Category: Statistics

Nutr Clin Pract. 2023 Dec 28. doi: 10.1002/ncp.11112. Online ahead of print.

ABSTRACT

BACKGROUND: The objective of this quality-improvement project was to increase documentation rates of anthropometrics (measured weight, length/height, and body mass index [BMI], which are critical to identify patients at malnutrition (undernutrition) risk) from <50% to 80% within 24 hours of hospital admission for pediatric patients.

METHODS: Multidisciplinary champion teams on surgical, cardiac, and intensive care (ICU) pilot units were established to identify and iteratively test interventions addressing barriers to documentation from May 2016 to June 2018. Percentage of patients with documented anthropometrics <24 h of admission was assessed monthly by statistical process control methodology. Percentage of patients at malnutrition (undernutrition) risk by anthropometrics was compared by χ² for 4 months before and after intervention.

RESULTS: Anthropometric documentation rates significantly increased (P < 0.001 for all): BMI, from 11% to 89% (surgical), 33% to 57% (cardiac), and 16% to 51% (ICU); measured weight, from 24% to 88% (surgical), 69% to 83% (cardiac), and 51% to 67% (ICU); and length/height, from 12% to 89% (surgical), 38% to 57% (cardiac), and 26% to 63% (ICU). Improvement hospital-wide was observed (BMI, 42% to 70%, P < 0.001) with formal dissemination tactics. For pilot units, moderate/severe malnutrition (undernutrition) rates tripled (1.2% [24 of 2081] to 3.4% [81 of 2374], P < 0.001).

CONCLUSION: Documentation of anthropometrics on admission substantially improved after establishing multidisciplinary champion teams. Goal rate (80%) was achieved within 26 months for all anthropometrics in the surgical unit and for weight in the cardiac unit. Improved documentation rates led to significant increase in identification of patients at malnutrition (undernutrition) risk.

PMID:38153693 | DOI:10.1002/ncp.11112

Int Urol Nephrol. 2023 Dec 28. doi: 10.1007/s11255-023-03889-3. Online ahead of print.

ABSTRACT

PURPOSE: Patients with atrial fibrillation (AF) and end-stage renal disease on chronic hemodialysis are at risk for thromboembolic and bleeding events. We aimed to perform a meta-analysis to evaluate the safety and efficacy of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) in this population.

METHODS: We systematically searched PubMed, Excerpta Medica Database (EMBASE) and Cochrane Library for randomized controlled trials (RCTs) comparing DOACs with VKAs in patients with AF on chronic hemodialysis from inception to February 2023 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Outcomes were reported using risk ratios (RRs) with 95% confidence intervals (CIs). Statistical analyses were performed using R version 4.2.2.

RESULTS: We selected three RCTs including 341 patients, of whom 176 (51.6%) were randomized to DOACs. Follow-up ranged from 174 days to 3.38 years. There was no significant difference between groups in terms of cardiovascular mortality (RR 1.34; 95% CI 0.69-2.60; p = 0.39), all-cause mortality (RR 0.96; 95% CI 0.72-1.27; p = 0.77), ischemic/uncertain type of stroke or transient ischemic attack (RR 0.50; 95% CI 0.19-1.35; p = 0.17), or major or life-threatening bleeding (RR 0.70; 95% CI 0.39-1.25; p = 0.22).

CONCLUSION: In this meta-analysis of three RCTs, no significant difference was observed between DOACs and VKAs in cardiovascular mortality, all-cause mortality, ischemic/uncertain type of stroke or transient ischemic attack, or major or life-threatening bleeding in patients with AF on chronic hemodialysis.

PMID:38153665 | DOI:10.1007/s11255-023-03889-3

Curr Med Sci. 2023 Dec;43(6):1173-1182. doi: 10.1007/s11596-023-2812-8. Epub 2023 Dec 28.

ABSTRACT

BACKGROUND AND OBJECTIVE: Although drugs are powerful therapeutic agents, they have a range of side effects. These side effects are sometimes cellular and not clinically noticeable. Vildagliptin/metformin hydrochloride is one of the most widely used oral antidiabetic drugs with two active ingredients. In this study, we investigated its harmful effects on the metabolic activation system in healthy human pancreatic cells “hTERT-HPNE”, and we aimed to improve these harmful effects by natural products. To benefit from the healing effect, we used the unique natural products produced by the bees of the Anzer Plateau in the Eastern Black Sea Region of Turkey.

METHODS: Cytotoxic and genotoxic effects of the drug were investigated by different tests, such as MTT, flow cytometry-apoptosis and comet assays. Anzer honey, pollen and propolis were analyzed by gas chromatography/mass spectrometry (G/C-MS). A total of 19 compounds were detected, constituting 99.9% of the samples.

