and happiness subscales. History of receiving aid and speech therapy has a clear correlation with Self-reliance, Well-being and happiness, and Communication and Education. Schooling statuses, sex, age of appearance, and communication mode were not correlated to any subscale score, and with the exception of Effect of implantation, all the other “Children with cochlear implantation: parent’s perspective” subscales were intercorrelated.

CONCLUSION: Properly validated QoL assessments for CI are a must, as outcomes of CI expand beyond audiometric performances to include the improvement of QoL.

PMID:38085762 | DOI:10.1097/MAO.0000000000004052

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An Investigation of the Impact of Expanding High-Deductible Health Plans on Patient Decision for Cochlear Implant Surgery and Postoperative Outcomes

Otol Neurotol. 2024 Jan 1;45(1):46-51. doi: 10.1097/MAO.0000000000004063. Epub 2023 Nov 26.

ABSTRACT

HYPOTHESIS: After the expansion of high deductibles, patients will delay cochlear implant (CI) surgery to the end of the year, and the risk of postoperative known risks will increase.

BACKGROUND: The Affordable Care Act was associated with increased enrollment in high-deductible health plans (HDHPs), which resulted in rising health insurance deductibles. Health insurance plans can cover a patient’s cost of healthcare once the deductible is met. Patients have been shown to be economic rational decision makers and make decisions based on cost rather than health. They wait for their deductible to be met, typically at the end of the year, then proceed to have costly care. The goal of this study was to evaluate the impact of rising health insurance deductibles on the rate and postoperative outcomes of cochlear implantation and to assess changes by the Tax Cuts and Jobs Act.

METHODS: TriNetX was used to accumulate summary data on patients who obtained a CI between 2005 and 2022 at the beginning (quarter 1) and the end of the year (quarter 4) from the electronic medical records of 75 healthcare organizations. The trends in average rate of cochlear implantation and resultant postoperative known risks or complications were statistically evaluated.

RESULTS: After expansion of HDHPs, the rate of cochlear implantation between quarter 4 (19 cases per year) and quarter 1 (17 cases/year) was similar (p = 0.18). For all patient groups, the case volume significantly increased. Between quarter 4 and quarter 1, postoperative tinnitus was more common in the beginning of the year (risk ratio, 0.68; 95% confidence interval, 0.46-0.99).

CONCLUSIONS: The number of patients receiving CIs significantly increased despite the expansion of HDHPs. Tinnitus was a rare postoperative known risk in the beginning of the year. Patients are less likely concerned about cost of CI surgery because of the impact of hearing loss on quality of life.

PMID:38085761 | DOI:10.1097/MAO.0000000000004063

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Nevin Manimala Statistics

Ocular Adverse Events After Influenza Vaccination in Older Adults: Self-Controlled Case Series Using a Large Database in Japan

Ophthalmic Epidemiol. 2023 Dec 12:1-6. doi: 10.1080/09286586.2023.2289990. Online ahead of print.

ABSTRACT

BACKGROUND: To clarify the risk of adverse ocular events following influenza vaccination.

METHODS: This self-controlled case series study used a claims database linked to vaccination records of a large city in Japan between April 2014 and September 2021. Individuals aged ≥ 65 years who developed adverse ocular events during the follow-up period were included. The exposure was influenza vaccination. The primary outcome was defined as the occurrence of at least one of the following five eye diseases: uveitis, scleritis, retinal vein occlusion, retinal artery occlusion, or optic neuritis. Conditional Poisson regression was used to estimate the within-subject incidence rate ratio of ocular adverse events during the risk period (0-56 days after vaccination) compared to the control period.

RESULTS: A total of 4,527 cases were eligible for the study (median age, 74 years; male, 42%). The incidence rate ratio for the outcome during the risk period was 0.99 (95% confidence interval, 0.87 to 1.14). No increased risk was observed for individual components of the outcome either; the incidence rate ratio was 0.94 (0.78 to 1.13) for uveitis, 1.17 (0.86 to 1.59) for scleritis, 0.98 (0.76 to 1.27) for retinal vein occlusion, 0.89 (0.42 to 1.87) for retinal artery occlusion, and 0.87 (0.44 to 1.70) for optic neuritis.

