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Nevin Manimala Statistics

Prophylactic Central Neck Dissection in Papillary Thyroid Carcinoma: All Risks, No Reward

J Surg Res. 2021 Apr 7;264:230-235. doi: 10.1016/j.jss.2021.02.035. Online ahead of print.

ABSTRACT

BACKGROUND: Central neck dissection (CND) remains a controversial intervention for papillary thyroid carcinoma (PTC) patients with clinically negative nodes (cN0) in the central compartment. Proponents state that CND in cN0 patients prevents locoregional recurrence, while opponents deem that the risks of complications outweigh any potential benefit. Thus, there remains conflicting results amongst studies assessing oncologic and surgical outcomes in cN0 PTC patients who undergo CND. To provide clarity to this controversy, we sought to evaluate the efficacy, safety, and oncologic impact of CND in cN0 PTC patients at our institution.

MATERIALS AND METHODS: Six hundred and ninety-five patients with PTC who underwent thyroidectomy at our institution between 1998 and 2018 were identified using an institutional cancer registry and supplemental electronic medical record queries. Patients were stratified by whether or not they underwent CND; identified as CND(+) or CND(-), respectively. Patients were also stratified by whether or not they received adjuvant radioactive iodine (RAI) therapy. Patient demographics, pathologic results, as well as surgical and oncologic outcomes were reviewed. Standard statistical analyses were performed using ANOVA and/or t-test and chi-squared tests as appropriate.

RESULTS: Among the 695 patients with PTC, 492 (70.8%) had clinically and radiographically node negative disease (cN0). The mean age was 50 ± 1 years old and 368 (74.8%) were female. Of those with cN0 PTC, 61 patients (12.4%) underwent CND. CND(+) patients were found to have higher preoperative thyroid stimulating hormone (TSH) values, 2.8 ± 0.8 versus 1.5 ± 0.2 mU/L (P = 0.028) compared to CND(-) patients. CND did not significantly decrease disease recurrence, development of distant metastatic disease (P = 0.105) or persistence of disease (P = 0.069) at time of mean follow-up of 38 ± 3 months compared to CND(-) patients. However, surgical morbidity rates were significantly higher in CND(+) patients; including transient hypocalcemia (36.1% versus 14.4%; P < 0.001), transient recurrent laryngeal nerve (RLN) injury (19.7% vers us 7.0%; P < 0.001), and permanent RLN injury (3.3% versus 0.7%; P < 0.001).

CONCLUSIONS: The majority of patients at our institution with cN0 PTC did not undergo CND. This data suggests that CND was not associated with improvements in oncologic outcomes during the short-term follow-up period and led to increased postoperative morbidity. Therefore, we conclude that CND should not be routinely performed for patients with cN0 PTC.

PMID:33838407 | DOI:10.1016/j.jss.2021.02.035

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Nevin Manimala Statistics

Relationship between the expression of TNFR1-RIP1/RIP3 in peripheral blood and cognitive function in occupational Al-exposed workers: A mediation effect study

Chemosphere. 2021 Apr 3;278:130484. doi: 10.1016/j.chemosphere.2021.130484. Online ahead of print.

ABSTRACT

Aluminium (Al), not essential for biological activities, accumulates in the tissues. It exerts toxic effects on the nervous system, inducing in humans’ irreversible cognitive impairment. In this study, a cluster sampling method was used to observe the cognitive function of long-term occupational Al-exposed workers in a large Al factory, and determine the expression of peripheral blood tumour necrosis factor receptor 1 (TNFR1), receptor-interacting protein 1 (RIP1), and RIP3. TNF-alpha, expressed in blood macrophages and microglia, with its receptors TNFR1, TR1 and TR3, enhances the necroptosis of neurons. Additionally, the relationship between the expression of TNFR1, RIP1, and RIP3 in the peripheral blood of long-term occupational Al-exposed workers and changes in their cognitive function was explored. The differences in the distributions of clock drawing test (CDT) scores among the three groups were statistically significant (P < 0.05). The results of correlation analysis showed that RIP1 and RIP3 protein contents were negatively correlated with mini-mental state examination (MMSE) and CDT scores (P < 0.05). Plasma Al content was positively correlated with other biological indicators (P < 0.05), and negatively correlated with MMSE and CDT scores (P < 0.05). Results showed that RIP3 protein had an incomplete mediation effect between plasma Al content and cognitive function. This suggests that Al may affect cognitive function by influencing the expression of TNFR1, RIP1, and RIP3 in the nervous system.

PMID:33838418 | DOI:10.1016/j.chemosphere.2021.130484

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Lobular neoplasia detected at MRI-guided biopsy: imaging findings and outcomes

Clin Imaging. 2021 Mar 31;78:171-178. doi: 10.1016/j.clinimag.2021.03.026. Online ahead of print.