RESULTS: The decrease in cell viability at all drug concentrations was statistically significant compared to the negative control (P<0.05). A statistically significant decrease was detected in the apoptosis caused by vildagliptin/metformin hydrochloride with the supplementation of Anzer honey, pollen and propolis in hTERT-HPNE cells (P<0.05).

CONCLUSION: This study can contribute to other studies testing the healing properties of natural products against the side effects of oral antidiabetics in human cells. In particular, Anzer honey, pollen and propolis can be used as additional foods to maintain cell viability and improve heal damage and can be evaluated against side effects in other drug studies.

PMID:38153628 | DOI:10.1007/s11596-023-2812-8

Paediatr Drugs. 2023 Dec 28. doi: 10.1007/s40272-023-00613-7. Online ahead of print.

ABSTRACT

BACKGROUND: Anti-disialoganglioside (anti-GD2) monoclonal antibodies are effective immunotherapeutic drugs for treating neuroblastoma, yet their toxicity spectrum is unclear.

OBJECTIVE: This study aimed to assess the toxicity profiles of three anti-GD2 monoclonal antibodies (dinutuximab, dinutuximab β, and naxitamab) in clinical applications by mining and evaluating the adverse drug reaction (ADR) signals from the US Food and Drug Administration Adverse Event Reporting System.

METHODS: Data in the US Food and Drug Administration Adverse Event Reporting System from the time anti-GD2 monoclonal antibodies became available in the market to the first quarter of 2023 were searched. The signals of anti-GD2 monoclonal antibody-associated ADRs were quantified using four types of algorithms, including the reporting odds ratio, the proportional reporting ratio, the combination of the proportional reporting ratio and χ² statistic method used by the UK Medicines and Healthcare Products Regulatory Agency, and the Bayesian confidence propagation neural network. The ADRs were categorized by System Organ Class based on the Medical Dictionary for Regulatory Activities, and were sorted according to the frequency and signal strength of ADRs.

RESULTS: A total of 370 adverse drug event reports with anti-GD2 monoclonal antibodies listed as the ‘primary suspected drugs’ were identified, with 116 ADR signals detected, of which 22 were not in the drug labels. Among the adverse drug event reports, 276 reports concerned dinutuximab/dinutuximab β as primary suspected drugs with 90 ADR signals, involving 19 System Organ Classes, of which 21 signals were not in the label; 94 adverse drug event reports concerned naxitamab as the primary suspected drug with 26 ADR signals, involving 11 System Organ Classes, of which one was not in the label. For dinutuximab/dinutuximab β-related ADRs, the top five most frequent were “fever”, “abdominal pain”, “elevated aspartate aminotransferase (AST)”, “elevated alanine aminotransferase (ALT)” and “hypotension”; the top five most intensive signals were “hypoalbuminemia”, “elevated AST”, “capillary leakage syndrome”, “hypoxia” and “elevated ALT”. For naxitamab-related ADRs, the top five most frequent were “hypotension”, “pain”, “urticarial”, “hypertension” and “rash”; the top five most intensive signals were “hypotension”, “urticaria”, “hypoxemia”, “bronchospasm” and “hypertension”. Involved System Organ Classes included “investigations” and “respiratory, thoracic and mediastinal disorders” containing the most types of ADR signals in dinutuximab/dintuximab β-related ADRs and naxitamab-related ADRs, respectively.

CONCLUSIONS: Our study comprehensively analyzed the toxicity profiles of anti-GD2 monoclonal antibodies and provides an important reference for clinical monitoring and ADR identification of these drugs.

PMID:38153627 | DOI:10.1007/s40272-023-00613-7

Mar Biotechnol (NY). 2023 Dec 28. doi: 10.1007/s10126-023-10278-5. Online ahead of print.

