Category: Statistics

Clin Exp Rheumatol. 2023 Dec 22. doi: 10.55563/clinexprheumatol/84kd56. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the clinical characteristics of subcutaneous emphysema (SE) and mediastinal emphysema (ME) occurring in patients with anti-melanoma differentiation-associated gene 5 antibody-positive dermatomyositis associated with interstitial lung disease (anti-MDA5-positive DM-ILD).

METHODS: In this retrospective study, a total of 117 anti-MDA5-positive DM-ILD patients were admitted to our hospital. All patients underwent assessment of autoantibodies, serum ferritin levels, and lung high-resolution CT scans.

RESULTS: In patients with anti-MDA5-positive DM-ILD, the incidence of SE/ME was found to be 11.1%, which was significantly higher compared to patients with anti-synthetase syndrome (p < 0.01). The mortality rate among anti-MDA5-positive DM-ILD patients with SE/ME was significantly higher than those without SE/ME (p = 0.0022). There was no statistically significant difference in the occurrence of SE/ME between patients with positive anti-Ro-52 antibodies and those with negative anti-Ro-52 antibodies (p = 0.18). Patients with higher serum ferritin levels (1000 ng/ml≤serum ferritin≤1500 ng/ml) had a higher likelihood of developing SE/ME compared to patients with lower serum ferritin levels (serum ferritin <500 ng/ml) (p < 0.01). Among 13 anti-MDA5-positive DM-ILD patients with SE/ME, six (46.2%) developed SE/ME within 1 month of being diagnosed and 53.8% of patients underwent positive pressure ventilation prior to the onset of SE/ME.

CONCLUSIONS: 1. SE/ME is not uncommon in anti-MDA5-positive DM-ILD and is an important factor associated with poor patient prognosis. 2. The occurrence of SE/ME is correlated with high levels of serum ferritin and is not related to anti-Ro-52 antibodies. 3. Rheumatologists should pay close attention to SE/ME caused by positive pressure ventilation in anti-MDA5-positive DM-ILD patients.

PMID:38147317 | DOI:10.55563/clinexprheumatol/84kd56

Updates Surg. 2023 Dec 26. doi: 10.1007/s13304-023-01733-y. Online ahead of print.

ABSTRACT

The aim of this pooled analysis was to evaluate the impact of robotic total mesorectal excision (TME) on pathology metrics in Male Overweight patients with Low rectal cancer (MOL). This was a multicenter retrospective pooled analysis of data. Two groups were defined: MOL (Male, Overweight, Low rectal cancer) and non-MOL. Overweight was defined as BMI ≥ 25 kg/m². Low rectal cancer was defined as cancer within 6 cm from the anal verge. The primary endpoints of this study were histopathological metrics, namely circumferential resection margin (CRM) (mm), CRM involvement rate (%), and the quality of TME. Circumferential resection margin (CRM) was involved if < 1 mm. 836 (106 MOL and 730 non-MOL) patients that underwent robotic TME by six surgeons over 3 years were compared. No significant differences in demographics and perioperative variables were found, except for operating time, distal margin, and number of lymph nodes harvested. CRM involvement rate did not significantly differ (7.5% vs. 5.5%, p = 0.395). Mean CRM was statistically significantly narrower in MOL patients (6.6 vs. 7.7 mm, p = 0.04). Quality of TME did not differ. Distance of tumor from the anal verge was the only independent predictor of CRM involvement. Robotic TME may provide optimal pathology metrics in overweight males with low rectal cancer. Although CRM was a few millimeters narrower in MOL, the values were within the range of uninvolved margins making the difference statistically significant, but not clinically. Being MOL was not a risk factor for involvement of circumferential resection margin.

PMID:38147292 | DOI:10.1007/s13304-023-01733-y

Updates Surg. 2023 Dec 26. doi: 10.1007/s13304-023-01730-1. Online ahead of print.