ABSTRACT

OBJECTIVE: To review MRI findings of pure lobular neoplasia (LN) on MRI guided biopsy, evaluate surgical and clinical outcomes, and assess imaging findings predictive of upgrade to malignancy.

METHODS: HIPAA compliant, IRB-approved retrospective review of our MRI-guided breast biopsy database from October 2008-January 2015. Biopsies yielding atypical lobular hyperplasia or lobular carcinoma in situ were included in the analysis; all biopsy slides were reviewed by a dedicated breast pathologist. Imaging indications, MRI findings, and histopathology were reviewed. Statistical analysis was performed using the two-tailed Fisher exact-test and the t-test, and 95% CIs were determined. A p < 0.05 was considered statistically significant.

RESULTS: Database search yielded 943 biopsies in 785 patients of which 65/943 (6.9%) reported LN as the highest risk pathologic lesion. Of 65 cases, 32 were found to have LN as the dominant finding on pathology and constituted the study population. All 32 findings were mammographically and sonographically occult. Three of 32 (9.3%) cases of lobular neoplasia were upgraded to malignancy, all LCIS (one pleomorphic and two classical). The most common MRI finding was focal, heterogenous non-mass enhancement with low T2 signal. No clinical features or imaging findings were predictive of upgrade to malignancy.

CONCLUSION: Incidence of pure lobular neoplasia on MRI guided biopsy is low, with comparatively low incidence of upgrade to malignancy. No imaging or clinical features are predictive of upgrade on surgical excision, therefore, prudent radiologic-pathologic correlation is necessary.

PMID:33838434 | DOI:10.1016/j.clinimag.2021.03.026

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Pre and postnatal exposure to mercury and respiratory health in preschool children from the Spanish INMA Birth Cohort Study

Sci Total Environ. 2021 Mar 20;782:146654. doi: 10.1016/j.scitotenv.2021.146654. Online ahead of print.

ABSTRACT

Effects of mercury on maturing immune system have been reported, however the association with respiratory and allergy problems during infancy remains unclear. The aim of this study is to evaluate the association between pre and postnatal mercury exposure and respiratory and allergy problems among preschool children and to examine the role of potential modifying factors. Study subjects were children participant in Spanish Childhood and Environment Project (INMA, 2003-2008). We measured total mercury levels in cord blood (n = 1868) and hair at 4 years of age (n = 1347). Respiratory outcomes (wheezing, severe wheezing, chestiness, persistent cough, eczema and otitis) were obtained by questionnaires administered to parents. Associations were investigated by logistic regression adjusted for socio-demographic and lifestyle-related variables in each cohort and subsequent meta-analysis. We tested effect modification by factors related to individual susceptibility, diet and co-exposure with other pollutants. The geometric mean of cord blood and hair total mercury was 8.20 μg/L and 0.97 μg/g, respectively. No statistically significant association between pre or postnatal mercury exposure and respiratory and allergy outcomes was found. Notwithstanding, lower maternal intake of fruits and vegetables increased the risk of some respiratory outcomes due to the prenatal exposure to mercury (pint < 0.05). Moreover, an inverse association between prenatal mercury exposure and some respiratory outcomes was observed among children with higher maternal exposure to organocholorine compounds or smoking (pint < 0.05). Also, sex and postnatal smoking exposure modulated mercury postnatal effects on persistent cough (pint < 0.05). In conclusion, no association between pre and postnatal mercury exposure and respiratory and allergy problems among the whole population at study was found. However, diet and other toxicants could modulate this relation, especially during prenatal period. More research on this topic is warranted due to the limited evidence.

PMID:33838378 | DOI:10.1016/j.scitotenv.2021.146654

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Identification of inference fallacies in solid waste generation estimations of developing countries. A case-study in Panama

Waste Manag. 2021 Apr 7;126:454-465. doi: 10.1016/j.wasman.2021.03.037. Online ahead of print.

ABSTRACT

The absence of sound sampling procedures and statistical analyses to estimate solid waste generation in many developing countries has resulted in incomplete historical records of waste quantity and composition. Data is often arbitrarily aggregated or disaggregated as a function of waste generators to obtain results at the desired spatial level of analysis. Inference fallacies arising from the generalization or individualization of results are almost never considered. In this paper, Panama, one of the fastest-growing developing countries, was used as a case-study to review the main methodological approaches to estimate solid waste generation per capita per day, and at different hierarchical levels (from households to the country). The solid waste generation intensity indicator is used by the Panamanian waste management authority to run the waste management system. It was also the main parameter employed by local and foreign companies to estimate solid waste generation in Panama between 2001 and 2008. The methodological approaches used by these companies were mathematically formalized and classified as per the expressions suggested by Subramanian et al. (2009). Seven inference fallacies (ecological, individualistic, stage, floating population, linear forecasting, average population and mixed spatial levels) were identified and allocated to the studies. Foreign companies committed three of the seven inference fallacies, while one was committed by the local entity. Endogenous knowledge played an important role in these studies to avoid spatial levels mismatch and multilevel measurements appear to produce more reliable information than studies obtained via other means.

