Tag: statistics

Circ Heart Fail. 2025 Mar 11:e011381. doi: 10.1161/CIRCHEARTFAILURE.123.011381. Online ahead of print.

ABSTRACT

BACKGROUND: Despite favorable hemodynamic and neurohormonal effects, endothelin receptor antagonists have not improved outcomes in patients with heart failure (HF), possibly because they cause fluid retention.

METHODS: In this randomized, double-blind, multicenter trial (SERENADE [Macitentan in Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease]), we evaluated the effects of an endothelin receptor antagonist, macitentan, in patients with HF, left ventricular ejection fraction ≥40%, and pulmonary vascular disease. After a 4-week placebo run-in (to ensure clinical stability), followed by a 5-week single-blind macitentan run-in, patients who did not exhibit fluid retention were randomized to macitentan or placebo. The primary end point was change in NT-proBNP (N-terminal pro-B-type natriuretic peptide; baseline to 24 weeks); secondary end points included change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score (baseline to 24 weeks) and time to worsening HF by 52 weeks.

RESULTS: Of 230 patients enrolled, 28 were excluded during the placebo run-in, 60 excluded during the macitentan run-in, and 142 were randomized. Macitentan had no effect on change in NT-proBNP (geometric mean ratio [macitentan/placebo], 1.02 [90% CI, 0.88-1.19]; P=0.79) or on secondary end points (placebo-corrected change in KCCQ clinical summary score, -3.5 [90% CI, -8.2 to +1.2]; P=0.22). Worsening HF occurred in 20 (28%) patients assigned to macitentan and 13 (18%) assigned to placebo (hazard ratio, 1.48 [90% CI, 0.83-2.67]; P=0.24). More macitentan-treated patients developed fluid retention (16 [23%] versus 10 [14%]) and cardiac adverse events (33 [46%] versus 22 [31%]) versus placebo.

CONCLUSIONS: Despite a novel enrichment trial design to target pulmonary vascular disease and exclude treatment-related fluid retention in patients with HF and preserved/mildly reduced left ventricular ejection fraction, macitentan neither lowered NT-proBNP nor improved HF outcomes.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03153111 and NCT03714815.

PMID:40066571 | DOI:10.1161/CIRCHEARTFAILURE.123.011381

Psychol Med. 2025 Mar 11;55:e78. doi: 10.1017/S0033291725000522.

ABSTRACT

BACKGROUND: It is unknown whether there is a general factor that accounts for the propensity for both physical and mental conditions in different age groups and how it is associated with lifestyle and well-being.

METHODS: We analyzed health conditions data from the Millennium Cohort Study (MCS) (age = 17; N = 19,239), the National Child Development Study (NCDS) (age = 44; N = 9293), and the English Longitudinal Study of Ageing (ELSA) (age ≥ 50; N = 7585). The fit of three Confirmatory Factor models was used to select the optimal solution by Comparative Fit Index, Tucker-Lewis Index, and Root Mean Square Error of Approximation. The relationship among d factor, lifestyles, and well-being was further explored.

RESULTS: Supporting the existence of the d factor, the bi-factor model showed the best model fit in 17-year-olds (MCS:CFI = 0.97, TFI = 0.96, RMSEA = 0.01), 44-year-olds (NCDS:CFI = 0.96, TFI = 0.95, RMSEA = 0.02), and 50+ year-olds (ELSA:CFI = 0.97, TFI = 0.96, RMSEA = 0.02). The d factor scores significantly correlated with lifestyle and well-being, suggesting healthier lifestyles were associated with a reduced likelihood of physical and mental health comorbidities, which in turn improved well-being.

CONCLUSIONS: Contrary to the traditional dichotomy between mental and physical conditions, our study showed a general factor underlying the comorbidity across mental and physical diseases, related to lifestyle and well-being. Our results inform the conceptualization of mental and physical illness as well as future research assessing risk and pathways of disease transmission, intervention, and prevention. Our results also provide a strong rationale for a systematic screening for mental disorders in individuals with physical conditions and vice versa, and for integrated services addressing multimorbidity.

PMID:40066566 | DOI:10.1017/S0033291725000522

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.240827.

ABSTRACT

BACKGROUND: Alloimmunization to red blood cells (RBCs) presents a significant challenge in blood transfusion for individuals afflicted with sickle cell disease (SCD) and thalassemia. However, there is a scarcity of data regarding the prevalence of RBC alloimmunization in such patients in Saudi Arabia. To address this gap, a comprehensive meta-analysis was undertaken to ascertain the rate of RBC alloimmunization in SCD and thalassemia patients who receive regular transfusions in Saudi Arabia.

