Category: Statistics

Chin J Dent Res. 2021 Sep 7;24(3):185-189. doi: 10.3290/j.cjdr.b1965019.

ABSTRACT

OBJECTIVE: To evaluate the clinical performance of direct composite restorations using the modified stamp technique (MST) in vivo.

METHODS: A total of 30 posterior teeth with undermining caries were randomly divided into two groups and then restored using the MST and conventional technique (CT), respectively. 3D images of the occlusal surface were obtained using an intraoral scanner (CEREC Omnicam, Dentsply Sirona, Charlotte, NC, USA) before and after treatment and the differences between these two 3D images were analysed with reverse engineering software. Statistical analysis was performed using a one-way analysis of variance (ANOVA) combined with a least significant difference (LSD) post hoc test using SPSS 20.0 software (IBM, Armonk, NY, USA).

RESULTS: The statistical analysis revealed that the average root mean square (RMS) values of best fit alignment errors were significantly different between groups (P < 0.01). The average RMS values in the MST and CT groups were 0.0738 ± 0.0279 and 0.1638 ± 0.0682, respectively. The LSD post hoc test revealed that the value was significant smaller in the MST group than in the CT group.

CONCLUSION: The MST was effective in direct composite restoration. The morphological consistency of the occlusal surface using the MST was better than with the CT.

PMID:34491013 | DOI:10.3290/j.cjdr.b1965019

Chin J Dent Res. 2021 Sep 7;24(3):177-183. doi: 10.3290/j.cjdr.b1964993.

ABSTRACT

OBJECTIVE: To assess the prevalence, location, diameter, course and anastomosis of the lateral lingual foramina (LLF) and canals (LLCs) in a northern Chinese population using CBCT.

METHODS: CBCT images of 506 patients (181 male and 325 female, mean age 21.03 ± 8.11 years) were collected. The prevalence, location, diameter, length, angle and anastomosis of the LLF and LLCs were assessed. The measurement variables were analysed by sex and age. Statistical analysis was performed using SPSS (v. 25, IBM, Armonk, NY, USA).

RESULTS: A total of 461 LLF were detected in 307 (60.7%) subjects, 175 (57.0%) of whom had unilateral LLF and 132 (43.0%) of whom had bilateral LLF, with each lateral having one to four LLF. The majority of LLF (375/461, 81.3%) were located below the premolars, particularly the first premolar. The mean diameter of the LLF was 0.58 ± 0.20 mm. The mean vertical distance from the LLF to the inferior border and the alveolar crest was 6.68 ± 1.43 mm and 23.65 ± 2.89 mm, respectively. In total, 197 LLCs were visible in the cancellous bone and evaluated. The mean length of LLCs was 6.26 ± 1.29 mm, and the mean angle of LLCs was 140.64° ± 17.29°. The overwhelming majority (93.4%) of LLCs communicated with the mandibular incisive canal and the rest connected with the mandibular canal.

CONCLUSION: The prevalence of LLCs was high in the northern Chinese population. The presence of LLCs is a significant predictor of communication with the mandibular incisive canal.

PMID:34491012 | DOI:10.3290/j.cjdr.b1964993

Chin J Dent Res. 2021 Sep 7;24(3):159-166. doi: 10.3290/j.cjdr.b1965031.

ABSTRACT

OBJECTIVE: To evaluate adhesives’ enamel bonding performance utilising the traditional microtensile bond strength test (µTBST) and a new double-sided microtensile bond strength test (DµTBST) to assess the suitability of the latter.

METHODS: A ‘tug-of-war’ direct encounter design was employed to compare the enamel bond strengths of two universal adhesives and their different application modes simultaneously under the same tensile load applied to double-sided bonded specimens. Clearfil Universal Bond (CU; Kuraray, Kurashiki, Japan) and Scotchbond Universal Adhesive (SB; 3M ESPE, St Paul, MN, USA) were applied in self-etch (S) and etch-and-rinse (E) mode on 110 human molar samples to perform two experiments. Experiment 1 compared the enamel bond strengths of the combinations of adhesive application modes utilising µTBST. The data were analysed using a Welch analysis of variance (ANOVA), followed by a Games-Howell test. Experiment 2 employed DµTBST to determine the suitability of the new double-sided bonded assembly and ascertain which of the adhesive application mode combinations was superior. The data were analysed using a Kaplan-Meier survival analysis, followed by pairwise comparisons with a Mantel-Cox log-rank test. The level of significance was set at P ˂ 0.05.