PMID:33838385 | DOI:10.1016/j.wasman.2021.03.037

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Nevin Manimala Statistics

Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-blind Study With Long-term Extension

Clin Gastroenterol Hepatol. 2021 Apr 7:S1542-3565(21)00393-1. doi: 10.1016/j.cgh.2021.04.005. Online ahead of print.

ABSTRACT

BACKGROUND & AIMS: Pediatric functional constipation (PFC) is a common problem in children that causes distress and presents treatment challenges to healthcare professionals. We conducted a randomized, placebo-controlled trial (Study 1) in patients with PFC (aged 6-17 years) to evaluate the efficacy and safety of lubiprostone, followed by an open-label extension for those who completed the placebo-controlled phase (Study 2).

METHODS: Study 1 (NCT02042183) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week study evaluating the efficacy and safety of lubiprostone 12 mcg twice-daily (BID) and 24 mcg BID. Study 2 (NCT02138136) was a phase 3, long-term, open-label extension of Study 1. In both studies, lubiprostone doses were based on patients’ weight. Efficacy was assessed solely based on Study 1, with a primary endpoint of overall spontaneous bowel movement (SBM) response (increase of ≥1 SBM/week vs baseline and ≥3 SBMs/week for ≥9 weeks, including 3 of the final 4 weeks).

RESULTS: 606 patients were randomized to treatment (placebo: n=202; lubiprostone: n=404) in Study 1. No statistically significant difference in overall SBM response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245). Both the 12-mcg BID and 24-mcg BID doses of lubiprostone were well tolerated in the double-blind and extension phases, with a safety profile consistent with that seen in adult studies.

CONCLUSIONS: Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC, but did demonstrate a safety profile similar to that in adults.

PMID:33838349 | DOI:10.1016/j.cgh.2021.04.005

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Cranial nerve involvement in COVID-19

Am J Otolaryngol. 2021 Mar 26;42(5):102999. doi: 10.1016/j.amjoto.2021.102999. Online ahead of print.

ABSTRACT

INTRODUCTION: The COVID-19 disease emerged in Wuhan province of China in November 2019 and spread across the world in a short time, resulting in a pandemic. The first case in Turkey was detected on March 11, 2020. The aim of the current study was to reveal the effects of COVID-19 on cranial nerves by monitoring people infected with the disease based on repeated examinations and surveys.

MATERIAL AND METHOD: The data of 356 patients with a positive COVID-19 polymerase chain reaction (PCR) test who received treatment between June 2020 and August 2020 in our hospital were prospectively evaluated after the study was approved by the relevant ethics committee.

RESULTS: Of the 356 patients included in the study, 47 under the age of 18 years were excluded due to their unreliable examination and anamnesis findings. In addition, seven patients that died while in hospital were excluded from the study due to the lack of examination and survey records during their hospitalization. The data of the remaining 302 patients were statistically analyzed. Symptoms of cranial nerve involvement were observed in 135 patients.

CONCLUSION: The COVID-19 disease caused by the SARS-CoV2 virus commonly results in cranial nerve symptoms. The fact that these findings are more common and severe in COVID-19 than previous SARS and MERS outbreaks suggests that it has a more neurotrophic and more aggressive neuroinvasion. While the negative effects of the virus on sensory functions resulting from cranial nerve involvement are evident, motor functions are rarely affected.

PMID:33838359 | DOI:10.1016/j.amjoto.2021.102999

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Development of statistical models for estimating daily nitrate load in Iowa

Sci Total Environ. 2021 Mar 22;782:146643. doi: 10.1016/j.scitotenv.2021.146643. Online ahead of print.

