Category: Statistics

Drug Metab Pers Ther. 2023 May 19. doi: 10.1515/dmpt-2023-0008. Online ahead of print.

ABSTRACT

OBJECTIVES: Development of the secondary to ACEI cough leads to discontinuation of the drugs of this group. Assessing the safety of the ACEIs with further development of customized approaches for their administration is a major scientific and practical problem. The objective of this study was to assess the association of the genetic markers with the development of the adverse drug reaction in the form of secondary to enalapril dry cough in the patients with essential arterial hypertension.

METHODS: Study involved 113 patients with the secondary to enalapril cough and 104 patients without development of the secondary to enalapril adverse drug reaction.

RESULTS: The patients carriers of the genotype AA rs2306283 of gene SLCO1B1 had 2-fold higher odds of developing the dry cough than those with the genotypes AG and GG (ОR=2.01, 95%CI=1.10-3.66, р=0.023). Similarly, the patients heterozygous for rs8176746 of gene АВО had 2.3-fold higher odds of developing the ADR in the form of dry cough than the carriers of the genotypes GG and TT (ОR=2.30, 95%CI=1.24-4.29, р=0.008).

CONCLUSIONS: Statistically significant association between the development of the ADR in the form of secondary to enalapril dry cough and polymorphisms rs2306283 of gene SLCO1B1 and rs8176746 of gene ABO was revealed.

PMID:37201212 | DOI:10.1515/dmpt-2023-0008

Eur J Cardiovasc Nurs. 2023 May 18:zvad048. doi: 10.1093/eurjcn/zvad048. Online ahead of print.

ABSTRACT

AIMS: Women are underrepresented in cardiovascular trials. We sought to explore the proportional representation of women in contemporary cardiovascular research and the factors (barriers and enablers) that affect their participation in cardiovascular studies.

METHODS AND RESULTS: Multiple electronic databases were searched between January 2011 and September 2021 to identify papers that defined underrepresentation of women in cardiovascular research and/or reported sex-based differences in participating in cardiovascular research and/or barriers for women to participate in cardiovascular research. Data extraction was undertaken independently by two authors using a standardised data collection form. Results were summarised using descriptive statistics and narrative synthesis as appropriate.From 548 identified papers, 10 papers were included. Of those, four were conducted prospectively and six were retrospective studies. Five of the retrospective studies involved secondary analysis of trial data including over 780 trials in over 1.1 million participants. Overall, women were reported to be underrepresented in heart failure, coronary disease, myocardial infarction and arrhythmia trials, compared to men. Barriers to participation included lack of information and understanding of the research, trial-related procedures, the perceived health status of the participant and patient-specific factors including travel, childcare availability and cost. A significantly higher likelihood of research participation was reported by women following a patient educational intervention.

CONCLUSIONS: This review has highlighted the underrepresentation of women in a range of cardiovascular trials. Several barriers to women’s participation in cardiovascular studies were identified. Researchers could mitigate against these in future trial planning and delivery to increase women’s participation in cardiovascular research.

REGISTRATION: The protocol was published on the public Open Science Framework (OSF) platform on 13th August 2021 (no registration reference provided) and can be accessed at https://osf.io/ny4fd/.

PMID:37201192 | DOI:10.1093/eurjcn/zvad048

Patient Prefer Adherence. 2023 May 12;17:1247-1255. doi: 10.2147/PPA.S408781. eCollection 2023.

ABSTRACT

PURPOSE: This study examined the mediating effect of medication adherence self-efficacy (MASE) on the relationship between drug attitude (DA) and medication adherence (MA) in patients with early psychosis.

PATIENTS AND METHODS: A total of 166 patients, aged 20 years or older, and who had received treatment within 5 years of their initial psychotic episode at a University Hospital outpatient center, participated in the study. Data were analyzed using descriptive statistics, t-tests, one-way analysis of variance, Pearson’s correlation coefficients, and multiple linear regression. Additionally, a bootstrapping test was conducted to determine the statistical significance of the mediating effect. All study procedures adhered to Strengthening the reporting of observational studies in epidemiology (STROBE) guidelines.

