Repeatability assessment of anterior segment measurements in myopic patients using an anterior segment OCT with placido corneal topography and agreement with a swept-source OCT.

BACKGROUND: The precision of anterior segment biometric measurements in eyes has become increasingly important in refractive surgery. The purpose of this study is to assess the repeatability of the automatic measurements provided by a new spectral-domain optical coherence tomograph (SD-OCT)/Placido topographer (MS-39, CSO) and its agreement with a swept-source OCT (SS-OCT) biometer (CASIA SS-1000, Tomey) in patients with myopia. METHODS: The right eye of 235 subjects was scanned 3 times with both devices. The evaluated parameters included central corneal radius of the steep meridian, central corneal radius of the flat meridian, mean central corneal radius, thinnest corneal thickness, central corneal thickness, anterior chamber depth, corneal volume and diameter. The intraobserver repeatability of the MS-39 measurements was calculated using intraclass correlation coefficient (ICC), within subject standard deviation, coefficient of repeatability, coefficient of variation and repeated-measures analysis of variance of the 3 repeated measurements. The agreement between the two devices was evaluated by 95% limits of agreement (LoA). RESULTS: The majority of the parameters acquired from MS-39 showed high repeatability. The repeatability of corneal diameter was slightly lower than the other measurements, although the ICC remained high. Agreement with the CASIA SS-1000 was good, indicated by the Bland-Altman plots with narrow 95% LoA values for all parameters assessed. CONCLUSIONS: The high repeatability of automatic measurements by the new device supports its clinical application in eyes with myopia, and the good agreement between the two devices indicates they could be used interchangeably for the parameters evaluated.

Healthcare costs among hemophilia A patients in the United States treated with rurioctocog alfa pegol (FVIII-PEG) or antihemophilic factor (recombinant), FC fusion protein (rFVIIIFc) using real-world data.

AIMS: To compare healthcare costs in patients with non-inhibitor hemophilia A treated with Rurioctocog Alfa Pegol (FVIII-PEG) versus Antihemophilic Factor (Recombinant), FC Fusion Protein (rFVIIIFc). MATERIALS AND METHODS: Administrative claims data from the Merative MarketScan Commercial (Commerical) and Medicaid (Medicaid) databases were used for these analyses. Males with non-inhibitor hemophilia A treated with FVIII-PEG or rFVIIIFc from 1 January 2016 to 31 March 2021 were identified (earliest treatment = index). Patients were required to have continuous database enrollment for six months before and after the index date. Follow-up was variable in length until disenrollment or study end. All-cause and hemophilia-related healthcare costs were reported per-patient per month [PPPM] and the average weekly dose during follow-up was compared between treatment groups. Generalized linear regressions were used to estimate multivariable-adjusted differences in total costs and weekly dosage in the two treatment groups. RESULTS: A total of 131 FVIII-PEG (66 Commercial; 65 Medicaid) and 204 rFVIIIFc (111 Commercial; 93 Medicaid) patients were eligible. Mean age was 20.5 and 24.4 for FVIII-PEG and rFVIIIFc in Commercial and 14.9 and 17.5 for FVIII-PEG and rFVIIIFc in Medicaid. PPPM mean (standard deviations [SD]) total healthcare costs in Commercially insured patients were $35,868 [$21,717] for FVIII-PEG vs $40,424 [$25,882] for rFVIIIFc. Costs in Medicaid were $27,495 [$23,243] for FVIII-PEG vs $30,237 [$28,430] for rFVIIIFc. After adjusting for baseline characteristics, the costs for rFVIIIFc (vs FVIII-PEG) were higher by $5,215 in Commercial and $3,895 in Medicaid, but the differences were not statistically significant (p > 0.05). Similar findings were observed for hemophilia-specific healthcare costs. The adjusted mean weekly dose was 6,047 vs 4,892 IU, p = 0.21 for FVIII-PEG vs rFVIIIFc in Commercial and 5,549 vs 7,228 IU, p = 0.07 for FVIII-PEG vs rFVIIIFc in Medicaid. CONCLUSIONS: Healthcare costs and treatment dosing were similar (p > 0.05) for non-inhibitor hemophilia A patients treated with FVIII-PEG and rFVIIIFc.

The Economic Burden of Schizophrenia in the United States.