RESULTS: The µTBST results did not show significant differences for CUE vs CUS, SBE vs SBS, CUS vs SBS and CUS vs SBE (P ˃ 0.05); however, from DµTBST, the survival distributions for the interventions were statistically significantly different (χ2(3) = 145.130, P ˂ 0.0005), indicating the superiority of universal adhesive CU over SB and application mode E over S with certainty.

CONCLUSION: DµTBST was able to add more discerning outcomes to the µTBST results, indicating that the new technique could become a valuable adjunct to the conventional method.

PMID:34491010 | DOI:10.3290/j.cjdr.b1965031

Pediatr Blood Cancer. 2021 Sep 7:e29336. doi: 10.1002/pbc.29336. Online ahead of print.

ABSTRACT

BACKGROUND: Childrenwith acute lymphoblastic leukemia (ALL) suffer a litany of chemotherapy-induced side effects. Constipation secondary to vinca alkaloids, psychological stressors, and opioid use are common issues for children newly diagnosed with leukemia. This study investigated the morbidity associated with constipation including infections, mucositis, and healthcare utilization in hospitalized children with ALL receiving induction chemotherapy.

METHODS: We analyzed data from 48 children’s hospitals in the Pediatric Health Information System, extracting patients 1-21 years of age with ALL, hospitalized for induction from October 2015 through December 2019. Data were analyzed using nonparametric statistics, and comparisons of outcomes between those with and without constipation were presented as adjusted odds ratios (aOR).

RESULTS: We identified 2586 (56%) patients with constipation out of a total of 4622 unique ALL patients in induction. Compared to patients without constipation during induction, patients with constipation were significantly more likely to have mucositis (aOR = 2.30; p = 0.0010), perirectal issues (aOR = 3.21; p = 0.0092), or abdominal radiograph exposure (aOR = 2.40; p < 0.0001). The median length of induction hospitalization was significantly greater in those with constipation compared to those without constipation (10 days vs. 8 days; p < 0.0001).

CONCLUSIONS: Children with ALL suffering from constipation during induction therapy have increased length of stay, mucositis, imaging, and overall healthcare utilization compared to children without constipation. Further research should explore the causative relationship between constipation and infections. Increased attention should be given to constipation management in patients with ALL at the start of induction therapy, particularly in patients with complications or prolonged hospitalizations.

PMID:34490990 | DOI:10.1002/pbc.29336

Birth Defects Res. 2021 Sep 7. doi: 10.1002/bdr2.1947. Online ahead of print.

ABSTRACT

BACKGROUND: Our aim was to describe the neuroimaging and clinical evaluations of children with antenatal Zika-virus (ZIKV) exposure.

METHODS: The Colombian National Institute of Health performed serial clinical evaluations of children with probable antenatal ZIKV exposure (i.e., born to ZIKV symptomatic mothers or born with birth defects compatible with ZIKV infection, regardless of laboratory results) over 2 years that included head circumference (HC), eye examination, and neurodevelopmental assessments. Clinical neuroimaging studies (head computed tomography and/or brain magnetic resonance imaging) were analyzed for abnormalities, two-dimensional measurements were made of the right and left frontal and occipital cortical thickness. Two abnormal patterns were defined: Pattern 1 (sum of four areas of cortex <6 cm) and Pattern 2 (sum of four areas of cortex ≥6 cm and < 10 cm).

RESULTS: Thirty-one children had a neuroimaging study; in 24, cortical thickness was measured. The median age at the first visit was 8 (range: 6-9) months and 22 (range: 19-42) months at the last evaluation. In the 24 cases with cortical measurements, three were normal, 12 were in Pattern 1, and nine were in Pattern 2. Children within Pattern 1 had lower mean HC at birth and in follow-up (both p < .05) and a higher frequency of structural eye abnormalities (p < .01). A trend towards poorer neuromotor development was seen in Pattern 1, although not statistically significant (p = .06).

CONCLUSION: Brain imaging classification based on cortical measurements correlate with ophthalmologic abnormalities and HC. Cortical thickness may be a marker for clinical outcomes in children with congenital ZIKV infection.