RESULTS: This study found a significant correlation between MA and DA (r=0.393, p<0.001), and between MA and MASE (r=0.697, p<0.001). MASE had a partial mediating effect on the association between DA and MA. The model that integrated both DA and MASE accounted for 53.4% of the variation in MA. Bootstrapping analysis indicated that MASE was a significant partial parameter (lower limit confidence interval [CI] 0.114; upper limit CI 0.356). Further, 64.5% of the study participants were either currently enrolled in college or had higher levels of education.

CONCLUSION: These findings could potentially lead to a more personalized approach to medication education and adherence, considering the unique DA and MASE of each patient. By identifying the mediating effect of MASE on the relationship between DA and MA, healthcare providers could tailor interventions to enhance the ability of patients with early psychosis to adhere to prescribed medication regimens.

PMID:37201154 | PMC:PMC10187643 | DOI:10.2147/PPA.S408781

Front Cell Infect Microbiol. 2023 May 2;13:1180714. doi: 10.3389/fcimb.2023.1180714. eCollection 2023.

ABSTRACT

INTRODUCTION: Intestinal colonization by Multi-Drug Resistant Organisms (MDROs) can pose a threat on the health of critically ill patients. The extent of colonization by these organisms is related to previous antibiotic treatments and their ability to cause infections among adult patients. The aim of this study is to determine the relationship between the intestinal Relative Loads (RLs) of selected antibiotic resistance genes, antibiotic consumption and extra-intestinal spread among critically ill pediatric patients.

METHODS: RLs of bla _{CTX-M-1-Family}, bla _OXA-1, bla _OXA-48 and bla _VIM were determined in 382 rectal swabs obtained from 90 pediatric critically ill patients using qPCRs. The RLs were compared to the patients’ demographics, antibiotic consumption, and detection of MDROs from extra-intestinal sites. 16SrDNA metagenomic sequencing was performed for 40 samples and clonality analyses were done for representative isolates.

RESULTS AND DISCUSSION: 76 (74.45%) patients from which 340 (89.01%) rectal swabs were collected had at least one swab that was positive for one of the tested genes. Routine cultures did not identify carbapenemases in 32 (45.1%) and 78 (58.2%) swabs that were positive by PCR for bla _OXA-48 and blaVIM, respectively. RLs of above 6.5% were associated with extra-intestinal spread of blaOXA-48-harboring MDROs. Consumption of carbapenems, non-carbapenem β-lactams, and glycopeptides were statistically associated with testing negative for bla _{CTX-M-1-Family} and bla _OXA-1 while the consumption of trimethoprim/sulfamethoxazole and aminoglycosides was associated with testing negative for blaOXA-48 (P<0.05). In conclusion, targeted qPCRs can be used to determine the extent of intestinal dominance by antibiotic resistant opportunistic pathogens and their potential to cause extra-intestinal infections among a critically ill pediatric population.

PMID:37201116 | PMC:PMC10188119 | DOI:10.3389/fcimb.2023.1180714

J Gastrointest Oncol. 2023 Apr 29;14(2):1037-1051. doi: 10.21037/jgo-23-33. Epub 2023 Apr 12.

ABSTRACT

BACKGROUND: Chemotherapy plays an important role in definitive chemoradiotherapy strategies. However, the most optimal concurrent chemotherapy scheme is still controversial. This study aimed to systematically evaluate the efficacy and toxicity of paclitaxel/docetaxel combined with platinum (PTX) and fluorouracil combined with cisplatin (PF) in the concurrent chemoradiotherapy (CCRT) of unresectable esophageal cancer.

METHODS: The PubMed, China National Knowledge Infrastructure (CNKI), Google Scholar and Embase databases were searched by combining subject words and free words through December 31, 2021. The inclusion criteria were pathologically confirmed esophageal cancer studies using CCRT, where the chemotherapy regimen only compared PTX and PF. Quality evaluation and data extraction of studies that met the inclusion criteria were carried out independently. Stata 11.1 software was used to perform the meta-analysis. The begger analysis and egger analysis were used to assess publication bias, and the robustness of the pooled results further assessed by the Trim and Fill analysis.