METHODS: A systematic search and subsequent meta-analysis, following PRISMA guidelines, were carried out. We meticulously combed through six prominent scientific databases, including PubMed, Web of Science, SCOPUS, EMBASE, MEDLINE, and Google Scholar, up to July 20, 2023, to identify pertinent English-language articles. Data were meticulously extracted from the selected studies. The meta-analysis adopted a random-effects model and included subgroup analyses to delineate the RBC alloimmunization rates specifically for SCD and thalassemia patients receiving regular transfusions. Heterogeneity was assessed through Cochran’s Q and I2 tests. The study protocol was registered under PROSPERO, with the code CRD42023440761.

RESULTS: Our comprehensive search yielded a total of 983 articles, with 12 meeting the criteria for the final analysis, encompassing a total of 1,811 SCD and thalassemia patients. The collective RBC alloimmunization rate across all the eligible articles for patients with SCD and thalassemia who received regular transfusions in Saudi Arabia was determined to be 18.2%. Subgroup analysis, comprising nine articles, indicated that the RBC alloimmunization rate among SCD patients was 18.6%, while analysis of six articles revealed that the rate among thalassemia patients stood at 19.5%.

CONCLUSIONS: This meta-analysis underscores that the RBC alloimmunization rate in SCD and thalassemia patients who regularly receive transfusions in Saudi Arabia stands at 18.2%. Considering these findings, it is essential to prioritize extended phenotyping prior to transfusion to significantly reduce the risk of RBC alloimmunization.

PMID:40066558 | DOI:10.7754/Clin.Lab.2024.240827

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.240146.

ABSTRACT

BACKGROUND: The incidence of colorectal cancer (CRC) is rapidly increasing, and early detection plays a crucial role in improving the prognosis and survival rates of patients. This study aimed to assess the diagnostic ability of combined SDC2-KCNQ5-IKZF1 methylation levels in plasma for CRC detection.

METHODS: A total of 92 patients were recruited from the Department of General Surgery at the Second Hospital of Hebei Medical University, including 56 CRC patients, 22 polyp and adenoma patients, and 14 healthy controls. Plasma cfDNA was extracted for methylation test of SDC2, KCNQ5, and IKZF1. Sanger sequencing was conducted to verify the methylation results. The performance of single-gene methylation and triple-gene methylation combined test were analyzed. The positive detection rates of methylation and CEA test were compared to the colonoscopy gold standard. ROC curve was utilized to evaluate the diagnostic value in CRC.

RESULTS: The positive detection rates of triple-gene tests in CRC and precancerous lesions were 87.50% and 95.45%, respectively. The triple-gene test performed better than single-gene or CEA test. Combined analysis of triple-gene and CEA test could further improve the detection rate. Univariate analysis showed no statistical correlation between the methylation levels and patients’ gender, age, history of diabetes, tumor site, lymph node metastasis, and tumor stage. In ROC curve analysis, AUC areas of SDC2, KCNQ5, and IKZF1 were 0.700, 0.646, and 0.645, respectively. The AUC area of triple-gene test was 0.924.

CONCLUSIONS: The triple-gene combined methylation test demonstrated excellent diagnostic performance for CRC and precancerous lesions.

PMID:40066557 | DOI:10.7754/Clin.Lab.2024.240146

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.240726.

ABSTRACT

BACKGROUND: Calcium (CA) is crucial for a wide range of biological functions. However, the correlation between total calcium and hyperuricemia in US adults remains unclear. This study aimed to assess whether total calcium is associated with hyperuricemia.

METHODS: Based on data from the NHANES (2011 – 2018), we conducted a cross-sectional study involving 20,028 US adults aged 18 or older. Logistic regression, fitting smooth curves, and interaction effects were utilized to support the research objectives.

RESULTS: Regression analyses demonstrated a positive relation between total calcium and hyperuricemia (p < 0.001). Positive association between levels of total calcium and the risk of hyperuricemia was observed after full adjustment for all the confounding variables (odds ratio: 13.28, 95% confidence interval: 10.38 – 16.99, p < 0.001). The interaction of total calcium and hyperuricemia with age and gender was significant (p values for interaction < 0.05), while there was no interaction in other subgroups (p-values for interaction > 0.05). In addition, curve fitting after adjusting for all the confounding variables indicated a nonlinear positive correlation between total calcium and hyperuricemia (p for nonlinearity = 0.024).

CONCLUSIONS: The present cross-sectional study revealed that a nonlinear positive association existed between total calcium and hyperuricemia in US adults. The results could be beneficial for the management and treatment of hyperuricemia.

PMID:40066556 | DOI:10.7754/Clin.Lab.2024.240726

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.241015.

