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Nevin Manimala Statistics

Functional outcomes and complications in refractory dysthyroid optic neuropathy management: Experience with 3 different surgical protocols

Am J Otolaryngol. 2022 Apr 11;43(3):103451. doi: 10.1016/j.amjoto.2022.103451. Online ahead of print.

ABSTRACT

INTRODUCTION: Dysthyroid optic neuropathy (DON) is the most severe complication of Graves’ orbitopathy (GO) and its management may require decompression surgery. Clear recommendations do not exist about which surgery should be performed and how extended the decompression should be. In this paper we present our experience regarding the management of DON via 3 different surgical protocols: a modified extended orbital apex decompression, a 2 walls decompression (inferior and lateral) and a 3 walls decompression (inferior, lateral and medial) and evaluate the functional outcomes.

METHODS: Retrospective evaluation of subjects affected by DON not responding to medical therapy has been performed. All patients were submitted to pre- and post-operative ophthalmologic evaluations and orbital and sinuses CT scan in order to evaluate functional and surgical outcomes.

RESULTS: 27 patients were enrolled in the study. Surgical procedures were performed on 42 orbits. A statistically significant post-operative improvement was recorded in visual acuity, proptosis, color vision and fundus oculi evaluation for all groups. No patient developed major or minor complications after surgery.

CONCLUSIONS: Extended endonasal approach and 3 walls decompression have been proved effective in the management of DON. The choice between them is done according to degree of proptosis, general status and eye-surface damages.

PMID:35439657 | DOI:10.1016/j.amjoto.2022.103451

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Nevin Manimala Statistics

Seropositivity and neutralising antibodies at six months after BNT162b2 vaccination in patients with solid tumours

Eur J Cancer. 2022 Apr 16;168:51-55. doi: 10.1016/j.ejca.2022.03.013. Online ahead of print.

ABSTRACT

AIM: Patients with cancer are at an increased risk for severe coronavirus disease of 2019. We previously reported initial findings from a single centre prospective study evaluating antibody response after BNT162b2 vaccine, showing that adequate antibody response was achieved after two doses, but not after one, in patients with cancer vaccinated during anticancer therapy. Herein, we report a follow-up study, evaluating antibody response six months after the second vaccine dose.

METHODS: The study included patients with solid tumours undergoing anticancer treatment, and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) IgG and neutralising antibodies (Nabs) were measured approximately six months after the second vaccine dose. Complete blood count values were collected and evaluated as predictors for antibody response.

RESULTS: The analysis included 93 patients with cancer (66.7% metastatic). Six months after the second vaccine dose (mean 176 ± 20 days), seropositivity rate among patients and controls was 83.9% versus 96.3% (p = 0.0001), respectively. Median RBD-IgG titre was lower among patients compared with controls (2.3 versus 3.2, p = 0.0002). Among seropositive individuals, median Nabs titre was similar between patients with cancer and controls (p = 0.566). Among patients with cancer, lymphocyte and neutrophil counts were not correlated with either RBD-IgG or Nabs titres.

CONCLUSIONS: Seropositivity rates and RBD-IgG titre at six months after second BNT162b2 vaccine dose are lower among patients with cancer compared with healthy controls. However, Nabs titre is similar, suggesting a comparable protection among seropositive individuals. Lymphocyte count is not predictive of antibody response.

PMID:35439660 | DOI:10.1016/j.ejca.2022.03.013

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Nevin Manimala Statistics

A parametric head geometry model accounting for variation among adolescent and young adult populations

Comput Methods Programs Biomed. 2022 Apr 10;220:106805. doi: 10.1016/j.cmpb.2022.106805. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Modeling the size and shape of human skull and scalp is essential for head injury assessment, design of helmets and head-borne equipment, and many other safety applications. Finite element (FE) head models are important tools to assess injury risks and design personal protective equipment. However, current FE head models are mainly developed based on the midsize male, failing to account for the significant morphological variation that exists in the skull and brain. The objective of this study was to develop a statistical head geometry model that accounts for size and shape variations among the adolescent and young adult population.

