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Nevin Manimala Statistics

Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis

Clin Chem Lab Med. 2022 Feb 3. doi: 10.1515/cclm-2022-0053. Online ahead of print.

ABSTRACT

OBJECTIVES: Among the diagnostic tests that have recently become commercially available for diagnosing coronavirus disease 2019 (COVID-19), the fully-automated Roche Elecsys severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen electrochemiluminescence immunoassay (ECLIA) is one of the most widespread for its adaptability within a system of laboratory automation, rapidity and high-throughput. This article is aimed to provide the results of the first pooled analysis of its accuracy for diagnosing SARS-CoV-2 infections.

CONTENT: We carried out an electronic search in Scopus and Medline, without language or date restrictions (i.e., up to January 18, 2022), to identify articles where the diagnostic performance of Roche Elecsys SARS-CoV-2 antigen ECLIA was compared with that of reference molecular diagnostic techniques.

SUMMARY: Overall, 11 studies were identified, 10 of which (n=6,095 swabs) provided necessary data for inclusion in a pooled analysis. The pooled diagnostic sensitivity, specificity and area under the curve (AUC) in nasopharyngeal samples were 0.68 (95%CI, 0.66-0.70), 0.99 (95%CI, 0.99-0.99) and 0.958 (95%CI, 0.936-0.980), respectively. The cumulative observed agreement with reference molecular assays was 89.5% and the kappa statistic was 0.735 (95%CI, 0.716-0.754). The pooled diagnostic sensitivity in samples with high viral load (i.e., cycle threshold values <28-30) was 0.95 (95%CI, 0.92-0.97).

OUTLOOK: The results of this pooled analysis confirm that the fully-automated Roche Elecsys SARS-CoV-2 antigen ECLIA has high diagnostic specificity and optimal diagnostic sensitivity for identifying nasopharyngeal samples with higher viral load, thus making it a reliable technique for mass screening and for supporting strategies based on shorten isolation and/or quarantine.

PMID:35114742 | DOI:10.1515/cclm-2022-0053

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Multi-dimensionality of patient reported outcome measures in rhinoplasty satisfaction

Facial Plast Surg. 2022 Feb 3. doi: 10.1055/a-1760-1422. Online ahead of print.

ABSTRACT

Background The FACE-Q rhinoplasty module (nose and nostrils), Utrecht Questionnaire and NOSE-scale are validated Dutch patient-reported outcome measures (PROMs) to evaluate rhinoplasty satisfaction. The objective of this study was to analyze the dimensionality of the measured variables in these four existing questionnaires. Additionally, we investigated the ability of the PROMS to measure change. Methods A prospective single center study was performed in a consecutive cohort of 106 Dutch-speaking patients. Patients were invited to fill in four PROMs: FACE-Q rhinoplasty module (nose and nostrils), Utrecht Questionnaire and NOSE-scale, preoperatively and 3 months postoperatively. Item quality was calculated in all four questionnaires. The ability of the questionnaires to differentiate between pre-and postoperative patients was determined with a binary logistic regression. Exploratory factor analysis was performed to determine the latent dimensions. Results Item quality was confirmed in all questionnaires. Backward binary logistic regression revealed that NOSE and FACE-Q nose module were the best discriminant factors pre- and postoperatively. Combination of these two questionnaires gave a specificity of 97,33% and a sensitivity of 94.52% to discriminate between pre-and post-operative cases. Exploratory factor analysis identified the presence of 4 dimensions: 1) cosmesis of the nose 2) cosmesis of the nostrils 3) nasal function and 4) psychosocial well-being in rhinoplasty patients. Lack of factorial invariance in the pre- as compared to the postoperative phase was detected, especially with the FACE-Q nose and to a lesser extent with the Utrecht questionnaire.

PMID:35114725 | DOI:10.1055/a-1760-1422

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Comparison of Optical Forceps-Assisted Single-Port Laparoscopic PIRS and Open Surgery in Morgagni Hernia Repair

Eur J Pediatr Surg. 2022 Feb 3. doi: 10.1055/s-0042-1742663. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to compare the results of classical surgery (CS) and optical forceps-assisted single-port laparoscopic percutaneous internal ring suturing (SP-PIRS) repair for the treatment of Morgagni hernia.

MATERIALS AND METHODS: Patients with Morgagni hernia who were operated on between January 2005 and July 2020 were included in the study. Patients were divided into two groups (CS or SP-PIRS) and compared retrospectively in terms of demographic data, defect size, duration of hospitalization, costs, postoperative complications, and recurrence.