ABSTRACT

The study aimed to compare the effects of crystalline L-lysine and L-glutamate (CAA), Lys-Glu dipeptide (KE) on the growth and muscle development of grass carp (Ctenopharyngodon idellus), and related molecular mechanisms. Five experimental diets (CR, 0.5% CAA, 1.5% CAA, 0.5% KE, 1.5% KE) containing Lys and Glu as free (Lys and Glu, CAA) dipeptide (Lys-Glu, KE) forms were prepared, respectively. A total of 450 juvenile grass carp with an initial weight of 10.69 ± 0.07 g were randomly assigned to 15 cages, and 5 treatments with 3 replicates of 30 fish each for 61 days of feeding. The results showed that the group of 0.5% KE exhibited the best growth performances according to the indicator’s weight gain rate (WGR) and specific growth rate (SGR), although no statistically significant occurred among all groups; diet supplemented with 0.5% CAA significantly elevated the condition factor (CF) and viscerasomatic index (VSI) of juvenile grass carp. Diet supplemented with different Lys and Glu co-forms at different levels promoted the muscle amino acid content compared with those of CR group. Comparing with the CR group and other groups, the hardness of 0.5% CAA group significantly increased, and the springiness of 0.5% KE group excelled. Both the muscle fiber diameter and density of 0.5% KE group showed significant difference with those of the CR group, and a negative correlation between them was also observed. To uncover the related molecular mechanism of the differences caused by the different co-forms of Lys and Glu, the effect of different diets on the expressions of protein absorption, muscle quality, and antioxidation-related genes was analyzed. The results suggested that comparing with those of CR group, the dipeptide KE inhibited the expressions of genes associated with protein metabolism, such as AKT, S6K1, and FoxO1a but promoted PCNA expression, while the free style of CAA would improve the FoxO1a expression. Additionally, the muscle development-related genes (MyoD, MyOG, and Myf5) were significantly boosted in CAA co-form groups, and the expressions of fMYHCs were blocked but fMYHCs30 significantly promoted in 0.5% KE group. Finally, the effect of different co-forms of Lys and Glu on muscle antioxidant was examined. The 0.5% CAA diet was verified to increase GPX1a but obstruct Keap1 and GSTP1 expressions, resulting in enhanced SOD activity and reduced MDA levels in plasma. Collectively, the different co-forms of Lys and Glu influenced the growth of juvenile grass carp, and also the muscle development and quality through their different regulation on the protein metabolism, muscle development- and antioxidative-related genes.

PMID:38153607 | DOI:10.1007/s10126-023-10278-5

Adm Policy Ment Health. 2023 Dec 28. doi: 10.1007/s10488-023-01325-3. Online ahead of print.

ABSTRACT

Measurement feedback systems (MFS) can help guide treatment and improve clinical outcomes. Studies of MFS are heterogeneous both in execution and results, and the effects of MFS seem restricted by limited attention to process and implementation elements and by limited adoption by health professionals. The current systematic review mapped the use of process and implementation elements in MFS studies. An overview of therapists’ use of and attitudes toward MFS is provided. Three-level meta-analyses were used to test theoretically informed process and implementation elements as moderators of the effects of MFS. Hypotheses and general propositions from Clinical Performance Feedback Intervention Theory (CP-FIT) were used to organize the elements of the studies and were used as moderator variables. Previous studies on MFS interventions have had a limited focus on implementation efforts and process elements that may increase the effects of MFS and their use among therapists. Efforts have sparsely been made to reduce barriers to MFS use, and several studies have reported limited engagement with MFS among therapists. Therapists’ attitudes toward MFS, feedback, or standardized measures were heterogeneously reported, making data synthesis challenging. Identified process and implementation elements were not significantly associated with effect sizes in the studies and the results did not support the propositions of CP-FIT. The lack of statistically significant associations may be due to limited reporting of details about process and implementation aspects. More research designed to test hypotheses regarding process and implementation elements is needed to improve the use and effects of MFS. Future studies should aspire to report findings in a manner that allows for an understanding of the implementation process and therapists’ adoption of these systems.

PMID:38153585 | DOI:10.1007/s10488-023-01325-3

Environ Sci Pollut Res Int. 2023 Dec 28. doi: 10.1007/s11356-023-31611-4. Online ahead of print.

ABSTRACT

Strengthening the synergistic management of carbon and haze is an important means to realize China’s “carbon peaking and carbon neutrality goals” and green development. In this paper, the entropy method is used to measure the key core technology innovation level of 30 provinces in China from 2011 to 2021, and the fixed-effect model is used to empirically test the impact of key core technology innovation on carbon haze synergistic governance and the internal mechanism. The study found that (1) key core technological innovation helps to promote carbon haze synergistic governance. (2) The mechanism test shows that key core technology innovation promotes the synergistic management of carbon haze by improving the clean energy structure. (3) The moderating effect shows that both market incentives and government environmental regulations will strengthen the positive relationship between key core technology innovation and carbon haze synergistic governance. The main contribution of this paper is to reveal the influence mechanism of key core technology innovation on carbon haze synergistic governance, and also to provide theoretical basis for the mechanism and law of carbon haze synergistic governance.

PMID:38153575 | DOI:10.1007/s11356-023-31611-4

Clin Oral Investig. 2023 Dec 28;28(1):43. doi: 10.1007/s00784-023-05453-w.

ABSTRACT

OBJECTIVES: This clinical study aims to analyze the levels of cortisol, dehydroepiandrosterone (DHEA), and tumor necrosis factor alpha (TNF-α) in the gingival crevicular fluid (GCF) of persons with bruxism and to compare the efficacy of botulinum toxin (botox) and occlusal splint treatments through biomarkers.