METHODS: To represent subject-specific geometry using a homologous mesh, threshold-based segmentation of head CT scans of 101 subjects between 14 and 25 years of age was performed, followed by landmarking, mesh morphing, and projection. Skull and scalp statistical geometry models were then developed as functions of age, sex, stature, BMI, head length, head breadth, and tragion-to-top of head using generalized Procrustes analysis (GPA), principal component analysis (PCA) and multivariate regression analysis.

RESULTS: The statistical geometry models account for a high percentage of morphological variations in scalp geometry (R2=0.63), outer skull geometry (R2=0.66), inner skull geometry (R2=0.55), and skull thickness (error < 1 mm) CONCLUSIONS: Skull and scalp statistical geometry models accounts for size and shape variations among the adolescent and young adult population were developed as functions of subject covariates. These models may serve as the geometric basis to develop individualized head FE models for injury assessment and design of head-borne equipment.

PMID:35439654 | DOI:10.1016/j.cmpb.2022.106805

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Nevin Manimala Statistics

Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow up? Statistical analysis plan for the MEL-SELF randomised controlled trial

Contemp Clin Trials. 2022 Apr 16:106761. doi: 10.1016/j.cct.2022.106761. Online ahead of print.

ABSTRACT

BACKGROUND: The MEL-SELF trial is a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised cutaneous melanoma (stage 0, I, II). The primary trial aim is to determine if patient led-surveillance compared to clinician-led surveillance increases the proportion of participants who are diagnosed with a new primary or recurrent melanoma at a fast-tracked unscheduled clinic visit. The secondary outcomes include time to diagnosis of any skin cancer, psychosocial outcomes, acceptability, and resource use.

OBJECTIVE: The objective of this report is to outline and publish the pre-determined statistical analysis plan before the database lock and the start of analysis.

METHODS/DESIGN: The statistical analysis plan describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes, and their respective analyses. In addition, we present the planned sensitivity and subgroup analyses. A separate analysis plan will be published for health economic outcomes.

RESULTS: The MEL-SELF statistical analysis plan has been designed to minimize bias in estimating effects of the intervention on primary and secondary outcomes. By pre-specifying analyses, we ensure the study’s integrity and believability while enabling the reproducibility of the final analysis.

CONCLUSION: This detailed statistical analysis plan will help to ensure transparency of reporting of results from the MEL-SELF trial.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered 18 February 2021, https://www.anzctr.org.au/ACTRN12621000176864.aspx.

PMID:35439647 | DOI:10.1016/j.cct.2022.106761

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Nevin Manimala Statistics

The emerging relevance of H3K27 trimethylation loss in meningioma: A systematic review of recurrence and overall survival with meta-analysis

World Neurosurg. 2022 Apr 16:S1878-8750(22)00496-X. doi: 10.1016/j.wneu.2022.04.048. Online ahead of print.

ABSTRACT

BACKGROUND: It has been proposed in the most recent 2021 World Health Organization (WHO) Classification of brain tumors that the loss of trimethylation at histone 3 lysine site 27 (H3K27me3) may prognosticate meningioma outcomes. However to date the emerging literature remains diffuse in its stance on this. Correspondingly, the aim of this study was to determine the prognostic relevance of H3K27me3 loss in meningiomas METHODS: Searches of 7 electronic databases from inception to October 2021 were conducted following PRISMA guidelines. Articles were screened against pre-specified criteria. Outcomes were pooled by random-effects meta-analyses of proportions where possible.

RESULTS: A total of 7 retrospective cohort studies satisfied all criteria. There were 2180 meningioma patients overall, with 1291 (59%) male patients, and a mean age of 56 years old. Across all 7 studies, the pooled incidence of H3K27me3 loss was estimated to be 15% (95% CI 8-24%). Across 6 studies the pooled multivariate-derived HR estimate for recurrence was 1.77 (95% CI 1.23-2.31, P<0.01). Overall survival by univariate analysis was significantly shorter with H3K27me3 loss in 2/4 (50%) studies, and 2 studies described significant association between H3K27me3 loss and shorter overall survival by means of multivariate analysis.

CONCLUSION: The contemporary metadata favors greater recurrence of meningioma based independently on H3K27me3 loss that is statistically significant. It is possible that these effects are more pronounced in Grade 2 meningiomas, but more robust data and analysis is needed to augment this position.