RESULTS: Thirty-two patients were included in this study. There were no statistically significant differences between the groups in terms of gender, defect size, postoperative complications, and recurrence (p > 0.05). The SP-PIRS group had a shorter operation time (p < 0.01), shorter hospital stay (p = 0.02), and lower cost (p < 0.01) than the CS group. The average follow-up was 24 months, and recurrence was detected in two patients in each group.

CONCLUSION: SP-PIRS repair is recommended because it is practical to perform and reduces the duration of surgery, hospital stay, and cost. It is superior to other laparoscopic techniques, as there is no need to use additional study forceps, except in extreme cases, and the surgeon can perform the procedure without an assistant to hold the laparoscope.

PMID:35114718 | DOI:10.1055/s-0042-1742663

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Accuracy of Intraoperative Mechanical Axis Alignment to Long-Leg Radiographs following Robotic-Arm-Assisted Unicompartmental Knee Arthroplasty

J Knee Surg. 2022 Feb 3. doi: 10.1055/s-0042-1742647. Online ahead of print.

ABSTRACT

Improper alignment and implant positioning following unicompartmental knee arthroplasty (UKA) has been shown to lead to postoperative pain and increase the incidence of revision procedures. The use of robotic-arm assistance for UKA (RAUKA) has become an area of interest to help overcome these challenges. The accuracy of intraoperative alignment compared with standing long-leg X-rays postoperatively following medial RAUKA has been in question. Therefore, the purpose of this study was to (1) determine final mean intraoperative coronal alignment in extension utilizing an image based intraoperative navigation system, and (2) compare final intraoperative alignment to 6-week weight-bearing (WB) long-leg X-rays. Patients who underwent RAUKA for medial compartmental osteoarthritis were identified from January 1, 2018, to August 31, 2019, through our institution’s joint registry. The query yielded 136 (72 right and 64 left) patients with a mean age of 72.02 years and mean body mass index (BMI) of 28.65 kg/m2 who underwent RAUKA. Final intraoperative alignment was compared with WB long leg X-rays 6 weeks postoperatively by measuring the mechanical alignment. Statistical analysis was primarily descriptive. Pearson’s correlation coefficient was used to determine the relationship between intraoperative alignment to 6-week alignment. A p-value of <0.05 was considered statistically significant. Mean intraoperative coronal alignment after resections and trialing was 4.39 varus ± 2.40 degrees for the right knee, and 4.81 varus ± 2.29 degrees for the left knee. WB long-leg X-rays 6 weeks postoperatively demonstrated mechanical axis alignment for the right and left knees to be 3.01 varus ± 2.10 and 3.7 varus ± 2.38 degrees, respectively. This resulted in a change in alignment of 1.36 ± 1.76 and 1.12 ± 1.84 degrees for the right and left knees, respectively (p < 0.05). Pearson’s correlation coefficient demonstrated a correlation of 0.69 between intraoperative to long-leg-X-ray alignment. RAUKA demonstrates excellent consistency when comparing postoperative WB long-leg X-rays to final intraoperative image-based non-WB alignment.

PMID:35114720 | DOI:10.1055/s-0042-1742647

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Does Metformin Treatment in Pediatric Population Cause Vitamin B12 Deficiency?

Klin Padiatr. 2022 Feb 3. doi: 10.1055/a-1702-2614. Online ahead of print.

ABSTRACT

BACKGROUND/AIM: There have been no studies to date examining the effect of metformin treatment on vitamin B12 status in children and adolescents. In this prospective study, the effects of metformin on blood vitamin B12, serum methylmalonic acid (MMA), homocysteine and holo-transcobalamin-II (holo-TC-II) levels were assessed in pediatric age group.

MATERIALS AND METHODS: This prospective study was conducted at the Pediatric Endocrinology and Adolescent Department between January 2017 and March 2019. Metabolic syndrome and polycystic ovary syndrome diagnosed patients with insulin resistance and/or impaired glucose tolerance, patients with type 2 diabetes mellitus (DM) treated with metformin were enrolled in study. Blood vitamin B12, MMA, homocysteine, holo-TC-II levels and hemogram values were evaluated.