PMID:34491004 | DOI:10.1002/bdr2.1947

Risk Anal. 2021 Sep 7. doi: 10.1111/risa.13810. Online ahead of print.

ABSTRACT

Regulatory agencies are required to evaluate the impacts of thousands of chemicals. Toxicological tests currently used in such evaluations are time-consuming and resource intensive; however, advances in toxicology and related fields are providing new testing methodologies that reduce the cost and time required for testing. The selection of a preferred methodology is challenging because the new methodologies vary in duration and cost, and the data they generate vary in the level of uncertainty. This article presents a framework for performing cost-effectiveness analyses (CEAs) of toxicity tests that account for cost, duration, and uncertainty. This is achieved by using an output metric-the cost per correct regulatory decision-that reflects the three elements. The framework is demonstrated in two example CEAs, one for a simple decision of risk acceptability and a second, more complex decision, involving the selection of regulatory actions. Each example CEA evaluates five hypothetical toxicity-testing methodologies which differ with respect to cost, time, and uncertainty. The results of the examples indicate that either a fivefold reduction in cost or duration can be a larger driver of the selection of an optimal toxicity-testing methodology than a fivefold reduction in uncertainty. Uncertainty becomes of similar importance to cost and duration when decisionmakers are required to make more complex decisions that require the determination of small differences in risk predictions. The framework presented in this article may provide a useful basis for the identification of cost-effective methods for toxicity testing of large numbers of chemicals.

PMID:34490933 | DOI:10.1111/risa.13810

Stat Med. 2021 Sep 7. doi: 10.1002/sim.9177. Online ahead of print.

ABSTRACT

Dynamic treatment regimes (DTRs) include a sequence of treatment decision rules, in which treatment is adapted over time in response to the changes in an individual’s disease progression and health care history. In medical practice, nested test-and-treat strategies are common to improve cost-effectiveness. For example, for patients at risk of prostate cancer, only patients who have high prostate-specific antigen (PSA) need a biopsy, which is costly and invasive, to confirm the diagnosis and help determine the treatment if needed. A decision about treatment happens after the biopsy, and is thus nested within the decision of whether to do the test. However, current existing statistical methods are not able to accommodate such a naturally embedded property of the treatment decision within the test decision. Therefore, we developed a new statistical learning method, step-adjusted tree-based reinforcement learning, to evaluate DTRs within such a nested multistage dynamic decision framework using observational data. At each step within each stage, we combined the robust semiparametric estimation via augmented inverse probability weighting with a tree-based reinforcement learning method to deal with the counterfactual optimization. The simulation studies demonstrated robust performance of the proposed methods under different scenarios. We further applied our method to evaluate the necessity of prostate biopsy and identify the optimal test-and-treat regimes for prostate cancer patients using data from the Johns Hopkins University prostate cancer active surveillance dataset.

PMID:34490942 | DOI:10.1002/sim.9177

Pain. 2021 Sep 2. doi: 10.1097/j.pain.0000000000002470. Online ahead of print.

ABSTRACT

Patients with chronic pain syndromes, such as those with painful peripheral neuropathy due to diabetes mellitus, have limited treatment options and suffer ongoing attrition of their quality of life. Safer and more effective treatment options are needed. One therapeutic approach encompasses phenotypic characterization of the neuropathic pain subtype, combined with the selection of agents that act on relevant mechanisms. ISC 17536 is a novel, orally available inhibitor of the widely expressed pain receptor, Transient Receptor Potential Ankyrin 1 (TRPA1), which mediates nociceptive signaling in peripheral small nerve fibers (SNF). In this randomized, placebo-controlled, proof-of-concept trial, we assessed the safety and efficacy of 28 day administration of ISC 17536 in 138 patients with chronic, painful diabetic peripheral neuropathy, and utilized Quantitative Sensory Testing (QST) to characterize the baseline phenotype of patients. The primary endpoint was change from baseline to end of treatment in the mean 24-hour average pain intensity (API) score based on an 11-point pain intensity numeric rating scale (NRS). The study did not meet the primary end-point in the overall patient population. However, statistically significant and clinically meaningful improvement in pain were seen with ISC 17536 in an exploratory hypothesis generating sub-population of patients with preserved SNF function defined by QST. These results may provide a mechanistic basis for targeted therapy in specific pain phenotypes in line with current approaches of “precision medicine” or personalized pain therapeutics. The hypothesis is planned to be tested in a larger Phase 2 study.