RESULTS: After screening, 13 randomized controlled trials (RCTs) were included. A total of 962 cases were enrolled, including 480 (49.9%) in the PTX group and 482 (50.1%) in the PF group. The gastrointestinal reaction to the PF regimen was the most serious [relative risk (RR) =0.54, 95% confidence interval (CI): 0.36-0.80, P=0.003]. The complete remission (CR) rate, objective response rate (ORR), and disease control rate (DCR) of the PTX group were higher than those of the PF group (RR =1.35, 95% CI: 1.03-1.76, P=0.030; RR =1.12, 95% CI: 1.03-1.22, P=0.006; RR =1.05, 95% CI: 1.01-1.09, P=0.022). In terms of the overall survival (OS) rate, the 2-year survival rates of the PTX group were higher than those of the PF group (P=0.005). There was no significant difference in the 1-, 3-, and 5-year survival rates between the two regimens (P=0.064, 0.144, and 0.341, respectively). There may be publication bias for ORR and DCR, and the results are reversed after applying the Trim and Fill method, so the combined results are not robust.

CONCLUSIONS: PTX may be the preferred regimen for CCRT of esophageal squamous cell carcinoma, with better short-term therapeutic effect and 2-year OS rate and lower gastrointestinal toxicity.

PMID:37201087 | PMC:PMC10186517 | DOI:10.21037/jgo-23-33

J Gastrointest Oncol. 2023 Apr 29;14(2):913-921. doi: 10.21037/jgo-23-125. Epub 2023 Apr 26.

ABSTRACT

BACKGROUND: Patients with T1 stage early colorectal cancer (CRC) can be treated with radical surgery or endoscopic surgery. Endoscopic surgery has a number of advantages, including minimal trauma and a rapid recovery. However, it cannot remove regional lymph nodes to assess whether there is lymph node metastasis. Thus, the analysis of the risk factors of lymph node metastasis in patients with T1 stage CRC is of great significance in the selection of appropriate treatment methods. Although previous studies have explored the risk factors for lymph node metastasis in T1 stage CRC patients, the number of cases were relatively insufficient, and further exploration is necessary.

METHODS: A total of 2,085 patients who had been pathologically diagnosed with CRC from 2015 to 2017 from the Surveillance, Epidemiology, and End Results (SEER) database. Among the patients, 324 had lymph node metastasis. A multivariate logistic regression analysis was conducted to analyze the risk factors of lymph node metastasis in patients with T1 stage CRC. Next, we established a prediction model to predict lymph node metastasis in patients with T1 stage CRC.

RESULTS: The results of the multivariate logistic regression analysis showed that age at diagnosis, rectosigmoid cancer, poorly differentiated or undifferentiated tumor cells, and distant metastasis were independent factors of lymph node metastasis in patients with T1 stage CRC (P<0.05). This study used the R4.0.3 statistical software for the statistical analysis. The data set was randomly divided into a training set and verification set. The training set comprised 1,460 patients, and the verification set comprised 625 patients. The area under the receiver operating characteristic curve (AUC) of the training set was 0.675 [95% confidence interval (CI): 0.635-0.714], and the AUC of the verification set was 0.682 (95% CI: 0.617-0.747). In the validation set, the model was tested by the Hosmer-Lemeshow Goodness-of-Fit Test (χ²=4.018, P=0.855), and the results showed that the model was reliable at predicting lymph node metastasis in patients with T1 stage CRC.

CONCLUSIONS: For CRC patients with high risk factors of lymph node metastasis, endoscopic physicians should carefully evaluate the advantages and disadvantages of the endoscopic surgery before deciding whether to perform this surgery.

PMID:37201073 | PMC:PMC10186551 | DOI:10.21037/jgo-23-125

J Gastrointest Oncol. 2023 Apr 29;14(2):544-553. doi: 10.21037/jgo-23-166. Epub 2023 Apr 14.

ABSTRACT

BACKGROUND: Esophageal cancer (EC) is one of the most common malignant tumor types. Surgery is considered the treatment of choice for patients with early- and mid-stage EC. However, because of the traumatic nature of EC surgery and the need for gastrointestinal reconstruction, high rates of postoperative complications such as anastomotic leakage or stenosis, esophageal reflux, and pulmonary infection exist. Its time to explore a novel esophagogastric anastomosis method for McKeown EC surgery to reduce the postoperative complication.