RESULTS: Twenty-four patients were enrolled in study. Among these, 15 (62.5%) were female. The mean age of patients was 13.7±2.3 (10-19) years. Sixteen patients were diagnosed with metabolic syndrome and 8 patients were type 2 DM. At 6-month follow-up of all patients, there was no statistically significant difference in terms of vitamin B12, homocysteine, MMA and holo-TC-II levels. A 0.6% decline in vitamin B12 levels were revealed. At 12-month follow-up of 11 patients (45.8%) (6 Type 2 DM, 5 metabolic syndrome), no statistically significant difference was determined in vitamin B12, homocysteine, MMA and holo-TC-II levels. There were 6% decline in vitamin B12 levels and 10.9% increase in homocysteine levels, 5.4% decrease was detected in holo-TC-II level.

CONCLUSION: Although no significant changes in the serum vitamin B12, homocysteine, MMA or holo-TC-II levels with metformin therapy were detected, long-term prospective studies with high-dose metformin treatment in pediatric population are needed to confirm our results.

PMID:35114702 | DOI:10.1055/a-1702-2614

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Geographical identification of strawberries based on stable isotope ratio and multi-elemental analysis coupled with multivariate statistical analysis: A Slovenian case study

Food Chem. 2022 Jan 21;381:132204. doi: 10.1016/j.foodchem.2022.132204. Online ahead of print.

ABSTRACT

The geographical classification and authentication of strawberries were attempted using discriminant and class-modelling methods applied to stable isotopes of light elements and elemental composition. The work involved creating a database of 92 authentic Slovenian strawberry samples and 32 imported samples. All samples were harvested between 2018 and 2020. A good geographical classification of Slovenian and non-Slovenian strawberries was obtained despite different production years using discriminant approaches. However, for verifying compliance with a given specification (geographical indications), a class-modelling approach was used to build an unbiased verification model. Class models generated by data-driven soft independent modelling of class analogy (DD-SIMCA) had high sensitivity (96% to 97%) and good specificity (81% to 91%) on a yearly basis, while a more generalised model combining total yearly data gave a lower specificity (63%). Of the 33 commercially available samples (test samples) with declared Slovenian origin, 39% were from outside of Slovenia.

PMID:35114619 | DOI:10.1016/j.foodchem.2022.132204

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Uncertainties in occupational eye lens doses from dosimeters over the apron in interventional practices

J Radiol Prot. 2022 Feb 3. doi: 10.1088/1361-6498/ac5187. Online ahead of print.

ABSTRACT

INTRODUCTION AND OBJECTIVES: It is relevant to estimate the uncertainties in the estimation of eye lens doses from a personal dosimeter over the protective apron without using additional dosimetry near the eyes. Additional dosimetry for interventionists represents a difficulty for routine clinical practice. This study analyses the estimated eye doses from dosimeter values taken at chest level over the apron and their uncertainties.

METHODS: Measurements of Hp(0.07) using OSL dosimeters located on the chest over the apron and on the glasses (in the inner and outer part of the protection) were taken from 10 interventionalists in a university hospital, in the period 2018-2019 during standard clinical practice.

RESULTS: For a total sample of 133 interventional procedures included in our study, the ratio between the Hp(0.07) on the glasses (left-outer side) and on the chest over the apron had an average of 0.74, with quartiles of 0.47, 0.64, 0.88. Statistically significant differences were found among operators using the U-Mann-Whitney test. The average transmission factor for the glasses was 0.30, with quartiles of 0.21, 0.25, 0.32.

CONCLUSION: Different complexity in the procedures, in the quality of the scatter radiation and in the individual operational practices, involve a relevant dispersion in the results for lens dose estimations from the over apron dosimeter. Lens doses may be between a 64% and an 88% of the over apron dosimeter values (using median or 3rd quartile). The use of 88% may be a conservative approach.

PMID:35114656 | DOI:10.1088/1361-6498/ac5187

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Can FeNO be a biomarker in the post-COVID-19 patients monitoring?

Respir Med. 2022 Jan 26;193:106745. doi: 10.1016/j.rmed.2022.106745. Online ahead of print.