ABSTRACT

BACKGROUND: This study investigated the expression and clinical significance of coiled-coil domain containing 12 (CCDC12) in the initial diagnosis of acute myeloid leukemia (AML).

METHODS: A total of 80 AML patients were enrolled as the experimental group, and 20 normal bone marrow specimens were used as the control group. Clinical data of AML patients were collected. The expression level of CCDC12 was measured using real-time fluorescent quantitative PCR (QRT-PCR) in both groups. The relationship between CCDC12 expression and clinical pathological characteristics and prognosis in AML patients was analyzed. Kaplan-Meier curves were used to evaluate the effect of CCDC12 expression on overall survival (OS) in AML patients, while Cox proportional hazards regression analysis was performed to assess prognosis.

RESULTS: CCDC12 expression was significantly higher in AML patients compared to the control group (p < 0.05). Patients in the high CCDC12 expression group were older, had higher platelet counts (PLT), poorer treatment responses, and worse prognoses, with statistically significant differences (p < 0.05). The OS in the high CCDC12 expression group was significantly shorter (p < 0.05). High CCDC12 expression was identified as an independent risk factor for poor AML prognosis.

CONCLUSIONS: CCDC12 is highly expressed in AML patients. Elevated CCDC12 expression is associated with unfavorable clinical pathological characteristics and poor prognosis. This marker may provide a new approach for the diagnosis, monitoring, and targeted therapy of AML.

PMID:40066551 | DOI:10.7754/Clin.Lab.2024.241015

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.241030.

ABSTRACT

BACKGROUND: There has been a large number of immigration to Turkey after 2011, and in the past 13 years, a mixed population has been formed with both the transition to Turkish citizenship and high fertility rates. Along with numerous human migrations, gene trait transfer also occurs. This study aimed to investigate the effects of migration on blood group changes in Turkey by determining the blood group distribution of Turkish citizens living in Turkey, the blood group distribution of foreign nationals coming to Turkey, and the blood group distribution of 0-year-old babies born in the last four years.

METHODS: Patients whose blood types were checked at our hospital between 2020 and 2024 were included in the study. For each patient, age, gender, citizenship identification numbers, ABO, and Rh blood groups were obtained from medical records. These constituted the study data.

RESULTS: Blood group tests were requested for 507,959 patients in our hospital. A total of 49.8% of them were female and 50.2% were male. The mean age was 38.2 ± 19.1 years. Citizens of the Republic of Turkey constituted 92.7% of the blood groups examined, and of these, A, B, AB, and O blood groups were found to be 44.2%, 15.2%, 7.1%, and 33.6%, respectively. Out of the Rh blood groups, 87.5% were Rh positive and 12.3% were Rh negative. Foreign Turkish citizens constituted 6.5% of the examined blood groups, and A, B, AB, and O blood groups were found to be 36.7%, 20.4%, 8.0%, and 34.9%, respectively; 90.2% of Rh blood groups were Rh positive and 9.7% were Rh negative. When the blood groups of babies born between 2020 – 2024 were examined, ABO and Rh blood groups were similar to the general blood group distribution of Turkey, and there was no difference. In addition, among all blood groups, the A2 and A2B rates were found to be 0.01% and 0.005%, and the variant (weak D – Partial D) Rh blood group rate was 0.2%.

CONCLUSIONS: In this study, the blood groups of foreign nationals who migrated to Turkey and became citizens were found to be statistically, significantly different from the Turkish blood group distribution (p < 0.05). The blood group distribution of babies born in the last four years still reflected the same blood group distribution as the Turkish blood group distribution. Good blood stock management is required to avoid problems in blood supply. In Turkey, which has become a mixed population due to migration, it was thought that these results could be a guide in the supply of blood and blood products needed by patients and that they would also contribute to our country’s blood group database and world literature.

PMID:40066545 | DOI:10.7754/Clin.Lab.2024.241030

Clin Lab. 2025 Mar 1;71(3). doi: 10.7754/Clin.Lab.2024.240801.

ABSTRACT

BACKGROUND: The purpose of the study was to understand the distribution and drug resistance characteristics of Enterococcus so as to provide a reliable basis for clinical use of antibiotics and hospital infection control.

METHODS: In total, 3,455 strains of Enterococcus, isolated from January 2010 through December 2021, were col-lected. Bruker MALDI biotyper, MICROSCAN walkaway 40 analysis system, and Vitek-2 compact automatic drug sensitivity identification analyzer were used to identify the strains and to test drug sensitivity, and then the results were analyzed. Whonet 5.6 software and SPSS 20.0 were used for data analysis.

