Category: Statistics

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2022 Mar;34(3):265-268. doi: 10.3760/cma.j.cn121430-20211022-01545.

ABSTRACT

OBJECTIVE: To investigate the effect of positive and negative pressure extubation on mechanical ventilation patients in the intensive care unit (ICU).

METHODS: A prospective randomized controlled study was performed, 105 ICU patients who successfully passed the spontaneous breathing test (SBT) after mechanical ventilation of Nanjing Jiangbei Hospital Affiliated to Nantong University from January 2019 to March 2021 were enrolled. According to random number table method, they were randomly divided into positive pressure extubation group (53 cases) and negative pressure extubation group (52 cases). During extubation, all patients were placed in semi-decubitus position (raising the head of bed at an angle range from 30 degree angle- 45 degree angle), the secretions from mouth, nose, throat and trachea were removed. In the negative pressure extubation group, the sputum suction tube was inserted into the tracheal tube and passed over the distal opening to carry out continuous negative pressure suction in the tracheal tube after disconnecting the ventilator. Meanwhile, after the tracheal tube balloon was evacuated, the sputum suction tube was pulled out together with the tracheal tube. In the positive pressure extubation group, the patients were guided to inspiratory forcibly under the original SBT mode. When the patients reached the inspiratory peak, the ballon was evacuated and the tracheal tube was removed. After extubation, all patients were given nasal catheter oxygen inhalation (oxygen flow 5 L/min). Arterial blood gas analysis indexes [pH value, arterial partial pressure of oxygen (PaO₂) and arterial partial pressure of carbon dioxide (PaCO₂)] were recorded 5 minutes and 1 hour after extubation in both groups. Vital signs (including tachypnea, tachycardia, elevated blood pressure and decreased oxygen saturation) and complications (including severe cough, airway hyperresponsiveness and pneumonia) were observed 30 minutes after extubation in both groups.

RESULTS: Five minutes after extubation, blood gas analysis showed that the PaO₂ of positive pressure extubation group was significantly higher than that of negative pressure extubation group [mmHg (1 mmHg ≈ 0.133 kPa): 123.4±30.2 vs. 111.0±21.1, P < 0.05], the pH value and PaCO₂ in positive pressure extubation group were slightly lower than that of negative pressure extubation group [pH value: 7.411±0.042 vs. 7.419±0.040, PaCO₂ (mmHg): 39.7±4.7 vs. 40.5±5.6], but the differences were not statistically significant (both P > 0.05). One hour after extubation, the pH value, PaO₂ and PaCO₂ in positive pressure extubation group were slightly lower than those in negative pressure extubation group, but the differences were not statistically significant. Within 30 minutes after extubation, the incedences of tachypnea, tachycardia, elevated blood pressure and oxygen desaturationin in positive pressure extubation group were significantly lower than those in negative pressure extubation group [tachypnea: 9.4% (5/53) vs. 28.8% (15/52), tachycardia: 15.1% (8/53) vs. 32.7% (17/52), elevated blood pressure: 11.3% (6/53) vs. 30.8% (16/52), oxygen desaturation: 7.5% (4/53) vs. 34.6% (18/52), all P < 0.05], the incidence of severe cough in positive pressure extubation group was significantly lower than that in negative pressure extubation group [9.4% (5/53) vs. 30.8% (16/52), P < 0.05], but there was no significant difference in the incidence of complications of airway hyperresponsiveness between the two groups [1.9% (1/53) vs. 5.8% (3/52), P > 0.05]. No pneumonia occurred in both groups within 48 hours after extubation.

CONCLUSIONS: The positive pressure extubation method can ensure full oxygenation of patients undergoing mechanical ventilation in ICU, avoid hypoxia, and reduce the occurrence of hypoxia and severe cough, which is more conducive to the stability of vital signs.

PMID:35574743 | DOI:10.3760/cma.j.cn121430-20211022-01545

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2022 Mar;34(3):274-279. doi: 10.3760/cma.j.cn121430-20211008-01441.

ABSTRACT

OBJECTIVE: To investigate the correlation between neutrophil/lymphocyte ratio (NLR) combined with low-density lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (LDL-C/HDL-C) and severity of coronary lesions in patients with acute coronary syndrome (ACS).