ABSTRACT

The nature of the inflammatory and fibrotic processes found in patients with post-COVID-19 syndrome makes it possible to speculate that in such patients fractional exhaled nitric oxide (FeNO) may be a useful biomarker. Consequently, we set out to verify the consistency of this hypothesis. We consecutively enrolled 68 post-COVID patients after being hospitalized for persistent clinical manifestations within 2 months from disease onset and 29 healthy volunteers as control group. None of post-COVID patients had bronchial asthma or were being treated with a corticosteroid. Only 19 out of 68 post-COVID-19 patients reported a FeNO value > 25 ppb. The mean FeNO value in post-COVID-19 patients was 18.55 ppb (95% CI: 15.50 to 21.58), while in healthy subjects it was 17.46 ppb (95% CI: 15.75 to 19.17). The mean difference was not statistically significant (P = 0.053). However, the mean FeNO value of post-COVID-19 patients was higher in men than in women (20.97 ppb; 95% CI: 16.61 to 25.33 vs 14.36 ppb; 95% CI: 11.11 to 17.61) with a difference between the two sexes that was statistically significant (P = 0.016). Mean FeNO was 14.89 ppb (95% CI: 10.90 to 18.89) in patients who had been treated with systemic corticosteroids because of their COVID-19, and 20.80 ppb (95% CI: 16.56 to 25.04) in those who had not taken them, with a difference that was statistically significant (P = 0.043). The data generated in this study suggest that measurement of FeNO is not useful as a biomarker in post-COVID-19 patient. However, this hypothesis needs solid validation with additional specifically designed studies.

PMID:35114576 | DOI:10.1016/j.rmed.2022.106745

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Menopausal hormone therapy and risk of cardiovascular events in women with prediabetes or type 2 diabetes: A pooled analysis of 2917 postmenopausal women

Atherosclerosis. 2022 Jan 22;344:13-19. doi: 10.1016/j.atherosclerosis.2022.01.016. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The effect of MHT on cardiovascular disease (CVD) risk among women with prediabetes or type 2 diabetes (PreDM or T2DM) is unclear. We examined the association between ever or early use MHT and CVD risk in postmenopausal women with PreDM or T2DM, and the potential modifying effect of race.

METHODS: 2,917 postmenopausal women with PreDM or T2DM were pooled from 3 prospective CVD cohorts (the Atherosclerosis Risk in Communities, the Multi-Ethnic Study of Atherosclerosis, and the Jackson Heart Study). Ever (yes vs no) or early use of MHT (MHT initiated ≤5 vs > 5 years since menopause), and their associations with ischemic stroke, coronary heart disease (CHD), and atherosclerotic cardiovascular disease (ASCVD) were assessed using Cox proportional hazards models.

RESULTS: During a median follow-up of 15 years, 264 stroke, 484 CHD, and 659 ASCVD events were observed. In fully adjusted models, ever use of MHT was associated with reduced risk of stroke (hazard ratio 0.86, 95% CI 0.76-0.98), CHD (0.85, 0.74-0.98), and ASCVD (0.83, 0.73-0.95) in white women with PreDM or T2DM. Early use of MHT was associated with reduced risk of stroke (0.82, 0.72-0.95), CHD (0.85, 0.74-0.98), and ASCVD (0.82, 0.70-0.96) in the white group. No risk reduction with ever or early use of MHT was found for black women with PreDM or T2DM.

CONCLUSIONS: MHT is associated with statistically reduced CVD risk among white but not black women with PreDM or DM. Race is an effect modifier in the association between MHT use and CVD.

PMID:35114556 | DOI:10.1016/j.atherosclerosis.2022.01.016

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Spatial identification of restored priority areas based on ecosystem service bundles and urbanization effects in a megalopolis area

J Environ Manage. 2022 Jan 31;308:114627. doi: 10.1016/j.jenvman.2022.114627. Online ahead of print.

ABSTRACT

Rapid urbanization has altered the structure and function of urban ecosystems with respect to the demand for planning ecological restoration to inhibit ecological degradation. However, there is still a challenge to quickly and effectively identify the restored priority areas to maximize ecological service (ES) supply and enhance human well-being. Taking the Shenzhen metropolitan region as a case study area, this study identified the restored priority sites based on the ES bundles evolution and urbanization effects. The ES bundles were identified by analyzing the spatial dynamics under the hybrid urban landscape, then the impact of urbanization on the ES bundles was explored using linear regression analysis characterized by different levels of urbanization in different stages. Furthermore, the spatial statistics were used to identify the priority sites. The results showed that 68.78% of the grids had changed their ES bundles in terms of their quantities, types, and sites in Shenzhen during 1978-2018. The urbanization driver spatially shifts from provision of service to regulation and cultural ecosystem services and significantly negatively influences the composition and structure of the ES bundles in different urbanization stages. 1196 of the 1 square kilometer grids, which accounted for 54.17%, were identified to prioritize for ecological restoration in Shenzhen. However, only 4.08% of them need to set as the key ecological restoration site. This study explored an effectively spatial way to implement ecological restoration planning in a rapidly urbanized area.

PMID:35114516 | DOI:10.1016/j.jenvman.2022.114627