CONCLUSIONS: This self-controlled case series showed no apparent increase in the risk of adverse ocular events after influenza vaccination among older adults. These results mitigate the concerns of older adults who may hesitate to receive influenza vaccination for fear of adverse ocular events.

ABBREVIATION: HR = hazard ratio; CI = confidence interval; RVO = retinal vein occlusion; SCCS = self-controlled case series.

PMID:38085757 | DOI:10.1080/09286586.2023.2289990

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A Model of Immediate Implant Placement to Evaluate Early Osseointegration in 129/Sv Diabetic Mice

Int J Oral Maxillofac Implants. 2023 Dec 12;38(6):1200-1210. doi: 10.11607/jomi.10335.

ABSTRACT

PURPOSE: To analyze the process of early oral osseointegration of titanium (Ti) implants in diabetic 129/Sv mice through microCT and histologic and immunohistochemical analysis.

MATERIALS AND METHODS: A group of 30 male 129/Sv mice was equally subdivided into two groups: (1) nondiabetic (ND), in which mice did not undergo systemic alterations and received a standard diet, and (2) diabetic (D), in which mice were provided a high-fat diet from the age of 6 weeks until the conclusion of the study and received two intraperitoneal (IP) injections of streptozotocin (STZ) at a concentration of 100 mg/Kg each. Each mouse underwent extraction of a maxillary first molar, and customized Ti screws (0.50 mm diameter, 1.5 mm length) were placed in the residual alveolar sockets of the palatal roots. At 7 and 21 days after implant placement, the animals were euthanized for maxilla and pancreas collection. Maxillae containing Ti implants were analyzed with microCT, histology, and immunohistochemistry for cells that were positive for F4/80, CD146, runt-related transcription factor 2 (Runx2), and proliferating cell nuclear antigen (PCNA). Pancreata were histologically analyzed. Quantitative data were statistically analyzed with a significance level at 5% (P < .05).

RESULTS: ND mice presented successful healing and osseointegration, with a significantly higher fraction of bone volume compared to D mice, both at the alveolar sockets (53.39 ± 5.93 and 46.08 ± 3.18, respectively) and at the implant sites (68.88 ± 7.07 and 44.40 ± 6.98, respectively) 21 days after implant placement. Histologic evaluation revealed that the ND mice showed a significant decrease in inflammatory infiltrate and a significant increase in newly formed bone matrix at 21 days, whereas peri-implant sites in the D mice were predominantly encapsulated by fibrous tissue and chronic inflammatory infiltrate. Immunohistochemical characterization revealed higher Runx2 osteoblast differentiation and higher cell proliferation activity in the ND mice at 7 days, while higher amounts of macrophages were present in D mice at 7 and 21 days. Interestingly, no differences were found in CD146-positive cells when comparing ND and D mice.

CONCLUSIONS: This study evaluated the effects of immediate dental implant placement in 129/Sv diabetic mice by using specific healing markers to identify changes in cellular events involved in early oral osseointegration. This approach may serve as tool to evaluate new materials and surface coatings to improve osseointegration in diabetic patients.

PMID:38085752 | DOI:10.11607/jomi.10335

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Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials

JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

ABSTRACT

BACKGROUND: Wearable sensors in digital health may pose a risk for skin irritation through the use of wearable patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite; Otsuka America Pharmaceutical, Inc) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through a wearable patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of wearable patches were developed, including raisin patch version 4 (RP4), followed by disposable wearable sensor version 5 (DW5), and then reusable wearable sensor version 2 (RW2).

OBJECTIVE: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches.

METHODS: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive.

RESULTS: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively.

CONCLUSIONS: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products.

TRIAL REGISTRATION: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889.