Aim: The economic burden of schizophrenia in the United States (US) was estimated at $155.7 billion in 2013. Since 2013, the US experienced significant health care reforms and treatment advances. This study analyzed recent data and literature to update the US economic burden estimate for schizophrenia.Methods: Direct and indirect costs associated with schizophrenia were estimated using a prevalence-based approach. Direct health care costs were assessed retrospectively using an exact matched cohort design in the IBM Watson Health MarketScan databases from October 1, 2015, through December 31, 2019. Patients with schizophrenia (identified using ICD-10-CM codes F20 and F25) were exactly matched to controls on demographics, insurance type, and index year. Direct non-health care costs were estimated using published literature and government data. Indirect costs were estimated using a human capital approach and the value of quality-adjusted life-years lost. Cost offsets were estimated to account for basic living costs avoided. Excess costs, comparing costs for individuals with and without schizophrenia, were reported in 2019 USD.Results: The estimated excess economic burden of schizophrenia in the US in 2019 was $343.2 billion, including $251.9 billion in indirect costs (73.4%), $62.3 billion in direct health care costs (18.2%), and $35.0 billion in direct non-health care costs (10.2%). The largest drivers of indirect costs were caregiving ($112.3 billion), premature mortality ($77.9 billion), and unemployment ($54.2 billion). Cost offsets, representing $6.0 billion (1.7%), were subtracted from direct non-health care costs.Conclusions: The estimated burden of schizophrenia in the US doubled between 2013 and 2019 and was $343.2 billion in 2019, highlighting the importance of effective strategies and treatment options to improve the management of this difficult-to-treat patient population.

Psychological Education Health Assessment Problems Based on Improved Constructive Neural Network.

In order to better assess the mental health status, combining online text data and considering the problems of lexicon sparsity and small lexicon size in feature statistics of word frequency of the traditional linguistic inquiry and word count (LIWC) dictionary, and combining the advantages of constructive neural network (CNN) convolutional neural network in contextual semantic extraction, a CNN-based mental health assessment method is proposed and evaluated with the measurement indicators in CLPsych2017. The results showed that the results obtained from the mental health assessment by CNN were superior in all indicators, in which F1 = 0.51 and ACC = 0.69. Meanwhile, ACC evaluated by FastText, CNN, and CNN + Word2Vec were 0.66, 0.67, 0.67, and F1 were 0.37, 0.47, and 0.49, respectively, which indicates the use of CNN in mental health assessment has feasibility.

Tunable, Low-Cost, Multi-Channel, Broadband Liquid Crystal Shutter for Fluorescence Imaging in Widefield Microscopy.

Bistable liquid crystal (LC) shutters have attracted much interest due to their low energy consumption and fast response time. In this paper, we demonstrate an electrically tunable/switchable biostable LC light shutter in biological optics through a three-step easy-assembly, inexpensive, multi-channel shutter. The liquid crystal exhibits tunable transparency (100% to 10% compared to the initial light intensity) under different voltages (0 V to 90 V), indicating its tunable potential. By using biomedical images, the response time, resolution, and light intensity changes of the LC under different voltages in three common fluorescence wavelengths are displayed intuitively. Particularly, the shutter's performance in tumor images under the near-infrared band shows its application potential in biomedical imaging fields.

The impact of lurasidone on functioning and indirect costs in adults with bipolar depression: a post-hoc analysis.

OBJECTIVE: The aim of this post-hoc analysis was to assess the impact of lurasidone monotherapy on functional impairment, productivity, and associated indirect costs in patients with bipolar depression. METHODS: Data were analyzed from a 6-week randomized, double-blind (DB; NCT00868699), placebo-controlled trial of lurasidone monotherapy and a 6-month open label extension (OLE; NCT00868959) study. Patients with bipolar depression who completed the 6-week DB trial were subsequently enrolled in the OLE. Analysis of the OLE was limited to patients who either continued lurasidone (LUR-LUR) or switched from placebo to lurasidone monotherapy (PBO-LUR). The Sheehan Disability Scale (SDS), which measures functional impairment and productivity, was collected at DB baseline, DB week 6/OLE baseline, OLE month 3, and OLE month 6. Annual indirect costs were calculated based on days lost or unproductive from work/school due to symptoms. Effect sizes (ES) in functioning and days lost/unproductive were reported for the DB trial and mean changes for the OLE. RESULTS: A total of 485 patients were enrolled in the DB trial (lurasidone: n = 323; placebo: n = 162) and 316 were in the lurasidone monotherapy group during the OLE (LUR-LUR: n = 210; PBO-LUR: n = 106). In the DB trial, improvements in functioning (work: ES = 0.36, p = .0071; social: ES = 0.55, p < .0001; family: ES = 0.50, p < .0001) were significantly greater for lurasidone compared to placebo. Reductions in days lost (ES = 0.33, p = .0050) and unproductive (ES = 0.45, p = .0001) were significantly higher for lurasidone vs. placebo. This resulted in a greater reduction in indirect costs for lurasidone vs. placebo (least squares mean (standard error) = -$32,322 ($2,100) vs. -$20,091 ($2,838)). Improvements in functioning and productivity were sustained during the 6-month OLE for both LUR-LUR and PBO-LUR. CONCLUSIONS: Lurasidone monotherapy for the treatment of bipolar depression significantly improved functioning and reduced indirect costs vs. placebo at week 6. Significant improvements in functioning and productivity were sustained for 6 months for both LUR-LUR and PBO-LUR.