MATERIALS AND METHODS: A total of 40 patients with bruxism were selected according to the clinical examination and anamnesis of which 20 received occlusal splint treatment and 20 botox treatment. GCF samples were taken from the patients before and after treatment. Cortisol, DHEA, and TNF-α levels were measured by enzyme-linked immunosorbent assay test. The change in measurements between time and groups and the time-group interaction were tested by repeated measures ANOVA.

RESULTS: There was a statistically significant difference between the cortisol levels before and after treatment in both groups (p = 0.001). In individuals with bruxism, a statistically significant decrease in cortisol levels was observed after both treatments (p < 0.05), while DHEA levels increased after treatment but were not statistically significant (p > 0.05). There was no statistically significant difference between TNF-α intra-group measurements (p > 0.05).

CONCLUSIONS: Stress and inflammatory biomarkers were found to be associated with bruxism. Cortisol levels decreased in people with bruxism after treatment with both occlusal splint and botox.

CLINICAL RELEVANCE: Both splint and botox treatments were effective for bruxism by reducing the stress levels.

PMID:38153567 | DOI:10.1007/s00784-023-05453-w

Clin Oral Investig. 2023 Dec 28;28(1):48. doi: 10.1007/s00784-023-05452-x.

ABSTRACT

OBJECTIVES: To assess the effect of Tideglusib and CHIR99021 small molecules on the odontogenic differentiation potential of human dental pulp stem cells (hDPSCs) via Wnt/β-catenin pathway activation.

METHODOLOGY: hDPSCs were isolated from impacted third molars indicated for extraction and were characterized by flow cytometry. hDPSCs were then induced to differentiate into odontogenic lineage in the presence of Tideglusib and CHIR99021. Odontogenic differentiation was evaluated using Alizarin Red stain and RT-PCR for expression of odontogenic specific differentiation markers: DSPP, DMP1, ALP, OPN, and RUNX2 in relation to undifferentiated cells. RT-PCR was also conducted to assess the expression of Wnt/β-catenin pathway activation marker (AXIN2). One-way ANOVA Kruskal-Wallis test was used for statistical analysis.

RESULTS: Wnt/β-catenin pathway was successfully activated by Tideglusib and CHIR99021 in hDPSCs where AXIN2 was significantly upregulated. Successful odontogenic differentiation was confirmed by Alizarin Red staining of calcified nodules. RT-PCR for odontogenic differentiation markers DSPP, DMP1, and RUNX expression by hDPSCs induced by CHIR99021 was higher than that expressed by hDPSCs induced by Tideglusib, whereas expression of OPN and ALP was higher in Tideglusib-induced cells than in CHIR99021-induced cells.

CONCLUSIONS: Both small molecules successfully induced odontogenic differentiation of hDPSCs through Wnt/β-catenin pathway activation.

CLINICAL RELEVANCE: These findings suggest that Tideglusib and CHIR99021 can be applied clinically in pulp regeneration to improve strategies for vital pulp regeneration and to promote dentine repair.

PMID:38153556 | DOI:10.1007/s00784-023-05452-x

Clin Oral Investig. 2023 Dec 28;28(1):50. doi: 10.1007/s00784-023-05461-w.

ABSTRACT

OBJECTIVES: Limitations of clinical periodontal measurements have led to the search for reliable biomarkers that can be used in diagnosis and monitoring of periodontal diseases. Considering the relationship of adipokines with periodontal disease, diabetes, and obesity, apelin may be a biomarker for periodontal diseases due to its modulating effects on inflammation. The present study was conducted to determine gingival crevicular fluid (GCF) apelin levels in systemically healthy individuals and to evaluate the potential of apelin as a biomarker for periodontal diagnosis.

MATERIALS AND METHODS: Ten individuals with clinically healthy periodontal tissues, 10 patients diagnosed with gingivitis, and 10 patients with periodontitis were included in the present study. Whole mouth clinical periodontal measurements were recorded and GCF samples were obtained from the buccal approximal regions of single-rooted teeth with features that would represent clinical periodontal diagnosis. Apelin level in the samples was determined by ELISA. Clinical and biochemical findings were statistically analyzed. Possible relationship between the variables was evaluated with Pearson correlation analysis.

RESULTS: Apelin level in the gingivitis group was higher than that in the clinically healthy group (p = 0.000) and lower than that in the periodontitis group (p = 0.000). A positive correlation was found between GCF apelin concentration and plaque score, bleeding on probing, and probing depth (p = 0.000).

CONCLUSIONS: Within the limits of this study, it can be suggested that GCF apelin concentration may be a biomarker that can distinguish between healthy periodontal tissues, gingivitis, and periodontitis patients.

CLINICAL RELEVANCE: Apelin concentration in the gingival crevicular fluid may aid in the diagnosis of periodontal disease.

PMID:38153555 | DOI:10.1007/s00784-023-05461-w