PMID:38085556 | DOI:10.2196/44768

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The relationship between echocardiographic parameters and albumin bilirubin score in patients with acute pulmonary thromboembolism

Perfusion. 2023 Dec 12:2676591231221706. doi: 10.1177/02676591231221706. Online ahead of print.

ABSTRACT

PURPOSE: The Albumin-Bilirubin (ALBI) score is useful and easy-to-use for objectively assessing liver function. We investigated whether the ALBI score, a parameter indicating liver stiffness, congestion and fibrosis, has any relationship with echocardiographic parameters in patients with acute pulmonary thromboembolism (PTE).

MATERIAL AND METHODS: A total of 140 patients diagnosed with acute PTE were retrospectively analyzed. These patients were divided into three groups according to the hemodynamic severity of acute PTE: Group I [Low risk]; Group II [Submassive or intermediate-risk]; and Group III [Massive or high-risk]. Biochemical data obtained from venous blood samples taken at admission were analyzed. In addition, data were also analyzed from transthoracic echocardiography and pulmonary computed tomographic angiography performed at admission. ALBI, Bova, and PESI scores were calculated.

RESULTS: ALBI scores (-3.32 ± 0.21 vs -2.86 ± 0.15 vs -2.46 ± 0.2, p < .001) were statistically significantly higher in Group III than Groups I and II. There was a significant difference between the three groups in terms of echocardiographic parameters, and LVEF and TAPSE values tended to decrease from group I to group III. In multivariate linear regression analysis, sPAP, RV/RA diameter, and NT-pro-BNP were found to be significantly associated with the ALBI score. An ALBI score higher than -2.87 was associated with Bova stage II-III in patients with Group I and Group II PTE, with a sensitivity of 87% and a specificity of 62% (AUC = 0.804; 95% CI 0.713-0.895; p < .001).

CONCLUSION: The ALBI score, which is a common, easy-to-use, and inexpensive method, may be beneficial to select intermediate and high-risk patients in patients with acute PTE. Additionally, it may have prognostic value in distinguishing low and intermediate-risk acute PTE patients.

PMID:38085551 | DOI:10.1177/02676591231221706

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Unraveling the Dynamic Helicity Inversion and Chirality Transfer by the Iterative Exponential Growth Synthesis of Azobenzene Discrete Oligomers

Angew Chem Int Ed Engl. 2023 Dec 12:e202315686. doi: 10.1002/anie.202315686. Online ahead of print.

ABSTRACT

Unraveling the chirality transfer mechanism of polymer assemblies and controlling their handedness is beneficial to exploring the origin of hierarchical chirality and developing smart materials with desired chiroptical activities. However, polydisperse polymers often lead to an ambiguous or statistical evaluation of the structure-property relationship, it remains unclear how the iterative number of repeating units can function in the helicity inversion of polymer assemblies. Herein, we report the macroscopic helicity and dynamic manipulation of the chiroptical activity of supramolecular assemblies from discrete azobenzene-containing oligomers (Azooligomers), together with the helicity inversion and morphological transition achieved solely by changing the iterative chain lengths. The chiral supramolecular assemblies of the iterative Azooligomers were collectively characterized by CD, UV-vis, small-angle X-ray scattering (SAXS), and wide-angle X-ray diffraction (WAXD) spectroscopy, transmission electron microscopy (TEM), and ultrasonic uncoiling experiments, revealing that their helicity inversions are governed by distinct stacking modes and delicate balance of kinetics and thermodynamics. The corresponding assemblies also differ from their polydisperse counterparts in terms of thermodynamic properties, chiroptical activities, and morphological control.

PMID:38085492 | DOI:10.1002/anie.202315686

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Detection of atmospheric aerosols and terrestrial nanoparticles collected in a populous city in southern Brazil

Environ Sci Pollut Res Int. 2023 Dec 12. doi: 10.1007/s11356-023-31414-7. Online ahead of print.