Point-in-time survey of healthcare resource utilization, employment, quality of life and caregiver status by disease severity in patients with schizophrenia in the US.

OBJECTIVE: The objective of this survey was to assess patient outcomes and caregiver status by disease severity among patients with schizophrenia in the United States. METHODS: A point-in-time survey was conducted between July and October 2019 via the Adelphi Schizophrenia Disease Specific Programme. Psychiatrists reported on their next 10 eligible patients with schizophrenia including demographics, disease severity, treatment history and hospitalizations. Patients receiving treatment for schizophrenia were classified as mild, moderate or severe based on disease severity. Regression models adjusted for age, sex and race/ethnicity. RESULTS: Psychiatrists (n = 124) reported on 435 mild, 401 moderate and 247 severe patients. Greater severity of schizophrenia was associated with a greater number of hospitalizations related to schizophrenia relapse in the previous 12 months (moderate vs. mild: adjusted incidence rate ratio (aIRR) [95% CI] = 2.17 [1.60-2.94]; severe vs. mild: aIRR = 5.45 [3.59-8.27]), lower full-time employment (moderate vs. mild: adjusted odds ratio (aOR) = 0.15 [0.08-0.28]; severe vs. mild: aOR = 0.02 [0.002-0.12]) and greater unemployment due to disability (moderate vs. mild: aOR = 4.24 [3.02-5.97]; severe vs. mild: aOR = 10.85 [6.85-17.17]). Patients with severe vs. mild schizophrenia had lower average quality of life (QoL) measured by the EuroQoL 5-dimension Health Index (difference = -0.16 [-0.23-0.09]). Among patients requiring care, patients with severe vs. mild schizophrenia received more caregiver hours per week (aIRR = 1.89 [1.25-2.84]). CONCLUSIONS: Greater severity of schizophrenia was associated with a significantly greater number of hospitalizations and greater unemployment due to disability. Compared with mild schizophrenia, severe schizophrenia was associated with worse patient QoL and greater caregiver hours.

Healthcare resource utilization, costs and treatment patterns in patients with bipolar disorder treated with lurasidone or cariprazine.

OBJECTIVE: To compare healthcare resource utilization (HCRU), costs, and treatment adherence and persistence for patients with bipolar disorder treated with lurasidone or cariprazine. METHODS: Adult patients with bipolar disorder who initiated lurasidone or cariprazine as monotherapy or adjunctive therapy between 1 January 2016 and 30 June 2019 were identified from the IBM MarketScan Commercial and Medicare Supplemental Database. The date of the first claim for lurasidone or cariprazine was defined as the index date. A difference-in-difference (DID) analysis, which mitigated bias by using each cohort as its own control, compared the changes in HCRU and costs from 6-months pre-treatment (baseline) to 6-months post-treatment (follow-up) between the two cohorts. Treatment adherence (medication possession ratio and proportion of days covered) and persistence (time to discontinuation) were assessed during the 6-month post-treatment period. Adjusted analyses were conducted using inverse probability of treatment weighting on HCRU, costs, and time to discontinuation. RESULTS: A total of 16,683 patients treated with lurasidone and 4,128 patients treated with cariprazine were identified. Average age (39-40) and proportion female (68-71%) were similar between cohorts. Both cohorts had reductions in hospitalizations from baseline to follow-up, and the decrease was significantly greater for the lurasidone cohort compared to the cariprazine cohort (change in the proportions of patients with all-cause hospitalizations: -5.3% vs. -2.5%, DID = -2.8%, p<.001). The total healthcare costs increased from baseline to follow-up in both cohorts, and the increase was significantly lower for the lurasidone cohort (change in total all-cause healthcare cost per person: $3,413 vs. $4,642, DID=-$1,228, p = .022). The lurasidone cohort had significantly lower risk of discontinuing treatment (hazard ratio = 0.86, p<.001) than the cariprazine cohort. CONCLUSIONS: Patients with bipolar disorder treated with lurasidone had greater reductions in hospitalizations from 6-months pre-treatment to 6-months post-treatment and had a lower increase in total costs compared to patients treated with cariprazine.