ABSTRACT

Concerning the perioperative outcomes of patients diagnosed with COVID-19 who underwent emergency laparotomy, more data must be collected. Because COVID-19 can affect multiple organs, cause various complications, and act as a risk factor for surgery, in this study, we aimed to compare the outcomes of emergency laparotomy between SARS-CoV-2 infected and uninfected patients. This retrospective cohort study was conducted on patients who underwent emergency laparotomy from December 2021 to December 2022. Postoperative outcomes were compared between patients with and without confirmed perioperative SARS-CoV-2 infection. The primary outcome was 30-day mortality. Secondary outcomes were postoperative intensive care unit admission, hospital length of stay, re-operation, and postoperative complications. Data were analyzed by SPSS statistic version 27. In this study, 50 patients in the COVID-19 group and 91 patients in the non-COVID-19 group were assessed. The 30-day mortality in the COVID-19 group was significantly higher than in the non-COVID-19 group (34% vs. 12.1%, respectively, P = 0.004). Postoperative complications were significantly higher in the COVID-19 group (64% vs. 26.4%, P < 0.001). The frequency of ICU admission and need for re-operation were significantly higher in the COVID-19 group (P = 0.003 and P = 0.039, respectively). Length of hospital stay was significantly lower in the non-COVID-19 group (P = 0.021). In patients with confirmed COVID-19, emergency laparotomy is associated with increased postoperative morbidity and mortality. Additionally, emergency laparotomy is associated with increasing postoperative complications, length of hospital stay, intensive care admission, and additional surgery requirement.

PMID:38147291 | DOI:10.1007/s13304-023-01730-1

J Endocrinol Invest. 2023 Dec 26. doi: 10.1007/s40618-023-02263-5. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess and compare the immunogenicity of recombinant Insulin Aspart [manufactured by BioGenomics Limited (BGL-ASP)] with its originator NovoRapid® (manufactured by Novo Nordisk) in adult patients with type 2 diabetes mellitus.

RESEARCH DESIGN AND METHODS: BGL-IA-CTP301 study was a randomized, open label, parallel group, multicenter phase-III clinical study to compare the efficacy and safety of recombinant Insulin Aspart 100 U/mL [manufactured by BioGenomics Limited (BGL-ASP)] with its reference medicinal product (RMP); NovoRapid® [manufactured by Novo Nordisk], in adult patients with Type 2 diabetes mellitus (T2DM). The primary objective of the study was to compare the immunogenicity of BGL-ASP and RMP; NovoRapid® in patient serum samples collected from phase-III clinical study. Immunogenicity was studied as the incidence of patients positive for anti-insulin Aspart (AIA) antibodies, developed against BGL-ASP/RMP at baseline, end of 12 week and end of 24 week of the treatment period. The changes in incidence of patients positive for AIA antibodies post-baseline were also studied to assess and compare the treatment-emergent antibody response (TEAR) between the treatment groups (BGL-ASP and RMP). Statistical evaluation was done by Fisher’s exact test to compare the overall incidence of patients positive for AIA antibodies and the TEAR positives observed post-baseline in both the treated groups. An in-vitro neutralizing antibody assay (Nab assay) was also performed to study the effect of AIA antibodies in neutralizing the biological activity/metabolic function of the insulin. The neutralizing potential of AIA was studied by its effect on %glucose uptake. We also evaluated the association between AIA antibody levels and its impact on biological activity by studying the correlation between them.

RESULTS: Analysis of immunogenicity data suggested that the percentage of patients positive for AIA antibodies until week 24 was similar and comparable in both the treatment groups, BGL-ASP and RMP; NovoRapid®. The changes in incidence of patients positive for AIA post-baseline in terms of TEAR positives were also similar and comparable between the treatment groups. The results of the Nab assay with confirmed positive AIA samples from BGL-ASP- and RMP-treated groups did not have any negative impact on %glucose uptake by the cells in Nab assay, confirming the absence of neutralizing antibodies in both the treatment groups. The correlation studies also showed absence of association between AIA antibody levels and percentage glucose uptake in both BGL-ASP and RMP-NovoRapid® treatment groups^. CONCLUSIONS: The immunogenicity assessment based on the overall incidence of patients positive for AIA, changes in incidence of patients positive for AIA post-baseline, TEAR rates and absence of neutralizing antibodies, were found to be apparently similar and comparable in both the treatment groups (BGL-ASP and RMP). We conclude from our studies that the immunogenicity of BGL-ASP is similar and comparable to RMP and the observed immunogenicity in terms of anti-insulin Aspart antibody levels had no impact on the biological activity of insulin.

PMID:38147290 | DOI:10.1007/s40618-023-02263-5

Environ Monit Assess. 2023 Dec 26;196(1):88. doi: 10.1007/s10661-023-12257-8.