METHODS: Patients who were diagnosed with ACS due to chest pain and received emergency coronary angiography in the First Affiliated Hospital of University of Science and Technology of China and the Affiliated Hospital of Anhui Medical University from January 2017 to June 2020 were enrolled in the final analysis. The data of gender, age, body mass index (BMI), past history, emergency blood routine indicators [neutrophil (NEU), lymphocyte (LYM), monocyte (MON), eosinophil (EOS), basophil (BAS), red blood cell (RBC), mean corpuscular volume (MCV), blood red cell distribution width (RDW), mean platelet volume (MPV), platelet volume distribution width (PDW)], blood lipid index [triglyceride (TG), total cholesterol (TC), HDL-C, LDL-C, very low-density lipoprotein cholesterol (VLDL-C)], and coronary angiography were collected. The results of coronary angiography were evaluated by the Gensini score. According to the Gensini score, the patients were divided into the control group (Gensini score = 0, 55 cases) and the study group (Gensini score > 0, 889 cases), and then the patients in the study group were divided into the low-Gensini-score group (Gensini score < 66, 419 cases) and the high-Gensini-score group (Gensini score ≥ 66, 470 cases). The differences in the general baseline data of the four groups were compared, and the correlation between the statistically significant data and the Gensini score was linearly analyzed, and then the combined diagnostic factors (NLR combined with LDL-C/HDL-C ratio) were obtained by Logistic regression analysis. The receiver operator characteristic curve (ROC curve) was used to evaluate the predictive value of NLR combined with LDL-C/HDL-C ratio in predicting the severity of coronary artery lesions in patients with ACS. Finally, multivariate linear regression analysis was used to establish the predictive model between NLR combined with LDL-C/HDL-C ratio and Gensini score.

RESULTS: A total of 944 patients were finally included. The differences in gender, age, BMI, hypertension, diabetes, smoking history, NEU, LYM, MON, EOS, RDW, TC, HDL-C, LDL-C, NLR, LDL-C/HDL-C ratio between the control group and the study group were statistically significant. The differences in BMI, hypertension, diabetes, smoking history, NEU, LYM, MON, EOS, TG, TC, HDL-C, LDL-C, NLR and LDL-C/HDL-C ratio between the low-Gensini-score group and the high-Gensini-score group were statistically significant. Linear regression analysis showed that compared with other indicators, the correlation between NLR, LDL-C/HDL-C ratio and Gensini score was stronger in the study group (r values were 0.634 and 0.663, respectively, both P < 0.05). Binary Logistic regression analysis of the indicators related to Gensini score showed that NEU, LYM, HDL-C and LDL-C were independent risk factors for coronary stenosis in patients with ACS [odds ratio (OR) were 0.189, 10.309, 13.993, 0.251, 95% confidence intervals (95%CI) were 0.114-0.313, 4.679-22.714, 3.402-57.559, 0.121-0.519, respectively, all P < 0.05]. ROC curve analysis showed that NLR combined with LDL-C/HDL-C ratio had higher predictive value in predicting the severity of coronary lesions in ACS patients [area under the ROC curve (AUC) was 0.952, 95%CI was 0.93-0.969], when the cutoff value was -3.152, the sensitivity was 98.20%, and the specificity was 81.60%. According to the results of multivariate linear regression analysis, the prediction model between NLR, LDL-C/HDL-C ratio and Gensini score was established, and the formula was Gensini score = -7.772+15.675×LDL-C/HDL-C ratio+8.288×NLR (R² = 0.862).

CONCLUSIONS: There is a significant correlation between emergency NLR combined with LDL-C/HDL-C ratio and Gensini score in patients with ACS at admission, which has a certain predictive value for the severity of coronary artery stenosis in patients with ACS, and can be used as a predictor for evaluating the severity of coronary artery disease.

PMID:35574745 | DOI:10.3760/cma.j.cn121430-20211008-01441

Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2022 Mar;34(3):245-249. doi: 10.3760/cma.j.cn121430-20211019-01525.

ABSTRACT

OBJECTIVE: To investigate the clinical value of nutritional indexes including body mass index (BMI), albumin (ALB), nutrition risk screening 2002 (NRS 2002) and the nutrition risk in critically ill score (NUTRIC) in 28-day prognosis of patients with sepsis related acute kidney injury (AKI).