Assessment of Visual Quality in Eyes with Forme Fruste Keratoconus and Mild and Moderate Keratoconus Based on Optical Quality Analysis System II Parameters.

PURPOSE: The study aimed to evaluate the visual quality of forme fruste keratoconus (FFK) and mild and moderate keratoconus by using an optical quality analysis system II (OQAS-II) and to explore the correlation between optical quality parameters and the disease progression. METHODS: Twenty-one normal eyes, twenty-one FFK eyes, twenty-one mild keratoconus eyes, and twenty-one moderate keratoconus eyes were included in this prospective study. The optical quality parameters, such as object scatter index (OSI), modulation transfer function cutoff (MTF cutoff), strehl ratio (SR), and OQAS-II values at contrasts of 100% (OV-100), 20% (OV-20), and 9% (OV-9), were measured by OQAS-II. The repeatability of these parameters was analyzed by intraclass correlation coefficient (ICC), repeatability coefficient (RC), and coefficient of variation (CVw). Correlations between optical quality parameters and mean central keratometry readings (K mean) were evaluated. The sensitivity and specificity of the parameters were analyzed using the receiver operating characteristic (ROC). RESULTS: All the optical quality parameters among four groups showed good repeatability (all ICC≥0.75). The MTF cutoff, SR, OV-100, OV-20, OV-9 in FFK, mild and moderate keratoconus eyes were significantly lower than those in the normal group (all P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all K mean) were evaluated. The sensitivity and specificity of the parameters were analyzed using the receiver operating characteristic (ROC). r = -0.710, P < 0.05). The ROC analyses of the MTF cutoff, SR, OV-100, OV-20, and OV-9 showed significant area under the curve (AUC) in discriminating FFK form normal, mild keratoconus from FFK, and moderate keratoconus from mild keratoconus (all. CONCLUSION: The repeatability of OQAS-II is good in measuring visual quality of normal as well as FFK, mild, and moderate keratoconus. The visual quality of the FFK, mild, and moderate keratoconus is worse than that in normal eyes. The OQAS-II has the potential value in screening FFK from normal eyes and might be a useful tool for evaluating the progression of keratoconus.

Pharmacoeconomic Evaluation of Cancer Biosimilars Worldwide: A Systematic Review.

Background and Purpose: The availability of oncology biosimilars is deemed as a fundamental strategy to achieve sustainable health care. However, there is scarce systematic evidence on economic effectiveness of cancer biosimilars. We aimed to synthesize evidence from pharmacoeconomic evaluation of oncology biosimilars globally, provide essential data and methodological reference for involved stakeholders. Materials and Methods: This systematic review was conducted in PubMed, embase, the Cochrane library, CRD, ISPOR and NICE utill December 31, 2019. Information on basic characteristics, evaluation methodology and results were extracted. Quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards Checklist. Results: For 17 studies identified (13 from Europe and four from United States), the overall quality was generally acceptable. A total of seven biological molecules involved with filgrastim, EPOETIN α, and trastuzumab leading the three. The mostly common evaluation perspective was payer, but the time horizon varied greatly. There were ten studies which adopted cost minimization analysis to evaluate efficiency while seven studies adopted budget impact analysis to address affordability, with cost ratio and cost saving being its corresponding primary endpoint. Although the comparability of included studies was limited and specific results were largely affected by uptake and price discount rates of the oncology biosimilar, the comprehensive results consistently favored its promotion. Conclusion: Globally, the economic evaluation of cancer biosimilars is in its initial phase. However, limited evidence from developed countries consistently supported both cost-effectiveness of efficiency and affordability of oncology biosimilars, while they were largely affected by uptake and price discount rate.

A Randomized Pilot Clinical Assessment Of Three Skincare Regimens On Skin Conditions In Infants.