ABSTRACT

Small island ecosystems and their inhabitants face a significant threat from global warming, jeopardizing their sustainability. These communities are particularly vulnerable to the impact of climate change, as they heavily rely on natural resources for their livelihoods and are more vulnerable than mainland regions. Therefore, it is essential to take urgent action to address the challenges small island states face and promote their resilience in the face of climate change. To preserve the coastal ecosystems in Karimunjawa Islands, Indonesia, this study proposes an alternative spatial plan through micro-zonation analysis. The study conducted literature reviews and field surveys to collect data and develop recommendations for the current spatial plans through spatial, descriptive statistics, and comparative analysis. The findings show that the sea surface temperatures of Karimunjawa and Kemujan Island have increased by 1-2 ℃. Stress levels were found for coral reefs at the bleaching warning position for all Karimunjawa Island marine areas, including Kemujan Island. Legon Lele and Tanjung Gelam were found to have suspended sediment traces and indications of heavy metal contamination, making them the research focus. The Karimunjawa micro-zonation boundaries were obtained, especially in the Legon Lele and Tanjung Gelam areas, with an area of 640.63 and 817.45 ha, respectively. The proposed micro-zonation for Karimunjawa National Park refers to watershed-sedimentary cells, making it an example of implementing integrated coastal management (ICM) spatial boundaries in Karimunjawa and other nations. By applying this micro-zonation, coastal ecosystem rehabilitation efforts can be carried out precisely.

PMID:38147264 | DOI:10.1007/s10661-023-12257-8

Environ Sci Pollut Res Int. 2023 Dec 26. doi: 10.1007/s11356-023-31494-5. Online ahead of print.

ABSTRACT

As part of their pursuit to succeed the Sustainable Development Goals (SDGs), European Union (EU) countries have placed great importance on realizing SDG 11, which aims to create sustainable cities and communities. The relationship between environmental quality and municipal solid waste remains understudied despite its significant impact on achieving SDG-11. Consequently, this study seeks to peruse municipal solid waste, renewable energy consumption, human capital, and natural resources impact on load capacity as a comprehensive measure of environmental quality. By utilizing the CS-ARDL approach, this study reveals the inadequacy of municipal solid waste conversion in EU countries and highlights the favorable effect of human capital and renewable energy on enhancing environmental quality. Moreover, this study provides concrete evidence that natural resources contribute to environmental corruption. EU economies should adopt policies to bolster municipal solid waste conversion to improve environmental quality.

PMID:38147253 | DOI:10.1007/s11356-023-31494-5

Environ Sci Pollut Res Int. 2023 Dec 26. doi: 10.1007/s11356-023-31588-0. Online ahead of print.

ABSTRACT

Policy adjustments can help strike a balance between economic growth and environmental sustainability, which has increasingly been the heart to nations and regions throughout the World. This paper examines how public investment affects economic growth, energy consumption, and CO2 emissions in eight ASEAN countries: Cambodia, Myanmar, Malaysia, Indonesia, the Philippines, Singapore, Thailand, and Vietnam. Extension of a Cobb-Douglas production function and application of panel cointegration techniques reveal bidirectional Granger causation between public investment and both private development and CO2 emissions from 1980 to 2019. Public investment Granger causes energy usage, the opposite does not hold statistically. More findings from pooled mean group estimations show a mean-reversion dynamic that corrects disequilibria by 14% yearly. State investment crowds in private sector growth, energy use, and carbon footprint. It also finds an inverted U-shaped relationship between public investment and energy consumption, and a U-shaped relationship between public investment and CO2 emissions, indicating complex regional interactions. It is suggested the implementation of public investment policies that enrich green infrastructure projects to foster growth while minimizing environmental impacts, and encourage a strategic approach to public investment for prioritizing environmental sustainability and thus, achieving Sustainable Development Goals 7 to 9 and 11 to 13 in this region.

PMID:38147250 | DOI:10.1007/s11356-023-31588-0

Infection. 2023 Dec 26. doi: 10.1007/s15010-023-02148-y. Online ahead of print.

ABSTRACT

BACKGROUND: Interstitial lung disease (ILD) is a new risk category for pneumocystis pneumonia (PCP) with a high mortality rate. The definite diagnostic criteria of PCP in ILD patients have not been established until now. The aims of this study were to identify potential risk factors of PCP in patients with ILD, and to evaluate the performance of metagenomic next-generation sequencing (mNGS), CD4 + T cell count, (1-3)-β-D-Glucan (BG) and lactate dehydrogenase (LDH) in the diagnosis of PCP in ILD patients.

METHODS: This is a retrospective, single-center, case-control study. ILD patients who underwent mNGS from December 2018 to December 2022 were included in the study. Based on the diagnosis criteria of PCP, these patients were divided into PCP-ILD and non-PCP-ILD groups. The potential risk factors for PCP occurrence in ILD patients were analysed via logistic regression. The diagnostic efficacy of mNGS was compared with serological biomarkers.