METHODS: A prospective cohort study was conducted. Patients with sepsis treated in the emergency intensive care unit (EICU) of China Rehabilitation Research Center from December 1, 2018 to December 1, 2020 were observed for 7 days. Patients with sepsis related AKI were enrolled in this study. The gender, age, BMI, basic diseases, shock, number of affected organs, length of hospital stay, ALB, mechanical ventilation (MV) and vasoactive drug use, sequential organ failure score (SOFA), rapid sequential organ failure score (qSOFA) and acute physiology and chronic health evaluation II (APACHE II) were recorded. The NRS 2002 score and NUTRIC score were calculated. Cox regression model was used to analyze the risk factors of 28-day mortality in patients with sepsis related AKI. The receiver operator characteristic curves (ROC curves) were drawn and the areas under the ROC curves (AUC) were calculated, and the value of BMI, ALB, NRS 2002 score and NUTRIC score was analyzed to predict 28-day mortality in patients with sepsis related AKI. Kaplan Meier survival curves were used to analyze the effects of NRS 2002 score and NUTRIC score stratification on the 28 day prognosis of patients with sepsis related AKI.

RESULTS: A total of 140 patients with sepsis related AKI were enrolled, including 73 survival patients and 67 died patients within 28 days. The 28-day mortality was 47.9% (67/140). BMI in the survival group was significantly higher than that in the death group [kg/m²: 22.0 (19.5, 25.6) vs. 20.7 (17.3, 23.9), P < 0.05], and NRS 2002 score and NUTRIC score were significantly lower than those in the death group [NRS 2002 score: 5 (4, 6) vs. 7 (6, 7), NUTRIC score: 6 (5, 7) vs. 7 (6, 9), both P < 0.05]. The ALB of the survival group was slightly higher than that of the death group, but the difference was not statistically significant. Cox regression analysis showed that NRS 2002 score and NUTRIC score were independent risk factors for 28-day death in patients with sepsis related AKI. ROC curve analysis showed that NUTRIC score had the strongest predictive ability for 28-day death [AUC = 0.785, 95% confidence interval (95%CI) was 0.708-0.850], followed by NRS 2002 score (AUC = 0.728, 95%CI was 0.647-0.800), but there was no significant difference between them. Compared with NRS 2002 score, the predictive ability of BMI and ALB was poor. Kaplan-Meier curve analysis showed that the prognosis of patients with NRS 2002 score≥5 was significantly worse than that of patients with NRS 2002 score < 5 (28-day cumulative survival rate: 42.1% vs. 75.6%, Log-Rank test: χ² = 11.884, P = 0.001), and the prognosis of patients with NUTRIC score ≥ 6 was significantly worse than that of patients with NUTRIC score < 6 (28-day cumulative survival rate: 40.4% vs. 86.1%, Log-Rank test: χ² = 19.026, P = 0.000).

CONCLUSIONS: Patients with sepsis related AKI have high nutritional risk. Both NRS 2002 score and NUTRIC score have good predictive value for the prognosis of patients with sepsis related AKI, while BMI and ALB have low predictive value. Due to the complex calculation of NUTRIC score, NRS 2002 score may be more suitable for emergency department.

PMID:35574739 | DOI:10.3760/cma.j.cn121430-20211019-01525

Stat Med. 2022 May 16. doi: 10.1002/sim.9433. Online ahead of print.

ABSTRACT

Time-varying biomarkers reflect important information on disease progression over time. Dynamic prediction for event occurrence on a real-time basis, utilizing time-varying information, is crucial in making accurate clinical decisions. Functional principal component analysis (FPCA) has been widely adopted in the literature for extracting features from time-varying biomarker trajectories. However, feature extraction via FPCA is conducted independent of the time-to-event response, which may not produce optimal results when the goal lies in prediction. With this consideration, we propose a novel supervised FPCA, where the functional principal components are determined to optimize the association between the time-varying biomarker and time-to-event outcome. The proposed framework also accommodates irregularly spaced and sparse longitudinal data. Our method is empirically shown to retain better discrimination and calibration performance than the unsupervised FPCA method in simulation studies. Application of the proposed method is also illustrated in the Alzheimer’s Disease Neuroimaging Initiative database.

PMID:35574725 | DOI:10.1002/sim.9433

Expert Opin Drug Saf. 2022 May 16. doi: 10.1080/14740338.2022.2078303. Online ahead of print.

ABSTRACT

BACKGROUND: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised concerns about its safety.

RESEARCH DESIGN AND METHODS: All the adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database were studied. A disproportionality analysis was performed to determine adverse effects reported with non-Covid and Covid patients. To explore potential drug-drug interactions, Omega (Ω) statistics was calculated.