INTRODUCTION: Few data are available on the comparison between the effects on infant skin of skin care products and those of water alone. PATIENTS AND METHODS: In this single-center, evaluator-blind, parallel-group pilot study, healthy infants were randomized to near-daily washing for 12 weeks (starting in the summer and finishing in the winter months) with a mild liquid baby wash followed by use of baby lotion (wash+lotion), water followed by baby lotion (water+lotion), or water alone. Clinical and instrumental assessments of skin moisturization and barrier function were made. RESULTS: As expected the skin condition in all groups was affected by the change of the season. The skin of infants in all groups was mildly deteriorated (clinical grading) and with reduced moisture levels and increased barrier function. Instrumental measurements indicated that skin moisture and barrier function were better maintained in the wash+lotion and water+lotion groups than in the water-only group at week 12. Clinical assessment scores increased slightly over 12 weeks in all groups (P<0.05). At week 12, the wash+lotion group (n = 44) had significantly less change from baseline in overall skin condition and softness (lower scores) than did the water+lotion (n = 43) or water-only (n = 43) groups. The wash+lotion regimen maintained stable erythema and rash scores with lower mean values over time than in the other groups. CONCLUSION: A regimen of a liquid baby wash and a baby skin lotion for 12 weeks resulted in less detrimental changes in instrumental and clinical measures of skin than using water and lotion or water alone.

Bioaccessibility and exposure assessment of trace metals from urban airborne particulate matter (PM10 and PM2.5) in simulated digestive fluid.

We describe a batch-extraction with simulated digestive fluid (salivary fluid, gastric fluid and intestinal fluid) to estimate the bioaccessibility of inhaled trace metals (TMs) in particulate matter less than 10 and 2.5 µm in aerodynamic diameter (PM10 and PM2.5). Concentrations of the assayed TMs (As, Cd, Cr, Ni, Mn, Cu, Zn, Sb, Hg and Pb) were determined in PM10 and PM2.5 samples by inductively coupled plasma-mass spectrometry. The TMs with the largest soluble fractions for airborne PM collected from winter and summer in saliva were Mn and Sb, respectively; in seasons this became Co in gastric fluid and Cu in intestinal fluid. Clearly, bioaccessibility is strongly dependent on particle size, the component of simulated digestive fluids (e.g., pH, digestive enzymes pepsin and trypsin), and the chemical properties of metal ions. The particle size and seasonal variation affected the inhaled bioaccessible fraction of PM-bound TMs during mucociliary clearance, which transported PM from the tracheal and the bronchial region to the digestive system. This study provides direct evidence for TMs in airborne PM being bioaccessible TMs are likely to possess an enhanced digestive toxic potential due to airborne PM pollution.

[Corrigendum] Integration of gene expression and DNA methylation profiles provides a molecular subtype for risk assessment in atherosclerosis.

After the publication of the article, the authors noted that they had made an error regarding the order of one of their names. For Professor Zheng Yu, the given name is Yu and the family name is Zheng, therefore he should be listed as Professor Yu Zheng in the author list and as the corresponding author. [the original article was published in the Molecular Medicine Reports 13: 4791-4799, 2016; DOI: 10.3892/mmr.2016.5120].

Integration of gene expression and DNA methylation profiles provides a molecular subtype for risk assessment in atherosclerosis.

The aim of the present study was to identify an effective method for detecting early­phase atherosclerosis (AS), as well as to provide useful DNA methylation profiles to serve as biomarkers for the detection of AS. A total of 300 individuals (150 AS patients and 150 healthy subjects) were recruited for peripheral blood DNA methylation analyses at 12 gene promoter loci using nested methylation­specific polymerase chain reaction in a test set. Based on the test set, the promoter methylation of TIMP metallopeptidase inhibitor 1 (TIMP1), ATP binding cassette subfamily A member 1 (ABCA1), and acetyl-CoA acetyltransferase 1 (ACAT1) were determined to be candidate biomarkers; demonstrating the highest sensitivity (88%) and specificity (90%). The biomarkers that were candidates for early AS detection were validated in an independent validation set (n=100). In the validation set, the combination of TIMP1, ABCA1 and ACAT1 methylation achieved sensitivity, specificity and coincidence rate values of 88, 70 and 79%, respectively. In the current pilot study, the patterns of DNA methylation of AS­associated genes were observed to be significantly altered in the peripheral blood of AS patients. Thus, the AS-specific methylation of the three­gene panel (TIMP1, ABCA1, and ACAT1) may serve as a valuable biomarker for the early detection of AS.