PMID:35439620 | DOI:10.1016/j.wneu.2022.04.048

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Nevin Manimala Statistics

Risk assessment of the exposure of Spanish children to acrylamide using human biomonitoring

Environ Pollut. 2022 Apr 16:119319. doi: 10.1016/j.envpol.2022.119319. Online ahead of print.

ABSTRACT

Acrylamide (AA) is an organic contaminant that naturally forms in starchy foods during high-temperature cooking under low-moisture conditions. It is mainly produced from the sugars and amino acids present in food by the Maillard reaction. When humans are exposed to AA, AA is eliminated in the urine as mercapturic acid conjugates, primarily including N-acetyl-S-(2-carbamoylethyl)-L-cysteine (AAMA), N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-L-cysteine (GAMA3), and N-acetyl-3-[(3-amino-3-oxopropyl)sulfinyl]-L-alanine (AAMA-Sul), which are used as exposure biomarkers of AA in human biomonitoring studies. Although the carcinogenic effects of AA on humans have not been demonstrated yet, some studies have shown that AA may negatively affect children’s health. The main objective of this study was to evaluate the exposure of Spanish children (n = 612) to AA. For this purpose, the levels of AAMA, AAMA-Sul, and GAMA3 in first-morning urine samples were analyzed by “dilute and shoot” and liquid chromatography coupled to tandem mass spectrometry. The three metabolites were detected in all the children involved in this study in the following order (geometric mean (GM)): AAMA (79 ng ml-1) > AAMA-Sul (28 ng ml-1) > GAMA3 (18 ng ml-1). Statistical analysis suggested that the intake of fried potato products and biscuits could be associated with higher levels of AA metabolites in urine. Estimated daily intakes of AA in the children under study were in the range of 1.2-1.5 μg AA·kg-body weight-1·day-1 (GM). Risk assessment calculations indicate that the health risk of AA exposure cannot be overlooked and the exposure of Spanish children to AA should be closely monitored.

PMID:35439595 | DOI:10.1016/j.envpol.2022.119319

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Nevin Manimala Statistics

A study on lipoprotein-a and PAI-1 in women with polycystic ovary syndrome

Horm Mol Biol Clin Investig. 2022 Apr 20. doi: 10.1515/hmbci-2021-0044. Online ahead of print.

ABSTRACT

OBJECTIVES: PCOS is the most common endocrinological disorder amongst women of reproductive age. The consequences of PCOS extend beyond the reproductive axis and may lead to the development of metabolic syndrome leading to a high risk for hypertension and cardiovascular disease. Therefore, a more comprehensive evaluation of biochemical markers that reflect the cardiovascular risk is required for further understanding of pathophysiologic mechanisms, diagnosis and management.

METHODS: In this case-control study, women diagnosed with PCOS (n=100) in the age group (18-35 years) years were taken as cases and age matched healthy controls (n=100) were enrolled. Estimations of fasting plasma Glucose, serum total cholesterol (TC), triglycerides (TG) and High-density lipoprotein (HDL) concentrations were assayed while Low-density lipoprotein (LDL) was calculated by using Fredrickson Friedwald’s formula. Serum Lipoprotein-a (Lp-a) was estimated using ELISA (Enzyme Linked Immunosorbent Assay). The quantitative data were expressed as Mean ± Standard Deviation (SD). Unpaired Student’s t-test was used to compare the values (PCOS vs Controls) and Pearson’s correlation coefficient was used to elucidate the relationship between the variables.

RESULTS: FBS and all lipid parameters were significantly increased in PCOS patients compared to control subjects. On the other hand, HDL-C was significantly decreased as compared to the control subjects. The hormones TSH, LH, FSH, PRL and LH/FSH ratio were significantly increased in PCOS patients compared to control subjects. Lipoprotein-a and PAI-1 was significantly increased in PCOS patients compared to the control subjects. Upon bivariate correlation analysis, Lp(a) had significant correlations with PAI-1 (r=0.35, p=0.000), WHR (r=0.25, p=0.000), LDL (r=0.52, p=0.000) and TSH (r=0.24, p=0.000). While the correlations with FBS (r=-0.008, p=0.91) and LH/FSH ratio (r=-0.004, p=0.95) were statistically insignificant.