RESULTS: Among the 3,455 pathogens, the top three were Enterococcus faecium (1,819 strains, 52.65%), Enterococcus faecalis (1,310 strains, 37.92%), and Enterococcus gallinarum (1,203 strains, 3.47%). There were more strains from females (1,808 strains, 52.33%) than from males (1,647 strains, 47.67%). Furthermore, 1,446 strains (41.85%) were isolated from urine samples, and the resistance rates to vancomycin and linezolid were 15.72% and 0.58%, respectively. The resistance rates to penicillin, ampicillin, ciprofloxacin, and levofloxacin were higher than 50%.

CONCLUSIONS: Enterococcus faecium was the main pathogen of enterococcal infection. Most of them were cultured in urine. The multi-drug resistance was high. Vancomycin-resistant Enterococcus cannot be ignored. Bacterial resistance monitoring provides an important theoretical basis for clinicians to rationally use antibiotics and prevent nosocomial infection.

PMID:40066540 | DOI:10.7754/Clin.Lab.2024.240801

Clin Exp Dent Res. 2025 Feb;11(1):e70063. doi: 10.1002/cre2.70063.

ABSTRACT

BACKGROUND: As a combination of curve of Spee and curve of Wilson, the Monson sphere reflects the arrangement of teeth in three-dimensional (3D) space. For occlusal analysis, the Monson sphere can provide an important reference for prosthetic reconstructions or orthodontic treatments.

OBJECTIVES: The purpose of this study was to generate and investigate the 3-D Monson sphere through a complete digital workflow with intraoral scanning models and custom software.

MATERIAL AND METHODS: Sixty-four Chinese adults (32 males and 32 females) with individual normal occlusion were recruited, and their intraoral scanning models were obtained using a digital intraoral scanner. Twenty-six landmarks on the scanning models were digitized using a reverse engineering software. Monson’s sphere was generated and evaluated by fitting a sphere to the cusp tips using a least-squares method by means of custom software program. Mann-Whitney’s U test was performed to test the radius difference of Monson’s sphere between males and females. One-sample t-test was used to test the statistical significance (α = 0.05).

RESULTS: Monson’s sphere could be generated by means of digital scanning combined with customed software. The mean radius of Monson’s sphere was 77.35 ± 13.38 mm, which was lower than the theoretical value proposed by Monson. Furthermore, there were significant differences between males and females in Monson’s sphere radius (p < 0.001).

CONCLUSIONS: This study explores a new best-fit algorithm for generating 3-D Monson’s sphere by complete digital workflow. The radius of Monson’s sphere in Chinese adults was lower than the classical value of four-inch proposed by Monson. There was a significant difference between males and females. Monson’s sphere value found in this study could be used as a reference for prosthetic reconstruction and orthodontic treatment and be applied to improve dental treatment results.

PMID:40066508 | DOI:10.1002/cre2.70063

Clin Exp Dent Res. 2025 Feb;11(1):e70109. doi: 10.1002/cre2.70109.

ABSTRACT

OBJECTIVES: This study aimed to assess the impact of incorporating glass ionomer fillers of varying sizes on fluoride release, antiplaque properties, and the abrasive effects of toothpaste.

MATERIALS AND METHODS: In this laboratory study, three toothpaste samples containing glass ionomer filler particles (0.5, 5 µm, and a hybrid combination of equal proportions of both fillers) were tested, along with a base toothpaste without fillers or fluoride and a commercial toothpaste (Colgate Total) as controls. Fluoride release was measured using a fluoride ion-selective electrode. Antiplaque properties were assessed by evaluating the effect of toothpaste on cultured saliva in tissue culture plates, with optical density measured using an ELISA reader. Abrasive effects were analyzed by changes in enamel thickness of bovine teeth using a three-body wear test. Data were analyzed with ANOVA and Tukey’s tests in SPSS software at a 0.05 significance level.

RESULTS: Toothpaste containing 0.5 µm fillers showed the highest fluoride release, whereas the lowest release was associated with 5 µm fillers. All formulations demonstrated antiplaque activity, though differences among filler-containing toothpastes were not statistically significant (p > 0.05). Enamel abrasion differed significantly among the samples (p < 0.001), with the greatest abrasion observed for toothpaste containing 5 µm fillers and the least abrasion observed for 0.5 µm fillers.

CONCLUSIONS: Incorporating glass ionomer fillers into toothpaste formulations provides fluoride release and antiplaque effects comparable to those of commercial toothpaste. Smaller filler sizes enhance fluoride release and reduce abrasiveness, though filler size does not significantly influence antiplaque efficacy.

PMID:40066482 | DOI:10.1002/cre2.70109