METHODS: This study recruited a total of 544 patients who underwent McKeown resection for EC between January 2017 and August 2020. The tubular stapler-assisted nested anastomosis was taken as the time node, including 212 patients in the traditional tubular mechanical anastomosis group and 332 patients in the tubular stapler-assisted nested anastomosis group. The 6-month postoperative incidence of anastomotic fistula and anastomotic stenosis was recorded. Anastomosis in McKeown operation for EC and the influence of different anastomosis methods on clinical efficacy were investigated.

RESULTS: Compared with traditional mechanical anastomosis, tubular stapler-assisted nested anastomosis had a lower incidence of anastomotic fistula (0% vs. 5.2%), lung infection (3.3% vs. 11.8%), gastroesophageal reflux (6.9% vs. 16.0%), anastomotic stenosis (3.0% vs. 10.4%), neck incision infection (0.9% vs. 7.1%), anastomositis (16.6% vs. 23.6%), and a shorter surgical duration (11.02±1.54 vs. 18.53±3.20 min). Statistical significance was indicated at P<0.05. No significant difference was detected in the incidence of arrhythmia, recurrent laryngeal nerve injury, or chylothorax between the 2 groups. Due to its good effect in McKeown surgery for EC, stapler-assisted nested anastomosis has been widely used in McKeown surgery for EC, and has become a common anastomosis method in our department for McKeown surgery for EC. However, large sample-sized studies and long-term efficacy observation are still needed.

CONCLUSIONS: The use of tubular stapler-assisted nested anastomosis can significantly reduce the incidence of complications such as anastomotic fistula, anastomotic stricture, gastroesophageal reflux, and pulmonary infection; therefore, it constitutes the preferred technique for cervical anastomosis in McKeown esophagogastrectomy.

PMID:37201068 | PMC:PMC10186550 | DOI:10.21037/jgo-23-166

J Gastrointest Oncol. 2023 Apr 29;14(2):572-584. doi: 10.21037/jgo-23-101. Epub 2023 Apr 24.

ABSTRACT

BACKGROUND: Esophageal cancer (EC) is the 6th leading cause of cancer-related deaths worldwide, and the morbidity and mortality of EC have continued to increase in recent years. The results of the clinical application of the Fast-track recovery surgery (FTS) concept in nursing interventions for EC patients after total endoscopic esophagectomy are unconvincing. This study sought to evaluate the nursing effect of the fast-track recovery surgical nursing model on patients with EC after total cavity endoscopic esophagectomy.

METHODS: We searched for articles on case-control trials about nursing interventions after total endoscopic esophagectomy. The search time was set from January 2010 to May 2022. The data were independently extracted by 2 researchers. RevMan5.3 statistical software (Cochrane) was used to analyze the extracted data. All the articles included in the review were assessed for risk of bias using the Cochrane Handbook 5.3 (https://training.cochrane.org/).

RESULTS: Ultimately, 8 clinical controlled trials, comprising 613 cases, were identified. A meta-analysis was conducted of the extubation times, and the results showed that the study group’s extubation times were remarkably shorter. In relation to the exhaust times, the study group had significantly shorter exhaust times than control group (P<0.05). In relation to the time, it took patients to leave bed, patients in the study group left bed in a considerably shorter time compared with controls (P<0.00001). In relation to the hospitalization time, a remarkable reduction in the length of hospital stay was observed in the study group (P<0.00001). The analysis of the funnel plots showed a small number of asymmetries, suggesting that the number of articles included was small due to the heterogeneity of the studies (P<0.00001).

CONCLUSIONS: FTS care is effective at accelerating patients’ postoperative recovery. This model of care needs to be further validated in the future by higher-quality and longer follow-up studies.

PMID:37201066 | PMC:PMC10186530 | DOI:10.21037/jgo-23-101

J Gastrointest Oncol. 2023 Apr 29;14(2):798-805. doi: 10.21037/jgo-23-134.

ABSTRACT

BACKGROUND: Frailty is closely related to cancer. Previous research has shown that cancer patients are prone to frailty, and frailty increases the risk of adverse outcomes in cancer patients. However, it is unclear whether frailty increases the risk of cancer. This 2-sample Mendelian-randomization (MR) study sought to analyze the relationship between frailty and the risk of colon cancer.