PMID:34490850 | DOI:10.1097/j.pain.0000000000002470

Epilepsia. 2021 Sep 7. doi: 10.1111/epi.17032. Online ahead of print.

ABSTRACT

OBJECTIVE: Drug-resistant temporal lobe epilepsy (TLE) is typically associated with hippocampal pathology. However, widespread network alterations are increasingly recognized and suggested to perturb cognitive function in multiple domains. Here we tested (1) whether TLE shows atypical cortical hierarchical organization, differentiating sensory and higher order systems; and (2) whether atypical hierarchy predicts cognitive impairment.

METHODS: We studied 72 well-characterized drug-resistant TLE patients and 41 healthy controls, statistically matched for age and sex, using multimodal magnetic resonance imaging analysis and cognitive testing. To model cortical hierarchical organization in vivo, we used a bidirectional stepwise functional connectivity analysis tapping into the differentiation between sensory/unimodal and paralimbic/transmodal cortices. Linear models compared patients to controls. Finally, we assessed associations of functional anomalies to cortical atrophy and microstructural anomalies, as well as clinical and cognitive parameters.

RESULTS: Compared to controls, TLE presented with bidirectional disruptions of sensory-paralimbic functional organization. Stepwise connectivity remained segregated within paralimbic and salience networks at the top of the hierarchy, and sensorimotor and dorsal attention at the bottom. Whereas paralimbic segregation was associated with atypical cortical myeloarchitecture and hippocampal atrophy, dysconnectivity of sensorimotor cortices reflected diffuse cortical thinning. The degree of abnormal hierarchical organization in sensory-petal streams covaried, with broad cognitive impairments spanning sensorimotor, attention, fluency, and visuoconstructional ability and memory, and was more marked in patients with longer disease duration and Engel I outcome.

SIGNIFICANCE: Our findings show atypical functional integration between paralimbic/transmodal and sensory/unimodal systems in TLE. Differential associations with paralimbic microstructure and sensorimotor atrophy suggest that system-level imbalance likely reflects complementary structural processes, but ultimately accounts for a broad spectrum of cognitive impairments. Hierarchical contextualization of cognitive deficits promises to open new avenues for personalized counseling in TLE.

PMID:34490890 | DOI:10.1111/epi.17032

Immunol Invest. 2021 Sep 7:1-15. doi: 10.1080/08820139.2020.1828911. Online ahead of print.

ABSTRACT

BACKGROUND: Peritoneal fibrosis (PF) can reduce the efficiency of peritoneal dialysis and eventually lead to ultrafiltration failure. Epithelial-mesenchymal transition (EMT) of peritoneal mesothelial cells (PMCs) is the start of PF. Macrophages are involved in the process. This study was to investigate the effect of macrophage polarization on EMT of PMCs.

METHODS: Monocyte-macrophage cells (THP-1) were treated to induce macrophage subsets (M1, M2a, M2c). The inducing was assessed by detecting protein and mRNA expression of cytokines using ELISA and RT-PCR. Subsequently, PMCs were co-cultured with M1, M2a and M2c, respectively, in Transwell chambers for 48 h and then expressions of E-cadherin and α-SMA were determined in PMCs. The PMCs that were not co-cultured with macrophages served as control PMCs. One-way ANOVA and SNK-q test were used to conduct statistics and P < .05 as significant.

RESULTS: Detection of the cytokines, including IL-6, IL-10, IL-12, TGF-β1, CCL17 and CXCL13, verified that the inducting of macrophage subtypes was successful. Compared to control, E-cadherin protein expression was significantly decreased and α-SMA protein expression increased in M1-treated PMCs (P < .05); M2a-treated PMCs had an increased gene expression of α-SMA (P < .05); E-cadherin protein and gene expression were decreased and α-SMA protein and gene expression increased significantly in M2c-treated PMCs (P < .05 or P < .01).

CONCLUSIONS: EMT of PMCs is enhanced by M2c macrophage polarization; meanwhile, M1 and M2a polarization may have the effect to some extent, but not as definite as M2c.

PMID:34490837 | DOI:10.1080/08820139.2020.1828911