ABSTRACT

The main objective of this study is to analyze hazardous elements in nanoparticles (NPs) (smaller than 100 nm) and ultrafine particles (smaller than 1 µm) in Porto Alegre City, southern Brazil using a self-made passive sampler and Sentinel-3B SYN satellite images in 32 collection points. The Aerosol Optical Thickness proportion (T550) identification was conducted using images of the Sentinel-3B SYN satellite at 634 points sampled in 2019, 2020, 2021, and 2022. Focused ion beam scanning electron microscopy analyses were performed to identify chemical elements present in NPs and ultrafine particles, followed by single-stage cascade impactor to be processed by high-resolution transmission electron microscopy. This process was coupled with energy-dispersive X-ray spectroscopy and later analysis via secondary ion mass spectrometry. Data was acquired from Sentinel-3B SYN images, normalized to a standard mean of 0.83 µg/mg, at moderate spatial resolution (260 m), and modeled in the Sentinel Application Platform (SNAP) software v.8.0. Statistical matrix data was generated in the JASP software (Jeffreys’s Amazing Statistics Program) v.0.14.1.0 followed by a K-means cluster analysis. The results demonstrate the presence of between 1 and 100 nm particles of the following chemical elements: Si, Al, K, Mg, P, and Ti. Many people go through these areas daily and may inhale or absorb these elements that can harm human health. In the Sentinel-3B SYN satellite images, the sum of squares in cluster 6 is 168,265 and in cluster 7 a total of 21,583. The use of images from the Sentinel-3B SYN satellite to obtain T550 levels is of great importance as it reveals that atmospheric pollution can move through air currents contaminating large areas on a global scale.

PMID:38085483 | DOI:10.1007/s11356-023-31414-7

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Monitoring agricultural drought in Peshawar Valley, Pakistan using long -term satellite and meteorological data

Environ Sci Pollut Res Int. 2023 Dec 12. doi: 10.1007/s11356-023-31345-3. Online ahead of print.

ABSTRACT

Monitoring agricultural drought across a large area is challenging, especially in regions with limited data availability, like the Peshawar Valley, which holds great agricultural significance in Pakistan. Although remote sensing provides biophysical variables such as precipitation (P), land surface temperature (LST), normalized difference vegetation index (NDVI), and relative soil moisture (RSM) to assess drought conditions at various spatiotemporal scales, these variables have limited capacity to capture the complex nature of agricultural drought and associated crop responses. Here, we developed a composite drought index named “Temperature Vegetation ET Dryness Index” (TVEDI) by modifying the Temperature Vegetation Precipitation Dryness Index (TVPDI) and integrating NDVI, LST, and remotely sensed evapotranspiration (ET) using 3D space and Euclidean distance. Several statistical techniques were employed to examine TVPDI and TVEDI trends and relationships with other commonly used drought indices such as the standardized precipitation index (SPI), standardized precipitation evapotranspiration index (SPEI), and standardized soil moisture index (SSI), as well as crop yield, to better understand how these indices captured the spatial and temporal distribution of agricultural drought in the Peshawar valley between 1986 and 2018. Results indicated that while the temporal patterns of the 3-month SPI, SPEI, and SSI generally align with those of TVEDI and TVPDI, TVEDI was more strongly correlated with these indices (e.g., correlation coefficient, r = 0.78-0.84 from TVEDI and r = 0.73-0.79 from TVPDI). Moreover, the crop yield, a measure of crop response to agricultural drought, demonstrated a significant positive correlation with TVEDI (r = 0.60-0.80), much higher than its correlation with TVPDI (r = 0.30-0.48). These outcomes indicate that the inclusion of ET in TVEDI effectively captured changes in soil moisture, crop water status, and their impact on crop yield. Overall, TVEDI exhibited enhanced capability to identify drought impacts compared to TVPDI, showing its potential for characterizing agricultural drought in regions with limited data availability.

PMID:38085478 | DOI:10.1007/s11356-023-31345-3