ABSTRACT

There is an ongoing need to increase our understanding of the sources and timing of stream nitrate loads across agricultural watersheds in Iowa as water quality improvement strategies are implemented. The goal of this study was to model the relationship between nitrate load and the two components of streamflow (i.e., baseflow and stormflow) to quantify in-stream nitrate patterns and develop a new method for estimating loads on days when monitoring data are not available. We analyzed eight watersheds in Iowa that had long-term water quality data where grab samples have been collected from 1987 to 2019. Four regression models were developed that related daily nitrate load to daily baseflow, stormflow, and streamflow discharge. The first model considered baseflow as a predictor, the second model used stormflow, the third model included both baseflow and stormflow as two different covariates, and the final model used total streamflow (unseparated). For all eight watersheds, the baseflowstormflow models had the highest correlation coefficients, which indicates that both components are necessary and together improve nitrate load estimates. While baseflow models estimated lower nitrate loads better, stormflow models captured the variability associated with larger loads. In addition, streamflow models tended to overestimate large nitrate loads. This simple modeling framework can be used to calculate daily, monthly and annual nitrate loads. Delineating nitrate loads between stormflow and baseflow can help identify differences in nitrate sources for nutrient reduction and remediation.

PMID:33838365 | DOI:10.1016/j.scitotenv.2021.146643

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Nevin Manimala Statistics

Entrustable professional activity-based assessments in undergraduate medical education: A Survey of Pediatric Educators

Acad Pediatr. 2021 Apr 7:S1876-2859(21)00213-8. doi: 10.1016/j.acap.2021.03.020. Online ahead of print.

ABSTRACT

OBJECTIVE: To explore the use of entrustable professional activities (EPAs) in undergraduate medical education (UME), characterization of EPAs by pediatric educators, and opportunities and challenges with an EPA framework.

METHODS: In 2020, nine survey questions were administered to members of the Council on Medical Student Education in Pediatrics, a national pediatric UME group. Clark’s Commitment and Necessary Effort model on motivation served as the theoretical framework for our study. Quantitative and qualitative data were analyzed using descriptive statistics and conventional content analysis, respectively.

RESULTS: 167 (31%) of 479 recipients, representing 75% of accredited schools responded. 83% agreed that they understood what EPAs were, yet a minority reported using EPAs. 85% of EPA users expressed satisfaction with EPAs in providing a shared framework and an opportunity to track student competence; dissatisfaction was expressed towards faculty resource needs. Among non-users, barriers hindering implementation included faculty development challenges and faculty time. Qualitative analyses revealed a rich understanding of EPAs: that they offer a framework to measure learner competence by assessing performance in workplace-based tasks that can be used for entrustment decisions and for program evaluation.

CONCLUSIONS: Although most pediatric UME educators report understanding EPAs (contributing to self-efficacy) and recognize their benefits (value), a minority report actually using EPAs. EPAs, while providing a valuable framework, pose challenges from contextual factors affecting personal agency, which could affect educator commitment in implementation. For more widespread adoption of the EPAs, efforts should focus on minimizing these perceived barriers.

PMID:33838345 | DOI:10.1016/j.acap.2021.03.020

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United States internet searches for “infertility” following COVID-19 vaccine misinformation

J Osteopath Med. 2021 Apr 12. doi: 10.1515/jom-2021-0059. Online ahead of print.

ABSTRACT

CONTEXT: On December 1, 2020, Drs. Wolfgang Wodarg and Micheal Yeadon petitioned to withhold emergency use authorization of the BNT162b2 messenger ribonucleic acid vaccine for coronavirus disease 2019 (COVID-19) manufactured by BioNTech and Pfizer, raising concern for female infertility risks but acknowledging the lack of evidence. The European Medicines Agency and the US Food and Drug Administration ultimately issued emergency use authorizations, but misinformation claiming that COVID-19 vaccines cause female infertility began circulating on social media, potentially influencing public perception and medical decision making among pregnant patients or those seeking to become pregnant.

OBJECTIVES: To determine the potential influence misinformation may have had on public interest in infertility related topics, as analyzed through internet search statistics in the US.

METHODS: The Google Trends tool was used to analyze results for the search terms “infertility,” “infertility AND vaccine,” and “infertility AND COVID vaccine” in the US from February 4, 2020 to February 3, 2021. We applied autoregressive integrated moving average models to forecast expected values, comparing them with actual observed values.

RESULTS: At peak interest (100), the forecasted relative search volumes interest for the search terms “infertility,” “infertility AND vaccine,” and “infertility AND COVID vaccine” were 45.47 (95% CI, 33.27-57.66; p<0.001), 0.88 (95% CI, 2.87-4.63; p<0.001), and 0.29 (95% CI, -2.25-2.82; p<0.001). The actual relative search volumes at peak searching represented 119.9, 11,251, and 34,900% increases, respectively, when compared with forecasted values.

CONCLUSIONS: COVID-19 vaccine misinformation corresponded with increased internet searches for topics related to infertility in the US. Dispelling misinformation and informing patients about the risks and benefits of COVID-19 vaccination may prevent unnecessary vaccine hesitancy or refusal, contributing to successful vaccination efforts.

PMID:33838086 | DOI:10.1515/jom-2021-0059