METHODS: The database was extracted from the Medical Research Council Integrative Epidemiology Unit (MRC-IEU) in 2021. The genome-wide association study (GWAS) data related to colon cancer was obtained from the GWAS website (http://gwas.mrcieu.ac.uk/datasets), involving 462,933 individuals’ gene information. Single-nucleotide polymorphisms (SNPs) were defined as the instrumental variables (IVs). The SNPs closely associated with the Frailty Index at a genome-wide significance level were selected. To further screen the IVs, we selected the confounding factors using the PhenoScanner (http://www.phenoscanner.medschl.cam.ac.uk/phenoscanner). To estimate the causal effect of the Frailty Index on colon cancer, the MR-Egger regression, weighted median (WM1), inverse-variance weighted (IVW), and weight mode (WM2) methods were applied to calculate the SNP-frailty index and the SNP-cancer estimates. Cochran’s Q statistic was used to estimate heterogeneity. The two-sample Mendelian randomization (TSMR) analysis was performed using the “TwoSampleMR” and “plyr” packages. All the statistical tests were 2-tailed, and a P value <0.05 was considered statistically significant.

RESULTS: We selected 8 SNPs as the IVs. The results of the IVW analysis [odds ratio (OR) =0.995, 95% confidence interval (CI): 0.990-1.001, P=0.052] showed that the genetic changes in the Frailty Index were not statistically associated with the risk of colon cancer, and no significant heterogeneity between these 8 genes was observed (Q =7.382, P=0.184). The MR-Egger (OR =0.987, 95% CI: 0.945-1.031, P=0.581), WM1 (OR =0.995, 95% CI: 0.990-1.001, P=0.118), WM2 (OR =0.996, 95% CI: 0.988-1.004, P=0.356), and SM (OR =0.996, 95% CI: 0.987-1.005, P=0.449) results were also consistent with each other. The sensitivity analysis based on the leave-one-out method showed that the individual SNPs did not affect the robustness of the results.

CONCLUSIONS: Frailty might have no effect on the risk of colon cancer.

PMID:37201057 | PMC:PMC10186545 | DOI:10.21037/jgo-23-134

J Gastrointest Oncol. 2023 Apr 29;14(2):806-814. doi: 10.21037/jgo-23-205.

ABSTRACT

BACKGROUND: Colorectal cancer is the most common gastrointestinal tumor. Gastrointestinal perforation is a common complication of colorectal cancer, resulting in peritonitis, abdominal abscess, and sepsis, and can eventually lead to death. The present study aimed to investigate the risk factors for sepsis in patients with colorectal cancer complicated with gastrointestinal perforation and its impact on prognosis.

METHODS: From January 2016 to December 2017, 126 patients with colorectal cancer complicated with gastrointestinal perforation admitted to the Dazu Hospital of Chongqing Medical University were retrospectively and continuously collected. The patients were divided into a sepsis group (n=56) and a control group (n=70) according to whether they developed sepsis or not. The clinical characteristics of the two groups were analyzed, and multivariate logistic regression analysis was performed to explore the risk factors of sepsis in patients with colorectal cancer complicated with gastrointestinal perforation. Finally, the impact of sepsis on the prognosis of patients was analyzed.

RESULTS: The multivariate logistic regression analysis showed that anemia, intestinal obstruction, preoperative chemotherapy, acidosis, and albumin <30 g/L were independent risk factors for sepsis in colorectal cancer patients complicated with gastrointestinal perforation (P<0.05). Albumin was valuable in predicting the absence of sepsis in colorectal cancer patients complicated with gastrointestinal perforation, and the area under the curve was 0.751 (95% confidence interval: 0.666-0.835). R4.0.3 statistical software was used to randomly divide the dataset into training and validation sets, with a sample size of 88 in the training set and 38 in the validation set. The areas under the receiver operating characteristic curves of the training and validation sets were 0.857 (95% confidence interval: 0.776-0.938) and 0.735 (95% confidence interval: 0.568-0.902), respectively. The Hosmer-Lemeshow Goodness-of-Fit Test was performed in the validation set; the chi-square value was 10.274 and the P value was 0.246, which indicated that the model had good confidence in predicting sepsis.

CONCLUSIONS: Patients with colorectal cancer complicated by gastrointestinal perforation have a high incidence of sepsis, which can lead to a poor prognosis. The model presented in this study can effectively identify patients with a high risk of sepsis.

PMID:37201047 | PMC:PMC10186544 | DOI:10.21037/jgo-23-205