RESULTS: 92 patients with ILD were enrolled, 31 of which had a definite PCP and were assigned to the PCP-ILD group while 61 were to the non-PCP-ILD group. The infection rate of PJ in ILD patients was 33.7% (31/92). The history of glucocorticoid therapy, CD4 + T cell count, BG level and traction bronchiectasis on HRCT were associated with PCP occurrence in ILD patients. LDH level did not reach statistical significance in the logistic regression analysis. mNGS was confirmed as the most accurate test for PCP diagnosis in ILD patients.

CONCLUSION: ILD is a new risk group of PCP with high PCP prevalence. Clinicians should pay close attention to the occurrence of PCP in ILD patients who possess the risk factors of previous glucocorticoid therapy, decreased CD4 + T cell count, increased BG level and absence of traction bronchiectasis on HRCT. mNGS showed the most excellent performance for PCP diagnosis in ILD patients. Peripheral blood CD4 + T cell count and BG level are alternative diagnostic methods for PCP in ILD patients. However, the diagnostic value of serum LDH level was limited in ILD patients.

PMID:38147199 | DOI:10.1007/s15010-023-02148-y

Environ Monit Assess. 2023 Dec 26;196(1):91. doi: 10.1007/s10661-023-12268-5.

ABSTRACT

The analysis of animal hair is a useful and non-invasive investigation method for monitoring metal content, whose beginning dates to a few decades ago. This study addresses the issue of wildlife mortality in Piedmont and Aosta Valley by linking the evidence to the characteristics of the territories and to hair elemental profile. The considered animal species were badger, fox, marten, and wolf. The quantitative data for 11 trace metals and 16 lanthanides were evaluated considering animal location and death causes regarding impacts, whose relevant number was confined to the Turin province and to the badger and fox species. The evaluation of the analytical results was performed after the out of bounds sample identification by mean of statistics. For trace metals, some areas have thus been identified, mainly in Turin province, in which the large excess of As, Cd, and Pb was related to district pollution. Moreover, the lower contents of Fe, Mn, and Al in Aosta Valley badgers’ hair seem influenced by the different characteristics of the subsoil, in comparison to Piedmont, and a relationship with the living environment and the habits was suggested. Regarding lanthanides, Biella province represents an area in which environmental contamination and abundance of rare-earth elements was recorded.

PMID:38147193 | DOI:10.1007/s10661-023-12268-5

Clin Oral Investig. 2023 Dec 26;28(1):30. doi: 10.1007/s00784-023-05457-6.

ABSTRACT

OBJECTIVES: This follow-up study aimed to report the 24- and 30-month outcomes of a cohort previously enrolled in a randomized clinical trial on surgical reconstructive treatment of peri-implantitis.

METHODS: Twenty-four patients were diagnosed with peri-implantitis and treated with surgical reconstructive therapy with or without the adjunctive use of Er:YAG laser. Within-group and between-group comparisons were tested with mixed model with repeated measures.

RESULTS: Regarding peri-implant pocket depth (PPD) reduction (control vs. laser test group) between 6 months (- 1.85 vs. – 2.65 mm) and 30 months (- 1.84 vs. – 3.04 mm), the laser group showed statistically significant changes but not the control group. In terms of radiographic marginal bone loss (RMBL) at 6 months (- 1.1 vs. – 1.46 mm) to 24 months (- 1.96 vs. – 2.82 mm), both groups showed statistical difference compared to baseline. The six explanted implants all were featured by severe peri-implantitis and mostly with no or limited keratinized tissue (< 2 mm) at baseline and membrane exposure after surgery. Among the 15 retained cases, eight cases achieved more than 50% peri-implant bone level gain.

CONCLUSIONS: Within the limitation and follow-up time frame of this trial, the outcome of the surgical reconstructive therapy sustained or improved in most of the cases. However, 25% of the implants with severe peri-implantitis failed 2 years after the surgical reconstructive therapy. The use of Er:YAG laser favors PPD reduction in the longer term up to 30 months.

CLINICAL RELEVANCE: Longer-term follow-up on reconstructive therapy of peri-implantitis revealed sustained or improved stability in certain cases, but the survival of implants with severe peri-implantitis has its limitation, especially when there is limited keratinized tissue (< 2 mm or no KT).

TRIAL REGISTRATION: Clinical Trials Registration Number: NCT03127228 and HUM00160290.

PMID:38147180 | DOI:10.1007/s00784-023-05457-6