CONCLUSIONS: The evaluation of serum biomarkers such as Lp-a, PAI-1 and lipid profile routinely in PCOS patients may have diagnostic role in the early detection of metabolic abnormalities and endocrine derangements and timely management of comorbid Diabetes and Cardiovascular disease in PCOS females.

PMID:35439403 | DOI:10.1515/hmbci-2021-0044

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Nevin Manimala Statistics

Sergej Aleksandrovich Novoselsky (1872-1953)

Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2022 Mar;30(2):339-342. doi: 10.32687/0869-866X-2022-30-2-339-342.

ABSTRACT

The article is devoted to one of the founders of sanitary and demographic statistics in Russia. The works of S. A. Novoselsky covering issues of natality, total and child mortality, average life expectancy attained blaze of publicity and until present time keep their significance. S. A. Novoselsky developed for the first time both complete Russian population mortality tables and first the USSR population mortality tables.

PMID:35439400 | DOI:10.32687/0869-866X-2022-30-2-339-342

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Nevin Manimala Statistics

The research activity of students in “The public health and health care, health care economics” discipline

Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2022 Mar;30(2):307-311. doi: 10.32687/0869-866X-2022-30-2-307-311.

ABSTRACT

The article considers research work of students in “The Public health and health care, health economics” discipline in 2001-2020, organized in course of public health and health care of the Medical Institute of Petrozavodsk State University. The article reveals such concepts as student scientific activity, knowledge requirements for discipline to prepare student research work, classification of student research works by degree of collection and analysis of material, levels of student work performance, stages and classes of social hygienic research, requirements for content of presentation, criteria of evaluating report and presentation. During 2001-2021, 250 students of medical institute in the section “Public health and health care” made more than 200 reports, published more than 20 thesis and articles. The annual plan of 30 topics for student research works was developed, including requirements for content of presentation, 3 indices to evaluate quality of work. The text of presentation-report in 90% included information on one discipline “Public health and health care, health economics”. At that, topic was disclosed in format of describing research objectives with construction of diagrams and graphs, comparison of indices and only 10% of reports contained statistical analysis of the results.

PMID:35439395 | DOI:10.32687/0869-866X-2022-30-2-307-311

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Nevin Manimala Statistics

The classifier of surgical operations and manipulations in system of medical services financing in the Kyrgyz Republic

Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2022 Mar;30(2):318-321. doi: 10.32687/0869-866X-2022-30-2-318-321.

ABSTRACT

The health care reforms in the Kyrgyz Republic are directed to develop hospital financing system. In 2003 the system of clinical-cost groups was introduced. The surgical clinical-cost groups are organized on the basis of existing classifier “The Surgical Operations and Manipulations”, which is not revised since its approval in 1997, that resulted in distortion of statistical information. Hence, need in development and implementation of modern reference book is obvious. The purpose of the study is to comparatively analyze international classifiers of surgical operations and manipulations, to evaluate their accordance to clinical practice in the Kyrgyz Republic and to develop new national classifier to be applied in the Kyrgyz Republic. The actually applied national classifier of Surgical Operations and Manipulations includes 2181 types of surgical interventions, 250 (12%) out of which have no accurate formulation (for example “The other types of brain surgeries”). In addition, 453 (21%) surgical operations are not applied. The detailed analysis of such international classifiers as the International Classification of Diseases-10 Procedure Coding System (ICD-10-PCS), the Australian Classification of Health Interventions (ACHI), the NOMESCO Classification of Surgical Procedures (NCSP), Nomenclature of Health Services, the Russian Nomenclature of Health Services (RNHS) was implemented. The systematization of analyzed data permitted to determine the Russian classifier “Nomenclature of medical services” as the most optimal for implementation in the Kyrgyz Republic. The obtained and analyzed data made it possible for the Ministry of Health of the Kyrgyz Republic to proceed activities related to development of new classifier of surgical interventions on the basis of the Nomenclature of Medical Services of the Russian Federation.

PMID:35439397 | DOI:10.32687/0869-866X-2022-30-2-318-321