RESULTS: More severe cases were reported when used in COVID-19. Main differences in frequency were observed in hepatobiliary, skin, gastrointestinal, eye, nervous system and heart ADRs. During the COVID-19 pandemic, high disproportionality in reports was found for Torsade de Pointes/QT prolongation with a ROR (-ROR) of 132.8 (76.7); severe hepatotoxicity, 18.7 (14.7); dyslipidaemias, 12.1 (6.1); shock, 9.5 (6.9) and ischaemic colitis, 8.9 (2.6). Myopathies, haemolytic disorders and suicidal behaviour increased their disproportionality during the pandemic. Disproportionality was observed for neoplasms, haematopoietic cytopaenias and interstitial lung disease in the pre-COVID-19 period. Potential interactions were showed between HCQ and azithromycin, ceftriaxone, lopinavir and tocilizumab.

CONCLUSIONS: The way in which HCQ has been used during the Covid-19 pandemic has resulted in a change in the profile of spontaneous reporting HCQ-related ADR in Spain. Of particular concern during the pandemic were arrhythmias, hepatotoxicity, severe skin reactions and suicide risk, but not ocular disorders. Some of the new ADRs identified will require more detailed analyses.

PMID:35574687 | DOI:10.1080/14740338.2022.2078303

Int J Neurosci. 2022 May 14:1-12. doi: 10.1080/00207454.2022.2078207. Online ahead of print.

ABSTRACT

BACKGROUND: Neurocysticercosis is a leading cause of acquired epilepsy. Calcified granulomas are known to cause seizure recurrence. Researchers have reported that vitamin D deficiency is associated with brain calcification and reduction in calcification occurs with vitamin D receptor agonist calcitriol through upregulation of SLC20A2. Based on these observations, a hypothesis was proposed that the occurrence of calcification could be reduced by optimizing vitamin D levels, resulting in early resolution of neurocysticercosis.

METHODOLOGY: A case-control (retrospective and prospective) study on 60 children with solitary intraparenchymal neurocysticercosis, 20 new cases prior to starting cysticidal therapy and other 40 resolved cases was carried out. Among new cases, children deficient in vitamin D were given megadose of vitamin D and vitamin D levels were rechecked after 30 days. Children having normal vitamin D were taken as cases and the deficient ones were taken as controls. Standard treatment for neurocysticercosis was given. Three monthly MRI scans were done. Outcome was evaluated as resolution/persistence of neurocysticercosis at 3, 6, 9 and 12 months. Statistics & Results: Pearson chisquare/Fisher’s exact test was used along with Kaplan Meier and log rank test. Of 60 patients, at 6 months 3 cases and 4 controls (p value 0.43), at 9 months 2 cases and 6 controls (p value 0.037) and at 12 months 3 cases and 6 controls (p value 0.029) had complete resolution of NCC.

CONCLUSION: The results do not show that adequate vitamin D levels result in early resolution of neurocysticercosis.

PMID:35574655 | DOI:10.1080/00207454.2022.2078207

Phytother Res. 2022 May 16. doi: 10.1002/ptr.7477. Online ahead of print.

ABSTRACT

To quantify the effects of curcumin supplementation on exercise-induced muscle damage, muscle soreness, inflammatory biomarkers, muscle strength, and joint flexibility via assessment of creatine kinase (CK), visual analogue scale (VAS) score, maximal voluntary contraction (MVC), and range of motion (ROM), respectively. Online databases, including PubMed, Google Scholar, and Scopus, were searched up to February 2021. RevMan® software (version 5.3) was used for assessing the risk of bias to assess the quality of studies. The mean differences (MD) and confidence intervals (95% CI) of CK activity (IU/L), VAS score, tumor necrosis factor (TNF-α) (pg/ml), interleukin-6 (IL-6) (pg/ml), IL-8 (pg/ml), MVC (nm) and ROM (degree) were pooled using a random- or fixed-effect model. Between-study heterogeneity was assessed using χ-square or I² statistic. Ten trials met the eligibility criteria and were included in the pooled analysis. Meta-analysis showed that curcumin supplementation significantly reduced serum CK activity [WMD = -65.98 IU/L, 95% CI (-99.53 to -32.44)], muscle soreness [WMD = -0.56, 95% CI (-0.84 to -0.27)], and TNF-α concentration [WMD = -0.22 pg/ml, 95% CI (-0.33 to -0.10)]. Also, curcumin supplementation elicited significant improvements in MVC [WMD = 3.10 nm, 95% CI (1.45-4.75)] and ROM [WMD = 6.49°, 95% CI (3.91-9.07)], although no significant changes in IL-6 and IL-8 levels were found. Dose-response analysis indicated that there is a significant non-linear association between the daily dose and the final effect size regarding TNF-α. Curcumin supplementation may improve some aspects of DOMS, including muscle damage, muscle soreness, inflammation, muscle strength, and joint flexibility. Further, well-designed and high-quality studies with larger sample sizes are needed to ascertain the long-term effects and safety of curcumin supplementation.

