Category: Statistics

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

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

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

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

Clin Exp Dent Res. 2022 May 15. doi: 10.1002/cre2.592. Online ahead of print.

ABSTRACT

OBJECTIVES: Evidence on the biocompatibility of three-dimensional (3D)-printed and milled resins for oral splints is limited. This in vitro study assessed the influence of the manufacturing method on the cytotoxicity of oral splint resins on L929 cells and human gingival fibroblasts (GF1).

MATERIALS AND METHODS: Standardized specimens of four 3D-printed, two-milled, one-thermoformed, and one-pressed splint resin were incubated with L929 and GF1 cells for 24 h. Immunofluorescence and WST-8 assay were performed to evaluate cytotoxic effects. One-way analysis of variance and Tukey’s multiple comparison test were applied with the variables “splint resin” and “manufacturing method” (p < .05).

RESULTS: Immunofluorescence showed attachment of L929 and GF1 cells to the splint resins. Irrespective of the manufacturing method, the WST-8 assay revealed significant differences between splint resins for the viability of L929 and GF1 cells. L929 cells generally showed lower viability rates than GF1 cells. The evaluation of cell viability by the manufacturing method showed no significant differences between 3D printing, milling, and conventional methods.

CONCLUSIONS: The cytotoxic effects of 3D-printed, milled, and conventional oral splint resins were similar, indicating minor influence of the manufacturing method on biocompatibility. Cytotoxicity of the resins was below a critical threshold in GF1 cells. The chemical composition might be more crucial than the manufacturing method for the biocompatibility of splint resins.

PMID:35570327 | DOI:10.1002/cre2.592

BMC Res Notes. 2022 May 15;15(1):178. doi: 10.1186/s13104-022-06067-3.

ABSTRACT

OBJECTIVE: The relationship of sagittal spinal shape in the pathogenesis of adolescent idiopathic scoliosis (AIS) is recognised. What is not clear is the relationship between the sagittal shape of those without scoliosis and the potential development of AIS, including the greater prevalence in females. The use of a new parameter, the kyphosis-lordosis (KL) difference, was developed to explore this further.

RESULTS: The KL difference was calculated for 117 males and 79 females over seven years with 831 measures made. For females, the KL difference, between the ages of 9 and 12 ½ years, decreases from 5° to nearly 0° until starting to climb again from the age of 14 years, back to 5° by the age of 16 ½ years. For males, there is a gradual decline from 9° at age 9 years to 5° at age 17 years. Both age and sex were statistically significant in the development of the parameter. When comparing to previously published data around the true, de-rotated, sagittal shape of the scoliotic spine, the KL difference has utility in explaining the female predominance in the prevalence of AIS. This adds to the weight of evidence behind understanding why AIS develops.

PMID:35570316 | DOI:10.1186/s13104-022-06067-3