PMID:35574627 | DOI:10.1002/ptr.7477

J Gastrointestin Liver Dis. 2022 May 15. doi: 10.15403/jgld-4219. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Several computed tomographic (CT) imaging features have been proposed to describe the infection of postoperative abdominal fluid collections; however, these features are vague, and there is a significant overlap between infected and non-infected collections. We assessed the role of textural parameters as additional diagnostic tools for distinguishing between infected and non-infected peritoneal collections in patients operated for gastric cancer.

METHODS: From 527 patients operated for gastric cancer, we retrospectively selected 82 cases with intraperitoneal collections who underwent CT exams. The fluid component was analyzed through a novel method (texture analysis); different patterns of pixel intensity and distribution were extracted and processed through a dedicated software (MaZda). A univariate analysis comparing the parameters of texture analysis between the two groups was performed. Afterwards, a multivariate analysis was performed for the univariate statistically significant parameters.

RESULTS: The study included 82 patients with bacteriologically verified infected (n=40) and noninfected (n=42) intraperitoneal effusions. The univariate analysis evidenced statistically significant differences between all the parameters involved. The multivariate analysis highlighted 10 parameters as being statistically significant, adjusted to Bonferroni correction.

CONCLUSIONS: Our evidence supports the fact that textural analysis can be used as a complementary diagnostic tool for the detection of infected fluid collections after gastric cancer surgery. Further studies are required to validate the accuracy of this method.

PMID:35574623 | DOI:10.15403/jgld-4219

Blood Press. 2022 Dec;31(1):100-108. doi: 10.1080/08037051.2022.2071674.

ABSTRACT

PURPOSE: Out-of-office blood pressure (BP) measurements are essential for the diagnosis and monitoring of hypertension. Current guidelines vary in their recommendations on the protocol for home blood pressure monitoring (HBPM). We aimed to assess the number of blood pressure (BP) measurement days needed for a reliable estimation of true home BP (the expected BP level over time) and hypertension status, using the European guideline-based 7-day HBPM protocol as a reference.

MATERIALS AND METHODS: Data from 567 adults who performed a 7-day HBPM were analysed. Blood pressure was measured twice daily (morning and evening readings) using the Microlife Average Mode (MAM), which takes a weighted average of 3 consecutive BP readings. The variability of average BP for an increasing number of measurements was assessed using a linear mixed model including a random intercept per individual and correlated residuals. The reliability of home hypertension status was assessed by the κ statistic.

RESULTS: Mean home BP of the population was 143 ± 16/84 ± 10 mm Hg. On average, the first BP measurements gave the highest values which then decreased over time. Systolic BP in the morning was systematically lower than systolic BP in the evening (142 ± 17mm Hg versus 144 ± 17 mm Hg, p <0.05). The average of 7 twice-daily MAM BP measurements was at most 5.2/3.3 mm Hg higher and 9.5/4.8 mm Hg lower than the true home BP for 95% of the individuals. Reducing this protocol to 3 days increased this variability by 1.5/1.0 mm Hg and 4.8/2.3 mm Hg, respectively. For diagnosing home hypertension, there was good agreement with a minimum of 4.5 days of HBPM (ĸ-statistic 0.88; 95% Confidence Interval: 0.82-0.94).

CONCLUSION: Twice-daily MAM BP measurements for 3 consecutive days provide a reliable estimate of home BP. At least 4.5 consecutive days of HBPM are required for a reliable diagnosis of home hypertension.

PMID:35574599 | DOI:10.1080/08037051.2022.2071674

CPT Pharmacometrics Syst Pharmacol. 2022 May 15. doi: 10.1002/psp4.12812. Online ahead of print.

ABSTRACT

Stan is an open-source probabilistic programing language, primarily designed to do Bayesian data analysis. Its main inference algorithm is an adaptive Hamiltonian Monte Carlo sampler, supported by state of the art gradient computation. Stan’s strengths include efficient computation, an expressive language which offers a great deal of flexibility, and numerous diagnostics that allow modelers to check whether the inference is reliable. Torsten extends Stan with a suite of functions that facilitate the specification of pharmacokinetic and pharmacodynamic models, and makes it straightforward to specify a clinical event schedule. Part I of this tutorial demonstrates how to build, fit, and criticize standard pharmacokinetic and pharmacodynamic models using Stan and Torsten.

PMID:35570331 | DOI:10.1002/psp4.12812